SINTIL 60%

COMPOSITION

Each g of product contains tylosin tartrate 600 mg

TARGET SPECIES

Pigs and broilers

INDICATIONS

Pigs - Treatment of dysentery and enzootic pneumonia.

Broilers - Treatment of necrotic enteritis and avian mycoplasmosis produced by tylosin-susceptible germs.

CONTRAINDICATIONS

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

ADVERSE REACTIONS

None known.

DOSAGE FOR EACH SPECIES, METHOD AND ROUTE(S) OF ADMINISTRATION

The treatment consists of oral administration of Sintil 60% in drinking water, individually or in mass, for 5 consecutive days at different doses, depending on species, age, body weight, physiological status and state of health. For the mass treatment, we recommend correct calculation of body weight and quantity of product to be administered.

In pigs - Administer a dose of 10-20 mg a.s./kg bw/day, respectively 17-34 mg SINTIL 60%/kg bw/day for 5 days.

In broilers - Administer a dose of 50-100 mg a.s./kg bw/day, respectively 84-168 mg SINTIL 60%/kg bw/day for 5 days. 

WARNINGS/ADVICE ON CORRECT ADMINISTRATION

Ingestion of medicated water by animals may be iimpaired by the disease. In case of insufficient water ingestion, the treatment schedule will be reviewed. Medicated drinking water should be freshly prepared every 24 hours.

To ensure a correct dose, the body weight of the animals should be accurately determined, whenever possible, to avoid underdosing.

WITHDRAWAL PERIOD(S)

Pigs - meat and offal: 1 day

Broilers - meat and offal: 5 days

Do not use in poultry laying eggs for human consumption.

SPECIAL PRECAUTIONS FOR STORAGE

Keep out of the sight and reach of children. Do not store above 25°C. Do not refrigerate or freeze. Store in the original package. Store in a dry place. Keep away from direct light. Do not use after the expiry date printed on the label.

SHELF LIFE

Shelf life of the veterinary medicinal product as packaged for sale: 2 years. Shelf-life after first opening the immediate packaging: 28 days. Shelf-life after reconstitution in drinking water: 24 hours.

SPECIAL PRECAUTIONS FOR EACH TARGET SPECIES

None.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS

The use of the product should be based on susceptibility testing of bacteria isolated from animals. If this is not possible, therapy should be based on local epidemiological information on the target bacteria’s susceptibility. National and regional antimicrobial policies shall be observed when using the product. Using the product in violation of the instructions in the SmPC may increase the prevalence of tylosin resistance and may decrease the effectiveness of antimicrobial treatments in the macrolide group as a result of cross-resistance.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE PRODUCT:

Tylosin may cause irritation of the respiratory tract and eyes in case of inhalation or contact. 

Adequate protective measures should be taken during handling of the product.

The personnel handling the product must wear goggles and protective masks.

In case of accidental contact with eyes, wash with water and soap.

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

In the case of accidental ingestion, seek advice from a physician, presenting the package leaflet.

USE DURING PREGNANCY, LACTATION AND EGG-LAYING PERIOD

Do not use in poultry laying eggs for human consumption.

Studies in laboratory animals have revealed no embryotoxic or teratogenic potential.

Product safety has not been demonstrated during the gestation and lactation period.

Product can be administered during gestation and lactation after the risk-benefit ratio has been assessed by a veterinarian.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION

None known.

OVERDOSE (SYMPTOMS, EMERGENCY PROCEDURES, ANTIDOTES)

The recommended doses should be observed.

INCOMPATIBILITIES

The absorption of the active substance is reduced by iron and calcium- and/or magnesium-containing acids.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY

Medicines should not be disposed of via waste water or household waste.

Ask your vet for information on how to dispose of medicines no longer required.

These measures contribute to environmental protection.

The product should not be discharged into water courses due to its danger to fish and other aquatic organisms. 

The treated animals will be kept in shelters throughout the treatment and the manure from them will be collected and SHALL NOT be used for soil fertilisation.

PRESENTATION/PACKAGE

1kg laminated PET foil/low-density polyethylene bags.