Consumer medicine information

Water for Injections Freeflex

Water for injections

BRAND INFORMATION

Brand name

Water for Injections Freeflex

Active ingredient

Water for injections

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Water for Injections Freeflex.

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?

Things you should do
  • 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.
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.

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

Active ingredient
(main ingredient)
Water
Other ingredients
(inactive ingredients)
None
Potential allergensNone

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

BRAND INFORMATION

Brand name

Water for Injections Freeflex

Active ingredient

Water for injections

Schedule

Unscheduled

 

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 water for injections.

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.

The dosage for Water for Injections 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 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 to be used for one patient on one occasion only. Any residue should be discarded. It does not contain antimicrobials. Care should be taken with intravenous administration and injection technique to avoid injection site reactions and infections.
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.

For irrigation.

Before using Water for Injections to irrigate small wounds, or during minor surgical procedures, inspect the contents to ensure that there has been no discolouration. Water for Injections is a sterile product and when used for irrigation, strict aseptic technique should be observed at all times. Water for Injections is for use for a single patient on a single occasion. Any residue remaining should be discarded.

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.
Check the product information of any substance, preparation or drug before use to ensure appropriate solubility, dilution or compatibility with other additives.
Before intravenous administration of a solution prepared with Water for Injections, ensure that the resultant solution is isotonic with blood. 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.

No data available.

Paediatric use.

No data available.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Not applicable.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
(Category A)
Check the product information document of the drug to be dissolved or diluted to ensure that it is safe to use during pregnancy.
Water for Injections can be administered to women who are breastfeeding. Check the product information document of the drug to be dissolved or diluted to ensure that it is safe to use during lactation.

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)

Haemolysis and hyponatraemia have been reported after irrigation during urological procedure. 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). 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.
The product information of any drug or substance used with Water for Injections must be consulted before use.
Intravenous administration of solutions may cause local reactions including pain, vein irritation, and thrombophlebitis. 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.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

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 131126 (Australia) or 0800 764 766 (New Zealand).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Water is the main constituent of the body fluids. Body weight is approximately 60% of water distributed in intracellular, interstitial and vascular compartments. The water content in the intracellular fluid, ie. the water inside the cells, is about 40 to 45 % of body weight. Water moves freely between these compartments. Thus, pharmacological action of the Water for Injection is as a vehicle for substances in maintaining the isotonicity across these compartments.

Clinical trials.

No data available.

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.

Water is the main constituent of the body fluids and is not known as a mutagen.

Carcinogenicity.

Water is the main constituent of the body fluids and is not known as a carcinogen.

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).

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 Freeflex 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

Molecular weight.

18.02.

Chemical structure.

Chemical formula is H2O.

CAS number.

The CAS number for water is 7732-18-5.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes