[Version 7General-EMEA/182460/2007 Neugebauerová Kateřina952005-07-27T07:58:00Z2009-01-22T10:23:00Z2018-01-12T12:13:00Z115289016Translation Centre19302475211052314General-EMEA/182460/2007V01a CS SPC-II-lab-pl v 7.1Holemarova Zuzana23/04/2007 10:24:26Holemarova ZuzanaHolemarova Zuzana23/04/2007 10:24:26emea_document0.2, CURRENT, published April 07EMEA/182460/2007182460nulldateGeneralEMEAnulldate2007nulldatePŘÍLOHA ISOUHRN ÚDAJŮ O PŘÍPRAVKU 1.NÁZEV VETERINÁRNÍHO LÉČIVÉHO PŘÍPRAVKUPestigon 50 mg roztok pro nakapání na kůži - spot-on pro kočky Fipronilum2.KVALITATIVNÍ A KVANTITATIVNÍ SLOŽENÍJedna 0,5ml pipeta obsahuje:Účinná látka:Fipronilum 50 mgPomocné látky: Butylhydroxyanisol E 320 0,1 mgButylhydroxytoluen E 321 0,05 mgÚplný seznam pomocných látek viz bod 6.1.3.LÉKOVÁ FORMA Roztok pro nakapání na kůži – spot-on.Čirý bezbarvý až nažloutlý roztok. 4.KLINICKÉ ÚDAJE4.1Cílové druhy zvířatKočky4.2Indikace s upřesněním pro cílový druh zvířatLéčba infestace blechami (Ctenocephalides felis). Přípravek má okamžitý insekticidní účinek a perzistentní insekticidní účinnost proti nové infestaci dospělými blechami po dobu až 5 týdnů. Přípravek má akaricidní účinek proti klíšťatům (Ixodes ricinus), k jejich úhynu dochází během 48 hodin.4.3KontraindikaceNepoužívat u koťat mladších osmi týdnů a/nebo vážících méně než 1 kg vzhledem k absenci dostupných údajů.Nepoužívat u nemocných zvířat (tj. systémová onemocnění, horečka..) nebo zvířat v rekonvalescenci.Nepoužívat u králíků z důvodu nebezpečí nežádoucích reakcí až úhynu.Nepoužívat v případě přecitlivělosti na léčivou látku nebo na některou z pomocných látek. 4.4Zvláštní upozornění pro každý cílový druhPřípravek nebrání přichycení klíšťat ke zvířeti. Jestliže jsou zvířata ošetřena před expozicí klíšťaty, klíšťata začnou hynout během prvních 24 - 48 hodin po přichycení, což je obvykle dříve než se nasají, čímž je riziko přenosu transmisivních onemocnění minimalizováno, ale není vyloučeno. Uhynulá klíšťata většinou sama odpadávají ze zvířete a jakákoliv zbylá klíšťata mohou být odstraněna jemným vytažením.Pro optimální tlumení bleších infestací v domácnostech s více domácími zvířaty by měli být všichni psi a kočky ošetřeni vhodným insekticidem.Je třeba se vyhnout častému koupání nebo šamponování zvířete, neboť zachování účinnosti přípravku v těchto případech nebylo testováno. Blechy z domácích zvířat často zamořují přepravky zvířat, podestýlky a místa, kde zvířata spí a odpočívají, jako jsou koberce a bytové zařízení, která je třeba v případě masivního zamoření a na začátku regulačních opatření pravidelně ošetřovat vhodnými insekticidy a vysávat.4.5Zvláštní opatření pro použitíZvláštní opatření pro použití u zvířatZamezte kontaktu přípravku s očima zvířete. V případě náhodného zásahu oka jej ihned a důkladně vypláchněte vodou.Je důležité zabezpečit, aby byl přípravek aplikován na místo, kde si jej zvíře nemůže olízat, a také, aby si jej zvířata po ošetření neolizovala navzájem.Může dojít k přichycení jednotlivých klíšťat. Z tohoto důvodu nelze zcela vyloučit přenos infekčních chorob klíšťaty, pokud jsou podmínky nepříznivé.Neaplikujte přípravek na rány nebo poraněnou kůži. Zvláštní opatření určené osobám, které podávají veterinární léčivý přípravek zvířatůmTento přípravek může způsobit podráždění sliznice a očí. Vyhněte se proto kontaktu přípravku s ústy a očima. V případě náhodného zasažení oka jej ihned a důkladně vypláchněte vodou. Pokud podráždění oka přetrvává, vyhledejte lékařskou pomoc a ukažte příbalovou informaci nebo etiketu praktickému lékaři. Zabraňte kontaktu přípravku s prsty. V případě potřísnění si umyjte ruce vodou a mýdlem.Po použití si umyjte ruce.Během aplikace přípravku nekuřte, nepijte ani nejezte.Lidé se známou přecitlivělostí na fipronil nebo pomocné látky (viz bod 6.1) by se měli vyhnout kontaktu s veterinárním léčivým přípravkem. Nemanipulujte s ošetřenými zvířaty a zamezte dětem hrát si s nimi, dokud nezaschne místo aplikace. Doporučuje se proto neošetřovat zvířata během dne, ale v podvečer, a nedovolit čerstvě ošetřeným zvířatům spát s jejich majiteli, zejména dětmi.Uchovávejte pipety v původním obalu a použité pipety ihned zlikvidujte.Další opatřeníVehikulum na bázi alkoholu může mít nepříznivý vliv na natřené, lakované nebo jiné plochy v domácnosti nebo vybavení bytu. Tento přípravek je hořlavý. Chraňte před teplem, jiskrami, otevřeným plamenem nebo jinými možnými zdroji zapálení. 4.6Nežádoucí účinky (frekvence a závažnost)Pokud dojde k olíznutí, může se objevit krátkodobá hypersalivace způsobená vlastnostmi nosiče. Mezi velmi vzácnými suspektními nežádoucími účinky byly po použití zaznamenány přechodné kožní reakce v místě aplikace (šupinatění kůže, lokální vypadávání srsti, svědění, zarudnutí kůže) a celkové svědění nebo vypadávání srsti. Výjimečně byly pozorovány hypersalivace, reversibilní neurologické příznaky (hyperestezie, deprese, nervozita) nebo zvracení.Četnost nežádoucích účinků je charakterizována podle následujících pravidel:: - velmi časté (nežádoucí účinky se projevily u více než 1 z 10 zvířat v průběhu jednoho ošetření)- časté (u více než 1, ale méně než 10 ze 100 zvířat) - neobvyklé (u více než 1, ale méně než 10 z 1 000 zvířat)- vzácné (u více než 1, ale méně než 10 z 10 000 zvířat)- velmi vzácné (u méně než 1 z 10 000 zvířat, včetně ojedinělých hlášení).4.7Použití v průběhu březosti, laktace nebo snáškyLaboratorní studie neprokázaly u fipronilu žádné teratogenní ani embryotoxické účinky. U březích a laktujících zvířat nebyly s tímto přípravkem provedeny studie. Použití v březosti a laktaci pouze v souladu s odborným veterinárním doporučením a po zvážení poměru terapeutického prospěchu a rizika. 4.8Interakce s dalšími léčivými přípravky a další formy interakceNejsou známy.4.9Podávané množství a způsob podáníPouze k zevnímu podání.Před ošetřením by měla být zvířata přesně zvážena.Cesta podání: lokální aplikace na kůži.Dávkování: 1 pipeta o obsahu 0,5 ml pro jednu kočku (přibližně 7,5 – 15 mg/kg ž.hm.).Způsob podání: Držte pipetu svisle vzhůru. Poklepejte na zúženou část pipety, abyste se ujistili, že obsah je uvnitř hlavní části pipety. Odlomte hrot v úzké části pipety ve vyznačené linii. Rozhrňte srst zvířete v oblasti mezi lopatkami tak, aby byla viditelná kůže. 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Je důležité zabezpečit, aby byl přípravek aplikován na místo, kde si jej zvíře nemůže olízat, a také, aby si jej zvířata po ošetření neolizovala navzájem. Podávejte opatrně, abyste se vyhnuli nadměrnému zvlhčení srsti přípravkem, jelikož může dojít ke slepení srsti v místě ošetření. Nicméně pokud se objeví, zmizí během 24 hodin po aplikaci. Za účelem optimálního tlumení infestací blechami a/nebo klíšťaty by měl být program ošetření založen na místní epidemiologické situaci.Vzhledem k absenci studií týkajících se bezpečnosti přípravku je minimální interval mezi aplikacemi čtyři týdny. 4.10Předávkování (symptomy, první pomoc, antidota), pokud je to nutnéToxicita přípravku aplikovaného na kůži je velmi nízká. Nebezpečí vzniku nežádoucích reakcí (viz bod 4.6) se však může zvýšit v případě předávkování. Zvířata by proto měla být vždy ošetřena pipetou správné velikosti podle živé hmotnosti zvířete.4.11Ochranná (é) lhůta (y)Není určeno pro potravinová zvířata.5.FARMAKOLOGICKÉ VLASTNOSTIFarmakoterapeutická skupina: ektoparazitika pro lokální aplikaci, včetně insekticidů. ATCvet kód: QP53AX15. 5.1Farmakodynamické vlastnostiFipronil je insekticid/akaricid náležící do skupiny fenylpyrazolů. Účinkuje inhibicí GABA komplexu, váže se na chloridové kanály a tím blokuje pre- a postsynaptický přenos chloridových iontů přes buněčné membrány. Výsledkem je nekoordinovaná činnost centrálního nervového systému a hmyzu a roztočů a jejich úhyn. Fipronil vykazuje insekticidní účinnost proti blechám (Ctenocephalides felis) a akaricidní účinnost proti klíšťatům (Ixodes ricinus) u koček.Nově příchozí blechy jsou usmrceny do 24 hodin po dosednutí na zvíře. Přípravek je účinný proti infestaci blechami po dobu přibližně 5 týdnů, během 48 hodin dochází k úhynu klíšťat (Ixodes ricinus), a to v závislosti na míře infestace. 5.2Farmakokinetické údajeFipronil je metabolizován především na sulfonový derivát (RM 1602), který má také insekticidní a akaricidní vlastnosti. Po lokální aplikaci fipronilu na kůži kočky je systémová absorpce zanedbatelná. Koncentrace fipronilu na srsti se snižují v závislosti na čase.6.FARMACEUTICKÉ ÚDAJE6.1Seznam pomocných látekButylhydroxyanisol (E 320)Butylhydroxytoluen (E 321)Povidon K12Polysorbát 80ButanolDiethylenglykol-monoethylether6.2Hlavní inkompatibilityNejsou známy.6.3Doba použitelnostiDoba použitelnosti veterinárního léčivého přípravku v neporušeném obalu: 3 roky. 6.4Zvláštní opatření pro uchováváníTento veterinární léčivý přípravek nevyžaduje žádné zvláštní teplotní podmínky uchovávání. Uchovávejte v původním obalu, aby byl přípravek chráněn před světlem a vlhkostí.6.5Druh a složení vnitřního obalu0,5ml pipeta vyrobená z třívrstvého materiálu: polypropylen/kopolymer na bázi cyklického olefinu/polypropylen, lakovaný laminát bez obsahu rozpouštědel a kopolymer polyethylenu/EVOH/polyethylenu. Pipety jsou zataveny ve čtyřvrstvém sáčku složeném z LDPE/nylonu/hliníkové fólie/polyesterové fólie s dětskou pojistkou a vložené do krabičky.Krabičky po 1, 2, 3, 4, 6, 8, 12, 24, 30, 60, 90, 120 nebo 150 pipetách.Na trhu nemusí být všechny velikosti balení.6.6Zvláštní opatření pro zneškodňování nepoužitého veterinárního léčivého přípravku nebo odpadu, který pochází z tohoto přípravkuVšechen nepoužitý veterinární léčivý přípravek nebo odpad, který pochází z tohoto přípravku, musí být likvidován podle místních právních předpisů.Fipronil může nepříznivě působit na vodní organismy. Nekontaminujte rybníky, vodní toky nebo stoky přípravkem nebo prázdnými obaly. 7.DRŽITEL ROZHODNUTÍ O REGISTRACINorbrook Laboratories LimitedStation Works,Newry,Co. Down,BT35 6JP,Spojené království8.REGISTRAČNÍ ČÍSLO (A)96/096/12-C9.DATUM REGISTRACE/ PRODLOUŽENÍ REGISTRACE4. 9. 2012/ 10. 1. 201810.DATUM REVIZE TEXTULeden 2018DALŠÍ INFORMACEVeterinární léčivý přípravek je vydáván pouze na předpis. PAGE \* MERGEFORMAT 8 PAGE \* MERGEFORMAT 1