Monograph Details
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Diagnostic Agents
> Diagnostic agents
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FULLTERM |
| Manufacturer |
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Cytyc Corporation |
| Legal Classification |
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PP |
| Generic Name |
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In vitro test; fetal fibronectin enzyme immunoassay. |
| Indications |
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Aid in assessing risk of preterm delivery in ≤7 or ≤14 days from the time of cervicovaginal sample collection in women with signs/symptoms of early preterm labor, intact amniotic membranes, and minimal cervical dilation (<3cm), sampled between ≥24 weeks and <35 weeks gestation. Aid in assessing risk of preterm delivery in <35 weeks during routine prenatal visit between 22 weeks and <31 weeks gestation in women with singleton gestation. |
| Precautions |
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See literature. Not for women with advanced cervical dilatation, ruptured amniotic membranes, cervical cerclage, moderate or gross vaginal bleeding. Collect vaginal sample before any activities that may disrupt cervix (eg, coitus, cervical examinations, vaginal ultrasound, pap smear). |
| Interactions |
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Lubricants, soaps, disinfectants may interfere with test results. |
| How Supplied |
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Contact supplier. |
| Additional Resources |
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• Related Prescribing Note |
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