Drug Class Description
Lung surfactants.

Generic Name
Beractant

Drug Description
Each ml contains Beractant equivalent to :Phospholipids 25 mg/ml (including disaturated phosphatidylcholines 11.0 - 15.5 mg/ml)Triglycerides 0.5 - 1.75 mg/mlFree Fatty Acids 1.4 - 3.5 mg/mlProtein 0.1 - 1.0 mg/ml

Presentation
Sterile suspension for intratracheal administration

Indications
Survanta is indicated for treatment of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in new born premature infants with a birth weight of 700g or greater and who are intubated and are receiving mechanical ventilation.Survanta is also indicated for the prophylactic treatment of premature infants <32 weeks gestational age at risk of developing RDS.

Adult Dosage
Not applicable.

Child Dosage
Dosage In Infants100 mg phosholipid/kg birth weight in a volume not exceeding 4ml/kg.Treatment: Survanta should be administered early in the course of RDS, i.e. 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.Prophylaxis: The first dose of Survanta should be administered 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.Method of Administration:Survanta should be administered by intratracheal administration (i.e. drug should be conducted into the lungs via an endotracheal tube) using a 5 Fr catheter. The tip of the catheter should lie at the end of the endotracheal tube. Infants should not be intubated solely for the administration of Survanta.Survanta should be warmed to room temperature before administration (see Precautions).Before administering Survanta to infants on mechanical ventilation, set the respiratory frequency at 60/minute - with inspiration time 0.5s and Fi2 at 1.0. Inspiratory pressure needs no change at this point.To ensure distribution of Survanta 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 15º).Left Lateral Position with the head lowered (i.e. head and body slanting down at an angle of approximately 15º).Right Lateral Position with head elevated (i.e. head and body slanting up at an angle of approximately 15º).Left Lateral Position with head elevated (i.e. head and body slanting up at an angle of approximately 15º).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 45º to the right.With infant supine, the head and body turned approximately 45º to the left.When two half-doses of Survanta are being administered there are 2 alternative methods of administration :Installation with disconnection from the ventilatorEach 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.Alternatively,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.

Elderly Dosage
Not applicable.

Contra Indications
No specific contraindications for Survanta have been defined by the clinical studies.

Special Precautions
Survanta should only be administered with adequate facilities for ventilation and monitoring of babies with RDS.Marked improvements in oxygenation may occur within minutes of the administration of Survanta. Therefore, frequent and careful monitoring of systemic oxygenation is essential to avoid hyperoxia. Following Survanta administration, monitoring of the arterial blood gases, the fraction of inspired oxygen and ventilatory change is required to ensure appropriate adjustments.During the dosing procedure, transient episodes of bradycardia and/or oxygen desaturation have been reported. If these occur, dosing should be stopped and appropriate measures to alleviate the condition should be initiated. After stabilisation, the dosing procedure should be resumed.Survanta is stored refrigerated (2-8ºC). Before administration, Survanta 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 rewarming to room temperature. Vials should not be returned to the refrigerator once warmed.Each vial of Survanta is for single use only. Used vials with residual drug should be discarded.Survanta should be inspected visually for discolouration prior to administration. The colour of Survanta is off-white to light brown. Some settling may occur during storage. If this occurs, gently invert the vial several times (DO NOT SHAKE) to redisperse.

Adverse Reactions
Intracranial haemorrhage has been observed in patients who received either Survanta or placebo. The incidence of intracranial haemorrhage in all patients is similar to that reported in the literature in this patient population. Pulmonary haemorrhage has also been reported. No other serious adverse reactions have been reported. No antibody production to Survanta proteins has been observed. Blockage of the endotracheal tube by mucous secretions has been reported.

Manufacturer
Abbott

Drug Availability
(POM)

Updated
10 June 2009