البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
ABACAVIR AS SULFATE; DOLUTEGRAVIR AS SODIUM; LAMIVUDINE
GLAXO SMITH KLINE (ISRAEL) LTD
J05AR13
FILM COATED TABLETS
DOLUTEGRAVIR AS SODIUM 50 MG; ABACAVIR AS SULFATE 600 MG; LAMIVUDINE 300 MG
PER OS
Required
VIIV HEALTHCARE UK LIMITED, UK
LAMIVUDINE AND ABACAVIR AND DOLUTEGRAVIR
Triumeq is indicated for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age weighing at least 40 kg.Before initiating treatment with abacavir-containing products, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin. Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
2020-02-29
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed according to a physician’s prescription only TRIUMEQ, FILM-COATED TABLETS EACH TABLET CONTAINS: DOLUTEGRAVIR (AS SODIUM) 50 MG ABACAVIR (AS SULFATE) 600 MG LAMIVUDINE 300 MG For the list of inactive and allergenic ingredients in the preparation, see section 2 – “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, refer to the 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. IMPORTANT — HYPERSENSITIVITY REACTIONS TRIUMEQ CONTAINS ABACAVIR AND DOLUTEGRAVIR. Both of these active ingredients can cause a serious allergic reaction known as a hypersensitivity reaction, which can be life-threatening in people who continue to take abacavir-containing products. ! YOU MUST CAREFULLY READ ALL THE INFORMATION UNDER ‘HYPERSENSITIVITY REACTIONS’ IN THE PANEL IN SECTION 4. The Triumeq pack includes an ALERT CARD, to remind you and the medical staff about hypersensitivity to abacavir. DETACH THIS CARD AND KEEP IT WITH YOU AT ALL TIMES. This card contains important safety information that you must know and act upon before starting and during treatment with Triumeq. Read the Alert Card and the patient leaflet before starting to use the preparation. 1. WHAT IS THE MEDICINE INTENDED FOR? Triumeq is used to treat HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION in adults and adolescents over 12 years old who weigh at least 40 kg. Before you are prescribed Triumeq your physician will arrange a test to find out whether you carry a particular type of gene called HLA-B*5701. Triumeq should not be used in patients who are known to carry the HLA-B*5701 gene. Patients w اقرأ الوثيقة كاملة
1 TRIUMEQ 1. NAME OF THE MEDICINAL PRODUCT Triumeq film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 50 mg dolutegravir (as sodium), 600 mg of abacavir (as sulfate) and 300 mg of lamivudine. For the full list of excipients see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet) Purple, biconvex, film- coated oval tablets, approximately 22 x 11 mm, debossed with “572 Trı” on one side. PATIENT ALERT CARD The marketing of Triumeq 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 _ _ Triumeq is indicated for the treatment of Human Immunodeficiency Virus (HIV) infected adults and adolescents above 12 years of age weighing at least 40 kg (see sections 4.4 and 5.1). Before initiating treatment with abacavir-containing products, 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 and adolescents (weighing at least 40kg) _ The recommended dose of Triumeq in adults and adolescents is one tablet once daily._ _ Triumeq should not be administered to adults or adolescents who weigh less than 40 kg because it is a fixed-dose tablet that cannot be dose reduced. 2 Separate preparations of dolutegravir, 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. A separate preparatio اقرأ الوثيقة كاملة