Imizol 85 mg/ml Solution for Injection

(as Imidocarb dipropionate 121.15 mg)
Excipient:
Qualitative composition of excipients
and other constituents
Propionic acid (for pH adjustment)Water for injections
Clear, colourless to pale brownish-yellow coloured solution.
3. CLINICAL INFORMATION
3.1 Target species
Cattle.
3.2 Indications for use for each target species
For the treatment and prevention of bovine babesiosis (Redwater fever -
divergens infection) only.
3.3 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.
3.4 Special warnings
None
3.5 Special precautions for use
Special precautions for safe use in the target species:
Estimate body weight carefully and do not exceed the recommended dosage.
Special precautions to be taken by the person administering the veterinary medicinal
product to animals:
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.
Special precautions for the protection of the environment:
Not applicable.
3.6 Adverse events
Cattle:
Very rare
(<1 animal / 10,000 animals
treated, including isolated reports):
Cholinergic disorder (e.g. Hypersalivation,
Discomfort, Muscle tremor, Tachycardia,
Cough, Colic)¹;
Anaphylaxis²;
symptoms can be alleviated by administering atropine sulphate.
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.
3.7 Use during pregnancy, lactation or lay
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.
3.8 Interaction with other medicinal products and other forms of interaction
None known.
3.9 Administration routes and dosage
Subcutaneous use.
The recommended dose regimen is as follows:
* 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.
3.10 Symptoms of overdose (and where applicable, emergency procedures
and antidotes)
At about 1.75x overdose of the recommended dose signs consistent with cholinergic
activity started to manifest themselves.
IndicationDoseTherapy (treatment)1.0 ml/100 kg body weight
(0.85 mg imidocarb/kg body
weight)
Prevention*2.5 ml/100 kg body weight
(2.125 mg imidocarb/kg body
weight)
Death can result at doses of 5x the recommended therapeutic dose or greater.
3.11 Special restrictions for use and special conditions for use, including
restrictions on the use of antimicrobial and antiparasitic veterinary
medicinal products in order to limit the risk of development of resistance
Not applicable.
3.12 Withdrawal periods
Meat and offal: 213 days.
Milk: 21 days.
4.