Summary of Product Characteristics (SmPC) - Water for Injections E.P
1 NAME OF THE MEDICINAL PRODUCT
Water for Injections Ph Eur
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
None
3 PHARMACEUTICAL FORM
Injection (solvent for reconstitution).
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Not applicable
(This product is supplied as a solvent for reconstitution of Targocid injection 100mg, 200mg and 400mg, PL 04425/0087, 88 & 89).
4.2 Posology and method of administration
Not applicable
(This product is supplied as a solvent for reconstitution of Targocid injection 100mg, 200mg and 400mg, PL 04425/0087, 88 & 89).
4.3 Contraindications
Not applicable
(This product is supplied as a solvent for reconstitution of Targocid injection 100mg, 200mg and 400mg, PL 04425/0087, 88 & 89).
4.4 Special warnings and precautions for use
Not applicable
(This product is supplied as a solvent for reconstitution of Targocid injection 100mg, 200mg and 400mg, PL 04425/0087, 88 & 89).
4.5 Interaction with other medicinal products and other forms of interaction
Not applicable
(This product is supplied as a solvent for reconstitution of Targocid injection 100mg, 200mg and 400mg, PL 04425/0087, 88 & 89).
4.6 Pregnancy and lactation
Not applicable
(This product is supplied as a solvent for reconstitution of Targocid injection 100mg, 200mg and 400mg, PL 04425/0087, 88 & 89).
4.7 Effects on ability to drive and use machines
Not applicable
(This product is supplied as a solvent for reconstitution of Targocid injection 100mg, 200mg and 400mg, PL 04425/0087, 88 & 89).
4.8 Undesirable effects
Not applicable
(This product is supplied as a solvent for reconstitution of Targocid injection 100mg, 200mg and 400mg, PL 04425/0087, 88 & 89).
4.9 Overdose
4.9 OverdoseNot applicable
(This product is supplied as a solvent for reconstitution of Targocid injection 100mg, 200mg and 400mg, PL 04425/0087, 88 & 89).
5.1 Pharmacodynamic properties
Not applicable.
(This product is supplied as a solvent for reconstitution of Targocid injection 100mg, 200mg and 400mg, PL 04425/0087, 88 & 89).
5.2 Pharmacokinetic properties
Not applicable.
(This product is supplied as a solvent for reconstitution of Targocid injection 100mg, 200mg and 400mg, PL 04425/0087, 88 & 89).
5.3 Preclinical safety data
5.3 Preclinical safety dataNot applicable.
(This product is supplied as a solvent for reconstitution of Targocid injection 100mg, 200mg and 400mg, PL 04425/0087, 88 & 89).
6.1 List of excipients
Water for Injection Ph.Eur.
(Solvent for reconstitution of Targocid injection 100mg, 200mg and 400mg, PL 04425/0087, 88 & 89).
6.2 Incompatibilities
None stated
6.3
5 years
6.4 Special precautions for storage
None
6.5 Nature and contents of container
6.5 Nature and contents of containerColourless, BP Type I glass ampoule.
Pack size: l.8m1 and 3.2ml.
6.6 Special precautions for disposal None stated.
7 MARKETING AUTHORISATION HOLDER
Aventis Pharma Limited
One Onslow Street
Guildford
Surrey
GU1 4YS
UK
Trading Styles: “Marion Merrell” and “Aventis Pharma”
or trading as
Sanofi-aventis or Sanofi
One Onslow Street
Guildford
Surrey
GU1 4YS
UK