Sterile Saline Solution (0.9%)

1. Name Of The Medicinal Product

Sterile Saline Solution (0.9%)

2. Qualitative And Quantitative Composition

None

3. Pharmaceutical Form

Diluent containing sterile solution for the reconstitution of lyophilised vaccine preparations.

4. Clinical Particulars

4.1 Therapeutic Indications

For reconstitution of lyophilised vaccines.

4.2 Posology And Method Of Administration

Subcutaneous or intramuscular injection.

4.3 Contraindications

As for the product to be reconstituted.

4.4 Special Warnings And Precautions For Use

As for the product to be reconstituted.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

As for the product to be reconstituted.

4.6 Pregnancy And Lactation

As for the product to be reconstituted.

4.7 Effects On Ability To Drive And Use Machines

As for the product to be reconstituted.

4.8 Undesirable Effects

As for the product to be reconstituted.

4.9 Overdose

As for the product to be reconstituted.

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

Sodium Chloride

Water for Injection

6.2 Incompatibilities

As for the product to be reconstituted.

6.3 Shelf Life

60 months.

6.4 Special Precautions For Storage

Protect from light, store between 2°C and 8°C. Do not freeze.

6.5 Nature And Contents Of Container

Type I, Ph Eur glass syringes with or without needles, fitted with rubber stoppers. The stoppers are attached to a polypropylene or polystyrene plunger.

This diluent is for use with the following vaccines:

Hiberix	PL 10592/0120
ACWY Vax	PL 10592/0014

6.6 Special Precautions For Disposal And Other Handling

As for the product to be reconstituted.

7. Marketing Authorisation Holder

Smith Kline & French Laboratories Limited

Great West Road, Brentford, Middlesex TW8 9GS

Trading as:

GlaxoSmithKline UK, Stockley Park West, Uxbridge, Middlesex, UB11 1BT

Or

SmithKline Beecham Pharmaceuticals*

*At the time of printing, only the marketed trading style will be printed

8. Marketing Authorisation Number(S)

PL 00002/0236

9. Date Of First Authorisation/Renewal Of The Authorisation

15 May 1998 / 28/01/2009

10. Date Of Revision Of The Text

07/05/2009