Šalis: Naujoji Zelandija
kalba: anglų
Šaltinis: Medsafe (Medicines Safety Authority)
Hydroxyethyl starch 130/0.4 6% (molar substitution 0.38-0.45, Av. MWt. 130,000 daltons); Sodium chloride 0.9%; Hydroxyethyl starch 130/0.4 6% (molar substitution 0.38-0.45, Av. MWt. 130,000 daltons)
Fresenius Kabi New Zealand Limited
Hydroxyethyl starch 130/0.4 6% (molar substitution 0.38-0.45, Av. MWt. 130,000 daltons)
Solution for infusion
Active: Hydroxyethyl starch 130/0.4 6% (molar substitution 0.38-0.45, Av. MWt. 130,000 daltons) Sodium chloride 0.9% Excipient: Hydrochloric acid Sodium hydroxide Water for injection Active: Hydroxyethyl starch 130/0.4 6% (molar substitution 0.38-0.45, Av. MWt. 130,000 daltons) Excipient: Hydrochloric acid Sodium chloride Sodium hydroxide Water for injection
Bag, plastic, 500mL, 10 dose units
General sale
General sale
Fresenius Kabi Austria GmbH
Treatment of hypovolaemia due to acute blood loss when chrystlloids 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.
Package - Contents - Shelf Life: Bag, plastic, 500mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C - Bag, plastic, 250mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C - Bag, plastic, 500mL - 15 dose units - 36 months from date of manufacture stored at or below 25°C - Bag, plastic, 500mL - 20 dose units - 36 months from date of manufacture stored at or below 25°C - Bag, plastic, 250mL - 20 dose units - 36 months from date of manufacture stored at or below 25°C - Bag, plastic, 250mL - 30 dose units - 36 months from date of manufacture stored at or below 25°C - Bag, plastic, 250mL - 35 dose units - 36 months from date of manufacture stored at or below 25°C - Bag, plastic, 250mL - 40 dose units - 36 months from date of manufacture stored at or below 25°C - Bottle, plastic, PE, 500mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C
2001-10-23
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 Perskaitykite visą dokumentą
NEW ZEALAND DATA SHEET NZ Data Sheet - VOLUVEN ® 6% - September 2021 Page 1 of 12 1 PRODUCT NAME VOLUVEN ® 6% solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Amount (L) Hydroxyethyl Starch 130/0.4 60g Excipient NaCl (Na + 154 mmol, Cl - 154 mmol) 9g For the full list of excipients, see Section 6.1 List of excipients. Chemical structure Molar substitution 0.38 – 0.45 Average Molecular weight: 110,000 - 150,000 Dalton Mean molecular weight (Mw) 130,000 Chemical name: Poly (O-2 hydroxyethyl) starch ACTIVE SUBSTANCE CAS NUMBER Hydroxyethyl Starch 130/0.4 9005-27-0 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. 3 PHARMACEUTICAL FORM Solution for infusion. Voluven 6% isotonic solution is colourless and clear and is slightly acidic (pH 4.0-5.5). Osmolality approx 304 mOsm/kg water Theoretical osmolarity 308 mosm/l 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 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. NEW ZEALAND DATA SHEET NZ Data Sheet - VOLUVEN ® 6% - September 2021 Page 2 of 12 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, keep Perskaitykite visą dokumentą