Micotil 300 mg/ml Solution for Injection
Active ingredient: Tilmicosin
Form
Injection
Species
Manufacturer
Elanco Europe Ltd
VMD MA No.
00879/5082
What it's used for
Cattle Treatment of bovine respiratory disease associated with Mannheimia haemolytica and Pasteurella multocida Treatment of interdigital necrobacillosis....
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Micotil 300 mg/ml Solution for Injection — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 26 Mar 2026.
Treatment of bovine respiratory disease associated with Mannheimia haemolytica and
Pasteurella multocida
Treatment of interdigital necrobacillosis.
Sheep
Treatment of respiratory tract infections caused by Mannheimia haemolytica and
Pasteurella multocida
Treatment of foot rot in sheep caused by Dichelobacter nodosus and
necrophorum.
Treatment of acute ovine mastitis caused by Staphylococcus aureus and Mycoplasma
agalactiae.
Use 10 mg tilmicosin per kg body weight (corresponding to 1 ml Micotil
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.
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.
Do not administer intramuscularly.
Do not administer to lambs weighing less than 15 kg.
Do not administer to primates
Revised: December 2025
MA split from NI Expiry following AN: 02085/2025Page 2 of 8
Do not administer to pigs.
Do not administer to horses and donkeys.
Do not administer to goats.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
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).
Revised: December 2025
MA split from NI Expiry following AN: 02085/2025Page 4 of 8
The clinical trials did not demonstrate a bacteriological cure in sheep with acute mastitis
caused by 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.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals
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.
Revised: December 2025
MA split from NI Expiry following AN: 02085/2025Page 3 of 8
Additional operator safety warnings:
• Avoid contact with skin and eyes. Rinse any splashes from skin or 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 onto be completed
nationally)
Revised: December 2025
MA split from NI Expiry following AN: 02085/2025Page 8 of 8
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 section 4.7 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 section 4.7 above), milk should not be used for human consumption
until 18 days after lambing.
5.
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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Other Products Containing Tilmicosin
These products share the same active ingredient and may be suitable alternatives. Always consult your vet.
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