देश: इसराइल
भाषा: अंग्रेज़ी
स्रोत: Ministry of Health
ABACAVIR; LAMIVUDINE
TARO INTERNATIONAL LTD, ISRAEL
J05AR02
FILM COATED TABLETS
LAMIVUDINE 300 MG; ABACAVIR 600 MG
PER OS
Required
REMEDICA LTD., CYPRUS
LAMIVUDINE AND ABACAVIR
ABACAVIR LAMIVUDINE TARO is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg.
2020-06-14
Page 1 of 12 Abacavir Lamivudine Taro – ENG Patient leaflet in accordance with the Pharmacists' Regulations (Preparations) - 1986 The medicine is dispensed according to a physician’s prescription only Abacavir-Lamivudine Taro Film-coated tablets Active ingredients: Each film-coated tablet contains: 600 mg abacavir 300 mg lamivudine Inactive ingredients and allergens: see section 2 under ‘Important information about some of the ingredients of the medicine’ and section 6 ‘Additional information’. Read the entire leaflet carefully before using the medicine. This leaflet contains concise information about the medicine. If you have any other questions, consult your physician or the 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 to yours. IMPORTANT - Hypersensitivity reactions Abacavir-Lamivudine Taro contains abacavir (which is also an active ingredient in medicines such as Trizivir, Triumeq and Ziagen). Some people who take abacavir may develop a hypersensitivity reaction (a serious allergic reaction), which can be life-threatening, if they continue to take products containing abacavir. You must carefully read al l the information under ‘Hypersensitivity reactions’ in the panel in section 4. The Abacavir-Lamivudine Taro 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 Abacavir-Lamivudine Taro. Read the alert card and patient leaflet before starting to use the medicine. 1. What is the medicine intended for? Abacavir-Lamivudine Taro is used to treat HIV (human immunodeficiency syndrome) infection in adults, adolescents and in children weighing at least 25 kg. Therapeutic group: Abacavir-Lamivudine Taro contains two active ingredients that are us पूरा दस्तावेज़ पढ़ें
Page 1 of 24 1. NAME OF THE MEDICINAL PRODUCT ABACAVIR LAMIVUDINE TARO 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg of abacavir (as sulfate) and 300 mg lamivudine. Excipient(s) with known effect: Each 600 mg/300 mg tablet contains 1.86 mg sunset yellow FCF (E110) and 2.02 mg sodium. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Orange, film-coated, modified capsule shaped tablets. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications ABACAVIR LAMIVUDINE TARO is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children weighing at least 25 kg (see sections 4.4 and 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 Therapy should be prescribed by a physician experienced in the management of HIV infection. Posology _Adults, adolescents and children weighing at least 25 kg _ The recommended dose of ABACAVIR LAMIVUDINE TARO is one tablet once daily. _Children Under 25 kg _ ABACAVIR LAMIVUDINE TARO should not be administered to children who weigh less than 25 kg because it is a fixed-dose tablet that cannot be dose reduced. ABACAVIR LAMIVUDINE TARO is a fixed-dose tablet and should not be prescribed for patients requiring dose adjustments. Separate preparations of abacavir or lamivudine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated. In these cases, the physician should refer to the individual product information for these medicinal products. Page 2 of 24 Special Populations _Elderly _ No pharmacokinetic data are currently available in patients over 65 years of age. Special care is advised in this age group due to age पूरा दस्तावेज़ पढ़ें