FrancophonIA/ELRC3.0 huggingface dataset:
English: Body temperature regulation
Danish: Kropstemperaturregulering
English: Therefore, Sycrest is not recommended in such patients.
Danish: Sycrest anbefales derfor ikke til disse patienter.
English: Except for fluvoxamine, none of the interacting medicinal products resulted in clinically relevant alterations in asenapine pharmacokinetics.
Danish: Bortset fra fluvoxamin, førte ingen af de interagerende lægemidler til klinisk relevante ændringer i asenapins farmakokinetik.
English: Asenapine caused mild maternal toxicity and slight retardation of foetal skeletal development.
Danish: Asenapin forårsagede mild maternel toksicitet og let forsinket skeletudvikling hos fosteret.
English: Furthermore, prolactin-mediated effects on mammary glands and oestrus cycle disturbances were observed.
Danish: Desuden blev der observeret prolaktin-medierede virkninger på brystkirtler og forstyrrelser af brunstcyklus.
English: Asenapine was not genotoxic in a battery of tests.
Danish: Asenapin var ikke genotoksisk i en serie af tests.
English: Hypotension and circulatory collapse should be treated with appropriate measures, such as intravenous fluids and/or sympathomimetic agents (epinephrine and dopamine should not be used, since beta stimulations may worsen hypotension in the setting of Sycrest-induced alpha blockade).
Danish: Hypotension og kredsløbskollaps bør behandles med passende foranstaltninger, såsom intravenøs væske og/eller sympatomimetika (adrenalin og dopamin bør ikke anvendes, da beta-stimulering kan forværre hypotension i tilfælde af Sycrest-induceret alfa-blokade).
English: - To ensure optimal absorption, place the tablet under the tongue and wait until it dissolves completely (Figure 3).
Danish: - Placer resoribletten under tungen og vent til den er helt opløst (figur 3).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Sycrest in one or more subsets of the paediatric population in bipolar I disorder (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Sycrest i en eller flere undergrupper af den pædiatriske population ved bipolar I lidelse (se pkt.
English: Therefore, make sure your concentration and alertness are not affected before you drive or operate machinery.
Danish: Vær opmærksom på, hvordan medicinen påvirker dig, og sørg derfor for, at din koncentrationsevne eller opmærksomhed ikke er påvirket, inden du kører eller arbejder med maskiner.
English: Asenapine is a high clearance compound, with a clearance after intravenous administration of 52 L/h.
Danish: Asenapin er et stof med høj clearance, med en clearance efter intravenøs indgift på 52 l/time.
English: If you forget to take Sycrest
Danish: Hvis du har glemt at tage Sycrest
English: Sycrest contains the active substance asenapine.
Danish: Sycrest indeholder det aktive stof asenapin.
English: Withdrawal of Sycrest may be needed.
Danish: Det kan være nødvendigt at stoppe med at tage Sycrest.
English: This leaflet was last revised in {month/YYYY}.
Danish: Denne indlægsseddel blev senest ændret { MM/ÅÅÅÅ }
English: The intake of water several (2 or 5) minutes after asenapine administration resulted in decreased (19 % and 10 %, respectively) asenapine exposure.
Danish: Indtag af vand flere (2 eller 5) minutter efter indtagelse af asenapin resulterede i et fald (hhv. 19 % og 10 %) i eksponering af asenapin.
English: Increased neonatal mortality was observed among the offspring of female rats treated during gestation and lactation.
Danish: Der blev observeret øget neonatal dødelighed blandt afkommet af hunrotter behandlet under drægtighed og laktation.
English: Paediatric studies with Sycrest were performed using flavoured sublingual tablets.
Danish: De pædiatriske studier med Sycrest blev udført med sublinguale resoribletter med smag.
English: Do not take Sycrest If you are allergic to asenapine or any of the other ingredients of this medicine (listed in section 6).
Danish: Hvis du er allergisk over for asenapin eller et af de øvrige indholdsstoffer i Sycrest (angivet i punkt 6).
English: The following symptoms may occur in newborn babies, of mothers that have used Sycrest in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Danish: Følgende symptomer kan forekomme hos nyfødte af mødre, som har taget Sycrest i sidste trimester (de sidste tre måneder af graviditeten): rystelser, muskelstivhed og/eller svaghed, søvnighed, rastløs uro, vejrtrækningsbesvær og besvær med at indtage føde.
English: What you need to know before you take Sycrest
Danish: Det skal du vide, før du begynder at tage Sycrest
English: In a dedicated study, concomitant smoking during administration of a single 5 mg sublingual dose had no effect on the pharmacokinetics of asenapine.
Danish: I en særlig undersøgelse, havde samtidig rygning under administration af en enkelt 5 mg sublingual dosis ingen effekt på farmakokinetikken af asenapin.
English: Store this medicine in the original package in order to protect from light and moisture.
Danish: Opbevar lægemidlet i den originale yderpakning for at beskytte mod lys og fugt.
English: However, adverse effects of treatment on weight gain and on plasma lipid profile appeared to be greater than effects observed in the adult trials.
Danish: Imidlertid synes de negative behandlingsrelaterede virkninger på vægtstigning og plasmalipidprofil at være mere udtalte end observeret i studier hos voksne.
English: When used in combination with other medicinal products, Sycrest should be taken last.
Danish: Når Sycrest tages i kombination med andre lægemidler skal Sycrest tages til sidst.
English: The possibility of elevated asenapine plasma levels cannot be excluded in some patients with moderate hepatic impairment (Child-Pugh B) and caution is advised.
Danish: Muligheden for forhøjet plasmaniveau af asenapin hos patienter med moderat nedsat leverfunktion (Child-Pugh B) kan ikke udelukkes, og forsigtighed tilrådes.
English: Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Danish: Tegn på denne øgede sensitivitet kan være forvirring, sløvhed, postural ustabilitet med hyppige fald samt ekstrapyramidale symptomer.
English: Overall, steady-state asenapine pharmacokinetics are similar to single-dose pharmacokinetics.
Danish: Samlet set svarer steady-state farmakokinetik af asenapin til enkeltdosis farmakokinetik.
English: Clinical drug interaction studies investigating the effects of CYP2D6 inhibition by asenapine showed the following results:
Danish: Kliniske lægemiddelinteraktionsstudier, som undersøgte asenapins effekt på CYP2D6-hæmning, viste følgende reultater:
English: fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome”).
Danish: - feber, svær muskelstivhed, svedtendens eller nedsat bevidsthedsniveau (en lidelse kaldet malignt neuroleptikasyndrom).
English: Available pharmacokinetic data are described in section 5.2.
Danish: De tilgængelige farmakokinetiske data er beskrevet i pkt.
English: Exactly how this medicine works is unknown, however, it is believed to adjust the balance of these chemicals.
Danish: Det antages dog, at medicinen justerer balancen mellem disse stoffer.
English: The coloured tab should be peeled back and the tablet should be removed gently.
Danish: Den farvede flap trækkes tilbage og resoribletten tages forsigtigt ud.
English: Newborn infants exposed to antipsychotics (including Sycrest) 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 børn, der har været udsat for antipsykotika (inklusive Sycrest) under tredje trimester af graviditeten, har risiko for bivirkninger inkluderende ekstrapyramidale symptomer og/eller abstinenssymptomer, som kan variere i sværhedsgrad og varighed efter fødslen.
English: Breast-feeding should be discontinued during treatment with Sycrest.
Danish: Amning bør afbrydes under behandling med Sycrest.
English: During combined administration with a single dose of asenapine 5 mg, fluvoxamine 25 mg twice daily resulted in a 29 % increase in asenapine AUC.
Danish: En kombineret administration med en enkeltdosis af asenapin 5 mg og fluvoxamin 25 mg to gange dagligt resulterede i en 29 % forøgelse af asenapins AUC.
English: Within each frequency grouping, ADRs are presented in order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er.
English: In an in vivo study in humans with radio-labelled asenapine, the predominant drug-related entity in plasma was asenapine +-glucuronide; others included N-desmethylasenapine, N-desmethylasenapine N-carbamoyl glucuronide, and unchanged asenapine in smaller amounts.
Danish: I et in vivo studie i mennesker med radioaktivt mærket asenapin fandt man følgende metabolitter af asenapin i plasma: i størst mængde asenapin +-glucuronide; andre inkluderede N-desmethylasenapin, N-desmethylasenapin N-carbamoyl glucuronide og uomdannet asenapin i mindre mængder.
English: Asenapine may induce orthostatic hypotension and syncope, especially early in treatment, probably reflecting its α1-adrenergic antagonist properties.
Danish: Asenapin kan give ortostatisk hypotension og besvimelse specielt tidligt i behandlingen, hvilket sandsynligvis skyldes dets α1-adrenerge antagonistiske egenskaber.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om Sycrest findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu
English: Caution should be exercised when Sycrest is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products thought to prolong the QT interval.
Danish: Der skal udvises forsigtighed ved ordinering af Sycrest til patienter med kendt kardiovaskulær sygdom eller med familiær disposition til QT-forlængelse og ved samtidig brug af andre lægemidler, der kan forlænge QT-intervallet.
English: Children and adolescents Sycrest is not recommended for use in patients below the age of 18 years.
Danish: Børn og unge Sycrest frarådes til patienter under 18 år.
English: Treatment-related adverse reactions included agitation and confusion, akathisia, orofacial dystonia, sedation, and asymptomatic ECG findings (bradycardia, supraventricular complexes, intraventricular conduction delay).
Danish: Behandlingsrelaterede bivirkninger omfattede agitation og forvirring, akatisi, orofacial dystoni, sedation og asymptomatiske EKG-fund (bradykardi, supraventrikulære komplekser, forsinkelse af den intraventrikulære overledning).
English: Following oral administration to pregnant rabbits during the period of organogenesis, asenapine adversely affected body weight at the high dose of 15 mg.kg twice daily.
Danish: Efter oral indgift af asenapin hos drægtige kaniner i organogenesefasen, påvirkede asenapin legemsvægten ved den høje dosis på 15 mg·kg to gange dagligt.
English: Falls*
Danish: Fald*
English: Study results showed statistically significant superiority for all three Sycrest doses in improving the Young Mania Rating Scale (YMRS) total score as measured by the change from baseline to Day 21, as compared with placebo.
Danish: Studieresultaterne var statistisk signifikant højere for alle tre Sycrest doser til forbedring af den totale YMRS-score målt ved ændring fra baseline til dag 21 sammenlignet med placebo.
English: Peelable aluminium/aluminium blisters in cartons of 20, 60 or 100 sublingual tablets per carton.
Danish: Oplukkelige aluminium/aluminium blisterpakninger (åbnes ved træk i den farvede flap), i kartoner af 20, 60 eller 100 resoribletter, sublinguale pr. karton.
English: Do not breast-feed when taking Sycrest.
Danish: Du må ikke amme, mens du tager Sycrest.
English: Increases in prolactin levels were observed in some patients with Sycrest.
Danish: Der er observeret forhøjelse af prolaktinniveauer hos nogle patienter i behandling med Sycrest.
English: Asenapine has some affinity to melanin-containing tissues.
Danish: Asenapin har en vis affinitet til melaninholdigt væv.
English: Peelable blister.
Danish: Oplukkelige blisterpakninger.
English: Orthostatic hypotension Hypotension
Danish: Ortostatisk hypotension Hypotension
English: Transient, asymptomatic elevations of hepatic transaminases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
Danish: Kortvarige asymptomatiske forhøjelser af leveraminotranferaser, alanin-aminotransferase (ALAT) og aspartat-aminotransferase (ASAT) er almindeligt, især i starten af behandlingen.
English: if you have a heart disease or a treatment for heart disease that makes you prone to low blood pressure if you are diabetic or prone to diabetes if you have Parkinson's disease or dementia if you have epilepsy (seizures) if you experience any difficulty in swallowing (dysphagia) if you have severe liver problems.
Danish: - hvis du har en hjertesygdom eller tager hjertemedicin, som kan give tilbøjelighed til lavt blodtryk - hvis du har sukkersyge eller har risiko for at få sukkersyge - hvis du har Parkinsons sygdom eller demens - hvis du har epilepsi (kramper) - hvis du oplever synkebesvær (dysfagi) - hvis du har alvorlige leverproblemer, må du ikke tage Sycrest.
English: Clinical efficacy in bipolar I disorder
Danish: Klinisk virkning i bipolar I lidelse
English: Neuroleptic malignant syndrome (NMS), characterised by hyperthermia, muscle rigidity, autonomic instability, altered consciousness and elevated serum creatine phosphokinase levels, has been reported to occur with antipsychotics, including asenapine.
Danish: Malignt neuroleptikasyndrom (NMS), som er karakteriseret ved hypertermi, muskelstivhed, autonom ustabilitet, ændret bevidsthed og forhøjet niveau af kreatinfosfokinase i serum, er blevet set ved brug af antipsykotika inklusive asenapin.
English: In adolescents, the 10 mg twice daily dose did not result in increased exposure compared to 5 mg twice daily.
Danish: Hos unge, har dosering på 10 mg to gange dagligt ikke resulteret i øget eksponering i forhold til 5 mg to gange dagligt.
English: Parkinson's disease and dementia with Lewy bodies Physicians should weigh the risks versus the benefits when prescribing Sycrest to patients with Parkinson's disease or dementia with Lewy Bodies (DLB) since both groups may be at increased risk of neuroleptic malignant syndrome as well as having an increased sensitivity to antipsychotics.
Danish: Læger bør afveje risici versus fordele ved ordination af Sycrest til patienter med Parkinsons sygdom eller Lewy Body-demens, da begge grupper kan have øget risiko for Malignt Neuroleptisk Syndrom samt have en øget følsomhed for antipsykotika.
English: The pharmacokinetics of asenapine were similar among subjects with mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment and subjects with normal hepatic function.
Danish: Farmakokinetikken for asenapin var ens blandt patienter med mild (Child-Pugh A) eller moderat (Child-Pugh B) nedsat leverfunktion og patienter med normal leverfunktion.
English: System organ class
Danish: Systemorganklasser Meget almindelig
English: NL-5349 AB Oss The Netherlands
Danish: NL-5349 AB Oss
English: The tablet should not be pushed through the tablet pack.
Danish: Resoribletten bør ikke presses igennem blisterpakningen.
English: Sycrest is not approved for the treatment of patients with dementia-related psychosis and is not recommended for use in this particular group of patients.
Danish: Sycrest er ikke godkendt til behandling af patienter med demensrelateret psykose og anbefales ikke til denne specielle patientgruppe.
English: A population pharmacokinetic analysis indicated that there is no evidence of gender-related differences in the pharmacokinetics of asenapine.
Danish: En populationsfarmakokinetisk analyse viste, at der ikke er tegn på kønsrelaterede forskelle i farmakokinetikken for asenapin.
English: Actions at other receptors e.g., 5-HT1A, 5-HT1B, 5-HT2C, 5-HT6, 5-HT7, D3, and α2-adrenergic receptors, may also contribute to the clinical effects of asenapine.
Danish: Virkninger på andre receptorer fx 5-HT1A, 5-HT1B, 5-HT2C, 5-HT6, 5-HT7, D3, og α2-adrenerge receptorer, kan også bidrage til den kliniske effekt af asenapin.
English: Potential for other medicines to affect Sycrest
Danish: Risiko for at andre lægemidler påvirker Sycrest
English: Appropriate care is advised when prescribing Sycrest for patients who will be experiencing conditions that may contribute to an elevation in core body temperature, e.g. exercising strenuously, exposure to extreme heat, receiving concomitant medicinal products with anticholinergic activity or being subject to dehydration.
Danish: Der bør udvises forsigtighed ved ordination af Sycrest til patienter, som vil opleve forhold, der kan bidrage til en stigning i kroppens kernetemperatur, f.eks. motionerer ihærdigt, udsættes for ekstrem varme, samtidig får lægemidler med antikolinerg aktivitet eller som påvirkes af dehydrering.
English: Asenapine may antagonise the effect of levodopa and dopamine agonists.
Danish: Asenapin kan have antagonistisk effekt på levodopa og dopaminagonister.
English: The potential effects of inhibitors and an inducer of several of these enzyme pathways on asenapine pharmacokinetics were studied, specifically fluvoxamine (CYP1A2 inhibitor), paroxetine (CYP2D6 inhibitor), imipramine (CYP1A2/2C19/3A4 inhibitor), cimetidine (CYP3A4/2D6/1A2 inhibitor), carbamazepine (CYP3A4/1A2 inducer) and valproate (UGT inhibitor).
Danish: De potentielle effekter af inhibitorer og en inducer af flere af disse enzymveje af asenapins farmakokinetik blev undersøgt, specifikt fluvoxamin (CYP1A2-inhibitor), paroxetin (CYP2D6-inhibitor), imipramin (CYP1A2/2C19/3A4-inhibitor), cimetidin (CYP3A4/2D6/1A2-inhibitor), carbamazepin (CYP3A4/1A2-inducer) og valproat (UGT inhibitor).
English: The most common adverse reactions (≥ 5 % and at least twice the rate of placebo) reported in paediatric patients with bipolar I disorder were somnolence, sedation, dizziness, dysgeusia, hypoaesthesia oral, paraesthesia oral, nausea, increased appetite, fatigue, and weight increased (see Weight increase above).
Danish: De hyppigst rapporterede bivirkninger (≥ 5 % og mindst to gange frekvensen for placebo) hos pædiatriske patienter med bipolar I lidelse var døsighed, sedation, svimmelhed, dysgeusi, oral hypæstesi, oral paræstesi, kvalme, øget appetit, træthed samt vægtstigning (se Vægtstigning ovenfor).
English: In a separate study, co-administration of a single 75 mg dose of imipramine with a single 5 mg dose of asenapine did not affect the plasma concentrations of the metabolite desipramine (a CYP2D6 substrate).
Danish: - I en separat undersøgelse, påvirkede samtidig indgift af en enkelt 75 mg dosis imipramin og en enkelt 5 mg dosis af asenapin ikke plasmakoncentrationen af metabolitten desipramin (et CYP2D6-substrat).
English: Asenapine exposure is increased 7-fold in patients with severe hepatic impairment (Child-Pugh C).
Danish: Asenapin-eksponering er 7-dobbelt hos patienter med svært nedsat leverfunktion (Child-Pugh C).
English: Asenapine may cause sleepiness, sudden drops in blood pressure when you stand up, dizziness and changes in your ability to move and balance, which may lead to falls and, consequently, fractures or other injuries.
Danish: Asenapin kan medføre søvnighed, pludseligt fald i blodtrykket, når du rejser dig op, svimmelhed samt ændret bevægelses- og balanceevne, som kan medføre fald og dermed også brud eller andre skader.
English: The efficacy of asenapine in the treatment of a DSM-IV manic or mixed episode of bipolar I disorder with or without psychotic features was evaluated in two similarly designed 3-week, randomized, double-blind, flexible-dose, placebo- and active controlled (olanzapine) monotherapy trials involving 488 and 489 patients, respectively.
Danish: Virkningen af asenapin i behandlingen af DSM-IV manisk episode eller blandingstilstande af bipolar I lidelse, med eller uden psykotiske træk, blev evalueret i to ens designede 3-ugers, randomiserede, dobbeltblindede, placebo- og aktivt-kontrollerede (olanzapin) monoterapiforsøg med fleksibel dosering med henholdsvis 488 og 489 patienter.
English: If you are taking other medicines, Sycrest should be taken last.
Danish: Hvis du tager anden medicin, skal Sycrest tages til sidst.
English: Asenapine is a weak inhibitor of CYP2D6.
Danish: Asenapin er en svag inhibitor af CYP2D6.
English: Fertility No impairment of fertility has been observed in nonclinical studies (see section 5.3).
Danish: Fertilitet Der er ikke observeret nedsat fertilitet i prækliniske studier (se pkt.
English: Accommodation disorder
Danish: Akkommodation sforstyrrelse
English: Asenapine is cleared primarily through direct glucuronidation by UGT1A4 and oxidative metabolism by cytochrome P450 isoenzymes (predominantly CYP1A2).
Danish: Asenapin udskilles primært ved direkte glucuronidering af UGT1A4 og oxidativ metabolisme ved cytochrom P450-isoenzymer (overvejende CYP1A2).
English: The pharmacokinetics of asenapine following a single dose of 5 mg asenapine were similar among subjects with varying degrees of renal impairment and subjects with normal renal function.
Danish: Farmakokinetikken for asenapin efter en enkelt dosis på 5 mg asenapin var ens blandt patienter med varierende grader af nedsat nyrefunktion og patienter med normal nyrefunktion.
English: There is no experience with asenapine in patients with severe renal impairment who have a creatinine clearance less than 15 mL/min.
Danish: Der er ingen erfaring med asenapin hos patienter med svært nedsat nyrefunktion, som har en kreatininclearance på mindre end 15 ml/min.
English: Both asenapine doses (5 mg BID and 10 mg BID) were superior to placebo and showed statistically significant improvement in change from baseline in Y-MRS total score at Day 21 compared with placebo.
Danish: Begge asenapin-doser (5 mg to gange dagligt og 10 mg to gange dagligt) viste bedre effekt end placebo og udviste statistisk signifikant forbedring i ændring fra baseline i total YMRS-score ved dag 21 sammenlignet med placebo.
English: Elderly patients with dementia-related psychosis Elderly patients with dementia-related psychosis treated with antipsychotic substances are at an increased risk of death.
Danish: Ældre patienter med demensrelateret psykose, som er i behandling med antipsykotiske midler har en større risiko for dødsfald.
English: Alanine aminotransferas e increased
Danish: Forhøjet alaninaminotransferase
English: In a population pharmacokinetic analysis, no clinical relevant effects of race on the pharmacokinetics of asenapine were found.
Danish: I en populationsfarmakokinetisk analyse blev der ikke fundet klinisk relevante virkninger af race på asenapins farmakokinetik.
English: There is no experience with asenapine in severe renal impairment patients with a creatinine clearance less than 15 mL/min.
Danish: Der er ingen erfaring med asenapin hos patienter med svært nedsat nyrefunktion med en kreatinin clearance på mindre end 15 ml/min.
English: From the short-term (6 weeks) schizophrenia trials there appears to be a dose-response relationship for akathisia in patients treated with asenapine, and for parkinsonism there was an increasing trend with higher doses.
Danish: Fra de kortvarige (6 ugers) skizofreni-studier var der en sammenhæng mellem dosis og -respons for akatisi hos patienter behandlet med asenapin, og der var en stigende tendens til parkinsonisme med højere doser.
English: Do not cut or tear the blister.
Danish: Du må ikke skære i eller rive i blisterpakningen.
English: - Peel back the coloured tab (Figure 1).
Danish: - Træk i den farvede flap (figur 1).