FrancophonIA/ELRC3.0 huggingface dataset:
English: The product contains three active substances, as follows:
Danish: Produktet indeholder følgende 3 aktive substanser:
English: The products are not expected to pose a risk to the environment.
Danish: Produkterne forventes ikke at udgøre en risiko for miljøet.
English: It is excreted within 24 hours to more than 95% of the administered dosage.
Danish: Indenfor 24 timer udskilles mere end 95 % af den administrerede dosis.
English: For oral administration.
Danish: Til oral administration.
English: In addition, a number of the target parasites have the potential to infect humans (zoonotic potential).
Danish: Derudover kan en række af målparasitterne inficere mennesker (zoonotisk potentiale).
English: Do not use after expiry date.
Danish: Må ikke anvendes efter udløbsdatoen.
English: No studies have been performed in dogs during early pregnancy.
Danish: Der er ikke foretaget undersøgelser af hunde under den tidlige drægtighed.
English: Since first marketing, the product has been shown to be well tolerated (very few reports of adverse effects) and there have been no reports of suspected lack of expected efficacy.
Danish: Siden produktet kom på markedet, har det vist sig at være veltolereret (meget få indberetninger om bivirkninger), og der har ikke været indberetninger om formodet mangelfuld virkning.
English: Therefore, use of the product to eliminate the target parasites will benefit both the treated animal and public health.
Danish: Anvendelse af produktet til at udrydde målparasitterne vil således være til fordel både for det behandlede dyr og for den offentlige sundhed.
English: To ensure administration of a correct dose, body weight should be determined as accurately as possible
Danish: For at sikre korrekt dosering bør legemsvægt bestemmes så nøjagtigt som muligt.
English: No starvation is needed before or after treatment.
Danish: Faste er ikke nødvendig før eller efter behandling.
English: This conclusion is in line with the view taken during the various mutual recognition procedures (IE/V/0241-0243/001/MR).
Danish: Denne konklusion er på linje med grundlaget for de forskellige gensidige anerkendelsesprocedurer (IE/V/0241-0243/001/MR).
English: Direct benefits
Danish: Direkte fordele
English: This rapid contraction has been explained by changes in divalent cation fluxes, especially calcium.
Danish: Denne hurtige kontraktion forklares ved forandringer i de divalente kationers flux, særligt for kalcium.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Danish: TEKSTEN “TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: The reference product is authorised for use from two weeks of age with no specific risk identified for this particular age group.
Danish: Referenceproduktet er godkendt til anvendelse fra 2-ugers alderen, uden at der er påvist særlig risiko for denne aldersgruppe.
English: The parasite dies upon exhaustion of its energy reserves, which occurs 2 - 3 days later.
Danish: Parasitten tømmes for dens energireserver og dør i løbet af 2-3 dage.
English: The product continues to have a positive benefit - risk balance.
Danish: Produktet har fortsat et positivt benefit/riskforhold.
English: ATC vet code: QP52AA51
Danish: ATCvet-kode: QP 52 AA 51
English: The tablets can be given directly to the dog or disguised in food.
Danish: Tabletterne kan gives direkte til hunden eller skjult i foderet.
English: It is recommended that the product is not used in dogs during the first 4 weeks of pregnancy.
Danish: Produktet bør ikke bruges til hunde under de første 4 uger af drægtighed.
English: None Known
Danish: Ingen kendte
English: Whipworms: Trichuris vulpis (adults).
Danish: Piskeorm: Trichuris vulpis (voksne).
English: The product is not expected to pose a risk to the user when used in accordance with label recommendations.
Danish: Produktet forventes ikke at udgøre en risiko for brugeren, når det anvendes i overensstemmelse med anbefalingerne i produktinformationen.
English: Labelling
Danish: Mærkning
English: Formation of microtubules is thereby prevented, resulting in disruption of structures vital to the normal functioning of the helminth.
Danish: Dannelsen af microtubuli hindres dermed, hvilket resulterer i forstyrrelser af strukturer, der er afgørende for helminters normale funktion.
English: The tablets can be divided into equal halves or equal quarters.
Danish: Tabletterne kan deles i to halve eller fire kvarte dele.
English: 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.
Danish: Formålet med indbringelsen er at ophæve divergenserne mellem produktresuméerne for ovenstående produkter og således harmonisere de forskellige produktresuméer i hele EU.
English: A pale yellow tablet with a cross breakline on one side.
Danish: En lysegul tablet med kryds delekærv på den ene side.
English: To be completed nationally.
Danish: Udfyldes nationalt
English: These data suggest that the test product is likely to be at least as effective as the reference product.
Danish: Disse data indikerer, at testproduktet må antages at være mindst lige så effektivt som referenceproduktet.
English: PROHIBITION OF SALE, SUPPLY AND/OR USE Not applicable.
Danish: FORBUD MOD SALG, UDLEVERING OG/ELLER BRUG
English: The product is well tolerated in the target species.
Danish: Produktet er veltolereret i måldyrearten.
English: The overall benefit - risk balance is considered positive.
Danish: Det overordnede benefit/risk-forhold anses for at være positivt.
English: Febantel, a probenzimidazole
Danish: Febantel, et probenzimidazol.
English: Glucose uptake in particular is affected, leading to a depletion in cell ATP.
Danish: Glukoseoptagelsen er især påvirket, hvilket fører til en udtømnng i celle ATP.
English: Only traces of non-metabolised praziquantel are excreted.
Danish: Kun meget små mængder ikke-metaboliseret praziquantel udskilles.
English: There is an almost instantaneous tetanic contraction of the parasite musculature and a rapid vacuolization of the syncytial tegument.
Danish: Der indtræder en næsten øjeblikkelig tetanisk kontraktion af parasittens muskulatur og en hurtig vakuolisering af det syncytiale tegument
English: 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.
Danish: Toleranceundersøgelsen omfattede ikke hvalpe på under 9 uger, men der er ikke grund til antage, at produktet medfører uacceptabel risiko for yngre hvalpe.
English: Any unused product or waste material should be disposed of in accordance with national requirements.
Danish: Eventuelt ubrugt produkt eller affald skal bortskaffes i overensstemmelse med nationale krav.
English: It is these chemical entities which exert the anthelmintic effect by inhibition of tubulin polymerisation.
Danish: Disse kemiske enheder udøver den anthelmintiske effekt ved hæmning af polymerisationen af tubulin.
English: 2, 4, 6, 8 tablets.
Danish: 2, 4, 6, 8 tabletter.
English: ANNEX III
Danish: Bilag III
English: • 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;
Danish: • CVMP gennemgik det produktresumé og den etikettering og indlægsseddel, der var forelagt af indehaveren af markedsføringstilladelsen, og tog alle forelagte data i betragtning,
English: In safety studies, a single dose of 5 times the recommended dose or greater gave rise to occasional vomiting.
Danish: Studier har vist, at en enkeltdosis på 5 gange den anbefalede dosis eller mere, medførte opkastninger.
English: Praziquantel is very rapidly absorbed through the parasite's surface and distributed throughout the parasite.
Danish: Praziquantel absorberes hurtigt gennem parasittens overflade og fordeles jævnt overalt i parasitten.
English: Discussion of the data available
Danish: Diskussion af de foreliggende data
English: It is considered that the claimed efficacy of the product has been adequately substantiated.
Danish: Den påberåbte virkning af produktet anses for at være tilfredsstillende godtgjort.
English: Following absorption, pyrantel pamoate is quickly and almost completely metabolized into inactive metabolites that are excreted rapidly in the urine.
Danish: Efter absorption, omdannes pyrantelpamoat hurtigt og næsten fuldstændigt til inaktive metabolitter, der udskilles i urinen.
English: Do not exceed the stated dose when treating pregnant bitches.
Danish: Den angivne dosis må ikke overskrides ved behandling af drægtige tæver.
English: Member State EU/EEA
Danish: EU/EEA
English: The target parasites have the potential to impact on welfare of individual infected animals.
Danish: Målparasitterne kan potentielt forringe de inficerede dyrs velfærd.
English: This veterinary medicinal product does not require any special storage conditions
Danish: Dette veterinærlægemiddel kræver ingen særlige forholdsregler vedrørende opbevaringen
English: Pharmacotherapeutic group: Anthelmintic, praziquantel combinations.
Danish: Farmakoterapeutisk klassifikation: Anthelmintikum, praziquantel kombinationspræparat.
English: Each tablet contains: Active substances: Praziquantel
Danish: Aktive stoffer: Praziquantel
English: 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.
Danish: In vitro og in vivo studier har vist, at parasittens integument skades alvorligt af praziquantel, hvilket resulterer i kontraktion og paralyse.
English: This product contains anthelmintics active against gastrointestinal roundworms and tapeworms.
Danish: Dette produkt indeholder anthelmintika, der er aktivt imod gastrointestinale rundorme og bændelorme.
English: The combination of praziquantel, pyrantel embonate and febantel is well tolerated in dogs.
Danish: Kombinationen af praziquantel, pyrantelembonat og febantel er veltolereret i hunde.
English: Please refer to package leaflet for disposal advice.
Danish: Der henvises til indlægssedlen for bortskaffelse rådgivning.
English: 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.
Danish: Hvis der er risiko for reinfestation , bør der rådføres med en dyrlæge vedrørende behov og frekvens af gentagen administration.
English: List of the names, pharmaceutical form, strength of the veterinary medicinal products, animal species, route of administration marketing authorisation holder in the Member States.
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform, styrke, dyrearter, indgivelsesvejen, indehaver af markedsføringstilladelse i medlemsstaterne
English: 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..
Danish: Hvis der er risiko for reinfestation, bør der rådføres med en dyrlæge vedrørende behov og frekvens af gentagen administration.
English: Individual blisters composed of 45 µm, soft temper aluminium foil and 25 µm hard temper aluminium foil, containing 2 or 8 tablets.
Danish: Individuelle blisters af 45 µm og bløde sind aluminiumsfolie og 25 µm hærdet aluminiumsfolie, indeholdende 2 eller 8 tabletter
English: This combination shows synergistic activity in the case of hookworms and febantel is effective against T. vulpis.
Danish: Denne kombination udviser synergistisk aktivitet overfor hageorme, og febantel er aktiv imod T. vulpis.
English: Scientific conclusions and grounds for amendment of the summary of product characteristics, labelling and package leaflet
Danish: Videnskabelige konklusioner og begrundelse for ændringen af produktresuméet, etiketteringen og indlægssedlen
English: Concurrent use with other cholinergic compounds can lead to toxicity.
Danish: Samtidig brug af andre kolinerge lægemidler kan have toksisk virkning.
English: 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.
Danish: Individuelle strips af aluminiumsfolie 30 µm/30 gsm ekstruderet polyethylen, indeholdende 2, 4, 6, 8, 10, 12, 14, 16, 18 eller 20 tabletter.
English: 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.
Danish: Endelig blev Chanelle Pharmaceuticals Manufacturing Ltd. anmodet om at fremsætte forslag til en harmoniseret produktinformation og dokumentation for oplysningerne heri.
English: 4.7 Use during pregnancy, lactation or lay
Danish: 4.7 Drægtighed, diegivning eller æglægning
English: 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.
Danish: Produkterne har samme komposition som det godkendte referenceprodukt hvad angår aktive indholdsstoffer, og produkternes påtænkte anvendelsesbetingelser er identiske med referenceproduktets.
English: 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.
Danish: 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.
English: Lactose monohydrate, Microcrystalline cellulose, Magnesium stearate, Colloidal anhydrous silica, Croscarmellose sodium, Sodium laurilsulfate Pork flavour
Danish: Lactosemonohydrat Mikrokrystallinsk cellulose Magnesium stearat Silica, kolloid vandfri Croscarmellosenatrium Natriumlaurilsulfat Smag af svinekød
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: or
Danish: Eller
English: The product is considered to be effective for the treatment of mixed infections by nematodes and cestodes of the following species:
Danish: Produktet anses for at være effektivt til behandling af blandede infestationer med nematoder og cestoder af følgende arter:
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Tapeworm infestation is unlikely in pups less than 6 weeks of age.
Danish: Infestation med bændelorm er usandsynlig hos hvalpe, der er under 6 uger gamle.
English: EXP {month/year} Discard any unused divided tablets.
Danish: EXP{måneder/år} Kassér ubrugte delte tabletter.
English: <PARTICULARS TO APPEAR ON THE OUTER PACKAGE>
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
English: • 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
Danish: • CHMP behandlede produkternes anvendelse til hvalpe under 9 uger og hunde under 2,5 kg,
English: The strips or blisters are packed into cartons containing either 2,4, 6, 8, 10, 12, 14, 16, 18, 20,
Danish: Strips og blistre er pakket i æsker der indeholder enten: 2,4, 6, 8, 10, 12, 14, 16, 18, 20, 24, 28, 30,
English: Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.
Danish: Parasitter kan udvikle resistens overfor en vis gruppe af anthelmintikum som følge af ofte gentaget anvendelse af et anthelmintikum fra denne gruppe
English: 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.
Danish: 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.
English: The spectrum of activity of praziquantel covers all important cestode species in dogs, in particular Taenia spp., Dipylidium caninum, Echinococcus granulosus and Echinococcus multilocularis.
Danish: Praziquantels aktivitetsspektrum dækker alle relevante bændelorme arter fundet i hunde, særligt Taenia spp., Dipylidium caninum, Echinococcus granulosus og Echinococcus multilocularis.
English: 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.
Danish: Af hensyn til god hygiejne, bør personer der administrerer lægemidlet direkte til hunden eller i hundens foder, vaske deres hænder efterfølgende.
English: The product is presented in either:
Danish: Præparatet præsenteres som:
English: These in vitro data confirm that, under the conditions tested, the dissolution profiles are similar for both products.
Danish: Disse in vitro-data viser, at opløsningsprofilerne for de to produkter er ens under de valgte testbetingelser.
English: Grounds for amendment of the summary of product characteristics, labelling and package leaflet
Danish: Begrundelse for ændringen af produktresuméet, etiketteringen og indlægssedlen
English: After absorption, the drug is distributed to all organs.
Danish: Efter absorption fordeles praziquantel i alle organer.
English: Do not use simultaneously with piperazine compounds.
Danish: Må ikke anvendes samtidigt med produkter, der indeholder piperazin.
English: 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.
Danish: Pyrantel i form af pamoatsalt har lav opløselighed, hvilket reducerer absorption i mave-tarmkanalen og medfører, at lægemidlet effektivt kan nå parasitter i tyktarmen.
English: 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.
Danish: Det berørte produkt kan derfor næppe antages at frembyde større risiko end referenceproduktet for måldyrearten.
English: ANNEX I:
Danish: Bilag I
English: Hookworms: Uncinaria stenocephala, Ancylostoma caninum (adults).
Danish: Hageorm: Uncinaria stenocephala, Ancylostoma caninum (voksne).
English: 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.
Danish: 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.
English: Use of the product during pregnancy should be in accordance with a benefit risk assessment by the responsible veterinarian.
Danish: Produktet bør derfor kun bruges under drægtighed, efter den af dyrlægen foretagne analyse af risiko og fordele.
English: Febantel is absorbed relatively rapidly and metabolized to a number of metabolites including fenbendazole and oxfendazole, which have anthelmintic activity.
Danish: Febantel absorberes relativt hurtigt og omdannes til blandt andet fenbendazol og oxfendazol, som udøver anthelmintisk effekt
English: 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.
Danish: 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.
English: 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.
Danish: In vivo-dataene støttes desuden af en sammenligning af opløsningsprofilerne af det berørte produkt og af referenceproduktet Drontal Plus tabletter.
English: Tapeworm infestation is certain to reoccur unless control of intermediate hosts such as fleas, mice, etc. is undertaken.
Danish: Angreb med bændelorm kan indtræffe igen, medmindre der foretages kontrol af mellemværter såsom lopper, mus etc.
English: 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.
Danish: 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.
English: Praziquantel, Febantel, Pyrantel.
Danish: Udfyldes nationalt Praziquantel, Pyrantel, Febantel
English: Praziquantel acts against all adult and immature forms of these parasites.
Danish: Praziquantel er aktivt over for alle udviklingsstadier i disse parasitter.
English: • the CVMP considered the primary scope of the referral regarding efficacy against Echinococcus granulosus and Echinococcus multilocularis;
Danish: • CVMP gennemgik det primære formål med henvisningen vedrørende virkningen mod Echinococcus granulosus og Echinococcus multilocularis,
English: Following administration of the product to dogs, peak plasma concentrations of praziquantel were achieved by approximately 2.5 hours.
Danish: Praziquantels maksimale plasma koncentration i hund blev opnået ca. 2,5 time efter administration.
English: For Animal Treatment Only.
Danish: Kun til dyr.
English: Praziquantel is metabolized into inactive forms in the liver and secreted in bile.
Danish: Praziquantel omdannes til inaktive metabolitter i leveren og udskilles i galden.
English: Not Applicable
Danish: Ikke relevant
English: Do not use in animals with a known sensitivity to the active ingredients or to any of the excipients.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne.