SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the Veterinary Medicinal Product

Dunlop’s 100% v/v Water for Injections

Solvent for parenteral use

2. Qualitative and Quantitative Composition

Active Substance

Water for injections 100% v/v

Excipients

For a full list of excipients, see section 6.1

3. Pharmaceutical Form

Solvent for parenteral use.

A clear colourless solution

4. Clinical Particulars

4.1 Target species:

As required

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.

4.3 Contraindications:

None.

4.4 Special Warnings for Each Target Species:

No special warnings

4.5 Special Precautions for Use:

Special Precautions for use in animals:

None

Special precautions to be taken by the person administering the product to the animals:

None

4.6 Adverse reactions (frequency and seriousness):

None.

4.7 Use during pregnancy, lactation or lay:

Water for Injections is safe for use during pregnancy and lactation.

4.8 Interactions with other medicinal products and other forms of interaction:

None.

4.9 Amount to be administered and administration route:

For parenteral use.

Dosage: as required

4.10 Overdose (symptoms, emergency procedures, antidotes) (if necessary):

Not Applicable

4.11 Withdrawal periods:

Meat – Zero days

Milk – Zero hours

5. PharmacologicalProperties

Pharmacotherapeutic group:Solvents and diluting agents, incl irrigation solutions

ATCvet Code: QV07AB

5.1 Pharmacodynamic properties:

Not Applicable

6. Pharmaceutical Particulars

None

6.2 Incompatibilities:

None known

6.3 Shelf-life:

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.

6.4 Special precautions forstorage:

Do not store above 25C

Take adequate precautions to maintain sterility.

This product does not contain an antimicrobial preservative

Any water remaining in the vial following withdrawal of the required dose should be discarded.

6.5 Nature and composition of immediate packaging:

Dunlop’s Water for Injection is packaged in 20ml, 50ml and 100ml clear grade I glass vials with bromobutyl bungs and aluminium seals.

Not all pack sizes may be marketed.

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

Norbrook Laboratories Limited

Station Works

Camlough Road

NEWRY

Co. Down, BT35 6JP

Northern Ireland

8. Marketing Authorisation Number

Vm 02000/4237

9. Date of First Authorisation/Renewal of the Authorisation

17^thMay 2004

10. Date of Revision of the Text

September 2008