SUMMARY CMI

Water for Injections B Braun

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 B. Braun Water for Injections?

B. Braun Water for Injections does not contain an active ingredient. B. Braun Water for Injections is used to dissolve or dilute other medicines.

For more information, see Section 1. Why am I using B. Braun Water for Injections? in the full CMI.

2. What should I know before I use B. Braun Water for Injections?

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 B. Braun Water for Injections? in the full CMI.

3. What if I am taking other medicines?

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

For more information, see Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use B. Braun Water for Injections?

• Water for injections will be used to dissolve or dilute other drugs or medicines, which may be given by injection.
• The reconstituted medicine is administered to you by a doctor or healthcare professional.

More instructions can be found in Section 4. How do I use B. Braun Water for Injections? in the full CMI.

5. What should I know while using B. Braun Water for Injections?

For more information, see Section 5. What should I know while using B. Braun Water for Injections? 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 B Braun

Active ingredient(s): None

Consumer Medicine Information (CMI)

This leaflet provides important information about using B. Braun 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 B. Braun Water for Injections.

Where to find information in this leaflet:

1. Why am I using B. Braun Water for Injections?
2. What should I know before I use B. Braun Water for Injections?
3. What if I am taking other medicines?
4. How do I use B. Braun Water for Injections?
5. What should I know while using B. Braun Water for Injections?
6. Are there any side effects?
7. Product details

1. Why am I using B. Braun Water for Injections?

B. Braun Water for Injections contains sterile water. B. Braun Water for Injections is used to dissolve or dilute other medicines when preparing water soluble injections.

2. What should I know before I use B. Braun Water for Injections?

Warnings

Your doctor or nurse will only use Water for Injections to dissolve or dilute other medicines that they will give you.

Before you are given Water for Injections

When you must not use it:

• Only to be used if solution is clear, colourless and the container and its closure or packaging are undamaged.
• Do not use Water for injections after the expiry date which is stated on the container and the outer carton after "EXP". The expiry date refers to the last day of the month.

Check with your doctor if you:

• have any other medical conditions
• take any medicines for any other condition

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 B. Braun Water for Injections.

4. How do I use B. Braun Water for Injections?

How much is given

• B. Braun Water for injections will be used to dissolve or dilute other drugs or medicines, which may be given by injection.
• The reconstituted medicine is administered to you by a doctor or healthcare professional.
• 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.

5. What should I know while using B. Braun Water for Injections?

Things you should do

Tell your doctor straight away if the injection makes you feel unwell.

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Looking after your medicine

Water for Injections will be stored by your doctor or pharmacist under the recommended conditions.

Water for injections should be stored at a temperature below 25°C.

Follow the instructions in the carton on how to take care of the medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

When to discard your medicine

Your doctor or nurse will safely dispose of any Water for injections that is not used.

Do not use this medicine 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 or pharmacist if you have any further questions about side effects.

Tell your doctor 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 or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What B. Braun Water for Injections contains

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

What B. Braun Water for Injections looks like

B. Braun Water for Injections is a clear, colourless, particle free sterile solution.

Water for Injections B. Braun is supplied in single-use containers.

Plastic (polyethylene) ampoules containing Water for injections 10 mL, 20 mL supplied in packs of:

20 x 10 mL ampoules, AUST R 199953

20 x 20 mL ampoules, AUST R 199952

Plastic bottles, containing Water for injections 100 mL, 250 mL, 500 mL, 1000 mL, supplied in packs of:

20 × 100 mL bottles, AUST R 199949

20 × 250 mL bottles, AUST R 199951

10 × 500 mL bottles, AUST R 199948

10 × 1000 mL bottles, AUST R 199950

Who distributes B. Braun Water for Injections

B. Braun Australia Pty Ltd
Level 5, 7-9 Irvine Place
Bella Vista NSW 2153
Australia

Toll free number: 1800 251 705

This leaflet was prepared in October 2023.

Published by MIMS December 2023

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 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

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.

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)

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.

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.

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

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.

CAS number.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes