País: Reino Unido
Idioma: inglés
Fuente: 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: 05413760283180 55413760283185
OBJECT 1 PHYSIONEAL 40 GLUCOSE 2.27% W/V / 22.7 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 40 Glucose 2.27% w/v / 22.7 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 33.3 g 30.3 g 0.245 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 19.95 g 9.29 g 6.73 g After mixing 1000 ML OF THE MIXED SOLUTION CONTAINS: Active substances: Glucose monohydrate equivalent to Glucose anhydrous 25.0 g 22.7 g Sodium chloride Calcium chloride dihydrate Magnesium chloride hexahydrate Sodium hydrogen carbonate Sodium (S)-lactate solution equivalent to sodium (S)- lactate 5.38 g 0.184 g 0.051 g 2.10 g 1.68 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 - 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 hydrogen carbonate = 40 mmol/l). 3. Pharmaceutical form Solution for peritoneal dialysis. Sterile, clear, colourless solution. The pH of the final solution is 7.4. Osmolarity 395 mOsmol/l 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 Leer el documento completo