Mircera

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

methoxy polyethylene glycol-epoetin beta

Available from:

Roche Diagnostics GmbH Sandhofer Strasse 116 D-68305 Mannheim for F. Hoffmann-La Roche Ltd.

INN (International Name):

methoxy polyethylene glycol-epoetin beta

Dosage:

0,05mg/0,3ml

Pharmaceutical form:

solution for i/v and s/c injection

Prescription type:

Prescription

Patient Information leaflet

MIRCERA
®
Methoxy polyethylene glycol-epoetin beta
1.
DESCRIPTION
1.1
THERAPEUTIC / PHARMACOLOGIC CLASS OF DRUG
MIRCERA is the fi rst molecule of a new class of Continuous
Erythropoietin
Receptor Activators called methoxy polyethylene glycol-epoetin beta.
1.2
TYPE OF DOSAGE FORM
Solution for injection supplied as a sterile, ready-to-use liquid in:

Single-dose pre-fi lled syringes
1.3
ROUTE OF ADMINISTRATION
Subcutaneous or intravenous.
1.4
STERILE / RADIOACTIVE STATEMENT
Not applicable.
1.5
QUALITATIVE AND QUANTITATIVE COMPOSITION
SINGLE-DOSE PRE-FI LLED SYRINGES:
containing 30

g, 50

g, 75

g, 100

g, 120

g,
150

g, 200

g, or 250

g methoxy polyethylene glycol-epoetin beta in 0.3 ml or
360

g of methoxy polyethylene glycol-epoetin beta in 0.6 ml.
The active substance, methoxy polyethylene glycol-epoetin beta, is a
covalent
conjugate of a protein produced by recombinant DNA technology in
Chinese
hamster ovarian cells and a linear methoxy polyethylene glycol (PEG).
This results
in an approximate molecular weight of 60 kDa. The dosage strength in

g indicates
the quantity of the protein moiety of the methoxy polyethylene
glycol-epoetin beta
molecule without consideration of the glycosylation.
The solution is clear and colorless to slightly yellowish.
EXCIPIENTS:
sodium phosphate monobasic monohydrate, sodium sulphate, mannitol,
methionine, poloxamer 188 and water for injections.
2.
CLINICAL PARTICULARS
2.1
THERAPEUTIC INDICATION(S)
MIRCERA is indicated for the treatment of anemia associated with
chronic kidney
disease (CKD) including patients on dialysis and patients not on
dialysis.
2.2
DOSAGE AND ADMINISTRATION
_STANDARD DOSAGE_
MIRCERA is administered less frequently than other
erythropoiesis-stimulating
agents (ESAs) due to the longer elimination half-life.
Treatment with MIRCERA has to be initiated under the supervision of a
healthcare
professional.
TREATMENT OF ANEMIC PATIENTS WITH CHRONIC KIDNEY DISEASE
The solution can be administered subcutaneously (s.c.) or
intrave

Summary of Product characteristics

1
Mircera-uk-ie-mt-spc-clean-1312-pfs
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
MIRCERA 50 micrograms/0.3 ml solution for injection in pre-filled
syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One pre-filled syringe contains 50 micrograms of methoxy polyethylene
glycol-epoetin beta* at a
concentration of 167 micrograms/ml. The strength indicates the
quantity of the protein moiety of the
methoxy polyethylene glycol-epoetin beta molecule without
consideration of the glycosylation.
*Protein produced by recombinant DNA technology in Chinese Hamster
Ovary (CHO) cells and
covalently conjugated to a linear methoxy-polyethylene glycol (PEG).
The potency of methoxy polyethene glycol-epoetin beta should not be
compared to the potency of
another pegylated or non-pegylated protein of the same therapeutic
class. For more information, see
section 5.1.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe (injection).
The solution is clear and colourless to slightly yellowish.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of symptomatic anaemia associated with chronic kidney
disease (CKD) in adult patients
(see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION.
_ _
Treatment with MIRCERA has to be initiated under the supervision of a
physician experienced in the
management of patients with renal impairment.
2
Mircera-uk-ie-mt-spc-clean-1312-pfs
Posology
_Treatment of symptomatic anaemia in adult chronic kidney disease
patients_
Anaemia symptoms and sequelae may vary with age, gender, and overall
burden of disease; a
physician’s evaluation of the individual patient’s clinical course
and condition is necessary.
MIRCERA should be administered either subcutaneously or intravenously
in order to increase
haemoglobin to not greater than 12 g/dl (7.45 mmol/l). Subcutaneous
use is preferable in patients who
are not receiving haemodialysis to avoid puncture of peripheral veins.
Due to intra-patient variability, occasio