ACQUA 250 ML Roztwór parenteralny
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Treść ulotki
- ACQUA PER PREPARAZIONI INIETTABILI BAXTER solvent for parenteral use
- What is ACQUA PER PREPARAZIONI INIETTABILI BAXTER and what is it used for?
- What you need to know before you use ACQUA PER PREPARAZIONI INIETTABILI BAXTER
- How to use ACQUA PER PREPARAZIONI INIETTABILI BAXTER
- Possible side effects
- How to store ACQUA PER PREPARAZIONI INIETTABILI BAXTER
- Package contents and other information
ACQUA PER PREPARAZIONI INIETTABILI BAXTER solvent for parenteral use
Sterile apyrogenic water
Equivalent Medicinal Product
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 have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
- If any side effects occur, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.
Contents of this leaflet:
- 1. What ACQUA PER PREPARAZIONI INIETTABILI BAXTER is and what it is used for
- 2. What you need to know before you use ACQUA PER PREPARAZIONI INIETTABILI BAXTER
- 3. How to use ACQUA PER PREPARAZIONI INIETTABILI BAXTER
- 4. Possible side effects
- 5. How to store ACQUA PER PREPARAZIONI INIETTABILI BAXTER
- 6. Contents of the pack and other information
1. What is ACQUA PER PREPARAZIONI INIETTABILI BAXTER and what is it used for?
ACQUA PER PREPARAZIONI INIETTABILI BAXTER contains sterile water not contaminated by microorganisms (apyrogenic), which is used to dissolve, dilute and carry other medicines to be administered by injection. ACQUA PER PREPARAZIONI INIETTABILI BAXTER is indicated for the preparation of solutions of medicines to be injected.
2. What you need to know before you use ACQUA PER PREPARAZIONI INIETTABILI BAXTER
Do not use ACQUA PER PREPARAZIONI INIETTABILI BAXTER
- alone and in all those conditions for which you should not use the medicine(s) dissolved, diluted or carried in ACQUA PER PREPARAZIONI INIETTABILI BAXTER.
Warnings and precautions
Consult your doctor, pharmacist or nurse before using ACQUA PER PREPARAZIONI INIETTABILI BAXTER
Use this medicine immediately after opening the container, after making sure that the solution is clear, colorless and free of visible particles and in one go, discarding any remaining solution. This medicine is a vehicle for other medicines, therefore it should not be administered alone.
If you use ACQUA PER PREPARAZIONI INIETTABILI BAXTER continuously, you may experience excessive water accumulation (fluid overload), congestion (congestive state), reduction of salt levels in the blood, if you do not add potassium to the solution, decreased potassium levels in the blood (hypokalemia) and decreased levels of red blood cells, which can cause kidney problems (renal failure - see paragraph: “4. Possible side effects”).
Other medicines and ACQUA PER PREPARAZIONI INIETTABILI BAXTER
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicine.
ACQUA PER PREPARAZIONI INIETTABILI BAXTER can be used to dissolve, dilute and carry other medicines, so tell your doctor if you are taking other medicines because they may interact with those dissolved, diluted or carried in ACQUA PER PREPARAZIONI INIETTABILI BAXTER
Pregnancy and breastfeeding
If 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.
Tell your doctor if you are pregnant or breastfeeding because ACQUA PER PREPARAZIONI INIETTABILI BAXTER can be used to dissolve, dilute and carry various medicines and the use of these medicines may be contraindicated in pregnancy and during breastfeeding.
Driving and operating machinery
ACQUA PER PREPARAZIONI INIETTABILI BAXTER does not impair the ability to drive vehicles or operate machinery. However, symptoms due to other medicines dissolved, diluted or carried in ACQUA PER PREPARAZIONI INIETTABILI BAXTER may occur. If this happens, avoid driving or operating machinery.
3. How to use ACQUA PER PREPARAZIONI INIETTABILI BAXTER
Use this medicine following exactly as stated in this leaflet or as instructed by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor, pharmacist, or nurse.
Use this medicine to dilute or suspend medicinal products for injection or other sterile preparations.
Choose the correct volume of ACQUA PER PREPARAZIONI INIETTABILI BAXTER to use based 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 BAXTER than you should
ACQUA PER PREPARAZIONI INIETTABILI BAXTER can be used to dissolve, dilute and deliver other medicines, and in the case of an excessive dose, symptoms of an overdose due to the presence of these medicines may occur. In this case, it is necessary to contact a doctor and discontinue treatment.
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 water in the body (fluid overload);
- congestion (congestive state);
- reduction of salt (electrolyte) levels in the body;
- especially when administered alone, a reduction in the number of red blood cells (hemolysis) may occur, which can cause kidney problems (renal failure).
These effects may occur if used continuously ACQUA PER PREPARAZIONI INIETTABILI
BAXTER.
ACQUA PER PREPARAZIONI INIETTABILI BAXTER 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 effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through 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 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.
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 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. Package contents and other information
What ACQUA PER PREPARAZIONI INIETTABILI BAXTER contains
ACQUA PER PREPARAZIONI INIETTABILI BAXTER 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 BAXTER and contents of the pack
ACQUA PER PREPARAZIONI INIETTABILI BAXTER is presented as a clear,
colourless solution, free from visible particles and other antimicrobial or other substances.
It is available in
- packs of 30 vials of 250 ml;
- packs 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, Rome (RM)
Italy
Manufacturer
Vials and bags:
BIEFFE MEDITAL S.p.A.
Via Nuova Provinciale
23034 Grosotto (So)
Italy
Alternatively, the bags may be produced by:
BIEFFE MEDITAL S.A.
Ctra de Biesca
22666 Sabiñanigo
Spain
Baxter S.A.
Boulevard Renè De Branquart 80
Lessines
Belgium
Baxter Healthcare S.A.
Moneen road
Castlebar
Ireland
Baxter Healthcare Ltd
Caxton way
Thetford
UK
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The following information is intended for healthcare professionals only
Special warnings and precautions for use
Water for injections is hypotonic and should not be administered alone.
Do not use for intravenous injection unless it is made isotonic by a suitable solute.
When water for injections is used as a diluent for hypertonic solutions, appropriate dilution must be carried out to make the solution isotonic.
Following the infusion of large volumes of hypotonic solutions, haemolysis may occur when using water for injections as a diluent.
Haemolysis may occur following infusion. Renal failure induced by haemoglobin has been reported following haemolysis.
When administering large volumes, the ionic balance must be regularly monitored.
500 and 1000 ml packs should be used as diluents and not for direct intravenous administration.
Dosage and method of administration
The rate of administration will depend on the dosage regimen of the prescribed medicine. After adequate
mixing of the prescribed additive, the dosage is usually dependent on the age, weight and clinical condition
of the patient as well as laboratory results.
Additives may be incompatible and those known for their incompatibility should not be used.
Before adding a medicine, 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 point of view, the diluted product must be used
immediately unless the dilution has taken place under controlled and validated aseptic conditions. If not used immediately, the storage times and conditions are the responsibility
of the user.
For further information, see the Summary of Product Characteristics.
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- Kraj rejestracji
- Postać farmaceutycznaParenteral solution, 250 ML
- Wymaga receptyNie
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
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AKQUA PER PREPARATSIONI INIETTABILI BAXTER jest produkowany przez BAXTER S.P.A.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
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