Ristempa

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

pegfilgrastim

Διαθέσιμο από:

Amgen Europe B.V.

Φαρμακολογική κατηγορία (ATC):

L03AA13

INN (Διεθνής Όνομα):

pegfilgrastim

Θεραπευτική ομάδα:

Immunostimulants,

Θεραπευτική περιοχή:

Neutropenia

Θεραπευτικές ενδείξεις:

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)

Περίληψη προϊόντος:

Revision: 3

Καθεστώς αδειοδότησης:

Withdrawn

Ημερομηνία της άδειας:

2015-04-13

Φύλλο οδηγιών χρήσης

25
B. PACKAGE LEAFLET
Medicinal product no longer authorised
26
PACKAGE LEAFLET: INFORMATION FOR THE USER
RISTEMPA 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 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 Ristempa is and what it is used for
2.
What you need to know before you use Ristempa
3.
How to use Ristempa
4.
Possible side effects
5.
How to store Ristempa
6.
Contents of the pack and other information
1.
WHAT RISTEMPA IS AND WHAT IT IS USED FOR
Ristempa 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.
Ristempa 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 white blood
cells fall

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
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
Ristempa 6 mg solution for injection.
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 (E420)
Each pre-filled syringe contains less than 1 mmol (23 mg) sodium (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
Ristempa 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 Ristempa is recommended
for each chemotherapy cycle,
given at least 24 hours after cytotoxic chemotherapy.
Medicinal product no longer authorised
3
Method of administration
Ristempa is injected subcutaneously. The injections should be given
into the thigh, abdomen or