Water for preparations for injection Bioindustria L.I.M.
Italy
Table of Contents
Patient Information Leaflet: Information for the User
ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. solvent for injection
Sterile pyrogen-free water for parenteral use
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 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:
- What ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. is and what it is used for
- What you need to know before using ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M.
- How to use ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M.
- Possible side effects
- How to store ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M.
- Contents of the pack and other information
1. What ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. is and what it is used for
ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. contains sterile water, free from microbial contamination (apyrogenic), which is used to dissolve, dilute, and carry other medicinal products intended for injection. ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. is indicated for the preparation of injectable medicinal solutions.
2. What you need to know before using INJECTABLE PREPARATIONS WATER Bioindustria
L.I.M.
Do not use INJECTABLE PREPARATIONS WATER Bioindustria L.I.M.
- in all conditions for which you must not use the medicinal product dissolved, diluted or carried in INJECTABLE PREPARATIONS WATER Bioindustria L.I.M.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using INJECTABLE PREPARATIONS WATER Bioindustria L.I.M.
Use this medicine immediately after opening the container, after ensuring that the solution is clear, colourless and free from visible particles, and in a single administration, discarding any unused portion.
If you continuously use INJECTABLE PREPARATIONS WATER Bioindustria L.I.M., you may develop 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 Bioindustria L.I.M.
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
INJECTABLE PREPARATIONS WATER Bioindustria L.I.M. can 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 PREPARATIONS WATER Bioindustria L.I.M.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist or nurse before using this medicine.
Inform your doctor if you are pregnant or breastfeeding, because INJECTABLE PREPARATIONS WATER Bioindustria L.I.M. 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 PREPARATIONS WATER Bioindustria L.I.M. does not affect the ability to drive or operate machinery. However, symptoms due to other medicinal products dissolved, diluted or carried in INJECTABLE PREPARATIONS WATER Bioindustria L.I.M. may occur. If this happens, avoid driving or operating machinery.
3. How to use ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M.
Use this medicinal product 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 medicinal product to dissolve, dilute, or suspend in solution injectable medicines or other
sterile preparations.
Choose the appropriate volume of ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. to use,
depending on the type of preparation to be injected and its compatibility with the medicine(s) to be dissolved and/or diluted.
If you use more ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. than you should
ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. may be used to dissolve, dilute, and
deliver other medicinal products; therefore, in case of excessive intake, symptoms of overdose due to
the presence of these medicinal products may occur.
If you have any doubts about the use of this medicinal product, 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 levels of salts (electrolytes) in the body.
These effects may occur if you continuously use ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. can be used to dissolve, dilute, and administer other medicines; therefore, side effects may arise due to the use of these medicines.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website: http://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 Bioindustria L.I.M.
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 "Expiry".
The expiry date refers to the last day of that month.
The expiry date applies to the medicine kept in its original intact packaging and stored correctly.
If you do not mix ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. with other medicines, no special storage conditions are required.
If you mix ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. 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 Bioindustria L.I.M. contains
ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. 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 Bioindustria L.I.M. and package contents
ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. is a clear, colourless solution without visible particles and without antimicrobial or other substances.
It is available in:
- package of 10 vials of 1, 2, 5 or 10 ml;
- package of 5 vials of 20 ml.
Marketing Authorization Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A.
Via de Ambrosiis 2
15067, Novi Ligure (AL)
Italy.
Package leaflet: information for the user
WATER FOR INJECTION Bioindustria L.I.M. 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 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:
- What ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. is and what it is used for
- What you need to know before using ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M.
- How to use ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M.
- Possible side effects
- How to store ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M.
- Contents of the pack and other information
1. What ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. is and what it is used for
ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. contains sterile, non-pyrogenic water, free from microbial contamination, which is used to dissolve, dilute, and carry other medicinal products intended for injection. ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. is indicated for the preparation of injectable medicinal solutions.
2. What you need to know before using INJECTABLE PREPARATIONS WATER Bioindustria
L.I.M.
Do not use INJECTABLE PREPARATIONS WATER Bioindustria L.I.M.
- in any condition where the medicinal product dissolved, diluted or carried in INJECTABLE PREPARATIONS WATER Bioindustria L.I.M. must not be used.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using INJECTABLE PREPARATIONS WATER Bioindustria L.I.M.
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 INJECTABLE PREPARATIONS WATER Bioindustria L.I.M., 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 PREPARATIONS WATER Bioindustria L.I.M.
Inform your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
INJECTABLE PREPARATIONS WATER Bioindustria L.I.M. can 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 PREPARATIONS WATER Bioindustria L.I.M.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor, pharmacist or nurse before using this medicine.
Inform your doctor if you are pregnant or breastfeeding, because INJECTABLE PREPARATIONS WATER Bioindustria L.I.M. 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
INJECTABLE PREPARATIONS WATER Bioindustria L.I.M. does not affect the ability to drive or operate machinery. However, symptoms may occur due to other medicinal products dissolved, diluted or carried in INJECTABLE PREPARATIONS WATER Bioindustria L.I.M. If this happens to you, avoid driving or operating machinery.
3. How to use ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M.
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 dissolve, dilute, or suspend injectable medicines or other sterile preparations.
Select the appropriate volume of ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. to use,
depending on the type of preparation to be injected and its compatibility with the medicine(s) to be dissolved and/or diluted.
If you use more ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. than you should
ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. may be used to dissolve, dilute, and
deliver other medicines; therefore, in case of overdose, symptoms of toxicity may occur due to the presence of these medicines.
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 levels of salts (electrolytes) in the body.
These effects may occur if you continuously use ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M.
ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. can be used to dissolve, dilute, and administer other medicinal products; therefore, side effects may 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 the following website: http://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 Bioindustria L.I.M.
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 Bioindustria L.I.M. with other medicines, no special storage conditions are required.
If you mix ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. 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 Bioindustria L.I.M. contains
ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. 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 Bioindustria L.I.M. and
packaging contents
ACQUA PER PREPARAZIONI INIETTABILI Bioindustria L.I.M. 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 vial containing 50, 100, 250 or 500 ml;
- 1 vial of 100 ml containing 50 ml of water for injectable preparations;
- 1 vial of 250 ml containing 100 ml of water for injectable preparations;
- 1 vial of 500 ml containing 250 ml of water for injectable preparations.
Marketing Authorisation Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A.
Via de Ambrosiis 2, 15067
Novi Ligure (AL)
Italy.
The 500 ml presentation may also be manufactured and controlled by:
BIEFFE MEDITAL S.p.A.
Via Provinciale
Grosotto (SO)
Italy.