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Water For Injections

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SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT

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

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

-    Water for Injections 5 ml is presented as a solvent for parenteral use containing 5 ml of Water for Injections (Ph. Eur.)

-    Water for Injections 10 ml is presented as a solvent for parenteral use containing 10 ml of Water for Injections (Ph. Eur.)

-    Water for Injections 15 ml is presented as a solvent for parenteral use containing 15 ml of Water for Injections (Ph. Eur.)

-    Water for Injections 20 ml is presented as a solvent for parenteral use containing 20 ml of Water for Injections (Ph. Eur.)

-    Water for Injections 30 ml is presented as a solvent for parenteral use containing 30 ml of Water for Injections (Ph. Eur.)

3. PHARMACEUTICAL FORM

Solvent for parenteral use

4. CLINICAL PARTICULARS

4.1. Therapeutic indications

Used for the reconstitution of freeze-dried human plasma fractions

4.2. Posology and method of administration

As for the product to be reconstituted

4.3.    Contraindications

As for the product to be reconstituted.

4.4.    Special warnings and precautions for use

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

As for the product to be reconstituted.

4.5.    Interactions with other medicinal products and other forms of interaction

As for the product to be reconstituted.

4.6.    Pregnancy and lactation

As for the product to be reconstituted.

4.7.    Effects on ability to drive and use machines

As for the product to be reconstituted.

4.8.    Undesirable effects

As for the product to be reconstituted

4.9.    Overdose

As for the product to be reconstituted

Not applicable.

5.2.    Pharmacokinetic properties

Not applicable

5.3.    Preclinical safety data

Not applicable

6. PHARMACEUTICAL PARTICULARS

6.1.    List of excipients

None

6.2.    Incompatibilities

None known.

6.3.    Shelf life

42 months

6.4.    Special precautions for storage

Do not store above 25°C. Do not freeze.

6.5


Nature and contents of container

Water for Injections is supplied in colourless Type I glass vials with a bromobutyl rubber stopper and covered with a flip off cap.

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

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

6.6 Instruction for use and handling (, and disposal)

Before use, the flip-off cap is removed and the rubber stopper cleaned with an alcohol swab. A sterile syringe is used to withdraw the contents of the vial and to reconstitute the freeze-dried human plasma fractions.

7    MARKETING AUTHORISATION HOLDER

Octapharma Ltd.

The Zenith Building,

26 Spring Gardens Manchester M2 1AB United Kingdom

8.    MARKETING AUTHORISATION NUMBER

PL 10673/0023

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

02/12/2008

10    DATE OF REVISION OF THE TEXT

31/01/2012