MIRCERA methoxy polyethylene glycol-epoetin beta 200 mcg solution for injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Methoxy polyethylene glycol-epoetin beta, Quantity: 0.2 mg

Available from:

Roche Products Pty Ltd

INN (International Name):

Methoxy polyethylene glycol-epoetin beta

Pharmaceutical form:

Injection, solution

Composition:

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

Patient Information leaflet

MIRCERA
®
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®
2
2
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6
2
2
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 MIRCERA?
Mircera contains the active ingredient methoxy polyethylene
glycol-epoetin beta. Mircera is used to treat anaemia caused by
chronic
kidney disease (kidney failure).
For more information, see Section 1. Why am I using Mircera? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE MIRCERA?
Do not use if you have ever had an allergic reaction to Mircera or any
of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
Mircera? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Mircera and affect how it works.
Tell your doctor or pharmacist if you are taking any medicines,
including any that you can get without a prescription or if you are
unsure about any medicine.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE MIRCERA?
Treatment with Mircera must be started under the supervision of a
healthcare professional.
Further injections can be given by a healthcare professional or, after
you have been trained, you can inject Mircera under the skin
yourself (see instructions "How to self-inject Mircera".)
Mircera can be injected under the skin on the abdomen, arm or thigh or
into a vein. Your doctor will decide which is best for you.
More instructions can be found in Section 4. How do I use Mircera? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING MIRCERA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit or tell the surgeon
or anaesthetist if you are going to
have surgery that you are using Mircera.
•
Tell your doctor if you feel unusually tired, we

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