natgillin/translations-raw huggingface dataset:
Note: You may see air bubbles in the liquid.
Opomba: V tekočini so lahko prisotni mehurčki.
Your doctor may recommend temporarily stopping Remsima.
Zdravnik vam bo morda priporočil začasno prekinitev zdravljenja z zdravilom Remsima.
EXP, if not refrigerated ___________________
EXP pri sobni temperaturi___________________
In the REACH study, infections were reported in 56.3% of randomised subjects treated with infliximab.
Okužbe V preskušanju REACH so o okužbah poročali pri 56,3 % randomiziranih preiskovancih, zdravljenih z infliksimabom.
It is important to check the product labels to ensure that the correct formulation is being given as prescribed.
Pomembno je, da preverite nalepko zdravila in zagotovite, da boste prejeli ustrezno obliko zdravila, ki vam je bila predpisana.
The analysis of other efficacy endpoints showed that efficacy profile of Remsima subcutaneous formulation compared to Remsima intravenous formulation in RA patients was generally comparable in terms of disease activity measured by DAS28 (CRP and ESR) and ACR response up to Week 54.
Analiza drugih primarnih opazovanih dogodkov je pokazala, da je profil učinkovitosti zdravila Remsima v subkutani obliki na splošno primerljiv s profilom učinkovitosti zdravila Remsima v intravenski obliki pri bolnikih z RA z vidika aktivnosti bolezni, izmerjene z odzivom DAS28 (CRP in ESR) in ACR do 54. tedna.
You may receive some vaccines during treatment with Remsima but you should not receive live vaccines (vaccines that contain a living but weakened infectious agent) while using Remsima because they may cause infections.
Med zdravljenjem z zdravilom Remsima lahko prejmete nekatera cepiva, vendar med uporabo zdravila Remsima ne smete prejeti živih cepiv (cepiv, ki vsebujejo žive, a oslabljene povzročitelje okužb), saj lahko le-ta povzročijo okužbo.
Systemic injection reaction/ localised injection site reaction/ hypersensitivity
Sistemska z injiciranjem povezana reakcija/lokalizirana reakcija na mestu injiciranja/preobčutljivost
b CDAI <150 at both Week 30 and 54 and not receiving corticosteroids in the 3 months prior to
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
• That treatment with Remsima 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 Remsima 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 subcutaneous administration of Remsima to New Zealand White rabbits was well tolerated at the actual concentration to be used in humans.
Novozelandski beli zajci so dobro prenašali zdravilo Remsima, ki so ga prejeli subkutano v dejanskih koncentracijah, namenjenih uporabi pri ljudeh.
• You will be monitored while you are given Remsima and also for 1 to 2 hours afterwards.
• Med prejemanjem zdravila Remsima in še eno do dve uri potem vas bodo spremljali.
Methotrexate was given concomitantly.
Sočasno so prejemali metotreksat.
Your doctor will start your treatment with two Remsima intravenous infusion doses of 3 mg for every kg of body weight (given to you into a vein, usually in your arm, over a period of 2 hours).
Zdravnik bo začel zdravljenje z dvema intravenskima infuzijama zdravila Remsima v odmerku 3 mg za kilogram telesne mase (ki ju boste prejeli v veno, običajno na roki, v obdobju dveh ur).
ACR 70 response* PASI response (% of patients)b N
ACR 70* Odziv PASI (% bolnikov)b N
The medicinal product may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Zdravilo lahko shranite pri temperaturi do 25 °C za največ 14 dni.
• A rare blood cancer affecting mostly young men (hepatosplenic T-cell lymphoma)
• redka vrsta krvnega raka, ki prizadane predvsem mlade moške (hepatosplenični limfom T celic)
If jaundice and/or ALT elevations ≥5 times the upper limit of normal develop(s), infliximab 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 infliksimaba in temeljito raziščite vzroke za nenormalne izvide.
• Tell your doctor if you have any abnormal skin openings (fistulae) before you are given Remsima.
• Obvestite zdravnika, če imate na koži nenormalne odprtine (fistule), preden začnete prejemati zdravilo Remsima.
≥90% improvement
N ≥ 90 % izboljšanje
• If you received Remsima during your pregnancy, your baby may have a higher risk for getting an infection.
• Če ste v času nosečnosti prejemali zdravilo Remsima, ima vaš dojenček lahko povečano tveganje za okužbe.
However, if the solution is prepared in germ-free conditions, it can be stored in a refrigerator at 2°C - 8°C up to 28 days and for an additional 24 hours at 25 °C after removal from the refrigerator.
Vendar, če je bila raztopina pripravljena v aseptičnih pogojih, jo lahko do 28 dni shranjujete v hladilniku pri temperaturi 2 °C - 8 °C ter dodatnih 24 ur pri temperaturi 25 °C, po tem ko jo vzamete iz hladilnika.
Since the possibility of increased risk of cancer development in patients with newly diagnosed dysplasia treated with infliximab 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 Remsima, ni ugotovljena, mora zdravnik skrbno pretehtati tveganje in koristi nadaljevanja zdravljenja za posameznega bolnika.
• Some patients receiving infliximab via injection under the skin have experienced local injection site reactions.
• Pri nekaterih bolnikih, ki so infliksimab prejeli z injiciranjem pod kožo, so se pojavile lokalne reakcije na mestu injiciranja.
• Tell your doctor before you are given Remsima if you have or have ever had lymphoma (a type of blood cancer) or any other cancer.
• Preden prejmete zdravilo Remsima, povejte zdravniku, če imate ali ste imeli kdaj v preteklosti limfom (vrsta krvnega raka) oziroma katero koli drugo vrsto raka.
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 prefiskav kot tudi lažji izmenjavi posebnih informacij glede trenutnega zdravljenja z zdravilom med bolnikom in zdravstvenim(i) delavcem(i), ki sodeluje(jo) pri zdravljenju bolnika.
Patients with no deterioration/patients evaluated (%)c
± SDc) medianac (interkvartilni razmik) bolniki brez poslabšanja/ pregledani bolniki (%)c spreminjanje HAQ
Ask your doctor to record the type and date of last screening(s) for tuberculosis (TB) below: Test:
Zdravnik naj zabeleži tip in datum zadnjega presejaln-ega(ih) test-a(ov) za tuberkulozo (TBC):
A damaged pen may not function properly.
Poškodovan injekcijski peresnik morda ne bo pravilno deloval.
Remsima works by selectively attaching to TNF alpha and blocking its action.
Zdravilo Remsima deluje tako, da se selektivno veže na TNF-alfa in zavira njegovo delovanje.
For subsequent injections and after proper training in subcutaneous injection technique, patients may self-inject with Remsima if their physician determines that it is appropriate and with medical followup as necessary.
Po ustreznem usposabljanju glede tehnike subkutanega injiciranja si lahko bolniki sami injicirajo zdravilo Remsima, če je po presoji zdravnika to ustrezno in če se po potrebi izvaja naknadno spremljanje bolnika.
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
Myocardial ischaemia/myocardial infarction
ishemija miokarda ali miokardni infarkt
• If your doctor feels that you are at risk for TB, you may be treated with medicines for TB before you are given Remsima.
• Če zdravnik sumi, da je možno da imate tuberkulozo, vas bo lahko zdravil z zdravili za tuberkulozo, preden boste začeli zdravljenje z zdravilom Remsima.
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 bolnikov-let (3.210 bolnikov), pa so poročali o 5 primerih limfomskihin 38 primerih nelimfomskih rakavih bolezni.
• Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes).
• Lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah).
Keratitis, periorbital oedema, hordeolum
keratitis, periorbitalni edem, hordeolum redki:
Anaphylactic shock, vasculitis, sarcoid-like reaction
anafilaktični šok, vaskulitis, sarkoidni podobna reakcija
• Serious skin problems such as toxic epidermal necrolysis, Stevens-Johnson syndrome and acute generalised exanthematous pustulosis
• resne težave s kožo, na primer toksična epidermalna nekroliza, Stevens-Johnsonov sindrom in akutna generalizirana eksantematozna pustuloza
Suitability of the patient for subcutaneous home use should be assessed and patients should be advised to inform their healthcare professional if they experience symptoms of an allergic reaction before administering the next dose.
Oceniti je treba primernost bolnika za subkutano uporabo zdravila v domačem okolju in ga poučiti, da mora v primeru simptomov, ki so značilni za alergijsko reakcijo, pred injiciranjem naslednjega odmerka o tem obvestiti zdravstvenega delavca.
Remsima should only be used in children if they are being treated for Crohn's disease or ulcerative colitis.
Zdravilo Remsima se sme pri otrocih uporabljati samo za zdravljenje Chronove bolezni ali ulceroznega kolitisa.
Tell your doctor if you are using, have recently used or might use any other medicines, including any other medicines to treat rheumatoid arthritis or medicines obtained without a prescription, such as vitamins and herbal medicines.
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katerokoli drugo zdravilo, vključno s katerimikoli drugimi zdravili za zdravljenje revmatoidnega artritisa in z zdravili, ki se jih dobi brez recepta, kot so vitamini in rastlinski pripravki.
The estimate of treatment difference was 0.27 with corresponding lower limit of the two-sided 95% confidence interval [CI] of 0.02 (95% CI: 0.02, 0.52), which was greater than the pre-specified non-inferiority margin of -0.6 indicating non-inferiority of Remsima subcutaneous formulation to Remsima intravenous formulation.
Ocenjena razlika je bila 0,27 z ujemajočo nižjo stopnjo na dvostranskem 95-% intervalu zaupanja [CI] 0,02 (95-% CI: 0,02; 0,52), ki je bila višja od predhodno opredeljene meje enakovrednosti -0,6, kar nakazuje, da je zdravilo Remsima v subkutani obliki enakovredno zdravilu Remsima v intravenski obliki.
Do not inject into skin that is within 5 cm of your belly button (navel), or is tender, damaged, bruised, or scarred.
Injiciranja ne smete izvajati na področju, ki je od vašega popka oddaljeno manj kot 5 centimetrov, ali na mestih z občutljivo, poškodovano, podpluto ali brazgotinasto kožo.
Chemical and physical in use stability of the diluted solution has been demonstrated for up to 28 days at 2 °C to 8 °C and for an additional 24 hours at 25°C after removal from refrigeration.
Po rekonstituciji in redčenju Dokazano je bilo, da je razredčena raztopina kemično in fizikalno stabilna do 28 dni pri temperaturi 2 °C do 8 °C ter dodatnih 24 ur pri temperaturi 25°C, po tem ko se vzame iz hladilnika.
• Some patients receiving infliximab have developed symptoms of an immune system disorder called lupus.
• Pri nekaterih bolnikih, ki prejemajo zdravilo Remsima, so se pojavili simptomi bolezni imunskega sistema, imenovane lupus.
The required total volume of reconstituted Remsima solution has to be calculated.
Izračunati morate celoten volumen potrebne rekonstituirane raztopine zdravila Remsima.
Population pharmacokinetic analysis based on data obtained from patients with ulcerative colitis (N=60), Crohn's disease (N=112), juvenile rheumatoid arthritis (N=117) and Kawasaki disease (N=16) with an overall age range from 2 months to 17 years indicated that exposure to infliximab was dependent on body weight in a non-linear way.
Analiza populacijske farmakokinetike na podlagi podatkov, pridobljenih pri bolnikih z ulceroznim kolitisom (n=60), Crohnovo boleznijo (N=112), juvenilnim revmatoidnim artritisom (N=117) in boleznijo Kawasaki (N=16) v starostni skupini od 2 mesecev do 17 let, je pokazala, da je izpostavljenost infliksimabu nelinearno odvisna od telesne mase.
Patients with tuberculosis or other severe infections such as sepsis, abscesses and opportunistic infections (see section 4.4).
Bolniki s tuberkulozo ali z drugimi hudimi okužbami, kot so sepsa, abscesi in oportunistične okužbe (glejte poglavje 4.4).
The volume of distribution at steady state (median Vd of 3.0 to 4.1 litres) was not dependent on the administered dose and indicated that infliximab is predominantly distributed within the vascular compartment.
Navidezni porazdelitveni volumen v stanju dinamičnega ravnovesja (mediana Vd od 3,0 do 4,1 litra) ni bil odvisen od danega odmerka, kar pomeni, da se infliksimab razporedi pretežno po žilnem razdelku.
If you forget or miss an appointment to receive Remsima, make another appointment as soon as possible.
Če ste pozabili ali izpustili odmerek zdravila Remsima Če ste pozabili ali izpustili dogovorjen termin, da bi prejeli zdravilo Remsima, se čim prej dogovorite za naslednjega.
In psoriasis patients treated with infliximab as a maintenance regimen in the absence of concomitant immunomodulators, approximately 28% developed antibodies to infliximab (see section 4.4: "Infusion reactions and hypersensitivity").
Pri bolnikih, ki so jim psoriazo vzdrževalno zdravili z infliksimabom brez spremljajočega imunomodulatorja, so se pri približno 28 % razvila protitelesa proti infliksimabu (glejte poglavje 4.4: ''Z infuzijo povezane reakcije in preobčutljivost'').
From experience with intravenous infliximab, if the signs and symptoms of disease recur, infliximab can be re-administered within 16 weeks following the last administration.
Izkušnje z intravenskim infliksimabom kažejo, da če se znaki in simptomi bolezni ponovijo, lahko infliksimab ponovno uporabite v roku 16 tednov po zadnjem dajanju.
a. Hold the pen so that you can see the window.
a. Injekcijski peresnik primite tako, da bosta videli okence.
Remsima is a biosimilar medicinal product.
Zdravilo Remsima je biološko podobno zdravilo.
• The doctor will decide your dose and how often you will be given Remsima.
• Zdravnik bo določil odmerek, ki ga boste prejemali, in kako pogosto ga boste prejemali.
Most of these reactions may occur immediately or within 24 hours after subcutaneous injection.
Večina teh reakcij se lahko pojavi takoj po subkutanem zdravljenju z infliksimabom ali v 24 urah po njem.
Secondary endpoints included the proportion of patients in clinical remission at week 4 (CDAI <150) and clinical response over time.
Sekundarna cilja študije sta bila odstotek bolnikov v klinični remisiji v 4. tednu (CDAI < 150) in klinični odziv po času.
Significant improvements from baseline were demonstrated in DLQI (p<0.001) and the physical and mental component scores of the SF 36 (p<0.001 for each component comparison).
Pri oceni po DLQI (p< 0,001) so dokazali bistveno izboljšanje glede na začetne vrednosti, pa tudi glede ocen telesne in duševne komponente po SF 36 (p< 0,001 za primerjavo vsake komponente).
Remsima must be given concomitantly with methotrexate.
Zdravilo Remsima morate uporabljati sočasno z metotreksatom.
• 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.
c. With a quick and “dart-like” motion, insert the needle completely into the fold of the skin at a 45-degree angle.
c. S hitrim sunkom, podobnim metu pri pikadu, iglo vstavite do konca v kožno gubo pod 45stopinjskim kotom.
Information regarding switching patients from the subcutaneous formulation to the intravenous formulation of Remsima is not available.
Informacij o prehodu bolnikov z zdravila Remsima v subkutani obliki na zdravilo Remsima v intravenski obliki ni na voljo.
In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded.
Z namenom izboljšanja sledljivosti bioloških zdravil je treba jasno zabeležiti ime in številko serije uporabljenega zdravila.
What Remsima looks like and contents of the pack
Izgled zdravila Remsima in vsebina pakiranja
• It is important that you tell your baby's doctors and other healthcare professionals about your Remsima use before your baby is given any vaccine.
• Pomembno je, da zdravniku vašega dojenčka in drugim zdravstvenim delavcem poveste, da ste prejemali zdravilo Remsima, še preden dojenček dobi katerokoli cepivo.
In studies in healthy subjects, the mean (± standard deviation) apparent clearance of Remsima 120 mg administered subcutaneously was 19.3 ± 6.9 mL/hr.
V študijah pri zdravih preiskovancih je mediana (± standardni odklon) navideznega očistka subkutano danega zdravila Remsima 120 mg znašala 19,3 ± 6,9 ml/uro.
Cases of TB have been reported in patients treated with infliximab, even in patients who have already been treated with medicines for TB.
Pri bolnikih, že zdravljenih z infliksimabom, so poročali o primerih tuberkuloze, tudi pri bolnikih, ki so že bili zdravljeni z zdravili proti TBC.
It is used in adults for the following inflammatory disease:
Uporablja se za zdravljenje naslednje vnetne bolezni pri odraslih:
For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of infliximab treatment should be carefully considered before initiation of infliximab therapy.
Pri bolnikih, ki so živeli ali potovali v kraje, kjer so invazivne glivične okužbe, kot so histoplazmoza, kokcidioidomikoza ali blastomikoza, endemične, je treba skrbno pretehtati koristi in tveganja zdravljenja z infliksimabom, preden bolniku uvedete to zdravilo.
Remsima treatment is to be initiated and supervised by qualified physicians experienced in the diagnosis and treatment of conditions for which Remsima is indicated.
Zdravljenje z zdravilom Remsima mora uvesti in nadzorovati kvalificiran zdravnik, ki je izkušen v diagnostiki in zdravljenju bolezni, za katere je indicirano zdravilo Remsima.
Before reconstitution:
Pred rekonstitucijo
b. Let the skin dry before injecting.
b. Pred injiciranjem počakajte, da se koža posuši.
Currently available data are described in sections 4.8 and 5.2 but no recommendation on a posology can be made.
Trenutno razpoložljivi podatki, so opisani v poglavjih 4.8 in 5.2, vendar priporočil o odmerjanju ni mogoče dati.
In Part 2 of this study, among 357 patients who were enrolled to receive 2 doses of Remsima 3 mg/kg intravenously at Weeks 0 and 2, 167 patients were randomised to receive Remsima 120 mg subcutaneously at Week 6 and every 2 weeks up to Week 54, while 176 patients were randomised to receive Remsima 3 mg/kg intravenously at Weeks 6, 14 and 22 and then switched to Remsima 120 mg subcutaneous at Week 30 once-every 2 weeks up to Week 54.
V 2. delu študije je bilo 167 od 357 bolnikov, ki so bili v študijo vključeni, da bi prejeli 2 odmerka zdravila Remsima 3 mg/kg intravensko na 0. in 2. teden, randomiziranih v skupino, ki je zdravilo Remsima 120 mg prejela subkutano na 6. teden in nato vsaka dva tedna do 54. tedna, 176 bolnikov pa je bilo randomiziranih v skupino, ki je prejela zdravilo Remsima 3 mg/kg intravensko na 6., 14. in 22. teden, nato pa je na 30. teden prešla na zdravilo Remsima 120 mg subkutano enkrat na dva tedna vse do 54. tedna.
a. Select an injection site.
a. Izberite mesto injiciranja.
Corticosteroids do not appear to affect the pharmacokinetics of infliximab to a clinically relevant extent.
Kortikosteroidi ne kažejo klinično pomembnega vpliva na farmakokinetiko infliksimaba.
Infliximab should be used with caution in patients with mild heart failure (NYHA class I/II).
Srčno popuščanje Infliksimab morate uporabljati previdno pri bolnikih z blagim srčnim popuščanjem (razred I/II
Remsima is indicated for treatment of severe, active ankylosing spondylitis, in adult patients who have responded inadequately to conventional therapy.
Zdravilo Remsima je indicirano za zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih bolnikih, ki so se nezadostno odzvali na konvencionalno terapijo.
For this reason, the initial intravenous administrations should take place where emergency equipment, such as adrenaline, antihistamines, corticosteroids and an artificial airway is immediately available.
Zato je treba zdravilo prvič dati intravensko na mestu, kjer so neposredno na voljo sredstva za nujno pomoč, npr. adrenalin, antihistaminiki, kortikosteroidi in oprema za umetno ventilacijo.
Remsima 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 Remsima mora uvesti in nadzorovati kvalificiran zdravnik, ki je izkušen v diagnostiki in zdravljenju revmatoidnega artritisa, vnetnih bolezni črevesa, ankilozirajočega spondilitisa, psoriatičnega artritisa ali psoriaze.
After single doses of 120, 180 and 240 mg of subcutaneous infliximab administered to healthy subjects, the mean Cmax values were 10.0, 15.1 and 23.1 µg/mL, respectively, and for all doses infliximab could be detected in the serum for at least 12 weeks thereafter.
Po enkratnem odmerku 120, 180 ali 240 mg subkutanega infliksimaba pri zdravih preiskovancih so bile njihove mediane vrednosti Cmaks 10,0, 15,1 in 23,1 mikrogramov/ml, pri vseh odmerkih pa so infliksimab našli v serumu še najmanj 12 tednov po odmerjanju.
In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤35%) were treated with 3 infusions of infliximab 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
V tej študiji je bilo 150 bolnikov s srčnim popuščanjem stopnje III do IV po NYHA (iztisni delež levega ventrikla ≤ 35 %) zdravljenih s tremi infuzijami: infliksimab v odmerkih 5 mg/kg, 10 mg/kg ali s placebom več kot 6 tednov.
• The front of the thighs.
• Sprednjo stran stegna.
• You should receive recommended vaccinations before starting Remsima treatment.
• Vsa priporočena cepljenja morate prejeti pred začetkom zdravljenja z zdravilom Remsima.
Remsima is indicated for treatment of active and progressive psoriatic arthritis in adult patients when the response to previous DMARD therapy has been inadequate.
Zdravilo Remsima je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih bolnikih v primeru nezadostnega odziva na predhodno zdravljenje s protirevmatičnimi zdravili DMARD.
• Some children and teenage patients who have received TNF-blockers such as infliximab have developed cancers, including unusual types, which sometimes resulted in death.
Poleg tega še: • Pri nekaterih otrocih in najstnikih, ki so prejemali zaviralce TNF, kot je infliksimab, se je razvil rak, vključno z zelo neobičajnimi oblikami, ki se včasih končajo s smrtnim izidom.