Negara: Uni Eropa
Bahasa: Inggris
Sumber: EMA (European Medicines Agency)
Etravirine
Janssen-Cilag International NV
J05AG04
etravirine
Non-nucleoside reverse transcriptase inhibitors, Antivirals for systemic use
HIV Infections
Intelence, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human-immunodeficiency-virus-type-1 (HIV-1) infection in antiretroviral-treatment-experienced adult patients and in antiretroviral-treatment-experienced paediatric patients from six years of age.This indication is based on week-48 analyses from two phase-III trials in highly pretreated patients where Intelence was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48-week analyses of a single-arm, phase-II trial in antiretroviral-treatment-experienced paediatric patients.
Revision: 30
Authorised
2008-08-28
45 B. PACKAGE LEAFLET 46 PACKAGE LEAFLET: INFORMATION FOR THE USER INTELENCE 25 MG TABLETS etravirine 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 INTELENCE is and what it is used for 2. What you need to know before you take INTELENCE 3. How to take INTELENCE 4. Possible side effects 5. How to store INTELENCE 6. Contents of the pack and other information 1. WHAT INTELENCE IS AND WHAT IT IS USED FOR INTELENCE contains the active substance etravirine. INTELENCE belongs to a group of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). INTELENCE is a medicine used for the treatment of Human Immunodeficiency Virus (HIV) infection. INTELENCE works by reducing the amount of HIV in your body. This will improve your immune system and reduces the risk of developing illnesses linked to HIV infection. INTELENCE is used in combination with other anti-HIV medicines to treat adults and children 2 years of age and older who are infected by HIV and who have used other anti-HIV medicines before. Your doctor will discuss with you which combination of medicines is best for you. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE INTELENCE DO NOT TAKE INTELENCE - if you are allergic to etravirine or any of the other ingredients of this medicine (listed in section 6) - if you are taking elbasvir/grazoprevir (a medicine to treat hepatitis C infection). WARNINGS AND PRECAUTIONS Talk to your doctor or pharmacist before taking INTELENCE. INTELENCE is not a cure for HIV infection. It is part of a t Baca dokumen lengkapnya
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT INTELENCE 25 mg tablets INTELENCE 100 mg tablets INTELENCE 200 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION INTELENCE 25 mg tablets Each tablet contains 25 mg of etravirine. Excipient with known effect Each tablet contains 40 mg lactose (as monohydrate). Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free. INTELENCE 100 mg tablets Each tablet contains 100 mg of etravirine. Excipient with known effect Each tablet contains 160 mg lactose (as monohydrate). Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free. INTELENCE 200 mg tablets Each tablet contains 200 mg of etravirine. Excipient with known effect Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM INTELENCE 25 mg tablets Tablet White to off-white, oval, scored tablet, debossed with “TMC” on one side. The tablet can be divided into two equal doses. INTELENCE 100 mg tablets Tablet White to off-white, oval tablet debossed with “T125” on one side and “100” on the other side. INTELENCE 200 mg tablets Tablet White to off-white, biconvex, oblong tablet debossed with “T200” on one side. 3 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS INTELENCE, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in antiretroviral treatment-experienced adult patients and in antiretroviral treatment-experienced paediatric patients from 2 years of age (see sections 4.4, 4.5 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 INTELENCE must always be given in combination with other antiretroviral medicinal products. _Adults_ The recommended dose of etravirine for adults is 200 mg (on Baca dokumen lengkapnya