📋 Indications & Clinical Dosage
*Treatment of respiratory distress syndrome or hyaline membrane disease in neonates, Prophylaxis of respiratory distress syndrome in preterm neonates:*
BY ENDOTRACHEAL TUBE: 100-200 mg/kg; further doses of 100 mg/kg may be repeated 12 hr later and after further 12 hr if still intubated; max total dose, 300-400 mg/kg.
💊 Mode of Administration
: For intratracheal use only. Before administering, ensure proper placement and patency of the endotracheal tube, the endotracheal tube may be suctioned before administering poractant alfa. Allow the infant to stabilize before proceeding with dosing.
⚠️ Precautions & Warnings
Continuous monitoring is required to avoid hy-peroxaemia caused by rapid improvement in arterial oxygen concentration.
⚠️ Adverse Reactions / Side Effects
Pulmonary haemorrhage (rarely), especially in more preterm neonates
🧪 Compatibility & Storage Stability
Stability & Storage: Store in a refrigerator at 2C-8C (36T-46T). Un-opened vials may be warmed to room temperature for up to 24 hours prior to use. Unopened, unused vials that have warmed to room temperature may be returned to refrigerated storage within 24 hours for future use. Do not warm to room temperature or return it to the refrigerator more than once. Protect from light. Enter each single-use vial only once, and discard the vial with any unused material after the initial entry.
📚 Official Regulatory & Clinical References
- Drug Regulatory Authority of Pakistan (DRAP): Drug Registration, S.R.O. Price Gazettes & National Essential Medicines List (NEML).
- World Health Organization (WHO): Collaborating Centre for Drug Statistics Methodology (ATC/DDD Index).
- Formulary Standards: British National Formulary (BNF) & Pakistan National Formulary (PNF) guidelines.