Water for injections braun

Package leaflet: Information for the user

Braun Water for Injections
Solvent for the preparation of parenteral medicines
(Aqua ad iniectabile)
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If any side effects worsen or if you experience any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents:

1. What Braun Water for Injections is and what it is used for
2. What you need to know before using Braun Water for Injections
3. How to use Braun Water for Injections
4. Possible side effects
5. How to store Braun Water for Injections
6. Contents of the pack and other information

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

Braun Water for Injections is sterile water for injections.
Braun Water for Injections is used as a solvent for the preparation of medicines administered directly into the vein (for parenteral administration).

2. Important information before using the medicinal product Water for Injections Braun

When not to use Water for Injections Braun
There are no known cases in which the medicinal product Water for Injections Braun should not be used.
Before intravenous administration, the solution must be made isotonic by adding an appropriate dissolved substance.
If Water for Injections is used to dilute hypertonic solutions, the dilution should be chosen so that the resulting solution is approximately isotonic.
Infusion of Water for Injections may lead to hemolysis. Cases of kidney failure caused by hemoglobin have been reported during hemolysis.
When administering large volumes of fluid, ionic balance should be monitored regularly. The doctor will mix Water for Injections with another medicinal product immediately before administration.

Water for Injections Braun and other medicinal products
You must tell your doctor or pharmacist about all medicinal products currently used or recently used, as well as any medicinal products you plan to use.
Interactions between Water for Injections Braun and other medicinal products are not known.

Water for Injections Braun with food and drink
Interactions between Water for Injections Braun and food and drink are not known.

Pregnancy, breastfeeding, and fertility
If the patient is pregnant or breastfeeding, suspects she might be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicinal product.
Water for Injections Braun may be used in pregnant women and breastfeeding mothers.

Driving and operating machinery
Water for Injections Braun has no effect on the ability to drive or operate machinery.

3. How to use Braun Water for Injections

This medicine should always be used in accordance with the instructions given by the doctor or pharmacist. If in doubt,
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 drug dissolved or diluted in
water for injections. The medicine must be reconstituted or diluted immediately before use.
The dosage of Braun Water for Injections and duration of treatment depend on the recommendations applicable to
the dissolved or diluted medicine.
Use of more than the recommended dose of the medicine
Since this medicine is used as a solvent for other parenteral medicines,
overdose is unlikely.
Overdose may manifest as overhydration. Following administration of a larger volume of hypotonic
fluid, disturbances in the form of hypoelectrolytemia may occur, particularly if renal
impairment is present.
If you have any further questions about the use of this medicine, consult your doctor or
pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everybody will experience them.
Adverse reactions are not expected when this medicine is used as recommended.
Reporting of adverse reactions
If any adverse effects occur, including any adverse effects not listed in
this leaflet, 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
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store the medicinal product Water for Injections Braun

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the stated month.
No special storage conditions are required.
Do not use the medicine if the packaging is damaged or if the solution is cloudy or discoloured.
Containers are intended for single use only.
Any unused solution should be discarded.

6. Contents of the packaging and other information

What Woda do wstrzykiwań Braun contains
1000 ml of parenteral solvent contains 1000 ml of water for injections.

What Woda do wstrzykiwań Braun looks like and contents of the pack
Woda do wstrzykiwań Braun is used as a solvent for preparing parenteral medicines.
The medicine is a clear, colourless liquid.

Glass bottles with rubber stoppers, with a capacity of 500 ml,
are available in multi-packs of 10 x 500 ml.

Polyethylene containers of Ecoflac plus type with capacities of: 100 ml, 250 ml, 500 ml, 1000 ml,
are available in multi-packs of:
20 x 100 ml,
10 x 250 ml,
10 x 500 ml,
10 x 1000 ml.

Marketing Authorisation Holder
Manufacturer
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen
Germany

B. Braun Medical SA
Carretera de Terrassa, 121
08191 Rubi (Barcelona)
Spain