Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1965
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SURVANTA (Suspension)
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For intratracheal administration
only. SURVANTA should
be administered by or under the supervision of clinicians experienced
in intubation, ventilator management, and general care of premature
infants. Marked improvements
in oxygenation may occur within minutes of administration of SURVANTA.
Therefore, frequent and careful clinical observation and monitoring
of systemic oxygenation are essential to avoid hyperoxia. Review of audiovisual instructional
materials describing dosage and administration procedures is recommended
before using SURVANTA. Materials are available upon request from Abbott
Nutrition.<br/>Dosage: Each dose of SURVANTA
is 100 mg of phospholipids/kg birth weight (4 mL/kg). The SURVANTA
Dosing Chart shows the total dosage for a range of birth weights. Four doses of
SURVANTA can be administered in the first 48 hours of life. Doses
should be given no more frequently than every 6 hours.<br/>Directions for Use: SURVANTA should
be inspected visually for discoloration prior to administration.
The color of SURVANTA is off-white to light brown. If settling occurs
during storage, swirl the vial gently (DO NOT SHAKE) to redisperse.
Some foaming at the surface may occur during handling and is inherent
in the nature of the product. SURVANTA is stored refrigerated (2-8��C). Date and time need
to be recorded in the box on front of the carton or vial, whenever
SURVANTA is removed from the refrigerator. Before administration,
SURVANTA should be warmed by standing at room temperature for at least
20 minutes or warmed in the hand for at least 8 minutes. Artificial
warming methods should not be used. If a prevention dose is to be
given, preparation of SURVANTA should begin before the infant's
birth. Unopened,
unused vials of SURVANTA that have been warmed to room temperature
may be returned to the refrigerator within 24 hours of warming, and
stored for future use. SURVANTA SHOULD NOT BE REMOVED FROM THE REFRIGERATOR
FOR MORE THAN 24 HOURS. SURVANTA SHOULD NOT BE WARMED AND RETURNED
TO THE REFRIGERATOR MORE THAN ONCE. Each single-use vial of SURVANTA
should be entered only once. Used vials with residual drug should
be discarded. SURVANTA does not require reconstitution or sonication before use.
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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 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 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).
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Endogenous pulmonary surfactant
lowers surface tension on alveolar surfaces during respiration and
stabilizes the alveoli against collapse at resting transpulmonary
pressures. Deficiency of pulmonary surfactant causes Respiratory
Distress Syndrome (RDS) in premature infants. SURVANTA replenishes
surfactant and restores surface activity to the lungs of these infants.<br/>Activity: In vitro, SURVANTA reproducibly lowers
minimum surface tension to less than 8 dynes/cm as measured by the
pulsating bubble surfactometer and Wilhelmy Surface Balance. In situ, SURVANTA restores pulmonary
compliance to excised rat lungs artificially made surfactant-deficient.
In vivo, single SURVANTA doses
improve lung pressure-volume measurements, lung compliance, and oxygenation
in premature rabbits and sheep.<br/>Animal Metabolism: SURVANTA is administered
directly to the target organ, the lungs, where biophysical effects
occur at the alveolar surface. In surfactant-deficient premature rabbits
and lambs, alveolar clearance of radio-labelled lipid components of
SURVANTA is rapid. Most of the dose becomes lung-associated within
hours of administration, and the lipids enter endogenous surfactant
pathways of reutilization and recycling. In surfactant-sufficient
adult animals, SURVANTA clearance is more rapid than in premature
and young animals. There is less reutilization and recycling of surfactant
in adult animals. Limited animal experiments have not found effects of SURVANTA on
endogenous surfactant metabolism. Precursor incorporation and subsequent
secretion of saturated phosphatidylcholine in premature sheep are
not changed by SURVANTA treatments. No information is available about the metabolic
fate of the surfactant-associated proteins in SURVANTA. The metabolic
disposition in humans has not been studied.
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None known.
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| dailymed-instance:supply |
SURVANTA (beractant) Intratracheal
Suspension is supplied in single-use glass vials containing 4 mL (NDC
0074-1040-04) or 8 mL of SURVANTA (NDC 0074-1040-08). Each milliliter
contains 25 mg of phospholipids suspended in 0.9% sodium chloride
solution. The color is off-white to light brown. Store unopened vials at refrigeration temperature (2-8��C).
Protect from light. Store vials in carton until ready for use. Vials
are for single use only. Upon opening, discard unused drug. May, 2008 LITHO IN USA Manufactured by: Hospira, Inc. Lake Forest , Illinois 60045
USA For: Abbott Nutrition Abbott Laboratories Columbus, Ohio 43215-1724 USA
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Overdosage with SURVANTA
has not been reported. Based on animal data, overdosage might result
in acute airway obstruction. Treatment should be symptomatic and
supportive. Rales and
moist breath sounds can transiently occur after SURVANTA is given,
and do not indicate overdosage. Endotracheal suctioning or other remedial
action is not required unless clear-cut signs of airway obstruction
are present.
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beractant
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SURVANTA (Suspension)
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The most commonly reported
adverse experiences were associated with the dosing procedure. In
the multiple-dose controlled clinical trials, each dose of SURVANTA
was divided into four quarter-doses which were instilled through a
catheter inserted into the endotracheal tube by briefly disconnecting
the endotracheal tube from the ventilator. Transient bradycardia occurred
with 11.9% of doses. Oxygen
desaturation occurred with 9.8% of doses. Other reactions during
the dosing procedure occurred with fewer than 1% of doses and included
endotracheal tube reflux, pallor, vasoconstriction, hypotension, endotracheal
tube blockage, hypertension, hypocarbia, hypercarbia, and apnea.
No deaths occurred during the dosing procedure, and all reactions
resolved with symptomatic treatment. The occurrence of concurrent illnesses common in premature infants
was evaluated in the controlled trials. The rates in all controlled
studies are in Table 3. When all controlled studies
were pooled, there was no difference in intracranial hemorrhage.
However, in one of the single-dose rescue studies and one of the multiple-dose
prevention studies, the rate of intracranial hemorrhage was significantly
higher in SURVANTA patients than control patients (63.3% v 30.8%, P = 0.001; and 48.8% v 34.2%, P = 0.047, respectively).
The rate in a Treatment IND involving approximately 8100 infants
was lower than in the controlled trials. In the controlled clinical trials, there was no effect of SURVANTA
on results of common laboratory tests: white blood cell count and
serum sodium, potassium, bilirubin, and creatinine. More than 4300 pretreatment and post-treatment serum samples from
approximately 1500 patients were tested by Western Blot Immunoassay
for antibodies to surfactant-associated proteins SP-B and SP-C. No
IgG or IgM antibodies were detected. Several other complications are known to occur in premature infants.
The following conditions were reported in the controlled clinical
studies. The rates of the complications were not different in treated
and control infants, and none of the complications were attributed
to SURVANTA.<br/>Respiratory: lung consolidation, blood from the endotracheal tube,
deterioration after weaning, respiratory decompensation, subglottic
stenosis, paralyzed diaphragm, respiratory failure.<br/>Cardiovascular: hypotension, hypertension, tachycardia, ventricular
tachycardia, aortic thrombosis, cardiac failure, cardio-respiratory
arrest, increased apical pulse, persistent fetal circulation, air
embolism, total anomalous pulmonary venous return.<br/>Gastrointestinal: abdominal distention, hemorrhage, intestinal perforations,
volvulus, bowel infarct, feeding intolerance, hepatic failure, stress
ulcer.<br/>Renal: renal failure, hematuria.<br/>Hematologic: coagulopathy, thrombocytopenia, disseminated intravascular
coagulation.<br/>Central Nervous System: seizures<br/>Endocrine/Metabolic: adrenal hemorrhage, inappropriate ADH secretion,
hyperphosphatemia.<br/>Musculoskeletal: inguinal hernia.<br/>Systemic: fever, deterioration.<br/>Follow-Up Evaluations: To date, no long-term
complications or sequelae of SURVANTA therapy have been found.<br/>Single-Dose Studies: Six-month adjusted-age
follow-up evaluations of 232 infants (115 treated) demonstrated no
clinically important differences between treatment groups in pulmonary
and neurologic sequelae, incidence or severity of retinopathy of prematurity,
rehospitalizations, growth, or allergic manifestations.<br/>Multiple-Dose Studies: Six-month adjusted
age follow-up evaluations have been completed in 631 (345 treated)
of 916 surviving infants. There were significantly less cerebral
palsy and need for supplemental oxygen in SURVANTA infants than controls.
Wheezing at the time of examination was significantly more frequent
among SURVANTA infants, although there was no difference in bronchodilator
therapy. Final
twelve-month follow-up data from the multiple-dose studies are available
from 521 (272 treated) of 909 surviving infants. There was significantly
less wheezing in SURVANTA infants than controls, in contrast to the
six-month results. There was no difference in the incidence of cerebral
palsy at twelve months. Twenty-four month adjusted age evaluations were completed in 429
(226 treated) of 906 surviving infants. There were significantly
fewer SURVANTA infants with rhonchi, wheezing, and tachypnea at the
time of examination. No other differences were found.
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SURVANTA is intended for
intratracheal use only. SURVANTA can rapidly affect oxygenation and lung compliance. Therefore,
its use should be restricted to a highly supervised clinical setting
with immediate availability of clinicians experienced with intubation,
ventilator management, and general care of premature infants. Infants
receiving SURVANTA should be frequently monitored with arterial or
transcutaneous measurement of systemic oxygen and carbon dioxide. During the dosing procedure,
transient episodes of bradycardia and decreased oxygen saturation
have been reported. If these occur, stop the dosing procedure and
initiate appropriate measures to alleviate the condition. After stabilization,
resume the dosing procedure.
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SURVANTA is indicated for
prevention and treatment (���rescue���) of Respiratory Distress
Syndrome (RDS) (hyaline membrane disease) in premature infants. SURVANTA
significantly reduces the incidence of RDS, mortality due to RDS and
air leak complications.<br/>Prevention: In premature infants
less than 1250 g birth weight or with evidence of surfactant deficiency,
give SURVANTA as soon as possible, preferably within 15 minutes of
birth.<br/>Rescue: To treat infants
with RDS confirmed by x-ray and requiring mechanical ventilation,
give SURVANTA as soon as possible, preferably by 8 hours of age.
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SURVANTA
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