Țară: Malaezia
Limbă: engleză
Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ZIDOVUDINE/AZIDOTHYMIDINE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
ZIDOVUDINE/AZIDOTHYMIDINE
200ml mL
Bora Pharmaceutical Services Inc.
_ _ _ _ _Consumer Medication Information Leaflet (RiMUP) _ _ _ RETROVIR ORAL SOLUTION _ _ Zidovudine (50mg/5ml) 1 WHAT IS IN THIS LEAFLET 1. What RETROVIR is used for 2. How RETROVIR works 3. Before you use RETROVIR 4. How to use RETROVIR 5. While you are using it 6. Side Effects 7. Storage and Disposal of RETROVIR 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT RETROVIR IS USED FOR RETROVIR is used to treat HIV (human immunodeficiency virus) infection. RETROVIR is used, in combination with other medicines (‘combination therapy’), to treat HIV infection in adults and children. If you are pregnant, your doctor may want you to take RETROVIR, to help prevent you passing HIV on to your unborn baby. After the birth, your baby may be given RETROVIR to help prevent HIV infection. HOW RETROVIR WORKS The active ingredient in RETROVIR is zidovudine. RETROVIR is a type of medicine known as an anti-retroviral. It belongs to a group of medicines called _nucleoside analogue reverse _ _transcriptase inhibitors_ (NRTIs) _. _ RETROVIR does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. RETROVIR also increases the _CD4 cell count_ in your blood. CD4 cells are white blood cells that are important in helping your body to fight infection. BEFORE YOU USE RETROVIR - _When you must not use it _ Do not take RETROVIR: • if you are allergic (hypersensitive) to zidovudine or any of the other ingredients of RETROVIR. • if you have a very low white blood cell count _ (neutropenia) _ or a very low red blood cell count ( _anaemia_ ). If you think any of these apply to you, do not take RETROVIR until you have checked with your doctor. - _Before you start to use it _ Before you take RETROVIR your doctor needs to know: • If you have ever had liver disease (including hepatitis B or C) • If you have a blood disorder Talk to your doctor if any of these apply to you. You may need extra check-ups, including blood tests, while you’re taking Citiți documentul complet
CONFIDENTIAL RETROVIR ZIDOVUDINE QUALITATIVE AND QUANTITATIVE COMPOSITION Oral solution containing 50 mg zidovudine per 5 ml. It is clear, pale yellow, strawberry- flavoured. CLINICAL INFORMATION INDICATIONS _ _ _RETROVIR_ is indicated in combination with other anti-retroviral agents for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children. _RETROVIR_ is indicated for use in HIV-positive pregnant women and their newborn infants as it has been shown to reduce the rate of maternal-foetal transmission of HIV ( _see _ _Pregnancy and Lactation_ ) _. _ DOSAGE AND ADMINISTRATION PHARMACEUTICAL FORM: Oral solution. _ _ _RETROVIR_ therapy should be initiated by a physician experienced in the management of HIV infection. • ADULTS AND ADOLESCENTS WEIGHING AT LEAST 30 KG The recommended dose of _RETROVIR_ in combination with other anti-retroviral agents is 250 or 300 mg twice daily. • CHILDREN _ _ _Oral solution: _ _ _ _Children weighing at least 9 kg and less than 30 kg: _ The recommended dose of _RETROVIR_ is 0.9 mL/kg (9 mg/kg) twice daily in combination with other anti-retroviral agents (e.g. a 15 kg child would require a 13.5 mL dose of oral solution twice daily). The maximum dosage should not exceed 300 mg (30 mL) twice daily. _ _ _Children weighing at least 4 kg and less than 9 kg: _ The recommended dose of _RETROVIR_ is 1.2 mL/kg (12 mg/kg) twice daily in combination with other antiretroviral agents (e.g. a 5 kg neonate would require a 6 mL dose of oral solution twice daily). CONFIDENTIAL Available data are insufficient to propose specific dosage recommendations for children weighing less than 4 kg ( _see _ _Prevention _ _of _ _maternal _ _foetal _ _transmission _ _and _ _Pharmacokinetics_ ). • ELDERLY Zidovudine pharmacokinetics have not been studied in patients over 65 years of age and no specific data are available. However, since special care is advised in this age group due to age-associated changes such as the decrease in renal function and alterations in haematological par Citiți documentul complet