Imochem 120 , Imidocarb, babesiosis in cattle, sheep, horses and dogs

Active substance:
Imidocarb dipropionate
(equivalent to 85 mg imidocarb)

PHARMACEUTICAL FORM

Clear, light yellow solution for injection.

CLINICAL PARTICULARS
Target species
Cattle, horses and dogs
Indications for use, specifying the target species
For the treatment and prophylaxis of piroplasmosis caused by Babesia spp. in cattle.
For the treatment of anaplasmosis caused by Anaplasma spp. in cattle.
For the treatment of piroplasmosis caused by Babesia spp. in dogs.
For the treatment of piroplasmosis caused by Babesia spp. and Theileria spp. in horses.

Contraindications
Do not administer intravenously.
Do not administer to donkeys and mules.
Do not administer to horses less than 1 year of age.
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Special warnings for each target species
None.
Special precautions for use
Special precautions for use in animals
FOR NATIONAL DISEASE CONTROL
The body weight of the animals should be determined accurately and the recommended dose should not be exceeded.
In the case of cattle that have been vaccinated against babesiosis or anaplasmosis, this veterinary medicinal product should not be administered within the first 4 weeks after vaccination, except in cases where the post-vaccination reaction is excessive, in which case the product may be administered to control the symptoms.
In dogs with pulmonary, hepatic or renal insufficiency, it should only be administered according to the benefit/risk assessment carried out by the responsible veterinarian.

Amounts to be administered and route of administration
For injection, subcutaneous or intramuscular administration.
For cattle and dogs, subcutaneous administration is recommended.
For horses, intramuscular administration is recommended.
To ensure a correct dose, body weight should be determined as accurately as possible to avoid underdosing.

Cattle:
Prophylaxis of piroplasmosis (Babesia spp.):
Administer to animals that have been exposed to infection or in case of movement of susceptible cattle to an area where babesiosis occurs.
All animals will be treated to be protected.
Administer subcutaneously, 2 mg imidocarb per kg body weight (equivalent to
product/kg body weight), in a single dose.
0.023 ml
2
GUVER
This veterinary medicinal product provides protection for a period of up to 4 weeks, depending on
the risk of contamination. During this period, immunity is established depending on the risk.
AUTHORITYHIELITAFEA
SEVTIONAL SAN
Treatment of piroplasmosis (Babesia spp.):
Administer subcutaneously, 1 mg imidocarb per kg body weight (equivalent to 0.014 ml product/kg body weight), in a single dose.
Treatment of anaplasmosis (Anaplasma spp.):
Administer subcutaneously, 2.1 mg imidocarb per kg body weight (equivalent to 0.025 ml
product/kg body weight), in a single dose.

Routes:
Treatment of piroplasmosis (Babesia spp.):
Administer intramuscularly, 2 mg imidocarb per kg body weight (equivalent to 0.023 ml
product/kg body weight), for 2 consecutive days.
Treatment of piroplasmosis (Theileria spp):
Administer intramuscularly, 4 mg imidocarb per kg body weight (equivalent to 0.047 ml
product/kg body weight), 4 – 5 times, at 72 hour intervals.

Dogs:
Treatment of piroplasmosis (Babesia spp.):
Administer subcutaneously, 4 – 5 mg imidocarb per kg body weight (equivalent to 0.047-
0.058 ml product/kg body weight), in a single dose.

Overdose (symptoms, emergency procedures, antidotes), as appropriate
After administration of a dose approximately 1.75 times higher than the recommended dose, symptoms characteristic of cholinergic activity may be observed. Overdose can be treated with atropine sulfate.
Administration of a dose 5 times higher than the recommended dose may lead to the death of the animal.

Withdrawal period

Cattle
Meat and offal: 213 days.
Milk: 6 days (12 milkings).
Horses: Not authorised for use in animals intended for human consumption.