Consumer medicine information

CAPD/DPCA stay safe

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

BRAND INFORMATION

Brand name

CAPD/DPCA Stay Safe

Active ingredient

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

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using CAPD/DPCA stay safe.

What is in this leaflet

This leaflet answers some common questions about CAPD/DPCA stay•safe 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 CAPD/DPCA stay•safe, ask your doctor or nurse.

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

What CAPD/DPCA stay•safe is used for

CAPD/DPCA stay•safe is a clear sterile solution for peritoneal dialysis containing electrolytes and glucose with a neutral pH, supplied in double chamber flexible plastic bags. The solution bag comes with a system disc connector, a rotating switch and a drainage bag in a clear protective overwrap.

CAPD/DPCA stay•safe 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 CAPD/DPCA stay•safe

When you must not use it

CAPD/DPCA stay•safe must not be used for intravenous infusion

Do not use CAPD/DPCA stay•safe:

  • 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)
  • if you have low calcium levels (hypocalcaemia)

Do not use CAPD/DPCA 18, 19 stay•safe solutions:

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

Before you start to use it

Tell your doctor if:

  • you are pregnant, or are trying to become pregnant, or are breast-feeding
  • you have high blood cholesterol or fat levels (hyperlipidemia)
  • you have a hernia
  • you have had any recent stomach-related problems, including injury or surgery, infection, tumor or burns
  • you have had peritonitis
  • you have a lung disease, especially pneumonia
  • you have an inflammation of your bowel (Crohn’s disease, diverticulitis, ulcerative colitis)
  • you have inflammatory abdominal skin reaction (dermatitis)
  • you have non-healing weeping wounds (abdominal fistulae)
  • you have had metabolic disorders (lactic acidosis); generalised blood poisoning (sepsis); in cases of accumulation of uraemic toxins in the blood (uraemia) the elimination of which can’t be managed by peritoneal dialysis
  • you have an intestinal blockage (ileus)
  • you have diarrhoea and/or vomiting
  • you have lost a lot of weight recently
  • 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.

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

How to use CAPD/DPCA stay•safe

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 of 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.

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 CAPD/DPCA stay•safe 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

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 CAPD/DPCA stay•safe if the solution is clear and the container undamaged.

Any unused portion of the solution must be discarded.

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 the Fresenius Thermosafe bag warmer. Do not use a microwave to warm the solution.
  3. Infuse the solution over 5 to 20 minutes through the peritoneal dialysis catheter into the peritoneal cavity.

If you forget to use CAPD/DPCA stay•safe

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 CAPD/DPCA stay•safe (overdose)

If your stomach feels tight and very uncomfortable, you may have let too much solution flow in. You can easily drain it into an 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.

While you are using CAPD/DPCA stay•safe

Things you must do

Follow the procedures and instructions from your nurse or doctor on how to carry out peritoneal dialysis with CAPD/DPCA stay•safe 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 CAPD/DPCA stay•safe does not impair your ability to drive or operate machines.

Things you must not do

Do not use CAPD/DPCA stay•safe for intravenous infusion.

Do not heat CAPD/DPCA stay•safe in the microwave. It can get too hot and burn you inside the abdominal cavity.

Use the Fresenius Thermosafe bag warmer to warm the solution to body temperature. It will not overheat the solution.

Do not stop using CAPD/DPCA stay•safe 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 while you are using CAPD/DPCA stay•safe. 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

After using CAPD/DPCA stay•safe

Storage

Keep unopened CAPD/DPCA stay•safe bags in a cool dry place where the temperature CAPD/DPCA stays below 25°C.

Do not refrigerate.

Keep CAPD/DPCA stay•safe 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 CAPD/DPCA stay•safe looks like

CAPD/DPCA stay•safe 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 packs of 4 x 3000 mL.

Ingredients

CAPD/DPCA stay•safe contains glucose monohydrate, sodium, sodium chloride, sodium lactate, calcium, calcium chloride dihydrate, chloride, lactate, magnesium, 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

CAPD/DPCA 17 stay safe
AUST R 62015
Glucose1.65%
Sodium134 mmol/L
Calcium1.25 mmol/L
Magnesium0.5 mmol/L
Chloride100.5 mmol/L
Lactate35 mmol/L
Bicarbonate2 mmol/L

 

CAPD/DPCA 18 stay safe
AUST R 62016
Glucose4.675%
Sodium134 mmol/L
Calcium1.25 mmol/L
Magnesium0.5 mmol/L
Chloride100.5 mmol/L
Lactate35 mmol/L
Bicarbonate2 mmol/L

 

CAPD/DPCA 19 stay safe
AUST R 62017
Glucose2.5%
Sodium134 mmol/L
Calcium1.25 mmol/L
Magnesium0.5 mmol/L
Chloride100.5 mmol/L
Lactate35 mmol/L
Bicarbonate2 mmol/L

Further Information

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

Supplier

CAPD/DPCA stay•safe is supplied in Australia by:

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

This leaflet was prepared in February 1998

Revised: June 2020

Published by MIMS August 2020

BRAND INFORMATION

Brand name

CAPD/DPCA Stay Safe

Active ingredient

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

Schedule

Unscheduled

 

1 Name of Medicine

Calcium, calcium chloride dihydrate, chloride, glucose monohydrate, lactate, magnesium, magnesium chloride hexahydrate, sodium, sodium chloride, sodium lactate.

6.7 Physicochemical Properties

Chemical structure.

Not applicable.

CAS number.

Not applicable.

2 Qualitative and Quantitative Composition

CAPD/DPCA Stay Safe is available in a number of different strengths in various calcium ranges. The strengths have the following compositions (see Table 1).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Irrigation solution.
CAPD/DPCA Stay Safe is a clear, sterile water-based solution.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

CAPD/DPCA Stay Safe is for peritoneal dialysis only. In peritoneal dialysis, the peritoneal membrane is used as the exchange membrane with transport of solutes and fluid occurring over time. Transfer of serum ions depends not only on serum and dialysate ion concentrations, but on the osmolarity of the dialysate, with higher osmolarity causing considerable solute transfer due to the associated ultrafiltration to the dialysate.
CAPD/DPCA Stay Safe solutions ensure sufficient elimination of substances usually eliminated via the kidneys, and help in the maintenance of homeostasis in the body's water and electrolyte balance.
The use of CAPD/DPCA Stay Safe, or other peritoneal dialysis solutions, differing in their glucose, sodium, calcium, or potassium concentrations should be individually adapted to patients' needs. Because potentially large shifts in fluid over a short time, as can occur in haemodialysis, are avoided, peritoneal dialysis is particularly suited to those with unstable circulatory or respiratory conditions and to the very young. In uraemic patients, metabolic disturbances as well as nutritional and therapeutic needs, should be taken into account when treating patients with peritoneal dialysis solutions.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Not applicable.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

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.

4.3 Contraindications

Calcium deficiency (hypocalcaemia).
Potassium deficiency (hypokalaemia).

CAPD/DPCA Stay Safe 18 and CAPD/DPCA Stay Safe 19.

Severe dehydration; arterial hypotension; hypovolaemia and hypotonia.
In the presence of the following conditions, CAPD/DPCA Stay Safe can only be used after a careful evaluation of the associated risks and benefits by the attending physician: advanced pregnancy; excessive dermatitis; localised peritonitis; intra-abdominal perforations; inflammatory bowel disease (Crohn's disease, ulcerative colitis, diverticulitis); intra-abdominal tumour; recent abdominal surgery; recent abdominal injury; fibrous bowel adhesions; ileus; hernia; internal or external abdominal fistula; pulmonary disease (particularly pneumonia); sepsis; cachexia and extreme weight loss (particularly in cases where the patient is unable to ingest sufficient protein); in cases where it is not possible to manage uraemia by means of peritoneal dialysis; hyperlipidaemia; in patients whose physical or mental status would make it impossible to conduct the specified course of dialysis as instructed by a physician.

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.
In general, expert training is required before the initiation of continuous ambulatory peritoneal dialysis, and this should be conducted under the overall supervision of an experienced dialysis unit.
The electrolytes sodium, potassium, calcium, magnesium, phosphate, as well as serum proteins, creatinine, urea, blood sugar, and acid base balance must be checked regularly. In addition, parathyroid hormone and other indicators of bone metabolism as well as residual renal function should be monitored regularly. A daily check of the bodyweight and the balance of inflow and outflow volumes is also recommended.
Damage to the container may cause microbial or fungal contamination of the dialysis solution. It is recommended that a visual check is carried out prior to connecting the bag and using the solution for peritoneal dialysis. Attention must be paid to the seal, seam and the corners of the container. In case of doubt, the bag should not be used. Use the solution only if the container and the seal are undamaged and the solution is clear.
The following situations require special attention and monitoring.

Loss of fluids and electrolytes due to vomiting and/or diarrhoea.

A temporary change to a peritoneal dialysis solution containing potassium may be necessary.

Hyperparathyroidism.

The therapy should comprise the administration of calcium containing phosphate binders and/or vitamin D to ensure adequate enteral calcium supply (see Section 4.8 Adverse Effects (Undesirable Effects); Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).

Hypocalcaemia.

If an adequate calcium supply cannot be maintained by calcium containing phosphate binders and/or vitamin D, a change to a peritoneal dialysis solution with a higher calcium concentration must be considered.

Digitalis therapy.

Regular monitoring of the serum potassium level is mandatory. Severe hypokalaemia may necessitate the use of a potassium containing dialysis solution or dietary counseling.

Use in diabetic patients.

Due to the glucose contained in the solution, an increase in the blood glucose concentration may occur. Consequently the blood glucose level should be checked regularly and the daily insulin dose should be adjusted for the increased glucose intake.

Use in the elderly.

The increased incidence of hernia in elderly patients should be taken into account before starting peritoneal dialysis.

Paediatric use.

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

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Concomitant administration of calcium compounds or vitamin D may cause calcium excess (see Section 4.4 Special Warnings and Precautions for Use).
The use of peritoneal dialysis can result in a loss of efficacy of other drugs if these are dialysable through the peritoneal membrane, in which case dosage adjustment of such medications may be necessary.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
The safe use of this product during pregnancy has 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 this product during lactation has not been determined.

4.8 Adverse Effects (Undesirable Effects)

CAPD/DPCA 17, 18, 19 Stay Safe.

Calcium deficiency (hypocalcaemia).
Longer-term treatment may be associated with hyperparathyroidism. In a study involving 173 patients on CAPD and receiving low calcium dialysate, Duncan et. al. have reported a rise in parathyroid levels from a median of 70 nanogram/L to a peak of 170 nanogram/L at 12-18 months before returning to 130 nanogram/L at 18-24 months.
Although there has been speculation in the literature regarding a higher incidence of peritonitis in patients on low calcium dialysates versus standard dialysates, two independent reviews have found no evidence to support this.

All CAPD/DPCA Stay Safe solutions.

Potassium deficiency (hypokalaemia).
Other serum electrolyte abnormalities.
Loss of plasma proteins (hypoproteinaemia).
Hyperglycaemia (see Section 4.4 Special Warnings and Precautions for Use, Use in diabetic patients).
Hypertriglyceridaemia and hypercholesterolaemia.
Obesity.
Inguinal and abdominal hernias.
Diarrhoea.
Constipation.
Encapsulating peritoneal sclerosis.
Disturbances in hydration.
Depending on the indwelling volume and the achieved ultrafiltration, sensations of fullness, shoulder pains, and dyspnoea due to elevated diaphragm may occur.
Infection (peritoneal and of catheter tunnel).
Hypotension associated with dialysis treatment has been reported in the literature. In most cases it has proven to be of no clinical significance.

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

Stay Safe solutions are for use in one patient on one occasion only. They contain no antimicrobial preservative. The solution should not be used if it is not clear, or if leaks are detected in the bag.
The choice of peritoneal dialysate will depend on each individual clinical situation and must be at the discretion of the treating physician.
The number of bag exchanges and the volumes are dependent on bodyweight, body size and residual kidney function. The usual adult dose is 1500 to 2000 mL solution per exchange administered 4 times daily with a dwell time of 4 to 8 hours. If dilation pain occurs at the commencement of a course of treatment, the dialysate volume should be temporarily reduced to 500 to 1500 mL per exchange.
In large adults, and if residual renal function is lost, an increased dose of dialysis will be necessary. In these patients, or patients who tolerate larger volumes, a dose of 2500 mL per exchange may be given.
The usual dose in children is 30 to 40 mL solution per kilogram of bodyweight per exchange.
If a machine is used for intermittent or continuous cycling peritoneal dialysis, it is advisable to use larger volume bags.
Creatinine and urea levels should be checked regularly to assess the efficacy of treatment.
Use only clear solutions and undamaged containers. Do not use after the expiry date.

Method of administration.

Warm the ready to use solution to body temperature. For intraperitoneal administration through an indwelling peritoneal dialysis catheter, instillation time of each dose should be between 5 to 20 minutes.
The solution should remain in the peritoneum for 4 to 8 hours (equilibration time) and then drained as per physician's instructions.
CAPD/DPCA Stay Safe may be used according to the necessary ultrafiltration and serum electrolyte concentration either alone or in combination with a different peritoneal dialysis solution.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.9 Overdose

Overdosing may be indicated by abdominal tension. If an excess volume of solution is allowed to enter the peritoneal cavity, it can be drained into the empty dialysate bag.
If fluid exchange is conducted too rapidly or too frequently, the patient may develop oedema, cardiac decompensation or electrolyte imbalances. When dialysis solutions with high glucose content are used, excessive ultrafiltration may lead to dehydration and circulatory collapse. Appropriate emergency medical treatment should be given.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

7 Medicine Schedule (Poisons Standard)

Not scheduled.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hydrochloric acid, sodium hydroxide, water for injections.

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.

6.4 Special Precautions for Storage

Store below 25°C. Do not refrigerate.

6.5 Nature and Contents of Container

CAPD/DPCA Stay Safe is supplied in flexible plastic bags made of non-PVC packaging material. The Stay Safe system consists of a 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.
CAPD/DPCA Stay Safe is available in packs of 4 x 3000 mL.

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