Lonquex 6mg0.6ml solution for injection pre-filled syringes

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Lipegfilgrastim

Available from:

Teva UK Ltd

ATC code:

L03AA14

INN (International Name):

Lipegfilgrastim

Dosage:

10mg/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Subcutaneous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 09010600; GTIN: 5017007025658

Patient Information leaflet

25
PACKAGE LEAFLET: INFORMATION FOR THE USER
LONQUEX 6 MG SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
lipegfilgrastim
▼ This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
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
Your doctor has prescribed Lonquex for you 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 im

Summary of Product characteristics

OBJECT 1
LONQUEX
Summary of Product Characteristics Updated 21-May-2018 | Teva Pharma
B.V.
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See
section 4.8 for how to report adverse reactions.
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 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.
Posology
One 6 mg dose of lipegfilgrastim (a single pre-filled syr