FrancophonIA/ELRC3.0 huggingface dataset:
English: Oculogyric crises, activation of latent Horner's syndrome, blepharospasm
Danish: Okulogyre kriser, aktivering af latent Horners syndrom, blefarospasme
English: Initial dose and titration in levodopa-naïve patients
Danish: Startdosis og -titrering hos levodopa-naive patienter
English: Levodopa/carbidopa preparations may provide a false-positive test result for ketone bodies, if a test strip is used for determining any ketonuria.
Danish: Levodopa/carbidopa kan give et falsk positivt testresultat for ketonstoffer, hvis en teststrimmel anvendes til at bestemme en hvilken som helst form for ketonuri.
English: Symptomatic treatment of adult patients with Parkinson's disease.
Danish: Symptomatisk behandling af voksne patienter med Parkinsons sygdom.
English: Suggested initial dose of Numient
Danish: Foreslået indledende daglig dosis Numient
English: Levodopa/carbidopa may make it harder for your body to use iron.
Danish: Levodopa/carbidopa kan gøre det sværere for din krop at anvende jern.
English: Dose recommendations should be followed at initiation of treatment and adapted according to clinical response.
Danish: Dosisanbefalinger skal følges ved iværksættelse af behandling og tilpasses klinisk respons.
English: Impulse control disorder (see below)
Danish: Impulskontrol (se nedenfor)
English: Swallow the medicine/food mixture completely and immediately without chewing and do not store for future use Take the capsules at regular time intervals according to your doctor's instructions Do not change the times at which you take your capsules or take any other medicines for Parkinson's disease without first consulting your doctor.
Danish: Slug medicin/mad-blandingen helt og med det samme uden at tygge, og undlad at opbevare den til senere brug Tag kapslerne med jævne mellemrum i henhold til lægens anvisninger Du må ikke ændre de tidspunkter, hvor du tager dine kapsler eller tage anden medicin for Parkinsons sygdom uden først at spørge din læge.
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE
English: Use of this medicinal product with other levodopa containing medicinal products has not been studied.
Danish: Brug dette lægemiddel med andre lægemidler indeholdende levodopa, som ikke er blevet undersøgt.
English: 30 months 90 days after first opening.
Danish: 30 måneder 90 dage efter anbrud af lægemidlet.
English: Medicinal products containing levodopa cause dyskinesias that may require treatment adjustment.
Danish: Lægemidler indeholdende levodopa forårsager dyskinesi, hvilket kan nødvendiggøre behandlingsjustering.
English: ASCEND-PD (cross-over)
Danish: ASCEND-PD (overkrydsning)
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.
Danish: Hvis levodopa administreres oralt, decarboxyleres det hurtigt til dopamin i ekstracerebrale væv, så kun en lille del af en given dosis transporteres uændret til centralnervesystemet.
English: Pharmacotherapeutic group: Anti-Parkinson drugs, dopaminergic agents, ATC code: N04BA02
Danish: Farmakoterapeutisk klassifikation: anti-Parkinson lægemidler, dopaminergika, ATC-kode: N04BA02
English: “On” time without troublesome dyskinesia (hrs)*
Danish: “On”-tid uden problematisk dyskinesi (timer)*
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.
Danish: Der kræves derfor store doser levodopa for at opnå en passende terapeutisk virkning, og disse doser kan ofte være ledsaget af kvalme og andre bivirkninger, der for nogens vedkommende skyldes dopamin, som dannes i ekstracerebrale væv.
English: 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.
Danish: Doser på nogle få gram kan resultere i CNS-forstyrrelser med en stigende sandsynlighed for kardiovaskulære forstyrrelser (f.eks. hypotension, sinus takykardi) og mere alvorlige psykiatriske problemer ved højere doser.
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.
Danish: Den endelige samlede daglige dosis af levodopa fra Numient er cirka dobbelt så stor som den endelige samlede daglige dosis levodopa fra tabletter med øjeblikkelig udløsning, mens den endelige samlede daglige dosis levodopa fra Numient er cirka tre gange større end den endelige samlede daglige dosis levodopa fra kombinationen af levodopa//DDC-hæmmer/entacapon.
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).
Danish: Effekten af og sikkerheden ved Numient på patienter med Parkinsons sygdom på et fremskredent stadie er blevet evalueret i 2 dobbeltblinde, aktiv-kontrollerede forsøg: parallel-forsøg ADVANCE-PD (forsøg IPX066-B09-02; 22 uger) og overkrydsningsforsøg ASCEND-PD (forsøg IPX066-B-09-06 del 1; 11 uger).
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.
Danish: I alt 471inkluderede patienter var blevet holdt på et stabilt regimen af levodopa på mindst 400 mg pr. dag før optagelsen i forsøget.
English: 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.
Danish: Den hårde kapsel med modificeret udløsning skal sluges hel og ikke tygges eller knuses for at kunne opretholde virkningen af den modificerede udløsning af levodopa/carbidopa-lægemidlet.
English: Patients should be maintained on the lowest dose required to achieve symptomatic control and to minimize adverse reactions such as dyskinesia and nausea.
Danish: Patienter skal holdes på den laveste dosis, der kræves for at opnå symptomatisk kontrol og for at minimere bivirkninger såsom dyskinesier og kvalme.
English: The terminal phase elimination half-life of levodopa, the active moiety of antiparkinsonian activity, is approximately 2 hours in the presence of carbidopa.
Danish: Den terminale halveringstid for levodopa, den aktive del af antiparkinson-aktiviteten, er cirka 2 timer i nærvær af carbidopa.
English: Both levodopa and combinations of carbidopa and levodopa have caused visceral and skeletal malformations in rabbits.
Danish: Både levodopa og kombinationer af carbidopa og levodopa har forårsaget viscerale og skeletale misdannelser hos kaniner.
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.
Danish: Denne unormale tankegang og adfærd kan give sig udslag i en eller flere af en række manifestationer, herunder angst, depression, paranoide tanker, vrangforestillinger, hallucinationer, forvirring, psykotisk adfærd, desorientering, aggressiv adfærd, agitation og delirium.
English: Carbidopa permits more levodopa to reach the brain and more dopamine to be formed increasing the risk for certain adverse CNS reactions including dyskinesia.
Danish: Carbidopa lader mere levodopa nå frem til hjernen og mere dopamin dannes, hvilket øger risikoen for visse skadelige CNS-reaktioner, herunder dyskinesi.
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.
Danish: Denne adfærd betegnes impulskontrollidelser og kan omfatte ludomani, overdreven spisning eller forbrug, en unormalt høj sexdrift eller en forøgelse af seksuelle tanker eller følelser.
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).
Danish: I de farmakokinetiske forsøg, der blev afholdt med patienter efter en enkelt dosis Numient, steg systemisk eksponering for levodopa generelt med stigende alder, idet AUC-værdier i gennemsnit var ca. 15 % højere hos ældre (≥ 65 år) end hos yngre forsøgspersoner (< 65 år).
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.
Danish: Af de ovenfor anførte grunde rådes patienterne og de ordinerende læger til at være på udkik efter melanomer ofte og regelmæssigt i forbindelse med anvendelse af levodopa/carbidopa, specielt hos patienter med mistænkelige, ikke-diagnosticerede hudlæsioner eller fortilfælde af melanom.
English: Dopamine D2 receptor antagonists, benzodiazepines and isoniazid
Danish: Dopamin D2-receptor-antagonister, benzodiazepiner og isoniazid
English: Carbidopa does not cross the blood-brain barrier at clinically relevant doses.
Danish: Carbidopa krydser ikke blod-hjerne-barrieren ved klinisk relevante doser.
English: Therefore, you must refrain from driving or engaging in activities where impaired alertness may put yourself or others at risk of serious injury or death (e.g. operating machines) until such recurrent episodes and somnolence have resolved.
Danish: Du skal derfor afstå fra at føre motorkøretøj eller deltage i aktiviteter, hvor nedsat opmærksomhed kan bringe dig selv eller andre i fare for alvorlig skade eller død (f.eks. betjening af maskiner), indtil sådanne tilbagevendende episoder og somnolens er ophørt.
English: Certain side effects such as sleepiness and dizziness that have been reported with this modified-release levodopa/carbidopa capsule medicinal product may affect some patients' ability to drive or operate machinery.
Danish: Visse bivirkninger som søvnighed og svimmelhed, der er blevet rapporteret med dette levodopa/carbidopakapsellægemiddel med modificeret udløsning, kan påvirke nogle patienters evne til at føre motorkøretøjer eller betjene maskiner.
English: 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).
Danish: Efter en enkelt dosis Numient hos patienter med Parkinsons sygdom var plasma AUC og Cmax for levodopa højere hos kvinder end hos mænd (i gennemsnit 37 % for AUC og 35 % for Cmax).
English: A previous history of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis.
Danish: Fortilfælde af malignt neuroleptikasyndrom (NMS) og/eller ikke-traumatisk rhabdomyolyse.
English: Decreased appetite, weight increase
Danish: Sænket appetit, vægtforøgelse
English: Carbidopa is excreted in rat milk, but it is not known whether carbidopa or its metabolites are excreted in human breast milk.
Danish: Carbidopa udskilles i rottemælk, men det vides ikke, hvorvidt carbidopa eller dets metabolitter udskilles i brystmælk.
English: The two major metabolic pathways are decarboxylation by dopa decarboxylase (DDC) and O-methylation by catechol-O-methyltransferase (COMT).
Danish: De to store metaboliske veje er decarboxylering af dopa-decarboxylase (DDC) og O-methylering af catechol-O-methyltransferase (COMT).
English: The most frequently recorded concomitant medicinal products for Parkinson's disease in randomized patients were dopamine agonists (64%), and MAO inhibitors (37%).
Danish: De hyppigst registrerede samtidige lægemidler for Parkinsons sygdom hos randomiserede patienter var dopaminagonister (64 %) og MAO-hæmmere (37 %).
English: Food effect
Danish: Fødevarevirkning
English: Patients with advanced Parkinson's disease
Danish: Patienter med fremskreden Parkinsons sygdom
English: 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.
Danish: Visse lægemidler, der kan bruges til at behandle psykose, kan desuden forværre symptomerne på Parkinsons sygdom og reducere virkningen af levodopa/carbidopa.
English: Benzodiazepines such as alprazolam, diazepam, and lorazepam used to treat anxiety Tricyclic antidepressants (TCAs; used to treat depression) Papaverine (used to improve blood flow around the body) Treatment for high blood pressure (hypertension)
Danish: Benzodiazepiner såsom alprazolam, diazepam og lorazepam anvendes til at behandle angst Tricykliske antidepressiva (TCA'er, der anvendes til at behandle depression) Papaverin (bruges til at forbedre blodgennemstrømningen rundt i kroppen) Behandling for højt blodtryk (hypertension)
English: If you stop taking Numient
Danish: Hvis du holder op med at tage Numient
English: Neoplasm benign, malignant and unspecified (including cysts and polyps)
Danish: Benigne, maligne og uspecificerede tumorer (inkl.cyster og polypper)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX/CARTON
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE/KARTON
English: The initial total daily dose of Numient described in Table 1 above may need to be decreased by approximately 30% for patients converting specifically from levodopa/DDC inhibitor modified-release medicinal products to Numient.
Danish: Den indledende samlede daglige dosis Numient, som er beskrevet i tabel 1 ovenfor, skal muligvis reduceres med ca. 30 % for patienter, der specifikt konverterer fra levodopa/DDC-hæmmere med modificeret udløsning til Numient.
English: Opaque, white, high-density polyethylene (HDPE) bottle with polypropylene screw closure.
Danish: Opak, hvid, polyethylen flaske med høj densitet (HDPE) og skrueaflukning af polypropylen.
English: Serious events of gastrointestinal haemorrhage (uncommon) and of allergic oedema (uncommon) were reported in the clinical studies with Numient.
Danish: Alvorlige hændelser med gastrointestinal blødning (ualmindelig) og allergisk ødem (ualmindelig) blev rapporteret i de kliniske forsøg med Numient.
English: The addition of entacapone to levodopa/carbidopa has been demonstrated to increase the levodopa bioavailability by 30%.
Danish: Tilsætningen af entacapon til levodopa/carbidopa er påvist at øge levodopa-biotilgængeligheden med 30 %.
English: If you must undergo surgery, please tell your doctor that you are using Numient.
Danish: Hvis du skal opereres, skal du fortælle lægen, at du bruger Numient.
English: Since its decarboxylase inhibiting activity is limited to extracerebral tissues, administration of carbidopa with levodopa makes more levodopa available for delivery to the brain.
Danish: Da dets decarboxylasehæmmende aktivitet er begrænset til ekstracerebrale væv, gør administration af carbidopa med levodopa, at der kan leveres mere levodopa til hjernen.
English: Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment (see section 4.7).
Danish: Patienter skal informeres herom og tilrådes at udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner, mens de er i behandling (se pkt.
English: Numient is a modified-release hard capsule.
Danish: Numient er en hård kapsel med modificeret udløsning.
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.
Danish: Ved undersøgelser af patienter med fremskreden Parkinsons sygdom er der begrænsede data for brug af doser over 2.450 mg levodopa og 612,5 mg carbidopa givet som Numient.
English: Numient is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
Danish: Numient er forbundet med somnolens og har tidligere i sjældne tilfælde været forbundet med overdreven somnolens i dagtimerne og pludselige søvnepisoder.
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.
Danish: Effektiviteten af Numient hos patienter med tidlig Parkinsons sygdom blev fastslået i et randomiseret, dobbelt-blindet, placebo-kontrolleret, 30-ugers klinisk fastdosisforsøg med parallelle grupper hos 381 patienter, som havde en middel sygdomsvarighed på 1 år og ingen eller begrænset forudgående eksponering for levodopa- og dopaminagonister.
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.
Danish: Forkortelser: CGI-C: clinical global impression of change from baseline (klinisk globalt indtryk af ændring i forhold til baseline); CI: confidence interval (konfidensinterval); IR: immediate release (øjeblikkelig udløsning); LCE: levodopa/carbidopa/entacapon; L-dopa†: Levodopa/Carbidopa; LS: least squares (mindste kvadrater); PD: Parkinsons sygdom; SD: standard deviation (standardafvigelse); I/A: ikke relevant; t: timer; år: år.
English: Periodic skin examinations performed by appropriately qualified individuals (e.g., dermatologists) are recommended.
Danish: Det anbefales at få foretaget regelmæssige hudundersøgelser af behørigt kvalificerede personer (f.eks. hudlæger).
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.
Danish: Det anbefales ikke at bruge Numient under graviditet og til kvinder i den fødedygtige alder, der ikke anvender prævention, med mindre fordelene for moderen opvejer de mulige risici for fosteret.
English: Numient shows dose proportional pharmacokinetics for both carbidopa and levodopa over the levodopa dose strength range of 95 mg to 245 mg.
Danish: Numient udviser dosisproportionel farmakokinetik for både carbidopa og levodopa over dosisstyrkeområdet for levodopa fra 95 mg til 245 mg.
English: Excessive or dark-coloured saliva, grinding of the teeth, hiccups Hair loss, rash (including a severe rash called Henoch-Schönlein purpura), dark-coloured sweat
Danish: For meget eller mørkfarvet spyt, tænderskæren, hikke Hårtab, udslæt (inklusive et alvorligt udslæt betegnet Henoch-Schönleins purpura), mørkfarvet sved
English: Dopamine D2 receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone), benzodiazepines and isoniazid may reduce the therapeutic effects of levodopa.
Danish: Dopamin D2-receptor antagonister (f.eks. phenothiaziner, butyrophenoner, risperidon), benzodiazepiner og isoniazid kan reducere de terapeutiske virkninger af levodopa.
English: In vivo, co-administration of Numient with up to 40% volume-to-volume (v/v) alcohol did not result in dosedumping of levodopa or carbidopa.
Danish: In vivo førte samtidig administration af Numient med op til 40 % volumen-til-volumen (v/v) alkohol ikke til dosis-dumping af levodopa eller carbidopa.
English: Increased levels of sugar, uric acid and/or liver enzymes in the blood Abnormal kidney function tests and/or blood in the urine
Danish: Øgede niveauer af sukker, urinsyre og/eller leverenzymer i blodet Anormale nyrefunktionstests og/eller blod i urinen
English: It is recommended to monitor patients for the onset or evolution of dyskinesia and to adjust levodopa/carbidopa doses accordingly.
Danish: Det anbefales at overvåge patienter for indtræden eller udvikling af dyskinesi og tilpasse levodopa/carbidopa-doserne på tilsvarende vis.
English: Numient is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Numient anbefales ikke under graviditet og hos kvinder, i den fødedygtige alder, som ikke anvender prævention.
English: Elevated urea nitrogen, alkaline phosphatases; positive Coomb's test; leucocytes, and bacteria in the urine a) Adverse reactions not observed in the clinical development of Numient, but reported for other levodopa/carbidopa medicinal products.
Danish: Forhøjet urinkvælstof, alkaliske fosfataser, positiv Coombs test, leukocytter og bakterier i urinen a) Bivirkninger er ikke observeret i den kliniske udvikling af Numient, men rapporteret for andre levodopa/carbidopa-lægemidler.
English: Caution should be exercised when interpreting the plasma and urine levels of catecholamines and their metabolites in patients on levodopa or levodopa/carbidopa therapy.
Danish: Der bør udvises forsigtighed ved fortolkning af plasma- og urinniveauer af katekolaminer og deres metabolitter hos patienter på levodopa eller levodopa/carbidopa-behandling.
English: Breast-feeding should be discontinued during treatment with Numient.
Danish: Amningen skal ophøre under behandling med Numient.
English: Patients continued on stable concomitant anti-Parkinson medicinal product.
Danish: Patienter fortsatte på stabil samtidig anti-Parkinsonlægemiddel.
English: Seeing or hearing things that are not real, depression, anxiety, somnolence (excessive drowsiness), difficulty falling and/or staying asleep, abnormal dreams, confusion, impaired memory and thinking skills
Danish: Se eller høre ting, som ikke er virkelige, depression, angst, somnolens (kraftig døsighed), svært ved at falde i søvn og/eller sove videre, unormale drømme, forvirring, nedsat hukommelse og tænkefærdigheder
English: 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)
Danish: Fortæl især lægen eller apotekspersonalet, hvis du tager følgende lægemidler: Andre lægemidler mod Parkinsons sygdom, såsom ‘antikolinergika' (f.eks. orphenadrin og, trihexyfenidyl), ‘selektive MAO-B-hæmmere' (f.eks. selegilin og rasagilin),, og en ‘COMThæmmer' betegnet (f.eks. entacapon)
English: Patients with a major psychotic disorder or a history of psychotic disorder must be treated cautiously with levodopa/carbidopa because of the risk of exacerbating psychosis.
Danish: Patienter med en alvorlig psykotisk lidelse eller en historie med psykotisk lidelse skal behandles med forsigtighed med levodopa/carbidopa på grund af risikoen for forværrende psykose.
English: 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.
Danish: Patienter med kronisk åbenvinklet glaukom kan behandles med forsigtighed med levodopa/carbidopa, såfremt det intraokulære tryk er velkontrolleret, og patienten overvåges nøje for ændringer i det intraokulære tryk under behandlingen.
English: 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.
Danish: Dosis blev øget fra og med dag 4 og den højeste måldosis (390 mg levodopa/97,5 mg carbidopa TID) blev opnået på dag 22.