FrancophonIA/ELRC3.0 huggingface dataset:
English: Tablets should be kept in the blister packs until required, and the blisters should be kept in the carton.
Danish: Tabletterne bør opbevares i blisterpakningen, indtil de skal bruges, og blisterpakningen bør opbevares i kartonen.
English: Further information on Nexgard Spectra can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPARs/nexgard-spectra.
Danish: Yderligere oplysninger om Nexgard Spectra findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPARs/nexgard-spectra.
English: In the case of accidental ingestion, particularly in the case of children, medical advice should be sought immediately and the package leaflet or label shown to the doctor.
Danish: Ved utilsigtet indtagelse, særligt hos børn, bør der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: The appropriate strength of tablets should be used according to the dog's weight.
Danish: Den anvendte tabletstyrke skal svare til hundens vægt.
English: The effectiveness of Nexgard Spectra was investigated in both laboratory and field studies.
Danish: Nexgard Spectras effektivitet er undersøgt i både laboratorie- og feltstudier.
English: Because fleas and ticks must start feeding on the dog in order to be killed by the medicine, there may be a risk of transmission of diseases with which they may be infected.
Danish: Da lopper og flåter skal begynde at tage næring fra hunden for at blive dræbt af lægemidlet, kan det ikke udelukkes, at de kan overføre sygdomme, de kan være inficeret med.
English: The European Medicines Agency decided that Nexgard Spectra's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Nexgard Spectra opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: In a field study conducted at sites in Europe where cases of eye worm are known to exist, dogs were confirmed free of eye worm at the start of the study.
Danish: I et feltstudie foretaget på steder i Europa, hvor der vides at forekomme tilfælde af øjenorm, blev det ved studiets start bekræftet, at hundene var fri for øjenorm.
English: Afoxolaner kills fleas before they can lay eggs and so helps to reduce contamination of the dogs' environment.
Danish: Afoxolaner dræber lopper, før de kan lægge æg, og nedsætter derved smitte til hundens omgivelser.
English: A laboratory study involved 20 dogs artificially infected with lungworm larvae.
Danish: Et laboratoriestudie omfattede 20 hunde, der var kunstigt inficeret med lungeormelarver.
English: For demodectic mange, treatment should be repeated monthly until the mange is successfully treated (as confirmed by two negative skin scrapings one month apart) whereas for sarcoptic mange treatment is given monthly for two months, or longer based on clinical signs and skin scrapings.
Danish: Ved demodicoseskab bør behandlingen gentages månedligt, indtil skabet er behandlet med vellykket resultat (som bekræftet ved to negative hudskrabninger med én måneds mellemrum), mens behandlingen ved sarcoptesskab gives månedligt i to måneder, eller længere på baggrund af kliniske tegn og hudskrabninger.
English: Nexgard Spectra (afoxolaner/milbemycin oxime)
Danish: Nexgard Spectra (afoxolaner/milbemycinoxim)
English: For more information about using Nexgard Spectra, see the package leaflet or contact your veterinarian or pharmacist.
Danish: Hvis du ønsker flere oplysninger om anvendelsen af Nexgard Spectra, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: The active substances in Nexgard Spectra work by interfering with the way that signals are passed between nerve cells (neurotransmission) in the nervous system of parasites, resulting in paralysis and death of the parasitic organism.
Danish: De aktive stoffer i Nexgard Spectra virker ved at forstyrre signalerne mellem nervecellerne (neurotransmission) i parasitternes nervesystem, hvorved parasitterne lammes og dør.
English: Other information about Nexgard Spectra
Danish: Andre oplysninger om Nexgard Spectra
English: For prevention of lungworm disease, in areas where infection regularly occurs, and for prevention of eye worm, monthly treatment is given.
Danish: Til forebyggelse af lungeorm i områder, hvor der regelmæssigt forekommer infektion, og til forebyggelse af øjenorm gives behandlingen en gang om måneden.
English: Afoxolaner acts as an ‘ectoparasiticide'.
Danish: Afoxolaner virker som et "ektoparasiticid".
English: All the dogs treated with Nexgard Spectra were free of eye worm at day 180 compared to 43% in the afoxolaner-treated group.
Danish: Alle de hunde, der blev behandlet med Nexgard Spectra, var frie for øjenorm på dag 180 sammenlignet med 43 % i afoxolanergruppen.
English: Flea and tick infestations
Danish: Loppe- og flåtangreb
English: Ten dogs were given Nexgard Spectra and the other 10 were untreated.
Danish: 10 af hundene fik Nexgard Spectra, og de øvrige 10 fik ingen behandling.
English: Nexgard Spectra reduced the number of fleas and ticks by at least 95% and was at least as effective as pyriprole.
Danish: Nexgard Spectra reducerede antallet af lopper og flåter med mindst 95 % og var mindst lige så effektivt som pyriprol.
English: The study showed that Nexgard Spectra was effective in treating flea and tick infestations in dogs for up to 30 days after treatment.
Danish: Studiet viste, at Nexgard Spectra var effektivt til behandling af loppe- og flåtangreb hos hunde i indtil 30 dage efter behandlingen.
English: In order to be exposed to afoxolaner, fleas and ticks must attach to the skin and commence feeding on the dog's blood.
Danish: For at lopper og flåter kan blive udsat for afoxolaner, skal de først hægte sig fast i huden og begynde at tage næring fra hundens blod.
English: Field studies involving 84 dogs in Japan and 320 dogs in the USA, none of which had heartworm before the treatment started, showed that Nexgard Spectra given monthly for six months prevented heartworm infection.
Danish: Feltstudier med 84 hunde i Japan og 320 hunde i USA, hvoraf ingen havde hjerteorm inden behandlingen, viste at Nexgard Spectra givet en gang om måneden i seks måneder forebyggede infektion med hjerteorm.
English: Nexgard Spectra is available as chewable tablets in five different strengths for use in dogs of different weights.
Danish: Nexgard Spectra fås som tyggetabletter i fem forskellige styrker, så de kan anvendes til hunde med forskellig vægt.
English: Why is Nexgard Spectra authorised in the EU?
Danish: Hvorfor er Nexgard Spectra godkendt i EU?
English: An overview of Nexgard Spectra and why it is authorised in the EU
Danish: Oversigt over Nexgard Spectra, og hvorfor det er godkendt i EU
English: Nexgard Spectra contains the active substances afoxolaner and milbemycin oxime.
Danish: Nexgard Spectra indeholder de aktive stoffer afoxolaner og milbemycinoxim.
English: Thirty seven dogs were treated with Nexgard Spectra and 42 dogs were treated with afoxolaner alone, which has no action against eye worm.
Danish: 37 hunde blev behandlet med Nexgard Spectra, og 42 hunde blev behandlet med afoxolaner alene, som ikke virker imod øjenorm.
English: For prevention of heartworm disease, treatment is given monthly during the mosquito season.
Danish: Til forebyggelse af hjerteorm gives behandlingen månedligt i myggesæsonen.
English: The study showed that Nexgard Spectra was effective in reducing gut worms and was at least as effective as the milbemycin oxime and praziquantel.
Danish: Studiet viste, at Nexgard Spectra var effektivt til at reducere indvoldsorm og var mindst lige så effektivt som milbemycinoxim og praziquantel.
English: Nexgard Spectra is a veterinary medicine used to treat infestations with fleas, ticks, as well as demodectic and sarcoptic mange (skin infestations caused by two different types of mites) in dogs when prevention of heartworm disease (caused by a worm that infects the heart and blood vessels and is transmitted by mosquitoes), lungworm disease, eye worm and/or treatment of gut worms (hookworms, roundworms and whipworm) is also required.
Danish: Nexgard Spectra er et lægemiddel til dyr, der anvendes til behandling af angreb med lopper og flåter såvel som demodicose- og sarcoptesskab (skadedyrsangreb i huden forårsaget af to forskellige typer af mider) hos hunde, der desuden behøver forebyggelse af hjerteorm (forårsaget af en orm, der inficerer hjerte og blodkar og overføres af myg), lungeorm, øjenorm og/eller behandling for indvoldsorm (hageorm, rundorm og piskeorm).
English: What is Nexgard Spectra and what is it used for?
Danish: Hvad er Nexgard Spectra, og hvad anvendes det til?
English: Nexgard Spectra reduced the number of live mites by 96% 56 days after starting treatment and by 98% 84 days after starting treatment.
Danish: Nexgard Spectra havde reduceret antallet af levende mider med 96 % 56 dage efter påbegyndelse af behandlingen og med 98 % 84 dage efter påbegyndelse af behandlingen.
English: The most common side effects (affecting inbetween 1 to 10 animals in 1,000 animals) were vomiting, diarrhoea, lack of energy, decreased appetite, and itching, which generally were short-lived and resolved spontaneously.
Danish: De hyppigste bivirkninger ved Nexgard Spectra (som kan optræde hos mellem 1 og 10 dyr ud af 1.000 dyr) var opkastning, diarré, manglende energi, nedsat appetit og kløe.
English: In a field study, 27 dogs with sarcoptic mange were treated with Nexgard Spectra monthly for two months.
Danish: I et feltstudie blev 27 hunde med sarcoptesskab behandlet med Nexgard Spectra en gang om måneden i to måneder.
English: Demodectic mange
Danish: Demodicoseskab
English: Nexgard Spectra reduced worm counts by 95% at 90-92 days after treatment.
Danish: Nexgard Spectra reducerede antallet af orm med 95 % 90-92 dage efter behandling.
English: Nexgard Spectra reduced the number of live mites by 99% 28 days after starting treatment and by 100% 56 days after starting treatment.
Danish: Nexgard Spectra havde reduceret antallet af levende mider med 99% 28 dage efter påbegyndelse af behandlingen og med 100% 56 dage efter påbegyndelse af behandlingen.
English: What are the risks associated with Nexgard Spectra?
Danish: Hvilke risici er der forbundet med Nexgard Spectra?
English: In a field study, 408 dogs with gut worm infections were given either a single treatment with Nexgard Spectra or a medicine containing milbemycin oxime and praziquantel (another medicine for worms).
Danish: I et feltstudie fik 408 hunde med indvoldsorm en enkelt behandling med enten Nexgard Spectra eller et lægemiddel med milbemycinoxim og praziquantel (et andet lægemiddel mod orm).
English: In a field study, 324 dogs with flea and/or tick infestations were given a single treatment with Nexgard Spectra or a spot-on medicine containing another active substance, pyriprole, that controls fleas and ticks.
Danish: I et feltstudie fik 324 hunde, der var angrebet af lopper og/eller flåter, én behandling med Nexgard Spectra eller et spot-on-lægemiddel med et andet aktivt stof, pyriprol, til kontrol af lopper og flåter.
English: Lungworm
Danish: Lungeorm
English: In a field study, 19 dogs with demodectic mange were treated with Nexgard Spectra monthly on three occasions.
Danish: I et feltstudie blev 19 hunde med demodicoseskab behandlet med Nexgard Spectra tre gange med en måneds mellemrum.
English: Heartworm
Danish: Øjenorm
English: Sarcoptic mange
Danish: Sarcoptesskab
English: How is Nexgard Spectra used?
Danish: Hvordan anvendes Nexgard Spectra?
English: How does Nexgard Spectra work?
Danish: Hvordan virker Nexgard Spectra?
English: A single dose of Nexgard Spectra is given to treat gut worms.
Danish: Til behandling af indvoldsorm gives en enkelt dosis Nexgard Spectra.
English: This means that it kills parasites like worms that live inside the body of animals.
Danish: Milbemycinoxim virker som et "endoparasiticid", dvs. det dræber parasitter som orm, der lever inde i dyrets krop.
English: What benefits of Nexgard Spectra have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Nexgard Spectra?
English: Treatment for fleas and ticks should be repeated at monthly intervals during the flea or tick seasons; Nexgard Spectra can be used as part of the seasonal treatment of fleas and ticks in dogs infected with gut worms.
Danish: Nexgard Spectra kan anvendes som en del af sæsonbehandlingen for lopper og flåter hos hunde med indvoldsorm.
English: 3 Conclusions and recommendations
Danish: 3 Konklusioner og anbefalinger
English: A white homogenous paste
Danish: En hvid, homogen pasta
English: However some consideration to this is given on the document that can be summarised as follows:
Danish: Dette punkt er dog i nogen udstrækning behandlet i et dokument, der kan sammenfattes således:
English: Oral Paste.
Danish: Oral pasta.
English: These points were included in the List of Questions that the Committee for Veterinary Medicinal Products adopted on 11 July 2007.
Danish: Disse punkter indgik i den række spørgsmål, som blev vedtaget af Udvalget for Veterinærlægemidler den 11. juli 2007.
English: No risk mitigation measures are considered appropriate.
Danish: Foranstaltninger til risikonedsættelse anses ikke for påkrævet.
English: The product under referral is intended for horses only.
Danish: Det produkt, som indbringelsen vedrører, er udelukkende bestemt til heste.
English: Although oral paste is not used in major species (cattle, sheep, pigs), oral forms exist.
Danish: Skønt oral pasta ikke anvendes i vigtige arter (kvæg, får, svin), findes der orale former.
English: Pursuant to Article 33(4) of Council Directive 2001/82/EC, as amended, the matter has been referred to the CVMP.
Danish: I henhold til artikel 33, stk. 4, i Rådets direktiv 2001/82/EF, med senere ændringer, blev sagen indbragt for CVMP.
English: The referral relates to the concerns raised by Germany that this veterinary medicinal product may present a potential serious risk to public health on the following grounds:
Danish: Indbringelsen vedrører de af Tyskland rejste betænkeligheder ved, at veterinærlægemidlet kan udgøre en alvorlig risiko for menneskers sundhed af følgende grunde:
English: The applicability of the following question of the VICH GL6 was considered:
Danish: Det blev overvejet, om følgende spørgsmål i VICH GL6 er relevant:
English: Oral explanations were heard on 10 October 2007.
Danish: Den mundtlige redegørelse blev fremsat den 10. oktober 2007.
English: • An updated Environmental Risk Assessment
Danish: • En ajourført miljørisikovurdering
English: Ivermectin-containing products are widely used in these species.
Danish: Produkter indeholdende ivermectin finder udstrakt anvendelse hos disse arter.
English: One syringe division of paste per 100 kg body weight (based on a recommended dosage of 200 microgram ivermectin per kg body weight).
Danish: Én inddeling på sprøjten pr. 100 kg legemsvægt (baseret på den anbefalede dosis på 200 mikrogram ivermectin pr. kg. legemsvægt).
English: 2 Information in respect to environmental risk assessment
Danish: 2 Oplysninger vedrørende miljørisikovurderingen
English: Despite this, Step 16 of the Phase I decision tree would indicate that a Phase II assessment is required for a product of this nature i.e. ecto/endoparasiticide for major species.
Danish: På trods heraf synes trin 16 i beslutningstræet i fase I at pege på, at en fase II-vurdering er nødvendig for et produkt af denne art, dvs. et ekto-/endoparasiticid til vigtige arter.
English: The Marketing Authorisation Holder submitted written responses to the List of Questions on 12 September 2007.
Danish: Indehaveren af markedsføringstilladelsen fremsendte en skriftlig besvarelse af spørgsmålene den 12. september 2007.
English: Product
Danish: Produktets
English: The referral procedure started on 11 July 2007.
Danish: Indbringelsesproceduren blev indledt den 11. juli 2007.
English: The Marketing Authorisation Holder provided the following information:
Danish: Indehaveren af markedsføringstilladelsen fremsendte følgende oplysninger:
English: The valid Summary of Product Characteristics, labelling and package leaflet are the final versions achieved at day 90 during the Coordination group procedure.
Danish: De gældende tekster til produktresumé, etikettering og indlægsseddel er de endelige versioner, der er fastlagt ved behandlingen i koordinationsgruppen på dag 90.
English: In addition, he considers that since this is a generic, there will not be an additional risk to the environment.
Danish: Ansøgeren gjorde endvidere gældende, at produktet, eftersom det er generisk, ikke vil udgøre en øget risiko for miljøet.
English: The PEC in soil were calculated for intensively reared animals and pasture animals, according to the CVMP Guideline on Environmental Impact Assessment for Veterinary medicinal Products in Support of the VICH Guidelines GL6 and GL38 (EMEA/CVMP/ERA/418282/2005-corr).
Danish: PEC i jord for intensivt opdrættede dyr og græsædende dyr blev beregnet i henhold til CVMP's "Guideline on Environmental Impact Assessment for Veterinary medicinal Products in Support of the VICH Guidelines GL6 and GL38" (EMEA/CVMP/ERA/418282/2005-corr).
English: An environmental risk was detected during the risk assessment Phase II Tier A for dung fauna organisms.
Danish: Der blev konstateret en miljørisiko i risikovurderingens fase II, trin A, for organismer i gødning.
English: The List of Questions was sent to the Marketing Authorisation Holder.
Danish: Spørgsmålene blev fremsendt til indehaveren af markedsføringstilladelsen.
English: The Netherlands As above
Danish: Nederlandene Som ovenstående
English: The Marketing Authorisation Holder provided an updated environmental risk assessment.
Danish: Indehaveren af markedsføringstilladelsen fremsendte en ajourført miljørisikovurdering.
English: The time frame agreed by the CVMP on 11 July 2007 was 58 days.
Danish: CVMP fastsatte den 11. juli 2007 en tidsramme på 58 dage.
English: PECSOIL- Intensively reared animals = 1.036 µg.kg-1
Danish: PECJORD for intensivt opdrættede dyr = 1,036 µg.kg-1
English: The applicant does not provide a formal justification for exemption of Phase II.
Danish: Ansøgeren gav ingen formel begrundelse for undtagelsen fra fase II.
English: Ecomectin 18.7 mg/g Oral Paste for Horses is intended to be used in horses for the treatment of nematode or arthropod infections caused by Strongylus vulgaris, Strongylus edentatus, Strongylus equinus, Small strongyles (including benzimidazole resistant strains): Cyathostomum spp, Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., Ascarids: Parascaris equorum, Pinworms: Oxyuris equim, Neck threadworms: Onchocerca spp, Stomach bots: Gasterophilus spp
Danish: Ecomectin 18,7 mg/g, oral pasta til heste, er bestemt til behandling af infektioner hos heste med rundorme eller leddyr forårsaget af Strongylus vulgaris, Strongylus edentatus, Strongylus equinus, små strongylider (herunder benzimidazol-resistente stammer): Cyathostomum spp, Cylicocyclus spp., Cylicodontophorus spp., Cylicostephanus spp., Gyalocephalus spp., spolorm: Parascaris equorum, haleorm: Oxyuris equim, filarier: Onchocerca spp.
English: Member State Marketing Authorisation Holder/Applicant
Danish: Medlemsstat Indehaver af markedsføringstilladelse/ansøger
English: • The complete information submitted to the Reference Member State and the CMD(v) in respect to environmental risk assessment.
Danish: • Alle de oplysninger, der var forelagt referencemedlemsstaten og CMD(v) vedrørende miljørisikovurderingen.
English: For two soil exposure scenarios the PECSOIL values did not exceed the 100 µg/kg threshold value as stated in the VICH Guideline for Phase I assessments of veterinary medicines.
Danish: For to jordeksponeringsscenarier oversteg PECJORD ikke den tærskelværdi på 100 µg/kg, der angives i VICH's retningslinjer for fase I-vurdering af veterinære lægemidler.
English: On the basis of the grounds for referral, the points considered by the CVMP were:
Danish: Baseret på begrundelsen for indbringelsen tog CVMP stilling til følgende punkter:
English: Question 4 - Is the VMP intended for use in a minor species that is reared and treated similarly to a major species for which an EIA (Environmental Impact Assessment) already exists?
Danish: Spørgsmål 4 - Er veterinærlægemidlet bestemt til anvendelse i en mindre udbredt art, der opdrættes og behandles på samme måde som en vigtig art, for hvilken der i forvejen foreligger en VVM (vurdering af virkninger på miljøet)?
English: Horses are reared under similar conditions to livestock or, alternatively to housed livestock such as pigs, for which species ivermectin has a well-established use, orally and by other routes of administration.
Danish: Heste opdrættes under betingelser svarende til kvægbesætninger, eller alternativt svarende til besætninger på stald som f.eks. svin, til hvilke arter ivermectin finder almindelig anvendelse såvel ad oral vej som ad andre administrationsveje.
English: The Committee concludes that, since the product is intended for use in a minor species (horses) that is reared and treated similarly to a major species, the conclusions on the Environmental Risk Assessment of the major species apply, the product should be exempt from providing a Phase II assessment and that no risk mitigation measures should be included in the SPC of the product.
Danish: Udvalget konkluderede, at da produktet er bestemt til anvendelse i en mindre udbredt art (hest), som opdrættes og behandles på samme måde som en vigtig art, er konklusionerne i miljørisikovurderingen for vigtige arter gyldige, produktet bør undtages fra fremlæggelse af en fase II-vurdering, og produktresuméet bør ikke indeholde foranstaltninger til risikonedsættelse.
English: 2.1 Updated Environmental Risk Assessment according to the CVMP guidelines on the matter, including any justification for exemption of Phase II
Danish: 2.1 Ajourført miljørisikovurdering i overensstemmelse med CVMP's retningslinjer herfor, herunder eventuel begrundelse for undtagelse fra fase II
English: No adequate data for Tier B were provided by the applicant to assess the long-term effects on dung fauna organisms caused by the use of the product.
Danish: Ansøgeren har ikke forelagt fyldestgørende dokumentation vedrørende trin B til vurdering af produktets langtidsvirkninger på organismer i gødning.
English: Ecomectin 18.7 mg/g Oral Paste for Horses is a generic product and as such an environmental risk assessment is now required under Directive 2001/82, as amended.
Danish: Ecomectin 18,7 mg/g, oral pasta til heste, er et generisk produkt og som sådant nu omfattet af kravet om en miljørisikovurdering i direktiv 2001/82, med senere ændringer.
English: The Marketing Authorisation Holder should discuss and propose, if considered appropriate, possible risk mitigation measures to be included in the SPC of the product.
Danish: Indehaveren af markedsføringstilladelsen skal gennemgå og, hvis det findes hensigtsmæssigt, foreslå mulige risikonedsættende foranstaltninger, som kan indgå i produktresuméet.
English: The applicant considers that the level of use in horses in terms of animal numbers and dose level, compared to other pasture animals (cattle and sheep) is low and that consequently the use in the horse will have limited impact on the environment.
Danish: Ansøgeren finder, at omfanget af anvendelsen, opgjort i antal dyr og dosisstørrelse, er lille for heste i forhold til andre græsædende dyr (kvæg og får) og derfor kun vil have begrænset indvirkning på miljøet.
English: ANNEX I NAME, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, AND MARKETING AUTHORISATION HOLDER/ APPLICANT(S)
Danish: BILAG I LÆGEMIDLETS NAVN, LÆGEMIDDELFORM, STYRKE, DYREARTER, INDGIVELSESVEJ OG INDEHAVERE AF MARKEDSFØRINGSTILLADELSE
English: A separate file for justification of exemption from phase II was not specifically given.
Danish: Der blev ikke forelagt en særskilt begrundelse for undtagelse fra fase II.