Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Sodium Chloride IV Infusion.
It does not contain all of the available information.
It does not take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has prescribed Sodium Chloride IV infusion for you in the knowledge that the benefits outweigh any possible risks.
If you have any concerns, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.

What Sodium Chloride IV Infusion is used for

Human body weight is about 60% water, which contains various mineral salts and other elements. Sodium chloride is one of the main mineral salts in the body fluid. An optimum level of salts in circulation is essential for good health.
Sodium Chloride IV Infusion is used for treatment of fluid loss and to restore sodium chloride balance.
It is used in the treatment of patients who are unable to take fluids and nutrients by mouth.
It is also used for dilution of other medicines before injection into the body.

Before you are given Sodium Chloride IV Infusion

Sodium Chloride IV Infusion should not be given to you if:

• you have congestive heart failure.

• you have ischaemic stroke, or

• you have severe renal insufficiency

You must tell your doctor if you:

• have heart disease

• have any other illness, especially the following: kidney disease, liver disease, swelling of the hands, ankles or feet, or breathlessness

• are taking any prescription medicine, or even non-prescription medicines

• If you are receiving corticosteroids or corticotrophin

• have ever had an allergic reaction to sodium chloride injection

• are pregnant

• are breast feeding

How Sodium Chloride IV Infusion is given

How much is given:

How it is given:

In Case of overdose

While you are having Sodium Chloride IV Infusion

Frequent clinical evaluation and laboratory tests may be required.
As Sodium Chloride IV Infusion is normally given in a hospital, your nurse or carer will make appropriate records during your treatment and will note any unexpected effects you may experience.

Things you must do

Things you must not do

Things to be careful of

Side effects

As with any medicine, some side effects may occur.
Some swelling of the hands, ankles and feet may be experienced due to retention of water in your body. In rare circumstances, this may also involve the lungs, which may cause some breathing difficulty. Other symptoms may include:

• allergic reactions

• itching

• rashes

• fever

• nausea

• vomiting

• headache

• dizziness

• drowsiness

• confusion

• tremor

• chills

How to store Sodium Chloride IV Infusion

Sodium Chloride IV Infusion should be stored below 30°C.
Do not freeze.
Do not expose to the heat. Keep out of reach of children.
If for any reason you need to keep this product at home it should be stored in a locked cupboard.

Product description

What does Sodium Chloride IV Infusion look like?

What is in Sodium Chloride IV Infusion?

Where can you get more information?

You can get more information from your doctor or pharmacist.

Name and address of the manufacturer (the sponsor)

Baxter Healthcare Pty Ltd
1 Baxter Drive
Old Toongabbie NSW 2146,
Australia
Australian registration numbers:

• AUST R 19477 – Sodium chloride 0.9% - 50 mL

• AUST R 48515 – Sodium chloride 0.9% - 100 mL

• AUST R 48517 – Sodium chloride 0.9% - 250 mL

• AUST R 48519 – Sodium chloride 0.9% - 500 mL

• AUST R 48520 – Sodium chloride 0.9% - 1000 mL

• AUST R 19477 – Sodium chloride 0.9% - 50 ml x 2

• AUST R 48515 – Sodium chloride 0.9% - 100 mL x 2

• AUST R 19472 – Sodium chloride 0.45% - 500 mL x 18

• AUST R 19500 – Sodium chloride 3% - 1000 mL

1 Name of Medicine

Sodium chloride.

2 Qualitative and Quantitative Composition

Baxter Sodium Chloride Intravenous (IV) Infusion preparations are sterile, non-pyrogenic solutions of sodium chloride in water for injections. The preparations do not contain an antimicrobial agent or added buffer, and have a pH of 4.0-7.0.
Baxter Sodium Chloride 0.9% IV Infusion is isotonic, Baxter Sodium Chloride 3% IV Infusion is hypertonic and Baxter Sodium Chloride 0.45% IV Infusion is hypotonic as indicated by their osmolarities. The concentration of sodium chloride in each preparation and their osmolarities are shown in Table 1 (see Section 6.5 Nature and Contents of Container).
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for Intravenous Infusion.

4 Clinical Particulars

4.9 Overdose

Infusion of excess Baxter Sodium Chloride IV Infusion preparations may cause: fluid overload; sodium overload (which can lead to central and/or peripheral oedema); hypernatraemia (0.9% or 3% Baxter Sodium Chloride IV Infusions); hyponatraemia (0.9% or 0.45% Baxter Sodium Chloride IV Infusions); other electrolyte abnormalities.
No specific antidotes to this preparation are known.
Should overdose occur, prompt and careful clinical assessment is essential. Treat the symptoms and institute appropriate supportive measures as required.
When assessing an overdose, any additives in the solution must also be considered.
Symptoms of hypernatraemia. Hypernatraemia may cause nausea, vomiting, diarrhoea and cramps, reduced salivation and lacrimation, increased thirst, hypotension and tachycardia.
CNS effects include headache, dizziness, restlessness, weakness, muscle twitching or rigidity, respiratory paralysis, seizures, coma, and death.
Treatment of hypernatraemia. Treatment usually requires free water replacement. Plasma sodium concentrations should be corrected slowly. If hypernatraemia is severe, IV hypotonic or isotonic saline or 5 percent glucose may be used to restore normal plasma sodium concentrations at a rate of no more than 10 to 12 mmol/L daily (0.5 mmol/L per hour). If plasma sodium levels are greater than 200 mmol/L or if the patient has renal impairment or is moribund, dialysis may be needed. Diazepam or other appropriate treatment may be required to treat convulsions.
Symptoms of hyponatraemia. Symptoms may include headache, confusion, nausea, vomiting, somnolence, weakness, cerebral oedema, seizures, coma, respiratory arrest and death.
Treatment of hyponatraemia. Acute hyponatraemia requires immediate assessment. Symptomatic hyponatraemia associated with plasma sodium concentrations below 120 mmol/L may require the administration of intravenous isotonic or hypertonic sodium chloride. A loop diuretic may be required if there is fluid overload. The aim is to render the patient asymptomatic, usually by restoring plasma sodium concentration to between 120 mmol/L and 130 mmol/L, at a rate of 10 to 12 mmol/L in each 24 hour period.
Careful monitoring of plasma sodium concentrations and total body water is essential.
As in hypernatraemia, rapid correction of hyponatraemia is potentially dangerous. If neurological deterioration occurs, further investigation by MRI imaging of brain, including brain stem, is indicated.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Studies with sodium chloride have not been performed to evaluate mutagenic potential.
Carcinogenicity. Studies with sodium chloride have not been performed to evaluate carcinogenic potential.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Sodium chloride. Molecular formula: NaCl.
Molecular Weight: 58.44.
Appearance: colourless or white crystal.
Solubility: freely soluble in water.
CAS number. Sodium chloride. CAS No.: 7647-14-5.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes

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