FrancophonIA/ELRC3.0 huggingface dataset:
English: Anaphylaxis, angioedema, and urticaria
Croatian: Prašak inhalata, dozirani
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]).
Croatian: U prvom je ispitivanju ANORO ELLIPTA od 55/22 mikrograma u 12. tjednu doveo do statistički značajnog i klinički važnog poboljšanja (na temelju minimalne klinički značajne razlike
English: Vilanterol 22 mcg (N = 421)
Croatian: ANORO ELLIPTA (N = 413) naspram vilanterola 22 µg (N = 421)
English: Inhalation powder, pre-dispensed 1 inhaler of 30 doses
Croatian: 1 inhalator s 30 doza
English: Pharmacotherapeutic group: Drugs for obstructive airway diseases, adrenergics in combination with anticholinergics incl.
Croatian: 5.1 Farmakodinamička svojstva Farmakoterapijska skupina: Lijekovi za liječenje opstruktivnih bolesti dišnih putova, kombinacije adrenergika i antikolinergika uključujući trostruke kombinacije s kortikosteriodima, ATK oznaka: R03AL03
English: However, other beta2-adrenergic agonists are detected in human milk.
Croatian: Međutim, u majčinu su mlijeku otkriveni drugi beta2-adrenergički agonisti.
English: Least squares mean
Croatian: Manje česte nuspojave
English: Placebo (N = 280) ANORO ELLIPTA (N =
Croatian: ANORO ELLIPTA (N = 413) naspram placeba (N = 280) ANORO ELLIPTA (N = 413) naspram umeklidinija 55 µg (N = 418)
English: ANORO ELLIPTA is for inhalation use only.
Croatian: Način primjene ANORO ELLIPTA se primjenjuje isključivo putem inhalacije.
English: TDI Focal Score
Croatian: Ukupan TDI rezultat
English: ANORO ELLIPTA demonstrated a statistically significant and clinically meaningful reduction in breathlessness as evaluated by an increase in TDI focal score at Week 24 (key secondary end-point) compared with placebo (see Table 1).
Croatian: ANORO ELLIPTA je doveo do statistički značajnog i klinički bitnog smanjenja nedostatka zraka, što je ocijenjeno na temelju povećanja ukupnog rezultata Prijelaznog indeksa dispneje (eng.
English: Posology
Croatian: Podložak
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.
Croatian: ELLIPTA inhalator se sastoji od svijetlosivog tijela, crvenog poklopca nastavka za usta i brojača doza,
English: versus
Croatian: OBLIK
English: Excipients: lactose and magnesium stearate See package leaflet for further information
Croatian: Pomoćne tvari: laktoza i magnezijev stearat
English: Bladder outlet obstruction
Croatian: Prijavljivanje nuspojava
English: In inhalation studies in rabbits, vilanterol caused effects similar to those seen with other beta2-adrenergic agonists (cleft palate, open eyelids, sternebral fusion and limb flexure/malrotation) at 6-times the human clinical exposure based on AUC.
Croatian: U inhalacijskim ispitivanjima na kunićima, vilanterol je izazvao učinke slične učincima zabilježenima kod ostalih beta2-adrenergičkih agonista (rascjep nepca,
English: Paradoxical bronchospasm
Croatian: Istodobna primjena s ketokonazolom
English: Following repeat dosing of inhaled umeclidinium, steady state was achieved within 7 to 10 days with 1.5 to 1.8-fold accumulation.
Croatian: stanje dinamičke ravnoteže postignuto je unutar 7 do 10 dana, a kumulacija se povećala za
English: Breast-feeding
Croatian: Hiperglikemija
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Croatian: KUTIJA (POJEDINAČNA PAKIRANJA)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (SINGLE PACKS) 55 micrograms/22 micrograms
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP POKLOPAC PODLOŠKA OD VIŠESLOJNE FOLIJE 55 mikrograma/22 mikrograma
English: The total treatment period was 17 weeks.
Croatian: Ukupno razdoblje liječenja trajalo je 17 tjedana.
English: The available data are insufficient to reach any conclusions.
Croatian: Dostupni podaci nisu dovoljni da bi se mogao donijeti ikakav zaključak.
English: The results in these adolescents were similar to those seen in the adult population.
Croatian: Rezultati u ovih adolescenata bili su slični onima opaženima u odrasle populacije.
English: After first opening: 90 days.
Croatian: Nakon prvog otvaranja: 90 dana.
English: - Oral contraceptives (also called “hormonal contraceptives”).
Croatian: - Oralni kontraceptivi (također se zovu “hormonski kontraceptivi”).
English: It may also cause you to have unusual or extreme changes in behaviour or mood.
Croatian: Osim toga, može Vam prouzročiti neuobičajene ili ekstremne promjene ponašanja ili raspoloženja.
English: It may take a few weeks to find the right dose of Fycompa for you.
Croatian: Može biti potrebno nekoliko tjedana da se pronađe prava doza Fycompe za Vas.
English: If you have any suspension left in the bottle more than 90 days after it was first opened, you should not use it.
Croatian: Ako je u boci ostalo suspenzije i stoji dulje od 90 dana od prvog otvaranja boce, ne smijete je upotrijebiti.
English: This was not statistically significant (p = 0.96).
Croatian: To nije bilo statistički značajno (p=0,96).
English: Oral suspension 340 ml.
Croatian: Oralna suspenzija 340 ml.
English: Suicidal ideation
Croatian: Suicidalna ideacija
English: Shake for at least 5 seconds before use.
Croatian: Prije uporabe protresati najmanje 5 sekundi.
English: * See section 4.4
Croatian: * Vidjeti dio 4.4
English: Elderly (65 years of age and above)
Croatian: Stariji (u dobi od 65 ili više godina)
English: For example, if you decide to take Fycompa with food, always take it that way.
Croatian: Primjerice, ako odlučite Fycompu uzimati s hranom, onda je uvijek uzmite na taj način.
English: It may be taken with or without food (see section 5.2).
Croatian: Može se uzeti s hranom ili bez nje (vidjeti dio 5.2).
English: Injury, poisoning and procedural complications
Croatian: Ozljede, otrovanja i proceduralne komplikacije pad
English: The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for perampanel.
Croatian: Mehanizam ovog rizika nije poznat i dostupni podaci ne isključuju mogućnost povećanog rizika i kod perampanela.
English: Speak to your doctor before drinking alcohol.
Croatian: Obratite se liječniku prije konzumiranja alkohola.
English: Do not drive or use machines until you know how Fycompa affects you.
Croatian: Nemojte upravljati vozilima niti rukovati strojevima dok ne saznate kako Fycompa djeluje na Vas.
English: There appears to be an increased risk of falls, particularly in the elderly; the underlying reason is unclear.
Croatian: Čini se da postoji povećan rizik od padova, osobito u starijih bolesnika; nije jasno koji je razlog u podlozi.
English: Study 332 included 22 adolescents between the ages of 12 and 18.
Croatian: Ispitivanje 332 uključilo je 22 adolescenta u dobi između 12 i 18 godina.
English: - Fycompa may make you aggressive, angry or violent.
Croatian: - Od Fycompe možete postati agresivni, ljuti ili nasilni.
English: Uncommon Not known
Croatian: Manje često Nepoznato
English: and 12 mg (24 ml) depending on your response.
Croatian: (24 ml) - ovisno o Vašem odgovoru.
English: See also section 2.
Croatian: Također vidjeti dio 2.
English: Cognitive function
Croatian: Kognitivna funkcija
English: Of the 140 subjects who completed the Study 332, 114 subjects (81.4%) had entered the Extension phase.
Croatian: Od 140 ispitanika koji su završili ispitivanje 332, 114 ispitanika (81,4%) ušlo je u fazu produžetka ispitivanja.
English: The population included 164 patients (perampanel N = 82, placebo N = 82).
Croatian: Populacija je uključivala 164 bolesnika (perampanel N=82, placebo N=82).
English: How to take
Croatian: Kako uzeti
English: - If you are allergic to perampanel or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na perampanel ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Levels peaked at one hour and were 3.65 times the levels in plasma.
Croatian: Razine su postigle vršnu vrijednost nakon jednog sata i bile su 3,65 puta iznad razine u plazmi.
English: A dose adjustment in the elderly is not considered to be necessary (see section 4.2).
Croatian: Smatra se da prilagodba doze u starijih osoba nije potrebna (vidjeti dio 4.2).
English: Subjects experiencing intolerable adverse events could remain on the same dose or have their dose decreased to the previously tolerated dose.
Croatian: Ispitanici koji su imali nepodnošljive štetne događaje mogli su ostati na istoj dozi ili im se doza mogla sniziti na prethodnu podnošljivu dozu.
English: The safety and efficacy of perampanel in children below 12 years of age have not been established yet.
Croatian: Sigurnost i djelotvornost perampanela u djece u dobi manjoj od 12 godina nisu još ustanovljene.
English: - Fycompa may make you more likely to fall over, particularly if you are an older person; this might be due to your illness.
Croatian: - Fycompa povećava vjerojatnost padova, osobito ako ste starije dobi; to može biti zbog Vaše bolesti.
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).
Croatian: Primijenila se sljedeća konvencija za klasifikaciju nuspojava: vrlo često (≥1/10), često (≥1/100 i <1/10), manje često (≥1/1000 i <1/100), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Nonclinical data reveal that perampanel was not genotoxic and had no carcinogenic potential.
Croatian: Neklinički podaci pokazuju da perampanel nije genotoksičan i nema kancerogeni potencijal.
English: There is no available specific antidote to the effects of perampanel.
Croatian: Ne postoji dostupan specifični antidot za učinke perampanela.
English: The mean average daily dose was 10.05 mg.
Croatian: Prosječna dnevna doza iznosila je 10,05 mg.
English: You may experience confusion, agitation and aggressive behaviour.
Croatian: Možete osjetiti smetenost i uznemirenost i agresivno se ponašati.
English: This includes medicines obtained without a prescription and herbal medicines.
Croatian: To uključuje i lijekove koje ste nabavili bez recepta i biljne pripravke.
English: If this happens to you, do not drive or use any tools or machines.
Croatian: Ako Vam se to dogodi, nemojte upravljati vozilima niti rukovati alatima ili strojevima.
English: It has been given to you by your doctor to reduce the number of fits that you have.
Croatian: Taj lijek Vam je dao liječnik da se smanji broj napadaja koje imate.
English: Alertness and mood
Croatian: Budnost i raspoloženje
English: Wash the oral syringe with clean water and dry thoroughly.
Croatian: Štrcaljku za usta operite čistom vodom i dobro je osušite.
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.
Croatian: Glutamat je primarni ekscitacijski neurotransmiter u središnjem živčanom sustavu i uključen je u brojne neurološke poremećaje uzrokovane pretjeranom neuronskom ekscitacijom.
English: If you take more Fycompa than you should
Croatian: Ako uzmete više Fycompe nego što ste trebali
English: These effects may also be seen when Fycompa is used in combination with other central nervous system (CNS) depressants.
Croatian: Ti se učinci također mogu vidjeti kad se Fycompa primjenjuje u kombinaciji s drugim depresivima središnjeg živčanog sustava (SŽS).
English: Fycompa with alcohol
Croatian: Fycompa s alkoholom
English: Women of childbearing potential and contraception in males and females
Croatian: Žene reproduktivne dobi i kontracepcija u muškaraca i žena
English: Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC code: N03AX22
Croatian: Farmakoterapijska skupina: antiepileptici, drugi antiepileptici, ATK oznaka: N03AX22
English: General supportive care of the patient is indicated including monitoring of vital signs and observation of the clinical status of the patient.
Croatian: Indicirana je opća potporna skrb uključujući praćenje vitalnih znakova i promatranje kliničkog statusa bolesnika.
English: In combination with the lack of age-related difference in perampanel exposure, the results indicate that dose-adjustment in the elderly is not required.
Croatian: U kombinaciji s nedostatkom razlika u izloženosti perampanelu povezanih s dobi, rezultati pokazuju da nije potrebna prilagodba doze u starijih osoba.
English: Fycompa must be titrated, according to individual patient response, in order to optimise the balance between efficacy and tolerability.
Croatian: Fycompa se mora titrirati prema individualnom odgovoru bolesnika kako bi se pronašla optimalna ravnoteža između djelotvornosti i podnošljivosti.
English: You must talk to your doctor about the effect of your epilepsy on driving and using machines.
Croatian: Morate porazgovarati sa svojim liječnikom o učinku epilepsije na Vašu sposobnost upravljanja vozilima i rukovanja strojevima.
English: Fycompa is not recommended for children aged under 12.
Croatian: Fycompa se ne preporučuje za djecu mlađu od 12 godina.
English: The precise mechanism by which perampanel exerts its antiepileptic effects in humans remains to be fully elucidated.
Croatian: Točan mehanizam kojim perampanel iskazuje svoje antiepileptičke učinke u ljudi tek treba razjasniti.
English: You can take Fycompa with or without food.
Croatian: Fycompu možete uzimati s hranom ili bez nje.
English: Oral suspension White to off-white suspension
Croatian: Oralna suspenzija Bijela do gotovo bijela suspenzija.
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Fycompa therapy taking into account the benefit of breast--feeding for the child and the benefit of therapy for the woman.
Croatian: Potrebno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom Fycompa uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: The placental transfer was relatively low; 0.09% or less of administered dose was detected in the foetus.
Croatian: Placentalni prijenos bio je relativno nizak; u fetusu je bilo otkriveno 0,09% ili manje primijenjene doze.
English: There was no statistically significant difference between the treatment groups (p = 0.145).
Croatian: Između terapijskih skupina nije bilo statistički značajne razlike (p=0,145).
English: Mood deteriorated following dosing of 12 mg/day only; the changes in mood were small and reflected a general lowering of alertness.
Croatian: Raspoloženje se pogoršalo samo nakon primjene doze od 12 mg na dan; promjene raspoloženja bile su male i odražavale su opće sniženje budnosti.
English: Tell your doctor if you are taking hormonal contraceptives.
Croatian: Obavijestite svog liječnika ako uzimate hormonske kontraceptive.
English: Date of first authorisation: 23/07/2012 Date of latest renewal: 6 April 2017
Croatian: Datum posljednje obnove odobrenja: 6. travnja 2017.
English: Most of the reported events were either mild or moderate and patients recovered either spontaneously or with dose adjustment.
Croatian: Ti su događaji većinom bili blagi ili umjereni i bolesnici su se oporavili spontano ili uz prilagodbu doze.
English: Before taking this medicine you should tell your doctor if you have a history of alcoholism or drug dependence.
Croatian: Prije uzimanja ovog lijeka morate obavijestiti svog liječnika ako bolujete od alkoholizma ili ovisnosti o drogama.
English: Swallow the tablet whole with a glass of water.
Croatian: Tabletu progutajte cijelu s čašom vode.
English: Fycompa is not recommended in women of childbearing potential not using contraception unless clearly necessary.
Croatian: Fycompa se ne preporučuje u žena reproduktivne dobi koje ne koriste kontracepciju, osim kad je to jasno neophodno.
English: The tablet should be swallowed whole with a glass of water.
Croatian: Tabletu treba progutati cijelu s čašom vode.
English: Your doctor may reduce your dose slowly to avoid your fits (seizures) coming back or getting worse.
Croatian: Liječnik Vam može polako snižavati dozu kako se napadaji ne bi vratili ili pogoršali.
English: However, due to its long half-life and subsequent slow decline in plasma concentrations, perampanel can be discontinued abruptly if absolutely needed.
Croatian: Međutim, zbog dugog poluvijeka i posljedičnog sporog smanjivanja koncentracija u plazmi, primjena perampanela se može naglo prekinuti ako je to apsolutno potrebno.
English: Study drug was given once per day.
Croatian: Ispitivani lijek davao se jedanput na dan.
English: Effect of perampanel on CYP3A substrates
Croatian: Učinak perampanela na supstrate CYP3A
English: The tablets cannot be split accurately as there is no break line.
Croatian: Tablete se ne mogu točno prelomiti, jer nema razdjelne crte.
English: Interactions between Fycompa and other anti-epileptic medicinal products
Croatian: Interakcije između Fycompe i drugih antiepileptičkih lijekova
English: The excretion into breast milk was measured in rats at 10 days post-partum.
Croatian: Izlučivanje u mlijeko mjerilo se u štakora 10 dana nakon okota.
English: Fycompa contains sorbitol (E420); therefore patients with rare hereditary problems of fructose intolerance should not take this medicinal product.
Croatian: Fycompa sadrži sorbitol (E420); stoga bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze ne bi trebali uzimati ovaj lijek.
English: Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic medicinal products in several indications.
Croatian: Suicidalna ideacija i suicidalno ponašanje zabilježeni su u bolesnika liječenih antiepileptičkim lijekovima u nekoliko indikacija.
English: Of these, 14 patients (27%) reverted to adjunctive therapy in the following months.
Croatian: Od tih bolesnika, 14 bolesnika (27%) vraćeno je na dodatno liječenje tijekom sljedećih mjeseci.
English: Primary Generalised Tonic-Clonic Seizures
Croatian: Primarno generalizirani toničko-klonički napadaji
English: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, United Kingdom
Croatian: Eisai Manufacturing Limited, European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN, Ujedinjeno Kraljevstvo
English: Data from in vitro studies indicate that perampanel is approximately 95% bound to plasma proteins.
Croatian: Podaci iz ispitivanja in vitro pokazuju da je perampanel približno 95% vezan za proteine plazme.
English: You should also do this for one month after stopping treatment.
Croatian: Također ih trebate koristiti mjesec dana nakon prestanka liječenja.
English: However, thoughts of harming others, physical assault or threatening behaviour were observed in some patients (<1% in perampanel clinical studies).
Croatian: Međutim, u nekih je bolesnika opažena pojava misli o ozljeđivanju drugih, fizičkom napadu ili prijeteće ponašanje (< 1% u kliničkim ispitivanjima perampanela).
English: This effect should be taken into account and managed when adding or withdrawing these anti-epileptic drugs from a patient's treatment regimen.
Croatian: Taj se učinak mora uzeti u obzir i zbrinuti kad se ti antiepileptički lijekovi dodaju ili uklanjanju iz terapijskog režima bolesnika.
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.
Croatian: Metaanaliza randomiziranih, placebom kontroliranih ispitivanja antiepileptičkih lijekova također je pokazala malo povećan rizik od suicidalne ideacije i suicidalnog ponašanja.
English: It may be taken with or without food, but preferably always under the same conditions.
Croatian: Može se uzimati s hranom ili bez nje, ali poželjno uvijek na isti način.
English: Other medicines and Fycompa
Croatian: Drugi lijekovi i Fycompa
English: If signs and symptoms suggestive of these reactions appear, perampanel should be withdrawn immediately and an alternative treatment considered (as appropriate).
Croatian: U slučaju pojave znakova i simptoma koji upućuju na te reakcije, potrebno je odmah prekinuti primjenu perampanela i razmotriti zamjensko liječenje (ako je prikladno).
English: Patients are advised not to drive a vehicle, operate complex machinery or engage in other potentially hazardous activities until it is known whether perampanel affects their ability to perform these tasks (see sections 4.4 and 4.5).
Croatian: Bolesnicima se savjetuje da ne upravljaju vozilima, ne rukuju složenim strojevima i ne upuštaju se u druge potencijalno opasne aktivnosti dok se ne sazna utječe li perampanel na njihovu sposobnost obavljanja takvih zadataka (vidjeti dio 4.4 i 4.5).
English: No efficacy benefit was observed at the dose of 12 mg as compared to the dose of 8 mg in the overall population.
Croatian: Nije bila opažena veća djelotvornost doze od 12 mg u usporedbi s dozom od 8 mg u ukupne populacije.
English: Single missed dose: As perampanel has a long half-life, the patient should wait and take their next dose as scheduled.
Croatian: Jedna propuštena doza: budući da perampanel ima dugi poluvijek, bolesnik treba pričekati i uzeti sljedeću dozu prema uobičajenom rasporedu.
English: There were no effects on male fertility (see section 5.3).
Croatian: Nije bilo učinaka na plodnost u mužjaka (vidjeti dio 5.3).
English: The safety and effectiveness are not yet known in this age group.
Croatian: Sigurnost i učinkovitost u ove dobne skupine još nisu poznate.
English: A larger decrease in exposure of midazolam (or other sensitive CYP3A substrates) at higher Fycompa doses cannot be excluded.
Croatian: Ne može se isključiti veće smanjenje izloženosti midazolamu (ili drugim osjetljivim supstratima CYP3A) kod viših doza Fycompe.
English: It belongs to a group of medicines called anti-epileptics.
Croatian: Pripada skupini lijekova koji se zovu antiepileptici.
English: The effect of these interactions on average steady state concentration is summarised in the following table.
Croatian: Učinak tih interakcija na prosječnu koncentraciju u stanju dinamičke ravnoteže sažeto je prikazan u sljedećoj tablici.
English: After up to 52 weeks of treatment with perampanel (n = 114), no effect on bone growth was observed.
Croatian: Poslije 52 tjedna liječenja perampanelom (n=114), učinak na rast kostiju nije opažen.
English: If you experience any of the above after taking Fycompa (or you are not sure) talk to your doctor or pharmacist.
Croatian: Ako osjetite nešto od gore navedenog nakon uzimanje Fycompe (ili niste sigurni), obratite se svom liječniku ili ljekarniku.
English: You should use other forms of safe and effective contraception (such as a condom or coil) when taking Fycompa.
Croatian: Trebate upotrebljavati druge oblike sigurne i djelotvorne kontracepcije (kao što su kondom ili spirala) dok uzimate Fycompu.
English: The majority of these patients had a history of partial onset seizures.
Croatian: Većina tih bolesnika imala je parcijalne napadaje u anamnezi.
English: Clinical studies of Fycompa in epilepsy did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
Croatian: Klinička ispitivanja Fycompe kod epilepsije nisu uključila dovoljan broj ispitanika u dobi od 65 ili više godina da bi se moglo utvrditi imaju li oni drugačiji odgovor od mlađih ispitanika.
English: Activation of AMPA receptors by glutamate is thought to be responsible for most fast excitatory synaptic transmission in the brain.
Croatian: Aktivacija AMPA receptora glutamatom smatra se zaslužnom za glavninu brzog ekscitacijskog sinaptičkog prijenosa u mozgu.
English: Blister Pack (PVC/Aluminium blister)
Croatian: Blister pakiranje (PVC/aluminijski blister)
English: - It is used to treat fits that affect one part of your brain (called a “partial seizure”).
Croatian: - Primjenjuje se za liječenje napadaja koji zahvaćaju jedan dio Vašeg mozga (zovu se “parcijalni napadaji”).