Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Sodium Chloride Injection BP 0.9%. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you being given Sodium Chloride Injection BP 0.9% against the benefits they expect it will have for you.

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

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

What Sodium Chloride Injection BP 0.9% is used for

Sodium Chloride Injection BP 0.9% is used to replace lost body fluids and salts. Other medicines which are given by injection or by drip may be diluted with Sodium Chloride Injection BP 0.9%.

Sodium Chloride Injection BP 0.9% can also be used as a sterile irrigation solution.

Your doctor will have explained why you are being given Sodium Chloride Injection BP 0.9%.

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

Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.

Sodium Chloride Injection BP 0.9% is not addictive.

Before you are given Sodium Chloride Injection BP 0.9%

You may already have been given Sodium Chloride Injection BP 0.9%.Your doctor will have considered the situation carefully and decided to use it. However, if any of the following applies to you, tell your doctor immediately.

When you must not be given it

Sodium Chloride Injection BP 0.9% will only be used if the solution is clear, the package is undamaged and the use by (expiry) date marked on the pack has not been passed.

You should not be given Sodium Chloride Injection BP 0.9% if you are pregnant or breastfeeding unless your doctor says it is safe. Ask your doctor about the risks and benefits involved.

You should not be given Sodium Chloride Injection BP 0.9% if you have, or have had, any of the following medical conditions:

• congestive heart failure
• severe kidney problems
• swelling due to excess fluid
• cirrhosis of the liver

Before you are given it

You must tell your doctor or pharmacist if you have allergies to any other medicines, foods, preservatives or dyes.

You may already have been given

Tell your doctor if you have or have any of these medical conditions:

• heart problems
• excess fluid in the lungs
• swelling due to excess fluid
• kidney disease
• high blood pressure including high blood pressure due to pregnancy
• problems with your urinary tract

It may not be safe for you to be given Sodium Chloride Injection BP 0.9% if you have these conditions.

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 or health food shop including:

• corticosteroids

These medicines may affect the way Sodium Chloride Injection BP 0.9% works. Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

If you have not told your doctor about any of these things, tell them before you are given any Sodium Chloride Injection BP 0.9%.

How Sodium Chloride Injection BP 0.9% is given

Sodium Chloride Injection BP 0.9% will be given to you by your doctor or a specially trained nurse.

It will be given by injection, or applied to open wounds if is being used as an irrigation solution.

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.

Overdose

The doctor or nurse giving you Sodium Chloride Injection BP 0.9% will be experienced in its use so it is extremely unlikely that you will be given too much.

However, the first signs of overdose can be nausea, vomiting, diarrhoea, cramps, reduced saliva and increased thirst.

Contact the Poisons Information Centre for any further information.

Australia: 13 11 26.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Sodium Chloride Injection BP 0.9%.

All medicines can have some side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

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

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

• nausea and vomiting
• stomach cramps
• diarrhoea
• thirst, dry mouth
• swelling of the hands, ankles or feet
• muscle twitches, weakness or cramps
• restlessness or irritability
• fever
• watery eyes
• reduced saliva or dry eyes
• headache
• tiredness or drowsiness
• dizziness
• increased sweating
• confusion

These are the more common side effects of Sodium Chloride Injection BP 0.9%. Mostly these are mild and short lived.

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

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 Injection BP 0.9% will be stored by your doctor or pharmacist under the recommended conditions.

It should be kept in a cool, dry place below 25°C.

Disposal

Ask your pharmacist what to do with any Sodium Chloride Injection BP 0.9% you have left over or you find that the expiry date has passed.

Product description

What it looks like

Sodium Chloride Injection BP 0.9% is a clear and colourless solution.

Ingredients

Sodium Chloride Injection BP 0.9% contains sodium chloride 0.9% as the active ingredient and Water for Injections. Sodium Chloride Injection BP 0.9% does not contain any preservatives.

Sodium Chloride Injection BP 0.9% is supplied in polypropylene ampoules in the following presentations:

• 5 mL - AUST R 235990
• 10 mL - AUST R 235989
• 20 mL - AUST R 235991

Supplier

InterPharma Pty Ltd
Suite 103, 39 East Esplanade
Manly NSW 2095
Ph: 02 9976 6876
www.interpharma.com.au

This leaflet was updated in July 2020.

Published by MIMS January 2021

1 Name of Medicine

Sodium chloride.

2 Qualitative and Quantitative Composition

Sodium Chloride Injection BP 0.9% is a sterile, preservative-free solution, containing sodium chloride 0.9% w/w in water for injections.

3 Pharmaceutical Form

Injection, solution.

4 Clinical Particulars

4.1 Therapeutic Indications

Sodium Chloride Injection BP 0.9% can be used as the vehicle for many parenteral drugs and as an electrolyte replenisher for maintenance or replacement of deficits of extracellular fluid. It can also be used as a sterile irrigation medium.

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. Sodium Chloride Injection BP 0.9% does not contain any antimicrobial preservatives. Care should be taken with intravenous technique to avoid injection site reactions and infections.
Dosage is dependent on the age, weight, clinical and fluid/electrolyte condition of the patient.

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

Solutions containing sodium chloride should be used cautiously in patients with cardiovascular or renal disease, pregnancy associated hypertension, pulmonary or peripheral oedema, those receiving corticosteroids or corticotrophin or any condition associated with sodium retention.
Excessive administration of sodium chloride solution may result in hypernatraemia, resulting in dehydration of internal organs, hypokalaemia and acidosis. 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.

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.
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 normal saline as a vehicle for parenteral drugs or as an electrolyte replacement therapy is unlikely to result in adverse effects.
If any adverse reactions are observed during administration, discontinue treatment and institute appropriate supportive treatment.
Thrombophlebitis may occur at the injection site during prolonged infusions.
Excess intravenous administration of sodium chloride may cause hypernatraemia, hypokalaemia and acidosis.
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 overdosage.

Treatment of overdosage.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

As 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.

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.

6.5 Nature and Contents of Container

Sodium Chloride Injection BP 0.9% 5 mL polypropylene ampoule (pack of 50).
Sodium Chloride Injection BP 0.9% 10 mL polypropylene ampoule (pack of 50).
Sodium Chloride Injection BP 0.9% 20 mL polypropylene ampoule (pack of 20).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.
For use in one patient on one occasion only. Discard any remaining portion.

6.7 Physicochemical Properties

Sodium chloride is a white, crystalline powder or colourless crystals, freely soluble in water and practically insoluble in ethanol. pH 4.5-7.0.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes