Patient Medication Information: uses, side effects, how to take - Neosurf
ABOUT THIS MEDICATION
What the medication is used for:
NEOSURF is used to treat or “rescue” premature babies
with Respiratory Distress Syndrome (RDS). What it does:
NEOSURF is an extract of a natural substance (lung surfactant) necessary for effective breathing. Babies with RDS who lack their own surfactant may have trouble receiving enough oxygen when they breathe. NEOSURF spreads through the lungs, allowing the lungs to expand properly and oxygen to enter the blood more easily. This will lower the baby’s need for extra oxygen under pressure.
When it should not be used:
Health professionals will monitor the baby to make sure that NEOSURF is not given at the same time the infant’s lungs may be bleeding.
What the medicinal ingredient is:
Bovine lipid extract surfactant contains natural fats and proteins found in cow lung surfactant.
What the important nonmedicinal ingredients are: The nonmedicinal ingredients are water with a small amount of salts. For a full listing of nonmedicinal ingredients, see Part I of the product monograph.
What dosage forms it comes in:
NEOSURF is a suspension that contains 27 milligrams of phospholipids and 0.2 to 0.5 milligrams of surfactant proteins SP-B and SP-C per milliliter.
WARNINGS AND PRECAUTIONS
Serious Warnings and Precautions
- NEOSURF should only be given by health professionals experienced in treating premature babies with Neonatal 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 interactions between NEOSURF and other drugs.
PROPER USE OF THIS MEDICATION
Usual dose:
For each kilogram of birth weight, the baby may receive 135 milligrams of phospholipid. If more than one dose is needed, the dose may be repeated up to three times within the first five days of life.
Overdose:
There is no record of an overdose having been given. Although it is possible that too much NEOSURF could block the baby’s airway, it can be removed by suction.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
NEOSURF is given to babies within several hours of birth by health professionals who will monitor the baby for any side effects. Because the baby’s breathing will be interrupted during dosing, your baby may require more oxygen for a short while. Your baby will receive surfactant as soon as possible after birth. Complications that develop may be due to your baby’s immaturity rather than this treatment. If you should have any concerns or questions about the baby’s condition after a dose, consult with the health professionals who are monitoring the baby.
REPORTING SUSPECTED SIDE EFFECTS You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
- Report online at www.healthcanada.gc.ca/medeffect;
- Call toll-free at 1-866-234-2345;
- Complete a Canada Vigilance Reporting Form; and
- Fax toll-free to 1-866-678-6789, or
Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701D Ottawa, Ontario K1A 0K9 Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at
www.healthcanada.gc.ca/medeffect.
NOTE: Should you require information related to the management of side effects, contact your health professional. 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 Canadian distributor, BLES Biochemicals Inc., at 1-519-457-2537 or at bles@wwdc.com.
This leaflet was prepared for Cipla Ltd. by
BLES Biochemicals Inc.
60 Pacific Court, Unit 8, London, Ontario, Canada N5V 3K4 Last revised: March 2012