Nchi: Nyuzilandi
Lugha: Kiingereza
Chanzo: Medsafe (Medicines Safety Authority)
Hydroxyethyl starch 130/0.4 60 g/L; Magnesium chloride hexahydrate 0.3 g/L; ; Potassium chloride 0.3 g/L; Sodium acetate trihydrate 4.63 g/L; ; Sodium chloride 6.02 g/L; ; ;
Fresenius Kabi New Zealand Limited
Hydroxyethyl starch 130/0.4 60 g/L
6 %
Solution for infusion
Active: Hydroxyethyl starch 130/0.4 60 g/L Magnesium chloride hexahydrate 0.3 g/L Potassium chloride 0.3 g/L Sodium acetate trihydrate 4.63 g/L Sodium chloride 6.02 g/L Excipient: Hydrochloric acid Sodium hydroxide Water for injection
Bag, plastic, 500mL Freeflex infusion bag, 15 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 Volulyte is not a substitute for the appropriate use of packed red blood cells or fresh frozen plasma.
Package - Contents - Shelf Life: Bag, plastic, 500mL Freeflex infusion bag - 15 dose units - 36 months from date of manufacture stored at or below 25°C. do not freeze - Bag, plastic, 500mL Freeflex infusion bag - 20 dose units - 36 months from date of manufacture stored at or below 25°C. do not freeze - Bag, plastic, 250mL Freeflex infusion bag - 20 dose units - 36 months from date of manufacture stored at or below 25°C. do not freeze - Bag, plastic, 250mL Freeflex infusion bag - 30 dose units - 36 months from date of manufacture stored at or below 25°C. do not freeze - Bag, plastic, 250mL Freeflex infusion bag - 35 dose units - 36 months from date of manufacture stored at or below 25°C. do not freeze - Bag, plastic, 250mL Freeflex infusion bag - 40 dose units - 36 months from date of manufacture stored at or below 25°C. do not freeze
2011-12-02
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 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 VOLULYTE You must NOT use this product if you: are critically ill to be admitted to intensive care unit. have too much fluid in your body and you have been told that you have a condition known as hyperhydration 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) suffer from bleeding within or around the brain (intracranial bleeding) are allergic (hypersensitive) to hydroxyethyl starch or any of the other ingredients. have coagulation or bleeding disorder have severe liver disease have too high sodium, potassium or chloride levels in your blood have a severe blood infection Your doctor may need to take special precautions and will decide whether you can receive Volulyte if you suffer fr Soma hati kamili
NEW ZEALAND DATA SHEET NZ Data Sheet - VOLUVEN ® 6% - September 2021 Page 1 of 15 1 PRODUCT NAME VOLULYTE ® 6% solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Amount(L) Hydroxyethyl starch 130/0.4 60.0 g Sodium chloride 6.02 g Sodium acetate trihydrate 4.63 g Potassium chloride 0.30 g Magnesium chloride hexahydrate 0.30 g Electrolytes Amount/L Sodium (Na + ) 137.0 mmol Potassium (K + ) 4.0 mmol Magnesium (Mg 2+ ) 1.5 mmol Chloride (Cl - ) 110.0 mmol Acetate (CH 3 COO - ) 34.0 mmol Titratable acidity: < 2.5 mmol NaOH/L For the full list of excipients, see Section 6.1 List of excipients. The use of Volulyte 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 15 Chemical structure Molar substitution: 0.4 (0.38 – 0.45) Weight average molecular weight: 130,000 ± 20,000 Dalton 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. Volulyte (HES 130/0.4 in a balanced electrolyte solution) is a clear to slightly opalescent solution, colourless to slightly yellow. Osmolality: approx. 260 - 310 mOsm/kg water Theoretical osmolarity 286.5mosm/l pH: 5.7 – 6.5 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 Volulyte 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 Volulyte should be restricted to the initial phase of volume resuscitation with a maximum duration of use of 24 hours. Soma hati kamili