For Animal Use Only
IMOCEL
Solution for Injection
Veterinary Antiprotozooner
COMPOSITION
It is a clear, sterile, colorless or light yellow solution containing 120 mg of imidocarb dipropionate equivalent to 85 mg of imidocarb per ml.
PHARMACOLOGICAL PROPERTIES
Imocel Solution for Injection is a veterinary specialty developed on the basis of the active substance imidocarb dipropionate for the clinical treatment and control of babesiosis and anaplasmosis in cattle, and babesiosis in sheep and horses. Imidocarb is a member of carbanilide derivative drugs with strong anti protozoan activity. Although the mode of action of the drug is not known exactly, its possible mechanism of action is that it affects the size and number of nuclei in susceptible protozoa, inhibition of repair processes, and kinetoplastid DNA replication, and morphological distortions (vacuolation) in the cytoplasm. In addition to its lethal effect against piroplasmosis agents, imidocarb also provides protection against disease in cattle, which is an important advantage over other drugs. At recommended therapeutic doses, imidocarb injected subcutaneously and intramuscularly to target animals is rapidly absorbed, reaching the highest blood density in 30 minutes in cattle and in less than 1 hour in sheep. The absorbed drug is bound primarily to blood proteins at high rates and to other tissues in increasing concentrations. Due to the specified pharmacokinetic profile, it creates a long-term protective effect. It accumulates in the liver and kidneys in the highest concentrations. It passes into the placental circulation in pregnant animals. The drug given as a single dose is excreted mainly in the urine and up to 10% in the feces without undergoing significant metabolic changes. It also passes into milk at low concentrations in milked animals.
When imidocarb is given in amounts 1.7 times higher than the therapeutic doses, it can cause the development of undesirable cholinergic effects and death at high doses of up to 5 times. The oral LD50 value in mice was found to be 544-863 mg/kg and the same dose in rats was between 1216-1652 mg/kg body weight.
AREA OF USE/INDICATIONS
Imocel Solution for Injection It is used in the treatment and protection of Babesiosis and Anaplasmosis diseases in cattle, in the treatment and protection of Babesiosis in horses, and in the treatment of Babesiosis in sheep.
Main protozoan species that it is effective in target animal species:
Babesia bovis, B. bigemina and Anaplasma marginale in cattle;
Babesia caballi and B. equi in horses,
B. ovis in sheep.
USAGE AND DOSAGE
Imocel Solution for Injection is administered subcutaneously or intramuscularly in cattle, sheep and horses, unless recommended otherwise by the veterinarian. However, in cattle and sheep, it is recommended to be administered subcutaneously in order to provide longer-term effectiveness and reduce the risk of residue. Since it is sufficient to use small volumes of drugs in sheep, it is more appropriate to choose small injectors with 0.1 ml graduations.
Pharmacological dose: The pharmacological dose of imidocarb dipropionate varies between 1.2-3 mg/kg body weight, depending on the purpose of administration and the animal species (see dosage table).
The pharmacological dose in cattle and sheep (for the treatment of babesiosis) is 1.2 mg/kg ca.
The pharmacological dose for the treatment of anaplasmosis in cattle is 3 mg/kg ca.
The protection dose is 3 mg/kg ca in cattle and 2.4 mg/kg ca in horses.
| Animal Types | Protozoa type | Treatment Dose and Method of Administration | Sterilization Dose And Method of Application | Protection Dose And Method of Administration |
| Cattle | B. bovis B. bigemina | 1 ml/100 kg ca (Subcutaneous or intramuscular) (1,2 mg/kg ca) | – | 2,5 ml/ 100 kg ca (Subcutaneous or |
| Anaplasma marginale | 2,5 ml/100 kg ca (Subcutaneous or intramuscular) (3mg/kg ca) | – | intramuscular) (3 mg/kg ca) | |
| Sheep | B. bovis | 0,1 ml/10 kg ca (Subcutaneous or intramuscular) (1,2 mg/kg ca) | – | – |
| Horse | B.equi | 2 ml/100 kg ca (Intramuscular) 2 doses with 48 hour intervals | 4 ml/100 kg ca (Intramuscular) 4 doses with 72 hour intervals | 2 ml/100 kg ca (Intramuscular) (2,4 mg/kg ca) |
| B. caballi | 2 ml/100 kg ca (Intramuscular) (2,4 ng/kg ca) | 2 ml/100 kg ca (Intramuscular) 2 doses with 24 hour intervals | 2 ml/100 kg ca (Intramuscular) (2,4 mg/kg ca) |
SPECIFIC CLINICAL INFORMATION AND WARNINGS FOR TARGET SPECIES
Imocel Solution for Injection can be used for 4-6 weeks protection from Babesia sp and Anaplasma marginale infections. For this purpose, Imocel Solution for Injection should be administered prior to the entry of susceptible animals into an endemic area. Over time, the level of Imidocarb in the animal body decreases, allowing a small number of parasites to introduce the infection while the animal is protected by the drug. The result is the development of immunity to the disease before clinical signs appear. However, when the level of imidocarb decreases, the animal will become susceptible to infection.
Imocel Solution for Injection provides protection against Babesiosis and Anaplasmosis in case of short transit of susceptible animals from an endemic place.
Animals that recover should be monitored for approximately 4 weeks following treatment for worsening and no need for repeat treatment. In order to reduce the risk of spreading the disease, ectoparasitic drugs for tick control should be applied to herds.
Sterilization of B.caballi infections in horses can be easily achieved with Imocel Solution for Injection. However, the success rate in sterilization of B equi infections is around 60%. In case of relapse, the second injection should be given at least 6 weeks after the first injection. It can be used in the treatment of Babesiosis caused by B.ovis in sheep. The second injection against recurrence of babesiosis should be given at least 7 days after the first injection. Recommended doses should not be exceeded. When the recommended dose rate is exceeded in sheep, cholinergic symptoms may occur (see Symptoms and antidote for overdose).
In the treatment of Babesiosis caused by B. bovis and B. bigemina and Anaplasmosis caused by A. marginale in cattle, 4-6 weeks of preventive drug application can be applied.
UNDESIRED EFFECTS
In animals administered infrequently, Imocel Solution for Injection may cause the development of cholinergic effects, manifested by salivation, discomfort, tremors, ataxia, convulsions, tachycardia, cough, urination, defecation, and colic. Also, deaths may occur as a result of anaphylactic reactions in some hypersensitive animals.
DRUG INTERACTIONS
Imidocarb may interact in vivo with cholinesterase inhibitor organophosphorus and carbamate insecticides and other cholinesterase inhibitor drugs. For the stated reason, it should not be used with or simultaneously with drugs from the same group.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
In overdose, symptoms similar to salivation, muscle tremors, tremors, ataxia, convulsions, urination and defecation, poisoning with cholinesterase inhibitors occur. Doses of 10 mg/kg and above in cattle and 8 mg/kg and above in horses may have toxic effects on the liver and kidneys. Its antidote is atropine. It is applied together with symptomatic treatment.
RESIDUAL WARNINGS FOR FOOD-PRODUCING ANIMALS
Drug Residue Elimination Period: During the treatment process and after the last drug application, cattle should not be sent to slaughter until 28 days after and sheep should not be sent to slaughter until 21 days after, and their meat should not be consumed as human food. Cow’s milk obtained during the treatment and for 2 days (4 milkings) after the last drug administration should not be offered for human consumption. It is not applied to dairy sheep whose milk will be offered for human consumption.
*However, when applied for 4-6 weeks for protection purposes and for the treatment of anaplasmosis (3 mg/kg ca) in cattle, the cattle should not be sent to slaughter and the cow’s milk obtained for 7 days (14 milkings) should not be offered for human consumption during the treatment and for 213 days after the last drug administration.
CONTRAINDICATIONS
Avoid intravenous administration. It should not be administered to animals with impaired lung, liver and kidney function. Repeated doses should not be administered to cattle.
Use during pregnancy: It can be applied to cattle and horses at the recommended doses during pregnancy. There is not enough information on sheep.
GENERAL PRECAUTIONS
It is used only in animal health. Consult your veterinarian before use and in case of an unexpected effect. Keep out of reach of children.
PRECAUTIONS TO BE TAKEN BY APPLICANTS AND WARNINGS FOR PHYSICIANS
In case of accidental ingestion of the drug, it is necessary to rinse the mouth with plenty of water, and in case of symptoms of poisoning due to the absorbed drug, a doctor should be consulted with the prospectus as soon as possible. If the drug gets into the eyes, they should be washed with plenty of clean water for 15 minutes, keeping the eye and/or eyes open. If the skin is contaminated with the drug, after removing the contaminated clothes, the contaminated skin parts should be washed with plenty of water and soap. In case of exposure through inhalation, after providing the opportunity to breathe with fresh air as much as possible, the mouth and nose area should be cleaned with plenty of water when necessary. A doctor should be consulted in order to prevent the health hazards that may arise in the listed inconvenient situations.
STORAGE CONDITIONS AND SHELF LIFE
Imocel Solution for Injection is stored at room temperature, protected from sunlight. It is recommended to use the drug, the package of which is opened, within 28 days, provided that it is kept at 2-8°C. Shelf life is 2 years from the date of manufacture.
END DISPOSAL AND WARNINGS FOR NON-TARGET SPECIES
It is inconvenient to use in goats due to the danger of acute toxicity. Empty bottles should be wrapped in a suitable paper and thrown away.
TRADE DRESS
Imocel Injectable Solution is offered for sale in 10 ml, 20 ml, 50 ml, and 100 ml amber-colored glass bottles and in cardboard boxes.
PLACE AND CONDITIONS OF SALE
Sold in veterinary offices and pharmacies with a veterinarian’s prescription.
