Ország: Malajzia
Nyelv: angol
Forrás: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
SODIUM CHLORIDE; MAGNESIUM CHLORIDE HEXAHYDRATE; CALCIUM CHLORIDE DIHYDRATE; Dextrose Monohydrate; SODIUM LACTATE
Bluecross Healthcare Sdn Bhd
SODIUM CHLORIDE; MAGNESIUM CHLORIDE HEXAHYDRATE; CALCIUM CHLORIDE DIHYDRATE; Dextrose Monohydrate; SODIUM LACTATE
2000 ml
CHI SHENG PHARMA & BIOTECH CO. LTD.
Consumer Medication Information Leaflet (RiMUP) 1 RENASOL Renasol100 Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 1.5%w/v Dextrose Renasol200 Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5%w/v Dextrose Renasol300 Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 4.25%w/v Dextrose ACTIVE INGREDIENTS: ELECTROLYTES RENASOL100 LOW CALCIUM (2.5MEQ/L) PERITONEAL DIALYSIS SOLUTION WITH 1.5%W/V DEXTROSE RENASOL200 LOW CALCIUM (2.5MEQ/L) PERITONEAL DIALYSIS SOLUTION WITH 2.5%W/V DEXTROSE RENASOL300 LOW CALCIUM (2.5MEQ/L) PERITONEAL DIALYSIS SOLUTION WITH 4.25%W/V DEXTROSE COMPOSITION/L Dextrose Monohydrate 15 g 25 g 42.5 g Sodium Chloride (NaCl) 5.38 g 5.38 g 5.38 g Sodium Lactate (C 3 H 5 NaO 3 ) 4.48 g 4.48 g 4.48 g Calcium chloride dihydrate (CaCl 2 ·2H 2 O) 0.183 g 0.183 g 0.183 g Magnesium chloride hexahydrate, (MgCl 2 ·6H 2 O) 0.0508 g 0.0508 g 0.0508 g IONIC CONCENTRATION (MEQ/L) Sodium 132 132 132 Calcium 2.5 2.5 2.5 Magnesium 0.5 0.5 0.5 Chloride 95 95 95 Lactate 40 40 40 OSMOLALITY (MOSMOL/L) (CALC.) 344 395 483 PH 5.0 – 6.5 5.0 – 6.5 5.0 – 6.5 WHAT IS IN THIS LEAFLET? 1. What RENASOL is used for 2. How RENASOL works 3. Before you use RENASOL 4. How to use RENASOL 5. While you are using it 6. Side effects 7. Storage and Disposal of RENASOL 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT RENASOL_ _IS USED FOR? RENASOL in Continuous Ambulatory Peritoneal Dialysis (CAPD) system container are indicated for use in chronic renal failure patients being maintained on CAPD when nondialytic medical therapy is judged to be inadequate. Peritoneal dialysis uses the body's own peritoneal or abdominal membrane as a filter to cleanse the blood. The peritoneal membrane lines the peritoneal cavity. HOW RENASOL WORKS? RENASOL is a peritoneal dialysis procedure for removing toxic substances and metabolites normally excreted by the kidneys, and for aiding in the regulation of fluid and electrolyte balance. The procedure is accomplished by insti Olvassa el a teljes dokumentumot
RENASOL100 LOW CALCIUM (2.5MEQ/L) PERITONEAL DIALYSIS SOLUTION WITH 1.5%W/V DEXTROSE RENASOL200 LOW CALCIUM (2.5MEQ/L) PERITONEAL DIALYSIS SOLUTION WITH 2.5%W/V DEXTROSE RENASOL300 LOW CALCIUM (2.5MEQ/L) PERITONEAL DIALYSIS SOLUTION WITH 4.25%W/V DEXTROSE For Continuous Ambulatory Peritoneal Dialysis (CAPD) and Automated Peritoneal Dialysis (APD) For intraperitoneal administration only 1.0) PRODUCT DESCRIPTION Renasol Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with with 1.5% Dextrose/2.5% Dextrose/4.25% Dextrose is clear sterile, nonpyrogenic solution in CAPD system container for intraperitoneal administration only. 2.0) QUALITATIVE AND QUANTITATIVE COMPOSITION ELECTROLYTES RENASOL100 LOW CALCIUM (2.5MEQ/L) PERITONEAL DIALYSIS SOLUTION WITH 1.5%W/V DEXTROSE RENASOL200 LOW CALCIUM (2.5MEQ/L) PERITONEAL DIALYSIS SOLUTION WITH 2.5%W/V DEXTROSE RENASOL300 LOW CALCIUM (2.5MEQ/L) PERITONEAL DIALYSIS SOLUTION WITH 4.25%W/V DEXTROSE COMPOSITION/L Dextrose Monohydrate 15 g 25 g 42.5 g Sodium Chloride (NaCl) 5.38 g 5.38 g 5.38 g Sodium Lactate (C 3 H 5 NaO 3 ) 4.48 g 4.48 g 4.48 g Calcium Chloride (CaCl 2 ·2H 2 O) 0.183 g 0.183 g 0.183 g Magnesium Chloride, (MgCl 2 ·6H 2 O) 0.0508 g 0.0508 g 0.0508 g IONIC CONCENTRATION (MEQ/L) Sodium 132 132 132 Calcium 2.5 2.5 2.5 Magnesium 0.5 0.5 0.5 Chloride 95 95 95 Lactate 40 40 40 OSMOLALITY (MOSMOL/L) (CALC.) 344 395 483 PH 5.0 – 6.5 5.0 – 6.5 5.0 – 6.5 3.0) PHARMACOLOGICAL PROPERTIES 3.1) PHARMACODYNAMICS Pharmacotherapeutic group: Peritoneal Dialytics, Hypertonic solutions ATC code: B05DB Peritoneal dialysis is a procedure for removing toxic substances and metabolites normally excreted by the kidneys, and for aiding in the regulation of fluid and electrolyte balance. The procedure is accomplished by instilling peritoneal dialysis fluid through a conduit into the peritoneal cavity. Toxic substances and metabolites, present in high concentration in the blood, cross the peritoneal membrane into the dialyzing fluid. Dextrose in the dialyzing fluid is used to produce Olvassa el a teljes dokumentumot