SUMMARY CMI

Sodium Chloride 23.4%

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 Sodium Chloride 23.4%?

Sodium Chloride 23.4% contains the active ingredient sodium chloride. Sodium Chloride 23.4% is added to intravenous solutions (IV) to treat patients with lower than normal salt levels (sodium or chloride ions) in their blood. It is also injected into small varicose veins to close them.

For more information, see Section 1. Why am I using Sodium Chloride 23.4%? in the full CMI.

2. What should I know before I use Sodium Chloride 23.4%?

Do not use if you have ever had an allergic reaction to Sodium Chloride 23.4% 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 Sodium Chloride 23.4%? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Sodium Chloride 23.4% 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 Sodium Chloride 23.4%?

• Sodium Chloride 23.4% must only give by a doctor or nurse. They will decide what dose and how long you will receive it for. This depends on your medical condition and other factors.

More instructions can be found in Section 4. How do I use Sodium Chloride 23.4%? in the full CMI.

5. What should I know while using Sodium Chloride 23.4%?

For more information, see Section 5. What should I know while using Sodium Chloride 23.4%? in the full CMI.

6. Are there any side effects?

Sodium Chloride 23.4% may cause nausea, vomiting, diarrhoea, cramps, decrease in saliva, tears or urination, increase in thirst and sweating, increase in heart rate, difficulty breathing or breathlessness which may worsen when lying down, swelling of hands, ankles and feet, dizziness, light headedness, drowsiness, restlessness or irritability, headaches, confusion, muscle weakness, twitching, rigidity or convulsions.

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

Sodium Chloride 23.4% concentrated injection for infusion

Active ingredient: sodium chloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Sodium Chloride 23.4% 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 Sodium Chloride 23.4%.

Where to find information in this leaflet:

1. Why am I using Sodium Chloride 23.4%?
2. What should I know before I use Sodium Chloride 23.4%?
3. What if I am taking other medicines?
4. How do I use Sodium Chloride 23.4%?
5. What should I know while using Sodium Chloride 23.4%?
6. Are there any side effects?
7. Product details

1. Why am I using Sodium Chloride 23.4%?

Sodium Chloride 23.4% is a concentrated injection containing the active ingredient sodium chloride. Sodium chloride is a mineral supplement.

Sodium Chloride 23.4% injection is combined with intravenous solutions (IV) to treat patients with lower than normal salt levels (sodium or chloride ions) in their blood.

It is also injected into small varicose veins to close them.

Your doctors may have prescribed it for another reason. Ask your doctor if you have any questions about why this medicine has been prescribed for you.

2. What should I know before I use Sodium Chloride 23.4%?

Warnings

Your doctor will have considered the need to give you Sodium Chloride 23.4% carefully. Make sure to tell the doctor if you have any allergies.

Do not use Sodium Chloride 23.4% if:

• you are allergic to
  - sodium chloride
  - any other medicines
  - any other substance such as food dyes, preservatives or plastics.
  - any of the ingredients listed at the end of this leaflet.

Some of the symptoms of an allergic reaction may include:

• shortness of breath
• wheezing or difficulty breathing
• swelling of the face, lips, tongue, or other parts of the body
• rash, itching or hives on the skin.

Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

• have or have had the following medical conditions:
  - heart problems
  - severe kidney disease
  - swelling of hands, ankles or feet due to excess fluid
  - breathlessness which may be severe or worsen when lying down
  - high blood pressure due to pregnancy
  - liver disease

You should not be given Sodium Chloride 23.4% if:

• the solution is discoloured, cloudy, turbid, or a precipitate is present. The solution is normally a clear colourless solution.
• upon dilution with another IV solution the solution becomes cloudy, turbid, discoloured, or form visible particles.

If you are not sure whether you should be given Sodium Chloride 23.4% talk to your doctor.

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.

Unless specifically prescribed by your doctor, you should not be given Sodium Chloride 23.4% if you are pregnant or breast feeding. Ask your doctor about the risks and benefits involved.

Use in Children

• Sodium Chloride 23.4% should be administered with care to very young patients.

Use in Elderly

• Sodium Chloride 23.4% should be administered with care to elderly patients.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking other medicines, including any medicines, vitamins or supplements that you by without a prescription from your pharmacy, supermarket, health food shop, herbalist or naturopath.

Some medicines may interfere with Sodium Chloride 23.4% and affect how it works.

These include:

• Corticosteroids
• other drugs that cause sodium to be retained in the body.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Sodium Chloride 23.4%.

4. How do I use Sodium Chloride 23.4%?

Sodium Chloride 23.4% must only be given by a doctor or nurse.

How much to use

• Your doctor or nurse will decide what dose of Sodium Chloride 23.4% you will receive and how long you will receive it for. This depends on your medical condition and other factors.
• Sometimes only a single dose of Sodium Chloride 23.4% is required.

How to use Sodium Chloride 23.4%

• When treating varicose veins the required volume and concentration of Sodium Chloride 23.4% will be injected into the affected vein all at once and a compression bandage applied.
• Sodium Chloride 23.4% should only be opened when it is time for you to have the injection.
• Sodium Chloride 23.4% is diluted in a suitable solution and slowly injected into a vein over a period of time determined by your doctor.

If you are given too much Sodium Chloride 23.4%

Overdose is unlikely to occur as Sodium Chloride 23.4% must only be given by a doctor or nurse. Your doctor or nurse will monitor the level of sodium and chloride in the blood. Some medical conditions may result in too much sodium or chloride in the body, and 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 Sodium Chloride 23.4%?

Things you should do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given Sodium Chloride 23.4%.

Tell any other doctors, dentists, and pharmacists who treat you that you have been given Sodium Chloride 23.4%.

If you are going to have surgery, tell the surgeon or anaesthetist that you have been given Sodium Chloride 23.4%. It may affect other medicines used during the surgery.

If you feel lightheaded or faint when getting out of bed or standing up, get up slowly.

Standing up slowly, especially when you get up from a bed or a chair, will help your body get used to the change in position and blood pressure. If this problem continues to get worse talk to your doctor.

Call your doctor straight away if you:

• become pregnant during the course of Sodium Chloride 23.4% treatment.

Remind any doctor, dentist, pharmacist or nurse you visit that you have been given Sodium Chloride 23.4%.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Sodium Chloride 23.4% affects you.

Sodium Chloride 23.4% may cause dizziness, light-headedness, drowsiness, or weakness in some people. If you have any of these symptoms, do not drive, operate machinery, or do anything else dangerous.

Looking after your medicine

• Sodium Chloride 23.4% will be stored in the surgery, pharmacy or ward of a hospital. The medicine is kept in a cool dry place where the temperature stays below 30°C.
• Sodium Chloride 23.4% will only be opened when it is time for you to have the injection.
• It should not be stored after it is opened nor used for more than one person.

Keep it where young children cannot reach it.

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.

If you are over 65 years of age or very young, you may have an increased chance of getting side effects.

Reporting side effects

After you have received medical advice for any side affects 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 Sodium Chloride 23.4% contains

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

Sodium Chloride 23.4% does not contain lactose, sucrose, gluten, tartrazine, alcohol, dyes or any preservatives.

What Sodium Chloride 23.4% looks like

Sodium Chloride 23.4% is a clear, colourless solution in a clear glass vial with a plastic yellow top. (AUST R 23119).

Who distributes Sodium Chloride 23.4%

Sodium Chloride 23.4% is supplied by:

Phebra Pty Ltd
19 Orion Road, Lane Cove West,
NSW 2066, Australia.
Telephone: 1800 720 020.

This leaflet was prepared in Jul 2021.

Phebra and the Phi symbol are both trademarks of Phebra Pty Ltd, 19 Orion Road, Lane Cove West, NSW 2066, Australia.

Published by MIMS September 2021

1 Name of Medicine

Sodium chloride.

2 Qualitative and Quantitative Composition

Each mL of Sodium Chloride 20% contains 200 mg of sodium chloride which is equivalent to 3.4 mmol of sodium ions and 3.4 mmol of chloride ions.
Each mL of Sodium Chloride 23.4% contains 234 mg of sodium chloride which is equivalent to 4.0 mmol of sodium ions and 4.0 mmol of chloride ions.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sodium Chloride 20% and 23.4% are hypertonic concentrated injections for infusion. pH 4.5 to 7.0. Dilute before use.

4 Clinical Particulars

4.1 Therapeutic Indications

As an additive to parenteral fluids in patients who have specific electrolyte needs for sodium or chloride ions.
As a sclerosing agent for small symptomatic varicose veins.

4.2 Dose and Method of Administration

The dosage of sodium chloride as an additive in intravenous fluids must be calculated after consideration of clinical and laboratory data. The correct volume of sodium chloride 20% or 23.4% is then aseptically withdrawn and diluted to the required concentration by addition to an appropriate intravenous solution such as 5% glucose. The final solution should be administered within 4 hours.

Sclerotherapy.

4.3 Contraindications

Congestive heart failure.
Severe renal impairment.
Conditions of sodium retention and oedema.
Liver cirrhosis.

4.4 Special Warnings and Precautions for Use

Sodium Chloride 20% and 23.4% are hypertonic (concentrated) and must be diluted before use.
Do not use unless the solution is clear. The entire contents of the vial should be used immediately on opening. Do not store opened vials. Do not re-sterilise. Do not use on more than one patient.
Any solution remaining should be discarded.
Excessive administration of sodium chloride causes hypernatraemia, resulting in dehydration of internal organs, hypokalaemia and acidosis. Monitoring of fluid, electrolyte and acid/ base balance may be necessary.
Congestive heart failure and pulmonary oedema may be precipitated, particularly in patients with cardiovascular disease or those receiving corticosteroids or other drugs that may give rise to sodium retention. Sodium chloride should be administered with care to patients with congestive heart failure, peripheral or pulmonary oedema, impaired renal function, pre-eclampsia and very young or elderly patients.

Use in hepatic impairment.

Use in renal impairment.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Sodium Chloride 20% and 23.4% may be incompatible with other solutions and drugs. The product information document of each solution or drug should be checked prior to use to ensure compatibility with the sodium chloride solution.
Co-medication of drugs inducing sodium retention may exacerbate any systemic effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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)

Proper use of hypertonic (concentrated) saline as an additive to parenteral fluids for electrolyte replacement is unlikely to result in adverse effects. Inadvertent administration of concentrated sodium chloride solutions may result in sudden hypernatraemia and potential complications such as somnolence, and confusion progressing to convulsions, cardiovascular shock, CNS disorders, extensive haemolysis, respiratory failure and cortical necrosis of the kidney.
If any adverse experience is observed during administration, discontinue infusion and evaluate the patient.

Mild hypernatraemia.

Reporting suspected adverse reactions.

4.9 Overdose

Excess sodium chloride in the body produces general gastrointestinal effects of nausea, vomiting, diarrhoea and cramps. Salivation and lacrimation are reduced, while thirst and sweating are increased. Hypotension, tachycardia, renal failure, peripheral and pulmonary oedema and respiratory arrest may occur. CNS symptoms include headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death.

Treatment.

5 Pharmacological Properties

The human body contains about 4 moles of sodium (about 92 g). About one third is found in the skeleton and approximately half is present in the extracellular fluid. Sodium chloride is well absorbed through the gastrointestinal tract (this is enhanced in the presence of glucose). Excess sodium is predominantly excreted by the kidney and small amounts are lost in the faeces and sweat.

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections.
Hydrochloric acid and/or sodium hydroxide are used for pH adjustment.
The injection does not contain antimicrobial preservative.

6.2 Incompatibilities

See Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.

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)¹. The expiry date can be found on the packaging.
¹ AUST R 23119; AUST R 23180; AUST R 48630.

6.4 Special Precautions for Storage

Sodium Chloride 23.4% (AUST R 23119) - store below 30°C.
Sodium Chloride 20% (AUST R 23180) - store below 25°C.
Sodium Chloride 20% (AUST R 48630) - store below 30°C.

6.5 Nature and Contents of Container

Sodium Chloride 23.4% is supplied in a 10 mL vial in a carton containing 10 vials.
Phebra Product Code - INJ027.
Sodium Chloride 20% (AUST R 23180) is presented in 10 mL vials.
Phebra Product Code - INJ025.
Sodium Chloride 20% (AUST R 48630) is presented in 50 mL vials.
Phebra Product Code - INJ026.
Not all presentations may be marketed.
The vial stopper is not made with natural rubber latex.

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

The molecular weight of the compound is 58.44. The molecular formula is NaCl.

CAS number.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes