INDICATIONS AND USAGE
SURVANTA 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 15 minutes of birth.
RESCUE
To treat infants with RDS confirmed by x-ray and requiring mechanical ventilation, give SURVANTA as soon as possible, preferably by 8 hours of age.
DIRECTIONS FOR USE
SURVANTA should be inspected visually for discoloration prior to administration. The color of SURVANTA is off-white to light brown. If settling occurs during storage, swirl the vial gently (DO NOT SHAKE) to redisperse. Some foaming at the surface may occur during handling and is inherent in the nature of the product.
SURVANTA is stored refrigerated (2-8°C). Date and time need to be recorded in the box on front of the carton or vial, whenever SURVANTA is removed from the refrigerator. Before administration, SURVANTA should be warmed by standing at room temperature for at least 20 minutes or warmed in the hand for at least 8 minutes. ARTIFICIAL WARMING METHODS SHOULD NOT BE USED. If a prevention dose is to be given, preparation of SURVANTA should begin before the infant's birth.
Unopened, unused vials of SURVANTA that have been warmed to room temperature may be returned to the refrigerator within 24 hours of warming, and stored for future use. SURVANTA SHOULD NOT BE REMOVED FROM THE REFRIGERATOR FOR MORE THAN 24 HOURS. SURVANTA SHOULD NOT BE WARMED AND RETURNED TO THE REFRIGERATOR MORE THAN ONCE. Each single-use vial of SURVANTA should be entered only once. Used vials with residual drug should be discarded.
SURVANTA DOES NOT REQUIRE RECONSTITUTION OR SONICATION BEFORE USE.
DOSING PROCEDURES
General
SURVANTA is administered intratracheally by instillation through a 5 French end-hole catheter. The catheter can be inserted into the infant's endotracheal tube without interrupting ventilation by passing the catheter through a neonatal suction valve attached to the endotracheal tube. Alternatively, SURVANTA can be instilled through the catheter by briefly disconnecting the endotracheal tube from the ventilator.
The neonatal suction valve used for administering SURVANTA should be a type that allows entry of the catheter into the endotracheal tube without interrupting ventilation and also maintains a closed airway circuit system by sealing the valve around the catheter.
If the neonatal suction valve is used, the catheter should be rigid enough to pass easily into the endotracheal tube. A very soft and pliable catheter may twist or curl within the neonatal suction valve. The length of the catheter should be shortened so that the tip of the catheter protrudes just beyond the end of the endotracheal tube above the infant's carina. SURVANTA should not be instilled into a mainstem bronchus.
To ensure homogenous distribution of SURVANTA throughout the lungs, each dose is divided into four quarter-doses.
Each quarter-dose is administered with the infant in a different position. The recommended positions are:
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Head and body inclined 5-10° down, head turned to the right
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Head and body inclined 5-10° down, head turned to the left
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Head and body inclined 5-10° up, head turned to the right
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Head and body inclined 5-10° up, head turned to the left
The dosing procedure is facilitated if one person administers the dose while another person positions and monitors the infant.
FIRST DOSE
Determine the total dose of SURVANTA from the SURVANTA DOSING CHART based on the infant's birth weight. Slowly withdraw the entire contents of the vial into a plastic syringe through a large-gauge needle (eg, at least 20 gauge). DO NOT FILTER SURVANTA AND AVOID SHAKING.
Attach the premeasured 5 French end-hole catheter to the syringe. Fill the catheter with SURVANTA. Discard excess SURVANTA through the catheter so that only the total dose to be given remains in the syringe.
BEFORE ADMINISTERING SURVANTA, assure proper placement and patency of the endotracheal tube. At the discretion of the clinician, the endotracheal tube may be suctioned before administering SURVANTA. The infant should be allowed to stabilize before proceeding with dosing.
In the prevention strategy, weigh, intubate and stabilize the infant. Administer the dose as soon as possible after birth, preferably within 15 minutes. Position the infant appropriately and gently inject the first quarter-dose through the catheter over 2-3 seconds.
After administration of the first quarter-dose, remove the catheter from the endotracheal tube. Manually ventilate with a hand-bag with sufficient oxygen to prevent cyanosis, at a rate of 60 breaths/minute, and sufficient positive pressure to provide adequate air exchange and chest wall excursion.
In the rescue strategy, the first dose should be given as soon as possible after the infant is placed on a ventilator for management of RDS. In the clinical trials, immediately before instilling the first quarter-dose, the infant's ventilator settings were changed to rate 60/minute, inspiratory time 0.5 second, and FiO2 1.0.
Position the infant appropriately and gently inject the first quarter-dose through the catheter over 2-3 seconds. After administration of the first quarter-dose, remove the catheter from the endotracheal tube and continue mechanical ventilation.
In both strategies, ventilate the infant for at least 30 seconds or until stable. Reposition the infant for instillation of the next quarter-dose.
Instill the remaining quarter-doses using the same procedures. After instillation of each quarter-dose, remove the catheter and ventilate for at least 30 seconds or until the infant is stabilized. After instillation of the final quarter-dose, remove the catheter without flushing it. Do not suction the infant for 1 hour after dosing unless signs of significant airway obstruction occur.
AFTER COMPLETION OF THE DOSING PROCEDURE, RESUME USUAL VENTILATOR MANAGEMENT AND CLINICAL CARE.
REPEAT DOSES
The dosage of SURVANTA for repeat doses is also 100 mg phospholipids/kg and is based on the infant's birth weight. The infant should not be reweighed for determination of the SURVANTA dosage. Use the SURVANTA DOSING CHART to determine the total dosage.
The need for additional doses of SURVANTA is determined by evidence of continuing respiratory distress. Using the following criteria for redosing, significant reductions in mortality due to RDS were observed in the multiple-dose clinical trials with SURVANTA.
Dose no sooner than 6 hours after the preceding dose if the infant remains intubated and requires at least 30% inspired oxygen to maintain a PaO2 less than or equal to 80 torr.
Radiographic confirmation of RDS should be obtained before administering additional doses to those who received a prevention dose.
Prepare SURVANTA and position the infant for administration of each quarter-dose as previously described. After instillation of each quarter-dose, remove the dosing catheter from the endotracheal tube and ventilate the infant for at least 30 seconds or until stable.
In the clinical studies, ventilator settings used to administer repeat doses were different than those used for the first dose. For repeat doses, the FiO2 was increased by 0.20 or an amount sufficient to prevent cyanosis. The ventilator delivered a rate of 30/minute with an inspiratory time less than 1.0 second. If the infant's pretreatment rate was 30 or greater, it was left unchanged during SURVANTA instillation.
Manual hand-bag ventilation should not be used to administer repeat doses. DURING THE DOSING PROCEDURE, VENTILATOR SETTINGS MAY BE ADJUSTED AT THE DISCRETION OF THE CLINICIAN TO MAINTAIN APPROPRIATE OXYGENATION AND VENTILATION.
AFTER COMPLETION OF THE DOSING PROCEDURE, RESUME USUAL VENTILATOR MANAGEMENT AND CLINICAL CARE.
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