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 leave or dispose of water containing tylosin tartrate where it may be accessible to either animals not under treatment or to wildlife.
Do not use in known cases of hypersensitivity to tylosin or other macrolides.
Special warnings for each target species
None
Special precautions for use
Special precautions for use in animals
Use of the product should be based 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 the target bacteria.
Official, national and regional antimicrobial policies should be taken into account when the product is used.
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.
Recommendations for use in chickens and turkeys:
Tylan Soluble is administered in the drinking water at a concentration of 0.5 g per litre.
As an aid in the control of outbreaks of necrotic enteritis caused by Clostridium perfringens in chickens use Tylan in the drinking water for 5 days at a concentration of 0.15 g per litre water (150ppm), to provide 20-50 mg/kg bw, depending on the age and the water consumption of the birds.
Recommendations for use in pigs:
Tylan Soluble is administered in the drinking water to provide 25 mg tylosin/kg bodyweight. This may normally be achieved by adding 0.25g per litre.
Recommendations for use in calves:
One gram of tylosin activity per calf administered orally twice daily for seven to fourteen days. The tylosin tartrate may be incorporated into the milk or reconstituted milk replacer at the time of feeding.
To ensure a correct dosage, body weight should be determined as accurately as possible to avoid under-dosing.
Recommended programmes
a) Chickens and turkeys
For preventative medication the following programmes are recommended:
As an aid to mycoplasmosis prevention in chickens |
Class of Stock | Age | Tylan Soluble at 0.5g per litre |
Broiler | 0-3 days | 35 g per 1000 birds |
| 4th week of life | 35 g per 1000 birds |
| | |
Layers and replacement pullets | 0-3 days | 35 g per 1000 birds |
| 4th week of life | 35 g per 1000 birds |
| 9-12th week | 48 hours medication |
| 16th-20th week | 48 hours medication |
| | |
Breeders | 0-3 days | 50 g per 1000 birds |
| 4th week of life | 80 g per 1000 birds |
| 9th, 12th, 16th, 20th, 24th weeks of age | 48 hours medication |
As an aid to mycoplasmosis prevention in turkeys |
Class of Stock | Age | Tylan Soluble at 0.5g per litre |
Table Turkeys | 0-5 days | 12.5 g per 100 birds |
| 4th week of life | 7.5 g per 100 birds |
For treatment of mycoplasmosis: |
Class of Stock | Tylan Soluble at 0.5g per litre |
Broilers | 24-72 hours medication |
Layers and replacement pullets | 48-72 hours medication |
Turkeys | 48-120 hours medication |
As an aid in the control of necrotic enteritis: |
Class of Stock | Tylan Soluble at 0.15g per litre |
Broilers | 5 days |
Layers and Replacement pullets | 5 days |
b) Pigs
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.
Tylan Soluble requirements per tonne of pigs daily: |
Disease Treatment | Tylan Soluble required | Water consumption (l) approx. |
enzootic pneumonia | 25 g | 100 litres |
Ileitis | 5-10 g | 100 litres |
c) Calves
One gram of tylosin activity 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 depends on the clinical condition of the animals. In order to obtain the correct dosage, the concentration of Tylan Soluble has to be adjusted accordingly.
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
Species | Indications | Treatment Duration (days) | Dose | Meat Withdrawal Period (days) | Egg Withdrawal period (days) |
| | | | | |
Chickens | For the control of chronic respiratory disease | 5 | 500 mg/litre water (50-200 mg tylosin/kg bw) | 1 | Zero |
Chickens | As an aid in the control of outbreaks of necrotic enteritis caused by Clostridium perfringens. | 5 | 150 mg /litre water (20-50 mg tylosin/kg bw) | Zero | Zero |
Turkeys | For the control of chronic respiratory disease | 5 | 500 mg/litre water | Zero | N/A |
Pigs | For the prevention and control of enzootic pneumonia, swine dysentery and other scours caused by organisms (e.g. Lawsonia intracellularis) sensitive to tylosin | 3-10 | 250 mg/litre water (25 mg tylosin/kg bw) | Zero | N/A |
Calves | For the control of pneumonia associated with mycoplasmata and Pasteurella multocida sensitive to tylosin. | 7-14 | 1000 mg per calf twice daily | 14 | N/A |
Tylan Soluble Powder for Oral Solution - Withdrawal Periods |
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