Target species
For use in calves, pigs, chickens and turkeys .
Indications for use, specifying the target species
For the control of Mycoplasma synoviae airsacculitis in chickens and Mycoplasma gallisepticum S6 in chickens and turkeys. In the field tylosin has also proved useful in reducing the level of infection following stress associated with live vaccination.
As an aid in the control of outbreaks of necrotic enteritis in chickens caused by Clostridium perfringens.
For the prevention and control of enzootic pneumonia, and scours caused by organisms (e.g. Lawsonia intracellularis) sensitive to tylosin, in pigs.
For the control of pneumonia in cattle associated with mycoplasmata and Pasteurella multocida sensitive to tylosin.
For information regarding swine dysentery see section Special precautions for use.
Contraindications
Do not use in cases of hypersensitivity to the active substance or other macrolides.
Special warnings for each target species
None
Special precautions for use
Special precautions for use in the target species
Use of the product 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.
Use of the product should be in accordance with official, national and regional antimicrobial policies.
A high rate of in vitro resistance has been demonstrated in European strains of Brachyspira hyodysenteriae implying that the product will not be sufficiently efficacious against swine dysentery.
Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to tylosin and may decrease the effectiveness of treatment with other macrolides, lincosamides and streptogramin B due to the potential for cross-resistance.
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 drinking water, 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 physician this warning. 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
Use during pregnancy, lactation or lay
No adverse effects to tylosin have been seen in fertility, multi-generation or teratology studies.
Interaction with other medicinal products and other forms of interaction
None known
Amounts to be administered and administration route
For oral administration through drinking water.
In calves, the veterinary medicinal product corresponds to 1 gram of tylosin. The dosages are as follows:
Chickens and turkeys:
For the control of chronic respiratory disease: 50-200mg tylosin per kg BW per day (corresponding to 55-220mg of the veterinary medicinal product per kg BW) for 5 days.
As an aid in the control of outbreaks of necrotic enteritis caused by Clostridium perfringens in chickens: 20-50 mg/kg tylosin per/kg BW per day (corresponding to 22-55mg of the veterinary medicinal product per kg BW), depending on the age and the water consumption of the birds.
Pigs:
For the treatment of enzootic pneumonia: 25 mg tylosin/kg BW (corresponding to 27.5 mg of the veterinary medicinal product per kg BW). A medicated solution of drinking water should generally be administered until 24 hours after scouring or respiratory symptoms have ceased, normally 3-10 days. The diagnosis should be reviewed if there is no response after 5 days of medication.
For the treatment of ileitis:
5 – 10 mg tylosin per kg BW per day (corresponding to 5.5 – 11 mg of the veterinary medicinal product per kg BW) for 3 – 10 days.
Calves:
1.1 g of the veterinary medicinal product should be incorporated in milk or milk replacer twice daily for each calf. This should be continued for 7-14 days dependent on response.
The intake of medicated water/milk/milk replacer depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of tylosin may need to be adjusted accordingly.
To ensure a correct dosage, body weight should be determined as accurately as possible.
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:
......mg veterinary medicinal product per kg body weight per day | X | average body weight (kg) of animals to be treated | |
| | | =......mg veterinary medicinal product per litre of drinking water or milk |
| average daily water or milk intake (l/animal) | | |
Overdose (symptoms, emergency procedures, antidotes), if necessary
There is no evidence of tylosin toxicity in animals, at dose rates of up to 1000 mg/kg.
Withdrawal periods
Animals must not be slaughtered for human consumption during treatment.
Chickens, when the veterinary medicinal product is used for the control of chronic respiratory disease:
Meat and offal: 1 day
Eggs: Zero days
Chickens, when the veterinary medicinal product is used as an aid in the control of outbreaks of necrotic enteritis caused by Clostridium perfringens (Meat, offal and eggs): Zero days
Turkeys (meat and offal): Zero days
Pigs (meat and offal): Zero days
Calves (meat and offal): 14 days