"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
(beractant) Intratracheal Suspension
For Intratracheal Administration Only
SURVANTA ® (beractant) Intratracheal Suspension is a sterile, non-pyrogenic pulmonary surfactant intended for intratracheal use only. It is a natural bovine lung extract containing phospholipids, neutral lipids, fatty acids, and surfactant-associated proteins to which colfosceril palmitate (dipalmitoylphosphatidylcholine), palmitic acid, and tripalmitin are added to standardize the composition and to mimic surface-tension lowering properties of natural lung surfactant. The resulting composition provides 25 mg/mL phospholipids (including 11.0-15.5 mg/mL disaturated phosphatidylcholine), 0.5-1.75 mg/mL triglycerides, 1.4-3.5 mg/mL free fatty acids, and less than 1.0 mg/mL protein. It is suspended in 0.9% sodium chloride solution, and heat-sterilized. SURVANTA contains no preservatives. Its protein content consists of two hydrophobic, low molecular weight, surfactant-associated proteins commonly known as SP-B and SP-C. It does not contain the hydrophilic, large molecular weight surfactant-associated protein known as SP-A.
Each mL of SURVANTA contains 25 mg of phospholipids. It is an off-white to light brown liquid supplied in single-use glass vials containing 4 mL (100 mg phospholipids) or 8 mL (200 mg phospholipids).
What are the possible side effects of beractant (Survanta Intratracheal)?
There is a possibility that the baby will have breathing difficulties during the beractant treatment, and these problems may require further treatment by health care professionals. Your baby will remain under constant supervision during treatment with beractant.
Tell your child's caregivers at once if the child has any of these serious side effects:
- pale skin;
- slow heartbeat;
- breathing that stops;
- urinating less than usual; or
- blood in the urine.
Less serious side effects include:
Last reviewed on RxList: 4/25/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Survanta Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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