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Thrombate Iii Generic Name & Formulations
Legal Class
Rx
General Description
Antithrombin III (human) 500 IU, 1000 IU; per vial; lyophilized pwd for IV infusion after reconstitution; preservative-free.
Pharmacological Class
Thrombin inhibitor (α2-glycoprotein).
How Supplied
Single-use vial—1 (w. diluent, needles)
Manufacturer
Thrombate Iii Indications
Indications
Treatment of patients with hereditary antithrombin III deficiency (AT-III) in surgical or obstetrical procedures and thromboembolism.
Thrombate Iii Dosage and Administration
Adult
Give by IV infusion over 10–20 minutes. Individualized. Dose (units required)= [desired (% of normal) – baseline (% of normal) AT-III level] X weight (kg)/1.4. Loading dose: increase AT-III to 120% of normal. Subsequent dose should be based on AT-III levels obtained 20 minutes post-infusion, every 12hrs, and before the next dose. Maintain AT-III levels at 80–120% of normal for 2–8 days.
Children
Not recommended.
Thrombate Iii Contraindications
Not Applicable
Thrombate Iii Boxed Warnings
Not Applicable
Thrombate Iii Warnings/Precautions
Warnings/Precautions
Surgery. Hemorrhage. Acute thrombosis. Monitor AT-III levels during treatment. Contains human plasma; monitor for possible infection transmission. Pregnancy (Cat.B).
Thrombate Iii Pharmacokinetics
See Literature
Thrombate Iii Interactions
Interactions
Potentiates anticoagulant effect of heparin; reduce heparin dose.
Thrombate Iii Adverse Reactions
Adverse Reactions
Dizziness, chest tightness, nausea, taste disturbances, chills, cramps, shortness of breath, chest pain, light-headedness, bowel fullness, hives, fever, hematoma formation.
Thrombate Iii Clinical Trials
See Literature
Thrombate Iii Note
Notes
Report all infections suspected to be transmitted by Thrombate III to (800) 520-2807.
Thrombate Iii Patient Counseling
See Literature
