TEVAGRASTIM filgrastim 480 microgram/0.8mL injection

País: Australia

Idioma: inglés

Fuente: Department of Health (Therapeutic Goods Administration)

Ingredientes activos:

Filgrastim, Quantity: 600 microgram/mL

Disponible desde:

Teva Pharma Australia Pty Ltd

Designación común internacional (DCI):

Filgrastim

formulario farmacéutico:

Injection, solution

Composición:

Excipient Ingredients: glacial acetic acid; polysorbate 80; sodium hydroxide; sorbitol; water for injections

Vía de administración:

Intravenous, Subcutaneous

Unidades en paquete:

1, 5, 10

tipo de receta:

(S4) Prescription Only Medicine

indicaciones terapéuticas:

To decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs in doses not usually requiring bone marrow transplantation. To reduce the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. For the mobilisation of autologous peripheral blood progenitor cells alone, or following myelosuppressive chemotherapy, in order to accelerate neutrophil and platelet recovery by infusion of such cells after myeloablative or myelosuppressive therapy in patients with nonmyeloid malignancies. For the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation. In patients receiving myeloablative chemotherapy, to reduce the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation. For chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia. In patients with HIV infection, for reversal of clinically significant neutropenia and subsequent maintenance of adequate neutrophil counts during treatment with antiviral and/or other myelosuppressive medications.

Resumen del producto:

Visual Identification: Clear, colourless solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 30 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Estado de Autorización:

Registered

Fecha de autorización:

2011-08-29

Información para el usuario

TEVAGRASTIM
®
_filgrastim (rbe)_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TEVAGRASTIM.
Please note that this leaflet does not
contain everything there is to know
about TEVAGRASTIM. It does not
take the place of talking to your
doctor, nurse or pharmacist.
All medicines have risks and
benefits. Your doctor has prescribed
TEVAGRASTIM after considering
its likely benefit to you, as well as
the potential risks.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH YOUR
MEDICINE.
You may need to read this
information again.
WHAT TEVAGRASTIM
IS USED FOR
Your doctor may have prescribed
TEVAGRASTIM because:
1.
YOU ARE RECEIVING
CHEMOTHERAPY FOR CANCER
Unfortunately, some chemotherapy
will reduce the number of neutrophils
in your body. Although
TEVAGRASTIM is not a treatment
for cancer, it does help the body to
make new neutrophils and this will
reduce your chance of developing
infections that might require
antibiotics and/or hospital stays. It
may even increase your chance of
receiving your chemotherapy on time
and at the right dose.
2.
YOU ARE RECEIVING A BONE
MARROW OR STEM CELL TRANSPLANT
Blood cells are produced in the bone
marrow and arise from special
'parent' cells, called stem cells. Some
chemotherapy has toxic effects on
bone marrow, so your doctor may
choose to collect stem cells from
your bone marrow or blood - or from
a donor's bone marrow or blood -
before you receive your
chemotherapy. These collected stem
cells are then stored and may be
given back to you later, to replace
those lost during chemotherapy. This
procedure is called a bone marrow or
stem cell transplant.
There are normally only a small
number of stem cells in your blood;
TEVAGRASTIM is typically used to
increase this number before stem cell
collection. You may also receive
TEVAGRASTIM after a bone
marrow or stem cell transplant, to
help speed up your recovery.
3.
YOU ARE DONATING STEM CELLS FOR
ANOTHER PERSON
If

Ficha técnica

TEVAGRASTIM – Product Information V3.0 November 2018
Page 1 of 29
PRODUCT INFORMATION
TEVAGRASTIM
NAME OF THE MEDICINE
Filgrastim (recombinant methionyl human granulocyte colony stimulating
factor)
Filgrastim is a 175 amino acid protein manufactured by recombinant DNA
technology. It is
produced by
_Escherichia coli_
bacteria into which has been inserted the human granulocyte
colony stimulating factor gene. Filgrastim is unglycosylated and
contains an N-terminal
methionine necessary for expression in
_E. coli_
.
Molecular weight: 18,800
CAS no. 121181-53-1
Chemical structure:
DESCRIPTION
TEVAGRASTIM Injections contain 600mcg/mL of filgrastim as the active
ingredient.
Excipients include glacial acetic acid, polysorbate 80, sodium
hydroxide, sorbitol and water for
injections.
TEVAGRASTIM – Product Information V3.0 November 2018
Page 2 of 29
PHARMACOLOGY
Actions: Colony stimulating factor.
Colony stimulating factors are glycoproteins which act on haemopoietic
cells by binding to
specific cell surface receptors and stimulating proliferation,
differentiation commitment, and
some end-cell functional activation.
Endogenous filgrastim (ie. granulocyte-colony stimulating factor) is a
lineage specific colony
stimulating factor with selectivity for the neutrophil lineage.
Filgrastim is not species specific
and has been shown to primarily affect neutrophil progenitor
proliferation, differentiation and
selected end-cell functional activation (including enhanced phagocytic
ability, priming of the
cellular metabolism associated with respiratory burst, antibody
dependent killing and the
increased expression of some functions associated with cell surface
antigens).
The pH of filgrastim is 4.12.
Preclinical studies - The results of all preclinical studies indicate
that the pharmacological effects
of filgrastim are consistent with its predominant role as a regulator
of neutrophil production and
function.
COMPARISON OF TEVAGRASTIM WITH NEUPOGEN
Comparability assessment of primary pharmacodynamic
_in vitro _
studies on receptor bi