Water for injection baxter

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aqua pro injectione Baxter
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

1. What Aqua pro injectione Baxter is and what it is used for
2. Important information before using Aqua pro injectione Baxter
3. How to use Aqua pro injectione Baxter
4. Possible side effects
5. How to store Aqua pro injectione Baxter
6. Contents of the pack and other information

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

Aqua pro injectione Baxter is pure, sterile water. It is used to dilute other medicines before they are administered. These medicines may be given, for example, by:

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

2. Important information before using Aqua pro injectione Baxter

DO NOT administer Aqua pro injectione Baxter alone. Injecting pure water into the bloodstream
may cause water to be absorbed by red blood cells, leading to their rupture (hemolysis). This occurs
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 medicinal products.
Please read the package leaflet of the added medicinal product or products. This information will inform the patient
whether the solution can be used in their case.
Warnings and precautions
Do not administer Aqua pro injectione Baxter alone. Prior to administration, Aqua pro
injectione Baxter:

• will always be mixed with one or more other medicinal products,
• medical personnel will ensure that the mixture has certain properties similar to blood (isotonicity). Depending on the type of medicinal product added, this may mean that:
• the medicinal product requires dilution in Aqua pro injectione Baxter,
• prior to administration, another substance must be added to the mixture of Aqua pro injectione Baxter and the added medicinal product.

After administration of Aqua pro injectione Baxter, hemolysis (destruction of red blood cells) may occur.
Hemoglobin released due to damage to red blood cells may lead to kidney failure in some patients.
To prevent this, the doctor will take a blood sample to test the balance of chemical substances in the
patient's blood (electrolyte balance).
Before administering medicinal products mixed with Aqua pro injectione Baxter, the doctor will ensure that:

• these medicinal products are stable in Aqua pro injectione Baxter,
• no interactions will occur between the medicinal products.

Aqua pro injectione Baxter and other medicinal products
Inform your doctor or pharmacist about all medicinal products the patient is currently taking, has recently taken, or plans to take.
Interactions may occur between medicinal products mixed in Aqua pro injectione Baxter.
Use of Aqua pro injectione Baxter with food, drink and alcohol
Please consult your doctor regarding what you may eat and drink.
Pregnancy, breastfeeding and fertility
If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor or pharmacist before using this medicinal product.
Any risk to the unborn child or pregnancy will depend on the medicinal products mixed with
Aqua pro injectione Baxter.
Any risk to a breastfed child will also depend on the medicinal products mixed with
Aqua pro injectione Baxter.
The doctor will inform the patient about the potential risks associated with the use of specific medicinal products.
Medicinal products will be administered to pregnant or breastfeeding women only if strictly necessary.
Driving and operating machinery
The use of Aqua pro injectione Baxter does not affect the ability to drive or operate machinery.
Any effect on the ability to drive or operate machinery will depend on the medicinal products mixed with Aqua pro injectione Baxter. Your doctor can provide information on this matter.

3. How to use Aqua pro injectione Baxter

Aqua pro injectione Baxter is administered by a doctor or nurse.
The doctor will decide the amount, timing, and method of administration of the medicinal product. This will depend on which medicinal product or products need to be given with Aqua pro injectione Baxter.
The doctor will also take into account the patient's age, body weight, clinical condition, and any other concomitant therapies.
DO NOT use Aqua pro injectione Baxter if it contains visible particles or if the packaging is in any way damaged.
Administration of a higher than recommended dose of Aqua pro injectione Baxter
If too much Aqua pro injectione Baxter is administered (overdose), haemolysis may occur. Haemolysis involves red blood cells absorbing water and subsequently rupturing.
Medicinal products mixed with Aqua pro injectione Baxter may also cause symptoms of overdose if administered in excessive amounts. Any signs and symptoms of overdose will depend on the medicinal products mixed with Aqua pro injectione Baxter.
If an overdose is accidentally administered, treatment will be discontinued and appropriate management initiated, depending on the symptoms present.
Please read the package leaflet of the medicinal product mixed with Aqua pro injectione Baxter to become familiar with possible symptoms of overdose.
If you have any doubts regarding the use of this medicinal product, consult your doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody gets them.

Haemolysis (breakdown of red blood cells) may occur if:

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

If another medicine is added to Aqua pro injectione Baxter, it may also cause adverse reactions. These will depend on the medicine added. Please read the package leaflet of the added medicine to become familiar with its possible adverse reactions.

Reporting of adverse reactions

If any adverse reactions not listed in the leaflet occur, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions 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

Adverse reactions can also be reported to the marketing authorization holder.

Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Aqua pro injectione Baxter

Keep out of sight and reach of children.
No special storage instructions apply.
Do not remove the Aqua pro injectione Baxter medication from the outer plastic bag until ready for use.
DO NOT use Aqua pro injectione Baxter after the expiry date stated on the bag following the words "Expiry date". The expiry date refers to the last day of the specified month.
After opening the packaging, Aqua pro injectione Baxter should be used immediately.

6. Contents of the pack and other information

What Aqua pro injectione Baxter contains
The only ingredient is sterile water for injections.
Each bag contains 100% sterile water for injections.

What Aqua pro injectione Baxter looks like and contents of the pack
Aqua pro injectione Baxter is a clear, colourless solution.
This medicine is supplied in plastic polyolefin/polyamide bags (Viaflo). Each bag is enclosed in a sealed protective outer plastic container.

Bag sizes:

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

The bags are supplied in cardboard packaging. 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 Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warszawa
Poland

Manufacturers:
Bieffe Medital S.A.
Ctra de Biescas- Senegüé
22666 Sabiñanigo (Huesca)
Spain

Baxter S.A.
Boulevard R. Branquart, 80
7860 Lessines
Belgium

Vantive Manufacturing Limited
Moneen Road, Castlebar – County Mayo
Ireland

Baxter and Viaflo are trademarks of Baxter International Inc.

Information intended exclusively for medical personnel or healthcare professionals:

Handling and preparation
Use only if the solution is clear, free from visible particles, and the container is undamaged. Administer immediately after connecting the infusion set.
Do not remove the bag from its outer protective packaging until ready for use.
The inner bag ensures sterility of the product.
Plastic containers must not be used in series (piggybacked). Such use may result in air embolism caused by residual air drawn from the first container before infusion from the second container is completed.
Do not administer Aqua pro injectione Baxter alone.
Prior to parenteral administration, the solution must be rendered isotonic.
Additional medications may be added before or during infusion via the medication addition port. Careful and thorough mixing under aseptic conditions is required with each added medication. Solutions containing added medications should be used immediately and must not be stored.
The infusion solution must be administered using sterile equipment, following aseptic techniques.
The infusion set should be primed with the solution to prevent air from entering the system.
Discard after single use.
Discard any unused portion of the solution.
Do not reconnect partially used bags.
When preparing the infusion, consider the following fill volumes:
59 ml for the 50 ml bag
111 ml for the 100 ml bag
271 ml for the 250 ml bag
530 ml for the 500 ml bag
1040 ml for the 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 leakage. If leakage is detected, discard the bag, as the contents may no longer be sterile.
c. Check whether the solution is clear and free from insoluble particles. If the solution is not clear or contains insoluble particles, discard it.

2. Preparation for administration after rendering isotonic

a. Hang the bag on an IV pole.
b. Remove the plastic cover from the administration port located at the bottom of the bag:

• Hold the smaller wing on the neck of the port with one hand,
• Hold the larger wing on the cap with the other hand and twist,
• the cap will pop off.
  c. Use aseptic technique when connecting the infusion set.
  d. Connect the infusion set according to the manufacturer's instructions for connecting, priming, and administering the solution.

3. Methods of adding additional medications

Note: Added medications may be incompatible:
Adding medications before administration
a. Disinfect the medication addition port.
b. Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, insert the needle through the self-sealing medication addition port and inject the medication.
c. Mix the solution thoroughly with the added medication. For viscous preparations, such as potassium chloride, gently tap both ports with the bag held port-side up and mix.
Note: Do not store bags containing added medications.
Adding medications during administration
a. Close the clamp on the infusion set.
b. Disinfect the medication addition port.
c. Using a syringe with a 19G (1.10 mm) to 22G (0.70 mm) needle, insert the needle into the self-sealing medication addition port and inject the medication.
d. Remove the bag from the pole and (or) invert it with ports facing upward.
e. Empty both ports by gently tapping the bag while held ports-up.
f. Mix the solution thoroughly with the medication.
g. Rehang the bag in its original position, reopen the clamp, and continue administration.

4. Stability during use (with added medications)

Prior to use, the chemical and physical stability of each added medication in the pH range of Aqua pro injectione Baxter (4.5 to 7.0) within the given container must be established.
From a microbiological standpoint, the diluted product should be used immediately unless preparation occurred under controlled and validated aseptic conditions. If the solution is not used immediately, the user is responsible for the duration and conditions of storage prior to use.

5. Incompatibilities of added medications

As with any parenteral solution, compatibility of any added medication with the solution in the Viaflo container must be evaluated prior to addition.
Refer to the package insert of the medication intended for addition to the solution.
Prior to adding a medication, verify that it is soluble and stable in water at the pH of Aqua pro injectione Baxter (4.5 to 7.0).
Baxter and Viaflo are trademarks of Baxter International Inc.