Zarzio
Country: Evrópusambandið
Tungumál: enska
Heimild: EMA (European Medicines Agency)
Upplýsingar fylgiseðill
(PIL)
06-12-2023
Vara einkenni
(SPC)
06-12-2023
Opinber matsskýrsla
(PAR)
17-02-2009
Virkt innihaldsefni:
filgrastim
Fáanlegur frá:
Sandoz GmbH
ATC númer:
L03AA02
INN (Alþjóðlegt nafn):
filgrastim
Meðferðarhópur:
Immunostimulants,
Lækningarsvæði:
Neutropenia; Hematopoietic Stem Cell Transplantation; Cancer
Ábendingar:
Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone-marrow transplantation considered to be at increased risk of prolonged severe neutropenia. The safety and efficacy of filgrastim are similar in adults and children receiving cytotoxic chemotherapy.Mobilisation of peripheral blood progenitor cells (PBPC).In children and adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of ≤0.5 x 109/l, and a history of severe or recurrent infections, long term administration of filgrastim is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Treatment of persistent neutropenia (ANC ≤ 1.0 x 109/l) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other therapeutic options are inappropriate.
Vörulýsing:
Revision: 24
Leyfisstaða:
Authorised
Leyfisdagur:
2009-02-06
Upplýsingar fylgiseðill
32
B. PACKAGE LEAFLET
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZARZIO 30 MU/0.5 ML SOLUTION FOR INJECTION OR INFUSION IN PRE-FILLED
SYRINGE
ZARZIO 48 MU/0.5 ML SOLUTION FOR INJECTION OR INFUSION IN PRE-FILLED
SYRINGE
filgrastim
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 Zarzio is and what it is used for
2.
What you need to know before you use Zarzio
3.
How to use Zarzio
4.
Possible side effects
5.
How to store Zarzio
6.
Contents of the pack and other information
1.
WHAT ZARZIO IS AND WHAT IT IS USED FOR
Zarzio is a white blood cell growth factor (granulocyte colony
stimulating factor) and belongs to a
group of proteins called cytokines. Growth factors are proteins that
are produced naturally in the body
but they can also be made using biotechnology for use as a medicine.
Zarzio works by encouraging the
bone marrow to produce more white blood cells.
A reduction in the number of white blood cells (neutropenia) can occur
for several reasons and makes
your body less able to fight infection. Zarzio stimulates the bone
marrow to produce new white cells
quickly.
Zarzio can be used:
•
to increase the number of white blood cells after treatment with
chemotherapy to help prevent
infections;
•
to increase the number of white blood cells after a bone marrow
transplant to help prevent
infections;
•
before high-dose chemotherapy to make the bone marrow produce more
stem cells which can be
collected and given back to you after your treatment. These can be
taken from you or from a
do
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Vara einkenni
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Zarzio 30 MU/0.5 mL solution for injection or infusion in pre-filled
syringe
Zarzio 48 MU/0.5 mL solution for injection or infusion in pre-filled
syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zarzio 30 MU/0.5 mL solution for injection or infusion in pre-filled
syringe
Each mL of solution contains 60 million units (MU) (equivalent to 600
micrograms [mcg]) filgrastim*.
Each pre-filled syringe contains 30 MU (equivalent to 300 mcg)
filgrastim in 0.5 mL.
Zarzio 48 MU/0.5 mL solution for injection or infusion in pre-filled
syringe
Each mL of solution contains 96 million units (MU) (equivalent to 960
micrograms [mcg]) filgrastim*.
Each pre-filled syringe contains 48 MU (equivalent to 480 mcg)
filgrastim in 0.5 mL.
* recombinant methionylated human granulocyte-colony stimulating
factor (G-CSF) produced in
_E. coli_ by recombinant DNA technology.
Excipient with known effect
Each mL of solution contains 50 mg sorbitol (E420).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection or infusion in pre-filled syringe (injection or
infusion).
Clear, colourless to slightly yellowish solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
Reduction in the duration of neutropenia and the incidence of febrile
neutropenia in patients
treated with established cytotoxic chemotherapy for malignancy (with
the exception of chronic
myeloid leukaemia and myelodysplastic syndromes) and reduction in the
duration of
neutropenia in patients undergoing myeloablative therapy followed by
bone marrow
transplantation considered to be at increased risk of prolonged severe
neutropenia.
The safety and efficacy of filgrastim are similar in adults and
children receiving cytotoxic
chemotherapy.
-
Mobilisation of peripheral blood progenitor cells (PBPCs).
-
In patients, children or adults, with severe congenital, cyclic, or
idiopathic neutropenia with an
absolute neutrophil count (ANC) of ≤ 0.5 × 10
9
/L, and a history
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