Sterile water for injection

Summary of Product Characteristics Updated 20-Feb-2015 | Pfizer Limited

1. Name of the medicinal product

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

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

Not applicable.

6. Pharmaceutical particulars

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 and other handling

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

02/2015

Ref: SW 2_1

Company Contact Details

Pfizer Limited

Address

Ramsgate Road, Sandwich, Kent, CT13 9NJ

Medical Information Website

www.pfizermedicalinformation.co.uk

Telephone

+44 (0)1304 616 161

Medical Information Direct Line

+44 (0)1304 616161