Drug guidance
Pulmonary surfactant for treating respiratory distress syndrome in premature infants
Condition
Respiratory
1 September 2020
Published on 02 May 2019
Last Updated on 01 Sep 2020
Guidance Recommendations
The Ministry of Health’s Drug Advisory Committee has recommended:
Calfactant 105 mg/3 ml and 210 mg/6 ml and poractant alfa 120 mg/1.5 ml intratracheal suspension vials for treating respiratory distress syndrome in premature infants.
Subsidy status
Calfactant 105 mg/3 ml and 210 mg/6 ml, and poractant alfa 120 mg/1.5 ml intratracheal suspension vials are recommended for inclusion on the MOH Standard Drug List (SDL) for the abovementioned indication.
SDL does not apply to beractant 200 mg/8 ml vial.
Poractant alfa does not have regulatory approval with the Health Sciences Authority (HSA). The responsibility of prescribing an unregistered product to patients lies with the treating clinician. Before poractant alfa is administered, it is important to consider the availability of other suitable registered alternatives and inform the parent(s) or carer of the infant that the product is unregistered.