Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Nevirapine hemihydrate 10.35 mg/mL equivalent 10 mg/mL nevirapine;
Boehringer Ingelheim (NZ) Ltd
Nevirapine hemihydrate 10.35 mg/mL (equivalent 10 mg/mL nevirapine)
10 mg/mL
Oral suspension
Active: Nevirapine hemihydrate 10.35 mg/mL equivalent 10 mg/mL nevirapine Excipient: Carbomer Methyl hydroxybenzoate Polysorbate 80 Propyl hydroxybenzoate Purified water Sodium hydroxide Sorbitol as 231.3 mg/mL Sorbitol 70% solution Sucrose
Bottle, plastic, ldpe liner and CRC, 240 mL
Prescription
Prescription
Boehringer Ingelheim Chemicals Inc.
VIRAMUNE is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children over the age of 2 months.
Package - Contents - Shelf Life: Bottle, plastic, ldpe liner and CRC - 240 mL - 36 months from date of manufacture stored at or below 30°C 6 months opened stored at or below 30°C
1998-10-29
VIRAMUNE CMI0057-17 1 VIRAMUNE ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I TAKING VIRAMUNE? Viramune contains the active ingredient nevirapine. Viramune is used in the treatment of the infection caused by the Human Immunodeficiency Virus (HIV-1). For more information, see Section 1. Why am I taking Viramune? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE VIRAMUNE? Do not take Viramune if you have ever had an allergic reaction to nevirapine or any of the ingredients listed at the end of the CMI. Do not take Viramune if you have rare inherited problems of galactose or fructose intolerance, severe liver dysfunction or if you previously experienced serious liver or skin reactions while taking Viramune. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I take Viramune? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with Viramune and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE VIRAMUNE? Adults 16 years and older: • FIRST 14 DAYS: Take one nevirapine 200 mg immediate release tablet or 20 mL Viramune oral suspension once daily. • AFTER THE FIRST 14 DAYS: Take one nevirapine 200 mg immediate release tablet or 20 mL Viramune oral suspension twice daily (i.e. at regular 12-hour intervals at about the same time each day: morning and night). Children (aged 2 months or older) and adolescents to 15 years: • Your child's doctor will determine the dose of Viramune based on your child's age and body weight, or body surface area. • FIRST 14 DAYS: Viramune oral suspension is given once daily. • AFTER THE FIRST 14 DAYS: Viramune oral suspension is given twice daily. More instructions c Read the complete document
VIRAMUNE NZ DS v02 1 NEW ZEALAND DATASHEET 1. PRODUCT NAME VIRAMUNE 50 mg/5 mL oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION VIRAMUNE 50 mg/5 mL oral suspension contains 10 mg nevirapine per mL (in the form of 10.35 mg/mL of nevirapine hemihydrate). Excipients with known effect: Each mL of oral suspension contains 150 mg sucrose, 162 mg sorbitol, 1.8 mg of methyl hydroxybenzoate and 0.24 mg of propyl hydroxybenzoate. 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 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and children over the age of 2 months. Resistant virus emerges rapidly and uniformly when VIRAMUNE is administered as monotherapy. Therefore, VIRAMUNE should always be administered in combination with at least two additional antiretroviral agents. 4.2 DOSE AND METHOD OF ADMINISTRATION Patients 16 years and older The recommended dose for VIRAMUNE is 20 mL (200 mg) oral suspension 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 oral suspension twice daily, in combination with at least two additional antiretroviral agents. VIRAMUNE can be taken with or without food. For concomitantly administered nucleoside therapy, the manufacturer's recommended dosage and monitoring should be followed. Paediatric Patients The total daily dose should not exceed 400 mg of VIRAMUNE. VIRAMUNE may be dosed in paediatric patients either by body surface area (BSA) or by body weight as follows: By BSA using the Mosteller formula the recommended oral dose for paediatric patients of all ages is 150 mg/m 2 once daily for two weeks followed by 150 mg/m 2 twice daily thereafter. Calculation of the volume of VIRAMUNE oral suspension (50 mg/5 ml) required for paediatric dosing on a body surface basis of 150 mg/m 2 : VIRAMUNE Read the complete document