Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Sodium Chloride Irrigation Solution. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have benefits and risks. Your doctor has weighed the risks of you using Sodium Chloride Irrigation Solution against the benefits the product is expected to have for you.

This medicine is likely to be used while you are at the clinic or in hospital. If possible, please read this leaflet carefully before this medicine is used. In some cases this leaflet may be given to you after the medicine has been used.

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

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

What SODIUM CHLORIDE IRRIGATION SOLUTION is used for

Your doctor or nurse will use Sodium Chloride Irrigation Solution 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.

Before you use SODIUM CHLORIDE IRRIGATION SOLUTION

Do not use it after the expiry date (EXP) printed on the label. It may have no effect at all, or an entirely unexpected effect if you use it after the expiry date.

Do not use Sodium Chloride Irrigation Solution if the packaging is torn or shows signs of tampering.

Do not use unless the solution is clear and the seal is intact.

Tell your doctor if you have any allergies to:

• any other medicine
• any other substances, such as foods, preservatives or dyes

Tell your doctor if:

• you have heart disease
• you have or have ever had problems with your liver or kidneys
• you have swelling of the hands, ankles or feet
• you are pregnant or planning to become pregnant
• you are breastfeeding.

Before Sodium Chloride Irrigation Solution is used tell your doctor about any of these things and anything else which you feel is important.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop. Some medicines may affect the way sodium chloride works. Your doctor will advise you about continuing to take other medicines.

How SODIUM CHLORIDE IRRIGATION SOLUTION is used

Your doctor or nurse will normally use the irrigation 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 or swallowed.

Your doctor or nurse will decide how much of the irrigation 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.

If you are given this product to use at home it must be used as directed by your doctor or nurse. Use a new solution each time. Discard the unused portion.

Overdose

This rarely happens as Sodium Chloride Irrigation Solution is administered under the care of a highly trained doctor or nurse. As it is for external use only, it is unlikely an overdose will occur.

Immediately telephone your doctor or go to your nearest hospital emergency department if you think that someone may have drunk Sodium Chloride Irrigation Solution even if there are no signs of discomfort or poisoning.

Side effects

Sodium Chloride Irrigation Solution may have some unwanted side-effects in a few people. If they occur, most are likely to be minor or temporary. However, some may be serious and need medical attention.

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

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

Storage

If you have this product at home, it should be kept in the original container, in a safe place, out of reach of children. A locked cupboard at least one and a half metres above the ground is a good place to store medicines.

Sodium Chloride Irrigation Solution should be stored below 25°C.

Do not leave Sodium Chloride Irrigation Solution in the car on hot days.

Product Description

What it looks like

Sodium chloride Irrigation Solution 0.9% is a clear, colourless solution contained in plastic Steritube®.

Sodium Chloride Irrigation Solution can be identified by an Australian Registration Number which is found on the packaging:
AUST R 11290: Sodium Chloride Irrigation Solution 0.9% (sterile) 30mL Steritube®

Ingredients

Sodium Chloride Irrigation Solution contains sodium chloride 0.9% in Water for Injections, sodium hydroxide and hydrochloric acid. It does not contain a preservative.

Sponsor and Distributor in Australia

Pfizer Australia Pty Ltd
Sydney, NSW

This Consumer Medicine Information was written in March 2020

®Registered Trademark

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