Target species
Pigs, chickens (broilers and pullets)
Indications for use, specifying the target species
Pigs
Treatment and metaphylaxis of Porcine Intestinal Adenomatosis (Ileitis)associated with Lawsonia intracellularis when the disease has been diagnosed at the group or herd level.
Chickens (broilers and pullets)
Treatment and metaphylaxis of respiratory infections caused by Mycoplasma gallisepticum and Mycoplasma synoviae, when the disease has been diagnosed in the flock.
Treatment and metaphylaxis of necrotic enteritis caused by Clostridium perfringens, when the disease has been diagnosed in the flock.
Contraindications
Do not use in cases of hypersensitivity to the active substance, to other macrolides or to any of the excipients.
Do not use where cross-resistance to other macrolides (MLS-resistance) is suspected.
Do not use in animals vaccinated with tylosin-sensitive vaccines either at the same time or within 1 week previously.
Do not use in animals with hepatic disorders.
Do not use in horses. Danger of inflammation of the cecum.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
Animals with acute infections may have a reduced feed intake and should be treated with a suitable injectable veterinary medicinal product first.
Due to likely variability (time, geographical) in susceptibility of bacteria for tylosin, bacteriological sampling and susceptibility testing are recommended.
Inappropriate use of the veterinary medicinal product may increase the prevalence of bacteria resistant to tylosin and other macrolides.
Special precautions for the person administering the veterinary medicinal product to animals
Tylosin may induce irritation. Macrolides, such a 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. Personal protective equipment, consisting of overalls, safety glasses, impervious gloves, and 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 should be worn during preparation of the medicated feed.
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 veterinary medicinal product if you are allergic to ingredients in the veterinary medicinal 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.
Special precautions for the protection of the environment
Not applicable.
Other precautions
Not applicable.
Adverse reactions (frequency and seriousness)
Pigs:
Undetermined frequency (cannot be estimated from available data) | Diarrhoea, rectal prolapse Rectal oedema Pruritus, erythema |
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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy, lactation or lay
Pregnancy:
Laboratory studies in mice and rats have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects. 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 aminoglycoside antibiotics antagonize the activity of tylosin.
Amount(s) to be administered and administration route
Oral use
Administration through the feed: for the preparation of a medicated feed containing 40 000 000-1 100 000 000 IU tylosine per ton of feed, the required amount of veterinary medicinal product should be homogenously mixed with a suitable carrier into a feed premixture so that at least 5 kg of this premixture can be added to the feed in order to obtain a medicated feed with the required concentration.
For the preparation of medicated feed:
As 1 kg of veterinary medicinal product contains 250 000 000 IU tylosin it follows that 4 mg Pharmasin 250 000 IU/g premix corresponds to 1000 IU tylosin. The dosages are as follows:
Pigs
For the treatment and metaphylaxis of porcine intestinal adenomatosis (PIA): 4000 – 5000 IU tylosin per kg BW (corresponding to 16 - 20 mg veterinary medicinal product per kg BW) for 3 weeks.
Chickens (broilers and pullets)|
For the treatment and metaphylaxis of respiratory infections:
127 000 IU tylosin per kg BW (corresponding to 508 mg veterinary medicinal product per kg BW) for the first 5 days of life
For the treatment and metaphylaxis of necrotic enteritis:
10 000 – 20 000 IU tylosin per kg BW (corresponding to 40 – 80 mg veterinary medicinal product per kg BW) 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 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:
X mg veterinary medicinal product/kg bodyweight/day | x | Average bodyweight (kg) of the animals to be treated | | | |
_____________________________ | = | mg veterinary medicinal product per kg/mixed feed | |
Average daily mixed feed intake/kg per animal | | | |
The mixing should be performed by an (authorised) feeding stuff manufacturer with adequate mixing apparatus.
The intake of medicated feed 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.
Should there be no clear response to treatment within 3 days the treatment approach should be reconsidered.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Tylosin has been shown to produce no adverse effects when fed to pigs at 600 ppm in the feed (three to six times the recommended dose level) for 28 days. At high levels diarrhoea, apathy, convulsions may occur. The therapy is symptomatic.
Withdrawal periods
Meat & offal.
Pigs: Zero days.
Chickens (broilers and pullets): 1 day.
Not for use in birds producing eggs for human consumption