Kraj: Australia
Język: angielski
Źródło: 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
2000mL x 4 bags, 2500mL 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
stay•safe balance CMI v3.0 (June 2022) 1 stay•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 stay•safe balance? stay•safe balance contains the active ingredients glucose monohydrate, calcium chloride dihydrate, sodium chloride, sodium S- lactate and magnesium chloride hexahydrate. stay•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 stay•safe balance? in the full CMI. 2. What should I know before I use stay•safe balance? Do not use if you have ever had an allergic reaction to stay•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 stay•safe balance? in the full CMI. 3. What if I am taking other medicines? Some medicines may interfere with stay•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 stay•safe balance? • Follow all directions given to you by your doctor or pharmacist carefully. • Qualified nurses will train you in the use of stay•safe balance 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 instructions can be found in Section 4. Przeczytaj cały dokument
_AUSTRALIAN _ _PRODUCT _ _INFORMATION _ _– _ _STAY•SAFE _ _BALANCE _ _(GLUCOSE _ _MONOHYDRATE, CALCIUM CHLORIDE DIHYDRATE, SODIUM CHLORIDE, SODIUM (S)-LACTATE _ _AND MAGNESIUM CHLORIDE HEXAHYDRATE) PERITONEAL DIALYSIS SOLUTIONS_ _STAY•SAFE _ _BALANCE _ 1.5% GLUCOSE 1.75 MMOL/L CALCIUM PERITONEAL DIALYSIS SOLUTION _STAY•SAFE _ _BALANCE _ 2.3% GLUCOSE 1.75 MMOL/L CALCIUM PERITONEAL DIALYSIS SOLUTION _STAY•SAFE _ _BALANCE _ 4.25% GLUCOSE 1.75 MMOL/L CALCIUM PERITONEAL DIALYSIS SOLUTION _STAY•SAFE _ _BALANCE _ 1.5% GLUCOSE 1.25 MMOL/L CALCIUM PERITONEAL DIALYSIS SOLUTION _STAY•SAFE _ _BALANCE _ 2.3% GLUCOSE 1.25 MMOL/L CALCIUM PERITONEAL DIALYSIS SOLUTION _STAY•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 _STAY•SAFE BALANCE _ready-to-use solution is available in a number of different strengths in various calcium ranges. _ STAY•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 solution contains: _STAY•SAFE_ _BALANCE _ 1.5% glucose 1.25 mmol/L calcium _STAY•SAFE_ _BALANCE _ 2.3% glucose 1.25 mmol/L calcium _STAY•SAFE _ _BALANCE _ 4.25% glucose 1.25 mmol/L calcium _STAY•SAFE_ _BALANCE _ 1.5% glucose 1.75 mmol/L calcium _STAY•SAFE_ _BALANCE _ 2.3% glucose 1.75 mmol/L calcium _STAY•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 11.279 g 11.279 g Magnesium chloride hex Przeczytaj cały dokument