Pigs and chickens.

Treatment and metaphylaxis of enzootic pneumonia caused by Mycoplasma hyopneumoniae.

The presence of the disease in the group must be established before the product is used.

Treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens.

The presence of the disease in the group must be established before the product is used.

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

Do not administer, and do not allow access to water containing lincomycin, to rabbits, hamsters, guinea pigs, chinchillas, horses or ruminants as this could result in severe gastro-intestinal disturbance.

Do not use in cases of known resistance to lincosamides.

Do not use in cases of hepatic dysfunction.

Medicated drinking water uptake can be affected by the severity of the disease. In case of insufficient uptake of water, pigs should be treated parenterally.

The susceptibility of Mycoplasma hyopneumoniae to antimicrobial agents is difficult to test in vitro owing to technical constraints. In addition, there is a lack of clinical breakpoints for both M. hyopneumoniae and C. perfringens. Where possible, therapy should be based on local (regional, farm level) epidemiological information concerning the response of enzootic pneumonia/necrotic enteritis to treatment with lincomycin.

Use of the veterinary medicinal product preferably should be based on identification of the target pathogen and susceptibility testing of the bacteria isolated from the animal. See also the above special warnings for each target species.

Official, national and regional antimicrobial policies should be taken into account when the veterinary medicinal product is used.

Use of the veterinary medicinal product deviating from the instructions given in the summary of product characteristics may increase the prevalence of bacteria resistant to the lincomycin and may decrease the effectiveness of treatment with other lincosamides, macrolides and streptogramin B due to the potential for cross-resistance.

Repeated or prolonged use should be avoided by improving the farm management and hygiene practices.

This product contains lincomycin and lactose monohydrate, either of which can cause allergic reactions in some people. People with known hypersensitivity to lincomycin or any other lincosamide, or to lactose monohydrate, should avoid contact with the veterinary medicinal product.

Care should be taken not to raise and inhale any dust.

Contact with skin and eyes should be avoided.

Personal protective equipment consisting of approved dust masks (either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator conforming to European Standard EN140 with a filter EN143), gloves and safety glasses should be worn when handling and mixing the product. If respiratory symptoms develop following exposure, seek medical advice and show this warning to the physician.

In case of accidental exposure to the skin, eyes or mucous membranes, wash the affected area thoroughly with plenty of water. If symptoms such as skin rash or persistent eye irritation appear after exposure, seek medical advice immediately and show the package leaflet or label to the physician.

Wash hands and any exposed skin with soap and water immediately after use.

Do not eat, drink or smoke while handling the product.

None.

None.

Chickens:

None known.

Pigs:

Rare (1 to 10 animals / 10,000 animals treated):

Irritability1,2 Diarrhoea3 Hypersensitivity reaction, Anal oedema (swelling)2,3 Reddening of the skin1

1 Usually self-correcting within 5-8 days without discontinuing the lincomycin treatment.

2 Mild.

3 Within the first 2 days after onset of treatment.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

The safety of the veterinary medicinal product has not been established during pregnancy, lactation or lay.

Laboratory studies in rats have not produced any evidence of teratogenic effects, although foetotoxicity has been reported. Use only according to the benefit-risk assessment by the responsible veterinarian.

Antagonism may exist between lincomycin and macrolides such as erythromycin and other bactericidal antibiotics; concurrent use is therefore not recommended due to competitive binding at the 50S ribosomal subunit of the bacterial cell.

The bioavailability of lincomycin may decrease in the presence of gastric antacids or activated charcoal, pectin or kaolin.

Lincomycin can potentiate neuromuscular effects of anaesthetics and muscle relaxants.

For use in drinking water.

To ensure a correct dosage, body weight should be determined as accurately as possible.

The intake of medicated water depends on the physiological and clinical condition of the animals. In order to obtain the correct dosage, the concentration of the lincomycin has to be adjusted accordingly.

The uptake of water should be monitored frequently.

The medicated water should be the only source of drinking water for the animals for the entire duration of the treatment period.

After the end of the medication period, the water supply system should be cleaned appropriately to avoid intake of sub-therapeutic amounts of the active substance.

Enzootic pneumonia: 10 mg lincomycin per kg of body weight (corresponding to 25 mg product per kg bodyweight) for 21 consecutive days.

Necrotic enteritis: 5 mg lincomycin per kg of body weight (corresponding to 12.5 mg product per kg bodyweight) for 7 consecutive days.

Based on the recommended dose and the number and weight of animals to be treated, the exact daily concentration of the veterinary medicinal product should be calculated according to the following formula:

A dosage greater than 10 mg lincomycin per kg of body weight may cause diarrhoea and loose stools in pigs.

In case of accidental overdose, the treatment must be stopped and restarted at the recommended dose level.

There is no specific antidote, treatment is symptomatic.

Meat and offal: 1 day.

Chickens:

Meat and offal: 5 days.

Not for use in birds producing or intended to produce eggs for human consumption.