STIMOFIL 480 MCG0.5 ML

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

FILGRASTIM

Commercializzato da:

TZAMAL BIO-PHARMA LTD

Codice ATC:

L03AA02

Forma farmaceutica:

SOLUTION FOR INJECTION / INFUSION

Composizione:

FILGRASTIM 480 MCG / 0.5 ML

Via di somministrazione:

S.C, I.V

Tipo di ricetta:

Required

Prodotto da:

INTAS PHARMACEUTICALS LTD., INDIA

Area terapeutica:

FILGRASTIM

Indicazioni terapeutiche:

Stimofil is indicated for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in patients treated with established cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes) and for the reduction in the duration of neutropenia in patients undergoing myeloablative therapy followed by bone marrow transplantation considered to be at increased risk of prolonged severe neutropenia.The safety and efficacy of Stimofil are similar in adults and children receiving cytotoxic chemotherapy.Stimofil is indicated for the mobilisation of peripheral blood progenitor cells (PBPCs).In patients, children or adults with severe congenital, cyclic, or idiopathic neutropenia with an absolute neutrophil count (ANC) of less or equal to 0.5 x 109 /L, and a history of severe or recurrent infections, long term administration of Stimofil is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Stimofil is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 x 109 /L) in patients with advanced HIV infection, in order to reduce the risk of bacterial infections when other options to manage neutropenia are inappropriate.

Data dell'autorizzazione:

2020-04-02

Scheda tecnica

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STIMOFIL 300 MCG/0.5 ML, 480 MCG/0.5 ML
PHYSICIAN'S PRESCRIBING INFORMATION
1.
NAME OF THE MEDICINAL PRODUCT
StimoFil 300 mcg/0.5 ml
StimoFil 480 mcg/0.5 ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
STIMOFIL 300 MCG/0.5 ML:
Each ml of solution contains 60 million units (MU) (equivalent to 600
micrograms [μg]) of
(filgrastim).
Each pre-filled syringe contains 30 MU (equivalent to 300 micrograms
of filgrastim in 0.5 ml solution
for injection or infusion.
STIMOFIL 480 MCG/0.5 ML:
Each ml of solution contains 96 million units (MU) (equivalent to 960
micrograms [μg]) of filgrastim.
Each pre-filled syringe contains 48 MU (equivalent to 480 micrograms
of filgrastim in 0.5 ml solution
for injection or infusion.
Filgrastim is a recombinant methionyl human granulocyte-colony
stimulating factor produced in
_Escherichia coli _(BL21) by recombinant DNA technology.
Excipient with known effect:
Each ml of solution contains 50 mg of D-sorbitol
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection or infusion
Clear, colourless solution
StimoFil is a biosimilar medicinal product that has been demonstrated
to be similar in quality, safety
and efficacy to the reference medicinal product Neupogen. 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
4.
CLINCAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
StimoFil is indicated for the reduction in the duration of neutropenia
and the incidence of febrile
neutropenia in patients treated with established cytotoxic
chemotherapy for malignancy (with the
exception of chronic myeloid leukemia and myelodysplastic syndromes)
and for the reduction in the
duration of neutropenia in patients undergoing myeloablative therapy
followed by bone marrow
transplantation considered to be at increased risk of prolonged severe
neutro