SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Sterile water for injection

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Sterile Water for Injection Ph. Eur. 100% w/v.

3    PHARMACEUTICAL FORM

Solution for injection or infusion

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

To be used to reconstitute certain medicinal products.

4.2    Posology and method of administration

Intramuscular or intravenous injection.

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

4.6    Fertility, 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

Not applicable.

6.1    List of excipients

Not applicable.

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

60 months.

6.4    Special precautions for storage

Discard any remaining solution after use.

6.5    Nature and contents of container

Ampoules:    Glass class I Ph. Eur., containing 1ml, 2ml, 3.2ml, 5ml or 10ml.

Vials: Glass class I Ph. Eur., containing 4ml, 7.8ml, 10ml, 15.6ml or 31.2ml.

All rubber stoppers for the vials used comply with Ph.Eur. testing for rubber closures.

6.6    Special precautions for disposal

No special requirements.

7    MARKETING AUTHORISATION HOLDER

Pfizer Limited Ramsgate Road Sandwich Kent

CT13 9NJ

8    MARKETING AUTHORISATION NUMBER(S)

PL 00057/1436

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

13 February 1990/19 May 1995

10    DATE OF REVISION OF THE TEXT

18/02/2015