1. NAME OF THE MEDICINAL PRODUCT

Bacteriostatic Saline for Injection

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Each vial contains sodium chloride, 0.9% w/v.

Excipient(s) with known effect

Each vial contains benzyl alcohol, 0.9% w/v.

For the full list of excipients, see section 6.1

3.    PHARMACEUTICAL FORM

Sterile Solution

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

To be used to reconstitute certain medicinal products.

4.2    Posology and method of administration

Extra-amniotic only.

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    Fertility, pregnancy and lactation

Not applicable.

4.7    Effects on ability to drive and use machines

Not applicable.

4.8 Undesirable effects

Benzyl alcohol is contained in the diluent and has been reported to be associated with a fatal "gasping syndrome" in premature infants.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov .uk/yellowcard.

4.9    Overdose

Not applicable.

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Solvents and diluting agents, incl. irrigating solutions, ATC code: V07AB

5.2    Pharmacokinetic properties

Not applicable.

5.3    Preclinical safety data

Not applicable.

6.1    List of excipients

Benzyl alcohol Sterile water for injection

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

5 years.

6.4    Special precautions    for storage

Store below 25°C. Discard any remaining solution after use.

6.5    Nature and contents of container

Type I flint glass vials and rubber closures (EP) which are sealed with a flip-top aluminium cap. Vials contain 18.5 ml or 50 ml.

6.6    Special precautions for disposal

No special requirements.

7 MARKETING AUTHORISATION HOLDER

Pfizer Limited Ramsgate Road Sandwich Kent CT13 9NJ UK

8 MARKETING AUTHORISATION NUMBER(S)

PL 00057/1513

9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

Date of first authorisation: 15 February 1990 Date of latest renewal: 23 May 2003

10 DATE OF REVISION OF THE TEXT

08/09/2016