SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

LINCOCIN™ SOLUBLE POWDER

400mg/g Powder for Oral Solution

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 1 gram contains 400 mg lincomycin (as lincomycin hydrochloride).

3. PHARMACEUTICAL FORM

Powder for oral solution.

4. CLINICAL PARTICULARS

4.1 Target species

Pigs.

4.2 Indications for use, specifying the target species

For the treatment of swine dysentery by oral administration via the drinking water.

4.3 Contraindications

Not applicable

None.

4.5 Special precautions for use

(i) Special precautions for use in animals

Not to be administered to animals with known hypersensitivity.

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

Persons who are hypersensitive (allergic) to the ingredients in this product should handle the product with care. Following eye contamination, the area should be flushed with water for 10-15 minutes.

Avoid contact with the product or inhaling dust. If accidental skin contact occurs, wash off with soap and water.

4.6 Adverse reactions (frequency and seriousness)

Occasionally, pigs given lincomycin-medicated water may, within the first 2 days after onset of treatment, develop soft stools and/or mild swelling of the anus. On rare occasions some pigs may show reddening of the skin and mild irritable behaviour. These conditions are usually self-correcting within 5-8 days without discontinuing the lincomycin treatment. If clinical signs of swine dysentery have not improved during the first 6 days of medication, discontinue treatment and re-determine the diagnosis.

Limited studies in experimental animals did not reveal any problems when lincomycin was used during pregnancy or lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Antagonism may exist between lincomycin and erythromycin and concurrent use is therefore not recommended.

4.9 Amounts to be administered and administration route

Dosage is based on an approved dosage level of 33 mg lincomycin (as lincomycin hydrochloride) per 1 litre of water as the sole source of drinking water for the pig.

Administration of 7.5 g (1 sachet) Lincocin Soluble Powder dissolved in 91 litres (20 gallons) water will provide a concentration of 33 mg lincomycin (as lincomycin hydrochloride) in 1 litre of water.

The 150g pack added to 1820 litres (400 gallons) of water will provide a concentration of 33 mg lincomycin (as lincomycin hydrochloride) in 1 litre of water.

When using a water proportioner, prepare a stock solution by dissolving the contents of one sachet (7.5 g) per litre of water. Set the proportioner to deliver 11 ml of Stock Solution per litre of drinking water.

Treatment should be administered for a 10-day period or at least 5 days after clinical signs disappear.

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

Higher levels of dosage than recommended may cause diarrhoea and loose stools in pigs.

Zero days.

5. PHARMACOLOGICAL PROPERTIES

Lincomycin is a lincosamide antibiotic and is produced by Streptomyces lincolnensis.It is bacteriostatic and primarily active against Gram-positive bacteria (both aerobic and anaerobic), Gram-negative anaerobic bacteria and mycoplasma.

The mode of action is inhibition of protein synthesis at the ribosomal 50S sub-unit level. Lincomycin has about 50% systemic bioavailability by the oral route in pigs. It is primarily excreted in the faeces as both parent compound and metabolites with large biliary contribution. Lincomycin is transported by polymorphonuclear neutrophils to the infection area; this may explain its efficient penetration and targeted activity in tissues difficult to reach.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Colloidal Anhydrous silica

Lactose Monohydrate

6.2 Incompatibilities

None.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 5 years.

Shelf life after dilution or reconstitution according to directions: 2 days

6.4. Special precautions for storage

Do not store above 25ºC. Discard medicated drinking water if not used within 2 days.

6.5 Nature and composition of immediate packaging

High density polyethylene tub with a tamper evident low density polyethylene lid, containing 150 grams.

6.6 Special precautions for the disposal of unused veterinary medicinal product 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

Zoetis UK Limited

5^thFloor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm 42058/4078

9. RENEWAL OF THE AUTHORISATION

21^stJanuary 2008

10. DATE OF REVISION OF THE TEXT

August 2013

Approved:07/08/2013