FrancophonIA/ELRC3.0 huggingface dataset:
English: Inhalation powder, hard capsule.
Danish: Inhalationspulver, hård kapsel.
English: Colfosceril palmitate (DPPC) Sodium chloride
Danish: Colfoscerilpalmitat (DPPC) Natriumchlorid
English: Patients selected for treatment with Inbrija should be able to recognize the onset of their 'OFF' symptoms and be capable of preparing the inhaler or else have a responsible care giver able to prepare the inhaler for them when required.
Danish: Patienter, der vælges til behandling med Inbrija, skal være i stand til at erkende, at deres OFFsymptomer indtræder, og være i stand til at klargøre inhalatoren eller have en ansvarlig plejer, der er i stand til at klargøre inhalatoren til dem, når det er nødvendigt.
English: Levodopa can cause orthostatic hypotension.
Danish: Levodopa kan forårsage ortostatisk hypotension.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Inbrija 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 Inbrija i alle undergrupper af den pædiatriske population ved behandling af idiopatisk Parkinsons sygdom (se pkt.
English: Your inhaler is now ready to store.
Danish: Din inhalator er nu klar til opbevaring.
English: Then breathe out.
Danish: Ånd herefter ud.
English: • You should inhale the contents of the second capsule within 10 minutes of the first one.
Danish: • Du skal inhalere indholdet i den anden kapsel inden for 10 minutter efter den første kapsel.
English: Full dose = 2 capsules.
Danish: Fuld dosis = 2 kapsler.
English: Levodopa may have a major influence on the ability to drive and use machines.
Danish: Levodopa kan i væsentlig grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: This endpoint was assessed in a clinical setting, i.e. patients had to take their regular morning oral levodopa/dopa-decarboxylase inhibitor dose and then visit the clinic 2-5 hours post dose.
Danish: Dette endepunkt blev vurderet under kliniske rammer, det vil sige, at patienterne skulle tage deres almindelige morgendosis af oral levodopa/dopa-decarboxylasehæmmer og herefter besøge klinikken 2-5 timer efter dosen.
English: - if you have previously suffered from neuroleptic malignant syndrome, a life-threatening reaction to certain medicines used to treat severe mental disorders or if you have suffered from non-traumatic rhabdomyolysis, a rare muscle disorder in which damaged muscle breaks down rapidly.
Danish: - hvis du tidligere har lidt af neuroleptisk malignt syndrom, en livstruende reaktion på visse lægemidler, der anvendes til behandling af svære mentale forstyrrelser, eller hvis du har lidt af ikke-traumatisk rhabdomyolyse, en sjælden muskellidelse, hvor beskadigede muskler hurtigt nedbrydes.
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 bestå af en eller flere af flere forskellige manifestationer, herunder angst, depression, paranoide forestillinger, vrangforestillinger, hallucinationer, forvirring, psykoselignende adfærd, desorientering, aggressiv adfærd, ophidselse og delirium.
English: 96 months
Danish: 96 måneder
English: • Dispose of the inhaler after you are finished all of the capsules in the carton.
Danish: • Bortskaf inhalatoren, når du har brugt alle kapslerne i kartonen.
English: • A complete dose is 2 capsules used one after the other.
Danish: • En fuld dosis er 2 kapsler, der anvendes den ene efter den anden.
English: do not drive or use tools or machines.
Danish: Hvis det sker for dig, må du ikke føre motorkøretøj eller betjene værktøj eller maskiner.
English: Talk to your doctor or pharmacist before using Inbrija if you have, or have ever had, or you develop: - asthma, breathing difficulties like chronic obstructive pulmonary disease (COPD) or other long term lung diseases or breathing problems; - any form of severe mental disorder like psychosis; - a heart attack, or heart beat problems.
Danish: Kontakt lægen eller apotekspersonalet, før du bruger Inbrija, hvis du har eller tidligere har haft eller du udvikler: - astma, åndedrætsbesvær, såsom kronisk obstruktiv lungesygdom (KOL) eller andre langvarige lungesygdomme eller åndedrætsproblemer, - nogen form for svær mental forstyrrelse, såsom psykose, - et hjerteanfald eller hjerterytmeproblemer.
English: The not known column represents adverse reactions reported for other oral levodopa medicinal products.
Danish: Kolonnen med “Ikke kendt” viser bivirkninger, der er rapporteret for andre orale levodopa-lægemidler.
English: The metabolite profile following Inbrija inhalation was not substantially different than that observed following oral carbidopa/levodopa administration.
Danish: Metabolitprofilen efter Inbrija-inhalation var ikke væsentlig forskellig fra den, der blev observeret efter oral carbidopa/levodopa-administration.
English: Inhalation only.
Danish: Udelukkende til inhalation.
English: Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely.
Danish: Der har været meget sjældne rapporter om pludseligt opstået søvnanfald under daglige aktiviteter, i nogle tilfælde uden bevidsthed herom eller advarselstegn.
English: The Inbrija inhaler is to be thrown away after all the capsules have been used.
Danish: Inbrija-inhalatoren skal kasseres, når alle kapslerne er blevet anvendt.
English: Close your lips firmly around the mouthpiece and breathe in, again holding your breath for 5 seconds.
Danish: Luk læberne fast omkring mundstykket, og træk vejret ind, hvorefter du igen holder vejret i 5 sekunder.
English: Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment (see section 4.7).
Danish: Patienterne skal informeres om dette og rådes til at udvise forsigtighed, når de fører motorkøretøj eller betjener maskiner, mens de er i behandling (se pkt.
English: Step 11: Dose with 2nd capsule
Danish: Trin 11: Dosér med den 2. kapsel
English: The impact of the amount of circulating dopa-decarboxylase at the end of an oral carbidopa/levodopa dosing interval on the efficacy of Inbrija was not studied.
Danish: Den påvirkning, som mængden af cirkulerende dopa-decarboxylase ved slutningen af et oralt carbidopa/levodopa-doseringsinterval har på virkningen af Inbrija, blev ikke undersøgt.
English: Levodopa may cause increased intraocular pressure in patients with glaucoma.
Danish: Levodopa kan forårsage forhøjet intraokulært tryk hos patienter med glaukom.
English: If an OFF period emerged subjects received placebo or inhaled levodopa.
Danish: Hvis der opstod en OFF-episode, fik forsøgspersonerne placebo eller inhaleret levodopa.
English: Contents of the pack and other information What Inbrija contains
Danish: Pakningsstørrelser og yderligere oplysninger Inbrija indeholder:
English: Gastrointestinal haemorrhage has been reported with levodopa medicinal products and was observed once in Inbrija clinical studies.
Danish: Gastrointestinal blødning er blevet rapporteret med levodopa-lægemidler og er observeret én gang i kliniske studier med Inbrija.
English: Inbrija may cause dyskinesia.
Danish: Inbrija kan forårsage dyskinesi.
English: There is limited data available on the use of Inbrija during a respiratory infection.
Danish: Der foreligger en begrænset mængde data om anvendelsen af Inbrija under en luftvejsinfektion.
English: isocarboxazid and phenelzine).
Danish: (f.eks. isocarboxazid og phenelzin).
English: • Do not load 2 capsules at the same time.
Danish: • Undlad at sætte 2 kapsler i samtidig.
English: Dopamine D2 receptor antagonists (e.g. phenothiazines, butyrophenones, risperidone, metoclopramide) and isoniazid may reduce the effectiveness of levodopa.
Danish: Dopamin-D2-receptorantagonister (f.eks. phenothiaziner, butyrophenoner, risperidon, metoclopramid) og isoniazid kan reducere virkningen af levodopa.
English: A total of 114 patients were randomised and treated with Inbrija 66 mg (two 33 mg capsules) and 112 patients received placebo.
Danish: I alt 114 patienter blev randomiseret og behandlet med Inbrija 66 mg (to 33 mg-kapsler), og 112 patienter fik placebo.
English: Firmly push the mouthpiece and handle together until you hear a click.
Danish: Pres mundstykket og håndtaget fast sammen, indtil du hører et klik.
English: Serious adverse reactions of allergic oedema have been reported with levodopa medicinal products but not in clinical studies with Inbrija.
Danish: Alvorlige bivirkninger med allergisk ødem er blevet rapporteret med levodopa-lægemidler, men ikke i kliniske studier med Inbrija.
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 neuroleptisk malignt syndrom (NMS, en sjælden svær reaktion på lægemidler, der anvendes til behandling af forstyrrelser i centralnervesystemet) eller rhabdomyolyse (en sjælden svær muskelforstyrrelse).
English: - if you have a rare tumour of the adrenal gland called phaeochromocytoma.
Danish: - hvis du har en sjælden tumor i binyrekirtlen, der kaldes fæokromocytom.
English: Patients with a major psychotic disorder or a history of psychotic disorder must be treated cautiously with a levodopa/dopa-decarboxylase inhibitor because of the risk of exacerbating psychosis.
Danish: Patienter med en svær psykotisk forstyrrelse eller en psykotisk forstyrrelse i anamnesen skal behandles med forsigtighed med en levodopa/dopa-decarboxylasehæmmer på grund af risikoen for forværring af psykose.
English: The use of Inbrija is not recommended in patients under 18 years of age.
Danish: Inbrija bør ikke anvendes til patienter under 18 år.
English: Levodopa is associated with somnolence and has been associated very rarely with excessive daytime somnolence and sudden sleep onset episodes.
Danish: Levodopa er forbundet med somnolens og har meget sjældent været forbundet med omfattende somnolens i løbet af dagen og episoder med pludseligt opstået søvnanfald.
English: Levodopa is a precursor of dopamine, and is given as dopamine replacement therapy in Parkinson's disease.
Danish: Levodopa er et forstadie til dopamin og gives som dopaminsubstitutionsbehandling ved Parkinsons sygdom.
English: Patients should be on a stable levodopa/dopa-decarboxylase inhibitor (e.g. carbidopa or benserazide) regimen before starting Inbrija.
Danish: Patienterne skal være i en stabil behandling med levodopa/dopa-decarboxylasehæmmer (f.eks. carbidopa eller benserazid) før start på Inbrija.
English: The use of selective MAO-B inhibitors (e.g. rasagiline, selegiline, and safinamide) with levodopa may be associated with orthostatic hypotension.
Danish: Anvendelse af selektive MAO-B-hæmmere (f.eks. rasagilin, selegilin og safinamid) sammen med levodopa kan være forbundet med ortostatisk hypotension.
English: Inbrija should be administered with caution in patients with severe cardiovascular disease.
Danish: Inbrija skal administreres med forsigtighed hos patienter med svær kardiovaskulær sygdom.
English: Reduction in mean daily OFF time and improvement on the Patient Global Impression of Change (PGI-C) scale, a patient reported outcome of the overall improvement and satisfaction with Inbrija treatment, and Responders ON were the main secondary endpoints.
Danish: De vigtigste sekundære endepunkter var reduktion i gennemsnitlig daglig OFF-tid og forbedring på skalaen for Patient Global Impression of Change (PGI-C), et patientrapporteret udfald af den samlede forbedring og tilfredshed med Inbrijabehandling samt Respondenter ON.
English: Exceeding the recommended dose may lead to increased levodopa associated adverse reactions.
Danish: En overskridelse af den anbefalede dosis kan medføre forøgede levodopaforbundne bivirkninger.
English: Before starting Inbrija, you must be taking regular treatment for Parkinson's disease combining a socalled dopa-decarboxylase inhibitor with levodopa.
Danish: Før du starter på Inbrija, skal du være i regelmæssig behandling for Parkinsons sygdom med en kombination af en såkaldt dopa-decarboxylasehæmmer og levodopa.
English: Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with levodopa.
Danish: Patienter og plejere skal gøres opmærksomme på, at adfærdsmæssige symptomer på manglende impulskontrol, herunder ludomani, forøget libido, hyperseksualitet, kompulsivt forbrug eller købetrang, overspisning og tvangsspisning, kan forekomme hos patienter, der behandles med levodopa.
English: Dose adjustment of the antihypertensive medicinal products may be required during concomitant use of Inbrija.
Danish: Dosisjustering af de antihypertensive lægemidler kan være nødvendig under samtidig anvendelse af Inbrija.
English: The effectiveness of Inbrija for the treatment of OFF episodes in patients with Parkinson's disease given on top of background dopaminergic treatment was evaluated in a 12-week, randomised, placebo-controlled, double-blind study.
Danish: Effektiviteten af Inbrija til behandling af OFF-episoder hos patienter med Parkinsons sygdom givet som supplement til dopaminerg baggrundsbehandling blev evalueret i et 12 ugers, randomiseret, placebokontrolleret, dobbeltblindet studie.
English: Do not load 2 capsules at the same time.
Danish: Indsæt ikke 2 kapsler samtidig.
English: Then, remove the used capsule and load a second capsule into the inhaler.
Danish: Herefter fjernes den brugte kapsel, og en anden kapsel sættes i inhalatoren.
English: If you stop using Inbrija
Danish: Hvis du holder op med at bruge Inbrija
English: Concurrent administration of levodopa and amantadine may increase confusion, hallucinations, nightmares, gastro-intestinal disturbances, or other atropine-like side effects.
Danish: Samtidig administration af levodopa og amantadin kan forøge konfusion, hallucinationer, mareridt, forstyrrelser i mave-tarm-kanalen eller andre atropinlignende bivirkninger.
English: • Load 1 capsule into the Inbrija inhaler, close your lips firmly around the mouthpiece, then breathe in (inhale) and hold that breath for 5 seconds.
Danish: • Indsæt 1 kapsel i Inbrija-inhalatoren, luk læberne fast omkring mundstykket, træk herefter vejret ind (inhalér), og hold vejret i 5 sekunder.
English: 64 years
Danish: 64 år
English: You should inhale the contents of the second capsule within 10 minutes of the first one.
Danish: Du skal inhalere indholdet af den anden kapsel inden for 10 minutter efter den første kapsel.
English: The safety and efficacy of Inbrija in children under 18 years of age have not been established.
Danish: Pædiatrisk population Inbrijas sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
English: Women should not breast-feed during treatment with Inbrija.
Danish: Kvinder bør ikke amme, mens de behandles med Inbrija.
English: Abnormalities in laboratory tests may include elevations of liver function tests such as alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactic dehydrogenase (LDH), and bilirubin.
Danish: Abnormaliteter i laboratorietests kan indbefatte forhøjelser af leverfunktionstests, såsom alkalisk phosphatase, aspartataminotransferase (ASAT), alaninaminotransferase (ALAT), laktatdehydrogenase (LDH) og bilirubin.
English: Hold the inhaler upright using the handle.
Danish: Hold inhalatoren lodret ved anvendelse af håndtaget.
English: You should hear the capsule “whirl”.
Danish: Du skal høre kapslen “hvirvle”.
English: There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and a levodopa/dopa-decarboxylase inhibitor.
Danish: Der har været sjældne rapporter om bivirkninger, herunder hypertension og dyskinesi, som følge af samtidig brug af tricykliske antidepressiva og en levodopa/dopa-decarboxylasehæmmer.
English: A dose adjustment of levodopa may be required.
Danish: Dosisjustering af levodopa kan være nødvendig.
English: Neoplasm benign, malignant and unspecified (incl.
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: Remove used capsule
Danish: Fjern den brugte kapsel
English: - The used capsule should be removed from the Inbrija inhaler and the second capsule loaded into the inhaler.
Danish: - Den brugte kapsel skal fjernes fra Inbrija-inhalatoren, og den anden kapsel sættes i inhalatoren.
English: Inbrija inhalation powder, hard capsules consist of a white powder for inhalation filled into white opaque hard capsules with “A42” printed in black on the cap of the caspule and two black bands printed on the body of the capsule.
Danish: Inbrija inhalationspulver, hårde kapsler består af et hvidt pulver til inhalation fyldt i hvide uigennemsigtige kapsler med “A42” trykt i sort på overdelen af kapslen og to sorte bånd trykt på underdelen af kapslen.
English: Each delivered dose contains 33 mg levodopa.
Danish: Hver leveret dosis indeholder 33 mg levodopa.
English: If you forget to use Inbrija
Danish: Hvis du har glemt at bruge Inbrija
English: Do not use more than 2 capsules for each off period.
Danish: Du må ikke bruge mere end 2 kapsler til hver off-periode.
English: Care should be exercised when Inbrija is administered to patients with a history of myocardial infarction who have residual atrial, nodal, or ventricular arrhythmias.
Danish: Der skal udvises forsigtighed, når Inbrija administreres til patienter med myokardieinfarkt i anamnesen, og som har residuale atriale, nodale eller ventrikulære arytmier.
English: Only remove 1 capsule at a time, and just before use.
Danish: Tag kun 1 kapsel ud ad gangen og først umiddelbart før brug.
English: The dose-normalised relative bioavailability of a single 66 mg emitted dose of Inbrija was 88.0% (90% CI: 80.3, 96.4) when compared to a single oral carbidopa/levodopa 25 mg/100 mg dose.
Danish: Den dosisnormaliserede relative biotilgængelighed af en enkelt 66 mg leveret dosis af Inbrija var 88,0 % (90 % CI: 80,3; 96,4) sammenlignet med en enkelt oral carbidopa/levodopa 25 mg/100 mg-dosis.
English: - The active substance is levodopa.
Danish: - Aktivt stof: levodopa.
English: The peak metabolite concentrations and total exposure achieved after Inbrija administration did not exceed those observed following an oral carbidopa/levodopa dose.
Danish: De maksimale metabolitkoncentrationer og den samlede eksponering opnået efter Inbrija-administration oversteg ikke værdierne observeret efter en oral carbidopa/levodopa-dosis.
English: Psychotic disorder, Impulse-control disorder (see section 4.4),
Danish: Ikke kendt psykotisk forstyrrelse, impulskontrolforstyrrelse (se pkt.
English: If you have any of these symptoms, you may have a eye condition called narrow angle glaucoma, which occurs suddenly: do not take
Danish: Hvis du har et eller flere af disse symptomer, kan du have en øjenlidelse, der kaldes snævervinklet glaukom, som opstår pludselig.
English: White opaque capsules containing white powder, with “A42” printed in black on the cap of the capsule and two black bands printed on the body of the capsule.
Danish: Hvide, uigennemsigtige kapsler indeholdende hvidt pulver med “A42” trykt i sort på overdelen af kapslen og to sorte bånd trykt på underdelen af kapslen.
English: Pre-dose score Change at 30 min Diff. (95% CI) p-value
Danish: Score før dosis Ændring efter 30 minutter Forskel (95 % CI) p-værdi
English: Urinary retention, Chromaturia, Urinary incontinence
Danish: Urinretention, kromaturi, urininkontinens
English: • Dispose of all used capsules immediately after use.
Danish: • Bortskaf alle brugte kapsler umiddelbart efter brug.
English: Fall a Cardiac rhythm disorder here is a combined term representing atrial fibrillation, atrial flutter, atrioventricular block, bundle branch block, sick sinus syndrome, bradycardia, and tachycardia.
Danish: Fald a Hjerterytmeforstyrrelse her er en kombineret term, der inkluderer atrieflimren, atrieflagren, atrioventrikulært blok, grenblok, syg sinus-syndrom, bradykardi og takykardi.
English: - The patient should load 1 capsule into the Inbrija inhaler, breathe in and hold their breath for 5 seconds.
Danish: - Patienten skal sætte 1 kapsel i Inbrija-inhalatoren, tage en indånding og holde vejret i 5 sekunder.
English: Get urgent medical help if you have bleeding in your stomach or intestines which may be seen as blood in your faeces or darkened faeces.
Danish: Søg akut lægehjælp, hvis du får blødning i mavesækken eller tarmene, der kan ses som blod i afføringen eller mørkfarvet afføring.
English: Caution should be exercised when interpreting the plasma and urine levels of catecholamines and their metabolites in patients on levodopa or levodopa/dopadecarboxylase inhibitor therapy.
Danish: Der skal udvises forsigtighed ved tolkning af plasma- og urinniveauerne af catecholaminer og deres metabolitter hos patienter i levodopa- eller levodopa/dopa-decarboxylasehæmmer-behandling.
English: The effect of Inbrija on pulmonary function was also evaluated in patients with Parkinson's disease treated with an oral levodopa/dopa-decarboxylase inhibitor in a 12-month, randomised, controlled, open-labeled study.
Danish: Virkningen af Inbrija på lungefunktionen blev også evalueret hos patienter med Parkinsons sygdom, der blev behandlet med en oral levodopa/dopa-decarboxylasehæmmer, i et 12 måneders, randomiseret, kontrolleret, åbent studie.
English: Cardiovascular ischaemic events
Danish: Kardiovaskulære iskæmiske hændelser
English: Get urgent medical help if your muscles get very rigid or jerk violently, you get tremors, agitation, confusion, fever, rapid pulse, or wide fluctuations in your blood pressure.
Danish: Søg akut lægehjælp, hvis dine muskler bliver meget stive eller laver kraftige spjæt, du oplever rysten, uro, forvirring, feber, hurtig puls eller store udsving i blodtrykket.
English: Abrupt dose reduction or withdrawal of any levodopa medicinal product should be carefully observed, particularly in patients who are also receiving neuroleptics.
Danish: En pludselig dosisreduktion eller seponering af et levodopa-lægemiddel bør overvåges nøje, især hos patienter, der også får neuroleptika.
English: Muscle spasms, Trismus
Danish: Muskelspasmer, trismus
English: Each carton includes blisters of 4 capsules.
Danish: Hver karton indeholder blistere med 4 kapsler.
English: Line up the white arrows on the handle and mouthpiece.
Danish: Ret de hvide pile på håndtaget og mundstykket ind med hinanden.
English: Get inhaler and strip of capsules.
Danish: Læg inhalator og strip med kapsler frem.
English: - a carton containing 60 hard capsules (15 blister strips) and one inhaler - a carton containing 92 hard capsules (23 blister strips) and one inhaler
Danish: - en karton indeholdende 60 hårde kapsler (15 blisterstrips) og én inhalator - en karton indeholdende 92 hårde kapsler (23 blisterstrips) og én inhalator
English: For use only with the inhaler provided in the pack.
Danish: Udelukkende til brug med inhalatoren, der medfølger i pakningen.
English: - The medicine must be used only with the Inbrija inhaler device.
Danish: - Lægemidlet må kun bruges ved anvendelse af Inbrija-inhalatoren.
English: - A previous history of neuroleptic malignant syndrome (NMS) and/or non-traumatic rhabdomyolysis.
Danish: - Neuroleptisk malignt syndrom (NMS) og/eller ikke-traumatisk rhabdomyolyse i anamnesen.
English: UPDRS-III score during OFF period n = 95a n = 94a
Danish: UPDRS-III-score under OFFperiode n = 95a n = 94a