Consumer medicine information

WATER FOR INJECTIONS BP [5729]

Water for injections

BRAND INFORMATION

Brand name

Water For Injections BP Ampoules (Solution for injection)

Active ingredient

Water for injections

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using WATER FOR INJECTIONS BP [5729].

What is in this leaflet

This leaflet answers some common questions about Water for Injections BP. It does not contain all the available information that is known about Water for Injections BP. It does not take the place of talking to your doctor, nurse or pharmacist.

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 Water for Injections BP is used for

Water for Injections BP is sterile water used to dilute or dissolve drugs.

Water for Injections BP can also be used for washing small wounds and during minor surgical procedures.

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

Before you are given Water for Injections BP

When you must not use it

Water for Injections BP will only be used if it is clear, colourless and free of particles, the package is undamaged and the use by (expiry) date marked on the pack has not been passed. It must not be injected unless it has been used to dissolve or dilute necessary drugs to be administered by your doctor or nurse.

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.

Your doctor, nurse or pharmacist can tell you what to do if you are taking any of these medicines.

If you have not told your doctor about any of these things, tell them before you are given any injection.

How Water for Injections BP is given

Water for Injections BP will be used to dissolve or dilute other drugs which may then be injected by your nurse or doctor.

Injections are usually given in your upper arm muscle (intramuscularly), under the skin (subcutaneously) or directly into a vein (intravenously) by a doctor or trained nurse.

Water for Injections BP is also used to clean away dirt and blood from small wounds or cuts.

Storage

Your doctor or pharmacist will store Water for Injections BP under the recommended conditions.

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

Disposal

Your doctor, nurse or pharmacist will safely dispose of any Water for Injections BP that is not used.

Product description

What it looks like

Water for Injections BP is a clear, colourless, particle-free, sterile solution. Water for Injections BP comes in 5 mL, 10 mL or 20 mL ampoules. They can be identified by the AUST R numbers;

5 mL ampoule AUST R 198332
10 mL ampoule AUST R 198330
20 mL ampoule AUST R 198331

Ingredients

Water for Injections contains sterile water for injections. It contains no other substances or antimicrobial agents.

BRAND INFORMATION

Brand name

Water For Injections BP Ampoules (Solution for injection)

Active ingredient

Water for injections

Schedule

Unscheduled

 

1 Name of Medicine

Water for injections.

6.7 Physicochemical Properties

The chemical name for water is hydrogen oxide. Molecular formula is H2O. Molecular weight: 18.02.

Chemical structure.


CAS number.

7732-18-5.

2 Qualitative and Quantitative Composition

Water for Injections BP injection solution contains 100% v/v water for injections.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Water for injections is a clear, colourless, particle-free, odourless and tasteless liquid. It is sterile, with a pH of 5.0-7.0 and contains no anti-microbial agents.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Water is the main constituent of the body fluids. Body weight is approximately 60% of water distributed in intracellular, interstitial and vascular compartments. The water content in the intracellular fluid, i.e. the water inside the cells, is about 40 to 45% of body weight. Water moves freely between these compartments. Thus, pharmacological action of the Water for Injection is as a vehicle for substances in maintaining the isotonicity across these compartments.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

As Water for injections is solute-free with osmolarity of zero (a hypotonic solution), its entry into the systemic circulation will result in a dilution of the electrolytes in the extracellular fluid leading to the movement of water into the red blood cells causing haemolysis. Thus, Water for injections should not be injected without adjusting it to isotonicity by the addition of suitable solute.

5.3 Preclinical Safety Data

Genotoxicity.

Water is the main constituent of the body fluids and is not known as a mutagen.

Carcinogenicity.

Water is the main constituent of the body fluids and is not known as a carcinogen.

4 Clinical Particulars

4.1 Therapeutic Indications

Water for injections is used to dissolve or dilute substances or preparations for parenteral administration.
Water for injections may also be used as an irrigating solution for small wounds or during minor surgical procedures.

4.3 Contraindications

Water for injections is hypotonic causing haemolysis if it is injected alone. It is contraindicated for intravenous administration if not adjusted to isotonicity by the addition of suitable solutes.

4.4 Special Warnings and Precautions for Use

Before dissolving or diluting any substance or preparation, ensure that Water for injections is the recommended solvent or diluent by consulting the Product Information for the substance, drug or preparation.
Ensure that the solution prepared with Water for injections is isotonic with blood before intravenous administration.
For use in one patient on one occasion only. Discard any remaining portion.

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.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

None known.
(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 foetus 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.

4.8 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 BP 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.

4.2 Dose and Method of Administration

For dissolving or diluting agents for parenteral administration.

The dosage for Water for injections is that required to dissolve or dilute other agents. Aseptic technique must be used when preparing solutions for parenteral administration. 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.
Usually solutions are prepared immediately before use. 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.

For irrigation.

Before using Water for injections to irrigate small wounds, or during minor surgical procedures, inspect the contents to ensure that there has been no discolouration. Water for injections is a sterile product and when used for irrigation, strict aseptic technique should be observed at all times. Water for injections is for use for a single patient on a single occasion. Any residue remaining should be discarded.

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

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 Poison 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

Not applicable.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
However, additives may be incompatible with Water for Injections BP (see Section 4.2 Dose and Method of Administration).

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.
The expiry date (month/year) is stated on the package after EXP.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Water for Injections BP injection solution is supplied in low density polyethylene (LDPE) ampoules in the following presentations:
Water for Injections BP 5 mL AUST R 198332 (packs of 20).
Water for Injections BP 10 mL AUST R 198330 (packs of 20 and 50).
Water for Injections BP 20 mL AUST R 198331 (packs of 20).

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