FrancophonIA/ELRC3.0 huggingface dataset:
English: Following an initial peak at about one hour, plasma concentrations are maintained for about 4 to 5 hours before declining.
Slovenian: Ko je dosežena najvišja koncentracija po približno eni uri, se koncentracija v plazmi ohranja približno 4 do 5 ur, preden se začne manjšati.
English: If therapy is interrupted temporarily, the usual dose should be administered as soon as the patient is able to take oral medicinal products.
Slovenian: Če se zdravljenje prekine začasno, je treba začeti dajati običajni odmerek takoj, ko bolnik lahko jemlje peroralna zdravila.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnih neželenih učinkih zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
English: These two metabolites are primarily eliminated in the urine unchanged or as glucuronide.
Slovenian: Ta presnovka se izločata predvsem z urinom, nespremenjena ali v obliki glukuronida.
English: Other medicines and Numient
Slovenian: Druga zdravila in zdravilo Numient
English: The efficacy and safety of Numient in patients with advanced stage Parkinson's disease have been evaluated in 2 double-blind, active-controlled studies: parallel study ADVANCE-PD (study IPX066-B09-02; 22 weeks) and cross-over study ASCEND-PD (study IPX066-B-09-06 Part 1; 11 weeks).
Slovenian: Učinkovitost in varnost zdravila Numient pri bolnikih z napredovalo Parkinsonovo boleznijo so ocenili v 2 dvojno slepih, z aktivno kontrolo nadzorovanih študijah: študiji vzporednih skupin ADVANCE-PD (študija IPX066-B09-02; 22 tednov) in študiji navzkrižnih skupin ASCEND-PD (študija IPX066-B-09-06, 1. del; 11 tednov).
English: Do not stop taking or change your dose of Numient without talking to your doctor first even if you feel better.
Slovenian: Ne prenehajte jemati zdravila Numient in ne spremenite odmerka, ne da bi se pred tem posvetovali z zdravnikom, tudi če se počutite boljše.
English: UPDRSII-III score
Slovenian: Rezultat UPDRSII-III
English: Depending on how you respond to treatment your doctor may then either increase or decrease your dose and adjust your dosing frequency
Slovenian: Glede na to, kako se odzivate na zdravljenje, lahko zdravnik po tem poveča ali zmanjša odmerek in spremeni pogostnost jemanja zdravila.
English: Levodopa may have a major influence on the ability to drive and use machines.
Slovenian: Levodope ima lahko pomemben vpliv na sposobnost vožnje in upravljanja s stroji.
English: *In the ADVANCE-PD study an Analysis of Covariance (ANCOVA) model for End of Study was used with treatment and centres as main effects and interaction term for treatment by centre and baseline as covariate.
Slovenian: * Pri študiji ADVANCE-PD so uporabili model za analizo kovariance (ANCOVA) za konec študije, kjer sta zdravljenje in ustanova ključna vpliva, člen interakcije za zdravljenje glede na ustanovo in izhodišče pa kovariat.
English: CGI-C much improved (95% CI)
Slovenian: Vrednost p Močno izboljšan rezultat CGI-C (95-odstotni IZ)
English: You should not take Numient capsules at intervals of less than 4 hours apart
Slovenian: Kapsul zdravila Numient ne smete jemati v presledkih, krajših od 4 ur.
English: Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Slovenian: Bolniki, pri katerih se je pojavila somnolenca in/ali epizoda nenadnega nastopa spanja, morajo opustiti vožnjo ali upravljanje vozil in strojev.
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.
Slovenian: Ne jemljite zdravila Numient, če ste v zadnjih 14 dneh vzeli zdravilo, imenovano »neselektivni zaviralec monoaminoksidaze« (MAO) za zdravljenje depresije.
English: Therefore, Numient should not be taken at the same time as high protein meals.
Slovenian: Zdravila Numient se torej ne sme jemati hkrati z obroki, bogatimi z beljakovinami.
English: The most frequently reported adverse reactions with Numient were nausea, occurring in approximately 12% of all patients; dizziness, headache, and dyskinesia, each occurring in approximately 8% of all patients; and insomnia, occurring in approximately 6% of all patients.
Slovenian: Najpogostejši neželeni učinki, o katerih so poročali pri uporabi zdravila Numient, so bili navzea, ki se je pojavljala pri približno 12 % vseh bolnikov; omotica, glavobol in diskinezija, ki so se pojavljali pri približno 8 % vseh bolnikov, in nespečnost, ki se je pojavljala pri približno 6 % vseh bolnikov.
English: There was no evidence of period, sequence/carry-over effects in the ASCEND-PD study (p-values all > 0.10).
Slovenian: V študiji ASCEND-PD ni bilo dokazanih vplivov obdobja/prehoda (vse vrednosti p > 0,10).
English: Each capsule strength may be used alone, or in combination with other capsule strengths as required.
Slovenian: Vsako jakost kapsul lahko uporabljate samostojno ali po potrebi v kombinaciji z drugimi jakostmi kapsul.
English: Anticholinergic medicinal products can work synergistically with levodopa, in order to improve tremor.
Slovenian: Antiholinergična zdravila lahko delujejo sinergistično z levodopo, tako da se izboljša tremor.
English: Dose (mg), median (range)
Slovenian: Odmerek (mg), mediana (razpon)
English: Further, high protein meals may impair clinical response by decreasing the absorption of levodopa (see section 4.5).
Slovenian: Nadalje obroki, bogati z beljakovinami, lahko zavrejo klinični odziv tako, da zmanjšajo absorpcijo levodope (glejte poglavje 4.5).
English: Numient can cause somnolence (excessive drowsiness) and sudden sleep onset episodes.
Slovenian: Zdravilo Numient lahko povzroča somnolenco (čezmerno dremavost) in epizode nenadnega nastopa spanca.
English: The most frequently recorded concomitant medicinal products for Parkinson's disease in randomized patients were dopamine agonists (64%), and MAO inhibitors (37%).
Slovenian: Najpogostejši sočasni zdravili proti Parkinsonovi bolezni pri randomiziranih bolnikih so bila agonisti dopamina (64 %) in zaviralci MAO (37 %).
English: Following this dose conversion, 91 study patients (mean age: 64.1 years; 75% male patients) were randomized to receive Numient followed by prestudy LCE or vice versa.
Slovenian: Po zamenjavi odmerka so 91 bolnikov v študiji (povprečna starost: 64,1 leta; 75 % moških bolnikov) randomizirali, tako da so prejemali zdravilo Numient in nato predštudijsko zdravljenje z LCE ali obratno.
English: Treatment, sequence and period were included as fixed effects, intra- and inter subject factors were included as random effects.
Slovenian: Zdravljenje, zaporedje in obdobje so bili vključeni kot fiksni vplivi, faktorji pri posameznih bolnikih in med bolniki pa kot naključni vplivi.
English: Depending on how you respond to treatment your doctor may then increase your dose on day four
Slovenian: Glede na to, kako se odzivate na zdravljenje, lahko zdravnik po tem četrti dan poveča odmerek.
English: Peak plasma concentrations are reached at about 4.5 hours.
Slovenian: Največje koncentracije v plazmi so dosežene po približno 4,5 ure.
English: 4.9 Overdose
Slovenian: 4.9 Prevelik odmerek
English: These medicines include isocarboxazid and phenelzine.
Slovenian: Ta zdravila vsebujejo izokarboksazid in 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.
Slovenian: Te nenormalne misli in vedenje lahko vključuje eno ali več manifestacij, kot so tesnoba, depresija, paranoidne misli, deluzije, halucinacije, zmedenost, vedenje, podobno psihozi, dezorientiranost, agresivno vedenje, nemir in delirij.
English: The pharmacokinetics of Numient were evaluated following single doses in healthy subjects and following single and multiple doses in patients with Parkinson's disease.
Slovenian: Farmakokinetiko zdravila Numient so ocenili po jemanju enkratnih odmerkov pri zdravih preizkušancih ter po jemanju enkratnih in večkratnih odmerkov pri bolnikih s Parkinsonovo boleznijo.
English: Avoid taking your capsules at the same time that you consume a high fat or high protein meal.
Slovenian: Izogibajte se jemanju kapsul takrat, kadar zaužijete obrok z veliko maščobami ali beljakovinami.
English: Use of this medicinal product with other levodopa containing medicinal products has not been studied.
Slovenian: Uporaba tega zdravila skupaj z drugimi zdravili, ki vsebujejo levodopo, ni raziskana.
English: Numient can be taken with or without food.
Slovenian: Zdravilo Numient lahko jemljete s hrano ali brez nje.
English: System organ class Very Common
Slovenian: Organski sistem Zelo pogosti
English: If you must undergo surgery, please tell your doctor that you are using Numient.
Slovenian: Če vam morajo opraviti kirurški poseg, povejte zdravniku, da uporabljate zdravilo Numient.
English: The terminal phase elimination half-life of carbidopa is approximately 2 hours.
Slovenian: Končna razpolovna doba karbidope je približno 2 uri.
English: Thus, impaired renal function may potentially have a small effect on the exposure of levodopa.
Slovenian: Zato ima lahko okvarjeno delovanje ledvic majhen potencialni učinek na izpostavitev levodope.
English: Numient contains two different medicines called levodopa and carbidopa in one hard capsule.
Slovenian: Zdravilo Numient vsebuje dve različni učinkovini, imenovani levodopa in karbidopa v eni trdi kapsuli.
English: For the reasons stated above, patients and prescribing physicians are advised to monitor for melanomas frequently and on a regular basis when using levodopa/carbidopa, especially in patients with suspicious, undiagnosed skin lesions or a history of melanoma.
Slovenian: Zaradi navedenih razlogov se bolnikom in zdravnikom svetuje, da pri uporabi levodope/karbidope redno in pogosto spremljajo morebiten pojav melanoma, zlasti pri bolnikih s sumljivimi, nediagnosticiranimi lezijami na koži ali melanomom v anamnezi.
English: In a study of one breastfeeding mother with Parkinson's disease, excretion of levodopa in human milk was reported.
Slovenian: V študiji z eno doječo materjo s Parkinsonovo boleznijo so poročali o izločanju levodope v mleko.
English: Renal excretion of intact levodopa accounts for only about 10% of clearance.
Slovenian: Izločanje nespremenjene levodope skozi ledvice predstavlja samo približno 10 % očistka.
English: Carbidopa is excreted in rat milk, but it is not known whether carbidopa or its metabolites are excreted in human breast milk.
Slovenian: Karbidopa se izloča v mleko pri podganah, vendar ni znano, ali se karbidopa ali njeni presnovki izločajo v mleko pri človeku.
English: Numient is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
Slovenian: Zdravilo Numient je povezano s somnolenco ter je zelo redko povezano s pretirano dnevno somnolenco in epizodami nenadnega nastopa spanca.
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.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: Dose recommendations should be followed at initiation of treatment and adapted according to clinical response.
Slovenian: Priporočila za odmerjanje je treba upoštevati na začetku zdravljenja in nato odmerjanje prilagoditi glede na klinični odziv.
English: Phenytoin and papaverine
Slovenian: Fenitoin in papaverin
English: The final total daily dose of levodopa from Numient is about double that of the final total daily dose of levodopa from immediate release tablets while the final total daily dose of levodopa from Numient is about three times that of the final total daily dose of levodopa from the combination of levodopa/DDC inhibitor/entacapone.
Slovenian: Končni skupni dnevni odmerek levodope iz zdravila Numient je približno dvakrat večji od končnega skupnega dnevnega odmerka levodope iz tablet s takojšnjim sproščanjem, medtem ko je končni skupni dnevni odmerek levodope iz zdravila Numient približno trikrat večji od končnega skupnega dnevnega odmerka iz kombinacije levodopa/zaviralca DDC/entakapona.
English: These inhibitors must be discontinued at least two weeks prior to initiating therapy (see section 4.5).
Slovenian: Uporabo teh zaviralcev je treba prekiniti vsaj dva tedna pred začetkom zdravljenja (glejte poglavje 4.5).
English: There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and levodopa/carbidopa.
Slovenian: Obstajajo redka poročila o neželenih učinkih, vključno s hipertenzijo in diskenizijo, ki so posledica sočasne uporabe tricikličnih antidepresivov in levodope/karbidope.
English: If you forget to take a dose of Numient
Slovenian: Če ste pozabili vzeti odmerek zdravila Numient
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.
Slovenian: Povejte zdravniku, če opazite (sami ali to opazijo vaši svojci ali skrbniki), da se je pri vas pojavila potreba ali želja, da se vedete nenavadno ali se ne morete upreti nagonu, težnji ali skušnjavi, da storite nekaj, kar lahko škodi vam ali drugim.
English: Numient is not recommended during pregnancy and in women of childbearing potential not using contraception.
Slovenian: Uporaba zdravila Numient ni priporočljiva med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
English: LCE treatment was converted into Numient over a 6-week period.
Slovenian: Zdravljenje z LCE so v 6-tedenskem obdobju zamenjali z zdravilom Numient.
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.
Slovenian: Zato so za ustrezen terapevtski učinek potrebni veliki odmerki levodope, te pa pogosto lahko spremljajo navzea in drugi neželeni učinki, med katerimi lahko nekatere pripišemo dopaminu, ki nastaja v zunajmožganskih tkivih.
English: Adverse reactions are listed below by system organ class (SOC) and frequency (Table 3).
Slovenian: Spodaj navedeni neželeni učinki so razvrščeni po organskih sistemih (OS) in pogostnosti (preglednica 3).
English: Electrocardiographic monitoring should be instituted and the patient should be observed carefully for the development of arrhythmias; if required, give appropriate antiarrhythmic therapy.
Slovenian: Treba je uvesti spremljanje elektrokardiograma in pozorno opazovati morebiten razvoj aritmij pri bolniku; po potrebi uporabite ustrezno terapijo proti aritmiji.
English: Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone), benzodiazepines and isoniazid may reduce the therapeutic effects of levodopa.
Slovenian: Antagonisti dopaminskih receptorjev D2 (npr. fenotiazini, butirofenoni, risperidon), benzodiazepini in izoniazid lahko zmanjšajo terapevtski učinek levodope.
English: The main secondary endpoints included “off” time, “on” time without troublesome dyskinesia, and UPDRS Parts II+III score.
Slovenian: Glavni sekundarni opazovani dogodki so vključevali čas »izklopa«, čas »vklopa« brez moteče diskinezije ter rezultat 2. in 3. dela UPDRS.
English: Impulse control disorders
Slovenian: Motnje nadzora impulzivnega vedenja
English: Adverse reactions observed in the clinical development of Numient
Slovenian: Neželeni učinki, ki so jih opazili pri kliničnem razvoju zdravila Numient
English: Therefore, do not take Numient and iron supplements or multivitamin supplements containing iron at the same time.
Slovenian: Zato ne jemljite hkrati zdravila Numient in nadomestkov železa ali nadomestkov vitaminov, ki vsebujejo železo.
English: Women should not breast-feed during treatment with Numient.
Slovenian: Ženske med zdravljenjem z zdravilom Numient ne smejo dojiti.
English: Carbidopa is metabolized to two main metabolites: α-methyl-3-methoxy-4-hydroxyphenylpropionic acid and α-methyl-3, 4-dihydroxy-phenylpropionic acid.
Slovenian: Karbidopa se presnavlja v dva glavna presnovka: α-metil-3-metoksi-4-hidroksifenilpropionsko kislino in α-metil-3, 4-dihidroksi-fenilpropionsko kislino.
English: Pharmacotherapeutic group: Anti-Parkinson drugs, dopaminergic agents, ATC code: N04BA02
Slovenian: Farmakoterapevtska skupina: antiparkinsoniki, dopaminergiki, oznaka ATC: N04BA02 Mehanizem delovanja
English: Abbreviations: CGI-C: clinical global impression of change from baseline; CI: confidence interval; IR: immediate release; LCE: Levodopa/Carbidopa/Entacapone; L-dopa†: Levodopa/Carbidopa; LS: least squares; PD: Parkinson's disease; SD: standard deviation; N/A: not available; hrs: hours; yrs: years.
Slovenian: Okrajšave: CGI-C: klinični globalni vtis o spremembi glede na izhodišče; IZ: interval zaupanja; IR: takojšnje sproščanje; LCE: levodopa/karbidopa/entakapon; L-dopa†: levodopa/karbidopa; LS: najmanjši kvadrati; PB: Parkinsonova bolezen; SD: standardni odklon; h: ure; let: leta.
English: The effectiveness of Numient in patients with early Parkinson's disease was established in a randomized, double-blind, placebo-controlled, fixed-dose, parallel-group, 30-week clinical trial in 381 patients who had a median disease duration of 1 year and limited or no prior exposure to levodopa and dopamine agonists.
Slovenian: Učinkovitost zdravila Numient pri bolnikih z zgodnjo Parkinsonovo boleznijo so ugotavljali v randomiziranem, dvojno slepem, s placebom nadzorovanem, 30-tedenskem kliničnem preskušanju s fiksnim odmerkom, ki je potekalo v vzporednih skupinah pri 381 bolnikih, pri katerih je bila mediana trajanja bolezni 1 leto ter pri katerih je bila izpostavitev levodopi in agonistom dopamina pred preskušanjem omejena ali pa je ni bilo.
English: Levodopa/carbidopa may make it harder for your body to use iron.
Slovenian: Zaradi levodope/karbidope lahko telo težje uporabi železo.
English: Following oral dosing of the modified-release levodopa/carbidopa medicinal product the maximum concentration occurred at approximately 3.5 hours.
Slovenian: Po peroralnem odmerjanju zdravila s prirejenim sproščanjem, ki vsebuje levodopo/karbidopo, je bila največja koncentracija dosežena po približno 3,5 ure.
English: Addition of other medicinal products for the treatment of Parkinson's disease
Slovenian: Dodajanje drugih zdravil za zdravljenje Parkinsonove bolezni
English: These behaviours are called impulse control disorders and can include addictive gambling, excessive eating or spending, an abnormally high sex drive or an increase in sexual thoughts or feelings.
Slovenian: Tako vedenje se imenuje motnja nadzora impulzivnega vedenja in lahko vključuje čezmerno predajanje igram na srečo, čezmerno hranjenje ali zapravljanje, nenormalno visoko spolno slo ali več razmišljanja o spolnosti.
English: In the pharmacokinetic studies conducted in patients following a single dose of Numient, systemic exposure to levodopa generally increased with increasing age with AUC values being, on average, approximately 15% higher in elderly (≥65 years) than younger subjects (<65 years).
Slovenian: V farmakokinetičnih študijah, ki so jih izvedli pri bolnikih po enkratnih odmerkih zdravila Numient, se je sistemska izpostavitev levodope na splošno povečala s starostjo, tako da so vrednosti AUC bile v povprečju približno 15 % večje pri starejših bolnikih (≥ 65 let) kot pri mlajših preizkušancih (< 65 let).
English: The combination may be associated with severe orthostatic hypotension.
Slovenian: Kombinacija teh zdravil je lahko povezana s hudo ortostatsko hipotenzijo.
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.
Slovenian: Kapsule zdravila Numient so pakirane v plastične vsebnike s sušilnim sredstvom in plastično zaporko; na voljo so v vsebnikih po 25, 100 ali 240 trdih kapsul.
English: Dark urine, urinary incontinence
Slovenian: Bolezni sečil retencija urina temen urin, urinska inkontinenca
English: Medicinal products containing levodopa cause dyskinesias that may require treatment adjustment.
Slovenian: Zdravila, ki vsebujejo levodopo, lahko povzročijo diskinezijo, zaradi katere je treba prilagoditi zdravljenje.
English: Further increases should be individualized based on clinical response.
Slovenian: Dodatno povečanje odmerka je treba prilagoditi posameznikom glede na klinični odziv.
English: A dose adjustment of levodopa may be required.
Slovenian: Morda bo treba prilagoditi odmerek levodope.
English: Avoid taking your capsules with a high fat meal or one high in protein since this will delay the time it takes for the medicine to work.
Slovenian: Izogibajte se jemanju kapsul skupaj z obroki, bogatimi z maščobami ali beljakovinami, saj to upočasni čas, potreben, da zdravilo začne delovati.
English: Concomitant use of antipsychotics should be monitored carefully for worsening of Parkinson's motor symptoms especially when D2-receptor antagonists are used (see section
Slovenian: Pri sočasni uporabi antipsihotikov je treba pozorno spremljati morebitno poslabšanje motoričnih simptomov Parkinsonove bolezni, zlasti pri uporabi antagonistov D2-receptorjev (glejte poglavje 4.5).
English: Carbidopa is approximately 36% bound to plasma proteins.
Slovenian: Vezava karbidope na beljakovine v plazmi je približno 36-odstotna.
English: The addition of carbidopa to levodopa reduces the peripheral effects (nausea, vomiting) due to decarboxylation of levodopa; however, carbidopa does not decrease the adverse reactions due to the central effects of levodopa.
Slovenian: Uporaba karbidope skupaj z levodope zmanjša periferne učinke (navzeo, bruhanje) zaradi dekarboksilacije levodope, vendar karbidopa ne zmanjša neželenih učinkov, ki so posledica delovanja levodope v osrednjem živčevju.
English: Suggested initial dose of Numient
Slovenian: Priporočeni začetni odmerek zdravila Numient
English: When levodopa is administered orally, it is rapidly decarboxylated to dopamine in extracerebral tissues so that only a small portion of a given dose is transported unchanged to the central nervous system.
Slovenian: Kadar se levodope daje peroralno, se hitro dekarboksilira v dopamin v zunajmožganskih tkivih, zato se samo majhen delež zaužitega odmerka transportira nespremenjen v osrednje živčevje.
English: Each of the three modified-release levodopa/carbidopa treatments was statistically significantly superior to placebo on the primary measure (Table 4).
Slovenian: Vsaka izmed treh terapij z zdravilom s prirejenim sproščanjem, ki vsebuje levodopo/karbidopo, je bila statistično pomembno učinkovitejša od placeba pri primarni meritvi (preglednica 4).
English: The addition of entacapone to levodopa/carbidopa has been demonstrated to increase the levodopa bioavailability by 30%.
Slovenian: Ugotovljeno je, da dodajanje entakapona levodopi/karbidopi poveča biološko uporabnost levodope za 30 %.
English: ASCEND-PD (cross-over)
Slovenian: ASCEND-PD (navzkrižna študija)
English: The two major metabolic pathways are decarboxylation by dopa decarboxylase (DDC) and O-methylation by catechol-O-methyltransferase (COMT).
Slovenian: Dve glavni presnovni poti sta dekarboksilacija z dopa-dekarboksilazo (DDC) in O-metilacija s katehol-O-metil-transferazo.
English: In studies in advanced Parkinson's disease patients, there is limited data using doses above 2,450 mg of levodopa and 612.5 mg of carbidopa given as Numient.
Slovenian: V študijah pri bolnikih z napredovalo Parkinsonovo boleznijo so podatki o uporabi odmerkov, ki presegajo 2.450 mg levodope in 612,5 mg karbidope v obliki zdravila Numient, omejeni.