FrancophonIA/ELRC3.0 huggingface dataset:
English: In the first study, ANORO ELLIPTA 55/22 micrograms demonstrated a statistically significant and clinically relevant improvement (based on a minimal clinically important difference (MCID) between 45 to 85 seconds) over placebo in exercise endurance time (EET) obtained 3 hours after dosing at Week 12 (69.4 seconds [p=0.003]).
Slovenian: [MCID - minimal clinically important difference] med 45 in 85 sekund) čas obremenitvene vzdržljivosti (EET - exercise endurance time), dosežen 3 ure po uporabi (69,4 sekunde [p = 0,003]).
English: Less than 1% of the orally administered dose (1% of recovered radioactivity) was excreted in urine, suggesting negligible absorption following oral administration.
Slovenian: najdene radioaktivnosti) se je izločil v urinu; to kaže zanemarljivo absorpcijo po peroralni uporabi.
English: In one 6-month Phase III study, ANORO ELLIPTA demonstrated statistically significant improvements in trough FEV1 (primary endpoint) at Week 24 compared with placebo and each monotherapy component treatment arm.
Slovenian: V eni 6-mesečni študiji III. faze je zdravilo ANORO ELLIPTA v primerjavi s placebom in vsako od obeh sestavin v monoterapiji po 24 tednih statistično značilno izboljšalo
English: If you get tightness of the chest, coughing, wheezing or breathlessness immediately after using your ANORO ELLIPTA inhaler:
Slovenian: Če se vam takoj po uporabi inhalatorja ANORO ELLIPTA pojavi tiščanje v prsih, kašelj, piskajoče dihanje ali težko dihanje:
English: ANORO ELLIPTA 55 micrograms/22 micrograms inhalation powder, pre-dispensed umeclidinium/vilanterol
Slovenian: ANORO ELLIPTA 55 mikrogramov/22 mikrogramov prašek za inhaliranje, odmerjeni umeklidinij/vilanterol
English: ANORO ELLIPTA contains lactose
Slovenian: Zdravilo ANORO ELLIPTA vsebuje laktozo
English: No clinically relevant effects on plasma glucose were observed in clinical studies with umeclidinium/vilanterol at the recommended therapeutic dose.
Slovenian: V kliničnih študijah kombinacije umeklidinij/vilanterol v priporočenih terapevtskih odmerkih niso opazili klinično pomembnih učinkov na koncentracijo glukoze v plazmi.
English: Each delivered dose contains 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms vilanterol (as trifenatate).
Slovenian: En oddani odmerek vsebuje 55 mikrogramov umeklidinija (to ustreza 65 mikrogramom umeklidinijevega bromida) in 22 mikrogramov vilanterola (v obliki trifenatata).
English: • Risk Management Plan (RMP)
Slovenian: • Redno posodobljena poročila o varnosti zdravila (PSUR)
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 65 micrograms umeclidinium bromide equivalent to 55 micrograms of umeclidinium and 22 micrograms of vilanterol (as trifenatate).
Slovenian: Ena inhalacija zagotavlja oddani odmerek (odmerek, ki pride iz ustnika inhalatorja) 65 mikrogramov umeklidinijevega bromida, kar ustreza 55 mikrogramom umeklidinija, in 22 mikrogramov vilanterola (v obliki trifenatata).
English: The proportion of patients who responded with at least the MCID in SGRQ score (defined as a decrease of 4 units from baseline) at Week 24 was greater for ANORO ELLIPTA (49%) compared with placebo (34%) and each monotherapy component (44% for umeclidinium and 48% for vilanterol).
Slovenian: Po 24 tednih zdravljenja je bil delež bolnikov, ki so dosegli vsaj MCID v seštevku SGRQ (opredeljen kot zmanjšanje za 4 enote od izhodišča), pri zdravilu ANORO ELLIPTA večji (49 %) v primerjavi s placebom
English: Cardiovascular effects, such as cardiac arrhythmias e.g. atrial fibrillation and tachycardia, may be seen after the administration of muscarinic receptor antagonists and sympathomimetics, including umeclidinium/vilanterol.
Slovenian: Po uporabi antagonistov muskarinskih receptorjev in simpatikomimetikov, vključno s kombinacijo umeklidinij/vilanterol, se lahko pojavijo učinki na srce in ožilje, npr. motnje srčnega ritma, kakršni sta atrijska fibrilacija in tahikardija.
English: ANORO ELLIPTA 55/22 mcg inhalation powder umeclidinium/vilanterol
Slovenian: ANORO ELLIPTA 55/22 µg prašek za inhaliranje umeklidinij/vilanterol
English: - if you have diabetes
Slovenian: če imate sladkorno bolezen, če imate hudo okvaro jeter.
English: The patient should be advised to not open the tray until they are ready to inhale a dose.
Slovenian: Bolniku je treba naročiti, naj ne odpira embalaže,
English: If you get eye pain or discomfort, temporary blurring of vision, visual halos or coloured images in association with red eyes during treatment with ANORO ELLIPTA:
Slovenian: Če se vam med zdravljenjem z zdravilom ANORO ELLIPTA pojavijo bolečine ali neugodje v očesu,
English: GlaxoSmithKline, S.A. Tel: + 34 902 202 700 es-ci@gsk.com
Slovenian: Tel: + 34 902 202 700 es-ci@gsk.com
English: ANORO ELLIPTA has also shown an improvement in health-related quality of life measured using the St. George's Respiratory Questionnaire (SGRQ) as indicated by a reduction in SGRQ total score at Week 24 compared with placebo and each monotherapy component (see Table 1).
Slovenian: Zdravilo ANORO ELLIPTA je izboljšalo tudi kakovost življenja povezano z zdravjem, merjeno z vprašalnikom SGRQ (St. George's Respiratory Questionnaire).
English: In the three 6-month active-comparator-controlled studies, ANORO ELLIPTA reduced the use of rescue medication with salbutamol compared with tiotropium, with statistically significant reductions observed in two of the studies (see Table 1).
Slovenian: zmanjšalo uporabo rešilnega zdravila s salbutamolom v primerjavi s tiotropijem; v dveh od teh treh študij je bilo zmanjšanje statistično značilno (glejte preglednico 1).
English: Each inhaler contains either 7 or 30 doses.
Slovenian: En inhalator vsebuje ali 7 ali
English: In the second study, ANORO ELLIPTA 55/22 micrograms showed improvements compared with placebo in change from baseline in lung volume measures at trough and at 3 hours post dose at Week 12 (inspiratory capacity: 198 ml and 238 ml respectively, residual volume: -295 ml and -351 ml respectively and functional residual capacity: -238 ml and -302 ml respectively); all p<0.001∗).
Slovenian: (inspiratorna kapaciteta: 198 ml oziroma 238 ml, rezidualni volumen: -259 ml oziroma -351 ml in funkcionalna rezidualna kapaciteta: -238 ml oziroma -302 ml, vse p < 0,001∗).
English: Patients with moderate hepatic impairment (Child-Pugh Class B) showed no evidence of an increase in systemic exposure to either umeclidinium or vilanterol (Cmax and AUC) following administration of umeclidinium/vilanterol with umeclidinium at twice the recommended dose and vilanterol at the recommended dose and no evidence of altered protein binding between patients with moderate hepatic impairment and healthy volunteers.
Slovenian: (umeklidinij v dvakratnem priporočenem odmerku in vilanterol v priporočenem odmerku) niso ugotovili večje sistemske izpostavljenosti umeklidiniju ali vilanterolu (Cmax in AUC); prav tako pri bolnikih z zmerno okvaro jeter v primerjavi z zdravimi prostovoljci niso ugotovili znakov spremenjene vezave na beljakovine.
English: ANORO ELLIPTA also demonstrated a greater increase from baseline in the proportion of days when no rescue medication was needed in all three studies (average within the range 17.6% to 21.5%) compared with tiotropium (average within the range 11.7% to 13.4%).
Slovenian: (povprečje v razponu od 17,6 % do 21,5 %), v primerjavi s tiotropijem (povprečje v razponu od 11,7 % do
English: Oropharyngeal pain Dysphonia
Slovenian: Porazdelitev Umeklidinij
English: Therefore, no clinically relevant pro-arrhythmic potential related to QT-interval prolongations was observed with umeclidinium/vilanterol 113/22 micrograms.
Slovenian: Pri uporabi kombinacije umeklidinij/vilanterol v odmerku 113/22 mikrogramov tako podaljšanje intervala QT ni imelo klinično pomembnih proaritmičnih učinkov.
English: Each single inhalation provides a delivered dose (the dose leaving the mouthpiece) of 55 micrograms umeclidinium (equivalent to 65 micrograms of umeclidinium bromide) and 22 micrograms of vilanterol (as trifenatate)
Slovenian: Z enim vdihom dobite odmerek (odmerek, ki pride iz ustnika) 55 mikrogramov umeklidinija (to ustreza 65 mikrogramom umeklidinijevega bromida) in 22 mikrogramov vilanterola (v obliki trifenatata).
English: Wait to open the cover until you are ready to inhale your dose.
Slovenian: Pokrovček odprite šele, ko ste pripravljeni, da uporabite odmerek.
English: In Phase III, 6-month studies umeclidinium/vilanterol provided clinically meaningful improvements over placebo in lung function (as measured by forced expiratory volume in 1 second [FEV1]) over 24 hours following once daily administration, which were evident at 15 minutes following administration of the first dose (improvement over placebo by 112 ml (p <0.001*).
Slovenian: Šestmesečne študije III. faze so pokazale, da kombinacija umeklidinij/vilanterol v primerjavi s placebom klinično pomembno izboljša pljučno funkcijo (merjeno s forsiranim ekspiracijskim volumnom v 1. sekundi
English: How to store ANORO ELLIPTA
Slovenian: Shranjevanje zdravila ANORO ELLIPTA
English: Anaphylaxis, angioedema, and urticaria
Slovenian: slabost, hiperglikemija in hipokaliemija).
English: What ANORO ELLIPTA is used for
Slovenian: Za kaj uporabljamo zdravilo ANORO ELLIPTA
English: The ELLIPTA inhaler consists of a light grey body, red mouthpiece cover and a dose counter, packed into a foil laminate tray containing a silica gel desiccant sachet.
Slovenian: ELLIPTA Inhalator je sestavljen iz svetlo sivega ohišja, rdečega pokrovčka ustnika in števca odmerkov.
English: No dose adjustment is required in patients with renal impairment.
Slovenian: Okvara ledvic Bolnikom z okvaro ledvic odmerka ni treba prilagoditi.
English: In addition, no clinically significant effects on cardiac rhythm were observed on 24-hour Holter monitoring in 53 patients with COPD who were treated with umeclidinium/vilanterol 55/22 micrograms once daily in
Slovenian: Poleg tega niso opazili klinično pomembnih vplivov na srčni ritem s 24-urno holtersko monitorizacijo pri
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj orofaringealna bolečina disfonija pogosti pogosti občasni
English: Your ANORO ELLIPTA inhaler carton contains
Slovenian: Škatla vašega zdravila ANORO ELLIPTA vsebuje
English: This leaflet
Slovenian: Na podtipu
English: • hoarseness.
Slovenian: • tresavica,
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE OUTER CARTON (WITHOUT BLUE BOX- MULTIPACK ONLY) 55 micrograms/22 micrograms
Slovenian: VMESNA ZUNANJA OVOJNINA (BREZ MODREGA OKENCA - SAMO PAKIRANJE Z VEČ INHALATORJI)
English: • tremor
Slovenian: • hripavost.
English: Renal and urinary disorders Urinary retention Dysuria
Slovenian: Bolezni sečil zastoj urina dizurija obstrukcija iztočnega dela sečnega mehurja redki redki redki
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Slovenian: D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČ
English: Least squares mean
Slovenian: Povprečje po metodi najmanjših kvadratov
English: The total treatment period was 17 weeks.
Slovenian: Celotno obdobje zdravljenja je bilo 17 tednov.
English: The available data are insufficient to reach any conclusions.
Slovenian: Podatki, ki so na voljo, ne zadostujejo za sprejemanje kakršnihkoli zaključkov.
English: After first opening: 90 days.
Slovenian: Po prvem odprtju: 90 dni.
English: Date of first authorisation: 23/07/2012 Date of latest renewal: 6 April 2017
Slovenian: Datum prve odobritve: 23/07/2012 Datum zadnjega podaljšanja: 6. april 2017
English: Elderly (65 years of age and above)
Slovenian: Starejši bolniki (stari 65 let in več)
English: - Oral contraceptives (also called “hormonal contraceptives”).
Slovenian: - Peroralni kontraceptivi (imenovani tudi „hormonski kontraceptivi“).
English: The results in these adolescents were similar to those seen in the adult population.
Slovenian: Rezultati pri teh mladostnikih so bili podobni kot pri odrasli populaciji.
English: There appears to be an increased risk of falls, particularly in the elderly; the underlying reason is unclear.
Slovenian: Kaže, da je tveganje za padce večja, zlasti pri starejših; osnovni razlog ni jasen.
English: The safety and effectiveness are not yet known in this age group.
Slovenian: Varnost in učinkovitost v tej starostni skupini še nista znani.
English: It may also cause you to have unusual or extreme changes in behaviour or mood.
Slovenian: Povzroči lahko tudi neobičajne in izjemne spremembe vedenja ali razpoloženja.
English: Shake for at least 5 seconds before use.
Slovenian: Pred uporabo vsaj 5 sekund stresajte.
English: EXP After first opening: use within 90 days.
Slovenian: EXP Po prvem odprtju: uporabite v 90 dneh.
English: This was not statistically significant (p = 0.96).
Slovenian: To ni bilo statistično značilno (p = 0,96).
English: <10% decrease
Slovenian: < 10 % zmanjšanje
English: * See section 4.4
Slovenian: * Glejte poglavje 4.4
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for perampanel.
Slovenian: Mehanizem tveganja ni znan in podatki, ki so na voljo, ne izključujejo povečanega tveganja za perampanel.
English: You may experience confusion, agitation and aggressive behaviour.
Slovenian: Pojavijo se lahko zmedenost, vznemirjenost in agresivno vedenje.
English: Levels peaked at one hour and were 3.65 times the levels in plasma.
Slovenian: Najvišja raven je bila dosežena po eni uri in je bila 3,65-krat višja od ravni v plazmi.
English: It should not be chewed, crushed or split.
Slovenian: Ne sme se je žvečiti, drobiti ali deliti.
English: Of the 140 subjects who completed the Study 332, 114 subjects (81.4%) had entered the Extension phase.
Slovenian: Od 140 oseb, ki so zaključile študijo 332, je 114 oseb (81,4 %) vstopilo v podaljšano fazo.
English: If you have any suspension left in the bottle more than 90 days after it was first opened, you should not use it.
Slovenian: Če v plastenki ostane suspenzija dlje kot 90 dni po prvem odprtju, je ne smete uporabiti.
English: It may be taken with or without food, but preferably always under the same conditions.
Slovenian: Lahko se jemlje s hrano ali brez nje, vendar po možnosti vedno v enakih okoliščinah.
English: It has been given to you by your doctor to reduce the number of fits that you have.
Slovenian: Dal vam ga je vaš zdravnik, da bi se zmanjšalo število napadov, ki jih imate.
English: The mean average daily dose was 10.05 mg.
Slovenian: Srednji povprečen dnevni odmerek je bil 10,05 mg.
English: Study 332 included 22 adolescents between the ages of 12 and 18.
Slovenian: Študija 332 je zajela 22 mladostnikov starosti od 12 do 18 let.
English: The effect of these interactions on average steady state concentration is summarised in the following table.
Slovenian: Učinki teh interakcij na povprečno koncentracijo v stanju dinamičnega ravnovesja so povzeti v naslednji preglednici.
English: Of these, 14 patients (27%) reverted to adjunctive therapy in the following months.
Slovenian: Od teh je 14 bolnikov (27 %) v naslednjih mesecih prešlo nazaj na adjuvantno zdravilo.
English: *The colourants are:
Slovenian: *Barvila so:
English: It may be taken with or without food (see section 5.2).
Slovenian: Zdravilo se lahko vzame s hrano ali brez nje (glejte poglavje 5.2).
English: If this happens to you, do not drive or use any tools or machines.
Slovenian: Če opazite te učinke, ne vozite avta in ne uporabljajte orodja ali strojev.
English: Cognitive function
Slovenian: Kognitivne funkcije
English: Women of childbearing potential and contraception in males and females
Slovenian: Ženske v rodni dobi in kontracepcija pri moških in ženskah
English: In view of its long half-life, the effects caused by perampanel could be prolonged.
Slovenian: Ob upoštevanju dolgega razpolovnega časa se lahko učinki, ki jih povzroči perampanel, podaljšajo.
English: The cap fits properly when the PIBA is in place.
Slovenian: Zaporka se pravilno prilega, ko je PIBA nameščen.
English: You must talk to your doctor about the effect of your epilepsy on driving and using machines.
Slovenian: Z zdravnikom se morate posvetovati o učinkih vaše epilepsije na vožnjo in upravljanje s stroji.
English: The majority of these patients had a history of partial onset seizures.
Slovenian: Večina teh bolnikov je imela anamnezo parcialnih napadov.
English: This includes medicines obtained without a prescription and herbal medicines.
Slovenian: To vključuje tudi zdravila, ki ste jih kupili brez recepta, in zeliščna zdravila.
English: - Fycompa may make you more likely to fall over, particularly if you are an older person; this might be due to your illness.
Slovenian: - Zaradi zdravila Fycompa se lahko poveča možnost padca, zlasti, če ste starejša oseba; vzrok za to je lahko vaša bolezen.
English: Oral suspension White to off-white suspension
Slovenian: peroralna suspenzija bela do belkasta suspenzija
English: The tmax was delayed by approximately 1 hour compared to that under fasted conditions.
Slovenian: Tmax je bil podaljšan za približno 1 uro v primerjavi s tistim na tešče.
English: Nonclinical data reveal that perampanel was not genotoxic and had no carcinogenic potential.
Slovenian: Predklinični podatki kažejo, da perampanel ni genotoksičen in da nima kancerogenega potenciala.
English: The excretion into breast milk was measured in rats at 10 days post-partum.
Slovenian: Izločanje v materino mleko so izmerili pri podganah 10 dni po kotitvi.
English: The tablets cannot be split accurately as there is no break line.
Slovenian: Tablet ni mogoče natančno deliti, saj nimajo razdelilne zareze.
English: - Fycompa may make you aggressive, angry or violent.
Slovenian: - Zaradi zdravila Fycompa lahko postanete agresivni, jezni ali nasilni.
English: The precise mechanism by which perampanel exerts its antiepileptic effects in humans remains to be fully elucidated.
Slovenian: Natančen mehanizem, s katerim perampanel izvaja svoj antiepileptični učinek pri ljudeh, bo treba še dokončno razjasniti.
English: You should continue doing this for one month after stopping treatment.
Slovenian: tem nadaljujte še en mesec po prenehanju zdravljenja.
English: The following convention has been used for the classification of adverse reactions: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), not known (cannot be estimated from the available data).
Slovenian: Neželeni učinki so razvrščeni po naslednjem dogovoru: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: Decreased appetite Increased appetite
Slovenian: Presnovne in prehranske motnje zmanjšan apetit zvečan apetit
English: If signs and symptoms suggestive of these reactions appear, perampanel should be withdrawn immediately and an alternative treatment considered (as appropriate).
Slovenian: Če se pojavijo znaki in simptomi, ki nakazujejo te reakcije, je treba dajanje perampanela nemudoma prekiniti in razmisliti o drugačnem zdravljenju (kot je primerno).
English: Glutamate is the primary excitatory neurotransmitter in the central nervous system and is implicated in a number of neurological disorders caused by neuronal overexcitation.
Slovenian: Glutamat je primarni ekscitatoren nevrotransmitor v osrednjem živčnem sistemu, ki je vpleten v številnih nevroloških motnjah, ki jih povzroči prevelika nevronska ekscitacija.
English: There was no statistically significant difference between the treatment groups (p = 0.145).
Slovenian: Med tretiranima skupinama ni bilo statistično značilne razlike (p = 0,145).
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX22
Slovenian: Farmakoterapevtska skupina: antiepileptiki, drugi antiepileptiki, oznaka ATC: N03AX22
English: Study drug was given once per day.
Slovenian: Preučevano zdravilo so bolniki prejemali enkrat na dan.
English: These effects may also be seen when Fycompa is used in combination with other central nervous system (CNS) depressants.
Slovenian: Te učinke je mogoče videti tudi pri uporabi zdravila Fycompa v kombinaciji z drugimi zaviralci osrednjega živčnega sistema (OŽS).
English: For example, if you decide to take Fycompa with food, always take it that way.
Slovenian: Na primer, če se odločite, da boste jemali zdravilo Fycompa s hrano, ga vedno jemljite tako.
English: Effect of perampanel on CYP3A substrates
Slovenian: Učinek perampanela na substrate CYP3A
English: A meta-analysis of randomised placebo-controlled trials of anti-epileptic medicinal products has also shown a small increased risk of suicidal ideation and behaviour.
Slovenian: Meta-analiza randomiziranih, s placebom kontroliranih preskušanj antiepileptičnih zdravil je pokazala tudi majhno povečanje tveganja za samomorilne misli in vedenje.
English: Suicidal ideation
Slovenian: Samomorilne misli
English: Cognitive function was assessed by the Cognitive Drug Research (CDR) System Global Cognition t-Score, which is a composite score derived from 5 domains testing Power of Attention, Continuity of Attention, Quality of Episodic Secondary Memory, Quality of Working Memory, and Speed of Memory.
Slovenian: Kognitivne funkcije so ocenjevali z rezultati vrednosti t globalnih kognitivnih funkcij sistema kognitivnih raziskav zdravil (CDR), ki je sestavljen rezultat, izpeljan iz 5 domen, s katerimi se testirali sposobnost pozornosti, stalnost pozornosti, kvaliteto epizodičnega sekundarnega spomina, kvaliteto delovnega spomina in hitrost spomina.
English: In these three trials, subjects had a mean duration of epilepsy of approximately 21.06 years.
Slovenian: V teh treh preskušanjih je epilepsija pri osebah povprečno trajala približno 21,06 let.
English: Subjects had partial-onset seizures with or without secondary generalisation and were not adequately controlled with one to three concomitant AEDs.
Slovenian: Osebe so doživele napade s parcialnim izvorom s sekundarno generalizacijo ali brez nje in niso bile pod ustreznim nadzorom s sočasno uporabo enega do treh AEZ.
English: The tablet should be swallowed whole with a glass of water.
Slovenian: Tableto je treba pogoltniti celo s kozarcem vode.
English: Fycompa contains sorbitol (E420); therefore patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Slovenian: Zdravilo Fycompa vsebuje sorbitol (E420); zato bolniki z redko dedno intoleranco za fruktozo ne smejo jemati tega zdravila.
English: General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
Slovenian: Potrebna je splošna podporna nega bolnika, vključno z nadziranjem življenjskih znakov in opazovanjem kliničnega stanja bolnika.
English: Mood deteriorated following dosing of 12 mg/day only; the changes in mood were small and reflected a general lowering of alertness.
Slovenian: Slabšanje razpoloženja po odmerjanju samo 12 mg/dan; spremembe v razpoloženju so bile majhne in so odražale splošno slabšanje zbranosti.
English: Tell your doctor if you are taking hormonal contraceptives.
Slovenian: Povejte svojemu zdravniku, če jemljete hormonske kontraceptive.
English: Fycompa is available in packs of:
Slovenian: Zdravilo Fycompa je na voljo v pakiranjih po:
English: The population included 164 patients (perampanel N = 82, placebo N = 82).
Slovenian: Populacija je zajemala 164 bolnikov (n = 82 za perampanel in n = 82 za placebo).
English: In urine and faeces, recovered radioactivity was primarily composed of a mixture of oxidative and conjugated metabolites.
Slovenian: V urinu in blatu je bila rekuperirana radioaktivnost primarno sestavljena iz mešanice oksidativnih in konjugiranih presnovkov.
English: This effect should be taken into account and managed when adding or withdrawing these anti-epileptic drugs from a patient's treatment regimen.
Slovenian: Ta učinek je treba upoštevati in nadzorovati, kadar za zdravljenja bolnika ta antiepileptična zdravila dodamo ali odvzamemo.
English: Abuse potential
Slovenian: Možnost zlorabe