PEGFILGRASTIM KAMADA

Země: Izrael

Jazyk: angličtina

Zdroj: Ministry of Health

Aktivní složka:

PEGFILGRASTIM

Dostupné s:

KAMADA LTD, ISRAEL

ATC kód:

L03AA13

Léková forma:

SOLUTION FOR INJECTION

Složení:

PEGFILGRASTIM 10 MG/ML

Podání:

S.C

Druh předpisu:

Required

Výrobce:

USV PRIVATE LIMITED, INDIA

Terapeutické oblasti:

PEGFILGRASTIM

Terapeutické indikace:

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 autorizace:

2023-07-18

Charakteristika produktu

1
Pegfilgrastim Kamada
Pre-filled syringe 6 mg/0.6 ml (10 mg/1 ml)
1.
NAME OF THE MEDICINAL PRODUCT
Pegfilgrastim Kamada
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 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 D-sorbitol (E-420) (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
Pegfilgrastim Kamada is a biosimilar medicinal product that has been
registered by the Israeli MOH for the
below indication and as similar in quality, safety and efficacy to the
reference medicinal product Neulastim
®
6 mg solution for injection as registered in Israel. Please be aware
of any differences in the indications
between the biosimilar medicinal product and the reference medicinal
product. Information regarding
biosimilar products can be found on the website of the Ministry of
Health:
https://www.gov.il/he/Departments/General/biosimilar
This biosimilar product is not to be switched with the reference
medicinal product or other biosimilars
unless specifically stated otherwise.
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).
4.2
Posology and method of administration
2
Pegfilgrastim therapy should be initiated and su