Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
Methoxy polyethylene glycol-epoetin beta, Quantity: 0.25 mg
Roche Products Pty Ltd
Methoxy polyethylene glycol-epoetin beta
Injection, solution
Excipient Ingredients: monobasic sodium phosphate monohydrate; sodium sulfate; methionine; mannitol; poloxamer; water for injections
Intravenous, Subcutaneous
One (pre-filled syringe)
(S4) Prescription Only Medicine
MIRCERA is indicated for the treatment of anaemia associated with chronic kidney disease (CKD).
Visual Identification: clear, colourless to slightly yellowish; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2009-07-28
1 Mircera 20220121 AUSTRALIAN PRODUCT INFORMATION MIRCERA ® (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) 1. NAME OF THE MEDICINE Methoxy polyethylene glycol-epoetin beta 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Mircera 30 micrograms/0.3 mL solution for injection in pre-filled syringe Mircera 50 micrograms/0.3 mL solution for injection in pre-filled syringe Mircera 75 micrograms/0.3 mL solution for injection in pre-filled syringe Mircera 100 micrograms/0.3 mL solution for injection in pre-filled syringe Mircera 120 micrograms/0.3 mL solution for injection in pre-filled syringe Mircera 150 micrograms/0.3 mL solution for injection in pre-filled syringe Mircera 200 micrograms/0.3 mL solution for injection in pre-filled syringe Mircera 250 micrograms/0.3 mL solution for injection in pre-filled syringe Mircera 360 micrograms/0.6 mL solution for injection in pre-filled syringe For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in pre-filled syringe. The solution if clear and colourless to slightly yellowish and the pH is 6.2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mircera is indicated for the treatment of anaemia associated with chronic kidney disease (CKD). 4.2 DOSE AND METHOD OF ADMINISTRATION DOSAGE General Use the lowest dose of Mircera that will gradually increase the haemoglobin concentration. Mircera is administered less frequently than Aranesp ® , Eprex ® and NeoRecormon ® due to the longer elimination half-life. Treatment with Mircera is to be initiated under the supervision of a healthcare professional. Treatment of Anaemic Patients with Chronic Kidney Disease The solution can be administered by subcutaneous (SC) or intravenous (IV) injection, according to clinical preference. Mircera can be injected SC in the abdomen, arm or thigh. All three injection sites are equally suitable for SC injection with Mircera. Patients being changed from SC to IV administration of Mircera (or vice-versa) should have their haemoglobin levels monitored to ensure that t Прочетете целия документ