natgillin/translations-raw huggingface dataset:
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.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
• Plan upravljanja rizicima (RMP) Nositelj odobrenja obavljat će dodatne farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom, a koji je opisan u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim nadopunama Plana.
Levodopa/carbidopa should be used with caution in case of concomitant use of medicinal products that may cause orthostatic hypotension, e.g. anti-hypertensive medicinal products.
Levodopa/karbidopa mora se oprezno primjenjivati u slučaju istodobne primjene lijekova koji mogu uzrokovati ortostatsku hipotenziju, npr. antihipertenzivnih lijekova.
There are no data on the effects of levodopa or carbidopa on human fertility.
Nema podataka o učincima levodope ili karbidope na ljudsku plodnost.
Table 5: Main results of studies in advanced Parkinson's disease Study
Tablica 5. Glavni rezultati ispitivanja uznapredovale Parkinsonove bolesti Ispitivanje
Keep this medicine out of the sight and reach of children.
Lijek treba čuvati izvan pogleda i dohvata djece.
Patients being treated with this modified-release levodopa/carbidopa capsule medicinal product and presenting with somnolence and/or sudden sleep episodes must be informed to refrain from driving or engaging in activities where impaired alertness may put themselves or others at risk of serious injury or death (e.g. operating machines), until such recurrent episodes and somnolence have resolved (see also section 4.4).
Bolesnike koji su liječeni ovim kapsulama lijeka s prilagođenim oslobađanjem levodope/karbidope i koji su imali somnolenciju i/ili epizode iznenadnog nastupa sna mora se uputiti da se suzdrže od vožnje ili uključivanja u aktivnosti gdje poremećena budnost može dovesti njih ili druge u opasnost od ozbiljne ozljede ili smrti (npr. rukovanje strojevima), dok se te ponavljajuće epizode i somnolencija ne riješe (vidjeti također dio 4.4).
If you need to have tests on your blood or urine, tell the doctor or nurse that you are taking Numient.
Ako trebate napraviti pretrage krvi ili mokraće, obavijestite liječnika ili medicinsku sestru da uzimate Numient.
Carbidopa is excreted in rat milk, but it is not known whether carbidopa or its metabolites are excreted in human breast milk.
Karbidopa se izlučuje u mlijeko štakora, ali nije poznato izlučuje li se karbidopa ili njegovi metaboliti u majčino mlijeko.
Further, high protein meals may impair clinical response by decreasing the absorption of levodopa (see section 4.5).
Nadalje, obroci s visokim udjelom bjelančevina mogu pogoršati klinički odgovor smanjenjem apsorpcije levodope (vidjeti dio 4.5).
In particular, tell your doctor or pharmacist if you are taking the following medicines: Other medicines for Parkinson's disease, such as ‘anticholinergics' (e.g. orphenadrine and trihexyphenidyl), ‘selective MAO-B inhibitors' (e.g. selegiline and rasagiline), and a ‘COMT inhibitor' (e.g. entacapone)
Posebice, obavijestite svog liječnika ili ljekarnika ako uzimate sljedeće lijekove: druge lijekove za Parkinsonovu bolest, kao što su „antikolinergici“ (npr. orfenadrin i triheksifenidil), „selektivni MAO-B inhibitori“ (npr. selegilin i razagilin) i „inhibitor COMT-a“ (npr. entakapon) željezov sulfat (za liječenje anemije uzrokovane niskom razinom željeza u krvi).
The addition of entacapone to levodopa/carbidopa has been demonstrated to increase the levodopa bioavailability by 30%.
Dodavanje entakapona levodopi/karbidopi pokazalo je da povećava bioraspoloživost levodope do 30 %.
Pharmacotherapeutic group: Anti-Parkinson drugs, dopaminergic agents, ATC code: N04BA02
Farmakoterapijska skupina: lijekovi protiv Parkinsonove bolesti, dopaminergička sredstva, ATK oznaka: N04BA02
Cases of falsely diagnosed phaeochromocytoma in patients on levodopa/carbidopa therapy have been reported very rarely.
Slučajevi pogrešno dijagnosticiranog feokromocitoma u bolesnika na terapiji levodopom/karbidopom prijavljeni su vrlo rijetko.
Medicinal products containing levodopa cause dyskinesias that may require treatment adjustment.
Lijekovi koji sadrže levodopu izazivaju diskineziju što može zahtijevati prilagodbu liječenja.
The two major metabolic pathways are decarboxylation by dopa decarboxylase (DDC) and O-methylation by catechol-O-methyltransferase (COMT).
Dva glavna metabolička puta su dekarboksilacija dopa dekarboksilazom (DDC) i O-metilacija pomoću katehol-O-metil transferaze (COMT).
Patients with chronic wide-angle glaucoma may be treated cautiously with levodopa/carbidopa provided the intraocular pressure is well-controlled and the patient is monitored carefully for changes in intraocular pressure during therapy.
Bolesnici s kroničnim glaukomom širokog kuta moraju se uz oprez liječiti levodopom/karbidopom pod uvjetom da je intraokularni tlak dobro kontroliran te se bolesnik pažljivo prati zbog promjena intraokularnog tlaka tijekom terapije.
The use of Numient is not recommended in patients under 18 years of age.
Ne preporučuje se primjena Numienta u bolesnika mlađih od 18 godina.
Addition of other medicinal products for the treatment of Parkinson's disease
Dodavanje drugih lijekova za liječenje Parkinsonove bolesti
Patients should be maintained on the lowest dose required to achieve symptomatic control and to minimize adverse reactions.
Bolesnike treba održavati na najnižoj dozi potrebnoj za postizanje kontrole simptoma i svođenje štetnih reakcija na najmanju moguću mjeru.
ASCEND-PD (cross-over)
ASCEND-PD (ukriženo)
A lower dose of levodopa can be used when it is coadministered with carbidopa, reducing the incidence and severity of peripheral side effects.
Niža doza levodope može se koristiti kada se primjenjuje zajedno s karbidopom, smanjujući incidenciju i težinu perifernih nuspojava.
Dopamine D2 receptor antagonists, benzodiazepines and isoniazid
Antagonisti dopaminskih D2 receptora, benzodiazepini i izoniazid
Do not stop taking or change your dose of Numient without talking to your doctor first even if you feel better.
Numienta bez prethodnog razgovora sa svojim liječnikom čak i ako se osjećate bolje.
Concomitant use of antipsychotics should be monitored carefully for worsening of Parkinson's motor symptoms especially when D2-receptor antagonists are used (see section
Istodobnu primjenu antipsihotika mora se pažljivo pratiti zbog pogoršanja motoričkih simptoma Parkinsonove bolesti, posebno kod primjene antagonista D2 receptora (vidjeti dio 4.5).
There have been rare reports that the beneficial effects of levodopa in Parkinson's disease are reversed by phenytoin and papaverine.
Rijetka su izvješća o poništenju korisnih učinaka levodope u Parkinsonovoj bolesti primjenom fenitoina i papaverina.