FrancophonIA/ELRC3.0 huggingface dataset:
English: All efficacy data is based on 84 patients who completed the study with the exception of patient diary data which is based on 83.
Danish: Alle effektdata er baseret på 84 patienter, som gennemførte forsøget med undtagelse af data fra patientdagbøger, som er baseret på 83 patienter.
English: Frequencies are defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥ 1/10,000 to <1/1,000), very rare (<1/10,000), not known (cannot be estimated from the available data).
Danish: Hyppigheder defineres som: meget almindelige (≥1/10), almindelige (≥1/100 til < 1/10), ikke almindelig (≥1/1.000 til < 1/100), sjældne (≥1/10.000 til < 1/1.000), meget sjældne (< 1/10.000) ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Further management should be as clinically indicated or as recommended by the national poisons centre, where available.
Danish: Yderligere behandling skal være som klinisk indiceret eller som anbefalet af det nationale giftcenter, hvor et sådant findes.
English: Numient with food and drink
Danish: Numient med mad og drikke
English: Adverse reactions are listed below by system organ class (SOC) and frequency (Table 3).
Danish: Bivirkninger er angivet nedenfor efter systemorganklasse (SOC) og hyppighed (tabel 3).
English: You may also experience the following side effects:
Danish: Du kan også opleve følgende bivirkninger:
English: This can cause muscle problems, fever and mental changes.
Danish: Det kan forårsage muskelproblemer, feber og psykiske ændringer.
English: Depending on how you respond to treatment your doctor may then increase your dose on day four
Danish: Afhængigt af hvordan du reagerer på behandlingen, kan din læge øge din dosis på dag fire
English: Do not use this medicine after the expiry date which is stated on the carton and on the bottle after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen og på flasken efter EXP (anv.
English: A total of 393 patients (mean age 63.2 years; 65% male patients) were randomized.
Danish: I alt 393 patienter (gennemsnitsalder 63,2 år; 65 % mænd) blev randomiseret.
English: Whether the increased risk observed was due to Parkinson's disease or other factors, such as medicinal products used to treat Parkinson's disease, is unclear.
Danish: Om den observerede øgede risiko skyldtes Parkinsons sygdom eller andre faktorer, såsom lægemidler, der anvendtes til at behandle Parkinsons sygdom, er uklart.
English: These two metabolites are primarily eliminated in the urine unchanged or as glucuronide.
Danish: Disse to metabolitter udskilles primært i urinen enten uændret eller som glucuronid.
English: Concurrent use can, however, cause a worsening of involuntary motor disorders.
Danish: Samtidig brug kan imidlertid forårsage en forværring af ufrivillige motoriske forstyrrelser.
English: However, your doctor may decide to give you Numient if the expected benefits of treatment outweigh possible risks to the unborn child.
Danish: Lægen vil dog muligvis beslutte at give dig Numient, hvis de forventede fordele ved behandling af moderen berettiger de mulige risici for det ufødte barn.
English: The dosing frequency may be changed from three times a day to a maximum of five times a day if sufficient symptomatic control is not observed.
Danish: Doseringshyppigheden kan ændres fra tre gange om dagen til maksimalt fem gange om dagen, hvis der ikke opretholdes tilstrækkeligt symptomatisk kontrol.
English: N/A
Danish: I/A
English: Following an initial peak at about one hour, plasma concentrations are maintained for about 4 to 5 hours before declining.
Danish: Efter en første peak efter ca. en time opretholdes plasmakoncentrationer i cirka 4 til 5 timer før de falder.
English: Numient should be administered with a glass of water and can be taken with or without food.
Danish: Numient skal administreres med et glas vand og kan tages med eller uden et måltid.
English: Therefore, the medicinal product should not be heated or added to hot food.
Danish: Lægemidlet må derfor ikke opvarmes eller tilføjes til varm mad.
English: Numient should be taken approximately every 6 hours no more than 5 times a day Take this medicine by mouth with a glass of water.
Danish: Numient skal tages cirka hver 6. time, højst 5 gange om dagen Tag denne medicin ad mundvejen med et glas vand.
English: Addition of other medicinal products for the treatment of Parkinson's disease
Danish: Tilføjelse af andre lægemidler til behandling af Parkinsons sygdom
English: Uncontrollable excessive shopping or spending Binge eating (eating large amounts of food in a short time period) or compulsive eating (eating more food than normal and more than is needed to satisfy your hunger)
Danish: Overdrevne ukontrollerbare indkøbs- og forbrugsvaner Overspisning (spiser store mængder mad på kort tid) eller tvangsspisning (spiser mere mad end normalt og mere end nødvendigt for at tilfredsstille din sult)
English: Dosing this medicinal product more than 5 times per day is not recommended.
Danish: Det anbefales ikke at dosere dette lægemiddel mere end 5 gange om dagen.
English: Therapy should be individualized and adjusted for each patient according to the desired therapeutic response.
Danish: Behandlingen skal individualiseres og justeres for hver patient i henhold til den ønskede terapeutiske respons.
English: N entered N in conversion N randomised N completed
Danish: N tilmeldt N konverteret N randomiseret N gennemført
English: Swelling of the arms and/or legs
Danish: Hævelse i arme og/eller ben
English: These medicines include isocarboxazid and phenelzine.
Danish: Disse lægemidler omfatter isocarboxazid og phenelzin.
English: Further increases should be individualized based on clinical response.
Danish: Yderligere forøgelse skal overvejes individuelt på grundlag af klinisk respons.
English: Treatment, sequence and period were included as fixed effects, intra- and inter subject factors were included as random effects.
Danish: Behandling, rækkefølge og periode blev inkluderet som faste effekter, intra- og interforsøgspersonfaktorer blev inkluderet som tilfældige effekter.
English: This is because other medicines can affect the way Numient works.
Danish: Dette skyldes, at andre lægemidler kan påvirke, hvordan Numient fungerer.
English: Do not take Numient if you have taken a medicine called a ‘non-selective monoamine oxidase (MAO) inhibitor' for treating depression in the last 14 days.
Danish: Tag ikke Numient, hvis du har taget et lægemiddel betegnet en ‘ikke-selektiv monoaminoxidase (MAO)-hæmmer' til behandling af depression i de sidste 14 dage.
English: If you have had levodopa before, your doctor will determine the appropriate starting dose regimen based on your current levodopa dose
Danish: Hvis du har fået levodopa før, vil din læge bestemme den relevante startdosis ud fra din aktuelle levodopa-dosis
English: Therefore, do not take Numient and iron supplements or multivitamin supplements containing iron at the same time.
Danish: Tag derfor ikke Numient og jerntilskud eller multivitamintilskud indeholdende jern samtidig.
English: Feeling sick to your stomach (nausea)
Danish: Føler sig syg i maven (kvalme)
English: Features of randomized patients
Danish: Kendetegn ved randomiserede patienter
English: Mean UPDRS (Part II and Part III) Score a)
Danish: Middel-UPDRS (del II og del III) -score a)
English: Data in the ASCEND-PD study were analysed using a standard mixed-model analysis of variance.
Danish: Data i ASCEND-PD-forsøget blev analyseret ved brug af standard blandet-model-analyse af varians.
English: Alcohol interaction
Danish: Alkoholinteraktion
English: High blood pressure, abnormally low blood pressure when you stand up Shortness of breath
Danish: Højt blodtryk, unormalt lavt blodtryk, når du står op Kortåndethed
English: Minimum dosing frequency was four times per day for at least 4 weeks upon entry into the trial.
Danish: Den mindste doseringshyppighed var fire gange om dagen i mindst 4 uger efter optagelsen i forsøget.
English: The main secondary endpoints included “off” time, “on” time without troublesome dyskinesia, and UPDRS Parts II+III score.
Danish: De øvrige sekundære effektmål inkluderede “off”-tid, “on”-tid uden problematisk dyskinesi samt UPDRS del II+III score.
English: CGI-C much improved (95% CI)
Danish: CGI-C stærkt forbedret (95 % CI)
English: There was no evidence of period, sequence/carry-over effects in the ASCEND-PD study (p-values all > 0.10).
Danish: Der var intet bevis for periode-, rækkefølge/overførselseffekter i ASCEND-PD-forsøget (p-værdier alle > 0,10).
English: Adverse reactions observed in the clinical development of Numient
Danish: Bivirkninger observeret under den kliniske udvikling af Numient
English: You should not take Numient capsules at intervals of less than 4 hours apart
Danish: Du må ikke tage Numient-kapsler med mindre end 4 timers mellemrum
English: Carbidopa is approximately 36% bound to plasma proteins.
Danish: Carbidopa er cirka 36 % bundet til plasmaproteiner.
English: Therefore, Numient should not be taken at the same time as high protein meals.
Danish: Numient bør derfor ikke indtages samtidigt med måltider med højt proteinindhold.
English: The daily dose must be determined by careful titration.
Danish: Dosen skal bestemmes ved omhyggelig titrering.
English: False negative results might be obtained upon application of glucose-oxidase methods for glucosuria.
Danish: Falsk-negative resultater kan fås ved anvendelse af glukoseoxidase-metoder mod glukosuri.
English: Furthermore a reduction of dose or termination of therapy may be considered.
Danish: Det kan desuden overvejes at reducere dosis eller afbryde behandlingen.
English: If you have any of the following symptoms during your treatment with Numient, contact your doctor immediately:
Danish: Hvis du udsættes for nogen af følgende symptomer under din behandling med Numient, skal du straks søge læge:
English: In case of an overdose, you may feel confused or agitated, and your heart rate may be slower or faster than normal.
Danish: Hvis du udsættes for en overdosis, kan du blive forvirret eller ophidset, og din puls kan være langsommere eller hurtigere end normalt.
English: Renal excretion of intact levodopa accounts for only about 10% of clearance.
Danish: Renal udskillelse af intakt levodopa udgør kun omkring 10 % af clearance.
English: Epidemiological studies have shown that patients with Parkinson's disease have a higher risk (2- to approximately 6-fold higher) of developing melanoma than the general population.
Danish: Epidemiologiske undersøgelser har vist, at patienter med Parkinsons sygdom har en højere risiko (2 til ca. 6 gange højere) for at udvikle melanom end den almene befolkning.
English: In both studies the primary endpoint was the percentage “off” time during waking hours.
Danish: I begge forsøg var det primære effektmål procentdelen af “off”-tid, mens patienten var vågen.
English: Percentage “off” time*
Danish: Procentdel “off”-tid *
English: Do not stop taking Numient suddenly
Danish: Hold ikke op med at tage Numient meget pludseligt
English: ≥1 hour improvement in “off” time (95% CI)
Danish: ≥ 1 times forbedring i “off”-tid (95 % CI)
English: Chest pain not due to heart disease
Danish: Brystsmerter, der ikke skyldes hjertesygdom
English: CNS effects and mental disturbances
Danish: CNS-virkninger og mentale forstyrrelser
English: Anaemia (low red blood cell counts)
Danish: Anæmi (lavt antal røde blodlegemer)
English: levodopa turns into a material called ‘dopamine' in your brain.
Danish: levodopa bliver til et materiale betegnet ‘dopamin' i din hjerne.
English: In such patients, cardiac function should be monitored with particular care during the period of initial dose adjustment.
Danish: Hos disse patienter skal hjertefunktionen overvåges med særlig omhu under den indledende dosisjustering.
English: If therapy is interrupted temporarily, the usual dose should be administered as soon as the patient is able to take oral medicinal products.
Danish: Hvis behandlingen afbrydes midlertidigt, skal den sædvanlige dosis administreres, lige så snart patienten er i stand til at tage orale lægemidler.
English: Ferrous sulphate (used to treat anaemia caused by low levels of iron in the blood).
Danish: Ferrosulfat (anvendes til at behandle anæmi forårsaget af lavt indhold af jern i blodet).
English: a) For the UPDRS, higher scores indicate greater severity of impairment b) All values based on 361 patients from the Intent to Treat population who had valid End of Study values c) Negative numbers indicate improvement as compared with the baseline value d) Three times per day e) P-value is less than 0.05 versus placebo
Danish: a) For UPDRS angiver de højere scorer en svækkelse af større sværhedsgrad b) Alle værdier er baseret på 361 patienter fra Intent til Treat-populationen, som havde gyldige forsøgsafslutningsværdier c) Negative tal angiver forbedring i forhold til baselineværdien d) Tre gange om dagen e) P-værdi er mindre end 0,05 versus placebo
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelig (kan berøre mere end 1 ud af 10 personer)
English: Do not break, crush or chew the capsules
Danish: Undlad at brække, knuse eller tygge kapslerne
English: Levodopa-naïve patients with Parkinson's disease APEX-PD
Danish: Levodopa-naive patienter med Parkinsons sygdom APEX-PD
English: After taking one of them, wait at least 2 to 3 hours before taking the other Phenothiazines - such as chlorpromazine, promazine and prochloroperazine (used to treat mental illness)
Danish: Når du har taget en af dem, skal du vente mindst 2-3 timer, før du tager den anden Phenothiaziner - såsom chlorpromazin, promazin og prochloroperazin (anvendes til at behandle psykisk sygdom)
English: Psychotic episode, agitation
Danish: Psykotisk episode, ophidselse
English: Table 5: Main results of studies in advanced Parkinson's disease Study
Danish: Tabel 5: Hovedresultater fra undersøgelser af fremskreden Parkinsons sygdom Forsøg
English: There is limited experience with a total daily dose of more than 1,170 mg of levodopa when administered in levodopa-naïve patients.
Danish: Der er begrænset erfaring med en samlet daglig dosis på mere end 1.170 mg levodopa, når det administreres hos levodopa-naive patienter.
English: Effect of levodopa and carbidopa on the metabolism of other medicinal products
Danish: Virkningen af levodopa og carbidopa på metabolisme af andre lægemidler
English: It does not cross the blood-brain barrier and does not affect the metabolism of levodopa within the central nervous system.
Danish: Det krydser ikke blod-hjerne-barrieren og påvirker ikke levodopas metabolisme i centralnervesystemet.
English: There have been rare reports that the beneficial effects of levodopa in Parkinson's disease are reversed by phenytoin and papaverine.
Danish: Der har været sjældne rapporter om, at de gavnlige virkninger af levodopa ved Parkinsons sygdom reverteres af phenytoin og papaverin.
English: Ferrous salts can form chelates with levodopa and carbidopa.
Danish: Ferrosalte kan danne chelater med levodopa og carbidopa.
English: Symptomatic postural hypotension has occurred when combinations of levodopa and a decarboxylase inhibitor are added to the treatment of patients already receiving certain antihypertensives.
Danish: Symptomatisk postural hypotension er forekommet, når kombinationer af levodopa og en decarboxylasehæmmer føjes til behandling af patienter, der i forvejen modtager visse antihypertensiva.
English: The medicinal product/food mixture should be swallowed completely and immediately without chewing and should not be stored for future use.
Danish: Denne lægemiddel/mad-blanding skal synkes fuldstændigt og med det samme, uden at der tygges, og den må ikke opbevares til senere brug.
English: The most frequently reported adverse reactions with Numient were nausea, occurring in approximately 12% of all patients; dizziness, headache, and dyskinesia, each occurring in approximately 8% of all patients; and insomnia, occurring in approximately 6% of all patients.
Danish: De hyppigst rapporterede bivirkninger med Numient var kvalme, der forekom hos cirka 12 % af alle patienter; svimmelhed; hovedpine og dyskinesi, som hver forekom hos ca. 8 % af alle patienter; og søvnløshed, der forekom hos ca. 6 % af alle patienter.
English: Dose (mg), median (range)
Danish: Dosis (mg), median (interval)
English: Responder analyses
Danish: Responder-analyser
English: Anticholinergic medicinal products can work synergistically with levodopa, in order to improve tremor.
Danish: Antikolinerge lægemidler kan arbejde synergistisk med levodopa for at forbedre tremor.
English: Tell your doctor if you or your family/carer notices you are developing urges or cravings to behave in ways that are unusual for you or you cannot resist the impulse, drive or temptation to carry out certain activities that could harm yourself or others.
Danish: Fortæl din læge, hvis du eller dine familie/plejer bemærker, at du udvikler en trang til at opføre dig på en måde, som er usædvanlig for dig, eller du ikke kan modstå impulsen, trangen eller fristelsen til at udføre bestemte aktiviteter, som kan skade dig selv eller andre.
English: Change from baseline at week 30 (or at early termination)c)
Danish: Ændring i forhold til baseline i uge 30 (eller ved førtidigt ophør)c)
English: Levodopa crosses the blood-brain barrier by active transporters for large neutral amino acids.
Danish: Levodopa krydser blod-hjernebarrieren via aktive transportører for store neutrale aminosyrer.
English: NMS is a life-threatening syndrome characterized by fever or hyperthermia and can be associated with rhabdomyolysis.
Danish: NMS er et livstruende syndrom, der er karakteriseret ved feber eller hypertermi og kan være forbundet med rhabdomyolyse.
English: The combination may be associated with severe orthostatic hypotension.
Danish: Kombinationen kan være forbundet med svær ortostatisk hypotension.
English: 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.
Danish: Det forhindrer metabolisme af levodopa til dopamin i den perifere cirkulation og sikrer, at en større andel af dosen når hjernen, hvor dopamin udøver sin terapeutiske virkning.
English: Numient contains two different medicines called levodopa and carbidopa in one hard capsule.
Danish: Numient indeholder to forskellige lægemidler betegnet levodopa og carbidopa i én hård kapsel.
English: *In the ADVANCE-PD study an Analysis of Covariance (ANCOVA) model for End of Study was used with treatment and centres as main effects and interaction term for treatment by centre and baseline as covariate.
Danish: *I ADVANCE-PD-forsøget blev der anvendt en kovariansanalysemodel (ANCOVA) for forsøgsafslutning med behandling og centre som hovedeffekter og interaktionsudtryk for behandling efter center og baseline som kovarians.
English: Numient capsules are supplied in plastic bottles with a dessicant and a plastic cap, available in bottles of 25, 100 or 240 hard capsules.
Danish: Numient-kapslerne leveres i plastflasker med et tørremiddel og et plastiklåg, fås i flasker med 25, 100 eller 240 hårde kapsler.
English: Within each frequency category, the adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver frekvenskategori er bivirkninger opstillet efter faldende alvorlighed.
English: However, dose adjustments may be required (see section 4.5).
Danish: Det kan dog være nødvendigt at foretage dosisjusteringer (se pkt.
English: Thus, impaired renal function may potentially have a small effect on the exposure of levodopa.
Danish: Nedsat nyrefunktion kan således potentielt have en lille indvirkning på eksponeringen af levodopa.
English: Avoid taking your capsules with a high fat meal or one high in protein since this will delay the time it takes for the medicine to work.
Danish: Undgå at tage kapslerne med et måltid med et højt fedteller proteinindhold, da dette vil forsinke den tid, som det tager, før lægemidlet virker.
English: Concomitant use of antipsychotics should be monitored carefully for worsening of Parkinson's motor symptoms especially when D2-receptor antagonists are used (see section
Danish: Samtidig brug af antipsykotika bør overvåges nøje for forværring af Parkinsons motoriske symptomer, især når der anvendes D2-receptorantagonister (se pkt.
English: A dose adjustment of levodopa may be required.
Danish: Det kan være nødvendigt at foretage en dosisjustering af levodopa.
English: What you need to know before you take Numient Do not take Numient:
Danish: Det skal du vide, før du begynder at tage Numient Tag ikke Numient:
English: 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.
Danish: Der sås ingen effekter på mandlige eller kvindelige kønsorganer ved gentagne dosistoksikologiske undersøgelser hos mus, rotter eller aber med levodopa alene, eller i kombination med carbidopa.
English: Numient is recommended to be dosed orally, approximately every 6 hours.
Danish: Det anbefales at dosere Numient oralt, cirka hver 6. time.
English: This reaction does not change upon boiling the urine sample.
Danish: Denne reaktion ændres ikke, når urinprøven koges.
English: The use of Numient is not recommended in patients under 18 years of age.
Danish: Brugen af Numient anbefales ikke hos patienter under 18 år.
English: Following this dose conversion, 91 study patients (mean age: 64.1 years; 75% male patients) were randomized to receive Numient followed by prestudy LCE or vice versa.
Danish: Efter denne dosiskonvertering blev 91 forsøgspersoner (gennemsnitsalder: 64,1 år; 75 % mænd) randomiseret til at modtage Numient efterfulgt af LCE før forsøget eller omvendt.
English: The extent of absorption of levodopa (AUCinf) was similar (13% increase) to that observed in the fasted state.
Danish: Absorptionen af levodopa (AUCinf) var næsten den samme (13 % stigning) som den, der blev observeret i den fastende tilstand.
English: Levodopa/carbidopa and ferrous salts or multivitamins containing ferrous salts should be co-administered with caution.
Danish: Levodopa/carbidopa og jernholdige salte eller multivitaminer, som indeholder ferrosalte, skal administreres med forsigtighed.
English: Each of the three modified-release levodopa/carbidopa treatments was statistically significantly superior to placebo on the primary measure (Table 4).
Danish: Hver af de tre levodopa/carbidopa-behandlinger med modificeret udløsning var statistisk signifikant bedre end placebo for det primære mål (tabel 4).
English: Avoid taking your capsules at the same time that you consume a high fat or high protein meal.
Danish: Undgå at tage dine kapsler samtidig med, at du indtager et måltid med højt fedt- eller proteinindhold.
English: Patients may experience new or worsening mental status and behavioural changes, which may be severe, including psychotic-like and suicidal behaviour during levodopa treatment or after starting or increasing the dose of levodopa.
Danish: Patienter kan opleve nye eller forværrede psykiske tilstands- og adfærdsændringer, som kan være alvorlige, herunder psykotisk adfærd og selvmordsadfærd under levodopa-behandling eller efter start eller forøgelse af levodopa-dosen.
English: Levodopa competes with certain amino acids for transport, therefore high protein meals may impair the absorption of levodopa.
Danish: Levodopa konkurrerer med visse aminosyrer om transport, og måltider med højt proteinindhold kan derfor forringe absorptionen af levodopa.
English: Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines.
Danish: Patienter, der har oplevet somnolens og/eller en episode, hvor de pludselig er faldet i søvn, skal undlade at føre motorkøretøj eller betjene maskiner.
English: If you forget to take a dose of Numient
Danish: Hvis du har glemt at tage en dosis Numient
English: Peak plasma concentrations are reached at about 4.5 hours.
Danish: Peak-plasmakoncentrationer nås efter cirka 4,5 time.