Human thrombin

FDA label, Ethicon, Inc, topical, effective 2009-09-13. Full label on DailyMed

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From MedlinePlus, U.S. National Library of Medicine

Quoted from the FDA label. Product labels differ by manufacturer and change over time; confirm against the label for the product you are using.

Human Blood Coagulation Factor

Dosing in kidney impairment

This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.

Preparation and administration

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Your numbers for human thrombin. Take vial strength, diluent, and limits from the label below.

Basis

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Reconstitution Prior to Application Reconstitute the lyophilized human thrombin powder. Use aseptic technique when handling vials and syringes. Remove the flip-off plastic cap from the vial to expose the rubber stopper. Using a sterile needle and syringe, add 2 ml of Water for Injection, USP to the glass vial. Shake gently until the solution is clear.

Reconstituted solution is stable for up to 8 hours at room temperature and should be used within this time period.

Drug interactions

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  • Human thrombin
Label text (1 paragraph)

No drug interactions are known.

Contraindications

Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products. Do not use for the treatment of severe or brisk arterial bleeding. Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products ( 4 ). Do not use for treatment of severe or brisk arterial bleeding ( 4 ).

Safety data

Reported adverse events (FAERS)

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Source: FDA Adverse Event Reporting System via openFDA

Liver injury (LiverTox)

LiverTox has no chapter for human thrombin. Check the label's hepatic warnings.

Pregnancy and lactation

Pregnancy

8.1 Pregnancy Teratogenic effects: Pregnancy category C Adequate and well-controlled studies in pregnant women have not been performed. EVITHROM should be used in pregnancy only if the potential benefit to the pregnant woman justifies the potential risk to the fetus. Studies to evaluate the potential reproductive/developmental toxicity of EVITHROM have not been performed due to the human origin of thrombin. However, studies to evaluate the potential reproductive/developmental toxicity of residual levels of Triton X-100 and tri-n-butyl phosphate (solvent/detergent reagents) were conducted in animals and are summarized in the Non Clinical Toxicology section ( 13 ).

Lactation

8.3 Nursing Mothers The safety of EVITHROM for use during breast-feeding has not been established. Use only if clearly needed.

For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.

Supply and cost

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Recalls (last 24 months)

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Therapeutic equivalence (Orange Book)

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