Details for: EVICEL
Company: OMRIX BIOPHARMACEUTICALS LTD
| DIN | DIN name | Active Ingredient(s) | Strength | Dosage Form | Route of Administration |
|---|---|---|---|---|---|
| 02348497 | EVICEL | FIBRINOGEN (HUMAN); THROMBIN (HUMAN) | 90 MG / ML; 1200 UNIT / ML | KIT | TOPICAL |
| 02348497 | EVICEL | FIBRINOGEN (HUMAN); THROMBIN (HUMAN) | 90 MG / ML; 1200 UNIT / 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
EVICEL is used as supportive treatment to reduce bleeding and oozing during and after the operation. Evidence of efficacy and safety has been demonstrated in the following clinical trials (1) Liver surgery such as liver resection and reduced-size liver transplantation (2) Orthopedic surgery such as total hip replacement and total knee replacement, (3) Retroperitoneal/intra-abdominal surgery, (4) Vascular surgery.
In addition, EVICEL is used to support watertight closure of the cerebral envelopes (dura mater) during neurosurgery when other surgical techniques are insufficient. (See Use in Neurosurgery)
What it does
Fibrinogen is a concentrate of clottable protein and thrombin is an enzyme that causes clottable protein to coalesce. Thus, when the two components are mixed together they clot instantly.
When it should not be used
Do not use EVICEL:
- If you are hypersensitive (allergic) to products made from human blood or to any of the other ingredients of EVICEL. Signs of such reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure and breathing difficulties. If these symptoms occur, the administration has to be discontinued immediately.
- For treatment of severe or brisk arterial bleeding
The spray application of EVICEL should not be used in endoscopic (intra luminal) procedures. For laparoscopy, see sections Warnings and Precautions, and Proper Use of This Medication.
What the medicinal ingredient is
This product is a human fibrin sealant kit, which is supplied as a package containing two components called Human Clottable Protein and Thrombin.
What the non-medicinal ingredients are
| Human Clottable Protein contains the following non-medicinal ingredients: Arginine hydrochloride Calcium chloride Glycine Sodium chloride Sodium citrate Water for injection |
Thrombin contains the following non-medicinal ingredients: Calcium chloride Human albumin Mannitol Sodium acetate Water for injection |
What dosage form it comes in
The EVICEL kit is available as 2x1 mL, 2x2 mL or 2x5 mL kits each containing one vial of Human Clottable Protein and one vial of Thrombin as frozen, sterile solutions, which is white to slightly yellowish opaque frozen mass. The thawed preparation is clear and colourless to slightly yellowish.
Human Clottable Protein contains 50-90 mg/mL clottable proteins. Thrombin contains 800-1200 IU/mL human thrombin.
Warnings and precautions
Warning
For topical use only. Do not apply intravascularly.
When medicinal products prepared from human blood or plasma are given to patients, the risk of transmission of an infection cannot be totally ruled out.
Life-threatening/fatal air or gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants including EVICEL. This event appears to be related to the use of the spray device at higher than recommended pressures and/or in close proximity to the surface of the tissue. To reduce the risk of potentially life threatening air embolism EVICEL should be sprayed using pressurized CO2 gas only.
Before you use EVICEL, talk to your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Data are too limited to support the safety and effectiveness of EVICEL in children.
There is not enough information available to know whether any particular risks are associated with the use of EVICEL during pregnancy, during labor and delivery or whilst breast-feeding. However, since
EVICEL is used during a surgical operation, if you are pregnant or breast-feeding you should discuss the overall risks of the operation with your doctor.
When spraying EVICEL, your doctor may monitor changes in blood pressure, pulse, oxygen saturation and end tidal carbon dioxide because of the possibility of occurrence of air or gas embolism.
Use in Tissue Gluing, Endoscopy or Gastro-Intestinal Anastomoses
Adequate data are not available to support the use of this product in tissue gluing, application through an endoscope for treatment of bleeding or in gastro-intestinal anastomoses.
Use in Neurosurgery
The use of EVICEL has not been studied in the following procedures, and there is therefore no information to show that it would be effective in these procedures:
- Gluing tissues together or fixing dural patches or implants
- Surgery to the brain except for support of watertight closure of cerebral envelopes (dura mater)
- Sealing in transphenoidal (through the nose) and otoneurosurgical (through the ear) procedures
- It is not known whether radiation therapy within a week after surgery could affect the effectiveness of fibrin sealant when used for suture line sealing during neurosurgery.
Interactions with this medication
No formal interaction studies have been performed. Similar to comparable products or thrombin solutions, the product may be denatured after exposure to solutions containing alcohol, iodine or heavy metals (e.g. antiseptic solutions). Such substances should be removed to the greatest possible extent before applying the product.
Proper use of this medication
Usual Dose
The doctor treating you will administer EVICEL during surgery.
During your operation, your doctor will drip or spray EVICEL onto raw tissue during operations, using an application device. This device allows equal amounts of the two components of EVICEL to be administered at the same time, and ensures that they mix evenly, which is important for the sealant to have its optimal effect. Your doctor will follow the spray distance and pressure recommended by the manufacturer in the spray application of EVICEL (see Table from Method of Application by Spraying).
The amount of EVICEL that will be applied depends on the surface area of tissue to be treated during the operation. It will be dripped onto the tissue in short bursts or sprayed in very small amounts (0.1 - 0.2 mL), to produce a thin, even layer. If application of a single layer of EVICEL does not completely stop the bleeding, a second layer may be applied.
Side effects and what to do about them
Like all medicines, EVICEL can have side effects, although not everybody gets them.
EVICEL is a fibrin sealant. Fibrin sealants in general may, in rare cases (1 to 10 patients in 10,000), cause an allergic reaction. If you experience an allergic reaction you might have one or more of the following symptoms: skin rash, hives or wheals (nettle-rash), tightness of the chest, chills, flushing, headache, low blood pressure, lethargy, nausea, restlessness, increased heart rate, tingling, vomiting or wheezing. No allergic reactions have so far been reported in patients treated with EVICEL.
There is also a theoretical possibility that you could develop antibodies to the proteins in EVICEL, which could potentially interfere with blood clotting.
In clinical studies with EVICEL some undesired events occurred for which a causal relation to the application of EVICEL could not be excluded. After abdominal surgery some patients presented with an abscess, and in vascular surgery some cases of an occluded graft occurred which had do be re-operated. Some undesired effects reported in the neurosurgery clinical trial included meningitis, blood accumulation and accumulation of CSF fluid in the brain cavities.
If you feel unwell tell your doctor immediately, even if your symptoms are different from those just described.
If you notice any other side effects, please inform your doctor or pharmacist.
How to store
Store frozen at ≤ -18°C. Do not use EVICEL after the expiry date printed on the carton.
Vials must be stored in an upright position in their carton and protected from light.
If thawed, do not refreeze. After thawing, the thaw date should be noted on the carton. Thawed, unopened vials can be stored at:
- 2- 8°C for up to 30 days, or
- up to 24 hours at room temperature in their carton
The thawed product should be used within 30 days from the thaw date or the product expiry date, whichever comes first.
Once drawn up into the application device, they must be used immediately.
Reporting side effects
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to: 866-678-6789, or
- Mail to:
Canada Vigilance Program
Health Canada
Postal Locator 0701E
Ottawa ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
More information
This document plus the full product monograph, prepared for health professionals can be found at:
http://www.omrix.com or by contacting Ethicon Customer Support Center at (800) 268-5577.
| Manufactured by: Omrix Biopharmaceuticals Ltd MDA Blood Bank, Sheba Hospital, Ramat-Gan POB 888, Kiryat Ono 5510801 ISRAEL |
Imported into Canada and distributed by: Johnson & Johnson Medical Products, a division of Johnson & Johnson Inc., Markham, Ontario L3R 0T5 CANADA |
This leaflet was prepared by Omrix Biopharmaceuticals Ltd.
Last revised: October 13, 2017