Binocrit 10 000 IU1 ml solution for injection in a pre-filled syringe

Kraj: Malezja

Język: angielski

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

Składnik aktywny:

EPOETIN ALFA

Dostępny od:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (International Nazwa):

EPOETIN ALFA

Sztuk w opakowaniu:

6Units Units

Wyprodukowano przez:

SANDOZ GMBH

Ulotka dla pacjenta

1
_Consumer Medication Information Leaflet (RiMUP) _
BINOCRIT
® PRE-FILLED SYRINGE
Epoetin alfa (2000IU/ml, 4000IU/0.4ml, 10 000IU/ml, 40 000IU/ml)
WHAT IS IN THIS LEAFLET
1.
What BINOCRIT
®
is used for
2.
How BINOCRIT
®
works
3.
Before you use BINOCRIT
®
4.
How to use BINOCRIT
®
5.
While you are using BINOCRIT
®
6.
Side effects
7.
Storage and disposal of BINOCRIT
®
8.
Product description
9.
Manufacturer and product
registration holder
10.
Date of revision
WHAT BINOCRIT
® IS USED FOR
BINOCRIT
®
is used to treat
symptomatic anemia caused by
kidney disease
-
in children on hemodialysis
-
in adults on hemodialysis, peritoneal
dialysis or not yet undergoing dialysis.
If you have kidney disease, you may be
short of red blood cells if your kidney
does not produce enough erythropoietin
(necessary for red cell production).
BINOCRIT
®
is prescribed to stimulate
your bone marrow to produce more red
blood cells.
BINOCRIT
®
is used to treat anemia if you
are receiving chemotherapy for solid
tumors, malignant lymphoma or multiple
myeloma (bone marrow cancer) and your
doctor decides you may have a need for a
blood transfusion. BINOCRIT
®
can
reduce the need for a blood transfusion.
BINOCRIT
®
is used in moderately
anemic people who donate some of their
blood before surgery, so that it can be
given back to them during or after the
operation. Because BINOCRIT
®
stimulates the production of red blood
cells, doctors can take more blood from
these people.
BINOCRIT
®
is used in moderately
anemic adults about to have major
orthopedic surgery (for example hip or
knee replacement operations), to reduce
the potential need for blood transfusions.
BINOCRIT
®
is used to treat anemia in
adults with low- or intermediate-1-risk
myelodysplastic syndromes. BINOCRIT
®
can reduce the need for a blood
transfusion.
HOW BINOCRIT
® WORKS
BINOCRIT
®
contains the active
substance epoetin alfa - a protein that
stimulates the bone marrow to produce
more red blood cells which carry
hemoglobin (a substance that transports
oxygen). Epoeti

Charakterystyka produktu

Page 1 of 28
BINOCRIT ®
EPOETIN ALFA
1.
NAME OF THE MEDICINAL PRODUCT
Binocrit solution for injection in a pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
a)
Binocrit 2,000 IU/1 ml solution for injection in a pre-filled syringe:
Each ml of solution contains 2,000 IU of epoetin alfa* corresponding
to 16.8 micrograms per ml
1 pre-filled syringe of 1 ml contains 2,000 international units (IU)
corresponding to 16.8
micrograms epoetin alfa
b)
Binocrit 4,000 IU/0.4 ml solution for injection in a pre-filled
syringe:
Each ml of solution contains 10,000 IU of epoetin alfa* corresponding
to 84.0 micrograms per
ml
1 pre-filled syringe of 0.4 ml contains 4,000 international units (IU)
corresponding to 33.6
micrograms epoetin alfa
c)
Binocrit 10,000 IU/1 ml solution for injection in a pre-filled
syringe:
Each ml of solution contains 10,000 IU of epoetin alfa* corresponding
to 84.0 micrograms per
ml
1 pre-filled syringe of 1 ml contains 10,000 international units (IU)
corresponding to 84.0
micrograms epoetin alfa
d)
Binocrit 40,000 IU/1 ml solution for injection in a pre-filled
syringe:
Each ml of solution contains 40,000 IU of epoetin alfa* corresponding
to 336.0 micrograms per
ml
1 pre-filled syringe of 1 ml contains 40,000 international units (IU)
corresponding to 336.0
micrograms epoetin alfa
* Produced in CHO cell line by recombinant DNA technology
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in a pre-filled syringe (injection).
Clear colourless solution.
Page 2 of 28
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
Treatment of anemia associated with chronic renal failure in adult
hemodialysis, peritoneal dialysis
and predialysis patients and pediatric patients on hemodialysis.
•
Treatment of anemia and reduction of transfusion in adult cancer
patients with non-myeloid
malignancies receiving chemotherapy.
•
To facilitate autologous blood collection within a predeposit program
and decrease the risk of
receiving allogeneic blood transfusions in pat