RECORMON PRE-FILLED SYRINGE 4000 IU0.3 ml

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:

VETTER PHARMA-FERTIGUNG, GMBH & CO.KG

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.

you have high b

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
Antianaemic agent
ATC code: B03XA
1.2
TYPE OF DOSAGE FORM
Solution for injection (pre-filled syringes) (s.c. or i.v.).
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 (recombinant human erythropoietin:
produced by recombinant DNA technology in
CHO cell line).
Recormon is provided as solution for injection in pre-filled syringes.
The solution is a colourless, clear to slightly opalescent.
_Solution for injection in pre-filled syringe:_
2000 IU = 16.6 micrograms epoetin beta with 0.3 ml solution for
injection
4000 IU = 33.2 micrograms epoetin beta with 0.3 ml solution for
injection.
5000 IU = 41.5 micrograms epoetin beta with 0.3 ml solution for
injection.
_LIST OF EXCIPIENTS:_
All presentations contain up to 0.3 mg phenylalanine per pre-filled
syringe (see section 2.4.1,
Warnings and
Precautions, General).
All other excipients
include:
urea,
sodium chloride,
polysorbate 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.

Treatment of symptomatic renal anemia in patients not yet undergoing
dialysis.

Prevention of anemia of prematurity in infants with a birth weight of
750g 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-based chemotherapy prone
to induce anemia (cisplatin: 75 mg/m2/cycle; carboplatin: 350
mg/m2/cycle).

Treatment
of symptomatic anemia
in adult patients with
multipl