Imidokal 85 mg/ml solution for injection for cattle and dogs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Imidocarb dipropionate

Available from:

Vet-Agro Multi-Trade Company Sp z o.o.

ATC code:

QP51E

INN (International Name):

Imidocarb dipropionate

Pharmaceutical form:

Solution for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

AGENTS AGAINST BABESIOSIS AND THEILERIOSIS - OPTIONAL CLASSIFICATION

Authorization date:

2023-09-29

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Imidokal 85 mg/ml solution for injection for cattle and dogs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
ACTIVE SUBSTANCE:
Imidocarb
85 mg
(as imidocarb dipropionate
121.15 mg)
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Propionic acid
Water for injection
Clear, pale brownish-yellow, free of visible particles solution
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Cattle, dogs.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
Cattle:
Treatment and prevention of piroplasmosis caused by
_Babesia argentina_
,
_B. bigemina, B. bovis _
and
_B. _
_divergens_
.
Treatment of anaplasmosis caused by
_Anaplasma marginale_
.
Dogs:
Treatment of piroplasmosis caused by
_Babesia canis_
,
_B. gibsoni _
and
_B. vogelli_
.
3.3
CONTRAINDICATIONS
Do not administer intravenously in cattle.
Do not use in cases of hypersensitivity to the active substance or to
any of the excipients.
3.4
SPECIAL WARNINGS
None.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
When used for prevention of piroplasmosis in cattle, the veterinary
medicinal product should be
administered to the entire group of animals when clinical signs of
disease are observed in one or two
cattle in the group, or at the time of moving susceptible cattle into
an area of known
_Babesia_
challenge. The product gives protection for a period of up to 4 weeks
depending on the severity of
challenge.
Unnecessary use of antiparasitics or use deviating from the
instructions given in the SPC may increase
the resistance selection pressure and lead to reduced efficacy. The
decision to use the product should be
based on confirmation of the parasitic species and/or burden, or of
the risk of infection based on its
epidemiological features, for each individual animal/herd.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
Symptoms of acetylcholinesterase inhibition include headache, blurred
vision, hypersalivation