COMPOSITION
Active substance:
Tilmicosin 300 mg/ml
Excipients:
Propylene glycol (E1520) 250 mg/ml
CONTRAINDICATIONS
Do not administer intravenously.
Do not administer intramuscularly.
Do not administer to lambs weighing less than 15 kg.
Do not administer to primates.
Do not administer to pigs.
Do not administer to horses and donkeys.
Do not administer to goats.
Do not use in case of hypersensitivity to the active substance or to any of the excipients.
ADVERSE REACTIONS
Occasionally, a soft diffuse swelling may occur at the injection site, but this disappears within five to eight days. In rare cases recumbency, incoordination and convulsions have been observed.
Deaths of cattle have been observed following a single intravenous dose of 5 mg/kg body weight and following the subcutaneous injection of doses of 150 mg/kg body weight at 72-hour intervals. In pigs, intramuscular injection at 20 mg/kg body weight has caused deaths. Sheep have died following a single intravenous injection of 7.5 mg/kg body weight.
DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION
For subcutaneous injection only.
Use 10 mg tilmicosin per kg body weight (corresponding to 1 ml Tyloplus Inj. per 30 kg body weight).
Cattle
Method of administration:
Withdraw the required dose from the vial and remove the syringe from the needle, leaving the needle in the vial. When a group of animals has to be treated, leave the needle in the vial to remove the subsequent doses. Restrain the animal and insert separate needle subcutaneously at the injection site, preferably in a skinfold over the rib cage behind the shoulder. Attach the syringe to the needle and inject into the base of the skinfold. Do not inject more than 20 ml per injection site.
Sheep
Method of administration:
Accurate weighing of lambs is important to avoid overdosing. The use of a 2 ml syringe or smaller improves accurate dosing. Withdraw the required dose from the vial and remove the syringe from the needle, leaving the needle in the vial. Restrain the sheep whilst leaning over the animal and insert a separate needle subcutaneously into the injection site, which should be in a skinfold over the rib cage behind the shoulder. Attach the syringe to the needle and inject into the base of the skin fold. Do not inject more than 2 ml per injection site.
ADVICE ON CORRECT ADMINISTRATION
Avoid introduction of contamination into vial during use. The vial should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vial.
WITHDRAWAL PERIODS
Cattle (meat and offal): 70 days.
Milk: 36 days.
If the product is administered to cows during the dry period or to pregnant dairy heifers, milk should not be used for human consumption until 36 days after calving.
Sheep (meat and offal): 42 days.
Milk: 18 days.
If the product is administered to ewes during the dry period or to pregnant ewes, milk should not be used for human consumption until 18 days after lambing.
SPECIAL STORAGE PRECAUTIONS
Do not store above 250C. Protect from direct sunlight. Do not refrigerate. Protect from frost.
SHELF-LIFE
Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf-life after first opening the immediate packaging: 28 days.
SPECIAL WARNINGS
Special warnings for each target species
Sheep
The clinical trials did not demonstrate a bacteriological cure in sheep with acute mastitis caused by Staphyloccocus aureus and Mycoplasma agalactiae.
Do not administer to lambs weighing less than 15 kg since there is a risk of overdose toxicity. Accurate weighing of lambs is important to avoid overdose. The use of a 2 ml or smaller syringe will facilitate accurate dosing.
Special precautions for use in animals
Official, national and regional antimicrobial policies should be taken into account when the product is used. To avoid self-injection do not use automatic injection equipment. Wherever possible, the use of the product should be based on susceptibility testing.
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