© Pfizer Ltd UK
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE VETERINARY MEDICINAL PRODUCT
WATER FOR INJECTION
Solvent for parental use
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of diluent contains 1ml of Water for Injection.
For a full list of excipients see section 6.1
3. PHARMACEUTICAL FORM
Solvent for parental use.
4. CLINICAL PARTICULARS
4.1 Target Species
Dogs and cats.
4.2 Indications for Use, Specifying the Target Species
For use as a sterile diluent to be used with Solu-Medrone V 125mg and 500mg.
For indications of Solu-Medrone V see Vm 00057/4242 (125mg) and Vm 00057/4243 (500mg).
4.3 Contraindications
As a sterile diluent - None.
When mixed with Solu-Medrone V, see relevant MA.
4.4 Special warnings for each target species
Not applicable.
4.5 Special precautions for use
Special precautions for use in animals
Aseptic injection techniques should be practised.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Care should be taken to avoid accidental self-administration of reconstituted solution.
4.6 Adverse reactions (frequency and seriousness)
As a sterile diluent - None.
When mixed with Solu-Medrone V, see relevant MA.
4.7 Use during pregnancy, lactation or lay
As a sterile diluent - None.
When mixed with Solu-Medrone V, see relevant MA.
4.8 Interaction with other medicinal products and other forms of interaction
As a sterile diluent - None.
When mixed with Solu-Medrone V, see relevant MA.
4.9 Amounts to be administered and administration route
For use as a sterile diluent to be used with Solu-Medrone V 125mg and 500mg.
For posology and method of administration of Solu-Medrone V see Vm 00057/4242 and Vm 00057/4243.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Not applicable.
4.11 Withdrawal Period(s)
Not applicable.
5. PHARMACOLOGICAL PROPERTIES
Sterile diluent for use with Solu-Medrone V only.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None.
6.2 Incompatibilities
As a sterile diluent - None.
When mixed with Solu-Medrone V, see relevant MA.
6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 5 years.
Upon reconstitution, use immediately. Discard any unused product.
6.4 Special Precautions for Storage
Do not store above 25°C. Do not freeze, Reconstituted solution should be used immediately.
6.5 Nature and composition of immediate packaging
2ml glass ampoule and 7.8ml glass vial with butyl rubber stopper containing water for injection. To be packaged as a solvent together with Solu-Medrone V 125mg and 500mg as sterile freeze dried powder contained in glass vials with bromo rubber stoppers.
6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products, if appropriate
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
7. MARKETING AUTHORISATION HOLDER
Pfizer Limited
Sandwich
Kent
CT13 9NJ
United Kingdom
8. MARKETING AUTHORISATION NUMBER(S)
Vm 00057/4244
9. DATE OF THE FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
28th January 2003
10. DATE OF REVISION OF THE TEXT
31st July 2007
SPC Water for Injections 24th April 2003
VMD Approved