Finished product reference
Surfactant (Bovine Lipid Extract)
Injection, Suspension · Transtracheal · 27 mg/1mL · 4 mL
- List code
- 53059
- Pharmacologic class
- Pulmonary surfactant (natural, bovine lung lipid extract)
What it is and how it works
A natural surfactant extracted from bovine lung, containing phospholipids (mainly dipalmitoylphosphatidylcholine) and surfactant-associated proteins SP-B and SP-C. Instilled into the trachea, it spreads over the alveolar surface, lowers surface tension and prevents alveolar collapse at end-expiration, improving lung compliance and gas exchange in surfactant-deficient preterm infants.
Indications
Prevention and treatment (rescue) of respiratory distress syndrome (hyaline membrane disease) in preterm neonates.
Dosage and administration (summary)
Given by endotracheal instillation in neonatal intensive care; the dose is calculated on birth weight (as phospholipid per kg) and repeat doses are given according to the product information and neonatal protocol.
Contraindications
No absolute contraindications in the approved indication when used by experienced staff.
Warnings and precautions
Should be administered only by clinicians experienced in neonatal intubation, ventilation and resuscitation, with continuous monitoring. Rapid improvement in oxygenation and compliance may require prompt adjustment of ventilator settings and oxygen to avoid hyperoxia and pneumothorax. Transient bradycardia, desaturation and endotracheal tube reflux or obstruction may occur during dosing.
Storage and supply
Store refrigerated at 2–8 °C, protected from light; warm to room temperature before use and do not shake.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
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.
Tell us the quantity, the market and the timing.
Send the molecule or ingredient, the specification and the destination. We reply from Tehran with the questions, the documents and the next step.