Summary of medicine characteristics - BACTERIOSTATIC SOLVENT (0.3%W/V METACRESOL IN WFI)
Bacteriostatic solvent (0.3% w/v metacresol in WFI).
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each cartridge contains not less than 1.37 ml of bacteriostatic solvent composed of a 0.3% w/v solution of metacresol in Water for injections Ph Eur.
Aqueous solution for injection.
4.1 Therapeutic indications
Bacteriostatic solvent (0.3% w/v metacresol in WFI) is supplied for reconstitution of Saizen 8 mg lyophilised product.
4.2 Posology and method of administration
1.37 ml to be used to reconstitution a 8 mg SAIZEN vial to produce 5.83 mg/ml.
4.3 Contraindications
4.3 ContraindicationsNot applicable.
4.4 Special warnings and precautions for use
Rarely, metacresol as a preservative may be associated with hypersensitivity reactions.
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
Not applicable.
4.9 Overdose
Not applicable.
5.1
5.2
Pharmacodynamic properties
Not applicable.
Pharmacokinetic properties
Not applicable.
5.3
Preclinical safety data Not applicable.
6.1 List of excipients
Water for Injections Ph Eur
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
6.4 Special precautions for storage Store below 25°C.
6.5 Nature and contents of container
6.5 Nature and contents of containerClear, colourless, neutral glass type I, cartridge which is fitted with an aluminium cap/rubber liner and a movable rubber plunger (thread piston).
6.6 Special precautions for disposal Store below 25°C.
MARKETING AUTHORISATION HOLDER
Merck Serono Limited
5 New Square
Bedfont Lakes Business Park
Feltham
Middlesex
TW14 8HA
UK
8 MARKETING AUTHORISATION NUMBER(S)
PL 11648/0260
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
16th July 1998.