| - | - | - |
|---|---|---|
| Product Group | : | Parasiticides |
| Pharmaceutical Form | : | Solution for Injection |
| Active Ingredient | : | İmidocarb Dipropionate |
| Target Species | : | Cattle, Horse, Dog |
| Package Form | : | 50 ml |
For Veterinary Use Only
For Veterinary Use Only
Solution for Injection
Veterinary Antiprotozooner
COMPOSITION
İmocel Solution for Injection is a clear, sterile, colorless or light yellow colored solution containing 120 mg Imidocarb dipropionate equivalent to 85 mg imidocarb.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic Properties
Imidocarb is an antiprotozoan used in the treatment of Babesiosis, belonging to the group of carbanilides. Knowledge about the mechanism of action is limited. In parasites, it affects the morphology of the cytoplasm and the number and size of the nucleus. The antiprotozoan effect is formed by acting on the glycolysis of parathyzine. It acts as an inhibitor of Type II topoisomerase after penetration into the parasite by urine-based protein carriers. This effect blocks the replication of DNA and inhibits the parasite's synthesis of polyamines.
Pharmacokinetics Properties
Pharmacokinetic studies have shown that imidocarb has prolonged activity due to its plasma and tissue protein binding and slow metabolism. In a radiolabeled study, it was shown that half of the dose given 10 days after the subcutaneous administration of imidocarb at a dose of 3 mg/kg to lactating and non-lactating cows. It is excreted mainly with stool. Plasma reaches its peak level 1 hour after administration (1.3 mg equivalent/kg). The peak level in milk is reached 24 hours after administration (0.37 mg equivalent/kg) and is reduced to half after 24 hours. It is excreted mainly in the form of parent compound.
Imidocarb has been shown to cross the placental barrier.
AREA OF USE/INDICATIONS
Cattle: Treatment and prevention of Babesiosis (Babesia argentina, B. bigemina, B. bovis and B. divergens) and Anaplasmosis marginale.
Dog: Treatment and prevention of Babesiosis (Babesia canis, B. gibsoni and B. vogelli)
Horse: Treatment and prevention of Babesiosis (B. equi and B. caballi)
USAGE AND DOSAGE
Cattle:
Babesiosis:
It is administered by deep intramuscular (hip or neck area) or subcutaneous route.
Prevention: 2.125 mg of imidocarb per kg of body weight (2.5 ml per 100 kg of body weight).
Treatment: 0.85 mg of imidocarb per kg of body weight (1 ml per 100 kg of body weight)
A single injection is administered.
Anaplasmosis:
- Bovine anaplasmosis: 2.125 mg of imidocarb per kg of body weight (2.5 ml per 100 kg of body weight)
Dog:
Babesiosis: It is administered intramuscularly or subcutaneously.
Prevention: 4.25 mg of imidocarb per kg of body weight (0.5 ml per 10 kg of body weight). Prevention period does not exceed 4-6 weeks.
Treatment: 2.125 mg of imidocarb per kg of body weight (0.25 ml per 10 kg of body weight).
A single injection is administered.
Horse:
It is administered intramuscularly. For B. caballi, a single dose of 2 ml per 100 kg of body weight is normally sufficient. However, for B. equi, two applications may be required at 24-72 hours intervals, depending on the clinical condition of the disease. A single dose administration provides protection for up to 4 weeks. For sterilization of B. caballi infestations, 2 ml administration per 100 kg body weight is required twice with 24 hours intervals. For sterilization of B. equi infestations, 4 ml administration per 100 kg body weight is required 4 times with 72 hours intervals. In resistant cases in horses, there should be at least 6 weeks between subsequent sterilization applications.
SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES
Imidocarb is an effective inhibitor of cholinesterase. The amount to be administered varies according to the target type and purpose. In any case, high attention should be paid to the administration according to body weight.
For the prevention of Babesiosis, it should be applied when one or two animals in the herd show symptoms or when cattle are shipped to areas where Babesia is seen. All animals should be given a protective dose and all animals should be kept under surveillance during the specified quarantine period.
Although the administration varies according to the severity of exposure to the parasite, it shows a protective effect for up to 4 weeks. Immunity can be achieved if sufficient exposure to the parasite occurs during this time.
Body weight should be measured accurately and the recommended dose should not be exceeded.
Do not administer together with other babesicids. Administration of high doses can be painful and this may cause the animals to react. Some dogs may be hypersensitive to this pain.
Use in Pregnancy and Lactation: No evidence of teratogenicity was found in studies in laboratory animals. The safety of this product in target breed pregnant animals has not been studied. Therefore, it should be used according to the benefit/risk assessment of the veterinarian.
ADVERSE REACTIONS
General condition disorders (hyperthermia, sweating, fatigue), digestive system disorders (vomiting, colic, hypersalivation), neuro-muscular disorders (tremor, convulsion) were observed in target species. Salivation, restlessness, muscle tremors, tachycardia, cough, colic are rare. Deaths due to anaphylactic shock have occurred after product administration. It is recommended that the physician keep the treated animals under observation for 15 minutes after the application.
It may be possible to attenuate the cholinergic effects seen after administration in animals with atropine sulfate.
DRUG INTERACTIONS
Do not administer together with cholinesterase inhibitors.
It should not be mixed with other medicinal products.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
At 1.75 times the recommended dose, symptoms associated with anticholinergic activity begin to appear. Overdose can be treated with atropine sulfate. Death occurs at 5 times or more of the recommended dose.
WITHDRAWAL PERIODS
Cattle should not be sent for slaughtering during treatment and for 213 days following the final drug administration. Milk obtained from cattle should not be offered for human consumption for 21 days (42 milkings).
CONTRAINDICATIONS
It is not used on mules and donkeys. Not for use in horses less than 1 year old.
Do not administer intravenously.
Do not administer in repeated doses.
Not for use in animals known to be sensitive to its active or excipients.
GENERAL WARNINGS
Consult your veterinarian before use and in case of an unexpected effect. Keep out of reach of children.
PRECAUTIONS TO BE TAKEN BY THE ADMINISTRATOR AND WARNINGS FOR VETERINARY SURGEON
If you have received medical advice that you should not work with products with anticholinesterase activity, do not use or contact this product.
In case of contact with skin or eyes, wash the area with plenty of water. Use appropriate protection when using the product. In case of accidental injection, seek immediate medical assistance and show the product label and leaflet to your doctor.
Seek immediate medical attention if symptoms suggestive of anticholinesterase activity such as hypersalivation, headache, abdominal pain, mydriasis, vomiting, diarrhea, blurred vision, and muscular tremor are observed.
STORAGE CONDITIONS AND SHELF LIFE
It should be stored under 25°C in the original package, protected from sunlight, without being frozen or placed in the refrigerator. Shelf life is 2 years. After opening, it should be stored under 2-8°C and used within 28 days.
WARNINGS FOR DISPOSAL AND NON-TARGET SPECIES
Unused or leftover product must be disposed of according to the relevant legislation.
COMMERCIAL PRESENTATION FORM
Offered for sale in 50 ml amber colored glass vials with cardboard boxes.
PLACE AND CONDITIONS OF SALE
Sold with Veterinary Surgeon’s prescription in pharmacies, veterinary clinics, polyclinics and animal hospitals (VSP).
APPROVAL DATE OF THE LEAFLET: 08.07.2022
MARKETING AUTHORIZATION DATE AND NO: 29.01.2008 - 019/0066
MARKETING AUTHORIZATION HOLDER
Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.
Malıköy Başkent OSB Mah. 26. Cad. No:34/A Sincan/Ankara-Türkiye
MANUFACTURER COMPANY
1- Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.
Malıköy Başkent OSB Mah. 26. Cad. No:34/A Sincan/Ankara-Türkiye
2- FDN İLAÇ SAN. VE TİC. LTD. ŞTİ.
Büyükkayacık OSB Mah. İnsu Sokak No:3 Selçuklu/Konya-Türkiye
