SUMMARY CMI

Sodium Chloride 0.9% Freeflex Injection

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 using Sodium Chloride 0.9% Injection?

Sodium chloride 0.9% contains the active ingredient sodium chloride.

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

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

Do not use if you have ever had an allergic reaction to Sodium Chloride 0.9% 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 use 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% 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 do I use Sodium Chloride 0.9% Injection?

• Sodium Chloride 0.9% Injection will be given to you by your doctor or specially trained nurse by infusion or drip into the vein. 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 do I use Sodium Chloride 0.9% Injection? in the full CMI.

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

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

6. Are there any side effects?

Sodium Chloride 0.9% may cause nausea, vomiting, diarrhoea, cramps, 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.

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% Freeflex Injection

Active ingredient(s): sodium chloride

Consumer Medicine Information (CMI)

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

Where to find information in this leaflet:

1. Why am I using Sodium Chloride Injection?
2. What should I know before I use Sodium Chloride Injection?
3. What if I am taking other medicines?
4. How do I use Sodium Chloride Injection?
5. What should I know while using Sodium Chloride Injection?
6. Are there any side effects?
7. Product details

1. Why am I using Sodium Chloride Injection?

Sodium Chloride Injection contains the active ingredient Sodium Chloride.

Sodium Chloride Injection is used to:

• replace lost body fluids and salts.
• dilute other medicines, which may be given by injection or drip

Your doctor may have prescribed it for another reason.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

2. What should I know before I use Sodium Chloride Injection?

Warnings

Do not use Sodium Chloride Injection if you are allergic to

• Sodium chloride
• Any other medicines
• Any other substance such as food dyes, preservatives or plastics
• Any of the ingredients listed at the end of this leaflet.

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.
• Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

• have any other medical conditions such as:
  - Heart problems
  - Severe kidney disease
  - Breathlessness which may be severe or worsen when lying down
  - Excess fluid in the lungs
  - Swelling due to excess fluid
  - Kidney disease
  - High blood pressure including high blood pressure due to pregnancy
  - Problems with urinary tract

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

Check with your doctor if you are pregnant or intend to become pregnant.

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

Unless specifically prescribed by your doctor, you should not be given Sodium Chloride 0.9% if you are pregnant or breast feeding. Ask your doctor about the risks and benefits involved.

Use in Children

• Sodium Chloride 0.9% should be administered with care to very young patients.

Use in Elderly

• Sodium Chloride 0.9% should be administered with care to elderly patients

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% and affect how it works.

These include:

• Corticosteroids
• Corticotrophin
• Other drugs 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 Injection.

4. How do I use Sodium Chloride Injection?

How much to use

• The dosage you will be given will depend on your age, weight, medical condition and response. Your doctor will have experience in injecting Sodium Chloride 0.9% Injection and will choose the best dose for you.

How to use Sodium Chloride 0.9%

Sodium Chloride 0.9% Injection will be given to you by your doctor or specially trained nurse by infusion or drip into the vein.

If you are given too much Sodium Chloride Injection

This rarely happens as Sodium Chloride Injection is administered under the care of a trained professional in a hospital or clinic setting.

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

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• 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 while using Sodium Chloride Injection?

Things you should do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given Sodium Chloride 0.9%.

Tell any other doctors, dentists, and pharmacists who treat you that you have been given Sodium Chloride 0.9%.

If you are going to have surgery, tell the surgeon or anaesthetist that you have been given Sodium Chloride 0.9%. It may affect other medicines used during the surgery.

If you feel lightheaded 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

Call your doctor straight away if you:

• become pregnant during the course of Sodium Chloride 0.9% treatment.

Remind any doctor, dentist, pharmacist or nurse you visit that you have been given Sodium Chloride 0.9%.

Driving or using machines:

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

Sodium Chloride 0.9% may cause dizziness, lightheadedness, drowsiness, or weakness in some people. If you have any of these symptoms, do not drive, operate machinery, or do anything else dangerous.

Looking after your medicine

• Sodium Chloride Injection 0.9% will be stored in the surgery, pharmacy or ward of a hospital. The medicine is kept in a cool dry place where the temperature stays below 25°C.
• Sodium Chloride Injection 0.9% 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

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

Any Sodium Chloride 0.9% Injection which is not used and which is left in the container, will be disposed of in a safe manner by your doctor or pharmacist.

6. Are there any side effects?

All medicines can have side effects. The use of Sodium Chloride 0.9% to replace lost body fluids and salts or addition to intravenous fluids is unlikely to result in any 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 pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

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

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

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

What Sodium Chloride Injection contains

Do not take this medicine if you are allergic to any of these ingredients.

What Sodium Chloride Injection looks like

Sodium Chloride Injection is a clear, colourless solution in a Freeflex bag.

Freeflex Bags

50mL AUST R 144596

100mL AUST R 144609

250mL AUST R 144632

500mL AUST R 29745

1000mL AUST R 47400

Who distributes Sodium Chloride Injection

Fresenius Kabi Australia Pty Limited
Level 2, 2 Woodland Way
Mount Kuring-gai NSW 2080
Australia
Telephone: (61-2) 9391 5555

Fresenius Kabi New Zealand Limited
c/o GNZCC, HSBC Tower, Level 14, 188 Quay Street,
Auckland
New Zealand
Freecall: 0800 144 892

This leaflet was prepared in November 2021

Published by MIMS March 2023

1 Name of Medicine

Sodium chloride.

2 Qualitative and Quantitative Composition

Sterile isotonic solution of sodium chloride 9 g/L in water for injections, containing no preservatives (normal saline).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for Injection.
Clear, colourless liquid.

4 Clinical Particulars

4.1 Therapeutic Indications

Normal saline 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

The dosage of sodium chloride as a vehicle for parenteral drugs and as an electrolyte replenisher must be calculated after consideration of clinical and laboratory data.
For use in one patient, on one occasion only. It does not contain antimicrobials. Any unused portion should be discarded. Care should be taken with intravenous technique to avoid injection site reactions and infections.

4.3 Contraindications

Sodium Chloride 0.9% is contraindicated in patients with congestive heart failure, severe renal impairment, conditions of sodium retention and oedema, liver cirrhosis and irrigation during electrosurgical procedures.

4.4 Special Warnings and Precautions for Use

Do not use unless the solution is clear. The entire contents of the bag should be used promptly.
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.
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, corticotrophin or other drugs that may give rise to sodium retention.
Sodium chloride solutions should be used with caution in geriatric patients and infants.
Sodium chloride should be administered with care to patients with congestive heart failure, hypertension, peripheral or pulmonary oedema, hypoproteinaemia, impaired renal function, urinary tract obstruction, pre-eclampsia and very young or elderly patients. Intravenous infusion during or immediately after surgery may result in sodium retention. Given that there is a possibility of systemic absorption of irrigation solutions, the same precautions apply.

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-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)

Excessive amounts of sodium chloride may cause hypernatraemia, hypokalaemia and acidosis. Proper use of normal saline as a vehicle for parenteral drugs or as an electrolyte replacement therapy is unlikely to result in adverse effects.
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. Pulmonary embolism or pneumonia may also result. Other symptoms include thirst, reduced salivation and lacrimation, fever, tachycardia, hypertension, headache, dizziness, restlessness, weakness and irritability.
Infusion of excess sodium chloride 0.9% solution may cause fluid overload or electrolyte imbalance. Intravenous administration of solutions may cause local reactions including pain, vein irritation and thrombophlebitis. Extravasation of solution may cause tissue injury.
If any adverse effects are observed during administration, discontinue infusion, evaluate the patient and institute appropriate supportive treatment.
Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may result in distension or disruption of tissues. Inadvertent contamination from careless technique may transmit infection. Adverse effects resulting from irrigation of body cavities, tissues or indwelling catheters and tubes are usually avoidable when appropriate procedures are followed.

Reporting suspected adverse effects.

4.9 Overdose

Infusion of excess intravenous fluid may cause hypervolaemia and electrolyte imbalances.
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.
Possible other symptoms include hypotension, tachycardia, renal failure, peripheral and pulmonary oedema and respiratory arrest.
Symptoms of the CNS include headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death.
If any adverse effects are observed during administration, discontinue infusion, evaluate the patient and institute appropriate supportive treatment.

Treatment.

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%.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections as well as hydrochloric acid and sodium chloride for pH adjustment.

6.2 Incompatibilities

Additives may be incompatible with sodium chloride. 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.

6.5 Nature and Contents of Container

Supplied in composite plastic laminate Freeflex bags and are available in packs of:
AUST R 144596 (40, 60, 65 and 70) x 50 mL bags.
AUST R 144609 (40, 50, 55 and 60) x 100 mL bags.
AUST R 144632 (20, 30, 35 and 40) x 250 mL bags.
AUST R 29745 1 x 500 mL bag.
AUST R 47400 1 x 1000 mL bag.
* Not all pack sizes/ volumes may be marketed.

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

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes