LONQUEX SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE 6MG0.6ML

দেশ: সিঙ্গাপুর

ভাষা: ইংরেজি

সূত্র: HSA (Health Sciences Authority)

সক্রিয় উপাদান:

Lipegfilgrastim

থেকে পাওয়া:

TEVA PHARMACEUTICAL INVESTMENTS SINGAPORE PTE. LTD.

এটিসি কোড:

L03AA14

ফার্মাসিউটিকাল ফর্ম:

INJECTION, SOLUTION

রচনা:

Lipegfilgrastim 6.00 mg/0.6ml

প্রশাসন রুট:

SUBCUTANEOUS

প্রেসক্রিপশন টাইপ:

Prescription Only

Manufactured by:

TEVA PHARMACEUTICAL INDUSTRIES LTD.

অনুমোদন অবস্থা:

ACTIVE

অনুমোদন তারিখ:

2020-09-25

তথ্য লিফলেট

1
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.
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
7.
Information for injecting yourself
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 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

পণ্য বৈশিষ্ট্য

1
LONQUEX PRE-FILLED SYRINGE 6MG/0.6ML
Lipegfilgrastim
1.
NAME OF THE MEDICINAL PRODUCT
LONQUEX PRE-FILLED SYRINGE 6MG/0.6M
L
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 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.
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.
2
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 studies with a limited number of elderly patients, there
was no relevant age-related
difference with regard to the efficac