Kraj: Wielka Brytania
Język: angielski
Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)
Lamivudine; Dolutegravir sodium; Abacavir sulfate
ViiV Healthcare UK Ltd
Lamivudine; Dolutegravir sodium; Abacavir sulfate
300mg ; 50mg ; 600mg
Tablet
Oral
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: 05030100; GTIN: 5000123114412
1 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TRIUMEQ 50 MG/600 MG/300 MG FILM-COATED TABLETS dolutegravir/abacavir/lamivudine This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 ingredients used to treat HIV infection: abacavir, lamivudine and dolutegravir. Abacavir and lamivudine belong to a group of anti-retroviral medicines 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 and children over 12 years old who weigh at least 40 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 ‘hy Przeczytaj cały dokument
OBJECT 1 TRIUMEQ 50MG, 300MG, 600MG TABLETS Summary of Product Characteristics Updated 20-Mar-2018 | ViiV Healthcare UK Ltd This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 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 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. Triumeq is a fixed-dose tablet and should not be prescribed for patients requiring dose adjustments. Separate preparations of dolutegravir, abacavir or lamivudine are available in cases where discontinuation or dose adjustment of one of the active substances i Przeczytaj cały dokument