A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Infasurf Warnings, Precautions, Pregnancy, Nursing, Abuse - Calfactant
Infasurf Warnings, Precautions, Pregnancy, Nursing, Abuse - Calfactant
WARNINGS
Infasurf is intended for intratracheal
use only.
THE ADMINISTRATION OF EXOGENOUS SURFACTANTS, INCLUDING INFASURF, OFTEN
RAPIDLY IMPROVES OXYGENATION AND LUNG COMPLIANCE. Following administration
of Infasurf, patients should be carefully monitored so that oxygen
therapy and ventilatory support
can be modified in response
to changes in respiratory status.
Infasurf therapy is not a
substitute for neonatal
intensive care. Optimal
care of premature infants
at risk for RDS
and newborn infants with RDS
who need endotracheal intubation
requires an acute care unit
organized, staffed, equipped, and experienced with intubation,
ventilator management,
and general care of these patients.
TRANSIENT EPISODES OF REFLUX OF INFASURF INTO THE ENDOTRACHEAL TUBE,
CYANOSIS, BRADYCARDIA, OR AIRWAY
OBSTRUCTION HAVE OCCURRED DURING THE DOSING PROCEDURES. These events require
stopping Infasurf administration
and taking appropriate measures to alleviate
the condition. After the patient
is stable, dosing can proceed with appropriate
monitoring.
PRECAUTIONS
When repeat dosing was given at fixed 12-hour intervals in the Infasurf
vs Exosurf Neonatal® trials, transient
episodes of cyanosis, bradycardia,
reflux of surfactant into
the endotracheal tube, and airway
obstruction were observed more frequently among infants in the Infasurf-treated
group.
An increased proportion of patients with both intraventricular
hemorrhage (IVH) and periventricular leukomalacia (PVL) was observed in
Infasurf-treated infants in the Infasurf-Exosurf Neonatal® controlled
trials. These observations were not associated with increased mortality.
No data are available on the use of Infasurf in conjunction with experimental
therapies of RDS, e.g., high-frequency ventilation. Data from controlled
trials on the efficacy of
Infasurf are limited to doses of approximately 100 mg
phospholipid/kg body weight
and up to a total of 4 doses.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenesis studies and animal
reproduction studies
have not been performed with Infasurf. A single mutagenicity study (Ames
assay) was negative.
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