WATER FOR INJECTABLE PREPARATIONS GRIFOLS SOLVENT FOR PARENTERAL USE

Introduction

Package Leaflet: Information for the Patient

Water forInjectable PreparationsGrifols Solvent for Parenteral Use

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

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

Contents of the Package Leaflet

1. What Water for Injectable Preparations Grifols is and what it is used for
2. What you need to know before starting to use Water for Injectable Preparations Grifols
3. How to use Water for Injectable Preparations Grifols
4. Possible side effects
5. Storage of Water for Injectable Preparations Grifols

1. Contents of the Packaging and Additional Information

1. What Water for Injectable Preparations Grifols is and what it is used for

The medication is a solvent for parenteral use used as a vehicle for the administration of medications, which is indicated as:

• Solvent for powder or lyophilized medications for subsequent administration
• Diluent for solutions and/or medications.

Given its markedly hypotonic character, Water forInjectable PreparationsGrifols is especially indicated for reconstituting medications and/or diluting hypertonic solutions.

2. What you need to know before starting to use Water for Injectable Preparations Grifols

The contraindications related to the added medications should be considered.

Warnings and Precautions

Consult your doctor or nurse before starting to use Water for Injectable Preparations Grifols.

The water for injectable preparations is markedly hypotonic (less concentrated than blood) and should not be injected without mixing with medications.Before administering intravenously, it should be checked that the final solution is isotonic with blood.

The administration of large volumes of hypotonic solution can cause hemolysis (destruction of red blood cells). To evaluate the appearance of hemolysis, it is recommended to monitor the hematocrit (percentage of red blood cells in blood), blood levels of hemoglobin, haptoglobin, bilirubin, and lactate dehydrogenase, and to check for hematuria (presence of blood in urine). It is also recommended to check the proper functioning of the kidney through laboratory tests.

When large volumes of this medication are administered, the ionic balance should be frequently checked.

If you are elderly, if your heart, liver, and/or kidneys do not function correctly, or if it is used in children, the complications related to incorrect or uncontrolled use of water for injectable preparations can be more severe.

Use ofWater forInjectable PreparationsGrifols withOther Medications

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

The possible interactions of the medications to be dissolved and/or diluted should be considered.

Pregnancy and Breastfeeding

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

The risk of using water for injectable preparations during pregnancy and breastfeeding is determined by the added medication.

Driving and Using Machines

The possible effects on the ability to drive and use machinery of the added medications should be considered.

3. How to Use Water for Injectable Preparations Grifols

Water for Injectable Preparations Grifols is a solvent and/or diluent for medications for subsequent parenteral administration.

It will be used in a hospital by the corresponding healthcare personnel.

The dosage of the obtained solution will depend mainly on the added medication and the patient's requirements.

If you are given moreWater forInjectable PreparationsGrifolsthan you should

If large volumes of hypotonic solution are administered when using water for injectable preparations as a diluent, hemolysis may occur.

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

In case of overdose, administration should be interrupted and symptomatic treatment should be initiated.

If a hemolytic reaction is suspected during the administration of a solution prepared with water for injectable preparations, it should be suspended and a red blood cell concentrate should be administered, diuresis should be induced with diuretics and intravenous fluids, and kidney function and coagulation status should be monitored.

In case of overdose or accidental ingestion, consult the Toxicology Information Service. Phone: 915 620 420.

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

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects associated with the administration technique may occur, including pain or reaction at the injection site, fever, infection, extravasation, venous thrombosis, and phlebitis extending from the injection site, among others.

Its use can cause hemolysis if it is injected without mixing with medications.

The nature of the added medication will determine the likelihood of any other side effect.

In case of side effects, administration of the solution should be interrupted and symptomatic treatment should be initiated.

Reporting Side Effects

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that is not listed in this package leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use (website: www.notificaRAM.es). By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Water for Injectable Preparations Grifols

Keep this medication out of sight and reach of children.

No special storage conditions are required.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Medications should not be disposed of through wastewater or household waste. In case of doubt, ask your pharmacist how to dispose of the packaging and medications that are no longer needed. This will help protect the environment.

6. Contents of the Packaging and Additional Information

Composition of Water forInjectable PreparationsGrifols

The active ingredient is water for injectable preparations (100%).

Appearance of the Product and Contents of the Packaging

It is a transparent and colorless solvent for parenteral use, which is presented in Type II glass vials of 100, 250, and 500 ml.

Marketing Authorization Holder

LABORATORIOS GRIFOLS, S.A.

Can Guasch, 2

08150 Parets del Vallès, Barcelona (SPAIN)

Manufacturer

LABORATORIOS GRIFOLS, S.A.

Polígono Industrial Autopista. Passeig Fluvial, 24.

08150 Parets del Vallès, Barcelona (SPAIN)

Date of the Last Revision of this Package Leaflet:October 2014

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

-----------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals:

Administer intravenously.

Once the packaging is opened, the contents should be used immediately. The unused volume should be discarded.

Do not use if the product is not transparent or contains visible particles.

Do not injectWater forInjectable PreparationsGrifols without mixing with medications.

Before adding medications, it should be checked that they are soluble and stable in water for injectable preparations and that they are compatible with each other.

It is recommended to perform the reconstitution and/or dilution of medications in Water for Injectable Preparations Grifols under controlled and validated aseptic conditions, and that the obtained solutions be used immediately after preparation.

When using water for injectable preparations as a solvent for medications and/or diluent for solutions, the osmolarity and tonicity of the final solution should be controlledand adjusted, whenever possible, to its isotonicity with plasma.

Use an aseptic procedure to administer the obtained solution.