WATER FOR INJECTIONS CSL BEHRING

PACKAGE LEAFLET: INFORMATION FOR

USERS
Water for Injections CSL Behring
Solvent for the preparation of parenteral medicines
Please read carefully the entire leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any further questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are identical.
• If the patient experiences any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

1. What Water for Injections CSL Behring is and what it is used for
2. Important information before use of 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 pack and other information

1. What Water for Injections CSL Behring is and what it is used for
Sterile Water for Injections is used to dissolve and dilute other medicinal products that need to be mixed with water before administration, for intravenous, intramuscular or other tissue injections and infusions (intravenous drip).

2. Important information before use of Water for Injections CSL Behring

The following sections contain information that the patient or physician should consider before using Water for Injections CSL Behring.
When not to use Water for Injections CSL Behring

• Do not administer Water for Injections CSL Behring alone. Water for Injections CSL Behring must only be used to dissolve and dilute required medicinal products.

Please refer to the package leaflet of the medicine or medicines to be mixed with Water for Injections CSL Behring. This information will help determine whether such a solution can be used.
Warnings and precautions
Do not administer Water for Injections CSL Behring alone. Before starting use of Water for Injections CSL Behring:

• It must always be mixed with one or more medicinal products.

Before administering any medicines mixed with Water for Injections CSL Behring, the physician should verify that:

• 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
Please refer to the patient leaflet of the medicine intended to be mixed with Water for Injections CSL Behring. Do not use medicinal products known to be incompatible with water for injections.
Pregnancy, breastfeeding and fertility
Please refer to the patient leaflet of the medicine intended to be mixed with Water for Injections CSL Behring.
Driving and operating machinery
Water for Injections CSL Behring has no effect on the ability to drive or operate machinery. Any effect on the ability to drive or operate machinery will depend on the medicines mixed with Water for Injections CSL Behring.

3. How to use Woda do wstrzykiwań CSL Behring

This medicine should always be used as directed by a doctor or pharmacist.
If in doubt, consult a doctor or pharmacist.
The doctor will decide how and in what amount the product should be administered. This will depend on the medicine or medicines that need to be used with Woda do wstrzykiwań CSL Behring.
The solution should only be used if it is clear, colourless, free from visible particles, and if the container is undamaged.
If there are any further doubts regarding the use of this medicine, consult a doctor or pharmacist.

4. Possible adverse reactions

Refer to the package leaflet of the medicinal product intended to be mixed with Woda do wstrzykiwań CSL Behring.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in the package 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
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of the medicinal product.

5. How to store Woda do wstrzykiwań CSL Behring

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

• Keep the medicine out of the sight and reach of children.
• Do not freeze.
• The doctor will inform the patient how to dispose of unused medicines or waste materials.
• After opening, the product should be used immediately.
• The batch number is indicated on the label and carton following the abbreviation (Lot).

To maintain efficacy, after reconstitution of the medicinal product, refer to the package
leaflet of the medicinal product reconstituted with Woda do wstrzykiwań CSL Behring.

6. Contents of the pack and other information

What Woda do wstrzykiwań CSL Behring contains
The only ingredient is sterile water for injections in a vial.

What Woda do wstrzykiwań CSL Behring looks like and contents of the pack
Woda do wstrzykiwań CSL Behring is a clear, colourless liquid.

| Pack size (1 vial in the pack) | Type of container | |-------------------------------|-------------------| | 2 ml, 2.5 ml, 3 ml, 4 ml, 5 ml, 6 ml | Vial made of colourless glass with a rubber stopper (chlorobutyl or bromobutyl) and an aluminium cap with a plastic flip-off cap made of polypropylene.
For sizes:
2 ml: blue/violet,
2.5 ml (overfill 0.3 ml): blue/blue,
2.5 ml (overfill 0.4 ml): blue/lemon,
2.5 ml (overfill 0.6 ml): blue/light blue,
3 ml: blue/orange,
4 ml (overfill 0.3 ml): blue/grey,
5 ml (overfill 0.4 ml): blue/green | | 5.6 ml, 10 ml | Vial made of colourless glass with a rubber stopper (chlorobutyl or bromobutyl) and an aluminium cap with a plastic flip-off cap made of polypropylene.
For sizes:
5.6 ml (overfill 0.46 ml): blue/lemon,
10 ml (overfill 0.5 ml): blue/blue | | 15 ml | Vial made of colourless glass with a rubber stopper (chlorobutyl or bromobutyl) and an aluminium cap with a plastic flip-off cap made of polypropylene.
For size:
15 ml (overfill 0.5 ml): blue/blue | | 20 ml, 25 ml | Vial made of colourless glass with a rubber stopper (chlorobutyl or bromobutyl) and an aluminium cap with a plastic flip-off cap made of polypropylene.
For size:
20 ml (overfill 1 ml): blue/blue | | 40 ml, 50 ml | Vial made of colourless glass with a rubber stopper (chlorobutyl or bromobutyl) and an aluminium cap with a plastic flip-off cap made of polypropylene.
For sizes:
40 ml (overfill 1.5 ml): blue/blue,
50 ml (overfill 2 ml): blue/blue |

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
CSL Behring GmbH
Emil-von-Behring-Str. 76
35041 Marburg
Germany

This medicinal product is authorised in the Member States of the European Economic Area under the following 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, Slovakia, United Kingdom Water for Injections CSL Behring
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 készítményekhez
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