SUMMARY CMI

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. How do I use stay•safe balance? in the full CMI.

5. What should I know while using stay•safe balance?

For more information, see Section 5. What should I know while using stay•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.

FULL CMI

stay•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 stay•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 stay•safe balance.

Where to find information in this leaflet:

1. Why am I using stay•safe balance?
2. What should I know before I use stay•safe balance?
3. What if I am taking other medicines?
4. How do I use stay•safe balance?
5. What should I know while using stay•safe balance?
6. Are there any side effects?
7. Product details

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 a solution for peritoneal dialysis.

stay•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 stay•safe balance?

Warnings

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

• you have very high calcium levels (severe hypercalcaemia)

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

• you have very low calcium levels (severe hypocalcaemia)

Do not use stay•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 stay•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 stay•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 stay•safe balance.

4. How do I use stay•safe balance?

Always use stay•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 stay•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. Unless otherwise advised, 2000 mL of dialysis solution should be slowly infused (over 5-20 minutes) into the peritoneal cavity using a permanent catheter four times a day. After a dwell time between 2 and 10 hours the solution should be drained.
• Children: the usual dose is 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 stay•safe balance until your doctor tells you to stop.

When to use stay•safe balance

stay•safe balance should be used regularly, as prescribed by your doctor.

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.

How to handle stay•safe balance

• 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 stay•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.

1. Wash your hands with an antiseptic lotion and dry them thoroughly before beginning the bag exchange.
2. Warm the solution bag to body temperature using an appropriate bag warmer. Do not use a microwave to warm the solution.
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. Infuse only 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 stay•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 stay•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 that you have used too much stay•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 stay•safe balance?

Things you should do

Follow the procedures and instructions from your nurse or doctor on how to carry out peritoneal dialysis with stay•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 stay•safe balance.

Things you should not do

• Do not use stay•safe balance for intravenous infusion.
• Do not heat stay•safe balance bag in the microwave.
  It can get too hot and burn you inside the abdominal cavity. Use an appropriate bag warmer to warm the solution to body temperature.
• Do not stop using stay•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

stay•safe balance has no or negligible influence on your ability to drive or operate machines.

Looking after your medicine

• Store stay•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

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 stay•safe balance contains

Do not take this medicine if you are allergic to any of these ingredients.

What stay•safe balance looks like

stay•safe balance is a clear sterile solution containing electrolytes and glucose for peritoneal dialysis in double chamber flexible plastic bags, with a tubing system, a system connector with a rotating switch, and a drainage bag. It is available in cartons containing flexible, non-PVC bags: 6 bags of 1500 mL or 4 bags of 2000 mL, or 2500 mL, respectively.

Not all pack sizes may be marketed.

stay•safe balance 1.5% glucose 1.25 mmol/L calcium:
Aust R 92945

stay•safe balance 2.3% glucose 1.25 mmol/L calcium:
Aust R 92956

stay•safe balance 4.25% glucose 1.25 mmol/L calcium:
Aust R 92959

stay•safe balance 1.5% glucose 1.75 mmol/L calcium:
Aust R 92954

stay•safe balance 2.3% glucose 1.75 mmol/L calcium:
Aust R 92957

stay•safe balance 4.25% glucose 1.75 mmol/L calcium:
Aust R 92960

Who distributes stay•safe balance

stay•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

1 Name of 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 constitution.

After constitution.

3 Pharmaceutical Form

Irrigation solution.
Stay Safe Balance is a double chamber bag containing clear solution.

4 Clinical Particulars

4.1 Therapeutic Indications

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

4.2 Dose and Method of Administration

Dose.

Dose adjustment.

Method of administration.

4.3 Contraindications

Stay Safe Balance 1.5% glucose, 1.75 mmol/L calcium and Stay Safe Balance 2.3% glucose, 1.75 mmol/L calcium.

Stay Safe Balance 4.25% glucose, 1.75 mmol/L calcium.

Stay Safe Balance 1.5% glucose, 1.25 mmol/L calcium and Stay Safe Balance 2.3% glucose, 1.25 mmol/L calcium.

Stay Safe Balance 4.25% glucose, 1.25 mmol/L calcium.

Peritoneal dialysis in general.

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.

Stay Safe Balance solutions containing 1.75 mmol/L calcium.

Stay Safe Balance solutions containing 1.25 mmol/L calcium.

Regular monitoring of the following parameters is recommended.

Check the following before use.

Use in patients with diabetes.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

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.

4.7 Effects on Ability to Drive and Use Machines

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

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.

Metabolism and nutrition disorders.

Cardiac and vascular disorders.

Respiratory disorders.

Renal disorders.

General disorders.

Potential adverse reactions of the treatment mode.

Infections.

Respiratory, thoracic and mediastinal disorders.

Gastrointestinal disorders.

General disorders and administration/catheter site conditions.

Peritoneal dialysis procedure related disorders.

Reporting suspected adverse effects.

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 Stay 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).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

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.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections, sodium hydroxide, sodium bicarbonate, 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

Shelf life as packed for sale.

Ready to use solution.

6.4 Special Precautions for Storage

Store below 25°C. Do not refrigerate.

6.5 Nature and Contents of Container

The Stay Safe Balance system consists of a double chamber solution bag, a tubing system, a system connector with a rotating switch and a drainage bag. The system is presented with a clear protective overwrap.
Stay Safe Balance is available in cartons containing flexible, non-PVC bags: 6 bags x 1500 mL, 4 bags x 2000 mL or 4 bags x 2500 mL.
Not all pack sizes and strengths may be marketed.

6.6 Special Precautions for Disposal

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

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes