Prospect: Information for the user

Water for injectable preparations Serra, solvent for parenteral use

Water for injectable preparations

Read this prospect carefully before starting to use this medication, as it contains important information for you.

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

1.What is Water for injectable preparations Serra and for what it is used

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

3.How to use Water for injectable preparations Serra

4.Possible adverse effects

5.Storage of Water for injectable preparations Serra

6.Contents of the package and additional information

Serra Water for Injectable Preparationsis a special type of sterile water.This means that it is very transparent and can be injected.

Serra Water for Injectable Preparationsis used to dissolve or dilute some medications so that they can be administered through an injection or infusion (drip) into the veins, muscles, or other tissues in the body.

Warnings and Precautions

Serra Water for Injectable Preparations is hypotonic (more diluted than your blood) and should not be administered alone, as it may cause hemolysis (destroy your red blood cells).

Use of Serra Water for Injectable Preparations with other medications

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

No interactions are known when Serra Water for Injectable Preparations is administered with other medications. Please make sure to read the prospectuses of all your medications, as Serra Water for Injectable Preparations is added to other medications to dissolve or dilute them.

Pregnancy and breastfeeding

No problems are known to be caused by Serra Water for Injectable Preparations during pregnancy or breastfeeding.

Since Serra Water for Injectable Preparations is administered with other medications, it is important that:

This medication will usually be administered by a doctor or nurse. This product is a solvent for injectable use.

The doctor or nurse will use the correct amount to dissolve or dilute another medication you are receiving as an injection or drip (your doctor or nurse may refer to this as an infusion).

Serra Injectable Preparations Water should not be mixed with oily liquids.

Your doctor will decide the amount (dose) of medication you should receive and for how long.

The dose will depend on the other medication dissolved or diluted.

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

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Remember that it may also have adverse effects related to other medications for which Serra Injectable Preparations Water is used to dissolve or dilute.Serra.

The expected benefit of your medication will generally be greater than the risk of experiencing harmful adverse effects.

Important: Adverse effects or symptoms to be aware of, and what to do if you are affected.

The first signs of having excess water in your blood is feeling tired and presenting pallor. If you have any of these symptoms, you must consult a doctor urgently.

No adverse effects of Serra Injectable Preparations Water are known, therefore, please read the prospectus of your other medications to which the water is added to dissolve or dilute them.

Reporting Adverse Effects

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

Keep out of sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after “CAD”. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

After the first opening:

Use your medication only if it is a transparent and colorless liquid. Open it and use it immediately. The unused portion of the product must be discarded after opening.

Medicines should not be thrown away through drains or in the trash.Ask your pharmacisthow to dispose ofthepackaging and of themedicines that you no longerneed.By doing so, you will help protect the environment.

Composition of Water for Injectable Preparations Serra

• The active ingredient is Water for injectable preparations. 1 ml contains 1 g of water for injectable preparations, 5 ml contain 5 g of water for injectable preparations, 10 ml contain 10 g of water for injectable preparations, 20 ml contain 20 g of water for injectable preparations.
• This medication does not contain any other component.

Aspect of the product and content of the packaging

Water for injectable preparations Serra is a parenteral solvent.

Water for injectable preparations Serra is a transparent and colorless liquid.

Each plastic ampoule contains 5 ml (milliliters), 10 ml or 20 ml of your medication.

The 5 ml ampoules are packaged in boxes with 20 or 50 ampoules.

The 10 ml ampoules are packaged in boxes with 20, 50 or 100 ampoules.

The 20 ml ampoules are packaged in boxes with 20 ampoules.

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Laboratorios SERRA PAMIES S.A.

Ctra. Castellvell, 24

43206 REUS (Tarragona)

Responsible for manufacturing

Demo S.A.

21st Km National Road Athens-Lamia

14568 Athens

Greece.

This medication is authorized in the member states of the European Economic Area with the following names:

UK: Water for Injections Ph.Eur.

DK: Sterilt vand Noridem.

ES: Water for injectable preparations Serra, parenteral solvent.

IE: Water for Injections Ph Eur.

SE: Vatten för injektiosvätskor Noridem.

DE: Wasser für Injektionszwecke Noridem 1mg/ml Lösungsmittel zur Herstellung von Parenteralia.

AT: Wasser für Injektionszwecke Noridem Lösungsmittel zur Herstellung von Parenteralia.

NO: Sterilt vann Noridem.

PT: Água para preparacoes Injectáveis Noridem.

ΕL: Water for Injections/Noridem, Διαλ?της για παρεντερικ? χρ?ση 100%(v/v)

NL: Water voor injecties Noridem, oplosmiddel voor parenteraal gebruik

Last review date of this leaflet: February 2018

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