Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OSELTAMIVIR PHOSPHATE
ROCHE (MALAYSIA) SDN. BHD.
OSELTAMIVIR PHOSPHATE
10Capsule Capsules
Delpharm Milano s.r.l
TAMIFLU ® CAPSULES _Oseltamivir 30mg, 45 mg and 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 Tamiflu 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 contains the active ingredient oseltamivir. Tamiflu is prescribed to you for treating or preventing influenza. HOW TAMIFLU WORKS Tamiflu belongs to a group of medicines named “neuraminidase inhibitors”. These medicines prevent the influenza virus from spreading inside the body and so help to ease or prevent the symptoms arising from the influenza virus infection. 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. the package is torn or shows signs of tampering the expiry date (EXP) printed on the pack has passed. if you take this medicine after the expiry date has passed, it may not work as well. if you are not sure if you should be taking Tamiflu, talk to your doctor. - _Use in the elderly _ Although there is limited experience with use of Tamiflu in patients 65 years and older, the dose recommended for use in elderly patients is the same as that recommended for adults. - _Use in children_ _ _ Safety and effectiveness of Tamiflu in children under 1 year of age has not been established. - _Before you start to take it _ Tell your doctor if: you are pregnant or plan to become pregnant It is not known whether Tamiflu is harmful to an unborn baby when taken by a pregnant woman. If there is a need to take Tamiflu when you are pregnant, your doctor will discuss the risks and benefits to you and the unborn baby. you are breast-feeding or plan to breast-feed. Tamiflu may pass into breast milk. Your doctor will discuss the r Perskaitykite visą dokumentą
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 “4 5 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 appea r 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 tre atment 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 infe ction. 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 Administrati on Tamiflu may be taken with o Perskaitykite visą dokumentą