Country: Israel
Bahasa: Inggeris
Sumber: Ministry of Health
CALCIUM CHLORIDE; GLUCOSE AS MONOHYDRATE; LACTIC ACID AS SODIUM; MAGNESIUM CHLORIDE; SODIUM CHLORIDE
FRESENIUS MEDICAL CARE ISRAEL P.B. LTD
B05CB10
SOLUTION FOR PERITONEAL DIALYSIS
MAGNESIUM CHLORIDE 0.1017 G; CALCIUM CHLORIDE 0.1838 G; GLUCOSE AS MONOHYDRATE 16.5 G; LACTIC ACID AS SODIUM 3.925 G; SODIUM CHLORIDE 5.786 G
PERITONEAL DIALYSIS
Required
FRESENIUS MEDICAL CARE DEUTSCHLAND GmbH
COMBINATIONS
COMBINATIONS
For use in patients with end-stage (decompensated)chronic renal failure of any origin which can be treated with peritoneal dealysis.17/10/2017 בקשה לשינוי משטר מינוןשינוי משטר מינון בהתאם למאושר באירופה
2021-06-30
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only CAPD 17 SOLUTION FOR PERITONEAL DIALYSIS CAPD 18 SOLUTION FOR PERITONEAL DIALYSIS CAPD 19 SOLUTION FOR PERITONEAL DIALYSIS COMPOSITION: Each liter of solution contains: CAPD 17 CAPD 18 CAPD 19 CALCIUM CHLORIDE DIHYDRATE 0.1838 g 0.1838 g 0.1838 g SODIUM CHLORIDE 5.786 g 5.786 g 5.786 g SODIUM-)S(-LACTATE SOLUTION )Sodium-)S(-lactate( 7.85 g )3.925 g( 7.85 g )3.925 g( 7.85 g )3.925 g( MAGNESIUM CHLORIDE HEXAHYDRATE 0.1017 g 0.1017 g 0.1017 g GLUCOSE MONOHYDRATE )Glucose( )Fructose, up to( 16.5 g )15.0 g( )0.75 g( 46.75 g )42.5 g( )2.1 g( 25 g )22.73 g( )1.1 g( CA 2+ 1.25 mmol/l 1.25 mmol/l 1.25 mmol/l NA + 134 mmol/l 134 mmol/l 134 mmol/l MG 2+ 0.5 mmol/l 0.5 mmol/l 0.5 mmol/l CL - 102.5 mmol/l 102.5 mmol/l 102.5 mmol/l )S(-LACTATE 35 mmol/l 35 mmol/l 35 mmol/l GLUCOSE 83.2 mmol/l 235.8 mmol/l 126.1 mmol/l THEORETICAL OSMOLARITY: 356 mOsm/l 509 mOsm/l 399 mOsm/l pH ≈ 5.5 Inactive ingredients and allergens – see section 6 “Further information” and section 2 “Before using the medicine”. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor, pharmacist or nurse. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their illness is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? For use in patients suffering from end-stage chronic renal failure who are being treated with peritoneal dialysis. THERAPEUTIC GROUP: Peritoneal dialytics, hypertonic solutions 2. BEFORE USING THE MEDICINE: DO NOT USE THE MEDICINE IF: • You are sensitive )allergic( to the active ingredients or to any of the additional ingredients contained in the medicine. • The level of potassium in your blood is very low. • The level of calcium in your blood is very low. • You suffer from di Baca dokumen lengkap
1/10 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT CAPD 17 SOLUTION FOR PERITONEAL DIALYSIS CAPD 18 SOLUTION FOR PERITONEAL DIALYSIS CAPD 19 SOLUTION FOR PERITONEAL DIALYSIS 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 litre contains: CAPD 17 CAPD 18 CAPD 19 Calcium chloride dihydrate 0.1838 g 0.1838 g 0.1838 g Sodium chloride 5.786 g 5.786 g 5.786 g Sodium-(S)-lactate solution (sodium-(S)-lactate) 7.85 g (3.925 g) 7.85 g (3.925 g) 7.85 g (3.925 g) Magnesium chloride hexahydrate 0.1017 g 0.1017 g 0.1017 g Glucose monohydrate 16.5 g (15.0 g anhydrous glucose) up to 0.75 g fructose 46.75 g (42.5 g anhydrous glucose) up to 2.1 g fructose 25.0 g (22.73 g anhydrous glucose) up to 1.1 g fructose Ca 2+ 1.25 mmol/l 1.25 mmol/l 1.25 mmol/l Na + 134 mmol/l 134 mmol/l 134 mmol/l Mg 2+ 0.5 mmol/l 0.5 mmol/l 0.5 mmol/l Cl - 102.5 mmol/l 102.5 mmol/l 102.5 mmol/l (S)-lactate 35 mmol/l 35 mmol/l 35 mmol/l Glucose 83.2 mmol/l 235.8 mmol/l 126.1 mmol/l For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Solution for peritoneal dialysis Clear colourless to slightly yellow solution CAPD 17 CAPD 18 CAPD 19 Theoretical osmolarity: 356 mOsm/l 509 mOsm/l 399 mOsm/l pH 5.5 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For use in patients with end-stage (decompensated) chronic renal failure of any origin which can be treated with peritoneal dialysis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY CAPD 17/18/19 is exclusively indicated for intraperitoneal use. The mode of therapy, frequency of administration, and dwell time required will be specified by the attending physician. Continuous ambulatory peritoneal dialysis (CAPD) 2/10 ADULTS: Unless otherwise prescribed, patients will receive an infusion of 2000 ml solution per exchange four times a day. After a dwell time between 2 and 10 hours the solution will be drained. Adjustment of dosage, volume and number of exchanges will be necessary for individual patients. If dilation pain occurs at the commencement of peritoneal dialysis t Baca dokumen lengkap