Neupogen 48 MU Solution for Injection (0.3 mg/ml)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FILGRASTIM

Available from:

Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Netherlands

ATC code:

L03AA02

INN (International Name):

FILGRASTIM 0.3 mg/ml

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

FILGRASTIM 0.3 mg/ml

Prescription type:

POM

Therapeutic area:

IMMUNOSTIMULANTS

Authorization status:

Withdrawn

Authorization date:

2005-07-26

Patient Information leaflet

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PACKAGE LEAFLET: INFORMATION FOR THE USER
NEUPOGEN 48 MU (0.3 MG/ML)
SOLUTION FOR INJECTION
FILGRASTIM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor, nurse or
pharmacist.

This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.

If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Neupogen is and what it is used for
2.
What you need to know before you use Neupogen
3.
How to use Neupogen
4.
Possible side effects
5.
How to store Neupogen
6.
Contents of the pack and other information
1.
WHAT NEUPOGEN IS AND WHAT IT IS USED FOR
Neupogen 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. Neupogen 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. Neupogen stimulates the
bone marrow to produce new
white cells quickly.
Neupogen 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 i

Summary of Product characteristics

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SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 24
1.
NAME OF THE MEDICINAL PRODUCT
Neupogen 48 MU (0.3 mg/ml) solution for injection
filgrastim
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 48 million units (MU)/480 micrograms (

g) of filgrastim in 1.6 ml (0.3 mg/ml).
Filgrastim (recombinant methionyl human granulocyte-colony stimulating
factor) is produced by r-
DNA technology in _E. coli_ (K12)._ _
Excipient with known effect:
Each ml of solution contains 0.0010 to 0.0022 mmol or 0.023 to 0.051
mg sodium and 50 mg
sorbitol (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Concentrate for solution for infusion.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Neupogen 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 Neupogen are similar in adults and children
receiving cytotoxic
chemotherapy.
Neupogen 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 ANC
of

0.5 x 10
9
/l, and a history of severe or recurrent infections, long term
administration of
Neupogen is indicated to increase neutrophil counts and to reduce the
incidence and duration of
infection-related events.
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Neupogen is indicated for the treatment of persistent neutropenia (ANC
less than or equal to
1.0 x 10
9
/l) in patients with advanced HIV infection, in order to reduce the
risk of bacterial
infections when other options to manage neutropenia are inappropria