RECOTHROM- thrombin topical recombinant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

THROMBIN ALFA (UNII: SCK81AMR7R) (THROMBIN ALFA - UNII:SCK81AMR7R)

Available from:

Mallinckrodt Hospital Products Inc.

INN (International Name):

THROMBIN ALFA

Composition:

THROMBIN ALFA 1000 [iU] in 1 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

RECOTHROM® Thrombin topical (Recombinant), is a topical thrombin indicated to aid 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 in adults and pediatric populations greater than or equal to one month of age. RECOTHROM may be used in conjunction with an absorbable gelatin sponge, USP. - Do not inject directly into the circulatory system. - Do not use for the treatment of massive or brisk arterial bleeding. - Do not administer to patients with a history of hypersensitivity to RECOTHROM or any components of RECOTHROM. - Do not use in patients with known hypersensitivity to hamster proteins. Pregnancy Category C Animal reproduction studies have not been conducted with RECOTHROM. It is also not known whether RECOTHROM can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RECOTHROM should be given

Product summary:

RECOTHROM Thrombin topical (Recombinant), is supplied in single-use, preservative-free vials in the following packages: NDC 43825-606-41 A 5000-unit vial of RECOTHROM with a 5-mL prefilled diluent syringe (containing sterile 0.9% sodium chloride, USP), a sterile needle-free transfer device, a 5-mL sterile empty syringe, and a pre-printed label. NDC 43825-707-41 A 20,000-unit vial of RECOTHROM with a 20-mL vial of diluent (containing sterile 0.9% sodium chloride, USP), 2 sterile needle-free transfer devices, a 20-mL sterile empty syringe, and a pre-printed label. NDC 43825-707-50 The 20,000-unit RECOTHROM kit co-packaged with RECOTHROM™ Spray Applicator Kit containing a spray pump, a spray bottle, a syringe spray tip, a syringe, a bowl, and 2 blank labels. No RECOTHROM kit components contain latex. Store RECOTHROM sterile powder vials at 2°C to 25°C (36°F to 77°F). Do not freeze. Reconstituted solutions of RECOTHROM prepared with sterile 0.9% sodium chloride, USP, may be stored for up to 24 hours at 2°C to 25°C (36°F to 77°F). Discard reconstituted solution after 24 hours.

Authorization status:

Biologic Licensing Application

Summary of Product characteristics

RECOTHROM- THROMBIN TOPICAL RECOMBINANT
MALLINCKRODT HOSPITAL PRODUCTS INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
RECOTHROM SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR RECOTHROM.
RECOTHROM THROMBIN TOPICAL (RECOMBINANT)
LYOPHILIZED POWDER FOR SOLUTION - FOR TOPICAL USE ONLY
INITIAL U.S. APPROVAL: 2008
INDICATIONS AND USAGE
RECOTHROM Thrombin topical (Recombinant), is a topical thrombin
indicated to aid 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
in adults and pediatric populations greater than or equal to
one month of age. (1)
RECOTHROM may be used in conjunction with an absorbable gelatin
sponge, USP. (1)
DOSAGE AND ADMINISTRATION
FOR TOPICAL USE ONLY. DO NOT INJECT. (2)
Reconstitute RECOTHROM powder with sterile 0.9% sodium chloride, USP,
yielding a solution containing 1000 units
(international units of potency) per mL. (2.1)
Apply RECOTHROM solution directly to bleeding site surface or in
conjunction with absorbable gelatin sponge. The
amount required depends upon the area of tissue to be treated. (2.2)
DOSAGE FORMS AND STRENGTHS
RECOTHROM is available as 5000-unit and 20,000-unit vials of sterile
recombinant topical thrombin lyophilized powder for
solution. When reconstituted as directed, the final solution contains
1000 units/mL of RECOTHROM. (3)
CONTRAINDICATIONS
Do not inject directly into the circulatory system. (4)
Do not use for the treatment of massive or brisk arterial bleeding.
(4)
Do not administer to patients with a history of hypersensitivity to
RECOTHROM, any components of RECOTHROM or
hamster proteins. (4)
WARNINGS AND PRECAUTIONS
RECOTHROM may cause thrombosis if it enters the circulatory system.
(5.1)
Hypersensitivity reactions, including anaphylaxis, may occur. (5.2)
ADVERSE REACTIONS
The most common adverse reaction (inc