MIRCERA SOLUTION FOR INJECTION IN PRE FILLED SYRINGE, 30mcg/0.3mL

Maa: Malesia

Kieli: englanti

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

Aktiivinen ainesosa:

Methoxy polyethylene glycol-epoetin beta

Saatavilla:

ROCHE (MALAYSIA) SDN. BHD.

INN (Kansainvälinen yleisnimi):

Methoxy polyethylene glycol-epoetin beta

Kpl paketissa:

0.3ml1Units mL

Valmistaja:

ROCHE DIAGNOSTICS GMBH

Pakkausseloste

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
MIRCERA
®
_ _
_Methoxy polyethylene glycol-epoetin beta (30μg/0.3mL, 50μg/0.3mL,
75μg/0.3mL, 100μg/0.3mL, 120μg/0.3mL, 150μg/0.3mL, _
_200μg/0.3mL, 250μg/0.3mL, 360μg/0.6mL, 800μg/0.6mL) _
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:
o
Mircera
(Methoxy
polyethylene glycol-epoetin
beta)
or
any
ingredients
listed
at
the
end
of
this
leaflet.
o
any other similar medicines
(i.e.
containing
erythropoietin).
Some
of
the
symptoms
of
an
allergic reaction may include:
o
shortness of breath
o
wheezing
or
difficulty
breathing
o
swelling
of
the
face,
lips,
tongue, or other parts of the
body
o
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

Valmisteyhteenveto

Clinical Study Report: Ro 50-3821 - F. Hoffmann-La Roche Ltd
Protocol NH19707 Report Number 1035312 16
6