SUMMARY CMI

Sodium Chloride 0.9% Intravenous Infusion

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 being treated with Sodium Chloride 0.9% Intravenous Infusion?

Sodium Chloride 0.9% Intravenous Infusion contains the active ingredient sodium chloride. This chemical is naturally present in body fluids and is needed for normal body function. It is given to patients who have low levels of salt in the body. It may also be used for dilution of other medicines before injecting into the body.

For more information, see Section 1. Why am I being treated with Sodium Chloride 0.9% Intravenous Infusion? in the full CMI.

2. What should I know before treatment with Sodium Chloride 0.9% Intravenous Infusion?

Talk to your doctor if you have any heart, kidney or liver disease, swelling of the hands, ankles or feet, suffer breathlessness, are taking corticosteroids or corticotrophin or have had any recent surgical procedures.

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 treatment with Sodium Chloride 0.9% Intravenous Infusion? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Sodium Chloride 0.9% Intravenous Infusion.

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% Intravenous Infusion given?

• Sodium Chloride 0.9% Intravenous Infusion is given through slow infusion “drip” into a vein by a doctor or nurse.
• Your doctor will decide how much Sodium Chloride 0.9% Intravenous Infusion is needed. More instructions can be found in Section 4. How is Sodium Chloride 0.9% Intravenous Infusion given? in the full CMI.

5. What should I know during treatment with Sodium Chloride 0.9% Intravenous Infusion?

For more information, see Section 5. What should I know during treatment with Sodium Chloride 0.9% Intravenous Infusion? in the full CMI.

6. Are there any side effects?

Common side effects include swollen or inflamed vein due to prolonged infusions.

Tell your doctor immediately if you experience nausea, vomiting, stomach cramps, diarrhoea, thirst, dry mouth, sweats, swelling of the hands, ankles or feet, muscle twitches, weakness, cramps or paralysis, restlessness or irritability, fever, reduced saliva or dry eyes, fast heart beat, difficulty breathing, headache, dizziness, sleepiness, drowsiness or confusion.

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% Intravenous Infusion

Active ingredient(s): sodium Chloride 0.9%

Consumer Medicine Information (CMI)

This leaflet provides important information about using Sodium Chloride 0.9% Intravenous Infusion. You should also speak to your doctor, nurse or pharmacist if you would like further information or if you have any concerns or questions about using this medicine.

Where to find information in this leaflet:

1. Why am I being treated with Sodium Chloride 0.9% Intravenous Infusion?
2. What should I know before treatment with Sodium Chloride 0.9% Intravenous Infusion?
3. What if I am taking other medicines?
4. How is Sodium Chloride 0.9% Intravenous Infusion given?
5. What should I know during treatment with Sodium Chloride 0.9% Intravenous Infusion?
6. Are there any side effects?
7. Product details

1. Why am I being treated with Sodium Chloride 0.9% Intravenous Infusion?

Sodium Chloride 0.9% Intravenous Infusion contains the active ingredient sodium Chloride. It is used to:

• treat low levels of salt in the body
• dilute other medicines before injecting into the body

2. What should I know before treatment with Sodium Chloride 0.9% Intravenous Infusion?

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

• heart disease, including congestive heart failure
• 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.

If you are not sure whether you should be given this medicine, 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?

This medicine is not addictive.

Pregnancy and breastfeeding

Check with your doctor if 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.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

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.

If you have not told your doctor about any of the above, tell them before you are given Sodium Chloride 0.9% Intravenous Infusion.

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 affect the way Sodium Chloride 0.9% Intravenous Infusion works. Your doctor will advise you about continuing to take other medicines.

4. How is Sodium Chloride 0.9% Intravenous Infusion given?

How much is given

• Your doctor will decide what dose, how often and how long you will receive Sodium Chloride 0.9% Intravenous Infusion.
• 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 Sodium Chloride 0.9% Intravenous Infusion given

• Sodium Chloride 0.9% Intravenous Infusion is given through slow infusion “drip” into your veins (this is called an intravenous infusion).
• This medicine must only be given by a doctor or nurse.

If too much Sodium Chloride 0.9% Intravenous Infusion is given

As Sodium Chloride 0.9% Intravenous Infusion is given to you under the supervision of your doctor, it is very unlikely that you will receive too much.

Symptoms of an overdose may include the side effects listed under Section 6. Are there any side effects?, with early signs of overdose being nausea, vomiting, diarrhoea, cramps, increased thirst and swelling.

If you think that you have been given too much Sodium Chloride 0.9% Intravenous Infusion, you may need urgent medical attention.

You should immediately:

• alert you doctor or nurse if in a hospital or clinic
• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor
• 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 during treatment with Sodium Chloride 0.9% Intravenous Infusion?

Things you should do

Tell any doctor or nurse giving you this medicine if you:

• are about to be started on any new medicine
• are planning to become pregnant. Tell your doctor immediately if you become pregnant during treatment with this medicine
• are breastfeeding or planning to breastfeed.

Remind any doctor, dentist or pharmacist you see that you are being given Sodium Chloride 0.9% Intravenous Infusion.

Keep all of your doctor's appointments so that your progress can be checked. Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Driving or using machines

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

Sodium Chloride 0.9% Intravenous Infusion may cause dizziness, drowsiness or confusion. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Drinking alcohol

Tell your doctor if you drink alcohol.

How is Sodium Chloride 0.9% Intravenous Infusion stored

• Sodium Chloride 0.9% Intravenous Infusion is stored in the pharmacy or on the ward.
• Store below 25°C. Keep in a cool dry place.

Getting rid of any unwanted medicine. This medicine should only be used once and any remaining solution discarded. It can be taken to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. Sodium Chloride 0.9% Intravenous Infusion may cause 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.

Common 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.

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 treatment with any of your medicines.

7. Product details

What Sodium Chloride 0.9% Intravenous Infusion contains

What Sodium Chloride 0.9% Intravenous Infusion looks like

Sodium Chloride 0.9% Intravenous Infusion is a clear, colourless solution packaged in plastic vials.

Australian Registration Number: AUST R 10804 and 49280

Who distributes Sodium Chloride 0.9% Intravenous Infusion

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

This leaflet was prepared in May 2024.

^® Registered trademark

Published by MIMS July 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