SUMMARY CMI

WATER FOR INJECTIONS BP

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using WATER FOR INJECTIONS BP?

WATER FOR INJECTIONS BP contains the active ingredient sterile water for injections. 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.

For more information, see Section 1. Why am I using WATER FOR INJECTIONS BP? in the full CMI.

2. What should I know before I use WATER FOR INJECTIONS BP?

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use WATER FOR INJECTIONS BP? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with WATER FOR INJECTIONS and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use WATER FOR INJECTIONS BP?

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.

More instructions can be found in Section 4. How do I use WATER FOR INJECTIONS BP? in the full CMI.

5. What should I know while using WATER FOR INJECTIONS BP?

For more information, see Section 5. What should I know while using WATER FOR INJECTIONS BP? in the full CMI.

6. Are there any side effects?

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

WATER FOR INJECTIONS BP

Active ingredient(s): Sterile Water For Injections

Consumer Medicine Information (CMI)

This leaflet provides important information about using WATER FOR INJECTIONS BP. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using WATER FOR INJECTIONS BP.

Where to find information in this leaflet:

1. Why am I using WATER FOR INJECTIONS BP?
2. What should I know before I use WATER FOR INJECTIONS BP?
3. What if I am taking other medicines?
4. How do I use WATER FOR INJECTIONS BP?
5. What should I know while using WATER FOR INJECTIONS BP?
6. Are there any side effects?
7. Product details

1. Why am I using WATER FOR INJECTIONS BP?

WATER FOR INJECTIONS BP contains the active ingredient sterile water for injections. WATER FOR INJECTIONS BP is sterile water.

WATER FOR INJECTIONS BP is used to dilute or dissolve drugs.

WATER FOR INJECTIONS BP can also be used for washing small wounds and during minor surgical procedures.

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

Follow all directions given to you by your doctor carefully.

They may differ from the information contained in this leaflet.

2. What should I know before I use WATER FOR INJECTIONS BP?

Warnings

Check with your doctor if you:

• take any medicines for any other condition.

See additional information under Section 6. Are there any side effects?

3. What if I am taking other medicines?

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

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect WATER FOR INJECTIONS BP.

4. How do I use WATER FOR INJECTIONS BP?

How it will be 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.

5. What should I know while using WATER FOR INJECTIONS BP?

Things you should do

Remind any doctor, dentist or pharmacist you visit that you are using WATER FOR INJECTION BP.

Things you should not do

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.

Looking after your medicine

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

Getting rid of any unwanted medicine

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

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

What WATER FOR INJECTIONS BP contains

Do not take this medicine if you are allergic to any of these ingredients.

What WATER FOR INJECTIONS BP looks like

WATER FOR INJECTIONS BP is a clear, colourless, particle-free, sterile solution.

Water for injections BP is available as

5 mL ampoule AUST R 198332

10 mL ampoule AUST R 198330

20 mL ampoule AUST R 198331

Who distributes WATER FOR INJECTIONS BP

Fresenius Kabi Australia Pty Limited
Level 2, 2 Woodland Way
Mount Kuring-gai NSW 2080
Australia
Telephone: (02) 9391 5555

This leaflet was prepared in July 2024.

Published by MIMS October 2024

1 Name of Medicine

Water for injections.

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.

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.

4.2 Dose and Method of Administration

For dissolving or diluting agents for parenteral administration.

For irrigation.

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.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

None known.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

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 BP must be consulted before use.

Reporting suspected adverse effects.

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).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

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.

Carcinogenicity.

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) and polypropylene (PP) 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).
*Not all pack sizes/volumes 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.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Australia: Not scheduled.

Summary Table of Changes