Voda do vstzhikivani Csl Behring

LEAFLET INCLUDED IN THE PACKAGE: INFORMATION FOR

THE USER

Water for Injections CSL Behring

Solvent for preparing parenteral medicines

You should carefully 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.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Water for Injections CSL Behring and what is it used for
• 2. Important information before using Water for Injections CSL Behring
• 3. How to use Water for Injections CSL Behring
• 4. Possible side effects
• 5. How to store Water for Injections CSL Behring
• 6. Contents of the package and other information

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

Sterile Water for Injections is used to dissolve and dilute other medicinal products that require mixing with water before administration, used in injections and infusions (drip) into veins, muscles or other tissues in the patient's body.

2. Important information before using Water for Injections CSL Behring

The following sections contain information that the patient or doctor should consider before using Water for Injections CSL Behring.

When not to use Water for Injections CSL Behring

• Water for Injections CSL Behring should not be administered alone. Water for Injections CSL Behring can only be used to dissolve and dilute necessary medicines.

You should read the leaflet of the medicine or medicines that will be mixed with Water for Injections CSL Behring. This information will allow you to assess whether such a solution can be used.

Warnings and precautions

Water for Injections CSL Behring should not be administered alone. Before starting to use Water for Injections CSL Behring:

• It should always be mixed with one or more medicines

Before using medicines mixed with Water for Injections CSL Behring, the doctor should check whether:

• the medicines are stable in Water for Injections CSL Behring
• there will be no interactions between the medicines

Water for Injections CSL Behring and other medicines

You should read the patient leaflet of the medicine that is to be mixed with Water for Injections CSL Behring. You should not use those medicinal products that are known to be incompatible with water for injections

Pregnancy, breastfeeding, and fertility

You should read the patient leaflet of the medicine that is to be mixed with Water for Injections CSL Behring.

Driving and using machines

Water for Injections CSL Behring has no effect on the ability to drive and use machines.
Any effect on the ability to drive and use machines will depend on the medicines that will be mixed with Water for Injections CSL Behring.

3. How to use Water for Injections CSL Behring

This medicine should always be used according to the doctor's or pharmacist's recommendations. In case of doubts, you should consult a doctor or pharmacist.
The doctor will decide how and in what quantity the product will be administered. This will depend on the medicine or medicines that will be needed to use with Water for Injections CSL Behring.
Water for Injections should only be used if it is clear, colorless, without visible particles, and if the container is not damaged.
In case of any further doubts related to the use of this medicine, you should consult a doctor or pharmacist.

4. Possible side effects

You should read the patient leaflet of the medicine that is to be mixed with Water for Injections CSL Behring.

Reporting side effects

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

5. How to store Water for Injections CSL Behring

Do not use this medicine after the expiry date stated on the label and carton after EXP.

• The medicine should be stored in a place that is out of sight and reach of children.
• Do not freeze.
• The doctor will inform the patient how to dispose of unused products or their waste.
• After opening, the product should be used immediately.
• The batch number is written on the label and carton after Lot.

In order to maintain validity, after reconstitution of the medicinal product, you should check the information leaflet of the medicinal product that was reconstituted with Water for Injections CSL Behring.

6. Contents of the package and other information

What Water for Injections CSL Behring contains

The only ingredient is sterile water for injections in a vial.

What Water for Injections CSL Behring looks like and what the package contains

Water for Injections CSL Behring is a clear, colorless liquid.

Package size (1 vial in the package)

Type of package

2 ml, 2.5 ml, 3 ml, 4 ml, 5 ml
6 ml Vial made of colorless glass with a rubber stopper
(chlorobutyl
or
bromobutyl)
and an aluminum cap with a plastic overlay
made of polypropylene.
For sizes:
2 ml: blue/ purple,

• 2.5 ml (overfill 0.3 ml): blue/ blue,
• 2.5 ml (overfill 0.4 ml): blue/ yellowish,
• 2.5 ml (overfill 0.6 ml): blue/ light blue 3 ml: blue/ orange, 4 ml (0.3 ml overfill): blue/ gray, 5 ml (0.4 ml overfill): blue/ green
• 5.6 ml, 10 ml

15 ml
10 ml Vial made of colorless glass with a rubber stopper
(chlorobutyl
or
bromobutyl) and an aluminum cap with a plastic overlay
made of polypropylene.
For sizes:

• 5.6 ml (overfill 0.46 ml): blue/ yellowish 10 ml (overfill 0.5 ml): blue/ blue

15 ml Vial made of colorless glass with a rubber stopper
(chlorobutyl
or
bromobutyl) and an aluminum cap with a plastic overlay
made of polypropylene.
For sizes:
15 ml (overfill 0.5ml): blue/ blue
20 ml
25 ml Vial made of colorless glass with a rubber stopper
(chlorobutyl
or
bromobutyl) and an aluminum cap with a plastic overlay
made of polypropylene.
For sizes:
20 ml (overfill 1 ml): blue/ blue
40 ml, 50 ml
50 ml Vial made of colorless glass with a rubber stopper
(chlorobutyl
or
bromobutyl) and an aluminum cap with a plastic overlay
made of polypropylene.
For sizes:
40 ml (overfill 1.5 ml): blue/ blue
50 ml (overfill 2 ml): blue/ blue
Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

CSL Behring GmbH
Emil-von-Behring-Str. 76
35041 Marburg
Germany

This medicinal product is authorized in the Member States of the European Economic Area under the names:

Austria
Wasser für Injektionszwecke CSL Behring
Lösungsmittel zur Herstellung von Parenteralia
Belgium
Water voor injecties CSL Behring, oplosmiddel
voor parenteraal gebruik
Bulgaria
ВОДА ЗА ИНЖЕКЦИИ CSL Behring
разтворител за парентерално приложение
Croatia
Voda za injekcije CSL Behring otapalo za
parenteralnu uporabu
Cyprus, Greece
Ύδωρ για ενέσιμα /CSL Behring
Czech Republic, Estonia, Malta,
Water for Injections CSL Behring
Slovakia, United Kingdom
Denmark
Vand til injektionsvæsker “CSL Behring“
Finland
Injektionesteisiin käytettävä vesi CSL Behring
France
EAU POUR PREPARATIONS INJECTABLES
CSL BEHRING, solvant pour préparation
parentérale
Germany
Wasser für Injektionszwecke CSL Behring
Hungary
Injekcióhoz való víz CSL Behring oldószer
parenterális készítménye khez
Iceland
Vatn fyrir stungulyf CSL Behring
Ireland
Water for Injections solvent for parenteral use
Italy
ACQUA PER PREPARAZIONI INIETTABILI
CSL Behring
Latvia
Water for Injections CSL Behring šķīdinātājs
parenterālai lietošanai
Lithuania
Water for Injections CSL Behring tirpiklis
parenteriniam vartojimui
Luxembourg
Eau pour préparation injectable CSL Behring
Netherlands
Water voor injecties CSL Behring, oplossing
voor parenteraal gebruik
Norway
Vann til injeksjonsvæsker CSL Behring
Poland
Woda do wstrzykiwań CSL Behring
Portugal
Água para preparações injetáveis CSL Behring
Romania
Apă pentru preparate injectabile CSL Behring,
solvent pentru preparate parenterale
Slovenia
Voda za injekcije CSL Behring vehikel za
parenteralno uporabo
Spain
Agua para preparaciones inyectables CSL
Behring disolvente para uso parenteral EFG
Sweden
Vatten för injektionsvätskor CSL Behring

Date of last revision of the leaflet: October 2021