RECOTHROM

Generic Name/API: Recombinant

Manufacturer: The Medicines Company

Dosage Forms & Strength & Pack Size:
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.

Storage:
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.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

INDICATION
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.

WARNINGS AND PRECAUTIONS
1 Thrombosis
RECOTHROM may cause thrombosis if it enters the circulatory system. Apply topically. DO NOT
INJECT.

2 Hypers ensitivity Reactions
Hypersensitivity reactions, including anaphylaxis, may occur. RECOTHROM is produced in a
genetically modified Chinese Hamster Ovary (CHO) cell line and may contain hamster or snake proteins
[see Contraindications (4) and Description (11)].

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