Imizol 100 ml MSD babesiosis treatment

mizol 85 mg/ml Solution for Injection for cattle 100ml.

Presentation

A sterile, clear, aqueous solution for injection containing imidocarb 85 mg/ml as imidocarb dipropionate 121.15 mg/ml.

Uses

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

For use in cattle only.

Dosage and administration

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

Indication

Dose

Therapy

(treatment)

1 ml/100kg bodyweight

(0.85 mg imidocarb/kg bw)

Prevention*

2.5 ml/100 kg bodyweight

(2.125 mg imidocarb/kg bw)

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

Estimate bodyweight carefully and do not exceed the recommended dosage. 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.

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.

Contra-indications, warnings, etc

Warnings

Imizol must not be administered intravenously or intramuscularly. Repeat doses of Imizol must not be given. Not for use in any other species.

Operator warnings:

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.

Adverse reactions:

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.

Overdose:

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.

Withdrawal periods:

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 any 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 any treatment.

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

Pharmaceutical precautions

Do no 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 the first dose, use the product within 28 days. When the container is broached (opened) for the first time, the date on which any product remaining in the container should be discarded should be calculated. A statement of the in-use shelf-life of the product is given on this package insert. This discard date should be written in the space provided on the label. Discard unused material.