Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
nevirapine, Quantity: 200 mg
Alphapharm Pty Ltd
Nevirapine
Tablet, uncoated
Excipient Ingredients: lactose monohydrate; colloidal anhydrous silica; microcrystalline cellulose; sodium starch glycollate type A; magnesium stearate; povidone
Oral
100, 60
(S4) Prescription Only Medicine
Nevirapine Viatris in combination with antiretroviral agents is indicated for the treatment of HIV-1 infection in adults. Resistant virus emerges rapidly when nevirapine is administered as monotherapy or in dual combination therapy with an antiretroviral agent. Therefore, nevirapine should always be administered in combination with at least two additional antiretroviral agents.
Visual Identification: White to off-white, oval shaped, biconvex uncoated tablet, debossed with 'NE" scoreline "200' on one side and "M" scoreline on the other side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2012-04-17
NEVIRAPINE VIATRIS N E V I R A P I N E V I A T R I S 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 USING NEVIRAPINE VIATRIS? NEVIRAPINE VIATRIS contains the active ingredient nevirapine. NEVIRAPINE VIATRIS 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 using NEVIRAPINE VIATRIS? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE NEVIRAPINE VIATRIS? Do not use if you have ever had an allergic reaction to nevirapine or any of the ingredients listed at the end of the CMI. 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 use NEVIRAPINE VIATRIS? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with NEVIRAPINE VIATRIS 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 USE NEVIRAPINE VIATRIS? Adults 16 years and older: • First 14 days: Take one NEVIRAPINE VIATRIS tablet once daily. • After the first 14 days: Take one NEVIRAPINE VIATRIS tablet twice daily. More instructions can be found in Section 4. How do I use NEVIRAPINE VIATRIS? in the full CMI. 5. WHAT SHOULD I KNOW WHILE USING NEVIRAPINE VIATRIS? THINGS YOU SHOULD DO • Remind any doctor or pharmacist you visit that you are using NEVIRAPINE VIATRIS. • Contact your doctor immediately if the rash is accompanied by other symptoms such as fever, blisters, mouth sores, conjunctivitis, facial swelling, muscle or joint aches or swollen lymph glands. THINGS YOU SHOULD NOT DO • Do not take NEVIRAPINE VIATRIS to treat any other complaints unless your doctor tells you to. • Do not stop taking your medicine or change the dosage without first checking wit Przeczytaj cały dokument
AUSTRALIAN PRODUCT INFORMATION NEVIRAPINE VIATRIS _nevirapine tablet _ 1 NAME OF THE MEDICINE Nevirapine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each NEVIRAPINE VIATRIS tablet contains 200 mg of nevirapine as the active ingredient. Excipients with known effect: sugars as lactose. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM NEVIRAPINE VIATRIS 200 mg tablets are white to off-white, oval shaped, biconvex uncoated tablets, debossed with “NE” scoreline “200” on one side and “M” scoreline on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS NEVIRAPINE VIATRIS in combination with antiretroviral agents is indicated for the treatment of HIV-1 infection in adults. Resistant virus emerges rapidly when nevirapine is administered as monotherapy or in dual combination therapy with an antiretroviral agent. Therefore, nevirapine should always be administered in combination with at least two additional antiretroviral agents. 4.2 DOSE AND METHOD OF ADMINISTRATION ADULTS 16 YEARS AND OLDER The recommended dose is NEVIRAPINE VIATRIS 200 mg 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 200 mg twice daily, in combination with at least two additional antiretroviral agents. For concomitantly administered antiretroviral therapy, the manufacturer’s recommended dosage and monitoring should be followed. NEVIRAPINE VIATRIS can be taken with or without food. DOSAGE MANAGEMENT CONSIDERATIONS Patients should be advised of the need to take nevirapine every day as prescribed. If a dose is missed the patient should not double the next dose but should take the next dose as soon as possible. Clinical chemistry tests, which include liver function tests, should be performed prior to initiating nevirapine therapy and at appropriate intervals during therapy. Nevirapine administration should be discontinued if patients who experience severe rash or a rash accompanied by constitutional s Przeczytaj cały dokument