Survanta - Consumer Medicine Information
|Condition:||Respiratory Distress Syndrome|
|Ingredients:||beractant, proteins, sodium chloride|
beractant, intratracheal suspension
About this Medication
What the medication is used for
SURVANTA is used to prevent and to treat Respiratory Distress Syndrome (also called Hyaline Membrane Disease) in premature infants. Respiratory Distress Syndrome is a breathing problem that affects premature babies whose lungs are not developed enough to make surfactant (a liquid that coats the inside of the lungs). Without surfactant, the lungs would not expand adequately and the baby might not be able to breathe in enough oxygen.
What it does
When infants are born at full-term, their lungs contain an adequate amount of a substance called pulmonary surfactant that lowers the surface tension in the lung alveoli (the air sacs in the lungs where oxygen is exchanged) and prevents alveolar collapse during breathing. Premature infants may lack adequate amounts of pulmonary surfactant, which can result in Respiratory Distress Syndrome (RDS), a condition that makes breathing difficult.
SURVANTA is a natural bovine lung extract containing a mixture of substances which mimic the surface-tension lowering properties of natural lung surfactant. When administered into the trachea soon after birth or early in the premature infant's life, SURVANTA spreads throughout the lungs, allowing the alveoli to expand and remain open for proper oxygen exchange at the alveolar level.
When it should not be used
There are no known contraindications to treatment with SURVANTA.
What the ingredients are
SURVANTA is composed of different types of lipids (including phosphatidylcholine and other phospholipids, triglycerides, and free fatty acids), proteins, and sodium chloride.
What dosage forms it comes in
SURVANTA is available in a 4 mL vial (100 mg strength) and an 8 mL vial (200 mg strength).
Warnings and Precautions
Serious Warnings and Precautions
- SURVANTA should only be given by Health Professionals experienced in treating premature babies with Respiratory Distress Syndrome.
- During and after receiving a dose, the baby will need to be monitored closely for any clinical changes.
Interactions with this Medication
There are no known drug interactions with SURVANTA.
Proper Use of this Medication
SURVANTA is administered by or under the supervision of clinicians experienced in intubation, ventilator management, and general care of premature infants.
The dose of SURVANTA is based on the infant’s birth weight (100 mg/kg birth weight). 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.
Overdosage with SURVANTA has not been reported.
Side Effects and what to Do about them
Most side effects occur during the dosing procedure. Common side effects include slow heartbeat and decreased oxygen in the blood. Less common side effects include paleness, low blood pressure, high blood pressure, decreased carbon dioxide in the blood, increased carbon dioxide in the blood, and temporary suspension of breathing. All of these side effects can be treated.
How to Store it
Vials are stored at 2-8ºC, protected from light.
Reporting Suspected Side Effects
To monitor drug safety, Health Canada through the Canada Vigilance Program collects information on serious and unexpected side effects of drugs. If you suspect you have had serious or unexpected reaction to this drug you may notify Canada Vigilance:
By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and
Effectiveness Information Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9
NOTE: Should you require information related to the management of the side effect, please contact your health care provider before notifying Canada Vigilance. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, AbbVie Corporation at 1-800-699-9948.