Dataset Information

Safety and efficacy of Coxiril® (diclazuril) for chickens reared for laying.

ABSTRACT: Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Coxiril® (diclazuril) for chickens reared for laying. Coxiril®, containing 0.5% diclazuril, is intended for the prevention of coccidiosis in chickens reared for laying at a dose range of 0.8-1.2 mg diclazuril/kg of complete feed up to a maximum age of 12 weeks. Derived from data already assessed for chickens and turkeys for fattening, diclazuril from Coxiril® is safe for chickens reared for laying up to 1.2 mg/kg complete feed when applied until 12 weeks of age. The FEEDAP Panel extended its previous assessment of consumer safety for the use of diclazuril from Coxiril® in chickens for fattening to chickens reared for laying. No measurable diclazuril residues were found in the first eggs laid from chickens reared for laying fed diclazuril from Coxiril® at 1.2 mg/kg complete feed until 12 weeks of age. Coxiril® was considered as a non-irritant to eyes and skin. It is not a potential skin sensitiser. User inhalation exposure to Coxiril®, as a result of normal handling, is unlikely to cause respiratory or systemic toxicity. The use of diclazuril from Coxiril® in chickens reared for laying at the highest proposed feed concentration would not pose a risk to the environment for neutral/alkaline soils (pH ? 7). A final conclusion on the risk resulting from the use of diclazuril in acid soil from Coxiril® cannot be done due to the high uncertainties related to potential accumulation of diclazuril over time. Derived from data already assessed for chickens for fattening, diclazuril from Coxiril® has the potential to control coccidiosis in chickens reared for laying at a minimum concentration of 0.8 mg/kg complete feed.

SUBMITTER: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP)

PROVIDER: S-EPMC7009511 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Safety and efficacy of Coxiril® (diclazuril) for chickens reared for laying.

Rychen Guido G Aquilina Gabriele G Azimonti Giovanna G Bampidis Vasileios V Bastos Maria de Lourdes ML Bories Georges G Chesson Andrew A Cocconcelli Pier Sandro PS Flachowsky Gerhard G Kolar Boris B Kouba Maryline M López Alonso Marta M López Puente Secundino S Mantovani Alberto A Mayo Baltasar B Ramos Fernando F Saarela Maria M Villa Roberto Edoardo RE Wallace Robert John RJ Wester Pieter P Brantom Paul P Halle Ingrid I van Beelen Patrick P Holczknecht Orsolya O Vettori Maria Vittoria MV Gropp Jürgen J

EFSA journal. European Food Safety Authority 20180329 3

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of Coxiril® (diclazuril) for chickens reared for laying. Coxiril®, containing 0.5% diclazuril, is intended for the prevention of coccidiosis in chickens reared for laying at a dose range of 0.8-1.2 mg diclazuril/kg of complete feed up to a maximum age of 12 weeks. Derived from da ...[more]

PMID: 32625831

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Project description:Poultry mites are the most significant pest affecting production systems in the egg-laying industry. Fluralaner is a novel systemic insecticide and acaricide that is effective against poultry mites (Dermanyssus gallinae, Ornithonyssus sylviarum) in chickens after oral administration. This study investigated the safety of oral administration of a 1% solution of fluralaner in drinking water to laying hens at the recommended treatment dose and at multiples of this dose.One hundred-twenty healthy 28-week-old laying hens, weighing 1.4-2.1 kg at first administration, were included in the study, and allocated to 4 treatment groups of 30 hens each receiving daily doses of 0, 0.5, 1.5 and 2.5 mg fluralaner/kg body weight, equivalent to 0, 1, 3, and 5 times the recommended dose of fluralaner. The product was administered via drinking water on a total of six occasions, as 3-day treatment periods twice with an interval of 4 days with no treatment (treatment on days 1, 2, 3 and 8, 9, 10), representing 3 times the recommended number of administrations. Hens supplied with non-medicated drinking water served as controls. During the study, all hens were clinically observed, and their health was carefully monitored including body weight, food and water consumption, hematology, clinical chemistry, and withdrawal reflex test. Eggs laid over the study were evaluated for main characteristics (e.g. weight, shape, strength, shell thickness and soundness, albumen height, yolk color, Haugh unit and presence of blood and/or meat spots). Following euthanasia of the hens at the end of the second treatment period (day 11) or 18 days later (day 29), complete gross post-mortem examination, including organ weight determination, and histopathological examination of multiple tissues were conducted.There were no clinical findings related to fluralaner treatment. Statistically significant differences between the treated groups and the control group were observed for some clinical pathology parameters; none of these findings were considered to be of clinical nor zootechnical relevance. Organ weights, gross post mortem and histopathological examinations did not reveal any finding associated with treatment with fluralaner.Oral administration of fluralaner via drinking water at the recommended treatment dose (0.5 mg/kg body weight twice at 1-week interval), is well tolerated and has a high safety margin up to an overall dose of 15 times the recommended one (5 times the daily dose given 3 times the number of days) in healthy adult laying hens. Based on the present results, the use of the new mite treatment based on fluralaner administered via drinking water is expected to be safe for laying hens under industrial conditions, and to have no negative impact on their egg quality and production.

Project description:Background and objectivesThis multicentre, open-label study investigated the safety and efficacy of Gammaplex, a 5% Intravenous Immunoglobulin (IVIg), in patients with idiopathic (immune) thrombocytopenic purpura (ITP).Materials and methodsPatients were between the ages of 6 and 70 years; had ITP for at least six months and had a platelet count ≤ 20 × 10(9)/L. Eligible patients were dosed with 1 g/kg of Gammaplex on two consecutive days, followed by assessment of safety and efficacy on Days 3, 5, 9, 14, 21, 32 and 90. Response was defined as the increase in platelet count to a threshold of ≥ 50 × 10(9)/L on or before Day 9 after the first dose of Gammaplex.ResultsAll 35 patients received at least one infusion of Gammaplex. Twenty-nine (83%) patients responded to Gammaplex, similar to the historical control, with a 95% lower one-sided confidence interval of 68.9%. Median duration of response was 10.0 days, with an overall reduction in bleeding episodes. Gammaplex provided supranormal concentrations of total IgG; mean peak concentration (Cmax) of 45.3 g/L (4.53 g/dL), with a mean half-life of 28.5 days. Fifteen patients reported 63 Adverse Drug Reactions (ADRs); the most common were headache (10 patients), vomiting (6 patients) and pyrexia (5 patients). Five of these ADRs were considered serious, one patient had three concurrent Serious Adverse Events (SAEs); these were vomiting, dehydration and headache. Two other patients each had one SAE (headache). There were no unexpected Adverse Events (AEs) or thromboembolic episodes and no significant changes in vital signs, biochemical, haematological and virology results.ConclusionGammaplex achieved a very high concentration of serum IgG but was well-tolerated and effective in the treatment of ITP with a similar degree of efficacy to the pre-determined historical control group and the pre-set statistical criteria.Trial registrationClinicalTrials.gov NCT00504075 Clinical Trials Registry India 000016.

Project description:There are no anticoccidial drugs labelled for rabbits in Kenya and those available are used as extra labels from poultry. The drugs are used in rabbits with limited knowledge of their efficacy and safety. The aim of this study was to determine the efficacy of sulphachloropyrazine, amprolium hydrochloride, and trimethoprim-sulphamethoxazole relative to diclazuril when used curatively against experimental and natural rabbit coccidiosis. In a controlled laboratory trial, sixty (60) rabbits were randomly allocated to six treatment groups, namely, 1A, 2B, 3C, 4D, 5E, and 6F, each with 10 rabbits. Groups 2B, 3C, 4D, 5E, and 6F were experimentally infected with mixed Eimeria species while group 1A served as uninfected-untreated (negative) control group. Four of the infected groups were treated with sulphachloropyrazine (5E), amprolium hydrochloride (2B), trimethoprim-sulphamethoxazole (6F), and diclazuril (4D) using dosages recommended by manufacturers. Group 3C served as infected-untreated (positive) control. A field efficacy trial in naturally infected rabbits was then undertaken. The results revealed that sulphachloropyrazine and diclazuril were effective against rabbit clinical coccidiosis by significantly reducing oocyst counts from 149.00±110.39 x 104 to 3.31±0.86 x 104 Eimeria spp. oocysts per gram of feces (opg) and 59.70±12.35 x 104 to 0.0±0.0 x 104 opg, respectively, in the laboratory trial. Similarly, sulphachloropyrazine and diclazuril recorded reduced oocyst counts in the field trial from 280.33±44.67 x 103 to 0.44±0.14 x 103 opg and 473.44±176.01 x 103 to 0.0±0.0 x 103 opg, respectively. Still, sulphachloropyrazine and diclazuril showed superior efficacy by registering lesion scores and fecal scores close to those of uninfected untreated control group. Trimethoprim-sulphamethoxazole recorded a satisfactory efficacy in the field trial by recording reduced oocyst counts from 266.78±37.03 x 103 to 0.75±0.11 x 103 opg but was not efficacious in the laboratory trial. Amprolium hydrochloride was not efficacious against clinical coccidiosis in both the experimental and field trials.

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Dataset Information

Safety and efficacy of Coxiril® (diclazuril) for chickens reared for laying.

Publications

Safety and efficacy of Coxiril<sup>®</sup> (diclazuril) for chickens reared for laying.

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