Land: Indonesien
Sprache: Indonesisch
Quelle: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
OSELTAMIVIR PHOSPHATE
MENARINI INDRIA LABORATORIES - Indonesia
OSELTAMIVIR PHOSPHATE
98,5 MG
KAPSUL
DUS,1 BLISTER @ 10 KAPSUL
DELPHARM MILANO S.R.L - Italy
2022-01-03
Draft_Tamiflu_PI_MAT_CDS13.0_EN_v1 Page 1 of 15 Tamiflu P ® Oseltamivir _______________________________________________________________________ Antiviral 1. DESCRIPTION 1.1 Therapeutic/Pharmacologic Class of Drug Tamiflu is an anti-viral agent 1.2 Type of Dosage Form Capsule, hard The hard 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. 1.3 Route of Administration Oral 1.4 Sterile/Radioactive Statement Not applicable 1.5 Qualitative and Quantitative Composition Active ingredient: oseltamivir phosphate. Capsules containing 98.5 mg oseltamivir phosphate equivalent to 75 mg of oseltamivir. 2. CLINICAL PARTICULARS 2.1 Therapeutic Indication(s) U Treatment of influenza U in adults and children one year of age or older 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. This indication is based on clinical studies of naturally occurring influenza in which the predominant infection was influenza A (see section 3.1 Pharmacodynamic Properties). U Prevention of influenza Post exposure prevention in adults and children one 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 situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in adults and children one years of age or older. U Tamiflu is not a substitute for influenza vaccination. The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations taking into consideration variability of Lesen Sie das vollständige Dokument