Summary of Product Characteristics Updated 06-Nov-2015 | AbbVie Ltd
|(including disaturated phosphatidylcholines 11.0 - 15.5 mg/ml)|
|Triglycerides Free Fatty Acids Protein||0.5 - 1.75 mg/ml 1.4 - 3.5 mg/ml 0.1 - 1.0 mg/ml|
Paediatric population100 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 AdministrationSurvanta 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 Fi02 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 15°).Left Lateral Position with the head lowered (i.e. head and body slanting down at an angle of approximately 15°).Right Lateral Position with head elevated (i.e. head and body slanting up at an angle of approximately 15°).Left Lateral Position with head elevated (i.e. head and body slanting up at an angle of approximately 15°).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° to the right.• With infant supine, the head and body turned approximately 45° 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.
Dosage in AdultsNot applicable.
Dosage in Older PeopleNot applicable.
Summary of the safety profileIntracranial haemorrhage has been observed in patients who received either beractant 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. Blockage of the endotracheal tube by mucous secretions has been reported. No other serious adverse reactions have been reported. These are presented in the following table:
|System Organ Class||Frequency||Adverse Reactions|
|Vascular disorders||Very common||Intracranial haemorrhage|
|Surgical and Medical Procedures||Uncommon||Blockage of endotracheal tube by mucous secretions|
Reporting of suspected adverse reactionsReporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme: Website: www.mhra.gov.uk/yellowcard
Paediatric PopulationIf an excessively large dose of Survanta is given, observe the infant for signs of acute airway obstruction. Treatment should be symptomatic and supportive. Rales and moist breath sounds can transiently occur after Survanta is given, and do not indicate overdosage. Endotracheal suction or other remedial action is not required unless clear-cut signs of airway obstruction are present.
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