Ziextenzo
Riik: Euroopa Liit
keel: inglise
Allikas: EMA (European Medicines Agency)
Infovoldik
(PIL)
04-12-2023
Toote omadused
(SPC)
04-12-2023
Avaliku hindamisaruande
(PAR)
16-01-2019
Toimeaine:
pegfilgrastim
Saadav alates:
Sandoz GmbH
ATC kood:
L03AA13
INN (Rahvusvaheline Nimetus):
pegfilgrastim
Terapeutiline rühm:
Immunostimulants,
Terapeutiline ala:
Neutropenia
Näidustused:
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).
Toote kokkuvõte:
Revision: 9
Volitamisolek:
Authorised
Loa andmise kuupäev:
2018-11-22
Infovoldik
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIEXTENZO 6 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
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 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 Ziextenzo is and what it is used for
2.
What you need to know before you use Ziextenzo
3.
How to use Ziextenzo
4.
Possible side effects
5.
How to store Ziextenzo
6.
Contents of the pack and other information
1.
WHAT ZIEXTENZO IS AND WHAT IT IS USED FOR
Ziextenzo 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.
Ziextenzo 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 Ziextenzo to encourage your bone marrow
(part of the bone which makes
blood cells) to produce more white blood ce
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Toote omadused
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Ziextenzo 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
Excipients 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 (injection)
Clear, colourless to slightly yellowish 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
Ziextenzo 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 Ziextenzo is
recommended for each chemotherapy cycle,
given at least 24 hours after cytotoxic chemotherapy.
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.
3
_Renal impairment_
No dose change is recommended in patients with renal impairment,
including those with end stage renal
disease.
Method of administration
Ziextenzo is for subcutaneous use.
The injections should be given into the thigh, abdomen o
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