Vistaseal: Uses, Side Effects and Dosage

What is VISTASEAL used for?

VISTASEAL is used as a sealant during surgical operations in adult and pediatric patients (< 18 years). It is applied to the surface of bleeding tissue to reduce bleeding during and after the operation when standard surgical techniques are not sufficient.

How does VISTASEAL work?

VISTASEAL is applied topically onto the surgical site to stop bleeding during surgery. VISTASEAL contains human fibrinogen and human thrombin, two proteins extracted from the blood that form a sealing clot when they are mixed together.

What are the ingredients in VISTASEAL?

Medicinal ingredients: human fibrinogen (80 mg/mL) and human thrombin (500 IU/mL).

Non-medicinal ingredients:

• the fibrinogen syringe includes: arginine, L-glutamic acid monosodium, L-isoleucine, sodium citrate dihydrate, sodium chloride and water for injections
• the thrombin syringe includes: calcium chloride, glycine, human albumin, sodium chloride and water for injections

VISTASEAL comes in the following dosage forms:

• 2 mL Solution (two 1 mL pre-filled syringes, one of fibrinogen and one of thrombin)
• 4 mL Solution (two 2 mL pre-filled syringes, one of fibrinogen and one of thrombin)
• 6 mL Solution (two 3 mL pre-filled syringes, one of fibrinogen and one of thrombin)
• 10 mL Solution (two 5 mL pre-filled syringes, one of fibrinogen and one of thrombin)

VISTASEAL is a kit consisting of two sterile solutions (fibrinogen and thrombin) filled in glass syringes with rubber stoppers and assembled in a syringe holder. An applicator for mixing the two solutions and for application by dripping or spraying is also provided.

Serious Warnings and Precautions

Do not use VISTASEAL if:

• You are allergic to human fibrinogen or human thrombin or to any ingredient of this medicine (see “What are the ingredients in VISTASEAL” above), or to rubber (see “VISTASEAL comes in the following dosage forms” above).
• You have severe or rapid bleeding from an artery.

To help avoid side effects and ensure proper use, talk to your healthcare professional before you are administered VISTASEAL. Talk about any health conditions or problems you may have, including if you:

• Have ever had an adverse reaction to a medicine like VISTASEAL in the past

• Are pregnant or breast-feeding

Other warnings you should know about:

VISTASEAL is made from human plasma and may carry a risk of transmitting infectious agents (e.g. virus), despite manufacturing steps designed to reduce this risk. These steps include using plasma obtained from the blood of healthy donors; each plasma donation as well as the manufacturing plasma pools are tested for certain viruses; and the manufacturing process has been shown to remove or inactivate viruses or pathogens.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with VISTASEAL:

Solutions containing alcohol, iodine or heavy metals (e.g. antiseptic solutions) that come into contact with VISTASEAL may denature the product. Antiseptic solutions are removed before applying VISTASEAL.

How to take VISTASEAL:

VISTASEAL will be applied only by an experienced surgeon during your surgery. VISTASEAL will be applied by dripping or spraying.

Usual dose:

The surgeon will determine how much VISTASEAL to use based on your needs during surgery.

Overdose:

An excessive thickness in the layer of VISTASEAL applied may interfere with the wound healing process.

What are possible side effects from using VISTASEAL?

These are not all the possible side effects you may have when using VISTASEAL. If you experience any side effects not listed here, tell your healthcare professional.

The most common side effects with VISTASEAL are as follows:

• Nausea
• Pain caused by the surgery
• Itching (pruritus)

As with any protein product, allergic reactions are possible.

Serious side effects and what to do about them

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

Storage:

Keep out of reach and sight of children.

Do not use after the expiration date printed on the outer carton and container labels. Discard if the package is damaged.

VISTASEAL must be stored in a freezer at -18 °C or colder. The cold storage chain must not be interrupted until use. Keep the sterilized blister in the outer carton to protect it from light.

Thaw completely before use. Do not refreeze once thawed. After thawing, it can be maintained not more than 7 days at 2 - 8 °C or 24 hours not above 25 °C before use.

Once the blister is opened, VISTASEAL should be used immediately.

Do not use if the solutions are cloudy or have deposits.

Any unused product or waste material should be disposed of in accordance with local requirements.

If you want more information about VISTASEAL:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html, or by calling 1-866-482-5226.

Manufacturer:

Instituto Grifols, S.A.

Can Guasc, 2 - Parets del Vallès

08150 Barcelona

Spain

Importer and Distributor:

Johnson and Johnson MedTech, a division of Johnson & Johnson (Canada) Inc.

200 Whitehall Dr.

Markham, ON

L3R 0T5

Canada

Last Revised: November 18, 2024