FrancophonIA/ELRC3.0 huggingface dataset:
English: A change in the time of administration of INVEGA may improve the impact of sedation on the patient.
Danish: Ændring af tidspunktet for administration af INVEGA kan forbedre den sederende virkning på patienten.
English: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Danish: Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: The primary efficacy endpoint was defined as a decrease in total Positive and Negative Syndrome Scale (PANSS) scores as shown in the following table.
Danish: Det primære effektmål var defineret som et fald i samlet PANSS-score (Positive and Negative Syndrome Scale) som vist i nedenstående tabel.
English: The PANSS is a validated multi-item inventory composed of five factors to evaluate positive symptoms, negative symptoms, disorganised thoughts, uncontrolled hostility/excitement, and anxiety/depression.
Danish: PANSS er en valideret flerpunktsliste sammensat af fem faktorer til evaluering af positive symptomer, negative symptomer, forstyrrede tanker, ukontrolleret fjendtlighed/affekt og angst/depression.
English: The apparent clearance of paliperidone following INVEGA administration is approximately 19% lower in women than men.
Danish: Paliperidons tilsyneladende clearance efter administration af INVEGA er ca. 19 % lavere hos kvinder end hos mænd.
English: • life threatening complications of uncontrolled diabetes
Danish: • livstruende komplikationer ved ukontrolleret diabetes mellitus
English: A 15 mg dose was also included in Study R076477-SCH-305, but results are not presented since this is above the maximum recommended daily dose of 12 mg.
Danish: I studie R076477-SCH-305 blev der også inkluderet en dosis på 15 mg, men disse resultater vises ikke, eftersom dette er over den maksimale, anbefalede daglige dosis på 12 mg.
English: - if you have liver problems.
Danish: • hvis du har leverproblemer.
English: The patient should be instructed to always take INVEGA in the fasting state or always take it together with breakfast and not to alternate between administration in the fasting state or in the fed state.
Danish: Patienten bør vejledes om altid at indtage INVEGA fastende eller altid sammen med morgenmaden og ikke skifte mellem administration i fastende tilstand og i forbindelse med et måltid.
English: Note: Negative change in score indicates improvement.
Danish: Bemærk: Negativ ændring i score er tegn på forbedring.
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine.
Danish: Patienter med sjældne arvelige problemer med galactoseintolerans, Lapp lactase-mangel eller glucose/galactosemalabsorption bør ikke tage dette lægemiddel.
English: Paliperidone also blocks alfa1-adrenergic receptors and blocks, to a lesser extent, H1-histaminergic and alfa2-adrenergic receptors.
Danish: Paliperidon blokerer også alfa-1-adrenerge receptorer og blokerer i mindre grad H1histaminerge og alfa-2-adrenerge receptorer.
English: No interaction study between INVEGA and lithium has been performed, however, a pharmacokinetic interaction is unlikely to occur.
Danish: Der er ikke udført interaktionsstudier med INVEGA og lithium, men det er usandsynligt, at der vil forekomme farmakokinetisk interaktion.
English: There is no relevant use of INVEGA in children aged less than 12 years.
Danish: Det er ikke relevant at anvende INVEGA til børn under 12 år.
English: Manifestation of this increased sensitivity can include confusion, obtundation, postural instability with frequent falls, in addition to extrapyramidal symptoms.
Danish: Manifestationen af denne øgede sensitivitet kan omfatte forvirring, sløvhed, postural instabilitet med hyppige fald samt ekstrapyramidale symptomer.
English: Dizziness and vision problems may occur during treatment with this medicine (see section 4, possible side effects).
Danish: Der kan forekomme svimmelhed og synsproblemer under behandlingen med dette lægemiddel (se punkt 4, Bivirkninger).
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 to a lesser extent than traditional neuroleptics.
Danish: Selv om paliperidon er en kraftig D2-antagonist, som menes at lindre skizofreniens positive symptomer, medfører stoffet mindre katalepsi og nedsætter de motoriske funktioner i mindre grad end traditionelle antipsykotika.
English: Predefined secondary endpoints included the Personal and Social Performance (PSP) scale and the Clinical Global Impression - Severity (CGI-S) scale.
Danish: Forud definerede, sekundære effektmål omfattede PSP-score (Personal and Social Performance) og CGI-S-score (Clinical Global Impression - Severity).
English: 9/L) should discontinue INVEGA and have their WBC followed until recovery.
Danish: 9/l) skal INVEGA seponeres, og leukocyttallet skal følges indtil restitution.
English: Each bottle contains two silica gel pouches which are provided to absorb moisture and keep the tablets dry.
Danish: Hver beholder indeholder to silikagelposer, der absorberer fugt og holder tabletterne tørre.
English: • very low body temperature, a decrease in body temperature
Danish: • meget lav kropstemperatur, fald i kropstemperatur
English: Patients with kidney problems Your doctor may adjust your dose of this medicine based upon your kidney function.
Danish: Patienter med nyreproblemer Din læge kan justere din dosis af dette lægemiddel ud fra din nyrefunktion.
English: It binds primarily to α1-acid glycoprotein and albumin.
Danish: Det bindes primært til surt alfa-1-glykoprotein og albumin.
English: During cataract surgery, a condition called intraoperative floppy iris syndrome (IFIS) can happen if you take or have taken INVEGA.
Danish: Under operation for grå stær kan der forekomme en tilstand kaldet intraoperativt floppy iris syndrom (IFIS), hvis du bruger eller har brugt INVEGA.
English: Hyperglycemia and diabetes mellitus
Danish: Hyperglykæmi og diabetes mellitus
English: What you need to know before you take INVEGA
Danish: Det skal du vide, før du begynder at tage INVEGA
English: Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluid and/or sympathomimetic agents.
Danish: Hypotension og kredsløbskollaps bør behandles med passende foranstaltninger, f.eks. intravenøs væske og/eller sympatomimetika.
English: Elderly Your doctor may reduce your dose of medicine if your kidney function is reduced.
Danish: Ældre Din læge kan reducere din dosis af dette lægemiddel, hvis din nyrefunktion er nedsat.
English: - This medicine has not been studied in elderly patients with dementia.
Danish: • Dette lægemiddel er ikke undersøgt til ældre patienter med demens.
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 sådanne symptomer.
English: This effect was not observed after discontinuation of treatment.
Danish: Denne virkning sås ikke efter seponering.
English: If you forget to take INVEGA
Danish: Hvis du har glemt at tage INVEGA
English: Data from a pharmacokinetic study in elderly subjects (≥ 65 years of age, n = 26) indicated that the apparent steady-state clearance of paliperidone following INVEGA administration was 20% lower compared to that of adult subjects (18-45 years of age, n = 28).
Danish: Data fra et farmakokinetisk studie med ældre patienter (≥ 65 år, n = 26) indikerer, at paliperidons tilsyneladende steady state-clearance efter administration af INVEGA var 20 % lavere sammenlignet med voksne patienter (18-45 år, n = 28).
English: In vitro studies in human liver microsomes showed that paliperidone does not substantially inhibit the metabolism of medicines metabolised by cytochrome P450 isozymes, including CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4, and CYP3A5.
Danish: In vitrostudier med humane levermikrosomer har vist, at paliperidon ikke væsentligt hæmmer metaboliseringen af lægemidler, som metaboliseres af cytokrom P450-isozymer, herunder CYP1A2, CYP2A6, CYP2C8/9/10, CYP2D6, CYP2E1, CYP3A4 og CYP3A5.
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 INVEGA, 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 INVEGA, vil din læge muligvis kontrollere antallet af hvide blodlegemer i dit blod.
English: Moreover, in the pooled population, INVEGA was not efficacious in patients concomitantly receiving mood stabiliser and antidepressants in regard to the psychotic symptoms, but this population was small (30 responders in the paliperidone group and 20 responders in the placebo group).
Danish: Ydermere havde INVEGA i den samlede population ingen effekt på psykotiske symptomer hos patienter, der fik stemningsstabiliserende lægemidler og antidepressiva, men denne population var lille (30 respondenter i paliperidon-gruppen og 20 respondenter i placebogruppen).
English: * Medium dose group: 3 mg for subjects < 51 kg, 6 mg for subjects ≥ 51 kg ** High dose group: 6 mg for subjects < 51 kg, 12 mg for subjects ≥ 51 kg
Danish: * Middeldosisgruppe: 3 mg for deltagere < 51 kg, 6 mg for deltagere ≥51 kg **Højdosisgruppe: 6 mg for deltagere < 51 kg, 12 mg for deltagere ≥51 kg
English: A population pharmacokinetic analysis showed a slightly lower exposure to paliperidone in smokers compared with non-smokers.
Danish: En farmakokinetisk populationsanalyse har vist en lidt lavere eksponering for paliperidon hos rygere end hos ikke-rygere.
English: Maximum mean increases of serum prolactin concentrations were generally observed on day 15 of treatment, but remained above baseline levels at study endpoint.
Danish: Maksimal gennemsnitlig stigning i serumprolaktinkoncentrationen blev generelt observeret på dag 15 i behandlingen, men koncentrationen forblev over udgangsniveauet ved studiets afslutning.
English: Paliperidone did not impair the neurobehavioural development in males at doses up to 2.5 mg/kg/day.
Danish: Paliperidon hæmmede ikke den neuroadfærdsmæssige udvikling hos handyr ved doser op til 2,5 mg/kg/dag.
English: You should not breastfeed when taking this medicine.
Danish: Du må ikke amme, når du tager dette lægemiddel.
English: There is no specific antidote to paliperidone.
Danish: Der findes ingen specifik antidot mod paliperidon.
English: As diabetes mellitus or worsening of pre-existing diabetes mellitus have been seen with patients taking INVEGA, 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 INVEGA, skal din læge tjekke, om der er tegn på højt blodsukker.
English: The 3 mg tablet of this medicine contains lactose, a type of sugar.
Danish: 3 mg tabletten af dette lægemiddel indeholder lactose, som er en sukkertype.
English: Schizophrenia (adults)
Danish: Skizofreni (voksne)
English: INVEGA with alcohol Alcohol should be avoided when taking this medicine.
Danish: Brug af INVEGA sammen med alkohol Du bør undgå alkohol, når du tager dette lægemiddel.
English: Pregnancy There are no adequate data from the use of paliperidone during pregnancy.
Danish: Der foreligger ikke tilstrækkelige data om brugen af paliperidon hos gravide kvinder.
English: Injury, poisoning and procedural complications fall
Danish: Traumer, forgiftninger og behandlingskom plikationer
English: Because of the potential effects of prolonged hyperprolactinemia on growth and sexual maturation in adolescents, regular clinical evaluation of endocrinological status should be considered, including measurements of height, weight, sexual maturation, monitoring of menstrual functioning, and other potential prolactin-related effects.
Danish: På grund af den potentielle virkning af langvarig hyperprolaktinæmi på vækst og seksuel modning hos unge bør regelmæssig klinisk evaluering af den endokrinologiske status overvejes, herunder måling af højde, vægt, seksuel modning, monitorering af menstruel funktion og andre potentielle prolaktinrelaterede virkninger.
English: The European Medicines Agency has waived the obligation to submit the results of studies with INVEGA in all subsets of the paediatric population in the treatment of schizoaffective disorders.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med INVEGA i alle undergrupper af den pædiatriske population ved skizo-affektive psykoser.
English: Pharmacologic group: Psycholeptics, other antipsychotics ATC code: N05AX13
Danish: Farmakoterapeutisk klassifikation: Psykoleptika, andre antipsykotika ATC-kode: N05AX13
English: Paliperidone was not teratogenic in rat and rabbit.
Danish: Paliperidon var ikke teratogent hos rotter og kaniner.
English: Because the INVEGA tablet is non-deformable and does not appreciably change shape in the gastrointestinal tract, INVEGA should not ordinarily be administered to patients with preexisting severe gastrointestinal narrowing (pathologic or iatrogenic) or in patients with dysphagia or significant difficulty in swallowing tablets.
Danish: Eftersom INVEGA-tabletterne ikke er deformerbare og ikke væsentligt ændrer form i mave-tarmkanalen, bør INVEGA normalt ikke administreres til patienter med eksisterende svær gastrointestinal forsnævring (patologisk eller iatrogen) eller til patienter med dysfagi eller signifikant vanskelighed ved at sluge tabletter.
English: There have been rare reports of obstructive symptoms in patients with known strictures in association with the ingestion of medicines in non-deformable controlled-release formulations.
Danish: Der er rapporteret sjældne tilfælde af obstruktive symptomer hos patienter med kendt striktur i forbindelse med indtagelse af lægemidler i ikke-deformerbare depotformuleringer.
English: Caution is recommended if paliperidone is used in such patients.
Danish: Forsigtighed tilrådes ved brug af paliperidon til disse patienter.
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 der endnu ikke er påvist nogen klar forbindelse til antipsykotika i kliniske og epidemiologiske studier, bør der udvises forsigtighed hos patienter med en relevant anamnese.
English: Adolescents generally experienced side effects that were similar to those seen in adults except the following side effects were seen more commonly:
Danish: Unge oplever generelt bivirkninger magen til dem, der ses hos voksne, med undtagelse af følgende bivirkninger, der er hyppigere:
English: Do not take INVEGA - if you are allergic to paliperidone, risperidone, or any of the other ingredients of this medicine
Danish: Tag ikke INVEGA - hvis du er allergisk over for paliperidon, risperidon eller et af de øvrige indholdsstoffer i
English: During treatment with INVEGA regular examination for extrapyramidal symptoms and other movement disorders should also be conducted.
Danish: Under behandling med INVEGA bør der også udføres regelmæssige undersøgelser for ekstrapyramidale symptomer og andre bevægelsesforstyrrelser.
English: Paliperidone binds strongly to serotonergic 5-HT2and dopaminergic D2-receptors.
Danish: Paliperidon binder kraftigt til serotonerge 5-HT2-receptorer og dopaminerge D2receptorer.
English: Paliperidone systemic exposure in adolescent subjects (15 years and older) was comparable to that in adults.
Danish: Den systemiske eksponering for paliperidon hos unge (15 år og derover) var sammenlignelig med eksponeringen hos voksne.
English: Other special populations No dose adjustment for INVEGA is recommended based on gender, race, or smoking status.
Danish: Andre særlige befolkningsgrupper Der er ingen behov for dosisjustering af INVEGA på baggrund af køn, race eller rygning.
English: INVEGA is for oral administration.
Danish: INVEGA er beregnet til oral anvendelse.
English: Parkinson's disease and dementia with Lewy bodies Physicians should weigh the risks versus the benefits when prescribing INVEGA 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: Parkinsons sygdom og demens med Lewy-legemer Risici og fordele bør afvejes ved ordination af INVEGA til patienter med Parkinsons sygdom eller demens med Lewy-legemer, eftersom begge grupper kan have øget risiko for malignt neuroleptikasyndrom samt øget sensitivitet for antipsykotika.
English: However, because elderly patients may have diminished renal function, dose adjustments may be required according to their renal function status (see Renal impairment below).
Danish: Eftersom ældre patienter kan have nedsat nyrefunktion, kan der dog være behov for dosisjustering alt efter nyrefunktionsstatus (se afsnittet "Nedsat nyrefunktion" nedenfor).
English: You should not stop this medicine unless told to do so by your doctor as your symptoms may return.
Danish: Du må ikke holde op med at tage medicinen, medmindre det er aftalt med lægen, da dine symptomer ellers kan vende tilbage.
English: On initiation of carbamazepine, the dose of INVEGA should be re-evaluated and increased if necessary.
Danish: Ved start af behandling med carbamazepin skal doseringen af INVEGA reevalueres og om nødvendigt øges.
English: It must not be chewed, broken, or crushed.
Danish: De må ikke tygges, deles eller knuses.
English: • symptoms of drug withdrawal.
Danish: • symptomer i forbindelse med ophør med medicinen.
English: Paliperidone can have minor or moderate influence on the ability to drive and use machines due to potential nervous system and visual effects (see section 4.8).
Danish: Paliperidon påvirker i mindre eller moderat grad evnen til at føre motorkøretøj eller betjene maskiner som følge af en potentiel påvirkning af nervesystemet og synet (se pkt.
English: If discontinuation during pregnancy is necessary, it should not be done abruptly.
Danish: Hvis seponering under graviditet er nødvendig, bør den ske gradvist.
English: Paliperidone may antagonise the effect of levodopa and other dopamine agonists.
Danish: Paliperidon kan modvirke effekten af levodopa og andre dopaminagonister.
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 stor udstrækning forårsaget af en øgning i renal clearance af paliperidon med 35 %, sandsynligvis som et resultat af induktion af renal P-gp forårsaget af carbamazepin.
English: The changes in PANSS total scores from baseline to week 8 and week 26 were numerically similar between the INVEGA and aripiprazole treatment groups.
Danish: Ændringerne i samlet PANSS-score fra baseline til uge 8 og uge 26 var numerisk ens i hhv. INVEGA-armen og aripiprazol-armen.
English: Statistically superior improvements in manic symptoms as measured by YMRS (secondary efficacy scale) were observed in patients from the flexible-dose study and the INVEGA higher dose in the second study.
Danish: Statistisk signifikante forbedringer i maniske symptomer målt efter YMRS (sekundær effekt-skala) observeredes hos patienter fra studiet med fleksibel dosis og fra den højeste INVEGA-dosis i det andet studie.
English: Intraoperative floppy iris syndrome (IFIS) has been observed during cataract surgery in patients treated with medicines with alpha 1a-adrenergic antagonist effect, such as INVEGA (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 INVEGA (se pkt.
English: • decrease in the type of white blood cells that help to protect you against infection, increase in eosinophils (a type of white blood cell) in your blood
Danish: • fald i den type hvide blodlegemer, som beskytter dig mod infektion, stigning i antallet af eosinofile granulocytter (en type hvide blodlegemer) i blodet
English: Conditions with decreased gastro-intestinal transit time Conditions leading to shorter gastrointestinal transit time, e.g., diseases associated with chronic severe diarrhoea, may result in a reduced absorption of paliperidone.
Danish: Tilstande med mindsket gastrointestinal transittid Tilstande, som kan føre til kortere gastrointestinal transittid, f.eks. sygdomme associeret med svær kronisk diaré, kan medføre nedsat absorption af paliperidon.
English: Each bottle contains two 1 g dessicant silica gel (silicone dioxide) pouches (pouch is food approved polyethylene).
Danish: Hver beholder indeholder to poser à 1 g med tørremiddel af silicagel (silikonedioxid) (poserne er af fødevaregodkendt polyethylen).
English: In the up to 2-year, open-label treatment study of INVEGA in adolescents with schizophrenia, incidence of elevated serum prolactin levels occurred in 48% of females and 60% of males.
Danish: I det åbne studie af INVEGA-behandling i op til 2 år hos unge med skizofreni var incidensen af forhøjet serum-prolaktin 48 % hos piger og 60 % hos drenge.
English: In one short-term and two longer-term studies with paliperidone prolonged-release tablets conducted in adolescents 12 years and older with schizophrenia, the overall safety profile was similar to that seen in adults.
Danish: I et kortvarigt og to længerevarende studier med paliperidon-depottabletter hos unge på 12 år og derover med skizofreni var den overordnede sikkerhedsprofil den samme som hos voksne.
English: The following side effects have been seen with the use of another medicine called risperidone that is very similar to paliperidone, so these can also be expected with INVEGA: sleep-related eating disorder, other types of blood vessel problems in the brain and crackly lung sounds.
Danish: Følgende bivirkninger er observeret i forbindelse med brug af et andet lægemiddel kaldet risperidon, som ligner paliperidon meget, og derfor kan disse bivirkninger også forventes med dette lægemiddel: søvnrelateret spiseforstyrrelse, andre typer af blodkarproblemer i hjernen og knitrende lungelyde.
English: • decreased oxygen in parts of your body (because of decreased blood flow), flushing
Danish: • nedsat iltforsyning til dele af kroppen (på grund af nedsat blodgennemstrømning), blussen
English: Enrolled subjects 1) met DSM-IV criteria for schizoaffective disorder, as confirmed by the Structured Clinical Interview for DSM-IV Disorders, 2) had a Positive and Negative Syndrome Scale (PANSS) total score of at least 60, and 3) had prominent mood symptoms as confirmed by a score of at least 16 on the Young Mania Rating Scale (YMRS) and/or Hamilton Rating Scale 21 for Depression (HAM-D 21).
Danish: De rekrutterede forsøgspersoner 1) opfyldte DSM-IV kriterierne for skizo-affektiv psykose bekræftet ved Structured Clinical Interview for DSM-IV Disorders 2) havde en samlet score i Positiv og Negativ Syndrom-skala (PANSS) på mindst 60, og 3) havde fremtrædende stemningssymptomer bekræftet ved en score på mindst 16 på Young Mania Rating Scale (YMRS) og/eller Hamilton Rating Scale 21 for Depression (HAM-D 21).
English: Caution should be exercised when INVEGA is prescribed in patients with known cardiovascular disease or family history of QT prolongation, and in concomitant use with other medicines thought to prolong the QT interval.
Danish: Der bør udvises forsigtighed, når INVEGA ordineres til patienter med kendt kardiovaskulær sygdom eller familiær disposition til forlængelse af QT-intervallet og ved samtidig brug af andre lægemidler, som menes at forlænge QT-intervallet.