Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
sodium bicarbonate, Quantity: 2.1 g/L; sodium lactate, Quantity: 1.68 g/L; magnesium chloride hexahydrate, Quantity: 51 mg/L; glucose monohydrate, Quantity: 25 g/L (Equivalent: glucose, Qty 22.7 g/L); calcium chloride dihydrate, Quantity: 0.184 g/L; sodium chloride, Quantity: 5.38 g/L
Vantive Pty Ltd
calcium chloride dihydrate,glucose monohydrate,magnesium chloride hexahydrate,sodium bicarbonate,sodium chloride,sodium lactate
Solution, dialysis
Excipient Ingredients: water for injections; hydrochloric acid; sodium hydroxide
Intraperitoneal
2500 mL, 5000 mL, 2000 mL, 1500 mL
Not scheduled. Not considered by committee
Physioneal 40 is indicated for use in peritoneal dialysis in patients with acute or chronic renal failure.
Visual Identification: Clear solution contained in a dual compartment Clear Flex PL 17552 plastic bag with medication port, access system and hanger.; Container Type: Bag; Container Material: Other composite material; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2005-05-31
1 CONSUMER MEDICINE INFORMATION PHYSIONEAL 40 PERITONEAL DIALYSIS SOLUTION READ THIS ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. Keep this leaflet in safe place. You may need to read it again. If you have further questions, please ask your doctor or your pharmacist. This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours IF YOU HAVE ANY CONCERNS ABOUT TAKING THE MEDICINE, ASK YOUR DOCTOR OR RENAL NURSE. WHAT IS IN THIS LEAFLET? What is PHYSIONEAL 40 and what is it used for? Before you use PHYSIONEAL 40 How to take PHYSIONEAL 40 Possible side effects Storing PHYSIONEAL 40 WHAT IS PHYSIONEAL 40 AND WHAT IT IS USED FOR? PHYSIONEAL 40 is a solution for peritoneal dialysis. PHYSIONEAL 40 is prescribed to patients whose kidneys are either temporarily or permanently not working. It removes water and waste products from the blood and corrects abnormal blood levels of salt. The higher the glucose strength in the solution, the greater the amount of water that can be removed from the blood. BEFORE YOU USE PHYSIONEAL 40: DO NOT USE PHYSIONEAL 40: _ _ There are no times when PHYSIONEAL 40 is not suitable for use during peritoneal dialysis. However, there are several conditions in which special precautions should be taken (see Precautions section below). TAKE SPECIAL CARE WITH PHYSIONEAL 40_ _ Your doctor will advise you about particular precautions as they apply to you. PHYSIONEAL 40 _is for intraperitoneal administration only_. PRODUCT IS FOR SINGLE USE IN ONE PATIENT ONLY. • It is generally not advisable to use peritoneal dialysis in the presence of serious conditions affecting the abdominal wall (e.g. skin infections or burns, recent surgery, hernia) or abdominal cavity (e.g. blockage of the intestine, fibrous bands causing abnormal joining of internal surfaces (adhesions), bowel perforation, problems with the diaphragm, tumours and advanced pregnancy) and in severe breat Leggi il documento completo
Physioneal 40 Glucose Version 1.0 1 of 15 AUSTRALIAN PRODUCT INFORMATION PHYSIONEAL 40 GLUCOSE (%W/V) SOLUTION FOR PERITONEAL DIALYSIS 1 NAME OF THE MEDICINE Glucose, Calcium Chloride Dihydrate, Magnesium Chloride Hexahydrate, Sodium Chloride, Sodium Lactate and Sodium Bicarbonate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION COMPOSITION: COMPOSITION OF THE SOLUTION IN EACH COMPARTMENT BEFORE MIXING IN G/L VIAFLEX BAG CLEAR FLEX BAG GLUCOSE 1.36% GLUCOSE 2.27% GLUCOSE 3.86% GLUCOSE 1.36% GLUCOSE 2.27% GLUCOSE 3.86% GLUCOSE BAG “A” Glucose monohydrate Calcium Chloride Dihydrate Magnesium Chloride Hexahydrate 37.50 0.507 0.140 62.60 0.507 0.140 106.50 0.507 0.140 18.2 0.245 0.068 30.3 0.245 0.068 51.5 0.245 0.068 BUFFER BAG “B” Sodium Chloride Sodium Bicarbonate Sodium Lactate 8.43 3.29 2.63 8.43 3.29 2.63 8.43 3.29 2.63 19.95 9.29 6.73 19.95 9.29 6.73 19.95 9.29 6.73 FINAL SOLUTION AFTER MIXING G/L Glucose monohydrate Sodium Chloride Calcium Chloride Dihydrate Magnesium Chloride Hexahydrate Sodium Bicarbonate Sodium Lactate 13.6 5.38 0.184 0.051 2.10 1.68 22.7 5.38 0.184 0.051 2.10 1.68 38.6 5.38 0.184 0.051 2.10 1.68 1000 mL of final solution after mixing corresponds to: • Viaflex Bag: 362.5 mL of solution A (Glucose) and 637.5 mL of solution B (Buffer). • Clear Flex Bag: 750 mL of solution A (Glucose) and 250 mL of solution B (Buffer). • The pH of the final solution is 7.4. • Hydrochloric acid (Solution A) and Sodium hydroxide (Solution B) are used for pH adjustment in the Clear Flex presentation. Physioneal 40 Glucose Version 1.0 2 of 15 COMPOSITION OF THE FINAL SOLUTION AFTER MIXING IN MMOL/L GLUCOSE 1.36% GLUCOSE 2.27% GLUCOSE 3.86% Glucose (C 6 H 12 O 6 ) Sodium (Na + ) Calcium (Ca ++ ) Magnesium (Mg ++ ) Chloride (Cl - ) Bicarbonate (HCO 3 - ) Lactate (C 3 H 5 O 3 - ) 75.5 132 1.25 0.25 95 25 15 126 132 1.25 0.25 95 25 15 214 132 1.25 0.25 95 25 15 Osmolarity* 344 mOsmol/L 395 mOsmol/L 483 mOsmol/L *Osmolarity is equivalent to osmolality in infinitively diluted conditions, including total diss Leggi il documento completo