Water for injections Fresenius Kabi solvent for parenteral use

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

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

What is in this leaflet:

1. What Agua para preparaciones inyectables Fresenius Kabi is and what it is used for
2. What you need to know before using Agua para preparaciones inyectables Fresenius Kabi
3. How to use Agua para preparaciones inyectables Fresenius Kabi
4. Possible side effects
5. How to store Agua para preparaciones inyectables Fresenius Kabi
6. Contents of the pack and other information

1. What Agua para preparaciones inyectables Fresenius Kabi is and what it is used for

Agua para preparaciones inyectables Fresenius Kabi is sterile water. It is used to dilute medicinal products before administration by injection.

2. What you need to know before using Fresenius Kabi Water for Injections

Do not use Fresenius Kabi Water for Injections

This medicine must not be injected alone. If injected directly into the bloodstream, it may cause red blood cells to absorb water and burst (haemolysis). This occurs because water for injections does not have the same concentration as blood.

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

You should read the package leaflet of the medicine or medicines to be mixed with Fresenius Kabi Water for Injections.

Warnings and precautions

Water for injections must not be administered on its own. Before using Fresenius Kabi Water for Injections:

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

You are more likely to experience haemolysis if large volumes of hypotonic solutions of Water for Injections (solutions less concentrated than your blood) are administered.

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

Before administering medicines mixed with Fresenius Kabi Water for Injections, your doctor will check that:

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

Other medicines and Fresenius Kabi Water for Injections

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

Use of Fresenius Kabi Water for Injections with food and drink

Consult your doctor regarding what you may eat or drink.

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

The risks to the foetus or to your pregnancy will depend on the medicines used in combination with Fresenius Kabi Water for Injections.

The risks to the infant during breastfeeding will depend on the medicines used in combination with Fresenius Kabi Water for Injections.

Your doctor can advise you on the specific risks associated with each medicine.

Driving and using machines

Fresenius Kabi Water for Injections does not affect your ability to drive or operate machinery.

The effects on your ability to drive and use machines will depend on the medicines used in combination with Fresenius Kabi Water for Injections. Your doctor will advise you accordingly.

3. How to use Water for Injections Fresenius Kabi

Follow exactly the instructions for administration of Water for Injections Fresenius Kabi as given by your doctor. Consult your doctor or pharmacist if you have any doubts.

Water for Injections Fresenius Kabi will be administered to you by a doctor or nurse.

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

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

You must not receive Water for Injections 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 Injections Fresenius Kabi than you should

If you have received too much Water for Injections Fresenius Kabi, you may experience haemolysis. Haemolysis occurs when red blood cells absorb water and burst.

Medicines mixed with Water for Injections Fresenius Kabi may also cause symptoms if administered in excessive amounts. The symptoms and signs of overdose will depend on the medicines being used in combination with Water for Injections 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 leaflet of the medicines mixed with Water for Injections Fresenius Kabi for a list of possible overdose symptoms.

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

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

4. Possible adverse effects

Like all medicines, this medicine can have adverse effects, although not everyone will experience them.

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

• Water for Injections Fresenius Kabi is used alone
• Water for Injections is used to make injectable solutions or infusions that are not of similar concentration to your blood (isotonic)

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

Reporting of adverse effects:

If you experience any kind of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Water for Injectable Preparations Fresenius Kabi

Keep this medicine 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 expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

Use only if the solution is clear, free from visible particles, and the container is intact.

For single use only. Discard any unused portion.

Medicines should not be disposed of via wastewater or household waste. Return empty containers and unused medicines to the SIGRE Point at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Water for Injections Fresenius Kabi

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

Each millilitre contains 1 ml of water for injections.

Appearance of the medicinal product and contents of the pack

Water for Injections Fresenius Kabi is a clear, particle-free solution and is available in the following pack sizes:

Glass vials containing 500 ml and 1,000 ml.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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 the most recent review of this leaflet: April 2014

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/