Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Sodium Chloride Intravenous Infusion. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you being given Sodium Chloride Intravenous Infusion against the benefits they expect it to have for you.

This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this leaflet carefully before this medicine is given to you. In some cases this leaflet may be given to you after the medicine has been used.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

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

What SODIUM CHLORIDE INTRAVENOUS INFUSION is used for

Sodium Chloride Intravenous Infusion is given to patients who have low levels of sodium or chloride. These chemicals are naturally present in body fluids and are needed for normal body function.

Sodium Chloride Intravenous Infusion may also be used for the dilution of other medicines before injecting into the body.

Sodium Chloride Intravenous Infusion may be used for the management of other conditions that are not mentioned above. Your doctor will be able to tell you about the specific condition for which you have been prescribed Sodium Chloride.

This medicine is available only with a doctor's prescription.

Before you are treated with SODIUM CHLORIDE INTRAVENOUS INFUSION

When you must not be given it

It may not be safe for you to be given sodium chloride. If you are not sure, check with your doctor.

Do not use it after the expiry date (EXP) printed on the label.

Do not use if the packaging is torn or shows signs of tampering.

Do not use unless the solution is clear and the seal is intact.

Before you are given it

Tell your doctor if:

1. you have any allergies to:

• any other medicine
• any other substances, such as foods, preservatives or dyes

2. you are pregnant or intend to become pregnant

your doctor will discuss the possible risks and benefit of being given Sodium Chloride Intravenous Infusion during pregnancy.

3. you are breastfeeding or plan to breast feed

it is not known whether sodium chloride passes into breast milk. Discuss with your doctor the risks and benefits being given Sodium Chloride Intravenous Infusion whilst breastfeeding.

4. you have or have had any medical conditions, especially the following:

• heart disease
• kidney problems
• liver disease
• swelling of the hands, ankles or feet
• breathlessness, which may be severe and usually worsens when lying down
• any condition for which you are taking corticosteroids or corticotrophin

Taking other medicines

Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may affect the way sodium chloride works. Your doctor will advise you about continuing to take other medicines.

How SODIUM CHLORIDE INTRAVENOUS INFUSION is given

Sodium Chloride Intravenous Infusion is given through slow injection into your veins (this is called an intravenous infusion). It will be given by your doctor or a specially trained nurse.

Your doctor will decide what dose, how often and how long you will receive it. This depends on your condition and other factors, such as your weight, age, blood tests, how well your kidneys are working, and whether or not other medicines are being given at the same time.

Follow all directions given to you by your doctor and pharmacist carefully. These directions may differ from the information contained in this leaflet.

Never administer this medicine yourself.

If you are given too much (overdose)

This rarely happens as Sodium Chloride Intravenous Infusion is administered under the care of a highly trained doctor or nurse.

However, if you are given too much sodium chloride you may experience some of the effects listed under "Side Effects" below.

Your doctor has information on how to recognise and treat an overdose. Ask your doctor if you have any concerns.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Sodium Chloride Intravenous Infusion. Like other medicines, sodium chloride can cause some side effects. If they occur, most are likely to be minor or temporary. However, some may be serious and need medical attention.

Ask your doctor or nurse to answer any questions that you may have.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Tell your doctor immediately if you notice any of the following:

• fast heart beat
• difficulty breathing
• headache or dizziness
• sleepiness, drowsiness or confusion

These may be serious side effects. You may need urgent medical attention. Serious side effects are rare.

Tell your doctor if you notice any of the following and they worry you:

• nausea and vomiting
• stomach cramps
• diarrhoea
• thirst, dry mouth
• sweats
• swelling of the hands, ankles or feet
• muscle twitches, weakness or cramps
• restlessness or irritability
• fever
• watery eyes
• reduced saliva or dry eyes

These are the more common side effects of sodium chloride. Mostly these are mild and short-lived.

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor. Some side effects may only be seen by your doctor.

Storage

Sodium Chloride Intravenous Infusion should be stored below 25°C.

Product Description

What it looks like

Sodium Chloride Intravenous Infusion is a clear, colourless solution contained in plastic vials.

Sodium Chloride products can be identified by an Australian Register Number which is found on the packaging:

AUST R 10804 and AUST R 49280

Ingredients

Sodium Chloride Intravenous Infusion contains:

Active ingredient:

• Sodium chloride

Other ingredients:

• Water for injections
• Sodium hydroxide
• Hydrochloric acid

It does not contain a preservative.

Sponsor and Distributor in Australia

Pfizer Australia Pty Ltd
Sydney, NSW
Toll Free Number: 1800 675 229
www.pfizermedicalinformation.com.au

Date of preparation

This leaflet was prepared in November 2023.

® Registered trademark

Published by MIMS January 2024

1 Name of Medicine

Sodium chloride.

2 Qualitative and Quantitative Composition

Sodium Chloride Intravenous Infusion BP 0.9% 50 mL vial contains sodium chloride 450 mg per 50 mL.
Sodium Chloride Intravenous Infusion BP 0.9% 100 mL vial contains sodium chloride 900 mg per 100 mL.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sodium Chloride Intravenous Infusion: Injection for intravenous infusion.
Sodium Chloride Intravenous Infusion is sterile, isotonic, preservative-free solutions.

4 Clinical Particulars

4.1 Therapeutic Indications

For the restoration and maintenance of salt and extracellular fluid levels or as a vehicle for the administration of parenteral drugs.

4.2 Dose and Method of Administration

To be used as directed by a physician.
Parenteral drug products should be inspected prior to administration for particulate matter and discolouration.

Dosage.

4.3 Contraindications

Congestive heart failure.
Severe renal impairment.
Conditions of sodium retention and oedema.
Liver cirrhosis.
Irrigation during electrosurgical procedures.

4.4 Special Warnings and Precautions for Use

Solutions containing sodium chloride should be used cautiously in patients with cardiovascular diseases such as congestive heart failure, hypertension, impaired renal function or other renal disease such as urinary tract obstruction, pregnancy associated hypertension, pulmonary or peripheral oedema, hypoproteinaemia, those receiving corticosteroids or corticotrophin or any condition associated with sodium retention. Congestive heart failure and pulmonary oedema may be precipitated, particularly in patients with cardiovascular disease or those receiving corticosteroids, corticotrophin or other drugs that may give rise to sodium retention.
Sodium chloride solutions should be used with caution in geriatric patients and infants.
Excessive administration of sodium chloride solution may result in hypernatraemia, hypokalaemia and acidosis resulting in dehydration of internal organs. Monitoring of fluid, electrolyte and acid-base balance may be necessary.
When used as a vehicle for intravenous drug delivery, the product information document of such drugs should be checked prior to use to ensure compatibility with the sodium chloride solution. Reconstitution instructions should be read carefully.
Do not use unless the solution is clear. The entire contents of the vial or ampoule should be used promptly.
Intravenous infusion during or immediately after surgery may result in sodium retention.

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

Additives may be incompatible with sodium chloride.
Do not store solutions containing additives unless compatibility has been proven.
Do not administer such preparations unless the solution is clear.
Coadministration 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)

Thrombophlebitis may occur at the injection site during prolonged infusions.
Excess IV administration may cause hypernatraemia, hypokalaemia, or acidosis.
If any adverse reactions are observed during administration, discontinue treatment and institute appropriate supportive treatment.
Hypernatraemia rarely occurs with therapeutic doses of sodium chloride, but may occur in excessive administration. A serious complication of this is dehydration of the brain causing somnolence and confusion, which may progress to convulsions, coma and ultimately respiratory failure and death. Other symptoms include thirst, reduced salivation and lachrymation, fever, tachycardia, hypertension, headache, dizziness, restlessness, weakness and irritability.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms of overdose.

Treatment of overdose.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

As the sodium chloride intravenous preparations are directly administered to the circulation, the bioavailability of the components is 100%. Excess sodium is predominantly excreted by the kidneys, with small amounts lost in faeces and sweat.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections, sodium hydroxide, hydrochloric acid.

6.2 Incompatibilities

See Section 4.4 Special Warnings and Precautions for Use; 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). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.
Use once only and discard any remaining portion.

6.5 Nature and Contents of Container

Sodium Chloride Intravenous Infusion BP 0.9% 50 mL plastic vial (10s), AUST R 10804.
Sodium Chloride Intravenous Infusion BP 0.9% 100 mL plastic vial (10s), AUST R 49280.
Not all presentations may be available.

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

Sodium chloride is a white, crystalline powder or colourless crystals, freely soluble in water and practically insoluble in ethanol.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes