Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ZIDOVUDINE/AZIDOTHYMIDINE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
ZIDOVUDINE/AZIDOTHYMIDINE
200ml mL
GLAXOSMITHKLINE 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 Read the complete document
CONFIDENTIAL RETROVIR Zidovudine QUALITATIVE AND QUANTITATIVE COMPOSITION Oral solution containing 50 mg zidovudine per 5 ml. It is clear, pale yellow, strawberry- flavoured. PHARMACEUTICAL FORM Oral solution. CLINICAL PARTICULARS 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 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 or 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: Read the complete document