Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
dolutegravir
ViiV Healthcare BV
J05AX12
dolutegravir
Antivirals for systemic use
HIV Infections
Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg.Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 4 weeks of age or older and weighing at least 3 kg.
Revision: 34
Authorised
2014-01-16
81 B. PACKAGE LEAFLET 82 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT TIVICAY 10 MG FILM-COATED TABLETS TIVICAY 25 MG FILM-COATED TABLETS TIVICAY 50 MG FILM-COATED TABLETS dolutegravir READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU (OR YOUR CHILD, IF THEY ARE THE PATIENT) 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 (or your child, if they are the patient) 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 Tivicay is and what it is used for 2. What you need to know before you take Tivicay 3. How to take Tivicay 4. Possible side effects 5. How to store Tivicay 6. Contents of the pack and other information 1. WHAT TIVICAY IS AND WHAT IT IS USED FOR Tivicay contains the active ingredient dolutegravir. Dolutegravir belongs to a group of anti-retroviral medicines called _integrase inhibitors (INIs)_ . Tivicay is used to treat HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION in adults, adolescents and children of at least 6 years of age or older, and who weigh at least 14 kg. Tivicay does not cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. As a result of that, it also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection. Not everyone responds to treatment with Tivicay in the same way. Your doctor will monitor the effectiveness of your treatment. Tivicay is always used in combination with other anti-retroviral medicines ( _combination therapy_ ). To control your HIV infection, and to stop your illness from getting worse, you must keep taking all your medicines, un Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Tivicay 10 mg film-coated tablets Tivicay 25 mg film-coated tablets Tivicay 50 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tivicay 10 mg film-coated tablets Each film-coated tablet contains dolutegravir sodium equivalent to 10 mg dolutegravir. Tivicay 25 mg film-coated tablets Each film-coated tablet contains dolutegravir sodium equivalent to 25 mg dolutegravir. Tivicay 50 mg film-coated tablets Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Tivicay 10 mg film-coated tablets White, round, biconvex tablets approximately 6 mm in diameter debossed with ‘SV 572’ on one side and ‘10’ on the other side. Tivicay 25 mg film-coated tablets Pale yellow, round, biconvex tablets approximately 7 mm in diameter debossed with ‘SV 572’ on one side and ‘25’ on the other side. Tivicay 50 mg film-coated tablets Yellow, round, biconvex tablets approximately 9 mm in diameter debossed with ‘SV 572’ on one side and ‘50’ on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children of at least 6 years of age or older and weighing at least 14 kg. 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Tivicay should be prescribed by physicians experienced in the management of HIV infection. _ _ Posology _Adults _ _ _ _Patients infected with HIV-1 without documented or clinically suspected resistance to the integrase class _ The recommended dose of dolutegravir is 50 mg orally once daily. Dolutegravir should be administered twice daily in this population when co-administered with some medicines (e.g. efavirenz, nevirapine, tipranavir/ritonavir, or rifampicin). Please refer to section 4.5. _Patients in Pročitajte cijeli dokument