Land: Israël
Taal: Engels
Bron: Ministry of Health
ABACAVIR AS SULFATE
GLAXO SMITH KLINE (ISRAEL) LTD
J05AF06
FILM COATED TABLETS
ABACAVIR AS SULFATE 300 MG
PER OS
Required
VIIV HEALTHCARE UK LIMITED, UK
ABACAVIR
Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected .
2023-11-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed according to a physician s prescription only ZIAGEN TABLETS, 300 mg Film-coated tablets Each tablet contains abacavir (as sulfate) 300 mg For the list of the inactive and allergenic ingredients in the medicine, see section 2 – Important information about some of the ingredients in the medicine and section 6 – Additional information . Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the physician or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their medical condition is similar. 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 preparations. 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 the medical staff about abacavir hypersensitivity. Detach this card and keep it with you at all times. This card contains important safety information that you must know and abide by before starting treatment and during the course of treatment with Ziagen. Read the Alert Card and patient leaflet before starting to use the preparation. 1. WHAT IS THE MEDICINE INTENDED FOR? Ziagen is used to treat HIV (human immunodeficiency syndrome) infection. Therapeutic group: 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, Lees het volledige document
Page 1 of 20 ZIAGEN TABLETS 1. NAME OF THE MEDICINAL PRODUCT Ziagen tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 300 mg of abacavir (as sulfate). For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablets) The scored tablets are yellow, biconvex, capsule shaped and are engr aved with ‘GX 623’ on both sides. The tablet can be divided into equal halves. PATIENT ALERT CARD The marketing of Ziagen Tablets is subject to risk management plan (RMP) including a "Patient Alert card". The "Patient Alert card", emphasizes important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review the card before starting treatment. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection. The demonstration of the benefit of Ziagen is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy (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. Page 2 of 20 To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing. Ziagen is also available as an oral solution for use in children over three months of age and weighing less than 14 kg and for those patients for whom the tablets are inappropriate. Alternatively, for patients who are unable to swallow tablets, the tablet(s) may be crushed and added to a small amount of semi-solid food or liquid, all o Lees het volledige document