Kraj: Australia
Język: angielski
Źródło: Department of Health (Therapeutic Goods Administration)
abacavir sulfate, Quantity: 23.4 mg/mL (Equivalent: abacavir, Qty 20 mg/mL)
ViiV Healthcare Pty Ltd
Oral Liquid, solution
Excipient Ingredients: sorbitol solution (70 per cent) (non-crystallising); sorbitol solution (70 per cent) (crystallising); propylene glycol; sodium citrate dihydrate; citric acid; methyl hydroxybenzoate; propyl hydroxybenzoate; saccharin sodium; hydrochloric acid; sodium hydroxide; purified water; Flavour
Oral
240mL
(S4) Prescription Only Medicine
Ziagen (abacavir) is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children (see Clinical Trials). This indication is based on surrogate endpoints in studies up to 48 weeks in duration.
Visual Identification: Clear to slightly opalescent, yellowish, aqueous solution with strawberry/banana flavouring.; Container Type: Bottle; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
1999-06-09
ZIAGEN ORAL SOLUTION _abacavir (as sulfate)_ CONSUMER MEDICINE INFORMATION PATIENTS TAKING ZIAGEN, WHICH CONTAINS ABACAVIR, MAY DEVELOP A HYPERSENSITIVITY REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF TREATMENT WITH ZIAGEN IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE ON WHETHER YOU SHOULD STOP TAKING ZIAGEN 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 ZIAGEN NEVER TAKE ZIAGEN, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (KIVEXA, TRIUMEQ, TRIZIVIR) AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN BE FATAL. THERE IS AN ALERT CARD INCLUDED IN THE ZIAGEN 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 ZIAGEN. WHAT IS IN THIS LEAFLET? Please read this leaflet carefully before you start ZIAGEN oral solution. This leaflet answers some common questions about ZIAGEN oral solution. 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 ZIAGEN 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 ORAL SOLUTION. You may need to read it again. _HYPERSENSITIVITY_ _REACTION_ ZIAGEN CONTAINS ABACAVIR (WHICH IS ALSO AN ACTIVE INGREDIENT IN KIVEXA, TRIUMEQ, TRIZIVIR). ABACAVIR CAN CAUSE A SERIOUS ALLERGIC REACTION KNOWN AS A HYPERSENSITIVITY REACTION, WHICH CAN BE LIFE-THREATENING IF TREATMENT WITH ABACAVIR CONTAINING PRODUCTS IS NOT STOPPED. IT IS IMPORTANT YOU READ THE IN Przeczytaj cały dokument
1 AUSTRALIAN PRODUCT INFORMATION ZIAGEN (ABACAVIR) TABLETS AND ORAL SOLUTION ZIAGEN (ABACAVIR) IS ASSOCIATED WITH HYPERSENSITIVITY REACTIONS, WHICH CAN BE LIFE- THREATENING AND IN RARE CASES FATAL. ZIAGEN, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (TRIUMEQ, TRIZIVIR, KIVEXA), 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 sulfate) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Abacavir sulfate is a white to off-white crystalline powder with a solubility of approximately 77 mg/mL in water at 25°C. ZIAGEN is supplied in tablets containing 300 mg of abacavir (as sulfate). ZIAGEN is supplied in oral solution containing 20 mg/mL of abacavir (as sulfate). ZIAGEN oral solution also contains sorbitol solution (70%), saccharin sodium, methyl hydroxybenzoate and propyl hydroxybenzoate. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM TABLETS The unscored film-coated tablets are yellow, biconvex, capsule shaped and engraved with “GX 623” on one side. The scored film-coated tablets are yellow, biconvex, capsule shaped and engraved with “GX 623” on both sides. ORAL SOLUTION The oral solution is a clear to slightly opalescent yellowish aqueous solution which may turn into a brown colour over time with strawberry/banana flavouring. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ZIAGEN (abacavir) is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children (see Section 5.1 2 PHARMACODYNAMIC PROPERTIES - Clinical trials). This indication is based on surrogate endpoints in studies up to 48 weeks in duration. 4.2 DOSE AND METHOD OF ADMINISTRATION To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing. For patients who are unable to swallow tablets, the tablet(s) may be crushed and 100% Przeczytaj cały dokument