SUMMARY CMI

WATER FOR INJECTIONS FREEFLEX

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 FREEFLEX?

Water for Injection Freeflex contains the active ingredient sterile water.

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

It can also be used for washing small wounds and during minor surgical procedures.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. For more information, see Section 1. Why am I using WATER FOR INJECTIONS FREEFLEX? in the full CMI.

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

Water for Injections will only be used if it is clear, colourless and free of particles.

You should not be given Water for Injections after the expiry date printed on the pack, or if the packaging is torn, shows signs of tampering and if the solution is not clear.

It may have no effect at all, or an entirely unexpected effect if you are given it after the expiry date has 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.

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

3. What if I am 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 or pharmacist can tell you what to do if you are taking any of these medicines.

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 FREEFLEX?

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

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

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

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

For more information, see Section 5. What should I know while using Water for Injections Freeflex? in the full CMI.

6. Are there any side effects?

Intravenous Infusion of Dissolved and diluted drugs should not cause any side effects. In some instances, swelling of the hands and feet can occur due to the retention of fluid in your body. Intravenous infusions can also cause local reactions such as pain, vein irritation and in rare cases thrombophlebitis inflammation that causes a blood clot to form and block one or more veins, usually in your legs). If the infusion leaks out of the vein, it may cause tissue injury depending on the drug that is diluted/dissolved.

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 FREEFLEX

Active ingredient(s): Water

Consumer Medicine Information (CMI)

This leaflet provides important information about using Water for Injections Freeflex. 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 Freeflex.

Where to find information in this leaflet:

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

1. Why am I using WATER FOR INJECTIONS FREEFLEX?

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

It can also be used for washing small wounds and during minor surgical procedures.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

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

Warnings

Before you are given Water for Injections Freeflex

Water for Injections will only be used if it is clear, colourless and free of particles.

You should not be given Water for Injections after the expiry date printed on the pack, or if the packaging is torn, shows signs of tampering and if the solution is not clear.

It may have no effect at all, or worse, an entirely unexpected effect if you are given it after the expiry date has 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.

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?

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 Freeflex.

4. How do I use WATER FOR INJECTIONS FREEFLEX?

How much to is given

Your doctor knows that Water for Injections should not be directly injected into your veins. Water for Injections is used to dissolve or dilute other drugs and will be administered by a doctor or nurse. Your health professionals know how much medicine should be added to Water for Injections Freeflex before this medicine is injected.

Water for Injections can also be used to clean away dirt and blood from small wounds or cuts. Your health care professional will determine how much is needed to be used.

If you use too much Water for Injections Freeflex

As Water for Injections is administered under the direct supervision of a health care professional it is very unlikely that you will receive too much.

However, if you experience severe side effects after being given this medicine, tell your health professional immediately.

Water for Injections should not be administered past the labelled expiry date.

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

Looking after your medicine

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

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

When to discard your medicine (as relevant)

Any Water for Injections which is not used and which is left in the container, will be disposed of in a safe manner by your in the car or on window sills.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

In case you experience side effects during or after the treatment with a medicine mixed in Water for Injections Freeflex, it is most likely caused by the added medicines.

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.

Intravenous administration of solutions may cause local reactions including pain, vein irritation, and thrombophlebitis (an inflammatory process that causes a blood clot to form and block one or more veins, usually in your legs). Extravasation (leaking of fluids into extravascular tissue) of solution may cause tissue injury.

In some instances, swelling of the hands and feet can occur due to the retention of fluid in your body. Intravenous infusions can also cause local reactions such as pain, vein irritation and in rare cases thrombophlebitis inflammation that causes a blood clot to form and block one or more veins, usually in your legs). If the infusion leaks out of the vein, it may cause tissue injury depending on the drug that is diluted/dissolved.

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 Water for Injections Freeflex contains

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

What Water for Injections Freeflex looks like Water for Injections is clear, colourless, particle free, sterile water.

Water for Injections comes in various pack sizes. They can be identified by the AUST R numbers;

Freeflex Bags

100mL AUST R 144795

250mL AUST R 144808

500mL AUST R 144809

1000mL AUST R 144814

Who distributes Water for Injections Freeflex

Fresenius Kabi Australia Pty Limited
Level 2, 2 Woodland Way
Mount Kuring-gai NSW 2080
Australia
Telephone: (61-2) 9391 5555

This leaflet was prepared in Jul 2021.

Published by MIMS September 2021

1 Name of Medicine

Water for Injections.

2 Qualitative and Quantitative Composition

Water for Injections Freeflex 100 mL, 250 mL, 500 mL or 1000 mL contains 100% v/v sterile water only.

3 Pharmaceutical Form

Injection, intravenous infusion.
Water for Injections Freeflex is a sterile, clear, colourless, particle-free, odourless and tasteless liquid with a pH of 5.6-7.7. It 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 it is not adjusted to isotonicity by the addition of suitable solutes.
The use of Water for Injection as irrigation during a major surgical procedure, or in a procedure where significant amounts may be absorbed or enter the circulation, is contraindicated.

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. Entry of water or hypotonic solution into the systemic circulation may cause haemolysis. Given that there is a possibility of systemic absorption of irrigation solutions, the same precautions apply.
Tissue damage may result from irrigation with large volumes or under pressure. See Section 4.8 Adverse Effects (Undesirable Effects).

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Not applicable.

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.
Haemolysis and hyponatraemia have been reported after irrigation during urological procedure.
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 infusion, or systemic absorption of irrigation solutions, may result in electrolyte disturbances including hyponatraemia, and cardiovascular/ pulmonary disorders due to oedema.
Intravenous administration of solutions may cause local reactions including pain and vein irritation or other adverse reactions such 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. Extravasation of solution may cause tissue injury.
Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volumes or pressure during irrigation of closed cavities may result in distension or disruption of tissues. Inadvertent contamination from careless techniques may transmit infection.

Reporting of suspected adverse reactions.

4.9 Overdose

If Water for Injections is inadvertently injected without first ensuring isotonicity, the hypotonic effects may include local cell damage or haemolysis.
Overdose using isotonic intravenous solutions prepared using Water for Injections or during irrigation, may cause fluid overload and electrolyte disturbances. See Section 4.8 Adverse Effects (Undesirable Effects).
Infusion or irrigation should be ceased and the patient assessed and treated appropriately.
For information on the management of overdose, contact the Poison Information Centre on 13 11 26 (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 Freeflex (see Section 4.2 Dose and Method of Administration; Section 4.4 Special Warnings and Precautions for Use).
Ensure appropriate solubility, dilution or compatibility with other additive 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 can be found on the packaging.

6.4 Special Precautions for Storage

Store below 25°C.

6.5 Nature and Contents of Container

Water for Injections is supplied in freeflex bags - polyolefin.
Water for Injections Freeflex 100 mL AUST R 144795 - available in packs of 40, 50, 55 and 60 bags.
Water for Injections Freeflex 250 mL AUST R 144808 - available in packs of 20, 30, 35 and 40 bags.
Water for Injections Freeflex 500 mL AUST R 144809 - available in packs of 20 bags.
Water for Injections Freeflex 1000 mL AUST R 144814 - available in packs of 10 bags.
Not all pack sizes are 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.

Molecular weight.

CAS number.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes