Država: Europska Unija
Jezik: engleski
Izvor: EMA (European Medicines Agency)
nevirapine
Boehringer Ingelheim International GmbH
J05AG01
nevirapine
Antivirals for systemic use
HIV Infections
Tablets and oral suspensionViramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents, and children of any age.Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.50- and 100-mg prolonged-release tabletsViramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adolescents and children three years and above and able to swallow tablets.Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.400-mg prolonged-release tabletsViramune is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults, adolescents and children three years and above and able to swallow tablets.Prolonged-release tablets are not suitable for the 14-day lead-in phase for patients starting nevirapine. Other nevirapine formulations, such as immediate-release tablets or oral suspension should be used.Most of the experience with Viramune is in combination with nucleoside reverse-transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing.
Revision: 44
Authorised
1998-02-04
99 B. PACKAGE LEAFLET 100 PACKAGE LEAFLET: INFORMATION FOR THE USER VIRAMUNE 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 further questions, please 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 Viramune is and what it is used for 2. What you need to know before you take Viramune 3. How to take Viramune 4. Possible side effects 5. How to store Viramune 6. Contents of the pack and other information 1. WHAT VIRAMUNE IS AND WHAT IT IS USED FOR Viramune 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, Viramune helps control HIV-1 infection. Viramune is indicated for the treatment of HIV-1 infected adults, adolescents, and children of any age. You must take Viramune together with other antiretroviral medicines. Your doctor will recommend the best medicines for you. IF VIRAMUNE 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 VIRAMUNE DO NOT TAKE VIRAMUNE - if you are allergic to nevirapine or any of the other ingredients of this medicine (listed in sect Pročitajte cijeli dokument
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Viramune 200 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of nevirapine (as anhydrous). Excipients with known effect Each tablet contains 318 mg of lactose (as monohydrate). Each tablet contains less than 1 mmol sodium (23 mg), that is to say essentially ‘sodium-free’. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet. White, oval, biconvex tablets. One side is embossed with the code “54 193”, with a single bisect separating the “54” and “193”. The opposite side is marked with the company symbol. The score line is not intended for breaking the tablet. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Viramune 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 Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Viramune should be administered by physicians who are experienced in the treatment of HIV infection. Posology _Patients 16 years and older_ The recommended dose of Viramune 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. 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 than 8 hours later, the patient should only take the next dose at the usual time. _Dose management considerations_ Patients experiencing rash during the 14-day lead-in period of 200 mg/day should not have their V Pročitajte cijeli dokument