FrancophonIA/ELRC3.0 huggingface dataset:
English: The CVMP concluded that the benefits of Zolvix exceed the risks for the approved indications and recommended that Zolvix be given a marketing authorisation.
Danish: CVMP konkluderede, at fordelene ved Zolvix opvejer risiciene, når det anvendes til den godkendte indikation og anbefalede udstedelse af markedsføringstilladelse for Zolvix.
English: Any contaminated clothes should be removed.
Danish: Hvis der spildes på tøjet, skal det tages af.
English: The New Zealand study and some additional studies compared the effectiveness of Zolvix to other anthelmintics.
Danish: I undersøgelsen i New Zealand og andre supplerende undersøgelser sammenlignedes virkningen af Zolvix med andre anthelmintika.
English: In case of accidental spillage onto skin or into eyes, the area should be washed immediately with water.
Danish: Hvis lægemidlet ved et uheld kommer i kontakt med huden eller øjnene, skal det pågældende område straks skylles med vand.
English: Zolvix is effective against a wide range of worm species.
Danish: Zolvix er effektivt imod en lang række ormearter.
English: To help delay the development of resistance, users are advised to check the success of the treatment by examining the sheep's clinical appearance, or by testing whether any parasite eggs can be found in the faeces.
Danish: For at forsinke udvikling af resistens anbefales det, at brugerne holder øje med, hvor godt behandlingen virker, enten ved at undersøge fårets kliniske symptomer eller ved at kontrollere, om der er parasitæg i afføringen.
English: Monepantel blocks part of a receptor, the nicotinic acetylcholine receptor, that is specific to the nematodes.
Danish: Monepantel blokerer en del af en receptor (den nikotinerge acetylkolinreceptor), som er specifik for nematoderne.
English: The studies showed that Zolvix is effective against infections of all of the major gastrointestinal nematodes, including effectiveness against strains of parasites resistant to the currently available broad-spectrum anthelmintics.
Danish: Undersøgelserne viste, at Zolvix er effektivt til at bekæmpe infektioner af alle de mest almindelige gastrointestinale nematoder, herunder også til parasitstammer, som er resistente over for de allerede eksisterende bredspektrede anthelmintika.
English: Zolvix is not authorised for use in lactating animals producing milk for human consumption.
Danish: Zolvix er ikke godkendt til anvendelse hos lakterende dyr, hvis mælk er beregnet til menneskeligt konsum.
English: Zolvix is used for the treatment and control of worm infections of the gut and associated diseases in sheep.
Danish: Zolvix anvendes til behandling og kontrol af ormeinfektioner i mave-tarmkanalen og tilknyttede sygdomme hos får.
English: In case of accidental ingestion medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Danish: I tilfælde af utilsigtet indtagelse skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: This causes paralysis and death of the worms.
Danish: Dette bevirker, at ormene lammes og dør.
English: What is the risk associated with Zolvix?
Danish: Hvilken risiko er der forbundet med Zolvix?
English: Why has Zolvix been approved?
Danish: Hvorfor blev Zolvix godkendt?
English: Helminths, also known as nematodes, are worm-like parasites that live in the gut of animals.
Danish: Helminter, også kaldet nematoder, er ormelignende parasitter, som lever i dyrs mave-tarmkanal.
English: In the studies, the effectiveness of Zolvix was measured by looking for parasite eggs in the sheep faeces at different time points during the trials.
Danish: I begge undersøgelser blev virkningen af Zolvix målt på baggrund af mængden af parasitæg i fårenes afføring på forskellige tidspunkter i løbet af undersøgelsen.
English: What is Zolvix?
Danish: Hvad er Zolvix?
English: Users who are administering this medicine to sheep should wear protective gloves.
Danish: Brugeren bør ved indgivelsen af lægemidlet anvende beskyttelseshandsker.
English: Monepantel is effective against nematodes resistant to other anthelmintics.
Danish: Monepantel virker på nematoder, som er resistente over for andre anthelmintika.
English: Monepantel, is an anthelmintic, a substance that is active against helminths.
Danish: Monepantel er et anthelmintikum, dvs. et stof, som er aktivt over for helminter.
English: What is Zolvix used for?
Danish: Hvad anvendes Zolvix til?
English: How has Zolvix been studied?
Danish: Hvordan blev Zolvix undersøgt?
English: How does Zolvix work?
Danish: Hvordan virker Zolvix?
English: What benefit has Zolvix shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Zolvix?
English: CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Danish: BILAG IV KONKLUSIONER VEDRØRENDE UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE UNDER BETINGEDE OMSTÆNDIGHEDER FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR
English: Store below 30 °C.
Danish: Opbevares under 30°C.
English: Date of first authorisation: 17/09/2019
Danish: Dato for første markedsføringstilladelse: 17/09/2019
English: Method of administration Tablets can be administered with or without food.
Danish: Anvendelsesmåde Tabletter kan administreres med eller uden føde.
English: 1 tablet 3 tablets 6 tablets
Danish: 1 tablet 3 tabletter 6 tabletter
English: ATC vet code: QP54AB52.
Danish: ATCvet-kode: QP54AB52
English: If the tablet is not taken up voluntarily by the dog it can also be given with food or directly into the mouth.
Danish: Hvis hunden ikke tager tabletten frivilligt, kan den også gives sammen med foderet eller direkte i munden.
English: Butylhydroxytoluene (E321, 0.018%).
Danish: Butylhydroxytoluen (E321, 0,018%).
English: Each tablet strength is available in pack sizes of 1, 3 or 6 tablets.
Danish: Tabletter i den enkelte styrke fås i pakningsstørrelser af 1, 3 og 6 tabletter.
English: Only negative animals should be treated.
Danish: Kun dyr, hvis resultater er negative, må behandles.
English: The use in these animals is not recommended.
Danish: Det anbefales ikke at bruge lægemidlet til disse dyr.
English: It is recommended that heartworm prevention treatment should be continued until at least 1 month after the last exposure to mosquitoes.
Danish: Det anbefales at fortsætte behandling til forebyggelse af hjerteorm mindst 1 måned efter sidste eksponering for myggene.
English: In the absence of available data, treatment of puppies less than 8 weeks of age and/or dogs less than 1.25 kg bodyweight should be based on a benefit-risk assessment by the responsible veterinarian.
Danish: Som følge af manglen på tilgængelige data bør behandling af hvalpe, der er under 8 uger gamle, og/eller hunde med en kropsvægt på mindre end 1,25 kg baseres på en benefit-risk-vurdering af den ansvarlige dyrlæge.
English: For dogs with, or at risk from, mixed external and internal parasitic infestations.
Danish: Til hunde, der har været eller risikerer at blive udsat for blandede eksterne og interne parasitære angreb.
English: To prevent children from accessing the product, only one chewable tablet at a time should be removed from the blister pack and only when required.
Danish: For at forhindre børn i at få adgang til produktet, må der kun fjernes en tyggetablet ad gangen fra blisterpakningen, og kun når det er nødvendigt.
English: Macrocyclic lactones including moxidectin have been shown to be substrates for p-glycoprotein.
Danish: Makrocykliske laktoner, herunder moxidectin, har vist sig at være substrater for p-glykoprotein.
English: Gastrointestinal nematodes
Danish: Gastrointestinale nematoder
English: Sarolaner is an acaricide and insecticide belonging to the isoxazoline family.
Danish: Sarolaner er et acaricid og insekticid tilhørende isoxazolin-familien.
English: Therefore, the use of this product should be based on the assessment of each individual case and on local epidemiological information about the current susceptibility of the target species in order to limit the possibility of a future selection for resistance.
Danish: Dette produkt skal således anvendes på basis af en vurdering af hvert enkelt tilfælde og lokale epidemiologiske oplysninger om den aktuelle risiko for den dyrearter, som lægemidlet er beregnet til, for at begrænse risikoen for fremtidig resistens.
English: Maintenance of the efficacy of macrocyclic lactones is critical for Dirofilaria immitis control.
Danish: Opretholdelse af virkningen af makrocykliske laktoner er kritisk for at sikre kontrol over Dirofilaria immitis.
English: No adverse reactions were observed in 8-weeks old healthy puppies administered with up to 5 times the maximum recommended dose for 7 consecutive monthly administrations.
Danish: Der blev ikke observeret bivirkninger hos 8-uger gamle, sunde hvalpe, der fik en dosis på op til 5 gange den maksimalt anbefalede dosis i 7 på hinanden følgende måneder.
English: Colorants: Sunset Yellow FCF (E110), Allura Red (E129), Indigo Carmine (E132).
Danish: Farvestoffer: Sunset Yellow FCF (E110), Allura Red (E129), Indigotin (E132).
English: However, accidental administration to dogs infected with adult heartworms should not pose safety concerns.
Danish: Utilsigtet administration af veterinærlægemidlet til hunde, der er inficeret med voksne hjerteorm, burde ikke give anledning til overvejelser om sikkerheden.
English: Pyrantel embonate is poorly absorbed and the absorbed portion has a tmax of 1.5 hours and half-life of 7.7 hours.
Danish: Pyrantelembonat absorberes dårligt, og de absorberede mængder har en tmaks på 1,5 time og en halveringstid på 7,7 timer.
English: − Uncinaria stenocephala adults.
Danish: − Uncinaria stenocephala voksne.
English: To minimise the risk of resistance selection, it is recommended that dogs should be checked for both circulating antigens and blood microfilariae at the beginning of each season of preventative treatment.
Danish: For at minimere risikoen for resistensselektion anbefales det, at hunde ved starten af hver sæson for forebyggende behandling kontrolleres både for cirkulerende antigener og mikrofilarier i blodet.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på den ydre emballage og blisterpakningen efter “EXP”.
English: However, in such sensitive breeds (which may include, but not necessarily limited to, Collies and related breeds), the recommended dose should be strictly observed.
Danish: Dog i sådanne følsomme racer (som kan omfatte, men ikke nødvendigvis er begrænset til collier og lignende racer), den anbefalede dosis skal overholdes nøje.
English: pyrantel (as embonate) (mg)
Danish: pyrantel (som embonat) (mg)
English: Hydrolysed vegetable protein Gelatin
Danish: Frysetørret vegetabilsk protein Gelatine
English: This results in flaccid paralysis and eventual death of parasites exposed to the drug.
Danish: Dette medfører paralyse og til sidst død hos de parasitter, der eksponeres for lægemidlet.
English: Pharmacotherapeutic group: antiparasitic products, moxidectin combinations.
Danish: Farmakoterapeutisk gruppe: parasitbekæmpende midler, kombinationer af moxidectin.
English: Manufacturer responsible for batch release: Corden Pharma GmbH Otto-Hahn-Str., Plankstadt 68723 Baden-Wuerttemberg GERMANY
Danish: Fremstiller ansvarlig for batchfrigivelse: Corden Pharma GmbH Otto-Hahn-Str., Plankstadt 68723 Baden-Wuerttemberg TYSKLAND
English: − The veterinary medicinal product can be used as part of a treatment strategy for the control of flea allergy dermatitis (FAD).
Danish: − Veterinærlægemidlet kan indgå i en behandlingsstrategi til kontrol af loppeallergi-dermatitis (Flea Allergy Dermatitis - FAD).
English: In particular, both active substances contribute to the overall efficacy against the gastrointestinal nematodes Ancylostoma caninum and Toxocara canis.
Danish: Begge aktive stoffer bidrager især til den samlede virkning mod de gastrointestinale nematoder Ancylostoma caninum og Toxocara canis.
English: Moxidectin is a second-generation macrocyclic lactone of the milbemycin family.
Danish: Moxidectin er en anden generations makrocyklisk lakton tilhørende milbemycin-gruppen.
English: Pyrantel is eliminated through faeces and the small absorbed portion is eliminated mainly via urine.
Danish: Pyrantel udskilles via fæces, og den lille absorberede mængde udskilles hovedsageligt i urinen.
English: In this fixed combination, moxidectin and pyrantel provide complementary anthelmintic efficacy through distinct mechanisms of action.
Danish: I denne faste kombination bidrager moxidectin og pyrantel med en komplimenterende, anthelmintisk virkning i kraft af en bestemt virkningsmekanisme.
English: Dogs in areas endemic for heartworm (or those which have travelled to endemic areas) may be infected with adult heartworms.
Danish: Hunde i områder med naturlig forekomst af hjerteorm (eller som har besøgt disse områder) kan være inficeret med voksne hjerteorm.
English: In a laboratory study, the product was well tolerated in dogs with a deficient multidrug-resistanceprotein 1 (MDR1 -/-) following single oral administration at 3 times the recommended dose.
Danish: I en laboratorieundersøgelse blev produktet tolereret godt hos hunde med defekt multidrugresistensprotein 1 (MDR1 - / -) efter enkelt oral indgivelse ved 3 gange den anbefalede dosis.
English: The veterinary medicinal product has immediate and persistent flea killing activity against new infestations for 5 weeks;
Danish: Veterinærlægemidlet har en øjeblikkelig og vedvarende dræbende virkning mod nye angreb af lopper i 5 uger.
English: The tablets are packaged in aluminium foil/foil blisters packaged into an outer carton box.
Danish: Tabletterne er pakket i aluminiumsfolie/blisterpakning i aluminiumsfolie i en kartonæske.
English: The product was well tolerated in dogs with a deficient multidrug-resistance-protein 1 (MDR1 -/-).
Danish: Lægemidlet tåles godt af hunde med en MDR1-defekt (multidrug-resistance-protein, MDR1 -/-).
English: Pyrantel is a nicotinic acetylcholine (ACh) channel receptor (nAChR) agonist.
Danish: Pyrantel er en nikotinlignende acetylkolin (ACh) kanalreceptoragonist (nAChR).
English: In the absence of the risk of mixed co-infestation, a narrower spectrum parasiticide should be used.
Danish: Ved fravær af risikoen for flere samtidige angreb skal der anvendes et mere smalspektret parasitdræbende middel.
English: − For the prevention of heartworm disease (Dirofilaria immitis);
Danish: − Til forebyggelse mod hjerteorm (Dirofilaria immitis)
English: After a single administration of 5 times the maximum recommended dose to this sensitive dog breed, transient ataxia and/or muscle fasciculation were observed.
Danish: Efter en enkelt indgivelse af 5 gange den maksimale anbefalede dosis til denne følsomme hunderacer blev der observeret forbigående ataksi og / eller muskelfasciculation.
English: When the product replaces another lungworm or heartworm preventive product, the first dose of the product should be given within a month of the last dose of the former veterinary medicinal product.
Danish: Hvis produktet erstatter et andet præparat til forebyggelse af lungeorm eller hjerteorm, skal første dosis af produktet gives senest 1 måned efter den sidste dosis af det tidligere veterinærlægemiddel.
English: Therefore, during treatment with the veterinary medicinal product, other products that can inhibit pglycoprotein (e.g. cyclosporine, ketoconazole, spinosad, verapamil) should only be used concomitantly according to the benefit-risk assessment of the responsible veterinarian.
Danish: I forbindelse med behandling med veterinærmidlet må andre præparater, der kan hæmme p-glykoprotein (f.eks. cyklosporin, ketoconazol, spinosad, verapamil), bør bruges samtidig kun i henhold til den ansvarlige dyrlæges vurdering af fordele og ulemper.
English: Simparica Trio chewable tablets sarolaner (mg)
Danish: Simparica Trio tyggetabletter sarolaner (mg)
English: Ticks on the animal prior to administration or from new infestations after product administration are killed within 48 hours.
Danish: Flåter, der forefindes på hunden, før den får produktet, eller som stammer fra nye angreb efter administration af produktet, dør i løbet af 48 timer.
English: A single treatment is efficacious for the treatment of gastrointestinal nematodes.
Danish: En enkelt behandling er tilstrækkelig til behandling af gastrointestinale nematoder.
English: After treatment of the nematode infections, further flea and tick treatment should be continued with a mono-active product.
Danish: Efter behandling af en nematodeinfektion skal yderligere behandling mod lopper og flåter fortsættes med et specifikt produkt.
English: Butylhydroxytoluene (E321) Pigment blend 018 (E110, E129, E132) Hydroxypropylcellulose Silica, colloidal anhydrous Magnesium stearate Maize starch
Danish: Butylhydroxytoluen (E321) Pigmentblanding 018 (E110, E129, E132) Hydroxypropylcellulose Silica, kolloid vandfri Magnesiumstearat
English: This interference leads to the opening of the chloride channels on the postsynaptic junction to allow the inflow of chloride ions.
Danish: Denne indgriben medfører åbning af kloridkanalerne på den postsynaptiske samling for at muliggøre tilførsel af kloridioner.
English: For fleas, the onset of efficacy is within 12 to 24 hours of attachment for five weeks after product administration.
Danish: Virkningen indtræffer for lopper inden for 12-24 timer, efter de har bidt sig fast, og fortsætter i 5 uger efter administration af produktet.
English: Sarolaner is readily and rapidly absorbed systemically following oral dosing, reaching maximum concentrations in plasma within 3.5 hours (tmax) after administration with a high bioavailability of 86.7%.
Danish: Sarolaner absorberedes hurtigt og nemt systemisk efter oral indtagelse og når maksimumkoncentrationen i plasma i løbet af 3,5 timer (tmaks) efter administration, med en høj biotilgængelighed på 86,7 %.
English: − For the treatment of flea infestations (Ctenocephalides felis and Ctenocephalides canis).
Danish: − Til behandling af loppeangreb (Ctenocephalides felis og Ctenocephalides canis).
English: The veterinary medicinal product kills newly emerged fleas on the dog before they can lay eggs and therefore it prevents environmental flea contamination in areas to which the dog has access.
Danish: Veterinærlægemidlet dræber nye lopper på hunden, før de kan lægge æg, og forhindrer således spredning af lopperne til de områder, hvor hunden færdes.
English: Tablet is debossed with the sarolaner strength on one face of the tablet.
Danish: Styrken (sarolaner) er præget ind i den ene side af tabletten.
English: In case of accidental ingestion, seek medical advice immediately and show the package leaflet or label to the physician.
Danish: I tilfælde af indtagelse ved et uheld skal der straks søges lægehjælp, og indlægssedlen eller etiketten vises til lægen.
English: Its principal mode of action is interfering with neuromuscular transmission at the level of the glutamate-gated chloride channels and, to a lesser extent, of GABA (gamma amino butyric acid)-gated channels.
Danish: Moxidectin virker hovedsageligt ved at gribe ind i den neuromuskulære transmission på niveau med de glutamatstyrede kloridkanaler og i mindre grad de GABA-styrede kanaler (Gamma Amino Butyric Acid).
English: Following receptor binding, the channel opens to allow the influx of cations resulting in a depolarization and excitatory effects on nematode muscle, ultimately leading to spastic paralysis of the worm and death.
Danish: Efter receptorbinding åbnes kanalen for at lade kationer flyde ind, hvilket medfører depolarisering og excitatorisk påvirkning af nematodens muskler og i sidste ende spastisk paralyse af ormen og død.
English: In endemic areas, dogs should receive lungworm and/or heartworm preventive treatments at monthly intervals.
Danish: I områder med naturlig forekomst af lunge- og/eller hjerteorm skal hunde behandles forebyggende med månedlige intervaller.
English: A reddish-brown colored, pentagon shaped tablet with rounded edges.
Danish: En rødbrun, femkantet tablet med afrundede hjørner.
English: A single administration also prevents lungworm disease (by reducing the immature adults (L5) of A. vasorum) and heartworm disease (D. immitis) for one month.
Danish: En enkelt behandling hindrer også lungeorm i 1 måned (ved at reducere antallet af uudviklede voksne (L5) A. vasorum) og hjerteorm (D. immitis).
English: Moxidectin is readily and rapidly absorbed systemically following oral dosing, reaching maximum concentrations in plasma within 2.4 hours (tmax) after administration and with 66.9% bioavailability.
Danish: Moxidectin absorberes hurtigt og nemt systemisk efter oral indtagelse og når maksimumkoncentrationen i plasma i løbet af 2,4 timer (tmaks) efter administration, med en biotilgængelighed på 66,9 %.
English: The prandial state of the dogs does not affect the extent of absorption of sarolaner and moxidectin.
Danish: Om hunden indtager lægemidlet med eller uden mad påvirker ikke omfanget af absorberingen af sarolaner og moxidectin.
English: The veterinary medicinal product has immediate and persistent tick killing activity for 5 weeks against Ixodes hexagonus, Ixodes ricinus and Rhipicephalus sanguineus and for 4 weeks against Dermacentor reticulatus;
Danish: Veterinærlægemidlet har en øjeblikkelig og vedvarende dræbende virkning i 5 uger mod flåtarterne Ixodes hexagonus, Ixodes ricinus og Rhipicephalus sanguineus og i 4 uger mod Dermacentor reticulatus.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS BLISTERPAKNING
English: Prevention of heartworm disease and angiostrongylosis:
Danish: Forebyggelse mod hjerteorm og angiostrongylose:
English: The safety of the veterinary medicinal product has not been established during pregnancy and lactation or in dogs intended for breeding.
Danish: Lægemidlets sikkerhed under drægtighed og laktation er ikke fastlagt; heller ikke for dyr, der er beregnet til avl.
English: Pyrantel mimics the agonist effects of ACh through high affinity binding to subtype specific ionophoric nAChRs in nematodes, while not binding at muscarinic mAChRs.
Danish: Pyrantel efterligner den agonistiske virkning ved ACh takket være en kraftig tilbøjelighed til at binde sig til subtypiske specifikke ionforiske mAChR'er i nematoder, men ikke til muskariniske mAChR'er.
English: The blister pack should then be returned into the carton immediately after use and the carton should be stored out of the sight and reach of children.
Danish: Blisterpakningen skal derefter straks efter brug lægges tilbage i æsken, som opbevares utilgængeligt for børn.
English: The accidental ingestion of the product may potentially result in adverse effects, such as transient excitatory neurological signs.
Danish: Utilsigtet indtagelse af produktet kan medføre bivirkninger som f.eks. forbigående forstærkede neurologiske symptomer.
English: Sarolaner blocks GABA- and glutamate-gated chloride channels in the central nervous system of insects and acarines.
Danish: Sarolaner blokerer for GABA- og de glutamat-styrede kloridkanaler i centralnervesystemet hos insekter og acariner.
English: Calcium hydrogen phosphate anhydrous
Danish: Calciumhydrogenphosphat, vandfri
English: − For the treatment of tick infestations.
Danish: − Til behandling af flåtangreb.
English: Treatment of flea and tick infestations and gastrointestinal nematodes:
Danish: Behandling af loppe- og flåtangreb og gastrointestinale nematoder:
English: The veterinary medicinal product should be administered at a dose of 1.2-2.4 mg/kg of sarolaner, 0.024-0.048 mg/kg of moxidectin and 5-10 mg/kg of pyrantel in accordance with the following table:
Danish: Veterinærlægemidlet skal administreres i doser af 1,2-2,4 mg/kg legemsvægt sarolaner, 0,0240,048 mg/kg moxidectin og 5-10 mg/kg pyrantel i henhold til følgende tabel:
English: − Ancylostoma caninum L4 larvae, immature adults (L5) and adults;
Danish: − Ancylostoma caninum L4 larver, uudviklede voksne (L5) og voksne