SUMMARY CMI

Sodium Chloride 0.9% Injection BP

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 nurse.

1. Why am I given Sodium Chloride 0.9% Injection?

Sodium Chloride 0.9% Injection contains the active ingredient sodium chloride. Sodium Chloride 0.9% Injection is given to replace lost body fluids and salts. It may also be used for the dilution of other medicines before injecting into the body.

For more information, see Section 1. Why am I given Sodium Chloride 0.9% Injection? in the full CMI.

2. What should I know before I am given Sodium Chloride 0.9% Injection?

Do not use if you have ever had an allergic reaction to Sodium Chloride 0.9% Injection 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 Sodium Chloride 0.9% Injection? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Sodium Chloride 0.9% Injection 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 is Sodium Chloride 0.9% Injection given?

Sodium Chloride 0.9% Injection will be given to you 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 is Sodium Chloride 0.9% Injection given? in the full CMI.

5. What should I know while being given Sodium Chloride 0.9% Injection?

For more information, see Section 5. What should I know after receiving Sodium Chloride 0.9% Injection? in the full CMI.

6. Are there any side effects?

Sodium Chloride 0.9% Injection may cause nausea, vomiting, stomach cramps, diarrhoea, thirst, dry mouth and eyes, swelling of the hands, ankles or feet, fever, increased heart rate, difficulty breathing or breathlessness which may worsen when lying down, weakness, muscle twitching or rigidity, restlessness or irritability, headache or dizziness, sleepiness and confusion, 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 0.9% Injection BP

Active ingredient(s): sodium chloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Sodium Chloride 0.9% Injection. You should also speak to your doctor or nurse if you would like further information or if you have any concerns or questions about receiving Sodium Chloride 0.9% Injection.

Where to find information in this leaflet:

1. Why am I given Sodium Chloride 0.9% Injection?
2. What should I know before I am given Sodium Chloride 0.9% Injection?
3. What if I am taking other medicines?
4. How is Sodium Chloride 0.9% Injection given?
5. What should I know after receiving Sodium Chloride 0.9% Injection?
6. Are there any side effects?
7. Product details

1. Why am I given Sodium Chloride 0.9% Injection?

Sodium Chloride 0.9% Injection contains the active ingredient sodium chloride. Sodium Chloride 0.9% Injection contains chemicals that are naturally present in body fluids and are needed for normal body function.

Sodium Chloride 0.9% Injection is given to replace lost body fluids and salts. It may also be used for the dilution of other medicines before injecting into the body.

2. What should I know before I am given Sodium Chloride 0.9% Injection?

Warnings

Your doctor will have considered the need to give you Sodium Chloride 0.9% Injection carefully.

Tell your doctor if you have or have had:

• any allergies to sodium chloride, any other medicines or any other substance such as foods, preservatives or dyes
• heart problems
• severe kidney disease
• liver disease
• swelling of the hands, ankles or feet due to excess fluid
• high blood pressure, including during pregnancy
• any condition associated with sodium retention.

If you are not sure whether any of these apply to you, check with 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

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. Your doctor can discuss with you the risks and benefits involved.

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 Sodium Chloride 0.9% Injection. These include:

• corticosteroids or corticotrophin
• other medicines 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 0.9% Injection.

4. How is Sodium Chloride 0.9% Injection given?

How much is given

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.

How is it given

Sodium Chloride 0.9% Injection will be given to you by a doctor or nurse. The way Sodium Chloride 0.9% Injection will be given will depend on why you need it.

If you are given too much

This rarely happens as Sodium Chloride 0.9% Injection will be given to you in hospital under the care of a highly trained doctor or nurse.

In the unlikely event that you are given too much (an overdose), you may experience some of the effects listed under Section 6. Are there any side effects?

The signs of overdose are nausea, vomiting, diarrhoea and cramps, increased thirst, swelling of hands, ankles or feet, fast heart rate, difficulty breathing or breathlessness which may worsen when lying down, headache, dizziness, weakness, muscle twitching or rigidity, convulsions may also occur.

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

5. What should I know after receiving Sodium Chloride 0.9% Injection?

Things you should do

Tell your doctor or nurse if you do not feel well after you have been given Sodium Chloride 0.9% Injection.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Sodium Chloride 0.9% Injection affects you.

Sodium Chloride 0.9% Injection may cause dizziness lightheadedness, drowsiness, or and weakness in some people.

Looking after your medicine

Sodium Chloride 0.9% Injection is usually stored in the hospital, clinic or at the pharmacy.

Your doctor, pharmacist or nurse is responsible for storing Sodium Chloride 0.9% Injection in a cool dry place, where the temperature stays below 25°C and disposing of any unused product correctly.

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 nurse 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

What Sodium Chloride 0.9% Injection contains

Sodium Chloride 0.9% Injection does not contain preservatives.

Tell your doctor if you are allergic to any of these ingredients. Symptoms of an allergic reaction 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.

What Sodium Chloride 0.9% Injection looks like

Sodium Chloride 0.9% Injection is a clear, colourless solution contained in plastic ampoules.

Sodium Chloride 0.9% (45 mg/ 5 mL) injection BP is available in packs of 50 ampoules (AUST R 49272).

Sodium Chloride 0.9% (90 mg/10 mL) injection BP is available in packs of 5, 50 or 600 ampoules (AUST R 49278).

Sodium Chloride 0.9% (180 mg/20 mL) injection BP is available in packs of 30 ampoules (AUST R 49279).

* Not all presentations and pack sizes may be marketed.

Who distributes Sodium Chloride 0.9% Injection

Bridgewest Perth Pharma Pty Ltd
15 Brodie Hall Drive
Bentley WA 6102
Telephone: 1800 161 156
[email protected]

This leaflet was prepared in September 2023.

Published by MIMS November 2023

1 Name of Medicine

Sodium chloride.

2 Qualitative and Quantitative Composition

Sodium Chloride 0.9% Injection BP 5 mL ampoule contains sodium chloride 45 mg per 5 mL.
Sodium Chloride 0.9% Injection BP 10 mL ampoule contains sodium chloride 90 mg per 10 mL.
Sodium Chloride 0.9% Injection BP 20 mL ampoule contains sodium chloride 180 mg per 20 mL.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Clear, colourless solution, free from visible impurities.
The solution is sterile, isotonic, preservative-free.

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 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.
Co-administration 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.

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 0.9% Injection BP 5 mL LDPE ampoule (50s), AUST R 49272.
Sodium Chloride 0.9% Injection BP 10 mL LDPE ampoule (5s, 50s, 600s), AUST R 49278.
Sodium Chloride 0.9% Injection BP 20 mL LDPE ampoule (30s), AUST R 49279.
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