Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Water for Injections/Irrigation. 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 using Water for Injections/Irrigation in your treatment.

If you have any concerns about being given Water for Injections/Irrigation, ask your doctor or your healthcare professional.

Keep this leaflet in a safe place.

You may need to read it again.

What Water for Injections/Irrigation is used for

Water for Injections/Irrigation is sterile water used to dissolve or dilute other medicines before they are given to you.

Water for Injections/Irrigation can also be used as a sterile washing solution.

Ask your doctor if you have any questions about why Water for Injections/Irrigation has been prescribed for you.

Your doctor may have prescribed it for another reason.

Before you are given Water for Injections/Irrigation

When it must not be given

Water for Injections/Irrigation should be used to dissolve or dilute other agents or used as a sterile washing solution. It should not be injected directly into the body.

Water for Injections/Irrigation should not be used if the solution is discoloured, cloudy, turbid, or particles are present.

The solution is normally a clear, colourless liquid.

Water for Injections/Irrigation should not be used if, when diluted with another solution, it causes the solution to precipitate, become cloudy, turbid, discolour, or form visible particles.

The doctor or nurse will check to ensure Water for Injections/Irrigation is not past its expiry date and has not been tampered with.

If you are not sure whether you should be given Water for Injections/Irrigation, talk to your doctor.

Before you are given it

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

Tell your doctor if you have or have had any medical conditions.

Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding. If you have not told your doctor about any of the above, tell them before you are given this medicine.

Taking other medicines

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

Your doctor has more information on medicines to be careful with, or avoid, while Water for Injections/Irrigation is being used.

How Water for Injections/Irrigation is used

Water for Injections/Irrigation must only be given by a doctor or a healthcare professional.

How it is given

Water for Injections/Irrigation is used to dissolve or dilute other medicines which may then be injected either into a vein, into a muscle or under the skin.

This will be done by your doctor or healthcare professional.

Water for Irrigation is also used as a sterile washing solution, so there is no dosage limitation with this product as normally applied to other medicines.

Your health professionals know how much washing solution should be used for your treatment.

If you are given too much (overdose)

Water for Injections/Irrigation must only be given by a doctor or a healthcare professional so an overdose is not likely to occur.

Water for Injections/Irrigation should be used to dissolve or dilute other agents or used as a sterile washing solution. It should not be injected directly into the body. If large volumes of Water for Injections/Irrigation are injected directly into the body the following symptoms may occur:

• red, red-brown, or brownish urine
• tiredness, pale skin
• a decrease in the amount of urine produced
• pain or redness at the injection site.

Side effects

Tell your doctor or a healthcare professional as soon as possible if you do not feel well while you are being given Water for Injections/Irrigation.

Water for Injections/Irrigation should not cause any side effects if it is used to dissolve or dilute medicines for injection or for sterile washing.

After being given Water for Injections/Irrigation

Storage

Water for Injections/Irrigation will be stored in the surgery, pharmacy or ward of a hospital. The injection is kept in a cool dry place where the temperature stays below 30°C.

Water for Injections/Irrigation will only be opened when it is time for it to be used for you.

Product description

What it looks like

Water for Injections/Irrigation is a clear, colourless solution in a clear glass vial with a plastic top.

Water for Injections is available in a 50mL vial.

Water for Injections/Irrigation is available in a 100mL vial.

Ingredients

Water for Injections/Irrigation contains sterile water only.

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

Manufacturer

Water for Injections/Irrigation is made in Australia by:
Phebra Pty Ltd
19 Orion Road
Lane Cove West, NSW 2066
Australia

Water for Injections BP 50 mL vial
AUST R 48353
Phebra product code: INJ075
This product is currently not available.

Water for Injections/Irrigation BP 100mL vial
AUST R 48354
Phebra product code: INJ077

This leaflet was revised:
March 2014

Version 02

1 Name of Medicine

Water for injections.

6.7 Physicochemical Properties

Chemical name: hydrogen oxide. Chemical formula is H₂O and molecular weight is 18.02.

Chemical structure.

CAS number.

2 Qualitative and Quantitative Composition

Water for Injection is sterile, with a pH of 5.6-7.7. The water is first distilled and then filtered through two successive pre-sterilised 0.22 micron membrane filters.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Water for Injection solution for injection is a clear, colourless, particle-free, odourless and tasteless liquid.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Distribution.

Metabolism.

Excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

4 Clinical Particulars

4.1 Therapeutic Indications

Water for Injection is used to dissolve or dilute substances or preparations for parenteral administration. It can also be used as a sterile irrigation solution for washing or irrigating patients.

4.3 Contraindications

No data available.

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 Injection is the recommended solvent or diluent before dissolving or diluting any substance or preparation. Prior to using Water for Injection to dissolve or dilute any substances or preparations, check the compatibility of all additives and drugs.
Before intravenous administration of a solution prepared with Water for Injection, ensure that the resultant solution is isotonic with blood.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.8 Adverse Effects (Undesirable Effects)

No adverse reactions are known to be associated with Water for Injection. There should be no adverse reaction to Water for Injection if used as indicated to dissolve compatible substances to form an isotonic solution prior to injection. Injection of Water for Injection 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 Injection must be consulted before use.

Reporting suspected adverse reactions.

4.2 Dose and Method of Administration

The dosage for Water for Injection 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 Injection may be administered intravenously, intramuscularly or subcutaneously using strict aseptic technique. Care should be exercised that all solutions prepared with Water for Injection are isotonic before use (see Section 4.4 Special Warnings and Precautions for Use). Water for Injection 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.

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 Injection is unlikely. If larger volumes of Water for Injection 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 131126 (Australia).

7 Medicine Schedule (Poisons Standard)

Not scheduled.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for Injection contains hydrochloric acid for pH adjustment. The injections contain no anti-microbial agents.

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)¹. The expiry date can be found on the packaging.
¹ AUST R 48353 (50 mL); AUST R 48354 (100 mL).

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Water for Injection 50 mL in a 50 mL glass vial.
Pack of 10 units.
Phebra Product Code - INJ075.
Water for Injection 100 mL in a 100 mL glass vial.
Pack of 10 units.
Phebra Product Code - INJ077.
The vial stopper is not made with natural rubber latex.
Not all presentations 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