natgillin/translations-raw huggingface dataset:
Reconstitute and dilute before use.
Pred uporabo rekonstituirajte in razredčite.
• Tell your surgeon or dentist that you are having treatment with Remicade by showing them your patient reminder card.
• Obvestite kirurga ali zobozdravnika, da prejemate zdravilo Remicade in mu pokažite svojo opozorilno kartico za bolnika.
• Some children and teenage patients who have received TNF-blockers such as Remicade have developed cancers, including unusual types, which sometimes resulted in death.
• Pri nekaterih otrocih in najstnikih, ki so prejemali zaviralce TNF, kot je zdravilo Remicade, se je razvil rak, vključno z zelo neobičajnimi oblikami, ki se včasih končajo s smrtnim izidom.
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) alfa.
Dosing continued for all patients through week 46.
Odmerjanje zdravila se je potem nadaljevalo do 46. tedna za vse bolnike.
In a 1-year clinical study with repeated infusions in patients with Crohn's disease (ACCENT I study), the incidence of serum sickness-like reactions was 2.4%.
V enoletni študiji z večkratnimi infuzijami zdravila pri bolnikih s Crohnovo boleznijo (študija ACCENT I), je bila incidenca reakcij, podobnih serumski bolezni, 2,4 %.
Other medicines and Remicade
Druga zdravila in zdravilo Remicade
Placebo (week 16)
Placebo (16. teden)
Tell your doctor if you are using or have recently used any other medicines, including any other medicines to treat Crohn's disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis or psoriasis or medicines obtained without a prescription, such as vitamins and herbal medicines.
Obvestite zdravnika, če jemljete ali ste pred kratkim jemali katero koli zdravilo, vključno s katerimi koli drugimi zdravili za zdravljenje Crohnove bolezni, ulceroznega kolitisa, revmatoidnega artritisa, ankilozirajočega spondilitisa, psoriatičnega artritisa ali psoriaze in z zdravili, ki se jih dobi brez recepta, kot so vitamini in rastlinski pripravki.
• Tell your doctor before you are given Remicade if you have ever lived in or travelled to an area where infections called histoplasmosis, coccidioidomycosis, or blastomycosis are common.
• Preden prejmete zdravilo Remicade, povejte zdravniku, če ste kdaj živeli v ali potovali po krajih, kjer so pogoste okužbe, imenovane histoplazmoza, kokcidioidomikoza ali blastomikoza.
Currently available pharmacokinetic data are described in section 5.2 but no recommendation on a posology can be made in children younger than 6 years.
Trenutno razpoložljivi farmakokinetični podatki so opisani v poglavju 5.2, vendar ni mogoče podati priporočil za odmerjanje za otroke, mlajše od 6 let.
In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded.
Zaradi izboljšanja sledljivosti bioloških zdravil morata biti jasno zabeležena lastniško ime in številka serije uporabljenega zdravila.
• Abnormal tissue swelling or growth
• nenormalno otekanje ali rast tkiva
• Collections of immune cells resulting from an inflammatory response (granulomatous lesions)
• kopičenje imunskih celic zaradi vnetnega odziva (granulomatozne lezije)
Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last Remicade treatment.
Ženske v rodni dobi morajo za preprečevanje nosečnosti razmisliti o uporabi ustrezne kontracepcije in z njo nadaljevati še najmanj 6 mesecev po zaključku zdravljenja z zdravilom Remicade.
In general, patients who developed ALT and AST elevations were asymptomatic, and the abnormalities decreased or resolved with either continuation or discontinuation of Remicade, 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 zdravilom Remicade, ali pa ob prilagoditvi drugih sočasnih terapij.
A reduction in signs and symptoms was defined to be at least a 20% improvement (ACR20) in both tender and swollen joint counts, and in 3 of the following 5 criteria: (1) evaluator's global assessment, (2) patient's global assessment, (3) functional/disability measure, (4) visual analogue pain scale and (5) erythrocyte sedimentation rate or C-reactive protein.
Zmanjšanje znakov in simptomov so opredelili kot najmanj 20 % izboljšanje (ACR 20) števila bolečih in oteklih sklepov ter 3 od naslednjih 5 meril: (1) zdravnikove splošne ocene, (2) bolnikove splošne ocene, (3) merila funkcionalne prizadetosti/neprizadetosti, (4) vizualne analogne lestvice bolečine in (5) hitrosti sedimentacije eritrocitov ali C-reaktivnega proteina.
• Liver problem that causes yellowing of the skin or eyes (jaundice)
• težave z jetri, ki povzročajo porumenelost kože ali oči (zlatenica)
Janssen Biologics B.V., Einsteinweg 101, 2333 CB Leiden, The Netherlands
Janssen Biologics B.V., Einsteinweg 101 2333 CB Leiden, Nizozemska
• Swelling of small blood vessels (vasculitis)
• otekanje majhnih krvnih žil (vaskulitis)
• Temporary loss of sight during or within 2 hours of infusion
• začasna izguba vida med infundiranjem ali v roku 2 ur po infundiranju
The effect of concomitant immunomodulator therapy was more profound in episodically-treated patients than in patients given maintenance therapy.
Učinek sočasne terapije z imunomodulatorji je bil močnejši pri občasno zdravljenih bolnikih kot pri tistih na vzdrževalni terapiji.
• Your doctor will also give you a patient reminder card, which contains important safety information you need to be aware of before and during your treatment with Remicade.
• Zdravnik vam bo dal tudi opozorilno kartico za bolnika, na kateri so navedeni pomembnejši varnostni podatki, ki jih morate poznati, preden prejmete zdravilo Remicade in tudi med zdravljenjem z njim.
Instructions for use and handling - reconstitution, dilution and administration
Navodila za uporabo in ravnanje z zdravilom - rekonstitucija, redčenje in infundiranje
This patient reminder card contains important safety information that you need to be aware of before and during treatment with Remicade.
Ta opozorilna kartica za bolnika vsebuje pomembne varnostne informacije, ki jih morate poznati preden prejmete zdravilo Remicade ter med zdravljenjem z njim.
• Viral infections such as herpes or flu
• virusne okužbe, na primer herpes ali gripa
You may receive some vaccines during treatment with Remicade but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Remicade because they may cause infections.
Med zdravljenjem z zdravilom Remicade lahko prejmete nekatera cepiva, vendar med uporabo zdravila Remicade ne smete prejeti živih cepiv (cepiv, ki vsebujejo žive, a oslabljene povzročitelje okužb), saj lahko le-ta povzročijo okužbo.
A response was observed within 2 weeks, with a maximum response at 4 weeks.
Klinični odziv na zdravljenje so ugotavljali v roku 2 tednov, največji odziv pa po 4 tednih.
A total of 573 patients with moderately to severely active Crohn's disease (CDAI ≥ 220 ≤ 400) received a single infusion of 5 mg/kg at week 0.
Skupaj 573 bolnikov z zmerno do hudo aktivno Crohnovo boleznijo (CDAI ≥ 220 ≤ 400) je prejelo enkratno infuzijo odmerka 5 mg/kg v tednu 0.
Remicade should be administered intravenously over a 2 hour period.
Zdravilo Remicade je treba dajati intravensko v času 2 ur.
In C0168T72, the most common adverse reactions were upper respiratory tract infection, pharyngitis, abdominal pain, fever, and headache.
V preskušanju C0168T72 so bili najpogostejši neželeni učinki okužba zgornjih dihal, faringitis, bolečine v trebuhu, zvišana telesna temperatura in glavobol.
Rheumatoid arthritis The usual dose is 3 mg for every kg of body weight.
Revmatoidni artritis Običajni odmerek je 3 mg na kg telesne mase.
It is unknown whether infliximab is excreted in human milk or absorbed systemically after ingestion.
Ni znano, ali se infliksimab izloča v materino mleko pri človeku, niti ali se po zaužitju sistemsko absorbira.
• Infections due to a weakened immune system
• okužbe zaradi oslabljenega imunskega sistema
At 102 weeks there were 49 subjects still on infliximab treatment and among those, 30 (61%) were BASDAI 50 responders.
Čez 102 tedna se je 49 preiskovancev še vedno zdravilo z infliksimabom in od tega jih je imelo 30 (61 %) odziv BASDAI 50.
Nine of these patients developed malignancies, including 1 lymphoma.
Devet od teh bolnikov je dobilo malignom, med njimi eden celo limfom.
The pharmacokinetics of infliximab in elderly patients has not been studied.
Farmakokinetike infliksimaba pri starejših bolnikih niso raziskovali.
Remicade, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:
Remicade je v kombinaciji z metotreksatom indiciran za zmanjšanje znakov in simptomov ter izboljšanje funkcije sklepov:
In all cases, Remicade treatment was discontinued and/or other treatment instituted with complete resolution of signs and symptoms.
V vseh primerih je bilo zdravljenje z zdravilom Remicade ukinjeno in/ali so bolniku uvedli drugo zdravljenje, znaki in simptomi bolezni pa so izginili.
• Tell your doctor if you have hepatitis B or if you know or suspect you are a carrier of the hepatitis B virus.
• Zdravniku povejte, če imate hepatitis B ali če sumite, da ste nosilec virusa hepatitis B.
• Stomach pain, feeling sick
• želodčne bolečine, občutek slabosti
Discontinuation of immunomodulators and corticosteroid taper were permitted after week 0.
Prenehanje uporabe imunomodulatorjev in zmanjševanje odmerka kortikosteroidov sta bila dovoljena po tednu 0.
• Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease,
• resne težave z živčevjem, na primer transverzni mielitis, multipli sklerozi podobna bolezen,
Paediatric Crohn's disease (6 to 17 years)
Pediatrična Crohnova bolezen (6 do 17 let)
Remicade and Orencia should not be used together.
Zdravili Remicade in Orencia se ne smeta uporabljati skupaj.
The most commonly reported infections were upper respiratory tract infection and pharyngitis, and the most commonly reported serious infection was abscess.
Najpogosteje prijavljene okužbe so bile okužbe zgornjih dihal in faringitis, medtem ko je bila najpogosteje prijavljena resna okužba absces.
Use only an infusion set with an in-line, sterile, non-pyrogenic, low protein-binding filter (pore size 1.2 micrometre or less).
Uporabite lahko le infuzijske komplete, opremljene z linijskim, sterilnim, nepirogenim filtrom, ki le malo veže beljakovine (velikost por 1,2 mikrometra ali manj).
There have been reports of active tuberculosis in patients receiving Remicade.
Bilo je nekaj poročil o aktivni tuberkulozi pri bolnikih, ki so prejemali zdravilo Remicade.
Clinical Remission
Klinična remisija
Remicade infusions should be administered by qualified healthcare professionals trained to detect any infusion-related issues.
Infuzije zdravila Remicade morajo bolniku dajati kvalificirani zdravstveni delavci, ki so usposobljeni za ugotavljanje morebitnih težav pri infundiranju zdravil.
Table 2 Proportion of patients with increased ALT activity in clinical studies
Preglednica 2 Delež bolnikov s povišano vrednostjo ALT v kliničnih preskušanjih
Signs include changes in your vision, weakness in your arms or legs, numbness or tingling in any part of your body.
Znaki vključujejo spremembe vida, šibkost v rokah in nogah, odrevenelost ali mravljinčenje v katerem koli delu telesa.
Name doctor:
Ime zdravnika:
In long-term safety follow-up of clinical studies with infliximab of up to 5 years, representing 6,234 patients-years (3,210 patients), 5 cases of lymphoma and 38 cases of non-lymphoma malignancies were reported.
Pri spremljanju dolgoročne varnosti infliksimaba do 5 let po kliničnih študijah, to pomeni pri skupaj 6.234 bolnikih x letih (3.210 bolnikov), pa so poročali o 5 primerih limfoma in 38 primerih nelimfomskih rakavih bolezni.
Children may receive some vaccines during treatment with Remicade but should not receive live vaccines while using Remicade.
Otroci lahko med zdravljenjem z zdravilom Remicade prejmejo nekatera cepiva, vendar med uporabo zdravila Remicade ne smejo prejeti živih cepiv.
Remicade belongs to a group of medicines called ‘TNF blockers'.
Zdravilo Remicade spada v skupino zdravil, ki se imenujejo zaviralci TNF.
• Children should receive recommended vaccinations before starting Remicade treatment.
• Otroci morajo prejeti priporočena cepljenja, preden se začnejo zdraviti z zdravilom Remicade.
• Narrowed airway in the lungs, causing difficulty breathing
• zoženje dihalnih poti v pljučih, ki povzroča težave z dihanjem
Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF) inhibitors, ATC code: L04AB02.
Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci tumorje nekrotizirajočega faktorja alfa (TNF), oznaka ATC: L04AB02.
In addition, statistically and clinically significant improvements in quality of life and height, as well as a significant reduction in corticosteroid use, were observed versus baseline.
Poleg tega so opazili statistično in klinično pomembno izboljšanje kakovosti življenja in dosežene višine otrok pa tudi bistveno zmanjšanje porabe kortikosteroidov v primerjavi z začetkom preskušanja.
It should be noted that suppression of TNF may mask symptoms of infection such as fever.
Treba je tudi poudariti, da lahko zaviranje TNF prikrije simptome okužbe, npr. zvišano telesno temperaturo.
Names and addresses of the manufacturer(s) of the biological active substance(s)
Ime in naslov izdelovalca (izdelovalcev) biološke učinkovine (učinkovin)
The usual dose is 5 mg for every kg of body weight.
Običajni odmerek je 5 mg na kg telesne mase.
Remicade should be used with caution in patients with mild heart failure (NYHA class I/II).
Zdravilo Remicade morate uporabljati previdno pri bolnikih z blagim srčnim popuščanjem (razred I/II po NYHA).
If patients are re-treated after a prolonged period, they must be closely monitored for signs and symptoms of delayed hypersensitivity.
Če bolnik po daljšem obdobju ponovno prejme zdravilo Remicade, ga morate skrbno spremljati zaradi morebitnega pojava znakov in simptomov pozne preobčutljivosti.
TNF alpha is involved in inflammatory processes of the body so blocking it can reduce the inflammation in your body.
TNF-alfa sodeluje v procesu vnetja v telesu, zato se z njegovim zaviranjem vnetje v telesu lahko zmanjša.
The following adverse reactions were reported more commonly in paediatric Crohn's disease patients in the REACH study (see section 5.1) than in adult Crohn's disease patients: anaemia (10.7%), blood in stool (9.7%), leucopenia (8.7%), flushing (8.7%), viral infection (7.8%), neutropenia (6.8%), bacterial infection (5.8%), and respiratory tract allergic reaction (5.8%).
O naslednjih neželenih učinkih so poročali pogosteje pri pediatričnih bolnikih s Crohnovo boleznijo v študiji REACH (glejte poglavje 5.1) kot pri odraslih bolnikih s Crohnovo boleznijo: anemija (10,7 %), kri v blatu (9,7 %), levkopenija (8,7 %), zardevanje (8,7 %), virusna okužba (7,8 %), nevtropenija (6,8 %), bakterijska okužba (5,8 %), alergijska reakcija dihal (5,8 %).
In post-marketing spontaneous reporting, infections are the most common serious adverse reaction.
V spontanih poročilih iz obdobja trženja so okužbe navedene kot najpogostejši resen neželeni učinek.
The proportion of patients with infections in C0168T72 was similar to that in the paediatric Crohn's disease study (REACH) but higher than the proportion in the adults ulcerative colitis studies (ACT 1 and ACT 2).
Delež bolnikov z okužbami je bil v preskušanju C0168T72 podoben kot v študiji Crohnove bolezni pri pediatričnih bolnikih (REACH), a večji od deleža v študijah ulceroznega kolitisa pri odraslih bolnikih (ACT 1 in ACT 2).
In an exploratory clinical study involving patients with moderate to severe COPD who were either current smokers or ex-smokers, 157 adult patients were treated with Remicade at doses similar to those used in rheumatoid arthritis and Crohn's disease.
V poskusnem kliničnem preskušanju pri bolnikih z zmerno do hudo KOPB, ki so bili bodisi aktivni kadilci ali bivši kadilci, je bilo 157 odraslih bolnikov zdravljenih z zdravilom Remicade v odmerkih, podobnih tistim, ki se uporabljajo pri revmatoidnem artritisu in pri Crohnovi bolezni.
Of the infliximab-treated patients who received at least one shortened infusion, infusion-related reactions occurred in 15% of patients and serious infusion reactions occurred in 0.4% of patients.
Pri bolnikih, zdravljenih z infliksimabom, ki so prejeli najmanj eno skrajšano infuzijo, so se z infuzijo povezane reakcije pojavljale pri 15 % bolnikov, resne z infuzijo povezane reakcije pa pri 0,4 % bolnikov.
The powder is a freeze-dried white pellet.
Prašek vsebuje liofilizirane bele pelete.
In infants exposed in utero to infliximab, fatal outcome due to disseminated Bacillus Calmette-Guérin (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.
The card is aimed at both serving as a reminder to record the dates and outcomes of specific tests and to facilitate the patient sharing of special information with healthcare professionals(s) (HCPs) treating the patient about on-going treatment with the product.
Kartica je namenjena beleženju datumov in rezultatov določenih preiskav kot tudi lažji izmenjavi posebnih informacij glede trenutnega zdravljenja z zdravilom med bolnikom in zdravstvenim(i) delavcem(i), ki sodeluje(jo) pri zdravljenju bolnika.
Current administrations:
Trenutno odmerjanje:
Nail psoriasis was assessed using the Nail Psoriasis Severity Index (NAPSI).
Psoriazo na nohtih so ocenjevali z indeksom jakosti psoriaze nohtov (Nail Psoriasis Severity Index-NAPSI).
The European Medicines Agency has waived the obligation to submit the results of studies with Remicade 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 zdravilom Remicade 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).
While using Remicade you should not receive live vaccines.
Med uporabo zdravila Remicade ne smete prejeti živih cepiv.
Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with Remicade is not established, the risk and benefits of continued therapy to the individual patients should be carefully considered by the clinician.
Ker verjetnost povečanega tveganja za nastanek karcinoma pri bolnikih z novo diagnosticirano displazijo, ki se zdravijo z zdravilom Remicade, ni ugotovljena, mora zdravnik skrbno pretehtati tveganje in koristi nadaljevanja zdravljenja za posameznega bolnika.
• adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
• pri odraslih bolnikih s hudo, aktivno in progresivno boleznijo, ki še niso bili zdravljeni z metotreksatom ali drugimi protirevmatičnimi zdravili DMARD.
Store at 2 °C - 8 °C.
Shranjujte pri temperaturi 2 °C - 8 °C.
In the psoriasis studies, delayed hypersensitivity reactions occurred early in the treatment course.
Pri študijah psoriaze so se reakcije pozne preobčutljivosti pojavile v zgodnjih fazah terapije.
Placebo (week 24)
Placebo (24. teden)
• 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 Remicade
• 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 Remicade.
Events (some fatal) of myocardial ischaemia/infarction and arrhythmia have been reported, some in close temporal association with infusion of infliximab; cerebrovascular accidents have also been reported in close temporal association with infusion of infliximab.
Poročali so o dogodkih (nekaterih s smrtnim izidom) ishemije miokarda/miokardnega infarkta in aritmije, nekaterih v tesni časovni povezanosti z infundiranjem infliksimaba; prav tako so v tesni časovni povezanosti z infundiranjem infliksimaba poročali o cerebrovaskularnih insultih.
The ATTRACT study 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 ATTRACT 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.
If response was lost during maintenance treatment, crossing over to a higher dose (10 mg/kg) and/or shorter dosing interval (q8 weeks) was allowed.
Če je v času vzdrževalnega zdravljenja odziv izzvenel, so bolniki lahko prešli na uporabo večjega odmerka (10 mg/kg) in/ali krajši interval odmerjanja (na vsakih 8 tednov).
Use of antituberculosis therapy should also be considered before the initiation of Remicade 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 Remicade pri bolniku, ki ima latentno ali aktivno tuberkulozo v pretekli anamnezi in pri katerem ni mogoče zagotovo potrditi, da je prejel zadostno zdravljenje.
Single intravenous infusions of 1, 3, 5, 10 or 20 mg/kg of infliximab yielded dose proportional increases in the maximum serum concentration (Cmax) and area under the concentration-time curve (AUC).
Sorazmerno s povečanjem enkratnega odmerka infliksimaba 1, 3, 5, 10 ali 20 mg/kg v intravenski infuziji sta se povečali tudi največja koncentracija tega zdravila v serumu (Cmaks) in površina pod krivuljo koncentracije po času (AUC).
Reports of lupus and lupus-like syndromes, however, remain uncommon (see section 4.4).
Poročila o pojavu lupusa in lupusu podobnih sindromov, pa so še vedno občasna (glejte poglavje 4.4).
Your doctor will advise you what other medicines you must keep using while you are having Remicade.
Zdravnik vam bo svetoval, katera zdravila morate še naprej jemati tudi med zdravljenjem z zdravilom Remicade.
While the numbers of patients in each subgroup are too small to draw definitive conclusions about the effect of age, there was a higher number of patients in the younger age group who stepped up in dose or discontinued treatment due to inadequate efficacy.
Število bolnikov v vsaki podskupini je sicer premajhno, da bi dopuščalo dokončne sklepe o vplivu starosti, vendar je bilo v mlajši starostni skupini več bolnikov, ki so zaradi nezadostne učinkovitosti potrebovali zvišanje odmerka ali so zaradi nje prekinili zdravljenje.
• Upper respiratory infections such as sinusitis
• okužbe zgornjih dihal, na primer sinusitis
In infliximab treated subjects, significant PASI 50 responses were apparent at the first visit (week 2) and PASI 75 responses by the second visit (week 6).
Pri preiskovancih, zdravljenih z infliksimabom, so bili signifikantni odzivi PASI 50 vidni že ob prvem obisku (2. teden), odzivi PASI 75 pa do drugega obiska (6. teden).
• Side effect due to an infusion
• neželeni učinek zaradi infuzije