NDC 0074-1040 Survanta

Beractant

NDC Product Code 0074-1040

NDC 0074-1040-04

Package Description: 1 VIAL, SINGLE-USE in 1 CARTON > 4 mL in 1 VIAL, SINGLE-USE

NDC 0074-1040-08

Package Description: 1 VIAL, SINGLE-USE in 1 CARTON > 8 mL in 1 VIAL, SINGLE-USE

NDC Product Information

Survanta with NDC 0074-1040 is a a human prescription drug product labeled by Abbvie Inc.. The generic name of Survanta is beractant. The product's dosage form is suspension and is administered via endotracheal form.

Labeler Name: Abbvie Inc.

Dosage Form: Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Survanta Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • BERACTANT 25 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • COLFOSCERIL PALMITATE (UNII: 319X2NFW0A)
  • TRIPALMITIN (UNII: D133ZRF50U)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Endotracheal - Administration directly into the trachea.
  • Endotracheal - Administration directly into the trachea.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Alveolar Surface Tension Reduction - [PE] (Physiologic Effect)
  • Surfactant - [EPC] (Established Pharmacologic Class)
  • Surfactant Activity - [MoA] (Mechanism of Action)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Abbvie Inc.
Labeler Code: 0074
FDA Application Number: BLA020032 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: BLA - A product marketed under an approved Biologic License Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 07-01-1991 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Survanta Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

(beractant)intratracheal suspensionSterile SuspensionFor Intratracheal Administration Only

Description

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).

Clinical Pharmacology

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.

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.

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.

Clinical Studies

Clinical
effects of SURVANTA were demonstrated in six single-dose and four
multiple-dose randomized, multi-center, controlled clinical trials
involving approximately 1700 infants. Three open trials, including
a Treatment IND, involved more than 8500 infants. Each dose of SURVANTA
in all studies was 100 mg phospholipids/kg birth weight and was based
on published experience with Surfactant TA, a lyophilized powder dosage
form of SURVANTA having the same composition.

Prevention Studies

Infants of 600-1250 g birth weight and 23 to 29 weeks estimated gestational age were enrolled in two multiple-dose studies. A dose of SURVANTA was given within 15 minutes of birth to prevent the development of RDS. Up to three additional doses in the first 48 hours, as often as every 6 hours, were given if RDS subsequently developed and infants required mechanical ventilation with an FiO2 ≥ 0.30. Results of the studies at 28 days of age are shown in Table 1.Table 1.Study 1 SURVANTAControlP-ValueNumber infants studied119124 Incidence of RDS (%)27.663.5< 0.001Death due to RDS (%)2.519.5< 0.001Death or BPD due to RDS (%)48.752.80.536Death due to any cause (%)7.622.80.001Air Leaksa (%)5.921.70.001Pulmonary interstitial emphysema (%)20.840.00.001Study 2b SURVANTAControlP-ValueNumber infants studied9196 Incidence of RDS (%)28.648.30.007Death due to RDS (%)1.110.50.006Death or BPD due to RDS (%)27.544.20.018Death due to any cause C(%)16.513.70.633Air Leaks a(%)14.519.60.374Pulmonary interstitial emphysema (%)26.533.20.298aPneumothorax or pneumopericardiumbStudy discontinued when Treatment IND initiatedcNo cause of death in the SURVANTA group was significantly increased; the higher number of deaths in this group was due to the sum of all causes.

Rescue Studies

Infants of 600-1750 g birth weight with
RDS requiring mechanical ventilation and an FiO2 ≥ 0.40 were enrolled in two multiple-dose rescue
studies. The initial dose of SURVANTA was given after RDS developed
and before 8 hours of age. Infants could receive up to three additional
doses in the first 48 hours, as often as every 6 hours, if they required
mechanical ventilation and an FiO2 ≥ 0.30.
Results of the studies at 28 days of age are shown in Table 2.Table 2.Study 3a SURVANTAControlP-ValueNumber infants studied198193 Death due to RDS (%)11.618.10.071Death or BPD due to RDS (%)59.166.80.102Death due to any cause (%)21.726.40.285Air Leaksb (%)11.829.5<0.001Pulmonary interstitial emphysema (%)16.334.0<0.001Study 4 SURVANTAControlP-ValueNumber infants studied204203 Death due to RDS (%)6.422.3< 0.001Death or BPD due to RDS (%)43.663.4< 0.001Death due to any cause (%)15.228.20.001Air Leaksb (%)11.222.20.005Pulmonary interstitial emphysema (%)20.844.4< 0.001aStudy discontinued when
Treatment IND initiatedbPneumothorax
or pneumopericardium

Acute Clinical Effects

Marked improvements in oxygenation may occur
within minutes of administration of SURVANTA.All controlled clinical studies with SURVANTA provided
information regarding the acute effects of SURVANTA on the arterial-alveolar
oxygen ratio (a/APO2), FiO2, and mean airway pressure (MAP) during the first 48 to 72 hours
of life. Significant improvements in these variables were sustained
for 48-72 hours in SURVANTA-treated infants in four single-dose and
two multiple-dose rescue studies and in two multiple-dose prevention
studies. In the single-dose prevention studies, the FiO2 improved significantly.

Indications And Usage

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.

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.

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.

Contraindications

None
known.

Warnings

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.

General

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.

  • SURVANTA is administered intratracheally
  • By instillation through a 5 French end-hole catheter. The catheter
  • Can be inserted into the infant’s endotracheal tube without interrupting
  • Ventilation by passing the catheter through a neonatal suction valve
  • Attached to the endotracheal tube. Alternatively, SURVANTA can be
  • Instilled through the catheter by briefly disconnecting the endotracheal
  • Tube from the ventilator.The
  • Neonatal suction valve used for administering SURVANTA should be a
  • Type that allows entry of the catheter into the endotracheal tube
  • Without interrupting ventilation and also maintains a closed airway
  • Circuit system by sealing the valve around the catheter.If the neonatal suction valve is used, the
  • Catheter should be rigid enough to pass easily into the endotracheal
  • Tube. A very soft and pliable catheter may twist or curl within the
  • Neonatal suction valve. The length of the catheter should be shortened
  • So that the tip of the catheter protrudes just beyond the end of the
  • Endotracheal tube above the infant’s carina. SURVANTA should not be
  • Instilled into a mainstem bronchus.To ensure homogenous distribution of SURVANTA throughout the lungs,
  • Each dose is divided into four quarter-doses.Each quarter-dose is administered with the
  • Infant in a different position. The recommended positions are:Head and body inclined 5-10° down, head turned to the rightHead and body inclined 5-10° down, head turned to the leftHead and body inclined 5-10° up, head turned to the rightHead and body inclined 5-10° up, head turned to the leftThe dosing procedure is facilitated
  • If one person administers the dose while another person positions
  • And monitors the infant.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Carcinogenicity studies have not been performed with SURVANTA. SURVANTA
was negative when tested in the Ames test for mutagenicity. Using
the maximum feasible dose volume, SURVANTA up to 500 mg phospholipids/kg/day
(approximately one-third the premature infant dose based on mg/m2/day) was administered subcutaneously to newborn rats
for 5 days. The rats reproduced normally and there were no observable
adverse effects in their offspring.

Adverse Reactions

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.Table 3.All Controlled
StudiesConcurrent EventSURVANTA (%)Control      (%)P-ValueaPatent ductus arteriosus46.947.10.814Intracranial hemorrhage48.145.20.241Severe intracranial hemorrhage24.123.30.693Pulmonary air leaks10.924.7< 0.001Pulmonary interstitial emphysema20.238.4< 0.001Necrotizing enterocolitis6.15.30.427Apnea65.459.60.283Severe apnea46.142.50.114Post-treatment sepsis20.716.10.019Post-treatment infection10.29.10.345Pulmonary hemorrhage7.25.30.166aP-value
comparing groups in controlled studies 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.

Respiratory

Lung consolidation, blood from the endotracheal
tube, deterioration after weaning, respiratory decompensation, subglottic
stenosis, paralyzed diaphragm, respiratory failure.

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.

Gastrointestinal

Abdominal distention, hemorrhage, intestinal
perforations, volvulus, bowel infarct, feeding intolerance, hepatic
failure, stress ulcer.

Renal

Renal failure, hematuria.

Hematologic

Coagulopathy, thrombocytopenia, disseminated
intravascular coagulation.

Central Nervous System

Seizures

Endocrine/Metabolic

Adrenal hemorrhage, inappropriate ADH secretion,
hyperphosphatemia.

Musculoskeletal

Inguinal hernia.

Systemic

Fever, deterioration.

Follow-Up Evaluations

To date, no long-term complications or sequelae
of SURVANTA therapy have been found.

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.

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.

Overdosage

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.

Dosage And Administration

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.

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.SURVANTA DOSING
CHART Weight (grams) Total Dose (mL) Weight (grams) Total Dose (mL) 600-6502.61301-13505.4651-7002.81351-14005.6701-7503.01401-14505.8751-8003.21451-15006.0801-8503.41501-15506.2851-9003.61551-16006.4901-9503.81601-16506.6951-10004.01651-17006.81001-10504.21701-17507.01051-11004.41751-18007.21101-11504.61801-18507.41151-12004.81851-19007.61201-12505.01901-19507.81251-13005.21951-20008.0Four doses of SURVANTA can be administered
in the first 48 hours of life. Doses should be given no more frequently
than every 6 hours.

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.

First Dose

Determine the total dose of SURVANTA from
the SURVANTA dosing chart based on the infant’s birth weight. Slowly
withdraw the entire contents of the vial into a plastic syringe through
a large-gauge needle (eg, at least 20 gauge). Do not filter SURVANTA
and avoid shaking.Attach the
premeasured 5 French end-hole catheter to the syringe. Fill the catheter
with SURVANTA. Discard excess SURVANTA through the catheter so that
only the total dose to be given remains in the syringe.Before administering SURVANTA, assure proper
placement and patency of the endotracheal tube. At the discretion
of the clinician, the endotracheal tube may be suctioned before administering
SURVANTA. The infant should be allowed to stabilize before proceeding
with dosing.In the prevention
strategy, weigh, intubate and stabilize the infant. Administer the
dose as soon as possible after birth, preferably within 15 minutes.
Position the infant appropriately and gently inject the first quarter-dose
through the catheter over 2-3 seconds.After administration of the first quarter-dose, remove
the catheter from the endotracheal tube. Manually ventilate with
a hand-bag with sufficient oxygen to prevent cyanosis, at a rate of
60 breaths/minute, and sufficient positive pressure to provide adequate
air exchange and chest wall excursion.In the rescue strategy, the first dose should be given
as soon as possible after the infant is placed on a ventilator for
management of RDS. In the clinical trials, immediately before instilling
the first quarter-dose, the infant’s ventilator settings were changed
to rate 60/minute, inspiratory time 0.5 second, and FiO2 1.0.Position the
infant appropriately and gently inject the first quarter-dose through
the catheter over 2-3 seconds. After administration of the first
quarter-dose, remove the catheter from the endotracheal tube and continue
mechanical ventilation.In both
strategies, ventilate the infant for at least 30 seconds or until
stable. Reposition the infant for instillation of the next quarter-dose.Instill the remaining quarter-doses using
the same procedures. After instillation of each quarter-dose, remove
the catheter and ventilate for at least30 seconds or until the infant is stabilized. After
instillation of the final quarter-dose, remove the catheter without
flushing it. Do not suction the infant for 1 hour after dosing unless
signs of significant airway obstruction occur.After completion of the dosing procedure, resume usual
ventilator management and clinical care.

Repeat Doses

The dosage of SURVANTA for repeat doses
is also 100 mg phospholipids/kg and is based on the infant’s birth
weight. The infant should not be reweighed for determination of the
SURVANTA dosage. Use the SURVANTA Dosing Chart to determine the total
dosage.The need for additional
doses of SURVANTA is determined by evidence of continuing respiratory
distress. Using the following criteria for redosing, significant
reductions in mortality due to RDS were observed in the multiple-dose
clinical trials with SURVANTA.Dose no sooner than 6 hours after the preceding dose if the infant
remains intubated and requires at least 30% inspired oxygen to maintain
a PaO2 less than or equal to 80 torr.Radiographic confirmation of RDS should
be obtained before administering additional doses to those who received
a prevention dose.Prepare SURVANTA
and position the infant for administration of each quarter-dose as
previously described. After instillation of each quarter-dose, remove
the dosing catheter from the endotracheal tube and ventilate the infant
for at least 30 seconds or until stable.In the clinical studies, ventilator settings used to
administer repeat doses were different than those used for the first
dose. For repeat doses, the FiO2 was increased
by 0.20 or an amount sufficient to prevent cyanosis. The ventilator
delivered a rate of 30/minute with an inspiratory time less than1.0 second. If the infant’s pretreatment
rate was 30 or greater, it was left unchanged during SURVANTA instillation.Manual hand-bag ventilation should not be
used to administer repeat doses. During the dosing procedure, ventilator
settings may be adjusted at the discretion of the clinician to maintain
appropriate oxygenation and ventilation.After completion of the dosing procedure, resume usual
ventilator management and clinical care.

Dosing Precautions

If an infant experiences bradycardia or oxygen desaturation during the dosing procedure, stop the dosing procedure and initiate appropriate measures to alleviate the condition. After the infant has stabilized, resume the dosing procedure.Rales and moist breath sounds can occur transiently after administration of SURVANTA. Endotracheal suctioning or other remedial action is unnecessary unless clear-cut signs of airway obstruction are present.

How Supplied

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, 2012

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