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Module 1.3.1 Package Leaflet

PATIENT INFORMATION LEAFLET Water for Injections

Read this leaflet carefully before you start using this medicine.

-    Keep this leaflet. You may need to read it again.

-    If you have further questions, please ask your doctor or your pharmacist.

-    This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.


In this leaflet:

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

2.    Before you use Water for Injections

3.    How to use Water for Injections

4.    Possible side effects

5 Storing Water for Injections 6. Further information

Water for Injections Water for Injections Water for Injections Water for Injections Water for Injections


5 ml, solvent for parenteral use 10 ml, solvent for parenteral use 15 ml, solvent for parenteral use 20 ml, solvent for parenteral use 30 ml, solvent for parenteral use

Marketing Authorisation Holder: Octapharma Ltd.

The Zenith Building,

26 Spring Gardens Manchester M2 1AB United Kingdom Manufacturer:

OCTAPHARMA AB S-112 75 Stockholm Sweden. or

B.Braun Medical S.A

C/. Ronda de los Olivares, 5

Poligono Industrial Los Olivares

23009 Jaen

Spain.

or

Solupharm GmbH Pharmazeutische Erzeugnisse IndustriestraBe 3 34212 Melsungen Germany.

1.    WHAT WATER FOR INJECTIONS IS AND WHAT IT IS USED FOR

Water for Injections is used for the reconstitution of medicines administered parenterally, allowing the medicinal product to be injected into the body.

Description of the package:

1 carton contains 1 vial with the solvent Water for Injections (Ph. Eur.) and the package leaflet.

Water for Injections comes in 5 pack sizes with the following filling volumes: 5 ml, 10, 15, 20 and 30 ml.

2.    BEFORE YOU USE WATER FOR INJECTIONS

The product should not be used if the solution is unclear or if the container is damaged. Pregnancy:

As for the product to be reconstituted.

Interactions with other medicines or other substances:

As for the product to be reconstituted.

Driving and using machines:

As for the product to be reconstituted.

3.    HOW TO USE WATER FOR INJECTIONS

The flip-off cap will be removed and the rubber stopper cleaned with an alcohol swab. A sterile syringe will be used to withdraw the contents of the vial and to reconstitute the parenteral medicinal product. The reconstituted product will be administered to you by intravenous or intramuscular injection.

4.    POSSIBLE SIDE EFFECTS

As for the product to be reconstituted.

5.    STORING WATER FOR INJECTIONS

The product should not be used after the expiry date on the label. Do not store above 25°C. Do not freeze.

Patient Information Leaflet produced: September 2008

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