Target species
Cattle and sheep.
Indications for use, specifying the target species
Cattle
Treatment of bovine respiratory disease associated with Mannheimia haemolytica and Pasteurella multocida.
Treatment of interdigital necrobacillosis.
SheepTreatment of respiratory tract infections caused by Mannheimia haemolytica and Pasteurella multocida.
Treatment of foot rot in sheep caused by Dichelobacter nodosus and Fusobacterium necrophorum.
Treatment of acute ovine mastitis caused by Staphylococcus aureus and Mycoplasma agalactiae.
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.
Special warnings for each target species
Sheep
The clinical trials did not demonstrate a bacteriological cure in sheep with acute mastitis caused by Staphylococcus 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
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.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Operator Operator Safety Warnings:
INJECTION OF TILMICOSIN IN HUMANS CAN BE FATAL - EXERCISE EXTREME CAUTION TO AVOID ACCIDENTAL SELF-INJECTION AND FOLLOW THE ADMINISTRATION INSTRUCTIONS AND THE GUIDANCE BELOW, PRECISELY This product should only be administered by a veterinary surgeon. Never carry a syringe loaded with Micotil 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 Micotil. In case of self-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. |
Additional operator safety warnings:
∙ Avoid contact with skin and eyes. Rinse any splashes from skin and eyes immediately with water.
∙ May cause sensitisation by skin contact. Wash hands after use.
NOTE TO THE PHYSICIAN INJECTION OF TILMICOSIN IN HUMANS 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 only be considered if there is positive 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 humans. Administration of dobutamine should also be considered due to 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 8920111 |
Adverse reactions (frequency and seriousness)
A soft diffuse swelling may occur at the injection site very rarely but this disappears within five to eight days. Recumbency, incoordination and convulsions have been observed in rare cases.
Hypersensitivity reactions may occur in very rare cases. Such reactions may include anaphylaxis, which may be life-threatening. If such reactions occur appropriate treatment is recommended. Death may occur in very rare cases.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Use during pregnancy, lactation or lay
The safety of the veterinary medicinal product has not been established during pregnancy.
Use only according to the benefit/risk assessment by the responsible veterinarian.
Interaction with other medicinal products and other forms of interaction
Interactions between macrolides and ionophores could be observed in some species.
Amounts to be administered and administration route
For subcutaneous injection only.
Use 10 mg tilmicosin per kg body weight (corresponding to 1 ml Micotil 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 a 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.
If no improvement is noted within 48 hours, the diagnosis should be confirmed.
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.
Overdose (symptoms, emergency procedures, antidotes), if necessary
In cattle subcutaneous injections of 10, 30 and 50 mg/kg body weight, repeated three times with a 72 hours interval, did not cause death. As expected, oedema developed at the site of injection. The only lesion observed at autopsy was a necrosis of the myocardium in the group treated with 50 mg/kg body weight.
Doses of 150 mg/kg body weight, administered subcutaneously with an interval of 72 hours caused death. Oedema at the site of injection was observed and at autopsy a light necrosis of the myocardium was the only lesion determined. Other symptoms observed were: difficulty in moving, reduced appetite and tachycardia.
In sheep single injections (approximately 30 mg/kg body weight) may cause a slight increase of the rate of respiration. Higher doses (150 mg/kg body weight) caused ataxia, lethargy and the inability to raise the head.
Deaths occurred after one single intravenous injection of 5 mg/kg body weight in cattle and 7.5 mg/kg in sheep body weight.
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 (in accordance with Use during pregnancy, lactation or lay section above), 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 (in accordance with Use during pregnancy, lactation or lay section above), milk should not be used for human consumption until 18 days after lambing.