Neupopeg
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
26-01-2009
Karatteristiċi tal-prodott
(SPC)
26-01-2009
Rapport ta 'Valutazzjoni Pubblika
(PAR)
26-01-2009
Ingredjent attiv:
pegfilgrastim
Disponibbli minn:
Dompé Biotec S.p.A.
Kodiċi ATC:
L03AA13
INN (Isem Internazzjonali):
pegfilgrastim
Grupp terapewtiku:
Immunostimulants,
Żona terapewtika:
Neutropenia; Cancer
Indikazzjonijiet terapewtiċi:
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).
Sommarju tal-prodott:
Revision: 9
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2002-08-22
Fuljett ta 'informazzjoni
Medicinal product no longer authorised
B. PACKAGE LEAFLET
Medicinal product no longer authorised
PACKAGE LEAFLET: INFORMATION FOR THE USER
NEUPOPEG
6 MG SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE
pegfilgrastim
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS M
EDICINE.
-
Keep this leaf
let. You may need to read it again.
-
If you
have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET
1.
What Neupop
eg is and what it is used for
2.
Before y
ou use Neupopeg
3.
How to use Neupopeg
4.
Possible side effects
5.
How to store Neupopeg
6.
Further information
1.
WHAT NEUPOPEG IS AND WHAT IT IS USED FOR
Neupopeg is used to reduce the duration of neutro
penia (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 Neupopeg to encourage your bo
ne marrow (part of the bone which makes
blood cells) to produce more white blood cells that help your body
fight infection.
2.
BEFORE YOU USE NEUPOPEG
DO NOT USE NEUPOPEG
•
if
you are hypersensitive (allergic) to pegfilgrastim, filgrastim,
_E. coli _
derived proteins, or any
of the other ingredients of Neupopeg.
TAKE SPECIAL CARE WITH NEUPOPEG
Please tell your doctor:
•
if
you experience a cough, fever and difficulty breathing;
•
if you
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Karatteristiċi tal-prodott
Medicinal product no longer authorised
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
1.
NAME OF THE MEDICINAL PRODUCT
Neupopeg 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 c_
_oli_
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 potenc
y of another pegylated or non-
pegylated protein of the same therapeutic class. For more information,
see section 5.1.
Excipients:
Excipients known to have a recognised action: sorbitol E420, sodium
acetate (see section 4.4).
For a 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 incid
ence of febrile neutropenia in patients treated
with cytotoxic chemotherapy for malignancy (with the exception of
chronic myeloid leukaemia and
myelodysplastic syndromes).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Neupopeg therapy should be initiated and supervised by
physicians experienced in oncology and/or
haematology.
One 6 mg dose (a single pre-filled syringe) of Neupopeg is recommended
for each chemotherapy
cycle, administered as a subcutaneous injection approximately 24 hours
following cytotoxic
chemotherapy.
Neupopeg is not recommended for use in children under 18
years of age due to insufficient data on
safety and efficacy.
Renal impairment: no dose change is recommended in patients with renal
impairment, including those
with end stage renal disease.
4.3
CONTRAINDICATIONS
Hypersensitivity to the active substance or to any of the excipients.
Medicinal product no longer authorised
4.4
SPECIAL WARNINGS AND PRECAUTI
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