WATER FOR INJECTIONS S.A.L.F.

Package leaflet: Information for the user

WATER FOR INJECTION S.A.L.F. solvent for parenteral use

Equivalent medicine
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• 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 of the side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What WATER FOR INJECTION S.A.L.F. is and what it is used for
2. What you need to know before using WATER FOR INJECTION S.A.L.F.
3. How to use WATER FOR INJECTION S.A.L.F.
4. Possible side effects
5. How to store WATER FOR INJECTION S.A.L.F.
6. Contents of the pack and other information

1. What ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. is and what it is used for

ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. contains sterile, non-contaminated water free from microorganisms (apyrogenic), which is used to dissolve, dilute, and carry other medicinal products intended for injection.
ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. is indicated for the preparation of injectable medicinal solutions.

2. What you need to know before using ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F.

Do not use ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F.

• in all conditions for which you should not use the medicine(s) dissolved, diluted, or suspended in ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F.

Refer to the package leaflet of the medicines that will be dissolved or diluted in ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. for information on contraindications.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F.
Use this medicine immediately after opening the container, after ensuring that the solution is clear, colourless, and free from visible particles, and use it only once, discarding any remaining solution.
If you continuously use ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F., you may develop excessive water accumulation (fluid overload), congestion (congestive state), reduced levels of electrolytes in the blood, and, if potassium is not added to the solution, decreased potassium levels in the blood (hypokalaemia) (See section: “4. Possible side effects”).
Other medicines and ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. is used to dissolve, dilute, and suspend other medicines; therefore, inform your doctor if you are taking other medicines, as they may interact with those dissolved, diluted, or suspended in ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F.
Consult the package leaflet of the medicines that will be dissolved or diluted in ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. for information on possible interactions.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor, pharmacist, or nurse for advice before using this medicine.
Inform your doctor if you are pregnant or breastfeeding, since ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. is used to dissolve, dilute, and suspend various medicines, and the use of these medicines may be contraindicated during pregnancy and breastfeeding.
Consult the package leaflet of the medicines that will be dissolved or diluted in ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. for information on use during pregnancy and breastfeeding.
Driving and using machines
ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. does not affect the ability to drive or operate machinery. However, symptoms may occur due to other medicines dissolved, diluted, or suspended in ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. If this happens, avoid driving or operating machinery.

3. How to use ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F.

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 this medicine to dilute or suspend in solution medicinal products intended for injection or other sterile preparations.
Select the volume of ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. to be used according to the type of preparation to be injected and its compatibility with the medicinal product(s) to be dissolved and/or diluted.
Refer to the package leaflet of the medicinal product(s) to be dissolved or diluted in ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. for information on the volume to be used.
If you use more ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. than you should
ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. may be used to dissolve, dilute, and deliver other medicinal products; therefore, in case of excessive intake, symptoms of overdose may occur due to the presence of these medicinal products.
Refer to the package leaflet of the medicinal product(s) to be dissolved or diluted in ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. 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.
The following side effects may occur:

• excessive accumulation of water in the body (fluid overload);
• congestion (congestive state);
• reduction in body levels of salts (electrolytes). These effects may occur if ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. is used continuously.

ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. can be used to dissolve, dilute, and administer other medicinal products; therefore, side effects related to the use of these medicinal products may occur.
Please consult the package leaflet of the medicinal products that will be dissolved or diluted in ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. for information on their side effects.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly through 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 ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F.

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 last day of that month.
Do not use this medicine if you notice that the solution is not clear and colourless, or if you see particles present.
If you do not mix ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. with other medicines, no special storage conditions are required.
If you mix ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. with other medicines, you must consider the storage requirements of those medicines.
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. Package contents and other information

What ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. contains
ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. solvent for parenteral use

• The active substance is sterile, pyrogen-free water. 1 ml of solution contains 1 ml of sterile, pyrogen-free water.

Description of the appearance of ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. and contents of the
package
ACQUA PER PREPARAZIONI INIETTABILI S.A.L.F. is a clear, colourless solution free from visible particles.
It is available in the following pack sizes:

• 1 vial of 50 ml, 100 ml, 250 ml, 500 ml or 1000 ml;
• 1 bag of 100 ml, 250 ml, 500 ml, 1000 ml, 2000 ml, 3000 ml, 4000 ml or 5000 ml;
• 20 bags of 100 ml;
• 20 bags of 250 ml;
• 15 bags of 500 ml;
• 10 bags of 1000 ml;
• 1 ampoule of 2 ml, 5 ml, 10 ml or 20 ml;
• 50 ampoules of 20 ml;
• 5 ampoules of 5 ml or 10 ml.

Marketing Authorisation Holder and Manufacturer
S.A.L.F. S.p.A. LABORATORIO FARMACOLOGICO
Via Marconi, 2
24069, Cenate Sotto (BG)
Italy