FrancophonIA/ELRC3.0 huggingface dataset:
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet:
English: Idiopathic epilepsy
Slovenian: Idiopatska epilepsija
English: The timing of tablet administration in relation to feeding should be kept consistent.
Slovenian: Časovni razpored dajanja tablet glede na hranjenje mora biti dosleden.
English: For the reduction of the frequency of generalised seizures due to idiopathic epilepsy in dogs for use after careful evaluation of alternative treatment options.
Slovenian: Za zmanjšanje pogostnosti generaliziranih epileptičnih napadov pri idiopatični epilepsiji pri psih, ki se uporablja po skrbni oceni alternativnih možnosti zdravljenja.
English: The required dose will vary between dogs and will depend on the severity of the disorder.
Slovenian: Potrebni odmerek se razlikuje med posameznimi psi in je odvisen od resnosti bolezni.
English: The in-vivo plasma protein binding of imepitoin in dogs is low (60 to 70%).
Slovenian: Sposobnost vezave imepitoina na beljakovine v plazmi in-vivo je nizka (60 do 70 %).
English: Pharmacotherapeutic group: Antiepileptics, Other antiepileptics, imepitoin ATCvet code: QN03AX90
Slovenian: Farmakoterapevtska skupina: Antiepileptiki, Drugi antiepileptiki, imepitoin Oznaka ATC vet: QN03AX90
English: For this reason, careful consideration should be given before deciding to switch a stabilized dog onto imepitoin from a different treatment.
Slovenian: Zaradi tega je treba skrbno pretehtati, preden se odločimo, da bomo stabiliziranemu psu drugo zdravilo zamenjali z imepitoinom.
English: The anxiolytic effect of imepitoin is mediated via the GABAA receptor.
Slovenian: Anksiolitični učinek imepitoina se posreduje preko receptorja GABAA.
English: Imepitoin has a relatively high volume of distribution (579 to 1548 ml/kg).
Slovenian: Imepitoin ima relativno visok porazdelitveni volumen (579 do 1.548 ml/kg).
English: Imepitoin is a centrally acting substance with anxiolytic and antiepileptic properties which crosses the blood brain barrier without involvement of active transport or active clearance, resulting in immediate equilibrium between plasma and brain.
Slovenian: Imepitoin je osrednje delujoče zdravilo z anksiolitičnimi in antiepileptičnimi lastnostmi, ki prehaja skozi krvno-možgansko bariero brez aktivnega transporta ali aktivnega očistka, kar povzroči takojšnje ravnovesje med plazmo in možgani.
English: Increasing doses of phenobarbital were associated with increasing levels of the liver enzymes ALT, AP, AST, GGT, and GLDH.
Slovenian: Večanje odmerkov fenobarbitala je bilo povezano z višanjem ravni jetrnih encimov ALT, AF, AST, GGT in GLDH.
English: In more than half of the dogs that experienced ataxia during this clinical trial the signs resolved spontaneously within 24 hours in spite of continued treatment and in half of the remaining dogs within 48 hours.
Slovenian: Pri več kot polovici psov, ki so doživeli ataksijo med tem kliničnim preskušanjem, so znaki kljub nadaljevanju zdravljenja spontano izginili v 24 urah in pri polovici preostalih psov v 48 urah.
English: See section 4.9 (amounts to be administered and administration route).
Slovenian: Glejte poglavje 4.9 (Odmerjanje in pot uporabe).
English: Do not use in dogs with severely impaired hepatic function, severe renal or severe cardiovascular disorders.
Slovenian: Ne uporabljajte pri psih s hudo jetrno okvaro, hudo ledvično ali hudo kardiovaskularno boleznijo.
English: Efficacy for reduction of anxiety and fear associated with noise phobia has not been tested in dogs younger than 12 months.
Slovenian: Učinkovitosti za zmanjšanje anksioznosti in strahu, povezanih s fobijo pred hrupom, niso testirali pri psih mlajših od 12 mesecev.
English: Imepitoin is rapidly cleared from blood (Cl = 260 to 568 ml/hours/kg) with an elimination half-life of approximately 1.5 to 2 hours.
Slovenian: Imepitoin se iz krvi hitro izloči (Cl = 260 do 568 ml/ur/kg) z razpolovnim časom izločanja približno 1,5 do 2 uri.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after EXP.
Slovenian: Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na škatli in steklenici po oznaki EXP.
English: In dogs with a history of aggression problems, a careful benefit-risk evaluation should be made prior to treatment.
Slovenian: Pri psih, ki imajo zgodovino težav z agresivnostjo je potrebno pred zdravljenjem pripraviti skrbno oceno koristi in tveganja.
English: Pharmacokinetic studies indicate that imepitoin is well absorbed (> 92%) after oral administration and that no pronounced first pass effect occurs.
Slovenian: Farmakokinetične študije nakazujejo, da se imepitoin dobro absorbira (> 92 %) po peroralnem dajanju in da se ne pojavi izrazit učinek presnove prvega prehoda.
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).
Slovenian: - pogosti (pri več kot 1, toda manj kot 10 živali od 100 zdravljenih živali) - občasni (pri več kot 1, toda manj kot 10 živali od 1.000 zdravljenih živali) - redki (pri več kot 1, toda manj kot 10 živali od 10.000 zdravljenih živali) - zelo redki (pri manj kot 1 živali od 10.000 zdravljenih živali, vključno s posameznimi primeri)
English: Longer treatment durations for noise phobia should be at the benefit-risk assessment of the veterinarian.
Slovenian: Daljše zdravljenje fobije pred hrupom mora temeljiti na veterinarjevi oceni koristi in tveganja.
English: See section “Dosage for each species, route(s) and method of administration”.
Slovenian: Glejte poglavje "Odmerjanje za vsako živalsko vrsto, pot(i) in način uporabe".
English: Do not use in cases of hypersensitivity to the active substance or to any of the excipients.
Slovenian: Ne uporabite v primerih preobčutljivosti na učinkovino ali katero koli pomožno snov.
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.
Slovenian: V primeru nenamernega zaužitja zdravila, zlasti s strani otrok, se takoj posvetujte z zdravnikom in mu pokažite navodila za uporabo ali ovojnino.
English: Should seizures not be adequately controlled, further diagnostic measures and other antiepileptic treatment should be considered.
Slovenian: Če napadi niso ustrezno obvladani, je treba razmisliti o dodatnih diagnostičnih ukrepih in drugem zdravljenju proti epilepsiji.
English: See also section "Pregnancy and lactation".
Slovenian: Glejte tudi poglavje "Brejost in laktacija".
English: Though efficacy may not be complete, imepitoin is considered to be a suitable treatment option in some dogs because of its safety profile.
Slovenian: Čeprav učinkovitost morda ni popolna, je imepitoin primeren za zdravljenje pri nekaterih psih.
English: In comparison, none of the five enzymes increased with increasing doses of imepitoin.
Slovenian: Pri skupini z imepitoinom se ni noben od teh petih encimov zvišal z večanjem odmerkov imepitoina.
English: In epileptic dogs, aggression has been uncommonly reported, and increased sensitivity to sound and anxiety have been rarely reported in the field.
Slovenian: Pri psih z epilepsijo so občasno poročali o agresivnosti, v redkih primerih pa so poročali o povečani občutljivosti na zvok in anksioznosti.
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)
Slovenian: EU/2/12/147/001 100 tablet (100 mg) EU/2/12/147/002 250 tablet (100 mg) EU/2/12/147/003 100 tablet (400 mg) EU/2/12/147/004 250 tablet (400 mg) EU/2/12/147/005 30 tablet (400 mg) EU/2/12/147/006 30 tablet (100 mg)
English: For the reduction of anxiety and fear associated with noise phobia in dogs.
Slovenian: Za zmanjšanje anksioznosti in strahu, povezanih s fobijo pred hrupom pri psih.
English: Co-administration of imepitoin tablets with food, reduces the total AUC by 30% but produces no significant change in Tmax and Cmax.
Slovenian: Sočasno dajanje tablet imepitoina s hrano zmanjša skupni AUC za 30 %, vendar nima značilnega vpliva na Tmax in Cmax.
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.
Slovenian: Varnosti zdravila za uporabo v veterinarski medicini niso testirali pri psih s telesno maso manj kot 2 kg ali pri psih, kjer obstajajo zdravstvene težave, kot so ledvične, jetrne, srčne, prebavne ali druge bolezni.
English: Bottle of 30, 100 or 250 tablets.
Slovenian: Plastenka s 30, 100 ali 250 tabletami.
English: See also section "Overdose".
Slovenian: Glejte tudi poglavje "Preveliko odmerjanje".
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.
Slovenian: V evropskem kliničnem terenskem preskušanju, kjer so primerjali učinkovitost imepitoina in fenobarbitala pri 226 psih z na novo diagnosticirano idiopatično epilepsijo, je bilo 45 % primerov iz skupine z imepitoinom in 20 % iz skupine s fenobarbitalom izključenih iz analize učinkovitosti, ker se med drugim na zdravljenje niso odzvali.
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.
Slovenian: Med 12-tedensko fazo ocenjevanja je bil delež psov brez generaliziranih epileptičnih napadov 47 % (30 psov) v skupini z imepitoinom in 58 % (51 psov) v skupini s fenobarbitalom.
English: Bioavailability is greater when administered to fasted dogs.
Slovenian: Biološka razpoložljivost je večja pri dajanju psom na tešče.
English: White, oblong, half-scored tablets with embedded logo “I 01” (100 mg) or “I 02” (400 mg) on one side.
Slovenian: Bele, podolgovate tablete z delilno zarezo in vtisnjenim logotipom "I 01" (100 mg) ali "I 02" (400 mg) na eni strani.
English: The efficacy of the veterinary medicinal product in dogs with status epilepticus and cluster seizures has not been investigated.
Slovenian: Učinkovitost zdravila za uporabo v veterinarski medicini pri psih z epileptičnim statusom in serijskimi epileptičnimi napadi ni bila dokazana.
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.
Slovenian: Če pes zdravilo za uporabo v veterinarski medicini dobro prenaša, lahko odmerek dvigujete v korakih po 50 do 100 % do največjega odmerka 30 mg na kg dvakrat na dan.
English: Therefore, imepitoin should not be used as primary treatment in dogs with cluster seizures and status epilepticus.
Slovenian: Zato imepitoina ne uporabljajte kot primarno zdravljenje pri psih z epileptičnim statusom in serijskimi epileptičnimi napadi.
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.
Slovenian: Večina imepitoina in njegovih presnovkov se izloči z blatom in ne z urinom, zato večjih sprememb v farmakokinetiki ali kopičenja pri psih z okvaro ledvic ni pričakovati.
English: PHARMACEUTICAL FORM Tablets
Slovenian: FARMACEVTSKA OBLIKA tablete
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.
Slovenian: Po peroralnem dajanju tablet imepitoina v odmerku 30 mg/kg brez hrane se najvišje koncentracije v krvi pojavijo hitro s Tmax približno 2 uri in Cmax približno 18 µg/ml.
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.
Slovenian: Pri preostalih psih (64 psov za zdravilo Pexion in 88 psov za fenobarbital) so prišli do naslednjih kliničnih rezultatov: povprečna pogostnost generaliziranih epileptičnih napadov se je po 20-tedenskem zdravljenju zmanjšala iz 2,3 napada na mesec v skupini z imepitoinom in iz 2,4 napada na mesec v skupini s fenobarbitalom na 1,1 napada na mesec v obeh skupinah.
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.
Slovenian: Da preprečite nenamerno zaužitje tablet, morate na steklenico takoj, ko iz nje vzamete število tablet, potrebno za eno dajanje, ponovno namestiti zamašek..
English: Number of tablets (to be given twice daily) for noise phobia treatment: Dose: 30 mg/kg twice daily
Slovenian: Število tablet (dajejo se dvakrat na dan) za zdravljenje fobije pred hrupom: Odmerek: 30 mg/kg dvakrat dnevno
English: At 5 times the recommended dose, decreased bodyweight may be observed.
Slovenian: Pri 5-kratniku priporočenega odmerka se lahko pojavi zmanjšana telesna masa.
English: Ingestion of this product may cause dizziness, lethargy and nausea.
Slovenian: Zaužitje tega zdravila lahko povzroči omotico, letargijo in slabost.
English: Please refer to section "Adverse reactions" for further details.
Slovenian: Za več podrobnosti glejte poglavje "Neželeni učinki".
English: At such doses, the symptoms are not usually lifethreatening and generally resolve within 24 hours if symptomatic treatment is given.
Slovenian: Pri takih odmerkih simptomi običajno niso življenjsko nevarni in navadno izginejo v roku 24 ur po simptomatskem zdravljenju.
English: Anxiolytic drugs acting at the benzodiazepine receptor site, such as imepitoin, may lead to disinhibition of fear-based behaviours.
Slovenian: Anksiolitična zdravila, kot je imepitoin, ki delujejo na mestu benzodiazepinskega receptorja, lahko privedejo do spremembe vedenja, ki temelji na strahu.
English: Clinical trials in epilepsy
Slovenian: Klinična preskušanja pri epilepsiji
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One tablet contains:
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA
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.
Slovenian: Če se epileptični napadi po vsaj 1-tedenskem zdravljenju s tem odmerkom ne zmanjšajo ustrezno, mora nadzorni veterinar psa ponovno oceniti.
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].
Slovenian: Lastnik je poročal o merjenju simptomov anksioznosti svojega psa (na podlagi Lincolnove lestvice za občutljivost na hrup) med hrupnim dogodkom: rezultati vsote so pokazali statistično pomemben učinek zdravljenja, ki daje prednost imepitoinu z razliko v anksioznosti med imepitoinom in placebom -6,1; p < 0,0001, 95 % CI [-8,6; -3,6].
English: In these dogs, additional measures to mitigate the risk of aggression problems should be implemented as appropriate before treatment is initiated.
Slovenian: Pri teh psih je treba pred začetkom zdravljenjem izvajati ustrezne ukrepe za nadaljnje zmanjšanje tveganja agresivnega vedenja.
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).
Slovenian: Nevrološki učinki lahko vključujejo izgubo izravnalnega refleksa (izgubo ravnotežja), zmanjšano aktivnost, zapiranje vek, lakrimacijo (pretirano solzenje), suho oko o (premalo solz) in nistagmus
English: Lactose monohydrate Cellulose microcrystalline Hypromellose Magnesium stearate Sodium starch glycolate
Slovenian: 6.1 Seznam pomožnih snovi laktoza monohidrat celuloza, mikrokristalna hipromeloza magnezijev stearat natrijev karboksimetilškrob
English: Noise phobia
Slovenian: Fobija pred hrupom
English: The use of the veterinary medicinal product is not recommended in male breeding dogs or in female dogs during pregnancy and lactation (see section 4.10).
Slovenian: Uporaba tega zdravila ni priporočljiva pri psih za razplod ali pri psicah v obdobju brejosti in laktacije (glejte poglavje 4.10).
English: 4.4 Special warnings for each target species
Slovenian: 4.4 Posebna opozorila za vsako ciljno živalsko vrsto Idiopatska epilepsija
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.
Slovenian: Pri psih, zdravljenih z imepitoinom, so opazili blago zvišanje plazemske ravni kreatinina sečnine in holesterola; vendar običajno niso prekoračile normalnih referenčnih razponov in niso bile povezane z nobenimi klinično pomembnimi opažanji ali dogodki.
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.
Slovenian: V primeru ponavljajočega se prevelikega odmerjanja z do 5-krat večjim odmerkom od priporočenega odmerka 30 mg imepitoina na kg telesne mase, so opazili učinke na osrednji živčni sistem, gastrointestinalni sistem in reverzibilno podaljšanje intervala QT.
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.
Slovenian: Z zdravljenjem začnite 2 dni pred pričakovanim hrupnim dogodkom in nadaljujte z zdravljenjem med hrupnim dogodkom z uporabo tabele telesne mase v kg in odmerjanja.
English: One tablet contains: Imepitoin 100 mg Imepitoin 400 mg
Slovenian: Ena tableta vsebuje: imepitoin 100 mg imepitoin 400 mg
English: Dose linearity occurs over the therapeutic dose range of imepitoin.
Slovenian: V terapevtskem razponu odmerka imepitoina se pojavi linearnost od odmerka.
English: Initiate therapy using the bodyweight in kg and the dosing table.
Slovenian: Zdravljenje uvedite s pomočjo telesne mase v kg in preglednice odmerjanja.
English: The recommended initial dose of imepitoin is 10 mg per kg bodyweight twice daily.
Slovenian: Priporočeni začetni odmerek imepitoina je 10 mg na kg telesne mase dvakrat na dan.
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].
Slovenian: Razlika med skupinama z imepitoinom in fenobarbitalom v pogostnosti epileptičnih napadov na mesec po zdravljenju (prilagojena za razliko ob izhodišču) je bila 0,004, 95-odstotni CI [-0,928; 0,935].
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.
Slovenian: pPoleg tega ima imepitoin šibak učinek na zaviranje kalcijevih kanalčkov, kar lahko prispeva k njegovim antikonvulzivnim lastnostim.
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).
Slovenian: Zdravilo so uporabili v kombinaciji s fenobarbitalom, kalijevim bromidom in/ali pri majhnem številu primerov z levetiracetamom, vendar neželenih kliničnih interakcij niso opazili (glejte poglavje 4.4).
English: Up to 2 days of pre-treatment may be necessary to achieve optimal anxiolytic efficacy in dogs with noise phobia.
Slovenian: Za doseganje optimalne anksiolitične učinkovitosti pri psih s fobijo pred hrupom je lahko potrebno predzdravljenje, ki traja do 2 dni.
English: No loss of anticonvulsant efficacy (tolerance development) during continuous treatment of 4 weeks was observed in experimental studies lasting 4 weeks.
Slovenian: Po stalnem 4-tedenskem zdravljenju v 4-tedenskih eksperimentalnih študijah ni bila opažena izguba protikonvulzivnega učinka (razvoja tolerance).
English: EU/2/12/147/003 100 tablets (400 mg)
Slovenian: EU/2/12/147/003 100 tablet (400 mg)
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.
Slovenian: Med zdravljenjem nekateri psi epileptičnih napadov ne bodo imeli, pri drugih jih bo manj, nekateri pa se na zdravljenje ne bodo odzvali.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton for 30, 100 and 250 tablets
Slovenian: PODATKI NA ZUNANJI OVOJNINI Škatla za 30, 100 in 250 tablet
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.
Slovenian: Klinično preskušanje pri fobiji pred hrupom V kliničnem terenskem preskušanju, nadzorovanim s placebom, s trajanjem zdravljenja 3 dni je bila učinkovitost imepitoina raziskana pri psih z diagnosticirano fobijo pred hrupom, razsikana med uporabo pirotehničnih sredstev na silvestrski večer.
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.
Slovenian: Dodatno so pri primerjavi imepitoina s fenobarbitalom opazili manj neželenih učinkov za poliurijo (10 % v primerjavi z 19 % psov), polidipsijo (14 % v primerjavi s 23 %) in znatno sedacijo (14 % v primerjavi s 25 %).
English: EU/2/12/147/004 250 tablets (400 mg)
Slovenian: EU/2/12/147/004 250 tablet (400 mg)
English: In a US field trial that compared the efficacy of imepitoin at a fixed dose of 30 mg/kg twice daily to a placebo in 151 dogs with idiopathic epilepsy during a treatment period of 84 days, the proportion of generalized seizure-free dogs was 21% (21 dogs out of 99; 95 % CI [0.131; 0.293]) in the imepitoin group and 8% (4 dogs out of 52; 95% CI [0.004; 0.149]) in the placebo group.
Slovenian: V ameriškem kliničnem terenskem preskušanju, kjer so primerjali učinkovitost imepitoina s fiksnim odmerkom 30 mg/kg dvakrat na dan in placeba pri 151 psih z idiopatično epilepsijo med obdobjem zdravljenja, ki je trajalo 84 dni, je delež psov brez generaliziranih epileptičnih napadov bil 21% (21 od 99 psov; 95 % CI [0.131; 0.293]) v skupini z imepitoinom in 8% (4 od 52 psov; 95% CI [0.004;
English: MARKETING AUTHORISATION HOLDER Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
Slovenian: IMETNIK DOVOLJENJA ZA PROMET Boehringer Ingelheim Vetmedica GmbH 55216 Ingelheim/Rhein
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.
Slovenian: Nekateri psi epileptičnih napadov ne bodo imeli, pri drugih jih bo manj, nekateri pa se na zdravljenje ne bodo odzvali.