FrancophonIA/ELRC3.0 huggingface dataset:
English: Any nonselective MAO inhibitors should be discontinued at least 14 days prior to initiating levodopa.
Danish: Eventuelle ikke-selektive MAO-hæmmere skal seponeres mindst 14 dage før start på levodopa.
English: Tricyclic antidepressants
Danish: Tricykliske antidepressiva
English: If you need to have surgery, tell your doctor that you are using Inbrija.
Danish: Hvis du skal opereres, skal du fortælle lægen, at du bruger Inbrija.
English: You must be sure that you do not get sudden sleep attacks, dizziness and drowsiness before you drive again or use machines.
Danish: Du skal være sikker på, at du ikke oplever pludselige søvnanfald, svimmelhed og døsighed, før du igen fører motorkøretøj eller betjener maskiner.
English: Start again from the beginning of Step 7 using the same capsule.
Danish: Start igen fra begyndelsen af trin 7 ved anvendelse af den samme kapsel.
English: Inbrija and get urgent medical attention.
Danish: Tag ikke Inbrija, og søg akut lægehjælp.
English: Due to cough, 2% of subjects withdrew from the clinical studies with Inbrija.
Danish: Som følge af hoste udgik 2 % af forsøgspersonerne fra de kliniske studier med Inbrija.
English: If you use more Inbrija than you should (or someone accidentally swallows Inbrija) get medical help immediately.
Danish: Hvis du har brugt for meget Inbrija (eller en person ved et uheld har slugt Inbrija), skal der straks søges lægehjælp.
English: Place the mouthpiece and inhaler on a clean and dry surface.
Danish: Anbring mundstykket og inhalatoren på en ren og tør overflade.
English: Certain side effects such as sleepiness and dizziness, that have been reported with other forms of levodopa medicinal products, may affect some patients' ability to drive or use machines.
Danish: Visse bivirkninger, såsom søvnighed og svimmelhed, der er blevet rapporteret med andre former af levodopa-lægemidler, kan påvirke nogle patienters evne til at føre motorkøretøj eller betjene maskiner.
English: Step 9: Hold breath for 5 seconds, then breathe out
Danish: Trin 9: Hold vejret i 5 sekunder, og ånd herefter ud
English: A summary of how to use Inbrija is provided below.
Danish: Nedenfor er anført et resumé af, hvordan Inbrija skal bruges.
English: Anticholinergic medicinal products may impair the effect of oral levodopa medicinal products, due to a delayed absorption.
Danish: Antikolinerge lægemidler kan svække virkningen af orale levodopa-lægemidler på grund af en forsinket absorption.
English: If the off period has passed, do not use Inbrija until the next off period.
Danish: Hvis off-perioden er overstået, skal du ikke bruge Inbrija før den næste off-periode.
English: Inbrija hard capsules must not be swallowed.
Danish: Inbrija hårde kapsler må ikke sluges.
English: No dose adjustment is required based on gender.
Danish: Dosisjustering er ikke nødvendig på baggrund af køn.
English: Using more than one dose of Inbrija (2 capsules) to treat the same OFF period may result in CNS disturbances, with an increasing likelihood of cardiovascular disturbance (e.g. hypotension, tachycardia) and more severe psychiatric problems at higher doses.
Danish: Hvis der anvendes mere end én dosis af Inbrija (2 kapsler) til behandling af den samme OFF-periode, kan det resultere i CNS-forstyrrelser med en forøget sandsynlighed for en kardiovaskulær forstyrrelse (f.eks. hypotension, takykardi) og sværere psykiske problemer ved højere doser.
English: Most cough reported in the clinical studies with Inbrija were mild to moderate in intensity, and usually reported within the first 30 days of the treatment.
Danish: De fleste tilfælde af hoste, der er rapporteret i de kliniske studier med Inbrija, var lette til moderate i styrke og blev sædvanligvis rapporteret inden for de første 30 dage af behandlingen.
English: 66 mg n = 114
Danish: Inbrija 66 mg n = 114
English: These inhibitors should already be discontinued for at least two weeks prior to initiating therapy due to the established underlying levodopa therapy (see section 4.5).
Danish: Disse hæmmere skal allerede være seponeret i mindst to uger før behandlingsstart på grund af den etablerede underliggende levodopabehandling (se pkt.
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 af pludseligt opstået søvnanfald, skal afholde sig fra at føre motorkøretøj eller betjene maskiner.
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: Det er uklart, om den observerede forhøjede risiko skyldtes Parkinsons sygdom eller andre faktorer, såsom lægemidler anvendt til behandling af Parkinsons sygdom.
English: Symptomatic postural hypotension has occurred when combinations of levodopa and a dopadecarboxylase inhibitor are added to the treatment of patients already receiving certain antihypertensives.
Danish: Symptomatisk postural hypotension er forekommet, når kombinationer af levodopa og en dopadecarboxylasehæmmer tilføjes behandlingen hos patienter, der allerede får visse antihypertensiva.
English: Please see the “Instructions for use” at the end of this leaflet on how to use your medicine with the provided inhaler.
Danish: I afsnittet “Brugsanvisning” i slutningen af denne indlægssedlen kan du se, hvordan du skal bruge din medicin med den medfølgende inhalator.
English: Adjustment of levodopa therapy or other medicinal products used for the treatment of Parkinson's disease may be considered.
Danish: Justering af levodopabehandling eller andre lægemidler, der anvendes til behandling af Parkinsons sygdom, kan overvejes.
English: The Inbrija inhaler is made of polybutylene terephthalate (PBT), polycarbonate (PC) and polypropylene (PP).
Danish: Inbrija-inhalatoren er fremstillet af polybutylenterephthalat (PBT), polycarbonat (PC) og polypropylen (PP).
English: Breathe out completely.
Danish: Ånd fuldstændigt ud.
English: Elderly No dose adjustment of Inbrija is required for elderly patients (≥65 years).
Danish: Det er ikke nødvendigt at justere dosis af Inbrija til ældre patienter (≥65 år).
English: After correcting the parameters for body weight, the gender difference after each treatment was no longer significant: the body-weight adjusted Cmax and AUC0-24 h after a dose of Inbrija in women were 9.7% and 15.1% higher than men.
Danish: Efter parametrene blev korrigeret for kropsvægt var kønsforskellen efter hver behandling ikke længere signifikant: den kropsvægtjusterede Cmax og AUC0-24 t efter en dosis Inbrija hos kvinder var 9,7 % og 15,1 % højere end hos mænd.
English: Psychotic reactions have been observed in patients receiving amantadine and levodopa.
Danish: Der er observeret psykotiske reaktioner hos patienter, der får amantadin og levodopa.
English: Cardiac function should be monitored with particular care in such patients during the initiation of treatment with Inbrija.
Danish: Hjertefunktionen skal overvåges særligt nøje hos sådanne patienter under start på behandling med Inbrija.
English: The primary efficacy endpoint was the mean change from baseline in Unified Parkinson's Disease Rating Scale (UPDRS) part III score 30 minutes post dose at week 12.
Danish: Det primære effektendepunkt var den gennemsnitlige ændring fra baseline i Unified Parkinsons Disease Rating Scale (UPDRS) del III-score 30 minutter efter dosering i uge 12.
English: Animal studies indicated no effect on fertility (see section 5.3).
Danish: Dyrestudier indikerede ingen virkning på fertilitet (se pkt.
English: Attach the mouthpiece to the handle by pushing until you hear a click.
Danish: Fastgør mundstykket til håndtaget ved at presse, indtil du hører et klik.
English: You should continue taking your main medicine for Parkinson's disease and use Inbrija to control worsening of symptoms (such as inability to move) during off periods.
Danish: Du skal fortsætte med at tage din primære medicin mod Parkinsons sygdom og anvende Inbrija til at kontrollere forværring af symptomer (såsom manglende evne til at bevæge dig) i off-perioder.
English: The most frequent adverse reactions reported in the Inbrija clinical studies were cough (15.6%), fall (8.7%), upper respiratory tract infection (5.8%), dyskinesia (5.7%) and sputum discoloured (2.8%).
Danish: De hyppigste bivirkninger, der er rapporteret i kliniske studier med Inbrija, var hoste (15,6 %), fald (8,7 %), øvre luftvejsinfektion (5,8 %), dyskinesi (5,7 %) og misfarvet opspyt (2,8 %).
English: Do not breathe into mouthpiece.
Danish: Undlad at ånde ud ind i mundstykket.
English: - if you get blurred vision, red eyes, severe eye and head pain, halos around lights, pupils of your eyes that are larger than normal size and feel sick.
Danish: - hvis du får sløret syn, røde øjne, kraftig øjensmerte og hovedpine, ser ringe af lys omkring et objekt, pupillerne i dine øjne er større end normal størrelse, og du får kvalme.
English: Inbrija is a medicine used by inhalation for treating the worsening of your symptoms during the “off periods” of Parkinson's disease.
Danish: Inbrija er et lægemiddel, der anvendes ved hjælp af inhalation til behandling af forværringen af dine symptomer i ”off-perioderne” af Parkinsons sygdom.
English: The maximum dose of Inbrija is 10 capsules per day.
Danish: Den maksimale dosis af Inbrija er 10 kapsler pr. dag.
English: See also under “Other medicines and Inbrija”.
Danish: Se også under “Brug af anden medicin sammen med Inbrija”.
English: Read these instructions before you start using Inbrija.
Danish: Læs denne brugsanvisning, før du starter med at bruge Inbrija.
English: Use Inbrija only during an off period.
Danish: Brug kun Inbrija i en off-periode.
English: If this happens start again at Step 4 using a new capsule.
Danish: Hvis dette sker, skal du starte forfra fra trin 4 ved anvendelse af en ny kapsel.
English: - inability to resist the impulse to perform an action that could be harmful, which may include: - strong impulse to gamble excessively despite serious personal or family consequences; - altersed or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive; - 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: - manglende evne til at modstå trangen til at udføre en handling, der kunne være skadelig, f.eks.: - stærk trang til at gamble for meget trods alvorlige personlige eller familiemæssige konsekvenser, - ændret eller øget seksuel interesse og adfærd, som du eller andre er meget bekymret over, for eksempel en øget seksualdrift, - 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: Patients should receive electrocardiographic monitoring for the development of arrhythmias; if needed, appropriate antiarrhythmic therapy should be given.
Danish: Patienterne skal overvåges elektrokardiografisk for udvikling af arytmier, og der skal om nødvendigt gives passende antiarytmisk terapi.
English: Apparent volume of distribution (Vz/F) was 168 L for Inbrija 66 mg (2 x 33 mg capsules).
Danish: Det tilsyneladende fordelingsvolumen (Vz/F) var 168 l for Inbrija 66 mg (2 x 33 mg-kapsler).
English: Step 13: Store inhaler Make sure there are no capsules in the inhaler
Danish: Trin 13: Opbevaring af inhalator Sørg for, at der ikke er nogen kapsler i inhalatoren
English: The acute symptoms of levodopa overdose can be expected to arise from dopaminergic overstimulation.
Danish: De akutte symptomer på overdosering af levodopa kan forventes at skyldes dopaminerg overstimulering.
English: No effects were seen on male or female reproductive organs in repeat dose toxicology studies in mice, rats or monkeys with levodopa alone.
Danish: Der blev ikke observeret nogen virkninger på reproduktionsorganer hos hanner eller hunner i toksicitetsstudier efter gentagne doser hos mus, rotter eller aber med levodopa alene.
English: These medicines include isocarboxazid and phenelzine.
Danish: Disse lægemidler inkluderer isocarboxazid og phenelzin.
English: Patients with chronic glaucoma may be treated cautiously with levodopa provided the intraocular pressure is well-controlled and the patient is monitored carefully for changes in intraocular pressure during therapy.
Danish: Patienter med kronisk glaukom kan behandles med forsigtighed med levodopa, forudsat at det intraokulære tryk er velkontrolleret, og at patienten overvåges nøje for ændringer i det intraokulære tryk under behandling.
English: Take out the used capsule.
Danish: Tag den brugte kapsel ud.
English: At baseline, patients had at least 2 hours of OFF time per day, and the levodopa/dopa-decarboxylase inhibitor medicines did not exceed 1,600 mg levodopa per day.
Danish: Ved baseline havde patienterne mindst 2 timers OFF-tid pr. dag, og levodopa/dopa-decarboxylasehæmmermedicin oversteg ikke 1.600 mg levodopa pr. dag.
English: Important information before you use Inbrija: - Inbrija capsules must not be swallowed.
Danish: Vigtig information, før du bruger Inbrija: - Inbrija-kapsler må ikke sluges.
English: If this applies to you, do not take Inbrija and ask your doctor or pharmacist for advice.
Danish: Hvis dette gælder for dig, skal du undlade at tage Inbrija og spørge lægen eller apotekspersonalet til råds.
English: In a subpopulation of the 12-week study, serial spirometry measurements were performed at 15, 30 and 60 minutes following the first dose of Inbrija 66 mg or placebo.
Danish: Der blev i en delpopulation i 12-ugers studiet udført serielle spirometrimålinger 15, 30 og 60 minutter efter den første dosis af Inbrija 66 mg eller placebo.
English: When experiencing an OFF period, subjects could use inhaled levodopa on demand up to five times a day.
Danish: Når forsøgspersonerne oplevede en OFF-periode, kunne de bruge inhaleret levodopa efter behov op til 5 gange om dagen.
English: The whirl means the inhaler is working and you are getting your medicine.
Danish: Dette betyder, at inhalatoren virker, og du får din medicin.
English: Subjects had to be able to recognise OFF periods and to handle the device.
Danish: Forsøgspersonerne skulle være i stand til at erkende OFFperioder og håndtere anordningen.
English: The active substance in Inbrija is levodopa.
Danish: Det aktive stof i Inbrija er levodopa.
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 4.5).
Danish: Samtidig anvendelse af antipsykotika bør overvåges nøje for en forværring af de motoriske symptomer ved Parkinsons sygdom, især når der anvendes D2-receptorantagonister (se pkt.
English: In this pack, you will find an inhaler together with peel-off blisters containing 4 hard capsules each.
Danish: I denne pakning finder du en inhalator sammen med aftrækningsblistre, der hver indeholder 4 hårde kapsler.
English: The two major metabolic pathways are decarboxylation by L-aromatic amino acid decarboxylase and O-methylation by catechol-Omethyltransferase (COMT).
Danish: De to primære metaboliske veje er decarboxylering ved hjælp af L-aromatisk aminosyre-decarboxylase og O-methylering ved hjælp af catechol-O-methyltransferase (COMT).
English: Mental disturbances
Danish: Mentale forstyrrelser
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: Patienterne kan opleve en ny eller forværret mental status og adfærdsændringer, som kan være svære, herunder psykoselignende og suicidal adfærd, under levodopabehandling eller efter start på eller forøgelse af dosen af levodopa.
English: After administration of Inbrija the Cmax and AUC0-24 h for women were 42.2% higher and 48.8% higher than for men, respectively.
Danish: Efter administration af Inbrija var Cmax og AUC0-24 t for kvinder henholdsvis 42,2 % højere og 48,8 % højere end for mænd.
English: Patients who are taking these medicinal products should be monitored for worsening Parkinson's symptoms (see section 4.4).
Danish: Patienter, der tager disse lægemidler, skal overvåges for en forværring af Parkinsons symptomer (se pkt.
English: If you need to have tests on your blood or urine, tell your doctor or nurse that you are taking Inbrija.
Danish: Hvis du skal have undersøgt dit blod eller din urin, skal du fortælle lægen eller sygeplejersken, at du tager Inbrija.
English: The recommended dose of Inbrija is 2 hard capsules up to 5 times per day each delivering 33 mg levodopa.
Danish: Den anbefalede dosis Inbrija er 2 hårde kapsler op til 5 gange om dagen, som hver leverer 33 mg levodopa.
English: Based on individual assessments of the severity of the intercurrent respiratory infection Inbrija may be continued or discontinued until the respiratory symptoms resolve (see section 4.2).
Danish: Baseret på individuelle vurderinger af sværhedsgraden af den interkurrente luftvejsinfektion kan Inbrija fortsættes eller seponeres, indtil luftvejssymptomerne har fortaget sig (se pkt.
English: The addition of entacapone to a levodopa/dopa-decarboxylase inhibitor has been demonstrated to increase the levodopa bioavailability by 30%.
Danish: Tilføjelsen af entacapon til en levodopa/dopa-decarboxylasehæmmer har vist sig at øge biotilgængeligheden af levodopa med 30 %.
English: 97 months
Danish: 97 måneder
English: Bronchospasm in patients with lung disease
Danish: Bronkospasme hos patienter med lungesygdom
English: The recommended dose of Inbrija is 2 capsules to treat each off period.
Danish: Den anbefalede dosis af Inbrija er 2 kapsler til behandling af hver off-periode.
English: You can use a dry cotton swab or tissue to wipe the outside of the inhaler.
Danish: Du kan bruge en tør vatpind eller serviet til at aftørre ydersiden af inhalatoren.
English: Carefully peel back the foil and take out 1 capsule.
Danish: Træk forsigtigt folien tilbage, og udtag 1 kapsel.
English: Levodopa may cause a false-positive reaction for urinary ketone bodies when a test tape is used for determination of ketonuria.
Danish: Levodopa kan forårsage en falsk positiv reaktion for ketonstoffer i urinen, når der anvendes en teststrimmel til bestemmelse af ketonuri.
English: Anticholinergic medicinal products can work synergistically with levodopa, in order to improve tremor.
Danish: Antikolinerge lægemidler kan virke synergistisk sammen med levodopa til forbedring af tremor.
English: Antihypertensives
Danish: Antihypertensiva
English: The UPDRS part III is designed to assess the severity of the cardinal motor findings (e.g. tremor, rigidity, bradykinesia, postural instability) in patients with Parkinson's disease.
Danish: UPDRS-del III er udformet til vurdering af sværhedsgraden af de vigtigste motoriske fund (f.eks. tremor, stivhed, bradykinesi, postural ustabilitet) hos patienter med Parkinsons sygdom.
English: There are no or limited amount of data from the use of levodopa in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af levodopa til gravide kvinder.
English: The dose that leaves the mouthpiece of the inhaler (delivered dose) is 33 mg of levodopa.
Danish: Den dosis, der forlader mundstykket på inhalatoren (den leverede dosis) er 33 mg levodopa.
English: Pharmacotherapeutic group: Anti-Parkinson drugs, dopaminergic agents, ATC code: N04BA01 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Anti-parkinsonmidler, dopaminerge stoffer, ATC-kode: N04BA01 Virkningsmekanisme
English: Inbrija 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: Inbrija skal anvendes med forsigtighed i tilfælde af samtidig anvendelse af lægemidler, der kan forårsage ortostatisk hypotension, f.eks. antihypertensiva.
English: Tell your doctor or pharmacist if you are taking:
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager:
English: Each perforated unit-dose blister strip contains 4 hard capsules.
Danish: Hver perforerede enhedsdosisblisterstrip indeholder 4 hårde kapsler.
English: Your doctor will monitor you closely during start of treatment; - an ulcer in your stomach or intestines; - an eye condition called glaucoma, because the pressure in your eyes may need to be monitored; - severe problems with your kidneys; - severe problems with your liver.
Danish: Lægen vil overvåge dig nøje, når behandlingen startes, - et sår i mavesækken eller tarmen, - en øjenlidelse, der kaldes glaukom, da det kan være nødvendigt at overvåge trykket i dine øjne, - svære problemer med nyrerne, - svære problemer med leveren.
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 pengeforbrug, en unormalt høj sexdrift eller en forøgelse af seksuelle tanker eller følelser.
English: - It is important to advise the patient that if they do not hear or feel the capsule “whirl” while inhaling they may need to take a deeper, longer breath, breathing in again using the same capsule.
Danish: - Det er vigtigt at informere patienten om, at hvis han/hun ikke hører eller føler kapslen “hvirvle” under inhalering, kan det være nødvendigt med en dybere og længere indånding ved anvendelse af den samme kapsel.
English: Dispose of used capsules in accordance with local requirements.
Danish: Bortskaf brugte kapsler i henhold til lokale retningslinjer.
English: Take the inhaler out of your mouth and hold your breath for 5 seconds.
Danish: Tag inhalatoren ud af munden, og hold vejret i 5 sekunder.
English: Dispose and store Step 12: Dispose of used capsules
Danish: Bortskaffelse og opbevaring Trin 12: Bortskaffelse af brugte kapsler
English: A total of 271 patients were treated with Inbrija 66 mg (two 33 mg capsules), and 127 patients in an observational control group were observed on their regular oral medication regimen for the treatment of Parkinson's disease.
Danish: I alt 271 patienter blev behandlet med Inbrija 66 mg (to 33 mg-kapsler), og 127 patienter i en observationskontrolgruppe blev observeret på deres sædvanlige orale medicin til behandling af Parkinsons sygdom.
English: Patients being treated with levodopa medicinal products 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. use machines), until such recurrent episodes and somnolence have resolved (see also section 4.4).
Danish: Patienter, der behandles med levodopa-lægemidler og oplever somnolens og/eller pludselige søvnepisoder, skal informeres om at afholde sig fra at føre motorkøretøj eller deltage i aktiviteter, hvor nedsat opmærksomhed kan udsætte dem selv eller andre for risiko for alvorlig skade eller død (f.eks. betjening af maskiner), indtil sådanne tilbagevendende episoder og somnolens er forsvundet (se også pkt.
English: Cleaning the inhaler
Danish: Rengøring af inhalatoren
English: Step 4: Remove 1 capsule from package
Danish: Trin 4: Tag 1 kapsel ud af emballagen
English: Intercurrent respiratory infection
Danish: Interkurrent luftvejsinfektion
English: Do not use this medicine after the expiry date which is stated on the blisters and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteren og kartonen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The patient should hear the capsule “whirl”.
Danish: Patienten skal høre kapslen “hvirvle”.
English: - This medicine is for use by inhalation only.
Danish: - Dette lægemiddel er udelukkende til brug ved hjælp af inhalation.
English: Each hard capsule contains 42 mg levodopa.
Danish: Hver hård kapsel indeholder 42 mg levodopa.