国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
mercaptopurine monohydrate, Quantity: 20 mg/mL
Link Medical Products Pty Ltd T/A Link Pharmaceuticals
mercaptopurine monohydrate
Oral Liquid, suspension
Excipient Ingredients: xanthan gum; aspartame; Rubus idaeus; sodium methyl hydroxybenzoate; sodium ethyl hydroxybenzoate; potassium sorbate; sodium hydroxide; purified water
Oral
1 x 100mL bottle
(S4) Prescription Only Medicine
ALLMERCAP oral liquid suspension is indicated for: Treatment of Acute Lymphoblastic Leukaemia (ALL) in paediatric patients.
Visual Identification: A pink brown viscous suspension; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Licence status A
2014-06-16
ALLMERCAP® 1 ALLMERCAP® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. WHY AM I USING ALLMERCAP®? ALLMERCAP® contains mercaptopurine monohydrate as the active ingredient. ALLMERCAP® is used solely or in combination with other medicines to treat acute leukaemia, a cancer of certain blood cells. For more information, see Section 1. Why am I using ALLMERCAP®? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I TAKE ALLMERCAP®? Do not use if you have ever had an allergic reaction to mercaptopurine monohydrate or any of the oral liquid suspension ingredients listed at the end of this CMI. TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, HAVE RECEIVED THE YELLOW FEVER VACCINE, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I take ALLMERCAP®? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may be affected by ALLMERCAP® or may affect how well it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I TAKE ALLMERCAP® • ALLMERCAP® is taken in the evening as an oral liquid suspension. • Your doctor will decide what dose and for how long you will be taking ALLMERCAP® depending on factors such as your age and weight, pre-existing medical condition, whether you are taking any other medications, and your response to treatment. More instructions can be found in Section 4. How do I take ALLMERCAP®? in the full CMI. 5. WHAT SHOULD I KNOW WHILE TAKING ALLMERCAP®? THINGS YOU MUST DO • Tell your doctor if, for any reason, you have not taken your medicine exactly as directed. • Tell any other specialist, doctor, dentist or pharmacist that you are on ALLMERCAP®. • Tell your doctor if you become pregnant, are trying to become pregnant or trying to father a child. • Use a sunscreen with 阅读完整的文件
1 AUSTRALIAN PRODUCT INFORMATION – ALLMERCAP ® (MERCAPTOPURINE MONOHYDRATE) 1 NAME OF THE MEDICINE Mercaptopurine monohydrate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ALLMERCAP oral liquid suspension contains 20 mg/mL mercaptopurine monohydrate. EXCIPIENTS WITH KNOWN EFFECT: hydroxybenzoates, sorbates, and aspartame. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM ALLMERCAP is a pink/brown oral liquid suspension. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS ALLMERCAP oral liquid suspension is indicated for: Treatment of Acute Lymphoblastic Leukaemia (ALL) in paediatric patients. 4.2 D OSE AND METHOD OF ADMINISTRATION DOSAGE (DOSE AND INTERVAL) ALLMERCAP is only indicated for use in children. For children the usual dose is 2.5 mg/kg bodyweight/day, but the dose and duration of administration depend on the nature and dosage of other cytotoxic agents given in conjunction with mercaptopurine. The dosage should be carefully adjusted to suit the individual patient. Mercaptopurine has been used in various combination therapy schedules for acute leukaemia and the literature should be consulted for details. When allopurinol and mercaptopurine are administered concomitantly it is essential that only a quarter of the usual dose of mercaptopurine is given since allopurinol decreases the rate of catabolism of mercaptopurine. Mercaptopurine is metabolised by the polymorphic Thiopurine Methyl Transferase (TPMT) enzyme. Patients with little or no inherited TPMT activity are at increased risk for severe toxicity from conventional doses of mercaptopurine and generally require substantial dose reduction. TPMT genotyping or phenotyping can be used to identify patients with absent or reduced TPMT activity. TPMT testing cannot substitute for haematological monitoring in patients receiving mercaptopurine. The optimal starting dose for homozygous deficient patients has not been established (see Section 4.4 Special warnings and precautions for use). 2 METHOD OF ADMINISTRATION ALLMERC 阅读完整的文件