NEUPOGEN 48 MU Pre-filled syringe

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

FILGRASTIM

Commercializzato da:

AMGEN EUROPE B.V.

Codice ATC:

L03AA02

Forma farmaceutica:

SOLUTION FOR INJECTION

Composizione:

FILGRASTIM 48 MU / 0.5 ML

Via di somministrazione:

I.V, S.C

Tipo di ricetta:

Required

Prodotto da:

AMGEN EUROPE B.V., NETHERLANDS

Gruppo terapeutico:

FILGRASTIM

Area terapeutica:

FILGRASTIM

Indicazioni terapeutiche:

Neupogen 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 Neupogen are similar in adults and children receiving cytotoxic chemotherapy.Neupogen 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 ≤ 0.5 × 109/l, and a history of severe or recurrent infections, long term administration of Neupogen is indicated to increase neutrophil counts and to reduce the incidence and duration of infection-related events.Neupogen is indicated for the treatment of persistent neutropenia (ANC less than or equal to 1.0 × 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:

2022-06-30

Foglio illustrativo

1
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS
(PREPARATIONS) - 1986
The medicine is dispensed with a doctor’s prescription only.
Neupogen 30 MU Pre-filled syringe
Neupogen 48 MU Pre-filled syringe
Neupogen 30 MU Vials
for intravenous/subcutaneous administration
Composition:
Each
Neupogen
30 MU syringe contains 30 million units (300 micrograms (mcg)) of
filgrastim in 0.5 ml
(0.6 mg/ml).
Each
Neupogen
48 MU syringe contains 48 million units (480 micrograms (mcg)) of
filgrastim in 0.5 ml
(0.96 mg/ml).
Each
Neupogen
30 MU vial contains 30 million units (300 micrograms (mcg)) of
filgrastim in 1 ml (0.3 mg/ml).
For inactive ingredients and allergens in the medicine – see section
6 “Further information”.
Read all of this leaflet carefully and until the end before using this
medicine.
This leaflet contains concise
information about the medicine. If you have further questions, contact
your doctor, nurse or pharmacist.
•
Keep this leaflet. You may need to read it again.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if it
seems to you that their medical condition is 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.
Important information for your attention
•
You can inject
Neupogen
30 MU pre-filled syringe,
Neupogen
48 MU pre-filled syringe yourself in your
home after receiving instructions from your healthcare professional.
Please carefully read the instructions
for self-injection of
Neupogen
pre-filled syringe that appear at the end of this leaflet.
•
Injecting
Neupogen
30 MU vials is done by a healthcare professional staff only.
•
Strict adherence to the doctor’s instructions (dosage, injection
times and duration of treatment) increases
the chance of treatment success. In any case, do not discontinue the
treatment without consulting the
attending doctor. Please read sections 2 and 4 for expanded safety
i

Scheda tecnica

1
Neupogen
Filgrastim
1.
NAME OF THE MEDICINAL PRODUCT
Neupogen 30 MU vials (0.3 mg/ml) solution for injection in vials
Neupogen 30 MU pre-filled syringe (0.6 mg/ml) solution for injection
in a pre-filled syringe
Neupogen 48 MU pre-filled syringe (0.96 mg/ml) solution for injection
in a pre-filled syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Neupogen 30 MU vials:
Each vial contains 30 million units (300 micrograms (µg)) of
filgrastim in 1 ml (0.3 mg/ml).
Filgrastim (recombinant methionyl human granulocyte-colony stimulating
factor) is produced by r-DNA
technology in
_E. coli_
(K12).
Excipient with known effect:
Each ml of solution contains 50 mg sorbitol.
Neupogen 30 MU pre-filled syringe:
Each pre-filled syringe contains 30 million units (MU)/300 micrograms
(µg) of filgrastim in 0.5 ml
(0.6 mg/ml).
Filgrastim (recombinant methionyl human granulocyte-colony stimulating
factor) is produced by r-DNA
technology in
_E. coli_
(K12).
_ _
Excipient with known effect:
Each pre-filled syringe contains 25 mg (or 50 mg/ml) of sorbitol.
Neupogen 48 MU pre-filled syringe:
Each pre-filled syringe contains 48 million units (MU)/480 micrograms
(µg) of filgrastim in 0.5 ml
(0.96 mg/ml).
Filgrastim (recombinant methionyl human granulocyte-colony stimulating
factor) is produced by r-DNA
technology in
_E. coli_
(K12).
Excipient with known effect:
Each pre-filled syringe contains 25 mg (or 50 mg/ml) of sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Neupogen 30 MU vials:
Solution for injection in a vial.
Concentrate for solution for infusion in a vial.
Neupogen 30 MU and 48 MU pre-filled syringe:
Solution for injection in a pre-filled syringe.
Concentrate for solution for infusion in a pre-filled syringe.
2
Clear, colorless solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Neupogen 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
o