FrancophonIA/ELRC3.0 huggingface dataset:
English: Interactions of Inbrija with local or systemic pulmonary medicinal products were not investigated because Inbrija is not recommended in patients with asthma, chronic obstructive pulmonary disease (COPD), or other chronic underlying lung disease (see section 4.4).
Danish: Interaktioner mellem Inbrija og lokale eller systemiske pulmonale lægemidler er ikke undersøgt, fordi Inbrija ikke bør anvendes til patienter med astma, kronisk obstruktiv lungesygdom (KOL) eller anden kronisk underliggende lungesygdom (se pkt.
English: Nausea, Vomiting
Danish: Kvalme, opkastning
English: Therefore, any 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 levodopalægemiddel bør derfor overvåges nøje, især hos patienter, der også får neuroleptika.
English: Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse ADOH B.V.
English: See section 4.4 regarding withdrawal emergent hyperpyrexia and confusion.
Danish: 4.4 vedrørende hyperpyreksi og forvirring fremkommet ved seponering.
English: There is limited data regarding chronic effect of Inbrija in respiratory compromised patients.
Danish: Der foreligger kun en begrænset mængde data vedrørende kronisk virkning af Inbrija hos patienter med svækket vejrtrækning.
English: A full dose is 2 capsules.
Danish: En fuld dosis er 2 kapsler.
English: 63 years
Danish: 63 år
English: A clinical study was performed with Inbrija 66 mg (2 x 33 mg capsules) administered to 56 healthy subjects (31 non-smokers and 25 smokers).
Danish: Der er udført et klinisk forsøg med Inbrija 66 mg (2 x 33 mg-kapsler), der blev administreret til 56 raske forsøgspersoner (31 ikke-rygere og 25 rygere).
English: Step 5: Load capsule
Danish: Trin 5: Indsæt kapsel
English: Common (may affect up to 1 in 10 people): - new or increased abnormal body movements (dyskinesia); - infections of nose, sinuses, throat or lungs; - change in colour of your mucus; - discoloured (i.e. not clear) nasal mucus; - irritation in throat or itchy throat; - feeling sick (nausea); vomiting; - being prone to falls.
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 personer): - nye eller forøgede abnorme kropsbevægelser (dyskinesi), - infektioner i næse, bihuler, hals eller lunger, - ændring af farven af dit slim, - misfarvet (det vil sige ikke klar) slim fra næsen, - irriteret eller kløende hals, - kvalme, opkastning, - faldtendens.
English: risperidone, chlorpromazine, fluphenazine decanoate, phenotiazine, butyrophenone, or trifluoperazine; - metoclopramide to treat nausea; - isoniazid, an antibiotic to treat tuberculosis; - medicines for high blood pressure, as the dose may need to be adjusted; - medicines for depression called tricyclic antidepressants such as clomipramin, desipramin, or doxepin; - amantadine to treat flu or your Parkinson's disease.
Danish: risperidon, chlorpromazin, fluphenazindecanoat, phenotiazin, butyrophenon eller trifluoperazin, - metoclopramid til behandling af kvalme, - isoniazid, et antibiotikum til behandling af tuberkulose, - lægemidler mod højt blodtryk, da det kan være nødvendigt at justere dosen, - lægemidler mod depression, der kaldes tricykliske antidepressiva, såsom clomipramin,
English: Inhalation powder, hard capsules 60 hard capsules + 1 inhaler
Danish: Inhalationspulver, hårde kapsler 60 hårde kapsler + 1 inhalator 92 hårde kapsler + 1 inhalator
English: Step 10: Remove capsule from inhaler Twist and pull off the mouthpiece
Danish: Trin 10: Fjern kapslen fra inhalatoren Drej og træk mundstykket af
English: Package leaflet: Information for the patient Inbrija 33 mg inhalation powder, hard capsules levodopa
Danish: Indlægsseddel: Information til patienten Inbrija 33 mg inhalationspulver, hårde kapsler levodopa
English: Baseline Levodopa dose
Danish: Levodopa-dosis ved baseline
English: Pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa (see section 4.4).
Danish: Ludomani, forøget libido, hyperseksualitet, kompulsivt forbrug eller købetrang, overspisning og tvangsspisning kan forekomme hos patienter, der behandles med dopaminagonister og/eller andre dopaminerge behandlinger indeholdende levodopa (se pkt.
English: Restless legs syndrome, Neuroleptic malignant syndrome (see section 4.4), Ataxia,
Danish: 4.4), restless legs-syndrom, neuroleptisk malignt syndrom (se pkt.
English: A clinical study was performed with Inbrija 66 mg (2 x 33 mg capsules) in 24 healthy subjects (13 men and 11 women).
Danish: Der er udført et klinisk studie med Inbrija 66 mg (2 x 33 mg-kapsler) hos 24 raske forsøgspersoner (13 mænd og 11 kvinder).
English: Carton containing 92 hard capsules (23 blister strips) and one inhaler.
Danish: Karton indeholdende 92 hårde kapsler (23 blisterstrips) og én inhalator.
English: It is not recommended to take more than 2 capsules per OFF period.
Danish: Der bør ikke tages mere end 2 kapsler pr. OFF-periode.
English: Prepare and use a total of 2 capsules.
Danish: Klargør og brug i alt 2 kapsler.
English: Pulmonary safety
Danish: Lungemæssig sikkerhed
English: Store in the original package in order to protect from light and moisture and remove immediately before use.
Danish: Opbevares i den originale yderpakning for at beskytte mod lys og fugt, og tages ud umiddelbart før brug.
English: Black iron oxide (E 172) Propylene glycol Potassium hydroxide
Danish: Sort jernoxid (E 172) Propylenglycol Kaliumhydroxid
English: Carton containing 60 hard capsules (15 blister strips) and one inhaler.
Danish: Karton indeholdende 60 hårde kapsler (15 blisterstrips) og én inhalator.
English: Sudden sleep onset
Danish: Pludseligt opstået søvnanfald
English: Breast-feeding should be discontinued during treatment with Inbrija.
Danish: Amning bør ophøre under behandling med Inbrija.
English: Because of the risk of bronchospasm, use of levodopa inhalation powder in patients with asthma, chronic obstructive pulmonary disease (COPD), or other chronic underlying lung disease is not recommended.
Danish: På grund af risikoen for bronkospasme bør levodopa-inhalationspulver ikke anvendes hos patienter med astma, kronisk obstruktiv lungesygdom (KOL) eller anden kronisk underliggende lungesygdom.
English: Baseline mean (SD) LS mean change Mean diff. (95% CI) p-value
Danish: Baseline-gennemsnit (SD) LS-gennemsnitlig ændring Gennemsnitlig forskel (95% CI) p-værdi
English: Inbrija is indicated for the intermittent treatment of episodic motor fluctuations (OFF episodes) in adult patients with Parkinson's disease (PD) treated with a levodopa/dopa-decarboxylase inhibitor.
Danish: Inbrija er indiceret til lejlighedsvis behandling af episoder af motoriske udsving (OFF-episoder) hos voksne patienter med Parkinsons sygdom (PD), som behandles med en levodopa/dopadecarboxylasehæmmer.
English: A dose adjustment of levodopa may be required with concomitant use of COMT inhibitors.
Danish: Dosisjustering af levodopa kan være nødvendig ved samtidig anvendelse af COMT-hæmmere.
English: The mean maximal plasma concentration at 10 minutes (C10min) and at peak concentration (Cmax) of levodopa following administration of Inbrija 66 mg (2 x 33 mg capsules) was 418 ng/mL and 696 ng/mL, respectively, with exposure over 4 hours (AUC0-4 h) of 1,280 ng●h/mL.
Danish: Den gennemsnitlige maksimale plasmakoncentration efter 10 minutter (C10min) og ved maksimal koncentration (Cmax) af levodopa, efter administration af Inbrija 66 mg (2 x 33 mg-kapsler), var henholdsvis 418 ng/ml og 696 ng/ml med eksponering over 4 timer (AUC0-4 t) på 1.280 ng●t/ml.
English: Agranulocytosis, Thrombocytopenia, Leukopenia
Danish: Anæmi, agranulocytose, trombocytopeni, leukopeni
English: Get urgent medical help if you have an allergic oedema with symptoms including hives (nettle rash), itching, rash, swelling of your face, lips, tongue, or throat.
Danish: Søg akut lægehjælp, hvis du får et allergisk ødem med symptomer, der indbefatter nældefeber, kløe, udslæt, hævelse af ansigt, læber, tunge eller hals.
English: - if you are taking certain antidepressant medicines called non-selective MAO inhibitors (e.g.
Danish: - hvis du tager en bestemt type antidepressiva, der kaldes ikke-selektive MAO-hæmmere
English: Other medicines and Inbrija
Danish: Brug af anden medicin sammen med Inbrija
English: - blurred vision; double vision; widening pupil; prolonged rolling eyes upwards; involuntary tight closure of the eyelids; - heart problems, a noticeably rapid, strong, or irregular heartbeat; - low blood pressure soon after standing up; high blood pressure; fainting; blood clot in a vein; hot flushes; - shortness of breath; difficulty in breathing; difficulty in speaking; hiccups; - stomach pains; constipation; diarrhoea; dry mouth; stomach and intestinal bleeding; stomach ulcer; difficulty in swallowing; indigestion; burning sensation in the mouth; passing wind; change in colour of saliva; more saliva than normal; - swelling of face, lips, tongue, limbs and genitals; excessive sweating; rash; severe itching of the skin; condition called Henoch-Schoenlein purpura, the symptoms of which include a purple spotted skin rash; allergic reaction causing a rash of round, red welts on the skin that itch intensely; hair loss; discoloured sweat; - muscle spasms; lockjaw; - difficulty in emptying the bladder; abnormal urine colour; loss of bladder control; - painful, abnormally long-lasting erection; - swelling of lower legs or hands; feeling weak and having no energy; feeling tired; lack of energy; difficulty in walking; chest pain; - abnormal blood investigation results; weight loss; weight gain.
Danish: - bevægelsesforstyrrelse, hvor en persons muskler trækker sig ukontrolleret sammen; pludselige og undertiden uforudsigelige forandringer af symptomer på grund af tilbagevenden af symptomer på Parkinsons sygdom; søvnighed, svimmelhed, forværring af Parkinsons sygdom, en prikkende fornemmelse i huden, hovedpine, rysten, krampeanfald, pludeligt opstået søvnanfald, uro i benene, ataksi (forstyrrelse, der påvirker koordination, balance og tale), ændret smagssans; forstyrrelser af den mentale sundhed, som påvirker indlæring, hukommelse, opfattelsesevne og problemløsning; Horners syndrom (en øjenforstyrrelse), demens, - sløret syn, dobbeltsyn, forstørret pupil, langvarig opaddrejning af øjne, ufrivillig tæt lukning af øjenlågene, - hjerteproblemer; en bemærkelsesværdig hurtig, kraftig eller uregelmæssig hjerterytme, - lavt blodtryk lige efter at have rejst sig, højt blodtryk, besvimelse, blodprop i en vene, hedeture, - stakåndethed, vejrtrækningsbesvær, talebesvær, hikke, - mavesmerter, forstoppelse, diarré, tør mund, mave- og tarmblødning, mavesår, synkebesvær, fordøjelsesbesvær, brændende fornemmelse i munden, luft i maven, farveændring af spyt, mere spyt end normalt, - hævelse af ansigt, læber, tunge, arme, ben og kønsorganer; kraftig svedtendens, udslæt, kraftig kløe på huden; tilstand, der kaldes Henoch-Schöenleins purpura, hvor symptomerne indbefatter et blåligrødt plettet hududslæt; allergisk reaktion, der forårsager et udslæt af runde, røde, kraftigt kløende strimer på huden; hårtab, misfarvet sved, - muskelkramper, stivkrampe - problemer med at tømme blæren, unormal urinfarve, tab af blærekontrol, - smertefuld, unormalt langvarig erektion, - hævede underben eller hænder, mathedsfølelse og energiløshed, træthedsfølelse, manglende energi, problemer med at gå, brystsmerter, - unormale resultater af blodundersøgelser, vægttab, vægtstigning.
English: The pharmacokinetics of the major levodopa metabolites 3-O-methyldopa (3-OMD), 3,4dihydroxyphenylacetic acid (DOPAC) and homovanillic acid (HVA) were studied following administration of a single inhaled dose of Inbrija and a single oral carbidopa/levodopa 25 mg/100 mg immediate release tablet.
Danish: Farmakokinetikken for de primære levodopa-metabolitter 3-O-methyldopa (3-OMD), 3,4dihydroxyphenyleddikesyre (DOPAC) og homovanillinsyre (HVA) blev undersøgt efter administration af en enkelt inhaleret dosis af Inbrija og en enkelt oral carbidopa/levodopa 25 mg/100 mg-tablet med øjeblikkelig frigivelse.
English: Henoch-Schonlein purpura, Urticaria,
Danish: Henoch-Schönleins purpura, urticaria, alopeci, misfarvning af sved
English: Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
Danish: Lægen vil drøfte forskellige måder at håndtere eller reducere symptomerne på.
English: Store in the original package in order to protect from light and moisture and only remove immediately before use.
Danish: Opbevares i den originale yderpakning for at beskytte mod lys og fugt, og tages først ud umiddelbart før brug.
English: Levodopa should be administered cautiously to patients with a history of peptic ulcer disease (because of the possibility of upper gastro-intestinal haemorrhage).
Danish: Levodopa skal administreres med forsigtighed til patienter med mavesår i anamnesen (på grund af muligheden for øvre gastrointestinal blødning).
English: The pharmacokinetics of Inbrija 66 mg (2 x 33 mg capsules) and carbidopa/levodopa 25 mg/100 mg immediate release tablets was evaluated in 24 healthy volunteers in a fasted state receiving a total of 50 mg carbidopa every 8 hours.
Danish: Farmakokinetikken for Inbrija 66 mg (2 x 33 mg-kapsler) og carbidopa/levodopa 25 mg/100 mgtabletter med øjeblikkelig frigivelse blev evalueret hos 24 raske frivillige i fastende tilstand, som fik i alt 50 mg carbidopa hver 8. time.
English: Contains colfosceril palmitate (DPPC), sodium chloride, hypromellose, titanium dioxide (E 171), carrageenan, potassium chloride, carnauba wax, maize starch, shellac, black iron oxide (E 172), propylene glycol, potassium hydroxide.
Danish: Indeholder colfoscerilpalmitat (DPPC), natriumchlorid, hypromellose, titandioxid (E 171), carrageenan, kaliumchlorid, carnaubavoks, majsstivelse, shellac, sort jernoxid (E 172), propylenglycol, kaliumhydroxid.
English: Attach the cap over the mouthpiece.
Danish: Påsæt hætten over mundstykket.
English: Treatment with Inbrija is not recommended during pregnancy and in women of childbearing age who do not use contraception.
Danish: Behandling med Inbrija bør ikke anvendes under graviditet og hos kvinder, der kan blive gravide, som ikke bruger sikker prævention.
English: Get urgent medical help if you have tremors, agitation, confusion, fever, rapid pulse, or dizziness and fainting upon standing up, or you notice that your muscles get very rigid or jerk violently.
Danish: Advarsler og forsigtighedsregler sSøg akut lægehjælp, hvis du oplever rysten, uro, forvirring, feber, hurtig puls eller svimmelhed og besvimmelse, når du rejser dig, eller du bemærker, at dine muskler bliver meget stive eller foretager kraftige ryk.
English: Orthostatic hypotension (see section 4.4),
Danish: Ortostatisk hypotension (se pkt.
English: - The other ingredients comprising the powder and capsule are colfosceril palmitate (DPPC), sodium chloride, hypromellose, titanium dioxide (E 171), carrageenan, potassium chloride, carnauba wax, maize starch, shellac, black iron oxide (E 172), propylene glycol and potassium hydroxide.
Danish: - Øvrige indholdsstoffer i pulveret og kapslen: colfoscerilpalmitat (DPPC), natriumchlorid, hypromellose, titandioxid (E 171), carrageenan, kaliumchlorid, carnaubavoks, majsstivelse, shellac, sort jernoxid (E 172), propylenglycol og kaliumhydroxid.
English: - Phaeochromocytoma.
Danish: - Fæokromocytom.
English: Place the cap to the side.
Danish: Læg hætten til side.
English: The pack sizes are
Danish: Pakningsstørrelser er:
English: - A complete dose is 2 capsules taken one right after the other.
Danish: - En fuld dosis er 2 kapsler, der tages umiddelbart efter hinanden.
English: Cases of falsely diagnosed pheochromocytoma in patients on levodopa/dopa-decarboxylase inhibitor therapy have been reported very rarely.
Danish: Der er meget sjældent blevet rapporteret tilfælde af falsk diagnosticeret fæokromocytom hos patienter i levodopa/dopa-decarboxylasehæmmer-behandling.
English: Hypromellose Titanium dioxide (E 171) Carrageenan
Danish: Hypromellose Titandioxid (E 171) Carrageenan Kaliumchlorid Carnaubavoks Majsstivelse
English: - Co-administration with non-selective monoamine oxidase (MAO) inhibitors.
Danish: - Administration sammen med ikke-selektive monoaminoxidase (MAO)-hæmmere.
English: Selective Monoamine Oxidase (MAO) inhibitors
Danish: Selektive monoaminoxidase (MAO)-hæmmere
English: The change from baseline for DLCO was compared between the Inbrija treatment group and the observational cohort; at the end of 12 months, there was no significant difference in the change from baseline between Inbrija group and the observational cohort in DLCO.
Danish: Ved udgangen af de 12 måneder var der ingen signifikant forskel i ændringen fra baseline i DLCO mellem Inbrija-gruppen og observationskohorten.
English: Vision blurred, Diplopia, Mydriasis, Oculogyric crisis, Blepharospasm
Danish: Sløret syn, diplopi, mydriasis, okulogyrisk krise, blefarospasme
English: Detailed instructions for use for the patients are included in the package leaflet.
Danish: Indlægssedlen indeholder en detaljeret brugsanvisning til patienterne.
English: What you need to know before you use Inbrija Do not use Inbrija:
Danish: Det skal du vide, før du begynder at bruge Inbrija Brug ikke Inbrija
English: b A responder was defined as a subject that changed from OFF to ON within 60 minutes post dose and who remained ON at 60 minutes post dose.
Danish: b En respondent blev defineret som en forsøgsperson, der skiftede fra OFF til ON i løbet af
English: In the presence of carbidopa, the apparent terminal elimination half-life (t1/2) of levodopa following a single administration of Inbrija 66 mg (2 x 33 mg capsules) was 2.3 hours and comparable to that following an oral dose of carbidopa/levodopa 25 mg/100 mg immediate release tablets of 1.9 hours.
Danish: Ved tilstedeværelse af carbidopa var den tilsyneladende terminale eliminationshalveringstid (t1/2) for levodopa efter en enkelt administration af Inbrija 66 mg (2 x 33 mg-kapsler) 2,3 timer og sammenlignelig med værdien efter en oral dosis carbidopa/levodopa 25 mg/100 mg-tabletter med øjeblikkelig frigivelse på 1,9 timer.
English: Do not swallow Inbrija capsules.
Danish: Undlad at sluge Inbrija-kapsler.
English: Tear off package of 2 capsules.
Danish: Træk pakke med 2 kapsler af.
English: The median time to maximal plasma concentration of levodopa was 30 minutes after a dose of Inbrija 66 mg (2 x 33 mg capsules) compared to 45 minutes after a dose of carbidopa/levodopa 25 mg/100 mg immediate release tablets.
Danish: Mediantiden til maksimal plasmakoncentration af levodopa var 30 minutter efter en dosis Inbrija 66 mg (2 x 33 mg-kapsler) sammenlignet med 45 minutter efter en dosis carbidopa/levodopa 25 mg/100 mg-tabletter med øjeblikkelig frigivelse.
English: - The capsules must only be removed from the blister pack immediately before use.
Danish: - Kapslerne må først tages ud af blisterpakningen umiddelbart før brug.
English: These may be symptoms of “withdrawal-emergent hyperpyrexia”.
Danish: Disse kan være symptomer på “hedeslag opstået ved ophør af lægemiddel”.
English: Responders ONb n = 97a n = 97a
Danish: Respondenter ONb n = 97a n = 97a
English: Cognitive disorder, Horner's syndrome, Dementia
Danish: 4.4), ataksi, dysgeusi, kognitiv forstyrrelse, Horners syndrom, demens
English: Respiration abnormal, Dysphonia, Hiccups
Danish: Dyspnø, unormal vejtrækning, dysfoni, hikke
English: Driving and using machines Inbrija can cause excessive drowsiness, dizziness and sudden sleep attacks.
Danish: Inbrija kan forårsage udtalt døsighed, svimmelhed og pludselige søvnanfald.
English: Inbrija is not recommended during pregnancy and in women of childbearing potential not using contraception.
Danish: Inbrija bør ikke anvendes under graviditeten og til fertile kvinder, som ikke anvender sikker kontraception.
English: A symptom complex resembling neuroleptic malignant syndrome and rhabdomyolysis may occur with levodopa/dopa-decarboxylase inhibitor medicinal products, although no cases have been identified in clinical studies with Inbrija.
Danish: Et symptomkompleks, der ligner neuroleptisk malignt syndrom og rhabdomyolyse, kan forekomme med levodopa/dopa-decarboxylasehæmmer-lægemidler.
English: Non-selective Monoamine Oxidase (MAO) inhibitors The use of non-selective MAO inhibitors with levodopa is contraindicated (see section 4.3).
Danish: Anvendelse af ikke-selektive MAO-hæmmere sammen med levodopa er kontraindiceret (se pkt.
English: The capsules must only be removed from the blister immediately before use.
Danish: Kapslerne må først udtages fra blisteren umiddelbart før brug.
English: Inbrija 33 mg inhalation powder, hard capsules
Danish: Inbrija 33 mg inhalationspulver, hårde kapsler
English: Abdominal pain, Constipation, Diarrhoea,
Danish: Abdominalsmerter, konstipation,
English: • Only remove the capsules from the blister immediately before use.
Danish: • Tag først kapslerne ud af blisteren umiddelbart før brug.
English: How to use Inbrija
Danish: Sådan skal du bruge Inbrija
English: No dose adjustment is required based on smoking status.
Danish: Dosisjustering er ikke nødvendig på baggrund af rygestatus.
English: It is recommended to administer this medicinal product cautiously to patients with severe renal disease.
Danish: Det anbefales, at dette lægemiddel administreres med forsigtighed til patienter med svær nyresygdom.
English: Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Inbrija 33 mg inhalation powder, hard capsules levodopa
Danish: Inbrija 33 mg inhalationspulver, hårde kapsler levodopa
English: A symptom complex that resembles neuroleptic malignant syndrome (characterised by elevated temperature, muscular rigidity, altered consciousness, and autonomic instability), with no other obvious aetiology, has been reported in association with rapid dose reduction, withdrawal of, or changes in the background dopaminergic therapy.
Danish: Hyperpyreksi og forvirring fremkommet ved seponering Der er i forbindelse med hurtig dosisreduktion, seponering af eller ændringer i den dopaminerge baggrundsbehandling uden anden klar ætiologi blevet rapporteret et symptomkompleks, der ligner neuroleptisk malignt syndrom (der er kendetegnet ved forhøjet temperatur, muskelstivhed, ændret bevidsthedstilstand og autonom ustabilitet).
English: There is insufficient information on the effects of levodopa in newborns/infants.
Danish: Der foreligger utilstrækkelige data for virkningen af levodopa på det ammede barn.
English: Anticholinergics
Danish: Antikolinergika