FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane kao: vrlo često (≥ 1/10); često (≥ 1/100 i < 1/10); manje često (≥ 1/1000 i < 1/100); rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
English: You should not take Numient capsules at intervals of less than 4 hours apart
Croatian: Ne smijete uzimati kapsule Numienta u intervalima manjim od 4 sata
English: All efficacy data is based on 84 patients who completed the study with the exception of patient diary data which is based on 83.
Croatian: Svi podaci o djelotvornosti temelje se na 84 bolesnika koji su završili ispitivanje s iznimkom dnevničkih podataka bolesnika koji se temelje na 83 bolesnika.
English: Further increases should be individualized based on clinical response.
Croatian: Daljnja povećanja treba individualizirati na temelju kliničkog odgovora.
English: Minimum dosing frequency was four times per day for at least 4 weeks upon entry into the trial.
Croatian: Najmanja učestalost doziranja bila je četiri puta dnevno u trajanju od najmanje 4 tjedna nakon ulaska u ispitivanje.
English: After opening the bottle, use within 90 days.
Croatian: Nakon otvaranja boce, upotrijebite unutar 90 dana.
English: This can cause muscle problems, fever and mental changes.
Croatian: To može izazvati mišićne probleme, vrućicu i duševne promjene.
English: Carbidopa is approximately 36% bound to plasma proteins.
Croatian: Karbidopa je otprilike 36 % vezana za proteine plazme.
English: What Numient looks like and contents of the pack
Croatian: Kako Numient izgleda i sadržaj pakiranja
English: In case of an overdose, you may feel confused or agitated, and your heart rate may be slower or faster than normal.
Croatian: U slučaju predoziranja, možete se osjećati smeteno ili uznemireno i otkucaji Vašeg srca mogu biti sporiji ili brži od normalnog.
English: Therefore, do not take Numient and iron supplements or multivitamin supplements containing iron at the same time.
Croatian: Stoga, ne uzimajte Numient i dodatke željeza ili multivitaminske dodatke koji sadrže željezo u isto vrijeme.
English: Do not break, crush or chew the capsules
Croatian: Nemojte lomiti, drobiti niti žvakati kapsule
English: It cannot be excluded that heating may change the properties of the medicinal product.
Croatian: Ne može se isključiti mogućnost da zagrijavanje može promijeniti svojstva lijeka.
English: Numient can be taken with or without food.
Croatian: Numient se može uzimati sa ili bez hrane.
English: Each capsule strength may be used alone, or in combination with other capsule strengths as required.
Croatian: Svaka jačina kapsule može se primjenjivati sama ili, prema potrebi, u kombinaciji s kapsulama drugih jačina.
English: However, your doctor may decide to give you Numient if the expected benefits of treatment outweigh possible risks to the unborn child.
Croatian: Međutim, Vaš liječnik može Vam odlučiti propisati Numient ako je očekivana korist liječenja veća od mogućih rizika za nerođeno dijete.
English: Do not stop taking Numient suddenly
Croatian: Nemojte prestati uzimati Numient iznenada
English: These two metabolites are primarily eliminated in the urine unchanged or as glucuronide.
Croatian: Ova se dva metabolita primarno eliminiraju nepromijenjeni u mokraći ili kao glukuronid.
English: Very common (may affect more than 1 in 10 people)
Croatian: Vrlo često (mogu se javiti kod više od 1 na 10 osoba)
English: Levodopa is bound to plasma protein only to a small extent (10-30%).
Croatian: Levodopa je vezana za protein plazme samo u malom opsegu (10 - 30 %).
English: Amneal Pharma Europe Ltd 70 Sir John Rogerson's Quay Dublin 2
Croatian: Ltd 70 Sir John Rogerson's Quay Dublin 2
English: Pyridoxine is not effective in reversing the actions of this combination medicinal product.
Croatian: Piridoksin nije učinkovit u suzbijanju djelovanja ovog kombiniranog lijeka.
English: In between these periods, all patients received open-label Numient treatment for 1 week.
Croatian: Između tih razdoblja, svi bolesnici su primali otvoreno liječenje Numientom tijekom 1 tjedna.
English: What Numient is and what it is used for What you need to know before you take Numient How to take Numient
Croatian: Što je Numient i za što se koristi Što morate znati prije nego počnete uzimati Numient Kako uzimati Numient
English: Numient should be administered with a glass of water and can be taken with or without food.
Croatian: Numient se mora primijeniti s čašom vode i može se uzimati sa ili bez hrane.
English: Therefore, the medicinal product should not be heated or added to hot food.
Croatian: Zbog toga se lijek ne smije zagrijavati ni dodavati u toplu hranu.
English: Do not heat the medicine/food mixture and do not sprinkle the contents of the capsule on hot food.
Croatian: Nemojte zagrijavati mješavinu lijek/hrana i nemojte posipati sadržaj kapsule na toplu hranu.
English: Alcohol interaction
Croatian: Interakcija s alkoholom
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Croatian: Daljnje zbrinjavanje mora biti provedeno prema kliničkoj indikaciji ili u skladu s preporukama nacionalnog centra za kontrolu trovanja, gdje je dostupno.
English: However, dose adjustments may be required (see section 4.5).
Croatian: Međutim, može biti potrebna prilagodba doze (vidjeti dio 4.5).
English: Data in the ASCEND-PD study were analysed using a standard mixed-model analysis of variance.
Croatian: Podaci u ispitivanju ASCEND-PD analizirani su standardnim miješanim modelom analize varijance.
English: Therapy should be individualized and adjusted for each patient according to the desired therapeutic response.
Croatian: Terapiju se mora individualizirati i prilagoditi svakom bolesniku u skladu sa željenim terapijskim odgovorom.
English: If you have had levodopa before, your doctor will determine the appropriate starting dose regimen based on your current levodopa dose
Croatian: Ako ste uzimali levodopu prije, Vaš će liječnik odlučiti o odgovarajućem režimu početne doze na temelju
English: Main study results are summarized in Table 5.
Croatian: Rezultati Glavni rezultati ispitivanja sažeti su u Tablici 5.
English: There was no evidence of period, sequence/carry-over effects in the ASCEND-PD study (p-values all > 0.10).
Croatian: Nije bilo dokaza o periodičnim učincima sekvence/prijenosa za ispitivanje ASCEND-PD (sve p-vrijednosti > 0,10).
English: Epidemiological studies have shown that patients with Parkinson's disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population.
Croatian: Epidemiološka ispitivanja pokazala su da bolesnici s Parkinsonovom bolešću imaju veći rizik (2 do otprilike 6 puta veći) od razvoja melanoma nego opća populacija.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o ažuriranju sigurnosti Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenim člankom 107(c) stavkom 7 Direktive 2001/83/EZ i svim sljedećim nadopunama objavljenim na europskom internetskom portalu za lijekove.
English: Desiccant is included in the bottle.
Croatian: Sredstvo za sušenje nalazi se u boci.
English: Concurrent use can, however, cause a worsening of involuntary motor disorders.
Croatian: Međutim, istodobna primjena može izazvati pogoršanje nevoljnih motoričkih poremećaja.
English: CGI-C much improved (95% CI)
Croatian: CGI-C jako poboljšanje (95 % CI)
English: If you take more Numient than you should (or someone has accidentally ingested Numient) talk to your doctor or pharmacist immediately.
Croatian: Ako uzmete više Numienta nego što ste trebali (ili netko slučajno proguta Numient) odmah razgovarajte sa svojim liječnikom ili ljekarnikom.
English: Depending on how you respond to treatment your doctor may then increase your dose on day four
Croatian: Ovisno o tome kakav je Vaš odgovor na liječenje, Vaš liječnik Vam može povisiti dozu četvrtog dana
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX/CARTON
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA/KARTON
English: Avoid taking your capsules at the same time that you consume a high fat or high protein meal.
Croatian: Izbjegavajte uzimati kapsule istodobno s obrokom s visokim udjelom masti ili proteina.
English: It does not cross the blood-brain barrier and does not affect the metabolism of levodopa within the central nervous system.
Croatian: Ona ne prelazi barijeru krv-mozak i ne utječe na metabolizam levodope unutar središnjeg živčanog sustava.
English: Following an initial peak at about one hour, plasma concentrations are maintained for about 4 to 5 hours before declining.
Croatian: Nakon početne vršne vrijednosti postignute za oko jedan sat, koncentracije u plazmi održane su oko 4 do 5 sati prije opadanja.
English: LCE treatment was converted into Numient over a 6-week period.
Croatian: Liječenje LCE-om prevedeno je u Numient tijekom 6tjednog razdoblja.
English: IR L-dopa†
Croatian: IR L-dopa† Numient
English: Periodic skin examinations performed by appropriately qualified individuals (e.g., dermatologists) are recommended.
Croatian: Preporučuju se periodični pregledi kože koje provode kvalificirane osobe (npr. dermatolozi).
English: Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Croatian: Obavijestite svog liječnika ako Vi ili Vaša obitelj/njegovatelj primijetite da razvijate nagon ili žudnju za ponašanjem na načine koji su za Vas neuobičajeni ili ne možete odoljeti impulsu, porivu ili iskušenju za neke aktivnosti koje mogu biti štetne za Vas ili druge.
English: a) For the UPDRS, higher scores indicate greater severity of impairment b) All values based on 361 patients from the Intent to Treat population who had valid End of Study values c) Negative numbers indicate improvement as compared with the baseline value d) Three times per day e) P-value is less than 0.05 versus placebo
Croatian: a) Za UPDRS, viši rezultati pokazuju veću težinu oštećenja b) Sve se vrijednosti temelje na 361 bolesniku iz populacije bolesnika koji se namjeravaju liječiti koji su imali važeće vrijednosti na kraju ispitivanja c) Negativni brojevi pokazuju poboljšanje u usporedbi s početnom vrijednošću d) Tri puta dnevno e) P-vrijednost manja je od 0,05 naspram placeba
English: Your doctor may need to review your treatments.
Croatian: Vaš će liječnik možda morati ponovno ispitati
English: False negative results might be obtained upon application of glucose-oxidase methods for glucosuria.
Croatian: Lažno negativni rezultati mogu se dobiti nakon primjena metoda glukoze oksidaze za glukozuriju.
English: This is because other medicines can affect the way Numient works.
Croatian: To je zbog toga jer neki lijekovi mogu utjecati na način djelovanja Numienta.
English: Depending on how you respond to treatment your doctor may then either increase or decrease your dose and adjust your dosing frequency
Croatian: Ovisno o tome kakav je Vaš odgovor na liječenje, Vaš liječnik Vam može povisiti ili sniziti dozu i prilagoditi učestalost Vašeg doziranja
English: This reaction does not change upon boiling the urine sample.
Croatian: Ova se reakcija ne mijenja zagrijavanjem uzorka mokraće do vrenja.
English: Whether the increased risk observed was due to Parkinson's disease or other factors, such as medicinal products used to treat Parkinson's disease, is unclear.
Croatian: Nije jasno je li povećani rizik opažen zbog Parkinsonove bolesti ili drugih faktora, kao što su lijekovi primijenjeni za liječenje Parkinsonove bolesti.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Numient in all subsets of the paediatric population in the treatment of idiopathic Parkinson's disease (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je izuzela obvezu podnošenja rezultata ispitivanja lijeka Numient u svim podskupinama pedijatrijske populacije u liječenju idiopatske Parkinsonove bolesti (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Levodopa has been associated with somnolence and episodes of sudden sleep onset (see section 4.7).
Croatian: Levodopa je povezana sa somnolencijom i epizodama iznenadnog nastupa sna (vidjeti dio 4.7).
English: In both studies the primary endpoint was the percentage “off” time during waking hours.
Croatian: U oba ispitivanja primarni ishod bio je postotak „off“ razdoblja (razdoblja bez uzimanja lijeka) u budnom stanju.
English: Do not take Numient if you have taken a medicine called a ‘non-selective monoamine oxidase (MAO) inhibitor' for treating depression in the last 14 days.
Croatian: Numient ako ste uzeli lijek koji se naziva „neselektivni inhibitor monoaminooksidaze (MAO)“ za liječenje depresije u zadnjih 14 dana.
English: Patients may experience new or worsening mental status and behavioural changes, which may be severe, including psychotic-like and suicidal behaviour during levodopa treatment or after starting or increasing the dose of levodopa.
Croatian: Bolesnici mogu iskusiti nov ili pogoršan mentalni status i promjene u ponašanju, koje mogu biti teške, uključujući psihotično i suicidalno ponašanje tijekom liječenja levodopom ili nakon početka ili povećanja doze levodope.
English: Numient capsules are supplied in plastic bottles with a dessicant and a plastic cap, available in bottles of 25, 100 or 240 hard capsules.
Croatian: Numient kapsule isporučuju se u plastičnim bocama sa sredstvom za upijanje vlage, dostupno u bocama od 25, 100 ili 240 tvrdih kapsula.
English: UPDRSII-III score
Croatian: Rezultat UPDRSII-III
English: A total of 393 patients (mean age 63.2 years; 65% male patients) were randomized.
Croatian: Randomizirano je ukupno 393 bolesnika (srednja vrijednost dobi je 63,2 godine; 65 % bolesnika muškog spola).
English: These inhibitors must be discontinued at least two weeks prior to initiating therapy (see section 4.5).
Croatian: Primjena tih inhibitora mora se prekinuti najmanje dva tjedna prije uvođenja terapije (vidjeti dio 4.5).
English: Treatment, sequence and period were included as fixed effects, intra- and inter subject factors were included as random effects.
Croatian: Liječenje, slijed i razdoblje uključeni su kao fiksni učinci, čimbenici unutar i između ispitanika uključeni su kao nasumični učinci.
English: In such patients, cardiac function should be monitored with particular care during the period of initial dose adjustment.
Croatian: . U takvih se bolesnika, s naročitom pažnjom mora pratiti srčana funkcija tijekom razdoblja početne prilagodbe doze.
English: Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i na boci nakon Rok valjanosti.
English: The extent of absorption of levodopa (AUCinf) was similar (13% increase) to that observed in the fasted state.
Croatian: Opseg apsorpcije levodope (AUCinf) bio je sličan (13 % povećanje) onom opaženom natašte.
English: Ferrous salts
Croatian: Soli željeza
English: Week 30 (or at early termination)
Croatian: 30. tjedan (ili kod ranog prekida)
English: Numient is not recommended during pregnancy and in women of childbearing potential not using contraception, unless the benefits for the mother outweigh the possible risks to the foetus.
Croatian: Numient se ne preporučuje tijekom trudnoće i u žena reproduktivnog potencijala koje ne koriste kontracepciju, osim ako koristi za majku nisu veće od mogućeg rizika za dijete.
English: Effect of levodopa and carbidopa on the metabolism of other medicinal products
Croatian: Učinak levodope i karbidope na metabolizam drugih lijekova
English: A total of 471 included patients had been maintained on a stable regimen of at least 400 mg per day of levodopa prior to entry into the trial.
Croatian: Ukupno 471 uključenih bolesnika održavano je na stabilnom režimu od najmanje 400 mg levodope dnevno prije ulaska u ispitivanje.
English: A dose adjustment of levodopa may be required.
Croatian: Može biti potrebna prilagodba doze levodope.
English: In the ADVANCE-PD study, the Clinical Global Impression of Change was also assessed.
Croatian: U ispitivanju ADVANCE-PD mjere ishoda također su procijenjene ljestvicom Clinical Global Impression of Change.
English: Thus, impaired renal function may potentially have a small effect on the exposure of levodopa.
Croatian: Stoga, oštećena bubrežna funkcija može potencijalno imati malen učinak na izloženost levodopi.
English: Dose (mg), median (range)
Croatian: Doza (mg), medijan (raspon)
English: Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Croatian: Bolesnici koji su imali somnolenciju i/ili epizodu iznenadnog nastupa sna moraju se suzdržati od upravljanja vozilom ili rukovanja strojevima.
English: If you forget to take a dose of Numient
Croatian: Ako ste zaboravili uzeti dozu Numienta
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking Numient.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego uzmete Numient.
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Croatian: UVJETI ILI OGRANIČENJA VEZANO UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
English: The combination may be associated with severe orthostatic hypotension.
Croatian: Kombinacija se može povezati s teškom ortostatskom hipotenzijom.
English: If you stop taking Numient
Croatian: Ako prestanete uzimati Numient
English: Within each frequency category, the adverse reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake kategorije učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: It prevents metabolism of levodopa to dopamine in the peripheral circulation, ensuring that a higher proportion of the dose reaches the brain, where dopamine exerts its therapeutic effects.
Croatian: Ona sprječava metabolizam levodope u dopamin u perifernoj cirkulaciji, osiguravajući da viši udio doze stigne u mozak gdje dopamin vrši svoje terapijske učinke.
English: Suggested initial dose of Numient
Croatian: Preporučena početna doza Numienta
English: Electrocardiographic monitoring should be instituted and the patient should be observed carefully for the development of arrhythmias; if required, give appropriate antiarrhythmic therapy.
Croatian: Mora se započeti elektrokardiografsko praćenje i bolesnika se mora pažljivo nadzirati zbog mogućeg razvoja aritmija; ako je potrebno, dati odgovarajuću antiaritmičku terapiju.
English: If therapy is interrupted temporarily, the usual dose should be administered as soon as the patient is able to take oral medicinal products.
Croatian: Ako je terapija prekinuta privremeno, uobičajena doza se mora primijeniti čim je bolesnik sposoban uzimati lijekove kroz usta.
English: Ferrous salts can form chelates with levodopa and carbidopa.
Croatian: Soli željeza mogu formirati kelate s levodopom i karbidopom.
English: The most frequently recorded concomitant medicinal products for Parkinson's disease in randomized patients were dopamine agonists (64%), and MAO inhibitors (37%).
Croatian: Najčešće zabilježeni istodobno uzimani lijekovi za Parkinsonovu bolest u randomiziranih bolesnika bili su agonisti dopamina (64 %) i MAO inhibitori (37 %).
English: Levodopa may have a major influence on the ability to drive and use machines.
Croatian: Levodopa može imati značajan utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
English: These medicines include isocarboxazid and phenelzine.
Croatian: Ti lijekovi uključuju izokarboksazid i fenelzin.
English: This abnormal thinking and behaviour can consist of one or more of a variety of manifestations including anxiety, depression, paranoid ideation, delusions, hallucinations, confusion, psychotic-like behaviour, disorientation, aggressive behaviour, agitation, and delirium.
Croatian: Ovakvo abnormalno razmišljanje i ponašanje može se sastojati od jedne ili više varijacija manifestacija uključujući anksioznost, depresiju, paranoidne ideacije, deluzije, halucinacije, konfuziju, psihotično ponašanje, dezorijentiranost, agresivno ponašanje, agitaciju i delirij.
English: Numient is a modified-release hard capsule.
Croatian: Numient je tvrda kapsula s prilagođenim oslobađanjem.
English: For this reason, large doses of levodopa are required for adequate therapeutic effect and these may often be accompanied by nausea and other adverse reactions, some of which are attributable to dopamine formed in extracerebral tissues.
Croatian: Zbog toga, potrebne su velike doze levodope za odgovarajući terapijski učinak, a to često može biti praćeno mučninom i drugim nuspojavama, od kojih se neke mogu pripisati dopaminu koji se stvara u ekstracerebralnom tkivu.
English: If this applies to you, do not take Numient and ask your doctor or pharmacist for advice.
Croatian: Ako se to odnosi na Vas, ne uzimajte Numient te Vašeg liječnika ili ljekarnika pitajte za savjet.
English: The medicinal product/food mixture should be swallowed completely and immediately without chewing and should not be stored for future use.
Croatian: Mješavinu lijeka/hrane mora se progutati u cijelosti i odmah, bez žvakanja i ne smije se pohraniti za buduću primjenu.
English: Use of this medicinal product with other levodopa containing medicinal products has not been studied.
Croatian: Primjena ovog lijeka s drugim lijekovima koji sadrže levodopu nije ispitivana.
English: The main secondary endpoints included “off” time, “on” time without troublesome dyskinesia, and UPDRS Parts II+III score.
Croatian: Glavni sekundarni ishodi uključivali su „off“ razdoblje, „on“ razdoblje bez neugodne diskinezije i rezultat UPDRS dijelove II+III.
English: No effects were seen on male or female reproductive organs in repeat dose toxicology studies in mice, rats or monkeys with levodopa alone, or in combination with carbidopa.
Croatian: Nisu uočeni učinci na muške ili ženske reproduktivne organe u ispitivanjima toksičnosti ponovljene doze u miševa, štakora ili majmuna samo s levodopom ili u kombinaciji s karbidopom.
English: Numient is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
Croatian: Numient je povezan sa somnolencijom, a vrlo rijetko je povezan s pretjeranom dnevnom somnolencijom te epizodama iznenadnog nastupa sna.
English: Peak plasma concentrations are reached at about 4.5 hours.
Croatian: Vršne vrijednosti koncentracije u plazmi dostignute su za oko 4,5 sata.
English: The safety and efficacy of Numient in children under 18 years of age have not been established.
Croatian: Sigurnost i učinkovitost Numienta u djece mlađe od 18 godina nisu ustanovljene.
English: The terminal phase elimination half-life of carbidopa is approximately 2 hours.
Croatian: Poluvrijeme terminalne faze eliminacije karbidope je otprilike 2 sata.
English: If you must undergo surgery, please tell your doctor that you are using Numient.
Croatian: Ako se morate podvrgnuti operativnom zahvatu, molim obavijestite svog liječnika da uzimate Numient.
English: EXP After opening the bottle, use within 90 days.
Croatian: Nakon otvaranja bočice upotrijebiti u roku od 90 dana.