FrancophonIA/ELRC3.0 huggingface dataset:
English: The active substance in Urorec, silodosin, is an alpha adrenoreceptor antagonist.
Danish: Det aktive stof i Urorec, silodosin, er en α-adrenoreceptorantagonist.
English: One of these studies also compared Urorec with tamsulosin (another medicine used for BPH).
Danish: I en af disse undersøgelser sammenlignede man også Urorec med tamsulosin (et andet lægemiddel mod BPH).
English: The CHMP decided that Urorec's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Urorec opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Urorec.
English: For the full list of all side effects and restrictions with Urorec, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Urorec fremgår af indlægssedlen.
English: After 12 weeks, it had fallen by around 6.4 points in the men who took Urorec, and by around 3.5 points in the men who took placebo.
Danish: Efter 12 uger var IPPS faldet med ca. 6,4 point hos mænd, der tog Urorec, og med ca. 3,5 point hos mænd, der tog placebo.
English: Why has Urorec been approved?
Danish: Hvorfor blev Urorec godkendt?
English: What is Urorec?
Danish: Hvad er Urorec?
English: Urorec is used to treat the symptoms of benign prostatic hyperplasia (BPH, an enlarged prostate gland) in adults.
Danish: Urorec anvendes til behandling af symptomer på godartet prostatahyperplasi (BPH, forstørrelse af blærehalskirtlen) hos voksne.
English: How has Urorec been studied?
Danish: Hvordan blev Urorec undersøgt?
English: What is Urorec used for?
Danish: Hvad anvendes Urorec til?
English: What benefit has Urorec shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Urorec?
English: How does Urorec work?
Danish: Hvordan virker Urorec?
English: How is Urorec used?
Danish: Hvordan anvendes Urorec?
English: 11527, Athens Greece
Danish: 11527, Athens
English: John Tsaprazis SA 157 Michalakopoulou Str.
Danish: Grækenland John Tsaprazis SA 157 Michalakopoulou Str.
English: Local or regional injection intra-oral Submucosal use
Danish: Lokal eller regional injektion intraoral
English: Dental use Infiltration and perineural use in the oral cavity
Danish: Dental brug Infiltration og perineural brug i mundhulen
English: Dental use Submucosal use
Danish: Dental brug Submukosal brug
English: Injektionslösung
Danish: Injektionslösun g
English: Septodont GmbH Felix-Wankel-Str. 9 D - 53859
Danish: Septodont GmbH Felix-Wankel-Str. 9 D - 53859 NiederkasselMondorf
English: Adrenaline 5 microg/ml
Danish: Adrenalin 5 microg/ml
English: Adrenaline 10 microg/ml
Danish: Adrenalin 10 microg/ml
English: Luxembourg Septodont Nv-Sa 87 Avenue de la Constitution
Danish: Luxembourg Septodont Nv-Sa 87 Avenue de la Constitution B-1083 Brussel
English: Infiltration Periodontal use
Danish: Infiltration Parodontal brug
English: Septanest Z Adrenaliną
Danish: Septanest Cu Adrenalină
English: Submucosal use Articaine hydrochloride 40 mg/ml
Danish: Infiltration Articainhydrochlorid 40 mg/ml
English: Belgium Septodont Nv-Sa 87 Avenue de la Constitution
Danish: Septodont Nv-Sa 87 Avenue de la Constitution B-1083 Brussel Belgien
English: 94107 Saint-Maur-DesFossés Cedex France
Danish: 58, rue du Pont de Créteil 94107 Saint-Maur-DesFossés Cedex Frankrig
English: Adrenalina, tartarato 0.0182mg/ml
Danish: Articainhydrochlorid 40 mg/ml adrenalin tartrat 0,0182mg/ml
English: Adrenaline 0.005 mg/ml adrénaline (tartrate d'): non précisé
Danish: Adrenalin 0,005 mg/ml adrenalin tartrat: uspecificeret
English: 40 mg/0,01 mg v 1 ml raztopina za injiciranje
Danish: Septanestepi 40 mg/0,01 m g v 1 ml raztopina za injiciranje
English: Adrenaline 0.01 mg/ml adrénaline (tartrate d') : non précisé
Danish: Adrenalin 0,01 mg/ml adrenalin tartrat: uspecificeret
English: Adrenalina, tartarato 0.0091 mg/ml
Danish: Articainhydrochlorid 40 mg/ml adrenalin tartrat 0,0091 mg/ml
English: Septanest s adrenalinem 1:100 000
Danish: Septanest Z Adrenaliną 1:
English: Dental use
Danish: Oromukosal brug
English: Germany Septodont GmbH Felix-Wankel-Str. 9
Danish: Septodont GmbH Felix-Wankel-Str. 9 D-53859 Niederkassel Tyskland
English: 94107 Saint-Maur-desFossés Cedex France
Danish: Septodont SAS 58, rue du Pont de Créteil 94107 Saint-Maur-DesFossés Cedex Frankrig
English: 58, rue du Pont de Créteil
Danish: 58, rue du Pont de Créteil 94100 Saint-Maur-desFossés
English: Spécialités Septodont 58 rue du Pont de Créteil
Danish: Spécialités Septodont 58 rue du Pont de Créteil 94100 Saint-Maur-desFossés
English: Solution for injection in cartridge
Danish: Adrenalinée au solution injectable à usage dentaire
English: Lithuania Septodont 58 rue du Pont de Créteil
Danish: Rumænien Septodont 58 rue du Pont de Créteil 94100 Saint-Maur-desFossés
English: Septodont SAS 58, rue du Pont de Créteil
Danish: Specialites Septodont 58, rue du Pont de Créteil 94100 Saint-Maur-desFossés
English: Laboratories Septodont 58, rue du Pont de Créteil
Danish: Bulgarien Laboratories Septodont 58, rue du Pont de Créteil 94107 Saint-Maur-desFossés Cedex
English: c OPAL BEYOND had a duration of 6 months.
Danish: OPAL BEYOND havde en varighed på 6 måneder.
English: Not Known (cannot be estimated from the available data)
Danish: Ikke kendt (kan ikke estimeres ud fra forhåndenv ærende data
English: b.Antimalarials were allowed.
Danish: b. Malariamidler var tilladt.
English: Possible serious side effects In rare cases, infection may be life-threatening
Danish: Alvorlige bivirkninger I sjældne tilfælde kan infektioner være livstruende.
English: Treatment groups (Randomisation ratio)
Danish: Behandlingsgrupper (Randomiseringsratio)
English: OTHER Mon., Tue., Wed., Thu., Fri., Sat., Sun.
Danish: ANDET man., tir., ons., tor., fre., lør., søn.
English: P Ratio and 90% CI
Danish: PK Ratio og 90 % CI
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: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC:
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA PC: {nummer}
English: • antibiotics such as clarithromycin and rifampicin, used to treat bacterial infections
Danish: • antibiotika, såsom clarithromycin og rifampicin, der bruges til at behandle bakterieinfektioner
English: NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MA holder logo)
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Pfizer Europe MA EEIG (som MA logo)
English: Tofacitinib binds predominantly to albumin and does not appear to bind to α1-acid glycoprotein.
Danish: Tofacitinib bindes hovedsageligt til albumin og synes ikke at binde til surt α1-glykoprotein.
English: Pharmacotherapeutic groups: Immunosuppressants, Selective Immunosuppressants; ATC code: L04AA29
Danish: Farmakoterapeutisk klassifikation: Immunsuppresiva, selektive immunsuppressiva, ACT-kode: L04AA29
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: Very rare (may affect up to 1 in 10,000 people): tuberculosis involving the brain and spinal cord, meningitis.
Danish: Meget sjælden (kan forekomme hos op til 1 ud af 10.000 personer): tuberkulose som involvere hjerne og rygrad, meningitis.
English: Time to Treatment Failure in Maintenance Study OCTAVE Sustain (Kaplan-Meier Curves)
Danish: Tid til behandlingssvigt i vedligeholdelsesstudiet OCTAVE Sustain (Kaplan-Meierkurver)
English: Study VII (ORAL Strategy)
Danish: Studie VII (ORAL Strategy)
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: • fluconazole, ketoconazole, clotrimazole, itraconazole, and voriconazole, used to treat fungal infections
Danish: • fluconazol, ketoconazol, clotrimazol, itraconazol og voriconazol, der bruges til at behandle svampeinfektioner
English: (E171), macrogol 3350, and triacetin (E1518).
Danish: macrogol 3350 og triacetin (E1518).
English: In a human radiolabeled study, more than 65% of the total circulating radioactivity was accounted for by unchanged active substance, with the remaining 35% attributed to 8 metabolites, each accounting for less than 8% of total radioactivity.
Danish: I et humant studie med radioaktivt mærket tofacitinib tegnede uomdannet aktivt stof sig for mere end 65 % af den samlede cirkulerende radioaktivitet, og de resterende 35 % blev tilskrevet 8 metabolitter, som hver især tegnede sig for mindre end 8 % af den samlede radioaktivitet.
English: Remission among patients in remission at baselinea,f
Danish: Remission hos patienter i remission ved baselinea,f
English: Table 13: Change From Baseline in HAQ-DI in PsA Studies OPAL BROADEN and OPAL BEYOND
Danish: Tabel 13: Ændring fra baseline i HAQ-DI i PsA-studierne OPAL BROADEN og OPAL BEYOND
English: • Your doctor may decide to stop XELJANZ if XELJANZ does not work for you within
Danish: • Din læge kan beslutte at stoppebehandlingen med XELJANZ, hvis XELJANZ ikke virker for dig inden for 16 uger.
English: • Previous venous thromboembolism, either deep venous thromboembolism or pulmonary embolism
Danish: • Tidligere venøs tromboemboli enten dyb venetrombose eller pulmonal emboli
English: Reduce Tofacitinib Dosea Reduce Tofacitinib Dosea May Decrease Efficacy
Danish: Reducér tofacitinib-dosisa Reducér tofacitinib-dosisa Kan nedsætte effekten
English: For patients with Baseline BSA ≥ 3% and PASI > 0.
Danish: For patienter med en baseline score > 0. g For patienter med en baseline BSA på ≥ 3 % og PASI > 0.
English: Hepatic steatosis
Danish: Hepatisk steatose
English: Study III (ORAL Standard)
Danish: Studie III (ORAL Standard)
English: 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.
Danish: Patienter skal overvåges nøje for udvikling af symptomer på TB, herunder også patienter som blev testet negative for latent TB-infektion, før behandlingen begyndte.
English: Study I (ORAL Solo)
Danish: Studie I (ORAL Solo)
English: • The centralised website shall contain: o The educational material in digital format o The patient alert card in digital format
Danish: • Det centraliserede websted skal indeholde: o Uddannelsesmaterialet i digitalt format o Patientinformationskortet i digitalt format
English: Table 10: Radiographic Changes at Months 6 and 12 ORAL Scan: MTX Inadequate Responders
Danish: Tabel 10: Radiografiske ændringer ved 6 og 12 måneder ORAL Scan: Patienter med utilstrækkelig respons på MTX
English: The safety and efficacy of tofacitinib in children aged 0 to less than 18 years have not been established.
Danish: Pædiatrisk population Tofacitinibs sikkerhed og virkning hos børn i alderen fra 0 til under 18 år er endnu ikke klarlagt .
English: HDPE bottles with silica gel desiccant and child-resistant caps containing 60 or 180 film-coated tablets.
Danish: HDPE-beholdere med silicagel som tørremiddel og børnesikre låg indeholdende 60 eller 180 filmovertrukne tabletter.
English: Month 6: mTSS ACR70
Danish: Måned 6: mTSS ACR70
English: Injury, poisoning and procedural complications
Danish: Traumer, forgiftninger og behandlings komplikatio ner
English: In vitro, tofacitinib is a substrate for MDR1, but not for breast cancer resistance protein (BCRP), OATP1B1/1B3, or OCT1/2, and is not an inhibitor of MDR1, OATP1B1/1B3, OCT2, OAT1/3, or MRP at clinically meaningful concentrations.
Danish: Tofacitinib er et substrat for MDR1 in vitro, men ikke for brystkræft resistent protein (BCRP), OATP1B1/1B3 eller OCT1/2 og er ikke en hæmmer af MDR1, OATP1B1/1B3, OCT2, OAT1/3 eller MRP ved klinisk relevante koncentrationer.
English: The most commonly reported adverse reactions during the first 3 months in controlled clinical trials were headache, upper respiratory tract infections, nasopharyngitis, diarrhoea, nausea and hypertension (see Table 6, Adverse Drug Reactions [ADRs] based on all study durations).
Danish: De hyppigst rapporterede bivirkninger i løbet af de første 3 måneder i kontrollerede kliniske studier var hovedpine, øvre luftvejsinfektioner, nasopharyngitis, diarré, kvalme og hypertension (se tabel 6, Bivirkninger baseret på alle studievarigheder).
English: Table 2: Low Absolute Neutrophil Count Low Absolute Neutrophil Count (ANC) (see section 4.4)
Danish: Tabel 2: Lavt absolut neutrofiltal Lavt absolut neutrofiltal (ANC) (se pkt.
English: Study V (ORAL Step)
Danish: Studie V (ORAL Step)
English: Tofacitinib 10 mg twice daily is contraindicated in patients who have one or more of the following conditions:
Danish: Tofacitinib 10 mg 2 gange daglig er kontraindiceret til patienter, med et eller flere af følgende forhold:
English: Serious infections may happen more often in people who also take corticosteroids (e.g., prednisone).
Danish: Alvorlige infektioner kan forekomme oftere hos personer, der også tager kortikosteroider (fx prednison).
English: CYP Rifampicin
Danish: CYP-induktor Rifampicin
English: a. ≤3 weekly doses (MTX-naïve).
Danish: ≤3 ugentlige doser (MTX-naive).
English: Tuberculosis Diverticulitis Pyelonephritis Cellulitis Herpes simplex Gastroenteritis viral
Danish: Tuberkulose Diverticulitis Pyelonephritis Cellulitis Herpes simplex Viral gastroenteritis Virusinfektion
English: In general, fewer side effects were seen when XELJANZ was used alone in rheumatoid arthritis.
Danish: Generelt er der færre bivirkninger, når XELJANZ bliver brugt alene til behandling af leddegigt.
English: Combined use of Tofacitinib with Tacrolimus should be avoided
Danish: Samtidig anvendelse af tofacitinib og tacrolimus bør undgås
English: Month 3 Month 6 (placebo subjects with < 20% improvement in swollen and tender joint counts advanced to tofacitinib at month 3)
Danish: Måned 3 Måned 6 (forsøgspersoner på placebo med < 20 % forbedring af antal hævede og ømme led skiftede til tofacitinib ved måned 3)
English: Coadministration of tofacitinib with potent CYP inducers (e.g., rifampicin) may result in a loss of or reduced clinical response (see Figure 1).
Danish: Samtidig administration af tofacitinib og potente CYP-induktorer (fx rifampicin) kan medføre manglende eller nedsat klinisk respons (se figur 1).
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: Table 9: Number (%) of Subjects Achieving DAS28-4(ESR) < 2.6 Remission at Months 3 and 6 Time Point
Danish: Tabel 9: Antal (%) forsøgspersoner, der opnåede DAS28-4(ESR) <2,6 remission ved 3 og 6 måneder
English: Study VI (ORAL Start)
Danish: Studie VI (ORAL Start)
English: No Dose Adjustment
Danish: Ingen dosisjustering
English: 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).
Danish: Skema over bivirkninger 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
English: Tofacitinib is not an inhibitor or inducer of CYPs (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, and CYP3A4) and is not an inhibitor of UGTs (UGT1A1, UGT1A4, UGT1A6, UGT1A9, and UGT2B7).
Danish: Tofacitinib er ikke en hæmmer eller inducer af CYPerne (CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 og CYP3A4) og ikke en hæmmer af UGTerne (UGT1A1, UGT1A4, UGT1A6, UGT1A9, og UGT2B7).
English: Table 12: Proportion (%) of PsA Patients Who Achieved Clinical Response and Mean Change from Baseline in OPAL BROADEN and OPAL BEYOND Studies Conventional Synthetic DMARD Inadequate Responders a
Danish: Tabel 12: Andel (%) af patienter med PsA, som opnåede klinisk respons og gennemsnitlig ændring fra baseline i studierne OPAL BROADEN og OPAL BEYOND Konventionel syntetisk DMARD Patienter med utilstrækkeligt responsa (TNFi-naive)
English: OCTAVE Induction Study 2 Central Endoscopy Read
Danish: OCTAVE Induction 2-studiet Central endoskopivurdering Lokal endoskopivurdering
English: Store in the original, bottle and/or blister, in order to protect from moisture.
Danish: Opbevares i den originale beholder og/eller blister for at beskytte mod fugt.
English: Urosepsis Disseminated TB Necrotizing fasciitis
Danish: Dissemineret TB Nekrotiserende fasciitis
English: Combined use of Tofacitinib with Ciclosporine should be avoided
Danish: Samtidig anvendelse af tofacitinib og ciclosporin bør undgås
English: At baseline, 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: Study IV (ORAL Scan)
Danish: Studie IV (ORAL Scan)
English: There were no confirmed decreases in ANC below 500 cells/mm3 observed in any treatment group.
Danish: Der var ingen bekræftede fald i ANC til under 0,50 x109 celler/l i nogen af behandlingsgrupperne.
English: For oral use.
Danish: Kun til oral anvendelse
English: XELJANZ 5 mg film-coated tablet contains approximately 59 mg lactose in each tablet and XELJANZ 10 mg film-coated tablet contains approximately 119 mg lactose in each tablet.
Danish: XELJANZ 5 mg film-coated tablet indeholder cirka 59 mg lactose og XELJANZ 10 mg filmovertrukket tablet indeholder ca. 119 mg lactose i hver tablet.
English: 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).
Danish: Tofacitinib skal bruges med forsigtighed hos patienter, som kan have en højere risiko for gastrointestinal perforation (fx patienter med en anamnese med diverticulitis, patienter i samtidig behandling med kortikosteroider og/eller non-steroide anti-inflammatoriske lægemidler).
English: X-Ray TNFi-IR Monotherapy, Active comparator (MTX),
Danish: Røntgen TNFi-IR Monoterap i, aktiv komparator (MTX), røntgen
English: c. 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: Least Squares Mean Change From Baseline in HAQ-DI Conventional Synthetic DMARD Inadequate Respondersa (TNFi-Naïve)
Danish: Mindste kvadraters gennemsnitlige ændring fra baseline i HAQ-DI Konventionel syntetisk DMARD Patienter med utilstrækkeligt responsa (TNFi naive)
English: Baseline Month 6
Danish: mTSSc Baseline Måned 6
English: Placebo Placebo Placebo Placebo Placebo MTX
Danish: Placebo Placebo Placebo Placebo Placebo MTX MTX, ADA
English: Patients treated with tofacitinib who are Japanese or Korean, or patients with long standing RA who have previously received two or more biological DMARDs, or patients with an ALC less than 1,000 cells/mm3, or patients treated with 10 mg twice daily may have an increased risk of herpes zoster (see section 4.4).
Danish: Patienter behandlet med tofacitinib, som er japanske eller koreanske, eller patienter, som har haft RA længe, og som tidligere har fået to eller flere biologiske DMARSs eller patienter med ALC under 1,0 x109 celler/l, eller patienter, der blev behandlet med 10 mg to gange dagligt, kan have øget risiko for herpes zoster (se pkt.
English: Coadministration with ketoconazole and fluconazole increased tofacitinib Cmax, while tacrolimus, ciclosporine and rifampicin decreased tofacitinib Cmax.
Danish: Samtidig administration af ketoconazol og fluconazol øgedetofacitinibs Cmax, mens tacrolimus, ciclosporin og rifampicin nedsatte tofacitinibs Cmax.
English: Study II (ORAL Sync)
Danish: Studie II (ORAL Sync)
English: Holes in stomach or intestines happen most often in people who also take nonsteroidal anti-inflammatory drugs or corticosteroids (e.g., prednisone).
Danish: Huller i mavesækken eller tarmene opstår oftest hos patienter, som også tager non-steroide antiinflammatoriske lægemidler (NSAID) eller kortikosteroider (fx prednison).
English: Joint swelling Tendonitis
Danish: Hævede led Tendonitis
English: g. N=101 for placebo, N=101 for tofacitinib 5 mg twice daily, N=87 for tofacitinib 10 mg twice daily.
Danish: g. N=101 for placebo, N=101 for tofacitinib 5 mg to gange dagligt, N=87 for tofacitinib 10 mg to gange dagligt.
English: croscarmellose sodium, magnesium stearate, hypromellose 6cP (E464), titanium dioxide
Danish: croscarmellosenatrium, magnesiumstearat, hypromellose 6cP (E464), titandioxid (E171),
English: XELJANZ may be used in combination with methotrexate or sometimes alone when used to treat rheumatoid arthritis.
Danish: XELJANZ kan bruges sammen med methotrexat eller sommetider alene ved behandling af leddegigt.
English: DAS284(ESR)<2.6 Month 3:
Danish: DAS284(ESR)< 2,6 Måned 3:
English: 2 years 6 months 2 years
Danish: 6 måneder 2 år
English: 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: In all studies, patients treated with either 5 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: - The other ingredients are microcrystalline cellulose, lactose monohydrate (see section 2), croscarmellose sodium, magnesium stearate, hypromellose 6cP (E464), titanium dioxide (E171), macrogol 3350, triacetin (E1518), FD&C Blue #2/Indigo Carmine Aluminum Lake (E132), and FD&C Blue #1/Brilliant Blue FCF Aluminum Lake (E133).
Danish: - De andre ingredienser er mikrokrystallinsk cellulose, lactosemonohydrat (se afsnit 2), croscarmellosenatrium, magnesiumstearat, hypromellose 6 cP (E464), titanoxid (E171), macrogol 3350, triacetin (E1518), Indigotin (indigocarmin) (E132), og Brilliant Blue FCF (E133).
English: MTX-IR MTX-IR TNFi-IR MTX-naïvea MTX-IR
Danish: DMARD-IR DMARD-IR MTX-IR MTX-IR TNFi-IR MTXnaivea
English: In a controlled clinical trial of patients with RA initiating tofacitinib 10 mg twice daily or placebo, the number of responders to influenza vaccine was similar in both groups: tofacitinib (57%) and placebo (62%).
Danish: I kontrollerede kliniske studier med RA-patienter, der startede med tofacitinib 10 mg 2 gange dagligt eller placebo, var antallet af respondenter på influenzavaccine ens i de 2 grupper: tofacitinib (57 %) og placebo (62 %).
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 (fx rifampicin).
English: Tofacitinib, alone or in combination with MTX, has shown improvements in physical function, as measured by the HAQ-DI.
Danish: Respons for fysisk funktion og helbredsrelaterede resultater Tofacitinib, alene eller kombineret med MTX, har vist forbedringer i fysisk funktion, målt ved HAQDI.
English: ≥1/10,000 to
Danish: Sjælden ≥ 1/10.000 til