Label: information for the user

Water for injectable preparations B.Braun

solvent for parenteral use

Read this label carefully before starting to use this medication because it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.See section 4.

1. What is Water for injectable preparations B.Braun and how is it used

2. What you need to know before starting to use Water for injectable preparations B.Braun

3. How to use Water for injectable preparations B.Braun

4. Possible adverse effects

5. Storage of Water for injectable preparations B.Braun

6. Contents of the container and additional information

B.Braun Water for Injectable Preparations is sterile water for injectable preparations.

It is used for the preparation and dilution of medications that are to be administered through a vein (parenteral route).

Do not use Agua for injectable preparations B.Braun.

There are no known situations in whichAgua for injectable preparationsB. Braun should not be used.

Warnings and precautions

Agua for injectable preparationsB. Braun should not be used alone.Your doctor will dissolve or dilute another medication in the injectable preparation water before administering the prepared medication.

Use of Agua for injectable preparations B.Braun with other medications

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

No known interactions with other medications.Interactions that may appear are those corresponding to the medications that are dissolved.

Use of Agua for injectable preparations B. Braun with food and beverages

No known interactions with food or beverages.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

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

Agua for injectable preparationsB. Braun may be used during pregnancy and breastfeeding.

Driving and operating machines

The influence ofAgua for injectable preparationsB. Braun on the ability to drive and operate machines is zero.

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

The method of administration depends on the instructions given for the medication to dissolve or dilute. The medication must be reconstituted or diluted immediately before use.

The dosage ofWater for Injectable PreparationsB. Braun and the duration of application are in accordance with the instructions pertaining to the medication to dissolve or dilute.

Before dissolving a medication, it is necessary to check that it is soluble and compatible with water for injectable preparations.

If you use more Water for Injectable Preparations B.Braun than you should

A overdose is very unlikely, since this medication is only for the preparation and dilution of parenteral preparations.

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

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

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

Like all medications, Agua for Injectable Preparations B.Braun may cause adverse effects, although not everyone will experience them.

The intravenous administration of Agua for Injectable Preparations B.Braun may cause hemolysis (destruction of red blood cells) if it is administered alone.

The nature of the medication added to the injectable preparation water will determine the likelihood of any other adverse reaction appearing.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, 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 for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store below 25°C.

Do not use this medication if you observe that the container is damaged and the liquid is not transparent and has color.Do not use this medication after the expiration date that appears on the container and on the outer packaging after CAD.The expiration date is the last day of the month indicated.

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

Medications should not be disposed of through drains or in the trash. Deposit containers and medications that you no longer need at the SIGRE collection point at the pharmacy. Ask your pharmacist how to dispose of containers and medications that you no longer need. By doing so, you will help protect the environment.

Composition of Water for Injectable Preparations B.Braun

-The active ingredient is water for injectable preparations.

Each 1 ml contains 1 ml of water for injectable preparations.

Appearance of the product and contents of the package

Water for injectable preparations B.Braun is a transparent and colorless solution, which is presented in:

-Plastic ampoules (Miniplasco) of 5, 10, and 20 ml of water for injectable preparations. It is presented in containers containing 1 ampoule, 20 ampoules, and 100 ampoules.

-Plastic ampoules (Miniplasco Basic) of 10 ml and 20 ml in containers containing 50 ampoules.

-Plastic ampoules (Miniplasco) of 5 ml in a container containing 500 ampoules.

-Plastic bottles (Ecoflac plus) of 100 ml of water for injectable preparations. It is presented in containers containing 1 bottle and 20 bottles.

Only some sizes of containers may be commercially marketed.

Marketing Authorization Holder:

B. Braun Medical, S.A.

Ctra. de Terrassa, 121

08191-Rubí (Barcelona)

Spain

Last review date of this leaflet: 11/2019

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

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This information is intended solely for medical professionals or healthcare professionals:

Single-use containers.

The product must be used immediately once the container is opened.

Dispose of any remaining unused content after completing the infusion.

Only use the solution if the container seal is not damaged and the solution is transparent.

Before mixing the solution with other medications, consider any possible incompatibilities.

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

The elimination of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.

Do not inject Water for Injectable Preparations without mixing with other medications.

After preparing the medication ready for use

From a microbiological point of view, ready-to-use preparations must be used immediately. If not used immediately, the times and conditions of conservation in use before use 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, the usual precautions for maintaining sterility must be respected.