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Water For Injections

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Document: document 9 change

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Water for Injections Ph.Eur.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Not applicable


3    PHARMACEUTICAL FORM

Solution for Injections

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

For use as a diluent for reconstitution of injectables

4.2 Posology and method of administration

Not applicable

4.3 Contraindications

Not applicable

4.4 Special warnings and precautions for use

Not applicable

4.5 Interaction with other medicinal products and other forms of interaction

Not applicable

4.6 Pregnancy and lactation

Not applicable

4.7 Effects on ability to drive and use machines

Not applicable

4.8 Undesirable effects

Not applicable

4.9 Overdose

Not applicable

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Not applicable

5.2 Pharmacokinetic properties

Not applicable

Preclinical safety data

5.3


Not applicable

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Not applicable

6.2 Incompatibilities

No known incompatibilities.

6.3 Shelf life

60 months.

6.4 Special precautions for storage

Do not store above 30°C. Do not freeze.

6.5 Nature and contents of container

Glass Type I 10 ml syringe for 5 ml

Glass Type I 10 ml syringe for 10 ml Glass Type I 20 ml syringe for 15 ml

6.6 Special precautions for disposal

For use as a diluent for reconstitution of lyophilised injectables

7    MARKETING AUTHORISATION HOLDER

Grifols UK Ltd

St Andrews Road Cambridge CB4 1DP

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MARKETING AUTHORISATION NUMBER(S)

PL 04447/0016

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

5th October 1989

DATE OF REVISION OF THE TEXT

25/04/2008

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