Negara: Singapura
Bahasa: Inggris
Sumber: HSA (Health Sciences Authority)
Aprotinin (synthetic) (for sealer protein solution); Calcium chloride (for thrombin solution); Fibrinogen (clottable protein) (for sealer protein solution); Thrombin (for thrombin solution)
BAXTER HEALTHCARE (ASIA) PTE LTD
B02BC, V03AK
SOLUTION
Aprotinin (synthetic) (for sealer protein solution) 2250-3750 KIU/ml; Calcium chloride (for thrombin solution) 36-44 umol/ml; Fibrinogen (clottable protein) (for sealer protein solution) 72-110 mg/ml; Thrombin (for thrombin solution) 400-625 IU/ml
TOPICAL
Prescription Only
Takeda Manufacturing Austria AG (Site: Industriestrasse 72)
ACTIVE
2014-12-22
Technical Info Dieline NA NA NA CODE 3 OF 9 DATAMATRIX CODE RSS / GS1-128 CODE BODY TEXT SIZE 8.4 pt 746769 CODE ITF 2/5 NA PHARMACODE NA GTIN / EAN-13 CODE BACK PANTONE 287 U TECHNICAL SPECIFICATION: ARTWORK DIMENSIONS/SIZE: ITEM NUMBER: FRONT 0746769 VERSION: 2.0 PROFILE: 0402126_1_PIL_Drwg 0402126 630 x 293 mm GRAPHICS HOUSE: SGK Redmond / Cathy Cole DATE: 01AUG2019 OPTIONAL: Artwork Approver outside the Shire Management System: ROLE: NAME: SIGNATURE: DATE: Swatch Swatch Swatch PANTONE 287 U Swatch Swatch Swatch 1. NAME OF THE MEDICINAL PRODUCT TISSEEL Fibrin Sealant VH S/D (frozen) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Component 1: Sealer protein solution Human fibrinogen (as clottable protein) 91 mg 1 /ml Aprotinin (synthetic) 3000 KIU 2 /ml Excipients: Polysorbate 80 0.6 – 1.9 mg/ml Component 2: Thrombin solution Human thrombin 500 IU 3 /ml Calcium chloride 40 μmol/ml 1, 2 or 5 ml deep frozen sealer protein solution (with synthetic aprotinin) and 1, 2 or 5 ml deep frozen thrombin solution (with calcium chloride) combine to make 2, 4 or 10 ml ready- to-use fibrin sealant solution. After mixing 1 ml 2 ml 4 ml 10 ml Component 1: Sealer protein solution Human fibrinogen (as clottable protein) Synthetic Aprotinin 45.5 mg 1500 KIU 91mg 3000 KIU 182 mg 6000 KIU 455 mg 15000 KIU Component 2: Thrombin solution Human thrombin Calcium chloride 250 IU 20 μmol 500 IU 40 μmol 1000 IU 80 μmol 2500 IU 200 μmol TISSEEL contains Human Factor XIII co-purified with Human Fibrinogen in a range of 0.6 – 5 IU/ml. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solutions for sealant Deep frozen When deep frozen: colorless to pale yellow, opalescent frozen solutions; After thawing: colorless to pale yellow liquids. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Supportive treatment where standard surgical techniques appear insufficient (see section 5.1) • For improvement of hemostasis • As a tissue glue to improve wound healing or to support sutures in vascular surgery and in gastroint Baca dokumen lengkapnya
Technical Info Dieline NA NA NA CODE 3 OF 9 DATAMATRIX CODE RSS / GS1-128 CODE BODY TEXT SIZE 8.4 pt 758200 CODE ITF 2/5 NA PHARMACODE NA GTIN / EAN-13 CODE BACK PANTONE 287 U TECHNICAL SPECIFICATION: ARTWORK DIMENSIONS/SIZE: ITEM NUMBER: FRONT 0758200 VERSION: 2 PROFILE: 0402126_1_PIL_Drwg 0402126 630 x 293 mm GRAPHICS HOUSE: SGK Redmond DATE: 04AUG2022 OPTIONAL: Artwork Approver outside the Shire Management System: ROLE: NAME: SIGNATURE: DATE: Swatch Swatch Swatch PANTONE 287 U Swatch Swatch Swatch 1. NAME OF THE MEDICINAL PRODUCT TISSEEL Fibrin Sealant VH S/D (frozen) 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Component 1: Sealer protein solution Human fibrinogen (as clottable protein) 91 mg 1 /ml Aprotinin (synthetic) 3000 KIU 2 /ml Excipients: Polysorbate 80 0.6 – 1.9 mg/ml Component 2: Thrombin solution Human thrombin 500 IU 3 /ml Calcium chloride 40 μmol/ml 1, 2 or 5 ml deep frozen sealer protein solution (with synthetic aprotinin) and 1, 2 or 5 ml deep frozen thrombin solution (with calcium chloride) combine to make 2, 4 or 10 ml ready-to-use fibrin sealant solution. After mixing 1 ml 2 ml 4 ml 10 ml Component 1: Sealer protein solution Human fibrinogen (as clottable protein) Synthetic Aprotinin 45.5 mg 1500 KIU 91mg 3000 KIU 182 mg 6000 KIU 455 mg 15000 KIU Component 2: Thrombin solution Human thrombin Calcium chloride 250 IU 20 μmol 500 IU 40 μmol 1000 IU 80 μmol 2500 IU 200 μmol TISSEEL contains Human Factor XIII co-purified with Human Fibrinogen in a range of 0.6 - 5 IU/ml. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solutions for sealant Deep frozen When deep frozen: colorless to pale yellow, opalescent frozen solutions; After thawing: they are colorless to pale yellow. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Supportive treatment where standard surgical techniques appear insufficient (see section 5.1) • For improvement of hemostasis • As a tissue glue to improve wound healing or to support sutures in vascular surgery and in gastrointestinal anastom Baca dokumen lengkapnya