EPO STADA 4000IU0.4ml Solution for Injection in a Pre-filled Syringe

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

epoetin zeta

Boleh didapati daripada:

DKSH MALAYSIA SDN BHD

INN (Nama Antarabangsa):

epoetin zeta

Unit dalam pakej:

6x0.4ml mL; 0.4ml mL

Dikeluarkan oleh:

STADA Arzneimittel AG

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
EPO STADA PREFILLED SYRINGE
Epoetin zeta (2 000 IU/0.6 ml,
4 000 IU/0.4ml,
10 000IU/1.0ml)
1
WHAT IS IN THIS LEAFLET
1.
What EPO STADA is used for
2.
How EPO STADA works
3.
Before you use EPO STADA
4.
How to use EPO STADA
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
EPO
STADA
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
This is a biosimilar medicinal
product referenced to Epoetin
alpha. It is not interchangeable
or substitutes with the reference
product.
WHAT EPO STADA IS USED FOR
EPO STADA is used:
-
in adults, children and adolescents
on
haemodialysis
to
treat
symptomatic
anaemia
(low
red
blood cell counts) associated with
chronic
renal
failure
(kidney
disease).
-
in
adult
patients
on
peritoneal
dialysis
to
treat
symptomatic
anaemia
associated
with
chronic
renal failure (kidney disease).
-
in
adult
patients
with
renal
insufficiency not yet on dialysis to
treat severe anaemia associated with
kidney
disease
accompanied
by
clinical symptoms.
-
in adult patients with chemotherapy
induced anaemia
-
in
adult
surgery
patients
in
an
autologous predonation programme.
HOW EPO STADA WORKS
EPO STADA contains a protein called
epoetin zeta, that stimulates the bone
marrow to produce more red blood
cells
which
carry
haemoglobin
(a
substance
that
transports
oxygen).
Epoetin zeta is a copy of the human
protein erythropoietin and acts in the
same way.
BEFORE YOU USE EPO STADA
-
_When you must not use it _
•
If
you
are
allergic
(hypersensitive)
to
erythropoietins or any of the other
ingredients
of
this
medicine
(listed in ingredient).
•
if you have developed Pure Red
Cell Aplasia (PRCA; reduced or
stopped production of red blood
cells)
following
treatment
with
any erythropoietin
•
if you have high blood pressure,
which is not properly controlled
with
blood
pressure-lowering
medicines
•
if you cannot be given medicines
to thin blood for the prevention of
blood clots
•
if
you
are
donating
your
own
blood

Ciri produk

EPO STADA 2,000IU/0.6ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
EPO STADA 4,000IU/0.4ML SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
EPO STADA 10,000IU/1.0ML SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
This is a biosimilar medicinal product referenced to Eprex®. It is
not interchangeable or substitutable with
the reference product.
NAME AND STRENGTH OF ACTIVE SUBSTANCE
Each pre-filled syringe contains epoetin zeta* (recombinant human
erythropoietin) solution for injection.
The solution contains 3,333IU Epoetin zeta per ml for 2000IU/0.6ml
dosage.
The solution contains 10,000IU Epoetin zeta per ml for 4,000IU/0.4ml
and 10,000IU/1.0ml dosage.
*Produced by recombinant DNA technology in Chinese Hamster Ovary (CHO)
cell line.
Excipient with known effect:
The solution contains 0.50 mg phenylalanine per ml.
Each pre-filled syringe of;
•
2,000IU/ 0.6ml contains 0.30 mg phenylalanine
•
4,000IU/ 0.4ml contains 0.20 mg phenylalanine
•
10,000IU/1.0ml contains 0.50 mg phenylalanine
LIST OF EXCIPIENTS
Disodium phosphate dihydrate
Phenylalanine
Glycine
Sodium dihydrogen phosphate dihydrate
Water for injections
Leucine
Sodium hydroxide (pH adjuster)
Sodium chloride
Isoleucine
Hydrochloric acid (pH adjuster)
Glutamic acid
Threonine
Polysorbate 20
Calcium chloride dihydrate
PRODUCT DESCRIPTION
Solution for injection in pre-filled syringe. Clear, colourless
solution
PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Other antianaemic preparations,
erythropoietin
ATC code: B03XA01
EPO STADA is a biosimilar medicinal product. Detailed information is
available on the website of the
European Medicines Agency.
http://www.ema.europa.eu.
_Pharmacodynamic effects_
Erythropoietin is a glycoprotein that stimulates, as a
mitosis-stimulating factor and differentiating
hormone, the formation of erythrocytes from precursors of the stem
cell compartment.
The apparent molecular weight of erythropoietin is 32 000-40 000
Dalton. The protein moiety of the
molecule contributes about 58% of total molecul