Loading…
SURVANTA is a brand name for Beractant, supplied as a suspension. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SURVANTA (beractant, intratracheal suspension) is indicated for: • Prevention (prophylaxis) and • Treatment (rescue) of Respiratory Distress Syndrome (RDS/Hyaline Membrane Disease) in premature infants Prevention For prophylactic treatment of infants at risk of developing RDS or who have evidence of pulmonary…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations For Intratracheal Administration Only SURVANTA should be administered by or under the supervision of health professionals experienced in intubation, ventilator management, and general care of premature infants.
During the dosing procedure, transient episodes of bradycardia and decreased oxygen saturation have been reported (see 8 ADVERSE REACTIONS). If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition.
After stabilization, resume the dosing procedure. Marked improvements in oxygenation may occur within minutes of administration of SURVANTA. Therefore, frequent and careful clinical observation and monitoring of systemic oxygenation are essential to avoid hyperoxia.
Review of audiovisual instructional materials describing dosage and administration procedures is recommended before using SURVANTA. Materials are available upon request. 2 Recommended Dose and Dosage Adjustment No information is available on the effects of doses other than 100 mg phospholipids/kg, more than 4 doses, dosing more frequently than every 6 hours, or administration after 48 hours of age.
Each dose of SURVANTA is 100 mg of phospholipids/kg birth weight (4 mL/kg). The SURVANTA Dosing Chart (Table 1) shows the total dosage for a range of birth weights. 0* * suggested dosages based on limited clinical experience in uncontrolled trials Four doses of SURVANTA can be administered in the first 48 hours of life.
Doses should be given no more frequently than every 6 hours. 3 Reconstitution Not applicable. 4 Administration Directions for Use SURVANTA should be inspected visually for discolouration prior to administration. The colour of SURVANTA is off-white to light brown opaque.
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 to the nature of the product. SURVANTA does not require sonication before use.
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 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. : 247544 Page 7 of 34 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.
). If these occur, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After stabilization, resume the dosing procedure. Marked improvements in oxygenation may occur within minutes of administration of SURVANTA.
Therefore, frequent and careful clinical observation and monitoring of systemic oxygenation are essential to avoid hyperoxia. Review of audiovisual instructional materials describing dosage and administration procedures is recommended before using SURVANTA.
Materials are available upon request. 2 Recommended Dose and Dosage Adjustment No information is available on the effects of doses other than 100 mg phospholipids/kg, more than 4 doses, dosing more frequently than every 6 hours, or administration after 48 hours of age.
Each dose of SURVANTA is 100 mg of phospholipids/kg birth weight (4 mL/kg). The SURVANTA Dosing Chart (Table 1) shows the total dosage for a range of birth weights. 0* * suggested dosages based on limited clinical experience in uncontrolled trials Four doses of SURVANTA can be administered in the first 48 hours of life.
Doses should be given no more frequently than every 6 hours. 3 Reconstitution Not applicable. 4 Administration Directions for Use SURVANTA should be inspected visually for discolouration prior to administration. The colour of SURVANTA is off-white to light brown opaque.
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 to the nature of the product. SURVANTA does not require sonication before use.
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 8 minutes. Artificial warming methods should not be used.
Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. : 247544 Page 13 of 34 General SURVANTA is intended for intratracheal use only (see 4 DOSAGE AND ADMINISTRATION). No information is available on the effects of doses other than 100 mg phospholipids/kg, more than 4 doses, dosing more frequently than every 6 hours, or administration after 48 hours of age.
Usage of SURVANTA should be restricted to a highly supervised clinical setting with immediate availability of health professionals experienced with intubation, ventilator management, and general care of premature infants. Vigilant clinical attention should be given to all infants prior to, during, and after administration of SURVANTA.
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 (see
There are no known contraindications to treatment with SURVANTA. : 247544 Page 5 of 34
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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. Dosing Procedures General SURVANTA is administered intratracheally.
It can be instilled through a 5 French end-hole catheter inserted into the infant's endotracheal tube by briefly disconnecting the endotracheal tube from the ventilator OR by inserting the catheter through a neonatal suction valve without disconnecting the endotracheal tube from the ventilator or by instillation through the secondary lumen of a double lumen endotracheal tube.
If the drug is instilled through an end-hole catheter, 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.
To ensure homogenous distribution of SURVANTA throughout the lungs, each dose is divided into fractional doses. Each dose can be administered in 2 half-doses or in 4 quarter-doses. Each fractional dose is administered with the infant in a different position.
: 247544 Page 8 of 34 The dosing procedure is facilitated if one person administers the dose while another person positions and monitors the infant. The different methods of administering SURVANTA were evaluated in clinical trials. In the 6 single-dose and 4 multiple-dose controlled clinical trials that established safety and efficacy, SURVANTA was instilled through a catheter that was inserted into the infant's endotracheal tube by briefly disconnecting the endotracheal tube from the ventilator.
Each dose was administered in 4 quarter- doses as described above. This method of administering SURVANTA was compared to 2 other methods in a multi-centre, randomized clinical study involving 299 infants weighing 600 g or more with RDS requiring mechanical ventilation.
The other methods evaluated were: • Two half-doses administered […]
If a prevention dose is to be given, preparation of SURVANTA should begin before the infant's birth. : 247544 Page 7 of 34 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. Dosing Procedures General SURVANTA is administered intratracheally.
It can be instilled through a 5 French end-hole catheter inserted into the infant's endotracheal tube by briefly disconnecting the endotracheal tube from the ventilator OR by inserting the catheter through a neonatal suction valve without disconnecting the endotracheal tube from the ventilator or by instillation through the secondary lumen of a double lumen endotracheal tube.
If the drug is instilled through an end-hole catheter, 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.
To ensure homogenous distribution of SURVANTA throughout the lungs, each dose is divided into fractional doses. Each dose can be administered in 2 half-doses or in 4 quarter-doses. Each fractional dose is administered with the infant in a different position.
: 247544 Page 8 of 34 The dosing procedure is facilitated if one person administers the dose while another person positions and monitors the infant. The different methods of administering SURVANTA were evaluated in clinical trials. In the 6 single-dose and 4 multiple-dose controlled clinical trials that established safety and efficacy, SURVANTA was instilled through a catheter that was inserted into the infant's endotracheal tube by briefly disconnecting the endotracheal tube from the ventilator.
Each dose was administered in 4 quarter- doses as described above. This method of administering SURVANTA was compared to 2 other methods in a multi-centre, randomized clinical study involving 299 infants weighing 600 g or more with RDS requiring mechanical ventilation.
The other methods evaluated were: • Two half-doses administered by inserting the catheter through the endotracheal tube while the endotracheal tube was briefly disconnected from the ventilator. The half-doses were administered in the 2 positions described above.
• Two half-doses administered without disconnecting the endotracheal tube from the ventilator by inserting the catheter through a neonatal suction valve into the endotracheal […]