Neupogen Singleject 30 MU/0.5 ml Solution for injection in a pre-filled syringe filgrastim

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Filgrastim

Available from:

Amgen Europe B.V.

ATC code:

L03AA; L03AA02

INN (International Name):

Filgrastim

Dosage:

30 MU (0.6) milligram(s)/millilitre

Pharmaceutical form:

Solution for injection in pre-filled syringe

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Colony stimulating factors; filgrastim

Authorization status:

Marketed

Authorization date:

2001-11-16

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEUPOGEN SINGLEJECT 30 MU/0.5 ML
NEUPOGEN SINGLEJECT 48 MU/0.5 ML
SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
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
7.
Instructions for injecting Neupogen
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
d

Summary of Product characteristics

Health Products Regulatory Authority
10 October 2022
CRN00CR1C
Page 1 of 16
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Neupogen Singleject 30 MU/0.5 ml Solution for injection in a
pre-filled syringe filgrastim
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 30 million units (MU)/300 micrograms
of filgrastim in 0.5 ml (0.6 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 50 mg of sorbitol (E420).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in a pre-filled syringe
Concentrate for solution for infusion in a pre-filled syringe
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 absolute neutrophil count (ANC)
of ≤ 0.5 × 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.
Neupogen is indicated for the treatment of persistent neutropenia (ANC
less than or equal to 1.0 × 10
9
/l) in patients with
advanced HIV infection, in order to reduce