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TISSEEL is a brand name for Aprotinin, supplied as a kit. The medicine, its uses, side effects and dosage are the same regardless of brand.
Verbatim from this product's HC label. Tap a section to expand.
and 7 WARNINGS AND PRECAUTIONS, Vascular Disorders) • Severe hypersensitivity and fatal anaphylactic reactions including anaphylactic shock have been reported with TISSEEL. ) • TISSEEL is made from pooled human plasma which may contain infectious agents, such as TISSEEL (Fibrin Sealant (Human), Vapor Heated, Solvent/Detergent Treated Page 5 of 41 viruses, that can cause disease (see 7 WARNINGS AND PRECAUTIONS, General) 4.
1. Dosing Considerations Dry the site of application. g. intermittent application of compresses, swabs, use of suction devices). Do not use pressurized air or gas for drying the site. If used for tissue adherence, it is recommended that the initial application cover the entire intended application area.
The application can be repeated, if necessary. However, avoid re-application to a pre-existing polymerized TISSEEL layer, as TISSEEL may not adhere firmly to a polymerized layer. 2. , the amount applied, is individualized based on the application area and purpose of use.
Only a thin layer of TISSEEL should be applied. Excessive thickness of the fibrin layer may interfere with the product’s efficacy and the wound healing process. The amount of TISSEEL to be applied depends on the size of the surface to be covered.
4. Administration For topical use only – do not inject. TISSEEL 500 IU (Fast Set) (Fibrin Sealant (Human), Vapor Heated, Solvent/Detergent Treated) is available in two different dosage forms: Kit and Frozen. TISSEEL Kit consists of two vials containing lyophilized powder preparations of Sealer Protein Concentrate and Thrombin and two vials containing liquid preparations of Aprotinin and Calcium Chloride.
The Sealer Protein Concentrate is reconstituted with the Aprotinin Solution and produces a solution that is referred to as the Sealer Protein-Aprotinin Solution. Thrombin is reconstituted with the Calcium Chloride Solution, which produces a solution that is referred to as the Thrombin-Calcium Area to be sealed (cannula, catheter) Area to be sealed using compressed gas (spray application) Required package size of TISSEEL 8 cm2 16 cm2 40 cm2 25-100 cm2 50-200 cm2 125-500 cm2 2 mL 4 mL 10 mL TISSEEL (Fibrin Sealant (Human), Vapor Heated, Solvent/Detergent Treated Page 6 of 41 Chloride Solution.
These two solutions are applied using an application device described in the DOSAGE AND ADMINISTRATION, Method of Application section. TISSEEL Kit is available in 2, 4 and 10 mL pack sizes (1, 2 and 5 mL reconstituted Sealer Protein Solution and 1, 2 and 5 mL reconstituted Thrombin Solution).
TISSEEL Frozen consists of a pre-filled double-chamber syringe containing Sealer Protein-Aprotinin Solution and Thrombin-Calcium Chloride Solution. TISSEEL Frozen is available in 2, 4 and 10 mL pack sizes. Various methods can be used to simultaneously apply the two components of TISSEEL: • using application cannula contained in DUPLOJECT System (TISSEEL Kit/ DUPLOJECT COMBI) • using TISSEEL / ARTISS Spray Set and EASYSPRAY Pressure Regulator • using DUPLOCATH Application Catheters or other accessories provided by Baxter • using DUPLOSPRAY MIS regulator, applicator and tips 1.
, Vascular Disorders). • Fatal air or gas embolism has occurred with application of TISSEEL using pressurized air or gas (see 4 DOSAGE AND ADMINISTRATION and 7 WARNINGS AND PRECAUTIONS, Vascular Disorders) • Severe hypersensitivity and fatal anaphylactic reactions including anaphylactic shock have been reported with TISSEEL.
) • TISSEEL is made from pooled human plasma which may contain infectious agents, such as TISSEEL (Fibrin Sealant (Human), Vapor Heated, Solvent/Detergent Treated Page 5 of 41 viruses, that can cause disease (see 7 WARNINGS AND PRECAUTIONS, General) 4.
1. Dosing Considerations Dry the site of application. g. intermittent application of compresses, swabs, use of suction devices). Do not use pressurized air or gas for drying the site. If used for tissue adherence, it is recommended that the initial application cover the entire intended application area.
The application can be repeated, if necessary. However, avoid re-application to a pre-existing polymerized TISSEEL layer, as TISSEEL may not adhere firmly to a polymerized layer. 2. , the amount applied, is individualized based on the application area and purpose of use.
Only a thin layer of TISSEEL should be applied. Excessive thickness of the fibrin layer may interfere with the product’s efficacy and the wound healing process. The amount of TISSEEL to be applied depends on the size of the surface to be covered.
4. Administration For topical use only – do not inject. TISSEEL 500 IU (Fast Set) (Fibrin Sealant (Human), Vapor Heated, Solvent/Detergent Treated) is available in two different dosage forms: Kit and Frozen. TISSEEL Kit consists of two vials containing lyophilized powder preparations of Sealer Protein Concentrate and Thrombin and two vials containing liquid preparations of Aprotinin and Calcium Chloride.
The Sealer Protein Concentrate is reconstituted with the Aprotinin Solution and produces a solution that is referred to as the Sealer Protein-Aprotinin Solution. Thrombin is reconstituted with the Calcium Chloride Solution, which produces a solution that is referred to as the Thrombin-Calcium Area to be sealed (cannula, catheter) Area to be sealed using compressed gas (spray application) Required package size of TISSEEL 8 cm2 16 cm2 40 cm2 25-100 cm2 50-200 cm2 125-500 cm2 2 mL 4 mL 10 mL TISSEEL (Fibrin Sealant (Human), Vapor Heated, Solvent/Detergent Treated Page 6 of 41 Chloride Solution.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Aprotinin in Canada.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
Preparation and reconstitution of TISSEEL Kit (Freeze-Dried) The procedures described below are provided as general guidance. For operation instructions of the DUPLOJECT System, please refer to the Instructions for Use provided together with this device.
• Check for appropriate component colour-coding before reconstitution of the component. • Use aseptic technique when preparing and reconstituting the fibrin sealant components. Prior to reconstitution of the fibrin sealant components, clean the rubber stoppers of all vials with suitable disinfectant, taking care to avoid direct contact with the product.
Do not expose to temperature above 37ºC. Do not microwave. After reconstitution, the product must be used within 4 hours. Do not refrigerate or freeze. The Sealer Protein Concentrate is dissolved with the Aprotinin Solution to form the Sealer Protein Solution.
Air-bubbles may make the reconstituted Sealer Protein Solution appear turbid, but such turbidity does not compromise the efficacy or usability of the product. Thrombin Powder is dissolved in the Calcium Chloride Solution to form the Thrombin Solution.
Always use separate syringes and cannulas for reconstituting the two solutions to prevent premature clotting. Both solutions should be clear or slightly opalescent. Check the reconstituted solutions visually prior to administration. Do not use solutions which are cloudy, discolored, have deposits or other changes in their appearance.
I) Reconstitution using FIBRINOTHERM device:
Ia. Pre-warming of TISSEEL Kit • Place all four vials from the TISSEEL Kit into the pre-warmed wells of the FIBRINOTHERM device, using the appropriately sized adapter ring(s), and allow the vials to warm for approximately 3 minutes.
TISSEEL (Fibrin Sealant (Human), Vapor Heated, Solvent/Detergent Treated Page 7 of 41 • The FIBRINOTHERM device maintains a constant temperature of 37°C and enables dissolution of the lyophilized Sealer Protein Concentrate by stirring.
Ib. Preparation of the Sealer Protein Solution (component 1) (FIBRINOTHERM) • Remove the caps from the Sealer Protein Concentrate and the Aprotinin Solution vials. • Transfer the Aprotinin Solution into the vial containing the Sealer Protein Concentrate using one cannula and the blue-scaled syringe provided in the sterile kit for reconstitution.
• Gently […]
These two solutions are applied using an application device described in the DOSAGE AND ADMINISTRATION, Method of Application section. TISSEEL Kit is available in 2, 4 and 10 mL pack sizes (1, 2 and 5 mL reconstituted Sealer Protein Solution and 1, 2 and 5 mL reconstituted Thrombin Solution).
TISSEEL Frozen consists of a pre-filled double-chamber syringe containing Sealer Protein-Aprotinin Solution and Thrombin-Calcium Chloride Solution. TISSEEL Frozen is available in 2, 4 and 10 mL pack sizes. Various methods can be used to simultaneously apply the two components of TISSEEL: • using application cannula contained in DUPLOJECT System (TISSEEL Kit/ DUPLOJECT COMBI) • using TISSEEL / ARTISS Spray Set and EASYSPRAY Pressure Regulator • using DUPLOCATH Application Catheters or other accessories provided by Baxter • using DUPLOSPRAY MIS regulator, applicator and tips 1.
Preparation and reconstitution of TISSEEL Kit (Freeze-Dried) The procedures described below are provided as general guidance. For operation instructions of the DUPLOJECT System, please refer to the Instructions for Use provided together with this device.
• Check for appropriate component colour-coding before reconstitution of the component. • Use aseptic technique when preparing and reconstituting the fibrin sealant components. Prior to reconstitution of the fibrin sealant components, clean the rubber stoppers of all vials with suitable disinfectant, taking care to avoid direct contact with the product.
Do not expose to temperature above 37ºC. Do not microwave. After reconstitution, the product must be used within 4 hours. Do not refrigerate or freeze. The Sealer Protein Concentrate is dissolved with the Aprotinin Solution to form the Sealer Protein Solution.
Air-bubbles may make the reconstituted Sealer Protein Solution appear turbid, but such turbidity does not compromise the efficacy or usability of the product. Thrombin Powder is dissolved in the Calcium Chloride Solution to form the Thrombin Solution.
Always use separate syringes and cannulas for reconstituting the two solutions to prevent premature clotting. Both solutions should be clear or slightly opalescent. Check the reconstituted solutions visually prior to administration. Do not use solutions which are cloudy, discolored, have deposits or other changes in their appearance.
I) Reconstitution using FIBRINOTHERM device:
Ia. Pre-warming of TISSEEL Kit • Place all four vials from the TISSEEL Kit into the pre-warmed wells of the FIBRINOTHERM device, using the appropriately sized adapter ring(s), and allow the vials to warm for approximately 3 minutes.
TISSEEL (Fibrin Sealant (Human), Vapor Heated, Solvent/Detergent Treated Page 7 of 41 • The FIBRINOTHERM device maintains a constant temperature of 37°C and enables dissolution of the lyophilized Sealer Protein Concentrate by stirring.
Ib. Preparation of the Sealer Protein Solution (component 1) (FIBRINOTHERM) • Remove the caps from the Sealer Protein Concentrate and the Aprotinin Solution vials. • Transfer the Aprotinin Solution into […]