Consumer medicine information

What is in this leaflet

This leaflet answers some of the common questions people ask about Sodium Chloride Injection. It does not contain all the information that is known about Sodium Chloride Injection.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you being given Sodium Chloride Injection against the benefits they expect it will have for you.

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

Keep this leaflet.

You may need to read it again.

What Sodium Chloride Injection is for

Sodium Chloride Injection 0.9% is used to replace lost body fluids and salts. Other medicines which are given by injection or by a drip, may be diluted with Sodium Chloride Injection 0.9%.

Sodium Chloride Injection 0.9% can also be used as a sterile irrigation solution.

Sodium Chloride Injection 20% can be used as an additive to glucose drips, to correct any salt and fluid imbalances in your body.

Sodium Chloride Injection 20% can also be used to treat varicose veins.

Your doctor will have explained why you are being given Sodium Chloride Injection.

Follow all directions given to you by your doctor carefully. They may differ from the information contained in this leaflet.

Your doctor may prescribe this medicine for another use. Ask your doctor if you want more information.

Sodium Chloride Injection is not addictive.

Before you are given Sodium Chloride Injection

You may already have been given Sodium Chloride Injection. Your doctor will have considered the situation carefully and decided to use it. However, if any of the following applies to you, tell your doctor immediately.

When you must not use it

Sodium Chloride Injection will only be used if the solution is clear, the package is undamaged and the use by (expiry) date marked on the pack has not been passed.

You should not be given Sodium Chloride Injection if you are pregnant or breastfeeding unless your doctor says it is safe. Ask your doctor about the risks and benefits involved.

You should not be given Sodium Chloride Injection if you have the following medical conditions:

• congestive heart failure
• severe kidney disease
• swelling due to excess fluid
• cirrhosis of the liver

Before you are given it

You must tell your doctor if you have any of these medical conditions

• heart problems
• excess fluid in the lungs
• swelling due to excess fluid
• kidney disease
• high blood pressure including high blood pressure due to pregnancy
• problems with your urinary tract

It may not be safe for you to be given Sodium Chloride Injection if you have any of these conditions.

Tell your doctor if you are taking any other medicines, including medicines that you buy at the chemist, supermarket or health food shop including:

• corticosteroids

These medicines may affect the way Sodium Chloride Injection works.

Your doctor or pharmacist can tell you what to do if you are taking any of these medicines.

If you have not told your doctor about any of these things, tell them before you are given any Sodium Chloride Injection.

How Sodium Chloride Injection is given

Sodium Chloride Injection will be given to you by your doctor or a specially trained nurse.

It will be given by injection, or applied to open wounds if is being used as an irrigation solution.

The dosage you will be given will depend on your body size, age and the condition being treated.

Overdose

The doctor or nurse giving you Sodium Chloride Injection will be experienced in its use so it is extremely unlikely that you will be given too much.

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

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Sodium Chloride Injection.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

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

Tell your doctor or nurse if you notice any of the following and they worry you:

• nausea, vomiting, diarrhoea
• reduced saliva or dry eyes
• headache
• tiredness or drowsiness
• dizziness
• increased sweating
• increased thirst
• muscle weakness or cramps
• restlessness or irritability
• confusion
• fever

Storage

Sodium Chloride Injection will be stored by your doctor or pharmacist under the recommended conditions.

It should be kept in a cool, dry place where the temperature stays below 30°C for glass ampoules, 25°C for the 0.9% 5 mL plastic ampoules and 30°C for the 0.9% 10 mL plastic ampoules and 20% 10 mL plastic ampoules.

Disposal

Ask your pharmacist what to do with any Sodium Chloride Injection you have left over or you find that the expiry date has passed.

Product description

Sodium Chloride Injection 0.9% is a clear, colourless solution.

• It contains sodium chloride 0.9% as the active ingredient,
  plus
  Water for Injections.
• Sodium Chloride Injection 0.9% is available as:
  - Polyamp DuoFit® 5 mL (plastic ampoules) in boxes of 50
  - Polyamp DuoFit® 10 mL (plastic ampoules) in boxes of 30, 50 and 400

Sodium Chloride Injection 20% is a clear, colourless solution.

• It contains sodium chloride 20% as the active ingredient,
  plus
  Water for Injections.
• Sodium Chloride Injection 20% is available as:
  - Polyamp DuoFit®10mL in boxes of 50

Manufacturer

AstraZeneca Pty Ltd
ABN 54 009 682 311
Alma Road
NORTH RYDE NSW 2113

This leaflet was prepared in March 2013.

Australian Registration Numbers

• Sodium Chloride 0.9% Injection
  10mL amp 48347
  5mL amp 48346
  2mL amp 11974
• Sodium Chloride 20% Injection
  10 mL amp 11983

®= Registered Trade Marks herein are the property of the AstraZeneca Group

1 Name of Medicine

Sodium chloride.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

2 Qualitative and Quantitative Composition

10 mL of clear, colourless, sterile, hypertonic solution for injection of pH 4.5 to 7.0 containing 2 g of sodium chloride.
Excipient with known effect: sodium hydroxide.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Injection concentrated. Clear, colourless solution.

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.

4 Clinical Particulars

4.1 Therapeutic Indications

As an additive to parenteral fluids in patients who have specific electrolyte needs.
As a sclerosing agent for small symptomatic varicose veins.

4.3 Contraindications

Congestive heart failure.
Severe renal impairment.
Conditions of sodium retention and oedema.
Liver cirrhosis.

4.4 Special Warnings and Precautions for Use

Sodium Chloride Injection 20% is hypertonic and must be diluted before use.
Do not use unless the solution is clear. The entire contents of the ampoule should be used promptly. Any solution remaining should be discarded.
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 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.

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

Sodium Chloride Injection 20% may be incompatible with other solutions and drugs, the product information document of each solution or drug should be checked prior to use to ensure compatibility with the sodium chloride solution.
Co-medication of drugs inducing sodium retention may exacerbate any systemic effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.8 Adverse Effects (Undesirable Effects)

Proper use of hypertonic saline as an additive to parenteral fluids for electrolyte replacement is unlikely to result in adverse effects. Inadvertent administration of hypertonic sodium chloride solutions may result in sudden hypernatraemia and potential complications such as cardiovascular shock, CNS disorders, extensive haemolysis and cortical necrosis of kidney.
A serious complication of hypernatraemia 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.
If any adverse experience is observed during administration, discontinue infusion, evaluate the patient and institute appropriate supportive treatment.

Reporting of suspected adverse reactions.

4.2 Dose and Method of Administration

The dosage of sodium chloride as an additive in intravenous fluids must be calculated after consideration of clinical and laboratory data. The correct volume of sodium chloride 20% is then aseptically withdrawn and diluted to the required concentration by addition to an appropriate IV solution such as 5% dextrose. The final solution should be administered within 4 hours.
Sclerotherapy: inject required volume and concentration of hypertonic sodium chloride solution into the affected vein and apply a compression bandage.

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.

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
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. Hypotension, tachycardia, renal failure, peripheral and pulmonary oedema and respiratory arrest may occur. CNS symptoms include headache, dizziness, restlessness, irritability, weakness, muscular twitching and rigidity, convulsions, coma and death.

Treatment.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injection.
Sodium hydroxide and/or hydrochloric acid for pH adjustment.

6.2 Incompatibilities

Sodium Chloride Injection 20% may be incompatible with other solutions and drugs, the product information document of each solution or drug should be checked prior to use to ensure compatibility with the sodium chloride solution.

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 30°C.

6.5 Nature and Contents of Container

10 mL polyethylene ampoules (Polyamp DuoFit) in packs of 50.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

Summary Table of Changes