Nivestim 480mcg/0.5ml solution for injection/infusion

Land: Maleisië

Taal: Engels

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

Werkstoffen:

Filgrastim

Beschikbaar vanaf:

HOSPIRA MALAYSIA SDN BHD

INN (Algemene Internationale Benaming):

Filgrastim

Eenheden in pakket:

0.5ml mL

Geproduceerd door:

Hospira Zagreb d.o.o

Bijsluiter

Pfizer Confidential
_ _
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
NIVESTIM
® SOLUTION FOR INJECTION
Filgrastim (12 MU/0.2 mL, 30 MU/0.5 mL, 48 MU/0.5 mL)
1
WHAT IS IN THIS LEAFLET
1.
What Nivestim is used for
2.
How Nivestim works
3.
Before you use Nivestim
4.
How to use Nivestim
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Nivestim
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
11.
Serial Number
WHAT NIVESTIM IS USED FOR
Nivestim is used mainly for reducing
the duration of neutropenia and to
prevent the occurrence of neutropenia
associated with fever for those who
undergo treatment with medicines for
cancer. Neutropenia means reduction in
neutrophils (type of white blood cell
important in the body’s fight against
infection). It is also used for reducing
the duration of neutropenia in patients
undergoing myeloablative therapy
(therapy aimed at reducing the bone
marrow cells) which is followed by
bone marrow cell transplantation.
It is used for mobilization of blood
progenitor cells (progenitor cells are
nothing but the cells that can
differentiate into a specific type of
cells).
It is also used for reducing the duration
of neutropenia in patients (children or
adults), with neutropenia less than or
equal to the count of 0.5 x 10
9
/L who
present this condition by birth and
those who have severe infections. It is
also used in patients with persistent
neutropenia whose count is less than or
equal to 1.0 x 10
9
/L like in patients
with HIV infection.
HOW NIVESTIM WORKS
Nivestim is a man-made form of
granulocyte colony-stimulating factor
(G-CSF). Human G-CSF is a substance
produced by our body which regulates
the production and release of
neutrophils from the bone marrow.
Nivestim stimulates the growth of
neutrophils along with a minor increase
in other type of blood cells like
monocytes, eosinophils and basophils.
BEFORE YOU USE NIVESTIM
-
_When you must not use it _
Do not take Nivestim if you are
allergic to filgrastim or any of the
ot

Productkenmerken

Pfizer Confidential
NIVESTIM
®
FILGRASTIM
1.
NAME OF THE MEDICINAL PRODUCT
Nivestim 12 MU/0.2 ml solution for injection/infusion
Nivestim 30 MU/0.5 ml solution for injection/infusion
Nivestim 48 MU/0.5 ml solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nivestim 12 MU/0.2 ml and 30 MU/0.5 ml solution for injection/infusion
Each ml of solution for injection or infusion contains 60 million
units [MU] (600
micrograms [
µ
g]) of filgrastim*.
Each pre-filled syringe contains 12 million units (MU) (120 micrograms
[
µ
g]) of filgrastim
in 0.2 ml (0.6 mg/ml).
Each pre-filled syringe contains 30 million units (MU) (300 micrograms
[
µ
g]) of filgrastim
in 0.5 ml (0.6 mg/ml).
Nivestim 48 MU/0.5 ml solution for injection/infusion
Each ml of solution for injection or infusion contains 96 million
units [MU] (960
micrograms [
µ
g]) of filgrastim*.
Each pre-filled syringe contains 48 million units (MU) (480 micrograms
[
µ
g]) of filgrastim
in 0.5 ml (0.96 mg/ml).
*Recombinant methionyl granulocyte-colony stimulating factor [G-CSF]
produced in
_ Escherichia coli _
(BL21) by recombinant DNA technology.
Excipient with known effect
Each ml of solution contains 50 mg of sorbitol (E420) (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion (injection/infusion).
Clear, colourless solution.
Pfizer Confidential
1
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Filgrastim is indicated for the reduction in the duration of
neutropenia and the incidence
of febrile neutropenia in patients treated with established cytotoxic
chemotherapy for
malignancy (with the exception of chronic myeloid leukaemia and
myelodysplastic
syndromes) and for the reduction in the duration of neutropenia in
patients undergoing
myeloablative therapy followed by bone marrow transplantation
considered to be at
increased risk of prolonged severe neutropenia. The safety and
efficacy of filgrastim are
similar in adults and children receiving cytotoxic chemotherapy.
F