Target Species:
Cattle
Indications for use:
For the treatment and prevention of bovine babesiosis (Redwater fever - Babesia divergens infection) only.
Contraindications:
Do not administer the veterinary medicinal product by the intramuscular or intravenous route.
Do not administer repeat doses of the veterinary medicinal product.
Do not use in any other species.
Special warnings for each target species:
None.
Special precautions for use:
Estimate bodyweight carefully and do not exceed the recommended dosage.
Operator warnings:
Do not use if under medical advice not to work with compounds which may exhibit anti-cholinesterase activity.
Personal protective equipment (i.e., impermeable gloves) should be worn when handling the veterinary medicinal product.
Wash splashes of the veterinary medicinal product off the skin and eyes immediately.
In case adverse signs indicative of anti-cholinesterase activity are experienced by operators, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse Reactions:
Animals may show cholinergic signs after dosing. It may be possible to alleviate these side effects by treatment with atropine sulphate.
Very rare (<1 animal / 10,000 animals treated, including isolated reports): | Cholinergic disorder (e.g. Hypersalivation, Discomfort, Muscle tremor, Tachycardia, Cough, Colic)¹; Anaphylaxis²; |
1symptoms can be alleviated by administering atropine sulphate.
2 may be fatal.
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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
Use during pregnancy or lactation:
Pregnancy:
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.
Interactions:
None known
Amounts to be administered and administration route:
Subcutaneous use.
The recommended dose regimen is as follows:
Indication | Dose |
Therapy (Treatment) | 1.0 ml/100 kg body weight (0.85 mg imidocarb/kg bw) |
Prevention* | 2.5 ml/100 kg body weight (2.125 mg imidocarb/kg bw) |
* For therapy of in-contact animals known to be exposed to an infection.
To ensure a correct dosage, body weight should be determined as accurately as possible. 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.
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:
Meat and offal: 213 days.
Milk: 21 days.