Water For Injections Bp
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