Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Sodium Chloride Injection 23.4%.

It does not contain all the available information. It does not take the place of talking to your doctor.

All medicines have risks and benefits Your doctor has weighed the risks of you being given Sodium Chloride Injection 23.4% against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor.

Keep this leaflet. You may need to read it again.

What Sodium Chloride Injection 23.4% is used for

Sodium Chloride Injection 23.4% is a concentrated solution and is normally diluted before it is used.

Sodium Chloride Injection 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.

Ask your doctor if you have any questions about why Sodium Chloride Injection 23.4% has been prescribed for you. Your doctors may have prescribed it for another reason.

Sodium Chloride Injection 23.4% should be administered with care to very young and elderly patients.

Before you are given Sodium Chloride Injection 23.4%

When you must not be given it

Your doctor will have considered the need to give you Sodium Chloride Injection 23.4% carefully.

Make sure you tell the doctor if you have any allergies to

• any other medicines
• any other substance such as food dyes, preservatives or plastics.

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.

You should not be given Sodium Chloride Injection 23.4% if the solution is discoloured, cloudy, turbid, or a precipitate is present. The solution is normally a clear, colourless solution. You should not be given Sodium Chloride Injection 23.4% if, when diluted with another IV solution, it causes the solution to become cloudy, turbid, discolour or form particles.

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

You should not be given Sodium Chloride Injection 23.4% if you have the following medical conditions:

• heart problems
• severe kidney disease
• swelling due to excess fluid
• liver disease.

The doctor or nurse will check to ensure the medicine is not past its expiry date and has not been tampered with.

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

Before you are given it

Tell your doctor if you have allergies to any medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• heart problems
• breathlessness which may be severe and worsen when lying down
• swelling of hands, ankles or feet
• kidney problems
• high blood pressure due to pregnancy.

If you have not told your doctor about any of the above, tell them before you are given Sodium Chloride Injection 23.4%.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket, health food shop, herbalist or naturopath. Some medicines may interfere with Sodium Chloride Injection 23.4%. These include corticosteroids or other drugs that cause sodium to be retained in the body.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while being given Sodium Chloride Injection 23.4%.

How Sodium Chloride Injection 23.4% is given

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

How it is given

Sodium Chloride Injection 23.4% is diluted in a suitable solution and slowly injected into a vein over a period of time determined by your doctor.

When treating varicose veins the required volume and concentration of Sodium Chloride Injection 23.4% will be injected into the affected vein all at once and a compression bandage applied.

How much is given

Your doctor will decide what dose of Sodium Chloride Injection 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 Injection 23.4% is required.

If you are given too much (overdose)

Sodium Chloride Injection 23.4% must only be given by a doctor or nurse so an overdose is not likely to occur. Some medical conditions may result in too much sodium chloride in the body.

Symptoms of an overdose are similar to side effects.

The symptoms of a side effect are listed under Side Effects.

If you notice any symptoms of an overdose immediately contact your doctor or go to the Emergency Department at the nearest hospital.

Contact the Poisons Information Centre on 13 11 26 for further advice on overdose management.

While you are being given Sodium Chloride Injection 23.4%

Things you must do

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

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

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

Things to be careful of

If you feel light headed 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.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Sodium Chloride Injection 23.4%.

The addition of Sodium Chloride Injection 23.4% to intravenous fluids is unlikely to result in any side effects.

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

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

Ask your doctor to answer any of the questions you may have.

An overdose of sodium chloride can result in side effects. If any of the following happen tell your doctor immediately or go to the Emergency Department at your nearest hospital:

• nausea, vomiting
• cramps
• diarrhoea
• 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.

The above list includes very serious side effects. You may need urgent medical attention. These side effects are very rare.

Tell your doctor or nurse if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

After being given Sodium Chloride Injection 23.4%

Storage

Sodium Chloride Injection 23.4% will be stored in the surgery, pharmacy or ward of a hospital. The injection is kept in a cool dry place where the temperature stays below 30°C.

Sodium Chloride Injection 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.

Product description

What it looks like

Sodium Chloride Injection 23.4% is a clear, colourless solution in a clear glass vial with a plastic top.

Ingredients

Sodium Chloride Injection 23.4% contains 234 mg/mL of sodium chloride in water for injections. Hydrochloric acid is added to adjust the pH when required.

This medicine does not contain lactose, sucrose, gluten, tartrazine, alcohol, dyes or any preservatives.

Manufacturer

Sodium Chloride Injection 23.4% is made in Australia by:
Phebra Pty. Ltd.
19 Orion Road
Lane Cove West, NSW 2066
Australia

Sodium Chloride Concentrated Injection 23.4% 10mL vial. AUST R 23119

Phebra product code - INJ027

This leaflet was prepared in May 2013.

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

Published by MIMS July 2014

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