Survanta

Χώρα: Νέα Ζηλανδία

Γλώσσα: Αγγλικά

Πηγή: Medsafe (Medicines Safety Authority)

Δραστική ουσία:

Bovine lung lipids 25 mg/mL (Total Phospholipids); Colfosceril palmitate 11 mg/mL - 15.5 mg/mL (Disaturated Phosphatidylcholine); Palmitic acid 1.4 mg/mL - 3.5 mg/mL (Free Fatty Acid); Tripalmitin 0.5 mg/mL - 1.75 mg/mL (Triglycerides)

Διαθέσιμο από:

AbbVie Limited

INN (Διεθνής Όνομα):

Bovine lung lipids 25 mg/mL (Total Phospholipids)

Δοσολογία:

25 mg/mL

Φαρμακοτεχνική μορφή:

Intratracheal suspension

Σύνθεση:

Active: Bovine lung lipids 25 mg/mL (Total Phospholipids) Colfosceril palmitate 11 mg/mL - 15.5 mg/mL (Disaturated Phosphatidylcholine) Palmitic acid 1.4 mg/mL - 3.5 mg/mL (Free Fatty Acid) Tripalmitin 0.5 mg/mL - 1.75 mg/mL (Triglycerides) Excipient: Sodium chloride Water for injection

Μονάδες σε πακέτο:

Vial, glass, single dose, 1x4mL, 100 mg

Kατηγορία:

Prescription

Τρόπος διάθεσης:

Prescription

Κατασκευάζεται από:

AbbVie Inc

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

Package - Contents - Shelf Life: Vial, glass, single dose, 1x4mL - 100 mg - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, single dose, 1x8mL - 200 mg - 18 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Ημερομηνία της άδειας:

1991-10-21

Αρχείο Π.Χ.Π.

_Survanta DS _
_Version 02 _
_8 June 2012 _
_Page 1 of 13 _

DATASHEET 

    SURVANTA 

BOVINE LUNG LIPIDS IN DISPERSION  200 MG/8ML 

PRESENTATION 

Survanta, (beractant) 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 dipalmitoylphosphatidylcholine, palmitic acid and 
tripalmitin are added to standardize the composition and to mimic the
surface-tension lowering 
properties of natural lung surfactant.  It is dispersed in 0.9%
sodium chloride solution and heat-
sterilized.  Survanta contains no preservatives.  It contains 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 8 mL (200
mg phospholipid). 

USES 

ACTIONS 

The mode of action of Survanta is biophysical rather than biochemical,
i.e. it reduces surface 
tension and concomitantly increases lung compliance. 

Intratracheally administered Survanta distributes rapidly to the
alveolar surfaces and stabilizes 
the alveoli against collapse during respiration thereby increasing
alveolar ventilation.  

In vitro, Survanta reproducibly lowers minimum surface tension to
less than 8 dynes/cm on 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 rabbit and sheep. 

In clinical studies of premature infants with