Riik: Austraalia
keel: inglise
Allikas: Department of Health (Therapeutic Goods Administration)
chloride, Quantity: 102.5 mmol/L; magnesium chloride hexahydrate, Quantity: 0.1017 g/L; lactate, Quantity: 35 mmol/L; magnesium, Quantity: 0.5 mmol/L; calcium, Quantity: 1.25 mmol/L; calcium chloride dihydrate, Quantity: 0.1838 g/L; sodium chloride, Quantity: 5.786 g/L; glucose monohydrate, Quantity: 46.75 g/L; sodium lactate, Quantity: 3.925 g/L; sodium, Quantity: 134 mmol/L
Fresenius Medical Care Australia Pty Ltd
Solution, irrigation
Excipient Ingredients: hydrochloric acid; water for injections; sodium hydroxide
Intraperitoneal
2 x 6000mL, 4 x 3000mL, 2 x 5000mL
Not scheduled. Not considered by committee
For use as a peritoneal dialysis solution in the management of end stage renal disease and acute renal failure.
Visual Identification: Clear solution.; Container Type: Bag; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
1999-07-19
Page 1 of 4 CMI FOR _CAPD/DPCA_ _SLEEP•SAFE_ Revised June 2020 _CAPD/DPCA SLEEP_ _SAFE _ _solution for peritoneal dialysis _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about _CAPD/DPCA sleep_ _safe _ peritoneal dialysis solutions and how they are used. It does not contain all available information. It does not take the place of talking to your doctor or nurse. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING _CAPD/DPCA _ _SLEEP_ _SAFE_, ASK YOUR DOCTOR OR NURSE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT _CAPD/DPCA _ _SLEEP_ _SAFE _IS USED FOR _CAPD/DPCA sleep_ _safe _is a clear sterile solution for peritoneal dialysis containing electrolytes and glucose with a neutral pH, supplied in flexible plastic bags. The solution bag comes with a tubing system in a clear protective overwrap The _CAPD/DPCA sleep_ _safe _ solutions can only be used with the _sleep_ _safe _cycler. _CAPD/DPCA sleep_ _safe _is used to treat acute and chronic kidney failure. It helps with the removal of waste products and excess fluid from your blood when your kidneys do not work properly. BEFORE YOU USE _CAPD/DPCA _ _SLEEP_ _SAFE _ _ _ _WHEN YOU MUST NOT USE IT _ _CAPD/DPCA SLEEP_ _SAFE _MUST NOT BE USED FOR INTRAVENOUS INFUSION DO NOT USE _CAPD/DPCA _ _SLEEP_ _SAFE: _ if the expiry date on the pack has passed if the packaging shows signs of being damaged or tampered with, or if you think it may be damaged if the solution in the bag looks cloudy or has small specks in it if you have low potassium levels (hypokalaemia) if you have low calcium levels (hypocalcaemia) DO NOT USE _CAPD/DPCA 18, 19 _ _SLEEP_ _SAFE _SOLUTIONS: if you have low blood pressure or are dehydrated if you have suffered acute blood loss or have muscle w Lugege kogu dokumenti
1 AUSTRALIAN PRODUCT INFORMATION – CAPD/DPCA SLEEP•SAFE RANGE OF STERILE PERITONEAL DIALYSIS SOLUTIONS CAPD/DPCA 17 SLEEP•SAFE CAPD/DPCA 18 SLEEP •SAFE CAPD/DPCA 19 SLEEP •SAFE 1 NAME OF THE MEDICINE Calcium, calcium chloride dihydrate, chloride, glucose monohydrate, lactate, magnesium, magnesium chloride hexahydrate, sodium, sodium chloride, sodium lactate. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CAPD/DPCA sleep•safe is available in a number of different strengths in various calcium ranges. The strengths have the following compositions: SOLUTIONS CONTAINING 1.25 MMOL/L CALCIUM CAPD/DPCA 17 CAPD/DPCA 18 CAPD/DPCA 19 Sodium chloride Sodium lactate Calcium chloride dihydrate Magnesium chloride hexahydrate Glucose monohydrate ≈Glucose anhydrous 5.786 g/L 3.925 g/L 0.1838 g/L 0.1017 g/L 16.5 g/L 15.0 g/L 5.786 g/L 3.925 g/L 0.1838 g/L 0.1017 g/L 46.75 g/L 42.5 g/L 5.786 g/L 3.925 g/L 0.1838 g/L 0.1017 g/L 25.0 g/L 22.7 g/L Na + Ca ++ Mg ++ Cl - Lactate - Glucose 134 mmol/L 1.25 mmol/L 0.5 mmol/L 102.5 mmol/L 35 mmol/L 83.2 mmol/L 134 mmol/L 1.25 mmol/L 0.5 mmol/L 102.5 mmol/L 35 mmol/L 235.8 mmol/L 134 mmol/L 1.25 mmol/L 0.5 mmol/L 102.5 mmol/L 35 mmol/L 126.1 mmol/L For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Irrigation solution. CAPD/DPCA sleep•safe is a clear, sterile water-based solution. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS 2 For use as a peritoneal dialysis solution in the management of end-stage renal disease and acute renal failure. 4.2 D OSE AND METHOD OF ADMINISTRATION Sleep•safe solutions are for use in one patient on one occasion only. They contain no antimicrobial preservative. The solution should not be used if it is not clear, or if leaks are detected in the bag. The choice of peritoneal dialysate will depend on each individual clinical situation and must be at the discretion of the treating physician. The number of bag exchanges and the volumes are dependant on body weight, body size and residual kidney function. The us Lugege kogu dokumenti