Country: Իսրայել
language: անգլերեն
source: Ministry of Health
NEVIRAPINE ANHYDROUS (AS HEMIHYDRATE)
BOEHRINGER INGELHEIM ISRAEL LTD.
J05AG01
SUSPENSION
NEVIRAPINE ANHYDROUS (AS HEMIHYDRATE) 50 MG / 5 ML
PER OS
Required
WEST-WARD COLUMBUS INC., USA
NEVIRAPINE
NEVIRAPINE
For use in combination with other antiretroviral agents for the treatment of HIV-1 infection.
2020-08-31
Proposed patient information Viramune April 2020 Suspension Page 1 of 11 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only VIRAMUNE ® SUSPENSION Name and quantity of active ingredient: Every 5 ml of Viramune suspension contain 50 mg nevirapine (as nevirapine anhydrous hemihydrate). Inactive ingredients and allergens in this medicine: See section 2 'Important information about some of this medicine’s ingredients' and section 6 'Additional information'. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? For the treatment of HIV-1 (human immunodeficiency virus) infections in combination with other antiretroviral medicines. THERAPEUTIC GROUP: antiretrovirals (anti-HIV - human immunodeficiency virus). The active ingredient, 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. By stopping the enzyme from working, nevirapine helps control HIV-1 infection. 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"). Proposed patient information Viramune April 2020 Suspension Page 2 of 11 2. BEFORE USING THIS MEDICINE SPECIAL WARNINGS ABOUT USING THIS MEDICINE TALK TO YOUR DOCTOR OR PHARMACIST BEFORE TAKING THIS MEDICINE. DURING THE FIRST 18 WEEKS OF TREATMENT WITH VIRAMUNE IT IS VERY IMPORTANT THAT YOU AND YOUR DOCTOR WATCH OUT FOR SIGNS OF LIVER OR SKIN REACTIONS, BECAUSE THESE CAN BECOME SEVERE AND EVEN LIFE THREAT read_full_document
Viramune Prescribing Information Suspension April 2020 Page 1 of 27 VIRAMUNE 50MG/5ML ORAL SUSPENSION PRESCRIBING INFORMATION 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. Excipients with known effect : Each ml of oral suspension contains 150 mg sucrose, 162 mg sorbitol, 1.8 mg of methyl paraben and 0.24 mg of propyl paraben. This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’. 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 For use in combination with other antiretroviral agents for the treatment of HIV-1 infection. 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). Viramune Prescribing Information Suspension April 2020 Page 2 of 27 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 olde read_full_document