Maa: Yhdistynyt kuningaskunta
Kieli: englanti
Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Abacavir sulfate
ViiV Healthcare UK Ltd
J05AF06
Abacavir sulfate
20mg/1ml
Oral solution
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030100; GTIN: 5000123109203
1 PACKAGE LEAFLET: INFORMATION FOR THE USER ZIAGEN 20 MG/ML ORAL SOLUTION Abacavir READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions ask your doctor or pharmacist. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IMPORTANT - HYPERSENSITIVITY REACTIONS ZIAGEN CONTAINS ABACAVIR (which is also an active substance in medicines such as KIVEXA , TRIUMEQ and TRIZIVIR ). Some people who take abacavir may develop a HYPERSENSITIVITY REACTION (a serious allergic reaction), which can be life-threatening if they continue to take abacavir. containing products. YOU MUST CAREFULLY READ ALL THE INFORMATION UNDER ‘HYPERSENSITIVITY REACTIONS’ IN THE PANEL IN SECTION 4 . The Ziagen pack includes an ALERT CARD , to remind you and medical staff about abacavir hypersensitivity. DETACH THIS CARD AND KEEP IT WITH YOU AT ALL TIMES . WHAT IS IN THIS LEAFLET 1. What Ziagen is and what it is used for 2. What you need to know before you take Ziagen 3. How to take Ziagen 4. Possible side effects 5. How to store Ziagen 6. Contents of the pack and other information 1. WHAT ZIAGEN IS AND WHAT IT IS USED FOR ZIAGEN IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION . Ziagen contains the active ingredient abacavir. Abacavir belongs to a group of anti-retroviral medicines called _nucleoside analogue reverse transcriptase inhibitors (NRTIs)_ . Ziagen does not completely 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 cell that are important in helping your body to fight infection. Not everyone respon Lue koko asiakirja
OBJECT 1 ZIAGEN 20 MG/ML ORAL SOLUTION Summary of Product Characteristics Updated 07-Mar-2018 | ViiV Healthcare UK Ltd 1. Name of the medicinal product Ziagen 20 mg/ml oral solution 2. Qualitative and quantitative composition Each ml of oral solution contains 20 mg of abacavir (as sulfate). Excipients with known effect: Sorbitol (E420) 340 mg/ml Methyl parahydroxybenzoate (E218) 1.5 mg/ml Propyl parahydroxybenzoate (E216) 0.18 mg/ml For the full list of excipients see section 6.1. 3. Pharmaceutical form Oral solution The oral solution is clear to slightly opalescent yellowish, aqueous solution which may turn into a brown colour over time 4. Clinical particulars 4.1 Therapeutic indications Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children (see sections 4.4 and 5.1). The demonstration of the benefit of Ziagen is mainly based on results of studies performed in treatment- naïve adult patients on combination therapy with a twice daily regimen (see section 5.1). Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin(see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele. 4.2 Posology and method of administration Ziagen should be prescribed by physicians experienced in the management of HIV infection. Ziagen can be taken with or without food. Ziagen is also available as a tablet formulation. _Adults, adolescents and children (weighing at least 25 kg): _ The recommended dose of Ziagen is 600 mg daily (30 ml). This may be administered as either 300 mg (15 ml) twice daily or 600 mg (30 ml) once daily (see sections 4.4 and 5.1). _Children (weighing less than 25 kg): _ _Children from one year of age_: The recommended dose is 8 mg/kg twice daily or 16 mg/kg once daily, up to a maximum total daily dose of 600 mg (30 ml). _Children from three months to one year of ag Lue koko asiakirja