Water for injection preparations Baxter
Italy
Table of Contents
Package leaflet: Information for the user
BAXTER WATER FOR INJECTION solvent for parenteral use
Sterile pyrogen-free water
Generic Medicine
Please read all of this leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any questions, ask your doctor, pharmacist, or nurse.
- This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as yours, as it may be harmful.
- If you experience any adverse reaction, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.
Contents of this leaflet:
- What ACQUA PER PREPARAZIONI INIETTABILI BAXTER is and what it is used for
- What you need to know before using ACQUA PER PREPARAZIONI INIETTABILI BAXTER
- How to use ACQUA PER PREPARAZIONI INIETTABILI BAXTER
- Possible side effects
- How to store ACQUA PER PREPARAZIONI INIETTABILI BAXTER
- Contents of the pack and other information
1. What ACQUA PER PREPARAZIONI INIETTABILI BAXTER is and what it is used for
ACQUA PER PREPARAZIONI INIETTABILI BAXTER contains sterile, non-contaminated water that is free from microorganisms (apyrogenic), used to dissolve, dilute, and carry other medicinal products intended for injection. ACQUA PER PREPARAZIONI INIETTABILI BAXTER is indicated for the preparation of injectable medicinal solutions.
2. What you need to know before using ACQUA PER PREPARAZIONI INIETTABILI BAXTER
Do not use ACQUA PER PREPARAZIONI INIETTABILI BAXTER
- alone and in all conditions for which you should not use the medicine(s) dissolved, diluted, or carried in ACQUA PER PREPARAZIONI INIETTABILI BAXTER.
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using ACQUA PER PREPARAZIONI
INIETTABILI BAXTER
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
amount. This medicine is a vehicle for other medicines and must not be administered alone.
If you continuously use ACQUA PER PREPARAZIONI INIETTABILI BAXTER, 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), as well as reduced red blood cell levels, which may cause kidney problems (renal
failure, see section: “4. Possible side effects”).
Other medicines and ACQUA PER PREPARAZIONI INIETTABILI BAXTER
Inform your doctor, pharmacist, or nurse if you are currently using, have recently used, or might use
any other medicines.
ACQUA PER PREPARAZIONI INIETTABILI BAXTER may be used to dissolve, dilute, and carry
other medicines; therefore, inform your doctor if you are taking other medicines, as they may interact with
those dissolved, diluted, or carried in ACQUA PER PREPARAZIONI INIETTABILI BAXTER.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your
doctor, pharmacist, or nurse before using this medicine.
Inform your doctor if you are pregnant or breastfeeding, because ACQUA PER
PREPARAZIONI INIETTABILI BAXTER may be used to dissolve, dilute, and carry various
medicines, and the use of these medicines may be contraindicated during pregnancy and breastfeeding.
Driving and use of machinery
ACQUA PER PREPARAZIONI INIETTABILI BAXTER does not affect the ability to drive or
operate machinery. However, symptoms due to other medicines dissolved, diluted, or carried in ACQUA PER PREPARAZIONI INIETTABILI BAXTER may occur. If this happens to you, avoid driving or operating machinery.
3. How to use ACQUA PER PREPARAZIONI INIETTABILI BAXTER
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 BAXTER 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 BAXTER than you should
ACQUA PER PREPARAZIONI INIETTABILI BAXTER may be used to dissolve, dilute, and carry other medicines; therefore, in case of overdose, symptoms related to an overdose of these medicines may occur. In such cases, you should contact your doctor immediately and discontinue treatment.
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 will experience 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);
- especially if administered alone, a reduction in the number of red blood cells (haemolysis) may occur, which can cause kidney problems (renal failure).
These effects may occur if you continuously use ACQUA PER PREPARAZIONI INIETTABILI BAXTER.
ACQUA PER PREPARAZIONI INIETTABILI BAXTER may be used to dissolve, dilute and administer other
medicines; therefore, side effects may occur due to the use of these medicines.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor or
pharmacist. You may also report side effects directly via the national reporting system at
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 BAXTER
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 BAXTER with other medicines, no special storage conditions are required.
If you mix ACQUA PER PREPARAZIONI INIETTABILI BAXTER 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 BAXTER contains
ACQUA PER PREPARAZIONI INIETTABILI BAXTER 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 BAXTER and package contents
ACQUA PER PREPARAZIONI INIETTABILI BAXTER is a clear, colourless solution without visible particles and contains no antimicrobial agents or other additives.
It is available in the following pack sizes:
- pack of 30 vials of 250 ml;
- pack of 20 vials of 500 ml;
- pack of 1 Clear Flex bag of 250 ml;
- pack of 20 Clear Flex bags of 500 ml;
- pack of 12 Clear Flex bags of 1000 ml;
- pack of 20 Viaflo bags of 500 ml;
- pack of 10 Viaflo bags of 1000 ml.
Marketing Authorisation Holder and Manufacturer
BAXTER S.p.A.
Piazzale dell’Industria 20
00144, Roma (RM)
Italy
Manufacturer
Vials and bags:
BIEFFE MEDITAL S.p.A.
Via Nuova Provinciale
23034 Grosotto (SO)
Italy
Alternatively, bags may be manufactured by:
BIEFFE MEDITAL S.A.
Ctra de Biesca
22666 Sabiñanigo
Spain
Baxter S.A.
Boulevard René De Branquart 80
Lessines
Belgium
Baxter Healthcare S.A.
Moneen Road
Castlebar
Ireland
Baxter Healthcare Ltd
Caxton Way
Thetford
UK
The following information is intended exclusively for healthcare professionals
Special warnings and precautions for use
Water for injections is hypotonic and must not be administered alone.
Do not use for intravenous injection unless rendered isotonic by the addition of a suitable solute.
When water for injections is used as a diluent for hypertonic solutions, appropriate dilution must be
performed to render the solution isotonic.
Following infusion of large volumes of hypotonic solutions, hemolysis may occur when using water for
injections as a diluent.
Hemolysis may occur following infusion. Hemoglobin-induced renal failure has been reported following
hemolysis.
When large volumes are administered, electrolyte balance must be regularly monitored.
The 500 ml and 1000 ml containers are intended to be used as diluents and not for direct intravenous
administration.
Dosage and method of administration
The rate of administration will depend on the prescribed drug dosage regimen. After adequate mixing of the
prescribed additive, dosage is usually based on the patient's age, weight, and clinical condition, as well as
laboratory results.
Additives may be incompatible; those known to be incompatible must not be used.
Before adding a drug, verify that it is soluble and stable in water at the pH of water for injections, and that
it is compatible.
Special precautions for storage
The chemical and physical stability of any additive at the pH of water for injections must be established
before use. From a microbiological standpoint, the diluted product should be used immediately unless
dilution has taken place under controlled and validated aseptic conditions. If not used immediately, the
duration and conditions of storage are the responsibility of the user.
For further information, consult the Summary of Product Characteristics.