natgillin/translations-raw huggingface dataset:
These inhibitors must be discontinued at least two weeks prior to initiating therapy (see section 4.5). 
Primjena tih inhibitora mora se prekinuti najmanje dva tjedna prije uvođenja terapije (vidjeti dio 4.5).
Treatment, sequence and period were included as fixed effects, intra- and inter subject factors were included as random effects. 
Liječenje, slijed i razdoblje uključeni su kao fiksni učinci, čimbenici unutar i između ispitanika uključeni su kao nasumični učinci.
In such patients, cardiac function should be monitored with particular care during the period of initial dose adjustment. 
. U takvih se bolesnika, s naročitom pažnjom mora pratiti srčana funkcija tijekom razdoblja početne prilagodbe doze.
Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP. 
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i na boci nakon Rok valjanosti.
The extent of absorption of levodopa (AUCinf) was similar (13% increase) to that observed in the fasted state. 
Opseg apsorpcije levodope (AUCinf) bio je sličan (13 % povećanje) onom opaženom natašte.
Ferrous salts 
Soli željeza
Week 30 (or at early termination) 
30. tjedan (ili kod ranog prekida)
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. 
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.
Effect of levodopa and carbidopa on the metabolism of other medicinal products 
Učinak levodope i karbidope na metabolizam drugih lijekova
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. 
Ukupno 471 uključenih bolesnika održavano je na stabilnom režimu od najmanje 400 mg levodope dnevno prije ulaska u ispitivanje.
A dose adjustment of levodopa may be required. 
Može biti potrebna prilagodba doze levodope.
In the ADVANCE-PD study, the Clinical Global Impression of Change was also assessed. 
U ispitivanju ADVANCE-PD mjere ishoda također su procijenjene ljestvicom Clinical Global Impression of Change.
Thus, impaired renal function may potentially have a small effect on the exposure of levodopa. 
Stoga, oštećena bubrežna funkcija može potencijalno imati malen učinak na izloženost levodopi.
Dose (mg), median (range) 
Doza (mg), medijan (raspon)
Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. 
Bolesnici koji su imali somnolenciju i/ili epizodu iznenadnog nastupa sna moraju se suzdržati od upravljanja vozilom ili rukovanja strojevima.
If you forget to take a dose of Numient 
Ako ste zaboravili uzeti dozu Numienta
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. 
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.
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
UVJETI ILI OGRANIČENJA VEZANO UZ SIGURNU I UČINKOVITU PRIMJENU LIJEKA
The combination may be associated with severe orthostatic hypotension. 
Kombinacija se može povezati s teškom ortostatskom hipotenzijom.
If you stop taking Numient 
Ako prestanete uzimati Numient
Within each frequency category, the adverse reactions are presented in order of decreasing seriousness. 
Unutar svake kategorije učestalosti, nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
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. 
Ona sprječava metabolizam levodope u dopamin u perifernoj cirkulaciji, osiguravajući da viši udio doze stigne u mozak gdje dopamin vrši svoje terapijske učinke.
Suggested initial dose of Numient 
Preporučena početna doza Numienta
Electrocardiographic monitoring should be instituted and the patient should be observed carefully for the development of arrhythmias; if required, give appropriate antiarrhythmic therapy. 
Mora se započeti elektrokardiografsko praćenje i bolesnika se mora pažljivo nadzirati zbog mogućeg razvoja aritmija; ako je potrebno, dati odgovarajuću antiaritmičku terapiju.
If therapy is interrupted temporarily, the usual dose should be administered as soon as the patient is able to take oral medicinal products. 
Ako je terapija prekinuta privremeno, uobičajena doza se mora primijeniti čim je bolesnik sposoban uzimati lijekove kroz usta.
Ferrous salts can form chelates with levodopa and carbidopa. 
Soli željeza mogu formirati kelate s levodopom i karbidopom.
The most frequently recorded concomitant medicinal products for Parkinson's disease in randomized patients were dopamine agonists (64%), and MAO inhibitors (37%). 
Najčešće zabilježeni istodobno uzimani lijekovi za Parkinsonovu bolest u randomiziranih bolesnika bili su agonisti dopamina (64 %) i MAO inhibitori (37 %).
Levodopa may have a major influence on the ability to drive and use machines. 
Levodopa može imati značajan utjecaj na sposobnost upravljanja vozilima i rada sa strojevima.
These medicines include isocarboxazid and phenelzine. 
Ti lijekovi uključuju izokarboksazid i fenelzin.
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. 
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.
Numient is a modified-release hard capsule. 
Numient je tvrda kapsula s prilagođenim oslobađanjem.
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. 
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.
If this applies to you, do not take Numient and ask your doctor or pharmacist for advice. 
Ako se to odnosi na Vas, ne uzimajte Numient te Vašeg liječnika ili ljekarnika pitajte za savjet.
The medicinal product/food mixture should be swallowed completely and immediately without chewing and should not be stored for future use. 
Mješavinu lijeka/hrane mora se progutati u cijelosti i odmah, bez žvakanja i ne smije se pohraniti za buduću primjenu.
Use of this medicinal product with other levodopa containing medicinal products has not been studied. 
Primjena ovog lijeka s drugim lijekovima koji sadrže levodopu nije ispitivana.
The main secondary endpoints included “off” time, “on” time without troublesome dyskinesia, and UPDRS Parts II+III score. 
Glavni sekundarni ishodi uključivali su „off“ razdoblje, „on“ razdoblje bez neugodne diskinezije i rezultat UPDRS dijelove II+III.
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. 
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.
Numient is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes. 
Numient je povezan sa somnolencijom, a vrlo rijetko je povezan s pretjeranom dnevnom somnolencijom te epizodama iznenadnog nastupa sna.
Peak plasma concentrations are reached at about 4.5 hours. 
Vršne vrijednosti koncentracije u plazmi dostignute su za oko 4,5 sata.
The safety and efficacy of Numient in children under 18 years of age have not been established. 
Sigurnost i učinkovitost Numienta u djece mlađe od 18 godina nisu ustanovljene.
The terminal phase elimination half-life of carbidopa is approximately 2 hours. 
Poluvrijeme terminalne faze eliminacije karbidope je otprilike 2 sata.
If you must undergo surgery, please tell your doctor that you are using Numient. 
Ako se morate podvrgnuti operativnom zahvatu, molim obavijestite svog liječnika da uzimate Numient.
EXP After opening the bottle, use within 90 days. 
Nakon otvaranja bočice upotrijebiti u roku od 90 dana.
Carbidopa does not cross the blood-brain barrier at clinically relevant doses. 
Karbidopa ne prolazi krvno-moždanu barijeru pri klinički relevantnim dozama.
Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment (see section 4.7). 
Bolesnici moraju biti obaviješteni o tome i savjetovani da budu oprezni pri upravljanju vozilom ili rukovanju strojevima tijekom liječenja (vidjeti dio 4.7).
It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body. 
Ona pomaže levodopi da djeluje učinkovitije usporavajući brzinu kojom se levodopa razgrađuje u Vašem tijelu.
Adverse reactions observed in the clinical development of Numient 
Nuspojave zabilježene u kliničkom razvoju Numienta
Levodopa is extensively metabolized to various metabolites. 
Levodopa se u velikoj mjeri metabolizira u različite metabolite.
Numient shows dose proportional pharmacokinetics for both carbidopa and levodopa over the levodopa dose strength range of 95 mg to 245 mg. 
Numient pokazuje farmakokinetiku proporcionalnu dozi i za karbidopu i za levodopu u rasponu jačine doze za levodopu od 95 mg do 245 mg.
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. 
Kada se levodopa primjenjuje kroz usta, ona se brzo dekarboksilira u dopamin u ekstracerebralnom tkivu tako da se samo manji dio dane doze transportira nepromijenjen u središnji živčani sustav.
Doses of a few grams may result in CNS disturbances, with an increasing likelihood of cardiovascular disturbance (e.g. hypotension, sinus tachycardia) and more severe psychiatric problems at higher doses. 
Doze od nekoliko grama mogu rezultirati poremećajima SŽS-a, s povećanom mogućnošću kardiovaskularnih poremećaja (npr. hipotenzije, sinus tahikardije) i pri višim dozama mnogo težim psihijatrijskim problemima.
Anticholinergic medicinal products can work synergistically with levodopa, in order to improve tremor. 
Antikolinergički lijekovi mogu djelovati sinergistički s levodopom kako bi poboljšali tremor.
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. 
Dodavanje karbidope levodopi smanjuje periferne učinke (mučninu, povraćanje) zbog dekarboksilacije levodope; međutim, karbidopa ne smanjuje nuspojave zbog središnjih učinaka levodope.
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. 
Nakon ove konverzije doze randomiziran je 91 bolesnik iz ispitivanja (srednja vrijednost dobi je 64,1 godina; 75 % bolesnika muškog spola) za primanje Numienta kojem je uslijedilo primanje LCE prije ispitivanja ili obrnuto.
NMS is a life-threatening syndrome characterized by fever or hyperthermia and can be associated with rhabdomyolysis. 
NMS je po život opasan sindrom kojeg karakterizira vrućica ili hipertermija i može biti povezan s rabdomiolizom.
Numient can be taken concomitantly with the recommended dose of an MAO inhibitor, which is selective for MAO inhibitor type B such as selegiline and rasagiline. 
Numient se može uzimati istodobno s preporučenom dozom MAO inhibitora, selektivnim za MAO inhibitor tip B, kao što su selegilin i rasagilin.
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. 
Numienta bile su mučnina, koja se javila u otprilike 12 % svih bolesnika; omaglica, glavobolja i diskinezija, od kojih se svaka javila u otprilike 8 % svih bolesnika; te nesanica koja se javila u otprilike 6 % svih bolesnika.
Food interaction 
Interakcija s hranom
Symptomatic postural hypotension has occurred when combinations of levodopa and a decarboxylase inhibitor are added to the treatment of patients already receiving certain antihypertensives. 
Simptomatska posturalna hipotenzija pojavila se kada su kombinacije levodope i inhibitora dopadekarboksilaze dodane liječenju bolesnika koji već primaju određene antihipertenzive.
Mental disturbances 
Mentalni poremećaji
However, levodopa has been shown to mildly affect mating behaviour in male rats. 
Međutim, levodopa je pokazala blagi učinak na ponašanje mužjaka štakora tijekom parenja.
Numient is not recommended during pregnancy and in women of childbearing potential not using contraception. 
Numient se ne proporučuje tijekom trudnoće i u žena u reproduktivnoj dobi koje ne koriste kontracepciju.
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. 
Iz gore navedenih razloga, bolesnicima i liječnicima koji propisuju lijek savjetuje se često i redovno praćenje zbog melanoma kod primjene levodope/karbidope, naročito u bolesnika sa sumnjivim, nedijagnosticiranim kožnim lezijama ili anamnezom melanoma.
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. 
Konačna ukupna dnevna doza levodope iz Numienta je otprilike dvostruko veća od konačne ukupne dnevne doze levodope iz tableta s trenutnim oslobađanjem, dok je konačna ukupna dnevna doza levodope iz Numienta otprilike tri puta veća od konačne ukupne dnevne doze levodope iz kombinacije levodope/DDC inhibitora/entakapona.
Levodopa crosses the blood-brain barrier by active transporters for large neutral amino acids. 
Levodopa prolazi krvnomoždanu barijeru aktivnim prijenosnicima za velike neutralne aminokiseline.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before taking Numient. 
Ako niste sigurni primjenjuje li se nešto od gore navedenog na Vas, obratite se svom liječniku ili ljekarniku prije uzimanja Numienta.
The modified-release hard capsule should be swallowed whole, and not chewed or crushed, in order to maintain the modified-release effect of the levodopa/carbidopa medicinal product. 
Tvrdu kapsulu s prilagođenim oslobađanjem se mora progutati cijelu, a ne žvakati ili drobiti, kako bi se održao učinak prilagođenog oslobađanja lijeka koji sadrži levodopu/karbidopu.
Following oral dosing of the modified-release levodopa/carbidopa medicinal product the maximum concentration occurred at approximately 3.5 hours. 
Nakon peroralnog doziranja lijeka s prilagođenim oslobađanjem levodope/karbidope , maksimalna koncentracija javila se za otprilike 3,5 sata.
Numient can cause somnolence (excessive drowsiness) and sudden sleep onset episodes. 
Numient može izazvati somnolenciju (pretjeranu pospanost) i napadaje iznenadnog nastupa sna.
Levodopa/carbidopa preparations may provide a false-positive test result for ketone bodies, if a test strip is used for determining any ketonuria. 
Pripravci s levodopom/karbidopom mogu uzrokovati lažno pozitivan rezultat pretraga na ketonska tijela ako se koristi test traka za određivanje ketonurije.
The dose was increased starting on Day 4 and the highest target dose (390 mg levodopa/97.5 mg carbidopa TID) was achieved by Day 22. 
Doza je povećana počevši od 4. dana, a najveća ciljna doza (390 mg levodope/97,5 mg karbidope TID) postignuta je do 22. dana.
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). 
U farmakokinetičkim ispitivanjima provedenim u bolesnika nakon pojedinačne doze Numienta, sistemska izloženost levodopi općenito je rasla s porastom godina s vrijednostima AUC u prosjeku, otprilike 15 % višim u starijih (≥ 65 godina) nego u mlađih ispitanika (< 65 godina).
In addition, certain medicinal products used to treat psychosis may exacerbate the symptoms of Parkinson's disease and may decrease the effectiveness of levodopa/carbidopa. 
Pored toga, neki lijekovi koji se koriste za liječenje psihoze mogu uzrokovati egzacerbaciju simptoma Parkinsonove bolesti te smanjiti učinkovitost levodope/karbidope.
Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone), benzodiazepines and isoniazid may reduce the therapeutic effects of levodopa. 
Antagonisti dopaminskih D2 receptora (npr. fenotiazini, butirofenoni, risperidon), benzodiazepini i izoniazid mogu smanjiti terapijski učinak levodope.
One bottle containing 25, 100 or 240 modified-release hard capsules. 
Jedna boca sadrži 25, 100 ili 240 tvrdih kapsula s prilagođenim oslobađanjem
Numient is recommended to be dosed orally, approximately every 6 hours. 
Preporučuje se doziranje Numienta kroz usta, otprilike svakih 6 sati.
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. 
Učinkovitost Numienta u bolesnika u ranom stadiju Parkinsonove bolesti ustanovljena je u randomiziranom, dvostruko slijepom, placebom kontroliranom kliničkom ispitivanju fiksne doze, u paralelnim skupinama u trajanju od 30 tjedana, na 381 bolesniku koji je imao medijan trajanja bolesti 1 godinu i ograničenu ili nikakvu prethodnu izloženost levodopi i agonistima dopamina.
Levodopa/carbidopa may make it harder for your body to use iron. 
Levodopa/karbidopa mogu u Vašem tijelu otežati iskorištavanje željeza.
Carbidopa is metabolized to two main metabolites: α-methyl-3-methoxy-4-hydroxyphenylpropionic acid and α-methyl-3, 4-dihydroxy-phenylpropionic acid. 
Karbidopa se metabolizira u dva glavna metabolita: α-metil-3-metoksi-4-hidroksifenilpropionatna kiselina i α-metil-3, 4-dihidroksifenilpropionatna kiselina.
In a study of one breastfeeding mother with Parkinson's disease, excretion of levodopa in human milk was reported. 
U ispitivanju jedne majke dojilje koja ima Parkinsonovu bolest, prijavljeno je izlučivanje levodope u majčino mlijeko.
Levodopa is a precursor of dopamine, and is given as dopamine replacement therapy in Parkinson's disease. 
Levodopa je prekursor dopamina i daje se kao nadomjesna terapija dopamina u Parkinsonovoj bolesti.
Each of the three modified-release levodopa/carbidopa treatments was statistically significantly superior to placebo on the primary measure (Table 4). 
Svako od tri liječenja lijekom s prilagođenim oslobađanjem levodope/karbidope bilo je statistički značajno bolje naspram placeba u primarnoj mjeri ishoda (Tablica 4).
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). 
Bolesnici s uznapredovalom Parkinsonovom bolešću Djelotvornot i sigurnost Numienta u bolesnika s uznapredovalom Parkinsonovom bolešću procijenjene su u dva dvostruko slijepa ispitivanja s aktivnom kontrolom: paralelno ispitivanje ADVANCE-PD (ispitivanje IPX066-B09-02; 22 tjedna) i ukriženo ispitivanje ASCEND-PD (ispitivanje IPX066-B-0906 1. dio, 11 tjedana).
The ASCEND-PD study was a randomized, double-blind, 2-treatment, 2-period crossover study in which 110 patients on a stable regimen of levodopa/carbidopa/entacapone (LCE) containing at least 400 mg per day of levodopa were included. 
Ispitivanje ASCEND-PD bilo je randomizirano, dvostruko slijepo, ukriženo ispitivanje 2 liječenja u 2 razdoblja u koje je uključeno 110 bolesnika na stabilnom režimu levodope/karbidope/entakapona (LCE) koji sadrži najmanje 400 mg levodope dnevno.
Levodopa/carbidopa and ferrous salts or multivitamins containing ferrous salts should be co-administered with caution. 
Levodopu/karbidopu i soli željeza ili multivitamine koji sadrže soli željeza istodobno treba primjenjivati uz oprez.
The terminal phase elimination half-life of levodopa, the active moiety of antiparkinsonian activity, is approximately 2 hours in the presence of carbidopa. 
Poluvrijeme terminalne faze eliminacije levodope, aktivnog ostatka aktivnosti protiv Parkinsonove bolesti, je otprilike 2 sata u prisutnosti karbidope.
Following a single dose of Numient in patients with Parkinson's disease the plasma AUC and Cmax of levodopa was higher in females than males (on average, 37% for AUC and 35% for Cmax). 
Nakon pojedinačne doze Numienta u bolesnika oboljelih od Parkinsonove bolesti, AUC i Cmax vrijednosti levodope u plazmi bile su više u žena nego u muškaraca (u prosjeku, 37 % za AUC i 35 % za Cmax).
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. 
U ispitivanjima bolesnika s uznapredovalom Parkinsonovom bolešću, postoje ograničeni podaci o primjeni doza iznad 2450 mg levodope i 612,5 mg karbidope u obliku Numienta.
Levodopa overdose may give rise to systemic complications, secondary to dopaminergic overstimulation. 
Predoziranje levodopom može dovesti do sistemskih komplikacija, sekundarno pretjeranoj dopaminergičkoj stimulaciji.
These can be symptoms of neuroleptic malignant syndrome (NMS, a rare severe reaction to medicines used to treat disorders of the central nervous system) or rhabdomyolisis (a rare severe muscle disorder) 
To mogu biti simptomi neuroleptičkog malignog sindroma (NMS-a, rijetke teške reakcije na lijekove koji se primjenjuju za liječenje poremećaja središnjeg živčanog sustava) ili rabdomiolize (rijetkog teškog mišićnog poremećaja)
You may need to have testing of your heart, liver, kidney, and blood cell functions during long-term treatment with medicines containing levodopa/carbidopa. 
Možda ćete trebati napraviti pretrage funkcije srca, jetre, bubrega i krvnih stanica tijekom dugotrajnog liječenja lijekovima koji sadrže levodopu/karbidopu.
Effects of levodopa on fertility were evaluated in mouse studies (see section 5.3). 
Učinci levodope na plodnost procijenjeni su u ispitivanjima na miševima (vidjeti dio 5.3).
≥1 hour improvement in “off” time (95% CI) 
Analiza ispitanika s odgovorom ≥ 1 sat poboljšanja u „off” vremenu (95 % CI)
There is insufficient information on the effects of levodopa/carbidopa or their metabolites in newborns/infants. 
Nema dovoljno informacija o učincima levodope/karbidope ili njihovih metabolita u novorođenčadi/dojenčadi.