Accofil

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

filgrastim

Available from:

Accord Healthcare S.L.U.

ATC code:

L03AA02

INN (International Name):

filgrastim

Therapeutic group:

Immunostimulants,

Therapeutic area:

Neutropenia

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 absolute neutrophil count (ANC) of ≤ 0.5 x 109/L, and a history of severe or recurrent infections, long term administration of Accofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Accofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109/L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Product summary:

Revision: 14

Authorization status:

Authorised

Authorization date:

2014-09-17

Patient Information leaflet

102
B. PACKAGE LEAFLET
103
PACKAGE LEAFLET: INFORMATION FOR THE USER
_ _
ACCOFIL 30 MU/0.5 ML (0.6 MG/ML) SOLUTION FOR INJECTION/INFUSION IN
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 Accofil is and what it is used for
2.
What you need to know before you use Accofil
3.
How to use Accofil
4.
Possible side effects
5. How to store Accofil
6. Contents of the pack and other information
1.
WHAT ACCOFIL IS AND WHAT IT IS USED FOR
WHAT ACCOFIL IS
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 b

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Accofil 30 MU/0.5 ml solution for injection/infusion in pre-filled
syringe
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) 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 in pre-filled syringe
Concentrate for solution for infusion in pre-filled syringe
Clear, colourless solution.
4.
CLINICAL 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 absolute
neutrophil count (ANC) of ≤ 0.5 x 10
9
/L, and a history of severe or recurrent infections, long term
administration of Accofil is indicated to increase neutrophil counts
and to reduce the incidence and
duration of infection-related events.
Accofil is indicated f
or 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 infec