FrancophonIA/ELRC3.0 huggingface dataset:
English: Lactose content (pertains only to the 3 mg tablets)
Danish: Laktoseindhold (vedrører kun 3 mg tabletter)
English: This effect, if it occurs in humans, may mask the signs and symptoms of overdosage with certain medicines or of conditions such as intestinal obstruction, Reye's syndrome, and brain tumour.
Danish: Hvis denne effekt forekommer hos mennesker, kan den skjule tegn og symptomer på overdosering af visse lægemidler eller tilstande som intestinal obstruktion, Reyes syndrom og hjernetumor.
English: - Blisters: The tablets are supplied in blisters packed in cartons of 14, 28, 30, 49, 56, and 98 tablets.
Danish: - Blisterkort: Tabletterne udleveres som blisterkort pakket i æsker med 14, 28, 30, 49, 56 eller 98 tabletter.
English: The release characteristics of INVEGA result in minimal peak-trough fluctuations as compared to those observed with immediate-release risperidone (fluctuation index 38% versus 125%).
Danish: INVEGAs afgivelsesegenskaber medfører minimale udsving i koncentrations-fluktuationen sammenlignet med risperidon med hurtig afgivelse (fluktuationsindeks 38 % over for 125 %).
English: In one of these trials, efficacy was assessed in 211 subjects who received flexible doses of INVEGA (3-12 mg once daily).
Danish: I et af disse studier blev effekten vurderet hos 211 forsøgspersoner, der fik fleksible doser af INVEGA (3-12 mg en gang dagligt).
English: Withdrawal of INVEGA may be needed.
Danish: Det kan være nødvendigt at ophøre med INVEGA.
English: • parkinsonism: This condition may include slow or impaired movement, sensation of stiffness or tightness of the muscles (making your movements jerky), and sometimes even a sensation of movement "freezing up" and then restarting.
Danish: • parkinsonisme: denne tilstand kan omfatte langsomme eller besværede bevægelser, følelse af at have stive eller stramme muskler (og dermed rykvise bevægelser) og undertiden også en følelse af, at bevægelsen "fryser" og derefter genoptages.
English: LOCF endpoint change from baseline INVEGA 3-9 mg N=112
Danish: Ændring i LOCF-endepunkt i forhold til baseline INVEGA 3-9 mg N = 112
English: • loss of consciousness, balance disorder, abnormal coordination
Danish: • bevidsthedstab, balanceforstyrrelse, unormal koordination
English: - if you have heart disease or heart disease treatment that makes you prone to low blood pressure.
Danish: • hvis du lider af en hjertesygdom eller er i behandling for en hjertesygdom, som giver dig tendens til lavt blodtryk.
English: • dystonia: This is a condition involving slow or sustained involuntary contraction of muscles.
Danish: • dystoni: dette er en tilstand, som medfører langsomme eller vedvarende, ufrivillige muskelsammentrækninger.
English: • chills, an increase in body temperature
Danish: • kulderystelser, stigning i kropstemperatur
English: Dominating central serotonin antagonism may reduce the tendency of paliperidone to cause extrapyramidal side effects.
Danish: Dominerende central serotoninantagonisme kan nedsætte paliperidons tendens til at forårsage ekstrapyramidale bivirkninger.
English: Antipsychotic medicinal products (including risperidone) with α-adrenergic blocking effects have been reported to induce priapism.
Danish: Antipsykotiske lægemidler med α-adrenerg blokerende effekt (inklusiv risperidon) er rapporteret at inducere priapisme.
English: The experience from risperidone is considered valid also for paliperidone.
Danish: Erfaringerne med risperidon betragtes også som værende gældende for paliperidon.
English: The administration of INVEGA should be standardised in relation to food intake (see section 5.2).
Danish: Administration af INVEGA skal fastsættes i forhold til fødeindtagelsen (se pkt.
English: Polyethylene oxide 200K
Danish: Polyethylenoxid 200K
English: Larger decreases in plasma concentrations of paliperidone could occur with higher doses of carbamazepine.
Danish: Større fald i plasmakoncentrationen af paliperidon kan forekomme ved højere doser af carbamazepin.
English: Do not use this medicine after the expiry date which is stated on the blister/bottle and carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisterkortet/beholderen og æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Only few subjects received the 3 mg dose in both studies and efficacy of this dose could not be established.
Danish: Dosis på 3 mg blev kun givet til få patienter i begge studier, og effekt af denne dosis kunne ikke påvises.
English: Medicines 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 dopaminreceptorantagonistiske egenskaber er blevet forbundet med induktion af tardiv dyskinesi, som er karakteriseret ved ufrivillige, rytmiske bevægelser, især af tunge og/eller ansigt.
English: Refer to ‘Extrapyramidal symptoms' below.
Danish: Se under 'Ekstrapyramidale symptomer' nedenfor.
English: Patients treated with any atypical antipsychotic, including INVEGA, should be monitored for symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus should be monitored regularly for worsening of glucose control.
Danish: Patienter, som behandles med atypiske antipsykotika, herunder INVEGA, skal monitoreres for symptomer på hyperglykæmi (f.eks. polydipsi, polyuri, polyfagi og svaghed), og patienter med diabetes mellitus skal monitoreres regelmæssigt for dårligere glucosekontrol.
English: In the other study, efficacy was assessed in 203 subjects who were assigned to one of two dose levels of INVEGA: 6 mg with the option to reduce to 3 mg (n = 105) or 12 mg with the option to reduce to 9 mg (n = 98) once daily.
Danish: I det andet studie blev effekten vurderet hos 203 forsøgspersoner, som blev delegeret til et af to dosisniveauer af INVEGA: 6 mg med mulighed for at reducere til 3 mg (n = 105) eller 12 mg med mulighed for at reducere til 9 mg (n = 98) en gang dagligt.
English: The following symptoms may occur in newborn babies of mothers that have used paliperidone in the last trimester (last three months of their pregnancy): shaking, muscle stiffness and/or weakness, sleepiness, agitation, breathing problems, and difficulty in feeding.
Danish: Følgende symptomer kan forekomme hos nyfødte af mødre, som har taget paliperidon i sidste trimester (de sidste tre måneder af graviditeten): rystelser, muskelstivhed og/eller -svaghed, søvnighed, ophidselse, vejrtrækningsbesvær og besvær med at indtage føde.
English: However, there was no discernable effect of age in the population pharmacokinetic analysis involving schizophrenia subjects after correction of age-related decreases in CrCl.
Danish: Der var dog ingen mærkbar alderseffekt i den farmakokinetiske populationsanalyse af skizofrenipatienter efter korrektion for aldersrelateret reduktion af CrCl.
English: No dose adjustment is required in patients with mild or moderate hepatic impairment.
Danish: Dosisjustering er ikke nødvendigt hos patienter med let eller moderat nedsat leverfunktion.
English: Response defined as decrease from baseline in PANSS Total Score ≥ 30% and CGI-C Score ≤ 2
Danish: Respons defineret som fald fra baseline i samlet PANSS-score ≥ 30 % og CGI-C Score ≤ 2
English: Colour overcoat:
Danish: Farvet overtræk:
English: Association with ketoacidosis has been reported very rarely and rarely with diabetic coma.
Danish: Tilknytning med ketoacidose er rapporteret i meget sjældne tilfælde og med diabetisk koma i sjældne tilfælde.
English: Response defined as decrease from baseline in PANSS Total Score ≥ 20% Note: Negative change in score indicates improvement.
Danish: Respons defineret som fald fra baseline i samlet PANSS-score ≥ 20 % Bemærk: En negativ ændring i score indikerer forbedring.
English: Dose dependence for EPS was seen with the two higher doses of INVEGA (9 and 12 mg).
Danish: Der blev observeret en dosisafhængig risiko for EPS ved de to højeste doser af INVEGA (9 mg og 12 mg).
English: Menstrual disorder includes: menstruation irregular, oligomenorrhoea
Danish: Menstruationsforstyrrelse omfatter: uregelmæssig menstruation, oligomenorré
English: The study showed a significantly longer time to relapse in patients treated with the long-acting injectable formulation of paliperidone compared to placebo (p < 0.001).
Danish: Studiet påviste en signifikant længere tid til recidiv hos patienter, der blev behandlet med den langtidsvirkende injicerbare formulering af paliperidon sammenlignet med placebo (p < 0,001).
English: In a meta-analysis of 17 controlled clinical trials, elderly patients with dementia treated with other atypical antipsychotics, including risperidone, aripiprazole, olanzapine, and quetiapine had an increased risk of mortality compared to placebo.
Danish: I en meta-analyse af 17 kontrollerede kliniske studier havde ældre patienter med demens, som blev behandlet med andre atypiske antipsykotika, bl.a. risperidon, aripiprazol, olanzapin og quetiapin, øget mortalitetsrisiko i forhold til placebo.
English: If you miss one dose, take your next dose on the day following the missed dose.
Danish: Hvis du glemmer at tage en dosis, skal du blot tage den næste dosis som normalt den næste dag.
English: These tumours can be related to prolonged dopamine D2 antagonism and hyperprolactinemia.
Danish: Disse tumorer kan være relateret til den langvarige dopaminD2-antagonisme og hyperprolaktinæmi.
English: Abnormalities of electrical function in the heart may occur when this medicine is taken with certain heart medicines that control heart rhythm, or some other types of medicines such as antihistamines, antimalarials, or other antipsychotics.
Danish: Der kan opstå problemer med hjertets elektriske funktion, når dette lægemiddel tages sammen med visse typer hjertemedicin til kontrol af hjerterytmen, eller visse andre typer medicin såsom antihistaminer, malariamidler og andre midler mod psykiske forstyrrelser.
English: Switching to other antipsychotic medicinal products There are no systematically collected data to specifically address switching patients from INVEGA to other antipsychotic medicinal products.
Danish: Der foreligger ingen systematisk indsamlede data, som specifikt vedrører skift af patienter fra INVEGA til andre antipsykotika.
English: Contact your doctor right away.
Danish: Søg straks læge.
English: • an interruption in conduction between the upper and lower parts of the heart, abnormal electrical conduction of the heart, prolongation of the QT interval from your heart, slow heart rate, rapid heart rate
Danish: • forstyrrelse i den elektriske overledning mellem den øvre og nedre del af hjertet, ledningsforstyrrelser i hjertet, forlængelse af QT-interval, langsom hjerterytme, hurtig hjerterytme
English: Concomitant use of INVEGA with risperidone
Danish: Samtidig brug af INVEGA og risperidon
English: Repeat-dose toxicity studies of paliperidone in rat and dog showed mainly pharmacological effects, such as sedation and prolactin-mediated effects on mammary glands and genitals.
Danish: Toksicitetsstudier med gentagne doser af paliperidon til rotter og hunde viste primært farmakologiske effekter som sedation og prolaktinmedierede virkninger på mammakirtler og genitalier.
English: An antiemetic effect was observed in preclinical studies with paliperidone.
Danish: Der er observeret en antiemetisk effekt i de prækliniske studier med paliperidon.
English: Torsade de pointes and ventricular fibrillation have been reported in association with overdose.
Danish: Torsades de pointes og ventrikulær fibrillation er rapporteret i forbindelse med overdosering.
English: • a sensation of spinning (vertigo), ringing in the ears, ear pain
Danish: • en følelse af, at det hele drejer rundt (vertigo), ringen for ørerne, smerter i ørerne
English: Due to the controlled-release design of the dosage form, INVEGA should only be used in patients who are able to swallow the tablet whole.
Danish: På grund af depotformuleringen bør INVEGA kun anvendes til patienter, som kan sluge tabletterne hele.
English: In rat reproduction studies using risperidone, which is extensively converted to paliperidone in rats and humans, a reduction was observed in the birth weight and survival of the offspring.
Danish: I rottereproduktionsstudier med risperidon, som omdannes ekstensivt til paliperidon hos rotter og mennesker, blev der observeret en reduktion i afkommets fødselsvægt og overlevelse.
English: Safety and efficacy of INVEGA in patients > 65 years of age with schizoaffective disorder have not been studied.
Danish: INVEGAs sikkerhed og virkning hos patienter > 65 år med skizo-affektiv psykose er ikke undersøgt.
English: Use in adolescents
Danish: Brug til unge
English: Talk to your doctor, pharmacist or nurse before taking INVEGA.
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager INVEGA.
English: Hyperglycaemia, diabetes mellitus, and exacerbation of pre-existing diabetes have been reported during treatment with paliperidone.
Danish: Der er rapporteret om hyperglykæmi, diabetes mellitus og forværring af eksisterende diabetes under behandling med paliperidon.
English: INVEGA doses, which varied across the three studies, ranged from 3 to 15 mg once daily.
Danish: INVEGA-doserne, som var forskellige i de tre studier, lå på 3-15 mg én gang dagligt.
English: Dosing recommendations for elderly patients with normal renal function (≥ 80 mL/min) are the same as for adults with normal renal function.
Danish: Den anbefalede dosis til ældre med normal nyrefunktion (≥ 80 ml/min) er den samme som for voksne med normal nyrefunktion.
English: In a study in subjects with moderate hepatic impairment (Child-Pugh class B), the plasma concentrations of free paliperidone were similar to those of healthy subjects.
Danish: I et studie med patienter med moderat nedsat leverfunktion (Child-Pugh-klasse B) var plasmakoncentrationerne af frit paliperidon de samme som hos raske forsøgsdeltagere.
English: Co-administration of INVEGA with divalproex sodium prolonged-release tablets increased the exposure to paliperidone (see below).
Danish: Samtidig administration af INVEGA og divalproexnatrium-depottabletter øgede eksponeringen for paliperidon (se nedenfor).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Danish: Yderligere oplysninger om INVEGA findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Dosage adjustment, if indicated, should occur only after clinical reassessment based on the individual need of the patient.
Danish: Hvis dosisjustering er indiceret, bør dette kun ske efter klinisk revurdering ud fra patientens individuelle behov.
English: Paliperidone is not extensively metabolised in the liver.
Danish: Paliperidon metaboliseres ikke ekstensivt i leveren.
English: Administration of paliperidone prolonged-release tablets with a standard high-fat/high-caloric meal increases Cmax and AUC of paliperidone by up to 50-60% compared with administration in the fasting state.
Danish: Administration af paliperidon depottabletter sammen med et standardmåltid med højt indhold af fedt og kalorier øger paliperidons Cmax og AUC med op til 50-60 % i forhold til administration i fastende tilstand.
English: The following are all the ADRs that were reported in clinical trials and post-marketing experience with paliperidone by frequency category estimated from INVEGA clinical trials in adults.
Danish: Nedenfor angives samtlige bivirkninger, som er rapporteret i kliniske studier og postmarketing med paliperidon efter hyppighedskategori estimeret på baggrund af kliniske studier med INVEGA hos voksne.
English: In general, expected signs and symptoms are those resulting from an exaggeration of paliperidone's known pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension, QT prolongation, and extrapyramidal symptoms.
Danish: Generelt udgør de forventede tegn og symptomer en forstærkning af paliperidons kendte farmakologiske virkninger, dvs. døsighed og sedation, takykardi og hypotension, forlængelse af QTintervallet og ekstrapyramidale symptomer.
English: • elated mood (mania), irritability, depression, anxiety
Danish: • opstemthed (mani), irritabilitet, depression, angst
English: During post-marketing surveillance priapism has also been reported with paliperidone, which is the active metabolite of risperidone.
Danish: Under postmarketing-overvågning har priapisme også været rapporteret for paliperidon, som er den aktive metabolit af risperidon.
English: (listed in section 6).
Danish: INVEGA (angivet i punkt 6).
English: The use of oral risperidone together with this medicine is not recommended as the combination of the two medicines may lead to increased side effects.
Danish: Risperidon til indtagelse gennem munden bør ikke bruges sammen med dette lægemiddel, da kombinationen af de to lægemidler kan øge bivirkningerne.
English: INVEGA has not been studied in elderly patients with dementia.
Danish: INVEGA er ikke undersøgt hos ældre patienter med demens.
English: • INVEGA can raise your levels of a hormone called "prolactin" found on a blood test (which may or may not cause symptoms).
Danish: • INVEGA kan medføre forhøjet koncentration af et hormon, som kaldes prolaktin, som påvises ved en blodprøve (medfører ikke altid symptomer).
English: Taking the results of both studies together (pooled study-data), INVEGA improved the psychotic and manic symptoms of schizoaffective disorder at endpoint relative to placebo when administered either as monotherapy or in combination with mood stabilisers and/or antidepressants.
Danish: Hvis man samler resultaterne af begge studier (poolede studiedata), forbedrede INVEGA de psykotiske og maniske symptomer på skizo-affektiv psykose ved endepunktet i forhold til placebo ved administration enten som monoterapi eller i kombination med stemningsstabilisatorer og/eller antidepressiva.
English: Refer to ‘Hyperprolactinaemia' below.
Danish: Se under 'Hyperprolaktinæmi' nedenfor.
English: Cases of venous thromboembolism (VTE) have been reported with antipsychotic medicinal products.
Danish: Tilfælde af venøs tromboemboli (VTE) er blevet rapporteret i forbindelse med antipsykotiske lægemidler.
English: • neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever, and severe muscle stiffness)
Danish: • malignt neuroleptikasyndrom (forvirring, nedsat eller tab af bevidsthed, høj feber og alvorlig muskelstivhed)
English: The amount you take depends on how well the medicine works for you.
Danish: Dosis afhænger af, hvor godt medicinen virker på dig.
English: In a 7-week juvenile toxicity study in rats administered oral doses of paliperidone up to 2.5 mg/kg/day, corresponding to an exposure approximately equal to the clinical exposure based on AUC, no effects on growth, sexual maturation and reproductive performance were observed.
Danish: I et 7-ugers toksicitetsstudie hos unge rotter, der fik orale doser af paliperidon op til 2,5 mg/kg/dag, svarende til en eksponering omtrent som den kliniske eksponering baseret på AUC, sås der ingen indvirkning på vækst, seksuel modning og reproduktionsevne.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per tablet, i.e., essentially sodium-free.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. tablet, dvs. at det stort set er natriumfrit.
English: Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% in mild (Creatinine Clearance [CrCl] = 50 to < 80 mL/min), 64% in moderate (CrCl = 30 to < 50 mL/min), and 71% in severe (CrCl = < 30 mL/min) renal impairment.
Danish: Hos personer med nedsat nyrefunktion var paliperidons totale clearance nedsat med 32 % ved let (kreatininclearance [CrCl] = 50 til < 80 ml/min), 64 % ved moderat (CrCl = 30 til < 50 ml/min) og 71 % ved svært (CrCl = < 30 ml/min) nedsat nyrefunktion.
English: In the study that examined two dose groups (see section 5.1), the increase in body weight of ≥ 7% was 3% in the lower-dose (3-6 mg) group, 7% in the higher-dose (9-12 mg) group, and 1% in the placebo group.
Danish: I det studie, der undersøgte to dosisgrupper (se punkt 5.1), var forøgelsen af legemsvægten på ≥ 7 % 3 % i den laveste dosisgruppe (3-6 mg), 7 % i den højeste dosisgruppe (9-12 mg) og 1 % i placebo-gruppen.
English: However, overall the magnitude of effect in regard to PANSS and YMRS observed on monotherapy was larger than that observed with concomitant antidepressants and/or mood stabilisers.
Danish: Den observerede virkning med hensyn til PANSS og YMRS med monoterapi var dog generelt større end den, der blev observeret ved kombination med antidepressiva og/eller stemningsstabiliserende lægemidler.
English: Population pharmacokinetics analyses indicated no discernible difference on the apparent clearance of paliperidone after administration of INVEGA between extensive metabolisers and poor metabolisers of CYP2D6 substrates.
Danish: Populationsfarmakokinetiske analyser indikerer, at der er en ikke mærkbar forskel i paliperidons tilsyneladende clearance efter administration af INVEGA mellem personer med ekstensiv metabolisering og personer med nedsat metabolisering af CYP2D6-substrater.
English: Schizoaffective disorder is a mental condition in which a person experiences a combination of schizophrenia symptoms (as listed above) in addition to mood disorder symptoms (feeling very high, feeling sad, feeling agitated, distracted, sleeplessness, talkativeness, losing interest in everyday activities, sleeping too much or too little, eating too much or too little, and recurrent thoughts of suicide).
Danish: Skizo-affektiv psykose er en psykisk tilstand, hvor man oplever en kombination af symptomer på skizofreni (som angivet ovenfor) samtidigt med forstyrrelser i stemningslejet (føler sig meget opstemt, bedrøvet, oprevet eller distraheret, lider af søvnløshed, snakkesalighed, mister interessen for dagligdags aktiviteter, sover for meget eller for lidt, spiser for meget eller for lidt og har tilbagevendende selvmordstanker).
English: Following a single dose, INVEGA exhibits a gradual ascending release rate, allowing the plasma concentrations of paliperidone to steadily rise to reach peak plasma concentration (Cmax) approximately 24 hours after dosing.
Danish: Efter en enkelt dosis afgives INVEGA med gradvist stigende hastighed, således at plasmakoncentrationen af paliperidon stiger støt, og maksimal plasmakoncentration (Cmax) nås ca. 24 timer efter dosering.
English: In vitro studies have shown that paliperidone is a P-gp substrate and a weak inhibitor of P-gp at high concentrations.
Danish: In vitro-studier har vist, at paliperidon er et P-gp-substrat og en svag hæmmer af P-gp ved høje koncentrationer.
English: In a 40-week juvenile toxicity study in dogs with oral doses of risperidone (which is extensively converted to paliperidone) up to 5 mg/kg/day, effects on sexual maturation, long bone growth and femur mineral density were observed from 3 times the clinical exposure based on AUC.
Danish: I et 40-ugers toksicitetsstudie hos unge hunde med orale doser af risperidon (som i udstrakt grad omdannes til paliperidon) op til 5 mg/kg/dag observeredes virkninger på seksuel modning, vækst af lange knogler og mineraldensitet i femur fra 3 gange den kliniske eksponering baseret på AUC.
English: Paliperidone should be used with caution in patients with possible prolactin-dependent tumours.
Danish: Paliperidon skal bruges med forsigtighed hos patienter med mulige prolaktinafhængige tumorer.
English: Neonates exposed to antipsychotics (including paliperidone) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Danish: Nyfødte, der har været udsat for antipsykotika (inklusive paliperidon) under tredje trimester af graviditeten, er i risiko for bivirkninger inkluderende ekstrapyramidale og/eller abstinenssymptomer, som kan variere i sværhedsgrad og varighed efter fødslen.