Each ml contains:

Imidocarb 85.00

(as Imidocarb dipropionate 121.15)

For the full list of excipients, see section “Pharmaceutical particulars”.

Solution for injection.

Clear, colourless to pale brownish-yellow coloured solution.

Cattle

For the treatment and prevention of bovine babesiosis (Redwater fever - Babesia divergens infection) only.

* Imizol must not be administered intravenously or intramuscularly.

* Repeat doses of Imizol must not be given.

Not for use in any other species.

Estimate body weight carefully and do not exceed the recommended dosage.

Do not use if under medical advice not to work with compounds which may exhibit anti-cholinesterase activity.

Wash splashes of the product off the skin and eyes immediately. Wear suitable protective clothing (ie impermeable gloves) when using the product.

Seek medical advice immediately if adverse signs indicative of anti-cholinesterase activity are experienced by operators.

Animals may show cholinergic signs after dosing. It may be possible to alleviate these side effects by treatment with atropine sulphate.

While side-effects (salivation, discomfort, muscle tremors, tachycardia, cough, colics) are rare, they do occur and deaths from anaphylactoid reactions have been recorded following product use.

Treatment of pregnant animals has demonstrated that although the compound does cross the placental barrier there does not appear to be an adverse effect on the foetus or calf.

None known

The product is for subcutaneous injection administration only. The recommended dose regimen is as follows:

* For therapy of in-contact animals known to be exposed to an infection.

The product should be administered on a single occasion only. Do not administer by the intramuscular or intravenous route. Do not inject more than 10 ml per injection site.

At about 1.75x overdose of the recommended dose signs consistent with cholinergic activity started to manifest themselves.

Death can result at doses of 5x the recommended therapeutic dose or greater.

Animals must not be slaughtered for human consumption during treatment. Cattle may be slaughtered for human consumption only after a period of at least 213 days from treatment.

Milk for human consumption must not be taken during treatment. Milk must not be taken for human consumption from cattle until after at least 21 days from treatment.

ATC Vet Code: QP51AE01

Imidocarb dipropionate is a substituted carbanilide, used as an antiprotozoan treatment for the control of Babesia spp.

Little is known about the mode-of-action of imidocarb dipropionate. It appears that imidocarb acts directly on the parasite, causing alteration in number and size of nuclei and in morphology (vacuolation) of the cytoplasm. The antiprotozoan activity is derived from the carbanilide acting on glycolyis of the parasite. This is the result of this class of drugs giving rise to hypoglycaemia in the host. Babesia as well as many other parasites like trypanosomes depend upon host glucose for aerobic glycolysis. There is also a selective blocking effect on the replication of the quinetoplastic DNA of the parasite.

Pharmacokinetic studies have been conducted with imidocarb dipropionate and have demonstrated that it has a long duration of activity, a result of it binding to plasma and tissue protein.

Imidocarb dipropionate is poorly absorbed when administered orally. Studies in rats, dogs and monkeys demonstrated that kidney and liver were the target organs, with it having the greatest affinity for kidney in rats and liver in the dog.

A radio-labelled study in lactating and non-lactating cattle, with imidocarb dipropionate being administered subcutaneously at a dose rate of 3 mg/kg body weight, demonstrated that imidocarb dipropionate was slowly excreted so that by 10 days post-dosing less than half the dose had been excreted. Main route of excretion was via the urine. Blood levels peaked at a mean level of 1.3 ppm equivalents 1 hour after injection. Milk levels peaked at a mean 0.37 ppm imidocarb dipropionate equivalents 24 hours post administration, and then depleted with a half-life of about 24 hours. All excreted material was mostly parent compound.

Other work has shown that imidocarb dipropionate can pass the placental barrier.

Studies have been conducted in sheep where imidocarb dipropionate was administered by intravenous injection at a dose rate of 2 mg/kg body weight. This was found to produce a peak level in plasma of 10.8 mg/mL, dropping to 1.9 mg/mL within an hour. It was also found that imidocarb dipropionate binds to plasma proteins, and detectable amounts were found in all major tissues up to four weeks after intramuscular injection.

Propionic acid (for pH adjustment)

Water for injections

None known.

Shelf life of the veterinary medicinal product as packaged for sale: 18 months.

Shelf life after first opening of the immediate packaging: 28 days

Do not store above 25°C. Protect from light. Do not freeze.

This product does not contain an antimicrobial preservative. Avoid introduction of contamination.

Following withdrawal of first dose, use the product within 28 days.

100 ml amber glass (Type I) vial with blue rubber chlorobutyl bung with clear lacquered aluminium overseal.

OR

100 ml amber glass (Type I) vial with a grey laminated bromobutyl rubber stopper sealed with a flip-off seal comprising a silver aluminium collar covered with a green polypropylene cap.

Pack size

Cardboard box with 1 x 100 ml vial.

Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

UK: Vm 01708/4576

18 July 1990

September 2022.

When used for prevention, Imizol should be administered when clinical signs of the disease are observed in one or two cattle of a group or at the time of moving susceptible cattle into an area of known Babesia challenge. The entire group of animals should be dosed to provide protection against babesiosis, and all must be kept to the withhold times shown above. The product gives protection for a period of up to 4 weeks depending on the severity of challenge. During this time, only if the challenge is adequate will immunity be established.

Veterinarians prescribing and/or treating animals that will enter the food chain with this product should notify the Animal and Plant Health Agency at Worcester APHA, County Hall, Spetchley Road, Worcester, WR5 2NP by email at this address CSCOneHealthVetMeds@apha.gov.uk with the name and address and CPH of the farmer on whose farm the product is to be administered and identity details of the animals treated. They should also inform the farmer that they must notify the APHA at the above address or on 03000 200 301 when treated animals are either to be slaughtered or their milk is to be used for human consumption.

For animal treatment only. Keep out of the sight and reach of children.