Țară: Noua Zeelandă
Limbă: engleză
Sursă: Medsafe (Medicines Safety Authority)
Mercaptopurine 20 mg/mL
Link Pharmaceuticals Ltd
Mercaptopurine 20 mg/mL
20 mg/mL
Oral suspension
Active: Mercaptopurine 20 mg/mL Excipient: Aspartame Potassium sorbate Purified water Raspberry flavour - concentrated juice (nova) Sodium ethyl hydroxybenzoate Sodium hydroxide Sodium methyl hydroxybenzoate Xanthan gum
Prescription
Fermion Oy
Allmercap is indicated for the treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients.
Package - Contents - Shelf Life: Bottle, glass, Amber glass bottle with a tamper evident child resistant closure (component) - 100 mL - 18 months from date of manufacture stored at or below 25°C protect from light 56 days opened stored at or below 25°C - Combination pack, Bottle + syringe adapter + 1 mL and 5 mL oral dosing syringes - 100 mL - 18 months from date of manufacture stored at or below 25°C protect from light 56 days opened stored at or below 25°C - Syringe, plastic, Graduated 1 mL oral dosing syringe - 1 mL - - Syringe, plastic, Graduated 5 mL oral dosing syringe - 5 mL - - Unknown, Syringe adapter for use wtih an oral dosing syringe, original cap replacement - 1 pieces -
2016-06-08
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 Citiți documentul complet
ALLMERCAP® NEW ZEALAND DATA SHEET ALLMERCAP Data Sheet August 2022 Page 1 of 11 1 PRODUCT NAME ALLMERCAP 20mg/mL oral suspension 2 QUALITATIVE AND QUANTITATIVE COMPOSITION ALLMERCAP oral suspension contains 20 mg/mL mercaptopurine monohydrate. The chemical name of mercaptopurine monohydrate is 1,7-dihydro-6H-purine-6-thione hydrate. Relative molecular mass: 170.2 Molecular formula is C 5 H 4 N 4 S ⋅ H 2 O CAS No.: 6112-76-1 (monohydrate) Chemical structure is: Mercaptopurine is odourless or practically odourless, yellow crystalline powder, with a solubility of 0.26 mg/mL in water at 37°C. For the full list of excipients see section 6.1. 3 PHARMACEUTICAL FORM ALLMERCAP is a pink/brown oral liquid suspension. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS ALLMERCAP oral suspension is indicated for: Treatment of Acute Lymphoblastic Leukaemia (ALL) in paediatric patients. 4.2 DOSE AND METHOD OF ADMINISTRATION 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 ALLMERCAP® NEW ZEALAND DATA SHEET ALLMERCAP Data Sheet August 2022 Page 2 of 11 genotyping or phenotyping can be used to identify patients with absent or Citiți documentul complet