Finished product reference
Calfactant
Suspension · Endotracheal · 35 mg/1mL · 6 mL
- List code
- 52041
- Pharmacologic class
- Surfactant
What it is and how it works
Mechanism class: Surfactant Activity
Indications
is indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates <29 weeks of gestational age at risk for RDS. for the rescue treatment of RDS in preterm neonates ≤72 hours of age with RDS who require endotracheal intubation. INFASURF ® is a surfactant indicated: to reduce the risk of respiratory distress syndrome (RDS) in preterm neonates < 29 weeks gestational age at risk for RDS. for the rescue treatment of preterm neonates ≤72 hours of age with RDS who require endotracheal intubation.
Dosage and administration (summary)
Recommended Dosage The recommended dose of INFASURF is 3 mL/kg body weight at birth administered intratracheally through an endotracheal tube. INFASURF can be administered every 12 hours for a total of up to three doses. To reduce the risk of RDS in preterm neonates <29 weeks of gestational age at risk for RDS, administer INFASURF within 30 minutes after birth. Preparation Instructions INFASURF does not require reconstitution. Do not dilute or sonicate. INFASURF does not need to reach room temperature before administration. Gently swirl or agitate the INFASURF intratracheal suspension vial for redispersion. Do not shake.
Contraindications
None. None.
Warnings and precautions
Acute Changes in Oxygenation and Lung Compliance The administration of exogenous surfactants, including INFASURF, can rapidly affect oxygenation and lung compliance. Frequently monitor neonates who receive INFASURF so that oxygen and ventilatory support can be modified in response to changes in respiratory status. INFASURF should only be administered by those trained and experienced in the care, resuscitation, and stabilization of preterm neonates with RDS who require intubation.
Storage and supply
(calfactant) intratracheal suspension is an off-white suspension available in a sterile, rubber-stoppered glass single-dose vial packaged as one vial per carton: 105 mg/3 mL (35 mg/mL) (NDC 61938-456-03) 210 mg/6 mL (35 mg/mL) (NDC 61938-456-06) Refrigerate INFASURF (calfactant) intratracheal suspension at 2°C to 8°C (36°F to 46°F) and protect from…
Source: Calfactant (Infasurf) — US FDA prescribing information, 2026-03-31, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.
Other presentations of the same active ingredient
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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