Nivestim 480mcg0.5mL Solution for Injection Infusion

Država: Singapur

Jezik: angleščina

Source: HSA (Health Sciences Authority)

Aktivna sestavina:

Filgrastim

Dostopno od:

PFIZER PRIVATE LIMITED

Koda artikla:

L03AA02

Odmerek:

0.480 mg/0.5ml

Farmacevtska oblika:

INFUSION, SOLUTION

Sestava:

Filgrastim 0.480 mg/0.5ml

Pot uporabe:

SUBCUTANEOUS, INTRAVENOUS DRIP

Tip zastaranja:

Prescription Only

Izdeluje:

Hospira Zagreb d.o.o. (SM site)

Status dovoljenje:

ACTIVE

Datum dovoljenje:

2012-07-17

Navodilo za uporabo

1. NAME OF THE MEDICINAL PRODUCT 
Nivestim 120 μg/0.2 ml solution for injection/infusion 
Nivestim 300 μg/0.5 ml solution for injection/infusion 
Nivestim 480 μg/0.5 ml solution for injection/infusion 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
Nivestim 
120 μg/0.2 ml and 300 μg/0.5 ml solution for injection/infusion 
Each ml of solution for injection or infusion contains 60
million units [MU] 
(600 micrograms) of filgrastim*. 

Each pre-filled syringe contains 12 million units (MU) (120
micrograms) of 
filgrastim in 0.2 ml (0.6 mg/ml). 

Each pre-filled syringe contains 30 million units (MU) (300
micrograms) of 
filgrastim in 0.5 ml (0.6 mg/ml). 

Nivestim 480 μg/0.5 ml solution for injection/infusion 
Each ml of solution for injection or infusion contains 96
million units [MU] 
(960 micrograms) of filgrastim*. 

Each pre-filled syringe contains 48 million units (MU) (480
micrograms) of 
filgrastim in 0.5 ml (0.96 mg/ml). 

*recombinant methionyl granulocyte-colony stimulating factor [G-CSF] produced
in 
_Escherichia Coli _(BL21) by recombinant DNA technology. 

Excipient(s): Each ml of solution contains 50 mg of sorbitol. 

For a full list of excipients, see section 6.1. 

3. PHARMACEUTICAL FORM 
Solution for injection/infusion (injection/infusion). 

Clear, colourlesss solution. 

4. CLINICAL PARTICULARS 
4.1 THERAPEUTIC INDICATIONS 
Filgrastim is indicated for the 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 for the 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. 
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Lastnosti izdelka

NIVESTIM™
Filgrastim (rbe)
Page 2 of 22
1.
NAME OF THE MEDICINAL PRODUCT
Nivestim 120 µg/0.2 ml solution for injection/infusion
Nivestim 300 µg/0.5 ml solution for injection/infusion
Nivestim 480 µg/0.5 ml solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Nivestim 120 µg/0.2 ml and 300 µg/0.5 ml solution for
injection/infusion
Each
ml
of
solution
for
injection
or
infusion
contains
60
million
units
(MU)
(600 micrograms [µg]) of filgrastim*.
Each pre-filled syringe contains 12 million units (MU) (120 micrograms
[µg]) of
filgrastim in 0.2 ml (0.6 mg/ml).
Each pre-filled syringe contains 30 million units (MU) (300 micrograms
[µg]) of
filgrastim in 0.5 ml (0.6 mg/ml).
Nivestim 480 µg/0.5 ml solution for injection/infusion
Each
ml
of
solution
for
injection
or
infusion
contains
96
million
units
(MU)
(960 micrograms [µg]) of filgrastim*.
Each pre-filled syringe contains 48 million units (MU) (480 micrograms
[µg]) of
filgrastim in 0.5 ml (0.96 mg/ml).
*recombinant methionyl granulocyte colony-stimulating factor [G-CSF]
produced in _ Escherichia coli_
(BL21) by recombinant DNA technology.
Excipient with known effect
Each ml of solution contains 50 mg of sorbitol (E420) (see section
4.4).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection/infusion (injection/infusion).
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Filgrastim is indicated for the 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 for the 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.
Filgrastim
is
indicated