Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
OSELTAMIVIR AS PHOSPHATE
ROCHE PHARMACEUTICALS (ISRAEL) LTD
J05AH02
CAPSULES
OSELTAMIVIR AS PHOSPHATE 30 MG
PER OS
Required
HOFFMANN LA ROCHE LTD, SWITZERLAND
OSELTAMIVIR
OSELTAMIVIR
Treatment of influenza : Treatment of uncomplicated acute illness due to influenza infection in adults and children 1 year of age or older who have been symptomatic for no more than 2 days. Prophylaxis of influenza : Post exposure prevention in adults and children 1 year of age or older patients 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 1 year of age or older.
2020-12-31
Tamiflu PL Ver 3 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 (This medicine is dispensed with a doctor’s prescription only) TAMIFLU TAMIFLU TAMIFLU 30 MG 45 MG 75 MG capsules capsules capsules Each capsule contains: Each capsule contains: Each capsule contains: OSELTAMIVIR 30 MG OSELTAMIVIR 45 MG OSELTAMIVIR 75 MG * For information on inactive ingredients, see section 2 “Before using the medicine” and section 6 “Additional information”. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Tamiflu is intended for the treatment of influenza in adults and children 1 year of age or older, who have presented influenza symptoms for no more than two days. Tamiflu is intended to prevent influenza in adults and children 1 year of age or older. Tamiflu 75 mg capsules are intended for adults and children weighing more than 40 kg only. Tamiflu 30 mg and 45 mg capsules are intended for adults and children one year of age and older. THERAPEUTIC GROUP: Tamiflu contains the active ingredient, oseltamivir, and belongs to a group of antiviral medicines named “neuraminidase inhibitors”. These medicines prevent the flu virus from spreading inside the body and help ease or prevent symptoms of the flu virus infection. Influenza is an infection caused by a virus. The signs of the flu generally include a sudden fever (more than 37.8°C), cough, runny or stuffy nose, headaches, muscle aches and extreme tiredness. These symptoms can also be caused by other infections. True influenza infection only occurs during annual outbreaks (epidemics) when flu viruses spread in the local community. When there is no outbreak of in Baca dokumen lengkap
1 Tamiflu PI version 2 TAMIFLU ® r Oseltamivir CAPSULES 1. NAME OF THE MEDICINAL PRODUCT Tamiflu 30 mg Tamiflu 45 mg Tamiflu 75 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tamiflu 30 mg hard capsules Each hard capsule contains oseltamivir (as 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 (as 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 (as 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 Tamiflu capsules 75 MG is indicated for adults patients and patients who weight > 40 kg body weight. Tamiflu capsules 30 MG AND 45 MG are indicated for adults and children 1 year of age or older. _Treatment of influenza_ The treatment of uncomplicated acute illness due to influenza infection in adults and children 1 year of age or older who have been symptomatic for no more than 2 days. 2 _Prophylaxis of influenza_ - Post-exposure prevention in adults and children 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 t Baca dokumen lengkap