natgillin/translations-raw huggingface dataset:
The concomitant use of infliximab with these biologics is not recommended because of the possibility of an increased risk of infection, and other potential pharmacological interactions. 
Sočasne uporabe infliksimaba s temi biološkimi zdravili ne priporočamo zaradi možnosti povečanega tveganja za okužbe in drugih možnih farmakoloških interakcij.
Remicade should only be used during pregnancy if your doctor feels it is necessary for you. 
Zdravilo Remicade se lahko uporablja med nosečnostjo le, če zdravnik meni, da je to pri vas potrebno.
Approximately 3% of patients discontinued treatment due to infusion-related reactions and all patients recovered with or without medical therapy. 
Pri približno 3 % bolnikov so terapijo ustavili zaradi z infuzijo povezanih reakcij in vsi bolniki so okrevali, z ali brez medikamentozne terapije.
Infliximab should only be used during pregnancy if clearly needed. 
Infliksimab se med nosečnostjo lahko uporablja le, če je nujno potrebno.
The new expiry date must be written on the carton. 
Novi datum izteka roka uporabnosti je treba napisati na škatlo.
No further clinically relevant accumulation was observed. 
Nadaljnjega klinično pomembnega kopičenja niso opažali.
• Tell your doctor if you have had treatment with Remicade in the past and are now starting Remicade treatment again. 
• Povejte zdravniku, če ste se v preteklosti že zdravili z zdravilom Remicade in sedaj ponovno začenjate zdravljenje.
• Your doctor should test you for hepatitis B virus. 
• Zdravnik vas mora testirati za virus hepatitisa B.
Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). 
V okviru razvrstitve po organskih sistemih so neželeni učinki razvrščeni po naslednjih kategorijah pogostnosti: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
Shortened infusions at doses > 6 mg/kg have not been studied (see section 4.8). 
Uporabe skrajšanih infuzij v odmerkih > 6 mg/kg niso proučevali (glejte poglavje 4.8).
Data about fistulas were derived from PCDAI scores. 
Podatke o fistulah so pridobili iz ocen PCDAI.
• Reduce the signs and symptoms of your disease 
• zmanjšanje znakov in simptomov vaše bolezni,
Specific studies of Remicade in elderly patients have not been conducted. 
Specifične študije zdravila Remicade pri starejših bolnikih niso bile izvedene.
If you feel tired, dizzy, or unwell after having Remicade, do not drive or use any tools or machines. 
Če se po prejemu zdravila Remicade počutite utrujeni ali se ne počutite dobro, ne smete voziti ali upravljati kakršnih koli orodij ali strojev.
• The doctor will decide your dose and how often you will be given Remicade. 
• Zdravnik bo določil odmerek, ki ga boste prejemali, in kako pogosto ga boste prejemali.
Do not use Remicade if any of the above applies to you. 
Ne uporabljajte zdravila Remicade, če menite, da se katero od zgoraj navedenih stanj nanaša na vas.
In this trial, sixty six percent of the patients (686 out of 1,040) received at least one shortened infusion of 90 minutes or less and 44% of the patients (454 out of 1,040) received at least one shortened infusion of 60 minutes or less. 
V tem preskušanju je 66 % bolnikov (686 od 1.040) prejelo najmanj eno skrajšano infuzijo v trajanju 90 minut ali manj, 44 % bolnikov (454 od 1.040) pa je prejelo najmanj eno skrajšano infuzijo v trajanju 60 minut ali manj.
Keep this card with you for 4 months after your dose of Remicade, or in case of pregnancy for at least 6 months after the birth of your baby. 
To kartico nosite s seboj še 4 mesece po odmerku zdravila Remicade ali v primeru nosečnosti še vsaj 6 mesecev po rojstvu otroka.
• Do not use this medicine after the expiry date which is stated on the label and the carton after “EXP”. 
• Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake "EXP".
Adult Crohn's disease Remicade is indicated for: 
Crohnova bolezen pri odraslih bolnikih Remicade je indiciran za:
Remicade is also used in adults and children 6 years of age or older for: 
Zdravilo Remicade se uporablja tudi za zdravljenje odraslih in otrok starih 6 let in več za:
Results from week 54 are shown in Table 4. 
Rezultati za 54. teden so prikazani v Preglednici 4.
Prior therapy with PUVA, methotrexate, ciclosporin, or acitretin had been received by 71.4% of patients, although they were not necessarily therapy resistant. 
Predhodno terapijo s PUVA, metotreksatom, ciklosporinom ali acitretinom je prejelo 71,4 % bolnikov čeprav ni nujno da so bili odporni na uvodno terapijo.
Post-marketing experience 
Izkušnje iz obdobja trženja
What Remicade is and what it is used for 
Kaj je zdravilo Remicade in za kaj ga uporabljamo
For women taking Remicade including those over 60 years of age, your doctor may recommend regular screening for cervical cancer. 
Ženskam, ki prejemajo zdravilo Remicade, vključno s starejšimi od 60 let, lahko zdravnik priporoči redne presejalne teste za raka materničnega vratu.
Between weeks 6 and 26, symptoms of psoriasis gradually returned with a median time to disease relapse of > 20 weeks. 
Med 6. in 26. tednom so se simptomi psoriaze postopoma povrnili, mediana vrednost časa do ponovitve bolezni pa je bila > 20 tednov.
Side effects may occur a long time after your last dose. 
Neželeni učinki se lahko pojavijo še dolgo časa po zadnjem odmerku zdravila.
In this situation, do not return to refrigerated storage again. 
V tem primeru ga ne vračajte ponovno v hladilnik.
In P01522, improvement in signs and symptoms was also observed as early as week 2. 
V študiji P01522 so tudi opazili izboljšanje znakov in simptomov bolezni že v 2. tednu.
• Changes in how your liver works, increase in liver enzymes (shown in blood tests) 
• spremenjeno delovanje vaših jeter, povečanje vrednosti jetrnih encimov (pokaže se v izvidih krvnih preiskav)
Median time to loss of response through week 54 
Mediana vrednost časa do izginotja odziva v obdobju do 54. tedna
• Remicade will be given to you by your doctor or nurse. 
• Zdravilo Remicade vam bo dal zdravnik ali medicinska sestra.
• adult patients with active disease when the response to disease-modifying antirheumatic drugs 
• pri odraslih bolnikih z aktivno boleznijo, kadar odziv na protirevmatična zdravila
The majority of the malignancies developed in the lung or head and neck. 
Večina malignomov se je pojavila na pljučih ali na glavi in vratu.
After the first year of the study, 78 patients continued into an open-label extension to week 98. 
Po prvem letu študije je 78 bolnikov nadaljevalo z odprtim podaljškom študije do 98. tedna.
Re-administration for Crohn's disease and rheumatoid arthritis If the signs and symptoms of disease recur, Remicade can be re-administered within 16 weeks following the last infusion. 
Ponovna uporaba zdravila pri Crohnovi bolezni in revmatoidnem artritisu Če se znaki in simptomi bolezni ponovijo, lahko zdravilo Remicade ponovno uporabite v roku 16 tednov po zadnji infuziji.
Failure to respond to treatment for Crohn's disease may indicate the presence of a fixed fibrotic stricture that may require surgical treatment. 
Neodzivanje na zdravljenje pri Crohnovi bolezni lahko kaže na prisotnost stalne fibrozne strikture, zaradi katere bo morda potrebno kirurško zdravljenje.
All patients administered Remicade are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions. 
Vse bolnike, ki prejmejo zdravilo Remicade, je treba opazovati najmanj 1 do 2 uri po infuziji zaradi akutnih z infuzijo povezanih reakcij.
Key results are presented in Table 10. 
Ključni izsledki so predstavljeni v Preglednici 10.
Remove flip-top from the vial and wipe the top with a 70% alcohol swab. 
Odstranite ploščico na zaporki viale in njen vrh obrišite z zložencem, prepojenim s 70 % alkoholom.
Other paediatric indications 
Druge pediatrične indikacije
It should be noted that in the majority of these reports tuberculosis was extrapulmonary, presenting as either local or disseminated disease. 
Treba pa je poudariti, da so pri večini teh bolnikov tuberkulozo ugotovili zunaj pljuč in je šlo bodisi za lokalno ali razsejano bolezen.
Calculate the dose and the number of Remicade vials needed. 
Izračunajte odmerek in število potrebnih vial zdravila Remicade.
Because human immunoglobulins are excreted in milk, women must not breast feed for at least 6 months after Remicade treatment. 
Ker pa se človeški imunoglobulini izločajo v materino mleko, matere ne smejo dojiti še najmanj 6 mesecev po zdravljenju z zdravilom Remicade.
• Tell your doctor if you have any heart problems, such as mild heart failure. 
• Povejte zdravniku, če imate kakršne koli težave s srcem, kot na primer blago srčno popuščanje.
• Abnormal values of a blood protein called ‘complement factor' which is part of the immune system. 
• nenormalne vrednosti beljakovine v krvi, imenovane faktor komplementa, ki je del imunskega sistema
Patients who have had their dose interval shortened to less than 8 weeks may be at greater risk for adverse reactions. 
Pri bolnikih, ki so imeli razmik med odmerki skrajšan na manj kot 8 tednov, lahko obstaja večje tveganje za pojav neželenih učinkov.
If adequate response is achieved, patients should be continued on the selected dose or dose frequency. 
Če dosežete zadosten odziv, naj bolnik nadaljuje z zdravljenjem z izbranim odmerkom in pogostnostjo odmerjanja.
• Inflammation in the eye that may cause changes in the vision, including blindness 
• vnetje očesa, ki lahko povzroči spremembe vida, vključno s slepoto
The proportion of patients in clinical response at week 8 was 73.3% (44/60). 
Delež bolnikov s kliničnim odzivom 8. teden je bil 73,3 % (44/60).
Cases of agranulocytosis have also been reported (see section 4.8). 
Poročali so tudi o primerih agranulocitoze (glejte poglavje 4.8).
An infusion-related reaction was defined in clinical studies as any adverse event occurring during an infusion or within 1 hour after an infusion. 
Z infuzijo povezana reakcija je bila opredeljena v kliničnih študijah kot katerikoli neželeni učinek, ki je nastopil med infuzijo ali 1 uro po infuziji.
• Difficult or painful breathing, chest pain 
• težko ali boleče dihanje, bolečine v prsih
This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. 
Ta redka oblika limfoma celic T ima zelo agresiven potek bolezni, običajno s smrtnim izidom.
Concurrent use of stable doses of conventional therapies was permitted, and 83% of patients continued to receive at least one of these therapies. 
Sočasna uporaba stalnih odmerkov konvencionalnih zdravil je bila dovoljena in 83 % bolnikov je še naprej prejemalo vsaj eno od teh terapij.
For storage conditions up to 25 °C before reconstitution of the medicinal product, see section 6.3. 
Za pogoje shranjevanja do 25 °C pred rekonstitucijo zdravila glejte poglavje 6.3.
Overall proportions of adverse events and infusion reactions were similar between the 6 to 11 and 12 to 17 year age groups. 
Celotni delež neželenih učinkov in infuzijskih reakcij je bil v starostni skupini od 6 do 11 let podoben kot v starostni skupini od 12 do 17 let.
Single doses up to 20 mg/kg have been administered without toxic effects. 
Uporabljeni so bili enkratni odmerki infliksimaba do 20 mg/kg in ti niso povzročili toksičnih učinkov.
There is no evidence to suggest that infliximab worsens or causes fibrotic strictures. 
Ni dokazov, da bi infliksimab poslabšal ali povzročil nastanek fibroznih striktur.
ACR 20 response* 5(10%) 34 (65%) 48 (62%) 16 (16%) 54 (54%) 53 (53%) ACR 50 response* 0(0%) 24 (46%) 35 (45%) 4 (4%) 41(41%) 33 (33%) ACR 70 response* 0(0%) 15 (29%) 27 (35%) 2 (2%) 27 (27%) 20 (20%) PASI response 
Odziv ACR 20* 5(10 %) 34 (65 %) 48 (62 %) 16 (16 %) 54 (54 %) 53 (53 %) Odziv ACR 50* 0(0 %) 24 (46 %) 35 (45 %) 4 (4 %) 41(41 %) 33 (33 %) Odziv ACR 70* 0(0 %) 15 (29 %) 27 (35 %) 2 (2 %) 27 (27 %) 20 (20 %) Odziv PASI
• You are allergic to infliximab or to any of the other ingredients in Remicade (listed in section 6). 
• če ste alergični na infliksimab ali katero koli sestavino zdravila Remicade (navedeno v poglavju 6),
Hypersensitivity to the active substance, to other murine proteins, or to any of the excipients listed in section 6.1. 
Preobčutljivost na učinkovino, druge glodalske beljakovine ali katero koli pomožno snov, navedeno v poglavju 6.1.
• It is recommended that when Remicade is prepared for infusion, it is used as soon as possible (within 3 hours). 
• Priporočljivo je, da se pripravljeno raztopino za infuzijo zdravila Remicade uporabi čim prej (v 3 urah).
The efficacy of Remicade through week 54 was assessed in the ACT 1 study. 
Učinkovitost zdravila Remicade do 54. tedna so ocenjevali v preskušanju ACT 1.
In vivo, infliximab rapidly forms stable complexes with human TNF, a process that parallels the loss of TNF bioactivity. 
In vivo infliksimab hitro tvori stabilne komplekse s humanim TNF, ta proces pa poteka vzporedno z izgubo biološke aktivnosti TNF.
Forty six percent of patients continued on stable doses of methotrexate (≤ 25 mg/week). 
46 % bolnikov je zdravljenje nadaljevalo s stalnimi odmerki metotreksata (≤ 25 mg/teden).
• Reduce the number of abnormal openings (fistulae) between your bowel and your skin that have not been controlled by other medicines or surgery. 
• zmanjšanje števila nenormalnih odprtin (fistul), ki tvorijo povezavo med črevesjem in kožo, in ki jih niso odpravila druga zdravila ali kirurški poseg.
It is important that you tell your baby's doctors and other healthcare professionals about your Remicade use so they can decide when your baby should receive any vaccine, including live vaccines such as BCG (used to prevent tuberculosis). 
Pomembno je, da zdravnike svojega otroka in druge zdravstvene delavce obvestite, da ste prejemali zdravilo Remicade, da bodo lahko presodili, kdaj sme vaš dojenček prejeti katero koli cepivo, vključno z živimi cepivi, kot je cepivo BCG (uporablja se za preprečevanje tuberkuloze).
After the first year of the study, 53 patients continued into an open-label extension to week 102. 
Po prvem letu študije je skupaj 53 bolnikov nadaljevalo z odprtim podaljškom študije do 102. tedna.
Of the 573 patients randomised, 335 (58%) achieved clinical response by week 2. 
Od 573 randomiziranih bolnikov jih je 335 (58 %) doseglo klinični odziv že v 2. tednu.
Antibodies to infliximab cannot always be detected in serum samples. 
Protiteles na infliksimab ni vedno mogoče odkriti v vzorcih seruma.
Patients who did not respond to infliximab at week 8 (n = 15) received no further medicinal product and returned for safety follow-up. 
Bolniki, ki se do 8. tedna niso odzvali na infliksimab (n = 15), niso več prejemali zdravila in so se vrnili na kontrolni pregled glede varnosti.
Key efficacy results for IMPACT and IMPACT 2 are shown in Table 9 below: 
Ključni izsledki o učinkovitosti zdravila iz študij IMPACT in IMPACT 2 so prikazani v spodnji Preglednici 9:
The potential risk with the combination of AZA or 6-MP and Remicade should be carefully considered. 
Natančno je treba pretehtati potencialno tveganje pri sočasnem dajanju AZA ali 6-MP z zdravilom Remicade.
Upper respiratory tract infection (7/60 [12%]) and pharyngitis (5/60 [8%]) were the most frequently reported respiratory system infections. 
Okužba zgornjih dihal (7/60 [12 %]) in faringitis (5/60 [8 %]) sta bili najpogosteje zabeleženi okužbi dihal.
There are insufficient preclinical data to draw conclusions on the effects of infliximab on fertility and general reproductive function (see section 5.3). 
Ni zadostnih predkliničnih podatkov, da bi lahko sklepali o učinkih infliksimaba na plodnost in splošno sposobnost razmnoževanja (glejte poglavje 5.3).
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. 
Podatki, ki so na voljo, kažejo, da klinični odziv običajno dosežemo v 12 tednih zdravljenja.
Before reconstitution: 3 years at 2 °C - 8 °C. 
Pred rekonstitucijo: 3 leta pri temperaturi 2 °C - 8 °C
While the proportion of patients with infections was also higher in the younger age group, for serious infections, the proportions were similar in the two age groups. 
V mlajši starostni skupini je bil večji tudi delež bolnikov z okužbami, toda kar zadeva resne okužbe, sta bila deleža v obeh starostnih skupinah podobna.
This will depend on your disease, weight and how well you respond to Remicade. 
To bo odvisno od vaše bolezni, telesne mase in tega, kako se odzivate na zdravilo Remicade.
Early recognition of atypical clinical presentations of serious infections and of typical clinical presentation of rare and unusual infections is critical in order to minimise delays in diagnosis and treatment. 
Bistvenega pomena je tudi zgodnja prepoznava atipičnih kliničnih slik resnih okužb in tipičnih kliničnih slik redkih in neobičajnih okužb, da bi lahko čimbolj zmanjšali zamude pri njihovi diagnozi in zdravljenju.
• Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher risk of developing lymphoma. 
• Bolniki s hudo obliko revmatoidnega artritisa, ki imajo to bolezen že dolgo časa, imajo lahko večje tveganje za nastanek limfoma.
Remicade is available in packs of 1, 2, 3, 4 or 5 vials. 
Remicade je na voljo v pakiranjih po 1, 2, 3, 4 ali 5 vial.
Your doctor will test you to see if you have TB. 
Zdravnik vas bo testiral, da bo ugotovil ali imate tuberkulozo.
Experimental data show that TNF is essential for the clearing of intracellular infections. 
Eksperimentalni podatki kažejo, da je TNF bistven za odpravljanje znotrajceličnih okužb.
There have also been post-marketing reports of new onset heart failure, including heart failure in patients without known pre-existing cardiovascular disease. 
Obstajajo tudi poročila iz obdobja trženja o novonastalem srčnem popuščanju, vključno s srčnim popuščanjem pri bolnikih brez znane predhodne srčnožilne bolezni.
No specific ophthalmologic examinations have been performed in patients to investigate the relevance of this finding for humans. 
Pri bolnikih specifične oftalmološke preiskave za oceno pomembnosti tega izsledka za človeka niso bile izvedene.
After 54 weeks of treatment, both doses of infliximab + methotrexate resulted in statistically significantly greater improvement in signs and symptoms compared to methotrexate alone as measured by the proportion of patients achieving ACR20, 50 and 70 responses. 
Po 54 tednih zdravljenja so oba odmerka infliksimaba in metotreksat povzročili statistično značilno večje izboljšanje znakov in simptomov v primerjavi s samim metotreksatom, kar so merili z odstotkom bolnikov, ki so dosegli odzive ACR 20, 50 in 70.
Most aminotransferase abnormalities were transient; however, a small number of patients experienced more prolonged elevations. 
Večinoma so bili nenormalni izvidi aminotransferaz prehodni, pri majhnem številu bolnikov pa je prišlo do dlje časa trajajočega zvišanja.
If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of Remicade, and in accordance with local recommendations. 
V primeru diagnoze neaktivne (latentne) tuberkuloze, morate uvesti zdravljenje za latentno tuberkulozo z antituberkulozno terapijo, še pred uvedbo zdravila Remicade, v skladu z lokalnimi priporočili.
The moderate number of prospectively collected pregnancies exposed to infliximab resulting in live birth with known outcomes, including approximately 1100 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn. 
Manjše število prospektivno zbranih podatkov o izpostavljenosti infliksimabu med nosečnostjo, ki se je končala z rojstvom živorojenega otroka z znanimi izidi, vključno s približno 1.100 primeri izpostavljenosti infliksimabu v prvem trimesečju, ne kaže na zvečano stopnjo malformacij pri novorojencih.
• Hepatitis B infection when you have had hepatitis B in the past 
• okužba s hepatitisom B, če ste ga že preboleli v preteklosti
The median AUCss in paediatric patients aged 2 years to less than 6 years was predicted to be approximately 40% lower than that in adults, although the number of patients supporting this estimate is limited. 
Pri pediatričnih bolnikih, starih od 2 leti do manj kot 6 let, je bila napovedana mediana vrednost AUCss 40 % nižja kot pri odraslih, vendar je število bolnikov, zajetih v to oceno, omejeno.
After in utero exposure to infliximab, infants may be at increased risk of infection, including serious disseminated infection that can become fatal. 
Po in utero izpostavitvi infliksimabu imajo dojenčki lahko povečano tveganje za okužbe, vključno z resno razsejano okužbo, ki je lahko smrtna.
Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient. 
Pri nekaterih bolnikih je za ohranjanje koristnih kliničnih učinkov zdravljenja lahko potreben krajši razmik med odmerki, pri drugih pa lahko zadoščajo infuzije ob daljših časovnih razmikih.
Maintenance therapy with infliximab every 8 weeks significantly reduced disease-related hospitalisations and surgeries compared with placebo. 
Vzdrževalno zdravljenje z infliksimabom na vsakih 8 tednov je bistveno zmanjšalo število z boleznijo povezanih hospitalizacij in kirurških posegov v primerjavi s placebom.
Name patient: 
Ime bolnika:
EU/1/99/116/001 1 vial 100 mg EU/1/99/116/002 2 vials 100 mg EU/1/99/116/003 3 vials 100 mg EU/1/99/116/004 4 vials 100 mg EU/1/99/116/005 5 vials 100 mg 
EU/1/99/116/001 1 viala 100 mg EU/1/99/116/002 2 viali 100 mg EU/1/99/116/003 3 viale 100 mg EU/1/99/116/004 4 viale 100 mg EU/1/99/116/005 5 vial 100 mg
38 weeks 
38 tednov
The primary endpoint in both studies was the percent of patients who achieved ≥ 75% improvement in PASI from baseline at week 10. 
Primarni končni rezultat v obeh študijah je bil odstotek bolnikov, ki so dosegli ≥ 75 % izboljšanje ocene PASI od začetne vrednosti v 10. tednu.
The solution may develop a few fine translucent particles, as infliximab is a protein. 
V raztopini se lahko pojavi nekaj drobnih prosojnih delcev, saj je infliksimab beljakovina.
Storage beyond 24 hours at 2 °C - 8 °C applies to preparation of Remicade in the infusion bag only. 
Shranjevanje pri temperaturi 2 °C - 8 °C, ki presega 24 ur, se nanaša samo na pripravo zdravila Remicade v infuzijski vrečki.
The primary endpoints were the reduction of signs and symptoms as assessed by the American College of Rheumatology criteria (ACR20 for ATTRACT, landmark ACR-N for ASPIRE), the prevention of structural joint damage, and the improvement in physical function. 
Primarni cilji študije so bili zmanjšanje znakov in simptomov bolezni, kar so ocenjevali po merilih Ameriškega revmatološkega združenja (ACR-American College of Rheumatology criteria) (ACR 20 za ATTRACT, mejna vrednost ACR-N za ASPIRE), preprečevanje strukturne okvare sklepov in izboljšanje njihove funkcije.
6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies. 
6-merkaptopurin (6-MP) ali azatioprin (AZA), ter pri tistih, ki ne prenašajo takšnega zdravljenja ali imajo medicinske kontraindikacije zanj.
• Melanoma (a type of skin cancer) 
• melanom (vrsta kožnega raka)
Patients in both studies had plaque psoriasis (Body Surface Area [BSA] ≥ 10% and Psoriasis Area and Severity Index [PASI] score ≥ 12). 
Bolniki v obeh študijah so imeli psoriazo s plaki (telesna površina [BSA] ≥ 10 % in indeks površine in jakosti psoriaze [PASI] ≥ 12).
These patients were classified as week-2 responders and were included in the primary analysis (see Table 5). 
Ti bolniki so bili razvrščeni v skupino z odzivom v 2. tednu zdravljenja in so bili vključeni v primarno analizo (glejte preglednico 5).