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EVICEL FIBRIN SEALANT (HUMAN)- fibrinogen human and thrombin human kit


Patient Information

  • Inform patient that EVICELis made from human plasma
  • Discuss the risks and benefits with the patient of being exposed to product made from human blood and explain risk of transmitting infectious agents that may be present in such products (e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the classic CJD agent) as indicated in Section 5.2 Infection Risk from Human Plasma.
  • Instruct the patient to consult their physician if symptoms of parvovirus B19 infection (fever, drowsiness, chills, and runny nose followed about two weeks later by a rash and joint pain) occur.
  • Instruct the patient to consult their physician if symptoms of hepatitis A (several days to weeks of poor appetite, fatigue, and low-grade fever followed by nausea, vomiting and abdominal pain, dark urine, yellowed complexion) appear.

Distributed by:
Ethicon, Inc.
P.O. Box 151,
Somerville, NJ 08876-0151
USA

Manufactured by:
Omrix Biopharmaceuticals Ltd.
MDA Blood Bank, Sheba Hospital,
Ramat-Gan
POB 888, Kiryat Ono 5510801,
ISRAEL

U.S. License No. 1603
Ethicon, Inc. 2017
Omrix Biopharmaceuticals Ltd. 2014
R6200

Issued: 05/2018
Article No. 80FZ00M3-7



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