Pays: Malaisie
Langue: anglais
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ABACAVIR SULFATE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
ABACAVIR SULFATE
1Units Units
Bora Pharmaceutical Services Inc.
Consumer Medication Information Leaflet (RiMUP) ZIAGEN TABLET / ORAL SOLUTION Abacavir sulfate (300mg, 20mg/mL) 1 What is in this leaflet 1. What Ziagen is used for 2. How Ziagen works 3. Before you use Ziagen 4. How to use Ziagen 5. While you are using it 6. Side Effects 7. Storage and Disposal of Ziagen 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision What Ziagen is used for Ziagen contains the active ingredient abacavir sulfate. This belongs to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs), which are used to treat Human Immunodeficiency Virus (HIV) infection. How Ziagen works Ziagen does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection. Not everyone responds to treatment with Ziagen in the same way. Your doctor will monitor the effectiveness of your treatment. Before you use Ziagen - When you must not use it Do not take Ziagen: if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir), or any other ingredients of Ziagen. Carefully read all the information about hypersensitivity reactions in section ‘Side Effects’. If you think this applies to you, don’t take Ziagen until you have checked with your doctor. - Before you start to use it Before you take Ziagen your doctor needs to know: if you have ever had liver disease, including hepatitis B or C Talk to your doctor if this apply to you. You may need extra check-ups, including blood tests, while you’re taking your medicine. Pregnancy: If you are pregnant, or think you could be, or if you are planning to become pregnant, don’t take Ziagen without checking with your doctor. Your doctor will weigh up the benefit to you against the risk to your baby of taking Ziagen while you're pregnant and advise you if you should Lire le document complet
CONFIDENTIAL ZIAGEN Abacavir QUALITATIVE AND QUANTITATIVE COMPOSITION Each ZIAGEN tablet contains 300 mg of abacavir as abacavir sulfate. The scored tablets are yellow, biconvex, and capsule shaped. They are engraved with GX 623 on both sides. ZIAGEN oral solution contains 20 mg/ml of abacavir as abacavir sulfate. ZIAGEN oral solution is a clear to slightly opalescent yellowish, aqueous solution which may turn into a brown colour over time with a fruity flavor. CLINICAL INFORMATION Indications ZIAGEN is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children. Dosage and Administration Pharmaceutical Form: Film-coated scored tablets and Oral solution. Therapy should be initiated by a physician experienced in the management of HIV infection. ZIAGEN can be taken with or without food. To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing. For patients who are unable to swallow tablets, ZIAGEN is available as an oral solution. Alternatively, the tablets may be crushed and added to a small amount of semi-solid food or liquid, all of which should be consumed immediately (see Pharmacokinetics). Adults, adolescents and children weighing at least 25 kg Tablets: The recommended dose of ZIAGEN tablets is 600 mg daily. This may be administered as either 300 mg (one tablet) twice daily or 600 mg (two tablets) once daily. CONFIDENTIAL Oral Solution: The recommended dose of ZIAGEN oral solution is 300 mg (15 ml) twice daily or 600 mg (30 ml) once daily. Children from three months and weighing less than 25 kg Tablets: Children weighing 14 to < 20 kg: one-half of a scored abacavir tablet twice daily. Children weighing ≥ 20 kg to < 25 kg: one-half of a scored abacavir tablet taken in the morning and one whole tablet taken in the evening. Children weighing at least 25 kg: the adult dosage of 300 mg twice daily or 600 mg once daily should be taken. The oral solution may be administered to childr Lire le document complet