United States - English - NLM (National Library of Medicine)

physicians total care, inc. - telithromycin (unii: ki8h7h19wl) (telithromycin - unii:ki8h7h19wl) - telithromycin 400 mg - 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 .) concomitant administration of ketek and colchicine is contraindicated in patients with renal or hepatic impairment. (see warnings, drug interactions and precautions, drug interactions .)

European Union - English - EMA (European Medicines Agency)

aventis pharma s.a. - telithromycin - sinusitis; tonsillitis; bronchitis, chronic; pharyngitis; community-acquired infections; pneumonia, bacterial - antibacterials for systemic use, - when prescribing ketek, consideration should be given to official guidance on the appropriate use ofantibacterial agents and the local prevalence of resistance.ketek is indicated for the treatment of the following infections:in patients of 18 years and oldercommunity-acquired pneumonia, mild or moderate.when treating infections caused by known or suspected beta-lactam- and / or macrolide-resistant strains (according to history of patients or national and / or regional resistance data) covered by the antibacterial spectrum of telithromycin:acute exacerbation of chronic bronchitis;acute sinusitis;in patients of 12 years and oldertonsillitis / pharyngitis caused by streptococcus pyogenes, as an alternative when beta-lactam antibiotics are not appropriate in countries / regions with a significant prevalence of macrolide-resistant s. pyogenes, when mediated by ermtr or mefa.

European Union - English - EMA (European Medicines Agency)

aventis pharma s.a. - telithromycin - community-acquired infections; pharyngitis; bronchitis, chronic; pneumonia; tonsillitis; sinusitis - antibacterials for systemic use, - when prescribing levviax consideration should be given to official guidance on the appropriate use of antibacterial agents and the local prevalence of resistance (see also sections 4.4 and 5.1).levviax is indicated for the treatment of the following infections:in patients of 18 years and older:-community-acquired pneumonia, mild or moderate (see section 4.4).- when treating infections caused by known or suspected beta-lactam and/or macrolide resistant strains (according to history of patients or national and/or regional resistance data) covered by the antibacterial spectrum of telithromycin (see sections 4.4 and 5.1):- acute exacerbation of chronic bronchitis,- acute sinusitisin patients of 12 years and older:- tonsillitis/pharyngitis caused by streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide resistant s. pyogenes, when mediated by ermtr or mefa (see sections 4.4 and 5.1).

Canada - English - Health Canada

sanofi-aventis canada inc - telithromycin - tablet - 400mg - telithromycin 400mg - ketolides

Namibia - English - Namibia Medicines Regulatory Council

aventis pharma (pty) limited - telithromycin - tablets - telithromycin tablets 400 mg

New Zealand - English - Medsafe (Medicines Safety Authority)

sanofi-aventis new zealand limited - telithromycin 400mg;   - film coated tablet - 400 mg - active: telithromycin 400mg   excipient: croscarmellose sodium hypromellose iron oxide red iron oxide yellow lactose monohydrate macrogol 8000 magnesium stearate maize starch microcrystalline cellulose povidone purified talc titanium dioxide

Singapore - English - HSA (Health Sciences Authority)

sanofi-aventis singapore pte. ltd. - telithromycin - tablet, film coated - 400 mg

Bahrain - English - الهيئة الوطنية لتنظيم المهن والخدمات الصحية، مملكة البحرين

yousif mahmood hussain pharmacy - telithromycin - film coated tablet - 400

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

sanofi - telithromycin - tablet - 400mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

sanofi-aventis - telithromycin - tablet - 400 mg