Land: Irland
Sprache: Englisch
Quelle: HPRA (Health Products Regulatory Authority)
POLY(O-2-HYDROXYETHYL)STARCH, LACTOBIONIC ACID, POTASSIUM HYDROXIDE, SODIUM HYDROXIDE (40%), ADENOSINE, ALLOPURINOL, POTASSIUM PHOSPHATE MONOBASIC, MAGNESIUM SULFATE, RAFFINOSE, GLUTATHIONE
Bristol-Myers Squibb Pharmaceuticals Ltd
V07AB
POLY(O-2-HYDROXYETHYL)STARCH, LACTOBIONIC ACID, POTASSIUM HYDROXIDE, SODIUM HYDROXIDE (40%), ADENOSINE, ALLOPURINOL, POTASSIUM P
%v/v
Solution for Organ Preservation
Product subject to prescription which may not be renewed (A)
Solvents and diluting agents, incl. irrigating solutions
Authorised
2001-12-03
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ViaSpan Solution for organ preservation 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 1 l Solution for organ preservation contains: 1) MS = moles hydroxyethyl groups per moles anhydroglucose units *German Patent Number 3,688,936. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for organ preservation. Clear, yellow solution. The solution has an approximate osmolality of 320 mosmol/kg, sodium final concentration of 29 mEq/l, potassium concentration of 125 mEq/l and pH of 7.4 at room temperature. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Solution for the preservation of kidney, liver and pancreas. Not for continuous machine perfusion. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Perfusion and preservation of organs. VIASPAN IS ONLY TO BE USED TO PREPARE BELZER UW COLD STORAGE SOLUTION. THE FOLLOWING CAN BE ADDED ASEPTICALLY TO EACH LITRE OF VIASPAN IMMEDIATELY BEFORE USE: 16 MG DEXAMETHASONE 40 UNITS OF REGULAR INSULIN 200,000 UNITS OF PENICILLIN G If desired, an additional 0.922g/l (3 mmol/l) freshly prepared reduced glutathione solution may be added immediately prior to use. Poly (0-2-hydroxyethyl) starch 0.40-0.50 MS 1) (Pentafraction*) 50.0 g/l Lactobionic Acid (as Lactone) 35.83 g/l (105 mmol/l) Potassium Hydroxide 56 % 14.5 g/l (100 mmol/l) Sodium Hydroxide 40 % 3.679 g/l ( 27 mmol/l) Adenosine 1.34 g/l ( 5 mmol/l) Allopurinol 0.136 g/l ( 1 mmol/l) Potassium Dihydrogen Phosphate 3.4 g/l ( 25 mmol/l) Magnesium Sulphate x 7H 2 O 1.23 g/l ( 5 mmol/l) Raffinose x 5H 2 O 17.83 g/l ( 30 mmol/l) Glutathione 0.922 g/l ( 3 mmol/l) IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 21/11/2012_ _CRN 2118981_ _page number: 1_ Remove the Lesen Sie das vollständige Dokument