TEVAGRASTIM

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

FILGRASTIM

Disponible desde:

TEVA ISRAEL LTD

Código ATC:

L03AA02

formulario farmacéutico:

SOLUTION FOR INJECTION / INFUSION

Composición:

FILGRASTIM 0.6 MG/ML

Vía de administración:

I.V, S.C

tipo de receta:

Required

Fabricado por:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

Grupo terapéutico:

FILGRASTIM

Área terapéutica:

FILGRASTIM

indicaciones terapéuticas:

Tevagrastim 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 Tevagrastim are similar in adults and children receiving cytotoxic chemotherapy. Tevagrastim is indicated for the mobilisation of peripheral blood progenitor cells in normal donors (allogeneic PBPC). In patients children or adults with severe congenital neutropenia cyclic or idiopathic neutropenia with an absolute nuetrophil count (ANC) less than or equal to 0.5 x 1000000000 /l and a history of severe or recurrent infections long term administration of Tevagrastim is indicated to increase neutophil count and to reduce the incidence and duration of infection-related events. Tevagrastim in indicated for the treatment of persistent neutopenia (ANC less than or equal to 1.0 x 1000000000/l ) in patients with advanced HIV infection in order to reduce the risk of bacterial infections when other options to manage neutopenia are inappropriate.

Fecha de autorización:

2015-03-31

Información para el usuario

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS
(PREPARATIONS) - 1986
THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY
TEVAGRASTIM
® 30 MIU/0.5 ML
Solution for injection or infusion
Pre-filled syringe with needle safety
guard
TEVAGRASTIM
® 48 MIU/0.8 ML
Solution for injection or infusion
Pre-filled syringe with needle safety
guard
COMPOSITION:
Filgrastim 30 million IU
(300 micrograms) in 0.5 ml
Filgrastim 48 million IU
(480 micrograms) in 0.8 ml
For information about inactive ingredients and allergens see section 2
‘Important
information about some of this medicine’s ingredients’ and section
6 ‘Additional
information’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems to you that their medical condition is
similar to yours.
PLEASE NOTE THAT, every time you get this medicine at the pharmacy, it
is important
to confirm that you have been given the same medicine that your
specialist has
prescribed you. If the medicine you are given looks different from
what you usually
get, or if the instructions for use have changed, please consult your
pharmacist
immediately to make sure you received the correct medicine. Only your
specialist
can switch your medicine or change the dosage of a medicine that
contains filgrastim
(the active ingredient in this medicine). Please check that the
medicine that your
specialist prescribed you has the same brand name as the medicine you
got from
the pharmacist.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Treating decreased white blood cell count (neutropenia) caused by
chemotherapy,
after bone marrow transplantation, in patients with severe chronic
neutropenia, in
AIDS (HIV) patients, and for mobilization of stem cells to the
peripheral blood in case
of cell transplantation.
Filgras

Ficha técnica

TevaGrastim ME 09/2023 Minor changes
SUMMARY OF PRODUCT CHARACTERISTICS
TEVAGRASTIM
 30 MIU/0.5 ML
SOLUTION FOR INJECTION OR INFUSION
IN PRE-FILLED SYRINGE
TEVAGRASTIM
 48 MIU/0.8 ML
SOLUTION FOR INJECTION OR INFUSION
IN PRE-FILLED SYRINGE
SUBCUTANEOUS INJECTION / INTRAVENOUS INFUSION
1.
NAME OF THE MEDICINAL PRODUCT
Tevagrastim 30 MIU/0.5 mL solution for injection/infusion
Tevagrastim 48 MIU/0.8 mL solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution for injection/infusion contains 60 million
international units [MIU] (600 µg) of
filgrastim.
Each pre-filled syringe contains 30 MIU (300 µg) of filgrastim in 0.5
mL solution for injection/
infusion.
Each pre-filled syringe contains 48 MIU (480 µg) of filgrastim in 0.8
mL solution for
injection/infusion.
Filgrastim (recombinant methionyl human granulocyte colony stimulating
factor) is produced in
_Escherichia coli_ K802 by recombinant DNA technology.
_Excipient with known effect _
Each mL of solution contains 50 mg of sorbitol.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tevagrastim 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 filgrastim are similar in adults and
children receiving cytotoxic
chemotherapy.
TevaGrastim ME 09/2023 Minor changes
Tevagrastim is indicated for the mobilisation of peripheral blood
progenitor cells in normal donors
(allogeneic PBPC).
In patients, children or adults, with severe congenital, cyclic, or
idiopathic neu