natgillin/translations-raw huggingface dataset:
Cmax (2.4 mg/ l vs 2.6 mg/ l), Cmin (1.2 mg/ l vs 1.4 mg/ l) and partial AUC (297 mgh/ l vs 316 mgh/ l), were shown to be comparable in RA patients treated with 50 mg etanercept once weekly (n=21) and 25 mg etanercept twice weekly (n=16), respectively.
Cmax (2, 4 mg/ l proti 2, 6 mg/ l), Cmin (1, 2 mg/ l proti 1, 4 mg/ l) in delna AUC (297 mg. h/ l proti 316 mg. h/ l).
In an open-label, single-dose, two-treatment, crossover study in healthy volunteers, etanercept administered as a single 50 mg/ ml injection was found to be bioequivalent to two simultaneous injections of 25 mg/ ml.
V odprti, enoodmerni, navzkrižni raziskavi pri zdravih prostovoljcih z dvema oblikama zdravljenja so ugotovili, da je enkratna injekcija po 50 mg/ ml etanercepta bioekvivalentna dvema hkratnima injekcijama po 25 mg/ ml.
In a population pharmacokinetics analysis in ankylosing spondylitis patients, the etanercept steady state AUCs were 466  g hr/ ml and 474  g hr/ ml for 50 mg Enbrel once weekly (N= 154) and 25 mg twice weekly (N = 148), respectively.
Analize farmakokinetike pri posameznih skupinah bolnikov kažejo, da so bile pri bolnikih z ankilozirajočim spondilitisom pri režimu odmerjanja zdravila Enbrel 50 mg enkrat na teden (N = 154) vrednosti AUC etanercepta v stanju dinamičnega ravnovesja 466 μg* ur/ ml, pri režimu odmerjanja 25 mg dvakrat na teden (N = 148) pa 474 μg* ur/ ml.
104 Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal or hepatic failure.
Čeprav se pri prostovoljcih in pri bolnikih po prejemu radioaktivno označenega etanercepta le- ta izloča v urinu, ni zaznati povečanih koncentracij etanercepta pri bolnikih z akutno odpovedjo ledvic ali jeter.
Elderly patients
99 Starostniki
105 6.3 Shelf life
6. 3 Rok uporabnosti
From a microbiological point of view, the product should be used immediately.
Z mikrobiološkega stališča je potrebno zdravilo uporabiti takoj.
6.4 Special precautions for storage
100 6. 4 Posebna navodila za shranjevanje
Cartons contain 2, 4 or 12 vials and 4, 8 or 24 alcohol swabs.
Enbrel je na voljo v škatlah z 2, 4 ali 12 vialami in 4, 8 ali 24 alkoholnimi tamponi.
Enbrel is reconstituted with 1 ml water for injections before use, and administered by subcutaneous injection.
Pred uporabo in subkutanim injiciranjem Enbrel raztopite v 1 ml vode za injekcije.
Enbrel contains no antibacterial preservative, and therefore, solutions prepared with water for injections should be administered as soon as possible and within 6 hours following reconstitution.
Enbrel ne vsebuje antibakterijskih konzervansov, zato je treba raztopino, pripravljeno z vodo za injekcije, injicirati čimprej oziroma najkasneje v 6- ih urah po pripravi.
Comprehensive instructions for the preparation and administration of the reconstituted Enbrel vial are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
Izčrpna navodila za pripravo in aplikacijo pripravljene viale zdravila Enbrel so navedena v navodilu za uporabo, poglavje 7, "Navodila za pripravo in dajanje injekcij Enbrel".
107 1.
101 1.
108 function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
Izkazalo se je, da Enbrel izboljša telesno funkcijo pri bolnikih s psoriatičnim artritisom in da upočasni hitrost napredovanja okvar perifernih sklepov, izmerjeno z rentgenskim slikanjem, pri bolnikih s poliartikularnimi simetričnimi podvrstami bolezni.
Ankylosing spondylitis
102 Ankilozirajoči spondilitis
Alternatively, 50 mg Enbrel administered once weekly has been shown to be safe and effective (see section 5.1).
Druga možnost je aplikacija 50 mg enkrat na teden; dokazano je, da je ta možnost varna in učinkovita (glejte poglavje 5. 1).
109 If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
V primeru ponovnega zdravljenja z zdravilom Enbrel je potrebno upoštevati zgornja navodila glede trajanja zdravljenja.
If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed.
103 Če je indicirano ponovno zdravljenje z zdravilom Enbrel, se ravnamo po zgornjih smernicah glede trajanja zdravljenja.
110 Tuberculosis
Tuberkuloza
If active tuberculosis is diagnosed, Enbrel therapy must not be initiated.
104 Če se postavi diagnoza aktivne tuberkuloze, ni dovoljeno uvesti zdravljenja z zdravilom Enbrel.
111 Allergic reactions associated with Enbrel administration have been reported commonly.
V povezavi z uporabo zdravila Enbrel so pogosto poročali o alergijskih reakcijah.
Malignancies and lymphoproliferative disorders
105 Maligne in limfoproliferativne bolezni
112 Haematologic reactions
Hematološke reakcije
113 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
114 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
In double-blind clinical trials comparing Enbrel to placebo, injection site reactions were the most frequent adverse events among Enbrel-treated patients.
108 V dvojno slepih kliničnih raziskavah, v katerih so zdravilo Enbrel primerjali s placebom, so bile reakcije na mestu injiciranja najpogostejši neželeni učinki pri bolnikih, zdravljenih z zdravilom Enbrel.
116 Additional information
Dodatne informacije
There were a total of 15 lymphomas reported in 5,966 patients treated with Enbrel in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials.
110 V raziskavah revmatoidnega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa in psoriaze, ki so vključevale 5. 966 bolnikov, zdravljenih z zdravilom Enbrel, so zabeležili skupno 15 limfomov.
117 Serious infections
Resne okužbe
118 There have been rare reports of patients, including rheumatoid factor positive patients, who have developed other autoantibodies in conjunction with a lupus-like syndrome or rashes that are compatible with subacute cutaneous lupus or discoid lupus by clinical presentation and biopsy.
Redko so poročali o bolnikih, vključno z bolniki s pozitivnim revmatoidnim faktorjem, ki so razvili druga avtoprotitelesa v povezavi z lupusu podobnim sindromom ali izpuščaji, ki bi po klinični sliki in bioptičnem izvidu lahko pomenili subakutni kožni lupus ali diskoidni lupus.
In studies when adult patients received concurrent treatment with Enbrel plus anakinra, a higher rate of serious infections compared to Enbrel alone was observed and 2% of patients (3/ 139) developed neutropenia (absolute neutrophil count < 1000 / mm3).
V raziskavah, v katerih so odrasli bolniki sočasno prejemali zdravilo Enbrel in anakinro, so opažali večjo pogostnost resnih okužb v primerjavi s samim etanerceptom in pri 2% bolnikov (3/ 139) se je pojavila nevtropenija (absolutno število nevtrofilcev < 1. 000/ mm3).
One rheumatoid arthritis patient mistakenly self- administered 62 mg Enbrel subcutaneously twice weekly for 3 weeks without experiencing undesirable effects.
Nek bolnik z revmatoidnim artritisom si je pomotoma subkutano injiciral 62 mg zdravila Enbrel 2- krat tedensko 3 tedne, ne da bi pri tem prišlo do kakršnega koli neželenega učinka.
119 arthritis and in serum and synovial tissue of patients with ankylosing spondylitis.
Pri psoriazi v plakih se zaradi infiltracije vnetnih celic (vključno s celicami T) v psoriatičnih spremembah v primerjavi z neprizadeto kožo poveča koncentracija TNF.
Enbrel 41% and 40%, placebo 8% and 5% at months 3 and 6 respectively; p < 0.01 Enbrel vs Placebo at all time points for both ACR 20 and ACR 50 responses).
113 Odstotek bolnikov, ki so po 3 oziroma 6 mesecih dosegli odziv ACR 20 ali ACR 50, je bil v skupini bolnikov, ki so bili zdravljeni z zdravilom Enbrel, večji kot pri bolnikih, ki so prejemali placebo (ACR 20, po 3 oziroma 6 mesecih: zdravilo Enbrel 62% oziroma 59%, placebo 23% oziroma 11%; ACR 50, po 3 oziroma 6 mesecih: zdravilo Enbrel 41% oziroma 40%, placebo 8% oziroma 5%; p < 0, 01 za zdravilo Enbrel proti placebu v vseh časovnih točkah, tako za odziv ACR 20 kot za odziv ACR 50).
Re-introduction of treatment with Enbrel after discontinuations of up to 24 months resulted in the same magnitudes of responses as patients who received Enbrel without interruption of therapy based on results of open-label studies.
Po podatkih iz odprtih raziskav je bila odzivnost na ponovno zdravljenje z zdravilom Enbrel po do 24 mesecev trajajoči prekinitvi enaka odzivnosti pri bolnikih, ki so zdravilo Enbrel prejemali neprekinjeno.
RADIOGRAPHIC PROGRESSION:
114 RENTGENSKO NAPREDOVANJE:
121 In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with Enbrel alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and of the combination of Enbrel and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate.
V drugi aktivno kontrolirani dvojno slepi randomizirani raziskavi so primerjali klinično učinkovitost, varnost in rentgensko napredovanje pri bolnikih z revmatoidnim artritisom, ki so jih zdravili samo z zdravilom Enbrel (25 mg 2- krat na teden), samo z metotreksatom (7, 5 do 20 mg na teden, mediana 20 mg) ali z zdravilom Enbrel in metotreksatom (s sočasnim začetkom), in sicer pri 682 odraslih bolnikih z aktivnim revmatoidnim artritisom, pri katerih je bolezen trajala od 6 mesecev do 20 let (mediana 5 let) in pri katerih je bil odziv na najmanj eno imunomodulirajoče protirevmatično zdravilo (DMARD) razen metotreksata manj kot zadovoljiv.
CLINICAL EFFICACY RESULTS AT 12 MONTHS:
115 KLINIČNA UČINKOVITOST PO 12 MESECIH:
122 RADIOGRAPHIC PROGRESSION:
116 RENTGENSKO NAPREDOVANJE:
(1) distal 123 interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis.
117 (1) distalna interfalangealna prizadetost (DIP); (2) poliartikularni artritis (odsotnost revmatoidnih nodulov in prisotnost psoriaze); (3) artritis mutilans; (4) asimetrični psoriatični artritis ali (5) spondilitisu podobna ankiloza.
MEAN (SE) ANNUALIZED CHANGE FROM BASELINE IN TOTAL SHARP SCORE
118 POVPREČNA (SE) SPREMEMBA SKUPNE SHARPOVE OCENE OD IZHODIŠČA NA LETO
Adult patients with ankylosing spondylitis
Odrasli bolnikiz ankilozirajočim spondilitisom
Doses of 25 mg of Enbrel (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered subcutaneously twice a week for 6 months in 138 patients.
138 bolnikov je prejemalo 25 mg odmerke zdravila Enbrel (na podlagi študije za ugotovitev odmerkov pri bolnikih z revmatoidnim artritisom) ali placeba subkutano dvakrat na teden v trajanju 6 mesecev.
125 RESPONSES OF PATIENTS WITH ANKYLOSING SPONDYLITIS IN A PLACEBO-CONTROLLED TRIAL Percent of Patients
119 ODZIVI BOLNIKOV Z ANKILOZIRAJOČIM SPONDILITISOM V S PLACEBOM KONTROLIRANEM PRESKUŠANJU Odstotek bolnikov
126 Study 1 was a Phase 2 study in patients with active but clinically stable plaque psoriasis involving  10% of the body surface area that were  18 years old.
Raziskava 1 je bila raziskava 2. faze pri bolnikih, starih ≥ 18 let, z aktivno, a klinično stabilno psoriazo v plakih, ki je zajemala ≥ 10% površine telesa.
Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening.
120 Raziskava 2 je ocenila 652 bolnikov s kronično psoriazo v plakih in je imela enaka vključitvena merila kot raziskava 1, le da so imeli bolniki ob presejanju indeks PASI vsaj 10.
127 Study 2 also had a drug withdrawal period during which patients who achieved a PASI improvement of at least 50% at week 24 had treatment stopped.
Raziskava 2 je vključevala tudi obdobje odtegnitve zdravila, med katerim so zdravljenje prekinili bolniki, ki so 24. teden dosegli izboljšanje PASI za vsaj 50%.
In study 3, the majority of patients (77%) who were initially randomised to 50 mg twice weekly and had their Enbrel dose decreased at week 12 to 25 mg twice weekly maintained their PASI 75 response through week 36.
121 V raziskavi 3 je večina bolnikov (77%), ki so bili uvodoma randomizirani na 50 mg dvakrat na teden in so jim odmerek zdravila Enbrel po 12 tednih znižali na 25 mg dvakrat na teden, odziv PASI 75 ohranila do 36. tedna.
128 Antibodies to Enbrel
Protitelesa proti zdravilu Enbrel
Cmax (2.4 mg/ l vs 2.6 mg/ l), Cmin (1.2 mg/ l vs 1.4 mg/ l), and partial AUC (297 mgh/ l vs 316 mgh/ l), were shown to be comparable in RA patients treated with 50 mg etanercept once weekly (n=21) and 25 mg etanercept twice weekly (n=16), respectively.
Cmax (2, 4 mg/ l proti 2, 6 mg/ l), Cmin (1, 2 mg/ l proti 1, 4 mg/ l) in delna AUC (297 mg. h/ l proti 316 mg. h/ l).
129 Although there is elimination of radioactivity in urine after administration of radiolabelled etanercept to patients and volunteers, increased etanercept concentrations were not observed in patients with acute renal or hepatic failure.
Čeprav se pri prostovoljcih in pri bolnikih po prejemu radioaktivno označenega etanercepta le- ta izloča v urinu, ni zaznati povečanih koncentracij etanercepta pri bolnikih z akutno odpovedjo ledvic ali jeter.
Elderly patients
123 Starostniki
130 6.2 Incompatibilities
6. 2 Inkompatibilnosti
6.6 Special precautions for disposal and other handling
124 6. 4 Posebna navodila za shranjevanje
Cartons contain 2, 4 or 12 vials of Enbrel with 2, 4 or 12 pre-filled solvent syringes, 2, 4 or 12 needles, 2, 4 or 12 vial adaptors and 4, 8 or 24 alcohol swabs.
Enbrel je na voljo v škatlah z 2, 4 ali 12 vialami, 2, 4 ali 12 z vehiklom napolnjenimi injekcijskimi brizgami, 2, 4 ali 12 iglami, 2, 4 ali 12 adapterji za viale in 4, 8 ali 24 alkoholnimi tamponi.
132 1.
126 1.
Enbrel 25 mg/ ml powder and solvent for solution for injection for paediatric use.
Enbrel 25 mg/ ml prašek in vehikel za raztopino za injiciranje za uporabo pri otrocih
When reconstituted, the solution contains 25 mg/ ml of etanercept.
Po rekonstituciji raztopina vsebuje 25 mg/ ml etanercepta.
The solution contains benzyl alcohol 9 mg/ ml as a preservative (see section 4.4).
Raztopina vsebuje kot konzervans 9 mg/ ml benzilalkohola (glejte poglavje 4. 4).
133 Each vial of Enbrel 25 mg/ ml should be used for a maximum of 2 doses administered to the same patient.
Posamezno vialo zdravila Enbrel 25 mg/ ml smete uporabiti za največ 2 odmerka, ki ju damo istemu bolniku.
Comprehensive instructions for the preparation, administration and re-use of the reconstituted Enbrel vial are given in the package leaflet, section 7, "Instructions for preparation and giving an injection of Enbrel."
127 Izčrpna navodila za pripravo, aplikacijo in ponovno uporabo pripravljene viale zdravila Enbrel so navedena v navodilu za uporabo, poglavje 7, "Navodila za pripravo in dajanje injekcij zdravila Enbrel".
Enbrel must not be given to premature babies or neonates as the solvent contains benzyl alcohol.
Zdravila Enbrel ne smete dajati nedonošenčkom ali novorojenčkom, ker vehikel vsebuje benzilalkohol.
134 Patients who develop a new infection while undergoing treatment with Enbrel should be monitored closely.
Bolnike, pri katerih se med zdravljenjem z zdravilom Enbrel pojavi nova okužba, je treba strogo nadzorovati.
Tuberculosis
128 Tuberkuloza
135 Concurrent Enbrel and abatacept treatment
Sočasno zdravljenje z zdravilom Enbrel in abataceptom
Immunosuppression
129 Imunosupresija
In this study most psoriatic arthritis patients receiving Enbrel were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine,
Večina bolnikov s psoriatičnim artritisom, ki so dobivali zdravilo Enbrel, je v tej raziskavi zmogla učinkovit imunski odziv celic B na polisaharidno cepivo proti pnevmokokom.
136 but titers in aggregate were moderately lower and few patients had two-fold rises in titers compared to patients not receiving Enbrel.
Toda celokupno so bili titri zmerno nižji in nekaj bolnikov je doživelo dvakraten porast titrov v primerjavi z bolniki, ki niso dobivali zdravila Enbrel.
CNS disorders
130 Motnje CŽS
In a controlled clinical trial of two years duration in adult rheumatoid arthritis patients, the combination of Enbrel and methotrexate did not result in unexpected safety findings, and the safety profile of Enbrel when given in combination with methotrexate was similar to the profiles reported in studies of Enbrel and methotrexate alone.
V dveletnem kontroliranem kliničnem preskušanju pri bolnikih z revmatoidnim artritisom ni bilo pri kombiniranem zdravljenju z zdravilom Enbrel in metotreksatom nobenih nepričakovanih ugotovitev glede varnosti; varnostni profil zdravila Enbrel pri kombiniranem zdravljenju z metotreksatom je bil podoben varnostnemu profilu, ki je bil ugotovljen pri monoterapiji z zdravilom Enbrel oziroma metotreksatom.
137 Wegener's granulomatosis
Wegenerjeva granulomatoza
Enbrel contains benzyl alcohol as an excipient, which may cause toxic reactions and anaphylactoid reactions in infants and children up to 3 years old and must not be given to premature babies or neonates.
Ta lahko pri dojenčkih in otrocih do 3. leta starosti povzroči toksične in anafilaktoidne reakcije, zato zdravila Enbrel ne smete dajati nedonošenčkom ali novorojenčkom.
4.5 Interaction with other medicinal products and other forms of interaction
131 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
In a clinical study of adult patients who were receiving established doses of sulfasalazine, to which Enbrel was added, patients in the combination group experienced a statistically significant decrease in mean white blood cell counts in comparison to groups treated with Enbrel or sulfasalazine alone.
V klinični študiji odraslih bolnikov, ki so prejemali ustaljene odmerke sulfasalazina, ki mu je bil dodano zdravilo Enbrel, se je pri bolnikih v skupini s kombinacijo obeh zdravil statistično signifikantno zmanjšala povprečna koncentracija belih krvničk v primerjavi s skupinama, zdravljenima samo z zdravilom Enbrel ali samo s sulfasalazinom.
138 4.6 Pregnancy and lactation
4. 6 Nosečnost in dojenje
4.8 Undesirable effects
132 4. 8 Neželeni učinki
These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year).
Pojavljali so se glavoboli (19%, 1, 7 dogodkov na bolniško leto), navzea (9%, 1, 0 dogodek na bolniško leto), bolečine v trebuhu (19%, 0, 74 dogodkov na bolniško leto) in bruhanje (13%, 0, 74 dogodkov na bolniško leto).
139 Undesirable effects in adults
Neželeni učinki pri odraslih
Five hundred and eight (508) ankylosing spondylitis patients were treated with Enbrel in 4 double-blind placebo-controlled studies.
Zdravilo Enbrel so raziskali
Enbrel has also been studied in 1,180 patients with plaque psoriasis for up to 6 months in 4 double-blind placebo- controlled studies.
133 tudi pri 1. 180 bolnikih s psoriazo v plakih, in sicer v 4 dvojno slepih, s placebom kontroliranih raziskavah, ki so trajale do 6 mesecev.
In double-blind clinical trials comparing Enbrel to placebo, injection site reactions were the most frequent adverse events among Enbrel-treated patients.
V dvojno slepih kliničnih raziskavah, v katerih so zdravilo Enbrel primerjali s placebom, so bile reakcije na mestu injiciranja najpogostejši neželeni učinki pri bolnikih, zdravljenih z zdravilom Enbrel.
Hepatobiliary disorders:
134 Bolezni jeter, žolčnika in žolčevodov:
141 Serious adverse events reported in clinical trials
Resni neželeni učinki iz kliničnih preskušanj
In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in Enbrel-treated patients.
V dvojno slepih in odprtih
Twenty-three malignancies were reported in plaque psoriasis patients treated with Enbrel in double-blind and open-label studies of up to 15 months involving 1,261 Enbrel-treated patients.
135 raziskavah, ki so trajale do 15 mesecev in so zajele 1. 261 bolnikov, zdravljenih z zdravilom Enbrel, so med bolniki s psoriazo v plakih, zdravljenimi z zdravilom Enbrel, zabeležili 23 malignomov.
There were a total of 15 lymphomas reported in 5,966 patients treated with Enbrel in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials.
V raziskavah revmatoidnega artritisa, psoriatičnega artritisa, ankilozirajočega spondilitisa in psoriaze, ki so vključevale 5. 966 bolnikov, zdravljenih z zdravilom Enbrel, so zabeležili skupno 15 limfomov.
142 (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection.
Med temi resnimi okužbami so bili abscesi (na različnih mestih), bakteriemija, bronhitis, burzitis, celulitis, holecistitis, diareja, divertikulitis, endokarditis (sum nanj), gastroenteritis, hepatitis B, herpes zoster, razjeda na nogi, okužba ustne votline, osteomielitis, otitis, peritonitis, pljučnica, pielonefritis, sepsa, septični artritis, sinuzitis, okužbe kože, kožne razjede, okužbe sečil, vaskulitis in okužbe ran.
In a pooled data set of clinical trials, the overall incidence of opportunistic infections was 0.09% for the 15,402 subjects who received Enbrel.
136 pojavnost oportunističnih okužb pri 15. 402 bolnikih, ki so prejeli Enbrel, 0, 09%.
In postmarketing experience, approximately half of all of the case reports of opportunistic infections worldwide were invasive fungal infections.
Po prihodu zdravila na trg je bilo približno pol vseh primerov okužb, opisanih v poročilih o primerih oportunističnih okužb po vsem svetu, invazivnih glivičnih okužb.
143 Interstitial lung disease
Intersticijska bolezen pljuč
144 Mechanism of action
Mehanizem delovanja
This section presents data from one study in polyarticular juvenile idiopathic arthritis, four studies in adults with rheumatoid arthritis, one study in paediatric patients with plaque psoriasis, and four studies in adults with plaque psoriasis.
V tem poglavju so prikazani podatki iz enega preskušanja pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, štirih preskušanj pri odraslih z revmatoidnim artritisom, enega preskušanja pri ottocih s psoriazo v plakih in štirih preskušanj pri odraslih s psoriazo v plakih.
Patients aged 4 to 17 years with moderately to severely active polyarticular juvenile idiopathic arthritis refractory to or intolerant of methotrexate were enrolled; patients remained on a stable dose of a single nonsteroidal anti- inflammatory drug and/ or prednisone ( 0.2 mg/ kg/ day or 10 mg maximum).
Bolniki so nadaljevali zdravljenje s stalnim odmerkom enega nesteroidnega protivnetnega zdravila in/ ali prednizona (< 0, 2 mg/ kg/ dan ali največ 10 mg).
Responses were measured using the JRA Definition of Improvement (DOI), defined as  30% improvement in at least three of six and  30% worsening in no more than one of six JRA core set criteria, including active joint count, limitation of motion, physician and patient/ parent global assessments, functional assessment, and erythrocyte sedimentation rate (ESR).
Učinke zdravljenja so merili po JRA kazalcih izboljšanja bolezni (Definition of Improvement, DOI); izboljšanje je pomenilo najmanj 30% izboljšanje v vsaj treh od šestih osnovnih JRA kazalcev aktivnosti bolezni in ≥ 30% poslabšanje v ne več kot enem od šestih osnovnih JRA kazalcev aktivnosti bolezni (število aktivno prizadetih sklepov, omejenost gibanja, zdravnikova splošna ocena, splošna ocena s strani bolnika ali staršev, ocena funkcionalnosti in sedimentacija