SUMMARY OF PRODUCT CHARACTERISTICS

1. Name of the veterinary medicinal product

Ketosaid 99.96% w/w Oral Solution

2. Qualitative and quantitative composition

Active Substance:

Each ml contains 0.9996 ml of active substance

Qualitative composition Quantitative composition

Propylene glycol 99.96% w/w

Excipients:

Carmoisine 0.04% w/w

For a full list of excipients, see section 6.1

3. Pharmaceutical form

Oral solution

A red, viscous, non-aqueous solution

4. Clinical Particulars

4.1 Target species

Cattle

Sheep

4.2 Indications for use, specifying the target species

Ketosaid is used as an aid in the treatment of acetonaemia and ketosis in cattle and sheep.

4.3 Contraindications

For oral administration only.

4.4 Special Warnings for each target species

None

4.5 Special precautions for use

Special precautions for use in animals

As Ketosis in sheep arises from prenatal metabolic stress, treatment with Ketosaid may be continued until symptoms resolve or until parturition. During this time a general improvement in nutritional status is recommended.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

In case of accidental eye contact, wash eyes with plenty of clean water. If irritation occurs, seek medical attention. In case of contact with skin, remove any contaminated clothing and wash affected area thoroughly with soap and water. If irritation occurs seek medical advice.

Ingestion: If accidentally swallowed, seek medical advice.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

No known undesirable effects.

4.7 Use during pregnancy, lactation or lay

Ketosaid can be safely administered to pregnant and lactating animals.

4.8 Interaction with other medicinal products and other forms of interaction

None

4.9 Amounts to be administered and administration route

Cattle: 200 ml twice daily on first day and 100 ml twice daily for next three days, administered orally as a drench.

Sheep: 100 ml daily for four days, administered orally as a drench.

Prior to administration, doses should be measured accurately by decanting Ketosaid from this container into a clear, dry, suitably sized vessel graduated in millilitres (e.g. measuring jug).

None

Meat: Zero days

Milk: Zero hours

5. pharmacological properties

Pharmacotherapeutic group: Propylene Glycol

ATC Vet Code: QA16QA01

5.1 Pharmacodynamic properties

Propylene glycol is present as an energy source. It is readily absorbed from the rumen and is glycogenic, the intermediate oxidation products being pyruvate and lactate. When administered over a 3- 4 day period propylene glycol is effective in elevating blood glucose levels.

6. Pharmaceutical particulars

6.1 List of excipients

Carmoisine (E122)

6.2 Incompatibilities

None known

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

Do not store above 25^oC.

A white, opaque, high density polyethylene can, with a white polypropylene cap (screw fit). Contains either; 1, 2.5, 5 and 10 litres.

Not all pack sizes may be marketed.

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

Newry

Co. Down, BT35 6JP

Northern Ireland

8. MARKETING AUTHORISATION NUMBER(S)

Vm 02000/4072

30 June 1986

10. DATE OF REVISION OF THE TEXT

28 August 2008