Zarzio 30 MU0.5 ml solution for injection or infusion

Țară: Malaezia

Limbă: engleză

Sursă: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredient activ:

Filgrastim

Disponibil de la:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

INN (nume internaţional):

Filgrastim

Unități în pachet:

0.5ml mL; 0.5ml mL; 0.5ml mL; 0.5ml mL

Produs de:

SANDOZ GMBH

Prospect

1
_Consumer Medication Information Leaflet (RiMUP) _
ZARZIO
® SOLUTION FOR INJECTION OR
INFUSION
Filgrastim (30MU/0.5ml)
WHAT IS IN THIS LEAFLET
1.
What ZARZIO
®
is used for
2.
How ZARZIO
®
works
3.
Before you use ZARZIO
®
4.
How to use ZARZIO
®
5.
While you are using ZARZIO
®
6.
Side effects
7.
Storage and disposal of ZARZIO
®
8.
Product description ni
9.
Manufacturer and product
registration holder
10.
Date of revision
WHAT ZARZIO
® IS USED FOR
ZARZIO
®
is used mainly for reducing
the duration of neutropenia and to
prevent the occurrence of neutropenia
associated with fever for those who
undergo treatment with medicines for
cancer. Neutropenia means reduction in
neutrophils (type of white blood cell
important in the body’s fight against
infection). It is also used for reducing
the duration of neutropenia in patients
undergoing myeloablative therapy
(therapy aimed at reducing the bone
marrow cells) which is followed by
bone marrow cell transplantation.
It is used for mobilization of blood
progenitor cells (progenitor cells are
nothing but the cells that can
differentiate into a specific type of
cells).
It is also used for reducing the duration
of neutropenia in patients (children or
adults), with neutropenia less than or
equal to the count of 0.5 x 10
9
/L who
present this condition by birth and those
who have severe infections. It is also
used in patients with persistent
neutropenia whose count is less than or
equal to 1.0 x 10
9
/L like in patients with
HIV infection.
HOW ZARZIO
® WORKS
ZARZIO
®
is a man-made form of
granulocyte colony-stimulating factor
(G-CSF). Human G-CSF is a substance
produced by our body which regulates
the production and release of
neutrophils from the bone marrow.
ZARZIO
®
stimulates the growth of
neutrophils along with a minor increase
in other type of blood cells like
monocytes, eosinophils and basophils
BEFORE YOU USE ZARZIO
®
-
_When you must not use it _
Do not take ZARZIO
®
if you are
allergic to filgrastim or any of the other
ingredients in ZARZIO
®
.
_Pregnancy

Caracteristicilor produsului

1
1.
NAME OF THE MEDICINAL PRODUCT
Zarzio 30 MU/0.5 ml solution for injection or infusion in pre-filled
syringe
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Zarzio 30 MU/0.5 ml - Each ml of solution contains 60 million units
(MU) [equivalent to 600 micrograms (μg)]
filgrastim*. Each pre-filled syringe contains 30 MU (equivalent to 300
μg) filgrastim in 0.5 ml.
* recombinant methionylated human granulocyte-colony stimulating
factor (G-CSF) produced in_ E. coli _ by
recombinant DNA technology.
Excipient: Each ml of solution contains 50 mg sorbitol (E420). For a
full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Zarzio has been developed as a similar biological medicinal product to
Neupogen and has been shown to
have a comparable quality, safety and efficacy profile to Neupogen.
Therefore, switching with the reference
product is possible, as long as this is in agreement with the treating
physician in consultation with the patient.
However, automatic substitution (i.e the practice by which a different
product to that specified on the
prescription is dispensed to the patient without the prior informed
consent of the treating physician) and active
substance-based prescription cannot apply to biologicals, including
biosimilars.
Solution for injection or infusion in pre-filled syringe.
Clear, colourless to slightly yellowish solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
-
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 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.
-
Mobilisation of peripheral blood progenitor cells (PBPC).
-
In children and adults wit