देश: मलेशिया
भाषा: अंग्रेज़ी
स्रोत: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ABACAVIR SULFATE
GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.
ABACAVIR SULFATE
60 Tablets; 60 Tablets
GLAXOSMITHKLINE PHARMACEUTICALS SA
_ _ _ _ _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 yo पूरा दस्तावेज़ पढ़ें
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 d पूरा दस्तावेज़ पढ़ें