FrancophonIA/ELRC3.0 huggingface dataset:
English: • breakdown of muscle fibers and pain in muscles (rhabdomyolysis)
Danish: • nedbrydelse af muskelfibre og muskelsmerter (rhabdomyolyse)
English: Positive means an excess of symptoms that are not normally present.
Danish: Positive symptomer henviser til en række symptomer, som normalt ikke er til stede.
English: • tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue,
Danish: • tardiv dyskinesi (ukontrollerede, rykvise bevægelser, som du ikke kan kontrollere i ansigtet,
English: Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Total Score - Change From Baseline to End Point- LOCF for Studies R092670-SCH-201, R092670-PSY-3003, R092670-PSY-3004 and R092670-PSY-3007: Primary Efficacy Analysis Set Placebo
Danish: Samlet PANSS-score (Positive And Negative Syndrome Scale) for skizofreni - ændring fra baseline til endepunkt - LOCF for forsøgene R092670-SCH-201, R092670-PSY-3003, R092670-PSY-3004 og R092670-PSY-3007: Analysesæt for primær effekt
English: • symptoms of drug withdrawal
Danish: • symptomer i forbindelse med ophør af medicin
English: Even though paliperidone is a strong D2-antagonist, which is believed to relieve the positive symptoms of schizophrenia, it causes less catalepsy and decreases motor functions less than traditional neuroleptics.
Danish: Selvom paliperidon er en kraftig D2-antagonist, som menes at lindre de positive symptomer på skizofreni, forårsager det mindre katalepsi og nedsætter de motoriske funktioner mindre end typiske antipsykotika.
English: Xeplion is intended for intramuscular use only.
Danish: Xeplion er udelukkende beregnet til intramuskulær anvendelse.
English: • yellowing of the skin and the eyes (jaundice)
Danish: • gulfarvning af huden og øjnene (gulsot)
English: Consideration should be given to the prolonged release nature of the medicinal product and the long elimination half-life of paliperidone when assessing treatment needs and recovery.
Danish: Der skal tages hensyn til lægemidlets forlængede frigivelse af lægemiddelstoffet og den lange eliminationshalveringstid for paliperidon, når behandlingsbehov og restitution skal vurderes.
English: The potential benefit of stopping alpha 1 blocking therapy prior to cataract surgery has not been established and must be weighed against the risk of stopping the antipsychotic therapy.
Danish: Den potentielle fordel ved at seponere alfa-1-blokerende behandling før en kataraktoperation er ikke blevet fastlagt og skal afvejes mod risikoen ved at seponere den antipsykotiske behandling.
English: Paliperidone is not expected to cause clinically important pharmacokinetic interactions with medicinal products that are metabolised by cytochrome P-450 isozymes.
Danish: Paliperidon forventes ikke at forårsage klinisk vigtige farmakokinetiske interaktioner med lægemidler, der metaboliseres af cytochrom P-450-isozymer.
English: Patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur.
Danish: Patienter med klinisk signifikant neutropeni skal monitoreres nøje for feber og andre symptomer eller tegn på infektion og behandles øjeblikkeligt ved opståen af sådanne symptomer.
English: • are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.
Danish: • planlægger at få dit øje opereret; hvis det er tilfældet, skal du sørge for at fortælle øjenlægen, at du tager denne medicin.
English: There was a statistically significant increase in mammary gland adenocarcinomas in female rats at 10, 30 and 60 mg/kg/month.
Danish: Der sås en statistisk signifikant stigning i brystkirteladenokarcinomer i hunrotter ved 10, 30 og 60 mg/kg/måned.
English: The dose should not be given in divided injections.
Danish: Dosen må ikke fordeles på flere injektioner.
English: This decrease is caused, to a substantial degree, by a 35% increase in renal clearance of paliperidone likely as a result of induction of renal P-gp by carbamazepine.
Danish: Dette fald er i væsentlig grad forårsaget af en 35 % stigning i renal clearance af paliperidon, som sandsynligvis skyldes induktion af renalt P-gp ved hjælp af carbamazepin.
English: As dangerously low numbers of a certain type of white blood cell needed to fight infection in your blood has been seen very rarely with patients taking this medicine, your doctor may check your white blood cell counts.
Danish: Da et faretruende lavt antal af en bestemt type hvide blodlegemer, som er nødvendige for at bekæmpe infektioner i blodet, er observeret i meget sjældne tilfælde hos patienter, som fik dette lægemiddel, vil din læge muligvis kontrollere antallet af hvide blodlegemer i dit blod.
English: Significant weight gain has been reported with Xeplion use.
Danish: Der er rapporteret om signifikant vægtøgning ved brug af Xeplion.
English: If you have mild kidney problems your doctor may give you a lower dose.
Danish: Hvis du har lette nyreproblemer, kan din læge give dig en lavere dosis.
English: In vitro studies in human liver microsomes showed that paliperidone does not substantially inhibit the metabolism of medicinal products metabolised by cytochrome P450 isozymes, including CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4, and CYP3A5.
Danish: In vitro-forsøg i humane levermikrosomer viste, at paliperidon ikke i væsentlig grad hæmmer metabolismen af lægemidler, der metaboliseres af cytochrom P450-isozymer, herunder CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4 og CYP3A5.
English: • low blood pressure, low blood pressure upon standing (consequently, some people taking this medicine may feel faint, dizzy, or may pass out when they stand up or sit up suddenly)
Danish: • lavt blodtryk, blodtryksfald efter at have rejst sig op (derfor kan nogle personer, som tager dette lægemiddel, føle, at de skal besvime, være svimle eller besvime, hvis de rejser sig eller sætter sig op pludseligt)
English: Priapism
Danish: Priapisme
English: Following a single intramuscular dose, the plasma concentrations of paliperidone gradually rise to reach maximum plasma concentrations at a median Tmax of 13 days.
Danish: Efter en enkelt intramuskulær dosis stiger plasmakoncentrationerne af paliperidon gradvist, til de når de maksimale plasmakoncentrationer ved en median-Tmax på 13 dage.
English: The frequency of these adverse reactions is qualified as “not known” because they were not observed in paliperidone palmitate clinical trials.
Danish: Hyppigheden af disse bivirkninger er angivet som 'ikke kendt', da de ikke blev observeret under kliniske studier af paliperidonpalmitat.
English: As diabetes mellitus or worsening of pre-existing diabetes mellitus have been seen with patients taking this medicine, your doctor should check for signs of high blood sugar.
Danish: Da der er observeret sukkersyge (diabetes mellitus) eller forværring af allerede eksisterende diabetes mellitus hos patienter, som tager dette lægemiddel, skal din læge tjekke, om der er tegn på højt blodsukker.
English: Discontinuation of antipsychotic medicinal products should be made in accordance with appropriate prescribing information.
Danish: Seponering af behandling med antipsykotika bør foretages i henhold til relevant ordinationsinformation.
English: • inappropriate secretion of a hormone that controls urine volume
Danish: • unormal udskillelse af et hormon, som styrer urinmængden
English: Elimination of paliperidone decreased with decreasing estimated creatinine clearance.
Danish: Elimination af paliperidon faldt med faldende estimeret kreatininclearance.
English: If you are planning to have an operation on your eye, make sure you tell your eye doctor that you are taking this medicine.
Danish: Hvis du planlægger at blive opereret i øjet, skal du sørge for at informere øjenlægen om, at du bruger dette lægemiddel.
English: The carcinogenic potential of intramuscularly injected paliperidone palmitate was assessed in rats.
Danish: Det karcinogene potentiale ved intramuskulært injiceret paliperidonpalmitat blev vurderet hos rotter.
English: Paliperidone palmitate and paliperidone were not genotoxic.
Danish: Paliperidonpalmitat og paliperidon var ikke genotoksiske.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xeplion in all subsets of the paediatric population in schizophrenia.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Xeplion i alle undergrupper af den pædiatriske population ved skizofreni.
English: • white blood cell count decreased, decrease in the type of white blood cells that help to protect you against infection, decrease in platelets (blood cells that help you stop bleeding), anaemia
Danish: • nedsat antal hvide blodlegemer, fald i den type hvide blodlegemer, som beskytter dig mod infektion, nedsat antal blodplader (blodlegemer, der medvirker til at stoppe blødninger), anæmi
English: If you have any of these conditions, please talk to your doctor as he/she may want to adjust your dose or monitor you for a while.
Danish: Tal med din læge, hvis du har eller har haft en eller flere af disse tilstande, da lægen kan ønske at ændre din dosis eller overvåge dig i en periode.
English: This study included a 33-week open-label acute treatment and stabilisation phase, a randomised, double-blind placebo-controlled phase to observe for relapse, and a 52-week open-label extension period.
Danish: Dette forsøg omfattede en 33-ugers, åben akut behandlings- og stabiliseringsfase, en randomiseret, dobbeltblind placebokontrolleret fase til observation for recidiv og en 52-ugers åben forlængelsesperiode.
English: Larger decreases in plasma concentrations of paliperidone could occur with higher doses of carbamazepine.
Danish: Større fald i plasmakoncentrationerne af paliperidon kunne forekomme ved højere doser af carbamazepin.
English: The safety and efficacy of Xeplion in children and adolescents < 18 years of age have not been established.
Danish: Xeplions sikkerhed og virkning hos børn og unge under 18 år er ikke klarlagt.
English: Seek medical attention right away if you experience a rash, swelling of your throat, itching, or problems breathing as these may be signs of a serious allergic reaction.
Danish: Du skal straks søge læge, hvis du får udslæt, hævelse i svælg eller hals, kløe eller vejrtrækningsproblemer, da dette kan være tegn på en alvorlig allergisk reaktion.
English: Menstrual disorder includes: menstruation delayed, menstruation irregular, oligomenorrhoea
Danish: Menstruationsforstyrrelse omfatter: forsinket menstruation, uregelmæssig menstruation, oligomenorré
English: Xeplion is also available in a Treatment initiation pack which contains two pre-filled syringes (150 mg + 100 mg) and 2 additional safety needles.
Danish: Xeplion er også tilgængeligt i en pakning til behandlingsstart, som indeholder to fyldte sprøjter (150 mg + 100 mg) og 2 ekstra sikkerhedskanyler.
English: Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Danish: Studier i vævskulturer tyder på, at cellevækst i humane brysttumorer muligvis stimuleres af prolaktin.
English: Neuroleptic malignant syndrome
Danish: Malignt neuroleptikasyndrom
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: Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluid and/or sympathomimetic agents.
Danish: Hypotension og kredsløbskollaps skal behandles med relevante midler såsom intravenøs væske og/eller sympatomimetika.
English: Paliperidone may antagonise the effect of levodopa and other dopamine agonists.
Danish: Paliperidon kan modvirke virkningen af levodopa og andre dopaminagonister.
English: Each pack contains 2 pre-filled syringes:
Danish: Hver pakning indeholder 2 fyldte sprøjter:
English: Elderly Your doctor may reduce your dose of this medicine if your kidney function is reduced.
Danish: Ældre Din læge kan reducere din dosis af dette lægemiddel, hvis din nyrefunktion er nedsat.
English: The recommended needle size for initial and maintenance administration of Xeplion into the deltoid muscle is determined by the patient's weight.
Danish: Den anbefalede kanylestørrelse til start- og vedligeholdelsesadministration af Xeplion i musculus deltoideus afhænger af patientens vægt.
English: • irritability, depression, anxiety
Danish: • irritabilitet, depression, angst
English: Intraoperative floppy iris syndrome (IFIS) has been observed during cataract surgery in patients treated with medicinal products with alpha 1a-adrenergic antagonist effect, such as Xeplion (see section 4.8).
Danish: Intraoperativt floppy iris syndrom (IFIS) er observeret under kataraktoperation hos patienter, der behandles med lægemidler med alfa-1a-adrenerg antagonisteffekt, såsom Xeplion (se pkt.
English: • sleep-related eating disorder
Danish: • søvnrelateret spiseforstyrrelse
English: This effect, if it occurs in humans, may mask the signs and symptoms of overdosage with certain medicinal products or of conditions such as intestinal obstruction, Reye's syndrome and brain tumour.
Danish: Denne virkning kan, hvis den forekommer hos mennesker, skjule tegn og symptomer på overdosering med visse lægemidler eller på tilstande såsom intestinal obstruktion, Reyes syndrom og hjernetumor.
English: The following information is intended for medical or healthcare professionals only and should be read by the medical or healthcare professional in conjunction with the full prescribing information (Summary of Product Characteristics).
Danish: Nedenstående oplysninger er til læger og sundhedspersonale og skal læses af læger og sundhedspersonale sammen med alle ordinationsoplysningerne i produktresuméet.
English: During post-marketing surveillance, priapism has also been reported with oral paliperidone, which is the active metabolite of risperidone.
Danish: Ved overvågning efter markedsføring er der endvidere rapporteret om priapisme ved oral paliperidon, som er den aktive metabolit af risperidon.
English: Potential for Xeplion to affect other medicines
Danish: Xeplions potentiale for påvirkning af andre lægemidler
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including paliperidone, should be considered.
Danish: Hvis der fremkommer tegn og symptomer på tardiv dyskinesi, bør det overvejes at seponere al behandling med antipsykotika, herunder paliperidon.
English: What you need to know before you use Xeplion
Danish: Det skal du vide, før du begynder at bruge Xeplion
English: If the target date for the second Xeplion injection (day 8 ± 4 days) is missed, the recommended reinitiation depends on the length of time which has elapsed since the patient's first injection.
Danish: Hvis måldagen for den anden Xeplion-injektion (dag 8 ± 4 dage) forpasses, afhænger den anbefalede omstart af, hvor lang tid der er gået siden patientens første injektion.
English: Dominating central serotonin antagonism may reduce the tendency of paliperidone to cause extrapyramidal side effects.
Danish: Dominerende central serotoninantagonisme kan reducere paliperidons tendens til at forårsage ekstrapyramidale bivirkninger.
English: Physicians should weigh the risks versus the benefits when prescribing Xeplion to patients with Parkinson's Disease or Dementia with Lewy Bodies (DLB) since both groups may be at increased risk of Neuroleptic Malignant Syndrome as well as having an increased sensitivity to antipsychotics.
Danish: Læger bør nøje afveje risici og fordele ved ordination af Xeplion til patienter med Parkinsons sygdom eller Lewy body-demens (DLB), da begge grupper kan have en øget risiko for udvikling af malignt neuroleptikasyndrom samt have en øget følsomhed over for antipsykotika.
English: This medicine can reduce the effect of medicines against Parkinson's disease and restless legs syndrome (e.g., levodopa).
Danish: Dette lægemiddel kan reducere virkningen af lægemidler mod Parkinsons sygdom og uro i benene (f.eks. levodopa).
English: Refer to ‘Hyperprolactinaemia' below.
Danish: Se 'Hyperprolaktinæmi' nedenfor.
English: Xeplion is designed to deliver paliperidone over a monthly period while prolonged release oral paliperidone is administered on a daily basis.
Danish: Xeplion er udformet således, at det tilfører paliperidon over en periode på en måned, mens oral depotpaliperidon administreres på daglig basis.
English: * For Study R092670-PSY-3007 an initiation dose of 150 mg was given to all subjects in the Xeplion treatment groups on day 1 followed by the assigned dose afterwards.
Danish: * I forsøg R092670-PSY-3007 blev der givet en startdosis på 150 mg til alle forsøgspersoner i Xeplion-behandlingsgrupperne på dag 1, efterfulgt af den tildelte dosis derefter.
English: Each injection should be administered by a health care professional.
Danish: Alle injektioner skal administreres af en læge eller andet sundhedspersonale.
English: On initiation of carbamazepine, the dose of Xeplion should be re-evaluated and increased if necessary.
Danish: Ved start på behandling med carbamazepin bør dosen af Xeplion revurderes og om nødvendigt øges.
English: Since no effect on the systemic clearance was observed, a clinically significant interaction would not be expected between divalproex sodium prolonged release tablets and Xeplion intramuscular injection.
Danish: Da der ikke blev observeret nogen effekt på den systemiske clearance, er det ikke forventeligt, at der er klinisk signifikant interaktion mellem divalproexnatrium-depottabletter og intramuskulær injektion af Xeplion.
English: There are no adequate data from the use of paliperidone during pregnancy.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af paliperidon til gravide kvinder.
English: • high blood sugar, weight gain, weight loss, decreased appetite
Danish: • højt blodsukker, vægtstigning, vægttab, nedsat appetit
English: Medicinal products 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 sat i forbindelse med induktion af tardiv dyskinesi, som er kendetegnet ved rytmiske, ufrivillige bevægelser, hovedsagelig af tungen og/eller ansigtet.
English: Although no clear association with the administration of antipsychotics has so far been demonstrated in clinical and epidemiological studies, caution is recommended in patients with relevant medical history.
Danish: Selvom kliniske og epidemiologiske forsøg indtil videre ikke har vist nogen klar sammenhæng med administration af antipsykotika, anbefales det at udvise forsigtighed hos patienter med en relevant medicinsk anamnese.
English: In animals treated with paliperidone palmitate an inflammatory reaction was seen at the intramuscular injection site.
Danish: Hos dyr behandlet med paliperidonpalmitat observeredes en inflammatorisk reaktion på det intramuskulære injektionssted.
English: Therefore, alternatively, it could be considered to give deltoid injections for the first 6 months.
Danish: Derfor kan det som alternativ overvejes at give injektioner i musculus deltoideus i de første 6 måneder.
English: Based on a limited number of observations with Xeplion in subjects with mild renal impairment and pharmacokinetic simulations, a reduced dose is recommended (see section 4.2).
Danish: Baseret på et begrænset antal observationer med Xeplion hos forsøgspersoner med let nedsat nyrefunktion og farmakokinetiksimuleringer anbefales en reduceret dosis (se pkt.
English: These tumours can be related to prolonged dopamine D2 antagonism and hyperprolactinemia.
Danish: Disse tumorer kan relateres til langvarig dopamin-D2-antagonisme og hyperprolaktinæmi.
English: • restlessness, feeling sleepy, or less alert
Danish: • følelse af rastløshed, søvnighed eller af at være mindre kvik
English: This medicine has not been studied in elderly patients with dementia.
Danish: Dette lægemiddel er ikke undersøgt hos ældre patienter med demens.
English: If a patient develops signs or symptoms indicative of NMS, paliperidone should be discontinued.
Danish: Hvis en patient udvikler tegn eller symptomer på MNS, skal paliperidon seponeres.
English: Caution should be exercised when paliperidone is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicinal products thought to prolong the QT interval.
Danish: Der skal udvises forsigtighed ved ordination af paliperidon til patienter med kendt kardiovaskulær sygdom eller en familieanamnese med QT-forlængelse, og ved samtidig brug af andre lægemidler, der menes at forlænge QT-intervallet.
English: Antipsychotic medicinal products (including risperidone) with alpha-adrenergic blocking effects have been reported to induce priapism.
Danish: Det er rapporteret, at antipsykotiske lægemidler (herunder risperidon) med alfa-adrenergt blokerende virkninger inducerer priapisme.
English: Subjects initially received flexible doses (25-100 mg) of Xeplion during a 9-week transition period, followed by a 24-week maintenance period, where subjects were required to have a PANSS score of ≤ 75.
Danish: Forsøgspersonerne fik indledningsvist fleksible doser (25-100 mg) af Xeplion i en 9-ugers overgangsperiode, efterfulgt af en 24-ugers vedligeholdelsesperiode, hvor det blev krævet, at forsøgspersonerne havde en PANSS-score på ≤ 75.
English: Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Danish: Denne øgede følsomhed kan manifestere sig ved konfusion, bevidsthedssvækkelse, postural ustabilitet med hyppige fald samt ekstrapyramidale symptomer.
English: Due to its extremely low water solubility, paliperidone palmitate dissolves slowly after intramuscular injection before being hydrolysed to paliperidone and absorbed into the systemic circulation.
Danish: På grund af paliperidonpalmitats ekstremt lave vandopløselighed opløses det langsomt efter intramuskulær injektion, før det hydrolyseres til paliperidon og absorberes til det systemiske kredsløb.
English: • Xeplion can raise your levels of a hormone called "prolactin" found on a blood test (which may or may not cause symptoms).
Danish: • Xeplion kan medføre en stigning i niveauet af et hormon, som kaldes "prolaktin", som påvises ved en blodprøve (medfører ikke altid symptomer).
English: However, because elderly patients may have diminished renal function, dose adjustment may be necessary (see Renal impairment below for dosing recommendations in patients with renal impairment).
Danish: Da ældre patienter kan have nedsat nyrefunktion, kan dosisjustering dog være nødvendig (se Nedsat nyrefunktion nedenfor for anbefalinger vedr.
English: Since this medicine works primarily in the brain, interference from other medicines that work in the brain can cause an exaggeration of side effects such as sleepiness or other effects on the brain such as other psychiatric medications, opioids, antihistamines and sleep medication.
Danish: Da dette lægemiddel primært virker i hjernen, kan andre lægemidler, der ligeledes virker i hjernen, medføre en forstærkning af bivirkninger, som f.eks. søvnighed eller andre virkninger på hjernen som f.eks. andre antipsykotika, opioider, antihistaminer og sovemidler.
English: If you are prone to develop convulsions, this medicine may increase your chance of experiencing them.
Danish: Hvis du har tendens til at få krampeanfald, kan dette lægemiddel forøge risikoen for, at de forekommer.
English: • dangerously excessive intake of water
Danish: • faretruende stor indtagelse af vand
English: • a reaction at the injection site, including itching, pain or swelling.
Danish: • reaktioner på injektionsstedet, herunder kløe, smerter eller hævelse.