natgillin/translations-raw huggingface dataset:
Nekrotiserend e fasciitis Bakteriæmi Stafylokokba kteriæmi Pneumocystis jiroveciipneumoni Pneumokokpn eu-moni Bakteriel pneumoni Encephalitis Atypisk mykobakteriel infektion Cytomegalovi rus-infektion Bakteriel artrit
Bacteraemia Staphylococcal bacteraemia Pneumocystis jirovecii pneumonia Pneumonia pneumococcal Pneumonia bacterial
Dog havde patienter, som fik tofacitinib 5 mg 2 gange dagligt, ikke et nominelt statistisk signifikant respons (behandlingsforskel fra placebo 8,4 % [95 % CI: -1,0; 17,8]) ved måned 3).
In OPAL BEYOND, MDA was achieved by 22.9% and 14.5% of tofacitinib 5 mg BID and placebo treated patients, respectively, however tofacitinib 5 mg BID did not achieve nominal statistical significance (treatment difference from placebo 8.4% [95% CI: -1.0, 17.8] at month 3).
Det anbefales ikke at initiere behandling med tofacitinib hos patienter med ANC under 1,0 x10
It is not recommended to initiate tofacitinib treatment in patients with an ANC less than 1,000 cells/mm3.
XELJANZ 5 mg tabletter tofacitinib
XELJANZ 5 mg tablets tofacitinib
Blødende tyktarmsbetændelse er en betændelsessygdom i tyktarmen.
Ulcerative colitis is an inflammatory disease of the large bowel.
Patienter, der fik 5 mg eller 10 mg tofacitinib 2 gange dagligt, opnåede signifikant større forbedringer fra baseline i træthed sammenlignet med placebo i alle 5 studier.
Patients receiving tofacitinib 5 mg or 10 mg twice daily demonstrated significantly greater improvement from baseline in fatigue compared to placebo in all 5 studies.
XELJANZ 10 mg tabletter tofacitinib
XELJANZ 10 mg tablets tofacitinib
KARTON TIL 10 MG BLISTERKORT
CARTON FOR 10 MG BLISTER PACK
De patienter, som blev randomiseret til tofacitinib, fik 5 mg 2 gange dagligt eller tofacitinib 10 mg 2 gange dagligt i 12 måneder.
Patients randomised to tofacitinib received 5 mg twice daily or tofacitinib 10 mg twice daily for 12 months.
I disse studier blev der observeret stigning i ASAT > 3 x ULN hos 0,72 %, 0,5 % og 0,31 % af de patienter, der fik henholdsvis placebo, 5 mg og 10 mg tofacitinib 2 gange dagligt.
In these studies, AST elevations greater than 3x ULN were observed in 0.72%, 0.5% and 0.31% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
I kliniske studier blev tofacitinib ikke evalueret hos forsøgspersoner med svært nedsat (Child Pugh C) leverfunktion (se pkt.
In clinical trials, tofacitinib was not evaluated in subjects with severe (Child Pugh C) hepatic impairment (see sections 4.2 and 4.4), or in patients screened positive for hepatitis B or C.
De patienter, som blev randomiseret til tofacitinib, fik 5 mg 2 gange dagligt eller tofacitinib 10 mg 2 gange dagligt i 6 måneder.
Patients randomised to tofacitinib received 5 mg twice daily or tofacitinib 10 mg twice daily for 6 months.
ΔDSS Måned 3 Måned 6 Måned 12
ΔLEIf Month 3 Month 6 Month 12
Patienter, som fik 5 mg eller 10 mg tofacitinib 2 gange dagligt, oplevede signifikant større forbedringer fra baseline sammenlignet med placebogruppen inden for alle 8 områder samt i scorerne for fysisk helbred og psykisk helbred ved måned 3 i ORAL Solo, ORAL Scan og ORAL Step.
Patients receiving either 5 mg or 10 mg tofacitinib twice daily experienced significantly greater improvement from baseline compared to placebo in all 8 domains as well as the Physical Component Summary and Mental Component Summary scores at month 3 in ORAL Solo, ORAL Scan and ORAL Step.
Hvis du har taget for meget XELJANZ
If you take more XELJANZ than you should
Tofacitinib 10 mg to gange dagligt N=476
Tofacitinib 10 mg twice daily N=476
Tofacitinib 5 mg 2 gange dagligt N=384
Tofacitinib 5 mg twice daily N=384
Placebo Tofacitinib 5 mg 2 gange dagligt
Placebo Tofacitinib 5 mg twice daily
ETIKET TIL 11 MG BEHOLDERENS INDRE EMBALLAGE
LABEL FOR 11 MG BOTTLE IMMEDIATE PACKAGING
I dette studie blev der observeret stigning i ASAT > 3 x ULN hos 3,3 %, 1,6 % og 1,5 % af de patienter, der fik henholdsvis MTX, 5 mg og 10 mg tofacitinib 2 gange dagligt.
In this study, AST elevations greater than 3x ULN were observed in 3.3%, 1.6% and 1.5% of patients receiving MTX, tofacitinib 5 mg and 10 mg twice daily, respectively.
TNFi Patienter med utilstrækkeligt respons
TNFi inadequate responders b
Patienter, der fik 5 mg eller 10 mg tofacitinib 2 gange dagligt, udviste en signifikant større forbedring i fysisk funktion sammenlignet med placebogruppen så tidligt som uge 2 i ORAL Solo og ORAL Sync.
Tofacitinib 5 mg or 10 mg twice daily-treated patients demonstrated significantly greater improvement in physical functioning compared to placebo as early as week 2 in ORAL Solo and ORAL Sync.
PK: Farmakokinetik Tofacitinibs dosis skal reduceres til 5 mg (som filmovertrukken tablet) én gang dagligt hos patienter, der får 11 mg (som depottablet) én gang dagligt (se pkt.
Tofacitinib dose should be reduced to 5 mg (as film-coated tablet) once daily in patients receiving 11 mg (as prolonged-release tablet) once daily (see section 4.2).
ETIKET TIL 10 MG BEHOLDERENS INDRE EMBALLAGE
LABEL FOR 10 MG BOTTLE IMMEDIATE PACKAGING
Tofacitinib 5 mg 2 gange dagligt + MTX Gennemsnitlig forskel fra placebo b (CI)
Tofacitinib 5 mg twice daily + MTX Mean difference from placebob (CI)
Tofacitinibs potentielle indvirkning på andre lægemidlers farmakokinetik
Potential for tofacitinib to influence the PK of other medicinal products
• Patientinformationskortet skal indeholde følgende nøgleinformation: o En advarsel til sundhedsprofessionelle, som på ethvert tidspunkt behandler patienten, herunder også i nødsituationer, om, at patienten får XELJANZ o At behandling med XELJANZ kan øge risikoen for infektioner og non-melanon hudkræft o At patienten skal informere sundhedsprofessionelle, hvis de planlægger at blive vaccineret eller at blive gravid o Tegn og symptomer på følgende sikkerhedsproblemer, og/eller hvornår der skal søges læge: Infektioner, re-aktivering af herpes zoster, non-melanom hudkræft, forhøjede aminotransferaser og risikoen for lægemiddelinduceret leverskade, gastrointestinal perforation, interstitiel lungesygdom, øget immunsuppression, når XELJANZ bruges sammen med biologiske lægemidler eller immunsuppressiva, herunder Blymfocytdepleterende lægemidler.
o That treatment with XELJANZ may increase the risk of infections and non melanoma skin cancer o That patients should inform health professionals if they are planning to receive any vaccine or become pregnant o Signs or symptoms of the following safety concern and/or when to seek attention from a HCP: infections, herpes zoster reactivation, non-melanoma skin cancer, transaminase elevation and potential for drug-induced liver injury, gastrointestinal perforation, interstitial lung disease, increased immunosuppression when used in combination with biologics and immunosuppressants including B lymphocyte depleting agents, increased risk of adverse events when XELJANZ is administered in combination with MTX, increased exposure to XELJANZ when co-administered with CYP3A4 and CYP2C19 inhibitors, effects on pregnancy and foetus, use in breast-feeding, effect on vaccination efficacy and the use of live/attenuated vaccines.
Unormale leverfunktio ns-test Forhøjet gammaglutamyltran sferase
Hepatic steatosis Hepatic enzyme increased T ransaminases increased Liver function test abnormal Gamma glutamyltransferase increased
Lipidniveauerne vendte tilbage til baseline-værdier efter seponering af tofacitinib.
Upon withdrawal of tofacitinib treatment, lipid levels returned to baseline.
De patienter, som blev randomiseret til placebo, blev på en blindet måde overført ved måned 3 til enten tofacitinib 5 mg 2 gange dagligt eller tofacitinib 10 mg 2 gange dagligt ved måned 3 og blev behandlet indtil måned 6.
Patients randomised to placebo were advanced in a blinded manner at month 3 to either tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily and received treatment until month 6.
ALC < 0,50
ALC less than 500
Bekræftet ALC til under 0,75 x10 9 celler/l var forbundet med en øget incidens af alvorlige infektioner
Confirmed ALC less than 750 cells/mm were associated with an increased incidence of serious infections (see section 4.4).
Tofacitinib 10 mg filmovertrukne tabletter
Tofacitinib 10 mg film-coated tablets
• Tofacitinibs dosis skal reduceres til 5 mg én gang dagligt hos patienter, der får 5 mg to gange dagligt.
• Tofacitinib dose should be reduced to 5 mg once daily in patients receiving 5 mg twice daily.
Tofacitinib 10 mg to gange dagligt N=197
Tofacitinib 10 mg twice daily N=197
Patienter, som fik tofacitinib 5 mg 2 gange dagligt, havde en større forbedring af artritsmerter (målt på en 0-100 visuel analog skala) fra baseline i uge 2 (første vurdering efter baseline) til måned 3 sammenlignet med placebo i studierne OPAL BROADEN- og OPAL BEYOND (nominel p≤ 0,05).
(as measured on a 0-100 visual analogue scale) from baseline at week 2 (first post-baseline assessment) through month 3 compared to placebo in studies OPAL BROADEN and OPAL BEYOND (nominal p≤ 0.05).
Tofacitinib 5 mg to gange dagligt N=198
Tofacitinib 5 mg twice daily N=198
Tofacitinib 5 mg 2 gange dagligt + MTX
Tofacitinib 5 mg twice daily + MTX
Tofacitinib 5 mg 2 gange dagligt monoterapi N= 241
Tofacitinib 5 mg twice daily monotherapy N=241
Hver filmovertrukken tablet indeholder tofacitinibcitrat, svarende til 5 mg tofacitinib.
Each film-coated tablet contains tofacitinib citrate, equivalent to 5 mg tofacitinib.
Tabel 14: Kliniske fase 3-studier med tofacitinib i doser på 5 mg og 10 mg to gange dagligt hos patienter med UC OCTAVE Induction 1 OCTAVE Induction 2 OCTAVE Sustain
Table 14: Phase 3 clinical studies of tofacitinib 5 mg and 10 mg twice daily doses in patients with UC
• Tofacitinibs dosis skal reduceres til 5 mg to gange dagligt hos patienter, der får 10 mg to gange dagligt.
• Tofacitinib dose should be reduced to 5 mg twice daily in patients receiving 10 mg twice daily.
Der blev observeret hibernoma (malignitet i brunt fedtvæv) hoshunrotter, der blev eksponeret for ≥ 83 eller 41 gange det kliniske eksponeringsniveau på 5 mg eller 10 mg to gange dagligt.
Hibernomas (malignancy of brown adipose tissue) were observed in female rats at exposures greater than or equal to 83 or 41 times the clinical exposure level at 5 mg or 10 mg twice daily.
KARTON TIL 5 MG BLISTERKORT
CARTON FOR 5 MG BLISTER PACK
Tofacitinib 10 mg to gange dagligt N=429
Tofacitinib 10 mg twice daily N=429
Med tidligere svigt af TNF-hæmmer
With prior TNF inhibitor failure
Tofacitinib 5 mg filmovertrukne tabletter
Tofacitinib 5 mg film-coated tablets
Skift mellem tofacitinib 5 mg filmovertrukne tabletter og tofacitinib 11 mg depottabletter Patienter, som behandles med tofacitinib 5 mg filmovertrukne tabletter to gange dagligt, kan skifte til tofacitinib 11 mg depottabletter én gang dagligt på dagen efter indtagelse af sidste dosis tofacitinib 5 mg filovertrukne tabletter.
Patients treated with tofacitinib 5 mg film-coated tablets twice daily may be switched to tofacitinib 11 mg prolonged-release tablets once daily on the day following the last dose of tofacitinib 5 mg film-coated tablets.
Hver filmovertrukken tablet indeholder tofacitinibcitrat, svarende til 10 mg tofacitinib.
Each film-coated tablet contains tofacitinib citrate, equivalent to 10 mg tofacitinib.
Fald > 1,24 mmol/l eller værdi < 4,96 mmol/l (bekræftet ved kontroltest)
Greater than 2 g/dL decrease or less than 8.0 g/dL (confirmed by repeat testing)
Patienter, der fik 5 mg eller 10 mg tofacitinib 2 gange dagligt, opnåede betydeligt større forbedringer fra baseline i begge skemaer sammenlignet med placebogruppen i ORAL Sync, ORAL Standard og ORAL Scan.
Patients receiving tofacitinib 5 mg or 10 mg twice daily demonstrated significantly greater improvement from baseline in both scales compared to placebo in ORAL Sync, ORAL Standard and ORAL Scan.
EU/1/17/1178/012 28 depottabletter EU/1/17/1178/013 91 depottabletter
EU/1/17/1178/012 28 prolonged-release tablets EU/1/17/1178/013 91 prolonged-release tablets
I kliniske studier og i rapporter efter markedsføring er der observeret pulmonal emboli (PE) hos patienter, som tager tofacitinib.
Pulmonary embolism (PE) has been observed in patients taking tofacitinib in clinical trials and post-marketing reports.
Din læge vil undersøge, om du har tuberkulose, før du begynder at få XELJANZ og vil måske undersøge dig igen i løbet af behandlingen.
Your doctor will test you for tuberculosis before starting XELJANZ and may retest during treatment - if you have any chronic lung disease - if you have liver problems
Placebo Tofacitinib 10 mg to gange dagligt
Placebo Tofacitinib 10 mg twice daily
Adalimumab 40 mg s.c. hver anden uge + MTX
Adalimumab 40 mg SC QOW + MTX
Tofacitinib 10 mg 2 gange dagligt + MTX
Tofacitinib 10 mg twice daily + MTX
Tofacitinib 10 mg 2 gange dagligt + DMARD N= 315
Tofacitinib 10 mg twice daily + DMARD(s) N=315
I dette studie blev der observeret stigning i ASAT > 3 x ULN hos 1,65 %, 0,41 % og 0 % af de patienter, der fik henholdsvis placebo, 5 mg og 10 mg tofacitinib 2 gange dagligt.
In this study, AST elevations greater than 3x ULN were observed in 1.65%, 0.41% and 0% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
*p <0,05, ***p<0,0001 versus placebo, s.c.=subkutant, N=antal forsøgspersoner analyseret
*p <0.05, ***p<0.0001 versus placebo, SC=subcutaneous, QOW=every other week, N=number of subjects analysed, DAS28=Disease Activity Scale 28 joints, ESR=Erythrocyte Sedimentation Rate.
Dyspnø Tilstoppede bihuler
Gastritis Dyspepsia
Tofacitinib 2 gange dagligt + MTX
Tofacitinib twice daily + MTX
EU/1/17/1178/007 56 filmovertrukne tabletter EU/1/17/1178/008 112 filmovertrukne tabletter EU/1/17/1178/009 182 filmovertrukne tabletter
EU/1/17/1178/007 56 film-coated tablets EU/1/17/1178/008 112 film-coated tablets EU/1/17/1178/009 182 film-coated tablets
Tofacitinib 10 mg 2 gange dagligt monoterapi N= 243
Tofacitinib 10 mg twice daily monotherapy N=243
Tofacitinib 5 mg 2 gange dagligt + MTX N=376
Tofacitinib 5 mg twice daily + MTX N=376
EU/1/17/1178/010 30 depottabletter EU/1/17/1178/011 90 depottabletter
EU/1/17/1178/010 30 prolonged-release tablets EU/1/17/1178/011 90 prolonged-release tablets
De patienter, som blev randomiseret til placebo, blev på en blindet måde overført til enten tofacitinib 5 mg 2 gange dagligt eller tofacitinib 10 mg 2 gange dagligt ved måned 3 og blev behandlet indtil måned 12.
Patients randomised to placebo were advanced in a blinded manner at month 3 to either tofacitinib 5 mg twice daily or tofacitinib 10 mg twice daily and received treatment until month 12.
EU/1/17/1178/003 56 filmovertrukne tabletter EU/1/17/1178/004 182 filmovertrukne tabletter EU/1/17/1178/014 112 filmovertrukne tabletter
EU/1/17/1178/003 56 film-coated tablets EU/1/17/1178/004 182 film-coated tablets EU/1/17/1178/014 112 film-coated tablets
EU/1/17/1178/005 60 filmovertrukne tabletter EU/1/17/1178/006 180 filmovertrukne tabletter
EU/1/17/1178/005 60 film-coated tablets EU/1/17/1178/006 180 film-coated tablets
- sig det til lægen, hvis du lider af spiserørsforsnævring, da der er indberettet sjældne tilfælde af blokering af spiserøret for patienter, der tager andre lægemidler med tilsvarende depottabletter.
Your doctor will decide whether you need to have herpes zoster vaccination - if you have heart problems, high blood pressure, or high cholesterol - if you have narrowing of the digestive tract tell your doctor as there have been rare reports of blockage in the digestive tract in patients taking other medicines using similar prolonged-release tablets - when you take XELJANZ 11 mg prolonged-release tablets, you may see something in your stool that looks like a tablet.
Tidspunkt for skift fra placebo til 5 mg eller 10 mg tofacitinib 2 gange dagligt
Time of mandatory placebo rescue to tofacitinib 5 mg or 10 mg twice daily
Leverenzymtest
Posology
Tabel 3: Lav hæmoglobinværdi Lav hæmoglobinværdi (pkt.
Table 3: Low haemoglobin value Low haemoglobin value (Section 4.4)
Dosis skal reduceres til 5 mg filmovertrukken tablet én gang dagligt, når den indicerede dosis ved tilstedeværelsen af normal leverfunktion er 11 mg depottablet én gang dagligt (se pkt.
Dose should be reduced to 5 mg film-coated tablet once daily when the indicated dose in the presence of normal renal function is 11 mg prolonged-release tablet once daily (see section 5.2).
Tegn på sår eller huller i mavesækken eller tarmene (ikke almindelige) inkluderer - feber - mavesmerter - blod i afføringen - uforklarlige ændringer i afføringsvaner
Signs of ulcers or holes in your stomach (uncommon) include
Tofacitinib 10 mg 2 gange dagligt
Tofacitinib 10 mg twice daily
I de langvarige RA-forlængelsesstudier blev stigning i ALAT eller ASAT > 3 x ULN observeret hos 1,1 % og 1,4 % af de patienter, der fik henholdsvis tofacitinib 5 mg og 10 mg 2 gange dagligt som monoterapi.
In the RA long-term extension studies, on monotherapy, ALT elevations greater than 3x ULN were observed in 1.1% and 1.4% of patients receiving tofacitinib 5 mg and 10 mg twice daily, respectively.
• Svært nedsat leverfunktion (se pkt.
• Severe hepatic impairment (see section 4.2).
Hver tablet indeholder 5 mg tofacitinib (som tofacitinibcitrat).
Each tablet contains 5 mg of tofacitinib (as tofacitinib citrate).
Hver depottablet indeholder tofacitinibcitrat, svarende til 11 mg tofacitinib.
Each prolonged-release tablet contains tofacitinib citrate, equivalent to 11 mg tofacitinib.
Tofacitinib 10 mg 2 gange dagligt N= 368 Gennemsnit (SD)
Tofacitinib 10mg twice daily N=368 Mean (SD)a
Tofacitinib 5 mg 2 gange dagligt + MTX N= 277 Gennemsnit (SD)
Tofacitinib 5 mg twice daily + MTX N=277 Mean (SD)a
Der var ingen bekræftede fald i ANC til under 0,50 x10
There were no confirmed decreases in ANC below 500 cells/mm3 observed in any treatment group.
- Hver enkelt 11 mg depottablet indeholder 11 mg tofacitinib (som tofacitinibcitrat).
- Each 11 mg prolonged-release tablet contains 11 mg of tofacitinib (as tofacitinib citrate).
Tofacitinib 10 mg 2 gange dagligt + MTX N= 309
Tofacitinib 10 mg twice daily + MTX N=309
Neutrofiler Behandling med tofacitinib var forbundet med en øget incidens af neutropeni (under 2,0 x10
Treatment with tofacitinib was associated with an increased incidence of neutropenia (less than 2,000 cells/mm3) compared to placebo.
Leddegigt • Den anbefalede dosis er 5 mg 2 gange dagligt.
Rheumatoid arthritis • The recommended dose is 5 mg twice a day.
Samtidigt administreret lægemiddel
Coadministered Drug
• Tjeklisten til ordinerende læger skal indeholde følgende nøgleinformation: o Lister med tests, som skal udføres i forbindelse med den intiale screening og vedligeholdelse af patienten o Hvilke vaccinationer, der skal gennemføres før behandling o Særlig henvisning til, at patienten er informeret og forstår, at tofacitinib er kontraindiceret under graviditet og amning, og at kvinder i den fødedygtige alder bør anvende effektiv prævention under behandling med tofacitinib og mindst 4 uger efter sidste dosis.
• The Prescriber checklist shall contain the following key messages: o Lists of tests to be conducted during the initial screening and maintenance of the patient o Vaccination course to be completed before treatment o A specific reference to the fact that the patient has been informed and understands that tofacitinib is contraindicated during pregnancy and breast-feeding and women of childbearing potential should use effective contraception during treatment with tofacitinib and for at least 4 weeks after the last dose o That the benefit risk of tofacitinib should be discussed with the patient, and the patient alert card should be given to and discussed with the patient o Relevant comorbidities for which caution is advised when XELJANZ is administered and conditions in which XELJANZ should not be administered o List of concomitant medications which are not compatible with treatment with XELJANZ o The need to discuss with the patients the risks associated with the use of XELJANZ, specifically in regards to infections, herpes zoster, tuberculosis (TB) and other opportunistic infections, malignancy, gastrointestinal perforations, interstitial lung disease, and laboratory abnormalities o The need to monitor for any signs and symptoms and laboratory abnormalities for early identification of the abovementioned risks.
XELJANZ skal tages gennem munden.
XELJANZ is for oral use.
XELJANZ 5 mg filmovertrukne tabletter XELJANZ 10 mg filmovertrukne tabletter
XELJANZ 5 mg film-coated tablets XELJANZ 10 mg film-coated tablets
I kontrollerede kliniske fase 3-studier med tofacitinib-monoterapi var infektionsraten over 03 måneder 16,2 % (100 patienter) i gruppen med 5 mg filmovertrukne tabletter 2 gange dagligt (i alt 616 patienter), 17,9 % (115 patienter) i gruppen med 10 mg 2 gange dagligt (i alt 642 patienter) og 18,9 % (23 patienter) i placebogruppen (i alt 122 patienter).
In controlled phase 3 clinical studies, the rates of infections over 0-3 months in the 5 mg film-coated tablets twice daily (total 616 patients) and 10 mg twice daily (total 642 patients) tofacitinib monotherapy groups were 16.2% (100 patients) and 17.9% (115 patients), respectively, compared to 18.9% (23 patients) in the placebo group (total 122 patients).
Tofacitinib 10 mg 2 gange dagligt + MTX N= 134
Tofacitinib 10 mg twice daily + MTX N=134
EU/1/17/1178/001 60 filmovertrukne tabletter EU/1/17/1178/002 180 filmovertrukne tabletter
EU/1/17/1178/001 60 film-coated tablets EU/1/17/1178/002 180 film-coated tablets
Tofacitinib 5 mg 2 gange dagligt + MTX N= 316
Tofacitinib 5 mg twice daily + MTX N=316
Dosis skal reduceres til 5 mg to gange dagligt, når den indicerede dosis ved tilstedeværelsen af normal leverfunktion er 10 mg to gange dagligt (se pkt.
Dose should be reduced to 5 mg twice daily when the indicated dose in the presence of normal hepatic function is 10 mg twice daily (see section 5.2).
Det anbefales ikke at initiere behandling hos patienter med hæmoglobin under 5,58 mmol/l.
It is recommended not to initiate dosing in patients with haemoglobin less than 9 g/dL.
Tofacitinib 10 mg 2 gange dagligt + MTX N= 290 Gennemsnit (SD)
Tofacitinib 10 mg twice daily + MTX N=290 Mean (SD)a
Det anbefales ikke at påbegynde behandling med tofacitinib, hvis patientens hæmoglobin er under 5,58 mmol/l.
It is not recommended to initiate tofacitinib treatment in patients with a haemoglobin value less than 9 g/dL.
XELJANZ 10 mg filmovertrukne tabletter
XELJANZ 10 mg film-coated tablets
Tofacitinib 5 mg 2 gange dagligt + MTX N= 133
Tofacitinib 5 mg twice daily + MTX N=133
• Psoriasisgigt
• psoriatic arthritis
Tofacitinib 5 mg 2 gange dagligt + DMARD N= 312
Tofacitinib 5 mg twice daily + DMARD(s) N=312
- Hver 10 mg filmovertrukket tablet indeholder10 mg tofacitinib (som tofacitinibcitrat).
- Each 10 mg film-coated tablet contains 10 mg of tofacitinib (as tofacitinib citrate).
- feber og kuldegysninger
• fever and chills
Yderligere prøver til at overvåge dit helbred
Additional monitoring tests
Hver tablet indeholder 10 mg tofacitinib (som tofacitinibcitrat).
Each tablet contains 10 mg of tofacitinib (as tofacitinib citrate).
Hvis du har taget for mange tabletter, skal du øjeblikkeligt fortælle det til din læge eller apotekspersonalet.
If you take more XELJANZ than you should If you take more tablets than you should, immediately tell your doctor or pharmacist.
I kontrollerede kliniske fase 3-studier med tofacitinib-monoterapi var infektionsraten over 03 måneder 16,2 % (100 patienter) i gruppen med 5 mg 2 gange dagligt (i alt 616 patienter), 17,9 % (115 patienter) i gruppen med 10 mg 2 gange dagligt (i alt 642 patienter) og 18,9 % (23 patienter) i placebogruppen (i alt 122 patienter).
In controlled phase 3 clinical studies, the rates of infections over 0-3 months in the 5 mg twice daily (total 616 patients) and 10 mg twice daily (total 642 patients) tofacitinib monotherapy groups were 16.2% (100 patients) and 17.9% (115 patients), respectively, compared to 18.9% (23 patients) in the placebo group (total 122 patients).
Svær
Headache
Adalimumab 40 mg hver anden uge + MTX
Adalimumab 40 mg QOW + MTX
XELJANZ 11 mg depottabletter
XELJANZ 11 mg prolonged-release tablets