RECORMON PRE-FILLED SYRINGES 4000IU/0.3ML

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Epoetin Beta

Boleh didapati daripada:

ROCHE (MALAYSIA) SDN. BHD.

INN (Nama Antarabangsa):

Epoetin Beta

Unit dalam pakej:

6Units Units

Dikeluarkan oleh:

ROCHE DIAGNOSTICS GMBH

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
RECORMON
®
_Epoetin beta (2000 iu/0.3 mL, 4000 iu/0.3 mL, 5000 iu/0.3 mL) _
_ _
_ _
1 WHAT IS IN THIS LEAFLET
1.
What Recormon is used for
2.
How Recormon works
3.
Before you use Recormon
4.
How to use Recormon
5.
While you are using Recormon
6.
Side effects
7.
Storage and Disposal of Recormon
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT RECORMON IS USED FOR
Recormon
is
used
to
treat
anaemia.
Anaemia
is
a
condition
where
your
blood does not have enough red blood
cells and your haemoglobin (a protein
which transports oxygen in the blood)
level is too low. Therefore, your body's
tissues
might
not
receive
enough
oxygen.
Anaemia
may
occur
if
a
person
has
kidney
disease.
There
are
also
other
circumstances
where
a
person
has
normal functioning kidneys but still has
anaemia
(such
as
patients
receiving
chemotherapy). Recormon may also be
useful in these circumstances.
Recormon is also used when a patient's
own blood is donated and stored for
transfusion prior to major surgery. This
means that the patient will not need to
receive
a
transfusion
from
a
blood
bank. Recormon is also used to treat
anaemia in premature babies.
Your
doctor,
however,
may
have
prescribed
Recormon
for
another
reason.
HOW RECORMON WORKS
Recormon
contains
the
active
ingredient epoetin beta (pronounced ee-
poe-tin
bee-ta).
Epoetin
beta
is
also
known
as
recombinant
human
erythropoietin (pronounced ee-rith-roe-
poy-tin).
Erythropoietin
is
a
natural
hormone
produced
by
the
kidneys
which
stimulates the production of red blood
cells in the bone marrow and spleen.
Like
erythropoietin,
Recormon
works
by increasing the number of red blood
cells
and
haemoglobin
level
in
your
blood.
BEFORE YOU USE RECORMON
-
_When you must not use it _
Do not take Recormon if:

you have had an allergic reaction
to epoetin beta or any ingredients
listed at the end of this leaflet.
Symptoms of an allergic reaction
include swelling, itching, rash or
breathing difficulties.
�

Ciri produk

PACK INSERT FOR MALAYSIA
Recormon ®
pre -filled
syringes

 
Epoetin beta Information as set forth in this label only applies to Recormon 1. DESCRIPTION 1.1 Therapeutic / Pharmacologic Class of Drug Antianemic, ATC code: B03XA 1.2 Type of Dosage Form Solution for injection (pre -filled syringes) . 1.3 Route of administration Solution for intravenous (i.v.) or subcutaneous (s.c.) injection . 1.4 Sterile / Radioactive Statement Sterile product . 1.5 Qualitative and Quantitative Composition Active ingredient: epoetin beta (synonyms: rhEPO, recombinant human erythropoietin: produced by recombinant DNA technology in CHO cell line). Recormon is supplied as a colourless, clear to slightly opalescent, solution for injection in glass syringes. Recormon 2000 1 pre -filled syringe contains 2000 international units (IU) (corresponding to 16.6 µg ) epoetin beta in 0.3 ml solution for injection. Recormon 4000 1 pre -filled syringe contains 4000 international units (IU) (corresponding to 33.2 µg ) epoetin beta in 0.3 ml solution for injection . Recormon 5000 1 pre -filled syringe contains 5000 international units (IU) (corresponding to 41.5 µg ) epoetin beta in 0.3 ml solution for injection . List of excipients: It contains phenylalanine (up to 0.3mg per pre -filled syringe) (see section 2.4.1 General, Warnings and Precautions). All other excipients include: urea, sodium chloride, polysorbat e 20, sodium dihydrogen phosphate, sodium monohydrogen phosphate, calcium chloride, glycine, leucine, isoleucine, threonine, and glutamic acid, 2. CLINICAL PARTICULARS 2.1 Therapeutic Indication(s) Recormon is indicated for:  Treatment of anemia associated with chronic renal failure (renal anemia) in patients on dialysis.  Treat ment of symptomatic renal anemia in patients not yet undergoing dialysis.  Prevention of anemia of prematurity in infants with a birth weight of 750 g to 1500 g and a gestational age of less than 34 weeks.  Treatment of anemia in adult patients with solid tumours and treated with platinum -ba