FrancophonIA/ELRC3.0 huggingface dataset:
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 karcinogenicitetsforsøg med oral risperidon til rotter og mus blev der observeret stigninger i hypofyseadenomer (mus), endokrine pankreasadenomer (rotte) og brystkirteladenomer (begge arter).
English: Co-administration of oral paliperidone prolonged release tablets at steady-state (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: Administration of orale paliperidon depottabletter ved steady-state (12 mg en gang dagligt) sammen med divalproexnatrium-depottabletter (500 mg til 2000 mg en gang dagligt) havde ingen indvirkning på steady state-farmakokinetikken for valproat.
English: Population pharmacokinetics analysis of data from studies with oral paliperidone revealed no evidence of race-related differences in the pharmacokinetics of paliperidone following Xeplion administration.
Danish: Farmakokinetiske populationsanalyser af data fra forsøg med oral paliperidon viste ingen tegn på racerelaterede forskelle i paliperidons farmakokinetik efter Xeplion-administration.
English: Thereafter, the monthly maintenance injections can be administered in either the DELTOID or GLUTEAL muscle using the appropriate needle for the injection site.
Danish: Derefter kan de månedlige vedligeholdelsesinjektioner gives i enten MUSCULUS DELTOIDEUS eller MUSCULUS GLUTEUS med anvendelse af en kanyle bestemt til injektionsstedet.
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 Xeplion 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 signifikante fald i leukocytter uden af andre årsagsfaktorer skal det overvejes seponere Xeplion.
English: • skin inflammation caused by mites, abscess under the skin
Danish: • betændelse i huden som skyldes mider, bylder under huden
English: Long acting paliperidone palmitate injection versus oral prolonged release paliperidone
Danish: Langtidsvirkende paliperidonpalmitat-injektion versus oral depot-paliperidon
English: Based on experience with oral paliperidone, no dose adjustment is required in patients with mild or moderate hepatic impairment.
Danish: På baggrund af erfaring med oral paliperidon er dosisjustering ikke påkrævet til patienter med let til moderat nedsat leverfunktion.
English: Use in patients with prolactin-dependent tumours
Danish: Anvendelse til patienter med prolaktin-afhængige tumorer
English: • accumulation of pus caused by infection at injection site, deep skin infection, a cyst at injection site, bruising at injection site.
Danish: • ophobning af pus på grund af infektion på injektionsstedet, dyb hudinfektion, cyste på injektionsstedet, blodudtrædning på injektionsstedet.
English: When making dose adjustments, the prolonged release characteristics of Xeplion should be considered (see section 5.2), as the full effect of maintenance doses may not be evident for several months.
Danish: 5.2), da den fulde virkning af vedligeholdelsesdoser muligvis ikke er tydelig i adskillige måneder.
English: • chapped lips
Danish: • sprukne læber
English: The combined use of psychostimulants (e.g., methylphenidate) with paliperidone can lead to extrapyramidal symptoms upon change of either or both treatments (see section 4.4).
Danish: Kombineret brug af psykostimulanser (f.eks. methylphenidat) og paliperidon kan medføre ekstrapyramidale symptomer efter ændring af den ene eller begge behandlinger (se pkt.
English: • lack of emotion
Danish: • manglende evne til at vise følelser
English: Missed second initiation dose (> 7 weeks from first injection) If more than 7 weeks have elapsed since the first injection of Xeplion, initiate dosing as described for the initial recommended initiation of Xeplion above.
Danish: Manglende anden startdosis (> 7 uger efter første injektion) Hvis der er gået mere end 7 uger siden den første injektion af Xeplion, startes behandlingen som beskrevet for den indledende anbefalede start på Xeplion ovenfor.
English: While it can involve any part of the body (and may result in abnormal posture), dystonia often involves muscles of the face, including abnormal movements of the eyes, mouth, tongue or jaw.
Danish: Dystoni kan omfatte alle dele af kroppen (og kan medføre en unormal kropsholdning), men involverer dog oftest ansigtsmusklerne, herunder unormale øjen-, mund-, tunge- eller kæbebevægelser (grimasser)
English: Although Xeplion was not studied on patients with hepatic impairment, no dose adjustment is required in patients with mild or moderate hepatic impairment.
Danish: Selvom Xeplion ikke er blevet undersøgt på patienter med nedsat leverfunktion, er dosisjustering ikke nødvendig hos patienter med let til moderat nedsat leverfunktion.
English: Paliperidone has not been studied in patients with severe hepatic impairment.
Danish: Paliperidon er ikke undersøgt hos patienter med svært nedsat leverfunktion.
English: Hyperprolactinaemia
Danish: Hyperprolaktinæmi
English: Extrapyramidal symptoms (EPS)
Danish: Ekstrapyramidale bivirkninger (EPS)
English: 59% of the dose was excreted unchanged into urine, indicating that paliperidone is not extensively metabolised in the liver.
Danish: C-paliperidon med øjeblikkelig frigivelse udskiltes 59 % af dosen uændret i urinen, hvilket indikerer, at paliperidon ikke gennemgår omfattende metabolisering i leveren.
English: Refer to ‘Extrapyramidal symptoms' below.
Danish: Se 'Ekstrapyramidale bivirkninger' nedenfor.
English: Co-administration of a single dose of an oral paliperidone prolonged release tablet 12 mg with divalproex sodium prolonged release tablets (two 500 mg tablets once daily) resulted in an increase of approximately 50% in the Cmax and AUC of paliperidone, likely as a result of increased oral absorption.
Danish: Administration af en enkelt dosis af en oral 12 mg paliperidon depottablet sammen med divalproexnatrium-depottabletter (to 500 mg tabletter en gang dagligt) resulterede i en stigning på ca. 50 % i Cmax og AUC for paliperidon, hvilket sandsynligvis skyldes øget oral absorption.
English: It should be injected slowly, deep into the deltoid or gluteal muscle.
Danish: Det skal injiceres langsomt, dybt ind i musculus deltoideus eller musculus gluteus maximus.
English: Total clearance of paliperidone was reduced in subjects with impaired renal function by 32% on average in mild (CrCl = 50 to < 80 mL/min), 64% in moderate (CrCl = 30 to < 50 mL/min), and 71% in severe (CrCl = 10 to < 30 mL/min) renal impairment, corresponding to an average increase in exposure (AUCinf) of 1.5, 2.6, and 4.8 fold, respectively, compared to healthy subjects.
Danish: Hos forsøgspersoner med nedsat nyrefunktion var total clearance af paliperidon reduceret med 32 % i gennemsnit ved let (CrCl = 50 til < 80 ml/min), 64 % ved moderat (CrCl = 30 til < 50 ml/min) og 71 % ved svært (CrCl = 10 til < 30 ml/min) nedsat nyrefunktion svarende til en gennemsnitlig stigning i eksponering (AUCinf) på henholdsvis 1,5, 2,6 og 4,8 gange sammenlignet med raske personer.
English: During the 33-week open-label transition/maintenance period of the long-term recurrence prevention trial, 12% of Xeplion-treated subjects met this criterion (weight gain of ≥ 7% from double-blind phase to endpoint); the mean (SD) weight change from open-label baseline was + 0.7 (4.79) kg.
Danish: I løbet af den 33 uger lange åbne transitions-/vedligeholdelsesperiode af forsøget med langtidsforebyggelse af tilbagefald opfyldte 12 % af de Xeplion-behandlede forsøgspersoner dette kriterium (vægtstigning på  7 % fra den dobbeltblinde fase til endepunktet).
English: Reporting suspected adverse reactions after authorisation of the medical product is important.
Danish: Når lægemidlet er godkendt, er indberetning af formodede bivirkninger vigtig.
English: Thereafter, you will receive an injection (ranging from 25 mg to 150 mg) in either the upper arm or buttocks once a month.
Danish: Derefter vil du få en injektion (på mellem 25 mg og 150 mg) enten i overarmen eller ballen én gang om måneden.
English: Discard the syringe with needle appropriately.
Danish: Bortskaf sprøjten med kanyle på passende vis.
English: • neuroleptic malignant syndrome (confusion, reduced or loss of consciousness, high fever, and severe muscle stiffness), blood vessel problems in the brain, including sudden loss of blood supply to brain (stroke or "mini" stroke), unresponsive to stimuli, loss of consciousness, low level of consciousness, convulsion (fits), balance disorder
Danish: • malignt neuroleptikasyndrom (forvirring, nedsat eller tab af bevidsthed, høj feber og svær muskelstivhed), problemer med blodkarrene i hjernen, herunder pludseligt tab af blodforsyning til hjernen (slagtilfælde eller "mini-slagtilfælde"), manglende respons på stimuli,
English: How to use Xeplion
Danish: Sådan skal du bruge Xeplion
English: For patients with mild renal impairment (creatinine clearance ≥ 50 to < 80 mL/min), recommended initiation of Xeplion is with a dose of 100 mg on treatment day 1 and 75 mg one week later, both administered in the deltoid muscle.
Danish: Til patienter med let nedsat nyrefunktion (kreatininclearance ≥ 50 til < 80 ml/min) anbefales det at starte med en dosis Xeplion på 100 mg på behandlingsdag 1 og 75 mg én uge senere, begge administreret i musculus deltoideus.
English: Although in vitro studies suggested a role for CYP2D6 and CYP3A4 in the metabolism of paliperidone, there is no evidence in vivo that these isozymes play a significant role in the metabolism of paliperidone.
Danish: Selvom in vitro-forsøg tydede på, at CYP2D6 and CYP3A4 spiller en rolle i metabolismen af paliperidon, er det ikke dokumenteret in vivo, at disse isozymer spiller en signifikant rolle i metabolismen af paliperidon.
English: During monthly maintenance treatment with Xeplion, patients previously stabilised on different doses of paliperidone prolonged release tablets can attain similar paliperdone steady-state exposure by injection.
Danish: Under den månedlige vedligeholdelsesbehandling med Xeplion kan patienter, der tidligere er stabiliseret på forskellige doser af paliperidon depottabletter, opnå en tilsvarende steady-state-eksponering for paliperidon med injektion.
English: • incontinence (lack of control) of urine, frequent passing of urine, pain when passing urine
Danish: • urininkontinens (ufrivillig vandladning), hyppig vandladning, smerter ved vandladning
English: Ear and labyrinth disorders vertigo, tinnitus, ear pain
Danish: Øre og labyrint vertigo, tinnitus, øresmerter
English: Xeplion is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min) (see section 4.4).
Danish: Xeplion anbefales ikke til patienter med moderat eller svært nedsat nyrefunktion (kreatininclearance < 50 ml/min) (se pkt.
English: Attach the safety needle to the luer connection of the syringe with an easy clockwise twisting motion.
Danish: Sæt sikkerhedskanylen på sprøjtens luerstykke med en let vridende bevægelse i retning med uret.
English: Paliperidone is the active metabolite of risperidone, therefore, the adverse reaction profiles of these compounds (including both the oral and injectable formulations) are relevant to one another.
Danish: Derfor er bivirkningsprofilen for disse stoffer (herunder både den orale og injicerbare formulering) relevant for hinanden.
English: should discontinue Xeplion and have their WBC followed until recovery.
Danish: 9/l) skal Xeplion seponeres, og leukocyttallet skal følges indtil restitution.
English: A third Xeplion injection of 75 mg in either the deltoid or gluteal muscles should be administered 5 weeks after the first injection (regardless of the timing of the second injection).
Danish: Der skal administreres en tredje Xeplioninjektion på 75 mg i enten musculus deltoideus eller gluteus maximus 5 uger efter den første injektion (uanset tidspunktet for den anden injektion).
English: Deltoid injections should be alternated between the two deltoid muscles.
Danish: Injektioner i musculus deltoideus bør veksle mellem de to skuldermuskler.
English: Xeplion 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: Xeplion skal anvendes med forsigtighed til patienter med kendt kardiovaskulær sygdom (f.eks. hjerteinsufficiens, myokardieinfarkt eller iskæmi, ledningsforstyrrelser), cerebrovaskulær sygdom eller tilstande, der prædisponerer patienten for hypotension (f.eks. dehydrering og hypovolæmi).
English: De-aerate the syringe by moving the plunger rod carefully forward.
Danish: Fjern luftbobler i sprøjten ved at presse stemplet forsigtigt fremad.
English: Events of leucopenia, neutropenia, and agranulocytosis have been reported with Xeplion.
Danish: Der er rapporteret tilfælde af leukopeni, neutropeni og agranulocytose med Xeplion.
English: Class effects
Danish: Klasseeffekter
English: Recommended initiation of Xeplion is with a dose of 150 mg on treatment day 1 and 100 mg one week later (day 8), both administered in the deltoid muscle in order to attain therapeutic concentrations rapidly (see section 5.2).
Danish: En anbefalet start på Xeplion er en dosis på 150 mg på behandlingsdag 1 og 100 mg én uge senere (dag 8), hvor begge administreres i musculus deltoideus for hurtigt at opnå terapeutiske koncentrationer (se pkt.
English: • hardening of the skin
Danish: • hård infiltration i huden
English: Patients previously stabilised on different doses of risperidone long acting injection can attain similar paliperidone steady-state exposure during maintenance treatment with Xeplion monthly doses according to the following:
Danish: Patienter, der tidligere er stabiliseret på forskellige doser risperidon som langtidsvirkende injektion, kan opnå en tilsvarende steady-state-eksponering for paliperidon under vedligeholdelsesbehandling med månedlige doser af Xeplion i henhold til følgende:
English: • severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure
Danish: • svær allergisk reaktion kendetegnet ved feber, hævelse af munden, ansigtet, læberne eller tungen, kortåndethed, kløe, udslæt og undertiden blodtryksfald
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 af eller begge lægemidler.
English: • experience a severe allergic reaction characterised by fever, swollen mouth, face, lip or tongue, shortness of breath, itching, skin rash and sometimes drop in blood pressure (amounting to an ‘anaphylactic reaction').
Danish: • oplever en svær allergisk reaktion, som er kendetegnet ved feber, hævet mund, ansigt, læbe eller tunge, stakåndethed, kløe, hududslæt og undertiden fald i blodtrykket (hvilket også kaldet en "anafylaktisk reaktion").
English: Rarely, cases of anaphylactic reaction after injection with Xeplion have been reported during post-marketing experience in patients who have previously tolerated oral risperidone or oral paliperidone (see section 4.4).
Danish: Der er i sjældne tilfælde efter markedsføring rapporteret om anafylaktisk reaktion efter injektion af Xeplion hos patienter, der tidligere har tålt oral risperidon eller oral paliperidon (se pkt.
English: Xeplion has not been systematically studied in patients with renal impairment (see section 5.2).
Danish: Xeplion er ikke blevet systematisk undersøgt hos patienter med nedsat nyrefunktion (se pkt.
English: Citric acid monohydrate Disodium hydrogen phosphate anhydrous Sodium dihydrogen phosphate monohydrate Sodium hydroxide (for pH adjustment) Water for injections
Danish: Citronsyremonohydrat Vandfrit dinatriumhydrogenphosphat Natriumdihydrogenphosphatmonohydrat Natriumhydroxid (til pH-justering) Vand til injektionsvæsker
English: Given the primary central nervous system (CNS) effects of paliperidone (see section 4.8), Xeplion should be used with caution in combination with other centrally acting medicinal products, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.
Danish: 4.8) bør Xeplion anvendes med forsigtighed i kombination med andre centralt virkende lægemidler, f.eks. anxiolytika, de fleste antipsykotika, hypnotika, opiater osv. eller alkohol.
English: No interaction study between Xeplion and lithium has been performed, however, a pharmacokinetic interaction is not likely to occur.
Danish: Der er ikke udført interaktionsundersøgelser mellem Xeplion og lithium.
English: Hypersensitivity to the active substance, to risperidone or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, over for risperidon eller over for et eller flere af hjælpestofferne anført i pkt.
English: • increased liver transaminases in your blood
Danish: • forhøjede leveraminotransferaser i blodet
English: If the patient is being switched from risperidone long acting injection to Xeplion, the first injection of Xeplion (ranging from 25 mg to 150 mg) can be administered in either the DELTOID or GLUTEAL muscle using the appropriate needle for the injection site at the time of the next scheduled injection.
Danish: Hvis patienten skiftes fra injektion af langtidsvirkende risperidon til Xeplion, kan den første injektion af Xeplion (i intervallet fra 25 mg til 150 mg) gives i enten MUSCULUS DELTOIDEUS eller MUSCULUS GLUTEUS med anvendelse af en kanyle bestemt til injektionsstedet, på tidspunktet for næste planlagte injektion.
English: Caution is advised when prescribing Xeplion with medicinal products known to prolong the QT interval, e.g. class IA antiarrhythmics (e.g., quinidine, disopyramide) and class III antiarrhythmics (e.g. amiodarone, sotalol), some antihistaminics, some other antipsychotics and some antimalarials (e.g. mefloquine).
Danish: Der bør udvises forsigtighed ved ordination af Xeplion sammen med lægemidler, der forlænger QTintervallet, f.eks. klasse IA-antiarytmika (f.eks. kinidin, disopyramid) og klasse III-antiarytmika (f.eks. amiodaron, sotalol), visse antihistaminer, visse andre antipsykotika og visse midler mod malaria (f.eks. mefloquin).
English: Intramuscular use
Danish: Intramuskulær anvendelse
English: The absolute bioavailability of paliperidone palmitate following Xeplion administration is 100%.
Danish: Efter administration af Xeplion er den absolutte biotilgængelighed af paliperidonpalmitat 100 %.
English: 50 mg every 2 weeks
Danish: 50 mg hver 2. uge
English: Excipients: Polysorbate 20, Polyethylene glycol 4000, Citric acid monohydrate, Disodium hydrogen phosphate anhydrous, Sodium dihydrogen phosphate monohydrate, Sodium hydroxide, Water for injections.
Danish: Hjælpestoffer: Polysorbat 20, polyethylenglycol 4000, citronsyremonohydrat, dinatriumhydrogenphosphat vandfri, natriumdihydrogenphosphatmonohydrat, natriumhydroxid, vand til injektionsvæsker.
English: There were no relevant effects observed in the non-clinical studies.
Danish: I de prækliniske forsøg blev der ikke set relevante virkninger.
English: Vascular disorders hypertension hypotension, orthostatic hypotension venous thrombosis, flushing pulmonary embolism, ischaemia
Danish: Vaskulære sygdomme hypertension hypotension, ortostatisk hypotension venetrombose, blussen lungeemboli, iskæmi
English: What Xeplion contains
Danish: Xeplion indeholder:
English: Xeplion should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Danish: Xeplion bør anvendes med forsigtighed til patienter med tidligere tilfælde af krampeanfald eller andre tilstande i anamnesen, som potentielt kan sænke krampetærkslen.
English: Because of its potential for inducing orthostatic hypotension (see section 4.4), an additive effect may be observed when Xeplion is administered with other therapeutic agents that have this potential, e.g., other antipsychotics, tricyclics.
Danish: 4.4) kan der muligvis observeres en additiv virkning ved administration af Xeplion sammen med andre terapeutiske stoffer, der har dette potentiale, f.eks. andre antipsykotika, tricykliske stoffer.
English: • fever, weakness, fatigue (tiredness)
Danish: • feber, svaghed, træthed
English: • an increase in body temperature
Danish: • forhøjet legemstemperatur
English: The second initiation dose of Xeplion (100 mg) is to also be administered in the DELTOID muscle one week later (Day 8) using the needle for DELTOID injection.
Danish: Den anden initieringsdosis af Xeplion (100 mg) skal også gives i MUSCULUS DELTOIDEUS én uge senere (dag 8) med en kanyle til injektion i MUSCULUS DELTOIDEUS.
English: Even if you have previously tolerated oral risperidone or oral paliperidone, rarely allergic reactions occur after receiving injections of paliperidone.
Danish: Selv om du tidligere har kunnet tåle oral risperidon eller oral paliperidon, er der i sjældne tilfælde forekommet allergiske reaktioner efter injektion af paliperidon.
English: Undesirable effects noted with risperidone formulations
Danish: Bivirkninger observeret med lægemidler indeholdende risperidon
English: Pre-filled syringe (cyclic-olefin-copolymer) with a plunger stopper, backstop, and tip cap (bromobutyl rubber) with a 22G 1½-inch safety needle (0.72 mm x 38.1 mm) and a 23G 1-inch safety needle (0.64 mm x 25.4 mm).
Danish: Fyldt injektionssprøjte (cyklisk-olefin-copolymer) med en stempelstopper, bagstopper og spidshætte (brombutylgummi) med en 22G 1½" sikkerhedskanyle (0,72 mm x 38,1 mm) og en 23G 1" sikkerhedskanyle (0,64 mm x 25,4 mm).
English: CARDBOARD CARTON (100 mg PRE-FILLED SYRINGE, COMPONENT OF TREATMENT INITIATION PACK - WITHOUT BLUE BOX)
Danish: PAPÆSKE (100 mg FYLDT INJEKTIONSSPRØJTE, KOMPONENT I PAKNING TIL BEHANDLINGSSTART - UDEN DANSKE KRAV TIL ”BLÅ BOKS”)
English: Xeplion 25 mg prolonged release suspension for injection Xeplion 50 mg prolonged release suspension for injection Xeplion 75 mg prolonged release suspension for injection Xeplion 100 mg prolonged release suspension for injection Xeplion 150 mg prolonged release suspension for injection
Danish: Xeplion 25 mg depotinjektionsvæske, suspension Xeplion 50 mg depotinjektionsvæske, suspension Xeplion 75 mg depotinjektionsvæske, suspension Xeplion 100 mg depotinjektionsvæske, suspension Xeplion 150 mg depotinjektionsvæske, suspension
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: Ældre patienter med demens, som blev behandlet med andre atypiske antipsykotika, herunder risperidon, aripiprazol, olanzapin and quetiapin, havde i en metaanalyse af 17 kontrollerede kliniske forsøg en øget mortalitetsrisiko sammenlignet med placebo.
English: These may be signs of a stroke.
Danish: Disse symptomer kan være tegn på et slagtilfælde.
English: • fast, shallow breathing, pneumonia caused by inhaling food, voice disorder
Danish: • hurtig overfladisk vejrtrækning, lungebetændelse på grund af fejlsynkning af mad, ændret stemme