Accofil (filgrastim) 48 MU0.5 ml Solution for injectioninfusion in Prefilled Syringe

Страна: Малайзія

мова: англійська

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

Активний інгредієнт:

Filgrastim

Доступна з:

ACCORD HEALTHCARE SDN.BHD.

ІПН (Міжнародна Ім'я):

Filgrastim

Одиниць в упаковці:

0.5 ml x 1 PFS ml; 0.5 ml x 3 PFS ml; 0.5 ml x 5 PFS ml

Виробник:

Intas Pharmaceuticals Limited Biopharma Division

інформаційний буклет

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ACCOFIL
30 MU/0.5 ML & 48 MU/0.5 ML (0.6 MG/ML) SOLUTION FOR INJECTION OR
INFUSION IN PRE-FILLED SYRINGE
Filgrastim 30 MU/0.5 ml & 48 MU/0.5 ml (0.6 mg/ml)
WHAT IS IN THIS LEAFLET
1.
What Accofil is used for
2.
How Accofil works
3.
Before you use Accofil
4.
How to use Accofil
5.
Possible side effects
6.
How to store and dispose Accofil
7.
Product Description
8.
Manufacturer and Product
Registration Holder
9.
Date of Revision
10.
Serial Number
WHAT ACCOFIL IS AND HOW IT WORKS
Accofil is a white blood cell growth
factor (granulocyte colony
stimulating factor) and belong to a
group of medicines called cytokines.
Growth factors are proteins that are
produced naturally in the body but
they can also be made using
biotechnology for use as a medicine.
Accofil works by encouraging the
bone marrow to produce more white
blood cells.
A reduction in the number of white
blood cells (neutropenia) can occur
for several reasons and makes your
body less able to fight infection.
Accofil stimulates the bone marrow
to produce new white cells quickly.
Accofil can be used:
•
to increase the number of white
blood cells after treatment with
chemotherapy to help prevent
infections;
•
to increase the number of white
blood cells after a bone marrow
transplant to help prevent
infections;
•
before high-dose chemotherapy
to make the bone marrow
produce more stem cells which
can be collected and given back
to you after your treatment. These
can be taken from you or from a
donor. The stem cells will then go
back into the bone marrow and
produce blood cells;
•
to increase the number of white
blood cells if you suffer from
severe chronic neutropenia to
help prevent infections;
•
in patients with advanced HIV
infection which will help reduce
the risk of infections
BEFORE YOU USE ACCOFIL
DO NOT USE ACCOFIL
•
If you are allergic
(hypersensitive) to filgrastim or
any of the other ingredients of
this medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or

Характеристики продукта

ACCOFIL
FRONT
450 mm
866 mm
124 mm
38 mm
1.
NAME OF THE MEDICINAL PRODUCT
Accofil 30 MU/0.5 ml solution for injection or infusion in
pre-filled syringe.
Accofil 48 MU/0.5 ml solution for injection or infusion in
pre-filled syringe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 60 million units (MU) (equivalent to 600
micrograms [μg]) of
filgrastim.
Each ml of solution contains 96 million units (MU) (equivalent to 960
micrograms [μg]) of
filgrastim.
Each pre-filled syringe contains 30 MU (equivalent to 300 micrograms
of filgrastim in 0.5 ml
solution for injection or infusion.
Each pre-filled syringe contains 48 MU (equivalent to 480 micrograms
of filgrastim in 0.5 ml
solution for injection or infusion.
Filgrastim is a recombinant methionyl human granulocyte-colony
stimulating factor produced
in_ Escherichia coli _(BL21) by recombinant DNA technology.
Excipient with known effect
Each ml of solution contains 50 mg of sorbitol (E420) For the full
list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection or infusion Clear, colourless solution
4.
CLINCAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Accofil 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 Accofil are similar in
adults and children
receiving cytotoxic chemotherapy.
Accofil is indicated for the mobilisation of peripheral blood
progenitor cells (PBPCs).
In patients, children or adults with severe congenital, cyclic, or
idiopathic neutropenia with an
9
absolute neutrophil count (ANC) of ≤ 0.5 x 10 /L, and a history of
severe or recurrent
infections, long term