Informations for option: Water For Injections, show other option

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1. Water For Injections
2. Water For Injections

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Water for Injections

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Water for Injections

3    PHARMACEUTICAL FORM

Solution for injection.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

For use as a diluent for reconstitution of CSL Behring coagulation products

4.2    Posology and method of administration

Posology Not applicable

Method of administration Intravenous injection.

4.3    Contraindications

None.

4.4    Special warnings and precautions for use

None

Interaction with other medicinal products and other forms of interaction

None

4.6    Fertility, pregnancy and lactation

None

4.7    Effects on ability to drive and use machines

None.

4.8    Undesirable effects

None.

4.9    Overdose

None.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Solvent and diluting agent Pharmacodynamics: Not applicable

5.2    Pharmacokinetic properties

Not applicable.

5.3    Preclinical safety data

Not applicable.

6    PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Not applicable.

6.2    Incompatibilities

None.

6.3    Shelf life

60 months

6.4    Special precautions for storage

Avoid freezing which may damage the container.

6.5    Nature and contents of container

Pack sizes    Container details

4 ml, 10 ml, 15 ml, 20 ml    Injection vial clear glass type I (Ph. Eur)

with rubber infusion stopper and cap.

6.6 Special precautions for disposal

Do not use after the expiry date given on the pack and container.

Do not use solutions, which are cloudy or contain residues (deposits/particles). Reconstitution and withdrawal must be carried out under aseptic conditions.

After administration, any unused solution and the administration equipment must be discarded appropriately.

7    MARKETING AUTHORISATION HOLDER

CSL Behring GmbH Emil-von-Behring-Strasse 76 35041 Marburg Germany

8    MARKETING AUTHORISATION NUMBER

PL 15036/0015

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

31st December1997

10 DATE OF REVISION OF THE TEXT

02/07/2015