SURVANTA Frequently Asked Questions
Single-Entry Vials
Can more than one dose of SURVANTA be drawn out of a vial?
SURVANTA is supplied as a single-use vial, and does not contain antimicrobial preservatives. Therefore, the vial should not be entered more than once. Used vials with residual drug should be discarded.1
Color of SURVANTA
Is there anything wrong with the vials of drug we just received if the color is different from previously received drug?
The color of SURVANTA is off-white to light brown. There may be variations within this range from batch to batch. Each SURVANTA vial is visually inspected.1
Foaminess
Can a vial of SURVANTA still be used if it looks foamy when removed from the carton?
A small amount of foaming on the surface may occur during routine handling and is inherent to the product.1 Therefore, if the vial has not been shaken, it is acceptable to use the drug provided that the extent of foaming does not prohibit accurate dosing. A large amount of foaming may indicate that the vial has been shaken and the product should not be used.
Refrigeration of SURVANTA
How long can a vial of SURVANTA remain unrefrigerated before it should be discarded?
A vial may remain at room temperature continuously for a maximum of 24 hours. In order to ensure stability of the drug, vials left out of the refrigerator for longer than 24 hours should not be used and should be discarded. SURVANTA vials can be carried through one cycle of removal and exposure to room temperature for a maximum of 24 hours and subsequent return to the refrigerator. Once a vial is returned to room temperature a second time, it must be used within 24 hours or discarded.1
pH of SURVANTA
What is the pH range of SURVANTA?
The pH range of SURVANTA is 6.2 - 7.6.2
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SAFETY CONSIDERATIONS1
- SURVANTA is intended for intratracheal use only.
- SURVANTA can rapidly affect oxygenation and lung compliance. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management, and general care of premature infants. Infants receiving SURVANTA should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide.
- During the dosing procedure, transient episodes of bradycardia and decreased oxygen saturation have been reported. If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure.
- In controlled clinical trials, an increased probability of post-treatment nosocomial sepsis was observed in SURVANTA-treated infants, which was not associated with increased mortality among these infants.
INDICATION AND IMPORTANT SAFETY INFORMATION1
INDICATION
SURVANTA® (beractant) is indicated for prevention and treatment (“rescue”) of Respiratory Distress Syndrome (RDS) (hyaline membrane disease) in premature infants. SURVANTA significantly reduces the incidence of RDS, mortality due to RDS and air leak complications.
Prevention: In premature infants less than 1250 g birth weight or with evidence of surfactant deficiency, give SURVANTA as soon as possible, preferably within
Rescue: To treat infants with RDS confirmed by x-ray and requiring mechanical ventilation, give SURVANTA as soon as possible, preferably by 8 hours
IMPORTANT SAFETY INFORMATION
Warnings: SURVANTA is intended for intratracheal use only.
SURVANTA can rapidly affect oxygenation and lung compliance. Therefore, its use should be restricted to a highly supervised clinical setting with immediate availability of clinicians experienced with intubation, ventilator management, and general care of premature infants. Infants receiving SURVANTA should be frequently monitored with arterial or transcutaneous measurement of systemic oxygen and carbon dioxide.
During the dosing procedure, transient episodes of bradycardia and decreased oxygen saturation have been reported. If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure.
Precautions: Rales and moist breath sounds can occur transiently after administration. Endotracheal suctioning or other remedial action is not necessary unless
Use of SURVANTA in infants less than 600 g birth weight or greater than
Adverse Reactions: The most commonly reported adverse experiences were transient bradycardia and oxygen desaturation; both were associated with the dosing procedure.
Other reactions during the dosing procedure occurred with fewer than 1% of doses and included endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal tube blockage, hypertension, hypocarbia, hypercarbia, and apnea. No deaths occurred during the dosing procedure, and all reactions resolved with symptomatic treatment.
The occurrence of concurrent illnesses common in premature infants was evaluated in the controlled trials. The rates in all controlled studies are in the
| Concurrent event | SURVANTA (%) | Control (%) | P-valuea |
| Patent ductus arteriosus | 46.9 | 47.1 | 0.814 |
| Intracranial hemorrhage | 48.1 | 45.2 | 0.241 |
| Severe intracranial hemorrhage | 24.1 | 23.3 | 0.693 |
| Pulmonary air leaks | 10.9 | 24.7 | <0.001 |
| Pulmonary interstitial emphysema | 20.2 | 38.4 | <0.001 |
| Necrotizing enterocolitis | 6.1 | 5.3 | 0.427 |
| Apnea | 65.4 | 59.6 | 0.283 |
| Severe apnea | 46.1 | 42.5 | 0.114 |
| Post-treatment sepsis | 20.7 | 16.1 | 0.019 |
| Post-treatment infection | 10.2 | 9.1 | 0.345 |
| Pulmonary hemorrhage | 7.2 | 5.3 | 0.166 |
aP-value comparing groups in controlled studies.
References:
2034288-1901412