Udenyca
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
29-11-2019
Vara einkenni
(SPC)
29-11-2019
Opinber matsskýrsla
(PAR)
23-10-2018
Virkt innihaldsefni:
pegfilgrastim
Fáanlegur frá:
ERA Consulting GmbH
ATC númer:
L03AA13
INN (Alþjóðlegt nafn):
pegfilgrastim
Meðferðarhópur:
Immunostimulants, , Colony stimulating factors
Lækningarsvæði:
Neutropenia
Ábendingar:
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).
Vörulýsing:
Revision: 3
Leyfisstaða:
Withdrawn
Leyfisdagur:
2018-09-21
Upplýsingar fylgiseðill
21
B. PACKAGE LEAFLET
22
PACKAGE LEAFLET: INFORMATION FOR THE USER
UDENYCA 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 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 UDENYCA is and what it is used for
2.
What you need to know before you use UDENYCA
3.
How to use UDENYCA
4.
Possible side effects
5.
How to store UDENYCA
6.
Contents of the pack and other information
1.
WHAT UDENYCA IS AND WHAT IT IS USED FOR
UDENYCA contains the active substance pegfilgrastim. Pegfilgrastim is
a protein produced by
biotechnology in bacteria called
_E. coli _
followed by conjugation with polyethylene glycol (PEG) It
belongs to a group of proteins called cytokines. The protein part is
very similar to a natural protein
produced by your own body.
The medicinal product is used to reduce the duration of low white
blood cell count (neutropenia) and
the occurrence of low white blood cell count with a fever (febrile
neutropenia) 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 le
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Vara einkenni
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
UDENYCA 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 content only**.
*The active substance is a covalent conjugate of filgrastim produced
in
_Escherichia coli_
cells by
recombinant DNA technology with polyethylene glycol (PEG).
** The concentration is 20 mg/ml if the PEG moiety is included.
The potency of this medicinal 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 with known effect
Each pre--filled syringe contains 30 mg sorbitol
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.
_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
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