Skip to Content

WATER FOR INJECTIONS E.P.

Active substance(s): WATER FOR INJECTIONS

PDF options:  View Fullscreen   Download PDF

PDF Transcript

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
(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
Not applicable
(This product is supplied as a solvent for reconstitution of Targocid injection
100mg, 200mg and 400mg, PL 04425/0087, 88 & 89).

5

PHARMACOLOGICAL PROPERTIES

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

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
02/08/1991 / 07/10/2002

10

DATE OF REVISION OF THE TEXT
24/02/2012

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide