natgillin/translations-raw huggingface dataset:
For at sikre korrekt dosering bør legemsvægt bestemmes så nøjagtigt som muligt. 
To ensure administration of a correct dose, body weight should be determined as accurately as possible
Faste er ikke nødvendig før eller efter behandling. 
No starvation is needed before or after treatment.
Denne konklusion er på linje med grundlaget for de forskellige gensidige anerkendelsesprocedurer (IE/V/0241-0243/001/MR). 
This conclusion is in line with the view taken during the various mutual recognition procedures (IE/V/0241-0243/001/MR).
Direkte fordele 
Direct benefits
Denne hurtige kontraktion forklares ved forandringer i de divalente kationers flux, særligt for kalcium. 
This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.
TEKSTEN “TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT 
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Referenceproduktet er godkendt til anvendelse fra 2-ugers alderen, uden at der er påvist særlig risiko for denne aldersgruppe. 
The reference product is authorised for use from two weeks of age with no specific risk identified for this particular age group.
Parasitten tømmes for dens energireserver og dør i løbet af 2-3 dage. 
The parasite dies upon exhaustion of its energy reserves, which occurs 2 - 3 days later.
Produktet har fortsat et positivt benefit/riskforhold. 
The product continues to have a positive benefit - risk balance.
ATCvet-kode: QP 52 AA 51 
ATC vet code: QP52AA51
Tabletterne kan gives direkte til hunden eller skjult i foderet. 
The tablets can be given directly to the dog or disguised in food.
Produktet bør ikke bruges til hunde under de første 4 uger af drægtighed. 
It is recommended that the product is not used in dogs during the first 4 weeks of pregnancy.
Ingen kendte 
None Known
Piskeorm: Trichuris vulpis (voksne). 
Whipworms: Trichuris vulpis (adults).
Produktet forventes ikke at udgøre en risiko for brugeren, når det anvendes i overensstemmelse med anbefalingerne i produktinformationen. 
The product is not expected to pose a risk to the user when used in accordance with label recommendations.
Mærkning 
Labelling
Dannelsen af microtubuli hindres dermed, hvilket resulterer i forstyrrelser af strukturer, der er afgørende for helminters normale funktion. 
Formation of microtubules is thereby prevented, resulting in disruption of structures vital to the normal functioning of the helminth.
Tabletterne kan deles i to halve eller fire kvarte dele. 
The tablets can be divided into equal halves or equal quarters.
Formålet med indbringelsen er at ophæve divergenserne mellem produktresuméerne for ovenstående produkter og således harmonisere de forskellige produktresuméer i hele EU. 
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.
En lysegul tablet med kryds delekærv på den ene side. 
A pale yellow tablet with a cross breakline on one side.
Udfyldes nationalt 
To be completed nationally.
Disse data indikerer, at testproduktet må antages at være mindst lige så effektivt som referenceproduktet. 
These data suggest that the test product is likely to be at least as effective as the reference product.
FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG 
PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Produktet er veltolereret i måldyrearten. 
The product is well tolerated in the target species.
Det overordnede benefit/risk-forhold anses for at være positivt. 
The overall benefit - risk balance is considered positive.
Febantel, et probenzimidazol. 
Febantel, a probenzimidazole
Glukoseoptagelsen er især påvirket, hvilket fører til en udtømnng i celle ATP. 
Glucose uptake in particular is affected, leading to a depletion in cell ATP.
Kun meget små mængder ikke-metaboliseret praziquantel udskilles. 
Only traces of non-metabolised praziquantel are excreted.
Der indtræder en næsten øjeblikkelig tetanisk kontraktion af parasittens muskulatur og en hurtig vakuolisering af det syncytiale tegument 
There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolization of the syncytial tegument.
Toleranceundersøgelsen omfattede ikke hvalpe på under 9 uger, men der er ikke grund til antage, at produktet medfører uacceptabel risiko for yngre hvalpe. 
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.
Eventuelt ubrugt produkt eller affald skal bortskaffes i overensstemmelse med nationale krav. 
Any unused product or waste material should be disposed of in accordance with national requirements.
Disse kemiske enheder udøver den anthelmintiske effekt ved hæmning af polymerisationen af tubulin. 
It is these chemical entities which exert the anthelmintic effect by inhibition of tubulin polymerisation.
2, 4, 6, 8 tabletter. 
2, 4, 6, 8 tablets.
Bilag III 
ANNEX III
• CVMP gennemgik det produktresumé og den etikettering og indlægsseddel, der var forelagt af indehaveren af markedsføringstilladelsen, og tog alle forelagte data i betragtning, 
• 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;
Studier har vist, at en enkeltdosis på 5 gange den anbefalede dosis eller mere, medførte opkastninger. 
In safety studies, a single dose of 5 times the recommended dose or greater gave rise to occasional vomiting.
Praziquantel absorberes hurtigt gennem parasittens overflade og fordeles jævnt overalt i parasitten. 
Praziquantel is very rapidly absorbed through the parasite's surface and distributed throughout the parasite.
Diskussion af de foreliggende data 
Discussion of the data available
Den påberåbte virkning af produktet anses for at være tilfredsstillende godtgjort. 
It is considered that the claimed efficacy of the product has been adequately substantiated.
Efter absorption, omdannes pyrantelpamoat hurtigt og næsten fuldstændigt til inaktive metabolitter, der udskilles i urinen. 
Following absorption, pyrantel pamoate is quickly and almost completely metabolized into inactive metabolites that are excreted rapidly in the urine.
Den angivne dosis må ikke overskrides ved behandling af drægtige tæver. 
Do not exceed the stated dose when treating pregnant bitches.
Målparasitterne kan potentielt forringe de inficerede dyrs velfærd. 
The target parasites have the potential to impact on welfare of individual infected animals.
Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen 
This veterinary medicinal product does not require any special storage conditions
Farmakoterapeutisk klassifikation: Anthelmintikum, praziquantel kombinationspræparat. 
Pharmacotherapeutic group: Anthelmintic, praziquantel combinations.
Aktive stoffer: Praziquantel 
Each tablet contains: Active substances: Praziquantel
In vitro og in vivo studier har vist, at parasittens integument skades alvorligt af praziquantel, hvilket resulterer i kontraktion og paralyse. 
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.
Dette produkt indeholder anthelmintika, der er aktivt imod gastrointestinale rundorme og bændelorme. 
This product contains anthelmintics active against gastrointestinal roundworms and tapeworms.
Kombinationen af praziquantel, pyrantelembonat og febantel er veltolereret i hunde. 
The combination of praziquantel, pyrantel embonate and febantel is well tolerated in dogs.
Der henvises til indlægssedlen for bortskaffelse rådgivning. 
Please refer to package leaflet for disposal advice.
Hvis der er risiko for reinfestation , bør der rådføres med en dyrlæge vedrørende behov og frekvens af gentagen administration. 
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.
Fortegnelse over lægemidlernes navne, lægemiddelform, styrke, dyrearter, indgivelsesvejen, indehaver af markedsføringstilladelse i medlemsstaterne 
List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration marketing authorisation holder in the Member States.
Hvis der er risiko for reinfestation, bør der rådføres med en dyrlæge vedrørende behov og frekvens af gentagen administration. 
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..
Individuelle blisters af 45 µm og bløde sind aluminiumsfolie og 25 µm hærdet aluminiumsfolie, indeholdende 2 eller 8 tabletter 
Individual blisters composed of 45 µm, soft temper aluminium foil and 25 µm hard temper aluminium foil, containing 2 or 8 tablets.
Denne kombination udviser synergistisk aktivitet overfor hageorme, og febantel er aktiv imod T. vulpis. 
This combination shows synergistic activity in the case of hookworms and febantel is effective against T. vulpis.
Samtidig brug af andre kolinerge lægemidler kan have toksisk virkning. 
Concurrent use with other cholinergic compounds can lead to toxicity.
Individuelle strips af aluminiumsfolie 30 µm/30 gsm ekstruderet polyethylen, indeholdende 2, 4, 6, 8, 10, 12, 14, 16, 18 eller 20 tabletter. 
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.
Endelig blev Chanelle Pharmaceuticals Manufacturing Ltd. anmodet om at fremsætte forslag til en harmoniseret produktinformation og dokumentation for oplysningerne heri. 
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.
4.7 Drægtighed, diegivning eller æglægning 
4.7 Use during pregnancy, lactation or lay
Produkterne har samme komposition som det godkendte referenceprodukt hvad angår aktive indholdsstoffer, og produkternes påtænkte anvendelsesbetingelser er identiske med referenceproduktets. 
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.
På grundlag af en samlet vurdering af de forelagte oplysninger anses virkningen af det berørte produkt at være den samme som for referenceproduktet, Drontal Plus. 
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.
Lactosemonohydrat Mikrokrystallinsk cellulose Magnesium stearat Silica, kolloid vandfri Croscarmellosenatrium Natriumlaurilsulfat Smag af svinekød 
Lactose monohydrate, Microcrystalline cellulose, Magnesium stearate, Colloidal anhydrous silica, Croscarmellose sodium, Sodium laurilsulfate Pork flavour
På denne baggrund anser CVMP det for usandsynligt, at anvendelse til hvalpe under 9 uger eller hunde under 2,5 kg giver anledning til sikkerhedsmæssige betænkeligheder, hvorfor det ikke er nødvendigt at begrænse anvendelsen hos sådanne dyr. 
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.
Hovedforskellen mellem produktresuméerne vedrører virkning mod Echinococcus granulosus og Echinococcus multilocularis og anvendelse til hvalpe på under 9 uger og hunde under 2,5 kg. 
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.
Eller 
or
Produktet anses for at være effektivt til behandling af blandede infestationer med nematoder og cestoder af følgende arter: 
The product is considered to be effective for the treatment of mixed infections by nematodes and cestodes of the following species:
På grundlag af de foreliggende data vedrørende virkning godtages det, at det berørte produkt vil være effektivt (op til 100 %) til behandling af infestation med umodne og modne former af E. granulosus og E. multilocularis hos hunde. 
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.
De bibliografiske data, der blev fremlagt af indehaveren af markedsføringstilladelsen, bekræftede den anerkendte virkning af praziquantel i en dosis på 5 mg/kg mod E. granulosus og E. multilocularis. 
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.
Infestation med bændelorm er usandsynlig hos hvalpe, der er under 6 uger gamle. 
Tapeworm infestation is unlikely in pups less than 6 weeks of age.
EXP{måneder/år} Kassér ubrugte delte tabletter. 
EXP {month/year} Discard any unused divided tablets.
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 
<PARTICULARS TO APPEAR ON THE OUTER PACKAGE>
• CHMP behandlede produkternes anvendelse til hvalpe under 9 uger og hunde under 2,5 kg, 
• 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
Strips og blistre er pakket i æsker der indeholder enten: 2,4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 30, 
The strips or blisters are packed into cartons containing either 2,4, 6, 8, 10, 12, 14, 16, 18, 20,
Parasitter kan udvikle resistens overfor en vis gruppe af anthelmintikum som følge af ofte gentaget anvendelse af et anthelmintikum fra denne gruppe 
Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
I en række af de beskrevne undersøgelser blev praziquantel påvist at være højeffektivt mod E. granulosus og E. multilocularis i doser på mindre end 5 mg/kg kropsvægt. 
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.
Praziquantels aktivitetsspektrum dækker alle relevante bændelorme arter fundet i hunde, særligt Taenia spp., Dipylidium caninum, Echinococcus granulosus og Echinococcus multilocularis. 
The spectrum of activity of praziquantel covers all important cestode species in dogs, in particular Taenia spp., Dipylidium caninum, Echinococcus granulosus and Echinococcus multilocularis.
Af hensyn til god hygiejne, bør personer der administrerer lægemidlet direkte til hunden eller i hundens foder, vaske deres hænder efterfølgende. 
In the interests of good hygiene, persons administering the tablets directly to a dog or adding them to the dog's food should wash their hands afterwards.
Præparatet præsenteres som: 
The product is presented in either:
Disse in vitro-data viser, at opløsningsprofilerne for de to produkter er ens under de valgte testbetingelser. 
These in vitro data confirm that, under the conditions tested, the dissolution profiles are similar for both products.
Begrundelse for ændringen af produktresuméet, etiketteringen og indlægssedlen 
Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Efter absorption fordeles praziquantel i alle organer. 
After absorption, the drug is distributed to all organs.
Må ikke anvendes samtidigt med produkter, der indeholder piperazin. 
Do not use simultaneously with piperazine compounds.
Pyrantel i form af pamoatsalt har lav opløselighed, hvilket reducerer absorption i mave-tarmkanalen og medfører, at lægemidlet effektivt kan nå parasitter i tyktarmen. 
The pamoate salt of pyrantel has low aqueous solubility, an attribute that reduces absorption from the gut and allows the drug to reach and be effective against parasites in the large intestine.
Det berørte produkt kan derfor næppe antages at frembyde større risiko end referenceproduktet for måldyrearten. 
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.
Bilag I 
ANNEX I:
Hageorm: Uncinaria stenocephala, Ancylostoma caninum (voksne). 
Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adults).
Uanset indgivelsesvej og formulering viste praziquantel sig i en dosis på 5 mg/kg kropsvægt konsekvent 100 % effektivt mod umodne og modne former E. granulosus og E. multilocularis. 
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.
Produktet bør derfor kun bruges under drægtighed, efter den af dyrlægen foretagne analyse af risiko og fordele. 
Use of the product during pregnancy should be in accordance with a benefit risk assessment by the responsible veterinarian.
Febantel absorberes relativt hurtigt og omdannes til blandt andet fenbendazol og oxfendazol, som udøver anthelmintisk effekt 
Febantel is absorbed relatively rapidly and metabolized to a number of metabolites including fenbendazole and oxfendazole, which have anthelmintic activity.
Til yderligere støtte for produktets sikkerhed og virkning fremlagde Chanelle Pharmaceuticals Manufacturing Ltd. lægemiddelovervågningsdata for Prazitel Plus og relaterede kopiprodukter, i hvis produktresumé der påberåbes virkning over for Echinococcus. 
In further support of the safety and efficacy of the product, Chanelle Pharmaceuticals Manufacturing Ltd.provided pharmacovigilance data for Prazitel Plus and related duplicate products which include in the SPC the claim for efficacy against Echinococcus.
In vivo-dataene støttes desuden af en sammenligning af opløsningsprofilerne af det berørte produkt og af referenceproduktet Drontal Plus tabletter. 
The in vivo data are further supported by the results of the comparative dissolution profiles of the concerned product with the reference product Drontal Plus tablets.
Angreb med bændelorm kan indtræffe igen, medmindre der foretages kontrol af mellemværter såsom lopper, mus etc. 
Tapeworm infestation is certain to reoccur unless control of intermediate hosts such as fleas, mice, etc. is undertaken.
En sikkerhedsundersøgelse i måldyrearten viste, at det berørte produkt (Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus og relaterede navne) er veltolereret hos hvalpe (9 uger gamle) ved administration af en dosis op til fem gange den anbefalede behandlingsdosis samt ved administration af den anbefalede behandlingsdosis i op til tre dage. 
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.
Udfyldes nationalt Praziquantel, Pyrantel, Febantel 
Praziquantel, Febantel, Pyrantel.
Praziquantel er aktivt over for alle udviklingsstadier i disse parasitter. 
Praziquantel acts against all adult and immature forms of these parasites.
• CVMP gennemgik det primære formål med henvisningen vedrørende virkningen mod Echinococcus granulosus og Echinococcus multilocularis, 
• the CVMP considered the primary scope of the referral regarding efficacy against Echinococcus granulosus and Echinococcus multilocularis;
Praziquantels maksimale plasma koncentration i hund blev opnået ca. 2,5 time efter administration. 
Following administration of the product to dogs, peak plasma concentrations of praziquantel were achieved by approximately 2.5 hours.
Kun til dyr. 
For Animal Treatment Only.
Praziquantel omdannes til inaktive metabolitter i leveren og udskilles i galden. 
Praziquantel is metabolized into inactive forms in the liver and secreted in bile.
Ikke relevant 
Not Applicable
Bør ikke anvendes i tilfælde af overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne. 
Do not use in animals with a known sensitivity to the active ingredients or to any of the excipients.
Det er ikke nødvendigt at ændre markedsføringstilladelserne for Prazitel Plus, Exitel Plus, Cazitel Plus og relaterede navne, der er godkendt ved MRP IE/V/0241-0243/001/MR (se bilag I). 
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.
Den maksimale plasmakoncentration for fenbendazol og oxbendazol i hund, blev opnået ca. 7-9 timer efter administration. 
Following administration of the product to dogs, peak plasma concentrations of fenbendazole and oxfendazole were achieved by approximately 7-9 hours.
106, 120, 140, 150, 180, 200, 204, 206, 250, 280, 300, 500 eller 1000 tabletter. 
106, 120, 140, 150, 180, 200, 204, 206, 250, 280, 300, 500 and 1000 tablets.
Der er tale om syv kopiprodukter med identiske hybride ansøgningsdossierer, der har Drontal Plus (Bayer Animal Health) som referenceprodukt. 
The products concerned are seven duplicates with identical hybrid application dossiers for which the reference product is Drontal Plus (Bayer Animal Health).
Særlige forsigtighedsregler for dyret 
Special precautions for use in animals
Der er tale om syv ens produkter med identiske hybride ansøgningsdossierer, som Drontal Plus er referenceprodukt for. 
The products concerned are seven duplicates with identical hybrid application dossiers for which the reference product is Drontal Plus.
Produkterne er tabletter, der anvendes til hunde og indeholder praziquantel, pyrantelembonat og febantel. 
The products are tablets for dogs containing praziquantel, pyrantel embonate and febantel and indicated for various parasitic infections.
Cestoder: 
Cestodes:
Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus og relaterede navne er tabletter, der anvendes til hunde og indeholder praziquantel, pyrantelembonat og febantel. 
Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names are tablets for dogs containing praziquantel, pyrantel embonate and febantel and indicated for various parasitic infections.
CVMP anmodede Chanelle Pharmaceuticals Manufacturing Ltd. om at dokumentere virkningen mod Echinococcus og fremlægge alle de relevante data, der underbygger virkningen mod Echinococcus og tidligere var fremlagt i dossierer til støtte for markedsføringsgodkendelsen. 
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.
Samlet resumé af den videnskabelige vurdering af Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus og relaterede navne (se bilag I) 
Overall summary of the scientific evaluation of Milaxyn Plus, Strantel Plus, Prazical Plus, Voxical Plus, Exitel Plus, Cazitel Plus, Prazitel Plus and associated names (see annex I)
INN/Særnavn 
INN/Strength
Spolorm: Toxocara canis, Toxascaris leonina (modne og sene umodne former). 
Ascarids: Toxocara canis, Toxascaris leonina (adult and late immature forms).
Produktinformationen indeholder passende sikkerhedsanvisninger til brugeren. 
Appropriate user safety advice is included in the product literature.
140, 150, 180, 200, 204, 206, 250, 280, 300, 500 og 1000 tabletter. 
150, 180, 200, 204, 206, 250, 280, 300, 500 or 1000 tablets.
Æske med 10 tabletter og derover 
{CARTON FOR PACK SIZES OF 10 TABLETS, AND UPWARDS}