SUMMARY OF PRODUCT CHARACTERISTICS

LINCOCIN STERILE SOLUTION 100 mg/ml Sterile Solution for Injection

Each 1 ml contains 100 mg lincomycin (as lincomycin hydrochloride) plus 9 mg benzyl alcohol as antimicrobial preservative.

Solution for injection.

Dogs, cats and pigs.

Dogs and cats

For the treatment of infections caused by lincomycin-susceptible Gram-positive organisms, particularly Streptococci and Staphylococci, and certain Gram-negative anaerobic organisms e.g. Bacteroides spp. or Fusobacterium spp.

Tonsillitis, laryngitis and other upper respiratory tract infections: The product has proved effective against most causal organisms.

Abscesses, infected wounds and purulent dermatitis: The product has proved useful in clearing dermal infection since it readily penetrates tissues and maintains its action in the presence of purulent material.

Septicaemia: The product has been used successfully to combat septicaemic conditions caused by organisms sensitive to lincomycin.

Pigs

For the treatment of infections caused by lincomycin-susceptible Gram-positive organisms, particularly Streptococci and Staphylococci, and certain Gram-negative anaerobic organisms e.g. Serpulina (treponema) hyodysenteriae, Bacteroides, Fusobacterium spp. and Mycoplasma spp.

Swine dysentery: Lincocin Sterile Solution has been found effective in the treatment of swine dysentery. Lincocin Sterile Solution may be used in the inappetent pig when 1-2 injections with a 24 hour interval given intramuscularly at a dose of 10 mg/kg will normally be adequate to return the appetite. Follow-up treatment should be provided either in feed or via the drinking water.

Enzootic or mycoplasmal pneumonia: the product has antimycoplasmal activity, and will provide an effective aid in the treatment of primary infective organisms and the secondary Gram-positive pathogens.

Septic arthritis, foot abscesses: Where these conditions are caused by staphylococci, streptococci, erysipelothrix and mycoplasma sensitive to lincomycin, this antibiotic provides useful treatment by the virtue of its ability to penetrate relatively avascular tissue (e.g. joints) and remain active in the presence of purulent material.

Not recommended for use in species other than the dog, cat and pig. Do not administer to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants as this could result in severe gastro-intestinal disturbance.

Not to be given to animals with known pre-existing monilial infection.

Not effective against E.coli, Salmonella spp., Streptococcus faecalisor yeasts.

Not to be used in animals hypersensitive to lincosamides.

None.

Not applicable.

Avoid contact with the product. In case of accidental eye or skin contact wash off the affected area thoroughly with water.

Not applicable.

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

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

For intramuscular or intravenous administration in dogs and cats. For intramuscular administration only in pigs.

Dogs and cats:

Intramuscular: 22 mg/kg bwt once daily or11 mg/kg bwt.

Intravenous: 11-22 mg/kg bwt once or twice daily by slow injection.

Pigs:

Intramuscular: 4.5-11 mg/kg bwt once daily for a maximum of 3 days.

When injecting large volumes, a maximum of 10 mls per injection site should be administered. It is recommended that no more than two injections per day are given. At the lowest dose rate of 4.5 mg/kg, the maximum recommended weight of animal for treatment is therefore 445 kg and at the higher dose rate of 11 mg/kg, the maximum weight of animal for treatment will be 180 kg.

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

Animals must not be slaughtered for human consumption during treatment. Pigs may be slaughtered for human consumption only after 3 days from the last treatment.

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 is quickly absorbed and distributed throughout the body, it is significantly metabolised, and is primarily excreted in the faeces as both parent compound and metabolites with large biliary contribution; after a single intramuscular injection at the recommended dose faecal excretion accounted for 38% and urinary excretion for 49% of the total dose. Lincomycin is transported by polymorphonuclear neutrophils to the infection area; this may explain its efficient penetration and targeted activity in tissues difficult to reach.

Benzyl alcohol

Water for injections

None known.

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

Shelf life after first opening the immediate packaging: 21 days.

Do not store above 25ºC. Do not freeze.

Discard contents within 21 days after first use.

Multidose 50 ml and 100 ml glass vials with rubber stopper and aluminium overseal.

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.

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

Vm:42058/4079

Date:20 July 1992

Date:July 2014

10 July 2014