| - | - | - |
|---|---|---|
| Product Group | : | Parasiticides |
| Pharmaceutical Form | : | Oral Tablet |
| Active Ingredient | : | Albendazole |
| Target Type | : | Cattle |
| Package Form | : | 10 Tablet |
For Animal Use Only
For Animal Use Only
ALFAZOL
Oral Tablet
Veterinary Anthelmintic
COMPOSITION
It is white - off-white colored and scored tablet containing 1200 mg Albendazole.
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.
Albendazole is a broad spectrum anthelmintic effective against gastrointestinal roundworms, lungworms, tapeworms and adult liver flukes in cattle. 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.
|
Indıcation |
Pharmacological Dose |
Practical Dose |
|
Roundworm (adult and egg), lungworm, tapeworm, liver fluke |
7.5 mg albendazole/ kg body weight |
160 kg body weight/ 1 tablet |
|
Liver fluke (Adult) |
10 mg albendazole/ kg body weight |
120 kg body weight/ 1 tablet |
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 in Pregnancy and Lactation: 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
Not known.
DRUG INTERACTIONS
Not known.
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,
Cow: 72 hours (6 milkings)
CONTRAINDICATIONS
It is not used in animals known to be sensitive to the substances in the product composition.
Not to be used when resistance to benzimidazoles may occur.
GENERAL WARNINGS
Consult your veterinarian before use and in case of an unexpected effect. Keep out of reach of children and foodstuff.
PRECAUTIONS TO BE TAKEN BY THE ADMINISTRATOR AND WARNINGS FOR VETERINARY SURGEON
Wash hands after use.
STORAGE CONDITIONS AND SHELF LIFE
It should be stored under 25°C in the original package, without being frozen or placed in the refrigerator. Protect from sunlight. Shelf life is 2 years
DISPOSAL AFTER USE AND WARNINGS FOR NON-TARGET SPECIES
Any used veterinary medicinal product or its residual material should be disposed of in accordance with local regulations. DANGEROUS TO FISH AND AQUATIC LIFE. Water sources (rivers, lakes, ditches, etc.) should not be contaminated with product or used product containers.
COMMERCIAL PRESENTATION FORM
10 tablets in blister with boxes.
PLACES AND CONDITIONS OF SALE
Sold with a veterinary prescription at pharmacies, veterinary clinics, polyclinics, and animal hospitals (VSP).
APPROVAL DATE OF LEAFLET:
MARKETING AUTHORIZATION DATE AND NO: 10.12.2009-022/0008
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
VİLSAN Veteriner İlaçları TİC. ve SAN. A.Ş.
Balıkhisar Mah. Balıkhisar Köy İçi Küme Evleri No:765A Akyurt/Ankara-Türkiye
