MIRCERA SOLUTION FOR INJECTION IN PRE FILLED SYRINGE 75MCG0.3ML

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

Methoxy polyethylene glycol-epoetin beta

Boleh didapati daripada:

ROCHE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Methoxy polyethylene glycol-epoetin beta

Unit dalam pakej:

1Units Units

Dikeluarkan oleh:

ROCHE DIAGNOSTICS GMBH

Risalah maklumat

Consumer Medication Information Leaflet (RiMUP)
MIRCERA
®
Methoxy polyethylene glycol-epoetin beta (50μg/0.3mL, 75μg/0.3mL,
100μg/0.3mL, 120μg/0.3mL, 150μg/0.3mL, 200μg/0.3mL)
1
What is in this leaflet
1.
What Mircera is used for
2.
How Mircera works
3.
Before you take Mircera
4.
How to take Mircera
5.
While you are using Mircera
6.
Side effects
7.
Storage and disposal of Mircera
8.
Product description
9.
Manufacturer
&
Product
Registration Holder
1.
What Mircera is used for
Mircera
is
used
to
treat
anaemia
caused
by
chronic
kidney
disease
(CKD)/kidney failure.
Anaemia is a condition where your
blood does not have enough red blood
cells,
causing
a
low
level
of
haemoglobin (a protein that transports
oxygen in the blood). As a result, your
body's
tissues
might
not
receive
enough oxygen.
2.
How Mircera works
Mircera belongs to a new
class of
hormones,
known
as
Continuous
Erythropoietin Receptor Activators.
Erythropoietin,
a
natural
hormone
produced by the kidneys, stimulates
the production of red blood cells in the
bone marrow and spleen.
Mircera
works
like
erythropoietin,
thereby increasing the number of red
blood cells and the haemoglobin level
in your blood. Consequently, this will
reduce
your
need
for
blood
transfusions.
Your
doctor,
however,
may
have
prescribed
Mircera
for
another
purpose.
3.
Before you take Mircera
-
When you must not use it
Do not take or receive Mircera if:
 you
have or have
had
an
allergic
reaction in the past to:

Mircera
(Methoxy
polyethylene
glycol-epoetin
beta)
or
any
ingredients listed at the end of this
leaflet.

any
other
similar
medicines
(i.e.
containing erythropoietin).
Some
of
the
symptoms
of
an
allergic reaction may include:
­ shortness of breath
­ wheezing
or
difficulty
breathing
­ swelling
of
the
face,
lips,
tongue, or other parts of the
body
­ rash, itching or hives on the
skin

you are diagnosed with Pure Red Cell
Aplasia
(PRCA)
through
examination of the bone marrow.

you have high blood pressure that is
not well controlled.

the package is torn

Ciri produk

PACK INSERT FOR MALAYSIA
Mircera
®
Methoxy polyethylene glycol-epoetin beta


1. DESCRIPTION
1.1 Therapeutic / Pharmacologic Class of Drug
MIRCERA is the first molecule of a new class of Continuous
Erythropoietin Receptor Activators called methoxy
polyethylene glycol-epoetin beta.
ATC Code – B03XA03
1.2 Type of Dosage Form
Solution for injection supplied as a sterile, ready to use liquid in:
 Single dose pre-filled 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-filled syringes: containing 50 g, 75 g, 100
g, 120 g, 150 g or 200 g methoxy polyethylene
glycol-epoetin beta in 0.3 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. The safety and efficacy of
MIRCERA therapy in other indications has not been
established.
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 admin