natgillin/translations-raw huggingface dataset:
The full EPAR for Removab can be found here. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Removab je na voljo tukaj.
What is Removab? 
Kaj je zdravilo Removab?
What is Removab used for? 
Za kaj se zdravilo Removab uporablja?
How is Removab used? 
Kako se zdravilo Removab uporablja?
Removab should not be used in people who may be hypersensitive (allergic) to catumaxomab, to any of the other ingredients, or to murine (rat or mouse) proteins. 
katumaksomab, katerokoli drugo sestavino zdravila ali beljakovine glodavcev (podgan ali miši).
Eye drops, solution Ocular use bottle (LDPE) 
200 µg/ml kapljice za oko, raztopina okularna uporaba plastenka (LDPE) 2,5 ml
MA(EU) number 
Številka (EU) dovoljenja za promet
The European Commission issued a decision on 2 June 2010. 
Evropska komisija je odločitev izdala dne 2. junija 2010.
Prof. Pieter de Graeff (the Netherlands) 
Prof. Pieter de Graeff (Nizozemska)
As the Member States were not able to reach an agreement, the German medicines regulatory agency referred the matter to the CHMP for arbitration on 29 October 2009. 
Ker države članice niso dosegle soglasja, je nemški regulatorni organ za zdravila dne 29. oktobra 2009 zadevo napotil na CHMP v arbitražo.
Based on evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the benefits of Clopidogrel Orion outweigh its risks and recommended that the marketing authorisation be granted in all the concerned Member States. 
Na podlagi ocenjevanja trenutno razpoložljivih podatkov in znanstvene razprave v okviru odbora je CHMP zaključil, da koristi zdravila Clopidogrel Orion odtehtajo njegova tveganja, zato je priporočil odobritev dovoljenja za promet z zdravilom v vseh zadevnih državah članicah.
The European Medicines Agency has completed an arbitration procedure following a disagreement among Member States of the European Union (EU) regarding the authorisation of the medicine Clopidogrel Orion and associated names. 
Evropska agencija za zdravila je zaključila arbitražni postopek, do katerega je prišlo po nesoglasju med državami članicami Evropske unije (EU) glede odobritve zdravila Clopidogrel Orion in povezanih imen.
It is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries) such as a heart attack or stroke. 
Uporablja se pri odraslih za preprečevanje aterotrombotičnih dogodkov (težav, ki jih povzročajo krvni strdki in otrdelost arterij), kot je srčni napad ali kap.
The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Clopidogrel Orion outweigh its risks, and the marketing authorisation can be granted in Germany and in the following Member States of the EU: the Czech Republic, Denmark, Finland, Lithuania, Latvia, Norway, Slovakia and Sweden. 
Odbor za zdravila za uporabo v humani medicini (CHMP) pri Agenciji je zaključil, da koristi zdravila Clopidogrel Orion odtehtajo njegova tveganja in da se lahko dovoljenje za promet z zdravilom odobri v Nemčiji in tudi v naslednjih državah članicah EU: na Češkem, Danskem, Finskem, v Litvi, Latviji, na Norveškem, Slovaškem in Švedskem.
Clopidogrel Orion is a generic medicine based on a ‘reference medicine', Plavix, which is authorised in the EU. 
Clopidogrel Orion je generično zdravilo na osnovi „referenčnega zdravila“ Plavix, ki je odobreno v EU.
Why was Clopidogrel Orion reviewed? 
Zakaj je bilo zdravilo Clopidogrel Orion pregledano?
Clopidogrel base is less stable than the salt form, and BHA is included in the medicine to stabilise it.. 
Klopidogrelna baza je manj stabilna kot sol, zato je za njeno stabilizacijo v zdravilo vključen BHA.
Teva Pharma B.V. submitted Clopidogrel Orion to Germany for a decentralised procedure. 
je predložila zdravilo Clopidogrel Orion Nemčiji v decentraliziran postopek.
2 June 2010 
2. junij 2010
What is Clopidogrel Orion? 
Kaj je zdravilo Clopidogrel Orion?
Clopidogrel Orion is a medicine that contains the active substance clopidogrel. 
Clopidogrel Orion je zdravilo, ki vsebuje zdravilno učinkovino klopidogrel.
This is a procedure where one Member State (the ‘reference Member State', in this instance Germany) assesses a medicine with a view to granting a marketing authorisation that will be valid in this country as well as in other Member States (the ‘concerned Member States', in this instance the Czech Republic, Denmark, Finland, Lithuania, Latvia, Norway, Slovakia and Sweden). 
državah članicah („zadevnih državah članicah“, v tem primeru na Češkem, Danskem, Finskem, v Litvi, Latviji, na Norveškem, Slovaškem in Švedskem).
Date of first authorisation: 18 May 2018 
Datum prve odobritve: 18. maj 2018
Not known (frequency cannot be estimated from the available data) 
Neznana (pogostnostni ni mogoče oceniti iz razpoložljivih podatkov)
The information above also applies to children and adolescents. 
Zgoraj navedene informacije veljajo tudi za otroke in mladostnike.
Radiographic changes were assessed in study 11. 
Spremembe na rentgenskih slikah so ocenjevali v študiji 11.
As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much. 
Ker boste zdravilo prejeli od zdravnika ali medicinske sestre, je zelo malo verjetno, da ga boste prejeli preveč.
For more information see section on Pregnancy and breastfeeding. 
Za več informacij glejte poglavje o Nosečnosti in dojenju.
In addition, bone fracture (6.8%) was reported, however, a causal association has not been established. 
Dodatno so poročali o zlomih kosti (6,8 %), vendar vzročna povezava ni bila dokazana.
EXP EXP, if not refrigerated 
EXP EXP izven hladilnika
In study 2, more than 90% of patients had at least two evaluable X-rays. 
V študiji 2 je imelo več kot 90 % bolnikov najmanj dve uporabni rentgenski sliki.
• Improve your physical function. 
• izboljšanje funkcije sklepov.
If you feel tired, dizzy or unwell after having Zessly, do not drive or use any tools or machines. 
Če se po prejemu zdravila Zessly počutite utrujeni, omotični ali se ne počutite dobro, ne smete voziti ali upravljati kakršnih koli orodij ali strojev.
• You are allergic to infliximab or to any of the other ingredients of this medicine (listed in section 6). 
• če ste alergični na infliksimab ali katero koli sestavino tega zdravila (navedeno v poglavju 6),
Check that the solution is colourless to light brown and opalescent. 
Preverite, ali je raztopina brezbarvna do svetlo rjava in opalescentna.
For more information about the safety of infliximab in elderly patients see sections 4.4 and 4.8. 
Za več informacij o varnosti infliksimaba pri starejših glejte poglavji 4.4 in 4.8.
• It is recommended that when Zessly is prepared for infusion, it is used as soon as possible (within 3 hours). 
• Priporočljivo je, da se pripravljeno raztopino za infuzijo zdravila Zessly, uporabi čim prej (v 3 urah).
Zessly should only be used during pregnancy if your doctor feels it is necessary for you. 
Zdravilo Zessly se lahko uporablja med nosečnostjo le, če zdravnik meni, da je to pri vas potrebno.
≥ 75% improvement 
≥ 75-% izboljšanje
This should be taken into consideration for patients on a controlled sodium diet (see section 6.6). 
To je treba upoštevati pri bolnikih, ki so na dieti z nadzorovanim vnosom natrija (glejte poglavje 6.6).
Study 11* 
Študija 11*
In this situation, do not return to the refrigerated storage again. 
V tem primeru ga ne vračajte ponovno v hladilnik.
Keep this card with you for 4 months after your dose of Zessly, 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 Zessly ali v primeru nosečnosti še vsaj 6 mesecev po rojstvu otroka.
This will depend on your disease, weight and how well you respond to Zessly. 
To bo odvisno od vaše bolezni, telesne mase in tega, kako se odzivate na zdravilo Zessly.
Key results are presented in Table 10. 
Ključni izsledki so predstavljeni v preglednici 10.
• In some patients receiving treatment with medicines containing infliximab, the body may not make enough of the blood cells that help fight infections or help stop bleeding. 
• Pri nekaterih bolnikih, ki prejemajo infliksimab, telo morda ne bo tvorilo dovolj krvnih celic, ki pomagajo v boju proti okužbam ali pri zaustavljanju krvavitve.
Zessly is available in packs containing 1, 2, 3, 4, or 5 vials. 
Zessly je na voljo v pakiranjih po 1, 2, 3, 4 ali 5 vial.
to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data). 
(≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000), neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti).
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 
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
For women taking Zessly including those over 60 years of age, your doctor may recommend regular screening for cervical cancer. 
Ženskam, ki prejemajo zdravilo Zessly, vključno s starejšimi od 60 let, lahko zdravnik priporoči redne presejalne teste za raka materničnega vratu.
Prior therapy with PUVA, methotrexate, cyclosporin, 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.
What Zessly is and what it is used for 
Kaj je zdravilo Zessly in za kaj ga uporabljamo
Study 4 (week-2 responders) % of Patients 
Študija 4 (bolniki z odzivom v 2. tednu) % bolnikov
Zessly and Orencia should not be used together. 
Zdravili Zessly in Orencia se ne smeta uporabljati skupaj.
All patients administered Zessly are to be observed for at least 1-2 hours post-infusion for acute infusion-related reactions. 
Vse bolnike, ki prejmejo zdravilo Zessly, je treba opazovati najmanj 1 do 2 uri po infuziji zaradi akutnih z infuzijo povezanih reakcij.
EU/1/18/1280/001 1 vial 100 mg EU/1/18/1280/002 2 vials 100 mg EU/1/18/1280/003 3 vials 100 mg EU/1/18/1280/004 4 vials 100 mg EU/1/18/1280/005 5 vials 100 mg 
EU/1/18/1280/001 1 viala 100 mg EU/1/18/1280/002 2 viali 100 mg EU/1/18/1280/003 3 viale 100 mg EU/1/18/1280/004 4 viale 100 mg EU/1/18/1280/005 5 vial 100 mg
In the first study, (study 8), improvement in signs and symptoms was also observed as early as week 2. 
V prvi študiji (študija 8) so tudi opazili izboljšanje znakov in simptomov bolezni že v 2. tednu.
Clinical Responsea Clinical Remission 
Klinični odziva Klinična remisija
• Tell your doctor if you have had treatment with medicines containing infliximab in the past and are now starting Zessly treatment again. 
• Povejte zdravniku, če ste se v preteklosti že zdravili z zdravili, ki vsebujejo infliksimab, in sedaj ponovno začenjate zdravljenje.
Your doctor will advise you what other medicines you must keep using while you are having Zessly. 
Zdravnik vam bo svetoval, katera zdravila morate še naprej jemati tudi med zdravljenjem z zdravilom Zessly.
Zessly is also used in adults and children 6 years of age or older for: 
Zdravilo Zessly se uporablja tudi za zdravljenje odraslih in otrok starih 6 let in več za:
• 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.
• The doctor will decide your dose and how often you will be given Zessly. 
• Zdravnik bo določil odmerek, ki ga boste prejemali, in kako pogosto ga boste prejemali.
Because human immunoglobulins are excreted in milk, women must not breast feed for at least 6 months after Zessly treatment. 
Ker pa se človeški imunoglobulini izločajo v materino mleko, matere ne smejo dojiti še najmanj 6 mesecev po zdravljenju z zdravilom Zessly.
Patients with no deterioration/patients evaluated (%)c 
bolniki brez poslabšanja/ pregledani bolniki (%)c spreminjanje HAQ
INFECTIONS Before treatment with Zessly 
OKUŽBE Pred zdravljenjem z zdravilom Zessly
N ≥ 90% improvement 
N ≥ 90-% izboljšanje
Shortened infusions across adult indications 
Skrajšane infuzije pri indikacijah za odrasle bolnike
For storage conditions up to 30°C before reconstitution of the medicinal product, see section 6.3. 
Za pogoje shranjevanja do 30 °C pred rekonstitucijo zdravila glejte poglavje 6.3.
In all situations described below, the benefit/risk balance of Zessly therapy should be very carefully considered. 
V vseh spodaj opisanih okoliščinah, je treba zelo skrbno pretehtati razmerje med koristmi in tveganji zdravljenja z zdravilom Zessly.
Subjects randomised Percentage ACR improvement Mean ± SDa 
Randomizirani preiskovanci Odstotek izboljšanja ACR Srednja vrednost ± SDa
The moderate number of prospectively collected pregnancies exposed to infliximab resulting in live birth with known outcomes, including approximately 1,100 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.
The requirements for submission of PSUR for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal. 
(seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES, in vseh kasnejših posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
Zessly will generally be stored by the health professionals. 
V glavnem bodo za shranjevanje zdravila Zessly poskrbeli zdravstveni delavci.
** PASI 75 response for study 10 not included due to low N; p < 0.001 for infliximab vs. placebo at week 24 for study 11. 
** Odziv PASI 75 iz študije 10 ni vključen zaradi majhnega števila N; p < 0,001 za infliksimab v primerjavi s placebom v 24. tednu v študiji 11
• Zessly will be given to you by your doctor or nurse. 
• Zdravilo Zessly vam bo dal zdravnik ali medicinska sestra.
Contents of the pack and other information What Zessly contains 
Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Zessly
Study 13 
Študija 13
Zessly is not likely to affect your ability to drive or use tools or machines. 
Zdravilo Zessly verjetno ne vpliva na vašo sposobnost vožnje in upravljanja z orodji ali stroji.
In study 10 and study 11 in patients with active psoriatic arthritis, clinical responses were observed as early as week 2 and were maintained through week 98 and week 54 respectively. 
V študiji 10 in študiji 11 pri bolnikih z aktivnim psoriatičnim artritisom so opazili klinični odziv že v 2. tednu, ohranjen pa je bil tudi še v 98. tednu in 54. tednu.
In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of Zessly (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour. 
Pri skrbno izbranih odraslih bolnikih, ki so dobro prenesli vsaj 3 začetne 2-urne infuzije zdravila Zessly (uvajalna faza zdravljenja) in so trenutno na vzdrževalnem zdravljenju, lahko razmislite o skrajšanju naslednjih infuzij, vendar ne na manj kot 1 uro.
Patients who have had their dose interval shortened to less than 8 weeks may be at greater risk for adverse reactions. 
ki so imeli razmik med odmerki skrajšan na manj kot 8 tednov, lahko obstaja večje tveganje za pojav neželenih učinkov.
Your doctor may recommend temporarily stopping Zessly. 
Zdravnik bo morda priporočil začasno prekinitev zdravljenja z zdravilom Zessly.
≥ 50% improvement PGA of cleared (0) or minimal (1) 
≥ 50-% izboljšanje PGA brez plakov (0) ali minimalni (1)
If inactive (‘latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with antituberculosis therapy before the initiation of Zessly, 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 Zessly, v skladu z lokalnimi priporočili.
(pleurisy) 
(furunkuloza)
• Treatment with TNF blockers such as Zessly may result in reactivation of hepatitis B virus in patients who carry this virus, which can be life-threatening in some cases. 
• Zdravljenje z zaviralci TNF, kot je zdravilo Zessly, lahko vodi do reaktivacije virusa hepatitisa B pri bolnikih, ki prenašajo ta virus, kar je lahko v nekaterih primerih življenjsko nevarno.
There is insufficient information regarding the concomitant use of infliximab with other biological therapeutics used to treat the same conditions as infliximab. 
Na voljo ni zadostnih podatkov o sočasni uporabi infliksimaba z drugimi biološkimi zdravili, ki se uporabljajo za enako zdravljenje kot infliksimab.
N ≥ 90% improvement ≥ 75% improvement ≥ 50% improvement 
N ≥ 90-% izboljšanje ≥ 75-% izboljšanje ≥ 50-% izboljšanje
Infliximab crosses the placenta and has been detected in the serum of infants up to 6 months following birth. 
Infliksimab prehaja skozi posteljico in so ga vse do 6. meseca po rojstvu zaznali v serumu dojenčkov.
Calculate the dose and the number of Zessly vials needed. 
Izračunajte odmerek in število potrebnih vial zdravila Zessly.
Calculate the total volume of reconstituted Zessly solution required. 
Izračunajte celoten volumen potrebne rekonstituirane raztopine zdravila Zessly.
If you received Zessly while pregnant, giving BCG vaccine (used to prevent tuberculosis) to your baby within 6 months after birth may result in infection with serious complications, including death. 
Če ste v času nosečnosti prejeli zdravilo Zessly, lahko cepljenje dojenčka s cepivom BCG (uporablja se za preprečevanje tuberkuloze) v obdobju 6 mesecev po rojstvu povzroči okužbo z resnimi zapleti, vključno s smrtjo.
The proportion of subjects who underwent colectomy at any time within 54 weeks following the first infusion of study agent were collected and pooled from study 6 and study 7 and their extensions. 
Podatke o odstotku preiskovancev, ki so jim opravili kolektomijo kadarkoli v času 54 tednov po prvi infuziji proučevanega zdravila iz študije 6 in študije 7 ter njihovih podaljšanj, so zbrali in jih združili.
Administration of Zessly should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled. 
Uporabo zdravila Zessly prekinite, če se pri bolniku pojavi nova resna okužba ali sepsa, in mu uvedite ustrezno protimikrobno ali protiglivično terapijo, dokler ne bo okužba obvladana.
• 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 Zessly. 
• Zdravnik vam bo dal tudi opozorilno kartico za bolnika, na kateri so navedeni pomembnejši varnostni podatki, ki jih morate poznati, preden prejmete zdravilo Zessly in tudi med zdravljenjem z njim.
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 Zessly, ga morate skrbno spremljati zaradi morebitnega pojava znakov in simptomov pozne preobčutljivosti.
In a 1-year clinical study with repeated infusions in patients with Crohn's disease, the incidence of serum sickness-like reactions was 2.4%. 
V enoletni študiji z večkratnimi infuzijami zdravila pri bolnikih s Crohnovo boleznijo, je bila incidenca reakcij, podobnih serumski bolezni, 2,4 %.
This includes multiple sclerosis, Guillain-Barré syndrome, if you have fits or have been diagnosed with ‘optic neuritis'. 
To vključuje bolezni, kot so multipla skleroza, GuillainBarréjev sindrom, če ste imeli napade krčev ali so vam diagnosticirali "optični nevritis".
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 Zessly 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 Zessly.
Antinuclear antibodies (ANA)/Anti-double-stranded DNA (dsDNA) antibodies 
Protitelesa proti celičnemu jedru (ANA-anticelular antibodies)/protitelesa proti dvojnoverižni DNA (dsDNA)
CDAI < 150 at both week 30 and 54 and not receiving corticosteroids in the 3 months prior to week 54 among patients who were receiving corticosteroids at baseline. 
b CDAI < 150 tako v 30. tednu kot v 54. tednu, brez prejemanja kortikosteroidov v 3 mesecih pred 54. tednom pri bolnikih, ki so prejemali kortikosteroide na začetku študije
Zessly belongs to a group of medicines called ‘TNF blockers'. 
Zdravilo Zessly spada v skupino zdravil, ki se imenujejo "zaviralci TNF".
• Severe allergic reaction that may cause loss of consciousness and could be life-threatening 
• huda alergijska reakcija, ki lahko povzroči izgubo zavesti in je lahko življenjsko nevarna (anafilaktični šok)
Current data do not indicate that infliximab treatment influences the risk for developing dysplasia or colon cancer . 
Dosedanji podatki nekažejo, da zdravljenje z infliksimabom vpliva na tveganje za nastanek displazije ali karcinoma kolona.
• Children should receive recommended vaccinations before starting Zessly treatment. 
• Otroci morajo prejeti priporočena cepljenja, preden se začnejo zdraviti z zdravilom Zessly.
However,studies from the published literature in variousindications (e.g. rheumatoid arthritis, psoriasis, Crohn's disease) suggestthat non-live vaccinations received during treatment with anti-TNF therapies, including infliximab, may elicit a lower immune response than in patients not receiving anti-TNF therapy." 
Vseeno pa študije iz objavljene literature za različne indikacije (npr. revmatoidni artritis, psoriaza, Crohnova bolezen) nakazujejo, da cepljenja z neživimi cepivi med prejemanjem anti-TNF terapije, vključno z infliksimabom, lahko izzovejo manjši imunski odgovor kot pri bolnikih, ki ne prejemajo anti-TNF terapije.
• Children and adults taking Zessly may have an increased risk of developing lymphoma or another cancer. 
• Otroci in odrasli, ki prejemajo zdravilo Zessly, imajo lahko povečano tveganje za pojav limfoma ali katere druge vrste raka.
Zessly, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in: 
Zdravilo Zessly je v kombinaciji z metotreksatom indicirano za zmanjšanje znakov in simptomov ter izboljšanje funkcije sklepov:
In the second clinical study (study 9), improvement in signs and symptoms was observed as early as week 2. 
V drugi klinični študiji (študija 9) so že v 2. tednu opazili izboljšanje znakov in simptomov bolezni.
If not used immediately, in use storage times and conditions prior to use are the responsibility of the user and should not be longer than 24 hours at 2°C - 8°C. 
Če raztopina ni uporabljena takoj, je za pogoje in čas shranjevanja pred uporabo odgovoren uporabnik, in le-to ne sme trajati dlje kot 24 ur pri temperaturi med 2 °C-8 °C.
Table 9 Effects on ACR and PASI in patients with active psoriatic arthritis, data from study 10 and study 11 
Učinki na ACR in PASI v študijah pri bolnikih z aktivnim psoriatičnim artritisom, podatki iz študije 10 in študije 11
There were no serious infusion reactions, and 2 subjects in the paediatric Crohn's disease study had non-serious anaphylactic reactions. 
Ni bilo nobene resne z infuzijo povezane reakcije, dva preiskovanca v pediatrični študiji Chronove bolezni pa sta imela anafilaktično reakcijo, ki ni bila resna.