Ministerul Sntii al Republicii Moldova INSTRUCIUNE PENTRU ADMINISTRARE METROBIOX gel Numrul certificatului de nre i!

trare n Re"u#lica M$ld$%a& nr. 17605 din 27.04.2012 DENUMIREA COMERCIA'( Metrobiox DCI)ul !u#!tan*el$r acti%e Metronida olu! "#lor#exidinu! COMPO+IIA 1 g gel conine$ substane active: !etronida ol %sub &or! de !etronida ol ben oat' 10 !g( clor#exidin digluconat %sub &or! de soluie de clor#exidin digluconat' 0(5 !g) excipieni: propilenglicol( carbopol *40( levo!entol( a#arin sodic( edetat disodic( #idroxid de sodiu( ap puri&icat. ,ORMA ,ARMACEUTIC( +el. DESCRIEREA MEDICAMENTU'UI +el opalescent de culoare alb sau aproape alb. -RUPA ,ARMACOTERAPEUTIC( .i c$dul ATC ,reparate sto!atologice. -ntiin&ecioase .i antiseptice pentru trata!ent oral local( -01-/11. PROPRIET(I'E ,ARMACO'O-ICE Proprieti farmacodinamice 0ste un preparat ce co!bin aciunea antibacterian .i antiproto oic a !etronida olului cu cea antibacterian( anti&ungic .i antiviral a clor#exidinei. Metronida olul !ani&est e&ect bactericid &a de proto oare .i bacterii anaerobe care provoac a&eciuni ale periodontului$ Porphyromonas gingivalis, Prevotella intermedia, Prevotella denticola, Fusobacterium fusiformis, Wolinella recta, Treponema spp., Ei enella corrodens, !orrelia vincenti, !acteroides melaninogenicus, "elenomonas spp.. 0ste inactiv &a de bacterii aerobe. Mecanis!ul de aciune$ 51nitrogrupa !etronida olului este redus bioc#i!ic de ctre proteinele de transport intracelulare ale !icroorganis!elor anaerobe .i proto oarelor. 51nitrogrupa redus interacionea cu -231ul celular al !icroorganis!elor( in#ib sinte a aci ilor nucleici( ceea ce provoac !oartea bacteriei.

"lor#exidina este un detergent cu proprieti tensioactive. "ationii &or!ai la disocierea clor#exidinei interacionea cu pereii celulei !icrobiene sau cu co!plexele extracelulare cu dereglarea ec#ilibrului os!otic intracelular al !icroorganis!elor .i re&luxul ionilor de potasiu .i &os&or din celul. "lor#exidina 4n do e !ici !ani&est aciune bacteriostatic &a de bacteriile gra!1po itive .i gra!1 negative aerobe .i anaerobe #Treponema spp., $eisseria gonorrhoeae, Trichomonas spp., %hlamydia spp., &reaplasma spp., !acteroides fragilis', &ungi( der!ato&ii .i viru.i lipo&ili. 5nele tulpini de Pseudomonas spp., Proteus spp. sunt slab sensibile la preparat( iar &or!ele acid1re istente de bacterii .i sporii sunt re istente. Proprieti farmacocinetice 6a ad!inistrarea local gelul Metrobiox practic nu se absoarbe. INDICAII TERAPEUTICE Maladii in&ecios1in&la!atorii ale periodontului .i !ucoasei cavitii bucale( inclusiv$ ) gingivit acut .i cronic) ) gingivit ulcero1necrotic acut 7ensan) ) parodontit acut .i cronic) ) parodontit 8uvenil) ) parodonto co!plicat cu gingivit) ) sto!atit a&toas) ) c#eilit) ) in&la!aia !ucoasei cavitii bucale la purttorii de prote e) ) alveolit postextractiv %in&la!area alveolei dup extracia dentar') ) periodontit( abces periodontal %4n terapia co!plex'. DO+E /I MOD DE ADMINISTRARE +el gingival. Se ad!inistrea local( nu!ai pentru u sto!atologic. +ingivit$ adulilor .i copiilor !ai !ari de 6 ani Metrobiox gel se aplic 4n strat subire 4n regiunea gingiilor de 2 ori pe i) nu se reco!and de splat gelul. 2up aplicarea gelului se reco!and abinere de la consu!ul de lic#ide .i ali!ente 4n decurs de 90 !in. 2urata curei de trata!ent constituie 4n !edie 7110 ile. :n parodontita aprut 4n ur!a 4nlturrii depunerilor dentare gelul se aplic 4n spaiile parodontale .i 4n regiunea gingiilor. 2urata expunerii ; 90 !in. 3u!rul de proceduri depinde de gravitatea !aladiei. 5lterior pacientul poate aplica gelul de sine stttor 4n regiunea gingiilor de 2 ori pe i 4n decurs de 7110 ile. :n sto!atita a&toas preparatul se aplic pe regiunea a&ectat a !ucoasei cavitii bucale de 2 ori pe i ti!p de 7110 ile. ,entru pro&ilaxia exacerbrilor gingivitei cronice .i parodontitei !edica!entul se aplic pe regiunea gingiilor de 2 ori pe i ti!p de 7110 ile. "urele de trata!ent pro&ilactic se e&ectuea de 219 ori pe an. ,entru pro&ilaxia alveolitei postextractive gelul se aplic dup extracia dentar pe alveol( apoi se utili ea de 219 ori pe i ti!p de 7110 ile 4n condiii de a!bulatoriu.

REACII AD0ERSE <recvena reaciilor adverse este de&init utili 4nd ur!toarea convenie$ &oarte &recvente %= 1>10'( &recvente %= 1>100 .i ?1>10') !ai puin &recvente %= 1>1000 .i ?1>100') rare %= 1>10000 .i ?1>1000') &oarte rare %?1>10000') cu &recven necunoscut %care nu poate &i esti!at din datele disponibile'. 6a aplicarea local a gelului riscul apariiei unor e&ecte adverse siste!ice este redus. Tulbur(ri generale )i la nivelul locului de administrare $ rare ; ce&alee( gust !etalic 4n gur. *feciuni cutanate )i ale esutului subcutanat: rare + erupii cutanate( prurit( urticarie. CONTRAINDICAII @ipersensibilitate individual la !etronida ol( c#lor#exidin .i alte co!ponente ale preparatului. Aulburri ale &unciei #epatice( a&eciuni #e!atologice( tulburri organice ale siste!ului nervos central( pri!ul tri!estru de sarcin. "opii cu v4rsta sub 6 ani. SUPRADO+A1 "a uri de suprado a8 n1au &ost se!nalate. :ns la ingerarea accidental sau intenionat a unei cantiti !ari de gel se pot !ani&esta e&ectele adverse provocate de !etronida ol % c#lor#exidina practic nu se absoarbe din tractul gastrointestinal'. ,ot aprea grea( vo!( verti8( 4n ca uri grave 1 pareste ii( convulsii. Tratament: lava8 gastric( terapie si!pto!atic. ATENION(RI /I PRECAUII SPECIA'E DE UTI'I+ARE -plicarea gelului Metrobiox nu substitue igiena bucal( de aceea pe durata trata!entului curatul dinilor trebuie continuat. - evita consu!ul conco!itent al alcoolului %sunt posibile reacii disul&ira!ice'. 3u se ad!ite aplicarea gelului pe !ucoasa ocular. ,ropilenglicolul din co!ponena gelului poate provoca iritaie cutanat. Administrarea n sarcin i perioada de alptare 3u se reco!and ad!inistrarea !edica!entului 4n pri!ul tri!estru de sarcin. 6a necesitatea ad!inistrrii 4n perioada de lactaie pe perioada trata!entului se reco!and suspendarea alptrii la s4n. Influena asupra capacitii de a conduce vehicule sau de a folosi utilaje Medica!entul nu in&luenea asupra capacitii de a conduce ve#icule sau de a !anevra utila8e potenial periculoase. INTERACIUNI CU A'TE MEDICAMENTE2 A'TE TIPURI DE INTERACIUNI Metronida olul potenea e&ectul anticoagulantelor. 6a ad!inistrarea conco!itent cu disul&ira! cre.te neurotoxicitatea preparatului. <enobarbitalul( &enitoina accelerea !etabolis!ul !etronida olului. "i!etidina spore.te concentraia plas!atic a !etronida olului.

PRE+ENTARE2 AMBA'A1 +el. "4te 20 g 4n tub de alu!iniu. "4te un tub 4nsoit de instruciunea pentru ad!inistrare 4n cutie individual din carton. P(STRARE - se pstra la te!peraturi sub 25B". - nu se congela. - nu se lsa la 4nde!4na .i vederea copiilor. TERMEN DE 0A'ABI'ITATE 9 ani. - nu se utili a dup data de expirare indicat pe a!bala8. STATUTU' 'E-A' <r prescripie !edical. DATA U'TIMEI RE0I+UIRI A TEXTU'UI Culie 2019. NUME'E /I ADRESA PRODUC(TORU'UI <-RM-,RCM SR6 str. "rinilor( 5( s. ,oru!beni( r1ul "riuleni( Republica Moldova( M214D2* ,,,.farmaprim.md La apariia oricrei reacii adverse informai secia de farmacovigilen a Ageniei Medicamentului i Dispozitivelor Medicale tel! " ## $$ %& &$'

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