Chemical Compatibility and Safety of Imidacloprid/Flumethrin Collar (Seresto®) Concomitantly Used with Imidacloprid/Moxidectin (Advocate®, Advantage® Multi) and Emodepside/Praziquantel (Profender®) Spot-on Formulations

Chemical Compatibility and Safety of Imidacloprid/Flumethrin Collar (Seresto®) Concomitantly Used with Imidacloprid/Moxidectin (Advocate®, Advantage® Multi) and Emodepside/Praziquantel (Profender®) Spot-on Formulations
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DOI:
10.1007/s00436-015-4514-z
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发表时间:
2015-08-01
影响因子:
2
通讯作者:
Stanneck, Dorothee
Stanneck, Dorothee
中科院分区:
医学3区
文献类型:
--
作者:
Kruedewagen, Eva Maria;Remer, Carolin;Stanneck, Dorothee

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兽药联合使用的安全性具有临床意义。进行了一系列研究,以评估与点滴剂或片剂配方同时使用的吡虫啉/氟菊酯项圈(Seresto (R)/Foresto (R),拜耳)的化学相容性以及短期皮肤和全身安全性。对项圈片进行体外化学相容性评估(研究参考 A),随后在猫和狗中进行两项小型非对照临床研究(研究参考 B)。研究表明,某些溶剂会影响体外项圈,但不会影响其市售配方。首先在一项针对猫和狗的小型非对照临床研究(研究参考 C)中仅通过临床观察评估了不同点滴剂或片剂配方的皮肤和全身安全性,然后在狗和猫中进行了与吡虫啉/莫昔克丁(Advocate (R)/Advantage (R) Multi,拜耳)联合使用的对照临床安全性研究(研究参考 D)和艾默德苷/吡喹酮(Profender (R),拜耳)在猫(研究参考文献 E)中,通过与基线值相比以及治疗组和对照组之间的血液学和临床化学参数的临床观察和统计分析来评估安全性。所有临床研究(研究参考文献 B 至 E)的皮肤安全性结果与已描述的相应产品相匹配,包括点涂部位的短暂美容变化(油性毛发和晶体形成)以及项圈部位的断发、短暂脱发和皮肤改变。没有迹象表明这些结果在同时使用的情况下会加重。在任何临床安全性研究中均未发现具有临床意义的系统性安全性结果(研究参考 C 至 E)。血液参数的评估显示狗和猫与基线水平和参考范围存在一些偏差,但无法推断出临床相关性。血液学和临床化学结果证实了伴随治疗的安全性。结论是,Seresto (R) 与市场上主要点滴配方中使用的溶剂在化学上相容,并且与 Advocate (R) 和 Profender (R) 点滴配方同时使用时,对成年狗和猫来说具有皮肤和全身安全性。
Safety of concomitant use of veterinary products is of clinical interest. A series of studies was performed to evaluate the chemical compatibility and short term dermal and systemic safety of an imidacloprid/ flumethrin collar (Seresto (R)/Foresto (R), Bayer) used concomitantly with spot-on or tablet formulations.Chemical compatibility was evaluated in-vitro (study reference A) on collar pieces, followed by two small, non-controlled clinical studies (study reference B) in both, cats and dogs. The studies showed, that certain solvents affected the collar in-vitro, but not in their marketed formulations. Dermal and systemic safety of different spot-on or tablet formulations was first evaluated in a small, non-controlled clinical study (study reference C) in cats and dogs, via clinical observations only, followed by controlled clinical safety studies of concomitant use with imidacloprid/ moxidectin (Advocate (R)/Advantage (R) Multi, Bayer) in dogs and cats (study reference D) and emodepside/ praziquantel (Profender (R), Bayer) in cats (study reference E), assessing safety aspects by clinical observations and statistical analyses of hematology and clinical chemistry parameters compared to baseline values and between treated and control groups.Dermal safety findings over all clinical studies (study references B to E) matched those already described for the respective products and included transient cosmetic changes (oily hair and crystal formation) at the site of spot-on application and broken hair, transient alopecia and skin alterations at the site of collar application. There were no indications of these findings aggravating under the conditions of concurrent use. There were no systemic safety findings of clinical significance in any of the clinical safety studies (study reference C to E). Assessment of blood parameters revealed some deviations from baseline levels and from the reference range in dogs as well as in cats, but no clinical relevance could be deduced. Hematology and clinical chemistry results confirmed the safety of the concomitant treatment. It is concluded that Seresto (R) is chemically compatible with solvents used in major spot-on formulations on the market and is dermally and systemically safe for adult dogs and cats when used concomitantly with Advocate (R) and Profender (R) spot-on formulations.