natgillin/translations-raw huggingface dataset:
Children may receive some vaccines during treatment with Zessly but should not receive live vaccines while using Zessly. 
Otroci lahko med zdravljenjem z zdravilom Zessly prejmejo nekatera cepiva, vendar med uporabo zdravila Zessly ne smejo prejeti živih cepiv.
Live vaccines/therapeutic infectious agents 
Živa cepiva/povzročitelji okužb v terapevtske namene
Key efficacy results for study 10 and study 11 in patients with active psoriatic arthritis are shown in Table 9 below: 
Ključni izsledki o učinkovitosti zdravila iz študije 10 in študije 11 pri bolnikih z aktivnim psoriatičnim artritisom so prikazani v spodnji Preglednici 9:
• A reminder to patients to show the patient reminder card to all treating HCPs, including in conditions of emergency, and a message for HCPs that the patient is using Zessly 
• Opomnik za bolnike, da morajo pokazati opozorilno kartico za bolnika vsem zdravstvenim delavcem, ki sodelujejo pri zdravljenju (tudi v nujnih stanjih) ter sporočilo za zdravstvene delavce, da bolnik uporablja zdravilo Zessly.
Other medicines and Zessly 
Druga zdravila in zdravilo Zessly
• Severe allergic reactions (e.g. anaphylaxis), an immune system disorder called lupus, allergic reactions to foreign proteins 
• hude alergijske reakcije (npr. anafilaksija), motnja v delovanju imunskega sistema (lupus), alergijske reakcije na tuje beljakovine
2 weeks after your 1st treatment 
2 tedna po prvem odmerku tretji odmerek
• Tell your surgeon or dentist that you are having treatment with Zessly by showing them your patient reminder card. 
• Obvestite kirurga ali zobozdravnika, da prejemate zdravilo Zessly in mu pokažite svojo opozorilno kartico za bolnika.
Zessly contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially ‘sodium-free'. 
Zdravilo Zessly vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology. 
Infliksimab je himerno človeško-glodalsko monoklonsko protitelo IgG1, pridobljeno iz ovarijskih celic kitajskega hrčka (CHO) s tehnologijo rekombinantne DNK.
• Tell your doctor before you are given Zessly if you have or have ever had lymphoma (a type of blood cancer) or any other cancer. 
• Preden prejmete zdravilo Zessly, povejte zdravniku, če imate ali ste imeli kdaj v preteklosti limfom (vrsta krvnega raka) oziroma katero koli drugo vrsto raka.
Infliximab is a monoclonal antibody - a type of protein that attaches to a specific target in the body called TNF (tumour necrosis factor) alpha. 
Infliksimab je monoklonsko protitelo - vrsta beljakovine, ki se veže na določeno tarčo v telesu, imenovano TNF (tumorje nekrotizirajoči faktor)
In infants exposed in utero to infliximab, fatal outcome due to disseminated Bacillus CalmetteGuérin (BCG) infection has been reported following administration of BCG vaccine after birth. 
Pri dojenčkih, ki so bili in utero izpostavljeni infliksimabu, so poročali o smrtnem izidu zaradi razsejane okužbe s Calmette-Guerinovim bacilom (BCG) po cepljenju s cepivom BCG po rojstvu.
Study 1 evaluated responses at 30, 54 and 102 weeks in a placebo-controlled study of 428 patients with active rheumatoid arthritis despite treatment with methotrexate. 
V študiji 1 so ocenjevali odziv v 30., 54. in 102. tednu v s placebom kontrolirani študiji, opravljeni pri 428 bolnikih, ki so imeli aktiven revmatoidni artritis kljub zdravljenju z metotreksatom.
Ask your doctor to record the type and date of last screening(s) for tuberculosis (TB) below: 
Zdravnik naj zabeleži tip in datum zadnjega presejaln-ega(ih) test-a(ov) za tuberkulozo (TBC):
The reduction in incidence of colectomy was also examined in another randomised, double-blind study in hospitalised patients (n = 45) with moderately to severely active ulcerative colitis who failed to respond to intravenous corticosteroids and who were therefore at higher risk for colectomy. 
Zmanjšanje incidence kolektomij so proučevali še v eni randomizirani, dvojno slepi študiji pri hospitaliziranih bolnikih (n = 45) z zmerno do močno aktivnim ulceroznim kolitisom, ki se niso odzvali na zdravljenje z intravenskimi kortikosteroidi in so imeli zato večje tveganje, da bo pri njih potrebna kolektomija.
In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of infliximab, or modification of concomitant therapy. 
Na splošno bolniki, pri katerih se je pojavilo zvišanje ALT in AST, niso imeli simptomov in nenormalni izvidi so se zmanjšali ali normalizirali bodisi z nadaljevanjem ali z ukinitvijo zdravljenja z infliksimabom, ali pa ob prilagoditvi drugih sočasnih terapij.
Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and 
Bolniki v obeh študijah so imeli psoriazo s plaki (telesna površina [BSA] ≥ 10 % in indeks površine in jakosti psoriaze [PASI] ≥ 12).
• The medicine will be given as an infusion (drip) over a 2 hours into one of your veins, 
• Zdravilo vam bodo dali v obliki infuzije (kapalne) (v času 2 ur) v eno od ven, običajno v roki.
• Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur (see ‘Re administration' below and section 4.4). 
• Ponovna uporaba zdravila: Infuzija v odmerku 5 mg/kg, če se ponovijo znaki in simptomi bolezni (glejte poglavje “Ponovna uporaba zdravila” spodaj in poglavje 4.4).
This leaflet was last revised in {MM/YYYY}. 
Navodilo je bilo nazadnje revidirano dne {MM/LLLL} Drugi viri informacij
The median duration of follow-up was 0.8 years (incidence 5.7% [95% CI 2.65%-10.6%]. 
Mediana dolžine spremljanja bolnikov je bila 0,8 let (incidenca 5,7 % [95-% IZ 2,65 %-10,6 %].
Concurrent administration with other biological therapeutics 
Sočasna uporaba z drugimi biološkimi zdravili
Patients who develop a new infection while undergoing treatment with Zessly, should be monitored closely and undergo a complete diagnostic evaluation. 
Tiste bolnike, pri katerih se med zdravljenjem z zdravilom Zessly pojavi nova okužba, je treba natančno spremljati in pri njih opraviti celotni diagnostični postopek.
The potential risk with the combination of AZA or 6-MP and Zessly should be carefully considered. 
Natančno je treba pretehtati potencialno tveganje pri sočasnem dajanju AZA ali 6-MP z zdravilom Zessly.
2nd dose 
drugi odmerek
What you need to know before you use Zessly You should not be given Zessly if: 
Kaj morate vedeti, preden boste uporabili zdravilo Zessly Ne uporabljajte zdravila Zessly:
In the first clinical study, (study 10), efficacy and safety of infliximab were studied in 104 patients with active polyarticular psoriatic arthritis. 
V prvi klinični študiji (študija 10) so proučevali učinkovitost in varnost infliksimaba pri 104 bolnikih z aktivnim poliartikularnim psoriatičnim artritisom.
The combination of Zessly and abatacept is not recommended. 
Kombiniranje zdravila Zessly in abatacepta torej ni priporočljivo.
Use of antituberculosis therapy should also be considered before the initiation of Zessly in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. 
O potrebi po predhodnem zdravljenju tuberkuloze premislite tudi, preden boste uvedli zdravilo Zessly pri bolniku, ki ima latentno ali aktivno tuberkulozo v pretekli anamnezi in pri katerem ni mogoče zagotovo potrditi, da je prejel zadostno zdravljenje.
Events (some fatal) of myocardial ischaemia/infarction and arrhythmia have also been reported, some in close temporal association with infusion of infliximab. 
Poročali pa so tudi o pojavih (nekaterih s smrtnim izidom) ishemije miokarda/miokardnega infarkta in aritmije, nekaterih v tesni časovni povezanosti z infundiranjem infliksimaba.
Study 10 
Študija 10
Limited experience from re-treatment with one single infliximab dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see section 5.1). 
Ponovna uporaba zdravila pri psoriazi Omejene izkušnje s ponovnim zdravljenjem z enim samim odmerkom infliksimaba pri psoriazi po časovnem presledku 20 tednov kažejo zmanjšano učinkovitost in večjo incidenco blagih do zmernih z infuzijo povezanih reakcij v primerjavi s prvotnim uvodnim režimom zdravljenja (glejte poglavje 5.1).
Placebo Maintenance (n = 110) 
Vzdrževalno zdravljenje s placebom (n = 110)
• Store in a refrigerator (2°C - 8°C). 
• Shranjujte v hladilniku (2 °C-8 °C).
Table 1 Undesirable effects in clinical studies and from post-marketing experience 
Neželeni učinki v kliničnih študijah in v obdobju trženja zdravila
• That treatment with Zessly may increase the risks of serious infections/sepsis, opportunistic infections, tuberculosis, hepatitis B reactivation, and BCG breakthrough in infants with in utero exposure to infliximab, and when to seek attention from a HCP 
• Da lahko zdravljenje z zdravilom Zessly zveča tveganje za resne okužbe/sepso, oportunistične okužbe, tuberkulozo, reaktivacijo hepatitisa B in okužbo z BCG pri dojenčkih, ki so bili in utero izpostavljeni infliksimabu, in kdaj poiskati zdravniško pomoč.
The European Medicines Agency has waived the obligation to submit the results of studies with the reference medicinal product containing infliximab in all subsets of the paediatric population in rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, psoriasis and Crohn's disease (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z referenčnim zdravilom, ki vsebuje infliksimab, za vse skupine pediatrične populacije z revmatoidnim artritisom, juvenilnim idiopatskim artritisom, psoriatičnim artritisom, ankilozirajočim spondilitisom, psoriazo in Crohnovo boleznijo (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Viral infection (e.g. influenza, herpes virus infection). 
virusna okužba (npr. gripa, okužba s herpes virusom)
Store at 2°C - 8°C. 
Shranjujte pri temperaturi 2 °C - 8 °C.
The safety and efficacy of re-administration after an infliximab-free interval of more than 16 weeks has not been established. 
Varnosti in učinkovitosti ponovnega dajanja zdravila po premoru brez infliksimaba, daljšem od 16 tednov, še niso ugotovili.
Analysis of lamina propria mononuclear cells obtained by biopsy of the intestinal mucosa showed that infliximab treatment caused a reduction in the number of cells capable of expressing TNFα and interferonγ. 
Analiza mononuklearnih celic iz lamine proprie, dobljenih z biopsijo črevesne sluznice, je pokazala, da zdravljenje z infliksimabom povzroči zmanjšanje števila celic, ki lahko tvorijo TNFα in interferon γ.
In both studies, physical function and quality of life as measured by the BASFI and the physical component score of the SF-36 were also improved significantly. 
V obeh študijah sta se bistveno izboljšala telesno stanje bolnikov in kakovost njihovega življenja, merjeno po lestvici BASFI, pa tudi telesna komponenta ocene po SF-36 je bila bistveno izboljšana.
Approximately half of infliximab-treated patients in clinical studies who were ANA negative at baseline developed a positive ANA during the study compared with approximately one fifth of placebo-treated patients. 
Približno polovica bolnikov, zdravljenih z infliksimabom v kliničnih študijah, ki so imeli na začetku negativen izvid na ANA, je imelo med študijo pozitiven izvid na ANA, v primerjavi s približno eno petino bolnikov, ki so prejemali placebo.
In study 6 and study 7, infliximab improved quality of life, confirmed by statistically significant improvement in both a disease specific measure, IBDQ, and by improvement in the generic 36-item short form survey SF-36. 
V študiji 6 in študiji 7 je infliksimab tudi izboljšal kakovost življenja bolnikov, kar je bilo potrjeno s statistično značilnim izboljšanjem rezultata vprašalnika za oceno vnetnih bolezni črevesja IBDQ, ki je specifičen za to bolezen, in z izboljšanjem rezultatov generične kratke ankete SF-36 s 36 postavkami.
Zessly should only be used in children if they are being treated for Crohn's disease or ulcerative colitis. 
Zdravilo Zessly se sme pri otrocih uporabljati samo za zdravljenje Crohnove bolezni ali ulceroznega kolitisa.
There are no known side effects of having too much of Zessly. 
Ni poznanih neželenih učinkov zaradi prejetja prevelikega odmerka zdravila Zessly.
There are insufficient data on the incidence of delayed hypersensitivity reactions after infliximabfree intervals of more than 1 year but limited data from clinical studies suggest an increased risk for delayed hypersensitivity with increasing infliximab-free interval (see section 4.4). 
Podatki o incidenci poznih preobčutljivostnih reakcij po premoru brez infliksimaba, daljšem od enega leta, so nezadostni, vendar omejeni podatki iz kliničnih preskušanj kažejo povečano tveganje za pozno preobčutljivost pri povečevanju premora brez infliksimaba (glejte poglavje 4.4).
However, before Zessly is given to you, it is mixed with a solution that contains sodium. 
Vendar pa se zdravilo Zessly, preden ga dajo vam, zmeša z raztopino, ki vsebuje natrij.
In the paediatric Crohn's disease study, infections were reported in 56.3% of randomised subjects treated with infliximab. 
V pediatrični študiji Chronove bolezni so o okužbah poročali pri 56,3 % randomiziranih preiskovancih, zdravljenih z infliksimabom.
Zessly infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues. 
Infuzije zdravila Zessly morajo bolniku dajati kvalificirani zdravstveni delavci, ki so usposobljeni za ugotavljanje morebitnih težav pri infundiranju zdravil.
• This medicine can also be stored in the original carton outside of refrigerated storage up to a maximum of 30°C for a single period of up to six months, but not beyond the original expiry date. 
• To zdravilo se lahko shranjuje tudi v originalni škatli izven hladilnika do največ 30 °C za enkratno obdobje do 6 mesecev, vendar ne dlje od originalnega datuma izteka roka uporabnosti.
In a clinical study of patients with Crohn's disease, infusion-related reactions occurred in 16.6% (27/163) of patients receiving infliximab monotherapy, 5% (9/179) of patients receiving infliximab in combination with AZA, and 5.6% (9/161) of patients receiving AZA monotherapy. 
V klinični študiji pri bolnikih s Crohnovo boleznijo so se z infuzijo povezane reakcije pojavile pri 16,6 % (27/163) bolnikov, ki so prejemali infliksimab v monoterapiji, pri 5 % (9/179) bolnikov, ki so prejemali infliksimab v kombinaciji z AZA, in pri 5,6 % (9/161) bolnikov, ki so prejemali AZA v monoterapiji.
If you are given too much Zessly 
Če ste prejeli prevelik odmerek zdravila Zessly
In the 3 mg/kg Infliximab group, 4 out of 60 patients had a serious infusion reaction and 3 patients reported a possible anaphylactic reaction (2 of which were among the serious infusion reactions). 
V skupini, ki je infliksimab prejemala v odmerku 3 mg/kg, so imeli 4 od 60-tih bolnikov resno z infuzijo povezano reakcijo, pri 3 pa so poročali o možni anafilaktični reakciji (od tega sta 2 sodili med resne z infuzijo povezane reakcije).
Powder for concentrate for solution for infusion 1 vial 100 mg 
Prašek za koncentrat za raztopino za infundiranje 1 viala 100 mg
At week 2, all patients were assessed for clinical response and randomised to one of 3 treatment groups; a placebo maintenance group, 5 mg/kg maintenance group and 10 mg/kg maintenance group. 
drugem tednu zdravljenja so pri vseh bolnikih ocenili klinični odziv in jih naključno razvrstili v eno od 3 terapevtskih skupin: skupino za vzdrževalno zdravljenje s placebom, skupino za vzdrževalno zdravljenje z odmerkom 5 mg/kg in skupino za vzdrževalno zdravljenje z odmerkom 10 mg/kg.
You may receive some vaccines during treatment with Zessly but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Zessly because they may cause infections. 
Zessly ne smete prejeti živih cepiv (cepiv, ki vsebujejo žive, a oslabljene povzročitelje okužb), saj lahko le-ta povzročijo okužbo.
Patients treated with infliximab should be given the patient reminder card. 
Bolniki, ki se zdravijo z infliksimabom, morajo prejeti opozorilno kartico za bolnika.
• If you received Zessly during your pregnancy, your baby may have a higher risk for getting an infection. 
• Če ste v času nosečnosti prejemali zdravilo Zessly, ima vaš dojenček lahko povečano tveganje za okužbe.
Chemical and physical in use stability of the reconstituted solution has been demonstrated for 24 hours at 2 °C - 30 °C. 
Pokazali so, da je rekonstituirana raztopina zdravila Zessly kemično in fizikalno stabilna 24 ur pri 2 °C - 30 °C.
If jaundice and/or ALT elevations ≥ 5 times the upper limit of normal develop(s), Zessly should be discontinued, and a thorough investigation of the abnormality should be undertaken. 
Če se pojavi zlatenica in/ali zvišanje vrednosti ALT ≥ 5-kratno zgornjo mejo normale, prenehajte z uporabo zdravila Zessly in temeljito raziščite vzroke za nenormalne izvide.
Appropriate screening tests, (e.g. tuberculin skin test, chest X-ray, and/or Interferon Gamma Release Assay), should be performed in all patients (local recommendations may apply). 
Pri vseh bolnikih je treba opraviti ustrezne presejalne teste (npr. tuberkulinski kožni test, rentgensko slikanje prsnega koša in/ali test sproščanja interferona gama) (v skladu z lokalnimi priporočili).
While using Zessly you should not receive live vaccines. 
Med uporabo zdravila Zessly ne smete prejeti živih cepiv.
Date of Zessly therapy initiation: 
Datum začetka zdravljenja z zdravilom Zessly:
There was one reported malignancy amongst 77 control patients (median duration of follow-up 0.8 years; incidence 1.3% [95% CI 0.03%-7.0%]). 
Pri 77 bolnikih iz kontrolne skupine so poročali o enem malignomu (mediana dolžine spremljanja bolnikov je bila 0,8 let, incidenca pa 1,3 % [95-% IZ 0,03 %-7,0 %]).
The proportion of patients with infections in the paediatric ulcerative colitis trial was similar to that in the paediatric Crohn's disease study but higher than the proportion in the adults' ulcerative colitis studies. 
Delež bolnikov z okužbami je bil v preskušanju pri pediatričnih bolnikih z ulceroznim kolitisom podoben kot v študiji Crohnove bolezni pri pediatričnih bolnikih, a večji od deleža v študijah ulceroznega kolitisa pri odraslih bolnikih.
• Tell your doctor before you are given Zessly if you have a lung disease called chronic obstructive pulmonary disease (COPD) or if you are a heavy smoker. 
• Preden prejmete zdravilo Zessly, povejte zdravniku, če imate kronično obstruktivno pljučno bolezen (KOPB) ali če veliko kadite.
Before starting treatment with Zessly, all patients must be evaluated for both active and inactive (‘latent') tuberculosis. 
Pred začetkom zdravljenja z zdravilom Zessly, morate vse bolnike pregledati in preiskati, da ugotovite morebitno aktivno ali neaktivno (latentno) tuberkulozo.
If these medicines or treatments do not work well enough, you will be given Zessly to reduce the signs and symptoms of your disease. 
Če ta zdravila ali terapije ne delujejo dovolj dobro, boste prejeli zdravilo Zessly za zmanjševanje znakov in simptomov bolezni.
If you forget or miss an appointment to receive Zessly, make another appointment as soon as possible. 
Če ste pozabili ali izpustili odmerek zdravila Zessly Če ste pozabili ali izpustili dogovorjen termin, da bi prejeli zdravilo Zessly, se čim prej dogovorite za naslednjega.
The combination of Zessly with other biological therapeutics used to treat the same conditions as Zessly, including anakinra and abatacept, is not recommended (see section 4.4). 
Kombiniranje zdravila Zessly z drugimi biološkimi zdravili za zdravljenje enakih bolezni kot z zdravilom Zessly, vključno z anakinro in abataceptom, ni priporočljivo (glejte poglavje 4.4).
Table 6 Percent of patients with Crohn's disease achieving corticosteroid-free clinical remission at week 26 
Odstotek bolnikov s Chronovo boleznijo, ki so dosegli klinično remisijo brez jemanja kortikosteroidov v 26. tednu
Three cases of pneumonia (1 serious) and 2 cases of herpes zoster (both non-serious) were reported. 
Poročali so tudi o treh primerih pljučnice (v enem primeru je šlo za resno pljučnico) in dveh primerih herpes zostra
Further treatment with Zessly must not be given if a patient develops a serious infection or sepsis. 
Bolnika ne smete več zdraviti s tem zdravilom, če dobi resno okužbo ali sepso.
Investigations Uncommon: 
Preiskave občasni:
This patient reminder card contains important safety information that you need to be aware of before and during treatment with Zessly. 
Ta opozorilna kartica za bolnika vsebuje pomembne varnostne informacije, ki jih morate poznati, preden prejmete zdravilo Zessly pa termed zdravljenjem z njim.
Table 10 Summary of PASI response, PGA response and percent of patients with all nails cleared at weeks 10, 24, and 50. 
Preglednica 10 Povzetek odzivov PASI,vrednosti PGA in delež bolnikov z nohti brez psoriatičnih sprememb v 10., 24. in 50. tednu.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Zessly and is positive for antibodies against double-stranded DNA, further treatment with Zessly must not be given (see section 4.8). 
Če se po zdravljenju z zdravilom Zessly pri bolniku pojavijo simptomi, ki kažejo na lupusu podoben sindrom, in je bolnik pozitiven na protitelesa proti dvojnoverižni DNA, ne sme več prejeti tega zdravila (glejte poglavje 4.8).
Zessly treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of rheumatoid arthritis, inflammatory bowel diseases, ankylosing spondylitis, psoriatic arthritis or psoriasis. 
Zdravljenje z zdravilom Zessly mora uvesti in nadzorovati kvalificiran zdravnik, ki je izkušen v diagnostiki in zdravljenju revmatoidnega artritisa, vnetnih bolezni črevesa, ankilozirajočega spondilitisa, psoriatičnega artritisa ali psoriaze.
• You should receive recommended vaccinations before starting Zessly treatment. 
• Vsa priporočena cepljenja morate prejeti pred začetkom zdravljenja z zdravilom Zessly.
Study 12 evaluated the efficacy of infliximab induction therapy in 249 patients with plaque psoriasis that had previously received PUVA or systemic therapy. 
V študiji 12 so ocenjevali učinkovitost uvodne terapije z infliksimabom pri 249 bolnikih s psoriazo s plaki, ki so pred tem prejemali PUVA ali sistemsko terapijo.
• Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Zessly treatment. 
• Bolniki s KOPB in tisti, ki veliko kadijo, imajo lahko povečano tveganje za nastanek raka pri zdravljenju z zdravilom Zessly.
In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, antituberculosis therapy should be considered before the initiation of Zessly. 
Pri bolnikih, ki imajo več dejavnikov tveganja oziroma pomembne dejavnike tveganja za tuberkulozo in pri katerih je bil test na latentno tuberkulozo negativen, premislite, ali bi bilo treba pri njih pred uvedbo zdravila Zessly najprej zdraviti tuberkulozo.
Efficacy and safety were assessed in two multicenter, double-blind, placebo-controlled studies in patients with active psoriatic arthritis (studies 10 and 11). 
Učinkovitost in varnost zdravila so ocenjevali v dveh multicentričnih, dvojno slepih in s placebom kontroliranih študijah pri bolnikih z aktivnim psoriatičnim artritisom (študiji 10 in 11).
Name and address of the manufacturer(s) responsible for batch release 
NEMČIJA Ime in naslov proizvajalca (proizvajalcev), odgovornega (odgovornih) za sproščanje serij
• Circulation problems such as low or high blood pressure, 
• težave s krvnim obtokom, na primer nizek ali visok krvni tlak
ACR response (% of patients) 
Odziv ACR (% bolnikov) N