FrancophonIA/ELRC3.0 huggingface dataset:
English: Common (may affect more than 1 user in 100) are: - increased or decreased appetite, weight gain - feeling aggressive, angry, irritable, anxious or confused - difficulty with walking or other balance problems (ataxia, gait disturbance, balance disorder) - slow speech (dysarthria) - blurred vision or double vision (diplopia) - spinning sensation (vertigo) - feeling sick (nausea) - back pain - feeling very tired (fatigue) - falling down
Croatian: Česte nuspojave (mogu se javiti u više od 1 korisnika na 100): - pojačan ili oslabljen apetit, povećanje tjelesne težine - osjećaj agresivnosti, ljutnje, razdraženosti, tjeskobe ili smetenosti - poteškoće s hodanjem ili druge poteškoće s ravnotežom (ataksija, poremećen hod, poremećaj ravnoteže) - usporen govor (dizartrija) - zamagljen vid ili dvostruki vid (diplopija) - osjećaj vrtnje (vrtoglavica) - mučnina - bol u leđima - jak umor (iscrpljenost) - padanje
English: A decrease in PGTC seizure frequency of at least 50% was seen in 65.9% of subjects after 1 year of treatment during the Extension Phase (relative to their pre-perampanel baseline seizure frequency).
Croatian: Smanjenje učestalosti primarno generaliziranih toničko-kloničkih napadaja za najmanje 50% bilo je opaženo u 65,9% ispitanika nakon 1 godine liječenja tijekom faze produžetka ispitivanja (u odnosu na njihovu početnu učestalost napadaja prije perampanela).
English: You can take Fycompa with or without food and should always take it the same way.
Croatian: Fycompu možete uzeti s hranom ili bez nje, ali je uzimajte uvijek na isti način.
English: Caution should be exercised in patients with a history of substance abuse and the patient should be monitored for symptoms of perampanel abuse.
Croatian: Potreban je oprez u bolesnika koji u anamnezi imaju zloporabu droga i takvog bolesnika treba pratiti zbog simptoma zloporabe perampanela.
English: Perampanel may cause dizziness and somnolence and therefore may influence the ability to drive or use machines (see section 4.7).
Croatian: Perampanel može prouzročiti omaglicu i pospanost te stoga može utjecati na sposobnost upravljanja vozilima i rukovanja strojevima (vidjeti dio 4.7).
English: In the controlled and uncontrolled trial in patients with primary generalised tonic-clonic seizures, 114 subjects have received perampanel of whom 68 have been treated for 6 months and 36 for longer than 12 months.
Croatian: U kontroliranim i nekontroliranim ispitivanjima u bolesnika s primarno generaliziranim toničko-kloničkim napadajima, od 114 ispitanika koji su primali perampanel, njih 68 bilo je liječeno 6 mjeseci, a 36 dulje od 12 mjeseci.
English: These studies show that once-daily administration of perampanel at doses of 4 mg to 12 mg was significantly more efficacious than placebo as adjunctive treatment in this population.
Croatian: Ova ispitivanja pokazuju da je primjena perampanela jedanput na dan u dozi od 4 mg do 12 mg bila značajno djelotvornija kao dodatno liječenje u ove populacije nego što je to bio placebo.
English: When coadministered with a high fat meal, Cmax and AUC0-inf of a single 12-mg dose of perampanel oral suspension were approximately 22% and 13%, respectively, lower compared to fasted conditions.
Croatian: Kada se primjenjuje uz obrok s visokim udjelom masti, vrijednosti za Cmax i AUC0-inf jedne doze oralne suspenzije perampanela od 12 mg bile su približno 22% odnosno 13% niže u usporedbi s onima dobivenim mjerenjem natašte.
English: Perampanel at a dose up to 8 mg/day has been shown to be effective in primary generalised tonic-clonic seizures.
Croatian: Perampanel u dozi do 8 mg na dan pokazao se učinkovit kod primarno generaliziranih toničko-kloničkih napadaja.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Fycompa.
Croatian: Ako Vam je liječnik rekao da ne podnosite neke šećere, savjetujte se s liječnikom prije uzimanja Fycompe.
English: Thirty four (34) patients were followed up for at least 6 months and, of these, 24 patients (71%) remained on perampanel monotherapy for at least 6 months.
Croatian: Od 34 bolesnika koja su praćena najmanje 6 mjeseci, 24 bolesnika (71%) ostalo je na monoterapiji perampanelom najmanje 6 mjeseci.
English: Fycompa 2 mg film-coated tablets Fycompa 4 mg film-coated tablets Fycompa 6 mg film-coated tablets Fycompa 8 mg film-coated tablets Fycompa 10 mg film-coated tablets Fycompa 12 mg film-coated tablets
Croatian: Fycompa 2 mg filmom obložene tablete Fycompa 4 mg filmom obložene tablete Fycompa 6 mg filmom obložene tablete Fycompa 8 mg filmom obložene tablete Fycompa 10 mg filmom obložene tablete Fycompa 12 mg filmom obložene tablete
English: Fycompa may make certain hormonal contraceptives such as levonorgestrel less effective.
Croatian: Fycompa može smanjiti djelotvornost nekih hormonskih kontraceptiva, kao što je levonorgestrel.
English: The 50% responder rates in the 4 mg, 8 mg and 12 mg groups were respectively 23.0%, 31.5%, and 30.0% in combination with enzyme-inducing anti-epileptic medicinal products and were 33.3%, 46.5% and 50.0% when perampanel was given in combination with non-enzyme-inducing anti-epileptic medicinal products.
Croatian: Stope bolesnika s 50%-tnim odgovorom u skupinama koje su primale doze od 4 mg, 8 mg i 12 mg iznosile su 23,0%, 31,5% odnosno 30,0% kad se perampanel davao u kombinaciji s antiepileptičkim lijekovima koji induciraju enzime te 33,3%, 46,5% odnosno 50,0% kad se perampanel davao u kombinaciji s antiepileptičkim lijekovima koji ne induciraju enzime.
English: Not known (the frequency of this side effect cannot be estimated from the available data) are: - widespread rash, high body temperature, liver enzyme elevations, blood abnormalities (eosinophilia), enlarged lymph nodes and other body organs involvement (Drug Reaction with Eosinophilia and Systemic Symptoms which is also known as DRESS or drug hypersensitivity syndrome).
Croatian: Nepoznato (učestalost ovih nuspojava ne može se procijeniti iz dostupnih podataka): - široko rasprostranjeni osip, visoka tjelesna temperatura, povišenje jetrenih enzima, abnormalnosti u krvi (eozinofilija), povećani limfni čvorovi s uključenošću drugih tjelesnih organa (reakcija na lijek s eozinofilijom i sustavnim simptomima poznata i pod nazivom DRESS ili sindrom preosjetljivosti na lijek).
English: - Your doctor may increase this in 2 mg steps to a maintenance dose between 4 mg and 12 mg depending on your response.
Croatian: - Liječnik je može povećavati po 2 mg do doze održavanja između 4 mg i 12 mg - ovisno o
English: Other concomitant (non- anti-epileptic) cytochrome P450 inducing or inhibiting medicinal products
Croatian: Istovremena primjena drugih lijekova (ne antiepileptičkih) koji induciraju ili inhibiraju citokrom P450
English: Some anti-epileptic drugs known as CYP450 3A enzyme inducers (carbamazepine, phenytoin, oxcarbazepine) have been shown to increase perampanel clearance and consequently to decrease plasma concentrations of perampanel.
Croatian: Pokazalo se da neki antiepileptički lijekovi koji su poznati kao induktori enzima CYP450 3A (karbamazepin, fenitoin, okskarbazepin), povećavaju klirens perampanela i posljedično snizuju koncentracije perampanela u plazmi.
English: Perampanel is a first-in-class selective, non-competitive antagonist of the ionotropic α-amino-3hydroxy-5-methyl-4-isoxazolepopionic acid (AMPA) glutamate receptor on post-synaptic neurons.
Croatian: Perampanel je prvi u klasi selektivnih, nekompetitivnih antagonista ionotropnog glutamatnog receptora α-amino-3-hidroksi-5-metil-4-izoksazolpropionatne kiseline (AMPA) na postsinaptičkim neuronima.
English: Perampanel is extensively metabolised via primary oxidation and sequential glucuronidation.
Croatian: Perampanel se opsežno metabolizira putem primarne oksidacije te potom glukuronidacije.
English: If at any time you have these thoughts, contact your doctor straight away.
Croatian: Ako Vam se ikad pojave takve misli, odmah se obratite svom liječniku.
English: The efficacy of perampanel in partial-onset seizures was established in three adjunctive therapy 19 week, randomised, double-blind, placebo-controlled, multicentre trials in adult and adolescent patients.
Croatian: Djelotvornost perampanela u parcijalnim napadajima bila je ustanovljena u tri randomizirana, dvostruko slijepa, placebom kontrolirana, multicentrična ispitivanja dodatne terapije u trajanju od 19 tjedana u odraslih i adolescentnih bolesnika.
English: Perampanel as adjunctive therapy in patients 12 years of age and older with idiopathic generalised epilepsy experiencing primary generalised tonic-clonic seizures was established in a multicenter, randomised, double-blind, placebo-controlled study (Study 332).
Croatian: Perampanel kao dodatna terapija u bolesnika u dobi od 12 i više godina s idiopatskom generaliziranom epilepsijom koji su imali primarno generalizirane toničko-kloničke napadaje bila je ustanovljena u multicentričnom, randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju (ispitivanje 332).
English: <10% decrease
Croatian: <10% sniženje klobazam nema utjecaja
English: Potential interactions between Fycompa (up to 12 mg once daily) and other anti-epileptic drugs (AEDs) were assessed in clinical studies and evaluated in the population PK analysis of four pooled Phase 3 studies including patients with partial-onset seizures and primary generalised tonic-clonic seizures.
Croatian: Moguće interakcije između Fycompe (u dozi do 12 mg jedanput na dan) i drugih antiepileptičkih lijekova bile su procijenjene u kliničkim ispitivanjima i pomoću populacijske farmakokinetičke analize objedinjenih podataka iz četiri ispitivanja faze 3 koja su uključila bolesnike s parcijalnim napadajima i primarno generaliziranim toničko-kloničkim napadajima.
English: The dosage of perampanel should be reduced if such symptoms occur and should be discontinued immediately if symptoms are severe.
Croatian: Ako se takvi simptomi pojave dozu perampanela treba smanjiti, a ako su simptomi teški, liječenje treba odmah prekinuti.
English: In healthy subjects, plasma concentrations of perampanel increased in direct proportion to administered doses over the range of 2 to 12 mg.
Croatian: Koncentracije perampanela u plazmi zdravih ispitanika povećavale su se proporcionalno primijenjenim dozama u rasponu od 2 do 12 mg.
English: You should not take Fycompa if you have serious liver problems or moderate or serious kidney problems.
Croatian: Ne smijete uzimati Fycompu ako imate ozbiljne tegobe s jetrom ili umjerene ili ozbiljne tegobe s bubrezima.
English: Tell your doctor if you are taking midazolam as your dose may need to be adjusted.
Croatian: Obavijestite svog liječnika ako uzimate midazolam jer će Vam možda trebati prilagoditi dozu.
English: Patients from the randomised trial were converted to perampanel over 16 weeks followed by a long term maintenance period (≥ 1 year).
Croatian: Bolesnici iz randomiziranih ispitivanja bili su prebačeni na perampanel u roku od 16 tjedana, a potom je slijedilo dugo razdoblje održavanja (≥1 godine).
English: What Fycompa contains
Croatian: Što Fycompa sadrži
English: In a population pharmacokinetic analysis of the adolescent patients pooled from the Phase 2 and 3 clinical studies, there were no notable differences between this population and the overall population.
Croatian: U populacijskoj farmakokinetičkoj analizi objedinjenih podataka za adolescentne bolesnike iz kliničkih ispitivanja faze 2 i 3 nije bilo primjetnih razlika između ove populacije i ukupne populacije.
English: Very common (may affect more than 1 user in 10) are: - feeling dizzy - feeling sleepy (drowsiness or somnolence)
Croatian: Vrlo česte nuspojave (mogu se javiti u više od 1 korisnika na 10): - omaglica - pospanost (omamljenost ili pospanost)
English: In a population pharmacokinetic analysis of patients with partial-onset seizures receiving Fycompa up to 12 mg/day in placebo-controlled clinical trials, Fycompa did not affect to a clinically relevant manner the clearance of clonazepam, levetiracetam, phenobarbital, phenytoin, topiramate, zonisamide, carbamazepine, clobazam, lamotrigine and valproic acid, at the highest perampanel dose evaluated (12 mg/day).
Croatian: U populacijskoj farmakokinetičkoj analizi bolesnika s parcijalnim napadajima koji su primali Fycompu u dozi do 12 mg na dan u placebom kontroliranim kliničkim ispitivanjima, Fycompa nije imala klinički važan utjecaj na klirens klonazepama, levetiracetama, fenobarbitala, fenitoina, topiramata, zonisamida, karbamazepina, klobazama, lamotrigina i valproatne kiseline pri najvišim ispitanim dozama perampanela (12 mg na dan).
English: Uncommon (may affect more than 1 user in 1000) are: - thoughts about harming yourself or ending your own life (suicidal thoughts), tried to end your own life (attempted suicide)
Croatian: Manje česte nuspojave (mogu se javiti u više od 1 korisnika na 1000): - misli o samoozljeđivanju ili samoubojstvu (suicidalne misli), pokušaj samoubojstva (pokušaj suicida).
English: Fycompa is indicated for the adjunctive treatment of partial-onset seizures with or without secondarily generalised seizures in adult and adolescent patients from 12 years of age with epilepsy.
Croatian: Fycompa je indicirana za dodatno liječenje parcijalnih napadaja sa sekundarnom generalizacijom ili bez nje u odraslih bolesnika i adolescenata u dobi iznad 12 godina s epilepsijom.
English: For patients with perampanel in the open label extension (n = 112), the mean change (SD) from baseline to end of open-label treatment (52 weeks) in CDR System Global Cognition t-Score was (minus) -1.0 (9.91).
Croatian: Za bolesnike koji su u otvorenom produžetku ispitivanja primali perampanel (n=112), srednja vrijednost promjene (SD) od početka ispitivanja do kraja otvorenog liječenja (52 tjedna) prema t-rezultatu za opće kognitivno funkcioniranje dobivenom sustavom CDR testova bila je (minus) -1,0 (9,91).
English: Take Fycompa for as long as your doctor recommends.
Croatian: Uzimajte Fycompu onoliko dugo koliko je to preporučio liječnik.
English: Switching between the tablet and suspension formulation should be done with caution (see section 5.2).
Croatian: Potreban je oprez kad se prelazi s tableta na primjenu suspenzije i obrnuto (vidjeti dio 5.2).
English: 1) Active metabolite monohydroxycarbazepine was not assessed.
Croatian: Aktivni metabolit monohidroksikarbazepin nije bio procijenjen.
English: Patients from the randomised trial were converted to perampanel over 6 weeks followed by a long term maintenance period (≥ 1 year).
Croatian: Bolesnici iz randomiziranog ispitivanja bili su prebačeni na perampanel tijekom 6 tjedana nakon čega je uslijedilo dugotrajno razdoblje terapije održavanja (≥1 godine).
English: Freedom from all seizures was achieved in 23.5% (19/81) of patients on perampanel compared to 4.9% (4/81) of patients on placebo.
Croatian: Prestanak svih napadaja postignut je u 23,5% (19/81) bolesnika koji su uzimali perampanel u usporedbi s 4,9% (4/81) bolesnika koji su uzimali placebo.
English: Fycompa is for oral use.
Croatian: Fycompa je namijenjena za oralnu primjenu.
English: Conversely, withdrawal of a concomitant CYP450 3A enzyme inducer can be expected to increase plasma concentrations of perampanel and dose reduction may be required.
Croatian: Suprotne tome, očekuje se da će se ukidanjem istovremene primjene induktora enzima CYP450 3A koncentracije perampanela u plazmi povećati, pa može biti potrebno smanjenje doze.
English: Taking Fycompa with other anti-epileptic medicine, which contains sorbitol, may affect how much they work.
Croatian: Uzimanje Fycompe s drugim lijekom protiv epilepsije koji sadrži sorbitol, može utjecati na njihovo djelovanje.
English: Patients should be closely monitored for tolerability and clinical response when adding or removing cytochrome P450 inducers or inhibitors, since perampanel plasma levels can be decreased or increased; the dose of perampanel may need to be adjusted accordingly.
Croatian: Kad se dodaju ili ukidaju lijekovi koji induciraju ili inhibiraju citokrom P450, bolesnike treba pažljivo pratiti zbog podnošljivosti i kliničkog odgovora, budući da razine perampanela u plazmi mogu biti snižene ili povišene; može biti potrebno prilagoditi dozu perampanela sukladno tome.
English: It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident.
Croatian: Važno je napomenuti da je moguća rana pojava reakcija preosjetljivosti, primjerice vrućice ili limfadenopatije, iako osip nije vidljiv.
English: You should continue doing this for one month after stopping treatment.
Croatian: Kontracepciju trebate nastaviti uzimati i jedan mjesec nakon prestanka liječenja.
English: Influence of AED on Fycompa concentration
Croatian: Utjecaj antiepileptika na koncentraciju Fycompe
English: In all three trials, following a 6-week Baseline Phase to establish baseline seizure frequency prior to randomisation, subjects were randomised and titrated to the randomised dose.
Croatian: U sva tri ispitivanja, nakon 6-tjednog početnog razdoblja tijekom kojeg se odredila osnovna učestalost napadaja prije randomizacije, ispitanici su bili randomizirani i titrirani do nasumično dodijeljene doze.
English: - Drinking alcohol while taking Fycompa can make you less alert and affect your ability to drive or use tools or machines.
Croatian: - Konzumiranje alkohola za vrijeme uzimanja Fycompe može Vam smanjiti budnost i utjecati na Vašu sposobnost upravljanja vozilima i rukovanja alatima i strojevima.
English: Symptoms of DRESS include typically, although not exclusively, fever, rash associated with other organ system involvement, lymphadenopathy, liver function tests abnormalities and eosinophilia.
Croatian: Simptomi DRESS-a uobičajeno, ali ne isključivo, obuhvaćaju vrućicu, osip povezan s uključenošću drugog organskog sustava, limfadenopatiju, abnormalnosti u pretragama funkcije jetre i eozinofiliju.
English: The pooled 50% responder rates were placebo 19%, 4 mg 29%, 8 mg 35% and 12 mg 35%.
Croatian: Stope ispitanika s 50%-tnim odgovorom u sva tri ispitivanja zajedno iznosile su 19% uz placebo, 29% uz 4 mg, 35% uz 8 mg i 35% uz 12 mg.
English: - Other anti-epileptic medicines, such as carbamazepine, oxcarbazepine, and phenytoin that are used to treat fits may affect Fycompa.
Croatian: - Drugi antiepileptici, kao što je karbamazepin, okskarbazepin i fenitoin koji se primjenjuju za liječenje napadaja mogu utjecati na Fycompu.
English: Perampanel may cause dizziness and somnolence and, therefore, may influence the ability to drive or use machines.
Croatian: Perampanel može prouzročiti omaglicu i pospanost pa stoga može utjecati na sposobnost upravljanja vozilima i rukovanja strojevima.
English: It is not known whether perampanel is excreted in human milk.
Croatian: Nije poznato izlučuje li se perampanel u majčino mlijeko.
English: In vitro, perampanel inhibited AMPA-induced (but not NMDA-induced) increase in intracellular calcium.
Croatian: In vitro je perampanel inhibirao povećanje unutarstaničnog kalcija koje inducira AMPA (ali ne ono koje inducira NMDA).
English: Perampanel is readily absorbed after oral administration with no evidence of marked first-pass metabolism.
Croatian: Perampanel se brzo apsorbira nakon peroralne primjene, bez dokaza izrazitog metabolizma prvog prolaza.
English: 7 film-coated tablets 28 film-coated tablets 98 film-coated tablets
Croatian: 7 filmom obloženih tableta 28 filmom obloženih tableta 98 filmom obloženih tableta
English: The median percent change in primary generalised tonic-clonic seizure frequency per 28 days during the Titration and Maintenance Periods (combined) relative to Prerandomisation was greater with perampanel (-76.5%) than with placebo (-38.4%), P < 0.0001.
Croatian: Medijan postotka promjene učestalosti primarno generaliziranih toničkokloničkih napadaja tijekom 28 dana u razdoblju titracije i terapije održavanja (kombinirano) u odnosu na razdoblje prije randomizacije bio je veći uz perampanel (-76,5%) nego uz placebo (-38,4%), P<0,0001.
English: Push down and turn cap to open bottle.
Croatian: Bocu otvorite tako da zatvarač pritisnete prema dolje i zakrenete.
English: The oral dosing syringes are graduated in 0.5 ml increments.
Croatian: Štrcaljke za usta graduirane su po 0,5 ml.
English: Each carton contains one bottle, two 20 mL graduated oral dosing syringes and an LDPE press-in bottle adapter (PIBA).
Croatian: Jedna kutija sadrži jednu bocu, dvije graduirane dozirne štrcaljke za usta od 20 ml i jedan LDPE nastavak za utiskivanje u bocu (PIBA).
English: The adverse reaction most commonly leading to discontinuation (≥ 2% in the perampanel group and greater than placebo) was dizziness.
Croatian: Nuspojava koja je najčešće dovela do prekida liječenja (≥2% u skupini koja je primala perampanel i više nego u skupini koja je primala placebo) bila je omaglica.
English: - If you have missed less than 7 days of treatment with Fycompa, continue taking your daily tablet as originally instructed by your doctor.
Croatian: - Ako ste propustili uzimati Fycompu manje od 7 dana, nastavite svakodnevno uzimati tabletu kako Vam je na početku preporučio liječnik.
English: Film coating (2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg tablets) Hypromellose 2910, talc, Macrogol 8000, titanium dioxide (E171), colourants*
Croatian: Film-ovojnica (tablete od 2 mg, 4 mg, 6 mg, 8 mg, 10 mg i 12 mg) hipromeloza 2910, talk, makrogol 8000, titanijev dioksid (E171), bojila*
English: A statistically significant effect on the reduction in 28-day seizure frequency (Baseline to Treatment Phase) as compared to the placebo group was observed with perampanel treatment at doses of 4 mg/day (Study 306), 8 mg/day (Studies 304, 305 and 306), and 12 mg/day (Studies 304 and 305).
Croatian: Statistički značajan učinak na smanjenje učestalosti napadaja tijekom 28 dana (početna faza do faze liječenja) opažen je uz liječenje perampanelom u dozi od 4 mg na dan (ispitivanje 306), 8 mg na dan (ispitivanja 304, 305 i 306) i 12 mg na dan (ispitivanja 304 i 305) u usporedbi sa skupinom koja je primala placebo.
English: The oral syringe should be inserted into the PIBA and the dose withdrawn from the inverted bottle.
Croatian: Štrcaljku za usta treba umetnuti u nastavak i iz preokrenute boce izvući dozu.
English: In the fertility study in rats, prolonged and irregular oestrous cycles were observed at high-dose (30 mg/kg) in females; however, these changes did not affect the fertility and early embryonic development.
Croatian: U ispitivanjima učinaka na plodnost u štakora, u ženki su opaženi produljeni i neredoviti reproduktivni ciklusi kod visokih doza (30 mg/kg); međutim, te promjene nisu utjecale na plodnost i rani embrionalni razvoj.
English: Perampanel at doses of 4 mg/day to 12 mg/day has been shown to be effective therapy in partial-onset seizures.
Croatian: Pokazalo se da je perampanel u dozama od 4 mg na dan do 12 mg na dan učinkovita terapija kod parcijalnih napadaja.
English: Effect of cytochrome P450 inhibitors on perampanel pharmacokinetics
Croatian: Učinak inhibitora citokroma P450 na farmakokinetiku perampanela
English: Insert the oral syringe into the opening of the adaptor as far as possible.
Croatian: Štrcaljku za usta umetnite što dublje u otvor nastavka.
English: Similar results were seen when all seizures and absence vs. myoclonic seizures were evaluated over time.
Croatian: Slični su rezultati dobiveni kad su se tijekom vremena procjenjivali svi napadaji i apsans napadaji naspram miokloničkih napadaja.
English: Partial-Onset Seizures
Croatian: Parcijalni napadaji
English: In the fertility study in rats, prolonged and irregular oestrous cycles were observed at the maximum tolerated dose (30 mg/kg) in females; however, these changes did not affect fertility and early embryonic development.
Croatian: U ispitivanjima učinaka na plodnost kod štakora, u ženki su bili primijećeni produljeni i nepravilni reproduktivni ciklusi pri maksimalnoj podnošljivoj dozi (30 mg/kg); međutim, ove promjene nisu utjecale na plodnost i rani embrionalni razvoj.
English: If any of these happens, talk to your doctor or pharmacist.
Croatian: Ako se dogodi nešto od navedenog, obratite se svom liječniku ili ljekarniku.