FOR ANIMAL TREATMENT ONLY.
INJECTION OF THIS DRUG IN MAN CAN BE FATAL – EXERCISE EXTREME CAUTION TO AVOID ACCIDENTAL SELF-INJECTION AND FOLLOW THE ADMINISTRATION INSTRUCTIONS AND THE GUIDANCE BELOW, PRECISELY.
∙ This product should be administered only by a veterinary surgeon.
∙ Never carry a syringe loaded with Apotil 300 mg/ml Solution for Injection with the needle attached. The needle should be connected to the syringe only when filling the syringe or administering the injection. Keep the syringe and needle separate at all other times.
∙ Do not use automatic injection equipment.
∙ Ensure that animals are properly restrained, including those in the vicinity.
∙ Do not work alone when using Apotil 300 mg/ml Solution for Injection.
∙ In case of human injection SEEK IMMEDIATE MEDICAL ATTENTION and take the vial or the package leaflet with you. Apply a cold pack (not ice directly) to the injection site.
NOTE TO THE PHYSICIAN: INJECTION OF THIS DRUG IN MAN HAS BEEN ASSOCIATED WITH FATALITIES
∙ The cardiovascular system is the target of toxicity, and this toxicity may be due to calcium-channel blockade. Administration of intravenous calcium chloride should be considered only if there is confirmation of exposure to tilmicosin.
∙ In dog studies, tilmicosin induced a negative inotropic effect with consequent tachycardia, and a reduction in systemic arterial blood pressure and arterial pulse pressure.
DO NOT GIVE ADRENALIN OR BETA-ADRENERGIC ANTAGONISTS SUCH AS PROPRANOLOL.
∙ In pigs, tilmicosin-induced lethality is potentiated by adrenalin.
∙ In dogs, treatment with intravenous calcium chloride showed a positive effect on the left ventricular inotropic state and some improvements in vascular blood pressure and tachycardia.
∙ Pre-clinical data and an isolated clinical report suggest that calcium-chloride infusion may help to reverse tilmicosin-induced changes in blood pressure and heart rate in man.
∙ Administration of dobutamine should also be considered for its positive inotropic effects, although it does not influence tachycardia.
∙ As tilmicosin persists in tissues for several days, the cardiovascular system should be closely monitored and supportive treatment provided.
∙ Physicians treating patients exposed to this compound are advised to discuss clinical management with the National Poison Information Service on: 0844 892 0111.
Keep out of the reach of children. Avoid contact with the eyes. May cause sensitisation by skin contact. Wash hands after use.
Do not administer Apotil intravenously or by the intramuscular route. Do not administer it to
∙ lambs weighing less than 15 kg
∙ pigs
∙ horses or donkeys
∙ goats
∙ primates.
Do not administer it in cases of known hypersensitivity to tilmicosin or any excipients.
Occasionally, a soft diffuse swelling may occur at the injection site, but this disappears within five to eight days.
Withdrawal periods
Cattle meat and offal: 70 days
Cattle milk: 36 days
Sheep meat and offal: 42 days
Sheep milk: 18 days
If Apotil 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. The dry period begins when a dry-cow tube is administered (CVMP 2000). If Apotil is administered after the last milking but before the administration of a dry-cow tube, the withdrawal period of 36 days begins on the date of drying off.
If it 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.