SURVANTA BERACTANT INTRATRACHEAL SUSPENSION

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

PHOSPHOLIPIDS

Available from:

ABBVIE PTE. LTD.

ATC code:

R07AA02

Dosage:

25 mg/ml

Pharmaceutical form:

SOLUTION, STERILE

Composition:

PHOSPHOLIPIDS 25 mg/ml

Administration route:

INTRATRACHEAL

Prescription type:

Prescription Only

Manufactured by:

AbbVie Inc.

Authorization status:

ACTIVE

Authorization date:

1991-12-09

Patient Information leaflet

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.
_EndocrinelMetabolic:_
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
not been completed. Preliminarily, in 605 (333
treated) of 916 surviving infants, there are trends for
decreased cerebral palsy and need for supplemental
oxygen in SURVANTA infants. Wheezing at the time
of examination tended to be more frequent among
SURVANTA infants, although there was no difference
in bronchodilator therapy.
Twelve-month follow-up data from the multiple-dose
studies have been completed in 328 (171 treated) of
909 surviving infants. To date no significant
differences between treatments have been found,
although there is a trend toward less wheezing in
SURVANTA infants in contrast to the six month
results.
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 obstructi

Summary of Product characteristics

SURVANTA
®
Beractant Intratracheal Suspension
Sterile Suspension
For Intratracheal Use 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), 0.5-1.75mg/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