FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequency of adverse reactions is defined using the following convention: - very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (flere end 1 ud af 10 behandlede dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (flere end 1, men færre end 10 dyr af 100 behandlede dyr) - Ikke almindelige (flere end 1, men færre end 10 dyr af 1000 behandlede dyr) - Sjældne (flere end 1, men færre end 10 dyr ud af 10 000 behandlede dyr) - Meget sjælden (færre end 1 dyr ud af 10 000 behandlede dyr, herunder isolerede rapporter)
English: Anxiolytic drugs acting at the benzodiazepine receptor site, such as imepitoin, may lead to disinhibition of fear-based behaviours.
Danish: Anxiolytika, som virker på benzodiazepinreceptorerne, f.eks. imepitoin, kan føre til disinhibering af frygtbaseret adfærd.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN
English: Bioavailability is greater when administered to fasted dogs.
Danish: Biotilgængeligheden er større hos fastende hunde.
English: Please refer to section 4.6 of the SPC for further details of adverse reactions.
Danish: Der henvises til punkt 4.6 i produktresumeet for yderligere oplysninger om bivirkninger.
English: White, oblong, half-scored tablets with embedded logo “I 01” (100 mg) or “I 02” (400 mg) on one side.
Danish: Hvide, aflange tabletter med delekærv og indsat logo “I 01” (100 mg) eller “I 02” (400 mg) på den ene side.
English: Imepitoin also inhibits seizures via potentiation of the GABAA receptor-mediated inhibitory effects on the neurons and in addition, imepitoin has a weak calcium channel blocking effect which may contribute to its anticonvulsive properties.
Danish: Imepitoin hæmmer også anfald via potensering af de GABAA receptor-medierede hæmmende virkninger på neuronerne, og imepitoin fungerer desuden som en svag calciumkanalblokker, hvilket kan bidrage til dets antikonvulsive egenskaber.
English: Co-administration of imepitoin tablets with food, reduces the total AUC by 30% but produces no significant change in Tmax and Cmax.
Danish: Samtidig adminstrering af imepitoin-tabletter med foder reducerer det totale AUC med 30%, men giver ingen væsentlig ændring i Tmax og Cmax.
English: Efficacy for reduction of anxiety and fear associated with noise phobia has not been tested in dogs younger than 12 months.
Danish: Effekten på reduktion af angst og frygt associeret med støjfobi er ikke afprøvet hos hunde på under 12 måneder.
English: Clinical trials in epilepsy
Danish: Kliniske forsøg med epilepsi
English: The required dose will vary between dogs and will depend on the severity of the disorder.
Danish: Den nødvendige dosis varierer fra hund til hund og afhænger af sygdommens sværhedsgrad.
English: For this reason, careful consideration should be given before deciding to switch a stabilized dog onto imepitoin from a different treatment.
Danish: Derfor bør det overvejes nøje, inden der træffes afgørelse om at skifte behandling til imepitoin på en stabiliseret hund i anden behandling.
English: Mild behavioural or muscular signs may be observed in dogs upon abrupt termination of treatment with imepitoin.
Danish: Milde adfærdsmæssige eller muskulære symptomer kan ses ved hunde med brat ophør af behandling med imepitoin.
English: A slight increase in creatinine values compared to baseline was observed in the imepitoin-treated dogs.
Danish: En lille stigning i kreatinin-værdier sammenlignet med startværdi blev observeret i de imepitoin-behandlede hunde.
English: In dogs with a history of aggression problems, a careful benefit-risk evaluation should be made prior to treatment.
Danish: Hos hunde med tidligere aggressionsproblemer skal der foretages en grundig benefit-risk-vurdering før behandling.
English: Should seizures not be adequately controlled, further diagnostic measures and other antiepileptic treatment should be considered.
Danish: Hvis anfald ikke er tilstrækkelig under kontrol, bør yderligere diagnostiske foranstaltninger samt anden antiepileptisk behandling overvejes.
English: At 5 times the recommended dose, decreased bodyweight may be observed.
Danish: Ved 5 gange den anbefalede dosis, kan der ses nedsat kropsvægt.
English: If seizures are not adequately reduced following a minimum of 1 week of treatment at the current dose the supervising veterinary surgeon should re-assess the dog.
Danish: Hvis ikke anfaldsfrekvensen er tilfredsstillende nedsat efter minimum 1 uges behandling med den aktuelle dosis, bør den tilsynsførende dyrlæge revurdere hunden.
English: No loss of anticonvulsant efficacy (tolerance development) during continuous treatment of 4 weeks was observed in experimental studies lasting 4 weeks.
Danish: Der er ikke observeret tab af krampestillende virkning (toleranceudvikling) ved kontinuerlig behandling i 4 uger i de eksperimentelle undersøgelser af fire ugers varighed.
English: The majority of imepitoin and its metabolites are excreted via the faecal route rather than the urinary route so that no major change in pharmacokinetics and no accumulation is expected in renally impaired dogs.
Danish: Størstedelen af imepitoin og dets metabolitter udskilles i højere grad via fæces end via urinvejene, så der forventes ingen væsentlig ændring i farmakokinetikken og ingen akkumulation hos nyresvækkede hunde.
English: For the reduction of anxiety and fear associated with noise phobia in dogs.
Danish: Til reduktion af angst og frygt i forbindelse med støjfobi hos hunde.
English: Here it acts as a low affinity partial agonist of the benzodiazepine receptor.
Danish: Her virker den som en partiel benzodiazepinreceptoragonist med lav affinitet.
English: During the evaluation phase of 12 weeks, the proportion of generalised seizure-free dogs was 47% (30 dogs) in the imepitoin group and 58% (51 dogs) in the phenobarbital group.
Danish: Under evalueringsfasen på 12 uger var andelen af generelt anfaldsfrie hunde 47% (30 hunde) i imepitoin-gruppen og 58% (51 hunde) i phenobarbital-gruppen.
English: EU/2/12/147/001 100 tablets (100 mg) EU/2/12/147/002 250 tablets (100 mg) EU/2/12/147/003 100 tablets (400 mg) EU/2/12/147/004 250 tablets (400 mg) EU/2/12/147/005 30 tablets (400 mg) EU/2/12/147/006 30 tablets (100 mg)
Danish: EU/2/12/147/001 100 tabletter (100 mg) EU/2/12/147/002 250 tabletter (100 mg) EU/2/12/147/003 100 tabletter (400 mg) EU/2/12/147/004 250 tabletter (400 mg) EU/2/12/147/005 30 tabletter (400 mg) EU/2/12/147/006 30 tabletter (100 mg)
English: To prevent accidental ingestion of tablets, the cap of the bottle should be replaced immediately after withdrawing the required number of tablets for one administration.
Danish: For at forhindre utilsigtet indtag af tabletter, bør låget sættes på flasken umiddelbart efter det nødvendige antal tabletter for én administrering, er taget ud.
English: After oral administration of imepitoin tablets at 30 mg/kg without food, peak blood concentrations are attained rapidly with a Tmax of around 2 hours, a Cmax of about 18 µg/ml.
Danish: Efter oral administrering af imepitointabletter på 30 mg/kg uden foder, opnås peak-blodkoncentrationerne hurtigt med en Tmax på ca. 2 timer, en Cmax på ca. 18 µg/ml.
English: They may also be present during the preictal or postictal period or as behaviour changes which occur as part of the disease itself.
Danish: De kan også ses i den præiktale eller postiktale fase (tiden umiddelbart før eller efter et anfald), eller som adfærdsændringer, der forekommer som en del af sygdommen.
English: In case of accidental ingestion especially by a child, seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: I tilfælde af at især et barn utilsigtet indtager tabletter, skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
English: Bottle of 30, 100 or 250 tablets.
Danish: Flaske med 30, 100 eller 250 tabletter.
English: The difference between imepitoin and phenobarbital groups in the seizure frequency per month after treatment (adjusted for baseline difference) was 0.004, 95% CI [-0.928, 0.935].
Danish: Forskellen mellem imepitoin- og phenobarbitalgrupperne i anfaldsfrekvens pr. måned efter behandling (justeret for forskel i startværdi) var 0.004, 95% CI [-0.928, 0.935].
English: Some dogs will be free of seizures, in other dogs a reduction of the number of seizures will be observed, whilst others will be non-responders.
Danish: Nogle hunde vil blive fri for anfald, hos andre hunde kan observeres en reduktion i antallet af anfald, mens andre igen ikke vil respondere.
English: At such doses, the symptoms are not usually life threatening and generally resolve within 24 hours if symptomatic treatment is given.
Danish: Ved sådanne doser er symptomerne normalt ikke livstruende, og de forsvinder generelt inden for 24 timer, hvis der gives symptomatisk behandling.
English: In the remaining dogs (64 dogs for Pexion and 88 dogs for phenobarbital), the following clinical results were observed: Mean frequency of generalised seizures was reduced from 2.3 seizures per month in the imepitoin group and from 2.4 seizures per month in the phenobarbital group to 1.1 seizures per month in both groups after 20 weeks of treatment.
Danish: Hos de resterende hunde (64 hunde for Pexion og 88 hunde for phenobarbital) blev følgende kliniske resutater observeret: Middelhyppighed af generaliserede anfald blev reduceret fra 2,3 anfald pr. måned hos imepitoin-gruppen og fra 2,4 anfald per måned hos phenobarbital-gruppen til 1,1 anfald pr. måned hos begge grupper efter 20 ugers behandling.
English: The claim for the treatment of noise phobia is based on a pivotal field study which investigated a 3 day course of treatment for a noise event associated with fireworks.
Danish: Indikationen for behandling af støjfobi er baseret på et pivotalt feltstudie, som undersøgte en 3dagesbehandling for en støjhændelse associeret med fyrværkeri.
English: One tablet contains: Imepitoin 100 mg Imepitoin 400 mg
Danish: En tablet indeholder: Imepitoin 100 mg Imepitoin 400 mg
English: Therefore, imepitoin should not be used as primary treatment in dogs with cluster seizures and status epilepticus.
Danish: Derfor bør imepitoin ikke anvendes som primær behandling hos hunde med serielle anfald (cluster seizures) og status epilepticus.
English: On treatment, some dogs will be free of seizures, in other dogs a reduction of the number of seizures will be observed, whilst others will be non-responders.
Danish: Ved behandling vil nogle hunde blive fri for anfald, hos andre hunde kan observeres en reduktion i antallet af anfald, mens andre igen ikke vil respondere.
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDER OG INDGIVELSESVEJ(E)
English: The efficacy of the veterinary medicinal product in dogs with status epilepticus and cluster seizures has not been investigated.
Danish: Effekten af veterinærlægemidlet hos hunde med status epilepticus og serielle anfald (cluster seizures) er ikke undersøgt.
English: See section “Dosage for each species, route(s) and method of administration”.
Danish: Se punktet ‘Dosering for hver dyreart, anvendelsesmåde og indgivelsesvej(e)'.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 30 tablets
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Longer treatment durations for noise phobia should be at the benefit-risk assessment of the veterinarian.
Danish: Ved længere behandlingsvarighed for støjfobi bør dyrlægen først foretage en benefit-risk-vurdering.
English: Lactose monohydrate Cellulose microcrystalline Hypromellose Magnesium stearate Sodium starch glycolate
Danish: Hypromellose Magnesiumstearat Natriumstivelsesglycolat
English: The safety of the veterinary medicinal product has not been tested in dogs weighing less than 2 kg or in dogs with safety concerns such as renal, liver, cardiac, gastrointestinal or other disease.
Danish: Virkningen af det veterinære lægemiddel er ikke testet på hunde, der vejer mindre end 2 kg eller hos hunde med mistanke om nyre-, lever-, hjerte-, mave-tarm eller anden sygdom.
English: These CNS effects may include loss of righting reflex, decreased activity, eyelid closure, lacrimation,
Danish: Disse CNS-relaterede bivirkninger kan inkludere tab af opretningsreflekser, nedsat aktivitet, lukkede øjenlåg, tåresekretion, øjentørhed og nystagmus.
English: In non-responders, an increase in seizure frequency may be observed.
Danish: Hos ikke-responderende hunde kan en stigning i anfaldsfrekvens observeres.
English: In a European field trial that compared the efficacy of imepitoin to phenobarbital in 226 dogs with newly diagnosed idiopathic epilepsy, 45% of cases from the imepitoin group and 20% from the phenobarbital group were excluded from the efficacy analysis for reasons that included failure to respond to treatment.
Danish: I et europæisk feltforsøg, der sammenlignede effekten af imepitoin med phenobarbital hos 226 hunde med nydiagnosticeret idiopatisk epilepsi, blev 45 % af tilfældene fra imepitoin-gruppen og 20 % fra phenobarbital-gruppen udelukket fra virkningsanalysen blandt andet på grund af manglende effekt af behandlingen.
English: In epileptic dogs, aggression has been uncommonly reported, and increased sensitivity to sound and anxiety have been rarely reported in the field.
Danish: Hos epileptiske hunde er hyppigheden af aggression rapporteret som ikke almindelig, og der har i sjældne tilfælde været rapporteret fra feltet om øget følsomhed over for lyd og angst.
English: Assuming that the veterinary medicinal product is well tolerated by the dog, the dose can be increased by 50 to 100% increments up to a maximum dosage of 30 mg per kg administered twice daily.
Danish: Hvis det veterinære lægemiddel tåles godt hos hunden kan den indgivne dosis øges med 50 til 100 % ad gangen til en maksimal dosis på 30 mg pr. kg legemsvægt to gange dagligt.
English: A mild elevation in plasma creatinine, urea and cholesterol levels has been observed in dogs treated with imepitoin; however these generally did not exceed the normal reference ranges and were not associated with any clinically significant observations or events.
Danish: En mild stigning i serumkreatinin, urea og kolesteroltal er observeret hos hunde i behandling med imepitoin, men disse oversteg generelt ikke de normale referenceværdier og var ikke forbundet med nogen klinisk signifikante observationer eller hændelser
English: Initiate therapy 2 days prior to the day of the expected noise event and continue through the noise event using the bodyweight in kg and the dosing table below.
Danish: Behandling intieres 2 dage før dagen med den forventede støjhændelse og fortsætter, indtil støjhændelsen er afsluttet, idet tabellen med nedenstående angivelser af legemsvægt i kg og dosering anvendes.
English: Dose linearity occurs over the therapeutic dose range of imepitoin.
Danish: Der forekommer dosislinearitet over imepitoins terapeutiske dosisinterval.
English: See section 4.9 (amounts to be administered and administration route).
Danish: 4.9 (dosering og indgivelsesvej).
English: Clinical trial in noise phobia In a placebo-controlled field trial with a treatment duration of 3 days, the efficacy of imepitoin was investigated in dogs diagnosed with noise phobia during the traditional New Year's Eve fireworks.
Danish: Kliniske forsøg med støjfobi I et placebokontrolleret feltforsøg med en behandlingsvarighed på 3 dage blev effekten af imepitoin undersøgt hos hunde, som havde fået konstateret støjfobi under det traditionelle nytårsfyrværkeri.
English: Initiate therapy using the bodyweight in kg and the dosing table.
Danish: Start behandlingen ved at at anvende legemsvægt i kg og doseringsskemaet.
English: In case of repeated overdose of up to 5 times the highest recommended dose of 30 mg imepitoin per kg bodyweight, central nervous system (CNS) effects, gastrointestinal-related effects and reversible prolongation of the QT interval have been noted.
Danish: I tilfælde af gentagen overdosering med op til 5 gange den højeste anbefalede dosis på 30 mg imepitoin pr. kg legemsvægt er der set påvirkning af centralnervesystemet (CNS), påvirkning af mave tarmkanalen og reversibel forlængelse af QT-intervallet.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING
English: Transient ataxia was reported very commonly during a clinical trial for noise phobia and occurred early in the treatment course.
Danish: Forbigående ataksi er rapportet med hyppigheden meget almindelig under et klinisk forsøg med støjfobi og forekom i begyndelsen i behandlingen.
English: The product has been used in combination with phenobarbital, potassium bromide and/or in a small number of cases with levetiracetam and no harmful clinical interactions were observed (see section 4.4).
Danish: Præparatet har været anvendt i kombination med phenobarbital, kaliumbromid og/eller i et mindre antal tilfælde i kombination med levetiracetam og ingen skadelige kliniske interaktioner blev observeret (se punkt 4.4).
English: Overdose (symptoms, emergency procedures, antidotes) In case of repeated overdose of up to 5 times the highest recommended dose of 30 mg imepitoin per kilogram bodyweight, neurological effects, gastrointestinal-related effects and reversible prolongation of the QT interval have been noted.
Danish: Overdosis (symptomer, nødforanstaltninger, modgift) I tilfælde af gentagen overdosering med op til 5 gange den højeste anbefalede dosis på 30 mg imepitoin pr. kg legemsvægt, er der set påvirkning af centralnervesystemet (CNS), påvirkning af mavetarmkanalen og reversibel forlængelse af QT-intervallet.
English: Owner-reported measure of their dog's anxiety symptoms (based on Lincoln Sound Sensitivity Scale) during a noise event: The sum scores showed a statistically significant treatment effect favouring imepitoin with a difference in anxiety score between imepitoin and placebo of -6.1; p < 0.0001, 95% CI [-8.6;-3.6].
Danish: Ejerrapporterede målinger af angstsymptomerne hos deres hunde (baseret på Lincoln Sound Sensitivity Scale) under en støjhændelse: Sumscorerne viste en statistisk signifikant behandlingseffekt til fordel for imepitoin med en forskel i angstscore mellem imepitoin og placebo på -6,1, p  0,0001, 95 % CI [-8,6,-3,6].
English: Do not use in dogs with severely impaired hepatic function, severe renal or severe cardiovascular disorders.
Danish: Bør ikke anvendes til hunde med alvorlig nedsat leverfunktion, svære nyresygdomme eller alvorlige hjertekarsygdomme
English: These neurological effects may include loss of righting reflex (loss of balance), decreased activity, eyelid closure, lacrimation (excessive tears), dry eye (inadequate tears), and nystagmus (unusual eye movement).
Danish: Disse CNS-relaterede bivirkninger kan inkludere tab af opretningsreflekser (balancetab), nedsat aktivitet, lukkede øjenlåg, tåresekretion (unormalt høj tåreproduktion), øjentørhed (utilstrækkelig tåreproduktion) og nystagmus (usædvanlig øjenbevægelse).
English: Interaction with other medicinal products and other forms of interaction The product has been used in combination with phenobarbital, potassium bromide and/or in a small number of cases with levetiracetam and no harmful clinical interactions were observed (see section “Special warnings”).
Danish: Interaktioner med andre lægemidler og andre former for interaktion Præparatet har været anvendt i kombination med phenobarbital, kaliumbromid og/eller i et mindre antal tilfælde i kombination med levetiracetam og ingen skadelige kliniske interaktioner er observeret (se også punktet ”Særlige advarsler”).
English: In these dogs, additional measures to mitigate the risk of aggression problems should be implemented as appropriate before treatment is initiated.
Danish: Hos disse hunde bør der, før behandlingen indledes, iværksættes yderligere foranstaltninger for at begrænse risikoen for aggressionsproblemer efter behov.
English: The recommended initial dose of imepitoin is 10 mg per kg bodyweight twice daily.
Danish: Den anbefalede startdosis af imepitoin er 10 mg pr. kg legemsvægt to gange dagligt.
English: Each tablet can be halved for appropriate dosing according to the individual bodyweight of the dog.
Danish: Hver tablet kan halveres for korrekt dosering i overensstemmelse med hundens individuelle legemsvægt.
English: Additionally, fewer adverse events were noted for polyuria (10% vs 19% of dogs), polydipsia (14% vs 23%) and marked sedation (14% vs 25 %) when comparing imepitoin to phenobarbital.
Danish: Derudover blev færre bivirkninger bemærket for polyuria (10 % vs 19 % ), polydipsia (14% vs 23 %) og udpræget sedation (14 % vs 25 %) ved sammenligning af imepitoin med phenobarbital.
English: Additionally, fewer adverse events were noted for polyuria (10% vs 19% of dogs), polydipsia (14% vs 23%) and marked sedation (14% vs 25%) when comparing imepitoin to phenobarbital.
Danish: Derudover blev færre bivirkninger bemærket for polyuria (10% vs 19% ), polydipsia (14% vs 23%) og udpræget sedation (14% vs 25%) ved sammenligning af imepitoin med phenobarbital.
English: Number of tablets (to be given twice daily) for initiation of epilepsy treatment: Dose: 10 mg/kg twice daily
Danish: Antal tabletter (der skal gives to gange dagligt) i den indledende epilepsibehandling: Dosis: 10 mg/kg to gange dagligt
English: No definitive conclusions can be drawn on the effectiveness of imepitoin as an add-on therapy to phenobarbital, potassium bromide and/or levetiracetam from the limited studies available (see section 4.8).
Danish: Ingen definitive konklusioner kan drages omkring imepitoins effekt, som supplerende terapi til phenobarbital, kaliumbromid og/eller levetiracetam, baseret på det begrænset antal af tilgængelige kliniske forsøg (se punkt 4.8).
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Bottle of 100 tablets (400 mg) and 250 tablets (100 and 400 mg)
Danish: Beholder med 100 tabletter (400 mg) og 250 tabletter (100 og 400 mg)
English: 6.5 Nature and composition of immediate packaging Pack sizes of high-density polyethylene bottle each containing 30, 100 or 250 tablets with a child resistant closure.
Danish: Pakningsstørrelser på 30, 100 eller 250 tabletter i polyethylenflaske af høj densitet med børnesikret lukning.
English: For the efficacy analysis, 226 dogs (104 imepitoin, 122 placebo) were eligible (at least one dose of medication & data for evaluation of co-primary endpoints), and the following results were observed for the two co-primary endpoints: Owner assessed overall effect of study treatment (based on signs during a noise event and a comparison to signs during a previous noise event(s) without treatment: The cumulative odds of a good or excellent effect were significantly greater in the imepitoin group compared with the placebo group (Odds Ratio = 4.689; p < 0.0001, 95% CI [2.79;7.89]).
Danish: Til effektanalysen blev 226 hunde (104 imepitoin, 122 placebo) medtaget (mindst én dosis medicin og data til evaluering af co-primære endepunkter), og følgende resultater blev observeret for de to coprimære endepunkter: Ejer vurderede den samlede effekt af forsøgsbehandlingen (baseret på tegn under en støjhændelse og en sammenligning med tegn under en eller flere tidligere støjhændelser uden behandling: De kumulative odds for en god eller glimrende effekt var signifikant højere i imepitopin gruppen end i placebogruppen (odds-ratio = 4,689, p  0,0001, 95 % CI [2,79;7,89]).