País: Unión Europea
Idioma: inglés
Fuente: EMA (European Medicines Agency)
telithromycin
Aventis Pharma S.A.
J01FA15
telithromycin
Antibacterials for systemic use,
Community-Acquired Infections; Pharyngitis; Bronchitis, Chronic; Pneumonia; Tonsillitis; Sinusitis
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).
Revision: 10
Withdrawn
2001-07-09
Medicinal Product no longer authorised 21 B. PACKAGE LEAFLET Medicinal Product no longer authorised 22 PACKAGE LEAFLET: INFORMATION FOR THE USER LEVVIAX 400 MG FILM-COATED TABLETS Telithromycin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have further questions, ask your doctor or your pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET : 1. What Levviax is and what it is used for 2. Before you take_ _Levviax. 3. How to take_ _Levviax. 4. Possible side effects 5. How to store Levviax 6. Further Information 1. WHAT LEVVIAX IS AND WHAT IT IS USED FOR Levviax belongs to one of a group of medicines called ketolides, a new class of antibiotics related to macrolides. Antibiotics stop the growth of bacteria which cause infections. Levviax is used in adults and adolescents of 12 years and older to treat infections due to bacteria against which the medicine is active. In adolescents of 12 years and older, Levviax can be used to treat: infections of the throat. In adults, Levviax can be used to treat infections of the throat, infections of the sinuses, chest infections in patients with long standing breathing difficulties and pneumonia. 2. BEFORE YOU TAKE LEVVIAX DO NOT TAKE LEVVIAX: - if you suffer from myasthenia gravis, a rare disease which causes muscle weakness. - if you are allergic (hypersensitive) to telithromycin, to any of the macrolide antibiotics or to any of the other ingredients of Levviax. If in doubt, talk to your doctor or pharmacist. if you have had a hepatitis and/or jaundice while taking Levviax in the past. - if you are taking certain medicinal products to control the blood level of cholesterol or other lipids. - if you or someone in your family are known to ha Leer el documento completo
Medicinal Product no longer authorised 1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal Product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Levviax 400 mg film-coated tablets. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg of telithromycin. For a 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 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 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 The recommended dose is 800 mg once a day i.e. two 400 mg tablets once a day. The tablets should be swallowed whole with a sufficient amount of water. The tablets may be taken with or without food. Consideration may be given to taking Levviax at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness (see section 4.4). _In patients of 18 years and older, according to the indication, the treatment regimen will be: _ - Comm Leer el documento completo