LONQUEX

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

LIPEGFILGRASTIM

Disponibil de la:

ABIC MARKETING LTD, ISRAEL

Codul ATC:

L03AA14

Forma farmaceutică:

SOLUTION FOR INJECTION

Compoziție:

LIPEGFILGRASTIM 6 MG / 0.6 ML

Calea de administrare:

S.C

Tip de prescriptie medicala:

Required

Produs de:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Zonă Terapeutică:

LIPEGFILGRASTIM

Indicații terapeutice:

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).

Data de autorizare:

2020-03-19

Prospect

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) – 1986
The medicine is dispensed with a doctor’s prescription only
LONQUEX
®
Solution for injection in a pre-filled syringe
For subcutaneous injection only
Composition
Each syringe contains:
Lipegfilgrastim 6 mg/0.6 ml
Corresponding to lipegfilgrastim 10 mg per 1 ml solution.
For information on the inactive and allergenic ingredients, see
section 2 –
“Important information about some of the ingredients of the
medicine”
and section 6 – “Further information”.
Read this leaflet carefully in its entirety before using the medicine.
This leaflet contains concise information about the medicine. If you
have further questions, refer to the doctor or pharmacist.
This medicine has been prescribed for the treatment of your ailment.
Do not pass it on to others. It may harm them even if it seems to
you that their medical condition is similar.
This medicine is intended for subcutaneous injection only.
This medicine is not intended for use in children or adolescents
under 18 years of age.
1. WHAT IS THE MEDICINE INTENDED FOR?
The medicine is intended to reduce the duration of neutropenia (low
white blood cell count) and the incidence of febrile neutropenia that
may be caused by chemotherapy treatment.
If you would like to find out why this medicine was prescribed for
you, please ask your doctor or pharmacist.
Therapeutic group:
A G-CSF-type protein that stimulates production of white blood cells
called neutrophils.
2. BEFORE USING THE MEDICINE
Do not use this preparation if:
∙ You are sensitive (allergic) to the active ingredient or to any of
the
additional ingredients contained in the medicine (see section 6 in
this leaflet – “Further information”).
Special warnings regarding use of the medicine
Before treatment with Lonquex, tell the doctor if:
∙ you experience left upper abdominal pain or pain at the tip of the
shoulder. This could indicate impaired spleen function (see section
4 – “Side effects”).
∙ you

Caracteristicilor produsului

Lonquex SPC Minor Updates 11/2023
SUMMARY OF PRODUCT CHARACTERISTICS
LONQUEX
®
Solution for injection
1.
NAME OF THE MEDICINAL PRODUCT
Lonquex
®
6 mg solution for injection in pre-filled syringe.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe 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) 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 contains 30 mg sorbitol.
Sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in pre-filled syringe (injection).
Clear, colourless solution
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Lonquex is indicated in adults for 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
_ _
Lonquex treatment should be initiated and supervised by physicians
experienced in oncology
or haematology.
_ _
Lonquex SPC Minor Updates 11/2023
_Posology _
One 6 mg dose of lipegfilgrastim (a single pre-filled syringe of
Lonquex) is recommended for
each chemotherapy cycle, given approximately 24 hours after cytotoxic
chemotherapy.
_ _
_ _
Special populations
_Elderly patients _
In clinical