FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not take Sycrest while you are pregnant, unless your doctor tells you so.
Danish: Du må ikke tage Sycrest, mens du er gravid, medmindre din læge har sagt, du skal gøre det.
English: The full therapeutic dose of fluvoxamine would be expected to produce a greater increase in asenapine plasma concentrations.
Danish: Den fulde terapeutiske dosis af fluvoxamin forventes at give en større forøgelse af plasmakoncentrationen for asenapin.
English: Few cases of overdose were reported in the asenapine program.
Danish: Der er rapporteret få tilfælde af overdosering i asenapin-programmet.
English: Patients at risk for fall should be evaluated prior to prescribing asenapine.
Danish: Patienter med risiko for fald skal vurderes før ordination af asenapin.
English: Patients should be advised to avoid alcohol while taking Sycrest.
Danish: Patienter bør rådes til at undgå indtagelse af alkohol, mens de tager Sycrest.
English: Patients with rapid cycling were excluded from these studies.
Danish: Patienter med hurtige episodeskift blev ekskluderet fra disse studier.
English: Sycrest is not advised if you are unable to take the tablet as described below.
Danish: Sycrest frarådes, hvis du ikke er i stand til at tage resoribletten som beskrevet nedenfor.
English: Gelatin Mannitol (E421)
Danish: Gelatine Mannitol (E421)
English: Patients from the two pivotal 3 week trials were studied for a further 9 weeks an extension trial.
Danish: Patienter fra to pivotale 3-ugers forsøg indgik i et 9-ugers forlængelsesforsøg.
English: You should avoid drinking alcohol when taking this medicine.
Danish: Du skal undgå at drikke alkohol, mens du tager dette lægemiddel.
English: In case of severe extrapyramidal symptoms, anticholinergic medicines should be administered.
Danish: I tilfælde af svære ekstrapyramidale symptomer bør antikolinerg medicin administreres.
English: The onset of extrapyramidal symptoms is a risk factor for tardive dyskinesia.
Danish: Forekomst af ekstrapyramidale symptomer er en risikofaktor for tardiv dyskinesi.
English: Disruption of the body's ability to reduce core body temperature has been attributed to antipsychotic medicines.
Danish: Forstyrrelser af kroppens evne til at nedsætte kernetemperatur er blevet tilskrevet antipsykotisk medicin.
English: If your baby develops any of these symptoms you may need to contact your doctor.
Danish: Hvis dit barn får nogle af disse symptomer, skal du kontakte din læge.
English: However, based on its receptor pharmacology, it is proposed that the efficacy of asenapine is mediated through a combination of antagonist activity at D2 and 5-HT2A receptors.
Danish: Baseret på dets receptor farmakologi er det foreslået, at effekten af asenapin medieres gennem en kombination af antagonist aktivitet på D2 og 5 HT2A receptorer.
English: Repeat-dose toxicity studies in rat and dog showed mainly dose-limiting pharmacological effects, such as sedation.
Danish: Gentagne toksicitetsundersøgelser af dosis på rotter og hunde viste primært dosisbegrænsende farmakologiske effekter, såsom sedation.
English: There is no specific antidote to Sycrest.
Danish: Der er ingen specifik antidot til Sycrest.
English: Sycrest should be used with care in the elderly.
Danish: Sycrest bør anvendes med forsigtighed hos ældre.
English: Long term efficacy could not be established in a 50-week, uncontrolled, open-label extension trial.
Danish: Langtidsvirkning kunne ikke fastlægges i et 50-ugers ukontrolleret, åbent forlængelsesstudie.
English: In the early stages of treatment, some people may faint, especially when getting up from a lying or sitting position.
Danish: Nogle patienter kan i det tidlige stadie af behandlingen besvime, specielt når de rejser sig fra en liggende eller siddende stilling.
English: Weight increase
Danish: Vægtstigning
English: Sexual dysfunction Amenorrhoea
Danish: Seksuel dysfunktion Amenorré
English: Be sure to tell your doctor if you meet any of these conditions as he/she may want to adjust your dose or monitor you for a while.
Danish: Fortæl det til lægen, hvis du har nogle af disse tilstande, da han/hun vil justere din dosis eller følge dig et stykke tid.
English: Therefore, patients should be cautioned about driving and using machines until they are reasonably certain that Sycrest therapy does not affect them adversely.
Danish: Patienter bør derfor advares mod at føre motorkøretøj og betjene maskiner, indtil de er sikre på, at behandling med Sycrest ikke påvirker dem negativt.
English: In dogs high oral doses resulted in hepatotoxicity that was not observed after chronic intravenous administration.
Danish: Hos hunde resulterede høje orale doser i hepatotoksicitet, hvilket ikke blev observeret efter kronisk intravenøs administration.
English: Appropriate clinical monitoring is advisable in diabetic patients and in patients with risk factors for the development of diabetes mellitus.
Danish: Der anbefales passende klinisk monitorering hos diabetespatienter og hos patienter med risikofaktorer for udvikling af diabetes mellitus.
English: To ensure optimal absorption, the Sycrest sublingual tablet should be placed under the tongue and allowed to dissolve completely.
Danish: For at sikre optimal absorption skal Sycrest sublingual resoribletten placeres under tungen og opløses helt.
English: Embryotoxicity was found in reproduction toxicology studies using rats and rabbits.
Danish: Embryotoksicitet blev fundet i reproduktionstoksicitetsstudier ved brug af rotter og kaniner.
English: Asenapine is highly bound (95 %) to plasma proteins, including albumin and α1-acid glycoprotein.
Danish: Asenapin er bundet (95 %) til plasmaproteiner herunder albumin og surt α1-glykoprotein.
English: Cerebrovascular events have been reported in patients treated with asenapine but there is no evidence of any excess incidence over what is expected in adults between 18 and 65 years of age.
Danish: Cerebrovaskulære hændelser er set hos patienter, som blev behandlet med asenapin, men der er ingen evidens for en større incidens i forhold til, hvad der forventes hos voksne mellem 18 og 65 år.
English: Long term safety in this population was explored in a 50-week, open-label, uncontrolled extension study.
Danish: Langtidssikkerheden hos denne population blev undersøgt i et 50-ugers åbent, ukontrolleret forlængelsesstudie.
English: Since Sycrest can lower blood pressure, care should be taken when Sycrest is taken with other medicines that lower blood pressure.
Danish: Da Sycrest kan sænke blodtrykket, skal du være forsigtig, når Sycrest tages sammen med anden medicin, der nedsætter blodtrykket.
English: Esophageal dysmotility and aspiration have been associated with antipsychotic treatment.
Danish: Synkeproblemer og aspiration har været associeret med antipsykotisk behandling.
English: However, when tested in vitro it was devoid of phototoxicity.
Danish: Men når det blev testet in vitro sås der ingen fototoksicitet.
English: Also contact your doctor immediately if any of these conditions develops or worsens while using Sycrest.
Danish: Kontakt også straks din læge, hvis du udvikler disse tilstande, eller de forværres, mens du tager Sycrest.
English: When asenapine was administered intravenously to pregnant rabbits, no signs of embryotoxicity were observed.
Danish: Når asenapin blev indgivet intravenøst til drægtige kaniner, blev der ikke observeret tegn på embryotoksicitet.
English: Oral hypoaesthesia and oral paraesthesia may occur directly after administration and usually resolves within 1 hour.
Danish: Oral hypæstesi og oral paræstesi kan opstå umiddelbart efter administration og forsvinder sædvanligvis inden for 1 time.
English: The dose can be increased to 10 mg twice daily based on individual clinical response and tolerability.
Danish: Dosis kan øges til 10 mg to gange dagligt på baggrund af individuelt respons og tolerabilitet.
English: The less than proportional increase of Cmax and AUC with dose may be attributed to limitations in the absorption capacity from the oral mucosa following sublingual administration.
Danish: At stigningen af Cmax og AUC med dosis er mindre end proportional kan muligvis tilskrives begrænsninger i absorptionskapacitet fra mundslimhinden efter sublingual administration.
English: No specific information is available on the treatment of overdose with Sycrest.
Danish: Ingen specifik information vedrørende behandling af overdosering med Sycrest er tilgængelig.
English: In subcutaneous carcinogenicity studies in rats and mice, no increases in tumour incidences were observed.
Danish: I et subkutan karcinogenicitet studie hos rotter og mus, blev der ikke observeret stigninger i forekomsten af tumorer.
English: - Do not remove a sublingual tablet from the blister until ready to take it. - Use dry hands when touching the tablet.
Danish: - Tag ikke resoribletten ud af blisterpakningen før du er klar til at tage den. - Dine hænder skal være tørre, når du rører ved resoribletten.
English: Asenapine demonstrated superior efficacy to placebo in the reduction of manic symptoms over 3 weeks.
Danish: Asenapin viste bedre effekt end placebo i reduktion af maniske symptomer over 3 uger.
English: Antipsychotic medicines affect the chemicals that allow communication between nerve cells (neurotransmitters).
Danish: Antipsykotisk medicin påvirker nogle af de stoffer i hjernen, der tillader kommunikation mellem nerveceller (kaldet neurotransmittere).
English: Very common side effects (may affect more than 1 in 10 people) - anxiety - sleepiness
Danish: Meget almindelige bivirkninger (kan påvirke flere end 1 ud af 10) - angst - søvnighed.
English: Elderly patients are particularly at risk for experiencing orthostatic hypotension (see section 4.8).
Danish: Ældre patienter har især risiko for at opleve ortostatisk hypotension (se pkt.
English: From a cross-fostering study it was concluded that asenapine induced peri- and postnatal losses are caused by impairment of the pups rather than altered nursing behaviour of the dams.
Danish: Fra en kryds-foster undersøgelse blev det konkluderet, at de asenapin-inducerede peri- og postnatale tab, er forårsaget af svækkelse af ungerne snarere end ændret yngelpleje hos moderen.
English: A statistically significant difference between asenapine and placebo was seen as early as day 2.
Danish: En statistisk signifikant forskel mellem asenapin og placebo sås allerede på dag 2.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle undersøgelser af sikkerhedsfarmakologi.
English: - The other ingredients are gelatin and mannitol (E421).
Danish: - Øvrige indholdsstoffer: Gelatine og mannitol (E421).
English: Packs may contain 20, 60 or 100 tablets.
Danish: Pakningen kan indeholde 20, 60 eller 100 resoribletter.
English: The table is based on adverse reactions reported during clinical trials and/or post-marketing use.
Danish: Tabellen er baseret på indberetning af bivirkninger fra kliniske forsøg og/eller brug efter markedsføring.
English: Increasing the dose from 5 to 10 mg twice daily (a two-fold increase) results in less than linear (1.7 times) increases in both the extent of exposure and maximum concentration.
Danish: En forøgelse af dosis fra 5 til 10 mg to gange dagligt (en fordobling) resulterer i mindre end lineære (1,7 gange) stigninger i både omfanget af eksponering og maksimal koncentration.
English: However, asenapine may enhance the inhibitory effects of paroxetine on its own metabolism.
Danish: Asenapin kan dog forstærke den hæmmende effekt af paroxetin på dets egen metabolisme.
English: Following sublingual administration, asenapine is rapidly absorbed with peak plasma concentrations occurring within 0.5 to 1.5 hours.
Danish: Efter sublingual administration absorberes asenapin hurtigt og maksimal plasmakoncentration opnås efter 0,5 til 1,5 time.
English: In addition, histopathological examination of the eyes from dogs treated chronically with asenapine did not reveal any signs of ocular toxicity, demonstrating the absence of a phototoxic hazard.
Danish: Endvidere viste histopatologiske undersøgelser af øjnene fra hunde behandlet kronisk med asenapin ingen tegn på okulær toksicitet, hvilket demonstrerer fravær af fototoksisk risiko.
English: Sycrest with food, drink and alcohol Do not eat or drink for 10minutes after taking this medicine.
Danish: Brug af Sycrest sammen med mad, drikke og alkohol Du må ikke spise eller drikke i 10 minutter, efter du har taget dette lægemiddel.
English: Asenapine did not impair fertility in rats and was not teratogenic in rat and rabbit.
Danish: Asenapin forringede ikke fertiliteten hos rotter og var ikke teratogent hos rotter og kaniner.
English: The incidence of orthostatic hypotension in elderly subjects was 4.1 % compared to 0.3 % in the combined phase 2/3 trial population.
Danish: Hyppigheden af ortostatisk hypotension hos ældre forsøgspersoner var 4,1 % sammenlignet med 0,3 % i den kombinerede fase 2/3-forsøgspopulation.
English: Therefore, eating and drinking should be avoided for 10 minutes after administration (see section 4.2).
Danish: Indtagelse af mad og drikke bør derfor undgås i 10 minutter efter administration (se pkt.
English: Assessment of the relationship between atypical antipsychotic use and glucose abnormalities is complicated by the possibility of an increased background risk of diabetes mellitus in patients with schizophrenia or bipolar disorder and the increasing incidence of diabetes mellitus in the general population.
Danish: Vurdering af forholdet mellem anvendelsen af atypiske antipsykotika og forstyrrelser i glukoseomsætningen kompliceres af muligheden for en øget baggrundsrisiko for diabetes mellitus hos patienter med skizofreni eller bipolar lidelse samt den stigende hyppighed af diabetes mellitus i den generelle population.
English: Manufacturer Organon (Ireland) Ltd. Drynam Road, Swords Co. Dublin, Ireland
Danish: Fremstiller Organon (Ireland) Ltd. Drynam Road, Swords Co. Dublin, Irland
English: Clinically relevant QT prolongation does not appear to be associated with asenapine.
Danish: Klinisk relevant QT-forlængelse ser ikke ud til at forekomme med asenapin.
English: Based on a small pharmacokinetic study, paediatric patients appeared to be more sensitive to dystonia with initial dosing with asenapine when a gradual up-titration schedule was not followed (see section 5.2).
Danish: På baggrund af et mindre farmakokinetisk studie synes pædiatriske patienter at være mere følsomme over for dystoni ved initial dosering med asenapin, når en gradvis titreringsplan ikke blev fulgt (se pkt.
English: Depending on the clinical response and tolerability in the individual patient, the dose can be increased to 10 mg twice daily.
Danish: Afhængig af klinisk respons og tolerabilitet hos den enkelte patient kan dosis øges til 10 mg to gange dagligt.
English: Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Danish: Yderligere kliniske tegn kan inkludere myoglobinuri (rabdomyolyse) og akut nyresvigt.
English: The tablet will dissolve in saliva within seconds.
Danish: Resoribletten opløses i spyt inden for få sekunder.
English: Overall mean (SD) weight gain at study endpoint was 3.5 (5.76) kg.
Danish: Totalt var den gennemsnitlige (SD) vægtstigning ved studiets endepunkt 3,5 (5,76) kg.
English: Treatment with Sycrest is not advised in patients who are unable to comply with this method of administration, as the bioavailability of asenapine when swallowed is low (< 2 % with an oral tablet formulation).
Danish: Behandling med Sycrest anbefales ikke til patienter, der ikke er i stand til at efterkomme denne indgivelsesmåde, da biotilgængeligheden af asenapin, når det sluges, er lav (< 2 % med en oral tabletformulering).
English: Medicinal products with dopamine receptor antagonistic properties have been associated with the induction of tardive dyskinesia characterised by rhythmical, involuntary movements, predominantly of the tongue and/or face.
Danish: Lægemidler med dopaminreceptor antagonistiske egenskaber har været associeret med induktion af tardiv dyskinesi, som er karakteriseret ved rytmiske, ufrivillige bevægelser af hovedsagelig tungen og/eller ansigtet.
English: In the long-term extension trial (50 weeks), a total of 34.8 % of subjects experienced clinically significant weight increase (i.e., ≥ 7 % increase in body weight at endpoint).
Danish: I det langvarige forlængelsesstudie (50 uger) oplevede i alt 34,8 % af forsøgspersonerne klinisk signifikant vægtstigning (dvs. ≥ 7 % vægtstigning ved endepunktet).
English: The absolute bioavailability of sublingual asenapine at 5 mg is 35 %.
Danish: Den absolutte biotilgængelighed af 5 mg asenapin indgivet sublingualt er 35 %.
English: Asenapine has no appreciable affinity for muscarinic cholinergic receptors.
Danish: Asenapin har ikke nogen væsentlig affinitet for cholinerge muscarinreceptorer.
English: Tell your doctor immediately if you experience involuntary rhythmic movements of the tongue, mouth and face.
Danish: Fortæl det omgående til din læge, hvis du oplever - ufrivillige rytmiske bevægelser af tunge, mund og ansigt.
English: Illnesses that affect the brain, such as bipolar I disorder, may be due to certain chemicals in the brain, such as dopamine and serotonin, being out of balance and these imbalances may cause some of the symptoms you may be experiencing.
Danish: Sygdomme, der påvirker hjernen såsom bipolar I lidelse, kan skyldes ubalance af visse stoffer såsom dopamin og serotonin, og denne ubalance kan give nogle af de symptomer, som du måske oplever.
English: A pharmacokinetic study and a short term efficacy and safety study were performed in a paediatric population (ages 10-17 years) with manic or mixed episodes associated with bipolar I disorder.
Danish: Der er udført et farmakokinetisk studie og et kortvarigt studie vedrørende virkning og sikkerhed i en pædiatrisk population (i alderen 10-17 år) med maniske episoder eller blandingstilstande af bipolar I lidelse.
English: Asenapine was excreted in milk of rats during lactation.
Danish: Asenapin udskilles i mælk hos rotter under laktation.
English: The absolute bioavailability of asenapine when swallowed is low (< 2 % with an oral tablet formulation).
Danish: Den absolutte biotilgængelighed af asenapin, når den sluges, er lav (< 2 % med en oral tablet formulering).
English: In in vitro assays asenapine acts as an antagonist at these receptors.
Danish: I in vitro-analyser virker asenapin som en antagonist på disse receptorer.
English: Asenapine does not cause induction of CYP1A2 or CYP3A4 activities in cultured human hepatocytes.
Danish: Asenapin skaber ikke induktion af CYP1A2- eller CYP3A4-aktivitet i dyrkede humane hepatocytter.
English: A population pharmacokinetic analysis indicated that smoking, which induces CYP1A2, has no effect on the clearance of asenapine.
Danish: En populationsfarmakokinetisk analyse viste, at rygning (der inducerer CYP1A2), ikke har nogen indflydelse på clearance af asenapin.
English: - Gently remove the tablet (Figure 2).
Danish: - Tag forsigtigt resoribletten ud (figur 2).
English: Some medicines may reduceor increasethe effect of Sycrest.
Danish: Nogle lægemidler kan reducere eller øge virkningen af Sycrest.
English: Uncommon side effects (may affect up to 1 in 100 people) - abnormal muscle movements: a collection of symptoms known as extrapyramidal symptoms
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100) - unormale muskelbevægelser: en samling af symptomer kendt som ekstrapyramidale symptomer
English: In case of overdose you may feel sleepy or tired, or have abnormal body movements, problems with standing and walking, feel dizzy due to low blood pressure and feel agitated and confused.
Danish: I tilfælde af overdosering kan du føle dig søvnig eller træt, eller have unormale kropsbevægelser, problemer med at stå og gå, føle dig svimmel pga. lavt blodtryk og føle dig irritabel og forvirret.
English: Oral mucosal lesions (ulcerations, blistering and inflammation)
Danish: Glossodyni Oral paræstesi Orale slimhindelæsion er (ulcerationer, blæredannelse og inflammation)
English: Asenapine is extensively metabolized.
Danish: Asenapin bliver i stor udstrækning metaboliseret.
English: You should tell your doctor if you are taking antidepressant medicines (specifically fluvoxamine, paroxetine or fluoxetine), as it may be necessary to change your Sycrest or antidepressant medicine dose.
Danish: Fortæl det til lægen, hvis du tager medicin mod depression (specielt fluvoxamin, paroxetin eller fluoxetin), da det kan være nødvendigt at ændre dosis af Sycrest eller den antidepressive medicin.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Sycrest.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Sycrest.
English: Sycrest has not been studied in elderly patients with dementia.
Danish: Sycrest er ikke undersøgt hos ældre patienter med demens.
English: Check with your doctor or pharmacist before taking Sycrest:
Danish: Spørg din læge eller på apoteket, før du tager Sycrest:
English: Asenapine was not teratogenic in animal studies.
Danish: Asenapin var ikke teratogent i dyreforsøg.
English: Since Sycrest works primarily in the brain, interference from other medicines(or alcohol) that work in the brain could occur due to an additive effect on brain function.
Danish: Da Sycrest primært virker i hjernen, kan der opstå forstyrrelser fra anden medicin (eller alkohol), som også påvirker hjernens funktion.
English: There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder in newborn infants.
Danish: Der er blevet rapporteret om agitation, hypertoni, hypotoni, tremor, døsighed, respirationsbesvær eller problemer med fødeindtagelse hos nyfødte børn.
English: N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands
Danish: Organon, Kloosterstraat 6, NL-5349 AB Oss, Holland
English: Manic episodes associated with bipolar I disorder is a condition with symptoms such as feeling “high”, having excessive amounts of energy, needing much less sleep than usual, talking very quickly with racing ideas and sometimes severe irritability.
Danish: Maniske episoder er en tilstand med symptomer såsom en følelse af at være ”høj”, have overdreven energi, mindre søvnbehov end normalt, tale meget hurtigt, have mange ideer og sommetider være meget irritabel.
English: Sycrest sublingual tablets should not be chewed or swallowed.
Danish: Sycrest sublinguale resoribletter må ikke tygges eller sluges.
English: In clinical trials, the incidence of extrapyramidal symptoms in asenapine-treated patients was higher than placebo (15.4 % vs 11.0 %).
Danish: I kliniske studier var forekomsten af ekstrapyramidale symptomer hos asenapin-behandlede patienter højere end placebo (15,4 % vs. 11,0 %).
English: However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death.
Danish: Ældre patienter med demens, som er i behandling med lignende typer af medicin, kan dog have en øget risiko for slagtilfælde eller dødsfald.
English: You should tell your doctor if you are taking medicines for Parkinson's disease (such as levodopa), as this medicine may make them less effective.
Danish: Fortæl det til lægen, hvis du tager medicin for Parkinsons sygdom (såsom levodopa), da Sycrest kan reducere virkningen af denne type medicin.
English: Following co-administration of dextromethorphan and asenapine in healthy subjects, the ratio of dextrorphan/dextromethorphan (DX/DM) as a marker of CYP2D6 activity was measured.
Danish: - Efter samtidig indgift af dextromethorphan og asenapin hos raske forsøgpersoner, blev forholdet mellem dextrophan/dextromethorphan (DX/DM), som en markør for CYP2D6aktivitet, målt.
English: If you stop taking Sycrest
Danish: Hvis du holder op med at tage Sycrest
English: Potential for Sycrest to affect other medicines
Danish: Risiko for at Sycrest påvirker andre lægemidler
English: Maternal and embryo toxic effects were found in animal studies (see section5.3).
Danish: Maternel og embryotoksisk effekt blev fundet i dyreforsøg (se pkt.