Consumer medicine information

Ionolyte

Sodium chloride; Sodium acetate trihydrate; Potassium chloride; Magnesium chloride hexahydrate

BRAND INFORMATION

Brand name

Ionolyte

Active ingredient

Sodium chloride; Sodium acetate trihydrate; Potassium chloride; Magnesium chloride hexahydrate

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Ionolyte.

SUMMARY CMI

Ionolyte®

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 being given Ionolyte?

Ionolyte contains the active ingredients sodium chloride, sodium acetate trihydrate, potassium chloride and magnesium chloride hexahydrate. Ionolyte is a sterile infusion solution used as a source of water and electrolytes (salts). It is used when there is an acid imbalance in the body.

For more information, see Section 1. Why am I being given Ionolyte? in the full CMI.

2. What should I know before I am given Ionolyte?

Do not use if you have ever had an allergic reaction to Ionolyte 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 am given Ionolyte? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Ionolyte and affect how it works. These include medicines used:

  • to treat digestive tract ulcers
  • to increase the urine volume
  • to control blood pressure and treat heart failure
  • to prevent organ rejection
  • to relax muscles
  • to treat pain

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How is Ionolyte given?

Ionolyte will be given to you in hospital by a doctor or nurse. You will receive your medicine by intravenous infusion (infusion into a vein). The amount and rate at which the infusion is given depends on your condition. Your doctor will decide on the correct dose for you to receive.

More instructions can be found in Section 4. How is Ionolyte given? in the full CMI.

5. What should I know while being given Ionolyte?

Things you should do
  • Remind any doctor, dentist, or pharmacist of the medications you are currently taking, especially those listed in Section 3.
  • Tell your doctor if you are pregnant.
Things not to do
Driving or using machines
  • Ionolyte has no effect on the ability to be able to drive or use machines.

For more information, see Section 5. What should I know while being given Ionolyte? in the full CMI.

6. Are there any side effects?

All medicines have side effects. Sometimes they are serious, most of the time they are not. You will be monitored by a doctor or nurse during treatment. Please tell your doctor or nurse immediately if you notice any side effects.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.



FULL CMI

Ionolyte®

Active ingredient(s): sodium chloride, sodium acetate trihydrate, potassium chloride and magnesium chloride hexahydrate

Consumer Medicine Information (CMI)

This leaflet provides important information about using Ionolyte. 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 Ionolyte.

Where to find information in this leaflet:

1. Why am I being given Ionolyte?
2. What should I know before I am given Ionolyte?
3. What if I am taking other medicines?
4. How is Ionolyte given?
5. What should I know while being given Ionolyte?
6. Are there any side effects?
7. Product details

1. Why am I being given Ionolyte?

Ionolyte contains the active ingredient sodium chloride, sodium acetate trihydrate, potassium chloride and magnesium chloride hexahydrate.

Ionolyte is used as a source of water and electrolytes (salts). It is also used

Ionolyte is used for mild metabolic acidosis as a source of water and electrolytes.

2. What should I know before being given Ionolyte?

Warnings

Do not use Ionolyte if:

  • you are allergic to sodium chloride, sodium acetate trihydrate, potassium chloride and magnesium chloride hexahydrate, or 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 too much fluid in your body, and you have been told that you have a condition known as hyperhydration
  • You have been told that you have pulmonary edema, where too much fluid is in your lungs
  • You have been told that you have a congestive heart failure (a condition in which your heart cannot pump enough blood to other organs of your body)
  • You have severely impaired kidney function
  • You have decreased acidity of the blood caused by a metabolic disorder
  • You have high potassium levels in your blood

Check with your doctor if you:

  • have any other medical conditions such as:
    - heart failure
    - severe heart rate disorders
    - impaired kidney function
    - severe electrolyte abnormalities (e.g too high blood levels of potassium, sodium, magnesium or chloride)
    - high blood pressure
    - eclampsia (complication of pregnancy mainly manifested by high blood pressure and significant amounts of protein in the urine)
    - aldosteronism (syndrome of high blood pressure and low blood potassium levels caused by an excess of the natural hormone aldosterone)
    - treatments or conditions associated with sodium retention (e.g. corticoids/steroids)
    - potassium-sparing diuretics (used to increase the urine volume)
    - severe potassium deficiency
    - heart disease where you take heavy doses of digitalis
    - myasthenia gravis (a disease involving severe muscle weakness)
    - an operation where a muscle relaxant was used (neuromuscular block)
  • take any medicines for any other condition

Tell your doctor if any of the warnings listed above applies to you or when this has been the case in the past.

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.

The safety of the product in pregnant and breast-feeding women has not been investigated. Your doctor will only give Ionolyte after having weighed the benefits versus the potential risk to the baby.

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.

Some medicines may interfere with Ionolyte and affect how it works.

Ionolyte is not recommended if you are taking/using:

  • corticoids/steroids (for the treatment of digestive tract ulcers) as these are associated with retention of sodium and water (with fluid accumulation in tissues and high blood pressure)
  • potassium-sparing diuretics (used to increase the urine volume, such as amiloride, spironolactone, triamterene, given alone or in combination)
  • angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists (medicines that are mainly used for controlling blood pressure, treating heart failure)
  • tacrolimus and cyclosporine (medicine used to prevent organ rejection)
  • muscle relaxants
  • salicylates (used to ease pains and reduce fever)
  • lithium (anti-psychotic)
  • alkaline drugs like sympathomimetics (such as amphetamine).

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Ionolyte.

4. How do is Ionolyte given?

How much is given

The amount and rate at which the infusion is given depends on your condition. Your doctor will decide on the correct dose for you to receive.

How is Ionolyte given

Ionolyte will be given to you in hospital by a doctor or nurse. You will receive your medicine by intravenous infusion (infusion into a vein).

If you are given too much Ionolyte

It is very unlikely that you will receive more infusion than you should because this medicine will be given to you by your doctor or nurse who will monitor you during the treatment. However, tell your doctor or nurse if you have any concerns.

In the event of accidental overdose, treatment will be stopped, and you will be observed for signs and symptoms related to the drug. Therapeutic removal of excessive fluid might be necessary.

5. What should I know while being given Ionolyte?

Things you should do

Tell any other doctors, dentists, and pharmacists who treat you that you have been given this medicine.

If you are going to have surgery, tell the surgeon or anesthetist that you have been given this medicine.

It may affect other medicines used during surgery.

If you become pregnant after being given this medicine, tell your doctor immediately.

If you are about to have any blood tests, tell your doctor that you have been given this medicine. It may interfere with the results of some tests.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Ionolyte affects you.

Ionolyte has no effect on the ability to drive or use machines.

Looking after your medicine

Ionolyte will be stored in the pharmacy or kept on the ward. Ionolyte should be stored below 30°C and not be frozen.

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.

You will be monitored by your doctor or nurse during treatment with this medicine. If any of these side effects appear, the treatment will be stopped.

Less serious side effects

Less serious side effectsWhat to do
Very common (occurring in more than 1 in 10 patients):
  • Hyperhydration (too much fluid in your body) and heart failure in patients with heart disorder or pulmonary oedema (fluid accumulation in the lungs)
Common (occurring in more than 1 in 100 patients, but less than 1 in 10 patients
  • Large volumes of this solution may lead to dilution of components of the blood and decrease in the haematocrit (proportion of blood volume that is occupied by red blood cells)
Other side effects include:
  • Fluid accumulation in tissues (oedema)
  • Fever
  • Infection at the site of injection, local pain or reaction
  • Vein irritation, venous thrombosis (formation of a clot) or phlebitis (inflammation of the vein) extending from the site of injection
  • Extravasation (fluid leakage from the vein)
Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effectsWhat to do
  • Rash, itching or hives on the skin
  • Swelling of the face, lips, tongue, or other part of the body.
  • Shortness of breath, wheezing, or trouble breathing.
Call your doctor or nurse straight away.

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 Ionolyte contains

Active ingredient
(main ingredient)		Sodium chloride
Sodium acetate trihydrate
Potassium chloride
Magnesium chloride hexahydrate
Other ingredients
(inactive ingredients)		Sodium hydroxide
Hydrochloric acid
Water for injections
Potential allergensNone

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

What Ionolyte looks like

Ionolyte is a sterile, clear and colourless solution for intravenous infusion that comes in 500 mL and 1000 mL freeflex® bags.

Ionolyte solution for infusion 500 mL in packs of 20 bags: (Aust R 211732).

Ionolyte solution for infusion 1000 mL in packs of 10 bags: (AUST R 213304).

Who distributes Ionolyte

Supplied in Australia by:

Fresenius Kabi Australia Pty Limited
Level 2, 2 Woodland Way
Mount Kuring-gai NSW 2080
Australia
Tel: (02) 9391 5555

® = Registered Trademark

This leaflet was prepared in Aug 2023.

Published by MIMS September 2023

BRAND INFORMATION

Brand name

Ionolyte

Active ingredient

Sodium chloride; Sodium acetate trihydrate; Potassium chloride; Magnesium chloride hexahydrate

Schedule

Unscheduled

 

1 Name of Medicine

Sodium chloride, sodium acetate trihydrate, potassium chloride, and magnesium chloride hexahydrate.

2 Qualitative and Quantitative Composition

Ionolyte solution for infusion is a clear and colourless solution.
1000 mL of Ionolyte solution for infusion contains: sodium chloride 6.02 g, sodium acetate trihydrate 4.63 g, potassium chloride 0.30 g, magnesium chloride hexahydrate 0.30 g.
Electrolytes per 1000 mL: sodium (Na+) 137 mmol, potassium (K+) 4 mmol, magnesium (Mg2+) 1.5 mmol, chloride (Cl-) 110 mmol, acetate (CH3COO-) 34 mmol.
List of excipients: sodium hydroxide for pH adjustment, hydrochloric acid for pH adjustment, water for injections q.s. to 1000 mL.
Osmolality: approx. 265 mOsm/kg water. Titratable acidity: < 2.5 mmol NaOH/L. pH: 6.9 to 7.9.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for infusion.

4 Clinical Particulars

4.1 Therapeutic Indications

Ionolyte is indicated for: mild metabolic acidosis; as a source of water and electrolytes.

4.2 Dose and Method of Administration

As directed by the physician. Dosage and rate of administration is dependent on age, weight and clinical condition of the patient as well as laboratory determinations (including acid-base balance) and the concomitant therapy.
Product is for single use in one patient only. Discard any residue. Contains no antimicrobial preservatives. To be used immediately after the bag is opened.
Parenteral medicine products should be inspected visually for particulate matter and discolouration prior to the administration whenever solution and container permit.
All injections in freeflex bags are intended for intravenous administration using sterile equipment.

Special handling instructions.

Before administering the product in plastic bags to patient, review these directions.

Freeflex IV solution container.

(1) Check the expiry date and the solution for visible particles or cloudiness, do not use unless the solution is clear. Inspect the container for damage or leakage, if damaged do not use.
(2) Using the pre-cut corner tabs, peel open and remove the over-wrap.
(3) Identify the blue infusion (administration) port. Use the blue port only to administer solution.
(4) Break off the blue tamper-evident cover from the freeflex blue infusion port.
(5) Close roller clamp. Insert the spike until the clear plastic collar of the port meets the shoulder of the spike. Use a non-vented standard infusion set and close air inlet. Hang the bag on the infusion stand. Press drip chamber to get fluid level. Prime infusion set. Connect and adjust the flow rate.

Warnings.

1. Do not remove the freeflex IV container from its overwrap until immediately before use.
2. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
3. Do not administer unless the solution is clear, free from particles and the freeflex IV container is undamaged.
4. Ionolyte should be used immediately after insertion of the administration set.
5. Use the blue port only to administer solution.
6. Do not vent.
7. If administered by pressure infusion, air should be withdrawn or expelled from the bag through the medication/administration port prior to infusion.
8. Discontinue the infusion if an adverse reaction occurs.
9. It is recommended that administration sets are changed at least once every 24 hours.
10. For single use only. Discard unused portion.

4.3 Contraindications

Fluid overload (hyperhydration), especially in cases of pulmonary oedema and congestive cardiac failure.
Severe renal insufficiency.
Metabolic alkalosis.
Hyperkalaemia.

4.4 Special Warnings and Precautions for Use

The patient's clinical status and laboratory parameters (fluid balance, blood and urine electrolytes as well as acid-base balance) must be monitored, especially during use of larger volumes of this solution.
Fluid overload caused by overdose should be avoided in general. Particularly for patients with cardiac insufficiency or severe kidney dysfunctions the increased risk of hyperhydration must be taken into consideration; posology must be adapted.
In metabolic alkalosis and clinical situations where alkalisation should be avoided, solutions like sodium chloride 0.9% solution should be preferred over alkalising solutions like Ionolyte.
Particular care must be taken in patients with severe electrolyte abnormalities, like hypernatraemia, hypermagnesaemia and hyperchloraemia.
Solutions containing sodium chloride should be administered with caution in patients with hypertension, heart failure, peripheral or pulmonary oedema, impaired renal function, pre-eclampsia, aldosteronism or other conditions or treatment (e.g. corticoids/steroids) associated with sodium retention (please also see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Since this solution contains potassium, combination with potassium-sparing diuretics is not recommended. Plasma potassium must be particularly closely monitored in patients at risk of hyperkalaemia, e.g. in the presence of severe chronic renal failure (please also see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Precaution must be taken to use this medicine in combination with angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists, suxamethonium, tacrolimus, cyclosporine or in case of severe digitalis intoxication (risk of cardiac symptoms).
Although Ionolyte has a potassium concentration similar to the concentration in plasma, it is insufficient to produce a useful effect in case of severe potassium deficiency and therefore it should not be used for this purpose.
Solutions containing magnesium salts should be used with caution in patients with renal impairment, severe heart rate disorders and in patients with myasthenia gravis. Patients should be monitored for clinical signs of excess magnesium, particularly when being treated for eclampsia. Administration in the postoperative period after neuromuscular block should be used with caution since magnesium salts can lead to a recurarisation effect (please also see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions).
Infusion of Ionolyte may cause metabolic alkalosis because of the presence of acetate ions. However, it is not suitable to treat severe metabolic or respiratory acidosis.
During long-term parenteral treatment, a convenient nutritive supply must be given to the patient.

Paediatric use.

Safety and efficacy of Ionolyte in paediatric patients have not been established by adequate or well controlled trials, however, the use of electrolyte solutions in the paediatric population is referenced in the medical literature. The precautions and adverse reactions identified in this document should be observed in the paediatric population.

Use in the elderly.

In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or medicine therapy.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Interactions related to the presence of sodium.

Combinations not recommended (please also see Section 4.4 Special Warnings and Precautions for Use): corticoids/steroids and carbenoxolone are associated with retention of sodium and water (with oedema and hypertension).

Interactions related to the presence of potassium.

The following combinations increase the concentration of potassium in the plasma and may lead to potentially fatal hyperkalaemia notably in case of renal failure increasing the hyperkalaemic effects.
Combinations not recommended (please also see Section 4.4 Special Warnings and Precautions for Use):
potassium-sparing diuretics: amiloride, spironolactone, triamterene, alone or in combination;
angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin II receptor antagonists;
tacrolimus, cyclosporine;
suxamethonium.

Interactions related to the presence of magnesium.

Combinations not recommended (please also see Section 4.4 Special Warnings and Precautions for Use): competitive and depolarising neuromuscular blockers.

Alkalisation of urine.

Precaution is to be taken, as alkalisation of the urine by bicarbonate resulting from acetate metabolism will increase the elimination of certain drugs (such as salicylates, lithium) and will decrease elimination of alkaline drugs like sympathomimetics (such as amphetamine).

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

Studies with Ionolyte have not been performed to evaluate the effect on fertility.
(No Category)
Animal reproduction studies have not been conducted with Ionolyte. It is also not known whether Ionolyte can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Ionolyte should be given to a pregnant woman only if clearly needed.
 It is not known whether Ionolyte is excreted in human milk. Because many medicines are excreted in human milk, caution should be exercised when Ionolyte is administered to a nursing mother.

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.

4.8 Adverse Effects (Undesirable Effects)

The undesirable effects are divided into: very common (> 1/10), common (> 1/100 to < 1/10), uncommon (> 1/1,000 to < 1/100), rare (> 1/10,000 to < 1/1,000), not known (cannot be estimated from the available data).
For similar products, the following adverse reactions have been described.

Metabolism and nutrition disorders.

During administration of electrolyte solutions, the following undesirable effects have been reported:
hyperhydration and heart failure in patients with cardiac disorder or pulmonary oedema (very common);
oedema due to water/sodium overload (unknown frequency).

General disorders and administration site conditions.

Adverse reactions may be associated with the technique of administration including febrile response, infection at the site of injection, local pain or reaction, vein irritation, venous thrombosis or phlebitis extending from the site of injection and extravasation.

Investigations.

In high doses the effects of dilution can commonly lead to a similar dilution of components of the blood, e.g. coagulation factors and other plasma proteins, and a decrease of the haematocrit.
Adverse reactions may be associated to the medicinal product added to the solution; the nature of the additive will determine the likelihood of any other undesirable effects.
In case of undesirable effect(s), the infusion must be discontinued.

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 https://www.tga.gov.au/reporting-problems.

4.9 Overdose

In the event of accidental overdose, treatment should be discontinued and the patient should be observed for the appropriate signs and symptoms related to the drug administered. The relevant symptomatic and supportive measures should be provided as necessary, e.g. administration of a diuretic. In oliguric or anuric patients haemofiltration or dialysis may be necessary in order to remove excessive fluid.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Ionolyte is an isotonic solution of electrolytes. The constituents of Ionolyte and their concentrations are designed to match those of plasma. The product is used for correction of disturbances in the serum electrolyte balance and in the acid-base balance. Electrolytes are given to achieve or to maintain normal osmotic conditions in the extracellular as well as the intracellular compartment. Acetate is metabolised into bicarbonate in hepatic and extrahepatic tissues (e.g. muscles and peripheral tissues) and produces a mild alkalising effect. Due to the amount of metabolisable anions, Ionolyte is suitable for patients with a tendency to acidosis.
The pharmacology of intravenously infused solutions with similar composition is known from long-standing use in clinical and emergency medicine.
The pharmacodynamic properties of this solution are those of its components (water, sodium, potassium, acetate, and chloride). The main effect of Ionolyte is the expansion of the extracellular compartment including both the interstitial and intravascular fluids. Ions, such as sodium, circulate through the cell membrane using various mechanisms of transport among which is the sodium pump (Na+/K+-ATPase). Sodium plays an important role in neurotransmission and cardiac electrophysiology.
Potassium is essential for numerous metabolic and physiological processes including nerve conduction, muscle contraction, and acid-base regulation. A normal concentration of potassium in plasma is approx. 3.5 to 5.0 mmoles per litre. Potassium is predominantly an intracellular cation, primarily found in muscle; only about 2% are present in the extracellular fluid. The passage of potassium into the cells and retention against the concentration gradient requires active transport via the Na+/K+-ATPase pump.
Chloride is mainly an extracellular anion found in low concentration in bone and in high concentration in some components of connective tissue such as collagen. Intracellular chloride concentration is high in red blood cells and gastric mucosa. The balance of anions and cations are regulated by the kidneys. Reabsorption of chloride generally follows reabsorption of sodium.
Magnesium is an activator of numerous enzyme systems and as such of general importance for metabolic functions. It is involved in the carbohydrate and fat metabolism, protein synthesis, and membrane transport and integrity. Nerve conduction and muscular contractility depend on magnesium.

Clinical trials.

Data not available.

5.2 Pharmacokinetic Properties

The pharmacokinetic properties of this solution are those of its components (water, sodium, potassium, magnesium, acetate and chloride).
The pharmacology of intravenously infused solutions with similar composition is known from the long-standing use in clinical and emergency medicine and from the fundamental understanding of the water and electrolyte balance regulation and metabolic processes in the body.
The cation Na+ and the anion Cl- are the predominant electrolytes in extracellular fluid. Maintenance of normal sodium balance is essential for proper blood volume and water distribution in the body. Fluid homeostasis is regulated by various related systems. The healthy body can compensate for widely divergent water and sodium chloride intakes by adaptation of the elimination. The kidneys, adrenals, pituitary gland, lungs and the sympathetic nervous system are mainly involved. Regulatory mechanisms for the body's water balance are associated with the cation Na+. Consequently, disturbances of water homeostasis cause sodium changes and vice versa. Furthermore, sodium is involved in all bio-electrical processes and in the function of numerous enzyme systems.
Chloride is essential for the maintenance of appropriate acid-base balance and plays an important role in the control of fluid homeostasis. High chloride concentrations exist in gastric fluids. Loss through diarrhoea, vomiting or other disturbances may result in hypochloraemia and metabolic alkalosis. Reduced chloride content compared to sodium chloride 0.9% solution helps to prevent the development of hyperchloremic metabolic acidosis.
Factors influencing potassium transfer between intracellular and extracellular fluid such as acid-base disturbances can distort the relationship between plasma concentrations and total body stores. Potassium is excreted mainly by the kidneys; it is secreted in the distal tubules in exchange for sodium or hydrogen ions. The capacity of the kidneys to conserve potassium is poor and some urinary excretion of potassium continues even when there is severe depletion. Some potassium is excreted in the faeces and small amounts may also be excreted in sweat.
Acetate serves as a metabolic precursor of bicarbonate. It is rapidly activated to acetyl-CoA and enters the corresponding biochemical pathways to be degraded to carbon dioxide. Bicarbonate is the principal extracellular buffer in the body, which is in a dynamic equilibrium with carbon dioxide and undissociated carbonic acid. Mainly the buffer capacity of this equilibrium adjusts the blood pH to its normal slightly basic value. Acetate has, after conversion to bicarbonate in a molar ratio, the corresponding anti-acidotic effect.

5.3 Preclinical Safety Data

Carcinogenicity.

Studies with Ionolyte have not been performed to evaluate carcinogenic.

Genotoxicity.

Studies with Ionolyte have not been performed to evaluate mutagenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium hydroxide for pH adjustment, hydrochloric acid for pH adjustment, water for injections q.s. to 1000 mL.

6.2 Incompatibilities

Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with a pharmacist, if available. If, in the informed judgement of the physician, it is deemed advisable to introduce additives, use aseptic technique. Mix thoroughly when additives have been introduced. Do not store solutions containing additives.

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 30°C. Do not freeze.

6.5 Nature and Contents of Container

Ionolyte solution for intravenous infusion is a clear and colourless solution in freeflex bags with overwrap available in the following pack sizes:

Freeflex bags with overwrap.

500 mL (cartons of 20 bags).

Freeflex bags with overwrap.

1000 mL (cartons of 10 bags).

Freeflex + (needle-free) bags with overwrap.

500 mL (cartons of 20 bags).

Freeflex + (needle-free) bags with overwrap.

1000 mL (cartons of 10 bags).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Chemical structure.

Ionolyte solution for infusion is an isotonic solution of electrolytes.

CAS number.

Sodium chloride (CAS no: 7647-14-5), sodium acetate trihydrate (CAS no: 6131-90-4), potassium chloride (CAS no: 7447-40-7) and magnesium chloride hexahydrate (CAS no: 7791-18-6).

7 Medicine Schedule (Poisons Standard)

Australia: Not scheduled.

Summary Table of Changes