Страна: Европейски съюз
Език: английски
Източник: EMA (European Medicines Agency)
nevirapine
Teva B.V.
J05AG01
nevirapine
Antivirals for systemic use
HIV Infections
Nevirapine Teva is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV 1 infected adults, adolescents, and children of any age.Most of the experience with nevirapine is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after nevirapine should be based on clinical experience and resistance testing.
Revision: 11
Withdrawn
2009-11-30
34 B. PACKAGE LEAFLET Medicinal product no longer authorised 35 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT NEVIRAPINE TEVA 200 MG TABLETS nevirapine 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 Nevirapine Teva is and what it is used for 2. What you need to know before you take Nevirapine Teva 3. How to take Nevirapine Teva 4. Possible side effects 5. How to store Nevirapine Teva 6. Contents of the pack and other information 1. WHAT NEVIRAPINE TEVA IS AND WHAT IT IS USED FOR Nevirapine Teva belongs to a group of medicines called antiretrovirals, used in the treatment of Human Immunodeficiency Virus (HIV-1) infection. The active substance of your medicine is called nevirapine. Nevirapine belongs to a class of anti-HIV medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs). Reverse transcriptase is an enzyme that HIV needs in order to multiply. Nevirapine stops reverse transcriptase from working. By stopping reverse transcriptase from working, Nevirapine Teva helps control HIV-1 infection. Nevirapine Teva is indicated for the treatment of HIV-1 infected adults, adolescents, and children of any age. You must take Nevirapine Teva together with other antiretroviral medicines. Your doctor will recommend the best medicines for you. IF NEVIRAPINE TEVA HAS BEEN PRESCRIBED FOR YOUR CHILD, PLEASE NOTE THAT ALL INFORMATION IN THIS LEAFLET IS ADDRESSED TO YOUR CHILD (IN THIS CASE PLEASE READ “YOUR CHILD” INSTEAD OF “YOU”). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE NEVIRAPINE TEV Прочетете целия документ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Nevirapine Teva 200 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of nevirapine (as anhydrous). Excipient with known effect: Each tablet contains 168 mg of lactose (as monohydrate). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White, oval, biconvex tablets. One side is debossed with "N", a scoreline and "200". The opposite side is debossed with a scoreline. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Nevirapine Teva is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age (see section 4.2). Most of the experience with nevirapine is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after nevirapine should be based on clinical experience and resistance testing (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Nevirapine Teva should be administered by physicians who are experienced in the treatment of HIV infection. Posology _Patients 16 years and older _ The recommended dose of Nevirapine Teva is one 200 mg tablet daily for the first 14 days (this lead- in period should be used because it has been found to lessen the frequency of rash), followed by one 200 mg tablet twice daily, in combination with at least two additional antiretroviral agents. For patients who are unable to swallow tablets or who weigh less than 50 kg or whose body surface area is below 1.25 m 2 according to the Mosteller formula, other nevirapine containing oral formulations are available and should be used if appropriate. If a dose is recognized as missed within 8 hours of when it was due, the patient should take the missed dose as soon as possible. If a dose is missed and it is more Прочетете целия документ