FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant use of TREVICTA with psychostimulants
Danish: Samtidig brug af TREVICTA og psykostimulanser
English: Even though paliperidone is a strong D2-antagonist, which is believed to relieve the 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 symptomer på skizofreni, forårsager det mindre katalepsi og nedsætter de motoriske funktioner mindre end typiske antipsykotika.
English: Paliperidone is not expected to cause clinically important pharmacokinetic interactions with medicinal products that are metabolised by cytochrome P450 isozymes.
Danish: Paliperidon forventes ikke at forårsage klinisk vigtige farmakokinetiske interaktioner med lægemidler, der metaboliseres af cytochrom P450-isozymer.
English: The median time to relapse in either group could not be estimated due to low percentage of subjects with relapse.
Danish: Mediantiden til recidiv i hver gruppe kunne ikke vurderes på grund af den lave procentdel af patienter med recidiv.
English: The hazard ratio was 3.81 (95% CI: 2.08, 6.99) indicating a 74% decrease in relapse risk with TREVICTA compared to placebo.
Danish: Hazard ratio var 3,81 (95 % KI: 2,08, 6,99), hvilket indikerer en 74 % reduktion i risikoen for recidiv med TREVICTA sammenlignet med placebo.
English: Based on the final analysis (N = 305), 42 subjects (29.0%) in the placebo group and 14 subjects (8.8%) in the TREVICTA group had experienced a relapse event during the double blind phase.
Danish: På baggrund af den endelige analyse (N = 305) havde 42 forsøgspersoner (29,0 %) i placebogruppen og 14 forsøgspersoner (8,8 %) i TREVICTA-gruppen oplevet en hændelse med recidiv i den dobbeltblindede fase.
English: If you have responded well to treatment with paliperidone palmitate injection given once a month, your doctor may start treatment with TREVICTA.
Danish: Hvis du har reageret positivt på behandling med paliperidonpalmitat til injektion givet én gang om måneden, kan din læge indlede behandlingen med TREVICTA.
English: Following a single intramuscular dose of TREVICTA, the plasma concentrations of paliperidone gradually rise to reach maximum plasma concentrations at a median Tmax of 30-33 days.
Danish: Efter en enkelt intramuskulær dosis af TREVICTA stiger plasmakoncentrationerne af paliperidon gradvist, til de når de maksimale plasmakoncentrationer ved en median-Tmax på 30-33 dage.
English: Consideration should be given to the long-acting 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 langtidsvirkende effekt og den lange eliminationshalveringstid for paliperidon, når behandlingsbehov og restitution skal vurderes.
English: In the clinical trials of TREVICTA, akathisia, dyskinesia, dystonia, parkinsonism, and tremor were reported in 3.9%, 0.8%, 0.9%, 3.6%, and 1.4% of subjects, respectively.
Danish: I kliniske forsøg med TREVICTA, blev akatisi, dyskinesi, dystoni, parkinsonisme og tremor rapporteret af henholdsvis 3,9 %, 0,8 %, 0,9 %, 3,6 % og 1,4 % af forsøgspersonerne.
English: Based on the investigators' ratings, induration, redness, and swelling were absent or mild in ≥ 95% of the assessments.
Danish: Induration, rødme og hævelse var fraværende eller mild i ≥ 95 % af evalueringerne baseret på investigators bedømmelser.
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 kontrollere, om der er tegn på højt blodsukker.
English: TREVICTA contains the active substance paliperidone which belongs to the class of antipsychotic medicines and is used as a maintenance treatment for the symptoms of schizophrenia in adult patients.
Danish: TREVICTA indeholder det aktive stof paliperidon, som tilhører klassen antipsykotiske lægemidler og anvendes til vedligeholdelsesbehandling af symptomerne på skizofreni hos voksne patienter.
English: Each injection must be administered only by a health care professional giving the full dose in a single injection.
Danish: Hver injektion må kun administreres af sundhedspersonale, og den fulde dosis skal administreres som én enkelt injektion.
English: Following the initial TREVICTA dose, TREVICTA should be administered by intramuscular injection once every 3 months (± 2 weeks, see also Missed dose section).
Danish: Efter den indledende dosis af TREVICTA, skal TREVICTA administreres som intramuskulær injektion én gang hver 3 måned (± 2 uger, se også afsnittet Oversprungne doser).
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 vitro-forsøg 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: Due to the long-acting nature of TREVICTA, the patient's response to an adjusted dose may not be apparent for several months (see section 5.2).
Danish: På grund af TREVICTA's langtidsvirkende effekt, er patientens respons på en justeret dosis muligvis ikke synlig i flere måneder (se pkt.
English: To avoid incomplete administration of TREVICTA, the pre-filled syringe must be shaken vigorously for at least 15 seconds within 5 minutes prior to administration to ensure a homogeneous suspension (see Information intended for medical or health care professionals).
Danish: For at undgå ufuldstændig administration af TREVICTA, skal den fyldte injektionssprøjte rystes kraftigt i mindst 15 sekunder inden for 5 minutter før administration for at sikre en homogen suspension (Se Oplysninger til læger og sundhedspersonale).
English: The frequency of adverse reactions is qualified as “not known” because they were not observed in paliperidone palmitate clinical trials.
Danish: Hyppigheden af bivirkninger er angivet som ”ikke kendt”, da de ikke blev observeret under kliniske forsøg af paliperidonpalmitat.
English: 9/L) should discontinue TREVICTA and have their WBC followed until recovery.
Danish: 9/l) skal TREVICTA seponeres, og leukocyttallet skal følges indtil restitution.
English: If you stop receiving your injections, your symptoms of schizophrenia may get worse.
Danish: Hvis du holder op med at bruge TREVICTA Hvis du ophører med at få indsprøjtningerne, kan dine symptomer på skizofreni blive værre.
English: Estimated Percent of Subjects Without Relapse
Danish: Anslået % af forsøgspersoner uden recidiv
English: To avoid a missed dose of TREVICTA patients may be given the injection up to 2 weeks before or after the 3-month time point.
Danish: For at undgå at en dosis TREVICTA springes over, kan patienten gives en injektion op til to uger før eller efter, at der er gået tre måneder.
English: At apparent steady-state with TREVICTA, the trough concentrations were similar among normal, overweight, and obese subjects.
Danish: Ved tilsyneladende steady state med TREVICTA var trough-koncentrationerne ens blandt normalvægtige, overvægtige og adipøse forsøgspersoner.
English: A population pharmacokinetic analysis based on data with oral paliperidone prolonged release tablets showed a slightly lower exposure to paliperidone in smokers compared with non-smokers.
Danish: En farmakokinetisk populationsanalyse baseret på data med orale paliperidon-depottabletter viste en lidt lavere eksponering for paliperidon hos rygere sammenlignet med ikke-rygere.
English: Switching from TREVICTA to other antipsychotic medicinal products If TREVICTA is discontinued, its prolonged release characteristics must be considered.
Danish: Skift fra TREVICTA til andre antipsykotiske lægemidler Hvis behandling med TREVICTA seponeres, skal der tages hensyn til dets forlængede frigivelse af lægemiddelstoffet.
English: Paliperidone should be used with caution in patients with a pre-existing tumour that may be prolactin-dependent.
Danish: Paliperidon skal anvendes med forsigtighed til patienter med en eksisterende tumor, der kan være prolaktin-afhængig.
English: On initiation of carbamazepine, the dose of TREVICTA should be re-evaluated and increased if necessary.
Danish: Ved start af behandling med carbamazepin skal doseringen af TREVICTA reevalueres og om nødvendigt øges.
English: Paliperidone binds strongly to serotonergic 5-HT2and dopaminergic D2-receptors.
Danish: Paliperidon binder kraftigt til serotonerge 5-HT2- og dopaminerge D2-receptorer.
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 TREVICTA (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 TREVICTA (se pkt.
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 lægen og sundhedspersonalet sammen med alle oplysningerne i produktresuméet.
English: Full instructions for use and handling of TREVICTA are provided in the package leaflet (See Information intended for medical or health care professionals).
Danish: En detaljeret vejledning i brug og håndtering af TREVICTA findes i indlægssedlen (se Oplysninger til læger og sundhedspersonale).
English: 12 mg * All doses of once daily paliperidone prolonged release tablets should be individualised to the specific patient, taking into consideration variables such as reasons for switching, response to previous paliperidone treatment, severity of psychotic symptoms, and/or propensity for side effects.
Danish: 12 mg * Dosering af paliperidon-depottabletter en gang dagligt bør individualiseres til den enkelte patient under hensyntagen til variabler såsom årsag til skift, respons på tidligere paliperidon-behandling, sværhedsgraden af psykotiske symptomer og/eller tilbøjelighed til bivirkninger.
English: This medicine can reduce the effect of medicines against Parkinson's disease and restless legs syndrome (e.g., levodopa).
Danish: Dette lægemiddel kan mindske effekten af lægemidler mod Parkinsons sygdom og uro i benene (Restless Legs Syndrome, RLS) (f.eks. levodopa).
English: Patients treated with TREVICTA should be monitored for symptoms of hyperglycaemia (such as polydipsia, polyuria, polyphagia, and weakness) and patients with diabetes mellitus should be monitored regularly for worsening of glucose control.
Danish: Patienter, som behandles med TREVICTA, skal monitoreres for symptomer på hyperglykæmi (f.eks. polydipsi, polyuri, polyfagi og svaghed), og patienter med diabetes mellitus skal monitoreres regelmæssigt for forværring af glucosekontrol.
English: Significant weight gain has been reported with TREVICTA use.
Danish: Der er rapporteret om signifikant vægtstigning ved brug af TREVICTA.
English: Dosing TREVICTA should be administered once every 3 months.
Danish: Dosering TREVICTA skal administreres en gang hver 3. måned.
English: They were either derived from spontaneous post-marketing reports and frequency cannot be determined, or they were derived from risperidone (any formulation) or oral paliperidone clinical trials data and/or post-marketing reports.
Danish: De blev enten afledt fra spontane indberetninger efter markedsføring, hvor hyppigheden ikke kan fastlægges, eller også blev de afledt fra data fra kliniske forsøg og/eller indberetninger efter markedsføringen for risperidon (alle formuleringer) eller oralt paliperidon.
English: TREVICTA is not recommended to treat elderly patients with dementia due to increased risk of overall mortality and cerebrovascular adverse reactions.
Danish: TREVICTA frarådes til behandling af ældre patienter med demens på grund af øget risiko for overordnet mortalitet og cerebrovaskulære bivirkninger.
English: TREVICTA is not recommended in patients with moderate or severe renal impairment (creatinine clearance < 50 mL/min).
Danish: TREVICTA bør ikke anvendes til patienter med moderat eller svært nedsat nyrefunktion (kreatininclearance < 50 ml/min).
English: • a decrease in body temperature
Danish: • et fald i kropstemperatur
English: Potential for TREVICTA to affect other medicines
Danish: TREVICTA's potentiale for påvirkning af andre lægemidler
English: Dispose properly
Danish: Bortskaf på korrekt vis
English: • loss of menstrual periods, leakage of milk from the breasts
Danish: • udebleven menstruation, lækage af mælk fra brysterne
English: What you need to know before you use TREVICTA
Danish: Det skal du vide, før du begynder at bruge TREVICTA
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 TREVICTA 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 TREVICTA.
English: In a study with oral immediate release
Danish: I et forsøg med oral
English: Since this medicine works primarily in the brain, using 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 brug af 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: Placebo (N=145)
Danish: TREVICTA (N=160) Placebo (N=145)
English: Subjects who were considered clinically stable at the end of the 12-week stabilisation phase were then randomised 1:1 to TREVICTA or placebo in a variable duration double-blind phase (the dose of TREVICTA was the same as the last dose received during the stabilisation phase; this dose remained fixed throughout the double-blind phase).
Danish: De forsøgspersoner, som blev anset for at være klinisk stabile i slutningen af stabiliseringsfasen på 12-uger, blev derefter randomiseret i forholdet 1:1 til TREVICTA eller placebo i en dobbeltblindet fase med variabel varighed (dosis af TREVICTA var den samme som den sidste dosis modtaget under stabiliseringsfasen, og denne dosis forblev fast i hele den dobbeltblindede periode).
English: The specified needle for administration of TREVICTA into the deltoid muscle is determined by the patient's weight.
Danish: Den anbefalede kanylestørrelse til administration af TREVICTA i musculus deltoideus afhænger af patientens vægt.
English: One female (2.4%) in the TREVICTA group experienced an adverse reaction of amenorrhea, while no potentially prolactin related adverse reactions were noted among females in the placebo group.
Danish: En kvinde (2,4 %) i TREVICTA-gruppen fik bivirkningen amenoré, mens ingen mulige prolaktinrelaterede bivirkninger blev konstateret blandt kvinder i placebogruppen.
English: TREVICTA is intended for intramuscular use only.
Danish: TREVICTA er udelukkende beregnet til intramuskulær anvendelse.
English: You will receive an injection of TREVICTA in the upper arm or buttocks once every 3 months.
Danish: Du får en indsprøjtning af TREVICTA i overarmen eller ballen én gang hver 3. måned.
English: TREVICTA should be injected once every 3 months.
Danish: TREVICTA skal injiceres en gang hver 3. måned.
English: • TREVICTA can raise your levels of a hormone called "prolactin" found on a blood test (which may or may not cause symptoms).
Danish: • TREVICTA kan medføre en stigning i niveauet af et hormon, som kaldes "prolaktin", som påvises ved en blodprøve (medfører ikke altid symptomer).
English: TREVICTA should not be used to manage acutely agitated or severely psychotic states when immediate symptom control is warranted.
Danish: TREVICTA bør ikke bruges til behandling af tilstande med akut agitation eller svær psykose, når der er behov for omgående symptomkontrol.
English: Do not use TREVICTA - if you are allergic to paliperidone or any of the other ingredients of this medicine (listed in section 6).
Danish: Brug ikke TREVICTA - Hvis du er allergisk over for paliperidon eller et af de øvrige indholdsstoffer i dette lægemiddel
English: Antipsychotic medicinal products (including paliperidone) with alpha-adrenergic blocking effects have been reported to induce priapism.
Danish: Det er rapporteret, at antipsykotiske lægemidler (herunder paliperidon) med alfa-adrenergblokerende virkninger kan inducere priapisme.
English: After shaking the syringe for at least 15 seconds, check the appearance of the suspension in the viewing window.
Danish: Efter omrystning af sprøjten i mindst 15 sekunder, kontrolleres suspensionens udseende i vinduet.
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: Patients with severe neutropenia (absolute neutrophil count
Danish: Hos patienter med svær neutropeni (absolut neutrofiltal < 1 x 10
English: The dose could be adjusted (i.e., 50 mg, 75 mg, 100 mg, or 150 mg) at the week 5 and 9 injections and the injection site could be deltoid or gluteal.
Danish: Dosis kunne justeres (dvs. 50 mg, 75 mg, 100 mg eller 150 mg) ved injektionerne i uge 5 og 9, og injektionsstedet var enten musculus deltoideus eller gluteus maximus.
English: Do not remove the pouch until the syringe and needle are securely attached.
Danish: Undgå at fjerne posen, indtil sprøjte og kanyle er forsvarligt fastgjort.
English: If needed, dose adjustment of TREVICTA can be made every 3 months in increments within the range of 175 mg to 525 mg based on individual patient tolerability and/or efficacy.
Danish: Dosen af TREVICTA kan om nødvendigt justeres hver 3. måned i trin inden for intervallet 175 mg til 525 mg afhængig af tolerabilitet og/eller virkning på den individuelle patient.
English: Subjects received TREVICTA once every 3 months and received placebo-injectable medication for the other months to maintain the blind.
Danish: Forsøgspersonerne fik TREVICTA en gang hver 3. måned og fik injektion med placebomedicin i de andre måneder for at opretholde blindingen.
English: The most frequently observed adverse drug reactions reported in ≥ 5% of patients in two double-blind controlled clinical trials of TREVICTA were weight increased, upper respiratory tract infection, anxiety, headache, insomnia, and injection site reaction.
Danish: De hyppigst forekommende bivirkninger, som blev rapporteret hos ≥ 5 % af patienterne i to dobbeltblinde, kontrollerede kliniske forsøg med TREVICTA, var vægtstigning, infektion i de øvre luftveje, angst, hovedpine, søvnløshed og reaktion på injektionsstedet.
English: Needle selection is determined by injection site and patient weight.
Danish: Valg af kanyle afhænger af injektionssted og patientens vægt.
English: Concomitant use of TREVICTA with risperidone or oral paliperidone
Danish: Samtidig brug af TREVICTA og risperidon eller oral paliperidon
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis, det vil sige, at det stort set er “natriumfrit”.
English: Needles from the 1-monthly paliperidone palmitate injectable pack or other commercially available needles must not be used when administering TREVICTA (see Information intended for medical or health care professionals).
Danish: Kanyler fra pakken med 1-månedlig paliperidonpalmitat til injektion eller andre kommercielt tilgængelige kanyler må ikke anvendes til administration af TREVICTA (Se Oplysninger til læger og sundhedspersonale).
English: Consideration should be given to the long-acting nature of TREVICTA.
Danish: Der skal tages højde for TREVICTA's langtidsvirkende effekt.
English: Inject slowly, deep into the muscle taking care to avoid injection into a blood vessel.
Danish: Injicer langsomt og dybt i den valgte muskel, og sørg for at undgå injektion i en blodåre.
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: I en meta-analyse af 17 kontrollerede kliniske forsøg havde ældre patienter med demens, som blev behandlet med andre atypiske antipsykotika, bl.a. risperidon, aripiprazol, olanzapin og quetiapin, øget mortalitetsrisiko i forhold til placebo.
English: • serious allergic reaction with swelling that may involve the throat and lead to difficulty breathing
Danish: • alvorlig allergisk reaktion med hævelse, som kan omfatte svælget og medføre vejrtrækningsbesvær
English: See also Information intended for medical or healthcare professionals for deltoid injection needle selection based on body weight.
Danish: Se også Oplysninger til læger og sundhedspersonale om valg af kanyle til injektion i musculus deltoideus baseret på kropsvægt.
English: Then, holding the syringe upright, twist and pull the rubber cap to remove.
Danish: Hold derefter sprøjten opad og vrid og træk i gummihætten for at fjerne den.
English: Physicians should weigh the risks versus the benefits when prescribing TREVICTA 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: Risici og fordele bør afvejes ved ordination af TREVICTA til patienter med Parkinsons sygdom eller Lewy body-demens, eftersom begge grupper kan have øget risiko for malignt neuroleptikasyndrom samt øget følsomhed for antipsykotika.
English: The total exposure of paliperidone following TREVICTA administration was dose-proportional over a 175-525 mg dose range, and approximately dose-proportional for Cmax.
Danish: Den totale eksponering for paliperidon efter administration af TREVICTA var dosisproportional over et 175-525 mg dosisinterval og omtrent dosisproportional for Cmax.
English: Due to its extremely low water solubility, the 3-monthly formulation of paliperidone palmitate dissolves slowly after intramuscular injection before being hydrolysed to paliperidone and absorbed into the systemic circulation.
Danish: På grund af den ekstremt lave vandopløselighed opløses den tremånedlige formulering af paliperidonpalmitat langsomt efter intramuskulær injektion, før det hydrolyseres til paliperidon og absorberes til det systemiske kredsløb.
English: Overall incidence from all clinical trials was 0.65% in all subjects treated 1-monthly paliperidone palmitate injectable.
Danish: Den samlede incidens fra alle kliniske forsøg var 0,65 % af alle forsøgspersoner, som blev behandlet med 1-måneds paliperidonpalmitat til injektion.
English: After injection
Danish: Efter injektion
English: • coma due to uncontrolled diabetes
Danish: • koma på grund af dårligt kontrolleret diabetes mellitus
English: • swelling of the face, mouth, eyes, or lips, swelling of the body, arms, or legs
Danish: • hævelse i ansigtet, munden, øjnene eller læberne, hævelse i kroppen, arme eller ben.
English: Then administer TREVICTA (into deltoid a or gluteal muscle)
Danish: Administrer derefter TREVICTA (i musculus deltoideus eller gluteus maximus)