What Survanta is used for and how to use it
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Survanta - Consumer Medicine Information

Manufacture: AbbVie
Country: Canada
Condition: Respiratory Distress Syndrome
Class: Lung surfactants
Form: Syrup
Ingredients: beractant, proteins, sodium chloride

SURVANTA

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.

Usual dose

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.

Overdose

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 toll-free telephone: 866-234-2345
By toll-free fax: 866-678-6789
Online: www.healthcanada.gc.ca/medeffect
By email: CanadaVigilance@hc-sc.gc.ca

By regular mail:
Canada Vigilance National Office
Marketed Health Products Safety and
Effectiveness Information Bureau
Marketed Health Products Directorate
Health Products and Food Branch
Health Canada
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.

More Information

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.