Grasustek

Nchi: Umoja wa Ulaya

Lugha: Kiingereza

Chanzo: EMA (European Medicines Agency)

Viambatanisho vya kazi:

pegfilgrastim

Inapatikana kutoka:

Juta Pharma GmbH

ATC kanuni:

L03AA13

INN (Jina la Kimataifa):

pegfilgrastim

Kundi la matibabu:

Immunostimulants,

Eneo la matibabu:

Neutropenia

Matibabu dalili:

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).

Bidhaa muhtasari:

Revision: 4

Idhini hali ya:

Authorised

Idhini ya tarehe:

2019-06-20

Taarifa za kipeperushi

22
B. PACKAGE LEAFLET
23
PACKAGE LEAFLET: INFORMATION FOR THE USER
GRASUSTEK 6 MG SOLUTION FOR INJECTION IN A 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 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 Grasustek is and what it is used for
2.
What you need to know before you use Grasustek
3.
How to use Grasustek
4.
Possible side effects
5.
How to store Grasustek
6.
Contents of the pack and other information
1.
WHAT GRASUSTEK IS AND WHAT IT IS USED FOR
Grasustek is for use in adults aged 18 and over.
Grasustek 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.
Grasustek is used 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 w

Tabia za bidhaa

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
Grasustek 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 non-
pegylated protein of the same therapeutic class. For more information,
see section 5.1.
Excipient(s) with known effect
Each pre-filled syringe contains 30 mg sorbitol (E 420) (see section
4.4).
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
Pegfilgrastim 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 pegfilgrastim is
recommended for each chemotherapy
cycle, given at least 24 hours after cytotoxic chemotherapy.
Special populations
_Paediatric population _
_ _
3
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 dosing
recommendations can be