البلد: نيوزيلاندا
اللغة: الإنجليزية
المصدر: Medsafe (Medicines Safety Authority)
Abacavir sulfate 23.4 mg/mL equivalent to 20 mg/ml abacavir base.; ;
GlaxoSmithKline NZ Limited
Abacavir sulfate 23.4 mg/mL (equivalent to 20 mg/ml abacavir base.)
20 mg/mL
Oral solution
Active: Abacavir sulfate 23.4 mg/mL equivalent to 20 mg/ml abacavir base. Excipient: Banana flavour 59.256 AP0551 Citric acid Hydrochloric acid Methyl hydroxybenzoate Propyl hydroxybenzoate Propylene glycol Purified water Saccharin sodium Sodium citrate dihydrate Sorbitol Strawberry flavour 057883 AP0551
Bottle, white HDPE, 240 mL
Prescription
Prescription
Piramal Enterprises Limited
ZIAGEN is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children.
Package - Contents - Shelf Life: Bottle, white HDPE - 240 mL - 24 months unopened stored at or below 30°C 60 days opened stored at or below 30°C
1998-07-22
ZIAGEN ORAL SOLUTION 1 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,TRIZIVIR AND TRIUMEQ) 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, TRIZIVIR AND TRIUMEQ). 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 S اقرأ الوثيقة كاملة
1 NEW ZEALAND DATA SHEET 1. PRODUCT NAME ZIAGEN Oral Solution 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Oral solution containing 20 mg/mL of abacavir as abacavir sulfate. For the full list of excipients, see section 6.1 List of excipients 3. PHARMACEUTICAL FORM 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 is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and children. 4.2_ _ POSOLOGY AND METHOD OF ADMINISTRATION Adults, adolescents and children weighing at least 25 kg The recommended dose of ZIAGEN is 300 mg (15 mL) twice daily or 600 mg (30 mL) once daily. _ _ Children ≥ three months and weighing less than 25 kg The recommended dose is 8 mg/kg twice daily or 16 mg/kg once daily up to a maximum dose of 300 mg twice daily or 600 mg once daily. Children less than three months The data available on the use of ZIAGEN in this age group are limited (see section 5.2 Pharmacokinetic Properties). ZIAGEN can be taken with or without food. ZIAGEN is also available as a tablet formulation. Therapy should be initiated by a physician experienced in the management of HIV infection. 2 Renal impairment No dosage adjustment of ZIAGEN is necessary in patients with renal dysfunction (see section 5.2 Pharmacokinetic Properties). Hepatic impairment Abacavir is metabolised primarily by the liver. The recommended dose of ZIAGEN in patients with mild hepatic impairment (Child-Pugh score 5-6) is 200 mg (10 mL) twice a day. Pharmacokinetic and safety data on the use of abacavir in patients with moderate and severe hepatic impairment are not available (see section 5.2 Pharmacokinetic Properties). Therefore the use of abacavir is not recommended in patients with moderate or severe hepatic impairment, unless the benefit of use outweighs the risk. 4.3 CONTRAINDICATIONS ZIAGEN is اقرأ الوثيقة كاملة