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DRUG INTERACTIONS
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenic bioassay studies have not been conducted in animals with HEMABATE due to the limited indications for use and short duration of administration. No evidence of mutagenicity was observed in the Micronucleus Test or Ames Assay.
Pregnancy
Teratogenic Effects
Pregnancy Category C
Animal studies do not indicate that HEMABATE is teratogenic, however, it has been shown to be embryotoxic in rats and rabbits and any dose which produces increased uterine tone could put the embryo or fetus at risk.
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CONTRAINDICATIONS
- Hypersensitivity to HEMABATE Sterile Solution
- Acute pelvic inflammatory disease
- Patients with active cardiac, pulmonary, renal or hepatic disease
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1Duff, Sanders, and Gibbs; The course of labor in term patients with chorioamnionitis; Am. J. Obstet. Gynecol.; vol. 147, no. 4, October 15, 1983 pp 391–395.
Rx only
LAB-0032-3.0
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