Nazione: Regno Unito
Lingua: inglese
Fonte: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nevirapine hemihydrate
Boehringer Ingelheim Ltd
J05AG01
Nevirapine hemihydrate
10mg/1ml
Oral suspension
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05030100; GTIN: 5012816049994
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VIRAMUNE 50 MG/5 ML ORAL SUSPENSION 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 section 6 “ _W Leggi il documento completo
OBJECT 1 VIRAMUNE 50MG/5ML ORAL SUSPENSION Summary of Product Characteristics Updated 28-Nov-2017 | Boehringer Ingelheim Limited 1. Name of the medicinal product Viramune 50 mg/5 ml oral suspension 2. Qualitative and quantitative composition Each ml of oral suspension contains 10 mg of nevirapine (as hemihydrate). Each bottle contains 2.4 g of nevirapine (as hemihydrate) in 240 ml of Viramune oral suspension. Excipient with known effect Each ml of oral suspension contains 150 mg sucrose, 162 mg sorbitol, 1.8 mg of methyl parahydroxybenzoate and 0.24 mg of propyl parahydroxybenzoate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Oral suspension White to off-white homogenous suspension. 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 for Viramune is 20 ml (200 mg) oral suspension once 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 20 ml (200 mg) oral suspension twice daily, in combination with at least two additional antiretroviral agents. Viramune is also available as a 200 mg tablet for patients 16 years and older, or for older children, particularly adolescents, weighing 50 kg or more or whose BSA is above 1.25 m 2 . 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 m Leggi il documento completo