natgillin/translations-raw huggingface dataset:
I RA langtidssikkerhedspopulationen forblev stigninger i lipidparametre konsistente med, hvad der blev set i de kontrollerede kliniske studier.
In the RA long-term safety populations, elevations in the lipid parameters remained consistent with what was seen in the controlled clinical studies.
Lægemiddeloverf ølsomhed* Angioødem* Urticaria
Drug hypersensitivity* Angioedema* Urticaria*
Lipidparametre skal vurderes 8 uger efter behandlingsstart med tofacitinib.
Assessment of lipid parameters should be performed after 8 weeks following initiation of tofacitinib therapy.
Behandlingsafbrydelse kan være nødvendig for at håndtere dosisrelaterede afvigelser i laboratorietal inklusive lymfopeni, neutropeni og anæmi.
Interruption of dosing may be needed for management of dose-related laboratory abnormalities including lymphopenia, neutropenia, and anaemia.
• patienter med en ALC under 1,0 x109 celler/mm3 (se pkt.
• Patients with an ALC less than 1,000 cells/mm3 (see section 4.2).
Hvis du har glemt at tage XELJANZ
If you forget to take XELJANZ
• Webstedets arkiv skal indeholde: o Uddannelsesmaterialet i digitalt format o Patientinformationskortet i digitalt format
• The website repository shall contain: o The educational material in digital format o The patient alert card in digital format
Samtidig administration af ketoconazol og fluconazol øgede tofacitinibs Cmax, mens tacrolimus, ciclosporin og rifampicin nedsatte tofacitinibs Cmax.
Coadministration with ketoconazole and fluconazole increased tofacitinib Cmax, while tacrolimus, ciclosporine and rifampicin decreased tofacitinib Cmax.
Der er blevet rapporteret om tilfælde med opportunistiske infektioner (se pkt.
Cases of opportunistic infections have been reported (see section 4.4).
Nominel p< 0,0001 for aktiv behandling versus placebo i måned 3.
Nominal p<0.0001 for active treatment versus placebo at month 3.
Hvis du holder op med at tage XELJANZ Du må ikke holde op med at tage XELJANZ uden først at diskutere det med lægen.
If you stop taking XELJANZ You should not stop taking XELJANZ without discussing this with your doctor.
Der kan også være en større risiko for, at du får visse lungeproblemer.
You may also be at higher risk of certain lung problems.
Undlad at synke tørremidlet.
Do not swallow the dessicant.
Samtidig administration af tofacitinib havde ikke nogen indvirkning på farmakokinetikken af orale kontraceptiva indeholdende levonorgestrel og ethinylestradiol hos frivillige raske kvinder.
Coadministration of tofacitinib did not have an effect on the PK of oral contraceptives, levonorgestrel and ethinyl estradiol, in healthy female volunteers.
Tofacitinibs virkning og sikkerhed blev vurderet i 2 randomiserede, dobbeltblinde, placebokontrollerede fase 3-studier hos voksne patienter med aktiv PsA (≥ 3 hævede og ≥ 3 ømme led).
The efficacy and safety of tofacitinib were assessed in 2 randomised, double-blind, placebo-controlled Phase 3 studies in adult patients with active PsA (≥ 3 swollen and ≥ 3 tender joints).
Andelen af patienter i begge tofacitinib-grupper, der havde behandlingssvigt, var lavere sammenlignet med placebo ved hvert tidspunkt så tidligt som ved uge 8, det første tidspunkt, hvor behandlingssvigt blev vurderet, som vist på Figur 2.
The proportion of patients in both tofacitinib groups who had treatment failure was lower compared to placebo at each time point as early as week 8, the first time point where treatment failure was assessed, as shown in Figure 2.
I hele behandlingsforløbet med tofacitinib var den generelle incidensrate for infektioner 60,3 hændelser pr. 100 patientår (der omfatter 49,4 % patienter; i alt 572 patienter).
In the entire treatment experience with tofacitinib, the overall incidence rate of infections was 60.3 events per 100 patient-years (involving 49.4% of patients; total 572 patients).
* p< 0,05, ** p< 0,001, *** p< 0,0001 versus placebo (versus MTX i ORAL Start studiet) ǂp<0,05 - tofacitinib 5 mg + MTX versus tofacitinib 5 mg for ORAL Strategy (normale p-værdier uden justeringer for multiple sammenligninger)
*p<0.05 **p<0.001 ***p<0.0001 verses placebo (versus MTX for ORAL Start) ǂp<0.05 - tofacitinib 5 mg + MTX versus tofacitinib 5 mg for ORAL Strategy (normal p-values without multiple comparison adjustment)
Tofacitinibs sikkerhed og virkning hos børn i alderen fra 0 til under 18 år er endnu ikke klarlagt.
The safety and efficacy of tofacitinib in children aged 0 to less than 18 years have not been established.
Tofacitinib 10 mg 2 gange dagligt er kontraindiceret til patienter, med et eller flere af følgende forhold:
Tofacitinib 10 mg twice daily is contraindicated in patients who have one or more of the following conditions:
Patienter med alvorlig nedsat nyrefunktion skal forblive på en reduceret dosis, selv efter hæmodialyse (se pkt.
Patients with severe renal impairment should remain on a reduced dose even after haemodialysis (see section 5.2).
I ORAL Scan og ORAL Start blev hæmning af progression af strukturel ledskade vurderet radiografisk og udtrykt som gennemsnitlig ændring fra baseline i mTSS og dets komponenter, erosionsscore og score for afsmalnet ledspalte (JSN), ved måned 6 og 12.
In ORAL Scan and ORAL Start, inhibition of progression of structural joint damage was assessed radiographically and expressed as mean change from baseline in mTSS and its components, the erosion score and joint space narrowing (JSN) score, at months 6 and 12.
Tofacitinib er et substrat for MDR1 in vitro, men ikke for brystkræft resistent protein (BCRP), OATP1B1/1B3 eller OCT1/2.
In vitro, tofacitinib is a substrate for MDR1, but not for breast cancer resistance protein (BCRP), OATP1B1/1B3, or OCT1/2.
Tofacitinib metaboliseres primært af CYP3A4 og i mindre grad af CYP2C19.
The metabolism of tofacitinib is primarily mediated by CYP3A4 with minor contribution from CYP2C19.
Da infektionsincidensen generelt er højere hos ældre mennesker, skal der udvises forsigtighed ved behandling af ældre (se pkt.
As there is a higher incidence of infections in the elderly population in general, caution should be used when treating the elderly (see section 4.4).
Hvis du er i tvivl om noget af ovenstående, skal du kontakte lægen.
If you are not sure regarding any of the information provided above, please contact your doctor.
Samtidig anvendelse af tofacitinib og ciclosporin bør undgås
Combined use of tofacitinib with ciclosporine should be avoided
- Aktivt stof: tofacitinib.
- The active substance is tofacitinib.
Tofacitinibs indvirkning på udviklingen af lymfom er ukendt.
The effect of tofacitinib on the development of lymphoma is uncertain.
Behandlingen skal påbegyndes og superviseres af speciallæger med erfaring inden for diagnosticering og behandling af sygdomstilstande, som tofacitinib er indiceret til.
Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which tofacitinib is indicated.
Samtidig administration af tofacitinib og potente CYP-induktorer (f.eks. rifampicin) kan medføre manglende eller nedsat klinisk respons (se figur 1).
Coadministration of tofacitinib with potent CYP inducers (e.g., rifampicin) may result in a loss of or reduced clinical response (see Figure 1).
Bivirkninger anført herunder er fra kliniske studier hos patienter med RA, PsA og UC og er klassificeret i henhold til systemorganklasse og hyppighed defineret som: Meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000) eller ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The ADRs listed in the table below are from clinical studies in patients with RA, PsA, and UC and are presented by System Organ Class (SOC) and frequency categories, defined using the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), or not known (cannot be estimated from the available data).
Resultaterne fra den farmakokinetiske populationsanalyse hos patienter med aktiv PsA eller moderat til svær UC var i overensstemmelse med de resultater, der sås hos patienter med RA.
Results from population PK analysis in patients with active PsA or moderate to severe UC were consistent with those in patients with RA.
Der er rapporteret tilfælde af interstitiel lungesygdom (nogle med dødelig udgang) hos patienter, der er behandlet med tofacitinib i kliniske RA-studier og efter markedsføring, selv om det ikke er kendt, hvilken rolle Januskinase- (JAK-) inhibering har i disse tilfælde.
Events of interstitial lung disease (some of which had a fatal outcome) have been reported in patients treated with tofacitinib in RA clinical trials and in the post-marketing setting although the role of Janus kinase (JAK) inhibition in these events is not known.
I kliniske studier blev tofacitinib ikke evalueret hos patienter med kreatininclearance (estimeret ved Cockroft-Gault-ligningen) under 40 ml/min ved baseline (se pkt.
In clinical trials, tofacitinib was not evaluated in patients with baseline creatinine clearance values (estimated by Cockroft-Gault equation) less than 40 mL/min (see section 4.2).
I RA langtidssikkerhedspopulationen forblev mønstret og forekomsten af bekræftede fald i ANC konsistent med, hvad der blev set i de kontrollerede kliniske studier (se pkt.
In the RA long-term safety population, the pattern and incidence of confirmed decreases in ANC remained consistent with what was seen in the controlled clinical studies (see section 4.4).
Hovedformålet med programmet er at øge kendskabet til risici ved præparatet, specielt med hensyn til alvorlige infektioner, herpes zoster, tuberkulose (TB) og andre opportunistiske infektioner, malignitet, gastrointestinal perforation, interstitiel lungesygdom og afvigelser i laboratorieværdier.
The main objective of the programme is to increase awareness about the risks of the product, specifically in regards to serious infections, herpes zoster, tuberculosis (TB) and other opportunistic infections, malignancy, gastrointestinal perforations, interstitial lung disease, and laboratory abnormalities.
Analyse af erosion og JSN-score var i overensstemmelse med de overordnede resultater.
Analysis of erosion and JSN scores were consistent with overall results.
56 filmovertrukne tabletter 112 filmovertrukne tabletter 182 filmovertrukne tabletter
56 film-coated tablets 112 film-coated tablets 182 film-coated tablets
Tofacitinib 10 mg 2 gange dagligt er kontraindiceret til patienter, som har høj risiko for pulmonal emboli.
Tofacitinib 10 mg twice daily is contraindicated in patients who are at high risk for pulmonary embolism.
Hvis du har taget for mange 11 mg depottabletter, skal du øjeblikkeligt fortælle det til din læge eller apotekspersonalet.
If you take more 11 mg prolonged-release tablets than you should, immediately tell your doctor or pharmacist.
Vaccinestudier
Vaccine studies
Samtidig administration af potente CYP3A4induktorer og tofacitinib anbefales ikke.
Coadministration of potent inducers of CYP3A4 with tofacitinib is not recommended.
Hos patienter med stigning i leverenzymer resulterede modifikation af behandlingsregimet, såsom nedsat dosis af samtidig DMARD, afbrydelse af tofacitinib-behandlingen eller nedsættelse af tofacitinib-dosis, i fald eller normalisering af leverenzymer.
In those patients experiencing liver enzyme elevation, modification of treatment regimen, such as reduction in the dose of concomitant DMARD, interruption of tofacitinib, or reduction in tofacitinib dose, resulted in decrease or normalisation of liver enzymes.
Sjælden (kan forekomme hos op til 1 ud af 1.000 personer): blodforgiftning (sepsis), tuberkulose i knogler, andre organer samt andre usædvanlige infektioner, led betændelse.
Rare (may affect up to 1 in 1,000 people): blood infection (sepsis), disseminated tuberculosis involving bones and other organs, other unusual infections, joint infections.
Måned 3 Måned 6 (forsøgspersoner på placebo med < 20 % forbedring af antal hævede og ømme led skiftede til tofacitinib ved måned 3)
Month 6 (placebo subjects with < 20% improvement in swollen and tender joint counts advanced to tofacitinib at month 3)
XELJANZ er et lægemiddel, der indeholder det aktive stof tofacitinib.
XELJANZ is a medicine that contains the active substance tofacitinib.
Analyser af erosion og JSN-scorer stemte overens med de overordnede resultater.
Analyses of erosion and JSN scores were consistent with overall results.
Hjælpestof, som behandleren skal være opmærksom på Hver filmovertrukken tablet indeholder 59,44 mg lactose.
Excipient with known effect Each film-coated tablet contains 59.44 mg of lactose.
Omfattede TNF-hæmmer-naive patienter.
Included TNF Inhibitor naïve patients.
Nominel p≤ 0,001;
Nominal p<0.001;
• Uddannelsesmaterialet til læger skal omfatte: o Produktresumé o Vejledning til sundhedsprofessionelle o Tjekliste til ordinerende læge o Patientinformationskort o En reference til et websted med uddannelsesmateriale og patientinformationskort
• The physician educational material should contain: o The Summary of Product Characteristics o Guide for healthcare professionals o Prescriber checklist o Patient alert card o A reference to the website with the educational material and patient alert card
Induktionsbehandling med tofacitinib skal seponeres hos patienter, der ikke udviser tegn på at få en god terapeutisk effekt efter 16 uger.
Tofacitinib induction therapy should be discontinued in any patient who shows no evidence of therapeutic benefit by week 16.
Placebo Placebo Placebo Placebo Placebo MTX MTX, ADA
Placebo Placebo MTX MTX, ADA
I non-kliniske studier blev der observeret virkninger på immunforsvaret og det hæmatopoietiske system, som blev henført til tofacitinibs farmakologiske egenskaber (JAK-hæmning).
In non-clinical studies, effects were observed on the immune and haematopoietic systems that were attributed to the pharmacological properties (JAK inhibition) of tofacitinib.
Tofacitinib skal bruges med forsigtighed hos patienter, som kan have en højere risiko for gastrointestinal perforation (f.eks. patienter med en anamnese med diverticulitis, patienter i samtidig behandling med kortikosteroider og/eller non-steroide anti-inflammatoriske lægemidler).
Tofacitinib should be used with caution in patients who may be at increased risk for gastrointestinal perforation (e.g., patients with a history of diverticulitis, patients with concomitant use of corticosteroids and/or nonsteroidal anti-inflammatory drugs).
Leukopeni Lymfopeni Neutropeni
Leukopenia Lymphopenia Neutropenia
For visse patienter, som f.eks. de patienter, hvis tidligere tumornekrose faktor (TNF antagonist behandling har fejlet, skal det overvejes at fortsætte med en daglig dosis på 10 mg to gange dagligt til vedligeholdelse for at kunne opretholde god terapeutisk effekt (se pkt.
For some patients, such as those who have failed prior tumour necrosis factor (TNF) antagonist therapy, consideration should be given to continuation of the 10 mg twice daily dose for maintenance in order to maintain therapeutic benefit (see section 5.1).
60 filmovertrukne tabletter 180 filmovertrukne tabletter
60 film-coated tablets 180 film-coated tablets
Der skal udvises forsigtighed ved administration af tofacitinib 11 mg depottabletter til patienter med svær gastrointestinal forsnævring (patologisk eller iatrogen) i anamnesen.
Caution should be used when administering tofacitinib 11 mg prolonged-release tablets to patients with pre-existing severe gastrointestinal narrowing (pathologic or iatrogenic).
Patienter skal overvåges nøje for udvikling af symptomer på TB, herunder også patienter, som blev testet negative for latent TB-infektion, før behandlingen begyndte.
Patients should be closely monitored for the development of signs and symptoms of TB, including patients who tested negative for latent TB infection prior to initiating therapy.
Det er blevet vist, at XELJANZ nedsætter smerte og hævelse i leddene og forbedrer evnen til at udføre daglige aktiviteter, når det tages alene eller sammen med methotrexat.
XELJANZ has been shown to reduce pain and swelling of the joints and improve the ability to perform daily activities, when given on its own or together with methotrexate.
Tabletkerne sorbitol (E420) hydroxyethylcellulose copovidon magnesiumstearat
Tablet core sorbitol (E420) hydroxyethyl cellulose copovidone magnesium stearate
Så tidligt som ved det tidligst planlagte studiebesøg i uge 2 og ved hvert efterfølgende besøg blev der observeret signifikante forskelle mellem tofacitinib 10 mg to gange dagligt og placebo i ændringen fra baseline, hvad angår rektal blødning og afføringshyppighed og partiel Mayo-score.
As early as week 2, the earliest scheduled study visit, and at each visit thereafter, significant differences were observed between tofacitinib 10 mg twice daily and placebo in the change from baseline in rectal bleeding and stool frequency, and partial Mayo score.
De mest almindeligt indberettede bivirkninger hos patienter, der får tofacitinib 10 mg to gange dagligt i induktionsstudierne var hovedpine, nasofaryngitis, kvalme og artralgi.
The most commonly reported adverse reactions in patients receiving tofacitinib 10 mg twice daily in the induction studies were headache, nasopharyngitis, nausea, and arthralgia.
mTSS = modificeret total Sharp-score, ACR20 (70) = American College of Rheumatology ≥ 20 % (≥ 70 %) forbedring, DAS28 = Disease Activity Score 28 led, ESR = erytrocyt-sedimentationshastighed, HAQ-DI = Health Assessment Questionnaire Disability Index, DMARD = sygdomsmodificerende antireumatisk lægemiddel, IR = utilstrækkeligt respons, csDMARD = konventionel syntetisk DMARD, TNFi = tumornekrosefaktorhæmmer, ADA = adalimumab, MTX = methotrexat.
mTSS=modified Total Sharp Score, ACR20(70)=American College of Rheumatology ≥20% (≥70%) improvement, DAS28=Disease Activity Score 28 joints, ESR=Erythrocyte Sedimentation Rate, HAQ-DI=Health Assessment Questionnaire Disability Index, DMARD=disease-modifying antirheumatic drug, IR=inadequate responder, csDMARD=conventional synthetic DMARD, TNFi=tumour necrosis factor inhibitor, NA=not applicable, ADA=adalimumab, MTX=methotrexate.
Virkningen og sikkerheden af tofacitinib til behandlingen af voksne patienter med moderat til svær aktiv UC (Mayo-score 6 til 12 med endoskopisk subscore ≥ 2 og rektal blødnings-subscore ≥ 1) blev vurderet i 3 multicenter, dobbeltblindede, randomiserede, placebokontrollerede studier: 2 identiske induktionsstudier (OCTAVE Induction 1 og OCTAVE Induction 2) efterfulgt af ét vedligeholdelsesstudie (OCTAVE Sustain).
The efficacy and safety of tofacitinib for the treatment of adult patients with moderately to severely active UC (Mayo score 6 to 12 with endoscopy subscore ≥ 2 and rectal bleeding subscore ≥ 1) were assessed in 3 multicentre, double-blind, randomised, placebo-controlled studies: 2 identical induction studies (OCTAVE Induction 1 and OCTAVE Induction 2) followed by 1 maintenance study (OCTAVE Sustain).
I ORAL Start resulterede tofacitinib-monoterapi i en signifikant større hæmning af progression af strukturel skade sammenlignet med MTX ved måned 6 og 12 som vist i tabel 10. Hæmningen var opretholdt ved måned 24.
In ORAL Start, tofacitinib monotherapy resulted in significantly greater inhibition of the progression of structural damage compared to MTX at months 6 and 12 as shown in Table 10, which was also maintained at month 24.
Lyserød, oval tablet med en størrelse på ca. 10,8 mm × 5,5 mm × 4,4 mm (længde × bredde × tykkelse) med et udboret hul i den ene ende af tablettens side og ”JKI 11” indgraveret på den ene side af tabletten.
Pink, oval tablet of approximate average dimension of 10.8 mm × 5.5 mm × 4.4 mm (length by width by thickness) with a drilled hole at one end of the tablet band and “JKI 11” printed on one side of the tablet.
Forsøgspersoner med let (Child-Pugh A) og moderat (Child-Pugh B) nedsat leverfunktion havde et AUC, der var henholdsvis 3 % og 65 % større end hos personer med normal nyrefunktion.
Subjects with mild (Child Pugh A) and moderate (Child Pugh B) hepatic impairment had 3%, and 65% higher AUC, respectively, compared to subjects with normal hepatic function.
Det vides ikke, hvilken effekt behandling med tofacitinib har for udvikling af maligniteter og deres forløb.
The effect of tofacitinib on the development and course of malignancies is not known.
Tofacitinib havde ikke nogen effekt på hanrotters fertilitet, sædmotilitet eller sædkoncentration.
Tofacitinib had no effects on male fertility, sperm motility or sperm concentration.
De hyppigste infektioner, der medførte seponering, var herpes zoster og pneumoni.
The most common infections resulting in discontinuation of therapy were herpes zoster and pneumonia.
Forsøgspersoner med let (kreatininclearance 50-80 ml/min), moderat (kreatininclearance 30-49 ml/min) og svært (kreatininclearance < 30 ml/min) nedsat nyrefunktion havde et AUC, der var henholdsvis 37 %, 43 % og 123 % større sammenlignet med raske forsøgspersoner med normal nyrefunktion (se pkt.
Subjects with mild (creatinine clearance 50-80 mL/min), moderate (creatinine clearance 30-49 mL/min), and severe (creatinine clearance < 30 mL/min) renal impairment had 37%, 43% and 123% higher AUC, respectively, compared to subjects with normal renal function (see section 4.2).
Det blev vist, at tofacitinib er teratogent hos rotter og kaniner og har en effekt på hunrotters fertilitet (nedsat drægtighedsrate, nedsat antal corpora lutea, implantationssteder og levedygtige fostre samt en stigning i tidlig resorption), fødsel og peri-/postnatal udvikling.
Tofacitinib was shown to be teratogenic in rats and rabbits, and have effects in rats on female fertility (decreased pregnancy rate; decreases in the numbers of corpora lutea, implantation sites, and viable foetuses; and an increase in early resorptions), parturition, and peri/postnatal development.
Tidligere behandling med en TNF-hæmmer var ikke tilladt i OPAL BROADEN.
In OPAL BROADEN, previous treatment with TNF inhibitor was not allowed.
Patienter fra OCTAVE Induction 1 eller OCTAVE Induction 2, der ikke opnåede klinisk respons efter 8 uger i OCTAVE Open, skulle udgå af OCTAVE Open.
Patients from OCTAVE Induction 1 or OCTAVE Induction 2 who did not achieve clinical response after 8 weeks in OCTAVE Open were to be discontinued from OCTAVE Open.
ANC skal monitoreres ved baseline, efter 4-8 ugers behandling og derefter hver 3. måned.
ANC should be monitored at baseline and after 4 to 8 weeks of treatment and every 3 months thereafter.
Tofacitinib er en potent, selektiv JAK-hæmmer.
Tofacitinib is a potent, selective inhibitor of the JAK family.
Alvorlige infektioner kan forekomme oftere hos personer, der også tager kortikosteroider (f.eks. prednison).
Serious infections may happen more often in people who also take corticosteroids (e.g., prednisone).
Opnået statistisk signifikans inden for ACR-serien (ACR50 og ACR70) ved p< 0,05 iht.
Achieved statistical significance within the ACR family (ACR50 and ACR70) at p≤ 0.05 per the pre-specified step-down testing procedure.
Tofacitinib kan gives som monoterapi i tilfælde af intolerans over for MTX, eller hvis behandling med MTX er uhensigtsmæssig (se pkt.
Tofacitinib can be given as monotherapy in case of intolerance to MTX or when treatment with MTX is inappropriate (see sections 4.4 and 4.5).
• patienter, der behandles med 10 mg to gange dagligt.
• Patients treated with 10 mg twice daily.
De to vigtige, sekundære effektmål var andelen af patienter med forbedring af det endoskopiske udseende ved uge 52, og andelen af patienter med vedligeholdt kortikosteroidfri remission både ved uge 24 og uge 52 hos patienter i remission ved baseline for OCTAVE Sustain.
The 2 key secondary endpoints were the proportion of patients with improvement of endoscopic appearance at week 52, and the proportion of patients with sustained corticosteroid-free remission at both week 24 and week 52 among patients in remission at baseline of OCTAVE Sustain.