Страна: Ірландія
мова: англійська
Джерело: HPRA (Health Products Regulatory Authority)
ICODEXTRIN SODIUM CHLORIDE PH.EUR. S(+) SODIUM LACTATE 960%W/W SOLUTION CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYDRATE
Innovata plc
ICODEXTRIN SODIUM CHLORIDE PH.EUR. S(+) SODIUM LACTATE 960%W/W SOLUTION CALCIUM CHLORIDE DIHYDRATE MAGNESIUM CHLORIDE HEXAHYD
40 Mg/Ml
Solvent for Parenteral Use
Withdrawn
2008-01-18
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dexemel 40g/litre Solvent for intraperitoneal use. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Theoretical osmolarity 278 (milliosmoles per litre). Electrolyte solution content per 1000ml: For excipients see section 6.1. 3 PHARMACEUTICAL FORM Solvent for intraperitoneal use. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Dexemel is recommended as a vehicle for the administration via the peritoneum of medicinal products compatible with the vehicle and shown to have been used safely and effectively by the intraperitoneal route. See section 6.2. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The Posology and technique applied depend on the pharmaco-kinetic attributes of the therapeutic agent which has been dissolved in Dexemel and are individually decided by the responsible physician. 1 Litre (approximately 15 ml/kg) may be instilled into the peritoneal cavity thrice weekly via a subcutaneously implanted port/catheter device. 2 Litres (approximately 30 ml/kg) may be instilled daily into the peritoneal cavity via a Tenckhoff catheter if drained out immediately prior to a second instillation. Each 1 litre contains: Icodextrin 40.0 g Sodium Chloride 5.4 g S (+) Sodium Lactate (60%w/w solution) 4.5 g Calcium Chloride 257.0 mg Magnesium Chloride 51.0 mg Sodium 133.0 mmol Calcium 1.75 mmol Magnesium 0.25 mmol Chloride 96.0 mmol Lactate 40.0 mmol IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 20/11/2007_ _CRN 2043438_ _page number: 1_ The dosage frequency of the therapeutic agent should be determined by its known pharmacokinetic attributes. Peritoneal administration requires the use of a specific and adequate ambulatory drug delivery system, permitting the conne Прочитайте повний документ