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Water For Injection Bp

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SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Steri-Amp Water for Injections BP.

2.    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Water for Injections Ph. Eur 100.00%.

3.    PHARMACEUTICAL FORM

Sterile solution for injection.

4.    CLINICAL PARTICULARS

4.1    Therapeutic indications

To be used in preparation or dilution of small volume injections.

4.2    Posology and method of administration

As required.

4.3    Contraindications

Not applicable.

4.4    Special warnings and precautions for use

Do not use unless the product is clear, or if there is evidence of leakage. Discard any surplus after use.

4.5    Interactions 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.

5.3    Preclinical safety data

6. PHARMACEUTICAL PARTICULARS 6.1    List of excipients

None.

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

36 months.

6.4    Special precautions for storage

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

6.5    Nature and contents of container

Plastic ampoule with a snap open closure containing 5ml, l0ml and 20ml.

6.6    Instructions for use and handling

Not applicable.

7    MARKETING AUTHORISATION HOLDER

Norton Healthcare Limited

Trading as Ivax Pharmaceuticals UK

Albert Basin

Royal Docks

London

E16 2QJ

United Kingdom

8. MARKETING AUTHORISATION NUMBER

PL 00530/0686

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

28/10/2005

10    DATE OF REVISION OF THE TEXT

28/10/2005