FrancophonIA/ELRC3.0 huggingface dataset:
English: Additional risk factors that should be considered in determining the patient's risk for PE are older age, obesity, smoking status, and immobilisation.
Danish: Yderligere risikofaktorer, som bør tages i betragtning, når patientens risiko for PE skal afgøres, er alder, overvægt, rygerstatus og immobilisering.
English: The treatment effect was similar in patients independent of rheumatoid factor status, age, gender, race, or disease status.
Danish: Behandlingseffekten var sammenlignelig hos patienterne uafhængigt af status af reumafaktor, alder, køn, race eller sygdomsstatus.
English: Table 7 provides information regarding the pertinent study design and population characteristics.
Danish: Tabel 7 indeholder oplysninger om relevante karakteristika for studiedesign og populationer.
English: Other side effects which have been observed with XELJANZ are listed below.
Danish: Andre bivirkninger, der er blevet observeret med XELJANZ, er anført nedenfor.
English: Possible serious side effects In rare cases, infection may be life-threatening.
Danish: Alvorlige bivirkninger I sjældne tilfælde kan infektioner være livstruende.
English: macrogol, and triacetin (E1518).
Danish: macrogol og triacetin (E1518).
English: For patients with Baseline BSA ≥ 3% and PASI > 0.
Danish: For patienter med en baseline BSA på ≥ 3 % og PASI > 0.
English: • Additional risk minimisation measures
Danish: • Yderligere risikominimeringstiltag
English: No data are available on the secondary transmission of infection by live vaccines to patients receiving tofacitinib.
Danish: Der foreligger ingen data om sekundær transmission af infektion via levende vacciner til patienter, der får tofacitinib.
English: Number of patients treated Total study duration
Danish: Antal patienter behandlet Samlet studievarighed
English: Pharmacotherapeutic groups: Immunosuppressants, Selective Immunosuppressants; ATC code: L04AA29
Danish: Farmakoterapeutisk klassifikation: Immunsuppresiva, selektive immunsuppressiva, ATC-kode: L04AA29
English: The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Danish: Der skal tages højde for den additive effekt af samtidigt administrerede produkter indeholdende sorbitol (eller fruktose) og indtagelse af sorbitol (eller fruktose) gennem kosten.
English: In addition, safety and efficacy of tofacitinib were assessed in an open-label long-term extension study (OCTAVE Open).
Danish: Endvidere blev tofacitinibs sikkerhed og effekt vurderet i et åbent, langvarigt forlængelsesstudie (OCTAVE Open).
English: Your doctor may also perform other tests, for example to check your blood cholesterol levels or monitor the health of your liver.
Danish: Lægen kan også udføre andre tests, såsom at tjekke kolesterolindholdet i dit blod eller undersøge, hvor godt din lever fungerer.
English: Mon., Tue., Wed., Thu., Fri., Sat., Sun.
Danish: man., tir., ons., tor., fre., lør., søn.
English: Pharmacokinetic data up to and including a single dose of 100 mg in healthy volunteers indicate that more than 95% of the administered dose is expected to be eliminated within 24 hours.
Danish: Farmakokinetiske data hos raske frivillige til og med en enkelt dosis på 100 mg antyder, at mere end 95 % af den administrerede dosis kan forventes at blive elimineret inden for 24 timer.
English: Your doctor should perform liver tests periodically.
Danish: Lægen bør undersøge din leverfunktion med jævne mellemrum.
English: Your doctor may reduce the dose if you have liver or kidney problems or if you are prescribed certain other medicines.
Danish: Lægen kan nedsætte din dosis, hvis du har problemer med leveren eller nyrerne, eller hvis du får ordineret visse andre lægemidler.
English: XELJANZ is not recommended for use in children or adolescents under 18 years of age.
Danish: XELJANZ anbefales ikke til børn eller unge under 18 år.
English: Changes in circulating T-lymphocyte counts and T-lymphocyte subsets (CD3+, CD4+ and CD8+) were small and inconsistent.
Danish: Ændringer i antal cirkulerende T-lymfocytter og undergrupper af T-lymfocytter (CD3+, CD4+ og CD8+) var små og inkonsistente.
English: Efficacy may be decreased
Danish: Kan nedsætte effekten
English: Tell your doctor right away if you become pregnant while taking XELJANZ.
Danish: Fortæl det straks til lægen, hvis du bliver gravid, mens du tager XELJANZ.
English: In subjects with end-stage renal disease (ESRD), contribution of dialysis to the total clearance of tofacitinib was relatively small.
Danish: Hos forsøgspersoner med nyresygdom i slutstadium (ESRD) var bidraget fra dialyse til den totale clearance af tofacitinib relativt lille.
English: Tofacitinib binds predominantly to albumin and does not appear to bind to 1-acid glycoprotein.
Danish: Tofacitinib bindes hovedsageligt til albumin og synes ikke at binde til surt 1-glykoprotein.
English: • who have resided or travelled in areas of endemic mycoses,
Danish: • som har været bosat eller rejst i områder med endemiske mykoser
English: • Your doctor may decide to stop XELJANZ if XELJANZ does not work for you within 16 weeks.
Danish: • Din læge kan beslutte at stoppebehandlingen med XELJANZ, hvis XELJANZ ikke virker for dig inden for 16 uger.
English: Clearance mechanisms for tofacitinib are approximately 70% hepatic metabolism and 30% renal excretion of the parent drug.
Danish: Clearance-mekanismer for tofacitinib er cirka 70 % hepatisk metabolisme og 30 % renal udskillelse af uomdannet lægemiddel.
English: Tofacitinib with and without MTX in comparison to ADA with MTX
Danish: Tofacitinib med og uden MTX sammenlignet med ADA med MTX
English: The most commonly reported infections were upper respiratory tract infections and nasopharyngitis (3.7% and 3.2%, respectively).
Danish: De hyppigst rapporterede infektioner var øvre luftvejsinfektioner og nasofaryngitis (henholdsvis 3,7 % og 3,2 %).
English: Patients were to be in clinical response at baseline of the maintenance study OCTAVE Sustain.
Danish: Patienter skulle have klinisk respons ved baseline i vedligeholdelsesstudiet OCTAVE Sustain.
English: Periodic skin examination is recommended for patients who are at increased risk for skin cancer (see Table 6 in section 4.8).
Danish: Periodisk undersøgelse af huden anbefales for patienter, der har øget risiko for hudkræft (se tabel 6 i pkt.
English: After intravenous administration, the volume of distribution is 87 L. Approximately 40% of circulating tofacitinib is bound to plasma proteins.
Danish: Efter intravenøs administration er fordelingsvolumenet 87 l. Cirka 40 % af cirkulerende tofacitinib bindes til plasmaproteiner.
English: An approximate linear relationship between body weight and volume of distribution was observed, resulting in higher peak (Cmax) and lower trough (Cmin) concentrations in lighter patients.
Danish: Der blev observeret et omtrent lineært forhold mellem kropsvægt og fordelingsvolumen, hvilket resulterer i højere maksimumskoncentrationer (Cmax) og lavere minimumskoncentrationer (Cmin) hos slankere patienter.
English: Vaccination with live vaccines should occur at least 2 weeks but preferably 4 weeks prior to initiation of tofacitinib or in accordance with current vaccination guidelines regarding immunomodulatory medicinal products.
Danish: Vaccination med levende vacciner bør ske mindst 2 uger, men helst 4 uger før behandling med tofacitinib initieres eller i overensstemmelse med gældende retningslinjer for vaccination med immunmodulerende lægemidler.
English: Open-label extension study (OCTAVE Open)
Danish: Åbent forlængelsesstudie (OCTAVE Open)
English: Keep this Patient Alert Card with you.
Danish: Du skal altid have dette patientkort på dig.
English: It is not known whether tofacitinib is secreted in human milk.
Danish: Det vides ikke, om tofacitinib udskilles i human mælk.
English: There is no specific antidote for overdose with tofacitinib.
Danish: Der er ikke nogen specifik antidot mod en overdosis af tofacitinib.
English: The between-subject variability (percentage coefficient of variation) in AUC of tofacitinib is estimated to be approximately 27%.
Danish: Den inter-individuelle variation (variationskoefficient i %) i AUC for tofacitinib anslås at være cirka 27 %.
English: The virus may become active while you are taking XELJANZ.
Danish: Virussen kan blive aktiv, mens du tager XELJANZ.
English: Pfizer Europe MA EEIG (as MA holder logo)
Danish: Pfizer Europe MA EEIG (som MA logo)
English: Patients screened positive for hepatitis B or C were excluded from clinical trials.
Danish: Patienter, der ved screening var positive for hepatitis B eller C, blev ekskluderet fra kliniske studier.
English: Patients in the phase 3 studies had a mean Disease Activity Score (DAS28-4[ESR]) of 6.1-6.7 at baseline.
Danish: Patienter i fase 3-studierne havde en gennemsnitlig Disease Activity Score (DAS28-4[ESR]) på 6,1-6,7 ved baseline.
English: Prophylactic zoster vaccination should be considered in accordance with vaccination guidelines.
Danish: Profylaktisk zoster-vaccination bør overvejes i henhold til gældende retningslinjer.
English: Changes in lipid parameters from baseline through the end of the study (6-24 months) in the controlled clinical studies in RA are summarised below:
Danish: Ændringer i lipidparametre i forhold til baseline frem til slutningen (6-24 måneder) af de kontrollerede kliniske RA-studier opsummeres nedenfor:
English: This is the empty shell from the prolonged-release tablet after the medicine has been absorbed by your body.
Danish: Det er den tomme skal fra depottabletten, der bliver tilbage, når din krop har absorberet lægemidlet.
English: • Active tuberculosis (TB), serious infections such as sepsis, or opportunistic infections (see section 4.4).
Danish: • Aktiv tuberkulose (TB), alvorlige infektioner såsom sepsis, opportunistiske infektioner (se pkt.
English: If you have active psoriatic arthritis you will be first given another medicine to treat your psoriatic arthritis.
Danish: Hvis du har aktiv psoriasisgigt, vil du først få en anden medicin til at behandle din psoriasisgigt.
English: A patient with no previous history of varicella infection and no anti-varicella antibodies at baseline experienced dissemination of the vaccine strain of varicella 16 days after vaccination.
Danish: En patient uden varicella-infektion i anamnesen og ingen antistoffer mod varicella ved baseline oplevede disseminering af den varicella-stamme, der var i vaccinen, 16 dage efter vaccinationen.
English: • who have resided or travelled in areas of endemic TB.
Danish: • har boet eller rejst i områder med endemisk TB.
English: Durability of effect was assessed by ACR20, ACR50, ACR70 response rates in studies of duration of up to two years.
Danish: Varigheden af effekt blev vurderet ved hjælp af ACR20-, ACR50- og ACR70-responsraterne i studier med en varighed på op til to år.
English: If you do not respond well enough or the medicine is not tolerated, you may be given XELJANZ to reduce the sign and symptoms of active psoriatic arthritis and improve the ability to perform daily activities.
Danish: Hvis du ikke reagerer tilstrækkeligt eller ikke kan tåle medicinen, vil du muligvis få XELJANZ for at nedsætte tegn og symptomer på aktiv psoriasisgigt og forbedre evnen til at udføre daglige aktiviteter.
English: Before you start XELJANZ, you should be up to date with all recommended vaccinations.
Danish: Inden du begynder at tage XELJANZ, skal du være ajour med alle anbefalede vaccinationer.
English: Signs of serious infections (common) include
Danish: Tegn på alvorlige infektioner (hyppighed ”almindelig”) inkluderer
English: Improvement in fatigue was evaluated by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale at month 3 in all studies.
Danish: Forbedring i træthed blev evalueret ved hjælp af Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)-skemaet ved måned 3 i alle studierne.
English: Classification
Danish: Klassificering
English: Dosing should be interrupted until haemoglobin values have normalised.
Danish: Behandlingen skal afbrydes, indtil hæmoglobinværdien er normaliseret.
English: Risk of infection may be higher with increasing degrees of lymphopenia and consideration should be given to lymphocyte counts when assessing individual patient risk of infection.
Danish: Der kan være en større risiko for infektion ved stigende grad af lymfopeni, og lymfocyttallene skal tages i betragtning ved vurdering af en patients infektionsrisiko.
English: CD19+ B cell counts showed no further increases after long-term tofacitinib treatment.
Danish: CD19+-B-celletallet viste ikke nogen yderligere stigning efter langtidsbehandling med tofacitinib.
English: Examination of age, sex, race, baseline disease activity and PsA subtype did not identify differences in response to tofacitinib.
Danish: En undersøgelse af alder, køn, race, sygdomsaktivitet ved baseline og PsA-undertype viste ingen forskel i respons på tofacitinib.
English: If lab value confirmed by repeat testing within 7 days, dosing should be discontinued.
Danish: Hvis laboratorieværdien bekræftes ved kontroltest inden for 7 dage, seponeres behandlingen.
English: In contrast, tofacitinib has a high degree of selectivity against other kinases in the human genome.
Danish: Derimod har tofacitinib en højere grad af selektivitet over for andre kinaser i det humane genom.
English: The efficacy results based on the endoscopic readings at the study sites were consistent with the results based on the central endoscopy readings.
Danish: Effektresultaterne baseret på de endoskopiske vurderinger på studiecentrene var konsistente med resultaterne baseret på de centrale endoskopivurderinger.
English: Taking XELJANZ with these medicines may increase your risk of side effects including infection.
Danish: Hvis du tager XELJANZ sammen med disse lægemidler, kan det øge din risiko for bivirkninger herunder infektioner.
English: If therapy is interrupted, restarting treatment with tofacitinib can be considered.
Danish: Hvis behandlingen afbrydes, kan det overvejes at genstarte behandlingen med tofacitinib.
English: Steady state concentrations are achieved within 48 hours with negligible accumulation after once daily administration.
Danish: Steady state-koncentrationer opnås inden for 48 timer med ubetydelig akkumulering efter administration én gang dagligt.
English: Women of childbearing potential/contraception in females
Danish: Kvinder i den fertile alder/prævention hos kvinder
English: Improvements were also observed in the EuroQoL 5-Dimension (EQ-5D) and various domains of the Work Productivity and Activity Impairment (WPAI-UC) questionnaire in both induction and maintenance studies compared to placebo.
Danish: Der blev også observeret forbedringer i EuroQoL 5-Dimension (EQ-5D) og forskellige domæner for spørgeskemaet Work Productivity and Activity Impairment (WPAI-UC) i både induktions- og vedligeholdelsesstudierne sammenlignet med placebo.
English: Time to treatment failure in maintenance study OCTAVE sustain (Kaplan-Meier Curves)
Danish: Tid til behandlingssvigt i vedligeholdelsesstudiet OCTAVE Sustain (Kaplan-Meierkurver)
English: The carcinogenic potential of tofacitinib was assessed in 6-month rasH2 transgenic mouse carcinogenicity and 2-year rat carcinogenicity studies.
Danish: Tofacitinibs karcinogene potentiale blev vurderet i et 6 måneders karcinogenicitetsstudie med transgene rasH2-mus og et 2-årigt karcinogenicitetsstudie med rotter.
English: This patient subsequently made a robust, though delayed, humoral and cellular response to the vaccine (see section 4.4).
Danish: Denne patient havde derefter et robust om end forsinket humoralt og cellulært respons på vaccinen (se pkt.
English: In addition to this leaflet, your doctor will also give you a Patient Alert Card, which contains important safety information that you need to be aware of before you are given XELJANZ and during treatment with XELJANZ.
Danish: Udover denne indlægsseddel vil lægen også give dig et patientkort, som indeholder vigtige sikkerhedsoplysninger, som du skal være opmærksom på, før du tager XELJANZ, og så længe du er i behandling med XELJANZ.
English: Other serious infections that were not reported in clinical studies may also occur (e.g., coccidioidomycosis).
Danish: Andre alvorlige infektioner, som ikke blev rapporteret i kliniske studier, kan også forekomme (f.eks. kokcidioidomykose).
English: Nominal p≤0.05;
Danish: Nominel p≤ 0,05;
English: Rheumatoid arthritis patients taking corticosteroids may be predisposed to infection.
Danish: Patienter med reumatoid artrit, der tager kortikosteroider, kan være prædisponerede for infektioner.
English: The MAH shall ensure that in each Member State where XELJANZ is marketed, all healthcare professionals and patients/carers who are expected to prescribe or use XELJANZ have access to/are provided with the following educational package:
Danish: MAH skal i alle EU-lande sikre, at alle sundhedsprofessionelle og patienter/pårørende, som kan forventes at ordinere eller tage XELJANZ, har adgang til/får udleveret følgende pakke:
English: As described in Tables 1, 2 and 3 below, recommendations for temporary dose interruption or permanent discontinuation of treatment are made according to the severity of laboratory abnormalities (see section 4.4).
Danish: Som beskrevet i tabel 1, 2 og 3 nedenfor er anbefalingerne for midlertidig behandlingsafbrydelse eller permanent seponering baseret på, hvor alvorlige afvigelserne i laboratorietal er (se pkt.
English: Some medicines should not be taken with XELJANZ.
Danish: Nogle lægemidler bør ikke tages sammen med XELJANZ.
English: Serious infections in the elderly
Danish: Alvorlige infektioner hos ældre mennesker
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af PSUR'er for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu..
English: In case of an overdose, it is recommended that the patient be monitored for signs and symptoms of adverse reactions.
Danish: I tilfælde af overdosering anbefales det, at patienten overvåges for symptomer på bivirkninger.
English: • with recurrent infections,
Danish: • med recidiverende infektioner
English: The primary endpoint in OCTAVE Sustain was the proportion of patients in remission at week 52.
Danish: Det primære effektmål i OCTAVE Sustain var andelen af patienter i remission ved uge 52.
English: Tofacitinib was administered as monotherapy (i.e., without concomitant use of biologics and immunosuppressants) for UC.
Danish: Tofacitinib blev givet som monoterapi (dvs. uden samtidig anvendelse af biologiske lægemidler og immunosuppressiva) mod UC.
English: If you notice any of the following serious side effects you need to tell a doctor straight away.
Danish: Hvis du oplever nogen af følgende alvorlige bivirkninger, skal du straks kontakte en læge.
English: In clinical trials, tofacitinib was administered without regard to meal.
Danish: I kliniske studier blev tofacitinib administreret uden hensyntagen til måltider.
English: Physical function response and health-related outcomes
Danish: Respons for fysisk funktion og helbredsrelaterede resultater
English: Tofacitinib was discontinued and the patient recovered after treatment with standard doses of antiviral medication.
Danish: tofacitinibbehandlingen blev seponeret, og patienten kom sig igen efter behandling med standarddoser af antiviral medicin.
English: OCTAVE induction study 2
Danish: OCTAVE Induction 2-studiet
English: The safety and benefits of XELJANZ in children or adolescents have not yet been established.
Danish: Sikkerheden og fordelene ved XELJANZ hos børn er endnu ikke blevet fastlagt.
English: Your doctor may also stop treatment temporarily or permanently if blood tests show low white blood cell or red blood cell counts.
Danish: Lægen kan også afbryde behandlingen midlertidigt eller permanent, hvis blodprøver viser et lavt indhold af hvide eller røde blodlegemer.
English: Table 8: Proportion (%) of patients with an ACR response ORAL Solo: DMARD inadequate responders
Danish: Tabel 8: Andel (%) af patienter med et ACR-respons ORAL Solo: Patienter med utilstrækkeligt respons på DMARD
English: There have been reports of patients treated with XELJANZ who have developed blood clots.
Danish: Der er rapporteret om patienter behandlet med XELJANZ, der har fået blodpropper.
English: In RA patients, the oral clearance of tofacitinib does not vary with time, indicating that treatment with tofacitinib does not normalise CYP enzyme activity.
Danish: Hos RA-patienter varierer tofacitinibs orale clearance ikke med tiden, hvilket peger på, at behandling med tofacitinib ikke normaliserer aktiviteten af CYP-enzymer.
English: Dose should be maintained.
Danish: Dosis fastholdes.
English: Take your next 11 mg prolonged-release tablet at the usual time and continue as before.
Danish: Tag den næste 11 mg depottablet på det sædvanlige tidspunkt og fortsæt som før.
English: XELJANZ is used for the treatment of the following inflammatory diseases:
Danish: XELJANZ bruges til behandling af følgende betændelsessygdomme:
English: Each prolonged-release tablet contains 152.23 mg of sorbitol.
Danish: Hver depottablet indeholder 152,23 mg sorbitol.
English: Abbreviations: TNFi=tumour necrosis factor inhibitor; UC=ulcerative colitis.
Danish: Forkortelser: TNFi = Tumornekrosefaktorhæmmer (Tumour necrosis factor inhibitor); UC = Ulcerativ colitis.
English: In patients who have responded to treatment with tofacitinib, corticosteroids may be reduced and/or discontinued in accordance with standard of care.
Danish: Hos patienter, der har responderet på behandling med tofacitinib, kan kortikosteroider reduceres og/eller seponeres i henhold til behandlingsstandarden.
English: Improvements from baseline in SF-36v2 and FACIT-F were maintained through month 6 (OPAL BROADEN and OPAL BEYOND) and month 12 (OPAL BROADEN).
Danish: Forbedringerne fra baseline i SF-36v2 og FACIT-F var opretholdt ved måned 6 (OPAL BROADEN og OPAL BEYOND) og måned 12 (OPAL BROADEN).
English: Other malignancies were observed in clinical studies and the post-marketing setting, including, but not limited to, lung cancer, breast cancer, melanoma, prostate cancer, and pancreatic cancer.
Danish: Andre maligniteter, der blev observeret i kliniske studier og efter markedsføring, inkluderer, men er ikke begrænset til lungekræft, brystkræft, melanom, prostatakræft og pancreaskræft.
English: Table 14 provides additional information regarding pertinent study design and population characteristics.
Danish: Tabel 14 indeholder yderligere vigtige oplysninger om studiedesign og populationsegenskaber.
English: Rare ≥1/10,000 to
Danish: Sjælden ≥ 1/10.000 til
English: The PK profile of tofacitinib is characterised by rapid absorption (peak plasma concentrations are reached within 0.5-1 hour), rapid elimination (half-life of ~3 hours) and dose-proportional increases in systemic exposure.
Danish: Tofacitinibs PK-profil er kendetegnet ved hurtig absorption (maksimum plasmakoncentration inden for 0,5-1 time), hurtig eliminering (halveringstid ~3 timer) og dosisproportional stigning i systemisk eksponering.
English: Asian RA patients are known to be at higher risk of interstitial lung disease, thus caution should be exercised in treating these patients.
Danish: Det er kendt, at asiatiske RA-patienter har øget risiko for interstitiel lungesygdom, og der bør derfor udvises forsigtighed ved behandling af disse patienter.
English: Tofacitinib is not mutagenic or genotoxic based on the results of a series of in vitro and in vivo tests for gene mutations and chromosomal aberrations.
Danish: Tofacitinib er ikke mutagent eller genotoksisk baseret på resultaterne af en række in vitro- og in vivoundersøgelser for genmutationer og kromosomafvigelser.
English: No dose adjustment required.
Danish: Ingen dosisjustering påkrævet.