natgillin/translations-raw huggingface dataset:
Når angiotensin-II-antagonister administreres samtidig med nonsteroide antiinflammatoriske lægemidler (fx selektive COX-2-hæmmere, acetylsalicylsyre ( &gt; 3 g/dag) og non-selektive NSAID) kan den antihypertensive virkning svækkes.
When angiotensin II antagonists are administered simultaneously with non-steroidal antiinflammatory drugs (i.e. selective COX-2 inhibitors, acetylsalicylic acid ( &gt; 3 g/day) and non-selective NSAIDs), attenuation of the antihypertensive effect may occur.
Syvogfyrre procent (47,2%) af patienterne i kombinationsbehandling nåede et dal-SeDBT &lt; 90 mmHg sammenlignet med 33,2% af patienterne behandlet med irbesartan (p = 0,0005).
Forty-seven percent (47.2%) of patients on the combination achieved trough SeDBP &lt; 90 mmHg compared to 33.2% of patients on irbesartan (p = 0.0005).
På grund af hydrochlorthiazid-komponenten frarådes Ifirmacombi til patienter med alvorlig nyreinsufficiens (kreatininclearance &lt; 30 ml/min).
Due to the hydrochlorothiazide component, Ifirmacombi is not recommended for patients with severe renal dysfunction (creatinine clearance &lt; 30 ml/min).
Faldet i SeSBT/SeDBT efter 5 uger var henholdsvis 30,8/24,0 mmHg og 21,1/19,3 mmHg for irbesartan/hydrochlorothiazid og irbesartan (p &lt; 0,0001).
The mean baseline blood pressure was approximately 172/113 mmHg in each treatment group and decreases of SeSBP/SeDBP at five weeks were 30.8/24.0 mmHg and 21.1/19.3 mmHg for irbesartan/hydrochlorothiazide and irbesartan, respectively (p &lt; 0.0001).
Ifirmacombi må ikke anvendes til patienter med alvorlig nyrefunktionsnedsættelse (kreatininclearance &lt; 30 ml/min) (se pkt.
Ifirmacombi should not be used in patients with severe renal impairment (creatinine clearance &lt; 30 ml/min) (see section 4.3).
4.4 og 4.6) - Alvorlig nyrefunktionsnedsættelse (kreatininclearance &lt; 30 ml/min) - Refraktær hypokaliæmi, hyperkalcæmi - Alvorlig leverfunktionsnedsættelse, biliær cirrose og kolestase - Samtidig brug af Ifirmacombi og lægemidler indeholdende aliskiren er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR &lt; 60 ml/min/1,73 m2) (se pkt.
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1, or to other sulfonamide-derived substances (hydrochlorothiazide is a sulfonamide-derived substance) - Second and third trimesters of pregnancy (see sections 4.4 and 4.6) - Severe renal impairment (creatinine clearance &lt; 30 ml/min) - Refractory hypokalaemia, hypercalcaemia - Severe hepatic impairment, biliary cirrhosis and cholestasis - The concomitant use of Ifirmacombi with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR &lt; 60 ml/min/1.73 m2) (see sections 4.5
Dog skal denne faste dosis-kombination gives med forsigtighed til patienter med let til moderat nedsat nyrefunktion (kreatininclearance ≥ 30 ml/min, men &lt; 60 ml/min).
However, in patients with mild to moderate renal impairment (creatinine clearance ≥ 30 ml/min but &lt; 60 ml/min) this fixed dose combination should be administered with caution.
Hvis dit blodsukker stadig er for lavt (under 4 mmol/l), eller hypoglykæmien vender tilbage, skal du tage yderligere 15-20 gram sukker.
If blood glucose levels are still too low ( &lt; 4 mmol/L) or hypoglycaemia comes back take another 15 to 20 gram of sugar.
Hovedårsagen til ikke at indgå i den randomiserede fase var faste-plasmaglucose (FPG) &gt; 13,9 mmol/l og HbA1c &lt; 7 % eller &gt; 10 % ved slutningen af indkøringsfasen.
The main reasons for not entering the randomized phase were FPG value &gt; 13.9 mmol/L and HbA1c value &lt; 7% or &gt; 10% at the end of the run-in phase
• For doser &gt; 40 dosistrin/dag skal titrering fortsættes med Suliqua (30-60) pen.
• For doses &gt; 40 dose steps/day titration must be continued with Suliqua (30-60) pen.
I en præ-specificeret analyse af dette primære endepunkt var de observerede forskelle i overensstemmelse med HbA1c ved baseline ( &lt; 8 % eller ≥8 %) eller oralt antidiabetikum ved baseline (metformin alene eller metformin plus et andet oralt antidiabetikum).
In a pre-specified analysis of this primary endpoint, the differences observed were consistent with regard to baseline HbA1c ( &lt; 8% or ≥8%) or baseline OAD use (metformin alone or metformin plus second OAD).
Patienterne i Suliqua-gruppen rapporterede statistisk signifikant større reduktion i den gennemsnitlige selvmonitorerede plasmaglucoseprofil (SMPG-profil) med 7 daglige målinger fra baseline til uge 30 (3,35 mmol/l) sammenlignet med patienterne i insulin glargin-gruppen (-2,66 mmol/l; forskel -0,69 mmol/l) og patienterne i lixisenatid-gruppen (-1,95 mmol/l; forskel -1,40 mmol/l) (p &lt; 0,0001 for begge sammenligninger).
Patients in the Suliqua group reported a statistically significantly greater decrease in the average 7-point self-monitored plasma glucose (SMPG) profile from baseline to Week 30 (-3.35 mmol/L) compared to patients in the insulin glargine group (-2.66 mmol/L; difference -0.69 mmol/L) and patients in the lixisenatide group (-1.95 mmol/L; difference -1.40 mmol/L) (p &lt; 0.0001 for both comparisons).
Ved uge 30 gav Suliqua statistisk signifikant forbedret HbA1c (p &lt; 0,0001) sammenlignet med insulin glargin.
At Week 30, Suliqua provided statistically significant improvement in HbA1c (p-value &lt; 0.0001) compared to insulin glargine.
Insulin glargin (100 enheder/ml)**≥20 til &lt; 30 enheder
Insulin glargine (100 units/ml)** ≥20 to &lt; 30 units
Ved uge 30 gav Suliqua statistisk signifikant forbedret HbA1c (p &lt; 0,0001) sammenlignet med de to indholdsstoffer enkeltvist.
At Week 30, Suliqua provided statistically significant improvement in HbA1c (p-value &lt; 0.0001) compared to the individual components.
Nedenstående behandlingsrelaterede bivirkninger fra kliniske studier er opstillet efter systemorganklasse og efter faldende hyppighed (meget almindelig: ≥1/10; almindelig: &gt; 1/100 til &lt; 1/10; ikke almindelig: ≥1/1.000 til &lt; 1/100; sjælden: ≥1/10.000 til &lt; 1/1.000; meget sjælden:
The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing frequency (very common: ≥1/10; common: ≥1/100 to &lt; 1/10;
Antal (%) patienter, der opnåede HbA1c &lt; 7,0 % uden vægtstigning ved uge 30
Number (%) of patients achieving HbA1c &lt; 7.0% with no body weight gain at week 30
• Suliqua må ikke anvendes ved et totalt antal daglige doser &gt; 60 dosistrin.
• For total daily doses &gt; 60 dose steps/day, Suliqua must not be used.
Faste-plasmaglucose (mmol/l) Baseline (gennemsnit) Ved afslutning af studie (gennemsnit) LS-ændring fra baseline (gennemsnit) LS-forskel versus glargin (gennemsnit) [95 % KI] (p-værdi)
HbA1c (%) Baseline (mean; post run-in phase) End of study (mean) LS change from baseline (mean) Difference vs. insulin glargine [95% confidence interval] (p-value) Difference vs. lixisenatide [95% confidence interval] (p-value) Number of Patients (%) reaching HbA1c &lt; 7% at week 30* Fasting plasma glucose (mmol/L) Baseline (mean) End of study (mean) LS change from baseline (mean) LS difference versus glargine (mean) [95%CI] (p-value)
Antal patienter [n (%)], der opnåede HbA1c &lt; 7 % ved uge 30*
Patients [n (%)] reaching HbA1c &lt; 7% at week 30* Fasting plasma glucose (mmol/L) Baseline (mean)
&gt; R (Resistent)
&gt; R (Resistant)
Legemsvægt &gt; 40 kg Legemsvægt ≤ 40 kg
Body weight &gt; 40 kg Body weight ≤ 40 kg
¶ Klinisk effekt blev også observeret ( &lt; 5 patienter) hos følgende Candida-arter: C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua og C. dubliniensis.
¶ Clinical efficacy was also observed ( &lt; 5 patients) in the following Candida species: C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua and C. dubliniensis.
I systemisk cirkulation er micafungin ekstensivt plasmabundet ( &gt; 99 %) primært til albumin.
In systemic circulation, micafungin is highly bound to plasma protein ( &gt; 99%), primarily to albumin.
De fleste patienter (97 %, N=882) havde neutropeni ved baseline ( &lt; 200 neutrofile/μL).
Most patients (97%, N=882) had neutropenia at baseline ( &lt; 200 neutrophils/µL).
Informer Deres lÃ¦ge, hvis De mÃ¦rker eventuelle bivirkninger, som kan give problemer med at kÃ¸re eller betjene maskiner.
Please inform your doctor if you experience any effects that may cause you to have problems with driving or using other machinery.
Infektionsbehandlingen bÃ¸r fortsÃ¦tte i mindst en uge, efter at to pÃ¥ hinanden fÃ¸lgende negative blodprÃ¸ver er taget, og efter at kliniske symptomer fra infektionen er ophÃ¸rt.
The antifungal treatment should continue for at least one week after two sequential negative blood cultures have been obtained and after resolution of clinical signs and symptoms of infection.
Micafunginbehandling var forbundet med signifikant forværring af leverfunktion (forhøjet ALAT, ASAT eller total-bilirubin &gt; 3 gange ULN) både hos raske frivillige og hos patienter.
Micafungin treatment was associated with significant impairment of liver function (increase of ALT, AST or total bilirubin &gt; 3 times ULN) in both healthy volunteers and patients.
Micafungin viste en mindre middelværdisreduktion i den estimerede glomerulære filtrationshastighed under behandlingen (P &lt; 0,001) og en lavere forekomst af infusionsrelaterede reaktioner (P=0,001) sammenlignet med liposomalt amphotericin B.
Micafungin demonstrated a smaller mean peak decrease in estimated glomerular filtration rate during treatment (p &lt; 0.001) and a lower incidence of infusion-related reactions (p=0.001) than liposomal amphotericin B.
Børn (inklusive nyfødte) og unge &lt; 16 år: - Behandling af invasiv candidiasis.
Children (including neonates) and adolescents &lt; 16 years of age: - Treatment of invasive candidiasis.
≥1/100 til &lt; 1/10
≥ 1/100 to &lt; 1/10
Patienter med nedsat nyrefunktion: Svært nedsat nyrefunktion (Glomerular Filtration Rate [GFR] &lt; 30 ml/min) påvirkede ikke farmakokinetikken af micafungin signifikant.
Patients with renal impairment: Severe renal impairment (Glomerular Filtration Rate [GFR] &lt; 30 ml/min) did not significantly affect the pharmacokinetics of micafungin.
1 mg/kg/dag *Hvis patientens respons er utilstrækkelig, f.eks. hvis kulturerne giver negative resultater, eller den kliniske tilstand ikke forbedres, kan dosis øges til 200 mg/dag hos patienter, der vejer &gt; 40 kg eller 4 mg/kg/dag hos patienter, som vejer ≤ 40 kg.
1 mg/kg/day *If the patient's response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing &gt; 40 kg or 4 mg/kg/day in patients ≤ 40 kg.
≥1/1.000 til &lt; 1/100
≥ 1/1,000 to &lt; 1/100
Desuden fik børn &lt; 1 år ca. dobbelt så ofte en stigning i ALAT, ASAT og ALP end ældre børn (se pkt.
Additionally, paediatric patients &lt; 1 year of age experienced about two times more often an increase in ALT, AST and AP than older paediatric patients (see section 4.4).
Den mest sandsynlige årsag var forskelle i de underliggende sygdomme hos børn &lt; 1 år i forhold til voksne eller ældre børn i de kliniske studier.
The most likely reason for these differences were different underlying conditions compared with adults or older paediatric patients observed in clinical studies.
Børn &lt; 1 år er muligvis mere udsatte for leverskade (se pkt.
Paediatric patients &lt; 1 year of age might be more prone to liver injury (see section 4.8).
Anvendelse til spædbørn og nyfødte &lt; 4 måneder
Use in children and newborns &lt; 4 months of age
- Profylakse mod Candida-infektion hos patienter, der gennemgår allogen hæmatopoietisk stamcelletransplantation eller patienter, der forventes at få neutropeni (absolut neutrofiltal &lt; 500
- Prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count &lt; 500 cells / µl) for 10 or more days.
Anvendelse til børn &gt; 4 måneder og unge &lt; 16 år
Use in children &gt; 4 months of age and adolescents &lt; 16 years of age
Infusionsflasken/posen bÃ¸r vendes forsigtigt for at fordele den fortyndede oplÃ¸sning, men for at undgÃ¥ skumdannelse mÃ¥ den IKKE rystes.
The infusion bottle/bag should be gently inverted to disperse the diluted solution but NOT agitated in order to avoid foaming.
Infusionsflasken/posen med den fortyndede oplÃ¸sning skal anbringes i en uigennemsigtig pose for at beskytte mod lys.
The infusion bottle/bag containing the diluted infusion solution should be inserted into a closable opaque bag for protection from light.
Brug hos børn ≥ 4 måneder og unge &lt; 16 år
Use in children ≥ 4 months of age up to adolescents &lt; 16 years of age
For patienter med en baseline score &gt; 0.
For patients with Baseline score &gt; 0.
For patienter med en baseline BSA på ≥ 3 % og PASI &gt; 0.
For patients with Baseline BSA ≥ 3% and PASI &gt; 0.
Tabel 9: Antal (%) forsøgspersoner, der opnåede DAS28-4(ESR) &lt; 2,6 remission ved 3 og 6 måneder
Table 9: Number (%) of subjects achieving DAS28-4(ESR) &lt; 2.6 remission at months 3 and 6
Andelen af patienter, der opnåede DAS28 klinisk remission (DAS28-4(ESR) &lt; 2,6) i Oral Step-, Oral Sync- og Oral Standard-studierne, vises i tabel 9.
The proportion of patients achieving a DAS28 clinical remission (DAS28-4(ESR) &lt; 2.6) in ORAL Step, ORAL Sync, and ORAL Standard is shown in Table 9.
CYP3A- og CYP2C19-hæmmer Fluconazol
CYP3A &amp; CYP2C19 Inhibitor Fluconazole
Nominel p &lt; 0,0001 for aktiv behandling versus placebo i måned 3.
Nominal p &lt; 0.0001 for active treatment versus placebo at month 3.
* p &lt; 0,05, ** p &lt; 0,001, *** p &lt; 0,0001 versus placebo (versus MTX i ORAL Start studiet) ǂp &lt; 0,05 - tofacitinib 5 mg + MTX versus tofacitinib 5 mg for ORAL Strategy (normale p-værdier uden justeringer for multiple sammenligninger)
*p &lt; 0.05 **p &lt; 0.001 ***p &lt; 0.0001 verses placebo (versus MTX for ORAL Start) ǂp &lt; 0.05 - tofacitinib 5 mg + MTX versus tofacitinib 5 mg for ORAL Strategy (normal p-values without multiple comparison adjustment)
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 &lt; 1/10), ikke almindelig (≥ 1/1.000 til &lt; 1/100), sjælden (≥ 1/10.000 til &lt; 1/1.000), meget sjælden ( &lt; 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 &lt; 1/10), uncommon (≥ 1/1,000 to &lt; 1/100), rare (≥ 1/10,000 to &lt; 1/1,000), very rare ( &lt; 1/10,000), or not known (cannot be estimated from the available data).
Måned 3 Måned 6 (forsøgspersoner på placebo med &lt; 20 % forbedring af antal hævede og ømme led skiftede til tofacitinib ved måned 3)
Month 6 (placebo subjects with &lt; 20% improvement in swollen and tender joint counts advanced to tofacitinib at month 3)
Nominel p≤ 0,001;
Nominal p &lt; 0.001;
Forsøgspersoner med let (kreatininclearance 50-80 ml/min), moderat (kreatininclearance 30-49 ml/min) og svært (kreatininclearance &lt; 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 &lt; 30 mL/min) renal impairment had 37%, 43% and 123% higher AUC, respectively, compared to subjects with normal renal function (see section 4.2).
Opnået statistisk signifikans inden for ACR-serien (ACR50 og ACR70) ved p &lt; 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.
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) &lt; 2,6 (remission).
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) &lt; 2.6 (remission).
* p &lt; 0,0001; **p &lt; 0,001; †p &lt; 0,05 for XELJANZ versus placebo.
* p &lt; 0.0001; **p &lt; 0.001; †p &lt; 0.05 for tofacitinib versus placebo.
Almindelig ≥ 1/100 til
Common ≥1/100 to &lt; 1/10
Ikke relevant Ikke relevant p &lt; 0,0001, tofacitinib versus placebo + MTX, LS = beregnet ved mindste kvadraters metode, N = antal patienter, HAQ-DI = Health Assessment Questionnaire Disability Index
p &lt; 0.0001, tofacitinib versus placebo + MTX, LS = least squares, N = number of patients, QOW = every other week, NA = not applicable, HAQ-DI = Health Assessment Questionnaire Disability Index
Patienter, som fik tofacitinib 5 mg to gange dagligt, havde en større forbedring (p &lt; 0,05) fra baseline i fysisk funktion sammenlignet med placebo ved måned 3 (se tabel 13).
Patients receiving tofacitinib 5 mg twice daily demonstrated greater improvement (p≤ 0.05) from baseline in physical functioning compared to placebo at month 3 (see Table 13).
Indigotin (indigocarmin) (E132) (kun i 10 mg styrke) Brilliant Blue FCF (E133) (kun i 10 mg styrke)
FD &amp; C Blue #2/Indigo Carmine Aluminum Lake (E132) (10 mg strength only) FD &amp; C Blue #1/Brilliant Blue FCF Aluminum Lake (E133) (10 mg strength only)
Patienter, der fik tofacitinib 5 mg 2 gange dagligt, opnåede en større forbedring i fysisk funktion fra baseline sammenlignet med placebo i SF-36v2, i den sammenlagte SF36v2-score og i FACIT-F-score ved måned 3 i OPAL BROADEN- og OPAL BEYOND (nominel p &lt; 0,05).
Patients receiving tofacitinib 5 mg twice daily demonstrated greater improvement from baseline compared to placebo in the SF-36v2 physical functioning domain, the SF-36v2 physical component summary score, and FACIT-F scores at month 3 in studies OPAL BROADEN and OPAL BEYOND (nominal p≤ 0.05).
I PsA I-studiet (OPAL BROADEN) vurderedes 422 patienter, som tidligere havde haft utilstrækkelig respons (på grund af manglende effekt eller intolerans) på en csDMARD (MTX for 92,7% af patienterne).
Study PsA-I (OPAL BROADEN) evaluated 422 patients who had a previous inadequate response (due to lack of efficacy or intolerance) to a csDMARD (MTX for 92.7% of patients); 32.7% of the patients in this study had a previous inadequate response to &gt; 1 csDMARD or 1 csDMARD and a targeted synthetic DMARD (tsDMARD).
p &lt; 0,0001 for tofacitinib 5 mg to gange dagligt versus placebo.
p &lt; 0.0001 for tofacitinib 5 mg twice daily versus placebo.
p &lt; 0,0001 for tofacitinib 10 mg to gange dagligt versus placebo.
p &lt; 0.0001 for tofacitinib 10 mg twice daily versus placebo.
I PsA II-studiet (OPAL BEYOND) vurderedes 394 patienter, som var blevet seponeret fra en TNFhæmmer på grund af manglende virkning eller intolerans.
Study PsA-II (OPAL BEYOND) evaluated 394 patients who had discontinued a TNF inhibitor due to lack of efficacy or intolerance; 36.0% had a previous inadequate response to &gt; 1 biological DMARD.
ASAT-stigning &gt; 3 x ULN blev observeret hos &lt; 1,0 % både ved 5 mg og 10 mg tofacitinib 2 gange dagligt.
AST elevations greater than 3x ULN were observed in &lt; 1.0% in both the tofacitinib 5 mg and 10 mg twice daily groups.
Remission blev defineret som klinisk remission (en Mayo-score ≤ 2 uden nogen individuel subscore &gt; 1) og en subscore for rektal blødning på 0.
Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore &gt; 1) and rectal bleeding subscore of 0.
DAS284(ESR) &lt; 2,
DAS284(ESR) &lt; 2.6 Month 3:
ANC &lt; 0,50
ANC less than 500
Primært effektmål: Remission blev defineret som klinisk remission (en Mayo-score ≤ 2 uden nogen individuel subscore &gt; 1) og en subscore for rektal blødning på 0.
Primary endpoint: Remission was defined as clinical remission (a Mayo score ≤ 2 with no individual subscore &gt; 1) and rectal bleeding subscore of 0.
I de langvarige RA-forlængelsesstudier med baggrunds-DMARD blev ALAT-stigning &gt; 3 x ULN observeret hos hhv. 1,8 % og 1,6 % af de patienter, der fik henholdsvis tofacitinib 5 mg og 10 mg 2 gange dagligt.
In the RA long-term extension studies, on background DMARDs, ALT elevations greater than 3x ULN were observed in 1.8% and 1.6% of patients receiving tofacitinib 5 mg and 10 mg twice daily, respectively.
Remission blev defineret som klinisk remission (en samlet Mayo-score ≤ 2 uden nogen individuel subscore &gt; 1) og en subscore for rektal blødning på 0.
Remission was defined as clinical remission (a total Mayo score ≤ 2 with no individual subscore &gt; 1) and rectal bleeding subscore of
ACR20 mTSS DAS284(ESR)
ACR20 mT SS DAS284(ESR) &lt; 2.6 Month 3:
I disse studier blev der observeret stigning i ASAT &gt; 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 dette studie blev der observeret stigning i ASAT &gt; 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.
ALC &lt; 0,50
ALC less than 500
Fald &gt; 1,24 mmol/l eller værdi &lt; 4,96 mmol/l (bekræftet ved kontroltest)
Greater than 2 g/dL decrease or less than 8.0 g/dL (confirmed by repeat testing)
I dette studie blev der observeret stigning i ASAT &gt; 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 &lt; 0,05, ***p &lt; 0,0001 versus placebo, s.c.=subkutant, N=antal forsøgspersoner analyseret
*p &lt; 0.05, ***p &lt; 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.
I de langvarige RA-forlængelsesstudier blev stigning i ALAT eller ASAT &gt; 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.
5.1), blev der observeret stigninger i ALAT &gt; 3 x ULN hos 0,9 %, 1,24 % og 1,14 % af de patienter, der fik henholdsvis placebo, 5 mg og 10 mg tofacitinib 2 gange dagligt.
In the controlled portion of the RA phase 3 studies on background DMARDs (0-3 months) (studies II-V, see section 5.1), ALT elevations greater than 3x ULN were observed in 0.9%, 1.24% and 1.14% of patients receiving placebo, tofacitinib 5 mg and 10 mg twice daily, respectively.
I de kliniske studier er der rapporteret om følgende bivirkninger, som er opstillet efter hyppighed i henhold til denne konvention: meget almindelig (≥1/10); almindelig (≥1/100 til &lt; 1/10), ikke almindelig (≥1/1.000 til &lt; 1/100); sjælden (≥1/10.000 til &lt; 1/1.000); meget sjælden ( &lt; 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
The following adverse reactions have been reported during clinical trials and are ranked using the following frequency: very common (1/10); common (1/100 to &lt; 1/10); uncommon (1/1,000 to &lt; 1/100); rare (1/10,000 to &lt; 1/1,000); very rare ( &lt; 1/10,000); not known (cannot be estimated from the available data).