Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Glucose monohydrate; Sodium Chloride; Sodium Chloride; Magnesium chloride hexahydrate.; Calcium chloride dihydrate.; Sodium Hydrogen Carbonate.
B.BRAUN MEDICAL INDUSTRIES SDN BHD
Glucose monohydrate; Sodium Chloride; Sodium Chloride; Magnesium chloride hexahydrate.; Calcium chloride dihydrate.; Sodium Hydrogen Carbonate.
2 X 5000 ml
B.Braun Avitum AG
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2. QUALITATIVE AND QUANTITATIVE COMPOSITION COMPOSITION OF THE READY-TO-USE SOLUTION FOR HAEMOFILTRATION AFTER MIXING: 1000 ml ready-to-use solution for haemofiltration contain [mmol/l]: Na + 140 Ca ++ 1.5 Mg ++ 0.5 Cl – 109 HCO 3 – 35.0 Glucose anhydrous 5.6 (equiv. to 1.0 g) Theoretical osmolarity [mOsm/l] 292 pH 7.0–8.0 For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for haemofiltration Clear and colourless solution, free from visible particles The solution is free from bacterial endotoxins. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The ready-to-use solution is indicated for use in patients with acute renal failure of any cause requiring continuous haemofiltration. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The use of solutions for haemofiltration in patients with acute renal failure should be under the direction of a physician with experience in using such treatment. Posology The filtration rate prescribed is dependent on the clinical status and the body weight of the patient. Unless otherwise prescribed, a filtration rate of 20-25 ml/kg body weight per hour is recommended for the removal of metabolic waste products normally excreted in the urine, depending on the metabolic condition of the patient. The dose-volume is at the discretion of the physician because the volume of substitution solution depends on the intensity of treatment performed and on the amount of fluid to be replaced in order to achieve fluid balance. _Paediatric population_ The dosage recommendations mentioned above are also applicable for the paediatric population. Method of administration Intravenous use. The ready-to-use solution for haemofiltration has to be prepared by opening the peel seam. The mixing is performed by twisting the bag five times. For further instructions, see section 6.6. The ready-to-use solution for haemofiltration is infused into the extracorporeal circulation by means of an infusion pump. During haemofiltration the solution for haemofiltration replaces the ultrafiltra Read the complete document