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. What WATER FOR INJECTIONS is used for?

WATER FOR INJECTIONS contain water for injections. WATER FOR INJECTIONS is used to dilute or dissolve medicines.

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

2. What should I know before being given WATER FOR IN JECTIONS?

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 being given WATER FOR INJECTIONS? 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 is WATER FOR IN JECTIONS given?

WATER FOR INJECTIONS is used to dilute or dissolve medicines for your treatment and is usually given by injection by a doctor or trained nurse.

More instructions can be found in Section 4. How is WATER FOR INJECTIONS given? in the full CMI.

5. What should I know while being given WATER FOR IN JECTIONS?

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

6. Are there any side effects?

Common side effects may include fever or pain, bruising or swelling at the injection site.

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): Water for injections

Consumer Medicine Information (CMI)

This leaflet provides important information about using WATER FOR INJECTIONS. 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.

Where to find information in this leaflet:

1. What WATER FOR INJECTIONS is used for?
2. What should I know before I am given WATER FOR INJECTIONS?
3. What if I am taking other medicines?
4. How is WATER FOR INJECTIONS given?
5. What should I know while being given WATER FOR INJECTIONS?
6. Are there any side effects?
7. Product details

1. What WATER FOR INJECTIONS is used for?

WATER FOR INJECTIONS contains sterile water for injections.

WATER FOR INJECTIONS is used to dilute or dissolve medicines.

2. What should I know before being given WATER FOR INJECTIONS?

Warnings

Your doctor or nurse will only use WATER FOR INJECTIONS to dissolve or dilute medicines for your treatment. WATER FOR INJECTIONS should not be injected directly.

Check with your doctor 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.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

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.

4. How is WATER FOR INJECTIONS given?

How much is given

WATER FOR INJECTIONS is used to dilute or dissolve medicines for your treatment and is usually given by injection by a doctor or trained nurse.

5. What should I know while being given WATER FOR INJECTIONS?

Things you should do

Tell your doctor straight away if:

• the injection makes you feel unwell.

Looking after your medicine

WATER FOR INJECTIONS will be stored in the pharmacy or on the ward 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 that is not used.

Do not use after the expiry date.

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.

See the information below and, if you need to, ask your doctor, nurse or pharmacist if you have any further questions about side effects.

Less serious side effects

Tell your doctor, nurse or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

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, nurse or pharmacist before you decide to stop taking any of your medicines.

7. Product details

What WATER FOR INJECTIONS contains

What WATER FOR INJECTIONS looks like

WATER FOR INJECTIONS is a clear, colourless solution in a plastic ampoule in packs of 200 units.

WATER FOR INJECTIONS BP is a clear, colourless solution in a vial in pack of 10 units.

WATER FOR INJECTIONS 2 mL BP ampoule
(AUST R 49284)

WATER FOR INJECTIONS 5 mL BP ampoule
(AUST R 49286)

WATER FOR INJECTIONS 10 mL BP ampoule
(AUST R 49287)

WATER FOR INJECTIONS 20 mL BP ampoule
(AUST R 49288)

WATER FOR INJECTIONS 100 mL BP vial
(AUST R 49298)

* Not all presentations and pack sizes may be marketed.

Who distributes WATER FOR INJECTIONS

Bridgewest Perth Pharma Pty Ltd
15 Brodie Hall Drive
Bentley WA 6102
Telephone: 1800 161 156
[email protected]

This leaflet was prepared in September 2023.

Published by MIMS November 2023

1 Name of Medicine

Water for injections.

2 Qualitative and Quantitative Composition

Water for Injections BP is a non-isotonic, ready to use, single dose solution. It does not contain preservatives.

3 Pharmaceutical Form

Water for Injections BP is a sterile, non-isotonic, clear, colourless solution in a ready-to-use, single dose presentation. It does not contain preservatives.

4 Clinical Particulars

4.1 Therapeutic Indications

Water for Injections is used for the reconstitution and preparation of aqueous injections.

4.2 Dose and Method of Administration

Dosage.

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

Do not use Water for Injections unless it is clear and the seal is intact.
Before dissolving or diluting any substance or preparation, consult the product information for the substance, drug or preparation to ensure that Water for Injections is the recommended solvent or diluent, check appropriate solubility, dilution or compatibility with other additives.
Ensure that the solution prepared with Water for Injections is isotonic with blood before intravenous administration. Intravenous administration of water or hypotonic solution may cause haemolysis.

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.

4.7 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)

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. The product information of any drug or substance used with Water for Injections must be consulted before use.
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). Haemolysis may lead to renal tubular obstruction. Expansion of intravascular fluid, through intravenous administration or systemic absorption of irrigation solutions, may result in electrolyte disturbances including hyponatraemia, and cardiovascular/ pulmonary disorders due to oedema.
Other adverse reactions may include fever, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia. These may not necessarily be due to Water for Injections itself.

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

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

None.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.
Ensure appropriate solubility, dilution or compatibility with other additives and ascertain the maximum time between aseptic preparation and administration by consulting the Product Information of any substance, preparation or drug before use.

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

6.4 Special Precautions for Storage

Store below 25°C.
Use once only and discard any remaining portion.

6.5 Nature and Contents of Container

AUST R 49284 Water for Injections BP 2 mL LDPE ampoule (200s).
AUST R 49286 Water for Injections BP 5 mL LDPE ampoule (50s).
AUST R 49287 Water for Injections BP 10 mL LDPE ampoule (50s).
AUST R 49287 Water for Injections BP 10 mL LDPE ampoule (600s) (Available in Australia only).
AUST R 49288 Water for Injections BP 20 mL LDPE ampoule (30s).
AUST R 49298 Water for Injections BP 100 mL LDPE vial (10s).

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

The chemical name for water is hydrogen oxide.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes