FrancophonIA/ELRC3.0 huggingface dataset:
English: Not known (frequency cannot be estimated from available data)
Slovenian: Neznana pogostnost (pogostnosti iz razpoloţljivih podatkov ni mogoče oceniti):
English: 1.1 Prepare a clean flat surface, such as a table or countertop, in a well-lit area.
Slovenian: 1.1 Pripravite čisto površino, na primer mizo ali pult, v dobro razsvetljenem prostoru.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: O neţelenih učinkih lahko poročate tudi neposredno na nacionalni center za poročanje, ki je naveden v Prilogi V. S tem, ko poročate o neţelenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Succursale de Corsier-sur-Vevey Chemin du Fenil Zone Industrielle B 1804 Corsier-sur-Vevey Switzerland
Slovenian: Succursale de Corsier-sur-Vevey Chemin du Fenil Zone Industrielle B 1804 Corsier-sur-Vevey Švica
English: In all situations described below, the benefit/risk balance of therapy should be very carefully considered.
Slovenian: V vseh spodaj opisanih okoliščinah je treba korist/tveganje zdravljenja zelo natančno pretehtati.
English: Approximately half the cases were lymphomas.
Slovenian: V pribliţno polovici primerov je šlo za limfome.
English: PROBABILITY OF FAILING TREATMENT
Slovenian: VERJETNOST ZA NEUSPEH ZDRAVLJENJA
English: Your child may first be given other medicines.
Slovenian: Vaš otrok bo morda najprej prejel druga zdravila.
English: Injecting cold medicine may be painful.
Slovenian: Injiciranje mrzlega zdravila je lahko boleče.
English: No effects on the breastfed newborns/infants are anticipated.
Slovenian: Ni pričakovanega učinka na dojene novorojenčke/dojenčke.
English: Most side effects are mild to moderate.
Slovenian: Večina neţelenih učinkov je blagih do zmernih.
English: The primary endpoint was ‘time to treatment failure'.
Slovenian: Primarni opazovani dogodek je bil “čas do neuspeha zdravljenja”.
English: According to a pregnancy study, there was no higher risk of birth defects when the mother had received adalimumab during pregnancy compared with mothers with the same disease who did not receive adalimumab.
Slovenian: Glede na študije v nosečnosti ni bilo večjega tveganja za defekte ob rojstvu, če je mati jemala adalimumab med nosečnostjo, v primerjavi z materami z enako boleznijo, ki adalimumaba niso jemale.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Slovenian: Poročanje o domnevnih neţelenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.
English: The liquid should be clear and colorless.
Slovenian: Tekočina mora biti bistra in brezbarvna.
English: Results from the overall UC-II study population are shown in Table 26.
Slovenian: Rezultate celotne populacije v študiji UC-II prikazuje preglednica 26.
English: Double-blind response at week 12
Slovenian: Dvojno slepa Odziv v 12. tednu
English: See section 4.8 for how to report adverse reactions.
Slovenian: Glejte poglavje 4.8, kako poročati o neţelenih učinkih.
English: See the end of section 4 for how to report side effects.
Slovenian: Glejte na koncu poglavja 4, kako poročati o neţelenih učinkih.
English: Disease flares at the end of 32 weeks a
Slovenian: Zagon bolezni na koncu 32-tedenskega obdobja a
English: There may be a need for dose interruption, for instance before surgery or if a serious infection occurs.
Slovenian: Potrebna je lahko prekinitev uporabe, npr. pred operacijo ali če se pojavi resna okuţba.
English: Reports included cases of pulmonary and extra-pulmonary (i.e. disseminated) tuberculosis.
Slovenian: Poročila so vključevala primere pljučne in zunajpljučne (tj. diseminirane) tuberkuloze.
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Slovenian: Kot vsa zdravila ima lahko tudi to zdravilo neţelene učinke, ki pa se ne pojavijo pri vseh bolnikih.
English: Injecting cold medicine can be painful (Figure E).
Slovenian: Injiciranje mrzlega zdravila je lahko boleče (Slika E)
English: The interpretation of data may be impacted due to methodological limitations of the study, including small sample size and nonrandomized design.
Slovenian: Na interpretacijo podatkov lahko vplivajo metodološke omejitve raziskave, vključno z majhno velikostjo vzorca in nerandomizirano zasnovo raziskave.
English: After 32 weeks or at disease flare, patients were eligible to enrol into the open label extension phase.
Slovenian: Po 32 tednih ali v primeru zagona bolezni so bili bolniki primerni za vključitev v odprto podaljšano fazo.
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 moţnost nadaljevati v odprti, dolgoročni podaljšani študiji (UC III).
English: • blood in urine;
Slovenian: • kri v urinu;
English: Warning: Call your healthcare professional or pharmacist if:
Slovenian: Opozorilo: Pokličite svojega zdravstvenega delavca ali farmacevta, če:
English: Concurrent administration of biologic DMARDs or TNF-antagonists
Slovenian: Sočasna uporaba bioloških DMARDs ali antagonistov TNF
English: Some side effects observed with adalimumab may not have symptoms and may only be discovered through blood tests.
Slovenian: Nekateri neţeleni učinki, ki so bili opaţeni pri adalimumabu, nimajo simptomov in se jih lahko odkrije le pri krvnih testih.
English: Monoclonal antibodies are proteins that attach to a specific target in the body.
Slovenian: Monoklonska protitelesa so beljakovine, ki se veţejo na specifične tarče v telesu.
English: Talk to your healthcare provider if you have any questions.
Slovenian: Posvetujte se s svojim zdravstvenim delavcem, če imate še kakšna vprašanja.
English: Double-blind response at week 68
Slovenian: Dvojno slepa Odziv v 68. tednu
English: Slowly release your thumb up.
Slovenian: Palec počasi odmaknite od bata.
English: Available data suggest that adalimumab does not worsen or cause strictures.
Slovenian: Razpoloţljivi podatki kaţejo, da adalimumab ne poslabša in ne povzroči striktur.
English: Seek medical attention urgently, if you notice any of the following signs of allergic reaction or heart failure:
Slovenian: Nujno morate poiskati zdravniško pomoč, če opazite katerega od naslednjih znakov alergijske reakcije ali popuščanja srca:
English: Kromeya may be available in other presentations depending on the individual treatment needs.
Slovenian: Zdravilo Kromeya je lahko na voljo v drugih oblikah, odvisno od individualnih potreb zdravljenja.
English: An asterisk (*) appears in the System Organ Class (SOC) column if further information is found elsewhere in sections 4.3, 4.4 and 4.8.
Slovenian: V koloni organski sistem po MedDRA se pojavi znak zvezdica (*), če so v zvezi s tem vključene dodatne informacije v poglavjih 4.3, 4.4 in 4.8.
English: 73% of patients enrolled in Psoriasis Studies I and II had received prior systemic therapy or phototherapy.
Slovenian: 73 % bolnikov, vključenih v študiji pri psoriazi I in II, je predhodno dobivalo sistemsko zdravljenje ali fototerapijo.
English: ASDAS inactive disease hs-CRP
Slovenian: ASDAS neaktivna bolezen hs-CRP
English: Among those, 109 subjects (63.7%) were reported to be in remission at 10 years.
Slovenian: Med temi je bilo 109 oseb (63,7 %) po 10 letih v stanju remisije.
English: • new onset or worsening of psoriasis;
Slovenian: • pojav ali poslabšanje psoriaze;
English: This is to remove any air gaps or bubbles.
Slovenian: S tem odstranite zrak ali zračne mehurčke.
English: The average absolute bioavailability of adalimumab estimated from three studies following a single 40 mg subcutaneous dose was 64%.
Slovenian: Povprečna absolutna biološka uporabnost adalimumaba, ocenjena iz treh študij po enem 40 mg odmerku subkutano, je 64 %.
English: Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level.
Slovenian: Omejeni podatki iz objavljene literature kaţejo, da se adalimumab izloča v materino mleko v zelo nizkih koncentracijah, s prisotnostjo adalimumaba v človeškem mleku v koncentraciji 0.1 % do 1 % glede na materin serum.
English: 4.7 Effects on ability to drive and use machines
Slovenian: 4.7 Vpliv na sposobnost voţnje in upravljanja strojev
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloţenem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: • At the request of the European Medicines Agency; • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Slovenian: • ob vsakršni spremembi sistema za obvladovanje tveganj, zlasti kadar je tovrstna sprememba posledica prejema novih informacij, ki lahko privedejo do znatne spremembe razmerja med koristmi in tveganji, ali kadar je ta sprememba posledica tega, da je bil doseţen pomemben mejnik (farmakovigilančni ali povezan z zmanjševanjem tveganja).
English: 1.3 Open the kit and take out all components and put them on a clean, dry, flat surface.
Slovenian: 1.3 Komplet odprite, vzemite ven vse pripomočke ter jih poloţite na čisto, suho, ravno površino.
English: TIME (MONTHS)
Slovenian: ČAS (MESECI)
English: MTX = methotrexate b
Slovenian: MTX = metotreksat b
English: • the lot number (on vial label).
Slovenian: • serijsko številko (na nalepki na viali).
English: For the full list of excipients, see section 6.1.
Slovenian: Za celoten seznam pomoţnih snovi glejte poglavje 6.1.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Slovenian: V razvrstitvah pogostnosti so neţeleni učinki navedeni po padajoči resnosti.
English: - if you have moderate or severe heart failure.
Slovenian: - če imate zmerno ali hudo srčno popuščanje.
English: * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies including spontaneous reporting data
Slovenian: *Nadaljnje informacije v zvezi s tem najdete v poglavjih 4.3, 4.4 in 4.8 **Vključno pri podaljšanih študijah brez placeba Vključno s podatki iz spontanega poročanja
English: Concomitant stable doses of one non-biologic immunosuppressant were permitted.
Slovenian: Sočasni stalni odmerki enega nebiološkega imunosupresiva so bili dovoljeni.
English: • A sharps container (see section 7.2).
Slovenian: • zbiralnik za ostre predmete (glejte poglavje 7.2).
English: Kromeya can also be given alone.
Slovenian: Zdravilo Kromeya se lahko daje tudi samo.
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Slovenian: Preobčutljivost na učinkovino ali katero koli pomoţno snov, navedeno v poglavju 6.1.
English: Week 8 and 52
Slovenian: 8. in 52. teden
English: Concomitant stable doses of aminosalicylates, corticosteroids, and/or immunomodulatory agents were permitted and 80% of patients continued to receive at least one of these medications.
Slovenian: Dovoljeni so bili sočasni stabilni odmerki aminosalicilatov, kortikosteroidov in/ali imunomodulatorjev in 80 % bolnikov je nadaljevalo z dobivanjem vsaj enega od teh zdravil.
English: If you still see air gaps or bubbles at the tip of the syringe, repeat this step until air gaps or bubbles are gone.
Slovenian: Če v konici injekcijske brizge še vedno vidite zrak ali zračne mehurčke, ta korak ponovite, dokler jih ne odstranite.
English: TREATMENT FAILURE RATE (%)
Slovenian: ODSTOTEK NEUSPEHA ZDRAVLJENJA (%)
English: Label area (Kromeya, dose, expiration date)
Slovenian: Nalepka (Kromeya, odmerek, rok uporabnosti)
English: Doing so could damage the syringe or activate the clear needle guard.
Slovenian: S tem bi lahko poškodovali injekcijsko brizgo ali aktivirali prozorno varovalo za iglo.
English: Psoriasis study I (REVEAL) evaluated 1212 patients within three treatment periods.
Slovenian: Študija pri psoriazi I (REVEAL) je ocenila 1212 bolnikov v treh obdobjih zdravljenja.
English: Side effects may occur up to 4 months or more after the last Kromeya injection.
Slovenian: Neţeleni učinki se lahko pojavijo še 4 mesece ali več po zadnji injekciji zdravila Kromeya.
English: Of those in clinical response at week 4, 48% had been previously exposed to other TNF-antagonists.
Slovenian: Od teh s kliničnim odzivom v 4. tednu jih je bilo 48 % prej izpostavljenih drugim TNF-antagonistom.
English: • When the syringe plunger has moved to the bottom and has stopped moving, continue holding it for 5 seconds.
Slovenian: • Ko se je bat premaknil do konca in se je prenehal premikati, drţite injekcijski peresnik na mestu še 5 sekund.
English: Appropriate screening tests (i.e. tuberculin skin test and chest X-ray) should be performed in all patients (local recommendations may apply).
Slovenian: Pri vseh bolnikih je treba narediti ustrezne presejalne preiskave (tj. tuberkulinski koţni test in rentgensko slikanje prsnih organov) (veljajo lahko lokalna priporočila).
English: Check components to make sure that the packaging and the content are not damaged.
Slovenian: Pripomočke preglejte in preverite, ali sta ovojnina in vsebina nepoškodovani.
English: Impaired lung function may increase the risk for developing infections.
Slovenian: Okvarjena pljučna funkcija lahko zveča tveganje za razvoj okuţbe.
English: One hundred patients (n=100) from the Paediatric CD study continued in an open-label long-term extension study.
Slovenian: Sto bolnikov (n = 100) iz študije Crohnove bolezni pri pediatričnih bolnikih je nadaljevalo v odprti dolgoročni podaljšani študiji.
English: Available data suggest that re-introduction of adalimumab after discontinuation for 70 days or longer resulted in the same magnitudes of clinical response and similar safety profile as before dose interruption.
Slovenian: Razpoloţljivi podatki kaţejo, da je adalimumab po ponovni uvedbi, ki je sledila prekinitvi za 70 dni ali več, dosegel enako velik klinični odziv in je imel podobne varnostne značilnosti kot pred prekinitvijo.
English: • If you are over 65 years you may be more susceptible to infections while taking Kromeya.
Slovenian: • Če ste starejši od 65 let, ste morda dovzetnejši za okuţbe, če jemljete zdravilo Kromeya.
English: A large number (approximately 2100) of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than 1500 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
Slovenian: Veliko število (pribliţno 2100) v naprej izbranih nosečnosti, med katerimi so bile matere izpostavljene adalimumabu in jim je sledilo rojstvo ţivorojenih otrok z znanim izidom, vključno s 1500 izpostavljenimi v prvem trimesečju, ne nakazuje povečanja razmerja malformacij pri novorojenčkih.
English: Tuberculosis can develop during therapy even if your child has had preventative treatment for tuberculosis.
Slovenian: Tuberkuloza se lahko razvije med zdravljenjem, tudi če je vaš otrok imel preventivno zdravljenje za tuberkulozo.
English: Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability.
Slovenian: Pri peroralnem dajanju so imunoglobulini G podvrţeni intestinalni proteolizi in imajo nizko biološko razpoloţljivost.
English: Preclinical data on fertility effects of adalimumab are not available.
Slovenian: Predkliničnih podatkov o učinkih adalimumaba na plodnost ni na voljo.
English: • serious infections (including blood poisoning and influenza);
Slovenian: • resne okuţbe (vključno z zastrupitvijo krvi in gripo);
English: Significant response was first observed at week 2 and maintained through 24 weeks (Table
Slovenian: Značilen odziv so najprej opazili po 2 tednih in se je ohranil do 24. tedna (preglednica 13).
English: Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1.
Slovenian: Za kombinirano uporabo z drugimi imunomodulirajočimi antirevmatičnimi zdravili razen metotreksata glejte poglavji 4.4 in 5.1.
English: For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Slovenian: Pri bolnikih, ki so pozitivni na okuţbo s hepatitisom B, se priporoča posvetovanje z zdravnikom specialistom za zdravljenje okuţb s hepatitisom B.
English: Clinical response (CR-100) was maintained in 102 and 233 patients, respectively.
Slovenian: Klinični odziv (CR-100) se je ohranil pri 102 oz. 233 bolnikih.
English: Health-related quality of life and physical function were assessed using the HAQ-S and the SF-36 questionnaires.
Slovenian: Z zdravjem povezano kakovost ţivljenja in telesno funkcijo so ocenjevali s pomočjo vprašalnikov HAQ-S in SF-36.
English: Solution for injection (injection).
Slovenian: Raztopina za injiciranje (injekcija).
English: Read all of this leaflet carefully before your child starts using this medicine because it contains important information.
Slovenian: Natančno preberite navodilo, preden vaš otrok začne uporabljati to zdravilo, ker vsebuje pomembne podatke!
English: The corresponding proportions of patients with no radiographic progression were 31.3%, 23.7% and 36.7% respectively.
Slovenian: Ustrezni deleţi bolnikov, ki niso imeli rentgenografskih znakov napredovanja, so bili 31,3 %, 23,7 % oz. 36,7 %.
English: Rare (may affect up to 1 in 1,000 people): • low blood measurements for white blood cells, red blood cells and platelet count.
Slovenian: Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): • nizke vrednosti za bele krvne celice, rdeče krvne celice in trombocite.
English: Open your sharps disposal container so it is ready to use.
Slovenian: Zbiralnik za ostre predmete odprite, da je pripravljen za uporabo.
English: 1.3 Remove the box from the refrigerator (Figure B).
Slovenian: 1.3 Škatlo vzemite iz hladilnika (Slika B).
English: Approximately 40% of patients in study UC-II had failed prior anti-TNF treatment with infliximab.
Slovenian: Pri pribliţno 40 % bolnikih v študiji UC-II predhodno anti-TNF zdravljenje z infliksimabom ni bilo uspešno.
English: Study UV II
Slovenian: Študija UV II
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Slovenian: Od zdravstvenih delavcev se zahteva, da poročajo o katerem koli domnevnem neţelenem učinku zdravila na nacionalni center za poročanje, ki je naveden v Prilogi V.
English: • worsening of a condition called dermatomyositis (seen as a skin rash accompanying muscle weakness).
Slovenian: • poslabšanje stanja, ki se imenuje dermatomiozitis (viden kot koţni izpuščaj, ki ga spremlja mišična šibkost).
English: In study UV II, statistically significant differences were observed for visual acuity only, but the other components were numerically in favour of adalimumab.
Slovenian: V študiji UV II so opazili statistično pomembne razlike samo za ostrino vida, toda tudi ostale komponente so bile glede številk v korist adalimumaba.
English: If retreatment with Kromeya is indicated, the above guidance on dose and treatment duration should be followed.
Slovenian: Če je indicirano vnovično zdravljenje z zdravilom Kromeya, je treba upoštevati zgoraj navedena navodila za odmerjanje in trajanje zdravljena.
English: After single intravenous doses ranging from 0.25 to 10 mg/kg, concentrations were dose proportional.
Slovenian: Po enem samem intravenskem odmerku od 0,25 do 10 mg/kg so bile koncentracije sorazmerne odmerku.
English: 2-sided p value from log rank test.
Slovenian: 2-stranska vrednost p testa log-rank.
English: Partial flare is defined as ASDAS ≥ 1.3 but < 2.1 at 2 consecutive visits.
Slovenian: Delni zagon bolezni je določen kot ASDAS ≥ 1,3 vendar < 2,1 pri dveh zaporednih obiskih.
English: The primary efficacy endpoint in both studies was ´time to treatment failure´.
Slovenian: Primarni opazovani dogodek kot merilo učinkovitosti je bil v obeh študijah ´čas do neuspeha zdravljenja´.
English: The primary non-responders were excluded from the studies and therefore these patients were not further evaluated.
Slovenian: Bolniki, ki se prvič niso odzvali, so bili izključeni iz študij in torej niso bili nadaljnje ovrednoteni.
English: Adalimumab is a recombinant human monoclonal antibody produced in Chinese Hamster Ovary cells.
Slovenian: Adalimumab je rekombinantno humano monoklonsko protitelo, pridobljeno v celicah jajčnika kitajskega hrčka.
English: Warning: Do not use the vial if:
Slovenian: Opozorilo: Vialo ne uporabljajte, če:
English: The highest dose level evaluated has been multiple intravenous doses of 10 mg/kg, which is approximately 15 times the recommended dose.
Slovenian: Največji ocenjeni odmerek je obsegal večkratno intravensko aplikacijo 10 mg/kg, kar je pribliţno 15-kraten priporočen odmerek.
English: Therapy continued beyond 12 weeks did not result in significantly more responses (see section 4.2).
Slovenian: Nadaljevanje zdravljenja po 12. tednu ni pokazalo pomembno več odzivov (glejte poglavje 4.2).
English: Steroid-free remission for ≥ 90 days a
Slovenian: Remisija brez steroidov za ≥ 90 dni a
English: Your child's symptoms may return upon stopping treatment.
Slovenian: Simptomi vašega otroka se lahko po prekinitvi zdravljenja povrnejo.
English: 2.3 Check the liquid to make sure that : The liquid is clear, colorless, and free of particles.
Slovenian: 2.3 Preglejte tekočino in preverite, ali je : bistra, brezbarvna in brez delcev.
English: You and your doctor should pay special attention to signs of infection while you are being treated with Kromeya.
Slovenian: Vi sami in vaš zdravnik morata biti posebej pozorna na znake okuţbe, medtem ko ste zdravljeni z zdravilom Kromeya.
English: After adjustment for weight differences, gender and age appeared to have a minimal effect on adalimumab clearance.
Slovenian: Po korekciji za razlike v teţi se je izkazalo, da spol in starost po vsem sodeč minimalno vplivata na očistek adalimumaba.
English: Discontinued corticosteroids
Slovenian: Prenehanje s kortikosteroidi
English: Patient reported outcomes regarding vision-related functioning were measured in both clinical studies, using the NEI VFQ-25.
Slovenian: Izidi poročil bolnikov glede opravil, povezanih z vidom, so bili merjeni v obeh kliničnih študijah z uporabo vprašalnika NEI VFQ -25.
English: TNF-antagonists, such as adalimumab affect the immune system and their use may affect the body's defence against infection and cancer.
Slovenian: TNF-antagonisti, kot je adalimumab, prizadenejo imunski sistem in njihova uporaba lahko vpliva na obrambo telesa proti okuţbi in raku.
English: Among the patients who discontinued the study prior to week 78, 11% discontinued due to adverse events, and 5% due to insufficient response to adalimumab treatment.
Slovenian: Med bolniki, ki so prekinili študijo pred 78. tednom, jih je 11 % prekinilo študijo zaradi neţelenih učinkov in 5 % zaradi nezadostnega odziva na zdravljenje z adalimumabom.
English: It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis (see section 5.1).
Slovenian: Priporočljivo je, da se vsako leto ocenijo koristi in tveganja nadaljnjega dolgotrajnega zdravljenja (glejte poglavje 5.1).
English: Treatment with Kromeya can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
Slovenian: Zdravljenje z zdravilom Kromeya se lahko začne v kombinaciji s kortikosteroidi in/ali z drugimi nebiološkimi imunomodulatorji.