FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has deferred the obligation to submit the results of the studies with Humira in one or more subsets of the paediatric population in ulcerative colitis, see section 4.2 for information on paediatric use.
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Humira za eno ali več podskupin pediatrične populacije z ulceroznim kolitisom, za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2.
English: Some patients who have been successfully treated for active tuberculosis have redeveloped tuberculosis while being treated with Humira.
Slovenian: Nekaterim bolnikom, ki so bili uspešno zdravljeni zaradi aktivne tuberkuloze, se je med zdravljenjem z zdravilom Humira ponovno razvila tuberkuloza.
English: P value*
Slovenian: P vrednost*
English: For more information on vaccines see the “Warnings and precautions” section.
Slovenian: Za več informacij o cepljenju glejte poglavje "Opozorila in previdnostni ukrepi".
English: Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with Humira.
Slovenian: Kortikosteroide, ki se jih daje sočasno, se lahko postopoma ukinja v skladu s klinično prakso, z začetkom dva tedna po začetku zdravljenja z zdravilom Humira.
English: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Humira should be discontinued immediately and appropriate therapy initiated.
Slovenian: Če se pojavi anafilaktična reakcija ali kakšna druga resna alergijska reakcija, je treba uporabo zdravila Humira nemudoma prekiniti in uvesti ustrezno zdravljenje.
English: You should record the date when the syringe is first removed from refrigerator and the date after which it should be discarded.
Slovenian: Zapisati si morate datum, ko je bila brizga vzeta iz hladilnika in datum, po katerem jo je potrebno zavreči.
English: Radiographs of hands, wrists, and feet were obtained at baseline and Week 24 during the double-blind period when patients were on Humira or placebo and at Week 48 when all patients were on open-label Humira.
Slovenian: Rentgenske posnetke dlani, zapestij in stopal so naredili izhodiščno in 24. teden med dvojno slepim obdobjem, med katerim so bolniki dobivali zdravilo Humira ali placebo, in 48. teden, ko so vsi bolniki odprto dobivali zdravilo Humira.
English: Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia.
Slovenian: Med resnimi okužbami, zabeleženimi v kliničnih preskušanjih, so bile pljučnica, pielonefritis, septični artritis in septikemija.
English: Humira can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Slovenian: Zdravilo Humira je mogoče uporabljati tudi za zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa brez predhodnega zdravljenja z metotreksatom.
English: Instructions for preparing and giving an injection of Humira
Slovenian: Navodila za pripravo in injiciranje zdravila Humira
English: The efficacy and safety of Humira were assessed in five randomised, double-blind and well-controlled studies.
Slovenian: Učinkovitost in varnost zdravila Humira so ocenili v petih randomiziranih, dvojno slepih in dobro kontroliranih študijah.
English: Ankylosing Spondylitis Disease Activity Score Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Slovenian: Activity Score) d Delni zagon bolezni je določen kot ASDAS ≥ 1,3 vendar < 2,1 pri dveh zaporednih obiskih.
English: Patients receiving MTX who achieved a PASI 50 response at Week 8 and/or 12 did not receive further dose increases.
Slovenian: Bolnikom, ki so dobivali metotreksat in so 8. in/ali 12. teden dosegli odziv PASI ≥ 50, odmerka niso več povečevali.
English: • Hold the syringe in one hand and with the other hand slide the outer protective shield over the exposed needle until it locks in place
Slovenian: • Z eno roko držite brizgo, z drugo pa potegnite zunanji ščitnik čez razgaljeno iglo, dokler se ne zaskoči.
English: Do not press the plum activator button until you are ready to inject.
Slovenian: Ne pritiskajte škrlatnega sprožilnega gumba, dokler niste pripravljeni za injiciranje.
English: PASI 75 and PGA clear or minimal increased with increasing adalimumab concentrations, both with a similar apparent EC50 of approximately 4.5 μg/mL (95% CI 0.4-47.6 and 1.9-10.5, respectively).
Slovenian: PGA čisto ali minimalno, sta se povečevali z zvečanjem koncentracije adalimumaba, obe s podobno navidezno EC50, za približno 4,5 μg/ml (95% IZ 0,4-47,6 in 1,9-10,5).
English: In adult plaque psoriasis patients on long term adalimumab monotherapy who participated in a withdrawal and retreatment study, the rate of antibodies to adalimumab after retreatment (11 of 482 subjects, 2.3%) was similar to the rate observed prior to withdrawal (11 of 590 subjects, 1.9%).
Slovenian: Pri odraslih bolnikih s psoriazo v plakih, ki so prejemali dolgotrajno monoterapijo z adalimumabom in so sodelovali v študiji prenehanja uporabe in ponovnega zdravljenja, je bil delež protiteles proti adalimumabu po ponovnem zdravljenju (11 od 482 bolnikov; 2,3 %) podoben kot pred prenehanjem uporabe (11 od 590 bolnikov; 1,9 %).
English: Cases of worsening congestive heart failure have also been reported in patients receiving Humira.
Slovenian: O primerih poslabšanja kongestivnega srčnega popuščanja so poročali tudi pri bolnikih, ki so prejemali zdravilo Humira.
English: Injection site pain of Humira 40 mg/0.4 ml was assessed in two randomised, active control, single-blind, two-period crossover studies.
Slovenian: Bolečina na mestu injiciranja zdravila Humira 40 mg/0,4 ml je bila ocenjena v dveh randomiziranih enojno slepih navzkrižnih študijah z aktivnim nadzorom, v dveh obdobjih.
English: • Humira should only be used during a pregnancy if needed.
Slovenian: • Zdravilo Humira se med nosečnostjo lahko uporablja samo, če je potrebno.
English: Psoriasis Study II (CHAMPION) compared the efficacy and safety of Humira versus methotrexate and placebo in 271 patients.
Slovenian: Študija pri psoriazi II (CHAMPION) je primerjala učinkovitost in varnost zdravila Humira z metotreksatom in placebom pri 271 bolnikih.
English: Patients should be tested for HBV infection before initiating treatment with Humira.
Slovenian: Bolnike je treba pred začetkom zdravljenja z zdravilom Humira testirati na okužbo s HBV.
English: You should record the date when the pen is first removed from refrigerator and the date after which it should be discarded.
Slovenian: Zapisati si morate datum, ko je bil peresnik vzet iz hladilnika in datum, po katerem ga je potrebno zavreči.
English: • vertigo (feeling of dizziness or spinning)
Slovenian: • vertigo (občutek omotice ali vrtenja)
English: • Throw away all other used items into your regular household waste.
Slovenian: • Zavrzite vse ostale enote zdravila v običajen koš za odpadke.
English: Take one dose tray containing a pre-filled pen of Humira from the refrigerator.
Slovenian: Vzemite enoodmerni ovitek z napolnjenim injekcijskim peresnikom zdravila Humira iz hladilnika.
English: Patients induced with 160/80 mg Humira achieved clinical remission versus placebo at Week 8 in statistically significantly greater percentages in study UC-I (18% vs. 9% respectively, p=0.031) and study UC-II (17% vs. 9% respectively, p=0.019).
Slovenian: Bolniki, ki so za indukcijo dobili 160/80 mg zdravila Humira, so 8. teden v primerjavi s placebom dosegli klinično remisijo v statistično značilno večjem odstotku tako v študiji UC-I (18 % v primerjavi z 9 %, p = 0,031) kot v študiji UC-II (17 % v primerjavi z 9 %, p = 0,019).
English: When the injection is completed, slowly pull the pre-filled pen from the skin.
Slovenian: Ko je injiciranje zaključeno, počasi odstranite napolnjen injekcijski peresnik s kože.
English: Hold the pre-filled syringe in one hand between the finger grip and the needle cover.
Slovenian: Napolnjeno injekcijsko brizgo držite v eni roki med držalom za prste in pokrovčom igle.
English: Patients from studies UC-I and UC-II had the option to roll over into an open-label long-term extension study (UC III).
Slovenian: Bolniki iz študij UC-I in UC-II so imeli možnost nadaljevati v odprti, dolgoročni podaljšani študiji
English: • Remove one box containing, one syringe, one vial adapter, one vial, two alcohol pads and one needle from the carton.
Slovenian: • Odprite eno škatlo, ki vsebuje eno brizgo, en adapter za vialo, dva alkoholna zloženca in eno iglo.
English: If you have COPD, or are a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for you.
Slovenian: Če imate KOPB ali če veliko kadite, se morate z zdravnikom posvetovati, ali je zdravljenje z zaviralcem TNF za vas primerno.
English: Mood alterations (including depression), anxiety, insomnia
Slovenian: Psihiatrične motnje pogosti spremembe razpoloženja (vključno z depresijo), anksioznost, nespečnost
English: • Make sure the liquid is clear and colourless
Slovenian: • Prepričajte se, da je tekočina bistra in brezbarvna
English: Polyarticular juvenile idiopathic arthritis is an inflammatory disease of the jointsthat usually first appears in childhood.
Slovenian: Poliartikularni juvenilni idiopatski artritis je vnetna bolezen sklepov, ki se običajno prvič pojavi v otroštvu.
English: confidence interval)
Slovenian: (95 % interval zaupanja)
English: Once removed from the refrigerator for room temperature storage, the syringe must be used within 14 days or discarded, even if it is returned to the refrigerator.
Slovenian: Ko ga enkrat, namesto v hladilniku, shranjujete pri sobni temperaturi, morate peresnik porabiti v 14 dneh ali pa zavreči, tudi če ga vrnete v hladilnik.
English: Some patients who have not responded by Week 4 may benefit from continued maintenance therapy through Week 12.
Slovenian: Nekaterim bolnikom, ki se ne odzovejo do 4. tedna, lahko koristi nadaljnje vzdrževalno zdravljenje do 12. tedna.
English: A patient who requires surgery while on Humira should be closely monitored for infections, and appropriate actions should be taken.
Slovenian: Bolnika, ki med zdravljenjem z zdravilom Humira potrebuje operacijo, je treba natančno nadzirati glede okužb in ustrezno ukrepati.
English: If your child has COPD, or is a heavy smoker, you should discuss with your doctor whether treatment with a TNF blocker is appropriate for your child.
Slovenian: Če ima vaš otrok KOPB ali če veliko kadi, se morate z zdravnikom posvetovati, ali je zdravljenje z zaviralcem TNF za vašega otroka primerno.
English: During treatment with Humira, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised.
Slovenian: Med zdravljenjem z zdravilom Humira je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ali imunomodulacijska zdravila).
English: If latent tuberculosis is diagnosed, appropriate treatment must be started with anti-tuberculosis prophylaxis treatment before the initiation of Humira, and in accordance with local recommendations.
Slovenian: Če ugotovite latentno tuberkulozo, morate pred uvedbo zdravila Humira začeti s protituberkuloznim profilaktičnim zdravljenjem v skladu z lokalnimi priporočili.
English: The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.45-2.73) with RA and CD combined.
Slovenian: Prilagojeno razmerje obetov (z ozirom na izhodiščne razlike) je bilo 1.10 (95 % interval zaupanja 0.45-2.73) z RA in CB skupaj.
English: ASDAS Inactive Disease hs-CRP
Slovenian: ASDAS neaktivna bolezen hs-CRPd,f,g
English: Humira is available in other strengths and presentations.
Slovenian: Zdravilo Humira je na voljo v drugih jakostih in oblikah.
English: Among patients who were not in response at Week 4, 43% of Humira maintenance patients responded by Week 12 compared to 30% of placebo maintenance patients.
Slovenian: Med bolniki, ki se v 4. tednu niso odzvali, se je 43 % bolnikov na vzdrževalnem odmerku zdravila Humira odzvalo do 12. tedna, v primerjavi s 30 % bolnikov na placebu.
English: Despite prophylactic treatment for tuberculosis, cases of reactivated tuberculosis have occurred in patients treated with Humira.
Slovenian: Kljub profilaktičnemu zdravljenju za tuberkulozo, so se pri bolnikih, zdravljenih z zdravilom Humira, pojavili primeri reaktivacije tuberkuloze.
English: b 50 Week 2 Week 12 Week 24 ***,** Statistically significant at p < 0.001, < 0.01 for all comparisons between Humira and placebo at Weeks 2, 12 and 24 Assessments in Ankylosing Spondylitis Bath Ankylosing Spondylitis Disease Activity Index
Slovenian: BASDAIb 50 2. teden 12. teden 24. teden ***,** Statistično značilno pri p < 0,001, < 0,01 za vse primerjave med zdravilom Humira in placebom po 2, 12 in 24 tednih a Ocene pri ankilozirajočem spondilitisu (Assessments in Ankylosing Spondylitis) b Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing
English: o One vial adapter (2) o One vial for paediatric use of Humira for injection (3) o Two alcohol pads (4) o One needle (5)
Slovenian: o eno 1 ml brizgo (1) o en adapter za vialo (2) o eno vialo zdravila Humira za injiciranje za otroke (3) o dva alkoholna zloženca (4) o eno iglo (5)
English: • facial oedema (swelling of the face) associated with allergic reactions
Slovenian: • edem obraza (otekanje obraza) povezan z alergijskimi reakcijami
English: You may notice a spot of blood at the injection site.
Slovenian: Na mestu injiciranja se lahko pojavi kapljica krvi.
English: Humira was studied in 9,506 patients in pivotal controlled and open label trials for up to 60 months or more.
Slovenian: Zdravilo Humira so raziskali pri 9506 bolnikih v kontroliranih in odprtih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet in so trajala do 60 mesecev ali več.
English: Point the white arrow toward the injection site (thigh or abdomen).
Slovenian: Belo puščico usmerite proti mestu injiciranja (stegno ali trebuh).
English: Patients participating in Studies HS-I and HS-II were eligible to enrol into an open-label extension study in which Humira 40mg was administered every week.
Slovenian: Bolniki, vključeni v študiji HS-I in HS-II, so bili primerni za vključitev v odprto podaljšano študijo, v kateri so prejemali zdravilo Humira 40 mg vsak teden.
English: The white needle sleeve will move down over the needle and lock into place over the needle tip.
Slovenian: Beli tulec igle se bo pomaknil navzdol prek igle in se bo zaskočil nad njeno konico.
English: Steroid-free remission for ≥ 90 days
Slovenian: Remisija brez steroidov za ≥ 90 dni a
English: These infections may be serious and include tuberculosis, infections caused by viruses, fungi, parasites or bacteria, or other opportunistic infections and sepsis that may, in rare cases, be life-threatening.
Slovenian: Te okužbe so lahko resne in vključujejo tuberkulozo, okužbe, ki jih povzročijo virusi, glive, paraziti ali bakterije ali druge oportunistične okužbe in sepso, in so lahko v redkih primerih smrtno nevarne.
English: Humira can be taken together with methotrexate or certain disease-modifying anti-rheumatic agents (sulfasalazine, hydroxychloroquine, leflunomide and injectable gold preparations), steroids or pain medications including non-steroidal anti-inflammatory drugs (NSAIDs).
Slovenian: Zdravilo Humira se lahko uporablja skupaj z metotreksatom ali nekaterimi imunomodulirajočimi antirevmatičnimi zdravili (sulfasalazinom, hidroksiklorokinom, leflunomidom in pripravki zlata za injiciranje), steroidi in zdravili proti bolečinam, vključno z nesteroidnimi protivnetnimi zdravili.
English: Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as nonresponders.
Slovenian: b Bolniki, ki izpolnjujejo merila, določena v protokolu za izgubo odziva ali brez izboljšanja, so bili izključeni iz študij in so še šteli pod bolnike brez odgovora (“nonresponders”).
English: • feeling weak or tired
Slovenian: • občutek šibkosti ali utrujenosti
English: Amongst those who responded (Pediatric ACR 30) at Week 24 (n=27 out of 30 patients), the Pediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received Humira throughout this time period.
Slovenian: Med tistimi, ki so se odzvali (Pediatric ACR 30) 24. teden (n = 27 od 30 bolnikov), se je odziv Pediatric ACR 30 v odprti podaljšani fazi ohranil do 60 tednov pri bolnikih, ki so med tem celotnim obdobjem prejemali zdravilo Humira.
English: Figure 2: Kaplan-Meier Curves Summarizing Time to Treatment Failure on or after Week 6 (Study UV I) or Week 2 (Study UV II)
Slovenian: Slika 2: Kaplan-Meier-jeve krivulje povzemajo čas do neuspeha zdravljenja v ali po 6. tednem (študija UV I) ali 2. tednu (študija UV II)
English: a 40
Slovenian: Med njimi 40
English: Subjects (n=215, 54.7%) who failed to achieve ASAS 20 at Weeks 12, or 16 or 20 received early escape open-label adalimumab 40 mg every other week subcutaneously and were subsequently treated as non-responders in the double-blind statistical analyses.
Slovenian: Preiskovanci (n = 215, 54,7 %), ki 12. ali 16. ali 20. teden niso dosegli ASAS 20, so začeli v predčasni odprti fazi dobivati 40 mg adalimumaba vsak drugi teden subkutano, v poznejših statističnih analizah dvojno slepe faza pa so bili obravnavani kot neodzivni bolniki.
English: If you forget to use Humira
Slovenian: Če ste pozabili uporabiti zdravilo Humira
English: Age Group
Slovenian: Starostna skupina
English: • Do not inject into skin that is sore, bruised, red, hard, scarred, has stretch marks, or areas with psoriasis plaques
Slovenian: • Ne injicirajte v kožo, ki je ranjena, obtolčena, rdeča, zatrdela, brazgotinasta, s strijami ali v predele, kjer je prisotna luskavica v plakih
English: To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.
Slovenian: Če želite poslušati ali zaprositi za kopijo tega navodila v <Braillovi pisavi>, <velikem tisku> ali
English: Physicians should exercise caution when considering the use of Humira in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Slovenian: Pri odločanju za uporabo zdravila Humira je potrebna previdnost pri bolnikih z anamnezo ponavljajoče se okužbe ali z osnovnimi boleznimi, ki lahko zvečajo nagnjenost k okužbam, vključno s sočasno uporabljenimi imunosupresivnimi zdravili.
English: No studies have been conducted that include patients with a history of malignancy or in whom treatment with Humira is continued following development of malignancy.
Slovenian: Študij, ki bi vključevale bolnike z anamnezo malignoma ali bolnike, pri katerih bi se zdravljenje z zdravilom Humira nadaljevalo po pojavu malignoma, ni bilo.
English: There is limited experience in the initiation of treatment with Humira alone.
Slovenian: O začetku zdravljenja samo z zdravilom Humira so izkušnje omejene.
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
Slovenian: • Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: • It is normal to see a few drops of liquid come out of the needle
Slovenian: • Normalno je, če iz igle prikaplja nekaj kapljic tekočine.
English: The decision to stop using Humira should be discussed with your doctor.
Slovenian: O odločitvi, da bi prenehali uporabljati zdravilo Humira, se morate posvetovati s svojim zdravnikom.
English: Population pharmacokinetic and pharmacokinetic/pharmacodynamic modelling and simulation predicted comparable adalimumab exposure and efficacy in patients treated with 80 mg every other week when compared with 40 mg every week (including adult patients with RA, HS, UC, CD or Ps, patients with adolescent HS, and paediatric patients ≥ 40 kg with CD).
Slovenian: Populacijsko farmakokinetično in farmakokinetično/farmakodinamično modeliranje in simulacija so za adalimumab napovedali primerljivo izpostavljenost in učinkovitost pri bolnikih, zdravljenih z 80 mg vsak drugi teden v primerjavi s 40 mg vsak teden (vključno z odraslimi bolniki z RA, HS, UC,
English: In addition, no malignancies were observed in 192 paediatric patients with an exposure of 498.1 patient years during Humira trials in paediatric patients with Crohn's disease.
Slovenian: Poleg tega niso opazili nobenega malignoma tudi pri 192 pediatričnih bolnikih, ki so bili izpostavljeni 498,1 bolnikov let med študijami z zdravilom Humira pri pediatričnih bolnikih s Crohnovo boleznijo.
English: Patients who achieved sustained remission for at least 12 weeks (N=305) (ASDAS < 1.3 at Weeks 16, 20, 24, and 28) during the open-label period were then randomized to receive either continued treatment with Humira 40 mg eow (N=152) or placebo (N=153) for an additional 40 weeks in a double-blind, placebo-controlled period (total study duration 68 weeks).
Slovenian: Bolniki, ki so v odprti fazi dosegli trajno remisijo za vsaj 12 tednov (N = 305) (ASDAS < 1,3 v 16., 20., 24. in 28. tednu), so bili nato randomizirani tako, da so prejemali bodisi nadaljevalno zdravljenje z zdravilom Humira 40 mg vsak drugi teden (N = 152) ali placebo (N = 153) dodatnih 40 tednov v dvojno slepem, s placebom kontroliranem obdobju (celotno trajanje študije 68 tednov).
English: After doses of 0.5 mg/kg (~40 mg), clearances ranged from 11 to 15 ml/hour, the distribution volume (Vss) ranged from 5 to 6 litres and the mean terminal phase half-life was approximately two weeks.
Slovenian: 15 ml/uro, volumen distribucije (Vss) od 5 do 6 litrov in povprečni razpolovni čas terminalne faze približno dva tedna.
English: If the white plunger rod is pulled completely out of the syringe, discard the syringe and contact your Humira provider for a replacement.
Slovenian: Če beli nosilec bata potegnete popolnoma iz brizge, brizgo zavrzite in se z dobaviteljem zdravila
English: You should continue to inject Humira for as long as your doctor has told you.
Slovenian: Nadaljevati morate z injiciranjem zdravila Humira tako dolgo, kot vam je naročil zdravnik.
English: In rheumatoid arthritis, methotrexate is continued while using Humira.
Slovenian: Pri revmatoidnem artritisu se uporaba metotreksata med uporabo zdravila Humira nadaljuje.
English: • melanoma;
Slovenian: • melanom;
English: This medicinal product contains less than 1 mmol of sodium (23 mg) per 0.8 ml dose, i.e. essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) v 0,8 ml odmerku, kar v bistvu pomeni ‘brez natrija'.
English: • heart attack
Slovenian: • srčni napad
English: • If your child is pregnant, thinks she may be pregnant or is planning to have a baby, ask her doctor for advice about taking this medicine.
Slovenian: • Če je vaš otrok noseč, misli, da je noseč ali načrtuje nosečnost, se glede uporabe tega zdravila posvetujte z otrokovim zdravnikom.
English: Österreich AbbVie GmbH Tel: +43 1 20589-0
Slovenian: AbbVie GmbH Tel: +43 1 20589-0
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Humira and is positive for antibodies against double-stranded DNA, further treatment with Humira should not be given (see section
Slovenian: Če se bolniku po zdravljenju z zdravilom Humira pojavijo simptomi, ki nakazujejo lupusu podobni sindrom, in ima pozitivna protitelesa proti dvojnoverižni DNA, zdravljenja z zdravilom Humira ne sme nadaljevati (glejte poglavje 4.8).
English: Significant improvements at Week 16 from baseline compared to placebo (Studies I and II) and MTX (Study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Slovenian: Značilno izboljšanje od izhodišča do 16. tedna se je v primerjavi s placebom (študiji I in II) in metotreksatom (študija II) izkazalo v dermatološkem indeksu kakovosti življenja (DLQIDermatology Life Quality Index).