Tisseel: Side Effects & Dosing

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Human fibrinogen, synthetic aprotinin, human thrombin, CaCl dihydrate

Indications/Uses

Supportive treatment where standard surgical techniques appear insufficient eg, for improvement of hemostasis; as tissue glue to improve wound healing or to support sutures in vascular surgery & GI anastomoses; for tissue sealing, to improve adhesion of separated tissue (eg, tissue flaps, grafts, split skin grafts [mesh grafts]).

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Dosage/Direction for Use

Epilesional Individualized dosage. Dose range: 4-20 mL. Apply 1 pack (2 mL) to an area of at least 10 cm². Procedures eg, liver traumata, or sealing of large burned surfaces Larger vol may be required.

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Overdosage

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Contraindications

Hypersensitivity. Massive & brisk arterial or venous bleeding. Replacing skin sutures intended to close surgical wound. Intravascular application.

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Special Precautions

Hypersensitivity & anaphylactic reactions (including anaphylactic shock). Discontinue use immediately if symptoms of hypersensitivity reactions eg, hives, generalized urticaria, chest tightness, wheezing, hypotension occur. Not to be applied intravascularly. Avoid inj into nasal mucosa. Not to be used w/ Easy Spray/Spray Set system in enclosed body areas; oxidized cellulose-containing prep. Potential risk of air or gas embolism, tissue rupture or gas entrapment w/ compression when applied using pressurized gas; compressive complications if applied in confined spaces, eg, brain or spinal cord. Possibility of transmitting infective agents. Open wound surgery. Coronary bypass surgery patients. Evaluate patients w/ allergy to bovine proteins. Monitor changes in BP, pulse, O₂ saturation & end tidal CO₂. Consider vaccination (hepatitis A & B) in patients on regular/repeated receipt of human plasma-derived fibrin sealant. Pregnancy & lactation. Paed patients.

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Use In Pregnancy & Lactation

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Adverse Reactions

Seroma. Post-op wound infection; sensory disturbance; axillary vein thrombosis; rash; pain in extremity; pain, increased body temp.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Tisseel detailed prescribing information

Storage

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Description

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Action

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MIMS Class

Haemostatics

ATC Classification

B02BC30 - combinations ; Belongs to the class of local hemostatics. Used in the treatment of hemorrhage.

Thai FDA Category

Presentation/Packing

Form

Tisseel topical soln

Packing/Price

2 mL x 1's;4 mL x 1's

Tisseel

Manufacturer:

Baxter International

Distributor:

Zuellig Pharma