PEGIL

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

PEGFILGRASTIM

Dostopno od:

UNIPHARM TRADING LTD, ISRAEL

Koda artikla:

L03AA13

Farmacevtska oblika:

SOLUTION FOR INJECTION

Sestava:

PEGFILGRASTIM 10 MG/ML

Pot uporabe:

S.C

Tip zastaranja:

Required

Izdeluje:

BIOCON BIOLOGICS INDIA LTD., INDIA

Terapevtsko območje:

PEGFILGRASTIM

Terapevtske indikacije:

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).

Datum dovoljenje:

2020-09-29

Navodilo za uporabo

PATIENT PACKAGE INSERT IN ACCORDANCE
WITH THE PHARMACISTS’ REGULATIONS
)PREPARATIONS( – 1986
The medicine is dispensed with a
doctor’s prescription only
PEGIL
SOLUTION FOR INJECTION
IN PRE-FILLED SYRINGE
6 MG/0.6 ML
For subcutaneous administration
COMPOSITION:
Each pre-filled syringe contains:
Pegfilgrastim 6 mg/0.6 ml
Inactive and allergenic ingredients in the preparation –
see section 6 – ”Further Information“ and section 2 –
“Important information about some of the ingredients
of the medicine“.
•
READ THE 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, pharmacist or nurse.
•
Keep this leaflet. You may need to read it again.
•
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 ailment is similar.
•
If any side effects occur, consult a 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 PEGIL.
•
PEGIL can be self-injected in your home after
receiving instruction from a healthcare professional.
Please carefully read the instructions for self-
injection appearing in the Instructions for Use
Leaflet attached to the package.
•
Carefully following the doctor’s instructions
(dosage, times of injection and duration of
treatment) increases the chances for treatment
success. In any case, do not discontinue the
treatment without consulting the attending doctor.
Please read sections 2 and 4 for extensive safety
information.
•
Keep PEGIL in the refrigerator (see section 5 – “How
Should The Medicine Be Stored?“(.
•
The medicine, PEGIL pre-filled syringe, is intended
for single use!
Note that it is important that you verify, each t

Lastnosti izdelka

1
PEGIL
(PEGFILGRASTIM)
SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
6 MG/0.6 ML (10 MG/1 ML)
1.
NAME OF THE MEDICINAL PRODUCT
PEGIL 6 mg solution for injection in pre-filled syringe.
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 sodium (23 mg) (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.
Pegil is a biosimilar medicinal product that has been demonstrated to
be similar in quality, safety and
efficacy to the reference medicinal product Neulastim®. Please be
aware of any differences in the
indications between the biosimilar medicinal product and the reference
medicinal product. The biosimilar
is not to be switched with the reference medicinal product unless
specifically stated otherwise.
More
detailed information regarding biosimilar medicinal products is
available on the website of the Ministry of
Health:
https://www.health.gov.il/UnitsOffice/HD/MTI/Drugs/Registration/Pages/Biosimilars.aspx
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
Pegfilgrastim