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Survanta
Overview
What is Survanta?
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).
What does Survanta look like?
What are the available doses of Survanta?
Sorry No records found.
What should I talk to my health care provider before I take Survanta?
Sorry No records found
How should I use Survanta?
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.
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 AbbVie Inc.
What interacts with Survanta?
Sorry No Records found
What are the warnings of Survanta?
Sorry No Records found
What are the precautions of Survanta?
Sorry No Records found
What are the side effects of Survanta?
Sorry No records found
What should I look out for while using Survanta?
None
known.
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.
What might happen if I take too much Survanta?
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.
How should I store and handle Survanta?
Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure and medication guide. Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight, light-resistant container with a child-resistant closure and medication guide. 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.LITHO IN USAAbbVie Inc.North Chicago, IL 60064, U.S.A.03-A683 December, 2012SURVANTA (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.LITHO IN USAAbbVie Inc.North Chicago, IL 60064, U.S.A.03-A683 December, 2012SURVANTA (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.LITHO IN USAAbbVie Inc.North Chicago, IL 60064, U.S.A.03-A683 December, 2012SURVANTA (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.LITHO IN USAAbbVie Inc.North Chicago, IL 60064, U.S.A.03-A683 December, 2012SURVANTA (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.LITHO IN USAAbbVie Inc.North Chicago, IL 60064, U.S.A.03-A683 December, 2012SURVANTA (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.LITHO IN USAAbbVie Inc.North Chicago, IL 60064, U.S.A.03-A683 December, 2012
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
p269124
In vitro,
In situ,
In vivo,
Non-Clinical Toxicology
None known.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.
Rales and moist breath sounds can occur transiently after administration. Endotracheal suctioning or other remedial action is not necessary unless clear-cut signs of airway obstruction are present.
Increased probability of post-treatment nosocomial sepsis in SURVANTA-treated infants was observed in the controlled clinical trials (Table 3). The increased risk for sepsis among SURVANTA-treated infants was not associated with increased mortality among these infants. The causative organisms were similar in treated and control infants. There was no significant difference between groups in the rate of post-treatment infections other than sepsis.
Use of SURVANTA in infants less than 600 g birth weight or greater than 1750 g birth weight has not been evaluated in controlled trials. There is no controlled experience with use of SURVANTA in conjunction with experimental therapies for RDS (eg, high-frequency ventilation or extracorporeal membrane oxygenation).
No information is available on the effects of doses other than 100 mg phospholipids/kg, more than four doses, dosing more frequently than every 6 hours, or administration after 48 hours of age.
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 . Oxygen desaturation occurred with 9.8% of .
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% 30.8%, = 0.001; and 48.8% 34.2%, = 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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