Target species
Pigs, broilers and pullets.
Indications for use, specifying the target species
Pigs:
For the prevention and control of enzootic pneumonia.
For the treatment and control of Lawsonia intracellularis, the organism associated with Porcine Intestinal Adenomatosis (Ileitis) and Porcine Haemorrhagic Enteropathy.
Broilers and pullets:
Treatment and prevention of respiratory infections caused by Mycoplasma gallisepticum and Mycoplasma synoviae, when the disease has been diagnosed in the flock.
Treatment and prevention of necrotic enteritis caused by Clostridium perfringens, when the disease has been diagnosed in the flock.
The presence of the disease in the group or flock must be established before the product is used.
Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Do not use in animals vaccinated with tylosin-sensitive vaccines either at the same time or within one week previously.
Special warnings for each target species
None.
Special precautions for use
Use of the product should be in accordance with official, national and regional antimicrobial policies.
Special precautions for use in animals
For incorporation into medicated feedingstuffs only.
To ensure thorough dispersion of the product it should first be mixed with a small quantity of feed ingredients before incorporation into the final mix.
Use of the product should be based on identification and susceptibility testing of the target pathogen(s). If this is not possible, therapy should be based on epidemiological information and knowledge of susceptibility of the target pathogens at farm level, or at local/regional level.
An antibiotic with a lower risk of antimicrobial resistance selection (lower AMEG category) should be used for first line treatment where susceptibility testing suggests the likely efficacy of this approach.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Tylosin may induce irritation. Macrolides, such as tylosin, may also cause hypersensitivity (allergy) following injection, inhalation, ingestion or contact with skin or eye. Hypersensitivity to tylosin may lead to cross reactions to other macrolides and vice versa. Allergic reactions to these substances may occasionally be serious and therefore direct contact should be avoided.
To avoid exposure during preparation of the medicated feed, wear overalls, safety glasses, impervious gloves and wear either a disposable half mask respirator conforming to European Standard EN149 or a non-disposable respirator to European Standard EN140 with a filter to EN143. Wash hands after use.
In the event of accidental skin contact, wash thoroughly with soap and water. In case of accidental eye contact, flush the eyes with plenty of clean, running water.
Do not handle the product if you are allergic to ingredients in the product.
If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the package leaflet or the label to the physician.
Swelling of the face, lips and eyes or difficulty in breathing are more serious symptoms and require urgent medical attention.
Adverse reactions (frequency and seriousness)
None known.
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.
Use during pregnancy, lactation or lay
No studies have been conducted in the target species population. Use only according to the benefit risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Lincosamides and aminogylcoside antibiotics antagonise the activity of tylosin.
Amounts to be administered and administration route
For incorporation into dry feed at the registered mill.
A manufacturer who is approved to incorporate directly at any concentration, veterinary medicinal products or premixtures containing such products must be responsible for mixing when incorporation is less than 2 kg per tonne for final feed.
For oral administration.
Pigs:
Prevention and control of enzootic pneumonia:
Treatment and control of Lawsonia intracellularis:
3-6 mg tylosin activity/kg bodyweight, which may normally be achieved by adding the product at the rate of 400 g per tonne, giving 100 g tylosin base per tonne. Feed as the only ration for 21 days.
The required levels of tylosin are obtained by mixing the appropriate quantity of the veterinary medicinal product with 20-50 kg of a suitable feed component, prior to incorporation into the bulk of the feed to be prepared.
Broilers and pullets:
For the treatment and prevention of respiratory infections:
127 mg tylosin per kg bodyweight (corresponding to 508 mg of the veterinary medicinal product per kg bodyweight) for the first 5 days of life. It is strongly recommended to repeat the treatment of the birds at the age of 3-4 weeks.
For the treatment and prevention of necrotic enteritis:
10 – 20 mg tylosin per kg bodyweight (corresponding to 40 – 80 mg of the veterinary medicinal product per kg bodyweight) for 7 days.
For the preparation of the medicated feed the body weight of the animals to be treated and their actual daily feed consumption should be taken into due account. Consumption may vary depending on factors like age, breed, husbandry system. To provide the required amount of active substance in mg per kg mixed feed the following calculation should be made:
mg veterinary medicinal product average body weight (kg)/kg bodyweight/day x of animals to be treated | = veterinary medicinal product per kg/mixed feed |
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The intake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of veterinary medicinal product has to be adjusted accordingly.
Overdose (symptoms, emergency procedures, antidotes), if necessary
The veterinary medicinal product has been shown to produce no adverse effects when fed to pigs at 600 ppm in the feed (six times the recommended maximum level) for 28 days.
Withdrawal periods
Meat and offal:
Pigs: Zero days.
Broilers and pullets: 1 day
Not authorised for use in birds producing eggs for human consumption.