text:
ketek (telithromycin) tablet, film coated
[Sanofi-Aventis U.S. LLC]
Ketek is contraindicated in patients with myasthenia gravis. There have been reports of fatal and life-threatening respiratory failure in patients with myasthenia gravis associated with the use of Ketek. (See CONTRAINDICATIONS.)
To reduce the development of drug-resistant bacteria and maintain the effectiveness of KETEK and other antibacterial drugs, KETEK should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.
KETEK® tablets contain telithromycin, a semisynthetic antibacterial in the ketolide class for oral administration. Chemically, telithromycin is designated as Erythromycin, 3-de[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-11,12-dideoxy-6-O-methyl-3-oxo-12,11-[oxycarbonyl[[4-[4-(3-pyridinyl)-1H-imidazol-1-yl]butyl]imino]]-.
Telithromycin, a ketolide, differs chemically from the macrolide group of antibacterials by the lack of α-L-cladinose at position 3 of the erythronolide A ring, resulting in a 3-keto function. It is further characterized by a C11-12 carbamate substituted by an imidazolyl and pyridyl ring through a butyl chain. Its empirical formula is C43H65N5O10 and its molecular weight is 812.03. Telithromycin is a white to off-white crystalline powder. The following represents the chemical structure of telithromycin.
KETEK tablets are available as light-orange, oval, film-coated tablets, each containing 400 mg or 300 mg of telithromycin, and the following inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, red ferric oxide, talc, titanium dioxide, and yellow ferric oxide.
Following oral administration, telithromycin reached maximal concentration at about 1 hour (0.5 – 4 hours).
It has an absolute bioavailability of 57% in both young and elderly subjects.
The rate and extent of absorption are unaffected by food intake, thus KETEK tablets can be given without regard to food.
In healthy adult subjects, peak plasma telithromycin concentrations of approximately 2 µg/mL are attained at a median of 1 hour after an 800-mg oral dose.
Steady-state plasma concentrations are reached within 2 to 3 days of once daily dosing with telithromycin 800 mg.
Following oral dosing, the mean terminal elimination half-life of telithromycin is 10 hours.
The pharmacokinetics of telithromycin after administration of single and multiple (7 days) once daily 800-mg doses to healthy adult subjects are shown in Table 1.
|Mean (SD)
|Single dose (n=18)
|Multiple dose (n=18)
|SD=Standard deviation
|Cmax=Maximum plasma concentration
|Tmax=Time to Cmax
|AUC=Area under concentration vs. time curve
|t1/2=Terminal plasma half-life
|C24h=Plasma concentration at 24 hours post-dose
|Cmax (µg/mL)
|1.9 (0.80)
|2.27 (0.71)
|Tmax (h)*
|1.0 (0.5–4.0)
|1.0 (0.5–3.0)
|AUC(0–24) (µg∙h/mL)
|8.25 (2.6)
|12.5 (5.4)
|Terminal t1/2 (h)
|7.16 (1.3)
|9.81 (1.9)
|C24h (µg/mL)
|0.03 (0.013)
|0.07 (0.051)
In a patient population, mean peak and trough plasma concentrations were 2.9 µg/mL (±1.55), (n=219) and 0.2 µg/mL (±0.22), (n=204), respectively, after 3 to 5 days of KETEK 800 mg once daily.
Total in vitro protein binding is approximately 60% to 70% and is primarily due to human serum albumin.
Protein binding is not modified in elderly subjects and in patients with hepatic impairment.
The volume of distribution of telithromycin after intravenous infusion is 2.9 L/kg.
Telithromycin concentrations in bronchial mucosa, epithelial lining fluid, and alveolar macrophages after 800 mg once daily dosing for 5 days in patients are displayed in Table 2.
| Hours
|Mean concentration (µg/mL)
|Tissue/Plasma Ratio
|Tissue or
|Bronchial mucosa
|Epithelial lining fluid
|Alveolar macrophages
Telithromycin concentration in white blood cells exceeds the concentration in plasma and is eliminated more slowly from white blood cells than from plasma. Mean white blood cell concentrations of telithromycin peaked at 72.1µg/mL at 6 hours, and remained at 14.1 µg/mL 24 hours after 5 days of repeated dosing of 600 mg once daily. After 10 days, repeated dosing of 600 mg once daily, white blood cell concentrations remained at 8.9 µg/mL 48 hours after the last dose.
In total, metabolism accounts for approximately 70% of the dose. In plasma, the main circulating compound after administration of an 800-mg radiolabeled dose was parent compound, representing 56.7% of the total radioactivity. The main metabolite represented 12.6% of the AUC of telithromycin. Three other plasma metabolites were quantified, each representing 3% or less of the AUC of telithromycin.
It is estimated that approximately 50% of its metabolism is mediated by CYP 450 3A4 and the remaining 50% is CYP 450-independent.
The systemically available telithromycin is eliminated by multiple pathways as follows: 7% of the dose is excreted unchanged in feces by biliary and/or intestinal secretion; 13% of the dose is excreted unchanged in urine by renal excretion; and 37% of the dose is metabolized by the liver.
There was no significant difference between males and females in mean AUC, Cmax, and elimination half-life in two studies; one in 18 healthy young volunteers (18 to 40 years of age) and the other in 14 healthy elderly volunteers (65 to 92 years of age), given single and multiple once daily doses of 800 mg of KETEK.
In a single-dose study (800 mg) in 12 patients and a multiple-dose study (800 mg) in 13 patients with mild to severe hepatic insufficiency (Child Pugh Class A, B and C), the Cmax, AUC and t1/2 of telithromycin were similar to those obtained in age- and sex-matched healthy subjects. In both studies, an increase in renal elimination was observed in hepatically impaired patients indicating that this pathway may compensate for some of the decrease in metabolic clearance. No dosage adjustment is recommended due to hepatic impairment. (See PRECAUTIONS, General and DOSAGE AND ADMINISTRATION.)
In a multiple-dose study, 36 subjects with varying degrees of renal impairment received 400 mg, 600 mg, or 800 mg KETEK once daily for 5 days. There was a 1.4-fold increase in Cmax,ss, and a 1.9-fold increase in AUC (0–24)ss at 800 mg multiple doses in the severely renally impaired group (CLCR< 30 mL/min) compared to healthy volunteers. Renal excretion may serve as a compensatory elimination pathway for telithromycin in situations where metabolic clearance is impaired. Patients with severe renal impairment are prone to conditions that may impair their metabolic clearance. Therefore, in the presence of severe renal impairment (CLCR< 30 mL/min), a reduced dosage of KETEK is recommended. (See DOSAGE AND ADMINISTRATION.)
In a single-dose study in patients with end-stage renal failure on hemodialysis (n=10), the mean Cmax and AUC values were similar to normal healthy subjects when KETEK was administered 2 hours post-dialysis. However, the effect of dialysis on removing telithromycin from the body has not been studied.
The effects of co-administration of ketoconazole in 12 subjects (age ≥ 60 years), with impaired renal function were studied (CLCR= 24 to 80 mL/min). In this study, when severe renal insufficiency(CLCR< 30 mL/min, n=2) and concomitant impairment of CYP 3A4 metabolism pathway were present, telithromycin exposure (AUC (0–24)) was increased by approximately 4- to 5-fold compared with the exposure in healthy subjects with normal renal function receiving telithromycin alone. In the presence of severe renal impairment (CLCR< 30 mL/min), with coexisting hepatic impairment, a reduced dosage of KETEK is recommended. (See PRECAUTIONS, General and DOSAGE AND ADMINISTRATION.)
Pharmacokinetic data show that there is an increase of 1.4-fold in exposure (AUC) in 20 patients ≥ 65 years of age with community acquired pneumonia in a Phase III study, and a 2.0-fold increase in exposure (AUC) in 14 subjects ≥ 65 years of age as compared with subjects less than 65 years of age in a Phase I study. No dosage adjustment is required based on age alone.
Studies were performed to evaluate the effect of CYP 3A4 inhibitors on telithromycin and the effect of telithromycin on drugs that are substrates of CYP 3A4 and CYP 2D6. In addition, drug interaction studies were conducted with several other concomitantly prescribed drugs.
A multiple-dose interaction study with itraconazole showed that Cmax of telithromycin was increased by 22% and AUC by 54%.
A multiple-dose interaction study with ketoconazole showed that Cmax of telithromycin was increased by 51% and AUC by 95%.
When telithromycin was given with 240 mL of grapefruit juice after an overnight fast to healthy subjects, the pharmacokinetics of telithromycin were not affected.
Steady-state peak plasma concentrations of cisapride (an agent with the potential to increase QT interval) were increased by 95% when co-administered with repeated doses of telithromycin, resulting in significant increases in QTc. (See CONTRAINDICATIONS.)
When simvastatin was co-administered with telithromycin, there was a 5.3-fold increase in simvastatin Cmax, an 8.9-fold increase in simvastatin AUC, a 15-fold increase in the simvastatin active metabolite Cmax, and a 12-fold increase in the simvastatin active metabolite AUC. (See PRECAUTIONS.)
In another study, when simvastatin and telithromycin were administered 12 hours apart, there was a 3.4-fold increase in simvastatin Cmax, a 4.0-fold increase in simvastatin AUC, a 3.2-fold increase in the active metabolite Cmax, and a 4.3-fold increase in the active metabolite AUC. (See PRECAUTIONS.)
Concomitant administration of telithromycin with intravenous or oral midazolam resulted in 2- and 6-fold increases, respectively, in the AUC of midazolam due to inhibition of CYP 3A4-dependent metabolism of midazolam. (See PRECAUTIONS.)
There was no pharmacokinetic effect on paroxetine when telithromycin was co-administered.
When metoprolol was co-administered with telithromycin, there was an increase of approximately 38% on the Cmax and AUC of metoprolol, however, there was no effect on the elimination half-life of metoprolol. Telithromycin exposure is not modified with concomitant single-dose administration of metoprolol. (See PRECAUTIONS, Drug interactions.)
The plasma peak and trough levels of digoxin were increased by 73% and 21%, respectively, in healthy volunteers when co-administered with telithromycin. However, trough plasma concentrations of digoxin (when equilibrium between plasma and tissue concentrations has been achieved) ranged from 0.74 to 2.17 ng/mL. There were no significant changes in ECG parameters and no signs of digoxin toxicity. (See PRECAUTIONS.)
When theophylline was co-administered with repeated doses of telithromycin, there was an increase of approximately 16% and 17% on the steady-state Cmax and AUC of theophylline. Co-administration of theophylline may worsen gastrointestinal side effects such as nausea and vomiting, especially in female patients. It is recommended that telithromycin should be taken with theophylline 1 hour apart to decrease the likelihood of gastrointestinal side effects.
Telithromycin has been shown to decrease the Cmax and AUC of sotalol by 34% and 20%, respectively, due to decreased absorption.
When co-administered with telithromycin in healthy subjects, there were no pharmacodynamic or pharmacokinetic effects on racemic warfarin.
When oral contraceptives containing ethinyl estradiol and levonorgestrel were co-administered with telithromycin, the steady-state AUC of ethinyl estradiol did not change and the steady-state AUC of levonorgestrel was increased by 50%. The pharmacokinetic/pharmacodynamic study showed that telithromycin did not interfere with the antiovulatory effect of oral contraceptives containing ethinyl estradiol and levonorgestrel.
There was no clinically relevant pharmacokinetic interaction of ranitidine or antacids containing aluminum and magnesium hydroxide on telithromycin.
During concomitant administration of rifampin and KETEK in repeated doses, Cmax and AUC of telithromycin were decreased by 79%, and 86%, respectively. (See PRECAUTIONS, Drug Interactions.)
Telithromycin belongs to the ketolide class of antibacterials and is structurally related to the macrolide family of antibiotics. Telithromycin concentrates in phagocytes where it exhibits activity against intracellular respiratory pathogens. In vitro, telithromycin has been shown to demonstrate concentration-dependent bactericidal activity against isolates of Streptococcus pneumoniae (including multi-drug resistant isolates [MDRSP*]).
*MDRSP=Multi-drug resistant Streptococcus pneumoniae includes isolates known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are isolates resistant to two or more of the following antimicrobials: penicillin, 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.
Telithromycin blocks protein synthesis by binding to domains II and V of 23S rRNA of the 50S ribosomal subunit. By binding at domain II, telithromycin retains activity against gram-positive cocci (e.g., Streptococcus pneumoniae) in the presence of resistance mediated by methylases (erm genes) that alter the domain V binding site of telithromycin. Telithromycin may also inhibit the assembly of nascent ribosomal units.
Staphylococcus aureus and Streptococcus pyogenes with the constitutive macrolide-lincosamide-streptogramin B (cMLSB) phenotype are resistant to telithromycin.
Mutants of Streptococcus pneumoniae derived in the laboratory by serial passage in subinhibitory concentrations of telithromycin have demonstrated resistance based on L22 riboprotein mutations (telithromycin MICs are elevated but still within the susceptible range), one of two reported mutations affecting the L4 riboprotein, and production of K-peptide. The clinical significance of these laboratory mutants is not known.
Telithromycin does not induce resistance through methylase gene expression in erythromycin-inducibly resistant bacteria, a function of its 3-keto moiety. Telithromycin has not been shown to induce resistance to itself.
Telithromycin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical settings as described in the INDICATIONS AND USAGE section.
Aerobic gram-positive microorganisms
*MDRSP=Multi-drug resistant Streptococcus pneumoniae includes isolates known as PRSP (penicillin-resistant S. pneumoniae), and are isolates resistant to two or more of the following antimicrobials: penicillin, 2nd generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and trimethoprim/sulfamethoxazole.
Aerobic gram-negative microorganisms
Other microorganisms
The following in vitro data are available, but their clinical significance is unknown.
At least 90% of the following microorganisms exhibit in vitro minimum inhibitory concentrations (MICs) less than or equal to the susceptible breakpoint for telithromycin. However, the safety and efficacy of telithromycin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials.
Aerobic gram-positive microorganisms
Other microorganisms
When available, the clinical microbiology laboratory should provide cumulative results of in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting the most effective antimicrobial.
Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MICs provide estimates of the susceptibility of bacteria to antibacterial compounds. The MICs should be determined using a standardized procedure. Standardized procedures are based on dilution methods (broth or agar dilution)1,3 or equivalent with standardized inoculum and concentrations of telithromycin powder. The MIC values should be interpreted according to criteria provided in Table 3.
Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antibiotics. One such standardized procedure2,3 requires the use of standardized inoculum concentrations. This procedure uses paper disks impregnated with 15 µg telithromycin to test the susceptibility of microorganisms to telithromycin. Disc diffusion zone sizes should be interpreted according to criteria in Table 3.
|Minimal Inhibitory Concentrations
|Disk Diffusion
(zone diameters in mm)
|≤ 1
|≥ 4
|≥ 19
|≤ 15
|≤ 4
|≥ 16
|≥ 15
|≤ 11
A report of "Susceptible" indicates that the antimicrobial is likely to inhibit growth of the pathogen if the antibacterial compound in the blood reaches the concentrations usually achievable. A report of "Intermediate" indicates that the result should be considered equivocal, and, if the microorganism is not fully susceptible to alternative, clinically feasible drugs, the test should be repeated. This category implies possible clinical applicability in body sites where the drug is physiologically concentrated or in situations where high dosage of drug can be used. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that the antimicrobial is not likely to inhibit growth of the pathogen if the antimicrobial compound in the blood reaches the concentrations usually achievable; other therapy should be selected.
Standardized susceptibility test procedures require the use of quality control microorganisms to determine the performance of the test procedures1,2,3. Standard telithromycin powder should provide the MIC ranges for the quality control organisms in Table 4. For the disk diffusion technique, the 15-µg telithromycin disk should provide the zone diameter ranges for the quality control organisms in Table 4.
|QC Strain
|Minimum Inhibitory Concentrations
|Disk Diffusion
(Zone diameter in mm)
|ATCC = American Type Culture Collection
Streptococcus pneumoniae
Haemophilus influenzae
KETEK tablets are indicated for the treatment of community-acquired pneumonia (of mild to moderate severity) due to Streptococcus pneumoniae, (including multi-drug resistant isolates [MDRSP*]), Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae, for patients 18 years old and above.
*MDRSP, Multi-drug resistant Streptococcus pneumoniae includes isolates known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are isolates resistant to two or more of the following antibiotics: penicillin, 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of KETEK and other antibacterial drugs, KETEK should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
KETEK is contraindicated in patients with myasthenia gravis. Exacerbations of myasthenia gravis have been reported in patients and sometimes occurred within a few hours of the first dose of telithromycin. Reports have included fatal and life-threatening acute respiratory failure with a rapid onset and progression.
KETEK is contraindicated in patients with previous history of hepatitis and/or jaundice associated with the use of KETEK tablets, or any macrolide antibiotic.
KETEK is contraindicated in patients with a history of hypersensitivity to telithromycin and/or any components of KETEK tablets, or any macrolide antibiotic.
Concomitant administration of KETEK with cisapride or pimozide is contraindicated. (See CLINICAL PHARMACOLOGY, Drug-drug Interactions and PRECAUTIONS.)
Acute hepatic failure and severe liver injury, in some cases fatal, have been reported in patients treated with KETEK. These hepatic reactions included fulminant hepatitis and hepatic necrosis leading to liver transplant, and were observed during or immediately after treatment. In some of these cases, liver injury progressed rapidly and occurred after administration of a few doses of KETEK. (See ADVERSE REACTIONS.) Physicians and patients should monitor for the appearance of signs or symptoms of hepatitis, such as fatigue, malaise, anorexia, nausea, jaundice, bilirubinuria, acholic stools, liver tenderness or hepatomegaly. Patients with signs or symptoms of hepatitis mustbe advised to discontinue KETEK and immediately seek medical evaluation, which should include liver function tests. (See ADVERSE REACTIONS, PRECAUTIONS, Information to Patients.) If clinical hepatitis or transaminase elevations combined with other systemic symptoms occur, KETEK should be permanently discontinued.
Ketek must not be re-administered to patients with a previous history of hepatitis and/or jaundice associated with the use of KETEK tablets, or any macrolide antibiotic. (See CONTRAINDICATIONS.)
In addition, less severe hepatic dysfunction associated with increased liver enzymes, hepatitis and in some cases jaundice was reported with the use of KETEK. These events associated with less severe forms of liver toxicity were reversible.
Telithromycin has the potential to prolong the QTc interval of the electrocardiogram in some patients. QTc prolongation may lead to an increased risk for ventricular arrhythmias, including torsades de pointes. Thus, telithromycin should be avoided in patients with congenital prolongation of the QTc interval, and in patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (e.g., quinidine and procainamide) or Class III (e.g., dofetilide) antiarrhythmic agents.
Cases of torsades de pointes have been reported post-marketing with KETEK. In clinical trials, no cardiovascular morbidity or mortality attributable to QTc prolongation occurred with telithromycin treatment in 4780 patients in clinical trials, including 204 patients having a prolonged QTc at baseline.
KETEK may cause visual disturbances particularly in slowing the ability to accommodate and the ability to release accommodation. Visual disturbances included blurred vision, difficulty focusing, and diplopia. Most events were mild to moderate; however, severe cases have been reported.
There have been post-marketing adverse event reports of transient loss of consciousness including some cases associated with vagal syndrome.
*Because of potential visual difficulties or loss of consciousness, patients should attempt to minimize activities such as driving a motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment with KETEK. If patients experience visual disorders or loss of consciousness while taking KETEK, patients should not drive a motor vehicle, operate heavy machinery or engage in other hazardous activities. (See PRECAUTIONS, Information for Patients. )
Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including KETEK, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.
C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C difficile, and surgical evaluation should be instituted as clinically indicated.
Prescribing KETEK in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.
Telithromycin is principally excreted via the liver and kidney. Telithromycin may be administered without dosage adjustment in the presence of hepatic impairment. In the presence of severe renal impairment (CLCR< 30 mL/min), a reduced dosage of KETEK is recommended. (See DOSAGE AND ADMINISTRATION.)
A Medication Guide is provided to patients when Ketek is dispensed. Patients should be instructed to read the MedGuide when Ketek is received. In addition, the complete text of the MedGuide is reprinted at the end of this document.
The following information and instructions should be communicated to the patient.
Patients should be advised that avoiding quick changes in viewing between objects in the distance and objects nearby may help to decrease the effects of these visual difficulties.
If patients experience visual difficulties or loss of consciousness/ fainting
Patients should also be advised:
Telithromycin is a strong inhibitor of the cytochrome P450 3A4 system. Co-administration of KETEK tablets and a drug primarily metabolized by the cytochrome P450 3A4 enzyme system may result in increased plasma concentration of the drug co-administered with telithromycin that could increase or prolong both the therapeutic and adverse effects. Therefore, appropriate dosage adjustments may be necessary for the drug co-administered with telithromycin.
The use of KETEK is contraindicated with cisapride. (See CONTRAINDICATIONS and CLINICAL PHARMACOLOGY, Drug-drug interactions.)
The use of KETEK is contraindicated with pimozide. Although there are no studies looking at the interaction between KETEK and pimozide, there is a potential risk of increased pimozide plasma levels by inhibition of CYP 3A4 pathways by KETEK as with macrolides. (See CONTRAINDICATIONS.)
In a pharmacokinetic study, simvastatin levels were increased due to CYP 3A4 inhibition by telithromycin. (See CLINICAL PHARMACOLOGY, Other drug interactions.) Similarly, an interaction may occur with lovastatin or atorvastatin, but not with pravastatin or fluvastatin. High levels of HMG-CoA reductase inhibitors increase the risk of myopathy. Use of simvastatin, lovastatin, or atorvastatin concomitantly with KETEK should be avoided. If KETEK is prescribed, therapy with simvastatin, lovastatin, or atorvastatin should be suspended during the course of treatment.
Monitoring of digoxin side effects or serum levels should be considered during concomitant administration of digoxin and KETEK. (See CLINICAL PHARMACOLOGY, Drug-drug interactions.)
Patients should be monitored with concomitant administration of midazolam and dosage adjustment of midazolam should be considered if necessary. Precaution should be used with other benzodiazepines, which are metabolized by CYP 3A4 and undergo a high first-pass effect (e.g., triazolam). (See CLINICAL PHARMACOLOGY, Drug-drug interactions.)
Concomitant treatment of KETEK with rifampin, a CYP 3A4 inducer, should be avoided. Concomitant administration of other CYP 3A4 inducers such as phenytoin, carbamazepine, or phenobarbital is likely to result in subtherapeutic levels of telithromycin and loss of effect. (See CLINICAL PHARMACOLOGY, Other drug interactions.)
In patients treated with metoprolol for heart failure, the increased exposure to metoprolol, a CYP 2D6 substrate, may be of clinical importance. Therefore, co-administration of KETEK and metoprolol in patients with heart failure should be considered with caution. (See CLINICAL PHARMACOLOGY, Drug-drug interactions.)
Spontaneous post-marketing reports suggest that administration of KETEK and oral anticoagulants concomitantly may potentiate the effectsof the oral anticoagulants. Consideration should be given to monitoring prothrombin times/INR while patients are receiving KETEK and oral anticoagulants simultaneously.
No specific drug interaction studies have been performed to evaluate the following potential drug-drug interactions with KETEK. However, these drug interactions have been observed with macrolide products.
Drugs metabolized by the cytochrome P450 system such as carbamazepine, cyclosporine, tacrolimus, sirolimus, hexobarbital, and phenytoin: elevation of serum levels of these drugs may be observed when co-administered with telithromycin. As a result, increases or prolongation of the therapeutic and/or adverse effects of the concomitant drug may be observed.
Ergot alkaloid derivatives (such as ergotamine or dihydroergotamine): acute ergot toxicity characterized by severe peripheral vasospasm and dysesthesia has been reported when macrolide antibiotics were co-administered. Without further data, the co-administration of KETEK and these drugs is not recommended.
There are no reported laboratory test interactions.
Long-term studies in animals to determine the carcinogenic potential of KETEK have not been conducted.
Telithromycin showed no evidence of genotoxicity in four tests: gene mutation in bacterial cells, gene mutation in mammalian cells, chromosome aberration in human lymphocytes, and the micronucleus test in the mouse.
No evidence of impaired fertility in the rat was observed at doses estimated to be 0.61 times the human daily dose on a mg/m2 basis. At doses of 1.8–3.6 times the human daily dose, at which signs of parental toxicity were observed, moderate reductions in fertility indices were noted in male and female animals treated with telithromycin.
Pregnancy Category C.
Telithromycin was not teratogenic in the rat or rabbit. Reproduction studies have been performed in rats and rabbits, with effect on pre-post natal development studied in the rat. At doses estimated to be 1.8 times (900 mg/m2) and 0.49 times (240 mg/m2) the daily human dose of 800 mg (492 mg/m2) in the rat and rabbit, respectively, no evidence of fetal terata was found. At doses higher than the 900 mg/m2 and 240 mg/m2 in rats and rabbits, respectively, maternal toxicity may have resulted in delayed fetal maturation. No adverse effects on prenatal and postnatal development of rat pups were observed at 1.5 times (750 mg/m2/d) the daily human dose.
There are no adequate and well-controlled studies in pregnant women. Telithromycin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Telithromycin is excreted in breast milk of rats. Telithromycin may also be excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when KETEK is administered to a nursing mother.
The safety and effectiveness of KETEK in pediatric patients has not been established.
In all Phase III clinical trials (n=4,780), KETEK was administered to 694 patients who were 65 years and older, including 231 patients who were 75 years and older. Efficacy and safety in elderly patients ≥ 65 years were generally similar to that observed in younger patients; however, greater sensitivity of some older individuals cannot be ruled out. No dosage adjustment is required based on age alone. (See CLINICAL PHARMACOLOGY, Special populations, Geriatric and DOSAGE AND ADMINISTRATION.)
In Phase III clinical trials, 4,780 patients (n=2702 in controlled trials) received daily oral doses of KETEK 800 mg once daily for 5 days or 7 to 10 days. Most adverse events were mild to moderate in severity. In the combined Phase III studies, discontinuation due to treatment-emergent adverse events occurred in 4.4% of KETEK-treated patients and 4.3% of combined comparator-treated patients. Most discontinuations in the KETEK group were due to treatment-emergent adverse events in the gastrointestinal body system, primarily diarrhea (0.9% for KETEK vs. 0.7% for comparators), nausea (0.7% for KETEK vs. 0.5% for comparators).
All and possibly related treatment-emergent adverse events (TEAEs) occurring in controlled clinical studies in ≥ 2.0% of all patients are included below:
|All and Possibly Related Treatment-Emergent Adverse Events Reported in Controlled Phase III Clinical Studies (Percent Incidence)
|Adverse Event*
|All TEAEs
|Possibly-Related TEAEs
|Dizziness (excl. vertigo)
|Loose Stools
The following events judged by investigators to be at least possibly drug related were observed infrequently (≥ 0.2% and < 2%), in KETEK-treated patients in the controlled Phase III studies.
Gastrointestinal system: abdominal distension, dyspepsia, gastrointestinal upset, flatulence, constipation, gastroenteritis, gastritis, anorexia, oral candidiasis, glossitis, stomatitis, watery stools.
Liver and biliary system: abnormal liver function tests: increased transaminases, increased liver enzymes (e.g., ALT, AST) were usually asymptomatic and reversible. ALT elevations above 3 times the upper limit of normal were observed in 1.6%, and 1.7% of patients treated with KETEK and comparators, respectively. Hepatitis, with or without jaundice, occurred in 0.07% of patients treated with KETEK, and was reversible. (See PRECAUTIONS, General.)
Nervous system: dry mouth, somnolence, insomnia, vertigo, increased sweating
Body as a whole: abdominal pain, upper abdominal pain, fatigue
Special senses: Visual adverse events most often included blurred vision, diplopia, or difficulty focusing. Most events were mild to moderate; however, severe cases have been reported. Some patients discontinued therapy due to these adverse events. Visual adverse events were reported as having occurred after any dose during treatment, but most visual adverse events (65%) occurred following the first or second dose. Visual events lasted several hours and recurred upon subsequent dosing in some patients. For patients who continued treatment, some resolved on therapy while others continued to have symptoms until they completed the full course of treatment. (See WARNINGS and PRECAUTIONS, Information for patients.)
Females and patients under 40 years old experienced a higher incidence of telithromycin-associated visual adverse events. (See CLINICAL STUDIES.)
Urogenital system: vaginal candidiasis, vaginitis, vaginosis fungal
Skin: rash
Hematologic: increased platelet count
Other possibly related clinically-relevant events occurring in <0.2% of patients treated with KETEK from the controlled Phase III studies included: anxiety, bradycardia, eczema, elevated blood bilirubin, erythema multiforme, flushing, hypotension, increased blood alkaline phosphatase, increased eosinophil count, paresthesia, pruritus, urticaria.
In addition to adverse events reported from clinical trials, the following events have been reported from worldwide post-marketing experience with KETEK.
Allergic: face edema, rare reports of severe allergic reactions, including angioedema and anaphylaxis.
Cardiovascular: atrial arrhythmias, palpitations
Gastrointestinal system: pancreatitis
Liver and biliary system: Hepatic dysfunction has been reported. Severe and in some cases fatal hepatotoxicity, including fulminant hepatitis, hepatic necrosis and hepatic failure have been reported in patients treated with KETEK. These hepatic reactions were observed during or immediately after treatment. In some of these cases, liver injury progressed rapidly and occurred after administration of only a few doses of KETEK. (See CONTRAINDICATIONS and WARNINGS). Severe reactions, in some but not all cases, have been associated with serious underlying diseases or concomitant medications.
Data from post-marketing reports and clinical trials show that most cases of hepatic dysfunction were mild to moderate. (See PRECAUTIONS, General.)
Musculoskeletal: muscle cramps, rare reports of exacerbation of myasthenia gravis. (See CONTRAINDICATIONS.)
Nervous system: loss of consciousness, in some cases associated with vagal syndrome.
In the event of acute overdosage, the stomach should be emptied by gastric lavage. The patient should be carefully monitored (e.g., ECG, electrolytes) and given symptomatic and supportive treatment. Adequate hydration should be maintained. The effectiveness of hemodialysis in an overdose situation with KETEK is unknown.
The dose of KETEK tablets is 800 mg (2 tablets of 400 mg) taken orally once every 24 hours, for 7–10 days. KETEK tablets can be administered with or without food.
KETEK may be administered without dosage adjustment in the presence of hepatic impairment.
In the presence of severe renal impairment (CLCR< 30 mL/min), including patients who need dialysis, the dose should be reduced to KETEK 600 mg once daily. In patients undergoing hemodialysis, KETEK should be given after the dialysis session on dialysis days. (See CLINICAL PHARMACOLOGY, Renal insufficiency.)
In the presence of severe renal impairment (CLCR< 30 mL/min), with coexisting hepatic impairment, the dose should be reduced to KETEK 400 mg once daily. (See CLINICAL PHARMACOLOGY, Multiple insufficiency.)
KETEK® 400 mg tablets are supplied as light-orange, oval, film-coated tablets, imprinted "H3647" on one side and "400" on the other side. These are packaged in bottles and blister cards (Ketek Pak™ and unit dose) as follows:
Bottles of 60 (NDC 0088-2225-41)
Ketek Pak™, 10-tablet cards (2 tablets per blister cavity) (NDC 0088-2225-07)
Unit dose package of 100 (blister pack) (NDC 0088-2225-49)
KETEK® 300 mg tablets are supplied as light-orange, oval, film-coated tablets, imprinted "38AV" on one side and blank on the other side. These are packaged in bottles as follows:
Bottles of 20 (NDC 0088-2223-20)
Store at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature].
KETEK was studied in four randomized, double-blind, controlled studies and four open-label studies for the treatment of community-acquired pneumonia. Patients with mild to moderate CAP who were considered appropriate for oral outpatient treatment were enrolled in these trials. Patients with severe pneumonia were excluded based on any one of the following: ICU admission, need for parenteral antibiotics, respiratory rate > 30/minute, hypotension, altered mental status, < 90% oxygen saturation by pulse oximetry, or white blood cell count < 4000/mm3. Total number of clinically evaluable patients in the telithromycin group included 2016 patients.
|Patients (n)
|Clinical cure rate
|Controlled Studies
|KETEK vs. clarithromycin 500 mg BID for 10 days
|KETEK vs. trovafloxacin* 200 mg QD for 7 to 10 days
|KETEK vs. amoxicillin 1000 mg TID for 10 days
|KETEK for 7 days vs. clarithromycin 500 mg BID for 10 days
Clinical cure rates by pathogen from the four CAP controlled clinical trials in microbiologically evaluable patients given KETEK for 7–10 days or a comparator are displayed in Table 7.
|Streptococcus pneumoniae
|73/78 (93.6%)
|63/70 (90.0%)
|Haemophilus influenzae
|39/47 (83.0%)
|42/44 (95.5%)
|Moraxella catarrhalis
|12/14 (85.7%)
|7/9 (77.8%)
|Chlamydophila (Chlamydia) pneumoniae
|23/25 (92.0%)
|18/19 (94.7%)
|Mycoplasma pneumoniae
|22/23 (95.7%)
|20/22 (90.9%)
Clinical cure rates for patients with CAP due to Streptococcus pneumoniae were determined from patients in controlled and uncontrolled trials. Of 333 evaluable patients with CAP due to Streptococcus pneumoniae, 312 (93.7%) achieved clinical success. Only patients considered appropriate for oral outpatient therapy were included in these trials. More severely ill patients were not enrolled. Blood cultures were obtained in all patients participating in the clinical trials of mild to moderate community-acquired pneumonia. In a limited number of outpatients with incidental pneumococcal bacteremia treated with KETEK, a clinical cure rate of 88% (67/76) has been observed. KETEK is not indicated for the treatment of severe community-acquired pneumonia or suspected pneumococcal bacteremia.
Clinical cure rates for patients with CAP due to multi-drug resistant Streptococcus pneumoniae (MDRSP*) were determined from patients in controlled and uncontrolled trials. Of 36 evaluable patients with CAP due to MDRSP, 33 (91.7%) achieved clinical success.
*MDRSP: Multi-drug resistant Streptococcus pneumoniae includes isolates known as PRSP (penicillin-resistant Streptococcus pneumoniae), and are isolates resistant to two or more of the following antibiotics: penicillin, 2nd generation cephalosporins, e.g., cefuroxime, macrolides, tetracyclines and trimethoprim/sulfamethoxazole.
|Screening Susceptibility
|Clinical Success in Evaluable MDRSP Patients
|2nd generation cephalosporin-resistant
Table 9 provides the incidence of all treatment-emergent visual adverse events in controlled Phase III studies by age and gender. The group with the highest incidence was females under the age of 40, while males over the age of 40 had rates of visual adverse events similar to comparator-treated patients.
≤ 40
> 40
≤ 40
> 40
Repeated dose toxicity studies of 1, 3, and 6 months' duration with telithromycin conducted in rat, dog and monkey showed that the liver was the principal target for toxicity with elevations of liver enzymes and histological evidence of damage. There was evidence of reversibility after cessation of treatment. Plasma exposures based on free fraction of drug at the no observed adverse effect levels ranged from 1 to 10 times the expected clinical exposure.
Phospholipidosis (intracellular phospholipid accumulation) affecting a number of organs and tissues (e.g., liver, kidney, lung, thymus, spleen, gall bladder, mesenteric lymph nodes, GI-tract) has been observed with the administration of telithromycin in rats at repeated doses of 900 mg/m2/day (1.8× the human dose) or more for 1 month, and 300 mg/m2/day (0.61× the human dose) or more for 3–6 months. Similarly, phospholipidosis has been observed in dogs with telithromycin at repeated doses of 3000 mg/m2/day (6.1× the human dose) or more for 1 month and 1000 mg/m2/day (2.0× the human dose) or more for 3 months. The significance of these findings for humans is unknown.
Pharmacology/toxicology studies showed an effect both in prolonging QTc interval in dogs in vivo and in vitro action potential duration (APD) in rabbit Purkinje fibers. These effects were observed at concentrations of free drug at least 8.8 (in dogs) times those circulating in clinical use. In vitro electrophysiological studies (hERG assays) suggested an inhibition of the rapid activating component of the delayed rectifier potassium current (IKr) as an underlying mechanism.
Rev. February 2007
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
© 2006 sanofi-aventis U.S. LLC
KETEK® (KEE tek) Tablets
Read the Medication Guide that comes with KETEK before you start taking it. Talk to your doctor if you have any questions about KETEK. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment.
What is the most important information I should know about KETEK?
KETEK can cause other serious side effects, including:
Stop KETEK and call your doctor right away if you have signs of liver problems. Do not take another dose of KETEK unlessyour doctor tells you to do so.
Signs of liver problems include:
Do not take KETEK if you have ever had side effects of the liver while taking KETEK or macrolide antibiotics. Macrolide antibiotics include erythromycin, azithromycin (Zithromax®), clarithromycin (Biaxin®) or dirithromycin (Dynabac®).
See " What are the possible side effects of KETEK? for other side effects of KETEK.
What is KETEK?
KETEK is an antibiotic. KETEK is used to treat adults 18 years of age and older with a lung infection called "community acquired pneumonia" that is caused by certain bacteria germs.
Who should not take KETEK?
Do not take KETEK if you:
KETEK may not be right for you. Before taking KETEK, tell your doctor about all of your medical conditions, including if you:
Tell your doctor about all of the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. KETEK and other medicines may affect or interact with each other, sometimes causing serious side effects.
You should not take the following cholesterol lowering medicines while taking KETEK:
Know the medicines you take. Keep a list of your medicines with you to show your doctor or pharmacist.
Do not take other medicines with KETEK without first checking with your doctor. Your doctor will tell you if you can take other medicines with KETEK.
How should I take KETEK?
What are the possible side effects of KETEK?
See " What is the most important information I should know about KETEK?" for worsening of myasthenia gravis symptoms, and serious liver, vision, and fainting side effects.
Other serious side effects include:
The most common side effects of KETEK are nausea, headache, dizziness, vomiting, and diarrhea.
These are not all of the side effects of KETEK. Ask your doctor or pharmacist for more information.
How should I store KETEK?
General Information about KETEK
This Medication Guide summarizes the most important information about KETEK. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about KETEK that was written for healthcare professional. This information is also available on the KETEK website at www.KETEK.com.
What are the ingredients in KETEK?
Active Ingredient: telithromycin
Inactive Ingredients: croscarmellose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, red ferric oxide, talc, titanium dioxide, and yellow ferric oxide
Medication Guide as of February 2007
This Medication Guide has been approved by the U.S. Food and Drug Administration.
sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
BIAXIN® (clarithromycin) is a registered trademark
of Abbott Laboratories.
ZITHROMAX® (azithromycin) is a registered trademark of Pfizer Inc.
DYNABAC® (dirithromycin) is a registered trademark of Eli Lilly and Company.
PROPULSID® (cisapride) is a registered trademark of Johnson & Johnson.
ORAP® (pimozide) is a registered trademark of Teva Pharmaceuticals USA, Inc.
LIPITOR® (atorvastatin) is a registered trademark of Pfizer Inc.
ZOCOR® (simvastatin) is a registered trademark of Merck & Co Inc.
VYTORIN® (simvastatin and ezetimibe) is a registered trademark of Merck/Schering Plough Pharmaceuticals.
MEVACOR® (lovastatin) is a registered trademark of Merck & Co Inc..
|Ketek (telithromycin)
|Ketek (telithromycin)
Data are from FDA and U.S. National Library of Medicine.


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Carne SA Italian steakhouse
If you love meat and Italian cuisine, Carne SA in Keerom is all you could wish for. This vibrant restaurant is a sanctuary of quality meat, carefully prepared by award winning chef Georgio Navas. Carne is designed to remind an Italian butcher shop, with a bar and lounge that blends modern decor with a rustic style. Featuring two more dining venues in Kloof and Constantia, Carne is the perfect place to enjoy a juicy steak in Cape Town.

subset: commoncrawl


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14 Jun 20 Things to Consider Before you start a Business
At some time found in career, every single person is convinced of beginning a organization. This kind of crazy consideration can become the first step to a multimillion bill provider, if perhaps the foundation is made with alert. To color this wish in to a exquisite reality, every single step ought to be taken following exhaustive study and planning. The pursuing is checklist of twenty things to be looked at before starting a small business which act as a base if you are powerful by it.
Produce a Thought: Prior to starting a business, people must have an idea about what has been to be done and the way to do it. Producing a business approach can become needed, as it definitely will serve when a reported and organised sort of your fuzzy idea.
Demand: The product you would like to trade really should have a require available in the market. You should come to be aware of such require or can create it.
Research: A great in-depth research and research of the market and its fads is of high importance for the purpose of constructing the business enterprise structure. As well, study about the history and prevailing methods and the successes of people in the common area. Be aware of every thing about the industry as well as the market segments. Likewise, analysis the rules and restrictions as well the client requirements.
Find out the abilities: Appearing familiar with features and place will be a great advantage, since you will end up being aware about the functional problems involved in the organization.
Be a novice: Regardless of how various years of experience you have in the market or inside the area, be a spanish student. Be open up to simply accept and change improvements.
Monitory benefits: Profit is what just about every business is aimed at. Possess a total thought about the profitability with the business.
Financial commitment required: Understand your capital and sources of capital. In case the funds expected exceeds your financial capacity, look for other resources to get procuring all of them. Though it can be appreciated to consider big, you should always take small ideas. You might have a dream and potential of beginning a mil buck business, although make an effort to start on a tiny range. You can further more expand your company once that gets began well.
Location of work: Offer valuable attention for the location of the business taking. It can be around customers to provide quick providers or can be close to the suppliers so as to preserve cost upon commuter routes.
What is within a Name?: The name of the business business definitely will legally represent you in the market place. It ought to be appealing plenty of to attract customers and reflect the proper image of what your organization and items stands intended for.
Company structure: The structure of your business should be many closely achieving the advantages of the market. You may choose to own personal any kind of structure that complies with your needs intended for providing your simplicity and ease functioning.
Resources you could have or can employ: Seek out human and material solutions that you will require. Find one of the most affordable methods to reduce the primary expense.
Tournaments and marketplaces: With respect to obtaining achievement in a business you need to know the competitors and their activities. You need to understand the promote what your location is heading to place your merchandise. Also, you need to have a complete understanding of each and every one the competition of that market site.
Become techno-friendly: Technology plays a major purpose in major enhancements found in any merchandise and firm. Having an eye about technology will help you adapt to improvements quickly and without difficulty.
Become a Hard worker: In the initial years, be in a position to flavor blood. Ignore about all your recreations and holidays. Whatever you will always be undertaking is job, work and more work.
Advertising sales: Advertising is not only advertising and marketing the product, it also involves a number of other things. Be ready with assorted innovative marketing ideas to enhance revenue.
Duty prices: One should come to be aware of the fees and costs from the talk about or perhaps region or perhaps region they're going to buy and sell the organization. You ought to have knowledge of the subsidies and other benefits provided by the federal government.
Legal thank you's: Be more truthfully right. 1 should maintain all the files and documents that relates to the company possibly before that starts.
Get help: There might be certain region which you will discover hard to deal with alone. You can earn help of friends, loved ones, loved ones and others prior to starting the business. As soon as the organization gets began, you may hire pros meant for such target.
Offered to Queries: You should be wide open to queries and should certainly get concerned to find their answers. This kind of will support you in creating good tactics both before and after the start .
Customers: One ought to come with an idea about their targeted customers. You can carry out market analysis and consumer polls just for many of these reasons to build up a product that meets the customer requirements.
For more information examine here glx-onca.com .


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I'm stepping out of my comfort zone and honestly, I'm really excited about it.
Because there was so much success and love during my 30 to 30 Yoga Challenge, I've started a brand new business venture that embodies many of the elements that made 30 to 30 so much fun.
MB Yoga to Go is an interactive yoga and wellness series for those who have an active life and are on the go!
Whether your schedule doesn't allow you to attend traditional classes or you want something to supplement your home practice, this is the place for you! This private Facebook group offers a variety of content including videos, articles, and blog posts tailored to you, the participant. No matter your skill level or experience, Yoga To Go allows you to create a practice as unique as you are, while being part of a growing, changing community.
Here's how it works for you!
Each week a new video will be uploaded or recorded LIVE to the Facebook group.
They will cover a range of themes and lengths so that you can always find something to fit your need. I will also offer and curate reading materials and resources to help you further your practice. AND I'll be available to answer any questions you might have or help you work toward reaching specific goals.
Think of this as the perfect mix of yoga videos and private lessons.
You can practice on your own time but have the piece of mind of knowing an instructor is there to help you along the way. PLUS you'll also receive all the love, energy, and support of learning and growing along side a beautiful community.
Inaugural Pricing
- Monthly Membership – $39.95
- 6 Month Membership (a 20% discount) – $191. 95
- Yearly Membership (a 30% discount) – $335.95
Payments can be made via Pay Pal or Venmo
Want to know more?
Message me here!


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Welcome to the Fenix Physical Therapy & Performance (Fenix PTP) Blog!
My name is Austin Fair, and I am a physical therapist. I recently opened Fenix PTP in the Gilbert/Queen Creek, Arizona area, and I can't wait to meet you.
I help people aged 30-60 get out of pain, move better, perform better, and avoid surgery. Everything in this blog will be about my journey helping people and sharing PT and performance advice. I want to help you stop taking pain meds, avoid permanent medical procedures and get you back to your "old self" again!
If you are tired of being in pain, feel a nagging injury is "holding you back," or simply want to feel good for that big event coming up, I'd love to see if I can help you.
My next post will be about my decision to start my own practice and how our healthcare system played a big role in it!


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Carers Creative Writing Course
Care for the Carers invites you to join a weekly creative writing course at the Hillcrest Centre during March and April.
Nominations for election
The following people have been nominated for election as Councillor for the Newhaven Denton Ward.
Great British Spring Clean
Sadly we have decided to CANCEL our Great British Spring Clean events due to a decided lack of spring weather!
New Young Mayor for Newhaven
Following the recent elections held at Seahaven Academy and UTC@Harbourside, the young people of Newhaven have chosen 14 year-old Huey Cripps to be ...
Revolutionary machine used on cricket grounds and bowling greens
Burleys is using a revolutionary sports turf aerification machine to bring bowling greens and cricket grounds up to championship standards across the South ...


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Tuesdays Football Rumours From The Papers – 8th July 2014
Suarez move to Barcelona held up as Liverpool want £75 million up front whilst Barcelona want to stagger the payments. Manchester United increasingly confident of landing Arturo Vidal from Juventus for £30 million plus Nani. Inter Milan are expressing an interest in Liverpool midfielder Lucas Leiva. Mathieu Debuchy on brink of completing £11 million move…Details


text: Intro to ReachUni webinar In this introductory webinar, teachers will have the opportunity to: Learn about the range of ReachUni programmes available for schools Understand how to use the RBC handbooks for classroom teaching Understand how to use IAG tools to support university access Registered participants will receive dial-in instructions via the contact email provided. This CPD workshop will be delivered by Dr Richard Branch. Richard completed a PhD in physics at the University of Oxford and continued his academic career as a postdoctoral fellow in biophysics at Harvard University. He trained as a classroom teacher in 2014 and now combines his role as teacher of science at Lampton School with his role as Curriculum Manager at AccessEd. Booking for this event has now closed.


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Books » Age » 7-9 years
By MacKenzie, Donald A.; Illustrated by Green, John
Charming collection of ancient and modern Scottish stories includes "Battle of the Fairy Kings," "Conall and the Thunder Hag," "In the Kingdom of Seals," "The Maid-of-the-Wave," and many more. 34 illustrations.
Wheelers ePlatform - please log in
By Green, John
Twenty-five exceptionally clear and detailed anatomical plates - with labels and extensive captions - depict the skeleton, spine, bones, joints, skull, muscles, skin and limbs; heart, stomach, other organs; much more.
Subscribe now to be the first to hear about specials and upcoming releases.
Copyright © 2020 Wheelers Books
· All rights reserved


text: That is $12 a metre. This fabric is part of the Daisies in the Wind range from David Textiles. 100% cotton and 112cm wide. All the fabric is in 10cm increments and price that way. So if you want to order 40cm of fabric you order 4 x 10cm pieces and you will receive a 40cm piece in your order. Minimum cut 50cm.


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Job Summary The Trade Compliance Manager, Americas is responsible for leading Zimmer Biomets Trade Compliance program to ensure compliance to applicable r...
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As your single-source manufacturing partner, we're problem solvers – ready to help you through any phase of the manufacturing cycle
To contact AJR Specialty Products, LLC, please call us toll free at 800-842-0810 or fill out the form below. We look forward to hearing from youAJR Specialty Products, LLC1200 Rukel WaySt. Charles, IL 60174Directions »Toll-Free: 800-842-0810
Website Design and Development By JET Advertising


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Simple Tofu Scramble
February 24, 2019 - by Robert Cheeke
Simple Tofu Scramble
Makes 1 serving
Macros: 8g carbs | 10g fat | 26g protein
- ½ block extra firm tofu, crumbled (198g)
- 1 tablespoon nutritional yeast (5g)
- 1 teaspoon Adobo seasoning
- 30g raw spinach
- 1 tablespoon mild salsa (optional)
- Heat a medium size non-stick pan over medium-high heat
- Add crumbled tofu and cook for 5 minutes. Stir frequently to prevent sticking
- Add nutritional yeast, Adobo, and spinach, and cook until spinach has reduced in size and is bright green. It should not take more than 30 seconds
- Top with optional salsa
- Serve warm on its own, on toast, with tortillas, or whatever your heart desires
Join our Vegan Strong community!


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Opening Keynote
Begin your event with an exciting, energetic speaker who not only has a contagious enthusiasm, but also who addresses participants with such crystal clear connection, optimism and participatory style that she immediately engages the entire audience, puts them at ease, and motivates them to feel better and to take personal responsibility for their own positive changes throughout the rest of the event and beyond.
Breakout Sessions
Attendees can expect to be talking, moving, laughing and learning as Dr. Lord engages them with her high levels of participation. Her combination of expert educational content, practical applications and ability to fully connect with the audience makes her a favorite at these programs.
Closing Keynote
Dr. Lord has two gifts which make her perfect as your closer: first is her consistently joyful and enthusiastic tone which can energize and reawaken a room even at the end of a long event; second is her unwavering knowing that positive changes are possible which leaves audiences with an uplifted sense of their own empowerment, responsibility and capability.
"You did make an impact!"
– Laura Clawson, Human Resource Analyst, City of Palm Bay, Florida
Join Darcy's Mailing List
Let her help you change things in a positive manner


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After unboxing, and sharing our second impressions, we thought it would be fun to pit the Huawei Honor 5X against our favorite budget phone from last year, the Alcatel OneTouch Idol 3. On paper these two handsets are surprisingly similar. We've got the same screen size (five and a half inches) and resolution (1080p). We've got the same RAM (2GB) and storage (16GB with MicroSD card expansion). We've got the same camera specs (13MP on a one third inch sensor). Plus each phone has its own "niche feature": a fingerprint scanner on the Huawei and front facing speakers on the Alcatel.
Moving away from listing the specs though, these two phones really couldn't be more different. They have very different approaches to build materials, and the custom software for each is about as different as two phones can get. It's an exciting time when even our inexpensive smartphones can carry so much character.
Phones at the sub $200 price point used to age quickly and poorly. How does an eight month old handset compare against the newest price-friendly phone from Huawei? It's time for a good old fashioned grudge match. Buckle up as we compare the two in a bang for buck Honor 5X vs Idol 3 showdown below.
Click here to watch this video on YouTube!


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Threats detected on regular basis – processing method required
My pc has gotten virus affected and it seems that my anti-virus is not up to it. It will start and close or just froze. Now I need to know the options to deal with the problem. I have not faced such a situation before so it is kind of troublesome for me. Someone kindly let me know of the methods so that I can out run this problem.
Adriel Roberts


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I love my friends they are all special and unique. Friends drive you crazy but pick you up when you need it are special indeed. I love the fact that distance and time is never an issue with these special ladies.
We had a special celebration pre-op party for Claire starting with a session at Jenna's sanctuary in Wroxton. 3 of the 5 of us pick by the medium for messages. Weird but wonderful. I am apparently surround by spirits and am very open to them as I am a happy and positive soul. Which is good to know. All positive vibes going out to Claire for Friday's op. Xxx
Great day out for Dad's birthday and Father's Day at the Cotswald wildlife Park. Was my first time there and would definitely recommend a visit to people coming to the area. Take a picnic as the food in the restuarant was basic and expensive.
Giraffe's and Zebra's were my favourite. Should book a session as a "keeper for a day" to start practicing for South Africa.


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Baseball News, Video And Gossip
When I was growing up I had a in-built baseball card accumulating community proper in my family as I've a twin brother (I am the gorgeous one) and my father was also a facilitator, too. QUICKLY EVALUATE and set swing goals for every participant. Splitting Video games 1 and a pair of at Nationals Park means Arrieta will get another chance to carry out in front of forty,000 fans at Wrigley Field. No the Phillies did not make the postseason. The batter swings at any ball (even one outdoors the strike zone) and misses, or foul ideas it directly into the catcher's hands.
Lots of the pre-sport and in-recreation strategic selections in baseball revolve around a elementary reality: usually, right-handed batters are typically extra profitable against left-handed pitchers and, to an even better degree, left-handed batters tend to be extra successful against proper-handed pitchers.
For reference, think about that Derek Jeter performed 2,747 games with the Yankees. Not like most games, a operating clock does not restrict the length of a baseball recreation. However this time of 12 months, something can happen. You'll discover find out how to throw a slider, what it feels prefer to soak within the adoration of a crowd, how come a baseball has stitches – in addition to the historical past of this widespread sport.
Looks like baseball followers need to dodge greater than foul balls. All those dynamics make Scherzer's hamstring tweak" – in the proper leg the place he pushes off and generates a lot energy – such an X-factor on Monday in a Game three that can leave one staff nine innings away from elimination.
Perhaps, because Musial was The Man ahead of his time when it got here to new metrics, there could possibly be an award offered within the National League for the very best OPS. SIMPLY MANAGE all your players from wherever on the earth. Bryce Harper lifts one deep to right area to bring the Nationals even with the Cubs in Sport 2, and Ryan Zimmerman's three-run homer later in the inning seals the win.


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Keep it Current
If you're looking for headshots for women, check out these 7 new images featuring LA actresses who were either recommended or happened to fall in love with the look and feel of my headshots. The talent is represented by some of Los Angeles' top-caliber talent agencies including Kim Dawson and Linda McAlister (both of which I am an agency approved photographer)
LA Headshots for Women 101
Ladies, please bare the following details in mind before you show up to your Headshot session.
- Get a good nights rest 3-4 days prior to your shoot. You do not want to show up looking tired.
- Your make-up should be clean, simple and fresh. This is not a super glam pageant photo.
- Avoid crazy patterns, logos and un-fitted garments. Ruffles and bell sleeves never look good on film.
- Most importantly, be comfortable and confident in your own skin. If you're not self-assured, no amount of make-up or Photoshop can fix that and more than likely you won't like 200+ photos of yourself either.
Ready for the Next Step?
Time to update your headshots. Book with Sergio Garcia Photography.


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- Sale
- New Arrivals
- Engagement & Wedding Rings
- Shop by Type
- Ready to Ship
- Learn More
A marquise-shaped diamond set sideways in a minimalistic engagement ring. The band starts at the setting with a knife edge which fades into a rounded comfortable shank. At the bottom, the ring is about 3.5mm wide tapering towards 2mm at the knife edge.
The ring will be finished with a mirror polish. The diamond is available in various sizes. The gem will be set securely in a hand-carved bezel setting.
Diamond options:
Custom rings with larger diamonds with GIA certificates are available upon request. Please contact me for price quotes based on your preferences. Price depending on actual diamond specifications. Harmony diamonds are available upon request. Harmony Diamonds are recycled diamonds. Recycled diamonds are the ultimate eco-friendly diamonds, as they do not cause destruction to our Earth.
Material options:
Available in white & yellow gold and platinum.
Available in sizes 4 to 9, larger sizes may vary in price.
Ring is Made to Order- for the most up-to-date fabrication time frame please check my listed turnaround times below in the footer area.


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Our Practitioners
Dr. Jennah Dieter, DC, CACCP
Pediatric/Perinatal Certified Chiropractor
Advanced Clinical Nutritionist
Dr. Jennah Dieter, owner of Healthcare Complete, is a licensed Chiropractor specializing in Pediatric and Perinatal Chiropractic serving the Newburyport community.
Dr. Jennah Dieter earned her Bachelor's degree in Health and Exercise Science from Wake Forest University and graduated Summa Cum Laude with a Doctor of Chiropractic degree from Palmer College of Chiropractic. During her years at Palmer, she embarked on a chiropractic mission trip to Brazil, where she provided chiropractic care to the under-served people of rural Brazil. After graduation, she ran her practice successfully for 2 ½ years in Bellingham, MA caring for a diverse group of patients, from newborns to pregnant moms, teenage athletes to seniors, and from active dads to busy moms. Wanting to be near the sun and sand, in 2008 she departed from her practice in Bellingham to help optimize the health of families in the North Shore of Massachusetts.
Dr. Jennah focuses her care on low and moderate force adjusting techniques for families, including children and pregnant mothers. She is a Certified Chiropractic Pediatric practitioner and has completed 180 hours of course work through the International Chiropractic Pediatrics Association/Academy of Chiropractic Family Practice and the Council on Chiropractic Pediatrics.
She also provides nutritional counseling using the Nutrition Response Testing technique, which is a unique analysis used to detect nutritional deficiencies and underlying nutritive stress factors. She has an individualized approach and uses a combination of Sacro-occipital techniques, craniopathy, organ reflex manipulation and extremity adjusting to assist in removing interferences to her patient's health expression.
Dr. Jennah is dedicated to providing complimentary community education on health and wellness topics such as nutrition, weight loss, raising healthy children, backpack safety, natural female hormone balance, stress and pain management, and many others upon request and interest. Dr. Jennah Dieter is also a devoted member of the International Chiropractic Pediatrics Association, Massachusetts Chiropractic Society, Sacro-occipital Technique Organization USA and the Newburyport Chamber of Commerce.
B.S. Health & Exercise Science, Wake Forest University, Winston Salem, NC
Doctor of Chiropractic, Palmer College of Chiropractic, Davenport, IA
Certification in Pediatric/Perinatal Chiropractic, International Chiropractic Pediatrics Association (ICPA)
Webster's Technique for Breech Fetal Presentation
National Board Certified (Parts I-IV, Physiotherapy)
Massachusetts Board Certified
- International Chiropractic Pediatrics Association (ICPA)
- Greater Newburyport Chamber of Commerce
- Port City Women's Club, Newburyport
- Massachusetts Chiropractic Society
- Sacro-occipital Technique Organization USA
- Holistic Mom's Network
- Greater Newburyport Mother's and Families Club
- Pediatric & Perinatal chiropractic- Certified through the ICPA
- Nutrition Response Testing, Advanced Clinical Training
- Children on autistic spectrum
- TMJ disorder
- Sports Injuries
- Female Hormone balance
- Digestive Disorders
Dr. Kim Belew
Dano Bass, LMT
Licensed Massage Therapist
Susan Weiss, LMT
Licensed Massage Therapist
Our Support Team Members
Elena Hogan
Front Desk Manager
Jennifer Andrade
Chiropractic Assistant
Susan Cook
Chiropractic Assistant
Donna Mitrano


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A bloated tummy from fluid retention can be uncomfortable, and for many people they equate this to feeling 'fat', which of course there is no relationship between the two. Water retention can cause swelling in other parts of the body too, but most commonly many people experience it around the stomach. Water retention can happen for a number of reasons which can sometimes be medical, but if there are no underlying health reasons and the bloating is fairly mild then a few simple dietary changes can make a huge difference:
- Stay hydrated – being dehydrated can result in the body holding on to water. Make sure you drink enough water throughout the day and account for any water losses through hot weather, exercise or alcohol consumption.
- Reduce your sodium intake – sodium helps regulate fluid levels in the cells. Excess sodium can result in water retention. Most commonly high salt foods tend to be processed foods. However, those that follow a diet containing mostly whole natural food probably don't have a diet high in salt and so this may not always apply. However, there are natural whole foods that may be high in salt such as cheeses or cured meats. In addition, some people do not experience fluid retention at all with increased salt intake and so this is very individual.
- Avoid eating too much refined carbohydrates (e.g. sugary foods, foods made from white flour) – these types of foods produce an insulin spike which causes the reabsorption of sodium back into the kidneys which results in the body holding on to more water. Eat minimally refined carbohydrates instead along with healthy fats and protein to produce a steady release of carbohydrate so that there aren't rapid spikes in blood sugar and insulin.
- Eat potassium rich foods – potassium and sodium work in conjunction with one another and this helps regulate water balance. To ensure you are getting enough potassium make sure you try to get your 5-7 portions of veg and fruit each day.
- Get enough B6 – some research has found that B6 as well as magnesium, can potentially help reduce bloating, particular for women around the menstrual cycle. Foods rich in B6 include poultry (e.g. chicken, turkey), eggs, vegetables, bananas, nuts, potatoes, milk. Foods containing magnesium include nuts, wholegrains and leafy green veg. Bear in mind however that commonly a woman's diet can change slightly around the period (e.g. increased sugar intake) which potentially could be responsible for some of the 'puffy' feeling.
- Reduce stress – stress increases cortisol which in turn can increase water retention. Stress overall can impact negatively on blood sugar and inflammation which ultimately can lead to fat retention as well as the bloat. Take steps to reduce stress by being more mindful and try to take time out to relax.
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Apparently, a segment on NPR's Morning Edition entitled, Real Estate Commissions Under Pressure, says a major story will appear this Sunday in the New York Times Magazine calling traditional real estate agents an "endangered species."
The use of the phrase "endangered species" tickles me, because The Real Estate Cafe is planning a series of meetings / online chats with real estate change agents and consumers in New England to celebrate the 10th anniversary of Ralph Nader's appearance at one of our real estate roundtables in 1996. The title for the series is "Intelligent REdesign," a deliberate pun on the evolution versus intelligent design debate raging across the country. What better place to host such an event than "Darwin's," a wifi cafe outside Harvard Square? (Darwin, survival of the fittest, endangered species, Intelligence REdesign, get it?)
The goal of the yearlong series is to:
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2. Involve consumers directly in the process of "redesigning" the real estate industry to better meet their needs. We've …
seen some client-developed tools that would make real estate programmers and agents envious.
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aware of similar efforts by individual consumers, or organized consumer
groups, to introduce pro-consumer legislation in their states?
If you would like to participate in the Intelligent REdesign series,
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chat was a smashing success, generating a 36 page transcript. Should
we host another "Bubble Hour" to discuss the pending sales index
the Massachusetts Association of Realtors is releasing on Monday, March
6th? If we get together in person, maybe we can combine it with a
planning session for the Intelligent REdesign series?


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Consider this your one-stop resource for how to make nut butter at home! It's so easy, often requires just 1 (or 2) ingredients, and comes together in less than 30 minutes! First, choose your base. I love starting with raw, organic almonds. Then I mix in a few walnuts ... Read more →
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+41 21 693 79 74
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Station 11
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Unit: IC-DO
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Fields of expertise
machine learning
computational harmonic analysis
inverse problems
compressive sensing
computer vision
Visit our lab web pages.
physics from the Université catholique de Louvain, Louvain-la-Neuve, Belgium, in 1995 and 1998, respectively. From 1998 to 2001, he was a Postdoctoral Researcher with the Signal Processing Laboratory, Swiss Federal Institute of Technology (EPFL), Lausanne, Switzerland. He was Assistant Professor at EPFL (2002-2007), where he is now a Full Professor of Electrical Engineering and, by courtesy, of Computer and Communication Sciences. As of 2015, Prof. Vandergheynst serves as EPFL's Vice-Provost for Education.
His research focuses on harmonic analysis, sparse approximations and mathematical data processing in general with applications covering signal, image and high dimensional data processing, computer vision, machine learning, data science and graph-based data processing.
He was co-Editor-in-Chief of Signal Processing (2002-2006), Associate Editor of the IEEE Transactions on Signal Processing (2007-2011), the flagship journal of the signal processing community and currently serves as Associate Editor of Computer Vision and Image Understanding and SIAM Imaging Sciences. He has been on the Technical Committee of various conferences, serves on the steering committee of the SPARS workshop and was co-General Chairman of the EUSIPCO 2008 conference.
Pierre Vandergheynst is the author or co-author of more than 70 journal papers, one monograph and several book chapters. He has received two IEEE best paper awards. Professor Vandergheynst is a laureate of the Apple 2007 ARTS award and of the 2009-2010 De Boelpaepe prize of the Royal Academy of Sciences of Belgium.