BeneFIX Powder and Solvent for Solution for Injection 2000iuvial

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Nonacog Alfa

Available from:

PFIZER PRIVATE LIMITED

ATC code:

B02BD04

Dosage:

2000IU/vial(550IU/mL)

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

Nonacog Alfa 2000IU/vial(550IU/mL)

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

(Diluent) Vetter Pharma-Fertigung GmbH & Co. KG

Authorization status:

ACTIVE

Authorization date:

2010-05-20

Patient Information leaflet

1.  NAME OF THE MEDICINAL PRODUCT 

BeneFIX 250 IU powder and solvent for solution for injection. 

BeneFIX 500 IU powder and solvent for solution for injection. 

BeneFIX 1000 IU powder and solvent for solution for injection. 

BeneFIX 2000 IU powder and solvent for solution for injection. 

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 

BeneFIX 250 IU powder and solvent for solution for injection 
Each vial contains nominally 250 IU nonacog alfa (recombinant
coagulation factor IX). After 
reconstitution with the accompanying 5 ml (0.234%)
sodium chloride solution for injection, each ml 
of the solution contains approximately 50 IU nonacog alfa. 

BeneFIX 500 IU powder and solvent for solution for injection 
Each vial contains nominally 500 IU nonacog alfa (recombinant
coagulation factor IX). After 
reconstitution with the accompanying 5 ml (0.234%)
sodium chloride solution for injection, each ml 
of the solution contains approximately 100 IU nonacog alfa. 

BeneFIX 1000 IU powder and solvent for solution for injection 
Each vial contains nominally 1000 IU nonacog alfa (recombinant
coagulation factor IX). After 
reconstitution with the accompanying 5 ml (0.234%)
sodium chloride solution for injection, each ml 
of the solution contains approximately 200 IU nonacog alfa. 

BeneFIX 2000 IU powder and solvent for solution for injection 
Each vial contains nominally 2000 IU nonacog alfa (recombinant
coagulation factor IX). After 
reconstitution with the accompanying 5 ml (0.234%)
sodium chloride solution for injection, each ml 
of the solution contains approximately 400 IU nonacog alfa. 

Excipients: 

For a full list of excipients, see section 6.1. 

3.   PHARMACEUTICAL FORM 

White/ almost white powder and clear and colourless solvent
for solution for injection. 

4. CLINICAL 
PARTICULARS 

4.

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
BeneFIX 250 IU powder and solvent for solution for injection.
BeneFIX 500 IU powder and solvent for solution for injection.
BeneFIX 1000 IU powder and solvent for solution for injection.
BeneFIX 2000 IU powder and solvent for solution for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BeneFIX 250 IU powder and solvent for solution for injection
Each vial contains nominally 250 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 ml (0.234%) sodium chloride
solution for injection, each
ml of the solution contains approximately 50 IU nonacog alfa.
BeneFIX 500 IU powder and solvent for solution for injection
Each vial contains nominally 500 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 ml (0.234%) sodium chloride
solution for injection, each
ml of the solution contains approximately 100 IU nonacog alfa.
BeneFIX 1000 IU powder and solvent for solution for injection
Each vial contains nominally 1000 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 ml (0.234%) sodium chloride
solution for injection, each
ml of the solution contains approximately 200 IU nonacog alfa.
BeneFIX 2000 IU powder and solvent for solution for injection
Each vial contains nominally 2000 IU nonacog alfa (recombinant
coagulation factor IX). After
reconstitution with the accompanying 5 ml (0.234%) sodium chloride
solution for injection, each
ml of the solution contains approximately 400 IU nonacog alfa.
EXCIPIENTS:
For a full list of excipients, see section 6.1
LIST OF EXCIPIENTS
.
3.
PHARMACEUTICAL FORM
White/almost white powder and clear and colorless solvent for solution
for injection.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATION
Treatment and prophylaxis of bleeding in patients with hemophilia B
(congenital factor IX
deficiency).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
DOSAGE
Treatment should be initiated under the supervision of a physician
experienced