WATER FOR INJECTIONS DIACO

Package leaflet: Information for the user

Water for Injections DIACO 50 ml solvent for parenteral use, 100 ml solvent for parenteral use, 250 ml solvent for parenteral use, 500 ml solvent for parenteral use, 1000 ml solvent for parenteral use

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 you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.
• Contact your doctor if you do not notice any improvement or if you experience worsening of symptoms.

Contents of this leaflet:

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

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

Acqua per preparazioni iniettabili DIACO contains sterile water free from microbial contamination. It belongs to the category of solvents and diluents and is indicated for the preparation of injectable medicinal solutions.

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

Do not use DIACO Water for Injections

• in any condition for which you must not use the medicine(s) dissolved, diluted or carried in DIACO Water for Injections

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using DIACO Water for Injections.
Use this medicine immediately after opening the container.
The solution must be clear, colourless and free from visible particles.
Any unused residue must not be reused.
Continuous administration may cause excessive water accumulation (fluid overload), congestion and reduced concentration of salts in the blood; continuous administration without addition of potassium may cause hypokalaemia (decrease in potassium concentration in the blood).

Other medicines and DIACO Water for Injections
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
DIACO Water for Injections is used to dissolve, dilute and carry other medicines; therefore, inform your doctor if you are taking other medicines, as they may interact with the medicines dissolved, diluted or carried in DIACO Water for Injections.
Please consult the package leaflet of the medicines to be dissolved or diluted in DIACO Water for Injections for information on possible interactions.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using this medicine.
DIACO Water for Injections is used to dissolve, dilute and carry various medicines; therefore, consult the package leaflet of those medicines for information on use during pregnancy and breastfeeding.

Driving and using machines
DIACO Water for Injections is used to dissolve, dilute and carry various medicines; therefore, you may experience symptoms caused by these medicines. If this occurs, avoid driving or operating machinery.

3. How to use Acqua per preparazioni iniettabili DIACO

Use this medicine exactly as stated in this leaflet or as directed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
Use Acqua per preparazioni iniettabili DIACO for preparing solutions, dilutions, or suspensions of injectable medicines or other sterile preparations.
Select the volume to use based on the type of dilution required for the injectable preparation.
Refer to the package leaflet of the medicines that will be dissolved or diluted in Acqua per preparazioni iniettabili DIACO for all necessary information.
If you use more Acqua per preparazioni iniettabili DIACO than you should
Acqua per preparazioni iniettabili DIACO may be used to dissolve, dilute, and administer other medicines; therefore, in case of an overdose, symptoms of overdose related to these medicines may occur.
Refer to the package leaflet of the medicines that will be dissolved or diluted in Acqua per preparazioni iniettabili DIACO for information on overdose.
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 gets them.
If you use Acqua per preparazioni iniettabili DIACO continuously, the following side effects may occur:

• excessive accumulation of water in the body (fluid overload);
• congestion;
• reduction in levels of salts (electrolytes) in the body.

Acqua per preparazioni iniettabili DIACO can be used to dissolve, dilute and carry other medicines; therefore, side effects may occur due to the use of these medicines.
Please consult the package leaflet of the medicines that will be dissolved or diluted in Acqua per preparazioni iniettabili DIACO for information on their 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 may also report side effects directly via the national reporting system at the website
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 Acqua per preparazioni iniettabili DIACO

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 “Scad.”.
The expiry date refers to the product in its original unopened packaging, properly stored.
The expiry date refers to the last day of that month.
Do not use this medicine if you notice that the solution is not clear and colourless, or if you notice the presence of particles.
Acqua per preparazioni iniettabili DIACO does not require any special storage conditions.
If you mix Acqua per preparazioni iniettabili DIACO with other medicines, consult the package leaflet of those medicines for storage instructions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

Water for Injections DIACO solvent for parenteral use contains sterile,
apyrogenic water for injectable preparations.
1 ml of solvent contains 1 ml of water for injections.
Description of the appearance of Water for Injections DIACO and contents of the
package
Water for Injections DIACO is a clear, colourless solution free from visible particles.
It is available in packages containing 1 glass bottle of 50 ml, 100 ml, 250 ml, 500 ml, 1000 ml.
Not all pack sizes may be marketed.
Marketing Authorization Holder
Diaco Biofarmaceutici S.r.l.
Via Flavia 124 – 34147 Trieste.
Manufacturers
S.M. FARMACEUTICI
Via Flavia 124 – 34147 – Trieste (Italy)