NEULASTIM

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

PEGFILGRASTIM

متاح من:

AMGEN EUROPE B.V.

ATC رمز:

L03AA13

الشكل الصيدلاني:

SOLUTION FOR INJECTION

تركيب:

PEGFILGRASTIM 10 MG/ML ML

طريقة التعاطي:

S.C

نوع الوصفة الطبية :

Required

المصنعة من قبل:

AMGEN EUROPE B.V., NETHERLANDS

المجموعة العلاجية:

PEGFILGRASTIM

المجال العلاجي:

PEGFILGRASTIM

الخصائص العلاجية:

Reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy, given at intervals of 14 days or more, for malignancy. ( with the exception of chronic myeloid leukaemia and myelodysplastic syndromes).

تاريخ الترخيص:

2020-12-31

نشرة المعلومات

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only
NEULASTIM
® PRE-FILLED SYRINGE
6 MG/0.6 ML (10 MG/1 ML)
For subcutaneous administration
COMPOSITION:
Each pre-filled syringe contains:
Pegfilgrastim 6 mg/0.6 ml
For information on the inactive ingredients see section 6 - “Further
Information”.
•
READ ALL OF THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THIS
MEDICINE.
This leaflet contains concise information
about the medicine. If you have further questions, refer to the
doctor, pharmacist or nurse.
•
Keep this leaflet. You may need to read it again.
•
This medicine has been prescribed for the treatment of your illness.
Do not pass it on to others. It may harm them, even
if it seems to you that their symptoms of illness are similar.
•
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 – “Side effects”.
IMPORTANT INFORMATION FOR YOUR ATTENTION
•
If you have been told that you are sensitive to certain types of
sugars, consult the doctor before using
NEULASTIM
.
•
NEULASTIM
can be self-injected in your home after receiving instruction from a
healthcare professional. Please carefully
read the instructions for self-injection at the end of this leaflet.
•
Following the doctor’s instructions (dosage, times of injection and
duration of treatment) increases the chances for
success of the treatment. In any case, do not discontinue the
treatment without consulting the attending doctor. Please
read sections 2 and 4 for broader safety information.
•
Keep
NEULASTIM
in the refrigerator (see section 5 - “How should the medicine be
stored?”).
•
The medicine,
NEULASTIM
pre-filled syringe, is intended for single-use!
1.
WHAT IS THE MEDICINE INTENDED FOR?
NEULASTIM
is used to reduce the duration of neutropenia (low white blood cell
count) and the occurrence of febrile neutropenia
(low whi

خصائص المنتج

1
Revised in January 2021 according to MoHs guidelines.
NEULASTIM
®
PEGFILGRASTIM
PRE-FILLED SYRINGE 6 MG/0.6 ML (10 MG/1 ML)
1.
NAME OF THE MEDICINAL PRODUCT
NEULASTIM
®
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 coli_
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 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 (see section 4.4).
Each pre-filled syringe contains less than 1 mmol (23 mg) sodium (see
section 4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colorless solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Reduction in the duration of neutropenia and the incidence of febrile
neutropenia in patients treated with
cytotoxic chemotherapy, given at intervals of 14 days or more, for
malignancy (with the exception of
chronic myeloid leukemia and myelodysplastic syndromes).
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Neulastim therapy should be initiated and supervised by physicians
experienced in oncology and/or
hematology.
Posology
One 6 mg dose (a single pre-filled syringe) of Neulastim is
recommended for each chemotherapy cycle,
given at least 24 hours after cytotoxic chemotherapy.
Method of administration
Neulastim is injected subcutaneously. The injections should be given
into the thigh, abdomen or upper arm.
For instructions on handling of the medicinal product before
administration, see section 6.6.
Pediatric population
The safety and efficacy of Neulastim in children has not yet been
established. Currentl