Patient Medication Information: uses, side effects, how to take - Tisseel
Serious warnings and precautions box
What TISSEEL is used for:
TISSEEL is a fibrin sealant used for
- the addition to standard measures, to achieve hemostasis, to seal or glue tissue, and to support wound healing
- abdominal surgery, cardiovascular surgery, orthopedic surgery, thoracic surgery, urology
How TISSEEL works:
TISSEEL is a two-component fibrin sealant made from pooled human plasma. When combined, the two components, Sealer Protein (Human) and Thrombin (Human), mimic the final stage of the blood coagulation cascade.
The ingredients in TISSEEL are:
Medicinal ingredient(s): Sealer Protein-Aprotinin solution and Thrombin-Calcium Chloride solution
Non-medicinal ingredients: Nonmedicinal ingredients in the Sealer Protein-Aprotinin solution are human albumin, niacinamide and water for injection (WFI)
Nonmedicinal ingredients in the Thrombin-Calcium Chloride solution are human albumin, sodium chloride and water for injection (WFI). Sodium Hydroxide and Hydrochloric Acid are used to adjust the
- TISSEEL is for topical use only. TISSEEL must not be injected inside a blood vessel because this may cause life-threatening blood clots.
- Risk of air getting into the blood circulation which can be serious or life-threatening
- Serious allergic (hypersensitive) reactions to any of the ingredients of TISSEEL has occurred. If you have any allergic reaction, your doctor will stop the use of TISSEEL immediately and give you appropriate treatment.
- TISSEEL is made from human blood which may carry a risk of transmitting infectious agents (e.g. viruses) that can cause disease.
pH in both solutions.
TISSEEL comes in the following dosage form(s):
Kit and Frozen
2-, 4- and 10-mL pack sizes.
Do not use TISSEEL if:
- you are allergic to any of the active substances or any other ingredients of this medicine (see “The ingredients in TISSEEL are” above),
- you have a known hypersensitivity to Aprotinin
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take TISSEEL. Talk about any health conditions or problems you may have, including if you:
are pregnant or breast-feeding
- have ever received TISSEEL or aprotinin before, even if you did not have an allergic reaction to it. It is possible your body may have become sensitive to TISSEEL, even if you did not react to the first application. If you think you have received either product in a previous operation, you have to inform your doctor about this.
Other warnings you should know about:
- TISSEEL is made from human plasma and may carry a risk of transmitting infectious agents (e.g. viruses, despite manufacturing steps designed to reduce this risk. The risk that such products will transmit an infectious agent has been reduced by screening plasma and by inactivating and removing certain viruses. Despite these measures, they may still carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
- TISSEEL MUST NOT be injected into blood vessels (veins or arteries), or into tissues. As TISSEEL forms a clot where it is applied, injecting TISSEEL may cause serious reactions (e.g., vessel occlusion blockage)
- TISSEEL alone should not be used for the treatment of massive brisk arterial or venous severe or rapid bleeding from an artery or vein.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may [also] interact with TISSEEL:
- TISSEEL can be used when you are receiving other medical products. There are no known interactions between TISSEEL and other medicinal products.
How to take TISSEEL:
- TISSEEL will be applied to you in a healthcare setting and only by an experienced surgeon who has been appropriately trained. TISSEEL will be applied by dripping or spraying.
Usual dose:
The surgeon will determine the amount of TISSEEL to use based on your needs during surgery.
Overdose:
As the product is actively used by the surgeon, overdose is very unlikely to occur. TISSEEL (Fast Set) (Fibrin Sealant (Human), Vapor Heated, Solvent/Detergent Treated) is only to be used by a physician in a hospital setting.
Excessive thickness of the fibrin layer may interfere with the wound healing process.
If you think you, or a person you are caring for, have taken too much TISSEEL, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects from using TISSEEL:
These are not all the possible side effects you may have when taking TISSEEL. If you experience any side effects not listed here, tell your healthcare professional.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking the/this drug (if applicable) and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Severe allergic reactions: Skin rash, hives, chest tightness, wheezing, swelling of tongue or throat, lightheadedness, nausea, or vomiting term | √ | ||
| Thromboembolic events/Air embolism: Shortness of breath, rapid breathing, chest pain, increased heart rate | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (canada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Keep out of reach and sight of children.
TISSEEL Kit (Freeze-Dried):
When stored between 2°C and 25°C (36°F and 77°F), TISSEEL (Fibrin Sealant (Human), Vapor Heated, Solvent/Detergent Treated) Kit, lyophilized, is stable until the expiry date indicated on the label. Do not freeze.
After reconstitution, the product must be used within 4 hours. Reconstituted solutions must not be refrigerated or frozen.
TISSEEL Pre-filled Syringe (Frozen):
When stored at ≤ -20°C (≤ -4°F), TISSEEL (Fibrin Sealant (Human), Vapor Heated, Solvent/Detergent Treated) Frozen, in pre-filled syringes, is stable until the expiry date indicated on the label.
Room Temperature Storage: Unopened pouches, thawed at room temperature, may be stored for up to 7 days at room temperature (15°C -25°C) after removal from the freezer.
If you want more information about TISSEEL:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes the Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.baxter.ca or by calling 1-888-719-9955.
Date of Authorization: 2025-10-09