NEUPOGEN filgrastim (rbe) 300 microgram/0.5mL injection syringe

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

Filgrastim, Quantity: 600 microgram/mL

Inapatikana kutoka:

Amgen Australia Pty Ltd

Dawa fomu:

Injection, solution

Tungo:

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

Njia ya uendeshaji:

Intravenous, Subcutaneous

Vitengo katika mfuko:

1 x 5 syringe, 1 x 1 syringe, 1 x 10 syringe

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

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. For reducing 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 of myelosuppressive therapy in patients with non-myeloid 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, for reducing 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

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

Idhini hali ya:

Licence status A

Idhini ya tarehe:

1995-11-13

Taarifa za kipeperushi

NEUPOGEN
®
_Filgrastim (rbe)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about NEUPOGEN. It does
not contain all the available
information.
It does not take the place of talking to
your doctor, nurse or pharmacist.
All medicines have risks and
benefits. Your doctor has prescribed
NEUPOGEN 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 THE MEDICINE.
You may need to read it again.
WHAT NEUPOGEN IS
USED FOR
NEUPOGEN is a copy of a substance
normally present in your body, called
Granulocyte Colony Stimulating
Factor or G-CSF. Using gene
technology, NEUPOGEN 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.
Your doctor may have prescribed
NEUPOGEN because:
•
YOU ARE RECEIVING
CHEMOTHERAPY FOR CANCER.
Unfortunately, some
chemotherapy will reduce the
number of neutrophils in your
body. Although NEUPOGEN is
not a treatment for cancer, it does
help the body to make new
neutrophils. 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 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 t

Tabia za bidhaa

NEUPOGEN
® (FILGRASTIM) – SOLUTION FOR INJECTION – PRODUCT INFORMATION
PAGE 1 OF 34
AUSTRALIAN PI - NEUPOGEN

(FILGRASTIM)
1
NAME OF THE MEDICINE
NEUPOGEN

is the Amgen Inc. trademark for filgrastim (rbe), a recombinant
methionyl
human granulocyte colony stimulating factor.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
NEUPOGEN
is available in single use prefilled syringes and vials. The single
use
prefilled syringes contain either 300

g or 480

g filgrastim at a fill volume of 0.5 mL.
The single use vials contain either 300

g or 480

g filgrastim at a fill volume of 1.0 mL
or 1.6 mL, respectively.
For the full list of excipients, see Section 6.1 List of excipients_.
_
3
PHARMACEUTICAL FORM
NEUPOGEN is a sterile, clear, colourless, preservative-free liquid for
parenteral
administration.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NEUPOGEN 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.
NEUPOGEN is indicated for reducing the duration of neutropenia and
clinical sequelae in
patients undergoing induction and consolidation chemotherapy for acute
myeloid
leukaemia (AML).
NEUPOGEN
is indicated 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.
NEUPOGEN is indicated for the mobilisation of peripheral blood
progenitor cells, in
normal volunteers, for use in allogeneic peripheral blood progenitor
cell (PBPC)
transplantation.
NEUPOGEN
® (FILGRASTIM) – SOLUTION FOR INJECTION – PRODUCT INFORMATION
PAGE 2 OF 34
In patients receiving myeloablative chemotherapy, NEUPOGEN
is indicated for reducing
the duration of neutropenia and clinical sequelae following autologous
or