Voda do vstzhikivani Braun

Leaflet attached to the packaging: information for the user

Braun Injection Water
Solvent for preparing parenteral medicines
(Aqua ad iniectabile)

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• You should consult a doctor, pharmacist, or nurse if you have any further doubts.
• If any of the side effects get worse or if you notice any side effects not listed in the leaflet, you should tell your doctor, pharmacist, or nurse. See section 4.

Table of contents:

• 1. What is Braun Injection Water and what is it used for
• 2. Important information before using Braun Injection Water
• 3. How to use Braun Injection Water
• 4. Possible side effects
• 5. How to store Braun Injection Water
• 6. Package contents and other information

1. What is Braun Injection Water and what is it used for

Braun Injection Water is a sterile water for injection.
Braun Injection Water is used as a solvent for preparing medicines administered directly into the vein (for parenteral administration).

2. Important information before using Braun Injection Water

When not to use Braun Injection Water

There are no known cases where Braun Injection Water should not be used.
Before intravenous administration, the solution should be made isotonic with an appropriate dissolved substance.
If injection water is used to dilute hypertonic solutions, the dilution should be chosen so that the resulting solution is approximately isotonic.
Administration of injection water by infusion poses a risk of hemolysis. Renal failure caused by hemoglobin has been reported during hemolysis.
When administering large volumes of fluid, the ionic balance should be regularly monitored. The doctor will mix the injection water with another medicine immediately before administration.

Braun Injection Water and other medicines

You should tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Interactions between Braun Injection Water and other medicines are not known.

Braun Injection Water with food and drink

Interactions between Braun Injection Water and food and drink are not known.

Pregnancy, breastfeeding, fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, you should consult your doctor or pharmacist before using this medicine.
Braun Injection Water can be used in pregnant women and breastfeeding mothers.

Driving and using machines

Braun Injection Water has no effect on the ability to drive and use machines.

3. How to use Braun Injection Water

This medicine should always be used in accordance with the doctor's or pharmacist's recommendations. If you have any doubts, you should consult your doctor or pharmacist.
This medicine is administered by a doctor or other qualified healthcare professional.
The method of administration depends on the instructions for administering the dissolved or diluted medicine in injection water. The medicine should be reconstituted or diluted immediately before use.
The dosage of Braun Injection Water and the duration of use depend on the recommendations for the dissolved or diluted medicine.

Using a higher dose of the medicine than recommended

Since this medicine is used as a solvent for other medicines for parenteral administration, overdose is unlikely.
Overdose may occur in the form of water poisoning. After taking a larger volume of hypotonic fluid, disturbances may occur in the form of hypoelectrolytemia, especially if there are pre-existing kidney function disorders.
If you have any further questions about using this medicine, you should consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
You should not expect side effects if you use this medicine according to the recommendations.

Reporting side effects

If you experience any side effects, including any side effects not listed in the leaflet, you should 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.
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Braun Injection Water

The medicine should be stored out of sight and out of reach of children.
You should not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the specified month.
There are no special storage conditions.
You should not use the medicine if you notice that the packaging is damaged, and the liquid is not clear or is discolored.
The containers are intended for single use only.
Any unused solution should be disposed of.

6. Package contents and other information

What Braun Injection Water contains

1000 ml of solvent for preparing parenteral medicines contains 1000 ml of injection water.

What Braun Injection Water looks like and what the packaging contains

Braun Injection Water is used as a solvent for preparing medicines administered directly into the vein.
The medicine is a clear, colorless liquid.
Glass bottles with rubber stoppers, with a capacity of 500 ml, are available in collective packaging of 10 x 500 ml.
Polyethylene containers of the Ecoflac plus type, with a capacity of 100 ml, 250 ml, 500 ml, are available in collective packaging of 20 x 100 ml, 10 x 250 ml, 10 x 500 ml.

Marketing authorization holder

Manufacturer

• B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany
• B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen Germany

B.Braun Medical SA
Carretera de Terrassa, 121
08191 Rubi (Barcelona)
Spain
Date of last update of the leaflet:2023-04-25