WATER FOR INJECTION PREPARATIONS B. BRAUN

Package leaflet: Information for the user

ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN solvent for parenteral use

Sterile, pyrogen-free water
Please read this leaflet carefully before using this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• 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 B. BRAUN is and what it is used for
  2. What you need to know before using ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN
  3. How to use ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN
  4. Possible side effects
  5. How to store ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN
  6. Contents of the pack and other information

1. What ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN is and what it is used for

ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN contains sterile, non-pyrogenic water that is free from microbial contamination. It is used to dissolve, dilute, and carry other medicinal products intended for injection. ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN is indicated for the preparation of injectable medicinal solutions.

2. What you should know before using INJECTABLE PREPARATION WATER

B. BRAUN
Do not use INJECTABLE PREPARATION WATER B. BRAUN

• under any conditions where you are advised not to use the medication dissolved, diluted, or carried in INJECTABLE PREPARATION WATER B. BRAUN

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using INJECTABLE PREPARATION WATER B. BRAUN.
Use this medicinal product immediately after opening the container, after ensuring that the solution is clear, colourless, and free from visible particles, and use it in a single administration, discarding any remaining residue.
If you continuously use INJECTABLE PREPARATION WATER B. BRAUN, you may experience 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 INJECTABLE PREPARATION WATER B. BRAUN
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicines.
INJECTABLE PREPARATION WATER B. BRAUN may be used to dissolve, dilute, and carry other medicinal products; therefore, inform your doctor if you are taking other medicines, as they may interact with those dissolved, diluted, or carried in INJECTABLE PREPARATION WATER B. BRAUN.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before using this medicinal product.

Inform your doctor if you are pregnant or breastfeeding, because INJECTABLE PREPARATION WATER B. BRAUN may be used to dissolve, dilute, and carry various medicinal products, and the use of these medicinal products may be contraindicated during pregnancy and breastfeeding.

Driving and using machines
INJECTABLE PREPARATION WATER B. BRAUN does not affect the ability to drive or operate machinery. However, symptoms due to other medicinal products dissolved, diluted, or carried in INJECTABLE PREPARATION WATER B. BRAUN may occur. If this happens to you, avoid driving or operating machinery.

3. How to use ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN

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 injectable medicines or other sterile preparations.
Select the appropriate volume of ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN to use based on the type of injectable preparation and compatibility with the medicine(s) to be dissolved and/or diluted.
If you use more ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN than you should
ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN may be used to dissolve, dilute, and administer other medicines; therefore, in case of an excessive dose, symptoms of overdose due to these concomitant medicines may occur.
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 you continuously use WATER FOR INJECTION B. BRAUN. WATER FOR INJECTION B. BRAUN may be used to dissolve, dilute, and administer other medicines; therefore, side effects related to the use of these medicines may also occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or pharmacist. Side effects can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store WATER FOR INJECTION B. BRAUN

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, undamaged packaging, correctly stored.
Store this medicine in tightly closed containers.
If you mix WATER FOR INJECTION B. BRAUN with other medicines, you must consider the storage conditions of those medicines.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN contains
ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN solvent for parenteral use

• The active substance is sterile, pyrogen-free water. 1000 ml of solution contain 1000 ml of sterile, pyrogen-free water.
  Description of the appearance of ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN and pack contents
  ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN is a clear, colourless solution free from visible particles and without antimicrobial or other added substances. It is available in the following pack sizes:
• 1 bottle of 100 ml, 250 ml, 500 ml or 1000 ml;
• 20 bottles of 100 ml or 250 ml;
• 10 bottles of 500 ml or 1000 ml;
• 1 bag of 1000 ml, 2000 ml, 3000 ml or 5000 ml.
  Marketing Authorization Holder
  B. Braun Melsungen AG, Carl Braun Strasse 1, D-34212 Melsungen (Germany).
  Manufacturer
  B. Braun Medical SA, Carretera de Terrassa 121, 08191 Rubi (Barcelona), Spain.
  B. Braun Melsungen AG, Carl-Braun-Strasse 1, D-34212 Melsungen, Germany.

Package leaflet: information for the user

WATER FOR INJECTION B. BRAUN solvent for parenteral use

Sterile, pyrogen-free water
Please read 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 further information or advice, consult your pharmacist.
• If you experience any of the side effects listed in this leaflet, or any others not mentioned, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN is and what it is used for

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

2. What you need to know before using WATER FOR INJECTION B. BRAUN

B. BRAUN
Do not use WATER FOR INJECTION B. BRAUN

• in any condition where the medicinal product dissolved, diluted or carried in WATER FOR INJECTION B. BRAUN must not be used.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using WATER FOR INJECTION B. BRAUN.
Use this medicine immediately after opening the container, after ensuring that the solution is clear, colourless and free from visible particles, and use it in a single administration, discarding any residue.
If you continuously use WATER FOR INJECTION B. BRAUN, you may experience excessive accumulation of water (water 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 WATER FOR INJECTION B. BRAUN
Inform your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicine.
WATER FOR INJECTION B. BRAUN may be used to dissolve, dilute and carry other medicinal products; therefore, inform your doctor if you are taking other medicines, as they may interact with those dissolved, diluted or carried in WATER FOR INJECTION B. BRAUN.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, ask your doctor, pharmacist or nurse for advice before using this medicine.

Inform your doctor if you are pregnant or breastfeeding, because WATER FOR INJECTION B. BRAUN may be used to dissolve, dilute and carry various medicinal products, and the use of these medicines may be contraindicated during pregnancy and breastfeeding.

Driving and using machines
WATER FOR INJECTION B. BRAUN does not affect the ability to drive or operate machinery. However, symptoms may occur due to other medicinal products dissolved, diluted or carried in WATER FOR INJECTION B. BRAUN. If this happens to you, avoid driving or operating machinery.

3. How to use ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN

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 appropriate volume of ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN to use, based on the type of injectable preparation and compatibility with the medicinal product(s) to be dissolved and/or diluted.
If you use more ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN than you should
ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN may be used to dissolve, dilute, and deliver other medicinal products; therefore, in case of overdose, symptoms related to an overdose of these medicinal products may occur.
If you have any doubts about how to use 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 B. BRAUN. ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN may be used to dissolve, dilute, and administer other medicines; therefore, adverse reactions related to the use of these medicines may also occur.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor or pharmacist. Adverse reactions can also be reported directly via the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN

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, undamaged packaging, correctly stored.
If you do not mix ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN with other medicines, no special storage conditions are required.
If you mix ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN 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. Contents of the pack and other information

What ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN contains
ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN 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 B. BRAUN and contents of the pack
  ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN is a clear, colourless solution free from visible particles and without antimicrobial or other substances. It is available in:
• pack of 1 vial of 5, 10 or 20 ml;
• pack of 20 vials of 5, 10 or 20 ml;
• pack of 100 polypropylene (PP) vials of 10 or 20 ml.

Marketing Authorization Holder
B. Braun Melsungen AG, Carl Braun Strasse 1, D-34212 Melsungen (Germany).
Manufacturer
B. Braun Melsungen AG, Mistelweg 2, D-12357 Berlin (Germany).