Quality of medicines: Deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections

European Medicines Agency Veterinary Medicines and Inspections

1. Ivermectin belongs to the macrocyclic lactone class of endectocides and consists of a mixture of two homologous compounds, 22,23-dihydroavermectin B1a (H2B1a, not less than 80%) and 22,23-dihydroavermectin B1b (H2B1b, not more than 20%). Avermectins are potent anthelmintic, insecticidal and acaracidal compounds which, by increasing the membrane permeability to chloride ions, mediate the para...

European Medicines Agency Veterinary Medicines and Inspections

1. Avilamycin is an orthosomycin antibiotic complex produced by the fermentation of Streptomyces viridochromogenes. Orthosomycin antibiotics are divided into two groups: those that contain an aminocyclitol residue and those that are esters of dichlorisoeverninic acid. Avilamycin falls into the latter group as do the evernimicins. Avilamycin is primarily active against gram-positive bacteria. Th...

European Medicines Agency Veterinary Medicines and Inspections

1. Monensin (CAS 17090-79-8, CAS 22373-78-0 for sodium salt) is a polyether antibiotic from the group of carboxylic ionophores produced by Streptomyces cinnamonensis. Monensin is used as the sodium salt. It is composed of the analogues A, B, C and D with monensin A being the major component (equivalent to 98%). The intended use as a veterinary medicinal product in lactating dairy cattle is as a...

European Medicines Agency Veterinary Medicines and Inspections

European Medicines Agency Veterinary Medicines and Inspections