Consumer medicine information

SODIUM CHLORIDE 0.9% INJECTION

Sodium chloride

BRAND INFORMATION

Brand name

Phebra Sodium Chloride 0.9% Injection BP

Active ingredient

Sodium chloride

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using SODIUM CHLORIDE 0.9% INJECTION.

What is in this leaflet

This leaflet answers some common questions about Sodium Chloride 0.9% Injection.

It does not contain all the available information. It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has 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 being given this medicine, ask your doctor.

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
  • dilute other medicines, which may be given by injection or drip
  • act as a sterile liquid for washing wounds, nasal passages, or during surgery.

Ask your doctor if you have any questions about why Sodium Chloride 0.9% Injection has been prescribed for you. Your doctor may have prescribed it for another reason.

Sodium Chloride 0.9% Injection should be administered with care to very young and elderly patients.

Before you are given Sodium Chloride 0.9% Injection

When you must not be given it

Your doctor will have considered the need to give you Sodium Chloride 0.9% Injection carefully.

Make sure you tell the doctor if you have any allergies to

  • any other medicines
  • any other substance such as food dyes, preservatives or plastics.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

You should not be given Sodium Chloride 0.9% Injection if the solution is discoloured, cloudy, turbid, or a precipitate is present. The solution is normally a clear, colourless solution.

You should not be given Sodium Chloride 0.9% Injection if when diluted with another IV solution or medicine it causes the solution to become cloudy, turbid, discoloured, or to form particles.

Unless specifically prescribed by your doctor, you should not be given Sodium Chloride 0.9% Injection if you are pregnant or breast feeding. Ask your doctor about the risks and benefits involved.

You should not be given Sodium Chloride 0.9% Injection if you have the following medical conditions:

  • heart problems
  • severe kidney disease
  • swelling due to excess fluid
  • liver disease.

The doctor or nurse will check to ensure the medicine is not past its expiry date and has not been tampered with.

If you are not sure whether you should be given Sodium Chloride 0.9% Injection, talk to your doctor.

Before you are given it

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

Tell your doctor if you have any of the following medical conditions:

  • heart problems
  • breathlessness which worsens when lying down
  • swelling of hands, ankles or feet
  • kidney problems
  • high blood pressure due to pregnancy.

If you have not told your doctor about any of the above, tell them before you are given Sodium Chloride 0.9% Injection.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without prescription from your pharmacy, supermarket, health food shop, naturopath or herbalist. Some medicines may interfere with Sodium Chloride 0.9% Injection. These include corticosteroids or other drugs that cause sodium to be retained in the body.

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

How Sodium Chloride 0.9% Injection is given

Sodium Chloride 0.9% Injection must only be given by a doctor or nurse.

How it is given

The way Sodium Chloride 0.9% Injection will be used by your doctor or healthcare professional will depend on why you need it.

How much is given

Your doctor will decide what dose of Sodium Chloride 0.9% Injection you will receive and how long you will receive it for. This depends on your medical condition and other factors.

Sometimes only a single dose of Sodium Chloride 0.9% Injection is required.

If you are given too much (overdose)

Sodium Chloride 0.9% Injection must only be given by a doctor or nurse so an overdose is not likely to occur.

Some medical conditions may result in too much sodium chloride in the body.

Symptoms of an overdose are similar to side effects.

The symptoms of side effect are listed under Side Effects.

If you notice any symptoms of an overdose immediately contact your doctor or go to the Emergency Department at the nearest hospital.

Contact the Poisons Information Centre on 13 11 26 for further advice on overdose management.

While you are being given Sodium Chloride 0.9% Injection

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given Sodium Chloride 0.9% Injection.

Tell any other doctors, dentists, and pharmacists who treat you that you have been given Sodium Chloride 0.9% Injection.

If you are going to have surgery, tell the surgeon or anaesthetist that you have been given Sodium Chloride 0.9% Injection. It may affect other medicines used during the surgery.

Things to be careful of

If you feel light headed or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from a bed or a chair, will help your body get used to the change in position and blood pressure. If this problem continues to get worse talk to your doctor.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Sodium Chloride 0.9% Injection. The use of Sodium Chloride 0.9% Injection to replace lost body fluids and salts or addition to intravenous fluids is unlikely to result in any side effects.

If you are over 65 years of age or very young you may have an increased chance of getting side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Ask your doctor to answer any questions you may have.

An overdose of sodium chloride can result in side effects. If any of the following happen tell your doctor or nurse immediately or go to the Emergency Department at your nearest hospital:nausea, vomiting, cramps or diarrhoea

  • nausea, vomiting
  • cramps
  • diarrhoea
  • decrease in saliva, tears and urination
  • increase in thirst and sweating
  • increase in heart rate
  • dizziness, light headedness, drowsiness, restlessness or irritabilityincrease in thirst and sweating
  • swelling of hands ankles and feet
  • headache
  • difficulty breathing or breathlessness which may worsen when lying down
  • muscle weakness, twitching, rigidity or convulsions.

The above list includes very serious side effects. You may need urgent medical attention. These side effects are very rare.

Tell your doctor or nurse if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

After being given Sodium Chloride 0.9% Injection

Storage

Sodium Chloride 0.9% Injection will be stored in the surgery, pharmacy or ward of a hospital.

It should be kept in a cool, dry place where the temperature stays below 25°C.

Sodium Chloride 0.9% Injection will only be opened when it is time for you to have the injection.

It should not be stored after it is opened or used for more than one person.

Product description

What it looks like

Sodium Chloride 0.9% Injection is a clear, colourless solution in a clear glass vial with a plastic top.

Ingredients

Sodium Chloride 0.9% Injection contains 9mg/mL of sodium chloride in water for injections. Hydrochloric acid and sodium hydroxide may be added to adjust the pH when required.

This medicine does not contain lactose, sucrose, gluten, tartrazine, alcohol, dyes or any preservatives

Manufacturer

Sodium Chloride 0.9% Injection is made in Australia by:
Phebra Pty Ltd
19 Orion Road
Lane Cove West, NSW 2066
Australia

Sodium Chloride 0.9% Injection 50mL vial*.
AUST R 11975
Phebra product code - INJ069
*Flip off cap only

Sodium Chloride 0.9% Injection 100mL vial**.
AUST R 48349
Phebra product code - INJ072
**Flip off, tear off cap

This leaflet was prepared in April 2014

Phebra and the Phi symbol are trademarks of Phebra Pty Ltd, 19 Orion Road, Lane Cove West, NSW 2066, Australia.

Published by MIMS July 2014

BRAND INFORMATION

Brand name

Phebra Sodium Chloride 0.9% Injection BP

Active ingredient

Sodium chloride

Schedule

Unscheduled

 

1 Name of Medicine

Sodium chloride.

2 Qualitative and Quantitative Composition

Each mL contains 9 mg sodium chloride equivalent to 0.15 mmol sodium ions and 0.15 mmol chloride ions.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Sodium chloride 0.9% is an isotonic solution for injection. pH 4.5 to 8.0. Osmolality of 296 mOsm/L.

4 Clinical Particulars

4.1 Therapeutic Indications

Prophylaxis of heat prostration or muscle cramps, chloride deficiency due to diuresis or salt restriction, prevention or treatment of extracellular volume depletion.

Parenteral.

Sodium chloride 0.9% (isotonic) is used to restore sodium chloride losses; to dilute or dissolve drugs for intravenous (IV), intramuscular (IM), or subcutaneous (SC) use; flushing of IV catheters; extracellular fluid replacement; priming solution for haemodialysis; initiate and terminate blood transfusions so red blood cells will not haemolyse; metabolic alkalosis when there is fluid loss and mild sodium depletion.

Topical or irrigation.

Relief of inflamed, dry, or crusted nasal membranes or as a topical irrigating or flush solution.

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.
Use in one patient on one occasion only and discard. Contains no antimicrobial preservative. Solutions containing visible, solid particles must not be used.

4.3 Contraindications

Congestive heart failure.
Severe renal impairment.
Conditions of sodium retention and oedema.
Liver cirrhosis.
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 vial should be used immediately on opening. Do not store opened vials. Do not re-sterilise. Do not use on more than one patient.
Any solution remaining should be discarded.
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 or other drugs that may give rise to sodium retention.
Sodium chloride should be administered with care to patients with congestive heart failure, peripheral or pulmonary oedema, impaired renal function, pre-eclampsia and very young or elderly patients.

Special concerns.

Use with caution in CV, cirrhotic, or renal disease; in presence of hypoproteinaemia, hypervolemia, urinary tract obstruction, and CHF; in those with concurrent oedema and sodium retention and in patients receiving corticosteroids or corticotropin; and during lactation.
Use with caution in geriatric or postoperative clients with renal or CV insufficiency with or without CHF.
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 hepatic impairment.

Use with caution in cirrhotic disease.

Use in renal impairment.

Care should be taken in administering sodium chloride solutions to patients with renal impairment.

Use in the elderly.

Sodium chloride should be administered with care in elderly patients.

Paediatric use.

Sodium chloride should be administered with care in very young patients.

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 whilst breastfeeding is recommended only when potential benefits outweigh potential risks to the newborn.

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)

Proper use of normal saline (0.9%) as a vehicle for parenteral drugs or as an electrolyte replacement is unlikely to result in adverse effects.

Mild hypernatraemia.

Symptoms include thirst, reduced salvation and lachrymation, fever, tachycardia, hypertension, headache, dizziness, restlessness, irritability and weakness.

Hypernatremia.

Excessive sodium chloride may lead to hypokalaemia and acidosis. Fluid and solute overload leading to dilution of serum electrolyte levels, CHF, over hydration, acute pulmonary oedema (especially in patients with cardiovascular disease or in those receiving corticosteroids or other drugs that cause sodium retention). Too rapid administration may cause local pain and venous irritation.

Postoperative intolerance of sodium chloride.

Cellular dehydration, weakness, asthenia, disorientation, anorexia, nausea, oliguria, increased BUN levels, dissention, deep respiration.

Symptoms due to solution or administration technique.

Fever, abscess, tissue necrosis, infection at injection site, venous thrombosis or phlebitis extending from injection site, local tenderness, extravasation, hypervolemia.
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.
Excessive administration of chloride ions can lead to a loss of bicarbonate with an acidifying effect.
If any adverse experience is observed during administration, discontinue infusion, evaluate the patient and institute appropriate supportive treatment.

Reporting suspected adverse reactions.

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 http://www.tga.gov.au/reporting-problems.

4.9 Overdose

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.

Normal plasma sodium concentrations should be carefully restored at a rate not greater than 10-15 mmol/day using intravenous hypotonic saline. In mild cases, oral administration of water and restriction of sodium intake is sufficient. In more severe cases, 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 are to be treated with intravenous diazepam.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The human body contains about 4 moles of sodium (about 92 g). About one third is found in the skeleton and approximately half is present in the extracellular fluid.
Sodium is the major cation of the body's extracellular fluid. It plays a crucial role in maintaining the fluid and electrolyte balance. Excess retention of sodium results in over hydration (oedema, hypervolemia), which is often treated with diuretics.
Abnormally low levels of sodium result in dehydration. The average daily requirement of salt is approximately 5 g.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Sodium chloride is well absorbed through the gastrointestinal tract (this is enhanced in the presence of glucose).

Distribution.

Sodium is the major cation of the body's extracellular fluid.

Metabolism.

No data available.

Excretion.

Excess sodium is predominantly excreted by the kidney and small amounts are lost in the faeces and sweat.

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections.
Hydrochloric acid and/or sodium hydroxide are used for pH adjustment.
The injection does not contain - preservative.

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)1. The expiry date can be found on the packaging.
1 AUST R 78928, AUST R 11975, AUST R 48349.

6.4 Special Precautions for Storage

Sodium Chloride 0.9% 10 mL ampoule (AUST R 78928).

Store below 30°C.

Sodium Chloride 0.9% 50 mL vial (AUST R 11975).

Store below 25°C.

Sodium Chloride 0.9% 100 mL vial (AUST R 48349).

Store below 25°C.

6.5 Nature and Contents of Container

Sodium Chloride 0.9% 50 mL glass vial is supplied in a carton containing 10 vials. Phebra product code - INJ069.
Sodium Chloride 0.9%** 100 mL glass vial is supplied in a carton containing 10 vials. Phebra product code - INJ072.
Sodium Chloride 0.9% 10 mL ampoule is supplied in a carton containing 10 ampoules. Phebra product code - INJ061.
Not all presentations may be marketed.
The vial stopper is not made with natural rubber latex.
** Injection/Irrigation solutions have a flip off/tear off top on the sterile vial.

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

Structural Formula: NaCl.
The molecular weight of the compound is 58.44

CAS number.

7647-14-5.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes