KOGENATE-FS for Injection 500 iuvial

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

ANTIHEMOPHILIC FACTOR (RECOMBINANT) SUCROSE FORMULATED

Boleh didapati daripada:

BAYER (SOUTH EAST ASIA) PTE LTD

Kod ATC:

B02BD02

Dos:

500IU/vial

Borang farmaseutikal:

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Komposisi:

ANTIHEMOPHILIC FACTOR (RECOMBINANT) SUCROSE FORMULATED 500IU/vial

Laluan pentadbiran:

INTRAVENOUS

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

BAYER HEALTHCARE LLC

Status kebenaran:

ACTIVE

Tarikh kebenaran:

2007-12-07

Risalah maklumat

 
Kogenate FS PI SG_CCDS7 27Feb2014 
1 
ANTIHEMOPHILIC FACTOR (RECOMBINANT) KOGENATE
®
 FS 
FORMULATED WITH SUCROSE 

HIGHLIGHTS OF PRESCRIBING INFORMATION 

These highlights do not include all the information needed to
use Kogenate FS safely and 
effectively. See full prescribing information for Kogenate FS. 

Kogenate FS (Antihemophilic Factor [Recombinant] Formulated with
Sucrose) 
For Intravenous Use, Lyophilized Powder with vial adapter. 

INDICATIONS AND USAGE 

Kogenate FS is an Antihemophilic Factor (Recombinant) indicated for: 

• Control and prevention of bleeding episodes in
adults and children (0-16 years) with 
hemophilia A (1.1). 
• Peri-operative management in adults and children with
hemophilia A (1.2). 
• 
Routine prophylaxis to
reduce the frequency of bleeding episodes
and the risk of joint 
damage in children with hemophilia A with
no pre-existing joint damage (1.3).

DOSAGE AND ADMINISTRATION 

FOR INTRAVENOUS USE ONLY 

• Each
vial of Kogenate FS contains the labeled amount of recombinant factor VIII in 
international units (IU). 

CONTROL AND PREVENTION OF BLEEDING EPISODES AND PERI-OPERATIVE
MANAGEMENT (2): 

• Dose administered should
be titrated to the patient’s clinical response. 

• Dose
(units) = body weight (kg) X desired factor VIII rise (IU/dL or % of normal) X 0.5 
(IU/kg per IU/dL). 

•
Frequency of intravenous injection of the reconstituted product is determined
by the type of 
bleeding episode and the recommendation
of the treating physician (2.1, 2.2). 

FOR ROUTINE PROPHYLAXIS
IN CHILDREN WITH NO PRE-EXISTING JOINT DAMAGE, the 
recommended dose is 25 IU/kg every other day (2.3). 

DOSAGE FORMS AND STRENGTHS 

• Kogenate FS is available
as lyophilized powder in 250, 500, 1000 and in single
use vials 
(3). 
• Ko

Ciri produk

Kogenate FS PI SG_CCDS7 29 Oct 2014
1
ANTIHEMOPHILIC FACTOR (RECOMBINANT) KOGENATE
® FS
FORMULATED WITH SUCROSE
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use
Kogenate FS safely and
effectively. See full prescribing information for Kogenate FS.
Kogenate FS (Antihemophilic Factor [Recombinant] Formulated with
Sucrose)
For Intravenous Use, Lyophilized Powder with vial adapter.
INDICATIONS AND USAGE
Kogenate FS is an Antihemophilic Factor (Recombinant) indicated for:
• Control and prevention of bleeding episodes in adults and children
(0-16 years) with
hemophilia A (1.1).
• Peri-operative management in adults and children with hemophilia A
(1.2).
•
Routine prophylaxis to reduce the frequency of bleeding episodes and
the risk of joint
damage in children with hemophilia A with no pre-existing joint damage
(1.3).
-
Routine prophylaxis to prevent or reduce the frequency of bleeding
episodes in adults with
hemophilia A (1.4).
DOSAGE AND ADMINISTRATION
FOR INTRAVENOUS USE ONLY
• Each vial of Kogenate FS contains the labeled amount of
recombinant factor VIII in
international units (IU).
CONTROL AND PREVENTION OF BLEEDING EPISODES AND PERI-OPERATIVE
MANAGEMENT (2):
• Dose administered should be titrated to the patient’s clinical
response.
• Dose (units) = body weight (kg) X desired factor VIII rise (IU/dL
or % of normal) X 0.5
(IU/kg per IU/dL).
• Frequency of intravenous injection of the reconstituted product is
determined by the type of
bleeding episode and the recommendation of the treating physician
(2.1, 2.2).
FOR ROUTINE PROPHYLAXIS IN ADULTS: 25 units per kg three times a week
(2.3).
FOR ROUTINE PROPHYLAXIS IN CHILDREN WITH NO PRE-EXISTING JOINT DAMAGE,
the
recommended dose is 25 IU/kg every other day (2.3).
DOSAGE FORMS AND STRENGTHS
• Kogenate FS is available as lyophilized powder in 250, 500, 1000
and in single use vials
(3).
• Kogenate FS is provided with a sterile vial adapter with
15-micrometer filter and a prefilled
diluent syringe,