Survanta Dosage/Direction for Use

Important Administration Instructions: FOR INTRATRACHEAL ADMINISTRATION ONLY.
SURVANTA should be administered by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants. The dosing procedure is facilitated if one person administers the dose while another person positions and monitors the infant.
Dosage: Each dose of SURVANTA is 100 mg of phospholipids/kg birth weight (4 ml/kg).
In the prevention strategy, administer the dose as soon as possible after birth, preferably within 15 minutes.
In the rescue strategy, the first dose should be given as soon as possible after RDS is confirmed by radiographic or clinical findings, preferably by eight hours of age.
Four doses of SURVANTA can be administered in the first 48 hours of life. Doses should be given no more frequently than every six hours.
The need for additional doses of SURVANTA is determined by evidence of continuing respiratory distress. Radiographic confirmation of RDS should be obtained before administering additional doses to those who received a prevention dose.
Preparation of the SURVANTA Suspension: SURVANTA should be inspected visually for discoloration prior to administration. The colour of SURVANTA is off-white to light brown.
If settling occurs during storage, swirl the vial gently (DO NOT SHAKE) to redisperse. Do not filter SURVANTA. Some foaming at the surface may occur during handling and is inherent in the nature of the product.
SURVANTA is stored refrigerated (2 to 8°C). Before administration, SURVANTA should be warmed by standing at room temperature for at least 20 minutes or warmed in the hand for at least eight 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 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.
General Dosing Procedures: Based on the selected procedure, each dose is either given as a single bolus or is divided into fractional doses.
Each fractional dose can be administered in two half-doses or in four quarter-doses with the infant in a different position.
To administer SURVANTA in two half-doses, the recommended positions are: Head and body turned approximately 45° to the right.
Head and body turned approximately 45° to the left.
To administer SURVANTA in four quarter-doses, the recommended positions are: Head and body inclined 5-10° down, head turned to the right.
Head and body inclined 5-10° down, head turned to the left.
Head and body inclined 5-10° up, head turned to the right.
Head and body inclined 5-10° up, head turned to the left.
The positions for four quarter-doses are stated as follows: 1. Infant's head and body inclined down, head turned to the right.
2. Head and body inclined down, head turned to the left.
3. Head and body inclined up, head turned to the right.
4. Head and body inclined up. head turned to the left.
Administration: Instillation Through End-Hole Catheter in Mechanically Ventilated Patients: Slowly withdraw the entire contents of the vial into a plastic syringe through a large-gauge needle (e.g., at least 20 gauge).
Attach the pre-measured 5 French end-hole catheter to the syringe. Fill the catheter with SURVANTA. Discard excess beractant through the catheter so 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.
Position the infant appropriately in one of the recommended positions.
Insert the 5 French end-hole catheter into the endotracheal tube. The length of the catheter should be shortened so that the tip of the catheter protrudes just beyond the endotracheal tube above the infant's carina. SURVANTA should not be instilled into a mainstem bronchus.
Gently inject the first fractional dose through the catheter over two to three seconds.
After administration of the first fractional dose, remove the catheter from the endotracheal tube and manually ventilate the infant for 30 seconds or until clinically stable. Ventilate with sufficient oxygen to prevent cyanosis and sufficient positive pressure to provide adequate air exchange and chest wall excursion.
When the infant is stable, reposition the infant for instillation of the next fractional dose.
Instill the remaining fractional doses using the same procedures.
After instillation of the final fractional dose, remove the catheter without flushing it. Do not suction the infant for one hour after dosing unless signs of significant airway obstruction occur.
Instillation Through Secondary Lumen of a Double-Lumen Endotracheal Tube in Mechanically Ventilated Patients: Ensure the infant is intubated with the appropriate size double-lumen endotracheal tube. Slowly withdraw the total dose from the vial into a plastic syringe through a large-gauge needle (e.g., at least 20 gauge).
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.
Attach the syringe containing SURVANTA to the secondary lumen. Position the infant appropriately in one of the recommended positions and gently inject the first fractional dose through the secondary lumen over two to three seconds without interrupting ventilation. If manually ventilated, ventilate the infant for at least 30 seconds or until stable. Ventilate with sufficient oxygen to prevent cyanosis and sufficient positive pressure to provide adequate air exchange and chest wall excursion.
Reposition the infant for instillation of the next fractional dose.
Instill the remaining fractional doses using the same procedures.
After instillation of the final fractional dose, remove the syringe from the secondary lumen, inject 0.5 mL of air to flush the secondary lumen and cap it.
Instillation in Spontaneously Breathing Patients: Intubation Surfactant Extubation (INSURE): Following intubation and catheterization as described previously, place the infant in a neutral position and gently inject the dose as a single bolus over 1 to 3 minutes in the delivery room or later after admission to the neonatal unit. After instillation, use a bagging technique and proceed to extubation and CPAP as clinically indicated.
Less Invasive Surfactant Administration (LISA): A small diameter catheter may be used to administer the dose without intubation. In such cases, place the catheter directly into the trachea with visualization of the vocal cords by laryngoscopy and gently inject the dose as a single bolus over 1 to 3 minutes. After instillation, immediately remove the catheter. Ensure continuous spontaneous breathing and continue CPAP treatment during the entire procedure.