FrancophonIA/ELRC3.0 huggingface dataset:
English: Key elements to be included in the educational materials:
Danish: Hovedpunkter, uddannelsesmaterialet skal omfatte:
English: Women in the schizophrenia trial were scarcely represented (26.5%), and about half of the patients were male (49.7%) in Study 004-302.
Danish: Kvinder var sparsomt repræsenteret i skizofreniundersøgelsen (26,5 %), og ca. halvdelen af patienterne var mænd (49,7 %) i undersøgelse 004-302.
English: Potential for ADASUVE to affect other medicinal products
Danish: ADASUVEs potentiale til at påvirke andre lægemidler
English: • worsening agitation or confusion, especially combined with fever or muscle stiffness (rare occurrence).
Danish: • forværring af uro eller omtågethed, navnlig i forbindelse med feber eller muskelstivhed (sjældent).
English: Loxapine binds with noradrenergic, histaminergic, and cholinergic receptors, and its interaction with these systems may influence the spectrum of its pharmacological effects.
Danish: Loxapin bindes til noradrenerge, histaminerge og kolinerge receptorer, og dets interaktion med disse systemer kan muligvis påvirke dets spektrum af farmakologiske virkninger.
English: Very common: sedation/somnolence
Danish: Meget almindelig: sedation/døsighed
English: If a patient develops signs and symptoms indicative of NMS, or presents with unexplained high fever without additional clinical manifestations of NMS, ADASUVE must be discontinued.
Danish: Hvis en patient udvikler tegn og symptomer tydende på NMS eller høj feber af ukendt årsag uden yderligere kliniske manifestationer af NMS, skal ADASUVE seponeres.
English: Loxapine is 96.6% bound to human plasma proteins.
Danish: Loxapin udviser 96,6 % plasmaproteinbinding hos mennesket.
English: The mean age of randomized patients was 43.1 years in Study 004-301 and 40.8 years in Study 004-302: young adults (18-25 years old) were scarcely (7.3%) represented in either trial.
Danish: Gennemsnitsalderen for de randomiserede patienter var 43,1 år i undersøgelse 004-301 og 40,8 år i undersøgelse 004-302: Unge voksne (18-25 år) var sparsomt (7,3 %) repræsenteret i begge undersøgelser.
English: Risk of bronchospasm:
Danish: Risikoen for bronkospasme:
English: This medicinal product does not require any special temperature storage conditions.
Danish: Der er ingen særlige krav til opbevaringstemperatur for dette lægemiddel.
English: Elderly patients with dementia-related psychosis
Danish: Ældre patienter med demensrelateret psykose
English: Similar changes, e.g., gynecomastia, are known in humans, but only after long-term administration of medicines causing hyperprolactinaemia.
Danish: Tilsvarende ændringer, f.eks. gynækomasti, kendes hos mennesker, men kun efter langtidsadministration af lægemidler, der forårsager hyperprolaktinæmi.
English: Pharmacokinetics in special patient populations
Danish: Farmakokinetik hos særlige patientpopulationer
English: • (Schizophrenia) Hearing, seeing, or sensing things which are not there, suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness.
Danish: • (skizofreni) tilbøjelighed til at høre, se eller føle ting, der ikke er der, mistænksomhed, vrangforestillinger, usammenhængende tale og springende adfærd samt følelsesmæssig træghed.
English: Changes in the level of excitability of subcortical inhibitory areas have been observed in several animal species, associated with calming effects and suppression of aggressive behaviour.
Danish: Der er iagttaget ændringer i excitabiliteten af subkortikale inhibitoriske områder i flere dyrearter med tilknyttet beroligende virkning og dæmpning af aggressiv adfærd.
English: Do not use ADASUVE if you notice an open or torn pouch or any signs of physical damage to the medicine.
Danish: Brug ikke ADASUVE, hvis posen er åben eller flænget, eller hvis der er tegn på fysisk beskadigelse af lægemidlet.
English: • lorazepam or other centrally acting medicines (to treat anxiety, depression, pain, or to help you sleep) or any other medicines that cause sleepiness
Danish: • lorazepam eller anden centralt virkende medicin (til behandling af angst, depression, smerter eller søvnløshed) eller andre lægemidler, der medfører søvnighed
English: After the doctor or nurse has prepared ADASUVE for you to use, you will be asked to take the device in your hand, exhale and then put the mouthpiece in your mouth, inhale the medicine through the device and then hold your breath briefly.
Danish: Når lægen eller sygeplejersken har klargjort ADASUVE til dig, vil du blive bedt om at tage apparatet i hånden, ånde ud og derefter tage mundstykket i munden, inhalere lægemidlet gennem inhalatoren og derefter holde vejret et øjeblik.
English: Do not drive or use any tools or machines after using ADASUVE until you know how ADASUVE affects you since dizziness, sedation, and sleepiness have been reported as a potential side effect of ADASUVE.
Danish: Undgå at føre motorkøretøj eller bruge værktøj eller maskiner efter at have fået ADASUVE, før du ved, hvordan ADASUVE påvirker dig, da svimmelhed, sløvhed og søvnighed er indberettet som mulige bivirkninger af ADASUVE.
English: PEC Change
Danish: Ændring i PEC
English: Loxapine is removed rapidly from the plasma and distributed in tissues.
Danish: Loxapin elimineres hurtigt fra plasma og fordeles i vævene.
English: • Availabilty of rescue medications (short acting beta agonist bronchodilator) during treatment
Danish: • rådighed over redningsmedicin (korttidsvirkende bronkodilaterende beta-agonist) under behandlingen
English: White device with a mouthpiece on one end and a pull-tab protruding from the other end.
Danish: Hvid anordning med mundstykke i den ene ende og afrivningsflig i den modsatte ende.
English: However, loxapine and its metabolites have been shown to be transported into the milk of lactating dogs.
Danish: Loxapin og dets metabolitter er imidlertid påvist at gå over i mælken hos lakterende hunde.
English: The recommended initial dose of ADASUVE is 9.1 mg. A second dose can be given after 2 hours, if necessary.
Danish: Den anbefalede initialdosis af ADASUVE er 9,1 mg. Om nødvendigt kan der gives endnu en dosis efter 2 timer.
English: The use of loxapine in patients with alcohol or medicinal product intoxication (either with prescribed or illicit medicinal products) has not been evaluated.
Danish: Anvendelse af loxapin hos patienter med alkohol- eller lægemiddelintoksikation (hvad enten der er tale om ordinerede eller ulovlige lægemidler) er ikke undersøgt.
English: ADASUVE has major influence on the ability to drive and use machines.
Danish: ADASUVE påvirker i væsentlig grad evnen til at føre motorkøretøj og betjene maskiner.
English: Primary endpoint was absolute change in PEC score from baseline to 2 hours following Dose 1 for both doses of ADASUVE compared with placebo.
Danish: Det primære endepunkt var den absolutte ændring i PEC-score fra baseline til 2 timer efter dosis 1 for de to styrker af ADASUVE sammenlignet med placebo.
English: PEC Responders = > 40% change from PEC Baseline; CGI-I Responders = Score of 1 (Very Much Improved) or 2 (Much Improved) PBO = placebo SD=Standard Deviation
Danish: PEC-respondere = > 40 % ændring fra PEC ved baseline CGI-I-respondere = score på 1 (meget stærkt forbedret) eller 2 (stærkt forbedret) PBO = placebo SD=standarddeviation
English: No cases of overdosage of ADASUVE were reported in clinical studies.
Danish: Der er ikke indberettet tilfælde af overdosering med ADASUVE i kliniske studier.
English: Consequently, patients receiving ADASUVE should be observed as appropriate following dosing.
Danish: Patienter i behandling med ADASUVE bør derfor observeres på passende måde efter dosering.
English: • A clear recommendation not to start ADASUVE treatment in patients with a respiratory medical history
Danish: • en klar anbefaling om ikke at påbegynde behandling med ADASUVE hos patienter med luftvejssygdom i anamnesen
English: You will use ADASUVE under the supervision of a doctor or nurse.
Danish: Du vil få ADASUVE under opsyn af en læge eller sygeplejerske.
English: Extrapyramidal symptoms (including acute dystonia) are known class effects for antipsychotics.
Danish: Ekstrapyramidale symptomer (herunder akut dystoni) er kendt som klassevirkninger af antipsykotika.
English: Uncommon: hypotension
Danish: Ikke almindelig: hypotension
English: The safety and efficacy of ADASUVE in patients older than 65 years of age have not been established.
Danish: ADASUVEs sikkerhed og virkning hos patienter over 65 år er endnu ikke klarlagt.
English: The medicinal product has been delivered when the green light turns off.
Danish: Lægemidlet er afgivet, når den grønne kontrollampe slukker.
English: Once the pull-tab is removed, a green light turns on, indicating the product is ready for use (Note: the product must be used within 15 minutes of pulling the tab).
Danish: Når afrivningsfligen fjernes, lyser en grøn lampe som tegn på, at produktet er klar til brug (Bemærk: Produktet skal bruges inden for 15 minutter, efter, afrivningsfligen er fjernet).
English: Patients should receive regular treatment immediately after control of acute agitation symptoms.
Danish: Patienterne skal have sædvanlig behandling, så snart de akutte symptomer på agitation er under kontrol.
English: Therefore, the risk of metabolic interactions caused by an effect on an individual isoform is limited.
Danish: Der er derfor kun begrænset risiko for metaboliske interaktioner ved påvirkning af blot en enkelt af disse isoformer.
English: • adrenaline
Danish: • adrenalin
English: Potential for other medicinal products to affect ADASUVE
Danish: Andre lægemidlers potentiale til at påvirke ADASUVE
English: A majority of the patients in both Phase 3 studies were smokers with about 82% of the patients with schizophrenia and 74% of the patients with bipolar disorder currently smoking.
Danish: I begge fase 3-undersøgelser var størstedelen af patienterne rygere; således var ca. 82 % aktive rygere blandt patienterne med skizofreni og 74 % blandt patienterne med bipolar lidelse.
English: Because of the potential for sedation/somnolence, fatigue, or dizziness, patients should not operate hazardous machines, including motor vehicles, until they are reasonably certain that loxapine has not affected them adversely (see section 4.8).
Danish: På grund af risiko for sedation/døsighed, træthed og svimmelhed bør patienterne ikke betjene farlige maskiner, herunder motorkøretøjer, før de er rimeligt sikre på, at loxapin ikke har påvirket dem negativt (se pkt.
English: For the main results, see the table below.
Danish: Hovedresultaterne er angivet i nedenstående tabel.
English: Do not use in patients with asthma or COPD or acute respiratory symptoms
Danish: Må ikke anvendes til patienter med astma, KOL eller akutte luftvejssymptomer
English: • (Bipolar disorder) Feeling “high”, having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas, and sometimes severe irritability.
Danish: • (bipolar sygdom) følelse af at være “høj”, meget energisk, med mindre søvnbehov end normalt, taler meget hurtigt med hurtige indskydelser og undertiden stærk irritabilitet.
English: Rescue medication (intramuscular lorazepam) was given if medically required.
Danish: Der blev givet redningsmedicin (intramuskulært lorazepam) i det omfang, det var indiceret.
English: When needed, the product is removed from the pouch.
Danish: Når produktet skal bruges, tages det ud af posen.
English: • have or had breathing problems like asthma or other chronic lung diseases such as bronchitis or emphysema
Danish: • har eller har haft vejrtrækningsproblemer som astma eller andre kroniske lungesygdomme som bronkitis eller emfysem
English: ADASUVE is for inhalation use.
Danish: ADASUVE er til inhalation.
English: About 35% of the patients with schizophrenia were taking concomitant antipsychotics at the time of dosing while approximately 13% of the patients with bipolar disorder were taking these drugs.
Danish: Ca. 35 % af patienterne med skizofreni var på doseringstidspunktet i sideløbende behandling med antipsykotika, mens dette gjaldt ca. 13 % af patienterne med bipolar lidelse.
English: In the two Phase 3 studies patients were enrolled who had acute agitation of at least moderate level (14 or higher on Positive and Negative Syndrome Scale (PANSS) Excited Component (PEC) scale (poor impulse control, tension, hostility, uncooperativeness, and excitement).
Danish: De to fase 3-undersøgelser omfattede patienter med akut agitation af mindst moderat grad (14 eller højere på skalaen “Positive and Negative Syndrome Scale (PANSS) Excited Component” (PEC) (dårlig impulskontrol, anspændthed, fjendtlighed, manglende samarbejdsvilje og uro).
English: The product is packaged in a sealed pouch.
Danish: Produktet er pakket i en forseglet pose.
English: Read the following 5 steps before administering ADASUVE to a patient:
Danish: Læs følgende fem punkter, før ADASUVE administreres til en patient:
English: • medicines to treat a breathing problem
Danish: • medicin mod vejrtrækningsproblemer
English: Hypersensitivity to the active substance, or to amoxapine.
Danish: Overfølsomhed over for det aktive stof eller amoxapin.
English: The green light turns on indicating that the inhaler is ready for use.
Danish: Den grønne lampe lyser som tegn på, at inhalatoren er klar til brug.
English: Becoming familiar with ADASUVE: The pictures below show the important features of ADASUVE.
Danish: Bliv fortrolig med ADASUVE: Nedenstående tegning viser de vigtige detaljer ved ADASUVE.
English: Most of these events occurred within 25 minutes of dosing, were mild to moderate in severity, and could be relieved with an inhaled bronchodilator.
Danish: Størstedelen af disse bivirkninger forekom inden for 25 minutter efter dosering, var af let til moderat sværhed og kunne lindres ved inhalation af en bronkodilator.
English: ADASUVE with alcohol Because ADASUVE affects the nervous system, alcohol should be avoided when using ADASUVE.
Danish: Brug af ADASUVE sammen med alkohol Da ADASUVE virker på nervesystemet, bør du undgå alkoholindtagelse, når du får ADASUVE.
English: The safety and efficacy of ADASUVE in children (less than 18 years of age) have not been established.
Danish: ADASUVEs sikkerhed og virkning hos børn (under 18 år) er endnu ikke klarlagt.
English: IMPORTANT: Check that the green light turns off after the patient inhales.
Danish: VIGTIGT: Se efter, at den grønne lampe slukker, når patienten inhalerer.
English: Non-clinical safety data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, and genotoxicity, except for changes to reproductive tissues related to the extended pharmacology of loxapine.
Danish: Prækliniske sikkerhedsdata viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet, bortset fra ændringer i de reproduktive væv som følge af den udstrakte farmakologiske effekt af loxapin.
English: Patients were randomised to placebo, ADASUVE 4.5 mg and ADASUVE 9.1 mg.
Danish: Patienterne blev randomiseret til placebo, ADASUVE 4,5 mg, og ADASUVE 9,1 mg.
English: AUC0-2h, AUCinf, and Cmax increased in a dose-dependent manner.
Danish: AUC0-2h, AUCinf og Cmax udviste dosisafhængig stigning.
English: What you need to know before you use ADASUVE 3.
Danish: Det skal du vide, før du begynder at bruge ADASUVE 3.
English: Patients should be advised not to breast feed for a period of 48 hours after receiving loxapine and discard the milk produced in the meantime.
Danish: Patienterne bør tilrådes at undgå amning i en periode på 48 timer efter at have fået loxapin og at kassere den mælk, der er produceret i mellemtiden.
English: In vitro studies indicated that loxapine was not a substrate for P-glycoprotein (P-gp), but does inhibit P-gp.
Danish: In vitro-undersøgelser har vist, at loxapin ikke er et substrat for P-glykoprotein (P-gp), skønt det hæmmer P-gp.
English: Very common (may affect more than 1 in 10 people): bad taste in the mouth or sleepiness.
Danish: Meget almindelig (forekommer hos mere end 1 ud af 10 behandlede): ubehagelig smag i munden eller søvnighed
English: Concomitant use of CYP1A2 inhibitors (e.g. fluvoxamine, ciprofloxacin, enoxacin, propranolol and refecoxib) should be avoided, if possible.
Danish: Om muligt bør samtidig brug af CYP1A2-hæmmere undgås (f.eks. fluvoxamin, ciprofloxacin, enoxacin, propranolol og refecoxib).
English: Among the other endpoints were PEC and Clinical Global ImpressionImprovement (CGI-I) responders at 2 hours after dose 1, and total number of patients per group who received 1, 2, or 3 doses of study medication with and without rescue medication.
Danish: Blandt de øvrige endepunkter var responderende patienter i henhold til PEC og “Clinical Global Impression - Improvement” (CGI-I) på tidspunktet to timer efter dosis 1, og det samlede antal patienter i hver gruppe, der fik 1, 2 eller 3 doser forsøgsmedicin med eller uden redningsmedicin.
English: Ferrer Internacional, S.A. Gran Vía Carlos III, 94 08028- Barcelona España
Danish: Ferrer Internacional, S.A. Gran Vía Carlos III, 94 08028- Barcelona Spanien
English: If vasopressor therapy is required, noradrenaline or phenylephrine is preferred.
Danish: Hvis vasopressorbehandling er nødvendig, bør noradrenalin eller phenylefrin foretrækkes.
English: • ADASUVE is provided in a sealed pouch.
Danish: • ADASUVE leveres i en forseglet pose.
English: • have or had heart problems or stroke
Danish: • har eller har haft hjerteproblemer eller slagtilfælde
English: No loxapine specific human data on fertility are available.
Danish: Der foreligger ikke specifikke data for loxapin vedrørende fertilitet hos mennesker.
English: The safety and efficacy of ADASUVE has not been evaluated in patients with agitation due to intoxication or physical disease (delirium).
Danish: Virkningen og sikkerheden af ADASUVE er ikke vurderet hos patienter med agitation som følge af intoksikation eller somatisk sygdom (delirium).
English: • Statement on acute setting of indication
Danish: • angivelse af de akutte betingelser for indikationen
English: Uncommon: dystonia, dyskinesia, oculogyration, tremor, akathisia/restlessness
Danish: Ikke almindelig: dystoni, dyskinesi, okulogyration, tremor, akatisi/rastløshed
English: • medicines to treat schizophrenia, depression, or pain since you may be more at risk for seizures Using ADASUVE and adrenaline together may cause your blood pressure to drop.
Danish: • medicin mod skizofreni, depression eller smerter, da det kan øge kramperisikoen Anvendelse af ADASUVE sammen med adrenalin kan medføre blodtryksfald.
English: These can be associated with a severe condition called neuroleptic malignant syndrome (NMS)
Danish: disse symptomer kan være forbundet med den alvorlige tilstand neuroleptisk malignt syndrom (NMS).
English: If benzodiazepine therapy is deemed necessary in addition to loxapine, patients should be monitored for excessive sedation and for orthostatic hypotension.
Danish: Hvis der skønnes at være behov for behandling med et benzodiazepin samtidig med loxapin, skal patienten overvåges for excessiv sedation og ortostatisk hypotension.
English: Metabolites are excreted in the urine in the form of conjugates and in the faeces unconjugated.
Danish: Metabolitterne udskilles i urinen som konjugater og ukonjugeret i fæces.
English: Responders were considered patients with a ≥40% decrease from baseline in the total PEC score or patients with CGI-I score of 1 (very much improved) or 2 (much improved).
Danish: Som responderende patienter ansås patienter med ≥40 % mindskelse i total PEC-score fra baseline og patienter med en CGI-I-score på 1 (meget stærkt forbedret) eller 2 (stærkt forbedret).
English: The MAH shall ensure that, following discussion and agreement with the National Competent Authorities in each Member State where ADASUVE is marketed, at launch and after launch, all healthcare professionals who are expected to use ADASUVE are provided with an information pack containing the following items:
Danish: Efter drøftelse og aftale med de nationale kompetente myndigheder i hver medlemsstat, hvor ADASUVE markedsføres, drager indehaveren af markedsføringstilladelsen omsorg for, at alle sundhedspersonale, der forventes at anvende ADASUVE, ved lanceringen og efter lanceringen får udleveret en informationspakke med følgende elementer:
English: A third dose was administered if needed after at least 4 hours after dose 2.
Danish: En tredje dosis blev efter behov givet mindst 4 timer efter dosis 2.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder.
Danish: Der er indberettet agitation, hypertoni, hypotoni, tremor, somnolens, respirationsdepression og spiseforstyrrelser.
English: Joan Buscalla, 1-9, 08173 Sant Cugat del Vallès Barcelona, Spain
Danish: Joan Buscalla, 1-9, 08173 Sant Cugat del Vallès Barcelona, Spanien
English: Mean peak plasma concentrations were similar after the first and third dose of ADASUVE, indicating minimal accumulation during the 4-hour dosing interval.
Danish: Den gennemsnitlige maksimale plasmakoncentration var den samme efter første og tredje dosis af ADASUVE, hvilket tyder på, at akkumuleringen er minimal i doseringstidsrummet på 4 timer.
English: Additional measures include oxygen and intravenous fluids.
Danish: Herudover kan der suppleres med oxygen og intravenøst væsketilskud.
English: Patient should be observed during the first hour after each dose for signs and symptoms of bronchospasm.
Danish: Patienten bør observeres i den første time efter hver dosis for tegn og symptomer på bronkospasme.
English: No data are available on the use of ADASUVE in patients with underlying cardiovascular diseases.
Danish: Der foreligger ingen oplysninger om anvendelse af ADASUVE hos patienter med underliggende kardiovaskulær sygdom.
English: The most commonly reported adverse reactions during treatment with ADASUVE were dysgeusia, sedation/somnolence and dizziness (dizziness was more common after placebo treatment than loxapine treatment).
Danish: De hyppigst indberettede bivirkninger under behandling med ADASUVE var dysgeusi, sedation/somnolens og svimmelhed (svimmelhed var hyppigere efter behandling med placebo end med loxapin).
English: How to use ADASUVE 4.
Danish: Sådan skal du bruge ADASUVE 4.
English: There were no important differences in the exposure or disposition of loxapine following administration of ADASUVE due to age, gender, race, weight, or body mass index (BMI).
Danish: Efter administration af ADASUVE var der ingen vigtige forskelle i eksponeringen for eller fordelingen af loxapin betinget af alder, køn, race, vægt eller legemsmasseindeks (BMI).
English: • medicines like fluvoxamine, propranolol, and enoxacin and other medicines that inhibit a certain liver enzyme called “CYP450 1A2.”
Danish: • medicin som fluvoxamin, propranolol og enoxacin samt anden medicin, der hæmmer leverenzymet CYP450 1A2.
English: No dosage adjustment is recommended based on smoking status.
Danish: Der kræves ingen dosisjustering på grundlag af rygestatus.
English: A lower dose of 4.5 mg may be given if the 9.1 mg dose was not previously tolerated by the patient or if the physician decides a lower dose is more appropriate.
Danish: I stedet for 9,1 mg kan der gives en lavere dosis på 4,5 mg, hvis den højere dosis ikke tåles af patienten, eller hvis lægen anser en lavere dosis for mere hensigtsmæssig.
English: Concomitant administration of benzodiazepines or other hypnosedatives or respiratory depressants may be associated with excessive sedation and respiratory depression or respiratory failure.
Danish: Samtidig administration af benzodiazepiner eller andre hypnotika/sedativa eller respirationssup primerende midler kan være forbundet med excessiv sedation og respirationsdepression eller respirationssvigt.
English: 8-OH-loxapine is not pharmacologically active at the D2 receptor while the minor metabolite, 7-OH-loxapine, has high binding affinity to D2 receptors.
Danish: 8-OH-loxapin er ikke farmakologisk aktiv over for D2-receptorer, hvorimod den mindre betydningsfulde metabolit 7-OH-loxapin har høj bindingsaffinitet til D2-receptorer.