Țară: Noua Zeelandă
Limbă: engleză
Sursă: Medsafe (Medicines Safety Authority)
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)
AbbVie Limited
Bovine lung lipids 25 mg/mL (Total Phospholipids)
25 mg/mL
Intratracheal suspension
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
Vial, glass, single dose, 1x4mL, 100 mg
Prescription
Prescription
AbbVie Inc
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.
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
1991-10-21
_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 Citiți documentul complet