Water For Injections 100% V/V Solvent For Parenteral Use
Revised 19 November 2008
SUMMARY OF PRODUCT CHARACTERISTICS
1. Name of the veterinary medicinal product
Water For Injection 100%v/v Solvent for Parenteral Use.
2. Qualitative and quantitative composition
Water for Injections 100% v/v
For full list of excipients see section 6.1
3. Pharmaceutical form
Solvent for parenteral use.
A clear, colourless sterile solvent.
4. Clinical Particulars
4.1 Target species
4.2 Indications for use, specifying the target species
For use as a sterile solvent for the preparation of medicines intended for parenteral administration where water is a component of the preparation and for reconstituting or diluting medicines for parenteral administration immediately before use.
4.4 Special Warnings for each target species
No special warnings
4.5 Special precautions for use
Special precautions for use in animals
Special precautions to be taken by the person administering the veterinary medicinal product to animals
4.6 Adverse reactions (frequency and seriousness)
4.7 Use during pregnancy, lactation or lay
Water for Injections is safe for use during pregnancy and lactation.
4.8 Interaction with other medicinal products and other forms of interaction
4.9 Amounts to be administered and administration route
For parenteral use.
Dosage: as required
Overdose (symptoms, emergency procedures, antidotes), if necessary
Meat - Zero days Milk – Zero hours
5. pharmacological properties
6. Pharmaceutical particulars
6.1 List of excipients
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Special precautions for storage
Do not store above 25C
Take adequate precautions to maintain sterility.
Any solution remaining in the vial following withdrawal of the required dose should be discarded.
This product does not contain an antimicrobial preservative.
Nature and composition of immediate packaging
20ml, 50ml and 100ml clear grade I glass vials with bromobutyl bungs and aluminium seals.
Not all pack sizes may be marketed.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
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
Norbrook Laboratories Limited
Co. Down, BT35 6JP
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION
17th May 1994
10. DATE OF REVISION OF THE TEXT