Țară: Uniunea Europeană
Limbă: engleză
Sursă: EMA (European Medicines Agency)
telithromycin
Aventis Pharma S.A.
J01FA15
telithromycin
Antibacterials for systemic use,
Sinusitis; Tonsillitis; Bronchitis, Chronic; Pharyngitis; Community-Acquired Infections; Pneumonia, Bacterial
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.
Revision: 25
Withdrawn
2001-07-09
24 B. PACKAGE LEAFLET Medicinal product no longer authorised 25 PACKAGE LEAFLET: INFORMATION FOR THE USER KETEK 400 MG FILM-COATED TABLETS Telithromycin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET: 1. What Ketek is and what it is used for 2. What you need to know before you take _ _ Ketek 3. How to take _ _ Ketek 4. Possible side effects 5. How to store Ketek 6. Contents of the pack and other information 1. WHAT KETEK IS AND WHAT IT IS USED FOR Ketek contains the active substance telithromycin. Ketek is an antibiotic of the type macrolides. Antibiotics stop the growth of bacteria which cause infections. Ketek is used to treat infections due to bacteria against which the medicine is active. - In adults, Ketek is used to treat infections of the throat, infections of the sinuses (hollow cavities in the bones around the nose) and chest infections in patients with long standing breathing difficulties and lung infection (pneumonia). - In adolescents of 12 years and older, Ketek is used to treat infections of the throat. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KETEK DO NOT TAKE KETEK: - if you are ALLERGIC to telithromycin, to any of the macrolide antibiotics or to any of the other ingredients of this medicine (listed in section 6). If in doubt, talk to your doctor or pharmacist. - if you suffer from MYASTHENIA GRAVIS, a rare disease which causes muscle weakness. - if you have had a liver disease (HEPATITIS and/or JAUNDICE) while taking Ketek in the past. - if you are TAKING OTHER MEDICINES Citiți documentul complet
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Ketek 400 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg of telithromycin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet. Light orange, oblong, biconvex tablet, imprinted with ‘H3647’ on one side and ‘400’ on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS When prescribing Ketek, 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). Ketek 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 sinusitis _In patients of 12 years and older: _ • Tonsillitis/pharyngitis caused by S _treptococcus 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). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 800 mg once a day i.e. two 400 mg tablets once a day. _In patients of 18 years and older, according to the indication, the treatment regimen will be: _ - Community-acquired pneumonia: 800 mg once a day for 7 to 10 days, - Acute exacerbation of chronic bronchitis: 800 mg once a day for 5 days, - Acute sinusitis: 800 mg once a day for 5 days, - Tonsillitis/pharyngitis caused by _Streptococcus pyogenes:_ 800 mg once a day for 5 days. _In patients of Citiți documentul complet