A white pale powder for use in drinking water, with each gram containing:

Lincomycin (as lincomycin hydrochloride) 222 mg

Spectinomycin (as spectinomycin sulphate) 444.7 mg

For the treatment and metaphylaxis of porcine proliferative enteropathy (ileitis) caused by Lawsonia intracellularis, and associated enteric pathogens (Escherichia coli) susceptible to lincomycin and spectinomycin.

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

For the treatment and metaphylaxis of chronic respiratory disease (CRD) caused by Mycoplasma gallisepticum and Escherichia coli susceptible to lincomycin and spectinomycin, and associated with a low mortality rate.

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

For use in drinking water. The recommended dosage rates are:

3.33 mg lincomycin and 6.67 mg spectinomycin/kg bw/day, for 7 days. This amounts to 15 mg powder/kg bw/day for 7 days.

16.65 mg lincomycin and 33.35 mg spectinomycin/kg bw/day, for 7 days. This amounts to 75 mg powder/kg bw/day for 7 days.

Treatment should be initiated as soon as first clinical signs occur.

For the preparation of drinking water, the incorporation rate of the veterinary medicinal product in water will depend on the bodyweight of the animals and their actual daily intake of water.

To ensure a correct dosage and avoid underdosing, mean bodyweights in the group of animals and daily water consumption should be determined as accurately as possible.

The medicated drinking water should be the sole source of drinking water for the treatment duration. Any medicated water which is not consumed within 24 hours should be discarded.

In case of disease accompanied with significant decrease in water intake, parenteral treatment may have to be initiated.

Use the following indications as a basis for the precise calculation of incorporation rate of the veterinary medicinal product in drinking water.

To determine the volume of dilution (in litres of drinking water) required for 150 g of the veterinary medicinal product, use the following formula:

In pigs 150 g of the veterinary medicinal product corresponds to the dose for 10,000 kg of bodyweight per day. As an indication, standard water intake varies around 0.15 L/kg bw/day. The table below shows the volume of water to be used for dilution of 150 g of the veterinary medicinal product.

To determine the volume of dilution (in litres of drinking water) for 150 g of the veterinary medicinal product, use the following formula:

150 g of the veterinary medicinal product corresponds to the dose for 2,000 kg of bodyweight per day.

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

Do not use in case of hepatic dysfunction.

Do not allow rabbits, rodents (e.g. chinchillas, hamsters, and guinea pigs), horses or ruminants to access to water or feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.

Do not use in laying hens.

It is sound clinical practice to base treatment on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of target bacteria.

Use of the veterinary medicinal product deviating from the instructions in the datasheet (or SPC) may increase the risk of development and selection of resistant bacteria and decrease the effectiveness of treatment with macrolides due to the potential for cross-resistance.

The oral use of preparations containing lincomycin is only indicated in swine and chickens.

Do not leave access to the medicated water for other animals. Lincomycin may lead to severe gastrointestinal disturbances in other animal species.

The repeated or prolonged use should be avoided, by improving the farm management and disinfection practices.

Diagnosis should be reconsidered if improvement is not seen after 5 days.

Sick animals have a reduced appetite and an altered drinking pattern, and severely affected animals may therefore require parenteral treatment.

This powder is for use in drinking water only and should be dissolved before use.

Cases of diarrhoea or soft faeces and/or perianal region inflammation have been encountered in healthy pigs at the start of treatment. The symptoms disappeared within 5 to 8 days without interruption of the treatment. Rare cases of irritability/excitation, skin rash/pruritus were also observed. Allergic/hypersensitive reactions are rare but can occur and require stopping treatment with the veterinary medicinal product. Symptomatic treatment must be implemented.

The frequency of adverse reactions is defined using the following convention:

In the event of overdose in pigs, a change in the consistency of the faeces (soft faeces and/or diarrhoea) may be observed.

In chickens treated at several times the recommended dose, enlargement of the caecum and abnormal caecum content was observed.

In case of accidental overdose, the treatment should be interrupted and restarted at the recommended dose.

Pigs: The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Laboratory studies in dogs and rats have not produced any evidence of reproductive, foetotoxic or teratogenic effects for lincomycin or spectinomycin. Lincomycin is excreted in milk. Use only accordingly to benefit-risk assessment by the responsible veterinarian.

Chickens: Do not use in birds in lay.

In general, mixing with other medicines should be avoided.

The combination of lincosamides and macrolides is antagonistic, due to competitive binding to their target sites. Combination with anaesthetics may lead to possible neuromuscular blocking.

Do not administer with kaolin or pectine as they impair lincomycin absorption. If co-administration is mandatory, respect a delay of two hours between intakes.

Pigs: Meat and offal: Zero days.

Chickens: Meat and offal: 5 days.

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

Animals must not be slaughtered for human consumption during treatment.

People with known hypersensitivity to lincomycin, spectinomycin or soybean millfeed 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 EN 140 with a filter EN 143), gloves and safety glasses should be worn when handling and mixing the product.

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

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.

This veterinary medicinal product does not require any special storage conditions.

In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.

Shelf life after first opening the immediate packaging: 6 months.

Shelf life after dilution according to directions: 24 hours.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Keep out of the sight and reach of children.

For animal treatment only.

White HDPE bottle containing 150 g or 1.5 kg with a white tamper evident LDPE lid and an aluminium cap (150 g pack only). Not all pack sizes may be marketed.

In E. coli, a significant part of the strains show high MIC values (minimum inhibitory concentrations) against the lincomycin-spectinomycin combination and may be clinically resistant, although no breakpoint is defined.

Due to technical constraints the susceptibility of L. intracellularis is difficult to test in vitro, and data about the lincomycin-spectinomycin resistance status in that species are lacking.