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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 (beractant) 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 (beractant) 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)?
Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.
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:
- noisy breathing;
- feeding or bowel...
Read All Potential Side Effects and See Pictures of Survanta »
Survanta Patient Information Including Side Effects
Brand Names: Survanta Intratracheal
Generic Name: beractant (Pronunciation: ber AK tant)
- What is beractant (Survanta)?
- What are the possible side effects of beractant (Survanta)?
- What is the most important information I should know about beractant (Survanta)?
- What should I discuss with my health care provider before my child receives beractant (Survanta)?
- How is beractant given (Survanta)?
- What happens if my child misses a dose (Survanta)?
- What happens if my child receives an overdose (Survanta)?
- What should be avoided after my child receives beractant (Survanta)?
- What other drugs will affect beractant (Survanta)?
- Where can I get more information?
What is beractant (Survanta)?
Beractant is made from animal lung extract and contains fatty acids and proteins. It works by reducing the surface tension of fluids inside the human lung to keep the lung from collapsing.
Beractant is used to treat or prevent respiratory distress syndrome (RDS) in newborn infants.
Beractant may also be used for purposes other than those listed in this medication guide.
What are the possible side effects of beractant (Survanta)?
Get emergency medical help if your child has any of these signs of an allergic reaction: hives; difficulty breathing; swelling of the face, lips, tongue, or throat.
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:
- noisy breathing;
- feeding or bowel problems; or
- bleeding around the endotracheal tube.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the most important information I should know about beractant (Survanta)?
Beractant is given within minutes or hours after the infant is born. The medication must be given in a neonatal intensive care unit (NICU), a specialized setting for premature babies or newborns who need special care.
Your child will require special care in the hospital during treatment with beractant. Talk with your doctor about any special instructions for handling the infant and watching for side effects while beractant is given.
Follow your doctor's instructions about any restrictions on feeding or other medications after your child has been treated with beractant.
- Survanta