FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of the veterinary medicinal product has not been tested at intervals of less than 2 weeks or in kittens weighing less than 0.6 kg and/or under 7 weeks of age.
Danish: Veterinærlægemidlets sikkerhed er ikke testet med kortere intervaller end 2 uger eller hos killinger, der vejer under 0,6 kg og/eller er yngre end 7 uger.
English: Do not inject, do not administer orally or via any other route.
Danish: Må ikke injiceres, indgives oralt eller administreres på anden måde.
English: Do not use in case of hypersensitivity to the active substances or to any of the excipients.
Danish: Må ikke anvendes i tilfælde af overfølsomhed over for de aktive stoffer eller over for et eller flere af hjælpestofferne.
English: In case of accidental eye exposure, flush the eyes thoroughly with water as the product can cause slight mucous membrane and eye irritation.
Danish: Hvis præparatet ved et uheld kommer i øjnene, skal der skylles omhyggeligt med vand, da præparatet kan forårsage let irritation af slimhinder og øjne.
English: All stages of fleas can infest the cat's basket, bedding and regular resting areas such as carpets and soft furnishings.
Danish: Alle loppestadier kan spredes til dyrets kurv, leje og sædvanlige hvilesteder såsom tæpper og bløde møbler.
English: Fipronil and its metabolite fipronil sulfone act at ligand-gated chloride channels, in particular those gated by the neurotransmitter gamma-aminobutyric acid (GABA) as well as desensitising (D) and nondesensitising (N) channels gated by glutamate (Glu, unique invertebrate ligand-gated chloride channels), thereby blocking pre- and post-synaptic transfer of chloride ions across cell membranes.
Danish: Fipronil og dets metabolit fipronilsulfon virker ved at påvirke de ligand-styrede kloridkanaler, især de, der styres af neurotransmitteren GABA (gamma-aminosmørsyre), såvel de desensibiliserende (D) som de ikkedesensibiliserende (N) kanaler styret af glutamat (Glu, unikke invertebrat ligand-styrede kloridkanaler), hvorved de blokerer den præ- og postsynaptiske overførsel af klorioner over cellemembraner.
English: The product is not for use in kittens weighing less than 0.6 kg and/or under 7 weeks of age.
Danish: Præparatet er ikke beregnet til killinger, der vejer under 0,6 kg og/eller er yngre end 7 uger.
English: Butylhydroxytoluene (E321) 1 mg/ml.
Danish: Butylhydroxytoluen (E321) 1 mg/ml.
English: Select the appropriate applicator size for the weight of the cat.
Danish: Vælg den applikatorstørrelse som passer til kattens vægt.
English: - The product can be used as part of a treatment strategy for the control of flea allergy dermatitis
Danish: - Præparatet kan indgå som led i behandlingen af loppebetinget allergisk dermatit (FAD).
English: - Treatment of infestations with vesical worms (Capillaria plica).
Danish: - Behandling af infestationer med blæreorm (Capillaria plica).
English: The veterinary medicinal product is a spot-on solution for topical use containing the insecticidal and acaricidal active ingredients fipronil (adulticide) and (S)-methoprene (ovicidal and larvicidal), combined with the endectocide eprinomectin and the cestocide praziquantel to complete the broad spectrum with activity against gastrointestinal nematodes, lungworms and tapeworms, and vesical worms.
Danish: Veterinærlægemidlet er en spot-on opløsning til udvortes brug som indeholder de insekticide og acaricide aktive stoffer fipronil (adulticid) og (S)-methopren (ovicid og larvicid), kombineret med eprinomectin, som er et endektocid, og praziquantel, som er et cestocid, for at komplettere den bredspektrede aktivitet mod gastrointestinale nematoder, lungeorm, bændelorm og blæreorm.
English: Tapeworm infestation may reoccur unless control of intermediate hosts such as fleas, mice etc. is undertaken.
Danish: Smitte med bændelorm kan ske igen, med mindre man kontrollerer tilstedeværelsen af mellemværter som bl.a. lopper og mus.
English: 24.9 mg (S)-Methoprene 30.0 mg Eprinomectin 1.20 mg Praziquantel
Danish: 24,9 mg (S)-Methopren 30, 0 mg Eprinomectin 1,20 mg Praziquantel
English: Box, pack sizes of 1, 3, 4, 6 or 15 applicators
Danish: ÆSKE, pakninger med 1, 3, 4, 6 eller 15 applikatorer
English: This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarisation of the nerve or muscle cell, resulting in paralysis and death of the parasite.
Danish: Denne egenskab fører til forøgelse af cellemembranens permeabilitet for kloridioner og dermed en hyperpolarisering af nerve- eller muskelceller, som resulterer i paralyse og drab af parasitterne.
English: In the absence of risk of co-infestation, the use of a narrow spectrum parasiticide should be considered as a first line therapy.
Danish: Hvor der ikke er risiko for blandingsinfestation, bør man som udgangspunkt overveje at anvende et smalspektret antiparasitært middel til behandlingen.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNIT
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER
English: Treatment of infestations with tapeworms (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis , Joyeuxiella pasqualei (adult), and Joyeuxiella fuhrmanni (adult)).
Danish: Cestoder - Behandling af infestationer med bændelorm (Dipylidium caninum, Taenia taeniaeformis, Echinococcus multilocularis, Joyeuxiella pasqualei (voksne) og Joyeuxiella fuhrmanni (voksne)).
English: Digestive tract and/or neurological disorders may result following an accidental oral ingestion of the veterinary medicinal product (see section ‘Special precautions for use in animals' under SPECIAL WARNINGS).
Danish: Symptomer fra fordøjelseskanalen og/eller neurologiske symptomer kan ses efter utilsigtet oral indtagelse af veterinærlægemidlet (se SÆRLIGE ADVARSLER under 'Særlige forholdsregler til brug hos dyr').
English: Part the hair on the midline of the neck, between the base of the skull and the shoulder blades until the skin is visible.
Danish: Del pelsen langs nakkens midterlinje mellem basis af hovedet og skulderbladene, således at huden bliver synlig.
English: Mild and transient neurological signs such as ataxia, disorientation, apathy and pupil dilation may be observed, with spontaneous recovery the day after.
Danish: Der kan observeres milde og forbigående neurologiske symptomer så som ataksi, forvirring, apati og udvidelse af pupillerne, som forsvinder spontant dagen efter.
English: Pull back the plunger slightly, twist and pull off the cap.
Danish: Træk stemplet lidt ud, vrid og træk hætten af.
English: Eprinomectin is a member of the macrocyclic lactone class of endectocides.
Danish: Eprinomectin er et endektocid fra gruppen af makrocykliske laktoner.
English: Although the veterinary medicinal product may be safely administered to cats infected with adult heartworms, no therapeutic effect against adult Dirofilaria immitis has been established.
Danish: Det er sikkert at administrere veterinærlægemidlet til katte, som er smittet med voksne hjerteorm, men der er ikke påvist nogen terapeutisk virkning mod voksne Dirofilaria immitis.
English: However, brief contact of the animal with water on one or two occasions within the month following application is unlikely to significantly reduce its efficacy.
Danish: Det er imidlertid usandsynligt, at virkningen reduceres markant, hvis dyret kommer i kortvarig kontakt med vand én til to gange inden for en måned efter påføringen.
English: Aelurostrongylus abstrusus, L4 larvae and adults of Troglostrongylus brevior).
Danish: Aelurostrongylus abstrusus, L4 larver og voksne stadier af Troglostrongylus brevior).
English: (FAD).
Danish: (ml)
English: Oral ingestion of the veterinary medicinal product resulted in common to uncommon vomiting, hypersalivation and/or in transient neurological signs such as ataxia, disorientation, apathy and pupil dilation in safety studies.
Danish: Oral indtagelse af veterinærlægemidlet resulterede i, at der i almindelige til ualmindelige tilfælde i sikkerhedsstudier sås opkastning, voldsom savlen og/eller forbigående neurologiske symptomer såsom ataksi, forvirring, apati og udvidelse af pupillerne.
English: (S)-methoprene (mg)
Danish: (S)-methopren (mg)
English: Excipient: Butylhydroxytoluene (E321) 1 mg/ml.
Danish: Hjælpestof: Butylhydroxytoluen (E321) 1 mg/ml.
English: For cats with, or at risk from mixed infestations by cestodes, nematodes and ectoparasites.
Danish: Til katte som har eller risikerer at få blandingsinfestationer med bændelorm, rundorm og ektoparasitter.
English: < 2.5 kg 2.5-7.5 kg > 7.5 kg appropriate combination of applicators
Danish: < 2,5 kg 2,5-7,5 kg > 7,5 kg
English: This results in uncontrolled activity of the central nervous system and death of insects or acarians.
Danish: Dette resulterer i en ukontrolleret CNS-aktivitet med deraf følgende drab af insekter og mider.
English: - Treatment of notoedric mange (Notoedres cati).
Danish: - Behandling af skab hos kat (Notoedres cati).
English: Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in invertebrate nerve or muscle cells.
Danish: Denne gruppes forbindelser bindes selektivt og de har en stor affinitet til de glutamatregulerede kloridionkanaler, som forekommer i nerve- og muskelceller hos hvirvelløse dyr.
English: Praziquantel undergoes hepatic metabolism followed by renal excretion.
Danish: Praziquantel gennemgår hepatisk metabolisme og udskilles efterfølgende via nyrerne.
English: Cats <2.5 kg Cats 2.5-7.5 kg
Danish: Kat <2,5 kg Kat 2,5-7,5 kg
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT ELLER BLISTERSTRIPS
English: Elimination of fleas within 24 hours.
Danish: Flåter dræbes inden for 48 timer.
English: The use of the veterinary medicinal product should exclusively be based on the confirmed mixed infestations or significant risk of such mixed infestation with ectoparasites and nematodes (including for heartworm disease prevention) and where concurrent treatment against cestodes is indicated.
Danish: Brugen af veterinærlægemidlet bør udelukkende baseres på bekræftet blandingsinfestation, eller betydelig risiko for blandingsinfestation, med ektoparasitter og nematoder (inkl.
English: In long hair breeds, special attention should be paid to apply the product onto the skin, and not on the hair to ensure optimal efficacy.
Danish: For at opnå optimal virkning ved behandling af langhårede racer skal man være særlig opmærksom på, at præparatet kommer ned på huden og ikke i pelsen.
English: Keep the unused applicator in the intact blister package.
Danish: Opbevar den ubrugte applikator i den ubrudte blisterpakning.
English: Use a pair of scissors to cut the blister along the dotted line, then pull the lid away.
Danish: Klip blisteret op med en saks langs den stiplede linje og træk filmen af.
English: Safety has been demonstrated with up to 5 times the maximum exposure dose (i.e. up to 15 times the recommended dose) in healthy kittens aged 7 weeks and older treated up to 6 times at four-week intervals.
Danish: Killingerne blev behandlet op til 6 gange med op til 5 gange den maksimale dosis (dvs. op til 15 gange den anbefalede dosis) med fire-ugers intervaller.
English: Each unit dose (applicator) delivers: Volume of unit dose (ml)
Danish: Hver applikator indeholder: Indhold pr. applikator (ml)
English: Brief contact of the animal with water within the month following application is unlikely to reduce the efficacy of the product.
Danish: Det er usandsynligt, at præparatets virkning nedsættes hvis dyret er i kortvarig kontakt med vand i måneden efter behandling.
English: - Treatment of infestations with feline lungworms (L3 larvae, L4 larvae and adults of
Danish: - Behandling af infestationer med kattens lungeorm (L3 larver, L4 larver og voksne stadier af
English: Temporary excessive salivation was commonly observed following licking the application site after treatment in clinical trials.
Danish: Det var almindeligt at se midlertidig, voldsom savlen i kliniske studier, hvis katten slikkede på applikationsstedet efter behandling.
English: Muscle tremors have been reported in very rare cases based on post marketing safety experience.
Danish: Efter at præparatet er markedsført, er der i meget sjældne tilfælde rapporteret tilfælde af muskelrysten.
English: infestation may nevertheless harbour a high proportion of juvenile worms, which are not susceptible to the product; therefore a post-treatment follow-up is recommended in case of such infestations.
Danish: infestation kan imidlertid have en høj tilstedeværelse af juvenile orm, som ikke er følsomme for produktet.
English: (S)-Methoprene is also effective in preventing flea larvae and pupae from developing, which prevents contamination of the environment of the treated animals with the immature stages of fleas.
Danish: (S)-methopren er også virksomt ved at forhindre loppelarver og -pupper i at udvikle sig.
English: Cardboard box containing 1, 3, 4, 6 or 15 applicator(s) (0.9 ml each).
Danish: Æske indeholdende 1, 3, 4, 6 eller 15 applikatorer (hver med 0,9 ml).
English: Nematodes - Treatment of infestations with gastrointestinal nematodes (L3, L4 larvae and adults of Toxocara cati, adults of Toxascaris leonina, L4 larvae and adults of Ancylostoma tubaeforme and
Danish: Rundorm - Behandling af infestationer med rundorm (nematoder) i mave-tarmkanalen (L3, L4 larver og voksne stadier af Toxocara cati, voksne stadier af Toxascaris leonina, L4 larver og voksne stadier af Ancylostoma tubaeforme og Ancylostoma ceylanicum samt voksne stadier af Ancylostoma brazilienze).
English: Cardboard box containing 1, 3, 4 or 15 applicator(s) (0.3 ml each).
Danish: Æske indeholdende 1, 3, 4, eller 15 applikatorer (hver med 0,3 ml).
English: The rationale for prescription should be tailored to the individual needs of the cat, based on clinical assessment, the animal's lifestyle and on the local epidemiological situation (including zoonotic risks, where relevant) in order to address exclusively situations of mixed infestations/risk of infestation.
Danish: For at sikre at der kun behandles i tilfælde af /risiko for blandingsinfestation, bør udskrivning tilpasses den enkelte kats behov og være baseret på en klinisk vurdering, dyrets livsstil og på den lokale epidemiologiske status (inkl.
English: However, since the attachment of single ticks after treatment cannot be excluded transmission of infectious diseases cannot be completely ruled out.
Danish: Overførsel af infektiøse lidelser kan imidlertid ikke helt udelukkes, da tilhæftning af enkelte flåter kan forekomme.
English: A temporary clumping or spiking of the hair and mild and transient skin reactions at the application site (itching, hair loss) have been commonly observed at the application site after treatment in clinical studies.
Danish: I kliniske studier var det almindeligt at se midlertidig sammenfiltring af pelsen samt milde og forbigående hudreaktioner på applikationsstedet (kløe, hårtab) efter behandling.
English: PACKAGE LEAFLET: BROADLINE spot-on solution for cats < 2.5 kg BROADLINE spot-on solution for cats 2.5-7.5 kg
Danish: INDLÆGSSEDDEL: BROADLINE spot-on, opløsning til kat <2,5 kg BROADLINE spot-on, opløsning til kat 2,5-7,5 kg
English: BROADLINE spot-on solution for cats <2.5 kg BROADLINE spot-on solution for cats 2.5-7.5 kg
Danish: BROADLINE spot-on opløsning til kat < 2,5 kg BROADLINE spot-on opløsning til kat 2,5-7,5 kg
English: Ancylostoma ceylanicum, and adults of Ancylostoma brazilienze).
Danish: Toxocara cati, voksne stadier af Toxascaris leonina, L4 larver og voksne stadier af Ancylostoma tubaeforme og Ancylostoma ceylanicum samt voksne stadier af Ancylostoma brazilienze).
English: BROADLINE spot-on solution for cats < 2.5 kg BROADLINE spot-on solution for cats 2.5-7.5 kg
Danish: BROADLINE spot-on, opløsning til kat < 2,5 kg BROADLINE spot-on, opløsning til kat fra 2,5-7,5 kg
English: Nematodes - Treatment of infestations with gastrointestinal nematodes (L3, L4 larvae and adults of Toxocara cati, adults of Toxascaris leonina , L4 larvae and adults of Ancylostoma tubaeforme and
Danish: - Behandling af infestationer med kattens lungeorm (L3 larver, L4 larver og voksne stadier af Aelurostrongylus abstrusus, L4 larver og voksne stadier af Troglostrongylus brevior).
English: Mild and transient signs may be observed with spontaneous recovery the day after - see description in section ADVERSE REACTIONS.
Danish: Der kan ses milde og forbigående neurologiske symptomer så som ukoordinerede bevægelser (ataksi), forvirring, apati og udvidelse af pupillerne, som forsvinder spontant dagen efter - se beskrivelse i afsnittet BIVIRKNINGER.
English: Volume of unit dose (ml)
Danish: Indhold pr. applikator (ml)
English: Cardboard box containing 1, 3, 4, 6 or 15 unit dose applicator(s) of 0.9 ml each.
Danish: Æske indeholdende 1, 3, 4 eller 15 dosisapplikatorer à 0,3 ml Æske indeholdende 1, 3, 4, 6 eller 15 dosisapplikatorer à 0,9 ml
English: The full EPAR for Levetiracetam Sun can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Levetiracetam Sun findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: This is a type of epilepsy where too much electrical activity in one side of the brain causes symptoms such as sudden, jerky movements of one part of the body, distorted hearing, sense of smell or vision, numbness, or a sudden sense of fear.
Danish: Det er en form for epilepsi, hvor for stærk elektrisk aktivitet i en side af hjernen giver symptomer som pludselige, sætvise bevægelser af en del af kroppen, forvrænget hørelse, lugt- eller synshallucinationer, følelsesløshed eller pludselig angst.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Levetiracetam Sun on 14 December 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Levetiracetam Sun den 14 december 2011.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levetiracetam Sun.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Levetiracetam Sun.
English: • partial-onset seizures with or without generalisation in patients from four years of age;
Danish: • partielle anfald med eller uden generalisering hos patienter i alderen fire år og opefter
English: It is available as a concentrate that is made up into a solution for infusion (drip into a vein, 100 mg/ml).
Danish: Det leveres som et koncentrat, der anvendes til at lave en opløsning, som bruges til infusion (drop i en blodåre, 100 mg/ml).
English: years of age with juvenile myoclonic epilepsy;
Danish: 12-års alderen med juvenil myoklon epilepsi
English: • primary generalised tonic-clonic seizures (major fits, including loss of consciousness) in patients from 12 years of age with idiopathic generalised epilepsy (the type of epilepsy that is thought to have a genetic cause).
Danish: • primære generaliserede tonisk-kloniske anfald (alvorlige krampeanfald, herunder med bevidsthedstab) hos patienter fra 12-års alderen med idiopatisk generaliseret epilepsi (en form for epilepsi, som menes at have en genetisk årsag).
English: Levetiracetam Sun is used as an alternative for patients when oral treatment is temporarily not feasible.
Danish: Levetiracetam Sun bruges som et alternativ til patienter, når oral behandling midlertidigt ikke kan gennemføres.
English: This is a summary of the European public assessment report (EPAR) for Levetiracetam Sun.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Levetiracetam Sun.
English: The CHMP concluded that, in accordance with EU requirements, Levetiracetam Sun has been shown to have comparable quality and to be bioequivalent to Keppra.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Levetiracetam Sun er af sammenlignelig kvalitet og er bioækvivalent med Keppra.
English: For more information about treatment with Levetiracetam Sun, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Levetiracetam Sun , kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The use of Levetiracetam Sun infusion should be temporary.
Danish: Anvendelse af Levetiracetam Sun infusion bør være en midlertidig løsning.
English: • myoclonic seizures (short, shock-like jerks of a muscle or group of muscles) in patients from 12
Danish: • myoklone anfald (kortvarige, rykvise trækninger i en muskel eller muskelgruppe) hos patienter fra
English: This means that Levetiracetam Sun is similar to a ‘reference medicine' already authorised in the European Union (EU) called Keppra.
Danish: Det betyder, at Levetiracetam Sun er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union, og som hedder Keppra.
English: Levetiracetam Sun is a ‘generic medicine'.
Danish: Levetiracetam Sun er et ‘generisk lægemiddel'.
English: Therefore, the CHMP's view was that, as for Keppra, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Keppra.
English: In patients aged between four and 17 years weighing less than 50 kg, the starting dose is 10 mg per kilogram body weight twice a day, which can be increased up to 30 mg/kg twice a day.
Danish: Hos patienter i alderen mellem 4 og 17 år, som vejer under 50 kg, er startdosis 10 mg pr. kg legemsvægt to gange dagligt, hvilket kan øges til op til 30 mg/kg to gange dagligt.
English: Other information about Levetiracetam Sun
Danish: Andre oplysninger om Levetiracetam Sun
English: EPAR summary for the public levetiracetam
Danish: EPAR sammendrag for offentligheden levetiracetam
English: This helps Levetiracetam Sun to stabilise electrical activity in the brain and prevent seizures.
Danish: På denne måde stabiliserer Levetiracetam Sunden elektriske aktivitet i hjernen og forhindrer anfald.
English: Levetiracetam Sun can be used on its own in patients from 16 years of age with newly diagnosed epilepsy, to treat partial-onset seizures (fits) with or without secondary generalisation.
Danish: Levetiracetam Sun kan uden supplerende behandling anvendes til patienter over 16 år med nydiagnosticeret epilepsi til behandling af partielle anfald med eller uden sekundær generalisering.
English: No additional studies in patients were needed as Levetiracetam Sun is a generic medicine that is given by infusion and contains the same active substance as the reference medicine, Keppra.
Danish: Der krævedes ingen supplerende undersøgelser, eftersom levetiracetam Sun er et generisk lægemiddel, der indgives ved infusion og indeholder det samme aktive stof som referencelægemidlet Keppra.
English: Levetiracetam Sun can also be used as an add-on to other anti-epileptic medicines to treat:
Danish: Levetiracetam Sun kan også anvendes som en tillægsbehandling til andre antiepileptika til behandling af:
English: Because Levetiracetam Sun is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Levetiracetam Sun er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: The active substance in Levetiracetam Sun, levetiracetam, is an anti epileptic medicine.
Danish: Det aktive stof i Levetiracetam Sun, levetiracetam, er et antiepileptikum.
English: The Committee recommended that Levetiracetam Sun be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Levetiracetam Sun.
English: What are the benefits and risks of Levetiracetam Sun?
Danish: Hvilken fordel og risiko er der forbundet med Levetiracetam Sun?