EVARREST- fibrinogen human and human thrombin patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Fibrinogen Human (UNII: N94833051K) (Fibrinogen Human - UNII:N94833051K), Human Thrombin (UNII: 6K15ABL77G) (Human Thrombin - UNII:6K15ABL77G)

Available from:

Ethicon, Inc.

INN (International Name):

Fibrinogen Human

Composition:

Fibrinogen Human 8.6 mg in 1 cm2

Administration route:

TOPICAL

Therapeutic indications:

EVARREST® is a fibrin sealant patch indicated for use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. Limitations for Use: - Cannot safely or effectively be used in place of sutures or other forms of mechanical ligation in the treatment of major arterial or venous bleeding. - Not for use in children under one month of age - Laparoscopic and other minimally invasive surgeries where manual compression would be difficult to achieve. Do not use EVARREST® for - Bleeding from large defects in visible arteries or veins where the injured vascular wall requires conventional surgical repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST to blood flow and/or pressure during absorption of the product. - Intravascular application. This can result in life-threatening thromboembolic events. - Individuals know

Product summary:

EVARREST® is packaged in a polyester tray and lid assembly within an outer pouch composed of polyester laminated aluminum foil with an inner heat seal coating. The tray and lid assembly maintains product integrity during storage and transport. The aluminum foil pouch serves as a barrier to moisture and microbial contamination to maintain product sterility. Each aluminum foil pouch is contained in a labeled cardboard package. Each individual package contains two 2 × 4 inch (5.1 × 10.2 cm) EVARREST patches (NDC 63713-050-25 per patch and NDC 63713-050-24 per package).

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

EVARREST- FIBRINOGEN HUMAN AND HUMAN THROMBIN PATCH
ETHICON, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EVARREST SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EVARREST .
EVARREST FIBRIN SEALANT PATCH
ABSORBABLE PATCH FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2012
RECENT MAJOR CHANGES
Indications and Usage (_1_)
10/2016
Adverse Reactions _(6.1, 6.2_)
10/2016
INDICATIONS AND USAGE
EVARREST® is a fibrin sealant patch indicated for use with manual
compression as an adjunct to
hemostasis in adult patients undergoing surgery, when control of
bleeding by conventional surgical
techniques (such as suture, ligature, and cautery) is ineffective or
impractical.
(_1_)
LIMITATIONS FOR USE:
Cannot be used in place of sutures or other forms of mechanical
ligation in the treatment of major
arterial or venous bleeding. (_1_)
Not for use in children under one month of age (_8.4_)
Laparoscopic and other minimally invasive surgeries where manual
compression would be difficult to
achieve.(_1_)
DOSAGE AND ADMINISTRATION
FOR TOPICAL USE ONLY.
Determine the number of patches to be applied based upon the surface
area and anatomic location of
the bleeding tissue to be treated. (_2_)
Keep the patch dry until use. (_2.1_)
Place the powdery (active) side of the patch on the surface of tissue.
(_2.2_)
Apply immediate manual compression over the entire surface of the
patch and maintain contact
pressure for 3 minutes to control the bleeding. (_2.2_)
DOSAGE FORMS AND STRENGTHS
EVARREST Fibrin Sealant Patch consists of human fibrinogen and human
thrombin embedded in a
flexible composite patch component. The active side is powdery, and
the non-active side has an
embossed wave pattern. (_3_)
Each 2 × 4 inch (5.1 × 10.2 cm) absorbable patch contains
55.5 mg per square inch (8.6 mg per square cm) human fibrinogen
241.9 Units per square inch (37.5 Units per square cm) human thrombin
CONTRAINDICATIONS
Do not use to treat bleeding from large defects in arteries or