ACQUA 500 ML Roztwór parenteralny

Treść ulotki

1. WATER FOR INJECTABLE PREPARATIONS B. BRAUN solvent for parenteral use
   1. What is ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN and what is it for?
   2. What you need to know before using ACQUA PER PREPARAZIONI INIETTABILI
2. ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN does not alter the ability to drive vehicles or
   1. How to use ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN
   2. Possible side effects
   3. How to store ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN
   4. Contents of the pack and other information
3. ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN solvent for parenteral use
4. WATER FOR INJECTABLE PREPARATIONS B. BRAUN solvent for parenteral use
   1. What is ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN and what is it for?
   2. What you need to know before you use ACQUA PER PREPARAZIONI INIETTABILI
5. WATER FOR INJECTABLE PREPARATIONS B. BRAUN does not alter the ability to drive vehicles or
   1. How to use WATER FOR INJECTABLE PREPARATIONS B. BRAUN
   2. Possible side effects
   3. How to store ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN
   4. Contents of the pack and other information
6. ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN solvent for parenteral use

WATER FOR INJECTABLE PREPARATIONS B. BRAUN solvent for parenteral use

Sterile apyrogenic water

Read this leaflet carefully before using this medicine as it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if they have the same symptoms as you, as it may be harmful
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4. Contents of this leaflet:
• 1. What is WATER FOR INJECTABLE PREPARATIONS B. BRAUN and what it is used for
• 2. What you need to know before using WATER FOR INJECTABLE PREPARATIONS B. BRAUN
• 3. How to use WATER FOR INJECTABLE PREPARATIONS B. BRAUN
• 4. Possible side effects
• 5. How to store WATER FOR INJECTABLE PREPARATIONS B. BRAUN
• 6. Contents of the pack and other information

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

Purpose
ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN contains sterile water that is not contaminated by microorganisms (apyrogenic), which is used to dissolve, dilute and deliver other medicines to be administered by injection. ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN is indicated for the preparation of solutions of medicines to be injected.

2. What you need to know before using ACQUA PER PREPARAZIONI INIETTABILI

• B. BRAUNDo not use ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN
• in all those conditions for which you should not use the dissolved, diluted or delivered medicine(s) in ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN Warnings and precautionsConsult your doctor, pharmacist or nurse before using ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN. Use this medicine immediately after opening the container, after ensuring that the solution is clear, colorless and free of visible particles and in a single use, eliminating any residue. If you use ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN continuously, you may experience excessive water accumulation (fluid overload), congestion (congestive state), reduction of salt levels in the blood and, if you do not add potassium to the solution, a decrease in potassium levels in the blood (hypokalemia) (See section: “4. Possible side effects”). Other medicines and ACQUA PER PREPARAZIONI INIETTABILI B. BRAUNInform your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicine. ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN can be used to dissolve, dilute and deliver other medicines, so inform your doctor if you are taking other medicines because they may interact with those dissolved, diluted or delivered in ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN Pregnancy and breastfeedingIf you are pregnant, suspect you are pregnant or are planning a pregnancy, 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 ACQUA PER
PREPARAZIONI INIETTABILI B. BRAUN can be used to dissolve, dilute and deliver various
medicines and the use of these medicines may be contraindicated in pregnancy and during
breastfeeding.

Driving and operating machinery

ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN does not alter the ability to drive vehicles or

operate machinery. However, symptoms may occur due to other medications
dissolved, diluted or conveyed in ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN If this happens to you,
avoid driving vehicles or operating machinery.

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

Use this medicine following exactly as stated in this leaflet or the instructions
of the doctor, pharmacist or nurse. If you have doubts, consult the doctor, pharmacist or
nurse.
Use this medicine to dilute or suspend in solution medications for injection or other sterile
preparations.
Choose the correct volume of ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN to be used based on the
type of preparation to be injected and compatibility with the medication(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 can be used to dissolve, dilute and
convey other medications for which, in case of an excessive dose, symptoms of an overdose may occur due to the presence of these medications.
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 gets them.
The following side effects may occur:

• excessive accumulation of body water (fluid overload);
• congestion (congestive state);
• reduction of body salt levels (electrolytes). These effects may occur if you use ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN continuously. ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN can be used to dissolve, dilute and deliver other medicines, therefore side effects due to the use of these medicines may occur. Reporting of side effectsIf you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting of side effects helps to 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 which is stated on the packaging after “Exp.”.
The expiry date refers to the last day of that month.
The expiry date refers to the medicine in unopened packaging, correctly stored.
Store this medicine in tightly closed containers.
If you mix ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN with other medicines, you should
consider the storage conditions of these medicines.
Do not dispose of any medicine in 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 ingredient is sterile, apyrogenic water. 1000 ml of solution contains 1000 ml of sterile, apyrogenic water. Description of the appearance of ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN andpack contentsACQUA PER PREPARAZIONI INIETTABILI B. BRAUN is presented as a clear, colorless solution, free from visible particles and other antimicrobial or other substances. It is available in:
• pack of 1 vial containing 100 ml, 250 ml, 500 ml or 1000 ml;
• pack of 20 vials containing 100 ml or 250 ml;
• pack of 10 vials containing 500 ml or 1000 ml;
• pack of 1 bag containing 1000 ml, 2000 ml, 3000 ml or 5000 ml. Marketing Authorisation 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.

WATER FOR INJECTABLE PREPARATIONS B. BRAUN solvent for parenteral use

Sterile apyrogenic water

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 told you to do.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What is WATER FOR INJECTABLE PREPARATIONS B. BRAUN and what it is used for
• 2. What you need to know before using WATER FOR INJECTABLE PREPARATIONS B. BRAUN
• 3. How to use WATER FOR INJECTABLE PREPARATIONS B. BRAUN
• 4. Possible side effects
• 5. How to store WATER FOR INJECTABLE PREPARATIONS B. BRAUN
• 6. Contents of the pack and other information

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

Purpose
ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN contains sterile water that is not contaminated by microorganisms (apyrogenic), which is used to dissolve, dilute and deliver other medicinal products for injection. ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN is indicated for the preparation of solutions of medicinal products to be injected.

2. What you need to know before you use ACQUA PER PREPARAZIONI INIETTABILI

• B. BRAUNDo not use ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN
• in all those conditions for which you should not use the dissolved, diluted or delivered medicinal product(s) in ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN Warnings and precautionsConsult your doctor, pharmacist or nurse before using ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN. Use this medicinal product immediately after opening the container, after ensuring that the solution is clear, colorless and free of visible particles and in a single use, eliminating any residue. If you use ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN continuously, you may experience excessive water retention (fluid overload), congestion (congestive state), reduced blood salt levels and, if you do not add potassium to the solution, a decrease in blood potassium levels (hypokalemia) (See section: “4. Possible side effects”). Other medicines and ACQUA PER PREPARAZIONI INIETTABILI B. BRAUNInform your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicine. ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN can be used to dissolve, dilute and deliver other medicines, so inform your doctor if you are taking other medicines because they may interact with those dissolved, diluted or delivered in ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN. Pregnancy and breastfeedingIf you are pregnant, suspect you are pregnant or are planning a pregnancy, 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 ACQUA PER
PREPARAZIONI INIETTABILI B. BRAUN can be used to dissolve, dilute and deliver various
medicines and the use of these medicines may be contraindicated in pregnancy and during
breastfeeding.

Driving and operating machinery

WATER FOR INJECTABLE PREPARATIONS B. BRAUN does not alter the ability to drive vehicles or

operate machinery. However, symptoms may occur due to other medications
dissolved, diluted or conveyed in WATER FOR INJECTABLE PREPARATIONS B. BRAUN If this happens to you,
avoid driving vehicles or operating machinery.

3. How to use WATER FOR INJECTABLE PREPARATIONS B. BRAUN

Use this medicine following exactly as stated in this leaflet or the instructions
of the doctor, pharmacist or nurse. If you have doubts, consult the doctor, pharmacist or
nurse.
Use this medicine to dilute or suspend in solution medications to be injected or other sterile
preparations.
Choose the correct volume of WATER FOR INJECTABLE PREPARATIONS B.BRAUN to be used in
based on the type of preparation to be injected and compatibility with the/with the medication/s to be dissolved and/or
diluted.

If you use more WATER FOR INJECTABLE PREPARATIONS B. BRAUN than you should
WATER FOR INJECTABLE PREPARATIONS B. BRAUN can be used to dissolve, dilute and
convey other medications for which, in case of an excessive dose, symptoms of an overdose may occur due to the presence of these medications.
If you have any doubts about the use of this medicine, consult the 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 of salt (electrolyte) levels in the body. These effects may occur if you use ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN continuously. ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN can be used to dissolve, dilute and deliver other medicines, therefore side effects due to the use of these medicines may occur. Reporting of side effectsIf you get any side effect, even if not listed in this leaflet, tell your doctor or pharmacist. Side effects can also be reported directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili. Reporting of side effects helps to provide more information on the safety of this medicine.

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

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after “Scad.”. The
expiry date refers to the last day of that month.
The expiry date refers to the medicine in intact 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 conditions of these medicines.
Do not dispose of any medicine in 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 ingredient is sterile, apyrogenic water. 1 ml of solution contains 1 ml of sterile and apyrogenic water. Description of the appearance of ACQUA PER PREPARAZIONI INIETTABILI B. BRAUN andpack contentsACQUA PER PREPARAZIONI INIETTABILI B. BRAUN is presented as a clear, colorless solution, free from visible particles and other antimicrobial or other substances. It is available in:
• pack of 1 vial containing 5, 10 or 20 ml;
• pack of 20 vials containing 5, 10 or 20 ml;
• pack of 100 vials in PP containing 10 or 20 ml.

Marketing authorisation holder

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