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Water For Injections

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Document: document 15 change

PRODUCT SUMMARY

1.    NAME OF THE MEDICINAL PRODUCT

Water for Injections BP.

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Not applicable.

3.    PHARMACEUTICAL FORM

Injection.

4.    CLINICAL PARTICULARS

4.1    Therapeutic Indications

As a diluent.

4.2    Posology and Method of Administration

Route of Administration Parenteral.

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 BP

6.2.    Incompatibilities

Not applicable.

6.3.    Shelf Life

3 years.

6.4.    Special Precautions for Storage

Store below 30°C

6.5.    Nature and Content of Container

Colourless 2ml type 1 neutral glass ampoules.

6.6.    Instruction for Use, Handling and Disposal

Not applicable.

ADMINISTRATIVE DATA

7.    MARKETING AUTHORISATION HOLDER

Glaxo Wellcome UK Limited

Stockley Park West

Uxbridge

Middlesex

UB11 1BT

8.    MARKETING AUTHORISATION NUMBER(S)

PL 10949/0092

9.    DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

15th October 1998

10.    DATE OF (PARTIAL) REVISION OF THE TEXT

June 1998. This is the first SmPC.