Medine.co.uk

Water For Injections

Informations for option: Water For Injections, show other option
Document: spc-doc_PL 01883-6160R change

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Water for Injections BP

2.    QUALITATIVE AND QUANTITATIVE COMPOSITION

Water for Injections BP 100%

3.    PHARMACEUTICAL FORM

Solvent for parenteral use

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

As a diluent for injections.

4.2    Posology and Method of administration

Not applicable.

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 Preclinical Safety Data

No additional pre-clinical data of relevance to the prescriber is available.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

None.

6.2 Incompatibilities

None stated.

6.3 Shelf Life

60 months.

6.4 Special Precautions for Storage

None stated.

6.5    Nature and contents of container

Clear type 1 Ph Eur glass ampoules each containing sufficient product to allow removal of the volume stated on the product label. 1, 2, 5, 10, 20 or 50ml are marketed in cardboard outers of 10 ampoules. The 1ml ampoules are also marketed in cardboard outers of 660 ampoules.

6.6    Instructions for Use, Handling and Disposal

None stated.

7 MARKETING AUTHORISATION HOLDER

Macarthys Laboratories Limited

T/A Martindale Pharmaceuticals

Bampton Road

Harold Hill

Romford

RM3 8UG

8. MARKETING AUTHORISATION NUMBER

PL 1883/6160R

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

First authorised : 8 October 1988

10 DATE OF REVISION OF THE TEXT

03/10/2011