Neulasta
Kraj: Unia Europejska
Język: angielski
Źródło: EMA (European Medicines Agency)
Ulotka dla pacjenta
(PIL)
27-06-2023
Charakterystyka produktu
(SPC)
27-06-2023
Sprawozdanie z oceny publicznego
(PAR)
04-10-2018
Składnik aktywny:
pegfilgrastim
Dostępny od:
Amgen Europe B.V.
Kod ATC:
L03AA13
INN (International Nazwa):
pegfilgrastim
Grupa terapeutyczna:
Immunostimulants,
Dziedzina terapeutyczna:
Neutropenia; Cancer
Wskazania:
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).
Podsumowanie produktu:
Revision: 39
Status autoryzacji:
Authorised
Data autoryzacji:
2002-08-22
Ulotka dla pacjenta
26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEULASTA 6 MG SOLUTION FOR INJECTION
pegfilgrastim
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 Neulasta is and what it is used for
2.
What you need to know before you use Neulasta
3.
How to use Neulasta
4.
Possible side effects
5.
How to store Neulasta
6.
Contents of the pack and other information
1.
WHAT NEULASTA IS AND WHAT IT IS USED FOR
Neulasta 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.
Neulasta 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 to a low level there may not be enough left in the body to fight
bacteria and you may have an
increased risk of infection.
Your doctor has given you Neulasta to encourage your bone marrow (part
of the bone which makes
blood cells) to produce more white blood cells that help your body
fight inf
Przeczytaj cały dokument
Charakterystyka produktu
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Neulasta 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.
Excipients with known effect
Each pre-filled syringe contains 30 mg sorbitol (E420) (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (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
Neulasta 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 Neulasta is recommended
for each chemotherapy cycle,
given at least 24 hours after cytotoxic chemotherapy.
Special populations
_Paediatric population _
The safety and efficacy of Neulasta 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.
3
_Patients with renal impairment _
No dose change is recommended in patients with renal impairment,
including those with end-stage
renal disease.
Method of administration
Neulasta is injected subcutaneously. The injections should be given
into the thigh, abdomen or upper
arm.
Przeczytaj cały dokument
