INFASURF®
is a medication used to treat respiratory distress syndrome (RDS),
a lung condition that can occur in prematurely born infants whose
lungs have not completely developed.
INFASURF®
treats and prevents RDS. RDS occurs when infants lack surfactant,
a natural substance normally produced in the body, which is necessary
for lungs to function normally. INFASURF®
is used exclusively in hospitals with a neonatal intensive care
unit (NICU) and is administered by neonatologists, neonatal nurses,
neonatal nurse practitioners and respiratory therapists. INFASURF®
has been used in over 100,000 infants.
Administration
of exogenous surfactants, including INFASURF®,
often rapidly improve oxygenation and lung compliance. Following
INFASURF®
administration, patients should be monitored so that oxygen and
ventilatory support can be modified. During dosing with INFASURF®,
the most common adverse reactions reported in clinical trials were
cyanosis (65%), airway obstruction (39%), bradycardia (34%), and
ETT reflux (21%). These events were generally transient, and not
associated with serious complications. If any of these events occur,
administration should be interrupted and the infant's condition
stabilized.
COUNTRY
RESIDENCY NOTICE
The above information is intended for use only by residents of Turkey,
Serbia, Bosnia, Macedonia, Albania, Egypt and Syria. Countries outside
of those mentioned above may have regulatory requirements or medical
practices that are different and may require reference to different
or additional information. Therefore, this information may not be
appropriate outside of those countries listed above.
Infasurf
is an approved FDA prescription product owned by ONY, Inc. and marketed
by Forest Labs in the US.
Currently, Samaritan
Pharmaceuticals is utilizing the US FDA approved regulatory file
in preparing marketing applications for Infasurf with regulatory
authorities in Turkey, Serbia, Bosnia, F.Y.R.O.M., Albania, Egypt
and Syria to gain country marketing authorization drug approval.
This
Web site is intended and designed specifically for healthcare professionals
from Turkey, Serbia, Bosnia, F.Y.R.O.M., Albania, Egypt, and Syria
only. If you are a healthcare professional practicing your profession
in a country other than those mentioned above, please visit http://www.frx.com/
to find information about Infasurf® outside of the countries
listed above. |