iMedi.co.uk

Water For Injections E.P.

SUMMARY OF PRODUCT CHARACTERISTICS

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

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

Not applicable

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

Not applicable.

(This product is supplied as a solvent for reconstitution of Targocid injection 100mg, 200mg and 400mg, PL 04425/0087, 88 & 89).

6 PHARMACEUTICAL PARTICULARS

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


Shelf life

5 years

6.4 Special precautions for storage

None

6.5 Nature and contents of container

Colourless, 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

8    MARKETING AUTHORISATION NUMBER(S)

PL 04425/0090

DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

02/08/1991 / 07/10/2002

10


DATE OF REVISION OF THE TEXT

24/02/2012