País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
hydroxyethyl starch 130/0.4, Quantity: 60 g/L
Fresenius Kabi Australia Pty Ltd
Hydroxyethyl starch 130/0.4
Injection, solution
Excipient Ingredients: sodium hydroxide; water for injections; hydrochloric acid; sodium chloride
Intravenous
20 x 250 mL, 30 X 250 mL, 10 x 250 mL
Not Scheduled after consideration by Committee
Treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient. The use of Voluven is not a substitute for the appropriate use of packed red blood cells or fresh frozen plasma.
Visual Identification: Clear solution.; Container Type: Bag; Container Material: Other composite material; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2006-11-13
Page 1 of 2 VOLUVEN ® 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 Voluven. 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 Voluven 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 VOLUVEN USED FOR Voluven is a plasma volume substitute that is used to restore the blood volume when you have lost blood when other products called crystalloids are not considered sufficient alone. It is not a substitute for blood or blood containing products. BEFORE YOU ARE GIVEN VOLUVEN You must NOT use this product if you: are critically ill to be admitted to intensive care unit. are allergic to hydroxyethyl starches or any of the other ingredients as listed at the end of this leaflet. have bleeding of the brain (cerebral haemorrhage) have too high sodium or chloride levels in your blood have a severe blood infection have severe liver disease have coagulation or bleeding disorder have been told that you have pulmonary oedema where too much fluid is in your lungs have been told that you have a congestive heart failure (a condition in which your heart cannot pump enough blood to other organs of your body) have kidney failure and you produce little or no urine and if this is not caused by low blood volumes (hypovolemia) are receiving dialysis treatment (an artificial kidney treatment) Before you use Voluven, you must also tell your doctor if you have problems with your heart, liver, lung or have severe lack of fluid (dehydration). Special care has to be taken while this product is given to you. Infusion of large quantitie Leia o documento completo
AUSTRALIAN PRODUCT INFORMATION - VOLUVEN ® 6% (HYDROXYETHYL STARCH 130/0.4 IN A BALANCED ELECTROLYTE SOLUTION) Page 1 of 12 1 NAME OF MEDICINE Hydroxyethyl Starch 130/0.4 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Amount (L) Hydroxyethyl Starch 130/0.4 60g Excipient NaCl (Na + 154 mmol, Cl - 154 mmol) 9g Hydroxyethyl starch is characterised by its molar substitution, molecular weight and the C 2 /C 6 ratio. See sections 5.2 PHARMACOKINETIC PROPERTIES and 6.7 PHYSICOCHEMICAL PROPERTIES. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solution for injection. Voluven 6% isotonic solution is colourless, clear and slightly acidic (pH 4.0-5.5). Osmolality approx 304 mOsm/kg water Theoretical osmolarity 308 mosm/l 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of hypovolaemia due to acute blood loss when crystalloids alone are not considered sufficient. The use of Voluven is not a substitute for the appropriate use of packed red blood cells or fresh frozen plasma. 4.2 DOSE AND METHOD OF ADMINISTRATION For intravenous infusion. Use of Voluven should be restricted to the initial phase of volume resuscitation with a maximum duration of use of 24 hours. Administration of Voluven may cause anaphylactic reactions that may manifest as acute hypotension. In all patients, the initial 10-20 mL of Voluven should be infused slowly, keeping the patient under close observation for anaphylactic/anaphylactoid reactions manifesting as unexpected hypotension, or the development of wheeze or rash. (Please also refer to sections 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE and 4.8. ADVERSE EFFECTS (UNDESIRABLE EFFECTS). The daily dose and rate of infusion depend on the patient’s blood loss, on the maintenance or restoration of haemodynamics and on the haemodilution (dilution effect). The use of Voluven in critically ill patients, including those with severe sepsis, is associated with an increased risk of death or the need for renal replacement therapy. Page 2 of 12 In clini Leia o documento completo