Country: Nýja-Sjáland
Tungumál: enska
Heimild: Medsafe (Medicines Safety Authority)
Abacavir sulfate 702mg equivalent to abacavir 600 mg; ; ; Lamivudine 300mg;
GlaxoSmithKline NZ Limited
Abacavir sulfate 702 mg (equivalent to abacavir 600 mg)
600mg/300mg
Film coated tablet
Active: Abacavir sulfate 702mg equivalent to abacavir 600 mg Lamivudine 300mg Excipient: Magnesium stearate Microcrystalline cellulose Opadry orange YS-1-13065A Sodium starch glycolate
Blister pack, PVdC x 30 tablets, 30 tablets
Prescription
Prescription
Piramal Enterprises Limited
KIVEXA is a combination of two nucleoside analogues (abacavir and lamivudine). It is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age.
Package - Contents - Shelf Life: Blister pack, PVC/child resistant/senior friendly foil - 30 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVdC - 30 tablets - 36 months from date of manufacture stored at or below 30°C
2004-02-27
KIVEXA TABLETS 1 KIVEXA TABLETS _Film-coated tablets _ _600 mg abacavir (as sulfate) and 300 mg lamivudine _ CONSUMER MEDICINE INFORMATION PATIENTS TAKING KIVEXA, WHICH CONTAINS ABACAVIR, MAY DEVELOP A HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF TREATMENT WITH KIVEXA IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING KIVEXA IF: 1) YOU GET A SKIN RASH OR 2) YOU GET ONE OR MORE SYMPTOMS FROM AT LEAST TWO OF THE FOLLOWING GROUPS: FEVER SHORTNESS OF BREATH, SORE THROAT OR COUGH NAUSEA OR VOMITING OR DIARRHOEA OR ABDOMINAL PAIN SEVERE TIREDNESS OR ACHINESS OR GENERALLY ILL FEELING IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO KIVEXA TABLETS, NEVER TAKE KIVEXA, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (ZIAGEN, TRIZIVIR AND TRIUMEQ) AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN BE FATAL. THERE IS AN ALERT CARD INCLUDED IN THE KIVEXA PACK, TO REMIND YOU AND MEDICAL STAFF ABOUT ABACAVIR HYPERSENSITIVITY. THIS CARD SHOULD BE REMOVED FROM THE PACK AND KEPT WITH YOU AT ALL TIMES. SEE MORE DETAILS UNDER BEFORE YOU TAKE KIVEXA. WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you start KIVEXA tablets. This leaflet answers some common questions about KIVEXA tablets. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist (also known as a chemist). All medicines have benefits and risks. Your doctor has weighed the expected benefits of you taking KIVEXA tablets against the risks this medicine could have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE TABLETS. You may need to read it again. WHAT KIVEXA TABLETS ARE USED FOR KIVEXA tablets contain abacavir and lamivudine which belong to a group of medicines called antiretrovirals. These are also available as separate medicinal products: ZIAGEN (abacavir) and 3TC (lamivudine). KIVEXA tablets are Lestu allt skjalið
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME KIVEXA abacavir and lamivudine 600 mg/300 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 600 mg of abacavir as abacavir sulfate and 300 mg lamivudine. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Film-coated tablets. Orange, film-coated, modified capsule shaped tablets, debossed with GS FC2 on one side. Do not halve tablets. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS KIVEXA is a combination of two nucleoside analogues (abacavir and lamivudine). It is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age. 4.2 DOSE AND METHOD OF ADMINISTRATION Therapy should be initiated by a physician experienced in the management of HIV infection. KIVEXA should not be administered to adults or adolescents who weigh less than 40 kg because it is a fixed-dose tablet that cannot be dose reduced. KIVEXA is a fixed-dose tablet and should not be prescribed for patients requiring dosage adjustments, such as those with creatinine clearance less than 50 mL/min. Separate preparations of abacavir (ZIAGEN) or lamivudine (3TC) should be administered in cases where discontinuation or dose adjustment is indicated. In these cases the physician should refer to the individual product information for these medicinal products. Dose KIVEXA can be taken with or without food. Do not halve tablet. _Adults and adolescents _ The recommended dose of KIVEXA in adults and adolescents weighing 40 kg or more is one tablet once daily. 2 Special populations _Elderly _ The pharmacokinetics of abacavir and lamivudine have not been studied in patients over 65 years of age. When treating elderly patients, consideration needs to be given to the greater frequency of decreased hepatic, renal and cardiac function, concomitant medicinal products or disease. _Renal impairment _ Whilst no dosage adjustment of abacavir is Lestu allt skjalið