Krajina: Európska únia
Jazyk: angličtina
Zdroj: EMA (European Medicines Agency)
elvitegravir
Gilead Sciences International Ltd
J05AX11
elvitegravir
Antivirals for systemic use
HIV Infections
Vitekta co-administered with a ritonavir-boosted protease inhibitor and with other antiretroviral agents, is indicated for the treatment of human-immunodeficiency-virus-1 (HIV-1) infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir.
Revision: 4
Withdrawn
2013-11-13
50 B. PACKAGE LEAFLET Medicinal product no longer authorised 51 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT VITEKTA 85 MG FILM-COATED TABLETS Elvitegravir 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 Vitekta is and what it is used for 2. What you need to know before you take Vitekta 3. How to take Vitekta 4. Possible side effects 5. How to store Vitekta 6. Contents of the pack and other information 1. WHAT VITEKTA IS AND WHAT IT IS USED FOR Vitekta contains the active substance elvitegravir. Vitekta is a TREATMENT FOR HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION in adults aged 18 years and over. VITEKTA MUST ALWAYS BE TAKEN WITH CERTAIN OTHER HIV MEDICINES. See section 3, _How to take _ _Vitekta_ . The HIV virus produces an enzyme called HIV integrase. This enzyme helps the virus to multiply in the cells in your body. Vitekta stops this enzyme working and reduces the amount of HIV in your body. This will improve your immune system and reduce the risk of developing illnesses linked to HIV infection. This medicine is not a cure for HIV infection. While taking Vitekta you may still develop infections or other illnesses associated with HIV infection. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VITEKTA DO NOT TAKE VITEKTA • IF YOU ARE ALLERGIC TO ELVITEGRAVIR or any of the o Prečítajte si celý dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 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 Vitekta 85 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 85 mg of elvitegravir. Excipient with known effect: Each tablet contains 6.2 mg lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). Green, pentagon-shaped, film-coated tablet of dimensions 8.9 mm x 8.7 mm, debossed with “GSI” on one side of the tablet and “85” on the other side of the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vitekta co-administered with a ritonavir-boosted protease inhibitor and with other antiretroviral agents, is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults who are infected with HIV-1 without known mutations associated with resistance to elvitegravir (see sections 4.2 and 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. Posology Vitekta must be administered in combination with a ritonavir-boosted protease inhibitor. The Summary of Product Characteristics for the co-administered ritonavir-boosted protease inhibitor should be consulted. The recommended dose of Vitekta is one 85 mg tablet or one 150 mg tablet taken orally once daily with food. The choice of dose of Vitekta depends on the co-administered protease inhibitor (see Table 1 and sections 4.4 and 4.5). For use of the 150 mg tablet, please refer to the Summary of Product Characteristics for Vitekta 150 mg tablets. Vitekta should be administered once daily as follows: - Either at the same time as a once daily ritonavir-boosted prot Prečítajte si celý dokument