Biosurgery

EVICEL® Fibrin Sealant (Human)

To see Important Safety Information scroll down to the bottom of page

Complex Problem. Simple Solution.

EVICEL® Fibrin Sealant, once thawed, is ready on-demand to meet your critical bleeding challenges by working independently of your patient’s clotting factors.

  • The only all human, aprotinin free, fibrin sealant indicated for general hemostasis.
  • <1 minute from refrigeration storage to application ready (When stored in refrigerator, after thawing (24hrs)*
  • 7X greater temperature range for use264,265
  • All-Human formulation – EVICEL® Fibrin Sealant does not contain aprotinin or bovine derivatives and does not expose patients to the risks associated with aprotinin264
  • Multiple, clog-resistant tip options – Standard 6 cm tip or 35 cm Rigid or 45 cm Flexible tip
  • Spray or drip application with all tips
DESCRIPTION (TOTAL VOLUME)CODENDC/DISTRIBUTOR CODEQUANTITY
1-mL Kit (2 mL)390167313-390-111
2-mL Kit (4 mL)390267313-390-221
5-mL Kit (10 mL)390567313-390-551
35 cm Rigid Tip3908N/ASet of 3
45 cm Flexible Tip3909N/ASet of 3

EVICEL® Fibrin Sealant (Human)

IMPORTANT SAFETY INFORMATION

Indication

EVICEL® Fibrin Sealant (Human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical.

Important Risk Information

  • Do not inject directly into the circulatory system. Intravascular application of EVICEL® may result in life-threatening thromboembolic events.
  • Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.
  • Do not use for the treatment of severe or brisk arterial bleeding.
  • Do not use EVICEL® for spraying in endoscopic or laparoscopic procedures where the minimum recommended distance from the applicator tip to the target site cannot be ensured.
  • Life-threatening gas embolism has occurred with the use of spray devices employing pressure regulator to administer fibrin sealants. These events appear to be related to the use of the spray device at pressures higher than recommended and/or at distances closer than recommended to the surface of the tissue. Follow labeled application instructions regarding pressure range and distance when using a spray device and monitor patients for the possibility of gas embolism.
  • Monitor changes in blood pressure, pulse oxygen saturation, and end-tidal CO2 when spraying EVICEL® because of the possibility of gas embolism.
  • To reduce the risk of potentially life-threatening gas embolism, spray EVICEL® using only pressurized CO2 gas at the recommended pressures and distances.
  • Use EVICEL® spray application only if it is possible to accurately judge the spray distance, especially during endoscopic or laparoscopic procedures. Apply as a thin layer.
  • Prior to applying EVICEL®, dry surface areas of the wound by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices). Prepare and administer EVICEL® according to the instructions and only with devices recommended for this product.
  • May carry a risk of transmitting infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and theoretically, the Creutzfeldt-Jakob disease (CJD) agent

Most common adverse events reported in clinical trials (=5%) are bradycardia, nausea, hypokalemia, insomnia, hypotension, pyrexia, graft infection, vascular graft occlusion, peripheral edema, and constipation.

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

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  • Distributed by
  • Omrix Biopharmaceuticals Ltd.
  • MDA Blood Bank,
  • Sheba Hospital, Ramar-Gan
  • POB 888, Kiryat Ono 55000
  • ISRAEL
  • Manufactured by:
  • Omrix Biopharmaceuticals Ltd.
  • MDA Blood Bank,
  • Sheba Hospital, Ramar-Gan
  • POB 888, Kiryat Ono 55000
  • ISRAEL

 

Site References

  • * Thaws within 10 minutes at 37°C (and must not be kept at this temperature for longer than 10 minutes); within 1 hour at 20°C to 25°C (room temperature); or within 1 day at 2°C to 8°C (refrigerator). Once thawed, EVICEL® must not be refrozen. Once at room temperature, EVICEL® must not be refrigerated.
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