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WATER FOR INJECTIONS E.P.

Active substance(s): WATER FOR INJECTIONS

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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

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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