Cegfila (previously Pegfilgrastim Mundipharma)

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

pegfilgrastim

Available from:

Mundipharma Corporation (Ireland) Limited

ATC code:

L03AA13

INN (International Name):

pegfilgrastim

Therapeutic group:

Immunostimulants,

Therapeutic area:

Neutropenia

Therapeutic indications:

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

Product summary:

Revision: 7

Authorization status:

Authorised

Authorization date:

2019-12-19

Patient Information leaflet

22
B.
PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE USER
CEGFILA 6 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
pegfilgrastim
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may
harm them, even if their symptoms 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 Cegfila is and what it is used for
2.
What you need to know before you use Cegfila
3.
How to use Cegfila
4.
Possible side effects
5.
How to store Cegfila
6.
Contents of the pack and other information
1.
WHAT CEGFILA IS AND WHAT IT IS USED FOR
Cegfila contains the active substance pegfilgrastim. Pegfilgrastim is
a protein produced by
biotechnology in bacteria called
_E. coli_
. It belongs to a group of proteins called cytokines, and is very
similar to a natural protein (granulocyte-colony stimulating factor)
produced by your own body.
Cegfila is used in adult patients to reduce the duration of
neutropenia (low white blood cell count) and
the occurrence of febrile neutropenia (low white blood cell count with
a fever) which can be caused by
the use of cytotoxic chemotherapy (medicines that destroy rapidly
growing cells). White blood cells
are important as they help your body fight infection. These cells are
very sensitive to the effects of
chemotherapy which can cause the number of these cells in your body to
decrease. If white blood cells
fall to a low level there may not be

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Cegfila 6 mg solution for injection in pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains 6 mg of pegfilgrastim* in 0.6 mL
solution for injection. The
concentration is 10 mg/mL based on protein only**.
*Produced in
_Escherichia coli _
cells by recombinant DNA technology followed by conjugation with
polyethylene glycol (PEG).
** The concentration is 20 mg/mL if the PEG moiety is included.
The potency of this product should not be compared to the potency of
another pegylated or
nonpegylated protein of the same therapeutic class. For more
information, see section 5.1
Excipient with known effect
Each pre-filled syringe contains 30 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction in the duration of neutropenia and the incidence of febrile
neutropenia in adult patients
treated with cytotoxic chemotherapy for malignancy (with the exception
of chronic myeloid leukaemia
and myelodysplastic syndromes).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Cegfila therapy should be initiated and supervised by physicians
experienced in oncology and/or
haematology.
Posology
One 6 mg dose (a single pre-filled syringe) of Cegfila is recommended
for each chemotherapy cycle,
given at least 24 hours after cytotoxic chemotherapy.
3
Special populations
_Paediatric population _
The safety and efficacy of pegfilgrastim in children has not yet been
established. Currently available
data are described in sections 4.8, 5.1 and 5.2 but no recommendation
on a posology can be made.
_Patients with renal impairment