Страна: Мальта
мова: англійська
Джерело: Medicines Authority
CALCIUM, GLUCOSE
Fresenius Medical Care Deutschland GmbH D-61346 Bad Homburg, Germany
B05DB
CALCIUM 1.75 mmol/l GLUCOSE 1.5 % (W/V)
SOLUTION FOR PERITONEAL DIALYSIS
CALCIUM 1.75 mmol/l GLUCOSE 1.5 % (W/V)
POM
BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
Withdrawn
2006-04-06
Package leaflet balance 1.5% glucose, 1.75 mmol/l calcium Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER _balance_ 1.5% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have any further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What _balance_ is and what it is used for 2. What you need to know before you use _balance_ 3. How to use _balance_ 4. Possible side effects 5. How to store _balance_ 6. Contents of the pack and other information 1. WHAT _BALANCE_ IS AND WHAT IT IS USED FOR _BALANCE_ IS USED FOR CLEANING THE BLOOD via the peritoneum in patients with end-stage chronic kidney failure. This type of blood cleaning is called peritoneal dialysis. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE _BALANCE_ DO NOT USE _BALANCE_ 1.5% GLUCOSE, 1.75 MMOL/L CALCIUM • if the level of POTASSIUM IN YOUR BLOOD IS VERY LOW • if the level of CALCIUM IN YOUR BLOOD IS VERY HIGH • if you have a DISORDER OF METABOLISM KNOWN AS LACTIC ACIDOSIS PERITONEAL DIALYSIS TREATMENT MUST NOT BE STARTED IF YOU HAVE • ALTERATIONS IN THE ABDOMINAL REGION such as - injuries or after surgery - burns - large inflammatory skin reactions - inflammation of the peritoneum - non-healing weeping wounds - umbilical, inguinal or diaphragmatic hernias - tumours in the abdomen or bowel • inflammatory bowel diseases Package leaflet balance 1.5% glucose, 1.75 mmol/l calcium Page 2 of 9 • intestinal obstruction • lung diseases, particularly pneumonia • blood poisoning caused by bacteria • extremely high le Прочитайте повний документ
Page 1 of 15 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT _balance_ 1.5% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis _balance_ 2.3% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis _balance_ 4.25% glucose, 1.25 mmol/l calcium, solution for peritoneal dialysis _balance_ 1.5% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis _balance_ 2.3% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis _balance_ 4.25% glucose, 1.75 mmol/l calcium, solution for peritoneal dialysis 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _balance_ 1.5%/2.3%/4.25% glucose, 1.25/1.75 mmol/l calcium is delivered in a double chamber bag. One chamber contains the alkaline lactate solution, the other chamber contains the acidic glucose- based electrolyte solution. Mixing of both solutions by opening the middle seam between the two chambers results in the neutral ready-to-use solution. BEFORE RECONSTITUTION 1 litre of acidic glucose based electrolyte solution contains: _balance_ 1.5% glucose, 1.25 mmol/l calcium _balance_ 2.3% glucose, 1.25 mmol/l calcium _balance_ 4.25% glucose, 1.25 mmol/l calcium _balance_ 1.5% glucose, 1.75 mmol/l calcium _balance_ 2.3% glucose, 1.75 mmol/l calcium _balance_ 4.25% glucose, 1.75 mmol/l calcium Calcium chloride dihydrate 0.3675 g 0.3675 g 0.3675 g 0.5145 g 0.5145 g 0.5145 g Sodium chloride 11.279 g 11.279 g 11.279 g 11.279 g 11.279 g 11.279 g Magnesium chloride hexahydrate 0.2033 g 0.2033 g 0.2033 g 0.2033 g 0.2033 g 0.2033 g Glucose monohydrate (anhydrous glucose) 33.0 g (30.0 g) 50.0 g (45.46 g) 93.5 g (85.0 g) 33.0 g (30.0 g) 50.0 g (45.46 g) 93.5 g (85.0 g) 1 litre of alkaline lactate solution contains: Sodium (S)-lactate solution 15.69 g (sodium (S)-lactate 7.85 g) Page 2 of 15 AFTER RECONSTITUTION 1 litre of the neutral _ _ ready-to-use solution contains: _balance_ 1.5% glucose, 1.25 mmol/l calcium _balance_ 2.3% glucose, 1.25 mmol/l calcium _balance_ 4.25% glucose, 1.25 mmol/l calcium _balance_ 1.5% glucose, 1.75 mmol/l calcium Прочитайте повний документ