Χώρα: Αυστραλία
Γλώσσα: Αγγλικά
Πηγή: Department of Health (Therapeutic Goods Administration)
Hydroxyethyl starch 130/0.4; Sodium acetate trihydrate; Magnesium chloride; Potassium chloride; Sodium chloride
Fresenius Kabi Australia Pty Limited
Medicine Registered
July 2012 CMI FOR VOLULYTE 6% Filename: VoluCMI120712 -cleanVoluCMI050510-clean.doc Page 1 of 2 VOLULYTE ® 6% _ _ Hydroxyethyl Starch 130/0.4 in a balanced electrolyte solution CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Volulyte. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you given Volulyte against any benefits they expect it will have for you. PLEASE READ THIS LEAFLET CAREFULLY. IF YOU HAVE ANY QUESTIONS OR ARE UNSURE ABOUT ANYTHING, PLEASE ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. WHAT IS VOLULYTE USED FOR Volulyte is an infusion solution containing an artificial starch. Due to limited availability, blood and blood containing products are not always used to replace fluid losses and are only used where absolutely essential. Smaller fluid losses are now replaced using “artificial” solutions called plasma substitutes or volume replacement fluids. Volulyte is one of these solutions. It may be necessary to maintain your circulating blood volume for example, during operation, or if you had suffered a burn or trauma. BEFORE YOU ARE GIVEN VOLULYTE You must NOT use this product if: • You have too much fluid in your body and you have been told that you have a condition known as hype Διαβάστε το πλήρες έγγραφο
Page 1 of 12 PRODUCT INFORMATION NAME OF MEDICINE VOLULYTE ® 6% (Hydroxyethyl starch 130/0.4 in a balanced electrolyte solution) Chemical Abstracts Service (CAS) registry name: [9005-27-0] Structural formula O OR RO OR 1 O O OR RO OR 1 O OR 1 OR RO O O OR 1 OR RO O O O OR RO OR 1 O ) ( n R = -H, -CH 2 CH 2 OH R 1 = -H, -CH 2 CH 2 OH or glucose units DESCRIPTION Hydroxyethyl Starch 130/0.4 is a white to yellowish white, odourless and tasteless, amorphous powder, readily soluble in water at room temperature, soluble in DMSO, practically insoluble in most organic solvents. Hydroxyethyl starch (HES) is a derivative of amylopectin, which is a highly branched compound of starch. In humans and animals amylopectin is rapidly hydrolysed by amylase. In order to reduce the metabolic degradation, glucose residues of the amylopectin are reacted with ethylene oxide. The hydroxyethyl groups can be introduced at three positions (C 2 , C 3 , C 6 ) of the glucose residues. The degree of substitution and the substitution pattern expressed by the C 2 /C 6 ratio determines the enzymatic degradation of HES. Volulyte is characterised by its molar substitution, molecular weight and the C 2 /C 6 ratio. Proper or common name: Hydroxyethyl starch (HES) 130/0.4 Chemical name: Poly (O-2 hydroxyethyl) starch Molar substitution: 0.4 (0.38 – 0.45) Weight average molecular weight: 130,000 ± 20,000 Dalton Molecular weight (Mw): The molecular weight indicates the weight average. The Mw of HES 130/0.4 lies between 110,000 and 150,000 Dalton, which corresponds approximately to Διαβάστε το πλήρες έγγραφο