Consumer medicine information

Sleep Safe Balance

Sodium chloride; Sodium lactate; Sodium bicarbonate; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Glucose

BRAND INFORMATION

Brand name

Sleep Safe Balance

Active ingredient

Sodium chloride; Sodium lactate; Sodium bicarbonate; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Glucose

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Sleep Safe Balance.

What is in this leaflet

This leaflet answers some common questions about sleep•safe balance 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 sleep•safe balance, ask your doctor or nurse.

Keep this leaflet with the medicine. You may need to read it again.

What sleep•safe balance is used for

sleep•safe balance is a clear sterile solution for peritoneal dialysis containing electrolytes and glucose with a neutral pH, supplied in double chamber flexible plastic bags. The double chamber solution bag comes with a tubing system in a clear protective overwrap.

The sleep•safe balance solutions can only be used with the sleep•safe cycler.

sleep•safe balance 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 sleep•safe balance

When you must not use it

sleep•safe balance must not be used for intravenous infusion

Do not use sleep•safe balance:

  • 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)

Do not use sleep•safe balance solutions containing 1.75 mmol calcium:

  • if you have high calcium levels (hypercalcaemia)

Do not use sleep•safe balance solutions containing 1.25 mmol calcium:

  • if you have low calcium levels (hypocalcaemia)

Do not use sleep•safe balance solutions containing 4.25% glucose:

  • if you have low blood pressure or are dehydrated,
  • if you have suffered acute blood loss or have muscle wastage

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, burns,
    - hernia,
    - 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).
  • if you have a lung disease (especially pneumonia); metabolic disorders (lactic acidosis); generalised blood poisoning (sepsis); 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; or very high levels of fat in the blood (hyperlipidaemia).

Should any of the above-mentioned disorders develop during peritoneal dialysis treatment, please consult your doctor who will decide how to proceed.

Before you start to use it

Tell your doctor if:

  • you are pregnant, or are trying to become pregnant, or are breast-feeding,
  • you suffer from diabetes.
    Blood glucose levels must be monitored and the daily insulin dose or other treatments for hyperglycaemia adjusted by your doctor if required
  • you have diarrhoea and/or vomiting,
  • you are dehydrated or have low blood pressure,
  • you are taking digitalis. Your potassium levels must be checked regularly by your doctor, to see your potassium levels do not get too low.
  • you are taking any other medicines, including those that you buy without a prescription from a pharmacy, supermarket or a health food shop. It is especially important to inform your doctor if you are using insulin or other blood sugar reducing drugs, digitalis, drugs that influence the calcium level (calcium-containing phosphate binders, vitamin D) or that increase the output of urine (diuretics). Peritoneal dialysis may affect how they work in the body. Your doctor will advise you.

How to use sleep•safe balance

Follow all directions given to you by your doctor or pharmacist carefully. They may differ from the information contained in this leaflet.

Adults: Unless otherwise advised, 2000 mL dialysis solution should be slowly infused (over 5-20 minutes) into the peritoneal cavity using a permanent catheter. After a dwell time between 2 and 10 hours the solution should be drained. This treatment is performed automatically by the sleep•safe cycler while you are asleep.

Children: In children, a dose of 250 - 1500 mL per treatment (30 - 40 mL/kg body weight) is recommended, depending on age, height and body weight.

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 use it

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.

The sleep•safe cycler automatically discards any unused portion of the solution.

It is for use in one patient on one occasion only.

  1. Wash your hands with an antiseptic lotion and dry them thoroughly before beginning the bag exchange.
  2. The solution bag is warmed to body temperature automatically by the sleep•safe cycler. You do not have to warm the solution beforehand.
  3. 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.
  4. 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.
  5. 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.
  6. The mixed ready-to-use solution should be used immediately, but within a maximum of 24 hours after mixing.

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 (e.g. 4 x 2000 mL for an adult), to avoid life-threatening consequences. Contact your doctor who will tell you exactly what to do.

If you use too much sleep•safe balance (overdose)

It should not be possible to use too much sleep•safe balance, because the sleep•safe cycler automatically controls it.

If you think there has been a machine fault or an error in the program, please consult your doctor. Your stomach will feel tight and very uncomfortable if too much solution has been instilled. If the exchanges have occurred too often, you may be dehydrated and/or have an electrolyte imbalance.

While you are using sleep•safe balance

Things you must 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, nutritional state, serum electrolyte concentrations, acid-base status, blood proteins, serum creatinine and urea, indicators of bone metabolism and residual renal 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.

When used as prescribed sleep•safe balance does not impair your ability to drive or operate machines.

Things you must not do

Do not use sleep•safe balance for intravenous infusion.

Do not heat sleep•safe balance. 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.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well. This medicine helps most people with end-stage chronic renal failure, but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • abdominal distension and feeling of fullness
  • slow inflow or outflow of the dialysis solution
  • hernia
  • shoulder pain
  • shortness of breath due to elevation of the diaphragm
  • diarrhoea and constipation

Tell your doctor or pharmacist as soon as possible if you notice any of the following:

  • peritonitis (with cloudy fluid in the drainage bag, abdominal pain, nausea and vomiting, fever, chills and, if untreated, generalised blood poisoning)
  • inflammation around the catheter (at the exit side and along the tunnel).
  • fluid and electrolyte imbalances, such as increased or decreased potassium and calcium levels
  • symptoms of overhydration (e.g. oedema, shortness of breath)
  • symptoms of dehydration (e.g. dizziness, muscle cramps)
  • increased blood sugar levels
  • obesity due to continuous glucose uptake
  • disorders of lipid metabolism
  • thickening and scarring of the peritoneum

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

After using sleep•safe balance

Storage

Keep unopened sleep•safe balance bags in a cool dry place where the temperature stays below 25°C.

Do not refrigerate.

Keep sleep•safe balance bags together with the supplies and equipment for your peritoneal dialysis treatments in a place where children cannot reach them.

Do not use after the expiry date on the bag.

Product description

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 1500 mL, 2000 mL, 2500 mL, 3000 mL and 5000 mL bags.

Ingredients

sleep•safe balance contains glucose monohydrate, sodium chloride, sodium lactate, calcium chloride dihydrate, sodium bicarbonate, and magnesium chloride hexahydrate. The other ingredients are water for injections, hydrochloric acid, and sodium hydroxide. It does not contain any antimicrobial preservative.

The formulations are as follows:

Solutions containing calcium 1.25 mmol/L

Solutions containing calcium 1.75 mmol/L

Further Information

Consult your doctor or dialysis unit for further information on your prescribed treatment.

Supplier

sleep•safe balance is supplied in Australia by:

Fresenius Medical Care Australia Pty. Ltd.
305 Woodpark Road
Smithfield NSW 2164 Australia

This leaflet was prepared in June 2003.

Revised: June 2020

Published by MIMS August 2020

BRAND INFORMATION

Brand name

Sleep Safe Balance

Active ingredient

Sodium chloride; Sodium lactate; Sodium bicarbonate; Calcium chloride dihydrate; Magnesium chloride hexahydrate; Glucose

Schedule

Unscheduled

 

1 Name of Medicine

Sleep Safe Balance 1.5% 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 2.3% 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 4.25% glucose 1.25 mmol/L calcium peritoneal dialysis solution.
Sleep Safe Balance 2.3% glucose 1.25 mmol/L calcium peritoneal dialysis solution.
Sodium lactate, sodium bicarbonate, calcium chloride dihydrate, glucose monohydrate, magnesium chloride hexahydrate, sodium chloride.

6.7 Physicochemical Properties

Chemical structure.

Not applicable.

CAS number.

Not applicable.

2 Qualitative and Quantitative Composition

Sleep Safe Balance ready to use solution is available in a number of different strengths in various calcium ranges. One litre of the ready to use solution has the following composition (see Tables 1 and 2).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Irrigation solution.
Sleep Safe Balance is a clear, sterile water-based solution delivered in a double chamber bag made of non-PVC plastic packaging material. One chamber contains the alkaline sodium 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 ready-to-use solution.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Sleep Safe Balance solutions are lactate buffered, glucose containing electrolyte solutions indicated for intraperitoneal administration for the treatment of endstage renal failure of any origin. The characteristic of continuous ambulatory peritoneal dialysis (CAPD) is the more of less continuous presence of usually two litres of dialysis solutions in the peritoneal cavity. This dialysis solution is replaced by fresh solution three to five times a day.
The basic principle behind every peritoneal dialysis technique is the use of the peritoneum as the semipermeable membrane allowing the exchange of solutes and water between blood and the dialysis solution by diffusion and convection according to their physicochemical properties.
The electrolyte profile of the solution is basically the same as that of physiological serum, although it has been adapted (e.g. the potassium content) for use in uraemic patients to enable renal function substitution therapy by means of the intraperitoneal substances and fluid exchange. Dialysis solutions containing low calcium concentration (1.0 mmol/L and 1.25 mmol/L) have been shown to reduce the risk of hypercalcaemia during concomitant treatment with calcium containing phosphate binders and/or vitamin D. Substances which are normally eliminated with the urine, like uraemic waste products, such as urea and creatinine, inorganic phosphorus, uric acid, other solutes and water, are removed from the body into the dialysis solution. The fluid balance can be maintained by the administration of different glucose concentrations in the solution, effecting the fluid removal (ultrafiltration). Metabolic acidosis secondary to endstage renal failure is counterbalanced by the presence of lactate in the solution. The complete metabolism of lactate results in the generation of bicarbonate.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Uraemic waste products (e.g. urea, creatinine, uric acid), inorganic phosphate and electrolytes like sodium, potassium, calcium and magnesium are removed from the body to the dialysis solution by diffusion and/or convection.
Glucose in the dialysate is used as an osmotic agent. It is slowly absorbed, reducing the diffusion gradient between dialysis solution and extracellular fluid. The ultrafiltration is maximal at the beginning of the swell time, reaching a peak after about two to three hours. Later absorption starts with a progressive loss of ultrafiltrate. During a dialysis period of six hours, 60%-80% of dialysate glucose is absorbed.
The transfer of calcium depends on the glucose concentration in the dialysis solution, the effluent volume and serum calcium concentration, and the lower the calcium concentration in the dialysis solution, the higher the calcium transfer from the patient to the dialysate.

5.3 Preclinical Safety Data

Genotoxicity.

No mutagenic studies with Sleep Safe Balance solutions have been carried out.

Carcinogenicity.

No carcinogenic studies with Sleep Safe Balance solutions have been carried out.

4 Clinical Particulars

4.1 Therapeutic Indications

For use as a peritoneal dialysis solution in the management of endstage renal disease and acute renal failure.

4.3 Contraindications

Solution for peritoneal dialysis must not be used for intravenous infusion. See Table 3.

Peritoneal dialysis in general.

Peritoneal dialysis should not be commenced if any of the following are present.
Recent abdominal surgery or injury, a history of abdominal operations with fibrous adhesions, abdominal burns, bowel perforations.
Extensive inflammatory conditions of the abdominal skin (dermatitis).
Inflammatory bowel disease (Crohn's disease, ulcerative colitis, diverticulitis).
Peritonitis.
Internal or external abdominal fistula.
Umbilical, inguinal or other abdominal hernia.
Intra-abdominal tumours.
Ileus.
Pulmonary disease (especially pneumonia).
Sepsis.
Lactic acidosis.
Extreme hyperlipidaemia.
In rare cases of uraemia, which cannot be managed by peritoneal dialysis.
Cachexia and severe weight loss, particularly in cases where ingestion of adequate protein is not guaranteed.
Patients who are physically or mentally incapable of performing peritoneal dialysis as instructed by the physician.
If any of the above mentioned disorders develops during treatment with peritoneal dialysis, the attending physician will have to decide how to proceed.

4.4 Special Warnings and Precautions for Use

Encapsulating peritoneal sclerosis is considered to be a known, rare complication of peritoneal dialysis therapy which can infrequently lead to fatal outcome.
Before performing peritoneal dialysis at home, the patient must be trained appropriately, must practise the technique and be shown to be proficient. The training should be performed by qualified personnel. The attending physician must ensure that the patient masters the handling techniques sufficiently before being discharged to carry out peritoneal dialysis at home. In case of any problems or uncertainty, the attending physician should be contacted. Peritoneal dialysis should be continued for as long as renal function substitution therapy is required (see Section 4.2 Dose and Method of Administration).

Use with caution in the following circumstances.

Sleep Safe Balance solutions should only be administered after careful benefit-risk assessment in:
Loss of electrolytes due to vomiting and/or diarrhoea (a temporary change to a peritoneal dialysis solution containing potassium may then become necessary).
Digitalis therapy: regular monitoring of the serum potassium level is mandatory. Severe hypokalaemia may necessitate the use of potassium containing dialysis solution together with dietary counselling.
Patients with large polycystic kidneys.

Sleep Safe Balance solutions containing 1.75 mmol/L calcium.

Hypercalcaemia, e.g. due to the administration of calcium containing phosphate binders and/or vitamin D (a temporary or permanent change to a peritoneal dialysis solution together with a lower calcium concentration should be considered).

Sleep Safe Balance solutions containing 1.25 mmol/L calcium.

Patients with hyperparathyroidism: therapy should include the administration of calcium containing phosphate binders and/or vitamin D to ensure adequate enteral calcium supply.
Hypocalcaemia: it may be necessary to use a peritoneal dialysis solution with a higher calcium concentration either temporarily or permanently in case adequate enteral supply of calcium, by calcium containing phosphate binders and/or vitamin D, is not possible.
The effluent should be checked for clarity and volume. Turbidity, which may or may not be accompanied by abdominal pain, or abdominal pain alone are indicators of peritonitis.
A loss of proteins, amino acids, and water soluble vitamins occurs during peritoneal dialysis. To avoid deficiencies, an adequate diet or supplementation should be ensured. The transport characteristics of the peritoneal membrane may change during long term peritoneal dialysis primarily indicated by a loss of ultrafiltration. In severe cases peritoneal dialysis must be stopped and haemodialysis commenced.

Regular monitoring of the following parameters is recommended.

Bodyweight for the early recognition of over or underhydration.
Serum sodium, potassium, calcium, magnesium, phosphate, acid base status, blood gases and blood proteins.
Serum creatinine and urea.
Parathormone and other indicators of bone metabolism.
Blood sugar.
Residual renal function in order to adapt the peritoneal dialysis.

Check the following before use.

Plastic containers may occasionally be damaged during transport or storage. This can result in a contamination with growth of microorganisms in the dialysis solutions. Thus all containers should be carefully inspected for damage prior to connection of the bag and prior to use of the peritoneal dialysis solution. Any damage, even minor, to connectors at the closure, container welds and corners must be noted because of possible contamination. Inspect the integrity of the middle seam. Damaged bags or bags with cloudy content should never be used.
The solution must only be used if the solution for dialysis is clear and the container undamaged. Any unused portion of the solution is to be discarded. The overwrap should only be removed before administration. Do not use before mixing. The solutions in the two chambers should be mixed just before use. The mixed solution should be used immediately, but within a maximum of 24 hours after mixing. Aseptic conditions must be maintained during dialysate exchange in order to reduce the risk of infection.

Use in patients with diabetes.

The daily dose of insulin or oral hypoglycaemic medicinal products should be adjusted to take account of the increased glucose load in patients with diabetes. Blood glucose levels should be checked regularly.

Use in the elderly.

The increased risk of hernia should be considered in elderly patients prior to the start of peritoneal dialysis.

Paediatric use.

In children, the dialysate volume should be reduced in accordance with age, height and bodyweight (see Section 4.2 Dose and Method of Administration).

Effects on laboratory tests.

None reported.

4.5 Interactions with Other Medicines and Other Forms of Interactions

The use of peritoneal dialysis solutions can lead to a loss of efficacy of other medicinal products if these are dialyzable through the peritoneal membrane. A dose adjustment may be necessary.
A distinct reduction in serum potassium level can increase the frequency of digitalis associated adverse reactions. Potassium levels must be monitored particularly closely during concurrent digitalis therapy.
The concurrent administration of calcium containing medicinal products or vitamin D may cause hypercalcaemia when using solutions of high calcium concentration.
The use of diuretic agents may help maintain residual diuresis, but may also result in water and electrolyte imbalances.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
There is no adequate data from the use of Sleep Safe Balance solutions in animal studies or in pregnant women. The safe use of this product during pregnancy has therefore not been determined. Peritoneal dialysis should be performed during pregnancy only after careful weighing of the potential risks and benefits to mother and foetus.
The safe use of Sleep Safe Balance solutions during lactation has not been determined.

4.8 Adverse Effects (Undesirable Effects)

Possible adverse reactions may result from the peritoneal dialysis technique or may be induced by the peritoneal dialysis solution. Very common adverse reactions of peritoneal dialysis are peritonitis and skin exit site infections. Other adverse reactions are less frequent.

Potential adverse reactions of the peritoneal dialysis solutions.

Endocrine disorders.

Secondary hyperparathyroidism with potential disturbances of the bone metabolism when using solutions of low calcium concentration.

Metabolism and nutrition disorders.

Increased blood sugar levels, hyperlipidaemia, hypoproteinaemia, increase in bodyweight due to the continuous uptake of glucose from the peritoneal dialysis solution.

Cardiac and vascular disorders.

Tachycardia, hypotension, hypertension.

Respiratory disorders.

Dyspnoea.

Renal disorders.

Electrolyte disturbances, e.g. hypokalaemia, hypocalcaemia when using solutions of lower calcium concentration, hypercalcaemia in combination with an increased calcium uptake due to the administration of calcium containing phosphate binders when using solutions of higher calcium concentration.

General disorders.

Dizziness, oedema, disturbances in hydration indicated either by a rapid decrease (dehydrations) or increase (overhydration) in bodyweight. Severe dehydration may occur when using solutions of higher glucose concentration and can cause low blood pressure, increase heart rate, dizziness and muscle cramps. Overhydration can cause increased bodyweight, high blood pressure, swollen legs and shortness of breath.

Potential adverse reactions of the treatment mode.

Infections.

Peritonitis, skin exit site and tunnel infections, in very rare cases sepsis.

Respiratory, thoracic and mediastinal disorders.

Dyspnoea caused by elevated diaphragm, shoulder pain.

Gastrointestinal disorders.

Diarrhoea, constipation, hernia, abdominal distension and sensation of fullness, encapsulating peritoneal sclerosis.

General disorders and administration/ catheter site conditions.

General malaise, redness, oedema, exudations, crusts and pain at the catheter exit site.

Peritoneal dialysis procedure related disorders.

Cloudy effluent, inflow and outflow disturbances of the dialysis solution.
Peritonitis is indicated by a cloudy effluent. Later, abdominal pain, fever and general malaise may develop or, in very rare cases, sepsis. The patient should seek medical advice immediately. The bag with the cloudy effluent should be closed with a sterile cap and assessed for microbiological contamination and white blood count.
In cases of skin exit site and tunnel infections, the attending physician should be consulted as soon as possible.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

Dose.

Sleep Safe Balance solutions are indicated exclusively for intraperitoneal use.
For use in one patient, on one occasion only. Does not contain antimicrobial preservatives.
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.

Dose adjustment.

If pain due to abdominal distension occurs at the commencement of peritoneal dialysis, the solution volume per exchange should be temporarily reduced to 500-1500 mL. In large patients and if residual renal function is lost, an increased volume of dialysis solution will be necessary. In these patients or in patients who will tolerate larger volumes, a volume of 2500 mL-3000 mL solution per exchange may be given. For patients using Sleep Safe Balance solutions, the volume of dialysis solution will be programmed into the Sleep Safe cycler by the attending medical personnel.
In children, the solution volume per exchange should be reduced according to age, height and bodyweight. The usual dose is 30-40 mL/Kg bodyweight per exchange. There are no special dosage adjustments necessary for elderly patients.
Peritoneal dialysis solutions with a high glucose concentration (2.3% or 4.25%) are used when the bodyweight is above the desired dry weight. The withdrawal of fluid from the body increases in relation to the glucose concentration of the peritoneal dialysis solution. These solutions should be used cautiously to handle the peritoneal membrane with care, to prevent dehydration and in order to keep the glucose burden as low as possible.
See Section 4.4 Special Warnings and Precautions for Use for recommended regular monitoring.

Method of Administration.

Dialysis using the prescribed doses should be performed daily. Peritoneal dialysis is a long-term therapy involving repeated administrations of single solutions. Before performing peritoneal dialysis at home, the patient must be trained appropriately, must practise the technique and be shown to be proficient. Peritoneal dialysis should be continued for as long as renal function substitution therapy is required.
The solution bag is first warmed up to body temperature. For patients using Sleep Safe Balance solutions, after mixing, warming of the solution bag occurs automatically when the bags are attached to the Sleep Safe cycler. The solutions in the two chambers must be mixed just before use. The mixed solution should be used immediately, but within a maximum of 24 hours after mixing. Do not use before mixing.
For that purpose, pressure must be exerted 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. Then a renewed pressure by rolling up the bag from the upper edge breaks the seam of the solution free outflow part ensuring that only mixed solution can be infused over 5 to 20 minutes through the peritoneal dialysis catheter into the peritoneal cavity.
Depending on the physician's instructions the dose should dwell in the peritoneal cavity for 2 to 10 hours (equilibrium time) and then be drained. Depending on the required osmotic pressure, Sleep Safe Balance solutions with lower or higher glucose content can be used sequentially.

4.7 Effects on Ability to Drive and Use Machines

Sleep Safe Balance solutions have no or negligible influence on the ability to drive or use machinery.

4.9 Overdose

No emergency situations in connection with overdose have been reported.
Excessive inflow of dialysis solution is easily drained into an empty bag. However, if the bag exchanges have been carried out too frequently or too rapidly, states of dehydration and/or electrolyte disturbances can occur which necessitate immediate medical attention. If an exchange has been forgotten, then as a rule the swell times of the next bags should be reduced in such a way that the total amount of dialysis solution required per day (e.g. 4 x 2000 mL) is achieved.
Incorrect balancing can lead to overhydration or dehydration and electrolyte disturbances. The most likely consequence of an overdosage with Sleep Safe Balance solutions is dehydration. Underdosage, interruption of treatment or discontinuation of treatment may lead to life-threatening overhydration with peripheral oedema and cardiac decompensation and/or other symptoms of uraemia, which may endanger life. The generally accepted rules for emergency care and intensive therapy must be applied. The patient may require immediate haemodialysis.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

Unscheduled.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections, sodium hydroxide, hydrochloric acid.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

Ready to use solution.

The ready to use solution should be used immediately, but within a maximum of 24 hours after mixing.

6.4 Special Precautions for Storage

Store below 25°C. Do not refrigerate.

6.5 Nature and Contents of Container

The Sleep Safe Balance system consists of a double chamber solution bag, a tubing system, a system connector. The Sleep Safe solutions are designed to be used only in conjunction with the Sleep Safe cycler. The system is presented with a clear protective overwrap.
Sleep Safe Balance is available in 1500 mL, 2000 mL, 2500 mL, 3000 mL and 5000 mL flexible, non-PVC bags.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

Summary Table of Changes