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Suspension for intratracheal administration containing beractant.
Prophylaxis/risk of respiratory distress syndrome-neonates
Respiratory distress syndrome - neonates
Administer early in the course of Respiratory Distress Syndrome, preferably less than 8 hours of age. Depending on clinical course, this dose may be repeated within 48 hours at intervals of at least six hours for up to 4 doses.
Administer first dose as soon as possible after birth, preferably within 15 minutes. Depending on clinical course, this dose may be repeated within 48 hours at intervals of at least six hours for up to 4 doses.
100mg phospholipid/kg birth weight in a volume not exceeding 4ml/kg.
The vial should be warmed by standing at room temperature for 20 minutes or warmed in the hand for 8 minutes. Artificial warming methods should not be used. Discard each vial if not used within 8 hours of warming to room temperature. Vials should not be returned to the refrigerator once warmed.
Beractant suspension is administered via the endotracheopulmonary route using a 5 Fr catheter.
Before administering beractant to infants on mechanical ventilation, set the respiratory frequency at 60/minute - with inspiration time 0.5s and Fi02 at 1.0. Inspiratory pressure needs no change at this point.
To ensure distribution of beractant throughout the lungs, each dose is divided into fractional doses. Each dose can be administered as either two half-doses or four quarter-doses. Each fractional dose is administered with the infant in different positions as given below. Between each position the infant should be ventilated for 30 seconds.
For four quarter-doses the recommended positions are:
Right Lateral Position with the head lowered (i.e. head and body slanting down at an angle of approximately 15 degrees).
Left Lateral Position with the head lowered (i.e. head and body slanting down at an angle of approximately 15 degrees).
Right Lateral Position with head elevated (i.e. head and body slanting up at an angle of approximately 15 degrees).
Left Lateral Position with head elevated (i.e. head and body slanting up at an angle of approximately 15 degrees).
For administration of each quarter dose, the ventilator is disconnected, the catheter inserted, the dose administered, then the ventilator reconnected. Between each quarter dose the infant is ventilated for 30 seconds.
For two half-doses the recommended positions are:
With infant supine, the head and body turned approximately 45 degrees to the right.
With infant supine, the head and body turned approximately 45 degrees to the left.
When two half-doses of beractant are being administered there are 2 alternative methods of administration:
Instillation with disconnection from the ventilator.
Each half dose is administered by disconnecting the endotracheal tube from the ventilator, inserting the catheter and administering the half dose. Between the half doses, the ventilator is reconnected for 30 seconds.
Instillation without disconnection from the ventilator (through a suction port connector).
The first half dose is administered by inserting the catheter through a suction port connector without disconnection from the ventilator. There should be at least 30 seconds between the half doses during which time the catheter is retracted from the endotracheal tube but not removed from the connector. The catheter is then reinserted into the endotracheal tube and the second half dose administered. The catheter is then withdrawn completely.
Precautions and Warnings
Discard part-used vials
Do not intubate infant solely to administer surfactant
If transient bradycardia occurs suspend dosing; resume when stable
If transient oxygen desaturation occurs suspend dosing; resume when stable
Monitor blood gases regularly
Monitor systemic oxygenation to avoid hyperoxaemia
Obstruction of endotracheal tube by mucous secretions
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: September 2019
Summary of Product Characteristics: Survanta 25mg/ml suspension. AbbVie Ltd. Revised October 2015.
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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