Ivermectin is a semi-synthetic antiparasitic medication derived from avermectins, a class of highly-active broad-spectrum antiparasitic agents isolated from the fermentation products of Streptomyces avermitilis.8 Ivermectin itself is a mixture of two avermectins, comprising roughly 90% 5-O-demethyl-22,23-dihydroavermectin A1a (22,23-dihydroavermectin B1a) and 10% 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro-25-(1-methylethyl)avermectin A1a (22,23-dihydroavermectin B1b).8
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Ivermectin is mainly used in humans for the treatment of onchocerciasis, but it may also be effective against other worm infestations such as strongyloidiasis, ascariasis, trichuriasis, and enterobiasis. Applied topically, it can be used to treat head lice infestations.
With the advent of 2020 and the COVID-19 pandemic, ivermectin began garnering notoriety due to its off-label use for the prophylaxis and treatment of COVID-19. While studies are still ongoing, much of the evidence for ivermectin in COVID-19 relies on pre-print in vitro data, and the clinical utility of this data remains unclear. Due to a number of factors - such as the relatively low number of patients per trial and the speed at which these trials were conducted - studies on the use of ivermectin in COVID-19 have been fraught with statistical errors and accusations of plagiarism.9,5 Additionally, the use of aggregate patient data in large-scale meta-analyses (as opposed to individual patient data (IPD)) has been shown to disguise otherwise blatant data errors, such as extreme terminal digit bias and the duplication of blocks of patient records.5
Until high-quality, peer-reviewed data regarding both the safety and efficacy of ivermectin for COVID-19 in humans become available, the use of ivermectin for these purposes should be avoided in favor of thoroughly-vetted therapies (e.g., COVID-19 vaccines like Comirnaty).
Poor-quality veterinary drugs hamper the effectiveness of animal health care systems, potentially endangering human safety through animal-derived food products. This study assessed the quality of veterinary albendazole, fenbendazole, and ivermectin boluses/tablets marketed in Gondar Zones, Northwest Ethiopia. A total of 42 samples were collected from all government veterinary clinics and private veterinary pharmacies in Gondar zones by mystery shoppers from October 2020 to January 2021. All samples were visually and physically inspected for proper labeling and packaging. Samples were evaluated based on Pharmacopoeias and manufacturers' methods for identification, assay, dosage uniformity, dissolution, disintegration, hardness, and friability tests. All samples passed the visual inspection criteria outlined in the joint WHO/FIP/USP checklist. In general, 80.95% (34/42) of the products examined were substandard, failing one or more quality test parameters, including all albendazole (30/30) and fenbendazole (4/4) samples. However, all of the ivermectin samples (8/8) passed the quality test parameters investigated in this work. The study indicated that low-quality veterinary albendazole and fenbendazole products are incredibly common in the study sites. The most crucial quality features investigated as failure were friability and disintegration. Thus, regulations and enforcements that guarantee the quality of veterinary anthelmintic medications should be strictly in place in the study area and in the country.
Livestock production has been projected to support roughly three-quarters of severely impoverished people throughout the world. Therefore, livestock is a highly significant aspect of the economy of many developing nations. Ethiopia is home to various populations of animals and is well suited for livestock production. The nation possesses the greatest livestock population in Africa.
The livestock subsector is vital to Ethiopia’s economy, with many livelihoods relying on it. The industry remains promising for the country’s future economic growth. However, diseases, ineffective nutrition and husbandry systems, and lack of effective veterinary services keep productivity low for this huge livestock population.
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Globally, parasitic diseases are a major threat to grazing livestock. Clinical and sub-clinical helminthic parasite infections cause low productivity. Poor feed utilization and mortality also contribute to reduced economic benefits from livestock.
Strategic parasite management is required for maintaining proper animal health. Various parasites can be controlled with anti-parasitic medications, which are widely used in animal production. Many broad-spectrum anthelmintics are available to treat helminthiasis. Among these anthelmintic medications, imidothiazoles (levamisole), tetrahydropyrimidines (pyrantel), and avermectins are the most widely utilized in most countries. Although veterinary anthelmintic medications provide a remedy to these animal health issues when used appropriately, there is increasing usage of ineffective treatments due to the existence of poor-quality pharmaceuticals in the supply chain system. The global animal medicines association has predicted the illicit veterinary drug trade to be around 1 billion USD annually, nearly 3% of the value of the legitimate veterinary market. This presents a major danger to animal health and welfare: not only are they inefficient at treating ailments, but they can also be hazardous for animals. Furthermore, poor-quality veterinary drugs in food-producing animals may affect food safety.
The WHO provides recommendations to nations to adopt veterinary medicine quality assurance systems. The International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products initiative helps nations set global standards for veterinary medicine. Global veterinary product specialists have been assembled by the World Organization for Animal Health (OIE), with each member country represented by a local authority on veterinary health and medicine.
There is evidence of counterfeiting of both branded and generic products. Veterinary drugs available on the market may contain the right components but may have an inadequate quantity of the active component, no active ingredients at all, or deceptive packaging. They may also include hazardous or poisonous contaminants.
Ivermectin, fenbendazole, and albendazole are the most extensively used anthelmintics in Ethiopia. Ivermectin (Ashiver 5 mg) is indicated for the treatment and control of gastrointestinal roundworms (adult & larval stages), eye worms, and lungworms. It is also effective against ectoparasites such as ticks, mites & suckling lice in sheep, goats, cattle, and pigs. Fenbendazole (fenacure 750 mg) is indicated for the removal & control of gastrointestinal roundworms (adult & 4th stage larvae), lungworms (adult & larval stages), hookworms, and tapeworms (heads & segments) in cattle, horses, and camel. Albendazole is a synthetic anthelmintic that belongs to the group of benzimidazole-derivatives with activity against a broad range of worms. It is also used at a higher dosage level against adult stages of liver fluke in cattle, sheep, and goats. Privately imported veterinary anthelmintic medications dominate the Ethiopian market, with little local production. The Ethiopian Veterinary Drug and Animal Feed Administration and Control Authority, recently re-organized as the Ethiopian Agricultural Authority (EAA), oversees the quality of veterinary medications imported, produced, and dispensed in Ethiopia.
The Authority monitors possible access and entry points for veterinary medicines and animal feeds to the country. However, low-quality medications may still be imported and distributed. Professionals and animal owners alike have expressed concerns about the efficacy of currently available medications. Treatment failures are a significant problem for many stakeholders in animal health. This is exemplified by in vivo studies that document treatment failures in Ethiopia. The reported low effectiveness may be due to parasite medication resistance or poor medicine quality. This demands further research and comparisons.
No comprehensive quality assessment of ivermectin, fenbendazole, and albendazole boluses is available in the study area. Therefore, the objective of this study was to assess the quality of albendazole, fenbendazole, and ivermectin products sold in Gondar zones, Northwest Ethiopia.
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