Milbotyl 300 mg/ml Solution for Injection for Cattle and Sheep
Active ingredient: Tilmicosin
Form
Injection
Species
Manufacturer
Chanelle Pharmaceuticals Manufacturing Ltd
VMD MA No.
08749/4023
What it's used for
For the treatment of interdigital necrobacillosis. Sheep For the treatment of respiratory tract infections caused by Mannheimia haemolytica and Pasteurella...
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Milbotyl 300 mg/ml Solution for Injection for Cattle and Sheep — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
Sheep
For the treatment 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
medicinal product per 30 kg bodyweight).
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
AN: 01701/2025 & 01702/2025
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 overdosage. The use of a 2ml or
smaller syringe will improve 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 skinfold. 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.
AN: 01701/2025 & 01702/2025
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 cases of hypersensitivity to the active substance or to any of the
excipients.
Rare
(1 to 10 animals / 10,000 animals treated):
Recumbency, incoordination and
convulsion
Undetermined frequencyInjection site swelling
, Death
1
Soft and diffuse. It disappears within five to eight days.
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
7.5mg/kg body weight.
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to
either the marketing authorisation holder or its local representative or the national
competent authority via the national reporting system. See the package leaflet for
respective contact details.
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 real risk of
overdosage toxicity. Accurate weighing of lambs is important to avoid overdosage.
The use of a 2 ml or smaller syringe will improve accurate dosing.
Special precautions for safe use in the target species:
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
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
•
•
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.
•
•
•
INJECTION.
AN: 01701/2025 & 01702/2025
•
take the vial or the package leaflet with you. Apply a cold pack (not ice
directly) to the injection site.
Additional operator safety warnings:
•
with water.
•
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:
018379964 (IE) or 0844 892 0111 (UK).
Special precautions for the protection of the environment:
Not applicable
AN: 01701/2025 & 01702/2025
species.
Protect from direct sunlight.
Meat and offal: 70 days.
AN: 01701/2025 & 01702/2025
Milk: 36 days.
If the product is to be administered to cows during the dry period or to pregnant dairy
heifers (in accordance with section 3.7 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 to be administered to ewes during the dry period or to pregnant ewes
(in accordance with section 43.7 above), milk should not be used for human
consumption until 18 days after lambing.
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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