Land: Storbritannia
Språk: engelsk
Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)
Glucose anhydrous; Sodium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium bicarbonate; Sodium lactate
Baxter Healthcare Ltd
B05DA
Glucose anhydrous; Sodium chloride; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Sodium bicarbonate; Sodium lactate
13.6gram/1litre ; 5.67gram/1litre ; 257mg/1litre ; 51mg/1litre ; 2.1gram/1litre ; 1.12gram/1litre
Solution for peritoneal dialysis
Intraperitoneal
No Controlled Drug Status
Never Valid To Prescribe As A VMP
BNF: ; GTIN: 05413760329512 55413760329517
OBJECT 1 PHYSIONEAL 35 GLUCOSE 1.36% W/V / 13.6 MG/ML CLEAR-FLEX, SOLUTION FOR PERITONEAL DIALYSIS. Summary of Product Characteristics Updated 22-Feb-2017 | Baxter Healthcare Ltd 1. Name of the medicinal product PHYSIONEAL 35 Glucose 1.36% w/v / 13.6 mg/ml Clear-Flex, Solution for peritoneal dialysis. 2. Qualitative and quantitative composition Before mixing 1000 ML OF ELECTROLYTE SOLUTION (LARGE CHAMBER ″A″) CONTAINS: Active substances: Glucose monohydrate equivalent to Glucose anhydrous Calcium chloride dihydrate Magnesium chloride hexahydrate 20.0 g 18.2 g 0.343 g 0.068 g 1000 ML OF BUFFER SOLUTION (SMALL CHAMBER ″B″) CONTAINS: Active substances: Sodium chloride Sodium hydrogen carbonate Sodium (S)-lactate solution equivalent to sodium (S)- lactate 21.12 g 9.29 g 4.48 g After mixing 1000 ML OF THE MIXED SOLUTION CONTAINS: Active substances: Glucose monohydrate equivalent to Glucose anhydrous 15.0 g 13.6 g Sodium chloride Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium hydrogen carbonate Sodium (S)-lactate solution equivalent to sodium (S)- lactate 5.67 g 0.257 g 0.051 g 2.10 g 1.12 g 1000 ml of final solution after mixing corresponds to 750 ml of solution A and 250 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 - 75.5 mmol/l 132 mmol/l 1.75 mmol/l 0.25 mmol/l 101 mmol/l 25 mmol/l 10 mmol/l For the full list of excipients, see section 6.1. The number '35' in the name specifies the buffer concentration of the solution (10 mmol/l of lactate + 25 mmol/l of hydrogen carbonate = 35 mmol/l). 3. Pharmaceutical form Solution for peritoneal dialysis. Sterile, clear, colourless solution. The pH of the final solution is 7.4. Osmolarity 345 mOsmol/l 4. Clinical particulars 4.1 Therapeutic indications PHYSIONEAL 35 is indicated whenever peritoneal dialysis is employed, including: • Acute and chronic renal failure; • Severe water retention; • Severe electrolyte imbalance; • Drug intoxicatio Les hele dokumentet