Lonquex

Krajina: Európska únia

Jazyk: angličtina

Zdroj: EMA (European Medicines Agency)

Aktívna zložka:

lipegfilgrastim

Dostupné z:

Teva B.V.

ATC kód:

L03AA14

INN (Medzinárodný Name):

lipegfilgrastim

Terapeutické skupiny:

Immunostimulants, , Colony stimulating factors

Terapeutické oblasti:

Neutropenia

Terapeutické indikácie:

Lonquex is indicated in adults and in children 2 years of age and older for 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).

Prehľad produktov:

Revision: 27

Stav Autorizácia:

Authorised

Dátum Autorizácia:

2013-07-25

Príbalový leták

30
B. PACKAGE LEAFLET
31
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LONQUEX 6 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
lipegfilgrastim
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 Lonquex is and what it is used for
2.
What you need to know before you use Lonquex
3.
How to use Lonquex
4.
Possible side effects
5.
How to store Lonquex
6.
Contents of the pack and other information
1.
WHAT LONQUEX IS AND WHAT IT IS USED FOR
WHAT LONQUEX IS
Lonquex contains the active substance lipegfilgrastim. Lipegfilgrastim
is a long-acting modified
protein produced by biotechnology in bacteria called
_Escherichia coli_
. It belongs to a group of proteins
called cytokines and is similar to a natural protein
(granulocyte-colony stimulating factor [G-CSF])
produced by your own body.
WHAT LONQUEX IS USED FOR
Lonquex is used in adults and in children aged 2 years and older.
Your doctor has prescribed Lonquex for you or for your child in order
to reduce the duration of a
condition called neutropenia (low white blood cell count) and the
occurrence of febrile neutropenia
(low white blood cell count with a fever). These can be caused by the
use of cytotoxic chemotherapy
(medicines that destroy rapidly-growing cells).
HOW LONQUEX WORKS
Lipegfilgrastim stimulates the bone marrow (the tissue where new blood
cells are made) to produce
more white blood 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
ca

Súhrn charakteristických

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Lonquex 6 mg solution for injection
in pre-filled syringe
Lonquex 6 mg/0.6 ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringe
Each pre-filled syringe contains 6 mg of lipegfilgrastim* in 0.6 ml
solution.
Vial
Each vial contains 6 mg of lipegfilgrastim* in 0.6 ml solution.
Each ml of solution for injection contains 10 mg of lipegfilgrastim.
The active substance is a covalent conjugate of filgrastim** with
methoxy polyethylene glycol (PEG)
via a carbohydrate linker.
*This is based on protein content only. The concentration is 20.9
mg/ml (i.e. 12.6 mg per pre-filled
syringe or vial) if the PEG moiety and the carbohydrate linker are
included.
**Filgrastim
(recombinant
methionyl
human
granulocyte-colony
stimulating
factor
[G-CSF])
is
produced in
_Escherichia coli _
cells by recombinant DNA technology.
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.
Excipients with known effect
Each pre-filled syringe or vial contains 30 mg sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection)
Clear, colourless solution
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lonquex is indicated in adults and in children 2 years of age and
older for 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).
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_ _
Lonquex treatment should be initiated and supervised by physicians
experienced in oncology or
haematology.
_ _
3
Posology
_Adults _
The recommended dose is 6 mg (0.6 ml solution in a single pre-filled
syringe or vial) of Lonquex for
each chemotherapy cycle, given approximately 24 hours after cytotoxic
ch