natgillin/translations-raw huggingface dataset:
Da Sycrest primært virker i hjernen, kan der opstå forstyrrelser fra anden medicin (eller alkohol), som også påvirker hjernens funktion. 
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.
Der er blevet rapporteret om agitation, hypertoni, hypotoni, tremor, døsighed, respirationsbesvær eller problemer med fødeindtagelse hos nyfødte børn. 
There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder in newborn infants.
Organon, Kloosterstraat 6, NL-5349 AB Oss, Holland 
N.V. Organon, Kloosterstraat 6, NL-5349 AB Oss, The Netherlands
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. 
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.
Sycrest sublinguale resoribletter må ikke tygges eller sluges. 
Sycrest sublingual tablets should not be chewed or swallowed.
I kliniske studier var forekomsten af ekstrapyramidale symptomer hos asenapin-behandlede patienter højere end placebo (15,4 % vs. 11,0 %). 
In clinical trials, the incidence of extrapyramidal symptoms in asenapine-treated patients was higher than placebo (15.4 % vs 11.0 %).
Ældre patienter med demens, som er i behandling med lignende typer af medicin, kan dog have en øget risiko for slagtilfælde eller dødsfald. 
However, elderly patients with dementia, who are treated with other similar types of medicine, may have an increased risk of stroke or death.
Fortæl det til lægen, hvis du tager medicin for Parkinsons sygdom (såsom levodopa), da Sycrest kan reducere virkningen af denne type medicin. 
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.
- Efter samtidig indgift af dextromethorphan og asenapin hos raske forsøgpersoner, blev forholdet mellem dextrophan/dextromethorphan (DX/DM), som en markør for CYP2D6aktivitet, målt. 
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.
Hvis du holder op med at tage Sycrest 
If you stop taking Sycrest
Risiko for at Sycrest påvirker andre lægemidler 
Potential for Sycrest to affect other medicines
Maternel og embryotoksisk effekt blev fundet i dyreforsøg (se pkt. 
Maternal and embryo toxic effects were found in animal studies (see section5.3).
Kropstemperaturregulering 
Body temperature regulation
Sycrest anbefales derfor ikke til disse patienter. 
Therefore, Sycrest is not recommended in such patients.
Bortset fra fluvoxamin, førte ingen af de interagerende lægemidler til klinisk relevante ændringer i asenapins farmakokinetik. 
Except for fluvoxamine, none of the interacting medicinal products resulted in clinically relevant alterations in asenapine pharmacokinetics.
Asenapin forårsagede mild maternel toksicitet og let forsinket skeletudvikling hos fosteret. 
Asenapine caused mild maternal toxicity and slight retardation of foetal skeletal development.
Desuden blev der observeret prolaktin-medierede virkninger på brystkirtler og forstyrrelser af brunstcyklus. 
Furthermore, prolactin-mediated effects on mammary glands and oestrus cycle disturbances were observed.
Asenapin var ikke genotoksisk i en serie af tests. 
Asenapine was not genotoxic in a battery of tests.
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). 
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).
- Placer resoribletten under tungen og vent til den er helt opløst (figur 3). 
- To ensure optimal absorption, place the tablet under the tongue and wait until it dissolves completely (Figure 3).
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. 
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).
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. 
Therefore, make sure your concentration and alertness are not affected before you drive or operate machinery.
Asenapin er et stof med høj clearance, med en clearance efter intravenøs indgift på 52 l/time. 
Asenapine is a high clearance compound, with a clearance after intravenous administration of 52 L/h.
Hvis du har glemt at tage Sycrest 
If you forget to take Sycrest
Sycrest indeholder det aktive stof asenapin. 
Sycrest contains the active substance asenapine.
Det kan være nødvendigt at stoppe med at tage Sycrest. 
Withdrawal of Sycrest may be needed.
Denne indlægsseddel blev senest ændret { MM/ÅÅÅÅ } 
This leaflet was last revised in {month/YYYY}.
Indtag af vand flere (2 eller 5) minutter efter indtagelse af asenapin resulterede i et fald (hhv. 19 % og 10 %) i eksponering af asenapin. 
The intake of water several (2 or 5) minutes after asenapine administration resulted in decreased (19 % and 10 %, respectively) asenapine exposure.
Der blev observeret øget neonatal dødelighed blandt afkommet af hunrotter behandlet under drægtighed og laktation. 
Increased neonatal mortality was observed among the offspring of female rats treated during gestation and lactation.
De pædiatriske studier med Sycrest blev udført med sublinguale resoribletter med smag. 
Paediatric studies with Sycrest were performed using flavoured sublingual tablets.
Hvis du er allergisk over for asenapin eller et af de øvrige indholdsstoffer i Sycrest (angivet i punkt 6). 
Do not take Sycrest If you are allergic to asenapine or any of the other ingredients of this medicine (listed in section 6).
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. 
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.
Det skal du vide, før du begynder at tage Sycrest 
What you need to know before you take Sycrest
I en særlig undersøgelse, havde samtidig rygning under administration af en enkelt 5 mg sublingual dosis ingen effekt på farmakokinetikken af asenapin. 
In a dedicated study, concomitant smoking during administration of a single 5 mg sublingual dose had no effect on the pharmacokinetics of asenapine.
Opbevar lægemidlet i den originale yderpakning for at beskytte mod lys og fugt. 
Store this medicine in the original package in order to protect from light and moisture.
Imidlertid synes de negative behandlingsrelaterede virkninger på vægtstigning og plasmalipidprofil at være mere udtalte end observeret i studier hos voksne. 
However, adverse effects of treatment on weight gain and on plasma lipid profile appeared to be greater than effects observed in the adult trials.
Når Sycrest tages i kombination med andre lægemidler skal Sycrest tages til sidst. 
When used in combination with other medicinal products, Sycrest should be taken last.
Muligheden for forhøjet plasmaniveau af asenapin hos patienter med moderat nedsat leverfunktion (Child-Pugh B) kan ikke udelukkes, og forsigtighed tilrådes. 
The possibility of elevated asenapine plasma levels cannot be excluded in some patients with moderate hepatic impairment (Child-Pugh B) and caution is advised.
Tegn på denne øgede sensitivitet kan være forvirring, sløvhed, postural ustabilitet med hyppige fald samt ekstrapyramidale symptomer. 
Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Samlet set svarer steady-state farmakokinetik af asenapin til enkeltdosis farmakokinetik. 
Overall, steady-state asenapine pharmacokinetics are similar to single-dose pharmacokinetics.
Kliniske lægemiddelinteraktionsstudier, som undersøgte asenapins effekt på CYP2D6-hæmning, viste følgende reultater: 
Clinical drug interaction studies investigating the effects of CYP2D6 inhibition by asenapine showed the following results:
- feber, svær muskelstivhed, svedtendens eller nedsat bevidsthedsniveau (en lidelse kaldet malignt neuroleptikasyndrom). 
fever, severe muscle stiffness, sweating or a lowered level of consciousness (a disorder called “neuroleptic malignant syndrome”).
De tilgængelige farmakokinetiske data er beskrevet i pkt. 
Available pharmacokinetic data are described in section 5.2.
Det antages dog, at medicinen justerer balancen mellem disse stoffer. 
Exactly how this medicine works is unknown, however, it is believed to adjust the balance of these chemicals.
Den farvede flap trækkes tilbage og resoribletten tages forsigtigt ud. 
The coloured tab should be peeled back and the tablet should be removed gently.
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. 
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.
Amning bør afbrydes under behandling med Sycrest. 
Breast-feeding should be discontinued during treatment with Sycrest.
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. 
During combined administration with a single dose of asenapine 5 mg, fluvoxamine 25 mg twice daily resulted in a 29 % increase in asenapine AUC.
Inden for hver frekvensgruppe er bivirkningerne opstillet efter, hvor alvorlige de er. 
Within each frequency grouping, ADRs are presented in order of decreasing seriousness.
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. 
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.
Asenapin kan give ortostatisk hypotension og besvimelse specielt tidligt i behandlingen, hvilket sandsynligvis skyldes dets α1-adrenerge antagonistiske egenskaber. 
Asenapine may induce orthostatic hypotension and syncope, especially early in treatment, probably reflecting its α1-adrenergic antagonist properties.
Yderligere oplysninger om Sycrest findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu 
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
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. 
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.
Børn og unge Sycrest frarådes til patienter under 18 år. 
Children and adolescents Sycrest is not recommended for use in patients below the age of 18 years.
Behandlingsrelaterede bivirkninger omfattede agitation og forvirring, akatisi, orofacial dystoni, sedation og asymptomatiske EKG-fund (bradykardi, supraventrikulære komplekser, forsinkelse af den intraventrikulære overledning). 
Treatment-related adverse reactions included agitation and confusion, akathisia, orofacial dystonia, sedation, and asymptomatic ECG findings (bradycardia, supraventricular complexes, intraventricular conduction delay).
Efter oral indgift af asenapin hos drægtige kaniner i organogenesefasen, påvirkede asenapin legemsvægten ved den høje dosis på 15 mg·kg to gange dagligt. 
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.
Fald* 
Falls*
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. 
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.
Oplukkelige aluminium/aluminium blisterpakninger (åbnes ved træk i den farvede flap), i kartoner af 20, 60 eller 100 resoribletter, sublinguale pr. karton. 
Peelable aluminium/aluminium blisters in cartons of 20, 60 or 100 sublingual tablets per carton.
Du må ikke amme, mens du tager Sycrest. 
Do not breast-feed when taking Sycrest.
Der er observeret forhøjelse af prolaktinniveauer hos nogle patienter i behandling med Sycrest. 
Increases in prolactin levels were observed in some patients with Sycrest.
Asenapin har en vis affinitet til melaninholdigt væv. 
Asenapine has some affinity to melanin-containing tissues.
Oplukkelige blisterpakninger. 
Peelable blister.
Ortostatisk hypotension Hypotension 
Orthostatic hypotension Hypotension
Kortvarige asymptomatiske forhøjelser af leveraminotranferaser, alanin-aminotransferase (ALAT) og aspartat-aminotransferase (ASAT) er almindeligt, især i starten af behandlingen. 
Transient, asymptomatic elevations of hepatic transaminases, alanine transferase (ALT), aspartate transferase (AST) have been seen commonly, especially in early treatment.
- 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. 
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.
Klinisk virkning i bipolar I lidelse 
Clinical efficacy in bipolar I disorder
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. 
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.
Hos unge, har dosering på 10 mg to gange dagligt ikke resulteret i øget eksponering i forhold til 5 mg to gange dagligt. 
In adolescents, the 10 mg twice daily dose did not result in increased exposure compared to 5 mg twice daily.
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. 
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.
Farmakokinetikken for asenapin var ens blandt patienter med mild (Child-Pugh A) eller moderat (Child-Pugh B) nedsat leverfunktion og patienter med normal leverfunktion. 
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.
Systemorganklasser Meget almindelig 
System organ class
NL-5349 AB Oss 
NL-5349 AB Oss The Netherlands
Resoribletten bør ikke presses igennem blisterpakningen. 
The tablet should not be pushed through the tablet pack.
Sycrest er ikke godkendt til behandling af patienter med demensrelateret psykose og anbefales ikke til denne specielle patientgruppe. 
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.
En populationsfarmakokinetisk analyse viste, at der ikke er tegn på kønsrelaterede forskelle i farmakokinetikken for asenapin. 
A population pharmacokinetic analysis indicated that there is no evidence of gender-related differences in the pharmacokinetics of asenapine.
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. 
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.
Risiko for at andre lægemidler påvirker Sycrest 
Potential for other medicines to affect Sycrest
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. 
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.
Asenapin kan have antagonistisk effekt på levodopa og dopaminagonister. 
Asenapine may antagonise the effect of levodopa and dopamine agonists.
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). 
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).
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). 
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).
- 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). 
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).
Asenapin-eksponering er 7-dobbelt hos patienter med svært nedsat leverfunktion (Child-Pugh C). 
Asenapine exposure is increased 7-fold in patients with severe hepatic impairment (Child-Pugh C).
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. 
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.
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. 
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.
Hvis du tager anden medicin, skal Sycrest tages til sidst. 
If you are taking other medicines, Sycrest should be taken last.
Asenapin er en svag inhibitor af CYP2D6. 
Asenapine is a weak inhibitor of CYP2D6.
Fertilitet Der er ikke observeret nedsat fertilitet i prækliniske studier (se pkt. 
Fertility No impairment of fertility has been observed in nonclinical studies (see section 5.3).
Akkommodation sforstyrrelse 
Accommodation disorder
Asenapin udskilles primært ved direkte glucuronidering af UGT1A4 og oxidativ metabolisme ved cytochrom P450-isoenzymer (overvejende CYP1A2). 
Asenapine is cleared primarily through direct glucuronidation by UGT1A4 and oxidative metabolism by cytochrome P450 isoenzymes (predominantly CYP1A2).
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. 
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.
Der er ingen erfaring med asenapin hos patienter med svært nedsat nyrefunktion, som har en kreatininclearance på mindre end 15 ml/min. 
There is no experience with asenapine in patients with severe renal impairment who have a creatinine clearance less than 15 mL/min.
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. 
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.