Water for injection Galenica Senese

Package leaflet: Information for the user

ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE solvent for parenteral use

Sterile, pyrogen-free water
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 side effects, including those not listed in this leaflet, consult your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE is and what it is used for
2. What you need to know before using ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE
3. How to use ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE
4. Possible side effects
5. How to store ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE
6. Contents of the pack and other information

1. What ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE is and what it is used for

ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE contains sterile, non-pyrogenic water free from microorganisms, which is used to dissolve, dilute, and carry other medicinal products intended for injection. ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE is indicated for the preparation of injectable medicinal solutions.

2. What you need to know before using GALENICA SENESE WATER FOR INJECTION PREPARATIONS

SENESE
Do not use GALENICA SENESE WATER FOR INJECTION PREPARATIONS
in any condition for which you should not use the medicinal product(s) dissolved, diluted or suspended in
GALENICA SENESE WATER FOR INJECTION PREPARATIONS.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using GALENICA SENESE WATER FOR INJECTION
PREPARATIONS.
Use this medicine immediately after opening the container, after checking that the solution is clear, colourless and free from visible particles. Any unused portion must be discarded.
If you use GALENICA SENESE WATER FOR INJECTION PREPARATIONS continuously, you may develop excessive water accumulation (fluid overload), congestion (congestive state), reduced levels of salts 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 GALENICA SENESE WATER FOR INJECTION PREPARATIONS
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
GALENICA SENESE WATER FOR INJECTION PREPARATIONS can be used to dissolve, dilute and suspend other medicinal products; therefore, inform your doctor if you are taking other medicines, as they may interact with those dissolved, diluted or suspended in GALENICA SENESE WATER FOR INJECTION PREPARATIONS.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant or are planning to become pregnant, or if you are breastfeeding, ask your doctor, pharmacist or nurse for advice before using this medicine.
Inform your doctor if you are pregnant or breastfeeding, because GALENICA SENESE WATER FOR INJECTION PREPARATIONS may be used to dissolve, dilute and suspend various medicinal products, and the use of these medicines may be contraindicated during pregnancy and breastfeeding.
Driving and using machines
GALENICA SENESE WATER FOR INJECTION PREPARATIONS does not affect the ability to drive or operate machinery. However, symptoms due to other medicinal products dissolved, diluted or suspended in GALENICA SENESE WATER FOR INJECTION PREPARATIONS may occur. If this happens to you, avoid driving or operating machinery.

3. How to use ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE

Use this medicine exactly as stated in this leaflet or according to the instructions given 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 injectable medicines or other sterile preparations.
Choose the correct volume of ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE to use, depending on the type of injectable preparation and on the compatibility with the medicine(s) to be dissolved and/or diluted.
If you use more ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE than you should
ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE may be used to dissolve, dilute, and carry other medicines; therefore, in case of overdose, symptoms of overdose related to these medicines may occur.
If you have any doubts about the use of 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.
The following side effects may occur:

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

These effects may occur if you continuously use ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE.
ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE may be used to dissolve, dilute, and administer other medicinal products; therefore, side effects may also occur due to the use of these medicinal products.

Reporting of side effects
If you experience any side effect, 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 GALENICA SENESE

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.
The expiry date applies to the medicine stored in its original intact packaging, correctly stored.
If you do not mix ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE with other medicines, no special storage conditions are required for the ampoules and vials.
Bags must be stored at a temperature not exceeding 30 °C in a tightly closed container.
If you mix ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE 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 no longer in use. This will help protect the environment.

6. Package contents and other information

What ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE contains
ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE, solvent for parenteral use, contains sterile water free from microorganisms (apyrogenic). 1 ml of solution contains 1 ml of sterile, apyrogenic water.

Description of the appearance of ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE and package contents
ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE is a clear, colourless solution, free from visible particles and without antimicrobial or other substances.

It is available in:

• Packaging containing 1 glass vial of 1, 2, 3, 5, 10 or 20 ml;
• Packaging containing 5 glass vials of 1, 2, 3, 5 or 10 ml;
• Packaging containing 10 glass vials of 1, 2, 3, 5, 10 or 20 ml;
• Packaging containing 1 glass bottle of 50 ml;
• Packaging containing 1 plastic bag of 50 ml.

Marketing Authorization Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l., Via Cassia Nord 351 – 53014 Monteroni d’Arbia (Siena)

Package leaflet: Information for the user

WATER FOR INJECTION PREPARATIONS GALENICA SENESE solvent for parenteral use

Sterile pyrogen-free water
Please read this leaflet carefully before using this medicine as 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.

Contents of this leaflet:

1. What ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE is and what it is used for
2. What you need to know before using ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE
3. How to use ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE
4. Possible side effects
5. How to store ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE
6. Package contents and other information

1. What ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE is and what it is used for

ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE 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 GALENICA SENESE is indicated for the preparation of injectable medicinal solutions.

2. What you need to know before using INJECTABLE PREPARATIONS WATER GALENICA SENESE

SENESE
Do not use INJECTABLE PREPARATIONS WATER GALENICA SENESE

• in all conditions for which you should not use the medicine(s) dissolved, diluted or suspended in INJECTABLE PREPARATIONS WATER GALENICA SENESE

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using INJECTABLE PREPARATIONS WATER GALENICA SENESE.
Use this medicine immediately after opening the container, after ensuring that the solution is clear, colourless and free from visible particles. Any unused residue must be discarded.
If you continuously use INJECTABLE PREPARATIONS WATER GALENICA SENESE, you may experience excessive water accumulation (fluid overload), congestion (congestive state), reduced levels of salts in the blood, and, if you do not add potassium to the solution, decreased potassium levels in the blood (hypokalaemia) (See section: “4. Possible side effects”).

Other medicines and INJECTABLE PREPARATIONS WATER GALENICA SENESE
Tell your doctor, pharmacist or nurse if you are taking, have recently taken, or might take any other medicines.
INJECTABLE PREPARATIONS WATER GALENICA SENESE can be 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 INJECTABLE PREPARATIONS WATER GALENICA SENESE.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, please consult your doctor, pharmacist or nurse before using this medicine.
Inform your doctor if you are pregnant or breastfeeding, because INJECTABLE PREPARATIONS WATER GALENICA SENESE may be used to dissolve, dilute and suspend various medicines, and the use of these medicines may be contraindicated during pregnancy and breastfeeding.

Driving and using machines
INJECTABLE PREPARATIONS WATER GALENICA SENESE does not affect the ability to drive or operate machinery. However, symptoms related to other medicines dissolved, diluted or suspended in INJECTABLE PREPARATIONS WATER GALENICA SENESE may occur. If this happens, avoid driving or operating machinery.

3. How to use ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE

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 other medicines intended for injection or other sterile preparations.
Choose the correct volume of ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE to use, depending on the type of preparation to be injected and on its compatibility with the medicine(s) to be dissolved and/or diluted.
If you use more ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE than you should
ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE may be used to dissolve, dilute, and deliver other medicinal products; therefore, in case of overdose, symptoms of overdose related to these medicinal products may occur.
If you have any doubts about the use of this medicine, consult your doctor, pharmacist, or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
The following adverse reactions may occur:

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

These effects may occur if you continuously use ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE.
ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE can be used to dissolve, dilute, and administer other medicinal products; therefore, adverse reactions may occur due to the use of these medicinal products.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor or pharmacist. You may also report adverse reactions directly via the Italian Medicines Agency - Website: http://www.agenziafarmaco.gov.it/it/responsabili. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE

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.
The expiry date applies to the medicine in its original, unopened packaging, correctly stored.
If you do not mix ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE with other medicines,
no special storage conditions are required for the vials. The bags must be stored at a temperature not exceeding 30 °C in a tightly closed container.
If you mix ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE 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 GALENICA SENESE contains
ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE, solvent for parenteral use, contains sterile water free from microorganisms (apyrogenic). 1 ml of solution contains 1 ml of sterile, apyrogenic water.

Description of the appearance of ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE and package contents
ACQUA PER PREPARAZIONI INIETTABILI GALENICA SENESE is a clear, colourless solution without visible particles and without antimicrobial or other substances.

It is available in:

• 1 glass vial of 100 ml, 250 ml, 500 ml or 1000 ml;
• pack of 1 or 20 polypropylene vials of 500 ml;
• 1 plastic bag of 100 ml, 250 ml, 500 ml or 1000 ml.

Marketing Authorization Holder and Manufacturer
Industria Galenica Senese S.r.l. Via Cassia Nord 351 – 53014 Monteroni d’Arbia (Siena)