FEIBA 500 U

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

ANTI INHIBITOR COAGULANT COMPLEX

Available from:

TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.

ATC code:

B02BD01

Dosage:

25 u/ml

Pharmaceutical form:

INJECTION, POWDER, FOR SOLUTION

Composition:

ANTI INHIBITOR COAGULANT COMPLEX 25 u/ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Takeda Manufacturing Austria AG

Authorization status:

ACTIVE

Authorization date:

1999-04-20

Patient Information leaflet

 
BAXTER 
NAME OF MEDICINAL PRODUCT 
FEIBA NF

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION  
FACTOR VIII INHIBITOR BYPASSING ACTIVITY 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

500 U* 
per vial 
1000 U* 
per vial 

25 U/ml after 
reconstitution 
50 U/ml after 
reconstitution 
Active Ingredient: 
Human Plasma Protein 
with a Factor Eight Inhibitor 
Bypassing Activity of 
200 – 600 mg 

500 U 
400 – 1200 mg 

1000 U 
Inactive Ingredients: 
Sodium Chloride 
Sodium Citrate 
160mg 
80 mg 
160 mg 
80 mg 
Sterilised Water for 
Injection (WFI) 
20 mL 
20 mL 
* A solution containing I U of FEIBA NF shortens the activated partial thromboplastin  
   (aPTT) of a factor VIII inhibitor plasma to 50% of the buffer value (blank). 
FEIBA NF also contains factors II, IX and X mainly in non-activated form as well as activated 
factor VII; factor VIII coagulant antigen (F VIII C:Ag) is present in a concentration of up to 0.1 
U/1 U FEIBA NF. The factors of the Kallikrein-Kinin system are present only in trace amounts, if 
at all. For excipients see “List of Excipients” 
PHARMACEUTICAL FORM 
Powder and solvent for solution for injection. 
CLINICAL PARTICULARS 
THERAPEUTIC INDICATIONS 
•
  Treatment and prophylaxis of bleeding in haemophilia A patients with F VIII inhibitor 
•
  Treatment and prophylaxis of bleeding in haemophilia B patients with F IX inhibitor 
•
  Treatment of bleeding in non-haemophiliacs with acquired inhibitors to factors VIII, XI, XII in 
cases of severe or life-threatening haemorrhages 
In one case FEIBA NF was successfully used in a patient with an inhibitor, suffering from von 
Willebrand’s disease. FEIBA NF was also used in combination with Factor VIII concentrate for a 
long-term therapy to achieve a c

Summary of Product characteristics

TAKEDA
NAME OF MEDICINAL PRODUCT
FEIBA
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
FACTOR VIII INHIBITOR BYPASSING ACTIVITY
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: Factor VIII Inhibitor Bypassing Activity
The presentation FEIBA 500 U*/10 mL (50 U/mL) contains 500 U factor
VIII inhibitor bypassing
activity in 200 – 600 mg human plasma protein.
The presentation FEIBA 500 U*/20 mL (25 U/mL) contains 500 U factor
VIII inhibitor bypassing
activity in 200 – 600 mg human plasma protein.
The presentation FEIBA 1000 U*/20 mL (50 U/mL) contains 1000 U factor
VIII inhibitor
bypassing activity in 400 – 1200 mg human plasma protein.
FEIBA also contains factors II, IX and X mainly in non-activated form
as well as activated factor
VII; factor VIII coagulant antigen (F VIII C:Ag) is present in a
concentration of up to 0.1 U/1 U
FEIBA. The factors of the Kallikrein-Kinin system are present only in
trace amounts, if at all. For
excipients see “List of Excipients”
* A solution containing 1 U of FEIBA shortens the activated partial
thrombin (aPTT) of a factor VIII inhibitor plasma to
50% of the buffer value (blank).
Reconstituted FEIBA contains 4 mg of trisodium citrate and 8 mg of
sodium chloride per mL.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection
CLINICAL PARTICULARS
THERAPEUTIC INDICATIONS
•
Treatment and prophylaxis of bleeding in haemophilia A patients with F
VIII inhibitor
•
Treatment and prophylaxis of bleeding in haemophilia B patients with F
IX inhibitor
•
Treatment of bleeding in non-haemophiliacs with acquired inhibitors to
factors VIII, XI, XII in
cases of severe or life-threatening haemorrhages
In one case FEIBA was successfully used in a patient with an
inhibitor, suffering from von
Willebrand’s disease. FEIBA was also used in combination with Factor
VIII concentrate for a
long-term therapy to achieve a complete and permanent elimination of
the F VIII inhibitor so as
to allow for regular treatment with F VIII concentrate as in patients
without inhibitor.
For