Ülke: Singapur
Dil: İngilizce
Kaynak: HSA (Health Sciences Authority)
rFVIII Octocog Alfa
TAKEDA PHARMACEUTICALS (ASIA PACIFIC) PTE. LTD.
B02BD02
250 IU
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
rFVIII Octocog Alfa 250 IU
INTRAVENOUS
Prescription Only
Takeda Manufacturing Austria AG
ACTIVE
2008-07-16
ADVATE [Antihaemophilic Factor VIII (Recombinant), Plasma/Albumin-Free Method] PRODUCT INFORMATION NAME OF THE DRUG: ADVATE 250 IU, 500 IU, 1000 IU, 1500 IU CHEMICAL NAME: Recombinant Coagulation Factor VIII (rch) INN: Octocog Alfa Laboratory Code: Recombinant Antihaemophilic FVIII, Plasma/Albumin Free Method (rAHF-PFM) COMPOSITION: Table 1: UNIT FORMULATION Powder for intravenous injection, after reconstitution with Sterile Water for Injection to 5 mL. The amounts of the inactive ingredients are constant in all strengths. ADVATE 250 IU 500 IU 1000 IU 1500 IU ACTIVE INGREDIENT Octocog alfa [Recombinant Coagulation FVIII (rch)] 250 IU 500 IU 1000 IU 1500 IU Inactive Ingredient: (mg) (mg) (mg) (mg) Trehalose 40.0 40.0 40.0 40.0 Histidine 8.0 8.0 8.0 8.0 Trometamol 6.0 6.0 6.0 6.0 Sodium Chloride 26.5 26.5 26.5 26.5 Calcium Chloride 1.0 1.0 1.0 1.0 Glutathione (reduced) 0.4 0.4 0.4 0.4 Polysorbate 80 0.5 0.5 0.5 0.5 Mannitol 160.0 160.0 160.0 160.0 DESCRIPTION ADVATE is formulated as a sterile, non-pyrogenic, white to off-white, lyophilised powder preparation of Recombinant Antihaemophilic Factor VIII. It is produced from a genetically engineered Chinese Hamster Ovary (CHO) cell-line under conditions, which are free from the use of animal derived protein. ADVATE (rAHF-PFM). is presented in a glass vial accompanied by sterile Water for Injection (5 mL) for reconstitution (see DOSAGE AND ADMINISTRATION). The reconstituted product is a clear, colourless solution for intravenous (IV) injection. Trehalose, a disaccharide of two glucose molecules Belgenin tamamını okuyun
Technical Info Dieline NA NA NA CODE 3 OF 9 DATAMATRIX CODE RSS / GS1-128 CODE BODY TEXT SIZE 8.0 pt NA CODE ITF 2/5 3615 PHARMACODE NA GTIN / EAN-13 CODE BACK PANTONE 259 C TECHNICAL SPECIFICATION: ARTWORK DIMENSIONS/SIZE: ITEM NUMBER: FRONT LE-07-56947 VERSION: 2 PROFILE: 0400374_1_PIL_Drwg LE0400374 310 x 446 mm GRAPHICS HOUSE: SGK Redmond DATE: 02MAR2022 OPTIONAL: Artwork Approver outside the Shire Management System: ROLE: NAME: SIGNATURE: DATE: Black Swatch Swatch Black Swatch Swatch Swatch PRODUCT INFORMATION NAME OF THE DRUG: ADVATE 250 IU, 500 IU, 1000 IU, 1500 IU CHEMICAL NAME: Recombinant Coagulation Factor VIII (rch) INN: Octocog Alfa Laboratory Code: Recombinant Antihaemophilic FVIII, Plasma/Albumin Free Method (rAHF-PFM) COMPOSITION: Table 1: UNIT FORMULATION Powder for intravenous injection, after reconstitution with Sterile Water for Injection to 5 mL. The amounts of the inactive ingredients are constant in all strengths. ADVATE 250 IU 500 IU 1000 IU 1500 IU ACTIVE INGREDIENT Octocog alfa [Recombinant Coagulation FVIII (rch)] 250 IU 500 IU 1000 IU 1500 IU Inactive Ingredient: (mg) (mg) (mg) (mg) Trehalose 40.0 40.0 40.0 40.0 Histidine 8.0 8.0 8.0 8.0 Trometamol 6.0 6.0 6.0 6.0 Sodium Chloride 26.5 26.5 26.5 26.5 Calcium Chloride 1.0 1.0 1.0 1.0 Glutathione (reduced) 0.4 0.4 0.4 0.4 Polysorbate 80 0.5 0.5 0.5 0.5 Mannitol 160.0 160.0 160.0 160.0 DESCRIPTION ADVATE is formulated as a sterile, non-pyrogenic, white to off-white, lyophilised powder preparation of Recombinant Antihaemophilic Factor VIII. It is produced from a genetically engineered Chinese Hamster Ovary (CHO) cell-line under conditions, which are free from the use of animal derived protein. ADVATE (rAHF-PFM) is presented in a glass vial accompanied by sterile Water for Injection (5 mL) for reconstitution (see DOSAGE AND ADMINISTRATION). The reconstituted product is a clear, colourless solution for intravenous (IV) injection. After reconstitution, the product contains 0.45 mmol (10 mg) sodium per vial. Trehalose, a disaccharide of two glu Belgenin tamamını okuyun