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Trade Names:Artiss- Powder for solution, topical 2 mL- Powder for solution, topical 4 mL- Powder for solution, topical 10 mL
Trade Names:Artiss- Solution, topical 2 mL- Solution, topical 4 mL- Solution, topical 10 mL
Trade Names:Tisseel- Powder for solution, topical 2 mL- Powder for solution, topical 4 mL- Powder for solution, topical 10 mL
Trade Names:Tisseel- Solution, topical 2 mL- Solution, topical 4 mL- Solution, topical 10 mL
Fibrin adheres to the wound surface and achieves sealing or gluing of tissues.
Polymerization takes approximately 60 seconds.
Adhere autologous skin grafts to surgically prepared wound beds resulting from burns.
TisseelAdjunct to hemostasis in surgeries involving cardiopulmonary bypass and treatment of splenic injuries; adjunct in the closure of colostomies.
Intravascular administration; hypersensitivity to aprotinin or any component of the product; bovine protein hypersensitivity ( Tisseel ).
Topical Dose depends on size of surface being covered. The approximate surface areas covered by each package size are as follows: for approximate areas of skin graft fixation of 100, 200, and 500 cm 2 , the required package size is 2, 4, and 10 mL, respectively.
Consult package insert for directions for preparing fibrin sealant.
Hemostasis in Surgeries; Colostomy Closure ( Tisseel only)AdultsTopical Dose depends on size of surface being covered. The approximate surface areas covered by each package size are as follows: for a maximum size area to be sealed of 8, 16, or 40 cm 2 or for maximum size area to be sealed using compressed gas of 100, 200, or 500 cm 2 , the required package size is 2, 4, and 10 mL, respectively.
Consult package insert for directions for preparing fibrin sealant.
Store at 36° to 77°F. Avoid freezing. After reconstitution, product must be used within 4 h.
Long-termPrefilled syringes may be stored at −4°F.
Short termUnopened pouches, thawed at room temperature, may be stored for up to 7 days at room temperature (59° to 77°F) after removal from the freezer. The product must be used within 12 hours after warming to 92° to 98.6°F or removal from original pouches. Do not refrigerate, microwave or refreeze.
TisseelStore at 36° to 77°F. Avoid freezing.
Long-termStore at −4°F or less.
Short-termThawed, unopened pouches may be stored for up to 48 h at room temperature (59° to 77°F) after removal from the freezer. Do not refrigerate or refreeze. After reconstitution of the solution and opening the package, fibrin sealant must be used within 4 h.
None well documented.
None well documented.
Bradycardia, hypotension, tachycardia, thromboembolic complications (postmarketing).
Pruritus, skin graft failure (more than 1%); dermal cyst, graph necrosis; urticaria (postmarketing).
Nausea (postmarketing).
Anaphylactic responses, hypersensitivity (postmarketing).
Dyspnea, mediastinal and thoracic disorders (postmarketing).
Edema, flushing, impaired healing, paralysis or other compression complications, pyrexia, seroma (postmarketing).
Category C .
Undetermined.
Safety and efficacy not established in children younger than 1 yr of age.
TisseelSafety and efficacy not established.
Clinical studies did not include subjects 65 years of age and older.
TisseelNo overall differences in safety and efficacy were observed between elderly and younger subjects.
Hypersensitivity, allergy, or anaphylactoid reactions may occur.
Apply fibrin sealant as a thin layer; excessive clot thickness may interfere with efficacy and the wound healing process.
When using Tisseel in cardiopulmonary bypass surgery, exercise caution to minimize the risk of inadvertent intravascular application.
Because fibrin sealant (human) is made from human plasma, there is a risk of transmitting infectious agents (eg, viruses), including Creutzfeldt-Jakob disease.
None reported.
Copyright © 2009 Wolters Kluwer Health.