Details for: VISTASEAL
Company: INSTITUTO GRIFOLS S.A.
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02514230 | VISTASEAL | FIBRINOGEN (HUMAN); THROMBIN (HUMAN) | 160 MG / 2 ML; 1000 UNIT / 2 ML | SOLUTION | TOPICAL |
| 02514257 | VISTASEAL | FIBRINOGEN (HUMAN); THROMBIN (HUMAN) | 400 MG / 5 ML; 2500 UNIT / 5 ML | SOLUTION | TOPICAL |
Summary Reports
Consumer Information
This information was provided by the drug’s manufacturer when this drug product was approved for sale in Canada. It is designed for consumers and care givers. It is a summary of information about the drug and will not tell you everything about the drug. Contact your doctor or pharmacist if you have any questions about the drug.
What the medication is used for
VISTASEAL is used as a sealant during surgical operations in adults. It is applied to the surface of bleeding tissue to reduce bleeding during and after the operation when standard surgical techniques are not sufficient.
What it does
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.
When it should not be used
- 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
What the medicinal ingredient is
Medicinal ingredients: human fibrinogen (80 mg/mL) and human thrombin (500 IU/mL).
What the non-medicinal ingredients are
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
What dosage form it comes in
- 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.
Warnings and precautions
- VISTASEAL is for topical use only. VISTASEAL must not be injected inside a blood vessel because of life-threatening blood clots may occur.
- VISTASEAL is made from human blood which may carry a risk of transmitting an infectious agent (e.g. virus) that can cause a disease.
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
- Are under the age of 18 years
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.
Interactions with this medication
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.
Proper use of this medication
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
Missed Dose
Side effects and what to do about them
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.
| Symptom / effect | Talk to your healthcare professional Only if severe | Talk to your healthcare professional In all cases | Stop taking drug and get immediate medical help |
|---|---|---|---|
| UNCOMMON | |||
| Abdominal or liver abscess: abdominal pain, nausea, vomiting | ✔ | ✔ | |
| Bile leak after surgery: swollen and painful abdomen, fever | ✔ | ✔ | |
| Blood clot (deep vein thrombosis or pulmonary embolism): swelling, reddish skin, leg or chest pain, trouble breathing, nausea, lightheadedness | ✔ | ✔ | |
| Infection of the abdominal lining (peritonitis): severe pain, swelling of the abdomen, fever | ✔ | ✔ | |
| Skin infection (cellulitis): red area of skin, swelling, tenderness, pain, warmth, fever | ✔ | ✔ | |
| Viral infection (Parvovirus B19): fever, headache, upset stomach and runny nose | ✔ | ✔ | |
| Wound infection after surgery: pain, swelling and cloudy fluid is draining from the wound | ✔ | ✔ | |
| Wound reopening (abdominal wound dehiscence): bleeding, pain, swelling, redness, fever | ✔ | ✔ | |
| RARE | |||
| Allergic reaction: hives, rash, tightness of the chest, wheezing, light headedness, fainting, blurred vision | ✔ | ✔ | |
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.
How to store
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 48 hours at 2 °C - 8 °C or 24 hours at room temperature (20 °C – 25 °C) before use.
Thaw completely before use. Do not refreeze once thawed. After thawing, it can be maintained not more than 48 hours at 2 °C - 8 °C or 24 hours at room temperature (20 °C – 25 °C) before use.
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.
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 (https://www.canada.ca/en/healthcanada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
More information
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-productdatabase.html, or by calling 1-866-482-5226.
Manufacturer:
Instituto Grifols, S.A.
Can Guasc, 2 - Parets del Vallès
08150 Barcelona
Spain