FrancophonIA/ELRC3.0 huggingface dataset:
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. tablet, det vil sige, at det stort set er “natriumfrit”.
English: The active ingredient, paliperidone, dissolves once swallowed and the tablet shell is passed out of the body as waste.
Danish: Det aktive stof, paliperidon, opløses, når tabletten kommer ned i maven, og tabletskallen udskilles fra kroppen som et affaldsstof.
English: Other medicinal products or herbals which are inducers, e.g., rifampicin and St John´s wort (Hypericum perforatum) may have similar effects on paliperidone.
Danish: Andre lægemidler og naturlægemidler, som er induktorer, f.eks. rifampicin og perikon (Hypericum perforatum) kan have en lignende effekt på paliperidon.
English: LOCF endpoint change from baseline
Danish: Ændring i LOCF-endepunkt i forhold til baseline
English: • dyskinesia: This is a condition involving involuntary muscle movements, and can include repetitive, spastic or writhing movements, or twitching.
Danish: • dyskinesi: dette er en tilstand, som omfatter ufrivillige muskelbevægelser, og som kan omfatte gentagne, spastiske eller vridende bevægelser eller muskeltrækninger.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Danish: Inden for hver enkelt hyppighedskategori er bivirkningerne opstillet efter, hvor alvorlige de er.
English: Efficacy was evaluated using PANSS.
Danish: Virkningen blev evalueret ved hjælp af PANSS.
English: Elimination of paliperidone decreased with decreasing renal function.
Danish: Eliminationen af paliperidon falder med faldende nyrefunktion.
English: If you stop INVEGA
Danish: Hvis du holder op med at tage INVEGA
English: • tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body).
Danish: • tardiv dyskinesi (ukontrollerede, rykvise bevægelser i ansigtet, tungen eller andre dele af kroppen).
English: QT prolongation, ventricular arrythmias (ventricular fibrillation, ventricular tachycardia), sudden unexplained death, cardiac arrest and Torsade de pointes may occur with antipsychotics.
Danish: Forlængelse af QT-interval, ventrikelarytmi (ventrikelflimren, ventrikulær takykardi), pludselige uforklarlige dødsfald, hjertestop og torsade de pointes-takykardi kan opstå med antipsykotika.
English: • glaucoma (increased pressure within the eyeball), increased tears, redness of the eyes, problems with movement of your eyes, eye rolling
Danish: • glaukom (øget tryk i øjet), øget tåreproduktion, røde øjne, problemer med øjenbevægelse,
English: Additionally, in study SCA-3001 in the ITT population the effect on psychotic symptoms measured by PANSS was clearly less pronounced and not reaching statistical significance for patients receiving concomitantly mood stabilisers and/or antidepressants.
Danish: I studie SCA-3001 var effekten på psykotiske symptomer målt efter PANSS desuden tydeligt mindre udtalt i ITT-populationen og var ikke statistisk signifikant hos patienter, der fik samtidig administration af stemningsstabiliserende lægemidler og/eller antidepressiva.
English: Efficacy was also evaluated by calculation of treatment response (defined as decrease in PANSS Total Score ≥ 30% and CGI-C Score ≤ 2) as a secondary endpoint.
Danish: Effekt blev også vurderet ved beregning af behandlingsrespons (defineret som reduktion i samlet PANSS-score ≥ 30 % og CGI-C Score ≤ 2) som et sekundært endepunkt.
English: Co-administration of INVEGA once daily with carbamazepine 200 mg twice daily caused a decrease of approximately 37% in the mean steady-state Cmax and AUC of paliperidone.
Danish: Co-administration af INVEGA en gang dagligt med carbamazepin 200 mg to gange dagligt forårsagede et fald på omkring 37 % i gennemsnitlig steady-state Cmax og AUC for paliperidon.
English: In schizophrenia clinical trials, there was no difference observed between placebo and the 3 and 6 mg doses of INVEGA.
Danish: I kliniske skizofreni-studier blev der ikke observeret forskel på placebo og doser på 3 mg og 6 mg af INVEGA.
English: • sleep disorder, confusion, decreased sexual drive, inability to reach orgasm, nervousness, nightmares
Danish: • søvnforstyrrelse, forvirring, nedsat lyst til sex, manglende evne til at få orgasme, nervøsitet, mareridt
English: INVEGA Medium Dose 3 or 6 mg* N=48
Danish: INVEGA Middeldosis 3 eller 6 mg* N = 48
English: Janssen-Cilag A/S Tlf: +45 45 94 82 82
Danish: Danmark Janssen-Cilag A/S Tlf: +45 45 94 82 82
English: In vitro studies have shown that paliperidone is a P-glycoprotein (P-gp) substrate.
Danish: In vitro-studier har vist, at paliperidon er substrat for P-glykoprotein (Pgp).
English: The mean terminal elimination half-life of paliperidone was 24, 40, and 51 hours in subjects with mild, moderate, and severe renal impairment, respectively, compared with 23 hours in subjects with normal renal function (CrCl ≥ 80 mL/min).
Danish: Paliperidons gennemsnitlige terminale eliminationshalveringstid var 24, 40 og 51 timer hos personer med henholdsvis let, moderat og svært nedsat nyrefunktion sammenlignet med 23 timer hos personer med normal nyrefunktion (CrCl ≥ 80 ml/min).
English: INVEGA may cause you to gain weight.
Danish: INVEGA kan medføre vægtstigning.
English: • experience involuntary rhythmic movements of the tongue, mouth and face.
Danish: • får ufrivillige, rytmiske bevægelser af tungen, munden eller ansigtet.
English: An approximately 3-fold increased risk of cerebrovascular adverse reactions have been seen in randomised placebo-controlled clinical trials in the dementia population with some atypical antipsychotics, including risperidone, aripiprazole, and olanzapine.
Danish: Der er set en tilnærmelsesvis 3-fold forøgelse af risikoen for cerebrovaskulære bivirkninger i randomiserede, placebokontrollerede kliniske studier med patienter med demens, der behandles med visse atypiske antipsykotika, bl.a. risperidon, aripiprazol og olanzapin.
English: Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs - Frequency unknown.
Danish: Tilfælde af venøs tromboemboli, inklusive tilfælde af lungeemboli og dyb venetrombose, er blevet rapporteret i forbindelse med antipsykotiske lægemidler - hyppigheden er ukendt.
English: • sensation of spinning (vertigo).
Danish: • en følelse af, at det hele drejer rundt (vertigo).
English: In a study conducted in elderly subjects with schizophrenia, the safety profile was similar to that seen in non-elderly subjects.
Danish: I et studie med ældre forsøgspersoner med skizofreni var sikkerhedsprofilen omtrent den samme som hos forsøgspersoner i andre aldersgrupper.
English: Population pharmacokinetics analysis revealed no evidence of race-related differences in the pharmacokinetics of paliperidone following INVEGA administration.
Danish: En farmakokinetisk populationsanalyse har ikke vist tegn på racerelaterede forskelle i paliperidons farmakokinetiske egenskaber efter administration af INVEGA.
English: The efficacy of INVEGA in the acute treatment of psychotic or manic symptoms of schizoaffective disorder was established in two placebo-controlled, 6-week trials in non-elderly adult subjects.
Danish: Effekten af INVEGA ved akut behandling af psykotiske eller maniske symptomer på skizo-affektiv psykose blev registreret ved to placebo-kontrollerede, 6-ugers studier hos ikke-ældre voksne forsøgspersoner.
English: In vitro studies indicate that paliperidone is not an inducer of CYP1A2 activity.
Danish: In vitro-studier tyder på, at paliperidon ikke inducerer CYP1A2-aktivitet.
English: INVEGA High Dose 6 or 12 mg** N=47
Danish: INVEGA Høj dosis 6 eller 12 mg** N = 47
English: Pack sizes of 30 and 350 prolonged-release tablets.
Danish: Pakningsstørrelser: 30 og 350 depottabletter.
English: - Patients with schizoaffective disorder treated with this medicine should be carefully monitored for a potential switch from manic to depressive symptoms.
Danish: • Patienter med skizo-affektiv psykose, der behandles med dette lægemiddel, skal overvåges omhyggeligt for et muligt skift fra maniske til depressive symptomer.
English: Paliperidone may induce orthostatic hypotension in some patients based on its alpha-blocking activity.
Danish: Paliperidon kan inducere ortostatisk hypotension hos nogle patienter på grund af stoffets alfablokerende aktivitet.
English: • blood vessel problems in the brain, coma due to uncontrolled diabetes, unresponsive to stimuli,
Danish: • problemer med blodkarrene i hjernen, koma på grund af dårligt kontrolleret diabetes mellitus,
English: Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Danish: Yderligere kliniske tegn er bl.a. myoglobinuri (rabdomyolyse) og akut nyresvigt.
English: The trial was stopped early for efficacy reasons by showing a significantly longer time to relapse in patients treated with INVEGA compared to placebo (p=0.0053).
Danish: Studiet blev standset før tid af effektmæssige årsager, fordi det viste signifikant længere tid til recidiv hos de patienter, som blev behandlet med INVEGA, end hos de placebobehandlede patienter (p = 0,0053).
English: Concomitant administration of INVEGA with paroxetine, a potent CYP2D6 inhibitor, showed no clinically significant effect on the pharmacokinetics of paliperidone.
Danish: Samtidig indgift af INVEGA og paroxetin, en kraftig CYP2D6-inhibitor, har ikke vist nogen klinisk signifikant effekt på paliperidons farmakokinetiske egenskaber.
English: In the short-term, placebo-controlled, fixed-dose adolescent study, the incidence of EPS was higher than placebo for all doses of INVEGA with an increased frequency of EPS at higher doses.
Danish: I det kortvarige, placebo-kontrollerede fast-dosis-studie hos unge var incidensen af EPS højere end ved placebo for alle doser af INVEGA med en øget hyppighed af EPS ved højere doser.
English: INVEGA should be used with caution in patients with known cardiovascular disease (e.g., heart failure, myocardial infarction or ischaemia, conduction abnormalities), cerebrovascular disease, or conditions that predispose the patient to hypotension (e.g., dehydration and hypovolemia).
Danish: INVEGA bør anvendes med forsigtighed til patienter med kendt kardiovaskulær sygdom (f.eks. hjerteinsufficiens, myokardieinfarkt eller iskæmi eller ledningsforstyrrelser), cerebrovaskulær sygdom eller tilstande, som prædisponerer patienten for hypotension (f.eks. dehydrering og hypovolæmi).
English: Both studies included subjects who received INVEGA either as monotherapy or in combination with mood stabilisers and/or antidepressants.
Danish: Begge studier omfattede forsøgspersoner, som fik INVEGA enten som monoterapi eller i kombination med stemningsstabiliserende lægemidler og/eller antidepressiva.
English: In schizophrenia clinical trials, increases in serum prolactin were observed with INVEGA in 67% of subjects.
Danish: I kliniske skizofreni-studier blev der observeret forhøjelse af serumprolaktin med INVEGA hos 67 % af deltagerne.
English: The absolute oral bioavailability of paliperidone following INVEGA administration is 28% (90% CI of 23%-33%).
Danish: Paliperidons absolutte orale biotilgængelighed efter administration af INVEGA er 28 % (90 % CI af
English: • a blockage in the bowels, stool incontinence, very hard stool, lack of bowel muscle movement that causes blockage
Danish: • blokering i tarmen, manglende evne til at holde på afføringen, meget hård afføring, manglende bevægelse af tarmmuskulaturen, som forårsager blokering
English: In adolescents weighing < 51 kg, a 23% higher exposure was observed than in adolescents weighing ≥ 51 kg. Age alone did not influence the paliperidone exposure.
Danish: Hos unge med en vægt < 51 kg observeredes 23 % højere eksponering end hos unge med en vægt ≥ 51 kg.
English: INVEGA contains the active substance paliperidone which belongs to the class of antipsychotic medicines.
Danish: Dette lægemiddel indeholder det aktive stof paliperidon, der tilhører klassen af antipsykotika.
English: Paliperidone is the active metabolite of risperidone.
Danish: Paliperidon er den aktive metabolit af risperidon.
English: With once-daily dosing of INVEGA, steady-state concentrations of paliperidone are attained within 4-5 days of dosing in most subjects.
Danish: Ved administration af INVEGA én gang dagligt opnås steady statekoncentration af paliperidon hos de fleste mennesker efter 4-5 dage.
English: If you need to have cataract surgery, be sure to tell your eye doctor if you take or have taken this medicine.
Danish: Hvis du skal opereres for grå stær, skal du sørge for at fortælle det til din øjenlæge, hvis du tager eller har taget dette lægemiddel.
English: Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leucopenia/neutropenia should be monitored during the first few months of therapy and discontinuation of INVEGA should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
Danish: Patienter, som tidligere har haft et klinisk relevant lavt leukocyttal eller lægemiddelinduceret leukopeni/neutropeni, skal monitoreres i de første måneder af behandlingen, og ved første tegn på klinisk signifikant fald i leukocytter uden andre årsagsfaktorer skal det overvejes at seponere INVEGA.
English: Weight gain Significant weight gain has been reported with INVEGA use.
Danish: Der er rapporteret om signifikant vægtøgning ved brug af INVEGA.
English: Concomitant use of INVEGA with oral risperidone is not recommended as paliperidone is the active metabolite of risperidone and the combination of the two may lead to additive paliperidone exposure.
Danish: INVEGA bør ikke bruges samtidigt med oral risperidon, da paliperidon er den aktive metabolit af risperidon, og en kombination af disse kan føre til en additiv eksponering af paliperidon.
English: If a patient develops signs or symptoms indicative of NMS, all antipsychotics, including INVEGA, should be discontinued.
Danish: Hvis en patient udvikler tegn eller symptomer på malignt neuroleptikasyndrom, bør alle antipsykotika, herunder INVEGA, seponeres.
English: Polyethylene oxide 200K Sodium chloride Povidone (K29-32) Stearic acid
Danish: Polyethylenoxid 200K Natriumchlorid Povidon (K29-32) Stearinsyre
English: Current or past use of medicines with alpha 1a-adrenergic antagonist effect should be made known to the ophthalmic surgeon in advance of surgery.
Danish: Øjenkirurgen bør informeres om aktuel eller tidligere brug af lægemidler med alfa-1a-adrenerg antagonisteffekt forud for operation.
English: In the lower dose group of the 2 dose-level study (6 mg/day with option to reduce to 3 mg/day), INVEGA was not significantly different from placebo as measured by the PANSS.
Danish: I den lave dosisgruppe i studiet med de to dosisniveauer (6 mg/dag med mulighed for at reducere til 3 mg/dag) adskilte INVEGA sig ikke signifikant fra placebo målt efter PANSS.
English: Events of leucopenia, neutropenia, and agranulocytosis have been reported with antipsychotic agents, including INVEGA.
Danish: Der er rapporteret tilfælde af leukopeni, neutropeni og agranulocytose med antipsykotika, herunder INVEGA.
English: Caution is warranted in patients receiving both, psychostimulants (e.g., methylphenidate) and paliperidone concomitantly, as extrapyramidal symptoms could emerge when adjusting one or both medications.
Danish: Der skal udvises forsigtighed hos patienter, der både får psykostimulanser (f.eks. methylphenidat) og paliperidon samtidigt, da der kan opstå ekstrapyramidale symptomer ved justering af et eller af begge lægemidler.
English: Efficacy of INVEGA over a flexible dose range of 3 mg/day to 9 mg/day in adolescent subjects (12 years and older) with schizophrenia (INVEGA N = 112, aripiprazole N = 114) was also evaluated in a randomised, double-blind, active-controlled study that included an 8-week, double-blind acute phase and an 18-week, double-blind maintenance phase.
Danish: Virkningen af INVEGA over et fleksibelt dosisinterval på 3 mg/dag til 9 mg/dag hos unge (12 år og derover) med skizofreni (INVEGA N = 112, aripiprazol N = 114) blev også vurderet i et randomiseret, dobbeltblindt studie med aktiv kontrol, der omfattede en 8-ugers dobbeltblind akutfase og en 18-ugers dobbeltblind vedligeholdelsesfase.
English: In a long-term trial designed to assess the maintenance of effect, the long-acting injectable formulation of paliperidone was significantly more effective than placebo in maintaining symptom control and delaying relapse of psychotic, manic, and depressive symptoms of schizoaffective disorder.
Danish: I et langtidsstudie, som var designet til at vurdere vedligeholdelse af effekt, var den langtidsvirkende injicerbare formulering af paliperidon signifikant mere effektiv end placebo til at opretholde symptomkontrol og forsinke recidiv af psykotiske, maniske og depressive symptomer ved skizoaffektiv psykose.
English: A minor decrease in the amount of active substance excreted unchanged in the urine suggests that there was little effect on the CYP metabolism or bioavailability of paliperidone during carbamazepine co-administration.
Danish: Et mindre fald i mængden af uforandret paliperidon udskilt i urinen tyder på, at der var lille effekt på CYPmetabolismen eller biotilgængeligheden af paliperidon, når det blev administreret sammen med carbamazepin.
English: After having been treated for an acute episode for 6 weeks and stabilised for an additional 8 weeks with INVEGA (doses ranging from 3 to 15 mg once daily) patients were then randomised in a double-blind manner to either continue on INVEGA or on placebo until they experienced a relapse in schizophrenia symptoms.
Danish: Efter at være blevet behandlet for en akut episode i 6 uger og stabiliseret i yderligere 8 uger med INVEGA (doser på 3-15 mg én gang dagligt) blev patienterne randomiseret i et dobbeltblindet design til enten at fortsætte med INVEGA eller med placebo, indtil de oplevede recidiv af skizofrenisymptomer.
English: Based on pooled data from the three, placebo-controlled, 6-week, fixed-dose trials with INVEGA (3, 6, 9, and 12 mg), orthostatic hypotension was reported by 2.5% of subjects treated with INVEGA compared with 0.8% of subjects treated with placebo.
Danish: På baggrund af opsummerede data fra tre placebokontrollerede 6-ugers studier med faste doser af INVEGA (3, 6, 9 og 12 mg), blev ortostatisk hypotension rapporteret hos 2,5 % af de patienter, som fik INVEGA, sammenlignet med 0,8 % af de patienter, som fik placebo.
English: Endocrine disorders hyperprolactinaemia inappropriate antidiuretic hormone secretion c, glucose urine present
Danish: Hyperprolaktinæmi a Unormal sekretion af antidiuretisk hormon c, glucose i urinen
English: In a long-term trial designed to assess the maintenance of effect, INVEGA was significantly more effective than placebo in maintaining symptom control and delaying relapse of schizophrenia.
Danish: I et langvarigt studie, som havde til formål at vurdere vedligeholdelseseffekten, var INVEGA signifikant mere effektiv end placebo til at opretholde symptomkontrol og forsinke recidiv af skizofreni.
English: Eye problems during cataract surgery may also occur.
Danish: Der kan også opstå øjenproblemer under operation for grå stær.
English: Paliperidone should not be used in patients with creatinine clearance below 10 mL/min.
Danish: Paliperidon må ikke anvendes til patienter med kreatininclearance under 10 ml/min.
English: Due to different pharmacodynamic and pharmacokinetic profiles among antipsychotic medicinal products, supervision by a clinician is needed when switching to another antipsychotic product is considered medically appropriate.
Danish: Da forskellige antipsykotika ikke har samme farmakodynamiske og farmakokinetiske profil, skal et medicinsk relevant skift til et andet antipsykotisk lægemiddel ske under lægeligt opsyn.
English: The efficacy of INVEGA in adolescent subjects with schizophrenia (INVEGA N = 149, placebo N = 51) was studied in a randomised, double-blind, placebo-controlled, 6-week study using a fixed-dose weight-based treatment group design over the dose range of 1.5 mg/day to 12 mg/day.
Danish: Virkningen af INVEGA hos unge med skizofreni (INVEGA N = 149, placebo N = 51) blev undersøgt i et randomiseret, dobbeltblindt, placebo-kontrolleret studie over 6 uger med et behandlingsgruppedesign med fast dosis baseret på vægt med et dosisområde på 1,5 mg/dag til 12 mg/dag.
English: No data are available in patients with a creatinine clearance below 10 mL/min.
Danish: Der foreligger ingen data for patienter med kreatininclearance under 10 ml/min.
English: • fever, weakness, fatigue (tiredness).
Danish: • feber, svaghed, træthed.
English: The effects of this medicine may be affected if you are taking medicines that affect the speed of movement in the gut (e.g., metoclopramide).
Danish: Det kan påvirke virkningen af dette lægemiddel, hvis du tager medicin, der påvirker transporten af tarmindholdet (f.eks. metoclopramid).
English: INVEGA contains sodium
Danish: INVEGA indeholder natrium
English: In oral carcinogenicity studies of risperidone in rats and mice, increases in pituitary gland adenomas (mouse), endocrine pancreas adenomas (rat), and mammary gland adenomas (both species) were seen.
Danish: I karcinogenicitetsstudier med peroral risperidon til rotter og mus blev der set en stigning i hypofyseadenomer (mus), endokrine pankreasadenomer (rotter) og mammakirteladenomer (begge arter).
English: In case of severe extrapyramidal symptoms, anticholinergic agents should be administered.
Danish: Ved svære ekstrapyramidale symptomer bør der indgives antikolinergika.
English: Patients with schizoaffective disorder treated with paliperidone should be carefully monitored for a potential switch from manic to depressive symptoms.
Danish: Patienter med skizo-affektiv psykose, der behandles med paliperidon, skal overvåges omhyggeligt for et potentielt skift fra maniske til depressive symptomer.
English: Co-administration of INVEGA 12 mg once daily with divalproex sodium prolonged-release tablets (500 mg to 2,000 mg once daily) did not affect the steady-state pharmacokinetics of valproate.
Danish: Samtidig administration af INVEGA 12 mg en gang dagligt og divalproexnatrium-depottabletter (500 mg til 2000 mg en gang dagligt) påvirkede ikke steady-state-farmakokinetikken for valproat.
English: Secondary by dose analysis demonstrated the efficacy of 3 mg, 6 mg, and 12 mg dose given once daily.
Danish: Sekundært efter dosisanalyse påvistes virkningen af 3 mg, 6 mg og 12 mg givet en gang om dagen.
English: INVEGA Low Dose 1.5 mg N=54
Danish: INVEGA Lav dosis 1,5 mg N = 54
English: Schizophrenia is a disorder with symptoms such as hearing things, seeing or sensing things that are not there, mistaken beliefs, unusual suspiciousness, becoming withdrawn, incoherent speech, and behaviour and emotional flatness.
Danish: Skizofreni er en lidelse, hvis symptomer bl.a. er, at man hører, ser eller mærker ting, som ikke er der, opfatter ting forkert, er usædvanligt mistroisk, bliver indadvendt, taler usammenhængende og får en afstumpet opførsel og følelsesmæssig opfattelse.
English: The active substance is paliperidone
Danish: Aktivt stof: paliperidon.
English: • white blood cell count decreased, decrease in platelets (blood cells that help you stop bleeding), anaemia, decrease in red blood cells
Danish: • nedsat antal hvide blodlegemer, nedsat antal blodplader (blodlegemer, der medvirker til at stoppe blødninger), anæmi, nedsat antal røde blodlegemer
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 paliperidone.
Danish: Malignt neuroleptikasyndrom, som er karakteriseret ved hypertermi, muskelstivhed, autonome symptomer, ændret bevidsthed og forhøjet serum-kreatinkinaseniveau, er rapporteret ved behandling med paliperidon.
English: • ear infection
Danish: • infektion i øret