Consumer medicine information

Sodium Chloride 0.9% Freeflex

Sodium chloride

BRAND INFORMATION

Brand name

Sodium Chloride 0.9% Freeflex Solution for injection

Active ingredient

Sodium chloride

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Sodium Chloride 0.9% Freeflex.

What is in this leaflet?

This leaflet answers some common questions about Sodium Chloride 0.9% 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 0.9% Injection against the benefits they expect it will have for you.

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

Keep this leaflet.

You may need to read it again.

What Sodium Chloride 0.9% Injection is used for

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

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

Your doctor will have explained why you are being treated with Sodium Chloride 0.9% Injection and told you what dose you will be given.

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.

Before you are given Sodium Chloride 0.9% Injection

When you must not be given it

You should not be given Sodium Chloride 0.9% Injection if you have, or have had, any of the following medical conditions:

  • Congestive heart failure
  • Severe kidney problems
  • Swelling due to excess fluid
  • Chronic liver disease

Before you are given it

Tell your doctor or pharmacist if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any medical conditions, especially the following:

  • 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 urinary tract

It may not be safe for you to be given Sodium Chloride 0.9% Injection if you have these conditions.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.

These include:

  • Corticosteroids
  • Corticotrophin

Your doctor or pharmacist will have more information on medicines to be careful with or avoid while being given Sodium Chloride 0.9% Injection.

How is Sodium Chloride 0.9% Injection given

Sodium Chloride 0.9% Injection will be given to you by your doctor or specially trained nurse by infusion or drip into the vein or applied to open wounds if it is being used as an irrigation solution.

How much is given

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.

If you are given too much (overdose)

This rarely happens as Sodium Chloride 0.9% 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.

Contact the Poisons Information Centre in your country for any further information.

Australia: 13 11 26

New Zealand: 0800 764 766

While you are being given Sodium Chloride 0.9% Injection

Frequent clinical evaluation and laboratory tests may be required as Sodium Chloride 0.9% Injection is normally given in a hospital. Your doctor or nurse will make appropriate records during your treatment and will note any unexpected effects you may experience.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Sodium Chloride 0.9% Injection.

All medicines can have some 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.

The following is a list of possible side effects. Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • Nausea (feeling sick)
  • Vomiting
  • Diarrhoea
  • Reduced saliva or dry eyes
  • Headache
  • Drowsiness
  • Increased sweating
  • Increased thirst
  • Muscle weakness
  • Cramps
  • Restlessness or irritability
  • Confusion
  • Fever
  • Dizziness
  • Convulsions
  • Increased heart rate
  • Inflammation at the site of injection.
  • Swelling of the veins near the site of injection

Do not be alarmed by this list. You may not experience any of them.

Storage

Storage

Sodium Chloride 0.9% Injection will be stored by your doctor or pharmacist under the recommended conditions of store below 25°C for the Freeflex bags.

Disposal

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.

Product description

What it looks like

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

Ingredients

Sodium Chloride 0.9% Injection contains sodium chloride and water for injections.

Products

Sodium Chloride 0.9% Injection comes in various pack sizes. They can be identified by the AUST R numbers.

Freeflex Bags
50mL AUST R 144596
100mL AUST R 144609
250mL AUST R 144632
500mL AUST R 29745
1000mL AUST R 47400

BRAND INFORMATION

Brand name

Sodium Chloride 0.9% Freeflex Solution for injection

Active ingredient

Sodium chloride

Schedule

Unscheduled

 

1 Name of Medicine

Sodium chloride.

6.7 Physicochemical Properties

Chemical structure.

Molecular formula: NaCl.
Molecular weight: 58.44.
Sodium chloride is a white, crystalline powder or colourless crystals, freely soluble in water and practically insoluble in ethanol.

CAS number.

7647-14-5.

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.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Sodium is the major cation of extracellular fluid and functions principally in the control of water distribution, fluid and electrolyte balance and osmotic pressure of body fluids. Chloride, the major extracellular anion, closely follows the physiological disposition of the sodium cation in maintenance of acid-base balance, isotonicity and electrodynamic characteristics of cells.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

As sodium chloride intravenous preparations are directly administered to the circulation, the bioavailability of the components is 100%.

Excretion.

Excess sodium is predominantly excreted by the kidneys, with small amounts lost in faeces and sweat.

5.3 Preclinical Safety Data

Genotoxicity.

The active ingredients sodium and chloride are not mutagenic. They are basic cellular components.

Carcinogenicity.

The active ingredients sodium and chloride are not carcinogenic. They are basic cellular components.

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.

4.3 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 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 the elderly.

For use in elderly, the dose should be based on individual patient assessment, including weight, fluid and electrolyte status and renal and cardiac function.

Paediatric use.

In paediatric use, the dose should be calculated for each patient based on clinical condition, including bodyweight and laboratory data.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Additives may be incompatible with sodium chloride.
Co-medication of drugs inducing sodium retention may exacerbate any systemic effects.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
Safety in pregnancy has not been established. Use is recommended only when clearly indicated.
Safety in lactation has not yet been established. Use of this product while breastfeeding is recommended only when potential benefits outweigh potential risks to the newborn infant.

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.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

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.

4.7 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

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. 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. If any adverse effects are observed during administration, discontinue infusion, evaluate the patient and institute appropriate supportive treatment.

Treatment.

Normal plasma sodium concentrations should be carefully restored at a rate not greater than 10-15 mmol/day using I.V. hypotonic saline. Dialysis may be necessary if there is significant renal impairment, the patient is moribund or plasma sodium levels are greater than 200 mmol/L. Convulsions may require diazepam or other appropriate treatment.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia) or 0800 764 766 (New Zealand).

7 Medicine Schedule (Poisons Standard)

Unscheduled.

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.

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.

Summary Table of Changes