Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OSELTAMIVIR PHOSPHATE
ROCHE (MALAYSIA) SDN. BHD.
OSELTAMIVIR PHOSPHATE
10Capsule Capsules
CENEXI SAS
TAMIFLU ® CAPSULES _Oseltamivir 75 mg _ 1 _ _ _ _ _Consumer Medication Information Leaflet (RiMUP) _ WHAT IS IN THIS LEAFLET 1. What Tamiflu is used for 2. How Tamiflu works 3. Before you use Tamiflu 4. How to use Tamiflu 5. While you are using it 6. Side effects 7. Storage and disposal of Tamiflu 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT TAMIFLU IS USED FOR Tamiflu is used for the treatment of influenza in children 6 to 12 months of age during pandemic influenza outbreak, for treatment of influenza in adults and children age 1 year and above. Tamiflu is also indicated for post exposure prevention in adults and children age 1 year and above following contact with clinically diagnosed influenza case when influenza virus is circulating in the community. HOW TAMIFLU WORKS Tamiflu contains oseltamivir which belongs to a group of medicines named neuraminidase inhibitors. These medicines prevent the influenza virus from spreading inside the body. They help to ease or prevent the symptoms of the influenza virus infection. Influenza, usually called flu, is an infection caused by a virus. The signs of flu often 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 are spreading in the local community. Outside epidemic periods, flu-like symptoms are usually caused by a different type of illness. _Tamiflu is not a flu vaccine _ Tamiflu is not a vaccine: it treats infection, or prevents the flu virus spreading. A vaccine gives you antibodies against the virus. Tamiflu will not change the effectiveness of a flu vaccine, and you might be prescribed both by your doctor. BEFORE YOU USE TAMIFLU - _When you must not take it _ _ _ Do not take or receive Tamiflu if: YOU ARE ALLERGIC ( _hypersensitive_ ) to oseltamivir or any of the other ingredients of Tamiflu. TALK Baca dokumen lengkap
PACK INSERT FOR MALAYSIA T a m iflu ® Oseltamivir phosphate 1. DESCRIPTION 1.1 Therapeutic/Pharmacologic Class of Drug Tamiflu is an antiviral agent 1.2 Type of Dosage Form Capsule, hard. 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. The content of the capsule appear as a white powder . 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. The content of the capsule appear as a white powder . 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. The content of the app ear as a white powder . 1.3 Route of Administration Oral 1.4 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. 2. CLINICAL PARTICULARS 2.1 Therapeutic Indications Treatment of influenza Tamiflu is indicated for the treatment of influenza in children 6 to 12 months of age during a pandemic influenza outbreak . Tamiflu is indicated for the treatment of influenza in adults and children ≥1 year of age (see sections 2.2.1 Special Dosage Instructions, 2.4 W arnings and Precautions and 3.3 Non clinical Safety). Treatment should commence as soon as possible but no later than forty -eight hours after the onset of the initial symptoms of infection. Prophylaxis of influenza Tamiflu is indicated for post exposure prophylaxis in adults and children ≥1 year following contact with a clinically diagnosed influenza case when influenza virus is circulating in the community. 2.2 Dosage and Administration Tamiflu may be taken with or w Baca dokumen lengkap