Aqua pro iniectione Baxter

1. What is Aqua pro injectione Baxter and what is it used for

Aqua pro injectione Baxter is a pure, sterile water. It is used to dilute other medicines before administration. These medicines can be administered, for example, by:

• injection (administered with a needle, e.g., into a vein),
• intravenous infusion (slow injection), also known as drip infusion.

2. Important information before using Aqua pro injectione Baxter

DO NOT administer Aqua pro injectione Baxter alone. Injecting only water into the bloodstream can cause water to be absorbed by red blood cells and their breakdown (hemolysis). This happens because Aqua pro injectione Baxter does not have the same properties as blood.
Before administration, medical personnel will always mix Aqua pro injectione Baxter with one or more other medicines.
You should read the leaflet of the added medicine or medicines. This information will tell you if the given solution can be used for you.

Warnings and precautions

Aqua pro injectione Baxter should not be administered alone. Before administration, Aqua pro injectione Baxter:

• will always be mixed with one or more other medicines,
• medical personnel will ensure that the mixture has a certain property similar to blood (isotonicity). Depending on the type of added medicine, this will mean that:
• this medicine requires dilution in Aqua pro injectione Baxter,
• before administration, it is necessary to add another substance to the mixture of Aqua pro injectione Baxter with the added medicine.

After administration of Aqua pro injectione Baxter, hemolysis (breakdown of red blood cells) may occur.
Hemoglobin released as a result of damage to red blood cells can cause kidney failure in some patients.
To prevent this, the doctor will take a blood sample to examine the balance of chemical substances in the patient's blood (ionic balance).
Before administering medicines mixed with Aqua pro injectione Baxter, the doctor will ensure that:

• these medicines are stable in Aqua pro injectione Baxter,
• there will be no interaction between the medicines.

Aqua pro injectione Baxter and other medicines

Tell your doctor or pharmacist about all medicines you are taking now or have taken recently, as well as about medicines you plan to take.
Interactions may occur between medicines mixed in Aqua pro injectione Baxter.

Using Aqua pro injectione Baxter with food, drinks, and alcohol

Ask your doctor what you can eat and drink.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor or pharmacist before using this medicine.
Any risk to the unborn child or pregnancy will depend on the medicines mixed with Aqua pro injectione Baxter.
Any risk to the breastfed child will also depend on the medicines mixed with Aqua pro injectione Baxter.
Your doctor will inform you about the possible risks of using individual medicines.
Medicines will be given to pregnant or breastfeeding women only if necessary.

Driving and using machines

Using Aqua pro injectione Baxter does not affect the ability to drive and use machines.
Any effect on the ability to drive and use machines will depend on the medicines mixed with Aqua pro injectione Baxter. Your doctor can provide information on this.

3. How to use Aqua pro injectione Baxter

Aqua pro injectione Baxter is administered by a doctor or nurse.
The doctor will decide on the amount, when, and how to administer the medicine. This will depend on which medicine or medicines need to be administered to the patient with Aqua pro injectione Baxter.
The doctor will also consider the patient's age, weight, condition, and other therapies used at the same time.

DO NOT use Aqua pro injectione Baxter if it contains visible particles or if the packaging is damaged in any way.

Overdose of Aqua pro injectione Baxter

In case of administration of too much Aqua pro injectione Baxter (overdose), hemolysis may occur. Hemolysis involves the absorption of water by red blood cells and their breakdown.
Medicines mixed with Aqua pro injectione Baxter may also cause overdose symptoms if administered in excessive amounts. All signs and symptoms of overdose will depend on the medicines mixed with Aqua pro injectione Baxter.
If an overdose occurs, treatment will be discontinued and appropriate action will be taken, depending on the symptoms that occur.
Read the leaflet of the medicine mixed with Aqua pro injectione Baxter to learn about possible overdose symptoms.
In case of doubts about using this medicine, consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Breakdown of red blood cells (hemolysis) may occur if:

• Aqua pro injectione Baxter is administered alone
• Aqua pro injectione Baxter is used to prepare solutions for injection or infusion that do not have a certain property of blood (isotonicity).

If another medicine is added to Aqua pro injectione Baxter, it may also cause side effects. These will depend on the added medicine. Read the leaflet of the added medicine to learn about its possible side effects.

Reporting side effects

If you experience any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Aqua pro injectione Baxter

Store in a place out of sight and reach of children.
No special precautions for storage.
Do not remove Aqua pro injectione Baxter from the outer plastic bag until use.
DO NOT use Aqua pro injectione Baxter after the expiry date stated on the bag, after the term "Expiry date". The expiry date is the last day of the given month.
Use Aqua pro injectione Baxter immediately after opening the packaging.

6. Contents of the pack and other information

What Aqua pro injectione Baxter contains

The only ingredient is sterile water for injection.
Each bag contains 100% sterile water for injection.

What Aqua pro injectione Baxter looks like and what the pack contains

Aqua pro injectione Baxter is a clear and colorless solution.
This medicine is supplied in polyolefin/polyamide plastic bags (Viaflo). Each bag is placed in a closed, protective, outer plastic packaging.
Bag sizes:

• -50 ml
• -100 ml
• -250 ml
• -500 ml
• 1000 ml

Bags are supplied in cardboard boxes. The cardboard box may contain the following quantities:

• 50 bags of 50 ml
• 50 bags of 100 ml
• 60 bags of 100 ml
• 30 bags of 250 ml
• 20 bags of 500 ml
• 10 bags of 1000 ml
• 12 bags of 1000 ml

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
Manufacturer:
Bieffe Medital S.A.
Ctra de Biescas- Senegüé
22666 Sabiñanigo (Huesca)
Spain
Baxter S.A.
Vantive Manufacturing Limited
Boulevard R. Branquart, 80
Moneen Road
7860 Lessines
Castlebar – County Mayo
Belgium
Ireland
Date of last revision of the leaflet:April 2025
Baxter and Viaflo are trademarks of Baxter International Inc.
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Information intended only for healthcare professionals or healthcare workers:

Procedure and preparation

Use only when the solution is clear, without visible particles, and if the container is undamaged. Administer immediately after connecting the infusion set.
Do not remove the bag from the outer protective packaging until use.
The inner bag ensures the sterility of the product.
Plastic containers should not be connected in series. Such use may cause an air embolism caused by residual air drawn from the first container before the administration of the fluid from the second container is completed.
Aqua pro injectione Baxter should not be administered alone.
Before parenteral administration, the solution should be brought to isotonicity.
Additional medicines can be introduced before infusion or during infusion through the self-sealing port for adding medicines. It is necessary to mix carefully and aseptically with each additional medicine. Solutions containing additional medicines should be used immediately, without storage.
The infusion solution should be administered using sterile equipment, applying aseptic principles.
The infusion equipment should be pre-filled with the solution to prevent air from entering the system.
Discard after single use.
Discard any unused solution.
Do not reconnect partially used bags.
When preparing the infusion, consider the following filling volumes:
59 ml
for a 50 ml bag
111 ml
for a 100 ml bag
271 ml
for a 250 ml bag
530 ml
for a 500 ml bag
1040 ml
for a 1000 ml bag

1. Opening

• a. Remove the Viaflo bag from the protective packaging immediately before use.
• b. Squeeze the inner bag firmly to check for leaks. If a leak is found, discard the bag, as the contents may not be sterile.
• c. Check if the solution is clear and does not contain insoluble particles. If the solution is not clear and contains insoluble particles, discard it.

2. Preparation for administration after bringing to isotonicity

• a. Hang the bag on a stand.
• b. Remove the plastic cover from the infusion port at the bottom of the bag:
• grasp the smaller wing on the neck of the port with one hand,
• grasp the larger wing on the plug with the other hand and twist,
• the plug will come off.
• c. When connecting the infusion, apply aseptic principles.

• d. Connect the infusion set according to the instructions provided with the set, regarding connection, filling the set, and administering the solution.

3. Methods of introducing additional medicines

Warning: Added medicines may be incompatible:
Adding medicines before administration

• a. Disinfect the port for adding medicines.
• b. Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, insert the needle into the self-sealing port for adding medicines and inject the medicine.
• c. Mix the solution with the added medicine carefully. For preparations with high density, such as potassium chloride, gently tap the ports with the bag in an upright position and mix.

Warning: Do not store bags containing added medicines.
Adding medicines during administration

• a. Close the clamp on the infusion set.
• b. Disinfect the port for adding medicines.
• c. Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, insert the needle into the self-sealing port for adding medicines and inject the medicine.
• d. Remove the bag from the stand and/or turn it upside down.
• e. Empty both ports by gently tapping in an upright position.
• f. Mix the solution with the medicine carefully.
• g. Hang the bag in its previous position, reopen the clamp, and continue administration.

4. Stability during use (additional medicines)

Before use, the chemical and physical stability of each added medicine should be established in the pH range of Aqua pro injectione Baxter (4.5 to 7.0) in the given container.
From a microbiological point of view, the diluted product should be used immediately, unless preparation has taken place in controlled and validated aseptic conditions. If the solution is not used immediately, the user is responsible for the time and conditions of storage before use.

5. Incompatibility of added medicines

As with any solution for parenteral administration, before adding medicines, their compatibility with the solution in the Viaflo container should be assessed.
Read the instructions for use of the medicine to be added to the solution.
Before adding the medicine, check if it is soluble and stable in water with the pH of Aqua pro injectione Baxter (4.5 to 7.0).
Baxter and Viaflo are trademarks of Baxter International Inc.