ZARZIO filgrastim (rbe) 480 microgram/0.5 mL solution for injection pre-filled syringe

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

Filgrastim, Quantity: 960 microgram/mL

זמין מ:

Sandoz Pty Ltd

INN (שם בינלאומי):

Filgrastim

טופס פרצבטיות:

Injection, solution

הרכב:

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

מסלול נתינה (של תרופות):

Subcutaneous, Intravenous

יחידות באריזה:

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

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

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. ,indicated for reducing the duration of neutropenia and clinical sequelae in patients undergoing induction and consolidation chemotherapy for acute myeloid leukaemia. ,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. ,indicated 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, is indicated for reducing the duration of neutropenia and clinical sequelae following autologous or allogeneic bone marrow transplantation.,indicated for chronic administration to increase neutrophil counts and to reduce the incidence and duration of infections in patients with severe chronic neutropenia.,indicated 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.

leaflet_short:

Visual Identification: Colorless to slightly yellowish solution; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

מצב אישור:

Licence status A

תאריך אישור:

2013-05-07

עלון מידע

ZARZIO
®
1
ZARZIO
®
_filgrastim 300 µg/0.5 mL and 480 µg /0.5 mL solution for injection
(pre-filled syringes) _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS
LEAFLET
This leaflet answers some common
questions about Zarzio
®
.
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 this medicine
against the benefits they expect it
will have for you.
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 ZARZIO
® IS
USED FOR
Zarzio
®
is a copy of a substance
normally present in your body, called
Granulocyte Colony Stimulating
Factor or G-CSF. Using gene
technology, Zarzio
®
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 has prescribed Zarzio
®
because:
1.
YOU ARE RECEIVING
CHEMOTHERAPY FOR CANCER.
Unfortunately, some
chemotherapy will reduce the
number of neutrophils in your
body. Although Zarzio
®
is not a
treatment for cancer, it does help
the body to make new
neutrophils. This will reduce the
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 collecte

מאפייני מוצר

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Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION
ZARZIO
® (FILGRASTIM (RBE)) SOLUTION FOR INJECTION (PRE-FILLED
SYRINGES)
1.
NAME OF THE MEDICINE
Filgrastim (rbe). A Recombinant Human Granulocyte Colony Stimulating
Factor (rmetHuG-
CSF) derived from
_E. coli_
.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zarzio
®
300 μg/0.5 mL solution for injection: Each pre-filled syringes
contains either 300 μg
(30 MU) filgrastim at a fill volume of 0.5 mL.
Zarzio
®
480 μg/0.5 mL solution for injection: Each pre-filled syringes
contains 480 μg (48
MU) filgrastim at a fill volume of 0.5 mL.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Zarzio
®
300 μg/0.5 mL and 480 μg/0.5 mL solution for injection is a sterile,
clear, colourless
to slightly yellowish, preservative-free liquid for parenteral
administration.
Zarzio
®
is available in single use pre-filled syringes.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Zarzio
®
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.
Zarzio
®
is indicated for reducing the duration of neutropenia and clinical
sequelae in patients
undergoing induction and consolidation chemotherapy for acute myeloid
leukaemia (AML). .
Zarzio
®
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.
Zarzio
®
is indicated for the mobilisation of peripheral blood progenitor
cells, in normal
volunteers, for use in allogeneic peripheral blood progenitor cell
(PBPC) transplantation.
In patients receiving myeloablative chemotherapy, Zarzio
®
is indicated for reducing the
duration of neutropenia and clinical seq