Package Leaflet: Information for the user

Fresenius Kabi injectable preparations diluent for parenteral use

Read this leaflet carefully before you start using this medicine,because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4

Fresenius Kabi Sterile Water for Injectionis sterile water. It is used to dilute medications before their use via injection.

No use Agua para preparaciones inyectables Fresenius Kabi

This medication should not be injected alone. If it is injected alone into the bloodstream, it may cause red blood cells to absorb water and burst (hemolysis). This occurs because the water for injectable preparations does not have the same consistency as blood.

Before administration, a healthcare professional will always mix Agua para preparaciones inyectables Fresenius Kabi with one or more medications. They will tell you if you can or cannot receive the solution.

You should read the prospectus of the medication or medications that are mixed with Agua para preparaciones inyectables Fresenius Kabi.

Warnings and precautions

Agua para preparaciones inyectables should not be administered alone. Before using Agua para preparaciones inyectables:

• it will always be mixed with one or more medications
• your healthcare professional will ensure that the mixture has approximately the same consistency as your blood (isotonic). Depending on the type of medication you are administered, this will mean that:
• • the medication needs to be diluted with Agua para preparaciones inyectables Fresenius Kabi
  • before use, another substance needs to be added to the mixture of Agua para preparaciones inyectables Fresenius Kabi and the medication

You will have a higher risk of hemolysis if you are administered large volumes of hypotonic solutions of Agua para preparaciones inyectables (solutions that are not as concentrated as your blood).

To prevent this, your doctor will take a blood sample to monitor the chemical balance in your blood (ionic balance).

Before administering medications mixed with Agua para preparaciones inyectables Fresenius Kabi, your doctor will check that:

• the medications are stable in Agua para preparaciones inyectables Fresenius Kabi
• the medications do not interact with each other.

Other medications and Agua para preparaciones inyectables Fresenius Kabi

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

Medications that are used dissolved in Agua para preparaciones inyectables Fresenius Kabi may interact with each other.

Use of Agua para preparaciones inyectables Fresenius Kabi with food and drinks

Consult with your doctor about what you can eat or drink.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

The risks to the fetus or your pregnancy will depend on the medications you use mixed with Agua para preparaciones inyectables Fresenius Kabi.

The risks to the baby during breastfeeding will depend on the medications you use mixed with Agua para preparaciones inyectables Fresenius Kabi.

Your doctor will be able to inform you about the risks associated with each medication in particular.

Driving and operating machines

Agua para preparaciones injectables Fresenius Kabi does not affect your ability to drive or operate machines.

The effects on your ability to drive and operate machines will depend on the medications you use mixed with Agua para preparaciones inyectables Fresenius Kabi. Your doctor will advise you about this.

Follow exactly the administration instructions for Water for injectable preparations Fresenius Kabi as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

A doctor or nurse will administer Water for injectable preparations Fresenius Kabi .

Your doctor will decide how much you need, and when and how it will be administered. This will depend on the medications you need to take with Water for injectable preparations Fresenius Kabi.

Your doctor will consider your age, weight, condition, and any other treatments you are receiving.

You should not receive Water for injectable preparations Fresenius Kabi if there are particles floating in the water or if the container is damaged in any way.

If you use more Water for injectable preparations Fresenius Kabi than you should

If you have received too much Water for injectable preparations Fresenius Kabi , you may experience hemolysis. Hemolysis occurs when red blood cells absorb water and burst.

The medications mixed with Water for injectable preparations Fresenius Kabi may also cause symptoms if administered in excessive amounts. The symptoms and signs of overdose will depend on the medications you are using mixed with Water for injectable preparations Fresenius Kabi .

If you accidentally receive an overdose, your treatment will be stopped and you will be given treatment depending on your symptoms.

You should read the package insert of the medications mixed with Water for injectable preparations Fresenius Kabi for the list of possible symptoms of overdose.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological Information Service. Phone 915 620 420, indicating the medication and the amount used.

Like all medications, this medication may have adverse effects, although not everyone may experience them.

You may experience hemolysis (swelling and bursting of red blood cells) if:

• You use Fresenius Kabi Injectable Water alone.
• Fresenius Kabi Injectable Water is used to make injectable solutions or for perfusion that are not similar in consistency to your blood (isotonic).

If you add a medication to Fresenius Kabi Injectable Water, the added medication may cause adverse effects. These adverse effects will depend on the medication added. You should read the prospectus of the added medication for the list of possible symptoms.

Reporting Adverse Effects:

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

No special storage conditions are required.

Do not use Water for Injectable Preparations Fresenius Kabi after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Use only if the solution is transparent, free of visible particles, and the packaging is intact.

For single use. Dispose of any remaining product.

Medications should not be disposed of through drains or in the trash. Deposit containers and unused medications at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of unused containers and medications. By doing so, you will help protect the environment.

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Composition of Water for Injections Fresenius Kabi

The only active substance is sterile water for injections. Each presentation contains 100% of sterile water for injections.

Each milliliter contains 1 ml of sterile water for injections.

Appearance of the product and contents of the packaging

Water for Injections Fresenius Kabi is a transparent solution, free of visible particles, and is available in the following formats:

Glass bottles containing 500 and 1,000 ml.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Fresenius Kabi España S.A.U

Torre Mapfre-Vila Olímpica

C/ Marina 16-18,

08005 Barcelona

Spain

Responsible for manufacturing

Fresenius Kabi Italia S.r.l.

Via Camagre, 41

I-37063 Isola della Scala

Italy

Fresenius Kabi Deutschland GmbH

Pfingstweide, 53

D-61169 Friedberg

Germany

Last review date of this leaflet: April 2014

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/