SUMMARY CMI

Sodium Chloride 0.9% Irrigation Solution

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 using Sodium Chloride 0.9% Irrigation Solution?

Sodium Chloride 0.9% Irrigation Solution contains the active ingredient sodium chloride.

Sodium Chloride 0.9% Irrigation Solution is used during surgical procedures for cleansing of tissues, body cavities, wounds or irrigation of a special tube called a catheter which is used to drain your bladder and has been designed to be left in place for a prolonged period of time. It is also used for diluting medications prior to use e.g. certain inhalation solutions prior to nebulisation

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

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

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

3. What if I am taking other medicines?

Some medicines may interfere with Sodium Chloride 0.9% Irrigation Solution 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 Sodium Chloride 0.9% Irrigation Solution is used?

Sodium Chloride 0.9% Irrigation Solution is likely to be used while you are at the clinic or in hospital.

Your doctor or nurse will use Sodium Chloride 0.9% Irrigation Solution to wash and clean body cavities, tissues or wounds. It is also used to dilute other medicines such as inhalation solutions. It is for external use only and should not be injected, for irrigation only. Your doctor or nurse will decide how much to use which will be sufficient for your needs.

More instructions can be found in Section 4. How do I use Sodium Chloride 0.9% Irrigation Solution? in the full CMI.

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

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

6. Are there any side effects?

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% Irrigation Solution

Active ingredient(s): sodium chloride

Consumer Medicine Information (CMI)

This leaflet provides important information about using Sodium Chloride 0.9% Irrigation Solution. 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 0.9% Irrigation Solution.

Where to find information in this leaflet:

1. Why am I using Sodium Chloride 0.9% Irrigation Solution?
2. What should I know before I use Sodium Chloride 0.9% Irrigation Solution?
3. What if I am taking other medicines?
4. How do I use Sodium Chloride Irrigation Solution?
5. What should I know while using Sodium Chloride 0.9% Irrigation Solution?
6. Are there any side effects?
7. Product details

1. Why am I using Sodium Chloride 0.9% Irrigation Solution?

Sodium Chloride 0.9% Irrigation Solution contains the active ingredient sodium chloride.

Sodium Chloride 0.9% Irrigation Solution is used during surgical procedures for cleansing of tissues, body cavities, wounds or irrigation of a special tube called a catheter which is used to drain your bladder and has been designed to be left in place for a prolonged period of time.

It is also used for diluting medications prior to use e.g., certain inhalation solutions prior to nebulisation.

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

Warnings

Do not use Sodium Chloride 0.9% Irrigation Solution if:

• the solution is cloudy, coloured or contains particles.
• the seal of the ampoule is broken.

Tell your doctor or nurse 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 disease
• kidney problems
• liver disease
• swelling of the hands, ankles or feet due to excess fluid

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, nurse 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% Irrigation Solution. These include:

• 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% Irrigation Solution.

4. How do I use Sodium Chloride 0.9% Irrigation Solution?

How much to use

Your doctor or nurse will decide how much of the irrigation solution to use which will be sufficient for your needs.

As the irrigation solution is sterile, your doctor or nurse will use a new solution each time.

How to use Sodium Chloride 0.9% Irrigation Solution

• Your doctor or nurse will normally use the irrigation to wash and clean body cavities, tissues or wounds during surgery or irrigation of a special tube called a catheter which is used to drain your bladder and has been designed to be left in place for a prolonged period of time. It is also used to dilute other medicines such as inhalation solutions.
• It is for external use only and should not be injected.
  For irrigation only.

If you are using too much

This rarely happens as Sodium Chloride 0.9% Irrigation Solution will be given to you in hospital under the care of a highly trained doctor or nurse. As it is for external use only, it is unlikely an overdose will occur.

If you think that someone may have swallowed Sodium Chloride 0.9% Irrigation Solution, 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 0.9% Irrigation Solution?

Things you should do

• If you are given this product to use at home, it must be used as directed by your doctor or nurse.
• Discard any unused portion. Sodium Chloride 0.9% Irrigation Solution is for single use only.

Looking after your medicine

• Store below 25°C and protect from light.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Do not use Sodium Chloride 0.9% Irrigation Solution if the seal is broken or the solution is cloudy, coloured or contains particles.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it 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. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

Tell your doctor, nurse or pharmacist as soon as possible if you feel anything unusual during or after Sodium Chloride 0.9% Irrigation Solution has been used.

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

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, nurse or pharmacist before you decide to stop taking any of your medicines.

7. Product details

What Sodium Chloride 0.9% Irrigation Solution contains

Sodium Chloride 0.9% Irrigation Solution does not contain lactose, sucrose, gluten, tartrazine, alcohol, dyes or any preservatives.

Do not use Sodium Chloride 0.9% Irrigation Solution if you are allergic to any of these ingredients.

What Sodium Chloride 0.9% Irrigation Solution looks like

Sodium Chloride 0.9% Irrigation Solution is a sterile, clear, colourless solution and comes in a 30 mL plastic ampoule.

Sodium Chloride 0.9% Irrigation Solution is available in packs of 30 ampoules (AUST R 11290).

Who distributes Sodium Chloride 0.9% Irrigation Solution

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

Each 1 mL of Sodium Chloride 0.9% contains 9 mg of sodium chloride.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution, irrigation.
Sodium Chloride 0.9% Irrigation Solution is a clear, colourless, sterile, isotonic, and preservative-free solution for irrigation.

4 Clinical Particulars

4.1 Therapeutic Indications

During surgical procedures where an isotonic irrigation is required, e.g. irrigation of body cavities, tissues or wounds, indwelling urethral catheters and surgical drainage tubes.
Dilution of medications prior to use in accordance with the product information for the medication being diluted, e.g. to dilute inhalation solutions prior to nebulisation.

4.2 Dose and Method of Administration

Sodium Chloride Irrigation Solution must not be administered by parenteral injection. The use of aseptic technique is essential when the irrigation solution is used for irrigation of body cavities, wounds and urethral catheters.

Dosage.

4.3 Contraindications

Sodium Chloride 0.9% Irrigation Solution should not be used for irrigation during electrosurgical procedures.
Sodium Chloride 0.9% Irrigation Solution should not be used for intravenous injection or injection by other usual parenteral routes.
Do not use unless the solution is clear and the seal is intact.

4.4 Special Warnings and Precautions for Use

For external use only. Not for injection, for irrigation only.
Sodium Chloride 0.9% Irrigation Solution should generally not be used in conditions in which systemic absorption is likely to result. It is possible that an amount may enter the systemic circulation depending on the nature of the surgical procedure.
Systemic absorption of irrigation solutions may cause fluid and/or solute overload resulting in dilution of serum electrolytes, overhydration, congestive conditions or pulmonary oedema.
The risk of dilutional conditions is inversely proportional to the electrolyte concentration administered and the risk of solute overload and resultant congestive conditions with peripheral and/or pulmonary oedema is directly proportional to the electrolyte concentration administered.
Given the possibility of systemic absorption of irrigation solutions, Sodium Chloride 0.9% Irrigation Solution should be used with caution in patients with congestive heart failure, renal impairment, liver cirrhosis, or any condition characterised by sodium retention and oedema.
If adverse effects, overhydration or solute overload occurs with Sodium Chloride 0.9% Irrigation Solution, it should be discontinued, the patient closely evaluated and appropriate corrective therapy instituted, if necessary.
The contents of an opened container should be used promptly to minimise a possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution, since no antibacterial agent has been added.

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 0.9% Irrigation Solution.
Product Information documents of intended medications for mixing should be checked beforehand to avoid incompatibility.
Do not store Sodium Chloride 0.9% Irrigation Solution after mixing with any additives.
Co-medication of drugs inducing sodium retention may exacerbate any systemic effects caused by this irrigation solution.

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)

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.
If a large quantity of Sodium Chloride 0.9% Irrigation Solution is absorbed during a surgical procedure, fluid overload and electrolyte disturbance may result. See Section 4.4 Special Warnings and Precautions for Use; Section 4.9 Overdose.
If an adverse reaction does occur, discontinue the administration of the irrigating solution, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.

Reporting suspected adverse effects.

4.9 Overdose

If poisoning occurs, contact a doctor or Poisons Information Centre.

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Hydrochloric acid, sodium hydroxide, water for injections.

6.2 Incompatibilities

Additives may be incompatible with Sodium Chloride 0.9% Irrigation Solution.
Product Information documents of intended medications for mixing should be checked beforehand to avoid incompatibility.
Do not store Sodium Chloride 0.9% Irrigation Solution after mixing with any additives.

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.
Single use only. Discard unused portion.

6.5 Nature and Contents of Container

Sodium Chloride 0.9% Irrigation Solution (sterile) is presented in 30 mL LDPE ampoules, pack of 30's. AUST R 11290.

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