Tisseel

Tisseel

Manufacturer:

Baxter

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Per mL of component 1 Human fibrinogen 91 mg, aprotinin 3,000 KIU. Per mL of component 2 Human thrombin 500 IU, Ca chloride 40 micromol
Indications/Uses
Hemostasis improvement; tissue glue to improve wound healing or to support sutures in vascular surgery & GI anastomoses; tissue sealing to improve adhesion of the separated tissue eg, tissue flaps, grafts, split skin grafts (mesh grafts).
Dosage/Direction for Use
Individualized dosage ranging from 4-20 mL. Surfaces gluing 2 mL for at least 10 cm2 area.
Contraindications
Hypersensitivity. Massive & brisk arterial or venous bleeding, replace skin sutures intended to close surgical wounds. Intravascular application.
Special Precautions
Hypersensitivity, allergies to bovine proteins. Application using pressurized air or gas. Excessive clot thickness may negatively interfere w/ efficacy & wound healing process. Monitor changes in BP, pulse, O2 saturation & end tidal CO2. Ensure sufficient protection/cover to parts outside the designated application area to prevent tissue adhesion at undesired sites. Discontinue use if any hypersensitivity reactions occur. Coronary bypass surgery patients. Avoid inj to nasal mucosa or into tissues. Perform selection of donors, screening of individual donations & plasma pools for specific markers of infection & inclusion of effective manufacturing steps for inactivation/removal of viruses to prevent transmitting infections. Parvovirus B19 infection in pregnant women & individuals w/ immunodeficiency or increased erythropoiesis eg, hemolytic anemia. Concurrent use w/ oxidized cellulose-containing prep. Pregnancy & lactation.
Adverse Reactions
Hypersensitivity or allergic reactions.
Drug Interactions
Denaturation after exposure to soln containing alcohol, iodine or heavy metals (eg, antiseptic soln).
MIMS Class
ATC Classification
B02BC30 - combinations ; Belongs to the class of local hemostatics. Used in the treatment of hemorrhage.
Presentation/Packing
Form
Tisseel soln for sealant
Packing/Price
(single-use double chamber) 2 mL x 2's (RM750/syringe)
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