THROMBIN HUMAN powder, for solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HUMAN THROMBIN (UNII: 6K15ABL77G) (HUMAN THROMBIN - UNII:6K15ABL77G)

Available from:

Ethicon, Inc

INN (International Name):

human thrombin

Composition:

human thrombin 2000 [iU] in 2 mL

Administration route:

TOPICAL

Therapeutic indications:

EVITHROM® Thrombin, Topical (Human), is indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. EVITHROM® Thrombin, Topical (Human), may be used in conjunction with an Absorbable Gelatin Sponge, USP. - Do not use in individuals known to have an anaphylactic or severe systemic reaction to EVITHROM® or to human blood products. - Do not use for the treatment of severe or brisk arterial bleeding. Risk Summary There are no data with EVITHROM® use in pregnant women to inform a drug-associated risk. Animal reproduction studies have not been conducted with EVITHROM® . It is not known whether EVITHROM® can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. EVITHROM® should be given to a pregnant woman only if clearly needed. In the U.S. general population, the estimated background

Product summary:

EVITHROM® is supplied in a single-use 2 ml vial containing 2000 (1600-2400) units of lyophilized human thrombin powder for reconstitution in 2 ml Water for Injection, USP. NDC 63713-461-02

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

THROMBIN HUMAN- THROMBIN HUMAN POWDER, FOR SOLUTION
ETHICON, INC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
EVITHROM SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR EVITHROM .
EVITHROM [THROMBIN, TOPICAL (HUMAN)]
LYOPHILIZED POWDER FOR SOLUTION
FOR TOPICAL USE
INITIAL U.S. APPROVAL: 2007
INDICATIONS AND USAGE
EVITHROM is a topical thrombin indicated as an aid to hemostasis
whenever oozing blood and minor
bleeding from capillaries and small venules is accessible and control
of bleeding by standard surgical
techniques (such as suture, ligature or cautery) is ineffective or
impractical (_1_).
EVITHROM may be used in conjunction with an Absorbable Gelatin Sponge,
USP (_1_).
DOSAGE AND ADMINISTRATION
FOR TOPICAL USE ONLY. DO NOT INJECT (_2.2_).
Apply EVITHROM on the surface of bleeding tissue only.
The amount of EVITHROM required depends upon the area of tissue to be
treated and the method of
application. In clinical studies, volumes up to 10 ml were used in
conjunction with Absorbable Gelatin
Sponge, USP (_2.2_).
DOSAGE FORMS AND STRENGTHS
EVITHROM is a lyophilized powder for solution containing 2000
(1600-2400) units of human thrombin.
After reconstituted the final solution contains 1000 (800-1200)
units/ml of EVITHROM (_3_).
CONTRAINDICATIONS
DO NOT USE IN INDIVIDUALS KNOWN TO HAVE AN ANAPHYLACTIC OR SEVERE
SYSTEMIC REACTION TO
EVITHROM OR TO HUMAN BLOOD PRODUCTS (_4_).
DO NOT USE FOR TREATMENT OF SEVERE OR BRISK ARTERIAL BLEEDING (_4_).
WARNINGS AND PRECAUTIONS
POTENTIAL RISK OF THROMBOSIS IF ABSORBED SYSTEMICALLY (_5.1_).
MAY CARRY A RISK OF TRANSMITTING INFECTIOUS AGENTS SUCH AS VIRUSES AND
THEORETICALLY, THE
CREUTZFELDT-JAKOB DISEASE (CJD) AGENT, DESPITE MANUFACTURING STEPS
DESIGNED TO REDUCE
THE RISK OF VIRAL TRANSMISSION (_5.2_).
HYPERSENSITIVITY REACTIONS, INCLUDING ANAPHYLAXIS, MAY OCCUR (_5.1_).
ADVERSE REACTIONS
The most common adverse reactions (incidence 2%) were prolonged
activated partial thromboplastin
time, increase