FrancophonIA/ELRC3.0 huggingface dataset:
English: The risk of NMSC may be higher in patients treated with tofacitinib 10 mg twice daily than in patients treated with 5 mg twice daily.
Danish: Risikoen for NMSC kan være højere hos patienter, der behandles med tofacitinib 10 mg to gange dagligt end hos patienter, der behandles med 5 mg to gange dagligt.
English: It is recommended that live vaccines not be given concurrently with tofacitinib.
Danish: Vaccination med levende vacciner anbefales ikke under tofacitinib-behandling.
English: Table 11: LS mean change from baseline in HAQ-DI at month 3 Placebo + MTX
Danish: Tabel 11: Gennemsnitlig ændring (LS) fra baseline i HAQ-DI ved 3 måneder Placebo + MTX
English: You should not switch between the XELJANZ 5 mg film-coated tablet and the XELJANZ 11 mg prolonged-release tablet unless instructed by your doctor.
Danish: Du må ikke skifte mellem XELJANZ 5 mg filmovertrukne tabletter og XELJANZ 11 mg depottabletter, medmindre det sker efter lægens anvisninger.
English: Excipient with known effect Each film-coated tablet contains 118.88 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på Hver tablet indeholder 118,88 mg lactose.
English: Swallow XELJANZ 11 mg prolonged-release tablets whole in order to ensure the entire dose is delivered correctly.
Danish: Slug XELJANZ 11 mg depottabletter hele for at sikre, at den samlede dosis indgives korrekt.
English: There was no evidence of a relationship between serious or opportunistic infections or herpes zoster and lymphocyte subset counts (see section 4.2 for absolute lymphocyte count monitoring).
Danish: Der var ingen evidens for en sammenhæng mellem alvorlige eller opportunistiske infektioner eller herpes zoster og lymfocytundergruppe-tal (se pkt.
English: Tofacitinib tablets may be crushed and taken with water.
Danish: Tofacitinib 5 mg tabletter kan knuses og indtages med vand.
English: Treatment with tofacitinib was associated with increases in lipid parameters such as total cholesterol, low-density lipoprotein (LDL) cholesterol, and high-density lipoprotein (HDL) cholesterol.
Danish: Behandling med tofacitinib var forbundet med forhøjede lipidparametre, såsom total-kolesterol, LDLkolesterol og HDL-kolesterol.
English: After 8 weeks on tofacitinib 10 mg twice daily in OCTAVE Open, remission was achieved in 35% (20/58) patients who received tofacitinib 5 mg twice daily in OCTAVE Sustain and 40% (40/99) patients with dose interruption in OCTAVE Sustain.
Danish: Efter 8 uger på tofacitinib 10 mg to gange dagligt i OCTAVE Open, blev remission opnået hos 35 % (20/58) patienter, der fik tofacitinib 5 mg to gange dagligt i OCTAVE Sustain og 40 % (40/99) patienter med dosisafbrydelse i OCTAVE Sustain.
English: In all studies, patients treated with either 5 mg or 10 mg twice daily tofacitinib had statistically significant ACR20, ACR50 and ACR70 response rates at month 3 and month 6 versus placebo (or versus MTX in ORAL Start) treated patients.
Danish: I alle studier havde patienter, der blev behandlet med 5 mg eller 10 mg tofacitinib 2 gange dagligt, statistisk signifikante ACR20-, ACR50- og ACR70-responsrater ved måned 3 og måned 6 versus placebogruppen (eller versus MTX i ORAL Start).
English: Malignancy and lymphoproliferative disorder
Danish: Malignitet og lymfoproliferative forstyrrelser
English: There was a higher incidence of adverse events for the combination of tofacitinib with MTX versus tofacitinib as monotherapy in RA clinical studies.
Danish: Bivirkningsfrekvensen var højere for kombinationen tofacitinib plus MTX end for tofacitinib som monoterapi i kliniske RA-studier.
English: Sustained corticosteroidfree remission among patients in remission at baseline
Danish: Vedvarende kortikosteroidfri remission hos patienter i remission ved baseline
English: o Contact details of the prescriber
Danish: o Kontaktinfo for lægen.
English: Over the course of ORAL Strategy, responses with tofacitinib 5 mg twice daily + MTX were numerically similar compared to adalimumab 40 mg + MTX and both were numerically higher than tofacitinib 5 mg twice daily.
Danish: I løbet af studiet ORAL Strategy var respons på tofacitinib 5 mg to gange dagligt + MTX numerisk ens sammenlignet med adalimumab 40 mg + MTX og begge var numerisk højere end tofacitinib 5 mg to gange dagligt.
English: Viral reactivation and cases of herpes virus reactivation (e.g., herpes zoster) were observed in clinical studies with tofacitinib.
Danish: Der er observeret viral reaktivering og tilfælde med reaktivering af herpes-virus (fx herpes zoster) i kliniske studier med tofacitinib.
English: Statistically significant ACR20 response rates were observed with tofacitinib 5 mg BID in both studies as early as week 2 (first post-baseline assessment) in comparison to placebo.
Danish: Der blev observeret statistisk signifikante ACR20-responsrater med tofacitinib 5 mg 2 gange dagligt i begge studier så tidligt som i uge 2 (første vurdering efter baseline) sammenlignet med placebo.
English: Month 6: ACR50
Danish: Måned 6: ACR50
English: Each pack contains 56, 112, or 182 film-coated tablets.
Danish: Hver pakning indeholdende 56, 112 eller 182 filmovertrukne tabletter.
English: Month 6: mT SS ACR70
Danish: Måned 6: mTSS ACR70
English: • The patient information pack should contain: o Patient information leaflet o The patient alert card
Danish: • Patientinformationspakken skal indeholde: o Indlægsseddel o Patientinformationskort
English: 80.7% and 49.2% of patients had enthesitis and dactylitis, respectively.
Danish: Ved baseline havde 80,7 % og 49,2 % af patienterne hhv. enthesitis og dactylitis.
English: Tofacitinib 11 mg prolonged-release tablets contains sorbitol.
Danish: Tofacitinib 11 mg depottabletter indeholder sorbitol.
English: White, round tablet of 7.9 mm diameter, debossed “Pfizer” on one side and “JKI 5” on the other.
Danish: Hvid, rund tablet med en diameter på 7,9 mm, med “Pfizer” indgraveret på den ene side og “JKI 5” på den anden.
English: Concomitant administration with MTX 15-25 mg once weekly had no effect on the PK of tofacitinib in RA patients (see Figure 1).
Danish: Samtidig administration af MTX 15-25 mg en gang om ugen påvirkede ikke tofacitinibs farmakokinetik hos RA-patienter (se figur 1).
English: Among opportunistic infections, TB and other mycobacterial infections, cryptococcus, histoplasmosis, oesophageal candidiasis, multidermatomal herpes zoster, cytomegalovirus, BK virus infections and listeriosis were reported with tofacitinib.
Danish: Blandt opportunistiske infektioner blev TB og andre mykobakterielle infektioner, kryptokokinfektion, histoplasmose, øsofageal candidiasis, multidermatomal herpes zoster, cytomegalovirus-infektion, BK-virus-infektioner og listeriose rapporteret for tofacitinib.
English: Patients who completed 1 of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) but did not achieve clinical response or patients who completed or withdrew early due to treatment failure in the maintenance study (OCTAVE Sustain) were eligible for OCTAVE Open.
Danish: Patienter, der fuldførte ét af induktionsstudierne (OCTAVE Induction 1 eller OCTAVE Induction 2), men ikke opnåede klinisk respons, eller patienter, der fuldførte eller udgik tidligt pga. behandlingssvigt i vedligeholdelsesstudiet (OCTAVE Sustain), var egnede til OCTAVE Open.
English: Lymphoma and other cancers (such as lung, breast, melanoma, prostate and pancreatic) have been reported in patients treated with XELJANZ.
Danish: Der er rapporteret om lymfom og andre former for kræft (såsom lunge-, bryst- og prostatakræft, melanom og kræft i bugspytkirtlen) hos patienter, der blev behandlet med XELJANZ.
English: N=59 for placebo, N=65 for tofacitinib 5 mg twice daily, N=55 for tofacitinib 10 mg twice daily.
Danish: N=59 for placebo, N=65 for tofacitinib 5 mg to gange dagligt, N=55 for tofacitinib 10 mg to gange dagligt.
English: The HAQ-DI responder rate (response defined as having decrease from baseline of ≥ 0.35) at month 3 in studies OPAL BROADEN and OPAL BEYOND was 53% and 50%, respectively in patients receiving tofacitinib 5 mg twice daily, 31% and 28%, respectively in patients receiving placebo, and 53% in patients receiving adalimumab 40 mg subcutaneously once every 2 weeks (OPAL BROADEN only).
Danish: HAQ-DI-responsraten (respons defineres som et fald fra baseline på ≥ 0,35) ved måned 3 i studierne OPAL BROADEN og OPAL BEYOND var på hhv. 53 % og 50 % hos patienter, som fik tofacitinib 5 mg 2 gange dagligt, hhv. 31 % og 28 % hos patienter, som fik placebo, og 53 % hos patienter, som fik adalimumab 40 mg subkutant en gang hver anden uge (kun OPAL BROADEN).
English: This treatment difference from placebo was similar between tofacitinib 5 mg twice daily and tofacitinib 10 mg twice daily in the subgroup of patients without prior TNF inhibitor failure.
Danish: Denne behandlingsforskel fra placebo var ens for både tofacitinib 5 mg to gange dagligt og tofacitinib 10 mg to gange dagligt i undergruppen af patienter uden tidligere svigt af TNF-hæmmer.
English: The recommended dose is 10 mg given orally twice daily for induction for 8 weeks and 5 mg given twice daily for maintenance.
Danish: Den anbefalede dosis er 10 mg, som indgives oralt to gange dagligt til induktion i 8 uger og 5 mg, som indgives to gange dagligt til vedligeholdelse.
English: Least squares mean change from baseline in HAQ-DI Conventional synthetic DMARD inadequate responders a
Danish: Mindste kvadraters gennemsnitlige ændring fra baseline i HAQ-DI Konventionel syntetisk DMARD Patienter med utilstrækkeligt respons a (TNFi naive)
English: Local endoscopy read
Danish: Lokal endoskopivurdering
English: Study II (O RAL Sync)
Danish: Studie II (ORAL Sync)
English: Tofacitinib has been shown to be teratogenic in rats and rabbits, and to affect parturition and peri/postnatal development (see section 5.3).
Danish: Det er vist, at tofacitinib er teratogent hos rotter og kaniner, og at det påvirker fødslen og den peri-/postnatale udvikling (se pkt.
English: DAS28-4(ESR) response
Danish: DAS28-4(ESR)-respons
English: HDPE bottles with 2 silica gel desiccants and child-resistant, polypropylene closure containing 30 or 90 prolonged-release tablets.
Danish: HDPE-beholdere med 2 silicagel som tørremiddel og børnesikker lukning i polypropylen indeholdende 30 eller 90 depottabletter.
English: If you suffer from rheumatoid arthritis, your doctor may switch your tablets from XELJANZ 5 mg film-coated tablets twice daily to XELJANZ 11 mg prolonged-release tablets once daily.
Danish: Hvis du lider af leddegigt, kan din læge ændre dine tabletter fra XELJANZ 5 mg filmovertrukne tabletter to gange dagligt til XELJANZ 11 mg depottabletter én gang dagligt.
English: In the subgroup of patients with prior TNF inhibitor failure, the observed treatment difference from placebo was numerically greater for tofacitinib 10 mg twice daily than tofacitinib 5 mg twice daily by 9.7 to 16.7 percentage points across the primary and key secondary endpoints.
Danish: I undergruppen af patienter med tidligere svigt af TNF-hæmmer var den observerede behandlingsforskel fra placebo numerisk større for tofacitinib 10 mg to gange dagligt i forhold til tofacitinib 5 mg to gange dagligt med 9,7 til 16,7 procentpoint på tværs af de primære og vigtige, sekundære effektmål.
English: Tofacitinib exposure is decreased when coadministered with potent CYP inducers (e.g., rifampicin).
Danish: Eksponeringen for tofacitinib nedsættes, når det administreres samtidigt med potente CYP-induktorer (f.eks. rifampicin).
English: • The Guide for healthcare professionals shall contain the following key elements: o Relevant information of the safety concerns addressed by the aRMM (e.g. seriousness, severity, frequency, time to onset, reversibility of the AE as applicable) o Details of the population at higher risk for the safety concern addressed by the aRMM (i.e. contraindications, risk factors, increased risk by interactions with certain medicine) o Details on how to minimise the safety concern addressed by the aRMM through appropriate monitoring and management (i.e. what to do, what not do, and who is most likely be impacted according to different scenarios, like when to limit or stop prescribing/ingestion, how to administer the medicine, when to increase/decrease the dosage according to laboratory measurements, signs and symptoms) o Key message to convey in patients counselling o Instructions on how to handle possible adverse events o Information about the BSRBR, ARTIS, RABBIT and BIODABASER and UC registries and the importance of contributing to these
Danish: • Vejledningen til sundhedsprofessionelle skal omfatte følgende nøgleinformationer: o Relevant information om sikkerhedsproblemer, som er omtalt i yderligere risikominimeringstiltag (aRMM) (fx alvorlighed, sværhedsgrad, frekvens, tid til indtræden, reversibilitet af den pågældende bivirkning) o Detaljer vedrørende den population, som har højere risiko for de sikkerhedsproblemer, der er omtalt i aRMM (fx kontraindikationer, risikofaktorer, øget risiko for interaktioner med visse lægemidler) o Detaljer om, hvordan sikkerhedsproblemerne i aRMM kan minimeres ved passende monitorering og håndtering (fx hvad man bør gøre, hvad man ikke bør gøre, og hvem der har størst sandsynlighed for at blive påvirket ved forskellige scenarier, for eksempel hvornår ordinering/indtagelse bør begrænses eller ophøre, hvordan lægemidlet skal tages, hvornår dosis bør øges/reduceres på baggrund af laboratorietal og symptomer) o Nøgleinformation, som skal gives ved rådgivning af patienten o Instruktioner i, hvordan bivirkninger håndteres o Information om BSRBR-, ARTIS-, RABBIT- og BIODABASER-registrene for RA og UC og vigtigheden af at bidrage til disse
English: If you develop cancer while taking XELJANZ your doctor will review whether to stop XELJANZ treatment.
Danish: Hvis du får kræft, mens du tager XELJANZ, vil din læge overveje, om behandlingen skal stoppes.
English: - The other ingredients are sorbitol (E420) (see section 2), hydroxyethyl cellulose, copovidone, magnesium stearate, cellulose acetate, hydroxypropyl cellulose (E463), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172), shellac (E904), ammonium hydroxide (E527), propylene glycol (E1520) and black iron oxide (E172).
Danish: - Øvrige indholdstoffer: sorbitol (E420) (se afsnit 2), hydroxyethylcellulose, copovidon, magnesiumstearat, celluloseacetat, hydroxypropylcellulose (E463), hypromellose (E464), titandioxid (E171), triacetin (E1518), rød jernoxid (E172), shellak (E904), ammoniumhydroxid (E527), propylenglycol (E1520) og sort jernoxid (E172).
English: N=101 for placebo, N=101 for tofacitinib 5 mg twice daily, N=87 for tofacitinib 10 mg twice daily.
Danish: N=101 for placebo, N=101 for tofacitinib 5 mg to gange dagligt, N=87 for tofacitinib 10 mg to gange dagligt.
English: Co-primary endpoints as follows: mean change from baseline in mTSS; percent of subjects achieving ACR20 or ACR70 responses; mean change from baseline in HAQ-DI; percent of subjects achieving a DAS28-4(ESR) <2.6 (remission).
Danish: De co-primære effektmål var følgende: Gennemsnitlig ændring fra baseline i mTSS, procent forsøgspersoner, der opnåede ACR20- eller ACR70-respons, gennemsnitlig ændring fra baseline i HAQ-DI, procent forsøgspersoner, der opnåede DAS28-4(ESR) < 2,6 (remission).
English: HAQ-DI
Danish: HAQDI
English: * p<0.0001; **p<0.001; †p<0.05 for tofacitinib versus placebo.
Danish: * p<0,0001; **p<0,001; †p<0,05 for XELJANZ versus placebo.
English: OCTAVE induction study 2 Central endoscopy read
Danish: OCTAVE Induction 2-studiet Central endoskopivurdering Lokal endoskopivurdering
English: XELJANZ can reduce your body's ability to respond to infections and may make an existing infection worse or increase the chance of getting a new infection - if you have or have a history of tuberculosis or have been in close contact with someone with tuberculosis.
Danish: XELJANZ kan nedsætte kroppens evne til at reagere på infektioner og kan forværre en eksisterende infektion eller øge risikoen for at få en ny infektion.
English: Patients who achieved clinical response in 1 of the induction studies (OCTAVE Induction 1 or OCTAVE Induction 2) with tofacitinib 10 mg twice daily but experienced treatment failure after their dose was reduced to tofacitinib 5 mg twice daily or following treatment interruption in OCTAVE Sustain (i.e., were randomised to placebo), had their dose increased to tofacitinib 10 mg twice daily in OCTAVE Open.
Danish: Patienter, der opnåede klinisk respons i ét af induktionsstudierne (OCTAVE Induction 1 eller OCTAVE Induction 2) med tofacitinib 10 mg to gange dagligt, men oplevede behandlingssvigt efter, at deres dosis blev reduceret til tofacitinib 5 mg to gange dagligt eller efter behandlingsafbrydelse i OCTAVE Sustain (dvs. blev randomiseret til placebo), fik deres dosis øget til tofacitinib 10 mg to gange dagligt i OCTAVE Open.
English: Urosepsis Disseminated TB Necrotizing fasciitis
Danish: Urosepsis Dissemineret TB
English: All patients were required to have 1 concomitant csDMARD; 71.6% of patients received concomitant MTX, 15.7% of patients received concomitant sulfasalazine, and 8.6% of patients received concomitant leflunomide.
Danish: 71,6 % af patienterne fik samtidig administreret MTX, 15,7 % af patienterne fik samtidig administreret sulfasalazin og 8,6 % af patienterne fik samtidig administreret leflunomid.
English: XELJANZ is used to treat a condition called psoriatic arthritis.
Danish: XELJANZ bruges til at behandle en sygdom, som kaldes psoriasisgigt.
English: Lymphomas have been observed in patients treated with tofacitinib.
Danish: Der er observeret lymfomer hos patienter, som blev behandlet med tofacitinib.
English: A patient who develops a new infection during treatment with tofacitinib should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored.
Danish: En patient, der udvikler en ny infektion under behandling med tofacitinib, skal med det samme gennemgå en komplet diagnostisk udredning, der er passende for en immunkompromitteret patient.
English: The overall incidence rate of infections with tofacitinib in the long-term safety all exposure population (total 4,867 patients) was 46.1 patients with events per 100 patient-years (43.8 and 47.2 patients with events for 5 mg and 10 mg twice daily, respectively).
Danish: Den generelle incidens af infektioner med tofacitinib i langtidssikkerhedspopulationen ved alle niveauer af eksponering (i alt 4.867 patienter) var 46,1 patienter med hændelser pr. 100 patientår (henholdsvis 43,8 og 47,2 patienter med hændelser for 5 mg og 10 mg 2 gange dagligt).
English: 28 prolonged-release tablets 91 prolonged-release tablets
Danish: 28 depottabletter 91 depottabletter
English: In ORAL Scan, tofacitinib 10 mg twice daily plus background MTX resulted in significantly greater inhibition of the progression of structural damage compared to placebo plus MTX at months 6 and 12.
Danish: I ORAL Scan blev der givet 10 mg tofacitinib 2 gange dagligt plus baggrunds-MTX, hvilket resulterede i betydelig større hæmning af progression af strukturel skade sammenlignet med placebo plus MTX ved måned 6 og 12.
English: (TNFi-naïve)
Danish: TNFi-IR MTXnaive
English: XELJANZ 11 mg prolonged-release tablets have 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.
Danish: Det er blevet vist, at XELJANZ 11 mg depottabletter nedsætter smerte og hævelse i leddene og forbedrer evnen til at udføre daglige aktiviteter, når det tages alene eller sammen med methotrexat.
English: Haemoglobin should be monitored at baseline and after 4 to 8 weeks of treatment and every 3 months thereafter.
Danish: Hæmoglobin skal monitoreres ved baseline, efter 4 til 8 ugers behandling og derefter hver 3. måned.
English: Increases in total and LDL cholesterol associated with tofacitinib may be decreased to pretreatment levels with statin therapy.
Danish: Forhøjet total- og LDLkolesterol i forbindelse tofacitinib-behandling kan reduceres til baseline-niveau med statinbehandling.
English: Treatment with tofacitinib has been associated with decreases in haemoglobin levels.
Danish: Behandling med tofacitinib har været associeret med et fald i hæmoglobinniveau.
English: • The recommended dose is 10 mg twice a day for 8 weeks, followed by 5 mg twice a day.
Danish: • Den anbefalede dosis er 10 mg to gange dagligt i 8 uger, efterfulgt af 5 mg to gange dagligt.
English: Blue, round tablet of 9.5 mm diameter, debossed “Pfizer” on one side and “JKI 10” on the other.
Danish: Blå, rund tablet med en diameter på 9,5 mm, med “Pfizer” indgraveret på den ene side og “JKI 10” på den anden.
English: Tofacitinib is not an inhibitor of MDR1, OATP1B1/1B3, OCT2, OAT1/3, or MRP at clinically meaningful concentrations.
Danish: Tofacitinib er ikke en hæmmer af MDR1, OATP1B1/1B3, OCT2, OAT1/3 eller MRP ved klinisk relevante koncentrationer.
English: If the history of chickenpox is considered doubtful or unreliable it is recommended to test for antibodies against VZV.
Danish: Hvis skoldkopper i anamnesen ikke med sikkerhed kan bekræftes, anbefales det at teste for antistoffer mod VZV.
English: Common ≥1/100 to <1/10
Danish: Almindelig ≥ 1/100 til
English: Tablet core microcrystalline cellulose lactose monohydrate croscarmellose sodium magnesium stearate
Danish: Tabletkerne mikrokrystallinsk cellulose lactosemonohydrat croscarmellosenatrium magnesiumstearat
English: Difference between least squares means tofacitinib minus placebo (95% CI = 95% confidence interval)
Danish: Forskel mellem middelværdierne, fundet ved mindste kvadraters metode, for tofacitinib minus placebo (95% CI = 95% konfidensinterval)
English: Table 5: Dose adjustment for renal impairment Renal impairment category
Danish: Tabel 5: Dosisjustering ved nedsat nyrefunktion Nedsat nyrefunktionkategori
English: What you need to know before you take XELJANZ
Danish: Det skal du vide, før du begynder at tage XELJANZ
English: Rheumatoid arthritis and psoriatic arthritis
Danish: Reumatoid artrit og psoriasisartrit
English: Study VI (O RAL Start)
Danish: Studie VI (ORAL Start)
English: Coadministration with ketoconazole (strong CYP3A4 inhibitor), fluconazole (moderate CYP3A4 and potent CYP2C19 inhibitor), tacrolimus (mild CYP3A4 inhibitor) and ciclosporine (moderate CYP3A4 inhibitor) increased tofacitinib AUC, while rifampicin (potent CYP inducer) decreased tofacitinib AUC.
Danish: Samtidig administration af ketoconazol (potent CYP3A4-hæmmer), fluconazol (moderat CYP3A4- og potent CYP2C19-hæmmer), tacrolimus (svag CYP3A4-hæmmer) og ciclosporin (moderat CYP3A4hæmmer) øgede tofacitinibs AUC, mens rifampicin (potent CYP-induktor) nedsatte tofacitinibs AUC.
English: Maintenance of clinical response was defined by a decrease from the induction study (OCTAVE Induction 1, OCTAVE Induction 2) baseline Mayo score of ≥ 3 points and ≥ 30%, with an accompanying decrease in the rectal bleeding subscore of ≥ 1 point or rectal bleeding subscore of 0 or 1.
Danish: Opretholdelse af klinisk respons blev defineret ud fra en reduktion i induktionsstudiets (OCTAVE Induction 1, OCTAVE Induction 2) baseline Mayo-score på ≥ 3 point og ≥ 30 %, med en ledsagende reduktion i subscoren for rektal blødning på ≥ 1 point eller en subscore for rektal blødning på 0 eller 1.
English: The incidence rates and types of serious infections in the UC clinical studies were generally similar to those reported in RA clinical studies with tofacitinib monotherapy treatment groups.
Danish: Incidensraterne og typerne af alvorlige infektioner ved de kliniske UC-studier lignede generelt dem, der blev indberettet i kliniske RA-studier i behandlingsgrupperne med tofacitinib som monoterapi.
English: - if you have been informed that you have severe liver problems, including cirrhosis (scarring of the liver) - if you are pregnant or breast-feeding
Danish: - hvis du har fået at vide, at du har alvorlige leverproblemer inklusive skrumpelever (cirrose,
English: Aluminium foil/PVC backed aluminium foil blisters containing 14 film-coated tablets.
Danish: Blisterkort af aluminiumsfolie/aluminiumsfolie med PVC-bagside med 14 filmovertrukne tabletter.