Target species
Pigs, broilers and pullets.
Indications for use
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.
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.
Contra-indications
Do not use in animals with known sensitivity to the active substance and/or to any of the excipients of the veterinary medicinal product.
Do not use in animals with known hyper-sensitivity to tylosin and other macrolides.
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 caecum.
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 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 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 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
In pigs, adverse reactions have been observed, including diarrhoea, pruritus, erythema, rectal oedema and prolapse.
Use during pregnancy, lactation or lay
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.
Interactions
Lincosamides and aminoglycoside antibiotics antagonize the activity of tylosin.
Amounts to be administered and administration route
Administration through the feed: for the preparation of a medicated feed containing 40-1100 gram tylosin per ton of feed, the required amount of Pharmasin 250 mg/g Premix 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 Pharmasin 250 mg/g premix contains 250 g tylosin activity it follows that 4 mg Pharmasin 250 mg/g premix corresponds to 1 mg tylosin activity. The dosages are as follows:
Pigs
For the treatment and prevention of porcine intestinal adenomatosis (PIA):
4 – 5 mg tylosin per kg BW (corresponding to 16 - 20 mg Pharmasin 250 mg/g premix per kg BW) for 3 weeks.
Broilers and pullets:
For the treatment and prevention of respiratory infections:
127 mg tylosin per kg BW (corresponding to 508 mg Pharmasin 250 mg/g premix per kg BW) for the first 5 days of life.
For the treatment and prevention of necrotic enteritis:
10 – 20 mg tylosin per kg BW (corresponding to 40 – 80 mg Pharmasin 250 mg/g premix 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 and husbandry system. To provide the required amount of active substance in mg per kg mixed feed the following calculation should be made:
--- mg Pharmasin 100 mg/g premix/kg BW/day | x | Average BW (kg) of the animals to be treated | | | |
_____________________________ | = | --- mg Pharmasin 100 mg/g premix per kg mixed feed | |
Average daily amount of mixed feed intake kg per animal | | | |
The mixing should be performed by an (authorised) feedingstuff manufacturer with adequate mixing apparatus.
The uptake of medicated feed depends on the clinical condition of the animals. In order to obtain the correct dosage the concentration of tylosin should be adjusted accordingly.
Should there be no clear response to treatment within 3 days the treatment approach should be reconsidered.
Body weight should be evaluated accordingly to avoid under dosing.
Overdose
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
Pig: zero days
Broilers and pullets: 1 day
Do not use in laying hens producing eggs for human consumption.