[Version 7General-EMEA/182460/2007Zemek JiříNeugebauerová Kateřina402005-07-27T07:58:00Z2016-06-17T11:56:00Z2018-01-02T12:03:00Z116259594Translation Centre79221119714General-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 PŘÍPRAVKU1.NÁZEV VETERINÁRNÍHO LÉČIVÉHO PŘÍPRAVKUSpizobactin 3 000 000 IU / 500 mg žvýkací tablety pro psy 2.KVALITATIVNÍ A KVANTITATIVNÍ SLOŽENÍ1 tableta obsahuje:Léčivé látky:Spiramycinum 3 000 000 IUMetronidazolum 500 mgPomocné látky:Úplný seznam pomocných látek viz bod 6.1.3.LÉKOVÁ FORMAŽvýkací tableta.Světle hnědá s hnědými skvrnami, kulatá a konvexní, ochucená tableta s křížovou dělící rýhou na jedné straně.Tablety lze dělit na 2 nebo 4 stejné části.4.KLINICKÉ ÚDAJE4.1Cílové druhy zvířatPsi.4.2Indikace s upřesněním pro cílový druh zvířatPro doplňkovou léčbu mechanické nebo chirurgické periodontální léčby při léčbě multibakteriálních infekčních periodontálních a souvisejících (peri)orálních stavů, jako je např. gingivitida, stomatitida, glossitida, periodontitida, tonzilitida, zubní píštěl a jiné píštělové rány v ústní dutině, cheilitida a sinusitida u psů, způsobených mikroorganismy citlivými ke spiramycinu/metronidazolu, například grampozitivními bakteriemi a anaeroby (viz také body 4.4 a 4.5).4.3KontraindikaceNepoužívat v případě jaterních onemocnění.Nepoužívat v případě přecitlivělosti na spiramycin, metronidazol, nebo na některou z pomocných látek. Nepoužívat současně s baktericidními antibiotiky.4.4Zvláštní upozornění pro každý cílový druhV mnoha případech endodontických/periodontálních onemocnění se uplatní základní ošetření bez použití léčivých přípravků a antimikrobiální léčba není nutná. Antimikrobiální léčbu onemocnění periodontu by měla doprovázet nebo předcházet endodontická léčba nebo profesionální čištění zubů, zejména v případě pokročilého onemocnění. Majitelé psů jsou vyzýváni, aby pravidelně čistili zuby svého psa, odstraňovali plak, aby zabránili nebo kontrolovali onemocnění periodontu. 4.5Zvláštní opatření pro použitíZvláštní opatření pro použití u zvířatKombinace spiramycinu a metronidazolu by neměla být používána jako empirická léčba první volby.Pokud je to možné, metronidazol a spiramycin by měly být používány pouze na základě výsledků testování citlivosti.Při použití tohoto přípravku je třeba vzít do úvahy oficiální celostátní a místní pravidla antibiotické politiky.Léčba tímto léčivým přípravkem nesmí běžně překročit stanovenou dobu léčby (6 až 10 dní). Tato lhůta může být překročena jen ve vzácných případech u určitých indikací. Opakování léčby je povoleno pouze při určitých indikacích. Omezení doby trvání léčby je nezbytné, protože při použití metronidazolu nelze vyloučit poškození zárodečných buněk a protože během dlouhodobých studií s vysokými dávkami přípravku byl u hlodavců pozorován nárůst některých nádorů.Zvláštní opatření určené osobám, které podávají veterinární léčivý přípravek zvířatůmNa laboratorních zvířatech, stejně jako u lidí bylo prokázáno, že metronidazol má mutagenní a genotoxické vlastnosti. Metronidazol je prokázaný karcinogen u laboratorních zvířat, a má možné karcinogenní účinky u lidí. Pro karcinogenitu metronidazolu u lidí nejsou však dostatečné důkazy. Spiramycin může ve vzácných případech vyvolat reakce přecitlivělosti, např. kontaktní dermatitidu. Z důvodu rizika senzibilizace zabraňte přímému kontaktu s pokožkou a sliznicemi. Lidé se známou přecitlivělostí na léčivé látky nebo na kteroukoli pomocnou látku by se měli vyhnout kontaktu s veterinárním léčivým přípravkem. Při aplikaci přípravku je třeba používat nepropustné rukavice, aby se zabránilo kontaktu kůže s přípravkem.Aby se zabránilo náhodnému pozření, zejména dítětem, musí se nepoužité části tablet vrátit do otevřeného prostoru blistru a vložit zpět do krabičky.V případě náhodného pozření vyhledejte ihned lékařskou pomoc a ukažte příbalovou informaci nebo etiketu praktickému lékaři. Po manipulaci s tabletami si pečlivě umyjte ruce.4.6 Nežádoucí účinky (frekvence a závažnost)Vzácně bylo u psů pozorováno zvracení. Ve vzácných případech může dojít k přecitlivělosti. V případě přecitlivělosti na přípravek musí být léčba ukončena.Ve velmi vzácných případech se mohou objevit poruchy spermatogeneze.Četnost nežádoucích účinků je charakterizována podle následujících pravidel: - velmi časté (nežádoucí účinek(nky) se projevil(y) u více než 1 z 10 ošetřených zvířat),- časté (u více než 1, ale méně než 10 ze 100 ošetřených zvířat), - neobvyklé (u více než 1, ale méně než 10 z 1000 ošetřených zvířat), - vzácné (u více než 1, ale méně než 10 z 10 000 ošetřených zvířat), - velmi vzácné (u méně než 1 z 10 000 ošetřených zvířat, včetně ojedinělých hlášení).4.7 Použití v době březosti a laktaceNebylo zjištěno, že by spiramycin byl teratogenní nebo embryo- nebo fetotoxický. Studie na laboratorních zvířatech prokázaly nekonzistentní výsledky, pokud jde o teratogenní/embryotoxické účinky metronidazolu. Z tohoto důvodu se nedoporučuje používání tohoto přípravku v průběhu březosti. Metronidazol a spiramycin jsou vylučovány do mateřského mléka a používání během laktace se proto nedoporučuje.4.8Interakce s dalšími léčivými přípravky a další formy interakceMakrolidy, jako např. spiramycin působí antagonisticky vůči penicilinům a cefalosporinům.Tento léčivý přípravek se nesmí používat v kombinaci s jinými antibiotiky makrolidové skupiny.Metronidazol může mít inhibiční účinek na degradaci jiných léčiv v játrech, jako jsou fenytoin, cyklosporin a warfarin.Fenobarbital může zvýšit jaterní metabolismus metronidazolu, což má za následek snížené sérové koncentrace metronidazolu.4.9Podávané množství a způsob podáníPerorální podání.Tablety se podávají v dávce 75 000 IU spiramycinu + 12,5 mg metronidazolu na kg živé hmotnosti a den, v závažnějších případech 100 000 IU spiramycinu + 16,7 mg metronidazolu na kg živé hmotnosti, denně po dobu 6 až 10 dnů v závislosti na závažnosti onemocnění.V závažných případech lze začít s vyšší dávkou a v průběhu léčby přejít na nižší dávku. Denní dávku je možné podávat jednou denně, nebo ji rozdělit na dvě stejné dávky podávané dvakrát denně. Léčba by měla vždy pokračovat 1–2 dny po odeznění symptomů, aby se zabránilo recidivám. Tablety se podávají buď hluboko do tlamy (na kořen jazyka) nebo se podávají s malým množstvím potravy obsahujícím tabletu, aby se zajistila konzumace celé tablety. Je třeba určit co možná nejpřesněji živou hmotnost, aby bylo zajištěno správné dávkování a aby nedošlo k poddávkování. Následující tabulka je návodem k dávkování přípravku přibližně při standardní dávce 75 000 IU spiramycinu + 12,5 mg metronidazolu na kg živé hmotnosti.Živá hmotnostSpizobactin 750 000 IU / 125 mgpro psy Spizobactin 1 500 000 IU / 250 mg pro psySpizobactin 3 000 000 IU / 500 mgpro psy 2,5 kgiVBORw0KGgoAAAANSUhEUgAAADsAAAA7CAMAAAGF/DIXAAAAAXNSR0IArs4c6QAAAARnQU1BAACx
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Půlky: zatlačte palci na obou stranách tablety.Čtvrtky: zatlačte palcem na střed tablety.4.10Předávkování (symptomy, první pomoc, antidota)Nežádoucí účinky jsou pravděpodobnější v dávkách a trvání léčby nad rámec doporučeného léčebného režimu. Pokud se objeví neurologické příznaky, léčba by měla být ukončena a pacient by měl být léčen symptomaticky.4.11Ochranná(é) lhůta(y)Není určeno pro potravinová zvířata.5.FARMAKOLOGICKÉ VLASTNOSTIFarmakoterapeutická skupina: kombinace antibakteriálních léčiv, spiramycin a metronidazol.ATCvet kód: QJ01RA04.5.1Farmakodynamické vlastnostiSpiramycin je antibiotikum patřící do skupiny makrolidů. Působí výrazně bakteriostaticky inhibicí syntézy proteinů (interferuje s translační reakcí na ribozomu). Jeho spektrum účinku zahrnuje zejména grampozitivní bakterie. Tři různé mechanismy zodpovídají největší měrou za bakteriální rezistenci k působení makrolidů: (1) metylace rRNA; (2) aktivní eflux; (3) enzymatická inaktivace. První dva mechanismy jsou nejčastější a geny kódující tyto mechanismy jsou často lokalizovány na mobilních genetických elementech. Metylace rRNA, kódovaná geny rezistence k erytromycinu - geny metyláz (erm), vede ke zkřížené rezistenci k makrolidům, linkosamidům a streptograminu B (rezistence MLSB).Metronidazol je derivát imidazolu a působí proti zástupcům prvoků (bičíkovci a améby) a proti grampozitivním a gramnegativním anaerobům.Kombinace spiramycinu a metronidazolu rozšiřuje spektrum na základě doplňujícího se antibakteriálního charakteru obou léčiv. Synergické účinky byly prokázány u některých patogenů ve studiích in vitro a při experimentálních infekcích u laboratorních zvířat. 5.2Farmakokinetické údajePo perorálním podání byly nejvyšší plazmatické hladiny spiramycinu-I (hlavní složky spiramycinu) o hodnotě 4,4 μg/ml pozorovány během 1,3 hodiny. Spiramycin rychle dosahuje vysoké hladiny v tkáních, které jsou 10 až 15krát vyšší než v plazmě. Koncentrace ve sliznicích a slinách jsou obzvláště vysoké. Po jedné perorální dávce koncentrace spiramycinu zůstává přítomna po dobu přibližně 30 až 40 hodin. Spiramycin je u psů eliminován žlučí. Terminální poločas je přibližně 8,6 hodiny.Po perorálním podání byly nejvyšší plazmatické hladiny metronidazolu o hodnotě 18 μg/ml pozorovány během 1,4 hodiny. Po perorálním podání metronidazol difunduje rychle a úplně do všech tělních tkání. Po 24 hodinách jsou u většiny psů stále detekovatelné krevní hladiny > 0,5 μg/ml. Vylučování probíhá močí. Terminální poločas je přibližně 5,3 hodiny. 6.FARMACEUTICKÉ ÚDAJE6.1Seznam pomocných látekPředbobtnalý škrobMikrokrystalická celulosaMonohydrát laktosyHyprolosaKvasnice (sušené)Kuřecí aromaKoloidní bezvodý oxid křemičitýMagnesium-stearát6.2Hlavní inkompatibilityNeuplatňuje se.6.3Doba použitelnostiDoba použitelnosti veterinárního léčivého přípravku v neporušeném obalu: 18 měsíců.Doba použitelnosti zbylých částí tablet po prvním otevření vnitřního obalu: 3 dny.6.4.Zvláštní opatření pro uchováváníUchovávejte při teplotě do 30 °C.6.5Druh a složení vnitřního obaluBlistr z vrstev hliníku a PVC/PE/PVDC.Lepenková krabice s 1, 2 nebo 3 blistry po 10 tabletáchLepenková krabice obsahující 10 lepenkových krabiček, z nichž každá obsahuje 1 blistr s 10 tabletami. 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.7.DRŽITEL ROZHODNUTÍ O REGISTRACILe Vet Beheer B.V.Wilgenweg 73421 TV OudewaterNizozemsko8.REGISTRAČNÍ ČÍSLO(A)96/060/17-C9.DATUM REGISTRACE/PRODLOUŽENÍ REGISTRACE21. 12. 2017 10DATUM REVIZE TEXTUProsinec 2017DALŠÍ INFORMACE Veterinární léčivý přípravek je vydáván pouze na předpis. PAGE \* MERGEFORMAT 2 PAGE \* MERGEFORMAT 1