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 instructions can be found in Section 4. How do I use sleep•safe balance? in the full CMI.
5. What should I know while using sleep•safe balance?
Things you should do |
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Things you should not do |
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Driving or using machines |
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Looking after your medicine |
Store sleep•safe balance below 25°C. Do not refrigerate.
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For more information, see Section 5. What should I know while using sleep•safe balance? in the full CMI.
6. Are there any side effects?
You may experience side effects such as hernia, shoulder pain, peritonitis, abdominal pain, inflammation around the catheter, fluid and electrolyte imbalances.
For more information, including full list of possible side effects and what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
sleep•safe balance
Active ingredient(s): Glucose monohydrate, calcium chloride dihydrate, sodium chloride, sodium (S)-lactate and magnesium chloride hexahydrate
Consumer Medicine Information (CMI)
This leaflet provides important information about using sleep•safe balance. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using sleep•safe balance.
Where to find information in this leaflet:
1. Why am I using sleep•safe balance?
2. What should I know before I use sleep•safe balance?
3. What if I am taking other medicines?
4. How do I use sleep•safe balance?
5. What should I know while using sleep•safe balance?
6. Are there any side effects?
7. Product details
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 a solution for peritoneal dialysis.
sleep•safe balance is used for cleaning the blood via the peritoneum in patients with 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. This type of blood cleaning is called peritoneal dialysis.
2. What should I know before I use sleep•safe balance?
Warnings
Do not use sleep•safe balance if:
- the expiry date on the pack has passed
- the packaging shows signs of being damaged or tampered with, or if you think it may be damaged
- the solution in the bag looks cloudy or has small specks in it
- you are allergic to any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine
- you have very low potassium levels (severe hypokalaemia)
Do not use sleep•safe balance solutions containing 1.75 mmol calcium if:
- you have very high calcium levels (severe hypercalcaemia)
Do not use sleep•safe balance solutions containing 1.25 mmol calcium if:
- you have very low calcium levels (severe hypocalcaemia)
Do not use sleep•safe balance solutions containing 4.25% glucose if:
- you have low blood pressure, (arterial hypotension, hypotonia), or the volume of your body fluids is too low (dehydration, hypovolaemia)
Peritoneal dialysis in general must not be started if:-
- you have, or have recently had, a disease of the abdominal wall or the cavity, including:
– injury or surgery,
– a history of abdominal operations with fibrous adhesions,
– bowel perforations,
– burns,
– umbilical, inguinal or abdominal hernia,
– large inflammatory abdominal skin reaction (dermatitis),
– inflammatory bowel diseases (Crohn’s disease, ulcerative colitis, diverticulitis),
– peritonitis,
– non-healing weeping wounds (abdominal fistulae),
– intra-abdominal tumours,
– intestinal obstruction (ileus). - you have a lung disease (especially pneumonia,
- you have generalised blood poisoning (sepsis),
- you have extreme weight loss (cachexia), particularly when adequate nutrition is impossible,
- in cases of accumulation of uraemic toxins in the blood (uraemia) the elimination of which can’t be managed by peritoneal dialysis,
- you have a disorder of metabolism known as lactic acidosis,
- you have very high levels of fat in the blood (hyperlipidaemia).
Check with your doctor if you:
- have a severe loss of electrolytes (salts) due to diarrhoea and/or vomiting
- have abnormal kidneys (polycystic kidneys)
- have an inflammation of the peritoneum, recognisable by a cloudy dialysate and/or abdominal pain. Please show the bag containing the drained dialysate to your doctor
- have severe abdominal pain, abdominal distension or vomiting. This can be a sign of encapsulating peritoneal sclerosis, a complication of the peritoneal dialysis therapy that can be fatal.
- have any other medical conditions
for sleep•safe balance solutions containing 1.25 mmol calcium:
- have an overactive parathyroid gland. It may be necessary to take additionally calcium-containing phosphate binders and/or vitamin D.
- have calcium levels which are too low. It may be necessary to take additionally calcium-containing phosphate binders and/or vitamin D or to use a peritoneal dialysis solution with a higher calcium concentration.
for sleep•safe balance solutions containing 1.75 mmol calcium:
- have calcium levels which are too high. A temporary or permanent change to the peritoneal dialysis solution together with a lower calcium concentration should be considered.
Peritoneal dialysis can lead to a loss of proteins and water-soluble vitamins. An adequate diet or nutritional supplements are recommended in order to avoid deficiency states.
During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.
Because peritoneal dialysis may influence the effects of medicines, your doctor may need to change their dosages, especially those of
- medicines for heart failure, such as digoxin. Your doctor will check the level of potassium in your blood and, if necessary, will take appropriate measures.
- medicines that influence calcium levels such as those containing calcium or vitamin D.
- medicines that increase the excretion of urine, such as diuretics.
- medicines taken by mouth that lower blood sugar levels or insulin. Your blood sugar level should be measured regularly. Diabetic patients may need to adjust the daily dose of insulin.
Your doctor will advise you.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect sleep•safe balance.
4. How do I use sleep•safe balance?
Always use sleep•safe balance exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Your doctor will determine the method, duration and frequency of use and the required volume of solution and dwell time in the peritoneal cavity.
Qualified nurses will train you in the use of sleep•safe balance at the hospital or the dialysis clinic.
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.
How much to use
- The mode of therapy, frequency of administration and dwell time required will be specified by the attending physician. Use of sleep•safe balance solutions must be made in conjunction with the sleep•safe cycler.
- Children: In children, a usual dose is 30 – 40 mL/kg body weight per exchange, depending on age, height and body weight.
- If tension in the abdominal region occurs your doctor may reduce the volume.
- Follow the instructions provided and use sleep•safe balance until your doctor tells you to stop.
When to use sleep•safe balance
sleep•safe balance should be used regularly, as prescribed by your doctor.
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.
How to handle sleep•safe balance with the sleep•safe cycler
- For further information on the sleep•safe cycler, please refer to the instructions booklet that comes with the machine.
- To change the dialysis bag, it is of vital importance that you carefully follow the steps that have been shown to you during training.
- Aseptic techniques must be maintained during the bag connection in order to reduce the risk of infection.
- Only use sleep•safe balance if the solution is clear and the container undamaged. You must check the integrity of the middle seam before use.
- The solutions in the two chambers must be mixed just before use.
- It is for use in one patient on one occasion only.
- Wash your hands with an antiseptic lotion and dry them thoroughly before beginning the bag exchange.
- The solution bag is warmed to body temperature automatically by the sleep•safe cycler. You do not have to warm the solution beforehand.
- Apply pressure on one solution chamber by rolling up the bag from one of the side edges until the middle seam opens. Due to the design of the bag the pressure will first open the middle seam allowing the mixture of both solutions by creating one single chamber.
- Apply more pressure by rolling up the bag from the upper edge to break the seam of the solution-free outflow part. The solution is now ready to use.
- Attach the bag to the sleep•safe cycler as instructed. The sleep•safe cycler will automatically infuse the mixed solution over 5 to 20 minutes through the peritoneal dialysis catheter into the peritoneal cavity.
- The mixed ready-to-use solution should be used immediately, but within a maximum of 24 hours after mixing.
- Any unused portion of the solution must be discarded.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
If you forget to use sleep•safe balance
Peritoneal dialysis should be carried out every day.
If you forget to do an exchange or have used too little solution, you must try to reach the total dialysate volume per 24 hours prescribed to avoid life-threatening consequences.
Contact your doctor if you are not sure.
If you use too much sleep•safe balance
If you allow too much solution to flow into the peritoneal cavity, the excess can easily be drained into the empty bag.
However, if you have made your bag exchanges too often, you may be dehydrated and/or have an electrolyte imbalance. In this case, please consult your doctor.
If you think there has been a machine fault or an error in the program, please consult your doctor.
If you think that you have used too much sleep•safe balance, you may need urgent medical attention.
You should immediately:
- phone the Poisons Information Centre
(by calling 13 11 26), or - contact your doctor, or
- go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using sleep•safe balance?
Things you should do
Follow the procedures and instructions from your nurse or doctor on how to carry out peritoneal dialysis with sleep•safe balance every time you do it. Always perform peritoneal dialysis regularly, as your doctor has told you to, even if you are not suffering any symptoms.
Body weight, phosphate, serum electrolyte concentrations, acid-base status, blood gases, blood proteins, serum creatinine and urea, indicators of bone metabolism, blood sugar and kidney function should be monitored regularly by your doctor.
If you are feeling tired or unwell, or think you need to dialyse more frequently, please discuss it with your doctor or nurse.
Call your doctor straight away if you:
- Do not feel well. This medicine helps most people with end-stage chronic renal failure, but it may have unwanted side effects. You may need medical attention if you get some of the side effects
Remind any doctor, dentist or pharmacist you visit that you are using sleep•safe balance.
Things you should not do
- Do not use sleep•safe balance for intravenous infusion.
- Do not heat sleep•safe balance bag in the microwave.
The sleep•safe cycler automatically heats it to the correct temperature. - Do not stop using sleep•safe balance without letting your doctor know. Life threatening accumulation of fluid in the tissues and lungs, or other symptoms of urea poisoning may appear.
Driving or using machines
sleep•safe balance has no or negligible influence on your ability to drive or operate machines.
Looking after your medicine
- Store sleep•safe balance below 25°C. Do not refrigerate.
- Keep it where young children cannot reach it.
Follow the instructions in the carton on how to take care of your medicine properly.
When to discard your medicine
The ready-to-use solution should be used immediately, but within a maximum of 24 hours after mixing. Unused solution remaining must be discarded.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.
Less serious side effects
Less serious side effects | What to do |
General disorders
Peritoneal dialysis procedure related disorders
Metabolism and nutrition disorders
Gastrointestinal disorders
Respiratory, thoracic and mediastinal disorders
Endocrine disorders
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Speak to your doctor if you have any of these less serious side effects and they worry you. |
Serious side effects
Serious side effects | What to do |
Infections
General disorders and administration/catheter site conditions
Renal disorders
Metabolism and nutrition disorders
Gastrointestinal disorders
Respiratory disorders
Cardiac and vascular disorders
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Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.
7. Product details
This medicine is only available with a doctor’s prescription.
What sleep•safe balance contains
Active ingredients (main ingredients) |
Glucose monohydrate, calcium chloride dihydrate, sodium chloride, sodium (S)-lactate, magnesium chloride hexahydrate |
Other ingredients (inactive ingredients) |
Water for injections, sodium hydroxide, sodium bicarbonate, hydrochloric acid |
Do not take this medicine if you are allergic to any of these ingredients.
What sleep•safe balance looks like
sleep•safe balance is a clear sterile solution containing electrolytes and glucose for peritoneal dialysis in double chamber flexible plastic bags, with tubing system for connection to the sleep•safe cycler. It is available in cartons containing flexible, non-PVC bags: 4 bags of 3000 mL or 2 bags of 5000 mL, respectively.
Not all pack sizes may be marketed.
sleep•safe balance 1.5% glucose 1.25 mmol/L calcium:
Aust R 92934
sleep•safe balance 2.3% glucose 1.25 mmol/L calcium:
Aust R 92937
sleep•safe balance 4.25% glucose 1.25 mmol/L calcium:
Aust R 92943
sleep•safe balance 1.5% glucose 1.75 mmol/L calcium:
Aust R 92935
sleep•safe balance 2.3% glucose 1.75 mmol/L calcium:
Aust R 92938
sleep•safe balance 4.25% glucose 1.75 mmol/L calcium:
Aust R 92944
Who distributes sleep•safe balance
sleep•safe balance is supplied in Australia by:
Australian Sponsor:
Fresenius Medical Care Pty Ltd
78 Waterloo Road
Macquarie Park, NSW 2113
Phone: (02) 9466 8000
Website: www.fmc-au.com
This leaflet was prepared in October 2023.
Published by MIMS December 2023