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<p style="text-align: justify; "> SIMIVET<b><sup> </sup></b><b>15 %</b> |
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</p> |
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</div> |
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<div align="Justify"> |
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<p style="text-align: justify; "> suspenzija za injiciranje </p> |
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</div> |
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<div align="Justify"> |
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<p style="text-align: justify; "> <b><br> |
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Za uporabo v veterinarski medicini</b> </p> |
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</div> |
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<div align="Justify"> |
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<p style="text-align: justify; "> <b></b> </p> |
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</div> |
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<p style="text-align: justify; "> Sestava </p> |
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</div> |
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<p style="text-align: justify; "> 1 ml suspenzije vsebuje: 150 mg amoksicilina |
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v obliki amoksicilin trihidrata. </p> |
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</div> |
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<p style="text-align: justify; "> </p> |
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</div> |
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<p style="text-align: justify; "> <b>Delovanje</b> </p> |
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<p style="text-align: justify; "> Amoksicilin je polsintetièni penicilin |
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z razširjenim spektrom delovanja glede na izvirni benzilpenicilin. Kot drugi |
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betalaktamski antibiotiki tudi amoksicilin s svojim baktericidnim delovanjem |
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ovira sintezo celiène stene v èasu pospešene rasti bakterij. |
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Antimikrobni spekter Simiveta 15 % obsega številne po Gramu pozitivne in |
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po Gramu negativne bakterije, kot so <i>Streptococcus spp., Staphylococcus |
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spp., Erysipelothrix rhusiopathiae, Actinomyces spp., Clostridium spp., Corynebacterium |
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spp., E. coli, Salmonella spp., Actinobacillus spp., Bordetella bronchiseptica, |
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Fusobacterium spp., Haemophilus spp., Moraxella spp., Pasteurella spp., Proteus |
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mirabilis</i> idr. </p> |
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<p style="text-align: justify; "> Po intramuskularnem in subkutanem dajanju |
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Simiveta 15 % dose¾e amoksicilin najvišjo raven v plazmi v 2 urah. |
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Injekcijska suspenzija je formulirana tako, da po enkratnem dajanju ostane |
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uèinkovita raven v organizmu 24 ur. V veèini tkiv se dobro |
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razporeja, zlasti visoko raven pa dose¾e v parenhimskih organih ter |
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seèu in ¾olèu. Skozi vnetno spremenjene membrane dihalnih |
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poti olajšano prehaja amoksicilin v bronhialno sluz, kar olajšuje zdravljenje |
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dihalnih infekcij. </p> |
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<p style="text-align: justify; "> Amoksicilin ni odporen proti bakterijskim |
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laktamazam beta, medtem ko se odpornost proti njemu razvija postopno. Toksiènost |
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amoksicilina je zanemarljiva, zato ¾ivali lahko prenašajo veèje |
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odmerke zdravila od priporoèenih. </p> |
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<p style="text-align: justify; "> </p> |
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<p style="text-align: justify; "> <b>Indikacije</b> </p> |
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<p style="text-align: justify; "> Simivet 15 % uporabljamo pri prašièih, |
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govedu, ovcah, psih in maèkah za zdravljenje splošnih in lokalnih |
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ter primarnih in sekundarnih infekcij, ki jih povzroèajo mikroorganizmi, |
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obèutljivi za amoksicilin: </p> |
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</div> |
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<ul> |
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<li> |
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<p style="text-align: justify; "> splošne infekcije, zlasti septikemije, |
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</p> |
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</div> |
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</li> |
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<li> |
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<div align="Justify"> |
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<p style="text-align: justify; "> sekundarna bakterijska vnetja, kadar |
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so posledica virusnih bolezni, </p> |
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</div> |
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</li> |
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<li> |
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<div align="Justify"> |
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<p style="text-align: justify; "> infekcije dihalnih poti, kot je npr. |
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kompleks bronhopnevmonije pri pitanih juncih, </p> |
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</div> |
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</li> |
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<li> |
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<p style="text-align: justify; "> infekcije prebavnih organov, </p> |
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</div> |
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</li> |
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<li> |
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<p style="text-align: justify; "> infekcije rodil in seèil, vkljuèno |
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s cistitisom in metritisom, </p> |
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</div> |
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</li> |
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<li> |
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<div align="Justify"> |
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<p style="text-align: justify; "> infekcije ko¾e in mehkih tkiv: |
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abscesi, flegmone, postoperacijske infekcije, omfalitis, vnetja sklepov, |
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panaricij idr., </p> |
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</div> |
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</li> |
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<li> |
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<div align="Justify"> |
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<p style="text-align: justify; "> akutni mastitis pri kravah s spremenjenim |
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splošnim stanjem ob soèasnem i/mam zdravljenju, </p> |
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</div> |
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</li> |
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<li> |
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<p style="text-align: justify; "> sindrom MMA pri plemenskih svinjah |
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in prašièji šen. </p> |
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</div> |
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</li> |
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</ul> |
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<p style="text-align: justify; "> </p> |
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<p style="text-align: justify; "> <b></b> </p> |
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<p style="text-align: justify; "> </p> |
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</div> |
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<p style="text-align: justify; "> </p> |
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</div> |
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<p style="text-align: justify; "> </p> |
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<p style="text-align: justify; "> </p> |
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<p style="text-align: justify; "> <b>Kontraindikacije</b> </p> |
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<p style="text-align: justify; "> Zdravila ne smemo dajati intravensko niti |
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intrarektalno. </p> |
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</div> |
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<div align="Justify"> |
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<p style="text-align: justify; "> ®ivali, pri katerih so predhodno ugotovili |
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preobèutljivost za penicilinske antibiotike, ne smemo zdraviti s Simivetom |
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15 %. </p> |
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</div> |
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<p style="text-align: justify; "> Zdravilo ni primerno za zdravljenje malih |
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vrst glodavcev in monogastriènih rastlinojedov, kot so kunec, morski |
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prašièek ali hrèek. </p> |
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</div> |
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<p style="text-align: justify; "> Zdravila ne dajemo ¾ivalim s hudimi |
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okvarami ledviènega delovanja, z anurijo ali oligurijo. </p> |
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<p style="text-align: justify; "> </p> |
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<p style="text-align: justify; "> <b>Naèin dajanja in odmerki</b> |
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</p> |
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<p style="text-align: justify; "> Zdravilo dajemo intramuskularno (govedu, |
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prašièem, ovcam, psom, maèkam) in subkutano (psom, maèkam). |
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</p> |
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<p style="text-align: justify; "> Odmerek, veèji od 20 ml, je treba |
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razdeliti in dati na dve mesti. </p> |
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<p style="text-align: justify; "> Pri psih in maèkah je priporoèljivo, |
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da po dajanju mesto vbrizganja rahlo zmasiramo. </p> |
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</div> |
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|
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<p style="text-align: justify; "> Pred uporabo je treba vsebino steklenièke |
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dobro pretresti. </p> |
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<p style="text-align: justify; "> </p> |
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</div> |
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<p style="text-align: justify; "> Povpreèni odmerek za vse ¾ivali |
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je 1 ml na 20 kg telesne mase (7 mg amoksicilina na kg t. m. na dan). </p> |
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</div> |
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<div align="Justify"> |
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<p style="text-align: justify; "> Dajanje ponavljamo vsakih 24 ur in zdravimo |
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še 48 ur po izginotju bolezenskih znakov (npr. 5 dni). </p> |
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</div> |
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<div align="Justify"> |
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<p style="text-align: justify; "> </p> |
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</div> |
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<div align="Justify"> |
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<p style="text-align: justify; "> </p> |
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</div> |
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|
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<table width="100%" border="1" cols="3" rows="11"> |
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<tbody> |
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<tr> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Justify"> |
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<p style="text-align: justify; "> <b>Vrsta in kategorija ¾ivali |
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</b> </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> <b>Telesna masa</b> </p> |
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</div> |
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|
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<div align="Center"> |
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<p style="text-align: center; "> (kg) </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> <b>Odmerek (Simivet 15 %)</b> </p> |
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</div> |
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|
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<div align="Center"> |
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<p style="text-align: center; "> (ml) </p> |
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</div> |
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</td> |
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</tr> |
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<tr> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Justify"> |
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<p style="text-align: justify; "> Govedo </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 500 </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 50 </p> |
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</div> |
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</td> |
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</tr> |
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<tr> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Justify"> |
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<p style="text-align: justify; "> Tele/junec |
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</p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 100 </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 5 </p> |
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</div> |
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</td> |
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</tr> |
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<tr> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Justify"> |
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<p style="text-align: justify; "> Ovca </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 50 </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 2,5 </p> |
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</div> |
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</td> |
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</tr> |
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<tr> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Justify"> |
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<p style="text-align: justify; "> Prašiè </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 7 do 10 </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 0,5 </p> |
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</div> |
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</td> |
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</tr> |
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<tr> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Justify"> |
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<p style="text-align: justify; "> Enoletni pujsek </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 70 </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 3,5 </p> |
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</div> |
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</td> |
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</tr> |
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<tr> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Justify"> |
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<p style="text-align: justify; "> Plemenska svinja </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 150 </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 7,5 </p> |
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</div> |
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</td> |
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</tr> |
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<tr> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Justify"> |
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<p style="text-align: justify; "> Majhen pes |
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</p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 10 </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 0,5 </p> |
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</div> |
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</td> |
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</tr> |
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<tr> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Justify"> |
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<p style="text-align: justify; "> Srednje velik pes </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 20 </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 1 </p> |
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</div> |
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</td> |
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</tr> |
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<tr> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Justify"> |
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<p style="text-align: justify; "> Velik pes |
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</p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 35 </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 2,5 </p> |
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</div> |
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</td> |
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</tr> |
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<tr> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Justify"> |
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<p style="text-align: justify; "> Maèka </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 5 </p> |
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</div> |
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</td> |
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<td bgcolor="White" width="33%" rowspan="1" colspan="1"> |
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<div align="Center"> |
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<p style="text-align: center; "> 0,25 </p> |
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</div> |
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</td> |
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</tr> |
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|
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</tbody> |
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</table> |
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|
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<div align="Justify"> |
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<p style="text-align: justify; "> </p> |
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</div> |
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<div align="Justify"> |
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<p style="text-align: justify; "> <b>Stranski uèinki</b> </p> |
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</div> |
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|
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<div align="Justify"> |
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<p style="text-align: justify; "> Niso znani. </p> |
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</div> |
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|
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<div align="Justify"> |
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<p style="text-align: justify; "> </p> |
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</div> |
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<div align="Justify"> |
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<p style="text-align: justify; "> <b>Opozorila in varnostni ukrepi</b> </p> |
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</div> |
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|
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<div align="Justify"> |
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<p style="text-align: justify; "> Kot drugi penicilinski pripravki je tudi |
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suspenzija Simivet 15 % nestabilna v stiku z vodo. Zaradi tega je treba za |
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dajanje in odvzem zdravila iz steklenièke uporabljati sterilne in |
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suhe igle ter brizge. </p> |
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</div> |
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|
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<div align="Justify"> |
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<p style="text-align: justify; "> Zaradi zmanjševanja antimikrobnega uèinka |
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ne smemo soèasno z amoksicilinom dajati antibiotikov iz skupine tetraciklinov, |
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makrolidov in kloramfenikolov. </p> |
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</div> |
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|
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<div align="Justify"> |
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<p style="text-align: justify; "> Èe se po tridnevnem zdravljenju |
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stanje ¾ivali vidno ne zboljša, lahko dajanje amoksicilina nadaljujemo |
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le, èe medtem laboratorijsko doka¾ejo njegovo uèinkovitost |
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proti odvzetim bakterijam. </p> |
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</div> |
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|
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<div align="Justify"> |
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<p style="text-align: justify; "> Na mestu vbrizganja se vèasih pojavi |
491 |
manjša oteklina, ki po nekaj dneh spontano izgine. </p> |
492 |
</div> |
493 |
|
494 |
<div align="Justify"> |
495 |
<p style="text-align: justify; "> </p> |
496 |
</div> |
497 |
|
498 |
<div align="Justify"> |
499 |
<p style="text-align: justify; "> </p> |
500 |
</div> |
501 |
|
502 |
<div align="Justify"> |
503 |
<p style="text-align: justify; "> <b>Karenca</b> </p> |
504 |
</div> |
505 |
|
506 |
<div align="Justify"> |
507 |
<p style="text-align: justify; "> Meso, organi in druga u¾itna tkiva |
508 |
goveda, prašièev in ovac: 21 dni </p> |
509 |
</div> |
510 |
|
511 |
<div align="Justify"> |
512 |
<p style="text-align: justify; "> Mleko: 3 dni </p> |
513 |
</div> |
514 |
|
515 |
<div align="Justify"> |
516 |
<p style="text-align: justify; "> </p> |
517 |
</div> |
518 |
|
519 |
<div align="Justify"> |
520 |
<p style="text-align: justify; "> <b>Rok uporabnosti</b> </p> |
521 |
</div> |
522 |
|
523 |
<div align="Justify"> |
524 |
<p style="text-align: justify; "> Oznaèen je na ovojnini (36 mesecev). |
525 |
</p> |
526 |
</div> |
527 |
|
528 |
<div align="Justify"> |
529 |
<p style="text-align: justify; "> Odprto steklenièko je treba porabiti |
530 |
v 4 tednih. </p> |
531 |
</div> |
532 |
|
533 |
<div align="Justify"> |
534 |
<p style="text-align: justify; "> </p> |
535 |
</div> |
536 |
|
537 |
<div align="Justify"> |
538 |
<p style="text-align: justify; "> <b>Naèin izdajanja</b> </p> |
539 |
</div> |
540 |
|
541 |
<div align="Justify"> |
542 |
<p style="text-align: justify; "> Na recept. </p> |
543 |
</div> |
544 |
|
545 |
<div align="Justify"> |
546 |
<p style="text-align: justify; "> </p> |
547 |
</div> |
548 |
|
549 |
<div align="Justify"> |
550 |
<p style="text-align: justify; "> <b>Naèin shranjevanja</b> </p> |
551 |
</div> |
552 |
|
553 |
<div align="Justify"> |
554 |
<p style="text-align: justify; "> Na temperaturi do 15 <sup>o</sup>C in |
555 |
nedosegljivo otrokom. </p> |
556 |
</div> |
557 |
|
558 |
<div align="Justify"> |
559 |
<p style="text-align: justify; "> Zdravilo ne sme zamrzniti. </p> |
560 |
</div> |
561 |
|
562 |
<div align="Justify"> |
563 |
<p style="text-align: justify; "> </p> |
564 |
</div> |
565 |
|
566 |
<div align="Justify"> |
567 |
<p style="text-align: justify; "> <b>Številka in datum odloèbe</b> |
568 |
</p> |
569 |
</div> |
570 |
|
571 |
<div align="Justify"> |
572 |
<p style="text-align: justify; "> 323-03-8/00-127, 21.05.2001 </p> |
573 |
</div> |
574 |
|
575 |
<div align="Justify"> |
576 |
<p style="text-align: justify; "> <b></b> </p> |
577 |
</div> |
578 |
|
579 |
<div align="Justify"> |
580 |
<p style="text-align: justify; "> Oprema </p> |
581 |
</div> |
582 |
|
583 |
<div align="Justify"> |
584 |
<p style="text-align: justify; "> Prebodna steklenièka s 100 ml suspenzije |
585 |
v posamezni ovojnini </p> |
586 |
</div> |
587 |
|
588 |
<div align="Justify"> |
589 |
<p style="text-align: justify; "> </p> |
590 |
</div> |
591 |
|
592 |
<div align="Justify"> |
593 |
<p style="text-align: justify; "> <b>Postopek s prazno ovojnino</b> </p> |
594 |
</div> |
595 |
|
596 |
<div align="Justify"> |
597 |
<p style="text-align: justify; "> Ostanke zdravila in prazno ovojnino je |
598 |
treba obravnavati kot posebne odpadke in jih ni dovoljeno odmetavati med |
599 |
obièajne komunalne odpadke. </p> |
600 |
</div> |
601 |
|
602 |
<div align="Justify"> |
603 |
<p style="text-align: justify; "> </p> |
604 |
</div> |
605 |
|
606 |
<div align="Justify"> |
607 |
<p style="text-align: justify; "> <b>Proizvajalec</b> </p> |
608 |
</div> |
609 |
|
610 |
<div align="Justify"> |
611 |
<p style="text-align: justify; "> VETERINA d.o.o., HRVAŠKA </p> |
612 |
</div> |
613 |
|
614 |
<div align="Justify"> |
615 |
<p style="text-align: justify; "> </p> |
616 |
</div> |
617 |
|
618 |
<div align="Justify"> |
619 |
<p style="text-align: justify; "> <b>Zastopnik</b> </p> |
620 |
</div> |
621 |
|
622 |
<div align="Justify"> |
623 |
<p style="text-align: justify; "> PLIVA LJUBLJANA d. o. o., SLOVENIJA </p> |
624 |
</div> |
625 |
|
626 |
<div align="Justify"> |
627 |
<p style="text-align: justify; "> </p> |
628 |
</div> |
629 |
|
630 |
<div align="Justify"> |
631 |
<p style="text-align: justify; "> Revidirano na seji Komisije za registracijo |
632 |
zdravil za uporabo v veterinarski medicini dne 18.12.2000. </p> |
633 |
</div> |
634 |
|
635 |
<div align="Justify"> |
636 |
<p style="text-align: justify; "> </p> |
637 |
</div> |
638 |
|
639 |
<div align="Justify"> |
640 |
<p style="text-align: justify; "> </p> |
641 |
</div> |
642 |
|
643 |
<div align="Justify"> |
644 |
<p style="text-align: justify; "> </p> |
645 |
</div> |
646 |
|
647 |
<div align="Justify"> |
648 |
<p style="text-align: justify; "> </p> |
649 |
</div> |
650 |
|
651 |
<div align="Justify"> |
652 |
<p style="text-align: justify; "> </p> |
653 |
</div> |
654 |
|
655 |
<div align="Justify"> |
656 |
<p style="text-align: justify; "> </p> |
657 |
</div> |
658 |
|
659 |
<div align="Justify"> |
660 |
<p style="text-align: justify; "> </p> |
661 |
</div> |
662 |
<!--Section Ends--> |
663 |
</body> |
664 |
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