Nazione: Armenia
Lingua: inglese
Fonte: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
oseltamivir (oseltamivir phosphate)
F. Hoffmann La Roche Ltd.
J05AH02
oseltamivir (oseltamivir phosphate)
75mg
capsules hard
(10/1x10/) blister
Prescription
Registered
2015-03-25
TAMIFLU ® Oseltamivir 1. DESCRIPTION 1.1 THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG Tamiflu is an antiviral agent. 1.2 TYPE OF DOSAGE FORM Hard capsule. 30 mg capsule consisting of a light yellow opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “30 mg”. Imprints are blue. 45 mg capsule consisting of a grey opaque body bearing the imprint “ROCHE” and a grey opaque cap bearing the imprint “45 mg”. Imprints are blue. 75 mg capsule consisting of a grey opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “75 mg”. Imprints are blue. Powder for oral suspension. The powder is a granulate or clumped granulate with a white to light yellow color. 1.3 ROUTE OF ADMINISTRATION Oral. 1.4 STERILE / RADIOACTIVE STATEMENT Not applicable. 1.5 QUALITATIVE AND QUANTITATIVE COMPOSITION _Active ingredient:_ oseltamivir phosphate. 30 mg capsules, containing 39.4 mg oseltamivir phosphate equivalent to 30 mg of oseltamivir. 45 mg capsules, containing 59.1 mg oseltamivir phosphate equivalent to 45 mg of oseltamivir. 75 mg capsules, containing 98.5 mg oseltamivir phosphate equivalent to 75 mg of oseltamivir. Powder for oral suspension, which when constituted with water to a concentration of 0.6% contains 6 mg/ml oseltamivir. LIST OF EXCIPIENTS Contains sorbitol and sodium benzoate. 2. CLINICAL PARTICULARS 2.1 THERAPEUTIC INDICATION(S) Tamiflu is indicated for the treatment of influenza in adults and children, including full‑term neonates (see sections 2.2.1 Special Dosage Instructions, 2.4 Warnings and Precautions, and 3.3 Preclinical Safety). Tamiflu is indicated for the prophylaxis of influenza in adults and children ≥1 year of age. 2.2 DOSAGE AND ADMINISTRATION Tamiflu may be taken with or without food (see section 3.2 Pharmacokinetic Properties). However, Tamiflu taken with food may enhance tolerability in some patients. During situations when commercially manufactured Tamiflu oral suspension is not readily available, adults, adole Leggi il documento completo
1 _ _ 1. NAME OF THE MEDICINAL PRODUCT Tamiflu 30 mg hard capsules Tamiflu 45 mg hard capsules Tamiflu 75 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Tamiflu 30 mg hard capsules Each hard capsule contains oseltamivir phosphate equivalent to 30 mg of oseltamivir. For the full list of excipients, see section 6.1. Tamiflu 45 mg hard capsules Each hard capsule contains oseltamivir phosphate equivalent to 45 mg of oseltamivir. For the full list of excipients, see section 6.1. Tamiflu 75 mg hard capsules Each hard capsule contains oseltamivir phosphate equivalent to 75 mg of oseltamivir. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tamiflu 30 mg hard capsules The hard capsule consists of a light yellow opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “30 mg”. Imprints are blue. Tamiflu 45 mg hard capsules The hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a grey opaque cap bearing the imprint “45 mg”. Imprints are blue. Tamiflu 75 mg hard capsules The hard capsule consists of a grey opaque body bearing the imprint “ROCHE” and a light yellow opaque cap bearing the imprint “75 mg”. Imprints are blue. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _Treatment of influenza_ Tamiflu is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms. _Prevention of influenza _ - Post-exposure prevention in individuals 1 year of age or older following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. - The appropriate use of Tamiflu for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional 2 situations (e.g. in case of a mismatch between t Leggi il documento completo