MIRCERA methoxy polyethylene glycol-epoetin beta 150 mcg solution for injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Methoxy polyethylene glycol-epoetin beta, Quantity: 0.15 mg

Available from:

Roche Products Pty Ltd

INN (International Name):

Methoxy polyethylene glycol-epoetin beta

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: monobasic sodium phosphate monohydrate; methionine; poloxamer; sodium sulfate; mannitol; water for injections

Administration route:

Intravenous, Subcutaneous

Units in package:

One (pre-filled syringe)

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

MIRCERA is indicated for the treatment of anaemia associated with chronic kidney disease (CKD).

Product summary:

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

Authorization status:

Registered

Authorization date:

2009-07-28

Summary of Product characteristics

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