WATER FOR INJECTION EUROSPITAL

Package leaflet: Information for the user

Water for Injections Eurospital 500 ml solvent for parenteral use

“Equivalent medicinal product”
Please read this leaflet carefully before using this medicine because it contains important information for you.
Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.
• Consult your doctor if you do not notice any improvement or if your symptoms worsen.

Contents of this leaflet:

1. What Acqua per preparazioni iniettabili Eurospital is and what it is used for
2. What you need to know before using Acqua per preparazioni iniettabili Eurospital
3. How to use Acqua per preparazioni iniettabili Eurospital
4. Possible side effects
5. How to store Acqua per preparazioni iniettabili Eurospital
6. Contents of the pack and other information

1. What Acqua per preparazioni iniettabili Eurospital is and what it is used for

Acqua per preparazioni iniettabili Eurospital belongs to the category of solvents and diluents and is indicated for
the preparation of medicinal solutions for injection.

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

Do not use Water for Injections Eurospital
Water for Injections is a vehicle for various medicinal products; therefore, consult the package leaflet of the medicine you intend to administer.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Water for Injections Eurospital.
Prolonged administration may cause excessive water accumulation (fluid overload), congestion (congestive state), and reduced levels of salts in the blood; prolonged administration without potassium supplementation may lead to decreased potassium levels in the blood (hypokalaemia).
This is a generic medicine manufactured according to the requirements of the Pharmacopoeia.
Water for Injections is a vehicle for various medicinal products; therefore, for further information regarding its use (precautions, drug interactions, adverse effects), consult the package leaflet of the medicine you intend to administer.

Other medicines and Water for Injections Eurospital
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Water for Injections is a vehicle for various medicinal products; therefore, if you are taking other medicines, consult the package leaflet of the medicine you intend to administer.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before using this medicine.
Water for Injections is a vehicle for various medicinal products; therefore, consult the package leaflet of the medicine you intend to administer for information on use during pregnancy and breastfeeding.

Driving and using machines
Not applicable

3. How to use Water for Injections Eurospital

Use this medicine exactly as stated in this leaflet or as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
You must use this medicine for preparing solutions, dilutions, or extemporaneous suspensions of injectable medicines or other sterile preparations.
Use this medicine immediately after opening the container.
The water must be clear, colourless, free from visible particles, and the vacuum must be present.
To check for the presence of vacuum, insert the vial adapter while the vial is inverted: bubbling will be observed.
Any unused residue must not be used.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Water for injections is a vehicle for various medicinal products; therefore, please consult the package leaflet of the medicine you intend to administer for information on side effects.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Water for Injections Preparations Eurospital

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.". The expiry date refers to the product in its original, undamaged packaging, correctly stored.
The expiry date refers to the last day of that month.
Store in tightly closed containers.
Do not store above 30°C.
Do not refrigerate.
Do not use this medicine if you notice that the solution is not clear, colourless, free from visible particles, or if vacuum is absent.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Acqua per preparazioni iniettabili Eurospital contains

• The active substance is water for injections. 500 ml of solvent contains 500 ml of water for injections.

Description of the appearance of Acqua per preparazioni iniettabili Eurospital and contents of the pack
Solvent for parenteral use in a 500 ml vial.
Marketing Authorization Holder
Eurospital S.p.A., via Flavia, 122 – Trieste.
Manufacturers
Bieffe Medital S.p.A., via Nuova Provinciale snc – 23034 Grosotto (SO)
Laboratorios Grifols S.A. – Pol. Ind. Autopista – Passeig Fluvial 24 – 08150 Parets del Valles –
Barcelona – Spain.