WATER FOR INJECTABLE PREPARATIONS B.BRAUN SOLVENT FOR PARENTERAL USE

Introduction

Package Leaflet: Information for the User

Water for Injection B.Braun

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.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What Water for Injection B.Braun is and what it is used for

Water for Injection B.Braun is sterile water for injection.

It is used for the preparation and dilution of medicines that are administered into a vein (parenterally).

2. What you need to know before you start using Water for Injection B.Braun

Do not use Water for Injection B.Braun.

There are no known situations in which Water for Injection B.Braun should not be used.

Warnings and Precautions

Water for Injection B.Braun should not be used alone. Your doctor will dissolve or dilute another medicine in the water for injection before administering the prepared medicine.

Using Water for Injection B.Braun with other medicines

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

There are no known interactions with other medicines. Any interactions that may occur are those corresponding to the medicines that are dissolved.

Using Water for Injection B.Braun with food and drinks

There are no known interactions with food or drinks.

Pregnancy and Breastfeeding

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

The possible interactions are those corresponding to the medicines that are dissolved.

Water for Injection B.Braun can be used during pregnancy and breastfeeding.

Driving and Using Machines

The influence of Water for Injection B.Braun on the ability to drive and use machines is nil.

3. How to use Water for Injection B.Braun

This medicine will be administered by a doctor or healthcare professional.

The method of administration depends on the instructions for the medicine to be dissolved or diluted. The medicine should be reconstituted or diluted immediately before use.

The dose of Water for Injection B.Braun and the duration of application are in accordance with the instructions for the medicine to be dissolved or diluted.

Before dissolving a medicine, it is necessary to check that it is soluble and compatible with the water for injection.

If you use more Water for Injection B.Braun than you should

An overdose is very unlikely, as this medicine is only for the preparation and dilution of parenteral preparations.

If you use more Water for Injection B.Braun than you should, hemolysis (breakdown of red blood cells) may occur.

The signs and symptoms of an overdose may also be related to the nature of the medicine that is added.

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

4. Possible Side Effects

Like all medicines, Water for Injection B.Braun can cause side effects, although not everybody gets them.

Intravenous administration of Water for Injection B.Braun may cause hemolysis (destruction of red blood cells) if it is administered alone.

The nature of the medicine that is added to the water for injection will determine the likelihood of any other adverse reaction.

Reporting of Side Effects

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

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5. Storage of Water for Injection B.Braun

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

Store below 25°C.

Do not use this medicine if you notice that the packaging is damaged and the liquid is not clear and colorless. Do not use this medicine after the expiry date stated on the packaging and outer packaging after CAD. The expiry date is the last day of the month indicated.

For single use only. After use, discard any unused contents.

Medicines should not be disposed of via wastewater or household waste. Dispose of the packaging and any unused medicines at the pharmacy's SIGRE point. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Contents of the Pack and Further Information

Composition of Water for Injection B.Braun

• The active ingredient is water for injection.

Each 1 ml contains 1 ml of water for injection

Appearance and Packaging of the Product

Water for Injection B.Braun is a clear and colorless solution, presented in:

• Plastic ampoules (Miniplasco) of 5, 10, and 20 ml of water for injection. Presented in packs containing 1 ampoule, 20 ampoules, and 100 ampoules.
• Plastic ampoules (Miniplasco Basic) of 10 ml and 20 ml in packs containing 50 ampoules.
• Plastic ampoules (Miniplasco) of 5 ml in packs containing 500 ampoules.
• Plastic bottles (Ecoflac plus) of 100 ml of water for injection. Presented in packs containing 1 bottle and 20 bottles.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

• Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Date of Last Revision of this Leaflet: 11/2019

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

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This information is intended only for healthcare professionals:

Single-use containers.

Once the container is opened, the product must be used immediately.

Discard any unused contents after completion of the infusion.

The solution should only be used if the container closure is not damaged and the solution is clear.

Before mixing the solution with other medicines, any potential incompatibilities should be considered.

When used as a solvent for medicines and/or diluent for parenteral administration solutions, the osmolarity of the final solution should be checked and adjusted to isotonicity with plasma whenever possible.

Disposal of unused medicines and all materials that have come into contact with them should be carried out in accordance with local regulations.

Do not inject Water for Injection B.Braun without mixing with other medicines.

After preparation of the ready-to-use medicine

From a microbiological point of view, ready-to-use preparations should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and should not exceed 24 hours between 2 and 8°C, unless the dilution has taken place in controlled and validated aseptic conditions.

For the preparation of parenteral solutions, usual hygiene precautions should be respected to maintain sterility.