FrancophonIA/ELRC3.0 huggingface dataset:
English: Dizziness, extreme tiredness and vision problems may occur during treatment with this medicine (see section 4).
Danish: Der kan forekomme svimmelhed, ekstrem træthed og synsproblemer under behandling med dette lægemiddel (se pkt.
English: There is no specific antidote to paliperidone.
Danish: Der findes ingen specifik modgift mod paliperidon.
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-forsøg har vist, at paliperidon er substrat for P-gp og en svag P-gp-hæmmer ved høje koncentrationer.
English: Patients treated with Xeplion 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 Xeplion, 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: Other medicines that have this effect include some medicines used to treat depression or to treat infection, and other antipsychotics.
Danish: Andre lægemidler, der har denne virkning, omfatter visse lægemidler, der anvendes til behandling af depression eller til behandling af infektion, og andre antipsykotika.
English: Intramuscularly injected paliperidone palmitate and orally administered paliperidone were not teratogenic in animal studies, but other types of reproductive toxicity were seen (see section 5.3).
Danish: Intramuskulært injiceret paliperidonpalmitat og oralt administreret paliperidon var ikke teratogene i dyreforsøg, men der sås andre typer af reproduktionstoksicitet (se pkt.
English: You will receive the first injection (150 mg) and second injection (100 mg) of this medicine in the upper arm approximately one week apart.
Danish: Du får den første (150 mg) og den anden indsprøjtning (100 mg) af dette lægemiddel i overarmen med ca. 1 uges mellemrum.
English: Patients who have been given too much paliperidone may experience the following symptoms: drowsiness or sedation, fast heart rate, low blood pressure, an abnormal electrocardiogram (electrical tracing of the heart), or slow or abnormal movements of the face, body, arms or legs.
Danish: Patienter, der har fået for meget paliperidon, kan muligvis opleve følgende symptomer: Døsighed eller sløvhed, hurtige hjerteslag, lavt blodtryk, et unormalt elektrokardiogram (måling af hjertets elektriske aktivitet) eller langsomme eller unormale bevægelser af ansigtet, kroppen, armene eller benene.
English: Pharmacokinetic studies with paliperidone palmitate have shown somewhat lower (10-20%) plasma concentrations of paliperidone in patients who are overweight or obese in comparison with normal weight patients (see section 4.2).
Danish: Farmakokinetiske forsøg med paliperidonpalmitat har vist noget lavere (10-20 %) plasmakoncentrationer af paliperidon hos patienter, som er overvægtige eller adipøse, sammenlignet med patienter med normal vægt (se pkt.
English: • a decrease in body temperature
Danish: • fald i kropstemperatur
English: The fixed doses of Xeplion in these studies were given on days 1, 8, and 36 in the 9-week study, and additionally on day 64 of the 13-week studies.
Danish: De faste doser af Xeplion i disse forsøg blev givet på dag 1, 8 og 36 i 9 ugers-forsøget og endvidere på dag 64 i 13 ugers-forsøget.
English: A total of 410 stabilised patients were randomised to either Xeplion (median duration 171 days [range 1 day to 407 days]) or to placebo (median duration 105 days [range 8 days to 441 days]) until they experienced a relapse of schizophrenia symptoms in the variable length double-blind phase.
Danish: Ialt 410 stabiliserede patienter blev randomiseret til enten Xeplion (median varighed 171 dage [interval 1 dag til 407 dage]) eller til placebo (median varighed 105 dage [interval 8 dage til 441 dage]), indtil de oplevede et recidiv af skizofrenisymptomer i den dobbeltblinde fase af variabel længde.
English: If hypersensitivity reactions occur, discontinue use of Xeplion; initiate general supportive measures as clinically appropriate and monitor the patient until signs and symptoms resolve (see sections 4.3 and
Danish: Hvis der opstår overfølsomhedsreaktioner, skal Xeplion seponeres, og der skal iværksættes generel klinisk relevant understøttende behandling samt monitorering af patienten, indtil tegn og symptomer ophører (se pkt.
English: - if you have Parkinson's disease - if you have ever been diagnosed with a condition whose symptoms include high temperature and muscle stiffness (also known as Neuroleptic Malignant Syndrome) - if you have ever experienced abnormal movements of the tongue or face (Tardive Dyskinesia) - if you know that you have had low levels of white blood cells in the past (which may or may not have been caused by other medicines) - if you are diabetic or prone to diabetes - if you have had breast cancer or a tumour in the pituitary gland in your brain - if you have a heart disease or heart disease treatment that makes you prone to low blood pressure - if you have low blood pressure when you stand up or sit up suddenly - if you have epilepsy - if you have kidney problems - if you have liver problems - if you have prolonged and/or painful erection - if you have problems with controlling core body temperature or overheating - if you have an abnormally high level of the hormone prolactin in your blood or if you have a possible prolactin-dependent tumour - if you or someone else in your family has a history of blood clots, as antipsychotics have been associated with formation of blood clots.
Danish: - hvis du har Parkinsons sygdom - hvis du nogensinde har fået stillet en diagnose på en tilstand, hvor symptomerne omfatter høj temperatur og muskelstivhed (der også er kendt som malignt neuroleptikasyndrom) - hvis du nogensinde har oplevet unormale bevægelser af tungen eller ansigtet (tardiv dyskinesi) - hvis du ved, at du tidligere har haft et lavt niveau af hvide blodlegemer (som måske eller måske ikke var forårsaget af andre lægemidler) - hvis du har diabetes eller er disponeret for at få diabetes - hvis du har haft brystkræft eller en tumor i hypofysen i hjernen - hvis du har en hjertesygdom eller får en behandling mod en hjertesygdom, der gør, at du har tendens til lavt blodtryk - hvis dit blodtryk falder, når du rejser dig eller sætter dig op pludseligt - hvis du har epilepsi - hvis du har nyreproblemer - hvis du har leverproblemer - hvis du har langvarig og/eller smertefuld rejsning - hvis du har problemer med at kontrollere din krops kernetemperatur eller med overophedning - hvis du har et unormalt højt niveau af hormonet prolaktin i blodet, eller hvis du muligvis har en prolaktinafhængig svulst - hvis du eller en anden i din familie har haft en eller flere blodpropper, da antipsykotika er sat i forbindelse med dannelse af blodpropper.
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 svarer de forventede tegn og symptomer til en forstærkning af de kendte farmakologiske virkninger af paliperidon, dvs. døsighed og sedation, takykardi og hypotension, QT-forlængelse og ekstrapyramidale symptomer.
English: They were either derived from spontaneous post-marketing reports and frequency cannot be determined, or they were derived from risperidone (any formulation) or oral paliperidone clinical trials data and/or post-marketing reports.
Danish: De blev enten afledt fra spontane indberetninger efter markedsføring, hvor hyppigheden ikke kan fastlægges, eller også blev de afledt fra data fra kliniske studier og/eller indberetninger efter markedsføringen for risperidon (alle formuleringer) eller oralt paliperidon.
English: Your doctor should regularly measure your body weight.
Danish: Din læge bør veje dig regelmæssigt.
English: Concomitant administration of oral paliperidone with paroxetine, a potent CYP2D6 inhibitor, showed no clinically significant effect on the pharmacokinetics of paliperidone.
Danish: Administration af oral paliperidon samtidig med paroxetin, en potent CYP2D6-inhibitor, viste ingen klinisk signifikant virkning på paliperidons farmakokinetik.
English: Do not use Xeplion - if you are allergic to paliperidone or to any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke Xeplion - Hvis du er allergisk over for paliperidon eller et af de øvrige indholdsstoffer i dette lægemiddel
English: GENERAL CLASSIFICATION FOR SUPPLY
Danish: GENERAL KLASSIFIKATION FOR UDLEVERING
English: • swelling of the face, mouth, eyes, or lips, swelling of the body, arms or legs
Danish: • hævelse i ansigtet, munden, øjnene eller læberne, hævelse i kroppen, arme eller ben
English: Paliperidone should be used with caution in patients with a pre-existing tumour that may be prolactin-dependent.
Danish: Paliperidon skal anvendes med forsigtighed til patienter med en præeksisterende tumor, som kan være prolaktin-afhængig.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, det vil sige, at det stort set er "natriumfrit".
English: The plasma concentrations of paliperidone are increased in patients with renal impairment and therefore, dose adjustment is recommended in patients with mild renal impairment.
Danish: Plasmakoncentrationerne af paliperidon er forhøjede hos patienter med nedsat nyrefunktion, og dosisjustering anbefales derfor til patienter med let nedsat nyrefunktion.
English: In general, overall initiation plasma levels with Xeplion were within the exposure range observed with 6-12 mg prolonged release oral paliperidone.
Danish: Generelt set lå de samlede startplasmaniveauer med Xeplion inden for eksponeringsintervallet observeret med 6-12 mg oral depot-paliperidon.
English: Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis, have been reported with antipsychotic medicinal products (frequency unknown).
Danish: Tilfælde af venøs tromboemboli, herunder tilfælde af lungeemboli og tilfælde af dyb venetrombose, er rapporteret med antipsykotiske lægemidler (hyppigheden ikke kendt).
English: Do not administer intravascularly or subcutaneously.
Danish: Må ikke indgives intravaskulært eller subkutant.
English: Your doctor may adjust your dose of this medicine based on your kidney function.
Danish: Lægen kan justere din dosis af dette lægemiddel i henhold til din nyrefunktion.
English: To avoid a missed dose, patients may be given the second dose 4 days before or after the one-week (day 8) time point.
Danish: For at undgå, at en dosis springes over, kan patienten få den anden dosis 4 dage før eller efter, at der er gået en uge (dag 8).
English: Gradual withdrawal of stimulant treatment is recommended (see section 4.5).
Danish: Gradvis seponering af behandling med stimulanser anbefales (se pkt.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially sodium-free.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, dvs. at det stort set er natriumfrit.
English: • 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: • 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: Population pharmacokinetics analysis showed no evidence of age related pharmacokinetics differences.
Danish: Farmakokinetiske populationsanalyser viste ingen tegn på aldersrelaterede forskelle i farmakokinetik.
English: To avoid a missed monthly dose, patients may be given the injection up to 7 days before or after the monthly time point.
Danish: For at undgå, at en dosis springes over, kan patienten få injektionen op til 7 dage før eller efter tidspunktet for den månedlige injektion.
English: Treatment initiation pack
Danish: Pakning til behandlingsstart
English: The trial was stopped early for efficacy reasons as a significantly longer time to relapse (p < 0.0001, Figure 1) was seen in patients treated with Xeplion compared to placebo (hazard ratio = 4.32; 95% CI: 2.4-7.7).
Danish: Forsøget blev standset tidligt på grund af effekten, da der observeredes signifikant længere tid til recidiv (p < 0,0001, Figur 1) hos patienter behandlet med Xeplion sammenlignet med placebo (risikoratio = 4,32, 95 %, CI: 2,4-7,7).
English: A population pharmacokinetic analysis based on data with oral paliperidone prolonged release tablets showed a slightly lower exposure to paliperidone in smokers compared with non-smokers.
Danish: En farmakokinetisk populationsanalyse baseret på data med orale paliperidon depottabletter viste en lidt lavere eksponering for paliperidon hos rygere sammenlignet med ikke-rygere.
English: The total exposure of paliperidone following Xeplion administration was dose-proportional over a 25-150 mg dose range, and less than dose-proportional for Cmax for doses exceeding 50 mg.
Danish: Den totale eksponering for paliperidon efter Xeplion-administration var dosis-proportional over et 25-150 mg dosisinterval og mindre end dosis-proportional for Cmax for doser over 50 mg.
English: Effect of smoking on the pharmacokinetics of paliperidone was not studied with Xeplion.
Danish: Virkningen af rygning på paliperidons farmakokinetik blev ikke undersøgt med Xeplion.
English: In clinical trials, median increases in serum prolactin were observed in subjects of both genders who received Xeplion.
Danish: I kliniske forsøg blev der observeret medianstigninger i serumprolaktin hos forsøgspersoner af begge køn, som fik Xeplion.
English: The following are all ADRs that were reported with paliperidone by frequency category estimated from paliperidone palmitate clinical trials.
Danish: De følgende er alle bivirkninger, der er blevet rapporteret med paliperidon efter frekvenskategori estimeret på baggrund af kliniske studier med paliperidonpalmitat.
English: Paliperidone is not bound to cholinergic receptors.
Danish: Paliperidon binder ikke til kolinerge receptorer.
English: Some patients switching from higher paliperidone oral doses (e.g., 9-12 mg daily) to gluteal injections with Xeplion may have lower plasma exposure during the first 6 months after the switch.
Danish: Visse patienter, der skifter fra højere doser af oralt paliperidon (f.eks. 9-12 mg dagligt) til injektioner med Xeplion i musculus gluteus maximus, kan have lavere plasmaeksponering i de første 6 måneder efter skiftet.
English: Maintaining symptom control and delaying relapse of schizophrenia The efficacy of Xeplion in maintaining symptomatic control and delaying relapse of schizophrenia was established in a longer-term double-blind, placebo-controlled, flexible-dose study involving 849 non-elderly adult subjects who met DSM-IV criteria for schizophrenia.
Danish: Opretholdelse af symptomkontrol og udsættelse af recidiv af skizofreni Effekten af Xeplion til opretholdelse af symptomkontrol og forsinkelse af recidiv af skizofreni blev klarlagt i et længerevarende dobbeltblindt, placebokontrolleret forsøg med fleksible doser, der omfattede 849 ikke-ældre, voksne forsøgspersoner, som opfyldte DSM-IV-kriterierne for skizofreni.
English: Leucopenia, neutropenia, and agranulocytosis
Danish: Leukopeni, neutropeni og agranulocytose
English: Additional clinical signs may include myoglobinuria (rhabdomyolysis) and acute renal failure.
Danish: Andre kliniske tegn kan være myoglobinuri (rabdomyolyse) og akut nyresvigt.
English: • have dementia and experience a sudden change in your mental state or sudden weakness or numbness of your face, arms or legs, especially on one side, or slurred speech, even for a short period of time.
Danish: • er dement og oplever en pludselig forandring i din sindstilstand eller pludselig svækkelse eller følelsesløshed i ansigtet, arme eller ben - især i den ene side - eller taleforstyrrelser, også selv om det er kortvarigt.
English: • fall.
Danish: • fald.
English: Body temperature regulation
Danish: Regulering af legemstemperaturen
English: Repeat-dose toxicity studies of intramuscularly injected paliperidone palmitate (the 1-month formulation) and orally administered paliperidone in rat and dog showed mainly pharmacological effects, such as sedation and prolactin-mediated effects on mammary glands and genitals.
Danish: Toksicitetsforsøg med gentagne doser af intramuskulært injiceret paliperidonpalmitat (1-måneds formuleringen) og oralt administreret paliperidon til rotter og hunde viste overvejende farmakologiske virkninger såsom sedation og prolaktinmedierede virkninger på brystkirtler og genitalier.
English: Xeplion contains the active substance paliperidone which belongs to the class of antipsychotic medicines and is used as a maintenance treatment for the symptoms of schizophrenia in adult patients stabilised on paliperidone or risperidone.
Danish: Xeplion indeholder det aktive stof paliperidon, som tilhører klassen antipsykotiske lægemidler og anvendes som vedligeholdelsesbehandling af symptomerne på skizofreni hos voksne patienter, der er stabiliseret på paliperidon eller risperidon.
English: Paliperidone is excreted in the breast milk to such an extent that effects on the breast-fed infant are likely if therapeutic doses are administered to breast-feeding women.
Danish: Paliperidon udskilles i human mælk i så stor en mængde, at en påvirkning af det ammede barn er sandsynlig, hvis terapeutiske doser administreres til ammende kvinder.
English: In patients with pre-existing diabetes mellitus blood glucose should be monitored regularly.
Danish: Hos patienter med allerede eksisterende diabetes mellitus, skal blodsukkeret måles regelmæssigt.
English: Male rats showed a statistically significant increase in mammary gland adenomas and carcinomas at 30 and 60 mg/kg/month which is 1.2 and 2.2 times the exposure level at the maximum recommended human 150 mg dose.
Danish: Hanrotter viste en statistisk signifikant stigning i brystkirteladenomer og karcinomer ved 30 og 60 mg/kg/måned, hvilket er henholdsvis 1,2 og 2,2 gange eksponeringsniveauet ved den maksimale anbefalede humane dosis på 150 mg.
English: The use of the Xeplion initiation regimen allowed patients to stay in this exposure window of 6-12 mg prolonged release oral paliperidone even on trough pre-dose days (day 8 and day 36).
Danish: Anvendelsen af Xeplion-startregimet åbnede mulighed for, at patienterne kunne forblive i dette eksponeringvindue på 6-12 mg oral depotpaliperidon selv på dage med bundniveau før næste dosis (dag 8 og dag 36).
English: These results support efficacy across the entire duration of treatment and improvement in PANSS and was observed as early as day 4 with significant separation from placebo in the 25 mg and 150 mg Xeplion groups by day 8.
Danish: Disse resultater understøtter en virkning i løbet af hele behandlingens varighed og en forbedring i PANSS og blev observeret så tidligt som dag 4 og med en signifikant adskillelse fra placebo for gruppen der fik 25 mg samt gruppen der fik 150 mg Xeplion, på dag 8.
English: • experience involuntary rhythmic movements of the tongue, mouth and face.
Danish: • får ufrivillige rytmiske bevægelser af tungen, munden eller ansigtet.
English: In rat reproduction studies with oral risperidone, which is extensively converted to paliperidone in rats and humans, adverse effects were seen on the birth weight and survival of the offspring.
Danish: I reproduktionsforsøg med oral risperidon til rotter, som i kraftig grad omdannes til paliperidon i rotter og mennesker, observeredes bivirkninger på afkommets fødselsvægt og overlevelse.
English: The Xeplion maintenance doses needed to attain similar steady-state exposure are shown as follows:
Danish: Vedligeholdelsesdoser af Xeplion, der er nødvendige for at opnå en tilsvarende steady-stateeksponering, er som følger:
English: Paliperidone also blocks alpha 1-adrenergic receptors and slightly less, H1-histaminergic and alpha 2-adrenergic receptors.
Danish: Paliperidon blokerer også alfa-1-adrenerge receptorer og i lidt mindre grad H1-histaminerge og alfa-2-adrenerge receptorer.
English: In this study, both the 100 mg/4 weeks and 150 mg /4 weeks, but not the 25 mg/4 weeks, treatment groups demonstrated statistical superiority to placebo for the PSP score.
Danish: I dette forsøg viste både behandlingsgrupperne 100 mg/4 uger og 150 mg/4 uger, men ikke 25 mg/4 uger, statistisk overlegenhed i forhold til placebo for PSP-scoren.
English: Xeplion is indicated for maintenance treatment of schizophrenia in adult patients stabilised with paliperidone or risperidone.
Danish: Xeplion er indiceret til vedligeholdelsesbehandling af skizofreni hos voksne patienter, der er stabiliseret med paliperidon eller risperidon.
English: Hyperglycaemia, diabetes mellitus, and exacerbation of pre-existing diabetes including diabetic coma and ketoacidosis, have been reported during treatment with paliperidone.
Danish: Der er rapporteret om hyperglykæmi, diabetes mellitus og forværring af præeksisterende diabetes, herunder diabetisk koma og ketoacidose, under behandling med paliperidon.
English: In placebo-controlled trials, diabetes mellitus was reported in 0.32% in Xeplion-treated subjects compared to a rate of 0.39% in placebo group.
Danish: I placebokontrollerede studier blev diabetes mellitus rapporteret hos 0,32 % af de forsøgspersoner, som fik Xeplion, sammenlignet med 0,39 % i placebogruppen.
English: Paliperidone binds strongly to serotonergic 5-HT2and dopaminergic D2-receptors.
Danish: Paliperidon binder kraftigt til serotonerge 5-HT2og dopaminerge D2-receptorer.
English: Adverse reactions that may suggest increase in prolactin levels (e.g., amenorrhoea, galactorrhoea, menstrual disturbances, gynaecomastia) were reported overall in < 1% of subjects.
Danish: Bivirkninger, som kan være tegn på forhøjede niveauer af prolaktin (f.eks. amenoré, galaktoré, menstruationsforstyrrelser, gynækomasti), rapporteredes sammenlagt hos < 1 % af forsøgspersonerne.
English: Weight should be monitored regularly.
Danish: Patienterne skal vejes regelmæssigt.
English: The median apparent half-life of paliperidone following Xeplion administration over the dose range of 25-150 mg ranged from 25-49 days.
Danish: Den mediane tilsyneladende halveringstid for paliperidon efter Xeplionadministration over dosisintervallet 25-150 mg lå i intervallet 25-49 dage.
English: The experience from risperidone cited below is considered valid also for paliperidone.
Danish: De nedenfor anførte erfaringer med risperidon er også relevante for paliperidon.
English: During an operation on the eye for cloudiness of the lens (cataract), the pupil (the black circle in the middle of your eye) may not increase in size as needed.
Danish: Under operation i øjet for uklarhed af linsen (grå stær) er det muligt, at pupillen (den sorte prik i midten af øjet) ikke forstørres som nødvendigt.
English: If Xeplion is discontinued, its prolonged release characteristics must be considered.
Danish: Hvis behandling med Xeplion seponeres, skal der tages hensyn til dets forlængede frigivelse af lægemiddelstoffet.
English: Patients who are overweight or obese may require doses in the upper range (see section 5.2).
Danish: Patienter, som er overvægtige eller adipøse, kan have behov for doser i den øvre ende af intervallet (se pkt.
English: Overall incidence from all clinical trials was 0.65% in all paliperidone palmitate -treated subjects
Danish: Den samlede incidens fra alle kliniske studier var 0,65 % af alle forsøgspersoner, som fik paliperidonpalmitat.