País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
icodextrin, Quantity: 75 g/L; sodium chloride, Quantity: 5.4 g/L; sodium lactate, Quantity: 4.5 g/L; calcium chloride dihydrate, Quantity: 257 mg/L; magnesium chloride hexahydrate, Quantity: 51 mg/L
Vantive Pty Ltd
calcium chloride dihydrate,Icodextrin,magnesium chloride hexahydrate,sodium chloride,sodium lactate
Solution, dialysis
Excipient Ingredients: water for injections; sodium hydroxide; hydrochloric acid
Intraperitoneal
3000mL, 2000mL, 2500mL, 1500mL
Not scheduled. Not considered by committee
Indicated as "an alternative osmotic agent in dialysis solution for the long dwell exchange in patients treated with peritoneal dialysis."
Visual Identification: EXTRANEAL IS PRESENTED IN A FLEXIBLE PVC CONTAINER. IT IS A CLEAR SOLUTION, FREE FROM VISIBLE PARTICULATES.; Container Type: Bag; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Licence status A
2002-10-29
PRODUCT INFORMATION CONSUMER MEDICINE INFORMATION EXTRANEAL (ICODEXTRIN 7.5%) BLOOD GLUCOSE MANAGEMENT WITH EXTRANEAL MUST BE DONE WITH A GLUCOSE-SPECIFIC METHOD TO AVOID INTERFERENCE RESULTING IN UNRECOGNISED HYPOGLYCEMIA. IF NON- SPECIFIC GLUCOSE TEST METHODS (GDH-PQQ) ARE USED, LOSS OF CONSCIOUSNESS, NEUROLOGICAL DAMAGE AND DEATH MAY OCCUR. WHAT IS IN THIS LEAFLET THIS LEAFLET ANSWERS SOME MORE COMMON QUESTIONS ABOUT EXTRANEAL. IT DOES NOT CONTAIN ALL OF THE AVAILABLE INFORMATION. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Extraneal against the benefit they expect it will have for you. It does not take the place of talking to your Doctor. If you have any concerns about taking the medicine, ask your doctor or Renal nurse. Keep this leaflet with the medicine, as you may need to read it again. WHAT EXTRANEAL IS USED FOR Extraneal is used as a replacement for a single glucose exchange (e.g. Dianeal product), as part of a Continuous Ambulatory Peritoneal Dialysis (CAPD) or Automated Peritoneal Dialysis (APD) regimen for chronic renal failure. BEFORE THE USE OF EXTRANEAL FORMULA DO NOT USE EXTRANEAL IF: You have a known allergy to any of the ingredients listed at the end of this leaflet or to starch. You have a glycogen storage disease. Additionally tell your Doctor if you have recently had surgery on your stomach or if you have any other stomach complaints. PRECAUTIONS: Blood glucose measurement must be done with a glucose-specific method to prevent maltose interference with test results. Since falsely elevated glucose levels have been observed with blood glucose monitoring devices and test strips that use glucose dehydrogenase pyrroloquinolinequinone (GDH PQQ)-based methods, GDH PQQ-based methods should not be used to measure glucose levels in patients administered EXTRANEAL. Tell your doctor if you: • Have a condition that restricts normal nutrition (you do not eat well) • Have a lung or breathing problem • Have low potassium levels in your blood • Have high cal Leia o documento completo
EXTRANEAL Peritoneal Dialysis Solution Version 1.2 1 of 17 AUSTRALIAN PRODUCT INFORMATION – EXTRANEAL PERITONEAL DIALYSIS SOLUTIONS (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE DIHYDRATE AND MAGNESIUM CHLORIDE HEXAHYDRATE) BLOOD GLUCOSE MANAGEMENT WITH EXTRANEAL PERITONEAL DIALYSIS (PD) SOLUTION MUST BE DONE WITH A GLUCOSE-SPECIFIC METHOD TO AVOID INTERFERENCE RESULTING IN UNRECOGNISED HYPOGLYCAEMIA. IF NON-SPECIFIC GLUCOSE TEST METHODS GLUCOSE DEHYDROGENASE PYRROLOQUINOLINEQUINONE (GDH-PQQ), GLUCOSE-DYE- OXIDOREDUCTASE (GDO) OR GLUCOSE DEHYDROGENASE FLAVIN-ADENINE DINUCLEOTIDE (GDH-FAD)) - BASED METHODS ARE USED, LOSS OF CONSCIOUSNESS, NEUROLOGICAL DAMAGE AND DEATH MAY OCCUR (SEE SECTION 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). 1 NAME OF THE MEDICINE Icodextrin, sodium chloride, sodium lactate, calcium chloride dihydrate and magnesium chloride hexahydrate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION EXTRANEAL PD solution contains icodextrin as the active ingredient at a concentration of 7.5% w/v in an electrolyte solution. Icodextrin is an α (1-4) linked glucose polymer which contains 5 - 10% α (1-6) links. It is produced by the hydrolysis of starch and fractionated by membrane separation technology to produce material with the desired molecular weight distribution (85% w/w within the molecular weight range 1,640 - 45,000). EXTRANEAL PD solution is presented in a flexible PVC bag and is sterile, non-pyrogenic and contains no bacteriostatic or antimicrobial agents or added buffers. Each 1000mL of EXTRANEAL PD solution contains: ACTIVE INGREDIENT QUANTITY Icodextrin 75 g Sodium chloride 5.4 g Sodium lactate 4.5 g Calcium chloride dihydrate 257 mg Magnesium chloride hexahydrate 51 mg EXCIPIENT Sodium hydroxide pH adjustment Hydrochloric acid pH adjustment Water for Injections q.s. to 1000 mL SOLUTION PROPERTIES Osmolarity 284 mOsm/L EXTRANEAL Peritoneal Dialysis Solution Version 1.2 2 of 17 Electrolyte Solution Content per 1000mL: Sodium 132 mmol Calcium 1.75 mmol Magnesium 0.25 mmol Chlo Leia o documento completo