| - | - | - |
|---|---|---|
| Product Group | : | Antiparasitics |
| Pharmaceutical Form | : | Oral Tablet |
| Active Ingredient | : | Albendazole |
| Target Animal | : | Cattle |
| Package Form | : | 2 blisters containing 5 tablets |
COMPOSITION
It is a white or whitish colored, bisect in the middle of the tablet containing 1500 mg Albendazole per tablet.
PHARMACOLOGICAL PROPERTIES
Pharmacodynamic properties
Albendazole inhibits the polymerization of microtubules by binding to tubulin, a structural protein in susceptible parasites. Intestinal cells of nematodes are particularly affected by this, leading to the loss of their ability to absorb, thus not being able to feed, and the death of the parasite by disrupting the cell integrity.
In addition, as with all benzimidazoles, albendazole acts by inhibiting the efficiency of fumarate reductase in glucose metabolism of parasites and disrupting the energy metabolism of parasites. At the end of this degradation, the use of glycogen increases and the parasite dies. The structural differences between mammalian and helminth tubulins make albendazole selectively toxic to helminths.
Two resistance mechanisms identified in nematodes include progressive loss of the "susceptible" beta tubulin gene isotype and the emergence of a "resistant" beta-tubulin gene isotype with a point mutation resulting from coding for tyrosine instead of phenylalanine.
Pharmacokinetic Properties
Albendazole has poor water solubility and limited absorption from the gastrointestinal tract (approximately 50% of the oral dose is absorbed in cattle). Following absorption, there is rapid first-pass metabolism in the liver, and the sulfur moiety of albendazole is oxidized to the pharmacologically active sulfoxide, then to the sulfone, followed by deacetylation of the carbamate group to form the 2-aminosulfone.
Metabolites with higher solubility than the main metabolite as a result of oxidation and hydrolysis are found in blood, tissues, bile and urine.
Excretion occurs through bile, feces and urine. In ruminants, 60-70% of the administered dose is excreted in the urine as various metabolites, most of which are sulfoxides.
AREA OF USE/INDICATIONS
Albendazole is a broad spectrum anthelmintic effective against gastrointestinal roundworms, lungworms, tapeworms and adult liver flukes in cattle, goats and sheep. It also has an ovicidal effect on flukes and roundworms, thus reducing meadow/pasture contamination.
Cattle:
Roundworm: Teladorsagia, Haemonchus, Trichostrongylus, Nematodirus, Oesophagostomum, Bunostomum, Cooperia, and Strongyloides spp. It is also effective against Cooperia and inhibited Ostertagia larvae.
Lungworm: Dictyocaulus viviparus,
Tapeworm: Moniezia spp.,
Adult liver fluke: Fasciola hepatica
USAGE AND DOSAGE
It is administered orally. Ensure that the tablets are swallowed by the animal.
Cattle:
It is administered at a dose of 7.5 mg albendazole/kg body weight for roundworm, lungworm, tapeworm, liver fluke and roundworm eggs.
It is administered at a dose of 10 mg albendazole/kg body weight for adult liver flukes.
Practical Dose:
|
Weight |
Roundworm, lungworm, tapeworm, liver fluke and roundworm eggs |
Weight |
Adult liver flukes |
|
|
|
150 kg |
1 tablet |
|
200 kg |
1 tablet |
300 kg |
2 tablets |
|
600 kg |
3 tablets |
600 kg |
4 tablets |
SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES
In cattle with severe lung injury from lungworms, cough may persist for several weeks after treatment.
The following points should be considered in case of increasing the risk of resistance development and the possibility of negative results of the treatment:
- The same class of anthelmintics should not be used frequently or repeatedly for long periods of time.
- It should not be given in doses lower than the pharmacological dose due to miscalculation of body weight, misapplication, etc.
If there is any doubt about the development of resistance to anthelmintics, further investigation with appropriate tests is required. It should be used where the results of the test(s) show strong resistance to a particular anthelmintic belonging to another pharmacological class and having a different mode of action.
It has been reported that Teladorsagia, Haemonchus, Cooperia and Trichostrongylus species that cause infestation in small ruminants in European Union countries develop resistance to benzimidazoles, including albendazole. Resistance to albendazole has been detected in Cooperia and Teladorsagia species in cattle in New Zealand. For this reason, the use of this product should be used according to regional/national and emiological susceptibility data and recommendations.
Consult your veterinarian for the management of resistance issues.
Use during pregnancy: Studies in sheep, mice, rats and rabbits have shown that albendazole has a teratogenic effect. Therefore, its use in the first 1/3 of pregnancy is contraindicated. It should be used in the later stages of pregnancy according to the benefit/risk assessment of the veterinarian.
ADVERSE EFFECTS
Unknown.
DRUG INTERACTIONS
Do not use in combination with other products.
SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE
It is generally well tolerated at recommended doses. No significant side effects were observed in 3-5 times the application. In case of overdose, depression and anorexia may occur.
WITHDRAWAL PERIODS
Meat: 14 days
Milk: 72 hours (6 milkings)
CONTRAINDICATIONS
Do not use in animals known to be hypersensitive to the ingredients.
Do not use when resistance to benzimidazoles may occur.
GENERAL WARNINGS
Consult a veterinarian before use and if any unexpected reactions occur.
Keep out of reach of children and away from foodstuffs.
PRECAUTIONS TO BE TAKEN BY THE ADMINISTRATOR AND WARNINGS FOR VETERINARY SURGEON
Wash your hands after use.
STORAGE CONDITIONS AND SHELF LIFE
It should be stored in the original packaging, protected from light, below 25°C, without refrigeration or freezing. Shelf life is 2 years.
DISPOSAL AFTER USE AND WARNINGS FOR NON-TARGET SPECIES
Used product containers and any unused or leftover product must be disposed of according to applicable regulations.
IT IS DANGEROUS FOR FISH AND AQUATIC LIFE. Water sources (streams, lakes, ditches, etc.) should not be contaminated with the product or used product containers.
COMMERCIAL PRESENTATION FORM
2 x 5 tablets with boxes.
PLACE OF SALE AND CONDITIONS
Sold by veterinary prescription in pharmacies and veterinary clinics (VHP).
APPROVAL DATE OF LEAFET: 21.03.2025
MARKETING AUTHORIZATION DATE AND NO: 21.10.2010 – 023/0046
NAME AND ADDRESS OF MARKETING AUTHORIZATION HOLDER
VİLSAN Veteriner İlaçları Tic. Ve San. A.Ş.
Balıkhisar Mah. Balıkhisar Köy içi Küme Evleri No:765A Akyurt/Ankara /Türkiye
MANUFACTURER COMPANY
VİLSAN Veteriner İlaçları Tic. Ve San. A.Ş.
Balıkhisar Mah. Balıkhisar Köy içi Küme Evleri No:765A Akyurt/Ankara /Türkiye
Made in Turkiye
