Tilmovet 300 mg/ml Solution for Injection for Cattle and Sheep

phase), because it could select antimicrobial-resistant bacteria within the intestinal
microbiota of the calf and increase the faecal shedding of these bacteria.
Official, national and regional antimicrobial policies should be taken into account
when the veterinary medicinal product is used.
Do not administer to lambs weighing less than 15 kg since there is a risk of overdose
toxicity.
AN: 02926/2024 & 02927/2024
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
•
veterinary surgeon.
•
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.
•
•
vicinity.
•
•
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:
•
immediately 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
AN: 02926/2024 & 02927/2024
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:
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Cattle and sheep:
Rare
(1 to 10 animals / 10,000
animals treated):
Recumbency, incoordination, convulsionsUndetermined frequency
(cannot be estimated from the
available data):
Injection site swelling
Death
1
Soft and diffuse. 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 7.5
mg/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 the national competent authority via the
national reporting system. See the package leaflet for respective contact details.
3.7 Use during pregnancy, lactation or lay
Pregnancy:
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.
3.8 Interaction with other medicinal products and other forms of interaction
Interactions between macrolides and ionophores could be observed in some species.
Tilmicosin may lessen the antibacterial activity of beta-lactam antibiotics.
Do not use simultaneously with bacteriostatic antimicrobial agents.
AN: 02926/2024 & 02927/2024
3.9 Administration routes and dosage
For subcutaneous use only.
Use a single treatment of 10 mg tilmicosin per kg body weight (corresponding to 1 ml
of the veterinary medicinal product per 30 kg body weight).
Cattle
Method of administration:
To ensure the correct dosage, the body weight must be determined as accurately as
possible in order to avoid underdosing.
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.
The closure should not be broached more than 15 times. In order to prevent
excessive broaching of the stopper, a suitable multiple dosing device should be used.
3.10 Symptoms of overdose (and where applicable, emergency procedures and
antidotes)
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
AN: 02926/2024 & 02927/2024
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.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary
medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Cattle
Meat and offal: 70 days.
Milk: 36 days.
If the veterinary medicinal product is administered to cows during the dry period or to
pregnant dairy heifers (in accordance with section