Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe

País: Malásia

Língua: inglês

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

Ingredientes ativos:

Filgrastim

Disponível em:

NOVARTIS CORPORATION (MALAYSIA) SDN. BHD.

DCI (Denominação Comum Internacional):

Filgrastim

Unidades em pacote:

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

Fabricado por:

IDT BIOLOGIKA GMBH

Folheto informativo - Bula

1
_Consumer Medication Information Leaflet (RiMUP) _
ZARZIO
® SOLUTION FOR INJECTION OR
INFUSION
Filgrastim (30MU/0.5ml and 48MU/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 ZARZ

Características técnicas

1
1. NAME O F TH E M ED IC INAL PR O DUC T
Z arz io 30 MU/0.5 m l s o lu tion f or in je cti on or in fu si on in p re -fil le d s yri nge
Z arz io 48 MU/0.5 ml so lu tion for in jec tion or in fus ion in pr e-fill ed syri nge
2. QUAL ITA TIVE AND QUANT ITA TIVE CO M PO SIT IO N
Z arz io 30 MU/0.5 m l - Each m l of s o lu tion cont ain s 60 m illi on un its ( MU) [ equ iv a le nt t o 6 00 mic ro gra m s ( μ g)]
fil gra stim *. Each p re -fill ed syr in ge con ta ins 3 0 M U ( e qu iv a lent t o 300 μ g) fil gra sti m i n 0.5 m l.
Z arz io 48 MU/0.5 ml - Each ml of so lu tion cont ains 96 milli on unit s (MU) [equ iv a lent t o 960 mic ro gra m s (μ g)]
fil gra sti m*. Each p re -filled syri nge con ta ins 48 MU (equi va lent to 480 μg) fil gra sti m in 0.5 ml.
* re co mbinant m ethi ony la ted hum an g ranul ocyte -co lo ny sti mula ting fa cto r (G -C SF) p rodu ced in E . co li by
r e co m binant DNA t ech no lo gy.
Exc ip ie nt: Each m l of s o lu tion cont ains 50 m g s o rb ito l (E420). For a f u ll lis t o f ex cip ie nts , s ee se cti o n 6.1.
3. PH ARM ACEUT IC AL FOR M
Si milar b io lo gical m edi cinal p roduct to N eupog en
®. Sol ution for in je cti on or inf usi on in p re -fill ed syr in ge .
C lear , c o lo url ess t o sli gh tly y e llo w is h s o lu tion.
4. CLINICA L PART IC ULAR S
4.1 Therapeu tic i ndi ca tions
- Redu ction in the dura tion of neu tropen ia and the in cide nce of fe bril e neu tr ope nia in p ati ents trea te d
w ith e sta blis hed cyto to xic ch em oth erapy fo r m alig nancy (w ith th e e xc eption of ch ro n ic mye lo id
l e u kaem ia and m ye lody sp la sti c s ynd ro m es) a nd re du cti on in the dura tion of neu trope nia in pa tie nts
und erg o ing mye loabl ative th e ra py fo llo wed by bone m arr ow transp lant ation con sid ered to be at
i n cre a se d r is k of p ro long ed se ve re neu tr ope nia.
The sa fe ty and effic acy of fil g ra sti m ar e sim ilar in adult s and ch ild re n re ce iv ing cyto to xic
chem oth era p y.
- Mobilis ation of p e ri phe ra