Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 24 April 2017

Indication(s)

Hemostasis: TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients.(1.1)

Sealing: TISSEEL is a fibrin sealant indicated as an adjunct to standard surgical techniques (such as suture and ligature) to prevent leakage from colonic anastomoses following the reversal of temporary colostomies (1.2)

Full Prescribing information

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Advisory information

Special warnings and precautions

• TISSEEL contains aprotinin, a protein known to be associated with anaphylactic reactions (4.2, 5.1, 6)
• Air or gas embolism has occurred when fibrin sealant was administered using pressurized gas. This can occur if a spray device is used at higher than recommended pressures and in close proximity to the surface of the tissue (5.2)
• TISSEEL is denatured when exposing to solutions containing alcohol, iodine or heavy metals (5.2)
• Apply only as a thin layer as excess clot thickness can negatively interfere with wound healing (2, 5.2)
• Exercise caution to minimize the risk of intravascular application when using TISSEEL in surgery (4.1, 5.3, 6.2)
• Safety has not been evaluated in neurosurgical procedures (5.4)
• TISSEEL is made from pooled human plasma which can contain infectious agents (5.5)

Adverse reactions
Hypersensitivity or allergic/anaphylactoid reactions have occurred (6)

Usage information

Dosing and administration

For Topical Use Only. Do Not Inject (2)
• Apply TISSEEL as a thin layer by dripping or spraying using cannula or spray set (2.3, 5.2)
• Ensure that the amount of TISSEEL to be applied is sufficient to entirely cover the intended application area (2.3)

Use in special populations
Pregnancy: No human or animal data. Use only if clearly needed (8.1)

Interactions

Oxidized cellulose-containing preparations can reduce the efficacy of TISSEEL and should not be used as carrier materials (7)

More information

Category Value
Authorisation number BLA103980
Orphan designation No
Product NDC 0338-4210; 0338-4211; 0338-4212; 0338-4301; 0338-4302; 0338-4303; 0338-8402; 0944-4201; 0944-4210; 0944-4211; 0944-4212; 0944-4301; 0944-4302; 0944-4303; 0944-8402
Date First Approved 01-05-1998
Marketing authorisation holder Baxter Healthcare Corporation