Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
ABACAVIR AS SULFATE
GLAXO SMITH KLINE (ISRAEL) LTD
J05AF06
SOLUTION (ORAL)
ABACAVIR AS SULFATE 20 MG/ML
PER OS
Required
GLAXO SMITH KLINE INC., CANADA
ABACAVIR
ABACAVIR
Ziagen is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infected .28/10/2018 בקשה לשינוי משטר מינון
2014-03-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed according to a physician's prescription only ZIAGEN ORAL SOLUTION EACH ML OF ZIAGEN ORAL SOLUTION CONTAINS: ABACAVIR (AS SULFATE) 20 MG. List of the additional ingredients is detailed in Section 6. READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have any other questions, refer to the physician or the pharmacist. This medicine has been prescribed for the treatment of your illness. Do not pass it on to others. It may harm them even if it seems to you that their illness 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 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 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 VIRUS) 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, 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 im Прочитайте повний документ
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 engraved with ‘GX 623’ on both sides. The tablet can be divided into equal halves. 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. 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. Page 2 of 20 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 of which should be consumed immediately (see section 5.2). _Adults, adolescents and children (weighing at least 25 kg): _ The recommended dose of Ziagen is 600 mg daily. This may be administered as either 300 mg (one tablet) twice daily or 600 mg (two tablets) once daily (see sections 4.4 and 5.1). _Children (weighing less than 25 kg): _ Dosi Прочитайте повний документ