Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
dolutegravir sodium, lamivudine, abacavir (as sulfate)
ViiV Healthcare B.V.
J05AR13
abacavir sulfate / dolutegravir sodium / lamivudine
Antivirals for systemic use
HIV Infections
Triumeq is indicated for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children weighing at least 25 kg who are antiretroviral treatment-naïve or are infected with HIV without documented or clinically suspected resistance to any of the three antiretroviral agents in Triumeq.
Revision: 32
Authorised
2014-08-31
92 B. PACKAGE LEAFLET 93 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRIUMEQ 50 MG/600 MG/300 MG FILM-COATED TABLETS dolutegravir/abacavir/lamivudine 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. WHAT IS IN THIS LEAFLET 1. What Triumeq is and what it is used for 2. What you need to know before you take Triumeq 3. How to take Triumeq 4. Possible side effects 5. How to store Triumeq 6. Contents of the pack and other information 1. WHAT TRIUMEQ IS AND WHAT IT IS USED FOR Triumeq is a medicine that contains three active substances used to treat HIV infection: abacavir, lamivudine and dolutegravir. Abacavir and lamivudine belong to a group of anti-retroviral medicines (medicines used to treat HIV infection) called _nucleoside analogue reverse transcriptase inhibitors _ _(NRTIs)_ , and dolutegravir belongs to a group of anti-retroviral medicines called _integrase inhibitors _ _(INIs)_ . Triumeq is used to treat HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION in adults, adolescents and children who weigh at least 25 kg. Before you are prescribed Triumeq your doctor 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 with this gene are at a high risk of developing a serious hypersensitivity (allergic) reaction if they use Triumeq (see ‘hypersensitivity reactions’ in section 4). Triumeq does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also inc Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Triumeq 50 mg/600 mg/300 mg 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. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _ _ Triumeq is indicated for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children weighing at least 25 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,adolescents and children (weighing at least 25kg) _ The recommended dose of Triumeq in adults,adolescents and children is one tablet once daily. _ _ Triumeq film-coated tablets should not be administered to adults, adolescents or children who weigh less than 25 kg because it is a fixed-dose tablet that cannot be dose reduced. Triumeq dispersible tablets should be administered to children who weigh at least 14 kg to less than 25 kg. 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 dose of dolutegravir (film-coated tablets or dispersible tablets) is applicable where a dose adjustment is indicated due to drug-drug interactions Aqra d-dokument sħiħ