1 Name of Medicine
Water for injections.
2 Qualitative and Quantitative Composition
The chemical name for water is hydrogen oxide.
Water for injections is a sterile, non-isotonic, clear, colourless solution. It does not contain any preservatives.
3 Pharmaceutical Form
Injection, solvent for.
4.1 Therapeutic Indications
Water for injections is used for the reconstitution and preparation of aqueous injections.
4.2 Dose and Method of Administration
The dosage for Water for injections is the amount required to dissolve or dilute other agents. The Product Information of substances or drugs to be dissolved or diluted must be consulted to ascertain the maximum time between aseptic preparation and use of the solution.
Aseptic technique must be used when preparing solutions for parenteral administration.
Usually solutions are prepared immediately before use. However, to reduce microbiological hazard, use as soon as practicable after reconstitution/preparation. If storage is necessary, hold at 2-8°C for not more than 24 hours.
Check the Product Information of any substance, preparation or drug before use to ensure appropriate solubility, dilution or compatibility with other additives.
Solutions prepared with Water for injections may be administered intravenously, intramuscularly or subcutaneously using strict aseptic technique. Care should be exercised that all solutions prepared with Water for injections are isotonic before use (see Section 4.4 Special Warnings and Precautions for Use).
Water for injections is for use for a single patient on a single occasion. Any residue should be discarded.
To reduce microbiological hazard, use as soon as practicable after reconstitution/preparation. If storage is necessary, hold at 2°-8°C for not more than 24 hours.
4.3 Contraindications
None.
4.4 Special Warnings and Precautions for Use
Consult the Product Information document for the substance, drug or preparation to be dissolved or diluted, to ensure that Water for injections is the recommended solvent or diluent before dissolving or diluting any substance or preparation. Prior to using Water for injections to dissolve or dilute any substances or preparations, check the compatibility of all additives and drugs.
Water for injections is strongly hypotonic. It must not be injected alone as it will cause haemolysis and hypotonic disorders. Ensure that the solution prepared with Water for injections is isotonic with blood before intravenous administration.
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
No data available.
4.6 Fertility, Pregnancy and Lactation
Effects on fertility.
No data available.
(Category A)
Water for injections has been administered to a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. Check the Product Information document of the drug to be dissolved or diluted to ensure that it is safe to use during pregnancy.
Water for injections can be administered to women who are breastfeeding. Check the Product Information document of the drug to be dissolved or diluted to ensure that it is safe to use during lactation.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 adverse reactions are known to be associated with Water for injections. There should be no adverse reaction to Water for injections if used as indicated to dissolve compatible substances to form an isotonic solution prior to injection.
Injection of Water for injections without the addition of solute may result in cell damage due to hypotonic effects (see Section 4.4 Special Warnings and Precautions for Use; Section 4.9 Overdose).
The Product Information of any drug or substance used with Water for injections must be consulted before use.
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 with small volume presentations of Water for injections is unlikely. If larger volumes of Water for injections are inadvertently injected without first ensuring isotonicity, the hypotonic effects may include local cell damage or haemolysis. Electrolyte abnormalities are possible. The patient should be assessed and treated appropriately.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).
5 Pharmacological Properties
5.1 Pharmacodynamic Properties
Mechanism of action.
No data available.
Clinical trials.
No data available.
5.2 Pharmacokinetic Properties
No data available.
5.3 Preclinical Safety Data
Genotoxicity.
No data available.
Carcinogenicity.
No data available.6 Pharmaceutical Particulars
6.1 List of Excipients
None.
6.2 Incompatibilities
Check the Product Information of any substance, preparation or drug before use to ensure appropriate solubility, dilution or compatibility with other additives.
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.
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.
6.5 Nature and Contents of Container
Water for Injections B. Braun injection solution contains 100% v/v Water for injections and is supplied in low density polyethylene (LDPE) ampoules and LDPE bottles in the following presentations:
Water for Injections B. Braun ampoules 10 mL AUST R 199953 in packs of 20.
Water for Injections B. Braun ampoules 20 mL AUST R 199952 in packs of 20.
Water for Injections B. Braun bottles 100 mL AUST R 199949 in packs of 20.
Water for Injections B. Braun bottles 250 mL AUST R 199951 in packs of 20.
Water for Injections B. Braun bottles 500 mL AUST R 199948 in packs of 10.
Water for Injections B. Braun bottles 1000 mL AUST R 199950 in packs of 10.
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
Chemical structure.
Molecular formula: H2O.
Molecular weight: 18.02.
CAS number.
7732-18-5.7 Medicine Schedule (Poisons Standard)
Not scheduled.
Summary Table of Changes
