Country: Singapura
Bahasa: Inggeris
Sumber: HSA (Health Sciences Authority)
ANTIHEMOPHILIC FACTOR (RECOMBINANT) SUCROSE FORMULATED
BAYER (SOUTH EAST ASIA) PTE LTD
B02BD02
250IU/vial
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
ANTIHEMOPHILIC FACTOR (RECOMBINANT) SUCROSE FORMULATED 250IU/vial
INTRAVENOUS
Prescription Only
BAYER HEALTHCARE LLC
ACTIVE
2007-12-07
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 Baca dokumen lengkap
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, Baca dokumen lengkap