主要成分(ACTIVEINGREDIENT):环孢素(Cyclosporin)
性状(PHARMACEUTICALFORM):
本品为淡黄色或黄色的澄清油状液体。
(Thisproductisalightyelloworyellowclarifiedoilyliquid.)
适应症(INDICATIONSFORUSE):
本品用于治疗猫慢性过敏性皮炎。
Thisproductisusedtotreatchronicallergicdermatitisincats.
用法用量DOSAGEANDADMINISTRATION:以有效成分计。内服:每1kg体重,猫7mg
(相当于以本品计。内服:每1kg体重,猫0.07ml)。
Intermsofactiveingredient.Internaluse:7mgofcatper1kgofbodyweight.
(Equivalenttotheproduct.Internal:0.07mlper1kgbodyweightincats.)
规格(HOWSUPPLIEDPACKAGE):
5mL/瓶、17mL/瓶(5mL/17mLperbottle.)
包装(PACKAGE):
1瓶/盒。(1bottleperbox.)
贮存(STORAGEINFORMATION):
15~30℃密封保存,避免冷藏。不要在低于20℃的条件下贮藏超过一个月。
(Keepsealedat15-30℃andavoidrefrigeration.Donotstoreatlessthan20℃formorethanonemonth.)
环胞舒产品特点
抗炎调免疫,控制原发病;
10+免疫病,适用范围广;
自微乳释药,纳米级好吸收;
宠物友好口服液,剂量精准更安全。
CyclospoProductFeatures
-Anti-inflammatorymodulationofimmunityandcontrolofprimarydisease;
-10+immunediseasescanbeused,withawiderangeofapplication;
-Self-microemulsiondrugrelease,nanoscalegoodabsorption;
-Pet-friendlyoralsolution,accurateandsaferdosage.
常见问题
1.药物的使用周期(以过敏性皮炎为例)
治疗初期,本品应每日给药,直至观察到满意的临床症状改善(通常4~8周内)。应定期重新评估患猫并复核治疗方案。
一旦过敏性皮炎的临床体征得到满意控制,本品可每隔一天给药一次。在每隔一天给药一次,即可控制临床症状的一些病例中,兽医可每3~4天给予本品一次。当临床症状得到控制时可停止治疗。当临床症状复发时,应恢复至每日给药进行治疗,在某些情况下,可能需要进行重复治疗。
1.Periodicityofuseofthedrug(inthecaseofatopicdermatitis)
Intheinitialstageoftreatment,thisproductshouldbeadministereddailyuntilsatisfactoryclinicalimprovementisobserved(usuallywithin4to8weeks).Theaffectedcatshouldbereassessedandthetreatmentregimenreviewedperiodically.
Oncetheclinicalsignsofatopicdermatitishavebeensatisfactorilycontrolled,theproductmaybeadministeredeveryotherday.Insomecaseswhereclinicalsignscanbecontrolledbyeveryotherdayadministration,theveterinarianmaygivetheproductevery3to4days.Treatmentmaybediscontinuedwhenclinicalsignsareundercontrol.Whenclinicalsignsrecur,treatmentshouldberesumedonadailybasisand,insomecases,repeattreatmentmaybenecessary.
2.环孢素安全使用年龄及体重范围。
农业部标签说明书:尚未在<6月龄或体重<2.3kg的猫中评估环孢素的有效性和安全性。不得用于6月龄以下或体重低于2.3kg的猫。
国际最新研究:环孢素适用于6月龄以上且体重大于1.4kg的猫。适用于体重大于1.8kg的犬。
2.Ageandweightrangeforsafeuseofcyclosporine.
USDALabelingStatement:Theefficacyandsafetyofcyclosporinehavenotbeenevaluatedincats<6monthsofageorweighing<2.3kg.Itshouldnotbeusedincats<6monthsofageorweighing<2.3kg.
Latestinternationalstudies:Cyclosporineisindicatedforcatsover6monthsofageandweighing>1.4kg.Fordogsweighingmorethan1.8kg.
3.可能的不良反应?
胃肠道症状,如呕吐和腹泻。这些症状通常是轻微和短暂的,不需要停止治疗。
·本品治疗期间可能发生食欲下降和体重减轻,建议监测体重。体重显著降低可
能导致肝脏脂质沉积。
·如果在治疗期间发生持续的、渐进性体重减轻,建议停止治疗,直至确定原因。
3.Possibleadversereactions
Gastrointestinalsymptomssuchasvomitinganddiarrhea.Thesesymptomsareusuallymildandtransientanddonotrequirediscontinuationoftreatment.
-Decreasedappetiteandweightlossmayoccurduringtreatmentwiththisproductandweightmonitoringisrecommended.Significantweightlossmay
Asignificantdecreaseinbodyweightmayresultinlipiddepositionintheliver.
-Ifpersistent,progressiveweightlossoccursduringtreatment,itisrecommendedthattreatmentbediscontinueduntilthecauseisdetermined.
环胞舒注意事项
1.本品不得用于感染白血病病毒(FeLV)或免疫缺陷病毒(FIV)的猫。
2.本品不得用于有恶性疾病史或进行性恶性疾病史的猫。
3.尚未在6月龄以下或体重低于2.3kg的猫中评估环孢素的有效性和安全性。不得用于6月龄以下或体重低于2.3kg的猫。
4.尚未在雄性种猫或在妊娠期或哺乳期母猫中研究药物的安全性。在用于繁殖期、妊娠期或哺乳期的猫之前,应进行全面的风险/效益分析。
5.环孢素可能引起血糖水平升高。尚未评价环孢素对患有糖尿病的猫的影响。患有糖尿病的猫不建议使用环孢素。
6.环孢素虽然不诱发肿瘤,但可以抑制T淋巴细胞,因此用环孢素治疗可能增加临床上明显的恶性肿瘤的发生率。如果在接受环孢素治疗的猫中观察到淋巴结病变,建议进行进一步的临床研究,必要时停止治疗。
7.多种药物可竞争性抑制或诱导参与环孢素代谢的酶,尤其是细胞色素P450(CYP3A4)。唑类化合物(如酮康唑)可增加猫体内环孢素的血药浓度。大环内酯类药物(如红霉素)可使血浆环孢素水平增加两倍。细胞色素P450的某些诱导剂、抗惊厥药和抗生素(如甲氧苄啶、磺胺嘧啶)可降低环孢素的血药浓度。
9.环孢素可增加氨基糖苷类抗生素和甲氧苄啶的肾毒性。不建议环孢素与这些活性成分同时使用。
10.本品治疗可能引起疫苗接种的免疫应答降低,不建议在治疗期间或给药前后两周内接种疫苗。
11.对于弓形虫血清呈阴性的猫,在治疗期间感染时会有患上弓形虫病的风险。在极少的情况下可能会致命。因此应尽量减少血清阴性猫接触弓形虫的可能性(例如,室内饲养、避免生肉或腐食)。在一项对照实验研究中,发现环孢素没有引起弓形虫卵母细胞脱落的增加。在治疗中发现弓形虫病或其他严重的全身性疾病时,应停止环孢素的使用并开始适当的治疗。
12.由于环孢素具有免疫抑制作用,因此在开始治疗前应对任何其他的感染进行适当治疗。治疗期间发生的感染无需停药,除非感染严重。
13.不建议与其他免疫抑制剂同时使用。
14.意外摄入本品可能导致恶心和/或呕吐,应立即就医。应避免与眼睛接触,如不慎接触,请用大量水冲洗。
15.环孢素可能引起超敏(过敏)反应。对环孢素过敏的人应避免接触本品。
16.置儿童不可触及处。
CyclospoAttention
1.Thisproductshouldnotbeusedincatsinfectedwithleukemiavirus(FeLV)orimmunodeficiencyvirus(FIV).
2.Thisproductshouldnotbeusedincatswithahistoryofmalignantdiseaseorprogressivemalignantdisease.
3.Theefficacyandsafetyofcyclosporinehavenotbeenevaluatedincatslessthan6monthsofageorweighinglessthan2.3kg.Cyclosporineshouldnotbeusedincatsunder6monthsofageorweighinglessthan2.3kg.
4.Thesafetyofthedrughasnotbeenstudiedinmalebreedingcatsorinpregnantorlactatingfemalecats.Beforeusinginbreeding,pregnantorlactatingcats,acomprehensiverisk/benefitanalysisshouldbeperformed.
5.Cyclosporinemaycauseelevatedbloodglucoselevels.Theeffectsofcyclosporineindiabeticcatshavenotbeenevaluated.Cyclosporineisnotrecommendedforcatswithdiabetesmellitus.
6.Cyclosporinedoesnotinducetumors,butitdoesinhibitTlymphocytes;therefore,treatmentwithcyclosporinemayincreasetheincidenceofclinicallysignificantmalignancies.Iflymphadenopathyisobservedincyclosporine-treatedcats,furtherclinicalstudiesarerecommendedandtreatmentshouldbediscontinuedifnecessary.
7.Avarietyofdrugscancompetitivelyinhibitorinduceenzymesinvolvedinthemetabolismofcyclosporine,particularlycytochromeP450(CYP3A4).Azoles(e.g.,ketoconazole)canincreasebloodlevelsofcyclosporineincats.Macrolides(e.g.,erythromycin)cantripleplasmacyclosporinelevels.CertaininducersofcytochromeP450,anticonvulsantsandantibiotics(e.g.,methotrexate,sulfadiazine)candecreasecyclosporinebloodlevels.
8.CyclosporineactsasasubstrateandinhibitoroftheMDRlP-glycoproteintransporter,andco-administrationofcyclosporinewithP-glycoproteinsubstrates(e.g.,macrolides)reducestheintracellulareffluxofthesedrugsfromtheblood-brainbarrier,whichmayresultinsignsofcentralnervoussystem(CNS)toxicity.Nocorrelationbetweenthecombinationofcyclosporineandselamectinormilbemycinincatsandneurotoxicitywasfoundinclinicalstudies.
9.Cyclosporinemayincreasethenephrotoxicityofaminoglycosideantibioticsandmethotrexate.Concomitantuseofcyclosporinewiththeseactiveingredientsisnotrecommended.
10.Treatmentwiththisproductmaycauseareductionintheimmuneresponsetovaccinationandvaccinationisnotrecommendedduringtreatmentorwithin2weeksbeforeorafteradministration.
11.Toxoplasmagondiiseronegativecatsareatriskofdevelopingtoxoplasmosisifinfectedduringtreatment.Inrarecasesthismaybefatal.ExposureofseronegativecatstoToxoplasmagondiishouldthereforebeminimized(e.g.,indoorhousing,avoidanceofrawmeatorcarrion).Inacontrolledexperimentalstudy,cyclosporinewasnotfoundtocauseanincreaseinToxoplasmagondiioocyteshedding.Iftoxoplasmosisorotherserioussystemicdiseaseisdetectedduringtreatment,cyclosporineshouldbediscontinuedandappropriatetherapyinitiated.
12.Becauseoftheimmunosuppressiveeffectofcyclosporine,anyotherinfectionsshouldbeappropriatelytreatedpriortoinitiatingtherapy.Infectionsoccurringduringtreatmentshouldnotbediscontinuedunlesstheyaresevere.
13.Concomitantusewithotherimmunosuppressiveagentsisnotrecommended.
14.Accidentalingestionofthisproductmayresultinnauseaand/orvomiting;seekmedicalattentionimmediately.Avoidcontactwiththeeyes;ifcontactoccurs,flushwithplentyofwater.
15.Cyclosporinemaycausehypersensitivity(allergic)reactions.Avoidcontactwiththisproductifyouareallergictocyclosporine.