Nazione: Israele
Lingua: inglese
Fonte: Ministry of Health
DOLUTEGRAVIR AS SODIUM
GLAXO SMITH KLINE (ISRAEL) LTD
J05AX12
FILM COATED TABLETS
DOLUTEGRAVIR AS SODIUM 50 MG
PER OS
Required
GLAXO WELLCOME SA, SPAIN
DOLUTEGRAVIR
Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children above 6 years of age.
2019-01-31
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986 The medicine is dispensed with a physician’s prescription only TIVICAY 10 MG TIVICAY 25 MG TIVICAY 50 MG FILM-COATED TABLETS. Each tablet contains: Tivicay 10 mg: DOLUTEGRAVIR (AS SODIUM) 10 MG Tivicay 25 mg: DOLUTEGRAVIR (AS SODIUM) 25 MG Tivicay 50 mg: DOLUTEGRAVIR (AS SODIUM) 50 MG The list of the additional ingredients is detailed in section 6. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further 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. 1. WHAT IS THE MEDICINE INTENDED FOR? Tivicay is used to treat HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION in adults, adolescents and children over 6 years old and weighing at least 15 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, 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 physician will monitor the effectiveness of your treatment. Tivicay treatment is always in combination with other antiretroviral medicines (_combination therapy_). To control your HIV infection, and to prevent your illness from getting worse, you must continue taking all your medicines, unless your physician tells you to stop taking any of them. THERAPEUTIC GROUP Tivicay contains the active ingredient dolutegravir. This medicine belongs to a group of antiretroviral medicines called _integrase _ _inhibitors (INIs)_. 2. BEFORE USING THE MEDICINE DO NOT USE THE MEDICINE: • if you (or your child, if they are the patient) are sensitive (allergic) to the active ingredient or to any of the other ingred Leggi il documento completo
1 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 2 Tivicay is indicated in combination with other anti-retroviral medicinal products for the treatment of Human Immunodeficiency Virus (HIV) infected adults, adolescents and children above 6 years of age. 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 (one tablet) 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 infected with HIV-1 with resistance to the integrase class (docume Leggi il documento completo