FrancophonIA/ELRC3.0 huggingface dataset:
English: Taking Reagila together with some medicines may require a dose adjustment of Reagila or the other medicine.
Danish: Hvis du tager Reagila sammen med visse lægemidler, kan det være nødvendigt at ændre dosis af Reagila eller det andet lægemiddel.
English: Your doctor will advise you to visit an ophthalmologist.
Danish: Lægen vil råde dig til at se en øjenlæge.
English: Patients should be monitored for adverse reactions and treatment response for several weeks after starting cariprazine and after each dosage change (see section 5.2).
Danish: Patienten skal overvåges for bivirkninger og behandlingsrespons i flere uger efter initiering af cariprazin og efter hver dosisændring (se pkt.
English: Schizophrenia is a disease characterised by symptoms such as hearing, seeing or sensing things which are not there (hallucination), suspiciousness, mistaken beliefs, incoherent speech and behaviour and emotional flatness.
Danish: skizofreni er en sygdom kendetegnet ved symptomer som for eksempel at høre, se eller fornemme ting, som ikke er der (hallucination), mistro, misopfattelse, usammenhængende tale og adfærd samt mangel på følelser.
English: Thereafter the dose can be increased slowly in 1.5 mg increments to a maximum dose of 6 mg/day, if needed.
Danish: Derefter kan dosis om nødvendigt øges langsomt i trin på 1,5 mg til en maksimal dosis på 6 mg/dag.
English: If prescribed to patients with Parkinson's disease, antipsychotic medicinal products may exacerbate the underlying disease and worsen symptoms of Parkinson's disease.
Danish: Ordination af antipsykotiske lægemidler til patienter med Parkinsons sygdom kan forværre den underliggende sygdom og symptomerne på Parkinsons sygdom.
English: Unchanged cariprazine is excreted by 1.2% of the dose in urine and 3.7% of the dose in feces.
Danish: Uændret cariprazin udskilles med 1,2 % af dosen i urin og 3,7 % af dosen i fæces.
English: Lethargy Dysaesthesia Dyskinesia6 Tardive
Danish: Sløvhed Dysæstesi Dyskinesi6 Tardiv dyskinesi
English: QT- prolongation
Danish: QT-forlængelse
English: The metabolites of HCAR, HDCAR, and HDDCAR are subsequently biotransformed to their corresponding sulfate and glucuronide conjugates.
Danish: Metabolitterne af HCAR, HDCAR og HDDCAR biotransformeres efterfølgende til deres korresponderende sulfat- og glukuronid-konjugater.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS blisterfoil
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP blisterfolie
English: Persistent predominant negative symptoms were defined as symptoms lasting for a period of at least 6 months with high level of negative symptoms and low level of positive symptoms [(PANSS factor score for negative symptoms ≥ 24, a score of ≥ 4 on a minimum 2 of the 3 PANSS items (N1: flat affect, N4: avolition, and N6: poverty of speech) and PANSS factor score for positive symptoms ≤ 19].
Danish: Vedvarende, overvejende negative symptomer blev defineret som symptomer i en periode på mindst 6 måneder med høje niveauer af negative symptomer og lave niveauer af positive symptomer [PANSS-faktorscore for negative symptomer ≥ 24, en score på ≥ 4 for mindst 2 af de 3 PANSSelementer (N1: affladet affekt, N4: initiativløshed og N6: sprogfattigdom) samt en PANSS-faktorscore for positive symptomer ≤ 19].
English: The effects of cariprazine on the QT interval were evaluated in patients with schizophrenia or schizoaffective disorder.
Danish: Cariprazins virkning på QT-intervallet blev evalueret hos patienter med skizofreni eller skizoaffektiv lidelse.
English: It should be considered that plasma concentration of cariprazine and its active metabolites will decline by 50% in ~1 week (see section 5.2).
Danish: Det skal tages i betragtning, at plasmakoncentrationen af cariprazin og dets aktive metabolitter vil falde med 50 % på ~1 uge (se pkt.
English: Nevertheless, patients who would develop symptoms potentially related to cataract should be advised to ophthalmologic examination and re-evaluated for treatment continuation.
Danish: Ikke desto mindre skal patienter, der måtte udvikle symptomer, som potentielt kan relateres til katarakt, rådes til at få en oftalmologisk undersøgelse og genvalueres til at fortsætte behandling.
English: The most commonly reported ocular adverse event was blurred vision (placebo: 1/683; 0.1%, cariprazine: 22/2048; 1.1%).
Danish: Den hyppigst rapporterede øjenrelaterede bivirkning var sløret syn (placebo: 1/683; 0,1 %, cariprazin: 22/2048; 1,1 %).
English: Prevention includes slow up-titration; treatment measures include slight down-titration of cariprazine or anti-EPS medication.
Danish: Forebyggelse omfatter langsom optitrering; behandling omfatter let nedtitrering af cariprazin eller anti-EPS-lægemidler.
English: Additional signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Danish: Yderligere tegn kan omfatte myoglobinuri (rabdomyolyse) og akut nyresvigt.
English: Patients should have their weight monitored regularly (see section 4.8).
Danish: Patientens vægt skal overvåges regelmæssigt (se pkt.
English: Akathisia develops early in treatment.
Danish: Akatisi udvikles tidligt i behandlingen.
English: These are medicines used to treat heart diseases containing digoxin, blood thinners containing dabigatran, or medicines affecting your mental functions.
Danish: Dette gælder for lægemidler, som bruges til at behandle hjertesygdomme, der indeholder digoxin, blodfortyndende midler, der indeholder dabigatran eller lægemidler, der påvirker din mentale funktion.
English: Management of overdose should concentrate on supportive therapy including maintenance of an adequate airway, oxygenation and ventilation and management of symptoms.
Danish: Behandling af overdosering skal koncentreres om understøttende behandling, herunder opretholdelse af frie luftveje, iltning samt ventilation og behandling af symptomer.
English: Dysuria Pollakisuria
Danish: Dysuri Pollakisuria
English: After discontinuation of cariprazine treatment contraception should be used for at least 10 weeks due to the slow elimination of active moieties.
Danish: Efter seponering af cariprazin skal der anvendes antikonception i mindst 10 uger på grund af den langsomme elimination af aktive molekyledele.
English: Available data in elderly patients aged ≥65 years treated with cariprazine are not sufficient to determine whether or not they respond differently from younger patients (see section 5.2).
Danish: Der foreligger utilstrækkelige data vedrørende behandling af ældre patienter i alderen ≥65 år med cariprazin til at fastlægge, hvorvidt disse reagerer anderledes end yngre patienter (se pkt.
English: If signs and symptoms of tardive dyskinesia appear in a patient treated with cariprazine, discontinuation should be considered.
Danish: Hvis der opstår tegn og symptomer på tardiv dyskinesi hos en patient, der behandles med cariprazin, skal seponering overvejes.
English: ° increased blood glucose (blood sugar), increased bile pigment (bilirubin) in the blood
Danish: ° Forhøjet blodglukose (blodsukker), øget indhold af galdepigment (bilirubin) i blodet
English: Potential for other medicinal products to affect cariprazine
Danish: Potentialet for, at andre lægemidler kan påvirke cariprazin
English: Elimination of cariprazine and its major active metabolites is mainly through hepatic metabolism.
Danish: Elimination af cariprazin og dets vigtigste aktive metabolitter foregår hovedsagelig gennem leverens metabolisme.
English: The capsules are filled with white to yellowish white powder.
Danish: Kapslerne er fyldt med et hvidt til gullig-hvidt pulver.
English: ° abnormal amount of lipids (e.g. cholesterol and/or fat) in the blood
Danish: ° unormalt indhold af lipider (f.eks. kolesterol og/eller fedt) i blodet
English: Cariprazine has no appreciable affinity for cholinergic muscarinic receptors (IC50 > 1000 nM).
Danish: Cariprazin har ingen mærkbar affinitet for cholinerge muskarinreceptorer (IC50 > 1000 nM).
English: Stabilized patients were then randomised to receive fixed doses of 3 or 6 mg cariprazine (n=51) or placebo (n=51) in a double-blind manner for up to 72 weeks.
Danish: Stabiliserede patienter blev derefter randomiseret til at få faste doser cariprazin på 3 eller 6 mg (n=51) eller placebo (n=51) i en dobbeltblindet fordeling i op til 72 uger.
English: Totally, 751 patients with acute symptoms of schizophrenia received cariprazine 3-9 mg/day for 20 weeks, of whom 337 received cariprazine in the dose-range of 3 or 6 mg/day.
Danish: I alt 751 patienter med akutte symptomer på skizofreni fik 39 mg/dag cariprazin i 20 uger, hvoraf 337 fik cariprazin i en dosis på 3 eller 6 mg/dag.
English: Change From Baseline to Week 6 in the PANSS Total Score in Studies of Acute Exacerbations of Schizophrenia-ITT Population
Danish: Ændringer fra baseline til uge 6 af den samlede PANSS-score i studier af akut forværring af skizofreni-ITT-population
English: Talk to your doctor or pharmacist before taking Reagila, or during treatment if you have: - ever experienced or start to experience restlessness and inability to sit still.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Reagila, eller i løbet af behandlingen, hvis du: - har følt eller begynder at føle dig rastløs og ude af stand til at sidde stille.
English: Patients with kidney or liver problems
Danish: Patienter med nyre- og leverproblemer
English: The mean terminal half-life (1 to 3 days for cariprazine and DCAR and 13 to 19 days for DDCAR) is not predictive of time to reach steady state or plasma concentration decline after treatment discontinuation.
Danish: Den gennemsnitlige terminale halveringstid (1 til 3 dage for cariprazin og DCAR og 13 til 19 dage for DDCAR) er ikke prædiktiv for den tid, det tager at nå steady state eller reduktion i plasmakoncentration efter seponering af behandlingen.
English: Because of the long half-life of cariprazine and its active metabolites, changes in dose will not be fully reflected in plasma for several weeks.
Danish: På grund af cariprazins og stoffets aktive metabolitters lange halveringstid vil ændringer af dosis ikke blive afspejlet fuldt ud i plasma før efter flere uger.
English: Therefore, cataract formation was closely monitored with slit lamp examinations in the clinical studies and patients with existing cataracts were excluded.
Danish: Derfor blev kataraktdannelse nøje monitoreret med spaltelampeundersøgelser i de kliniske studier, og patienter med katarakt blev ekskluderet.
English: Studies in animals have shown reproductive toxicity including developmental malformations in rats (see section 5.3).
Danish: Dyreforsøg har påvist reproduktionstoksicitet, herunder udvikling af misdannelser hos rotter (se pkt.
English: These can be the signs of the so-called neuroleptic malignant syndrome.
Danish: Dette kan være tegn på såkaldt malignt neuroleptikasyndrom.
English: People with this condition may also feel depressed, guilty, anxious, tense, or not being able to start or keep up planned activities, unwillingness to speak, lack of emotional response to a situation that would normally stimulate feelings in others.
Danish: Personer med denne sygdom kan også føle sig deprimerede, have skyldfølelse eller være urolige, anspændte eller ude af stand til at påbegynde og gennemføre planlagte aktiviteter, være fåmælte eller have utilstrækkelig følelsesmæssig reaktion på situationer, som fremkalder følelser hos andre.
English: In other clinical trials, only a few, non-serious, QT-prolongations have been reported with cariprazine.
Danish: I andre kliniske forsøg blev kun få, ikke alvorlige QT-forlængelser rapporteret med cariprazin.
English: Seizures/ Convulsion Amnesia Aphasia
Danish: Krampeanfald/ konvulsion Amnesi Afasi
English: A potentially fatal symptom complex referred to as neuroleptic malignant syndrome (NMS) has been reported in association with antipsychotic treatment.
Danish: Et potentielt letalt symptomkompleks, som kaldes malignt neuroleptikasyndrom (NMS), er blevet rapporteret i forbindelse med antipsykotisk behandling.
English: Cariprazine has minor or moderate influence on the ability to drive and use machines.
Danish: Cariprazin påvirker i mindre eller moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING folded carton
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE foldet karton
English: Take Reagila at the same time each day with or without food.
Danish: Du skal tage Reagila på samme tidspunkt hver dag, og du kan tage det sammen med eller uden mad.
English: The primary endpoint was change from baseline to week 6 in the Positive and Negative Syndrome Scale (PANSS) total score and the secondary endpoint was change from baseline to week 6 in the Clinical Global Impressions-Severity (CGI-S) score in all acute schizophrenia studies.
Danish: Det primære endepunkt var ændring fra baseline til uge 6 i PANSS-totalscore (Positive and Negative Syndrome Scale), og det sekundære endepunkt var ændring fra baseline til uge 6 i CGI-S-score (Clinical Global Impressions-Severity) i alle studier af akut skizofreni.
English: - irregular heart beat or if someone else in your family has a history of irregular heart beat (including so called QT prolongation seen with ECG monitoring), and tell your doctor if you are taking other medicines, because they might cause or worsen this ECG change.
Danish: - har uregelmæssig hjerterytme, eller hvis en anden i din familie har eller har haft uregelmæssig hjerterytme (herunder såkaldt QT-forlængelse, der kan ses på et elektrokardiogram (EKG), og fortæl det til lægen, hvis du tager anden medicin, da dette kan forårsage eller forværre denne EKG-ændring.
English: Cariprazine should be used with caution in patients with known cardiovascular disease predisposing to blood pressure changes.
Danish: Cariprazin skal anvendes med forsigtighed hos patienter med kendt kardiovaskulær sygdom, som prædisponerer for blodtryksændringer.
English: Therefore CYP2D6 inhibitors are unlikely to have a clinically relevant effect on cariprazine metabolism.
Danish: Derfor er det ikke sandsynligt, at CYP2D6-hæmmere har en klinisk relevant virkning på cariprazin-metabolismen.
English: Sedation Dizziness Dystonia4 Other
Danish: Sedation Svimmelhed Dystoni4
English: Differences on the Clinical Global Impression Severity (p=0.005) and Improvement (p<0.001) scales,
Danish: Foreskelle på skalaerne for overordnet klinisk indtryk af sværhed (p=0,005) og forbedring (p< 0,001)
English: Cariprazine caused bilateral cataract and secondary retinal changes (retinal detachment and cystic degeneration) in the dog.
Danish: Cariprazin medførte bilateral katarakt og sekundære ændringer af retina (nethindeløsning og cystisk degeneration) hos hunde.
English: There was a dose-dependent occupancy of brain dopamine D3 and D2 receptors (with preferential occupancy in regions with higher D3 expression) in patients with schizophrenia within the therapeutic dose range of cariprazine for 15 days.
Danish: Der var dosis-afhængig okkupans af dopamin D3- og D2-receptorer i hjernen (med præferentiel okkupans i regioner med højere D3-udtrykkelse) hos patienter med skizofreni inden for cariprazins terapeutiske dosisinterval i 15 dage.
English: Since cariprazine is highly bound to plasma proteins, haemodialysis is unlikely to be useful in the management of overdose.
Danish: Da cariprazin binder sig tæt til plasmaproteiner, er det usandsynligt, at hæmodialyse vil være nyttigt ved behandling af en overdosering.
English: In the population PK analysis there were no clinically relevant differences in the PK parameters (AUC and Cmax of the sum of cariprazine and its major active metabolites) based on age, gender and race.
Danish: I den farmakokinetiske populationsanalyse var der ingen klinisk relevante forskelle i de farmakokinetiske parametre (AUC og Cmax af summen af cariprazin og dets vigtigste aktive metabolitter) på baggrund af alder, køn og race.
English: Total cariprazine (sum of cariprazine + DCAR and DDCAR) exposure approaches 50% of steady state exposure in ~1 week of daily dosing while 90% of steady state is achieved in 3 weeks.
Danish: Eksponering for total cariprazin (summen af cariprazin + DCAR og DDCAR) nærmer sig 50 % af steady state-eksponering på ~1 uge med daglig dosering, mens 90 % af steady state nås på 3 uger.
English: The plasma concentration of total cariprazine decreases by 50% in ~1 week and greater than 90% decline in total cariprazine concentration occurs in ~3 weeks.
Danish: Plasmakoncentrationen af total cariprazin falder med 50 % på ~1 uge, og der vil være en nedgang større end 90 % i koncentrationen af total cariprazin efter ~3 uger.
English: - dementia (loss of memory and other mental abilities) especially if you are elderly - Parkinson's disease - if you have diabetes or risk factors for diabetes (e.g. obesity, or someone else in your family has diabetes).
Danish: - er dement (har svært ved at huske eller lignende problemer), især hvis du er ældre - har Parkinsons sygdom - hvis du har diabetes eller er i risikogruppen for diabetes (f.eks. overvægt, eller nogen i din familie har diabetes).
English: Side effects with not known frequency (frequency cannot be estimated from the available data) - inflammation of the liver (pain in the upper right abdomen, yellowing of the eye and skin,
Danish: Bivirkninger med ukendt hyppighed (hyppigheden kan ikke vurderes ud fra forhåndenværende data) - leverbetændelse (smerter i øverste højre del af maven, gulfarvning af øjne og hud, svækkelse,
English: Efficacy with short-term use
Danish: Virkning ved kortvarig anvendelse
English: Based on a population pharmacokinetic analysis, the apparent volume of distribution (V/F) was 916 L for cariprazine, 475 L for DCAR and 1,568 L for DDCAR, indicating extensive distribution of cariprazine and its major active metabolites.
Danish: På baggrund af en farmakokinetisk populationsanalyse var det tilsyneladende fordelingsvolumen (V/F) 916 l for cariprazin, 475 l for DCAR og 1.568 l for DDCAR, hvilket indikerer omfattende fordeling af cariprazin og dets vigtigste aktive metabolitter.
English: Physicians should, therefore, weigh the risks versus the benefits when prescribing cariprazine to patients with Parkinson's disease.
Danish: Lægen skal derfor opveje risici i forhold til fordele ved ordination af cariprazin til patienter med Parkinsons sygdom.
English: Efficacy with long-term use
Danish: Virkning ved langvarig brug
English: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000
Danish: Bivirkningerne er anført efter hyppighed med den følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til
English: (Side effect with frequency not known) - thoughts or feelings about hurting yourself or to commit suicide, suicide attempt.
Danish: (En bivirkning med ukendt hyppighed) - tanker eller følelser om at skade dig selv eller begå selvmord, eller selvmordsforsøg (Ikkealmindelig bivirkning)
English: Anaemia Eosinophilia
Danish: Anæmi Eosinofili
English: Akathisia is a movement disorder characterized by a feeling of inner restlessness and a compelling need to be in constant motion, as well as by actions such as rocking while standing or sitting, lifting the feet as if marching on the spot, and crossing and uncrossing the legs while sitting.
Danish: Akatisi er en bevægelsesforstyrrelse, der er karakteriseret ved en følelse af indre rastløshed og et ubetvingeligt behov for at være i konstant bevægelse samt af handlinger, såsom at rokke frem og tilbage når man står eller sidder, løfte fødderne, som om man marcherer på stedet og krydse ben hele tiden, mens man sidder ned.
English: The recommended starting dose is 1.5 mg once a day by mouth.
Danish: Den anbefalede startdosis er 1,5 mg en gang dagligt taget gennem munden.
English: Phospholipidosis was observed in the lungs of rats, dogs, and mice (with or without inflammation) and in the adrenal gland cortex of dogs at clinically relevant exposures.
Danish: Fosfolipidose blev observeret i lungerne hos rotter, hunde og mus (med eller uden inflammation) samt i binyrebark hos hunde ved klinisk relevante eksponeringer.
English: - The active substance is cariprazine.
Danish: - Aktivt stof: cariprazin.
English: Reagila is not recommended during pregnancy and in women of childbearing potential not using effective contraception.
Danish: Reagila bør ikke anvendes under graviditet og til kvinder i den fertile alder, som ikke anvender effektiv kontraception.
English: Weight increased Decreased appetite Increased appetite Dyslipidaemia
Danish: Vægtøgning Nedsat appetit Øget appetit Dyslipidæmi
English: The efficacy of cariprazine for the treatment of acute schizophrenia was studied in three multi-center, multinational, randomized, double-blind, placebo-controlled 6-week trials including 1,754 patients with the age of 18 to 60 years.
Danish: Cariprazins virkning til behandling af akut skizofreni blev undersøgt i tre multinationale, randomiserede, placebo-kontrollerede, dobbeltblindede multicenter-forsøg af 6 ugers varighed, som omfattede 1.754 patienter i alderen 18 til 60 år.
English: During the schizophrenia clinical development program of cariprazine, few cataract cases were reported, characterized with minor lens opacities with no visual impairment (13/3192; 0.4%).
Danish: I løbet af det kliniske udviklingsprogram med cariprazin til behandling af skizofreni blev der rapporteret få tilfælde af katarakt, kendetegnet ved en mindre grad af linseuklarhed og uden tab af synsevne (13/3192; 0,4 %).
English: (Rare side effect) - symptoms related to blood clots in the veins especially in the legs (symptoms include swelling, pain and redness in the leg), which may travel through blood vessels to the lungs causing chest pain and difficulty in breathing.
Danish: (Sjælden bivirkning ) - blodpropper i venerne, især i benene (symptomerne omfatter hævelse, smerte og rødmen i benet), som kan bevæge sig gennem blodkarrene til lungerne og medføre brystsmerter og åndedrætsbesvær.
English: Tell your doctor immediately if you have: - a severe allergic reaction seen as fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes a drop in blood pressure.
Danish: Fortæl det straks til lægen, hvis du får: - en alvorlig allergisk reaktion, der er kendetegnet ved feber, hævelser i mund, ansigt, læber eller tunge, kortåndethed, kløe, hududslæt og nogle gange et fald i blodtrykket.
English: Women of childbearing potential/contraception
Danish: Kvinder i den fødedygtige alder/antikonception
English: - dizziness on standing up due to a drop in your blood pressure, which may cause fainting - a history of blood clots, or if someone else in your family has a history of blood clots, as medicines for schizophrenia have been associated with formation of blood clots - a history of stroke, especially if you are elderly or know that you have other risk factors for stroke.
Danish: - bliver svimmel, når du rejser dig op, fordi dit blodtryk falder, hvilket kan føre til besvimelse - har haft en blodprop, eller hvis nogen i din familie har haft en blodprop, da lægemidler mod skizofreni er blevet forbundet med dannelse af blodpropper - har haft et slagtilfælde, især hvis du er ældre, eller du ved, at du er i risikogruppen for slagtilfælde.
English: Due to the long half-life of the active moieties of cariprazine a further increase in plasma exposure of total cariprazine can be expected during longer co-administration.
Danish: På grund af den lange halveringstid for cariprazins aktive molekyledele kan der forventes en yderligere forøgelse af plasmaeksponering for total cariprazin ved længerevarende samtidig administration.
English: A 2-part study (a single dose of 1 mg cariprazine [Part A] and a daily dose of 0.5 mg cariprazine for 14 days [Part B] was conducted in patients with varying degrees of impaired hepatic function (ChildPugh Classes A and B).
Danish: Der blev udført et studie i 2 dele (en enkeltdosis på 1 mg cariprazin [del A] og en daglig dosis på 0,5 mg cariprazin i 14 dage [del B]) hos patienter med forskellige grader af nedsat leverfunktion (Child-Pugh-klasse A og B).