Patient Medication Information: uses, side effects, how to take - Artiss
Serious warnings and precautions box
What ARTISS is used for:
ARTISS is a tissue sealant.
- the fixation (gluing) of autologous skin grafts and tissue flaps.
- as an adjunct to haemostasis on subcutaneous tissue surfaces to treat burns in adult and pediatric patients.
- as an adjunct to adhere tissue flaps during facial rhytidectomy surgery (face-lift).
How ARTISS works:
ARTISS is a two-component fibrin sealant, and it contains two of the proteins that make blood clot. These proteins are called fibrinogen and thrombin. When these proteins mix during application, they form a clot where the surgeon applies them.
ARTISS is prepared as two solutions (Sealer Protein Solution and Thrombin Solution), which
- ARTISS is for topical use only. ARTISS 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 ARTISS can occur. If you have any allergic reaction, your doctor will stop the use of ARTISS immediately and give you appropriate treatment.
- ARTISS is made from human blood which may carry a risk of transmitting infectious agents (e.g. viruses) that can cause disease.
mix when applied.
The ingredients in ARTISS are:
Medicinal ingredient(s): Sealer Protein-Aprotinin Solution & 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 pH in both solutions.
ARTISS comes in the following dosage form(s):
2-, 4- and 10-mL pack sizes.
Do not use ARTISS if:
- you are allergic to any of the active substances or any other ingredients of this medicine (see “The ingredients in ARTISS 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 ARTISS. Talk about any health conditions or problems you may have, including if you:
are pregnant or breast-feeding
- have ever received ARTISS or aprotinin before, even if you did not have an allergic reaction to it. It is possible your body may have become sensitive to ARTISS, 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:
- ARTISS 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. These steps include: using plasma obtained from the blood of healthy donors; testing of each plasma donation as well as the manufacturing plasma pools for certain viruses; a manufacturing process that has been shown to remove or inactivate some viruses and other pathogens.
- ARTISS MUST NOT be injected into blood vessels (veins or arteries), or into tissues. As ARTISS forms a clot where it is applied, injecting ARTISS may cause serious reactions (e.g., vessel occlusion blockage)
- ARTISS 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 ARTISS:
- ARTISS can be used when you are receiving other medical products. There are no known interactions between ARTISS and other medicinal products.
How to take ARTISS:
- ARTISS will be applied to you in a healthcare setting and only by an experienced surgeon who is been appropriately trained. ARTISS will be applied by dripping or spraying.
Usual dose:
The surgeon will determine the amount of ARTISS to use based on your needs during surgery.
Overdose:
As the product is actively used by the surgeon, overdose is very unlikely to occur. ARTISS (Fibrin Sealant (Human), Slow Set) 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 ARTISS, 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 ARTISS:
These are not all the possible side effects you may have when taking ARTISS. If you experience any side effects not listed here, tell your healthcare professional.
The most common side effects with ARTISS are as follows:
- Itching
- Bruising at the site of the surgery
- Build-up of fluid under the skin at the site of the surgery
- Failure of the skin graft
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, light headedness, nausea, or vomiting | √ | ||
| 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.
Keep the syringe in the outer carton in order to protect from light.
Do not use this medicine after the expiry date which is stated on the label after “EXP”.
Store and transport frozen (at ≤ -20°C). The cold storage chain must not be interrupted until use.
Storage after thawing:
After thawing, the solutions must not be refrozen or refrigerated. Unopened pouches, thawed at room temperature, may be stored for up to 7 days at controlled room temperature (15°C to
25°C).
The product must be used within 12 hours after warming to 33°C to 37°C or removal from original pouches.
If you want more information about ARTISS:
- 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: 2025-09-03