NIVESTIM filgrastim (rbe) 120microgram/0.2mL injection solution pre-filled syringe

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

Filgrastim, Quantity: 120 microgram

Inapatikana kutoka:

Pfizer Australia Pty Ltd

INN (Jina la Kimataifa):

Filgrastim

Dawa fomu:

Injection, solution

Tungo:

Excipient Ingredients: sorbitol; polysorbate 80; acetate; water for injections; sodium

Njia ya uendeshaji:

Intravenous, Subcutaneous

Vitengo katika mfuko:

5 pack, 10 pack, single pack

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

a) to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs in doses not usually requiring bone marrow transplantation, b) for reducing the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia, c) 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 non-myeloid malignancies, d) for the mobilisation of peripheral blood progenitor cells, in normal volunteers, for use in allogeneic peripheral blood progenitor cell transplantation, e) In patients receiving myeloablative chemotherapy, for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation, f) for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia, g) 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.

Bidhaa muhtasari:

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; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Registered

Idhini ya tarehe:

2010-09-16

Taarifa za kipeperushi

NIVESTIM
®
_Filgrastim [rbe] (fil-GRAS-tim)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Nivestim. It does not
contain all the available information.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Nivestim
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT NIVESTIM IS USED
FOR
Nivestim – also known as Filgrastim
(rbe) – is a copy of a substance
normally present in your body, called
Granulocyte Colony Stimulating
Factor or G-CSF. Using gene
technology, Nivestim is produced in
a specific type of bacteria, called E.
coli.
G-CSF is produced in the bone
marrow and assists in the production
of neutrophils, which are a type of
white blood cell. Neutrophils help the
body fight infections by surrounding
and destroying the bacteria that cause
them. G-CSF also helps neutrophils
to do this work better.
This medicine may have been
prescribed for you for one of the
following reasons:
•
YOU ARE RECEIVING
CHEMOTHERAPY FOR CANCER
Some chemotherapy will reduce
the number of white blood cells
in your body. Although Nivestim
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.
•
YOU ARE RECEIVING A BONE
MARROW TRANSPLANT OR A 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 colle

Tabia za bidhaa

Version: pfpnivei10621
Supersedes: pfpnivei10420
Page 1 of 31
AUSTRALIAN
PRODUCT
INFORMATION
–
[NIVESTIM
® (FILGRASTIM)]
1.
NAME OF THE MEDICINE
Filgrastim (rbe).
A Recombinant Human Granulocyte Colony Stimulating Factor
(r-metHuG-CSF) derived
from
_E. coli_
.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 0.2 mL pre-filled syringe contains 120 micrograms filgrastim.
Each 0.5 mL pre-filled syringe contains 300 micrograms or 480
micrograms filgrastim.
Nivestim is a 175 amino acid protein manufactured by recombinant DNA
technology.
Nivestim is produced by
_Escherichia coli _
bacteria into which has been inserted the human
granulocyte colony stimulating factor gene. It has a molecular weight
of 18,800 daltons.
Nivestim is unglycosylated and contains an N-terminal methionine
necessary for expression in
_E. coli_
.
The specific activity of filgrastim by in vitro proliferative cell
assay is 1 x 10
8
IU/mg when
assayed against the WHO international standard for granulocyte colony
stimulating factor,
88/502. The clinical significance of this in vitro potency assignment
is unknown.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Nivestim is a sterile, clear, colourless, preservative-free liquid for
parenteral administration,
formulated in a 10 mM sodium acetate buffer at pH 4.0. The product is
available in single use
pre-filled syringes. The single use pre-filled syringes contain either
120 µg filgrastim at a fill
volume of 0.2 mL or 300 µg or 480 µg filgrastim at a fill volume of
0.5 mL.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Nivestim is indicated to decrease the incidence of infection,
as manifested by febrile
neutropenia, in patients with non-myeloid malignancies receiving
myelosuppressive anti-
cancer drugs in doses not usually requiring bone marrow
transplantation.
Nivestim is indicated for reducing the duration of neutropenia and
clinical sequelae in patients
undergoing induction and consolidation chemotherapy for acute myeloid
leukaemia (AML).
Nivesti