Valsts: Austrālija
Valoda: angļu
Klimata pārmaiņas: Department of Health (Therapeutic Goods Administration)
abacavir hydrochloride monohydrate,lamivudine
Lupin Australia Pty Limited
abacavir hydrochloride monohydrate,Lamivudine
Registered
CONSUMER MEDICINE INFORMATION ABACAVIR/LAMIVUDINE GH 600/300 (ABACAVIR HYDROCHLORIDE MONOHYDRATE AND LAMIVUDINE) FILM-COATED TABLET PATIENTS TAKING ABACAVIR/LAMIVUDINE GH 600/300, WHICH CONTAINS ABACAVIR, MAY DEVELOP A HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE- THREATENING IF TREATMENT WITH ABACAVIR/LAMIVUDINE GH 600/300 IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING ABACAVIR/LAMIVUDINE GH 600/300 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 ABACAVIR/LAMIVUDINE GH 600/300, NEVER TAKE ABACAVIR/LAMIVUDINE GH 600/300, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (TRIUMEQ, TRIZIVIR OR ZIAGEN) AGAIN AS YOU MAY DEVELOP A LIFE- THREATENING REACTION WHICH CAN BE FATAL. THERE IS AN ALERT CARD INCLUDED IN THE ABACAVIR/LAMIVUDINE GH 600/300 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 BELOW BEFORE YOU TAKE ABACAVIR/LAMIVUDINE GH 600/300. WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start Abacavir/Lamivudine GH 600/300. This leaflet answers some common questions about Abacavir/Lamivudine GH 600/300. 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 Abacavir/Lamivudine GH 600/300 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 ABACAVIR/ LAMIVUDINE GH 600/300 IS USED FOR Abacavir/L Izlasiet visu dokumentu
AUSTRALIAN PRODUCT INFORMATION – ABACAVIR/LAMIVUDINE GH 600/300 (ABACAVIR (AS HYDROCHLORIDE MONOHYDRATE) AND LAMIVUDINE) TABLET, FILM COATED Abacavir, a component of ABACAVIR/LAMIVUDINE GH 600/300 (abacavir 600 mg and lamivudine 300 mg) tablet, is associated with hypersensitivity reactions, which can be life-threatening, and in rare cases fatal. ABACAVIR/LAMIVUDINE GH 600/300 (abacavir 600 mg and lamivudine 300 mg) tablets, or any other medicinal product containing abacavir (KIVEXA®, TRIUMEQ®, TRIZIVIR® and ZIAGEN®), MUST NEVER be restarted following a hypersensitivity reaction (see SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and SECTION 4.8 ADVERSE EFFECTS (UNDESIRABLE EFFECTS)). 1 NAME OF THE MEDICINE Abacavir (as hydrochloride monohydrate) and lamivudine. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ABACAVIR/LAMIVUDINE GH 600/300 is supplied as film-coated tablets each containing 600 mg of abacavir as abacavir hydrochloride monohydrate and 300 mg lamivudine. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM ABACAVIR/LAMIVUDINE GH 600/300 is an orange coloured, modified capsule shaped, biconvex, film- coated tablet debossed with “300” on one side and “600” on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ABACAVIR/LAMIVUDINE GH 600/300 is a combination of two nucleoside analogues (abacavir and lamivudine). ABACAVIR/LAMIVUDINE GH 600/300 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. ABACAVIR/LAMIVUDINE GH 600/300 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/Lamivudine GH 600/300 v2.0 Page 2 of 21 (abacavir (as hydrochloride monohydrate) and lamivudine) tablet, film coated ABACAVIR/LAMI Izlasiet visu dokumentu