natgillin/translations-raw huggingface dataset:
Further, it is considered that use of this product, in accordance with label recommendations in the product literature, sufficiently manages the risk associated with its use. 
Poleg tega velja, da uporaba tega zdravila v skladu s priporočili na etiketi v strokovni literaturi o zdravilu v zadostni meri obvladuje tveganje, povezano z njegovo uporabo.
The target parasites have the potential to impact on welfare of individual infected animals. 
Ciljni paraziti lahko vplivajo na dobro počutje posameznih okuženih živali.
None known. 
Niso poznani.
This conclusion is in line with the view taken during the various mutual recognition procedures (IE/V/0241-0243/001/MR). 
Ta zaključek je v skladu s stališčem v različnih postopkih z medsebojnim priznavanjem (IE/V/02410243/001/MR).
Pyrantel acts as a cholinergic agonist. 
Pirantel deluje kot holinergični agonist.
In addition, a number of the target parasites have the potential to infect humans (zoonotic potential). 
Poleg tega lahko številni ciljni paraziti okužijo ljudi (možnost zoonotskega prenosa).
Formation of microtubules is thereby prevented, resulting in disruption of structures vital to the normal functioning of the helminth. 
S tem je preprečeno nastajanje mikrotubulov, kar ima za posledico motnjo v strukturi, ki je vitalna za normalno funkcioniranje helmintov.
The product is not expected to pose a risk to the user when used in accordance with label recommendations. 
To zdravilo naj ne bi predstavljajo tveganja za uporabnika, če se uporablja v skladu z priporočili na etiketi.
No studies have been performed in dogs during early pregnancy. 
V obdobju zgodnje brejosti niso bile opravljene študije pri psih.
The reference product is authorised for use from two weeks of age with no specific risk identified for this particular age group. 
Referenčno zdravilo je odobreno za uporabo od drugega tedna starosti brez posebnega tveganja za to starostno skupino.
Do not use simultaneously with piperazine compounds. 
Ne uporabite istočasno z zdravili s piperazinom.
The tablets can be given directly to the dog or disguised in food. 
Tablete lahko dajete psu neposredno ali skrite v hrani.
This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium. 
Hitre kontrakcije so posledica sprememb v fluksih divalentnih kationov, posebej kalcija.
The parasite dies upon exhaustion of its energy reserves, which occurs 2 - 3 days later. 
Parazit pogine zaradi izčrpanja lastnih zalog energije v 2 -3 dneh.
While plasma concentrations are not a direct measure of the concentrations of active available locally in the gastro intestinal tract, it is considered that similar systemic availability (similar extent of absorption) is indicative of similar behaviour locally in the gastro intestinal tract following product administration. 
Medtem ko plazemske koncentracije niso neposredno merilo za aktivne koncentracije, ki so na voljo lokalno v gastrointestinalnem traktu, velja, da podobna sistemska razpoložljivost (podoben obseg absorpcije) kaže na podobno lokalno vedenje v gastrointestinalnem traktu po zaužitju.
It is excreted within 24 hours to more than 95% of the administered dosage. 
Več kot 95% apliciranega odmerka se izloči v 24 urah.
In safety studies, a single dose of 5 times the recommended dose or greater gave rise to occasional vomiting. 
V študijah varnosti je enkratni odmerek 5 krat ali večkrat priporočenega odmerka povzročil občasno bruhanje.
Therefore, it can be assumed that the concerned product is unlikely to present any greater risk to the target animal relative to that posed by the reference product. 
Zato lahko sklepamo, da zadevni izdelek verjetno ne predstavlja večjega tveganja za ciljne živali kot referenčno zdravilo.
There is extensive literature for the individual active substances and the combination which supports the safety of this product in younger puppies. 
Obstaja obsežna literatura za posamezne zdravilne učinkovine in kombinacije, ki potrjuje varnost tega zdravila pri mlajših mladičih.
These data suggest that the test product is likely to be at least as effective as the reference product. 
Ti podatki kažejo, da je poskusno zdravilo verjetno vsaj tako učinkovito kot referenčno zdravilo.
It is recommended that the product is not used in dogs during the first 4 weeks of pregnancy. 
Priporočeno je, da zdravila ne uporabljate v prvih 4 tednih brejosti.
No starvation is needed before or after treatment. 
Pred ali po zdravljenju post ni potreben.
The products are not expected to pose a risk to the environment. 
Ta zdravila naj ne bi predstavljala tveganja za okolje.
Tapeworm infestation is certain to reoccur unless control of intermediate hosts such as fleas, mice, etc. is undertaken. 
Okužba s trakuljo se bo zagotovo ponovila, razen če se ne opravi nadzor nad vmesnimi gostitelji kot so bolhe, miši in podobno.
Direct benefits 
Neposredne koristi
Praziquantel is very rapidly absorbed through the parasite's surface and distributed throughout the parasite. 
Prazikvantel se zelo hitro absorbira skozi površino parazita in distribuira skozi celotnega parazita.
Tapeworm infestation is unlikely in pups less than 6 weeks of age. 
Okužba s trakuljo je malo verjetna pri psičkih mlajših od 6 tednov.
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class. 
Rezistenca na določen razred antiparazitikov se lahko razvije po pogosti, ponavljajoči se uporabi tega antiparazitika.
Do not use simultaneously with piperazine compounds as the anthelmintic effects of pyrantel and piperazine may be antagonized. 
Ne uporabite istočasno s piperazinskimi zdravili, ker je lahko antihelmintični učinek pirantela in piperazina antagonističen.
• the CVMP reviewed the summary of products characteristics, labelling and package leaflet proposed by the marketing authorisation holder and considered all the overall submitted data; 
• pregledal povzetek glavnih značilnosti zdravila, označevanje in navodilo za uporabo, ki jih je predlagal imetnik dovoljenja za promet z zdravilom, in obravnaval vse splošno predložene podatke,
The products have been formulated to have the same composition, in terms of active substances, as the authorised reference product and the proposed conditions of use of the products are identical to those of the reference product. 
Izdelki so bili oblikovani tako, da imajo enako sestavo zdravilnih učinkovin, saj so odobreno referenčno zdravilo in predlagani pogoji uporabe zdravil enaki kot za referenčno zdravilo.
While the tolerance study was not performed on puppies less than 9 weeks of age, there is no reason to expect that this product presents an unacceptable risk to younger puppies. 
Čeprav študije o toleranci niso izvajali na mladičih, starih manj kot 9 tednov, ni nobenega razloga za pomisleke glede nesprejemljivega tveganja tega zdravila za mlajše mladiče.
Use of the product during pregnancy should be in accordance with a benefit risk assessment by the responsible veterinarian. 
V obdobju brejosti uporabite le v skladu z oceno razmerja korist/tveganje odgovornega veterinarja.
Cestodes: 
Cestodi:
Glucose uptake in particular is affected, leading to a depletion in cell ATP. 
Prizadeta je predvsem resorbcija glukoze, kar vodi do izčrpanja ATP v celicah.
Any part used tablet should be discarded. 
Vsako delno porabljeno tableto je potrebno zavreči.
List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration marketing authorisation holder in the Member States. 
Seznam imen, farmacevtska oblika, jakosti za uporabo v veterinarski medicini, živalske vrste, pot uporabe, imetnikov dovoljenja za promet v državah članicah
This combination shows synergistic activity in the case of hookworms and febantel is effective against T. vulpis. 
Navedena kombinacija kaže sinergistično delovanje proti ankilostomidom, febantel pa je učinkovit proti T. Vulpis.
Based on the findings of this study, the test and reference products can be considered equivalent with respect to AUCinf of praziquantel; therefore similar systemic availability can be assumed. 
Glede na ugotovitve iz te študije je poskusna in referenčna zdravila mogoče obravnavati kot enakovredna vrednosti AUCinf prazikvantela, zato lahko sklepamo o podobni sistemski razpoložljivosti.
2, 4, 6, 8 tablets. 
2, 4, 6, 8 tablet
There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolization of the syncytial tegument. 
Pride do skoraj trenutnega tetaničnega krča parazitove muskulature in hitre vakuolizacije sincicijske plasti.
EXP {month/year} Discard any unused divided tablets. 
EXP {mesec/leto} Neporabljene prelomljene tablete zavržite.
The overall benefit - risk balance is considered positive. 
Splošno razmerje med koristmi in tveganji je pozitivno.
INN/Strength 
INN/Jakosti
It is these chemical entities which exert the anthelmintic effect by inhibition of tubulin polymerisation. 
Te kemične snovi delujejo antihelmintično z inhibicijo polimerizacije tubulina.
Praziquantel, Febantel, Pyrantel. 
Prazikvantel, febantel, pirantel
Concurrent use with other cholinergic compounds can lead to toxicity. 
Istočasna uporaba z drugimi holinergičnimi zdravili je lahko toksična.
Febantel is absorbed relatively rapidly and metabolized to a number of metabolites including fenbendazole and oxfendazole, which have anthelmintic activity. 
Febantel se relativno hitro resorbira in metabolizira v številne metabolite, vključno s fenbendazolom in oksfendazolom, ki imata antihelmintično delovanje.
These in vitro data confirm that, under the conditions tested, the dissolution profiles are similar for both products. 
Ti podatki in vitro potrjujejo, da so v preizkušenih pogojih profili raztapljanja podobni pri obeh zdravilih.
Fleas serve as intermediate hosts for one common type of tapeworm - Dipylidium caninum. 
Bolhe so vmesni gostitelj za enega pogostih tipov trakulje - Diphylidium caninum.
The main difference between the SPCs for the products relates to the claim regarding efficacy against Echinococcus granulosus and Echinococcus multilocularis and use of the product in pups less than 9 weeks of age and dogs weighing less than 2.5 kg. 
Glavna razlika med povzetki glavnih značilnosti teh zdravil se nanaša na trditev v zvezi z učinkovitostjo proti Echinococcus granulosus in Echinococcus multilocularis in uporabo zdravila pri pasjih mladičih, starih manj kot 9 tednov, in psih, ki tehtajo manj kot 2,5 kg.
The aim of the referral is to resolve divergences between the SPCs for the above mentioned products and thus to harmonise the different SPCs across the EU. 
Namen napotitve je rešitev neskladij med povzetki glavnih značilnosti zdravila za zgoraj navedene izdelke in s tem uskladitev različnih povzetkov glavnih značilnosti zdravil po vsej EU.
Praziquantel acts against all adult and immature forms of these parasites. 
Prazikvantel je učinkovit proti vsem odraslim in razvojnim oblikam navedenih parazitov.
The product contains three active substances, as follows: 
Zdravilo vsebuje tri zdravilne učinkovine:
Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet 
Znanstveni zaključki in podlaga za spremembo povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo
Individual blisters composed of 45 µm, soft temper aluminium foil and 25 µm hard temper aluminium foil, containing 2 or 8 tablets. 
ali individualni pretisni omot, ki je sestavljen iz 45 µm mehke aluminijaste folije in 25 µm trde aluminijaste folije in vsebuje 2 ali 8 tablet.
Febantel, a probenzimidazole 
1. febantel, probenzimidazol
It is considered that the claimed efficacy of the product has been adequately substantiated. 
Zatrjena učinkovitost zdravila je bila ustrezno dokazana.
ANNEX III 
Priloga III
Its mode of action is to stimulate nicotinic cholinergic receptors of the parasite, induce spastic paralysis of the nematodes and thereby allow removal from the gastrointestinal system by peristalsis. 
Njegov način delovanja stimulira nikotinske holinergične receprtorje parazita, vključno s spastično paralizo nematodov in s tem omogoči odstranitev parazitov iz gastro intestinalnega sistema s peristaltiko.
In addition the Chanelle Pharmaceuticals Manufacturing Ltd.was requested to provide a proposal for harmonised product information and supportive data for the harmonised product information. 
Poleg tega je Odbor zaprosil družbo Chanelle Pharmaceuticals Manufacturing Ltd., naj predloži predlog za uskladitev informacij o zdravilu in podporne podatke za usklajene informacije o zdravilu.
Both in vitro and in vivo studies have shown that praziquantel causes severe damage to the parasite integument, resulting in the contraction and paralysis of the parasites. 
In vitro ter in vivo študije so pokazale, da prazikvantel povzroči resne poškodbe na parazitovi povrhnjici, kar se kaže v kontrakcijah in paralizi parazita.
Following administration of the product to dogs, peak plasma concentrations of praziquantel were achieved by approximately 2.5 hours. 
Po dajanju zdravila psu je vrh koncentracije prazikvantela v plazmi dosežen v približno 2,5 urah.
The product continues to have a positive benefit - risk balance. 
Zdravilo ima še vedno pozitivno razmerje med koristmi in tveganji.
To ensure administration of a correct dose, body weight should be determined as accurately as possible 
Za pravilno določitev odmerka je potrebno natančno določiti telesno težo.
Teratogenic effects attributed to high doses of febantel have been reported in sheep and rats. 
Pri visokih odmerkih febantela so poročali o teratogenih učinkih pri ovcah in podganah.
Individual strips composed of aluminium foil 30 µm/30 gsm extruded polythene, containing 2, 4, 6, 8, 10, 12, 14, 16, 18 or 20 tablets. 
dvojni trak sestavljen iz aluminijaste iztisnjene polietilenske 30 µm/30 gsm folije, ki vsebuje 2, 4, 6, 8, 10, 12, 14, 16, 18 ali 20 tablet.
Following absorption, pyrantel pamoate is quickly and almost completely metabolized into inactive metabolites that are excreted rapidly in the urine. 
Pirantelpamoat se po resorbciji hitro in skoraj popolno metabolizira v neaktivne metabolite, ki se hitro izločijo z urinom.
Based on the totality of information presented, it is considered that the efficacy of the concerned product will be similar to that of the reference product, Drontal Plus. 
Na podlagi celokupnih predstavljenih informacij velja, da je učinkovitost zadevnega zdravila podobna učinkovitosti referenčnega zdravila Drontal Plus.
The bibliographic data provided by the marketing authorisation holder confirmed the well established efficacy of praziquantel at a dose of 5 mg/kg against E. granulosus and E. multilocularis. 
Bibliografski podatki, ki jih je predložil imetnik dovoljenja za promet z zdravili, so potrdili dobro uveljavljeno učinkovitost prazikvantela v odmerku 5 mg/kg proti E. granulosus in E. multilocularis.
Whipworms: Trichuris vulpis (adults). 
Bičeglavec: Trichuris vulpis (odrasli).
The Committee considered on basis of a target animal safety study that the use of the concerned product in puppies less than 9 weeks of age or dogs less than 2.5 kg is unlikely to give rise to a safety concern and therefore a restriction on use in such animals is unnecessary. 
Odbor je na podlagi varnostne študije o ciljnih živalih menil, da naj uporaba zadevnega zdravila pri pasjih mladičih, starih manj kot 9 tednov, ali psih, ki tehtajo manj kot 2,5 kg, ne bi povzročala pomislekov glede varnosti in zato omejitev uporabe pri teh živalih ni potrebna.
The spectrum of activity of praziquantel covers all important cestode species in dogs, in particular Taenia spp., Dipylidium caninum, Echinococcus granulosus and Echinococcus multilocularis. 
Spekter delovanja prazikvantela zajame vse pomembne vrste cestodov pri psih, posebej Taenia spp., Dipylidium caninum, Echinococcus granulosus in Echinococcus multilocularis.
Following administration of the product to dogs, peak plasma concentrations of fenbendazole and oxfendazole were achieved by approximately 7-9 hours. 
Po dajanju zdravila psu doseže koncentracija fenbendazola in oksfendazola v plazmi vrh v približno 7-9 urah.
The products are tablets for dogs containing praziquantel, pyrantel embonate and febantel and indicated for various parasitic infections. 
Zdravila so tablete za pse in vsebujejo prazikvantel, pirantel embonat in febantel ter so inducirana za različne okužbe s paraziti.
If there is a risk for re-infestation, the advice of a veterinarian should be sought regarding the need for and the frequency of repeat administration.. 
Pri možnosti ponovne okužbe je potrebno nasvet o nujnosti in pogostosti ponavljanja odmerka poiskati pri veterinarju
In a number of the studies reported, praziquantel was shown to be highly effective against E. granulosus and E. multilocularis at doses less than 5 mg/kg bw. 
V številnih študijah, o katerih so poročali, se je prazikvantel pokazal kot zelo učinkovit proti E. granulosus in E. multilocularis v odmerkih manj kot 5 mg/kg telesne teže.
106, 120, 140, 150, 180, 200, 204, 206, 250, 280, 300, 500 and 1000 tablets. 
104, 106, 120, 140, 150, 180, 200, 204, 206, 250, 280, 300, 500 in 1000 tablet.
In view of the above, the CVMP considers use in puppies less than 9 weeks of age or dogs less than 2.5 kg is unlikely to give rise to a safety concern, therefore a restriction on use in such animals is unnecessary. 
Glede na zgoraj navedeno Odbor CVMP meni, da naj uporaba pri mladičih, starih manj kot 9 tednov, ali psih, ki tehtajo manj kot 2,5 kg, ne bi povzročala pomislekov glede varnosti, zato omejitev uporabe pri teh živalih ni potrebna.
While the majority of references cited by Chanelle Pharmaceuticals Manufacturing Ltd.reported on the efficacy of praziquantel when presented as a monosubstance tablet (Droncit, Bayer Animal Health), a number of the references reported on the efficacy of praziquantel when presented in other pharmaceutical forms (injectable, paste, powder) and/or for administration by other routes (intramuscular, subcutaneous) and/or when combined with other active substances (e.g. Drontal Plus, Bayer Animal Health). 
Medtem ko je večina referenc, ki jih je navedla družba Chanelle Pharmaceuticals Manufacturing Ltd. poročala o učinkovitosti tablete prazikvantela v obliki monosubstance (Droncit, Bayer Animal Health), pa so številne reference poročale o učinkovitosti prazikvantela v drugih farmacevtskih oblikah (injiciranje, pasta, prašek) in/ali za druge načine uporabe (intramuskularna, subkutana) in/ali v kombinaciji z drugimi zdravilnimi učinkovinami (npr. Drontal Plus, Bayer Animal Health).
Do not use after expiry date stated on the label. 
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini.
The CVMP requested Chanelle Pharmaceuticals Manufacturing Ltd.to justify the claim for efficacy against Echinococcus species and to provide all relevant data in support of the Echinococcus claim, which were presented previously in the dossiers submitted for marketing authorisation, together with comments on the suitability of the documentation to support the extrapolation of efficacy from the reference product to the hybrid product. 
Odbor CVMP je zahteval, da družba Chanelle Pharmaceuticals Manufacturing Ltd. utemelji trditev o učinkovitosti proti vrstam Echinococcus in zagotovi vse ustrezne podatke za podkrepitev trditve glede učinkovitosti zdravila proti vrstam Echinococcus, ki jih je predhodno predstavila v dokumentaciji, ki jo je predložila za pridobitev dovoljenja za promet z zdravilom, skupaj s pripombami glede ustreznosti dokumentacije, in tako dokaže prenos učinkovitosti referenčnega zdravila na hibridno zdravilo.
Pharmacotherapeutic group: Anthelmintic, praziquantel combinations. 
Farmakoterapevtska skupina: antihelnimtik, kombinacija prazikvantela.
Do not use in animals with a known sensitivity to the active ingredients or to any of the excipients. 
Ne uporabite v primeru preobčutljivosti na zdravilne učinkovine ali na katero koli pomožno snov.
Based on the available efficacy data, it is accepted that the concerned product will be effective (up to 100%) in the treatment of immature and mature forms of E. granulosus and E. multilocularis in the dog. 
Na podlagi razpoložljivih podatkov o učinkovitosti je sprejeto, da je zadevno zdravilo učinkovito (do 100-odstotno) pri zdravljenju nezrelih in zrelih oblik E. granulosus in E. multilocularis pri psih.
The strips or blisters are packed into cartons containing either 2,4, 6, 8, 10, 12, 14, 16, 18, 20, 
Trak ali pretisni omot sta pakirana v škatlo, ki vsebuje 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 30, 32, 36,
• the CVMP considered the in use of the products in puppies less than 9 weeks of age and dogs weighing less than 2.5 kg 
• obravnaval uporabo zdravil pri pasjih mladičih, starih manj kot 9 tednov, in psih, ki tehtajo manj kot 2,5 kg,
Perorally administered praziquantel is absorbed almost completely from the intestinal tract. 
Peroralno apliciran prazikvantev se skoraj popolnoma resorbira iz prebavnega trakta.
Lactose monohydrate, Microcrystalline cellulose, Magnesium stearate, Colloidal anhydrous silica, Croscarmellose sodium, Sodium laurilsulfate Pork flavour 
Laktoza monohidrat Celuloza, mikrokristalna Magnezijev stearat Silicijev dioksid, koloidni, brezvodni Natrijev karmelozat, premreženi Natrijev lavrilsulfat Aroma svinjine
The marketing authorisations for Prazitel Plus, Exitel Plus, Cazitel Plus and associated names, authorised by MRP IE/V/0241-0243/001/MR (see Annex I) do not need to be amended. 
Dovoljenj za promet z zdravili Prazitel Plus, Exitel Plus, Cazitel Plus in z njimi povezanimi imeni, ki so dobila dovoljenje po postopku z medsebojnim priznavanjem IE/V/0241-0243/001/MR (glejte Prilogo I) ni potrebno spreminjati.
Regardless of the administration route and the formulation, praziquantel at a dose of 5 mg/kg bw was consistently shown to be up to 100% effective against immature and mature forms of E. granulosus and E. multilocularis. 
Ne glede na način uporabe in sestave je bil prazikvantel v odmerku 5 mg/kg telesne teže dosledno do 100-odstotno učinkovit proti nezrelim in zrelim oblikam E. granulosus in E. multilocularis.
Benefit assessment 
Ocena koristi
Any unused product or waste material should be disposed of in accordance with national requirements. 
Vsako neporabljeno zdravilo za uporabo v veterinarski medicini ali odpadne snovi, ki nastanejo iz teh zdravil, je treba odstraniti v skladu z lokalnimi predpisi.
In dogs: Treatment of mixed infections by nematodes and cestodes. 
Psi: zdravljenje mešanih infekcij z nematodi in cestodi.
A target animal safety study confirmed that the concerned product (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names) is well tolerated when administered to pups (9 weeks of age) at doses up to five times the recommended treatment dose or when administered at the recommended treatment dose for up to three days. 
Varnostna študija o ciljnih živalih je potrdila, da se zadevno zdravilo (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus in z njimi povezana imena) dobro prenaša, če ga dajemo pasjim mladičem (starim 9 tednov) v odmerkih, ki so do petkrat večji od priporočenega odmerka za zdravljenje, ali v priporočenem odmerku do tri dni.
Within the mammalian system, febantel undergoes ring closure, forming fenbendazole and oxfendazole. 
V organizmu sesalca se febantelu zapre prstan pri čemer nastaneta fenbendazol in oksfendazol.
The product is considered to be effective for the treatment of mixed infections by nematodes and cestodes of the following species: 
Zdravilo velja za učinkovito pri zdravljenju mešanih okužb z nematodi in cestodi naslednjih vrst: