Medine.co.uk

Water For Injections Ph.Eur.

Document: spc-doc_PL 00101-0479 change

SUMMARY OF PRODUCT CHARACTERISTICS

PRODUCT SUMMARY

1.    NAME OF THE MEDICINAL PRODUCT

Water for Injection Ph.Eur.

2.    QUALITATIVE AND QUANTITATIVE    COMPOSITION

Water for injections 100.0 v/v

3.    PHARMACEUTICAL FORM

Solvent or suspension medium in ampoules    for dry    substances    for injection.

4.    CLINICAL PARTICULARS

4.1.    Therapeutic Indications

Not applicable (to be used as a suspension for a prescription only medicine).

4.2.    Posology and Method of Administration

As 4.1

4.3.    Contra-Indications

Not applicable.

4.4.    Special Warnings and Special Precautions for Use

Not applicable.

4.5.    Interactions with other Medicinal Products and other Forms of Interaction

Not applicable.

4.6.    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.    PHARMACOLOGICAL PROPERTIES

5.1.    Pharmacodynamic Properties

Not applicable.

5.2.    Pharmacokinetic Properties

Not applicable.

5.3.    Pre-clinical Safety Data

Not applicable.

6.    PHARMACEUTICAL PARTICULARS

6.1.    List of Excipients

Water for Injections Ph.Eur. 100.0 v/v

6.2.    Incompatibilities

None

6.3.    Shelf-Life

6.4.    Special Precautions for Storage

None.

6.5.    Nature and Content of Container

Colourless glass ampoules, Glass Type I, according to Ph.Eur. in packs containing 5 or 10 ampoules.

6.6.    Instructions for Use, Handling and Disposal

None.

ADMINISTRATIVE DATA

7. MARKETING AUTHORISATION HOLDER

Novartis Pharmaceuticals UK Limited

T/A Ciba Laboratories

Frimley Business Park

Camberley

Surrey

GU6 7SR

8.    MARKETING AUTHORISATION NUMBER(S)

PL 00101/0479

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION

1 August 1997

10.    DATE OF (PARTIAL) REVISION OF THE TEXT

November 1997