מדינה: אוסטרליה
שפה: אנגלית
מקור: Department of Health (Therapeutic Goods Administration)
sodium (S)-lactate, Quantity: 7.85 g/L
Fresenius Medical Care Australia Pty Ltd
calcium chloride dihydrate,glucose monohydrate,hydrochloric acid,magnesium chloride hexahydrate,sodium bicarbonate,sodium (S)-la
Solution, irrigation
Excipient Ingredients: water for injections; sodium bicarbonate
Intraperitoneal
3000mL x 4 bags
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: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2003-06-20
sleep•safe balance CMI v3.0 (June 2022) 1 sleep•safe balance Consumer Medicine Information (CMI) summary The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist. 1. Why am I using sleep•safe balance? sleep•safe balance contains the active ingredients glucose monohydrate, calcium chloride dihydrate, sodium chloride, sodium S-lactate and magnesium chloride hexahydrate. sleep•safe balance is used to treat acute and end-stage chronic kidney failure. It helps with the removal of waste products and excess fluid from your blood when your kidneys do not work properly. For more information, see Section 1. Why am I using sleep•safe balance? in the full CMI. 2. What should I know before I use sleep•safe balance? Do not use if you have ever had an allergic reaction to sleep•safe balance or any of the ingredients listed at the end of the CMI. Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding. For more information, see Section 2. What should I know before I use sleep•safe balance? in the full CMI. 3. What if I am taking other medicines? Some medicines may interfere with sleep•safe balance and affect how it works. A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI. 4. How do I use sleep•safe balance? • Follow all directions given to you by your doctor or pharmacist carefully. • Qualified nurses will train you in the use of sleep•safe balance with the sleep•safe cycler at the hospital or the dialysis clinic. Your doctor will make certain that you can carry out peritoneal dialysis correctly before you are discharged from the hospital or dialysis clinic, and before you do it at home. • You must follow the procedures and instructions given by your nurse every time you do peritoneal dialysis. Contact your doctor if you are having problems or are unsure about any of the techniques. More קרא את המסמך השלם
_AUSTRALIAN _ _PRODUCT _ _INFORMATION _ _– _ _SLEEP•SAFE _ _BALANCE _ _(GLUCOSE _ _MONOHYDRATE, CALCIUM CHLORIDE DIHYDRATE, SODIUM CHLORIDE, SODIUM (S)- _ _LACTATE _ _AND _ _MAGNESIUM _ _CHLORIDE _ _HEXAHYDRATE) _ _PERITONEAL _ _DIALYSIS _ _SOLUTIONS_ _SLEEP•SAFE _ _BALANCE _ 1.5% GLUCOSE 1.75 MMOL/L CALCIUM PERITONEAL DIALYSIS SOLUTION _SLEEP•SAFE _ _BALANCE _ 2.3% GLUCOSE 1.75 MMOL/L CALCIUM PERITONEAL DIALYSIS SOLUTION _SLEEP•SAFE _ _BALANCE _ 4.25% GLUCOSE 1.75 MMOL/L CALCIUM PERITONEAL DIALYSIS SOLUTION _SLEEP•SAFE _ _BALANCE _ 1.5% GLUCOSE 1.25 MMOL/L CALCIUM PERITONEAL DIALYSIS SOLUTION _SLEEP•SAFE _ _BALANCE _ 2.3% GLUCOSE 1.25 MMOL/L CALCIUM PERITONEAL DIALYSIS SOLUTION _SLEEP•SAFE _ _BALANCE _ 4.25% GLUCOSE 1.25 MMOL/L CALCIUM PERITONEAL DIALYSIS SOLUTION 1 NAME OF THE MEDICINE Sodium (S)-lactate, calcium chloride dihydrate, glucose monohydrate, magnesium chloride hexahydrate, sodium chloride. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION _SLEEP•SAFE BALANCE_ ready-to-use solution is available in a number of different strengths in various calcium ranges. _ SLEEP•SAFE 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: Table 1: 1 litre of acidic glucose based electrolyte solutions contains: _SLEEP•SAFE _ _BALANCE _ 1.5% glucose 1.25 mmol/L calcium _SLEEP•SAFE _ _BALANCE _ 2.3% glucose 1.25 mmol/L calcium _SLEEP•SAFE _ _BALANCE _ 4.25% glucose 1.25 mmol/L calcium _SLEEP•SAFE _ _BALANCE _ 1.5% glucose 1.75 mmol/L calcium _SLEEP•SAFE _ _BALANCE _ 2.3% glucose 1.75 mmol/L calcium _SLEEP•SAFE _ _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 קרא את המסמך השלם