País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
abacavir sulfate,lamivudine
Apotex Pty Ltd
Abacavir sulfate,Lamivudine
Registered
ABACAVIR/LAMIVUDINE 600/300 APOTEX TABLET _Contains the active ingredients abacavir (as sulfate) and lamivudine_ CONSUMER MEDICINE INFORMATION PATIENTS TAKING ABACAVIR AND LAMIVUDINE COMBINATION TABLETS, WHICH CONTAINS ABACAVIR, MAY DEVELOP A HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF TREATMENT WITH THIS MEDICINE IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING ABACAVIR AND LAMIVUDINE COMBINATION TABLETS 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 GENERAL ILL FEELING IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO ABACAVIR AND LAMIVUDINE COMBINATION TABLETS, NEVER TAKE ABACAVIR AND LAMIVUDINE, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR, AS YOU MAY DEVELOP A LIFE-THREATENING REACTION WHICH CAN BE FATAL. THERE IS AN ALERT CARD INCLUDED IN THE ABACAVIR AND LAMIVUDINE 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 ABACAVIR AND LAMIVUDINE. _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR This medicine contains the active ingredients abacavir (as sulfate) and lamivudine which belong to a group of medicines called antiretrovirals. Abacavi Leia o documento completo
1 AUSTRALIAN PRODUCT INFORMATION ABACAVIR/LAMIVUDINE 600/300 APOTEX (ABACAVIR SULFATE AND LAMIVUDINE) TABLET WARNING: ABACAVIR, A COMPONENT OF ABACAVIR AND LAMIVUDINE COMBINATION TABLETS, IS ASSOCIATED WITH HYPERSENSITIVITY REACTIONS, WHICH CAN BE LIFE-THREATENING, AND IN RARE CASES FATAL. ABACAVIR AND LAMIVUDINE COMBINATION TABLETS, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR, MUST NEVER BE RESTARTED FOLLOWING A HYPERSENSITIVITY REACTION (SEE SECTIONS 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE AND 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)). 1 NAME OF THE MEDICINE Abacavir (as sulfate) and lamivudine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 600 mg abacavir (as sulfate) and 300 mg lamivudine as the active ingredient. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM Orange coloured, modified capsule-shaped, biconvex film-coated tablet with engraved “APO” on one side and “600/300” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Abacavir and lamivudine combination tablets are a combination of two nucleoside analogues (abacavir and lamivudine). Abacavir and lamivudine combination tablets are 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 Abacavir/Lamivudine 600/300 APOTEX tablets are intended for oral administration. DOSAGE Therapy should be initiated by a physician experienced in the management of HIV infection. Abacavir and lamivudine combination tablets 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. Abacavir and lamivudine combination tablets can be taken with or without food. 2 Abacavir and lamivudine combination tablets should not be prescribed for patients requiring dosage adjustments, such as those with creatinine clearance < 50 mL/min. Separate preparations of abaca Leia o documento completo