AGUA PARA PREPARACIONES INYECTABLES FRESENIUS KABI SOLVENT FOR PARENTERAL USE

Introduction

Package Leaflet: Information for the User

Water for Injection Fresenius Kabi Solvent for Parenteral Use

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.,Keep this leaflet, you may need to read it again.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet:

1. What Water for Injection Fresenius Kabi is and what it is used for
2. What you need to know before you use Water for Injection Fresenius Kabi
3. How to use Water for Injection Fresenius Kabi
4. Possible side effects
5. Storage of Water for Injection Fresenius Kabi
6. Contents of the pack and further information

1. What Water for Injection Fresenius Kabi is and what it is used for

Water for Injection Fresenius Kabi is sterile water. It is used to dilute medicines before they are given by injection.

2. What you need to know before you use Water for Injection Fresenius Kabi

Do not use Water for Injection Fresenius Kabi

This medicine must not be injected on its own. If it is injected alone into the bloodstream, it can cause red blood cells to absorb water and burst (hemolysis). This happens because the water for injection does not have the same consistency as blood.

Before administration, a healthcare professional will always mix Water for Injection Fresenius Kabi with one or more medicines. They will tell you if you can or cannot receive the solution.

You should read the package leaflet of the medicine or medicines that are mixed with Water for Injection Fresenius Kabi.

Warnings and Precautions

Water for injection must not be administered alone. Before using Water for Injection Fresenius Kabi:

• it will always be mixed with one or more medicines
• your healthcare professional will ensure that the mixture has approximately the same consistency as your blood (isotonic). Depending on the type of medicine being administered, this will mean that:
• • the medicine needs to be diluted with Water for Injection Fresenius Kabi
  • another substance needs to be added to the mixture of Water for Injection Fresenius Kabi and the medicine before use

You are more likely to suffer from hemolysis if you are given large volumes of hypotonic solutions of Water for Injection Fresenius Kabi (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 medicines mixed with Water for Injection Fresenius Kabi, your doctor will check that:

• the medicines are stable in Water for Injection Fresenius Kabi
• the medicines do not interact with each other

Other Medicines and Water for Injection Fresenius Kabi

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

Medicines used dissolved in Water for Injection Fresenius Kabi may interact with each other.

Using Water for Injection Fresenius Kabi with Food and Drink

Ask your doctor about what you can eat or drink.

Pregnancy, Breast-feeding, and Fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

The risks to the fetus or your pregnancy will depend on the medicines used mixed with Water for Injection Fresenius Kabi.

The risks to the baby during breast-feeding will depend on the medicines used mixed with Water for Injection Fresenius Kabi.

Your doctor can inform you about the risks associated with each medicine.

Driving and Using Machines

Water for Injection Fresenius Kabi does not affect the ability to drive or use machines.

The effects on your ability to drive or use machines will depend on the medicines used mixed with Water for Injection Fresenius Kabi. Your doctor will advise you on this.

3. How to Use Water for Injection Fresenius Kabi

Follow exactly the administration instructions of Water for Injection Fresenius Kabi given by your doctor. Ask your doctor or pharmacist if you have any questions.

A doctor or nurse will administer Water for Injection Fresenius Kabi to you.

Your doctor will decide what dose you need, and when and how it will be given to you. This will depend on what medicines you need to take with Water for Injection Fresenius Kabi.

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

Do not receive Water for Injection 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 Injection Fresenius Kabi than you should

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

Medicines mixed with Water for Injection Fresenius Kabi may also cause symptoms if they are given in too high a dose. The symptoms and signs of overdose will depend on the medicines you are using mixed with Water for Injection Fresenius Kabi.

If you are accidentally given an overdose, your treatment will be stopped, and you will be given a treatment that depends on your symptoms.

You should read the package leaflet of the medicines mixed with Water for Injection Fresenius Kabi for the list of possible symptoms of overdose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

In case of overdose or accidental ingestion, contact your doctor or pharmacist or call the Toxicology Information Service. Telephone 915 620 420, indicating the medicine and the amount used.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• you use Water for Injection Fresenius Kabi alone
• Water for Injection is used to make injectable solutions or for perfusion that are not of similar consistency to your blood (isotonic)

If a medicine is added to Water for Injection Fresenius Kabi, the added medicine may cause side effects. These side effects will depend on the medicine that has been added. You should read the package leaflet of the added medicine for the list of possible symptoms.

Reporting of side effects:

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Water for Injection Fresenius Kabi

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

No special storage conditions are required.

Do not use Water for Injection Fresenius Kabi after the expiry date which is stated on the container after EXP. The expiry date is the last day of the month shown.

Use only if the solution is clear, without visible particles, and if the container is intact.

For single use only. Discard any unused product.

Medicines should not be disposed of via wastewater or household waste. Place the container and any unused medicines in the SIGRE collection point at the pharmacy. If you are unsure, ask your pharmacist how to dispose of the container and any unused medicines. This will help protect the environment.

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6. Contents of the Pack and Further Information

Composition of Water for Injection Fresenius Kabi

The active substance is sterile water for injection. Each presentation contains 100% sterile water for injection.

Each milliliter contains 1 ml of water for injection.

Appearance and Pack Contents

Water for Injection Fresenius Kabi is a clear solution, free from visible particles, and is presented in the following formats:

Glass bottles containing 500 and 1,000 ml.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Fresenius Kabi España S.A.U

Torre Mapfre-Vila Olímpica

C/ Marina 16-18,

08005 Barcelona

Spain

Manufacturer

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

Date of Last Revision of this Leaflet: April 2014

Detailed and up-to-date information on this medicine is available on the website of the Spanish Agency for Medicines and Healthcare Products (AEMPS) http://www.aemps.gob.es/