Sterile Saline Solution (0.9%)
SUMMARY OF PRODUCT CHARACTERISTICS
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
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
PL 00002/0236
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
15th May 1998 / 28/01/2009
10 DATE OF REVISION OF THE TEXT
07/05/2009