Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Glucose anhydrous; Sodium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium bicarbonate; Sodium lactate
Vantive Ltd
B05DA
Glucose anhydrous; Sodium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium bicarbonate; Sodium lactate
22.7gram/1litre ; 5.38gram/1litre ; 184mg/1litre ; 51mg/1litre ; 2.1gram/1litre ; 1.68gram/1litre
Solution for peritoneal dialysis
Intraperitoneal
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: ; GTIN: 05413760159072
OBJECT 1 PHYSIONEAL 40 GLUCOSE 2.27% W/V / 22.7 MG/ML SOLUTION FOR PERITONEAL DIALYSIS Summary of Product Characteristics Updated 21-Mar-2018 | Baxter Healthcare Ltd 1. Name of the medicinal product PHYSIONEAL 40 Glucose 2.27% w/v / 22.7 mg/ml Solution for peritoneal dialysis 2. Qualitative and quantitative composition Before mixing 1000 ML OF ELECTROLYTE SOLUTION (SMALL CHAMBER ″A″) Active substances: Glucose monohydrate Equivalent to Anhydrous glucose Calcium chloride dihydrate Magnesium chloride hexahydrate 68.85 g 62.6 g 0.507 g 0.140 g 1000 ML OF BUFFER SOLUTION (LARGE CHAMBER ″B″) Active substances: Sodium chloride Sodium bicarbonate Sodium (S)-lactate solution 8.43 g 3.29 g 2.63 g After mixing 1000 ML OF THE MIXED SOLUTION CONTAINS: Active substances: Glucose monohydrate Equivalent to Anhydrous glucose Sodium chloride 25.0 g 22.7 g 5.38 g 0.184 g Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium bicarbonate Sodium (S)-lactate solution 0.051 g 2.10 g 1.68 g 1000 ml of final solution after mixing corresponds to 362.5 ml of solution A and 637.5 ml of solution B. COMPOSITION OF THE FINAL SOLUTION AFTER MIXING IN MMOL/L Glucose anhydrous (C 6 H 12 O 6 ) Na+ Ca ++ Mg ++ Cl - HCO 3 - C 3 H 5 O 3 - 126 mmol/l 132 mmol/l 1.25 mmol/l 0.25 mmol/l 95 mmol/l 25 mmol/l 15 mmol/l For the full list of excipients, see section 6.1. The number '40' in the name specifies the buffer concentration of the solution (15 mmol/l of lactate + 25 mmol/l of bicarbonate = 40 mmol/l). 3. Pharmaceutical form Solution for peritoneal dialysis. Sterile, clear, colourless solution. The pH of the final solution is 7.4. Osmolarity (MOSMOL/L) 395 4. Clinical particulars 4.1 Therapeutic indications PHYSIONEAL 40 is indicated whenever peritoneal dialysis is employed, including: • Acute and chronic renal failure; • Severe water retention; • Severe electrolyte imbalance; • Drug intoxication with dialysable substances, when a more adequate therapeutic alternative is not available. PHYSIONEAL 40 bicarbonate/lactate based Read the complete document