1 Name of Medicine
Sodium chloride.
2 Qualitative and Quantitative Composition
100 mL of the 0.9% sodium chloride solution for injection contains:
Sodium chloride 0.90 g.
See Table 1.
3 Pharmaceutical Form
Clear to colourless solution for injection.
4.1 Therapeutic Indications
Solvent or diluent for compatible electrolyte concentrates or drugs.
4.2 Dose and Method of Administration
The quantity to be chosen depends on the desired concentration of the medicament to be dissolved. For the use of this solution as solvent/diluent for compatible electrolyte concentrates or medicaments, the instructions for use relating to the medicament to be added must be observed.
Method of administration.
Intravenous or subcutaneous injection.4.3 Contraindications
None.
4.4 Special Warnings and Precautions for Use
0.9% sodium chloride injection should only be administered with caution in cases of hypernatraemia and hyperchloraemia.
Use in the elderly.
No data available.
Paediatric use.
No data available.
Effects on laboratory tests.
No data available.4.5 Interactions with Other Medicines and Other Forms of Interactions
None known.
When mixing with other medicaments, possible incompatibilities should be considered.
4.6 Fertility, Pregnancy and Lactation
Effects on fertility.
No data available.
0.9% sodium chloride injection can be used as indicated.
0.9% sodium chloride injection can be used as indicated.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)
No data available.
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.4.9 Overdose
Overdose of 0.9% sodium chloride injection may result in hypernatraemia, hyperchloraemia, hyperhydration, hyperosmolarity of the serum, and metabolic acidosis.
Emergency treatment, antidotes.
Immediate stop of administration, administration of diuretics with continuous monitoring of serum electrolytes, correction of electrolyte and acid-base imbalances.
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.
Sodium is the primary cation of the extracellular space and together with various anions, regulates the size of this. Sodium and potassium are the major mediators of bioelectric processes within the body.
The sodium content and the liquid metabolism of the body are closely coupled to each other. Each deviation of the plasma sodium concentration from the physiological one simultaneously affects the fluid status of the body.
An increase in the sodium content of the body also means reduction of the body's free water content independent of the serum osmolality.
A 0.9 per cent sodium chloride solution has the same osmolarity as plasma. Administration of this solution primarily leads to a replenishment of the interstitial space which is about 2/3 of the entire extracellular space. Only 1/3 of the administered volume remains in the intravascular space. Therefore the haemodynamic effect of the solution is of short duration only.
Clinical trials.
No data available.
5.2 Pharmacokinetic Properties
The total sodium content of the body is ca. 80 mmol/kg of which ca. 97% is extracellular and ca. 3% intracellular. The daily turnover is ca. 100 - 180 mmol (corresponding to 1.5 - 2.5 mmol/kg body weight).
The kidneys are the major regulator of the sodium and water balances. In co-operation with the hormonal control mechanisms (renin-angiotensin-aldosterone system, antidiuretic hormone) and the hypothetical natriuretic hormone they are primarily responsible for keeping the volume of the extracellular space constant and regulating its fluid composition.
Chloride is exchanged for hydrogen carbonate in the tubule system and is, thus, involved in the regulation of the acid base balance.
5.3 Preclinical Safety Data
Genotoxicity.
No data available.
Carcinogenicity.
No data available.6 Pharmaceutical Particulars
6.1 List of Excipients
Water for injections.
6.2 Incompatibilities
Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
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. Shelf life 3 years.
6.4 Special Precautions for Storage
The solutions should be stored in a cool, dry place, below 25°C and used before the expiry date on the container.
6.5 Nature and Contents of Container
This product is supplied in:
Polyethylene ampoules Mini-Plasco. Contents: 10 mL, 20 mL.
6.6 Special Precautions for Disposal
Single-dose container. Discard unused contents. Solution should be used immediately after opening of the container.
Only to be used if the solution is clear and the container does not show visible signs of damage.
6.7 Physicochemical Properties
Chemical structure.
Na-Cl.
CAS number.
7647-14-5.7 Medicine Schedule (Poisons Standard)
Not scheduled.
Summary Table of Changes
