FrancophonIA/ELRC3.0 huggingface dataset:
English: • diabetes or worsening diabetes, high blood sugar, increased waist size, loss of appetite resulting in malnutrition and low body weight, high blood triglycerides (a fat)
Danish: • sukkersyge (diabetes mellitus) eller forværret diabetes mellitus, højt blodsukker, øget livvidde, appetittab med deraf følgende dårlig ernæringstilstand og lav vægt, højt niveau af triglycerider (fedtstoffer) i blodet
English: Manufacturer Janssen-Cilag SpA Via C. Janssen 04100 Borgo San Michele Latina
Danish: Janssen-Cilag SpA Via C. Janssen 04100 Borgo San Michele Latina
English: Fertility There were no relevant effects observed in the non-clinical studies.
Danish: Fertilitet De prækliniske studier viste ingen relevante virkninger.
English: Appropriate care is advised when prescribing INVEGA to patients who will be experiencing conditions which may contribute to an elevation in core body temperature, e.g., exercising strenuously, exposure to extreme heat, receiving concomitant medication with anticholinergic activity, or being subject to dehydration.
Danish: Der bør udvises forsigtighed ved ordination af INVEGA til patienter, som forventes at opleve forhold, der kan bidrage til en forøgelse af kroppens kernetemperatur, f.eks. kraftig fysisk aktivitet, eksponering for kraftig varme, samtidig indtagelse af lægemidler med antikolinerg aktivitet eller dehydrering.
English: neutropenia, eosinophil count increased
Danish: neutropeni, forhøjet eosinofiltal
English: The efficacy of INVEGA in the treatment of schizophrenia was established in three multi-centre, placebo-controlled, double-blind, 6-week trials in subjects who met DSM-IV criteria for schizophrenia.
Danish: Effekten af INVEGA ved behandling af skizofreni blev påvist i tre placebokontrollerede, dobbeltblinde, 6-ugers multicenterstudier med patienter, som opfyldte DSM-IV-kriterierne for skizofreni.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apotektet.
English: Blisters: Do not store above 30°C.
Danish: Blisterkort: Må ikke opbevares ved temperaturer over 30 C.
English: The INVEGA group in the flexible-dose study (dosed between 3 and 12 mg/day, mean modal dose of 8.6 mg/day) and the higher dose group of INVEGA in the 2 dose-level study (12 mg/day with option to reduce to 9 mg/day) were each superior to placebo in the PANSS at 6 weeks.
Danish: INVEGA-gruppen i studiet med fleksibel dosis (doser mellem 3 og 12 mg/dag, gennemsnitlig modal dosis på 8,6 mg/dag) og den højeste dosisgruppe i INVEGA-studiet med 2 dosisniveauer (12 mg/dag med mulighed for at reducere til 9 mg/dag) lå hver for sig over placebo i PANSS efter 6 uger.
English: Paliperidone is not expected to cause clinically important pharmacokinetic interactions with medicines that are metabolised by cytochrome P-450 isozymes.
Danish: INVEGAs potentielle indvirkning på andre lægemidler Paliperidon forventes ikke at forårsage klinisk vigtige farmakokinetiske interaktioner med lægemidler, som metaboliseres af cytokrom P450-isozymer.
English: 59% of the dose was excreted unchanged into urine, indicating that paliperidone is not extensively metabolised by the liver.
Danish: C-paliperidon med hurtig afgivelse blev 59 % af dosis udskilt uforandret med urinen, hvilket indikerer, at paliperidon ikke metaboliseres ekstensivt af leveren.
English: • weight gain, increased appetite, weight loss, decreased appetite
Danish: • vægtstigning, øget appetit, vægttab, appetitløshed
English: The 3 mg tablets are white and printed with “PAL 3”, the 6 mg tablets are beige and printed with “PAL 6”, the 9 mg tablets are pink and printed with “PAL 9”, and the 12 mg tablets are dark yellow and printed with “PAL 12”.
Danish: 3 mg tabletterne er hvide med teksten “PAL 3”, 6 mg tabletterne er beige med teksten “PAL 6”, 9 mg tabletterne er lyserøde med teksten “PAL 9” og 12 mg tabletterne er mørkegule med teksten “PAL 12”.
English: In schizoaffective disorder clinical trials, a higher percentage of INVEGA-treated subjects (5%) had an increase in body weight of ≥ 7% compared with placebo-treated subjects (1%).
Danish: Ved kliniske studier med patienter med skizo-affektiv psykose havde en højere procentdel af INVEGA-behandlede forsøgspersoner (5 %) en forøgelse af legemsvægten på ≥ 7 % end placebobehandlede forsøgspersoner (1 %).
English: Paliperidone was not genotoxic in a battery of tests.
Danish: Paliperidon var ikke genotoksisk i en række studier.
English: 30 prolonged-release tablets 350 prolonged-release tablets
Danish: 30 depottabletter 350 depottabletter
English: • trouble breathing during sleep (sleep apnea), fast, shallow breathing
Danish: • vejrtrækningsbesvær under søvn (søvnapnø), hurtig, overfladisk vejrtrækning
English: It must be swallowed whole with liquid, and must not be chewed, divided, or crushed.
Danish: Tabletten skal synkes hel med væske og må ikke tygges, deles eller knuses.
English: • common cold symptoms
Danish: • forkølelsessymptomer
English: In the pooled adolescent schizophrenia population (12 years and older, N = 545) exposed to INVEGA, the frequency and type of undesirable effects were similar to those in adults except for the following ADRs that were reported more frequently in adolescents receiving INVEGA than adults receiving INVEGA (and more frequently than placebo): sedation/somnolence, parkinsonism, weight increase, upper respiratory tract infection, akathisia, and tremor were reported very commonly (≥ 1/10) in adolescents; abdominal pain, galactorrhoea, gynaecomastia, acne, dysarthria, gastroenteritis, epistaxis, ear infection, blood triglyceride increased, and vertigo were reported commonly (≥ 1/100, < 1/10) in adolescents.
Danish: I den poolede population af unge med skizofreni (12 år og derover, N = 545), der blev eksponeret for INVEGA, var hyppigheden og typen af bivirkninger lig dem, der sås hos voksne med undtagelse af følgende bivirkninger, som blev rapporteret hyppigere hos unge, der fik INVEGA, end hos voksne, der fik INVEGA (og hyppigere end placebo): sedation/døsighed, parkinsonisme, vægtøgning, infektion i øvre luftveje, akatisi og tremor blev rapporteret som meget almindeligt (≥ 1/10) hos unge; abdominalsmerter, galaktorré, gynækomasti, acne, dysartri, gastroenteritis, epistaxis, infektion i øret, forhøjede triglycerider i blodet og vertigo blev rapporteret som almindeligt (≥ 1/100, < 1/10) hos unge.
English: This medicine must be taken by mouth, swallowed whole with water or other liquids.
Danish: Sådan og på hvilket tidspunkt skal du tage INVEGA Tabletterne skal indtages gennem munden og sluges hele med vand eller anden væske.
English: Dosage adjustment, if indicated, should occur only after clinical reassessment.
Danish: Hvis dosisjustering er indiceret, bør den kun finde sted efter klinisk revurdering.
English: Schizoaffective disorder: The safety and efficacy of INVEGA in the treatment of schizoaffective disorder in patients aged 12 to 17 years has not been studied or established.
Danish: Skizo-affektiv psykose: INVEGAs sikkerhed og virkning ved behandling af skizo-affektiv psykose hos patienter i alderen 12 til 17 år er ikke blevet undersøgt eller klarlagt.
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 brystmælk i et sådant omfang, at terapeutiske doser med sandsynlighed vil påvirke det ammede barn.
English: Adverse reactions that may suggest increase in prolactin levels (e.g., amenorrhoea, galactorrhoea, menstrual disturbances, gynaecomastia) were reported overall in 9.3% of subjects.
Danish: Bivirkninger, der kan tyde på forhøjet prolaktinniveau (f.eks. amenorré, galaktorré, menstruationsforstyrrelser, gynækomasti), blev rapporteret hos 9,3 % af deltagerne.
English: INVEGA Higher Dose (9-12 mg)
Danish: INVEGA Højeste dosis (9-12 mg)
English: INVEGA Flexible Dose (3-12 mg)
Danish: INVEGA Fleksibel dosis (3-12 mg)
English: • irregular heartbeat, abnormal electrical tracing of the heart (electrocardiogram or ECG), a fluttering or pounding feeling in your chest (palpitations)
Danish: • uregelmæssig hjerterytme, unormalt ekg (elektrokardiogram, registrering af hjertets elektriske aktivitet), en flagrende eller hamrende fornemmelse i brystet (hjertebanken)
English: Caution is advised when prescribing INVEGA with medicines 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 tilrådes forsigtighed ved ordination af INVEGA sammen med lægemidler, som vides at forlænge QT-intervallet, f.eks. antiarytmika klasse IA (f.eks. kinidin, disopyramid) og klasse III (f.eks. amiodaron, sotalol), visse antihistaminer, andre antipsykotika, og visse malariamidler (f.eks. mefloquin).
English: In clinical trials with some other atypical antipsychotics, increased risks of death and cerebrovascular accidents have been reported (see section 4.4).
Danish: I kliniske studier med visse atypiske antipsykotika sås en øget risiko for død og akut vaskulær hændelse (se pkt.
English: As INVEGA has not been studied in patients with creatinine clearance below 10 mL/min, use is not recommended in such patients.
Danish: Eftersom INVEGA ikke er undersøgt hos patienter med kreatininclearance under 10 ml/min, bør INVEGA ikke bruges til disse patienter.
English: Medicinal products affecting gastrointestinal transit time may affect the absorption of paliperidone, e.g., metoclopramide.
Danish: Lægemidler, som påvirker den gastrointestinale transittid, f.eks. metoclopramid, kan påvirke absorptionen af paliperidon.
English: Bottles: Do not store above 30°C.
Danish: Beholdere: Må ikke opbevares ved temperaturer over 30 C.
English: • stomach or intestinal infection
Danish: • mave- eller tarminfektion
English: • incontinence (lack of control) of urine, frequent passing of urine, inability to pass urine, pain when passing urine
Danish: • urininkontinens (ufrivillig vandladning), hyppig vandladning, manglende evne til at lade vandet, smerter ved vandladning
English: Concomitant use of INVEGA with psychostimulants 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: Samtidig brug af INVEGA og psykostimulanser Kombineret brug af psykostimulanser (f.eks. methylphenidat) og paliperidon kan medføre ekstrapyramidale symptomer efter ændring af den ene eller begge behandlinger (se pkt.
English: INVEGA should be used with caution in elderly patients with dementia who have risk factors for stroke.
Danish: Der bør udvises forsigtig hed ved brug af INVEGA hos ældre patienter med demens, som har risikofaktorer for slagtilfælde.
English: Other signs of parkinsonism include a slow shuffling walk, a tremor while at rest, increased saliva and/or drooling, and a loss of expression on the face.
Danish: Andre tegn på parkinsonisme omfatter en langsom slæbende gang, rystelser i hvile, øget spytproduktion og/eller savlen samt tab af ansigtsmimik.
English: Tissue culture studies suggest that cell growth in human breast tumours may be stimulated by prolactin.
Danish: Vævsdyrkningsundersøgelser viser, at prolaktin kan stimulere cellevækst i humane brysttumorer.
English: If signs and symptoms of tardive dyskinesia appear, the discontinuation of all antipsychotics, including INVEGA, should be considered.
Danish: Hvis en patient udvikler tegn eller symptomer på tardiv dyskinesi, bør seponering af alle antipsykotika, herunder INVEGA, overvejes.
English: In addition to the above adverse reactions, the following adverse reactions have been noted with the use of risperdone products and can be expected to occur with INVEGA.
Danish: Ud over ovennævnte bivirkninger er der ved brug af risperidon-præparater observeret følgende bivirkninger, som også kan forventes at forekomme med INVEGA.
English: Dosage reduction for INVEGA should be considered when INVEGA is co-administered with valproate after clinical assessment.
Danish: Dosisreduktion af INVEGA bør overvejes efter klinisk vurdering, hvis INVEGA administreres samtidigt med valproat.
English: • oversensitivity of the eyes to light, eye infection or "pink eye", dry eye
Danish: • lysfølsomme øjne, øjeninfektion eller røde øjne, tørre øjne
English: • dangerously excessive intake of water, low blood sugar, excessive drinking of water, increased cholesterol in your blood
Danish: • faretruende stor indtagelse af vand, lavt blodsukker, uforholdsmæssig stor indtagelse af vand,
English: • convulsion (fits), fainting, a restless urge to move parts of your body, dizziness upon standing, disturbance in attention, problems with speech, loss or abnormal sense of taste, reduced sensation of skin to pain and touch, a sensation of tingling, pricking, or numbness of skin
Danish: • krampeanfald, besvimelse, rastløs trang til at bevæge kroppen, svimmelhed efter at have rejst sig op, opmærksomhedsforstyrrelse, talebesvær, tab af eller unormal smagssans, nedsat følelse i huden over for smerte og berøring, prikkende eller stikkende fornemmelse i huden eller følelsesløshed
English: Schizoaffective disorder (adults)
Danish: Skizo-affektiv psykose (voksne)
English: Paliperidone is a selective blocking agent of monoamine effects, whose pharmacological properties are different from that of traditional neuroleptics.
Danish: Paliperidon er en selektiv monoaminantagonist og har andre farmakologiske effekter end traditionelle antipsykotika.
English: Adolescents weighing ≥ 51 kg: the maximum recommended daily dose of INVEGA is 12 mg.
Danish: Unge, der vejer ≥ 51 kg: Den maksimale anbefalede daglige dosis af INVEGA er 12 mg.
English: The dose may be increased to 6 mg once daily based on clinical response and tolerability.
Danish: Dosis kan dog øges til 3 mg én gang dagligt efter klinisk vurdering.
English: For patients with mild renal impairment (creatinine clearance ≥ 50 to < 80 mL/min), the recommended initial dose is 3 mg once daily.
Danish: Til patienter med let nedsat nyrefunktion (kreatininclearance ≥ 50 og < 80 ml/min) er den anbefalede startdosis 3 mg én gang dagligt.
English: CARTON FOR PVC-PCTFE/ALUMINIUM BLISTER (for white and clear blister)
Danish: ÆSKE TIL BLISTERKORT AF PVC-PCTFE/ALUMINIUM (for hvide og klare blisterkort)
English: Co-administration of a single dose of INVEGA 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.
Danish: Samtidig administration af en enkelt dosis INVEGA 12 mg og divalproexnatrium-depottabletter (to 500 mg tabletter en gang dagligt) medførte en forhøjelse på cirka 50 % af Cmax og AUC for paliperidon.
English: Some patients may benefit from higher doses within the recommended range of 6 mg to 12 mg once daily.
Danish: Nogle patienter kan have gavn af højere doser inden for det anbefalede område på 6 mg til 12 mg en gang dagligt.
English: Hypromellose Titanium dioxide (E171) Lactose monohydrate Triacetin
Danish: Hypromellose Titandioxid (E171) Laktosemonohydrat Triacetin
English: Some patients may benefit from lower or higher doses within the recommended range of 3 mg to 12 mg once daily.
Danish: Nogle patienter kan have gavn af en lavere eller højere dosis inden for det anbefalede område på 3 mg til 12 mg én gang dagligt.
English: • an increase of CPK (creatine phosphokinase) in your blood, an enzyme which is sometimes released with muscle breakdown, muscle spasms, joint stiffness, joint swelling, muscle weakness, neck pain
Danish: • stigning i kreatinkinase i blodet (et enzym, der undertiden frigives ved muskelnedbrydning), muskelkramper, stive led, hævede led, muskelsvaghed, nakkesmerter
English: In the schizoaffective disorder studies, the incidence of EPS was observed at a higher rate than placebo in all dose groups without a clear relationship to dose.
Danish: I studierne med patienter med skizo-affektive psykoser forekom EPS med større hyppighed end ved placebo i alle dosisgrupper uden klar relation til dosis.
English: Class effects
Danish: Klasseeffekt
English: • breast swelling in boys
Danish: • brystforstørrelse hos drenge
English: Hypersensitivity to the active substance, 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: The dose may be increased or decreased by your doctor within the dose range of 3 mg to 12 mg once a day for schizophrenia or 6 mg to 12 mg once a day for schizoaffective disorder.
Danish: Lægen kan ændre din dosis inden for området 3 mg til 12 mg en gang dagligt ved skizofreni og 6 mg til 12 mg ved skizo-affektiv psykose.
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: Selv om in vitro-studier tyder på, at CYP2D6 og CYP3A4 spiller en rolle i metaboliseringen af paliperidon, findes der ingen in vivo-evidens for, at disse isozymer spiller en signifikant rolle i metaboliseringen af paliperidon.
English: Coated tablet core:
Danish: Overtrukket tabletkerne:
English: INVEGA is also used to treat schizoaffective disorder in adults.
Danish: INVEGA anvendes også til behandling af skizo-affektiv psykose hos voksne.
English: Iron oxide (Black) (E172) (9 mg tablet only)
Danish: Jernoxid (sort) (E172) (kun 9 mg tabletter)
English: Do not stop taking this medicine since you will lose the effects of the medicine.
Danish: Du skal blive ved med at tage medicinen, da du ellers ikke får nogen effekt af lægemidlet.
English: In vitro studies indicate that CYP2D6 and CYP3A4 may be minimally involved in paliperidone metabolism, but there are no indications in vitro nor in vivo that these isozymes play a significant role in the metabolism of paliperidone.
Danish: Andre lægemidlers potentielle indvirkning på INVEGA In vitro-studier indikerer, at CYP2D6 og CYP3A4 muligvis er minimalt involveret i metaboliseringen af paliperidon, men der er ingen indikationer, hverken in vitro eller in vivo, på, at disse isozymer spiller en signifikant rolle i metaboliseringen af paliperidon.
English: INVEGA Lower Dose (3-6 mg)
Danish: INVEGA Laveste dosis (3-6 mg)
English: For adolescents weighing less than 51 kg the dose may be increased to 6 mg once a day.
Danish: Hos unge, der vejer under 51 kg, kan dosis øges til 6 mg en gang dagligt.
English: For specific posology recommendations in the paediatric population see section 4.2.
Danish: For specifikke doseringsanbefalinger for den pædiatriske population henvises til pkt.
English: Responder, n (%) Non-responder, n (%) P value (vs Placebo)
Danish: Responder, n (%) Non-responder, n (%) P værdi (vs. placebo)
English: Given the primary CNS effects of paliperidone (see section 4.8), INVEGA should be used with caution in combination with other centrally acting medicines, e.g., anxiolytics, most antipsychotics, hypnotics, opiates, etc. or alcohol.
Danish: 4.8) bør INVEGA anvendes med forsigtighed i kombination med andre centralt virkende lægemidler, f.eks. anxiolytika, antipsykotika, hypnotika, opiater etc. eller alkohol.
English: • shortness of breath, wheezing, nosebleeds
Danish: • kortåndethed, hvæsen, næseblod
English: Caution is advised if paliperidone is combined with other medicines known to lower the seizure threshold (i.e., phenothiazines or butyrophenones, clozapine, tricyclics or SSRIs, tramadol, mefloquine, etc.).
Danish: Der bør udvises forsigtighed, hvis paliperidon administreres samtidig med lægemidler, der vides at sænke krampetærsklen (f.eks. phenothiazin eller butyrophenon, clozapin, tricykliske antidepressiva eller SSRI, tramadol, mefloquin ect.
English: The recommended dose in adults is 6 mg once a day taken in the morning.
Danish: Den anbefalede dosis til voksne er 6 mg en gang dagligt om morgenen.
English: Children and adolescents INVEGA is not for use in children and adolescents under 15 years for the treatment of schizophrenia.
Danish: Børn og unge INVEGA er ikke beregnet til behandling af skizofreni hos børn og unge under 15 år.
English: In the short-term, placebo-controlled, fixed-dose adolescent study, a higher percentage of INVEGA-treated subjects (6-19% depending on dose) had an increase in body weight of ≥ 7% compared to placebo-treated subjects (2%).
Danish: I det kortvarige, placebo-kontrollerede fast-dosis-studie hos unge oplevede en højere procentdel af deltagerne i INVEGA-armen (6-19 % afhængigt af dosis) en stigning i kropsvægt på ≥ 7 % i forhold til deltagerne i placebo-armen (2 %).
English: Adolescents weighing < 51 kg: the maximum recommended daily dose of INVEGA is 6 mg.
Danish: Unge, der vejer < 51 kg: Den maksimale anbefalede daglige dosis af INVEGA er 6 mg.
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 alvorlig allergisk reaktion, der er karakteriseret ved feber, hævelser i mund, ansigt, læber eller tunge, kortåndethed, kløe, hududslæt og nogle gange et fald i blodtrykket (anafylaktisk reaktion).
English: headache dystonia b, dizziness, dyskinesia b,
Danish: Dystoni svimmelhed, dyskinesi b, tremor
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, allergic reaction
Danish: • alvorlig allergisk reaktion kendetegnet ved feber, hævelse af munden, ansigtet, læberne eller tungen, kortåndethed, kløe, udslæt og undertiden blodtryksfald, allergisk reaktion
English: Pack sizes of 14, 28, 30, 49, 56, and 98 prolonged-release tablets.
Danish: Pakningsstørrelser: 14, 28, 30, 49, 56 og 98 depottabletter.
English: Take this medicine exactly as the doctor, pharmacist or nurse has told you to.
Danish: Tag lægemidlet nøjagtigt efter lægens, apotekspersonalets eller sundhedspersonalets anvisning.
English: INVEGA should be used cautiously in patients with a history of seizures or other conditions that potentially lower the seizure threshold.
Danish: INVEGA bør anvendes med forsigtighed til patienter, hvis anamnese omfatter krampeanfald eller andre tilstande, som kan sænke krampetærskelen.
English: Pack sizes of 14, 28, 49, 56, and 98 prolonged-release tablets.
Danish: Pakningsstørrelser: 14, 28, 49, 56 og 98 depottabletter.
English: Dosage reduction for this medicine should be considered when this medicine is co-administered with valproate.
Danish: Dosis af dette lægemiddel skal muligvis sættes ned, hvis det tages samtidig med valproat.
English: - if you have kidney problems.
Danish: • hvis du har nyreproblemer.