FrancophonIA/ELRC3.0 huggingface dataset:
English: If signs and symptoms of tardive dyskinesia appear in a patient being treated with loxapine, discontinuation should be considered.
Danish: Ved tegn og symptomer på tardiv dyskinesi hos patienter i behandling med loxapin bør seponering overvejes.
English: A second dose can be given after 2 hours, if necessary.
Danish: Om nødvendigt kan der gives endnu en dosis efter 2 timer.
English: • any breathing symptoms such as wheezing, cough, shortness of breath, or chest tightness, as these could mean that the medicine is irritating your airways (uncommon occurrence unless you have asthma or COPD);
Danish: • alle vejrtrækningssymptomer, såsom hvæsen, hoste, stakåndethed eller trykken i brystet, da dette kan skyldes, at lægemidlet irriterer dine luftveje (ikke almindeligt, medmindre du har astma eller KOL)
English: The following symptoms may occur in newborn babies of mothers that have repeatedly used antipsychotic medicines in the last three months of their pregnancy: shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Danish: Følgende symptomer kan optræde hos nyfødte børn af mødre, der flere gange har fået antipsykotiske lægemidler i de sidste tre måneder af graviditeten: rysten, muskelstivhed og/eller muskelsvaghed, søvnighed, rastløs uro, vejrtrækningsproblemer og vanskelighed ved at spise.
English: Severe extrapyramidal reactions should be treated with anticholinergic antiparkinson medicinal products or diphenhydramine hydrochloride, and anticonvulsant therapy should be initiated as indicated.
Danish: Svære ekstrapyramidale reaktioner bør behandles med antikolinerge antiparkinsonmidler eller diphenhydraminhydrochlorid, og antikonvulsiv behandling bør indledes efter behov.
English: • When ADASUVE is removed from the pouch, the indicator light is off.
Danish: • Når ADASUVE inhalatoren tages ud af posen, er kontrollampen slukket.
English: Severe hypotension might be expected to respond to the administration of noradrenaline or phenylephrine.
Danish: Svær hypotension kan tænkes at respondere på noradrenalin eller phenylefrin.
English: Adrenaline should not be used, since beta-adrenoceptor stimulation may worsen hypotension in the setting of loxapine-induced partial alpha-adrenoceptor blockade (see section 4.5).
Danish: Adrenalin bør ikke anvendes, da stimulation af beta-adrenoreceptorer kan forstærke hypotension i situationer med loxapin-induceret partiel alfa-adrenoceptorblokade (se pkt.
English: In female smokers exposure (AUCinf) to ADASUVE and its active metabolite 7-OH-loxapine is lower than in female non-smokers (84% vs 109% 7-OH-loxapine/Loxapine Ratio), which is probably due to an increase in loxapine clearance in smokers.
Danish: Hos kvindelige rygere er eksponeringen (AUCinf) for ADASUVE og dets aktive metabolit 7-OHloxapin lavere end hos kvindelige ikke-rygere (forholdet 7-OH-loxapin/loxapin er 84 % mod 109 %), antagelig som følge af større clearance af loxapin hos rygere.
English: Inclusion in Study 004-302 required a diagnosis of bipolar disorder (current episode manic or mixed).
Danish: En betingelse for inklusion i undersøgelse 004-302 var diagnosen bipolar lidelse (i manisk eller blandet fase).
English: Before treatment with ADASUVE, tell your doctor or nurse if you:
Danish: Inden du begynder behandlingen med ADASUVE, skal du fortælle det til lægen eller sygeplejersken, hvis du:
English: Each inhaler is packaged in a sealed foil pouch.
Danish: Hver inhalator er pakket i en forseglet foliepose.
English: The efficacy of loxapine is proposed to be mediated through high affinity antagonism of dopamine D2 receptors and serotonin 5-HT2A receptors.
Danish: Virkningen af loxapin antages at være medieret ved højaffinitetsantagonisme med dopamin D2receptorer og serotonin 5-HT2A-receptorer.
English: • The indicator light turns on (green) when the tab is pulled out.
Danish: • Kontrollampen lyser (grønt), når plastfligen trækkes af.
English: Loxapine may cause severe respiratory depression if combined with other CNS-depressants (see section 4.4).
Danish: Loxapin kan medføre svær respirationsdepression, hvis det anvendes sammen med andre CNS-depressiva (se pkt.
English: A short-acting beta-agonist bronchodilator should be available for treatment of possible bronchospasm.
Danish: En korttidsvirkende bronkodilaterende beta-agonist bør være til rådighed til behandling af eventuel bronkospasme.
English: • ever had muscle or eye movements you can't control, lack of coordination, sustained muscle contraction, or feeling restless or unable to sit still
Danish: • nogensinde har haft ukontrollerede muskel- eller øjenbevægelser, manglende koordination eller vedvarende muskelsammentrækning eller har følt dig rastløs eller ude af stand til at sidde stille
English: The potential risk of QTc prolongation due to interaction with medicinal products known to prolong QTc interval is unknown.
Danish: Der savnes viden om den potentielle risiko for QTc-forlængelse ved interaktion med lægemidler, der vides at forlænge QTcintervallet.
English: Adverse reactions seen with chronic oral loxapine use
Danish: Bivirkninger ved kronisk oral brug af loxapin
English: Co-administration of loxapine and adrenaline may cause worsening of hypotension (see section 4.4).
Danish: Koadministration af loxapin og adrenalin kan forværre eksisterende hypotension (se pkt.
English: • Addtional risk minimisation measures
Danish: • Yderligere foranstaltninger til risikominimering
English: Caution should be used in patients receiving concomitant treatment with other medicinal products that are either inhibitors or inducers of these enzymes, particularly if the concomitant medicinal product is known to inhibit or induce several of the enzymes involved in loxapine metabolism.
Danish: Der bør udvises forsigtighed ved sideløbende behandling med andre lægemidler, som enten hæmmer eller inducerer disse enzymer, navnlig hvis det pågældende lægemiddel vides at hæmme eller inducere flere af de enzymer, der medvirker ved metaboliseringen af loxapin.
English: • Observation of patients for 1 hour after each dose of ADASUVE
Danish: • observation af patienten i en time efter hver dosis af ADASUVE Risikoen for QT-forlængelse:
English: Clinically relevant QT prolongation does not appear to be associated with single and repeat doses of ADASUVE.
Danish: ADASUVE synes ikke at være forbundet med klinisk relevant QT-forlængelse hverken ved en enkelt eller ved gentagne doser.
English: Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure.
Danish: Andre tegn kan være forhøjet kreatinfosfokinase, myoglobinuri (rabdomyolyse) og akut nyresvigt.
English: General disorders and administration site conditions Common: fatigue
Danish: Almene symptomer og reaktioner på administrationsstedet Almindelig: træthed
English: You should not breast-feed for a period of 48 hours after receiving ADASUVE and should discard the milk produced in the meantime.
Danish: Du skal undgå at amme i et tidsrum af 48 timer efter at have fået loxapin, og du skal kassere den mælk, der i mellemtiden er produceret.
English: ADASUVE works by blocking certain chemicals in the brain (neurotransmitters) such as dopamine and serotonin thus causing calming effects and relieving aggressive behaviour.
Danish: ADASUVE virker ved at blokere visse kemiske stoffer i hjernen (neurotransmittere) såsom dopamin og serotonin.
English: The extent of the excretion of loxapine or its metabolites in human milk is not known.
Danish: Det vides ikke, i hvilket omfang loxapin eller dets metabolitter udskilles i modermælk.
English: Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac dysrhythmia).
Danish: De kliniske manifestationer af NMS er hyperpyreksi, muskelrigiditet, ændret mental status og tegn på autonom ustabilitet (uregelmæssig puls eller uregelmæssigt blodtryk, takykardi, diaforese og hjertearytmi).
English: The white inhaler (housing) is molded from a medical-grade polycarbonate.
Danish: Den hvide inhalator er støbt i medicinsk polycarbonat.
English: Loxapine is metabolised extensively in the liver, with multiple metabolites formed.
Danish: Loxapin metaboliseres for en stor del i leveren med dannelse af mange metabolitter.
English: Neuroleptic malignant syndrome (NMS)
Danish: Malignt neuroleptikasyndrom NMS
English: Additional side effects which have been related to long term use of loxapine by mouth and which may be relevant for ADASUVE include faintness upon standing, increased heart rate, increased blood pressure, blurred vision, dry eyes, and decreased urination.
Danish: Andre bivirkninger, der er blevet sat i forbindelse med langvarig indtagelse af loxapin gennem munden, og som kan være relevante for ADASUVE, er svimmelhed, når man rejser sig op, øget hjerterytme, øget blodtryk, sløret syn, øjentørhed og mindsket vandladning.
English: • light-headedness or fainting, as these could mean that the medicine is lowering your blood pressure (uncommon occurrence);
Danish: • svimmelhed eller besvimelse, som følge af, at lægemidlet sænker blodtrykket (ikke almindeligt)
English: Administration of ADASUVE resulted in rapid absorption of loxapine with a median time of maximum plasma concentration (Tmax) by 2 minutes.
Danish: Loxapin absorberedes hurtigt efter administration af ADASUVE; den mediane tid (Tmax) til opnåelse af maksimal plasmakoncentration var således under 2 minutter.
English: Treatment with ADASUVE may have to be stopped if this occurs.
Danish: Hvis dette optræder, kan det være nødvendigt at stoppe behandlingen med ADASUVE.
English: A population pharmacokinetic analysis that compared exposures in smokers versus non-smokers indicated that smoking, which induces CYP1A2, had a minimal effect on the exposure to ADASUVE.
Danish: En populationsfarmakokinetisk sammenligning af eksponeringen hos rygere og ikke-rygere viste, at rygning har minimal indvirkning på eksponeringen for ADASUVE, skønt rygning inducerer CYP1A2.
English: Mild hypotension was reported in short-term (24-hour), placebo-controlled trials in agitated patients administered ADASUVE.
Danish: Der er beskrevet let hypotension i placebokontrollerede korttidsundersøgelser (24 timer) hos agiterede patienter, der fik ADASUVE.
English: Adrenaline
Danish: Adrenalin
English: ADASUVE may have limited effectiveness when patients are on concomitant medicinal products, predominantly other antipsychotics.
Danish: Effekten af ADASUVE kan være begrænset hos patienter på anden samtidig medicin, navnlig andre antipsykotika.
English: • ADASUVE should be used with caution in patients who are intoxicated or delirious.
Danish: • Der bør udvises forsigtighed ved anvendelse af ADASUVE til patienter, der er berusede eller har delirium.
English: Animal studies following oral administration suggest an initial preferential distribution in the lungs, brain, spleen, heart and kidney.
Danish: Efter oral administration til dyr fordeles loxapin fortrinsvis i lunger, hjerne, milt, hjerte og nyrer.
English: What you need to know before you use ADASUVE
Danish: Det skal du vide, før du begynder at bruge ADASUVE
English: EU/1/13/823/001 (5 single-dose inhalers) EU/1/13/823/003 (1 single-dose inhaler)
Danish: EU/1/13/823/001 (5 enkeltdosisinhalatorer) EU/1/13/823/003 (1 enkeltdosisinhalator)
English: EU/1/13/823/002 (5 single-dose inhalers) EU/1/13/823/004 (1 single-dose inhaler)
Danish: EU/1/13/823/002 (5 enkeltdosisinhalatorer) EU/1/13/823/004 (1 enkeltdosisinhalator)
English: New-born infants exposed repeatedly to antipsychotics during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Danish: Nyfødte, der gentagne gange har været eksponeret for antipsykotika i tredje trimester af graviditeten, har efter fødslen risiko for bivirkninger, herunder ekstrapyramidale virkninger og/eller abstinenssymptomer af varierende grad og varighed.
English: Hold the inhaler away from the mouth and breathe out fully to empty lungs.
Danish: Hold inhalatoren væk fra munden og ånd helt ud, så lungerne tømmes for luft.
English: Short-acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side-effects (bronchospasm).
Danish: En korttidsvirkende bronkodilaterende beta-agonist skal være til rådighed til behandling af eventuelle svære respiratoriske bivirkninger (bronkospasme).
English: The possibility of occurrence of extrapyramidal symptoms and/or convulsive seizures should be kept in mind.
Danish: Der bør udvises opmærksomhed over for mulige ekstrapyramidale symptomer og/eller krampeanfald.
English: In short-term (24-hour), placebo-controlled trials in patients with agitation associated with schizophrenia or bipolar disorder without active airways disease, bronchospasm (which includes reports of wheezing, shortness of breath or cough) was uncommon in patients treated with ADASUVE.
Danish: I de placebokontrollerede kortvarige (24 timer) kliniske undersøgelser hos patienter med agitation ved skizofreni eller bipolar lidelse uden aktiv luftvejssygdom var bronkospasme (herunder rhonchi, stakåndethed eller hoste) ikke almindelig hos patienter behandlet med ADASUVE.
English: Directions for use
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN
English: The active substance is loxapine.
Danish: Aktivt stof: loxapin.
English: Given the primary CNS effects of loxapine, ADASUVE should be used with caution in combination with alcohol or other centrally acting medicinal products, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc.
Danish: På baggrund af loxapins primære CNS-virkninger bør der udvises forsigtighed ved anvendelse af ADASUVE i kombination med alkohol eller andre centralt virkende lægemidler, f.eks. anxiolytika, de fleste antipsykotika, hypnotika, opiater osv.
English: As would be expected from the pharmacologic actions of loxapine, the clinical findings may range from mild depression of the CNS and cardiovascular systems to profound hypotension, respiratory depression, and unconsciousness (see section 4.4).
Danish: Som forventeligt ud fra loxapins farmakologiske virkninger kan det kliniske billede spænde fra let depression af CNS og hjerte-kar-systemet til dyb hypotension, respirationsdepression og bevidstløshed (se pkt.
English: • Antipsychotic medicines like ADASUVE can cause movements that you may not be able to control including making faces, sticking out your tongue, smacking or puckering your lips, blinking rapidly, or moving your legs, arms or fingers rapidly.
Danish: • Antipsykotiske lægemidler som ADASUVE kan medføre ukontrollerede bevægelser såsom skæren ansigt, rækken tunge, smækken med læberne, trutmund, hurtig blinken og hurtige bevægelser af ben, arme eller fingre.
English: • Treatment with ADASUVE to be limited to a hospital setting
Danish: • begrænsning af behandling med ADASUVE til hospitalsregi
English: ADASUVE is indicated for the rapid control of mild-to-moderate agitation in adult patients with schizophrenia or bipolar disorder.
Danish: ADASUVE er indiceret til hurtig kontrol af let til moderat agitation hos voksne patienter med skizofreni eller bipolar lidelse.
English: When it occurred, it was typically reported within 25 minutes after dosing.
Danish: Når bronkospasme forekom, blev den typisk iagttaget inden for 25 minutter efter dosering.
English: Embryo/fetal developmental and perinatal studies have shown indications of developmental delay (reduced weights, delayed ossification, hydronephrosis, hydrourether, and/or distended renal pelvis with reduced or absent papillae) as well as increased numbers of perinatal and neonatal deaths in offspring of rats treated from mid-pregnancy with oral doses below the maximum recommended human dose for ADASUVE on a mg/m basis (see section 4.6).
Danish: Studier af den embryo/føtale udvikling og perinatale studier har vist tegn på forsinket udvikling (reduceret vægt, forsinket ossifikation, hydronefrose, hydroureter og eller/udvidet nyrebækken med formindskede eller manglende papiller) samt øget perinatal og neonatal dødelighed hos afkommet af rotter, der fra midten af drægtighedsperioden blev behandlet med orale doser, der var mindre end den maksimale anbefalede humane dosis af ADASUVE, angivet som mg/m
English: ADASUVE has not been studied in elderly patients, including those with dementia-related psychosis.
Danish: ADASUVE er ikke undersøgt hos ældre patienter, herunder patienter med demensrelateret psykose.
English: ADASUVE contains the active substance loxapine, which belongs to a group of medicines called antipsychotics.
Danish: ADASUVE indeholder det aktive stof loxapin, som er et antipsykotisk lægemiddel.
English: Assessment of adverse reactions from clinical study data is based on two Phase 3 and one Phase 2A short-term (24-hour) placebo-controlled clinical trials enrolling 524 adult patients with agitation associated with schizophrenia (including 27 patients with schizoaffective disorder) or bipolar disorder, treated with ADASUVE 4.5 mg (265 patients) or ADASUVE 9.1 mg (259 patients).
Danish: Vurderingen af bivirkningerne i de kliniske undersøgelser bygger på to fase 3-undersøgelser og én fase 2A-korttidsundersøgelse (24 timer), der alle var placebokontrollerede og omfattede 524 voksne patienter med agitation i forbindelse med skizofreni (herunder 27 med skizoaffektiv sygdom) eller bipolar lidelse, der blev behandlet med ADASUVE 4,5 mg (265 patienter) eller ADASUVE 9,1 mg (259 patienter).
English: Loxapine is a substrate for flavin-containing mono-oxygenases (FMOs), and for several CYP450 isozymes (see section 5.2).
Danish: Loxapin er substrat for flavinholdige monooxygenaser (FMO) og adskillige CYP450-isoenzymer (se pkt.
English: Uncommon: bronchospasm (including shortness of breath) Gastrointestinal disorders
Danish: Ikke almindelig: bronkospasme (herunder stakåndethed) Mave-tarm-kanalen
English: A study of inhaled loxapine and intramuscular lorazepam 1 mg in combination found no significant effects on respiratory rate, pulse oximetry, blood pressure, or heart rate compared with either drug administered alone.
Danish: I et studie med inhaleret loxapin og intramuskulær lorazepam 1 mg i kombination fandtes ikke signifikante virkninger på respirationsfrekvens, pulsoximetri, blodtryk eller hjertefrekvens sammenlignet med de enkelte lægemidler administreret hver for sig.
English: Correct use of ADASUVE inhaler is important for administration of the full dose of loxapine.
Danish: Det er vigtigt, at ADASUVE-inhalatoren bruges korrekt, så patienten får den fulde dosis af loxapin.
English: ADASUVE is not indicated for the treatment of patients with dementia-related psychosis.
Danish: ADASUVE er ikke indiceret til behandling af patienter med demensrelateret psykose.
English: • if you are allergic to loxapine or amoxapine;
Danish: • hvis du er allergisk over for det aktive stof eller amoxapin
English: ADASUVE has not been investigated in patients with other forms of lung disease.
Danish: ADASUVE er ikke blevet undersøgt hos patienter med andre former for lungesygdom.
English: Patients with acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (such as patients with asthma or chronic obstructive pulmonary disease [COPD] (see section 4.4).
Danish: Ved akutte tegn/symptomer fra luftvejene (f.eks. rhonchi) eller aktiv luftvejssygdom (såsom astma eller kronisk obstruktiv luftvejssygdom [KOL]) (se pkt.
English: Rescue
Danish: Redningsmedicin
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ADASUVE in the subset of the paediatric population from 12 to less than 18 years of age for the treatment of schizophrenia and in the subset from 10 years to less than 18 years of age in bipolar disorder (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med ADASUVE i undergruppen i alderen 12-18 år af den pædiatriske population til behandling af skizofreni og i undergruppen i alderen 10-18 år ved bipolar lidelse (se pkt.
English: Because of anticholinergic action, ADASUVE should be used cautiously in patients with glaucoma or a tendency to urinary retention, particularly with concomitant administration of anticholinergic-type antiparkinson medicinal products.
Danish: På grund ADASUVEs antikolinerge virkning bør der udvises forsigtighed ved anvendelse til patienter med glaukom eller disposition for urinretention, navnlig ved samtidig administration af antikolinerge antiparkinsonmidler.
English: Renal failure following oral loxapine overdosage has also been reported.
Danish: Derudover er nyresvigt beskrevet ved oral overdosering med loxapin.
English: Check with your doctor or nurse if you are not sure.
Danish: Spørg lægen eller sygeplejersken, hvis der er noget, du er i tvivl om.
English: With chronic oral administration of loxapine, the reported adverse reactions include sedation and drowsiness; extrapyramidal symptoms (e.g., tremor, akathisia, rigidity, and dystonia); cardiovascular effects (e.g., tachycardia, hypotension, hypertension, orthostatic hypotension, light-headedness, and syncope); and anticholinergic effects (e.g., dry eyes, blurred vision, and urinary retention).
Danish: Ved kronisk oral administration af loxapin er de indberettede bivirkninger sedation og døsighed, ekstrapyramidale symptomer (f.eks. tremor, akatisi, rigiditet og dystoni), kardiovaskulære virkninger (f.eks. takykardi, hypotension, hypertension, ortostatisk hypotension, svimmelhed og synkope) samt antikolinerge virkninger (f.eks. øjentørhed, sløret syn og urinretention).
English: ADASUVE is not recommended in patient populations with known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure or conduction abnormalities), cerebrovascular disease, or conditions which would predispose patients to hypotension (dehydration, hypovolaemia, and treatment with antihypertensive medicinal products).
Danish: Det frarådes at anvende ADASUVE til patientpopulationer med kendt kardiovaskulær sygdom (anamnese med myokardieinfarkt eller iskæmisk hjertesygdom, hjertesvigt eller ledningsforstyrrelser), cerebrovaskulær sygdom eller tilstande, der disponerer for hypotension (dehydrering, hypovolæmi og behandling med antihypertensiva).
English: Clinical studies with both atypical and conventional antipsychotic medicinal products have demonstrated that elderly patients with dementia-related psychosis are at an increased risk of death compared to placebo.
Danish: Kliniske undersøgelser har vist, at dødeligheden blandt ældre patienter med demensrelateret psykose er større med både atypiske og konventionelle antipsykotika end med placebo.
English: ADASUVE should not be re-administered in patients who develop any respiratory signs/symptoms (see section 4.3).
Danish: ADASUVE må ikke gives igen til patienter, der udvikler tegn eller symptomer fra luftvejene (se pkt.
English: Uncommon (may affect up to 1 in 100 people): muscle or eye movements you can't control, lack of coordination, sustained muscle contraction, or feeling restless or unable to sit still.
Danish: Ikke almindelig (forekommer hos indtil 1 ud af 100 behandlede): ukontrollerede muskel- eller øjenbevægelser, manglende koordination, vedvarende muskelsammentrækning, rastløshed eller manglende evne til at sidde stille
English: For complete instructions on how to use ADASUVE see information for the healthcare professional section of the package leaflet.
Danish: Fuldstændig vejledning i brugen af ADASUVE er givet i anvisningerne til sundhedspersonalet i indlægssedlen.
English: In female rats, reproductive effects have been observed (see section 5.3).
Danish: Hos hunrotter er iagttaget påvirkning af reproduktionen (se pkt.