Paediatric Population
If 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.
18 months
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 warming to room temperature. Vials should not be returned to the refrigerator once warmed.
None experienced to date, as product administration is unique.
Sodium chloride
Palmitic acid
Dipalmitoyl Phosphatidylcholine
Tripalmitin
Sodium Hydroxide (for pH adjustment)
Hydrochloric acid (for pH adjustment)
Water for injection
Paediatric population
Summary of the safety profile
Intracranial 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 |
| Respiratory | Common | Pulmonary haemorrhage |
| Surgical and Medical Procedures | Uncommon | Blockage of endotracheal tube by mucous secretions |
The following frequency categories are used: Very common (>1/10); common (>1/100, <1/10); uncommon (>1/1,000, <1/100).
No antibody production to Survanta proteins has been observed.
Reporting of suspected adverse reactions
Reporting 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
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
Pharmacotherapeutic group: Lung Surfactant
ATC Code R07AA02
The mode of action of Survanta is biophysical rather than biochemical, i.e. it reduces surface tension and concomitantly increases lung compliance.
Intratracheally administered Survanta distributes rapidly to the alveolar surfaces and stabilises the alveoli against collapse during respiration thereby increasing alveolar ventilation.
In clinical studies of premature infants with Respiratory Distress Syndrome (RDS), a significant improvement in oxygenation was demonstrated after treatment with a single dose of Survanta.
These infants showed a decreased need for supplemental oxygen and an increase in the arterial/alveolar oxygen ratio (a/Ap02). Significantly decreased need for respiratory support, as indicated by a lower mean airway pressure, was also observed. In most cases these effects were maintained for at least 72 hours after the administration of the single dose of Survanta.
In preclinical studies using radiolabelled phosphatidylcholine, the clearance rate of Survanta in the lung of three day old rabbits has been shown to be similar to that of natural calf and sheep surfactants (approximately 13% within 24 hours). In addition some re-uptake and secretion of Survanta was shown, implying its entry into a metabolically active surfactant pool.
Since an exogenous preparation of Survanta is delivered directly to the lung, classical clinical pharmocokinetic parameters (blood levels, plasma half-life etc.) have not been studied.
30 October 2015
AbbVie Ltd.
Maidenhead,
SL6 4UB
UK
Store under refrigerated conditions (2-8°C) protected from light. Do not freeze. Any inadvertently frozen product should be discarded.
21ml glass bottle with a 20mm rubber stopper and a 20mm aluminium seal finish containing 8ml of product.
Pack sizes: 1, 3 and 10
PL 41042/0003
Not applicable.
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.
Not relevant.
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.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
13th October 1998
No interaction studies have been performed.
