FrancophonIA/ELRC3.0 huggingface dataset:
English: In a study of one breastfeeding mother with Parkinson's disease, excretion of levodopa in human milk was reported.
Danish: I en undersøgelse af en ammende mor med Parkinsons sygdom rapporteredes udskillelsen af levodopa i modermælk.
English: One bottle containing 25, 100 or 240 modified-release hard capsules.
Danish: En flaske indeholder 25, 100 eller 240 kapsler med modificeret udløsning, hård.
English: Numient can cause somnolence (excessive drowsiness) and sudden sleep onset episodes.
Danish: Numient kan forårsage somnolens (kraftig døsighed) og pludselige søvnepisoder.
English: Initial total daily dose of Numient (levodopa in mg)
Danish: Indledende samlet daglig dosis Numient (levodopa i mg)
English: Following oral dosing of the modified-release levodopa/carbidopa medicinal product the maximum concentration occurred at approximately 3.5 hours.
Danish: Efter oral dosering af levodopa/carbidopa-lægemidlet med modificeret udløsning forekom den maksimale koncentration efter ca. 3,5 timer.
English: Management of acute overdose with levodopa/DDC preparations is the same as management of acute overdose with levodopa.
Danish: Behandlingen af akut overdosis med levodopa/DDC-præparater er den samme som behandlingen af akut overdosis med levodopa.
English: Neurological findings, including muscle rigidity, involuntary movements, altered consciousness, mental status changes; other disturbances, such as autonomic dysfunction, tachycardia, tachypnoea, sweating, hyper- or hypotension; laboratory findings, such as creatine phosphokinase elevation, leucocytosis, myoglobinuria, and increased serum myoglobin have been reported.
Danish: Der er rapporteret neurologiske fund, herunder muskelstivhed, ufrivillige bevægelser, ændret bevidsthed, ændringer i den mentale tilstand; andre forstyrrelser, såsom autonom dysfunktion, takykardi, takypnø, svedafsondring, hyper- eller hypotension; laboratorieresultater, såsom forhøjet kreatinfosfokinase, leukocytose, myoglobinuri og øget serum myoglobin.
English: 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.
Danish: ASCEND-PD-forsøget var et randomiseret, dobbeltblindet, dobbeltbehandling, dobbeltperiode overkrydsningsforsøg, som inkluderede 110 patienter, der havde modtaget et stabilt regimen af levodopa/carbidopa/entacapon (LCE), som indeholdt mindst 400 mg levodopa pr. dag.
English: The dopamine helps to improve the symptoms of your Parkinson's disease.
Danish: Dopamin hjælper med at forbedre symptomerne på din Parkinsons sygdom.
English: 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.
Danish: Levodopa/carbidopa bør anvendes med forsigtighed i tilfælde af samtidig brug af lægemidler, der kan forårsage ortostatisk hypotension, f.eks. antihypertensive lægemidler.
English: Carbidopa is metabolized to two main metabolites: α-methyl-3-methoxy-4-hydroxyphenylpropionic acid and α-methyl-3, 4-dihydroxy-phenylpropionic acid.
Danish: Carbidopa metaboliseres til to hovedmetabolitter: α-methyl-3-methoxy-4-hydroxyphenylpropionsyre og α-methyl-3, 4-dihydroxy-phenylpropionsyre.
English: When converting patients from levodopa/DDC inhibitor medicinal products to Numient, the dose should be adjusted to maintain sufficient symptomatic control.
Danish: Ved konvertering af patienter fra levodopa/DDC-hæmmeree til Numient, skal dosis justeres for at opretholde tilstrækkelig symptomatisk kontrol.
English: If this applies to you, do not take Numient and ask your doctor or pharmacist for advice.
Danish: Hvis det er tilfældet for dig, må du ikke tage Numient, og du skal spørge din læge eller apotekspersonalet til råds.
English: Concomitant anti-Parkinson medicinal products were kept stable during the study.
Danish: Samtidige anti-Parkinson-lægemidler blev holdt stabile i løbet af forsøget.
English: Contents of the pack and other information What Numient contains
Danish: Pakningsstørrelser og yderligere oplysninger Numient indeholder
English: Levodopa/carbidopa can cause orthostatic hypotension.
Danish: Levodopa/carbidopa kan forårsage ortostatisk hypotension.
English: The terminal phase elimination half-life of carbidopa is approximately 2 hours.
Danish: Eliminationshalveringstiden for den terminale fase af carbidopa er ca. 2 timer.
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.
Danish: Numients farmakokinetik blev evalueret efter enkeltdoser hos raske forsøgspersoner og efter enkelte og gentagne doser hos patienter med Parkinsons sygdom.
English: You may need to have testing of your heart, liver, kidney, and blood cell functions during long-term treatment with medicines containing levodopa/carbidopa.
Danish: Du skal muligvis have foretaget tests af din hjerte-, lever-, nyre- og blodcellefunktion under langtidsbehandling med medicin, der indeholder levodopa/carbidopa.
English: If you need to have tests on your blood or urine, tell the doctor or nurse that you are taking Numient.
Danish: Hvis du skal have taget blodeller urinprøver, skal du fortælle lægen eller sygeplejersken, at du tager Numient.
English: Levodopa overdose may give rise to systemic complications, secondary to dopaminergic overstimulation.
Danish: Levodopa-overdosis kan give anledning til systemiske komplikationer sekundært i forhold til dopaminergisk overstimulering.
English: 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.
Danish: Numient kan indtages samtidig med den anbefalede dosis MAO-hæmmer, som er selektiv for MAO type B- hæmmer såsom selegilin og rasagilin.
English: There are no data on the effects of levodopa or carbidopa on human fertility.
Danish: Der findes ingen data om virkningerne af levodopa eller carbidopa på human fertilitet.
English: Laboratory testing
Danish: Laboratorieprøver
English: Levodopa may have a major influence on the ability to drive and use machines.
Danish: Levodopa påvirker i væsentlig grad evnen til at føre motorkøretøjer og betjene maskiner.
English: b) Combined term that includes atrial fibrillation, atrial flutter, atrioventricular block, bundle branch block, sick sinus syndrome, bradycardia, and tachycardia
Danish: b) Kombineret udtryk, der omfatter atrieflimren, atrieflagren, atrioventrikulær blok, grenblok, syg sinus-syndrom, bradykardi og takykardi
English: The primary efficacy endpoint was the mean change from baseline of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living) score plus Part III motor score at week 30 or early termination.
Danish: Det primære effektmål var den gennemsnitlige ændring i forhold til baseline af samlet vurderingsskala for Parkinsons sygdom (UPDRS) del II- (dagligdags aktiviteter) scorer plus del III-motorscore i uge 30 eller ved førtidigt ophør.
English: Do not heat the medicine/food mixture and do not sprinkle the contents of the capsule on hot food.
Danish: Medicin/mad-blandingen må ikke opvarmes, og kapslens indhold må ikke drysses ud på varm mad.
English: Anticholinergic medicinal products may impair the effect of levodopa, due to a delayed absorption.
Danish: Antikolinerge lægemidler kan forringe virkningen af levodopa på grund af en forsinket absorption.
English: A lower dose of levodopa can be used when it is coadministered with carbidopa, reducing the incidence and severity of peripheral side effects.
Danish: En lavere dosis levodopa kan bruges, når den administreres samtidig med carbidopa, hvilket reducerer forekomsten og sværhedsgraden af perifere bivirkninger.
English: No dose adjustment of the modified-release levodopa/carbidopa medicinal product is required for elderly patients.
Danish: Ingen dosisjustering af levodopa/carbidopa-lægemidlet er påkrævet for ældre patienter.
English: Your doctor will tell you exactly how many capsules of Numient to take each day If you have never had levodopa before, the usual starting dose for Numient is one 95 mg capsule three times a day for three days.
Danish: Er du i tvivl, må du spørge lægen eller apotekspersonalet Din læge vil fortælle dig, præcis hvor mange Numient-kapsler, du skal tage hver dag Hvis du aldrig har fået levodopa før, er den normale startdosis for Numient én 95 mg kapsel tre gange om dagen i tre dage.
English: Levodopa is extensively metabolized to various metabolites.
Danish: Levodopa metaboliseres i udstrakt grad til forskellige metabolitter.
English: Following multiple dosing in patients, modified-release levodopa/carbidopa had reduced fluctuations in levodopa plasma concentrations with peak-to-trough fluctuation index of 1.5 with minimal accumulation of levodopa.
Danish: Efter multipel dosering hos patienter havde levodopa/carbidopa med modificeret udløsning reduceret udsvingene i levodopa plasmakoncentrationer med et peak-til-bundværdi fluktuationsindeks på 1,5 med minimal ophobning af levodopa.
English: 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)
Danish: Disse kan være symptomer på malignt neuroleptikasyndrom (MNS, en sjælden alvorlig bivirkning på medicin, der anvendes til behandling af sygdomme i centralnervesystemet) eller rhabdomyolisis (en sjælden alvorlig muskelsygdom)
English: Eligible patients were randomized (1:1:1:1) to placebo or one of three fixed levodopa/carbidopa doses of 145 mg/36.25 mg, 245 mg/61.25 mg, or 390 mg/97.5 mg, three times a day.
Danish: Kvalificerede patienter blev randomiseret (i forholdet 1:1:1:1) til placebo eller en af tre faste levodopa/carbidopa-doser på 145 mg/36,25 mg, 245 mg/61,25 mg eller 390 mg/97,5 mg, tre gange om dagen.
English: Numient is used to improve the symptoms of Parkinson's disease in adults.
Danish: Numient bruges til at forbedre symptomerne på Parkinsons sygdom hos voksne.
English: It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.
Danish: Det hjælper levodopa med at fungere mere effektivt ved at nedsætte den hastighed, hvormed levodopa nedbrydes i kroppen.
English: These inhibitors must be discontinued at least two weeks prior to initiating therapy (see section 4.5).
Danish: Disse hæmmere skal seponeres mindst to uger før behandlingsstart (se pkt.
English: The other ingredients are cellulose, microcrystalline, mannitol, tartaric acid, ethylcellulose, hypromellose, sodium starch glycolate, sodium laurilsulfate, povidone, talc, methacrylic acidmethyl methacrylate copolymers (1:1), methacrylic acid - methyl methacrylate copolymers (1:2), triethyl citrate, croscarmellose sodium and magnesium stearate
Danish: De øvrige indholdsstoffer er cellulose, mikrokrystallinsk, mannitol, vinsyre, ethylcellulose, hypromellose, natriumstivelsesglycolat, natriumlaurylsulfat, povidon, talkum, methacrylsyremethyl- methacrylatcopolymerer (1:1), methacrylsyre - methyl methacrylatcopolymerer (1:2), triethylcitrat, croscarmellosenatrium og magnesiumstearat
English: “Off” time (hrs)*
Danish: “Off”-tid (timer)*
English: The European Medicines Agency has waived the obligation to submit the results of studies with Numient in all subsets of the paediatric population in the treatment of idiopathic Parkinson's disease (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Numient i alle undergrupper af den pædiatriske population (se pkt.
English: If general anaesthesia is required, the modified-release levodopa/carbidopa capsule medicinal product may be continued as long as the patient is permitted to take oral medicinal products.
Danish: Hvis der er behov for generel anæstesi, kan patienten fortsætte med levodopa/carbidopakapsellægemidlet med modificeret udløsning, så længe patienten har tilladelse til at tage orale lægemidler.
English: There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and levodopa/carbidopa.
Danish: Der har været sjældne rapporter om bivirkninger, herunder hypertension og dyskinesier som følge af samtidig brug af tricykliske antidepressiva og levodopa/carbidopa.
English: Effects of levodopa on fertility were evaluated in mouse studies (see section 5.3).
Danish: Virkningerne af levodopa på fertilitet blev evalueret i museforsøg (se pkt.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Tag altid lægemidlet nøjagtigt som beskrevet i denne indlægsseddel eller efter lægens eller apotekspersonalets anvisning.
English: Modified-release levodopa/carbidopa may be used together with other medicinal products for the treatment of Parkinson's disease.
Danish: Levodopa/carbidopa med modificeret udløsning kan anvendes sammen med andre lægemidler til behandling af Parkinsons sygdom.
English: The safety and efficacy of Numient in children under 18 years of age have not been established.
Danish: Sikkerheden og virkning af Numient hos børn, som er under 18 år, er ikke fastslået.
English: Methacrylic acid - methyl methacrylate copolymers (1:1) Methacrylic acid - methyl methacrylate copolymers (1:2) Triethyl citrate
Danish: Methacrylsyre - methyl methacrylatkopolymerureaer (1:1) Methacrylsyre - methyl methacrylatkopolymerer (1:2) Triethylcitrat
English: Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely.
Danish: Det er i sjældne tilfælde rapporteret, at personer pludselig er faldet i søvn under daglige aktiviteter, i nogle tilfælde uden forudgående advarselssignaler.
English: Further, high protein meals may impair clinical response by decreasing the absorption of levodopa (see section 4.5).
Danish: Måltider med et højt proteinindhold kan desuden svække det kliniske respons ved at reducere absorberingen af levodopa (se pkt.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE/HDPE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE FLASKE/HDPE
English: In patients with Parkinson's disease, multiple-dose pharmacokinetics was comparable to single-dose pharmacokinetics, i.e. there was a minimal accumulation of levodopa from the modified-release levodopa/carbidopa medicinal product.
Danish: Hos patienter med Parkinsons sygdom kunne farmakokinetikken ved flere doser sammenlignes med farmakokinetikken ved enkelt-dosis, dvs. der var en minimal ophobning af levodopa fra levodopa/carbidopa-lægemidlet med modificeret udløsning.
English: Levodopa is bound to plasma protein only to a small extent (10-30%).
Danish: Levodopa er kun i ringe grad (10-30 %) bundet til plasmaprotein.
English: Antihypertensives
Danish: Antihypertensiver
English: Non-selective monoamine oxidase inhibitors must be discontinued at least 2 weeks prior to treatment initiation with the modified-release levodopa/carbidopa capsule medicinal product (see section 4.3).
Danish: Ikke-selektive monoaminoxidasehæmmere skal seponeres mindst 2 uger før behandlingsstart med kapsellægemidlet med modificeret udløsning af levodopa/carbidopa (se pkt.
English: In the ADVANCE-PD study, the Clinical Global Impression of Change was also assessed.
Danish: Det kliniske globale indtryk af ændring blev også vurderet i ADVANCE-PD-forsøget.
English: For patients currently treated with other levodopa/DDC inhibitor modified-release medicinal products, limited information regarding conversion to Numient is available.
Danish: For patienter, som i øjeblikket er i behandling med andre levodopa/DDC-hæmmere med modificeret udløsning, findes der kun begrænsede oplysninger om konvertering til Numient.
English: Unchanged levodopa accounts for less than 10% of the total urinary excretion.
Danish: Uændret levodopa udgør mindre end 10 % af den samlede urinudskillelse.
English: If you take more Numient than you should (or someone has accidentally ingested Numient) talk to your doctor or pharmacist immediately.
Danish: Hvis du har taget for meget Numient (eller nogen har indtaget Numient ved et uheld), skal du straks spørge lægen eller apotekspersonalet til råds.
English: Dark urine, urinary incontinence
Danish: Mørk urin, urininkontinens
English: 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).
Danish: Patienter, som behandles med dette levodopa/carbidopa-kapsellægemiddel med modificeret udløsning, og som har somnolens og/eller pludselige søvnepisoder, skal informeres om, at de skal afstå fra at føre motorkøretøjer eller deltage i aktiviteter, hvor nedsat årvågenhed kan udsætte dem eller andre for risiko for alvorlig skade eller død (f.eks. betjene maskiner), indtil sådanne tilbagevendende episoder og somnolens er ophørt (se også pkt.
English: Next, patients were randomized to a double-blind, 13-week study treatment period of either optimized immediate release levodopa/carbidopa treatment or Numient.
Danish: Derefter blev patienterne randomiseret til en dobbeltblindet, 13-ugers forsøgsbehandlingsperiode med enten levodopa/carbidopa-behandling med optimeret øjeblikkelig udløsning eller Numient.
English: Loss of strength, fatigue
Danish: Styrketab, træthed
English: The effect of co-administration of this modified-release levodopa/carbidopa capsule product and COMT inhibitors such as entacapone has not been studied.
Danish: Virkningen af samtidig administration af dette levodopa/carbidopa-kapselprodukt med modificeret udløsning og COMT-hæmmere såsom entacapon er ikke blevet undersøgt.
English: A symptom complex resembling neuroleptic malignant syndrome and rhabdomyolysis may occur with levodopa/carbidopa medicinal products, although no cases have been identified in clinical studies with Numient.
Danish: Et symptomkompleks, der ligner malignt neuroleptikasyndrom og rhabdomyolyse, kan forekomme med levodopa/carbidopa-lægemidler, selvom der ikke er identificeret noget tilfælde i kliniske forsøg med Numient.
English: In healthy adults, oral administration of Numient after a high-fat, high-calorie meal reduced levodopa Cmax 21% while the overall extent of absorption of levodopa (AUCinf) was similar (13% increase) to that observed in the fasted state (see section 5.2).
Danish: Hos raske voksne reducerede oral administration af Numient efter et måltid med højt fedt- og kalorieindhold levodopa Cmax 21 %, mens det samlede omfang af absorptionen af levodopa (AUCinf) lignede (13 % stigning) det, der blev observeret i den fastende tilstand (se pkt.
English: The ADVANCE-PD study was a 22-week study consisting of a 3-week dose adjustment of pre-study immediate release levodopa/carbidopa treatment prior to a 6-week conversion to Numient.
Danish: ADVANCE-PD-forsøget var et 22-ugers forsøg, der bestod af en 3-ugers dosisjustering af levodopa/carbidopa-behandling med øjeblikkelig udløsning før forsøget forud for en 6-ugers konvertering til Numient.
English: Phenytoin and papaverine
Danish: Phenytoin og papaverin
English: Levodopa is a precursor of dopamine, and is given as dopamine replacement therapy in Parkinson's disease.
Danish: Levodopa er et forstadium af dopamin og gives som dopamin erstatningsterapi mod Parkinsons sygdom.
English: There are no or limited amount of data from the use of levodopa/carbidopa in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af levodopa/carbidopa hos gravide kvinder.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelig (kan berøre op til 1 ud af 10 personer) Vægttab
English: Dyskinesias
Danish: Dyskinesi
English: Impact of renal function on levodopa/carbidopa clearance is limited (see section 5.2).
Danish: Nyrefunktionens indvirkning på levodopa/carbidopa-clearance er begrænset (se pkt.
English: Dosing of concomitant antiParkinson medicinal products was kept stable.
Danish: Doseringen af samtidig anti-Parkinson lægemidler blev holdt stabil.
English: The following side effects have also been reported but the chance that they will occur is unknown: Low blood cell counts (white blood cells, platelets) Drug abuse of certain medicines used to treat Parkinson's Disease Suicide attempt, feeling disoriented, increased sexual feelings Severe prolonged abnormal eye movements, Horner's Syndrome (drooping eyelid, small pupil and decreased sweating on one side of the face), eyelid twitching Abnormal breathing pattern
Danish: Følgende bivirkninger er også rapporteret, men chancen for, at de vil forekomme, kendes ikke: Lavt antal blodlegemer (hvide blodlegemer, trombocytter) Stofmisbrug af visse lægemidler, der anvendes til at behandle Parkinsons sygdom Selvmordsforsøg, desorienteret, øgede seksuelle følelser Svære langvarige unormale øjenbevægelser, Horners syndrom (hængende øjenlåg, lille pupil og nedsat svedafsondring på den ene side af ansigtet), trækninger i øjenlåg Unormal vejrtrækning
English: In healthy adults, oral administration of the modified-release levodopa/carbidopa medicinal product after a high-fat, high-calorie meal reduced levodopa Cmax by 21%.
Danish: Hos raske voksne reducerede oral administration af levodopa/carbidopa-lægemidlet med modificeret udløsning efter et måltid med højt fedt- og kalorieindhold levodopa-Cmax med 21 %.
English: Other medicines and Numient
Danish: Brug af anden medicin sammen med Numient
English: Dose adjustment of the antihypertensive medicinal products may be required during the titration phase of treatment with this modified-release levodopa/carbidopa medicinal product.
Danish: Det kan være nødvendigt at justere dosen af de antihypertensive lægemidler under behandlingens titreringsfase med dette levodopa/carbidopa-lægemiddel med modificeret udløsning.
English: Elevated AST, ALT, LDH, bilirubin, blood sugar, creatinine, uric acid; lowered values of haemoglobin and haematocrit; blood in urine
Danish: Forhøjet AST, ALT, LDH, bilirubin, blodsukker, kreatinin, urinsyre, nedsatte værdier af hæmoglobin og hæmatokrit, blod i urinen
English: Care should be exercised in administering levodopa/carbidopa to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias.
Danish: Der skal udvises forsigtighed ved administration af levodopa/carbidopa til patienter med fortilfælde af myokardieinfarkt, der har resterende atriale, nodale eller ventrikulære arytmier.
English: System organ class Very Common
Danish: Systemorganklasse
English: Somnolence and episodes of sudden sleep onset
Danish: Somnolens og pludselige søvnepisoder
English: The acute symptoms of levodopa/DDC inhibitor overdose can be expected to arise from dopaminergic overstimulation.
Danish: De akutte symptomer på overdosis af levodopa/DDC-hæmmer kan forventes at opstå som følge af dopaminerg overstimulering.
English: Table 4: Mean change from baseline in UPDRS Part II plus Part III score at week 30 (or at early termination) in levodopa naïve patients with Parkinson's disease (APEX-PD)
Danish: Tabel 4: Gennemsnitlig ændring i forhold til baseline i UPDRS del II plus del III score i uge 30 (eller ved førtidigt ophør) hos levodopa-naive patienter med Parkinsons sygdom (APEXPD)