survanta 25mg beractant intratracheal suspension

Survanta is a prescription medicine used to treat the symptoms of Respiratory Distress Syndrome (RDS) in premature babies. Survanta may be used alone or with other medications.

Survanta belongs to a class of drugs called Lung Surfactants.

Survanta may cause serious side effects including:

• pale skin,
• slow heartbeat,
• breathing that stops,
• urinating less than usual, and
• blood in the urine

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Survanta include:

• noisy breathing,
• feeding or bowel problems, and
• bleeding around the endotracheal tube

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Survanta. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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, surfactantassociated 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.