natgillin/translations-raw huggingface dataset:
Infusion of 5 mg/ kg if signs and symptoms of the disease recur followed by infusions of 5 mg/ kg every 8 weeks (see ‘ Re-administration’ below and section 4.4).
Infuzija 5 mg/ kg zdravila, če se ponovijo znaki in simptomi bolezni, čemur naj sledijo infuzije z odmerkom 5 mg/ kg na vsakih 8 tednov (glejte poglavje “ Ponovno dajanje zdravila ” spodaj in poglavje 4. 4).
Continued therapy should be carefully reconsidered in patients who show no evidence of therapeutic benefit after dose adjustment.
Čeprav so omejeni razpoložljivi podatki o bolnikih, ki so se najprej odzvali na odmerek 5 mg/ kg, potem pa so se prenehali odzivati na zdravljenje, so pokazali, da se lahko nekateri bolniki ponovno odzovejo na zdravljenje, če jim povečamo odmerek (glejte poglavje 5. 1), medtem ko je treba dobro premisliti, ali je umestno nadaljevanje zdravljenja pri tistih bolnikih, ki niti po prilagoditvi odmerka niso pokazali nobenih znakov, da jim tovrstno zdravljenje koristi
In Crohn’ s disease, experience with re-administration if signs and symptoms of disease recur is limited and comparative data on the benefit/ risk of the alternative strategies for continued treatment are lacking.
Pri Crohnovi bolezni je malo izkušenj s ponovnim dajanjem zdravila po ponovitvi znakov in simptomov bolezni, primerjalnih podatkov o koristih ali tveganjih drugih možnosti nadaljnjega zdravljenja pa ni.
4 Ulcerative colitis 5 mg/ kg given as an intravenous infusion over a 2 hour period followed by additional 5 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Temu naj sledita dva dodatna infuzijska odmerka po 5 mg/ kg v 2. in 6. tednu po prvi infuziji, potem pa zdravilo infundirajte bolniku na vsakih 8 tednov.
Available data suggest that the clinical response is usually achieved within 14 weeks of treatment, i. e. three doses.
Razpoložljivi podatki kažejo, da klinični odziv običajno dosežemo v 14 tednih zdravljenja, to je s tremi odmerki.
Ankylosing spondylitis 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 6 to 8 weeks.
Ankilozirajoči spondilitis Odmerek je 5 mg/ kg v intravenski infuziji v času 2 ur, čemur naj sledita dodatni infuziji z odmerkoma 5 mg/ kg 2 in 6 tednov po prvi infuziji, potem pa na vsakih 6 do 8 tednov.
If a patient does not respond by 6 weeks (i. e. after 2 doses), no additional treatment with infliximab should be given.
Če se bolnik ne odzove na zdravilo do 6 tedna (t. j. po 2 odmerkih), ga ne smete več zdraviti z infliksimabom.
Psoriatic arthritis 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Psoriatični artritis Odmerek je 5 mg/ kg v intravenski infuziji v času 2 ur, čemur naj sledita dodatni infuziji z odmerkoma 5 mg/ kg 2 in 6 tednov po prvi infuziji, potem pa na vsakih 8 tednov.
Psoriasis 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Psoriaza 5 mg/ kg, dano v obliki 2- urne intravenske infuzije, potem pa dodatne infuzije odmerkov 5 mg/ kg 2 in 6 tednov po prvi infuziji, potem pa na vsakih 8 tednov.
If a patient shows no response after 14 weeks (i. e. after 4 doses), no additional treatment with infliximab should be given.
Če bolnik ne pokaže nobenega odziva po 14 tednih (t. j. po 4 odmerkih), mu ne smete dati nobenega dodatnega zdravljenja z infliksimabom.
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.
In clinical studies, delayed hypersensitivity reactions have been uncommon and have occurred after Remicade-free intervals of less than 1 year (see section 4.4 and 4.8: delayed hypersensitivity).
V kliničnih študijah so bile pozne preobčutljivostne reakcije občasne in so se pojavile po premoru brez prejemanja zdravila manj kot 1 leto (glejte poglavji 4. 4 in 4. 8: pozna preobčutljivost).
This applies to both Crohn’ s disease patients and rheumatoid arthritis patients.
To velja tako za bolnike s Crohnovo boleznijo kot za tiste z revmatoidnim artritisom.
Re-administration for ulcerative colitis The safety and efficacy of re-administration, other than every 8 weeks, has not been established.
Ponovna uporaba pri ulceroznem kolitisu Varnosti in učinkovitosti ponovne uporabe, razen na vsakih 8 tednov, še niso ugotovili.
Re-administration for ankylosing spondylitis The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established.
Ponovna uporaba zdravila pri ankilozirajočem spondilitisu Varnosti in učinkovitosti ponovne uporabe zdravila, razen na vsakih 6 do 8 tednov, še niso ugotovili.
Re-administration for psoriatic arthritis The safety and efficacy of re-administration, other than every 8 weeks, has not been established.
Ponovna uporaba zdravila pri psoriatičnem artritisu Varnosti in učinkovitosti ponovne uporabe zdravila, razen na vsakih 8 tednov, še niso ugotovili.
Re-administration for psoriasis Limited experience from re-treatment with one single Remicade dose in psoriasis after an interval of 20 weeks suggests reduced efficacy and a higher incidence of mild to moderate infusion reactions when compared to the initial induction regimen (see section 5.1).
Omejene izkušnje s ponovnim zdravljenjem z enim samim odmerkom zdravila Remicade pri psoriazi po časovnem presledku 20 tednov kažejo zmanjšano učinkovitost in večjo incidenco blagih do zmernih infuzijskih reakcij v primerjavi s prvotnim uvodnim režimom zdravljenja (glejte poglavje 5. 1).
Crohn’ s disease (6 to 17 years) 5 mg/ kg given as an intravenous infusion over a 2-hour period followed by additional 5 mg/ kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Crohnova bolezen (pri bolnikih, starih od 6 do 17 let) Običajen odmerek je 5 mg/ kg.
Some patients may require a shorter dosing interval to maintain clinical benefit, while for others a longer dosing interval may be sufficient.
Bolniku ga dajte v obliki 2- urne intravenske infuzije, ki naj ji sledita še dve infuziji v istem odmerku, in sicer 2 in 6 tednov po prvi infuziji, potem pa nadaljujte z infuzijami za vzdrževalno zdravljenje na vsakih 8 tednov.
Available data do not support further infliximab treatment in paediatric patients not responding within the first 10 weeks of treatment.
Dosedanji podatki ne govorijo v prid nadaljevanju zdravljenja z infliksimabom pri tistih pediatričnih bolnikih, ki se na zdravljenje ne odzovejo v prvih 10 tednih.
5 4.3 Contraindications
5 4. 3 Kontraindikacije
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, kakor so npr. sepsa, abscesi in oportunistične okužbe (glejte poglavje 4. 4).
Patients with moderate or severe heart failure (NYHA class III/ IV) (see sections 4.4 and 4.8).
Bolniki z zmernim do hudim srčnim popuščanjem (razred III/ IV po NYHA) (glejte poglavji 4. 4 in 4. 8).
Patients with a history of hypersensitivity to infliximab (see section 4.8), to other murine proteins, or to any of the excipients.
Bolniki z anamnezo preobčutljivosti na infliksimab (glejte poglavje 4. 8), druge mišje beljakovine ali katero od pomožnih snovi.
Infusion reactions and hypersensitivity Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Infuzijske reakcije in preobčutljivost Zdravljenje z infliksimabom je bilo povezano z akutnimi infuzijskimi reakcijami, vključno z anafilaktičnim šokom in poznimi preobčutljivostnimi reakcijami (glejte poglavje 4. 8).
Acute infusion reactions including anaphylactic reactions may develop during (within seconds) or within a few hours following infusion.
Akutna infuzijska reakcija, vključno z anafilaktično reakcijo, lahko nastopi med infuzijo (t. j. v nekaj sekundah) ali v roku nekaj ur po infuziji.
If acute infusion reactions occur, the infusion must be interrupted immediately.
Če se pojavi akutna infuzijska reakcija, morate infuzijo takoj prekiniti.
Patients may be pre-treated with e. g., an antihistamine, hydrocortisone and/ or paracetamol to prevent mild and transient effects.
Za preprečevanje blagih in prehodnih učinkov lahko bolnikom pred zdravljenjem z zdravilom Remicade date premedikacijo, npr. antihistaminik, hidrokortizon in/ ali paracetamol.
Antibodies to infliximab may develop and have been associated with an increased frequency of infusion reactions.
Pojavijo se lahko protitelesa proti infliksimabu, ki so bila povezana s povečano pogostnostjo infuzijskih reakcij.
A low proportion of the infusion reactions was serious allergic reactions.
Majhen odstotek infuzijskih reakcij so predstavljale hude alergijske reakcije.
Concomitant administration of immunomodulators has been associated with lower incidence of antibodies to infliximab and a reduction in the frequency of infusion reactions.
Sočasna uporaba imunomodulatorjev je bila povezana z manjšo incidenco protiteles na infliksimab in zmanjšanjem pogostnosti infuzijskih reakcij.
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.
"Immunogenicity").
Če se pojavijo resne reakcije, morate uvesti simptomatično zdravljenje in bolniku ne smete več dajati infuzij tega zdravila (glejte poglavje 4. 8 “ Imunogenost ”).
Advise patients to seek immediate medical advice if they experience any delayed adverse event (see section 4.8: “ Delayed hypersensitivity”).
Bolnikom naročite, naj nemudoma poiščejo zdravniško pomoč, če opazijo katerega od poznih neželenih učinkov (glejte poglavje 4. 8 “ Pozna preobčutljivost ”).
Infections Patients must be monitored closely for infections including tuberculosis before, during and after treatment with Remicade.
Okužbe Pred, med in po zdravljenju z zdravilom Remicade morate bolnike skrbno spremljati, da ugotovite morebitne okužbe, npr. tuberkulozo.
Patients should be advised of and avoid exposure to potential risk factors for infection as appropriate.
Bolnike poučite o potencialnih dejavnikih tveganja za okužbe in jim svetujte, naj se izogibajo izpostavljanju le- tem, odvisno od primera
It should be noted that suppression of TNFα may mask symptoms of infection such as fever.
6 Treba je tudi poudariti, da lahko zaviranje TNFα prikrije simptome okužbe, npr. zvišano telesno temperaturo.
Early recognition of atypical clinical presentations of serious infections is critical in order to minimize delays in diagnosis and treatment.
Bistvenega pomena je tudi zgodnja prepoznava atipičnih kliničnih slik resnih okužb, da bi lahko čimbolj zmanjšali zamude pri njihovi diagnozi in zdravljenju.
6 Patients taking TNF-blockers are more susceptible to serious infections.
Bolniki, ki jemljejo zaviralce TNF, so bolj občutljivi za resne okužbe.
Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal infections, and other opportunistic infections have been observed in patients treated with infliximab.
Pri bolnikih, zdravljenih z infliksimabom, so ugotavljali tuberkulozo, bakterijske okužbe vključno s sepso in pljučnico, invazivne glivične okužbe in druge oportunistične okužbe.
Some of these infections have been fatal.
Nekatere od teh okužb so bile tudi smrtne.
For patients who have resided in or traveled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of Remicade treatment should be carefully considered before initiation of Remicade therapy.
Pri bolnikih, ki so živeli ali potovali v kraje, kjer so endemične invazivne glivične okužbe, kot so histoplazmoza, kokcidioidomikoza ali blastomikoza, je treba skrbno pretehtati koristi in tveganja zdravljenja z zdravilom Remicade, preden bolniku uvedete to zdravilo.
Opportunistic infections reported in patients on Remicade have included, but are not limited to pneumocystosis, histoplasmosis, cytomegalovirus infection, atypical mycobacterial infections, listeriosis and aspergillosis.
Med oportunistične okužbe, o katerih so poročali pri bolnikih, ki so prejemali zdravilo Remicade, sodijo na primer (vendar ne izključno) pnevmocistoza, histoplazmoza, okužba s citomegalovirusom, atipične mikobakterijske okužbe, listerioza in aspergiloza.
In clinical studies, infections have been reported more frequently in paediatric patient populations than in adult patient populations (see section 4.8).
V kliničnih preskušanjih so o okužbah poročali pogosteje pri pediatričnih bolnikih kot pri odraslih bolnikih (glejte poglavje 4. 8).
Before starting treatment with Remicade, all patients must be evaluated for both active and inactive (‘ latent’) tuberculosis.
Pred začetkom zdravljenja z zdravilom Remicade morate vse bolnike pregledati in preiskati, da ugotovite morebitno aktivno ali neaktivno (latentno) tuberkulozo.
This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/ or current immunosuppressive therapy.
Pri tem morate opraviti podrobno zdravstveno anamnezo in osebno anamnezo v zvezi s tuberkulozo ali morebitnimi prejšnjimi stiki s tuberkuloznimi bolniki in v zvezi z morebitno prejšnjo in/ ali sedanjo imunosupresivno terapijo.
Appropriate screening tests, i. e. tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
Pri vseh bolnikih opravite ustrezne presejalne preiskave, npr. tuberkulinski kožni test in rentgensko slikanje prsnega koša (v skladu z lokalnimi priporočili).
It is recommended that the conduct of these tests should be recorded in the patient’ s alert card.
Priporočamo, da te preiskave vpišete v bolnikovo opozorilno kartico.
If active tuberculosis is diagnosed, Remicade therapy must not be initiated (see section 4.3).
Če postavite diagnozo aktivne tuberkuloze, ne smete uvesti zdravljenja z zdravilom Remicade (glejte poglavje 4. 3).
In all situations described below, the benefit/ risk balance of Remicade therapy should be very carefully considered.
V vseh spodaj opisanih okoliščinah je treba zelo skrbno pretehtati razmerje med koristmi in tveganji zdravljenja z zdravilom Remicade.
If inactive (‘ latent’) tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis 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.
In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, anti-tuberculosis therapy should be considered before the initiation of Remicade.
Pri bolnikih, ki imajo več dejavnikov tveganja oziroma pomembne dejavnike tveganja za tuberkulozo in pri katerih je bil test na latentno tuberkulozo negativen, premislite, ali bi bilo treba pri njih pred uvedbo zdravila Remicade najprej zdraviti tuberkulozo.
Use of anti-tuberculosis 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.
All patients should be informed to seek medical advice if signs/ symptoms suggestive of tuberculosis (e. g. persistent cough, wasting/ weight loss, low-grade fever) appear during or after Remicade treatment.
7 Vsem bolnikom morate naročiti, naj pridejo k zdravniku, če se v času zdravljenja z zdravilom Remicade ali po njem pojavijo znaki ali simptomi, ki kažejo na tuberkulozo (npr. trdovraten kašelj, hujšanje ali nekoliko zvišana telesna temperatura).
Patients with fistulising Crohn’ s disease with acute suppurative fistulas must not initiate Remicade therapy until a source for possible infection, specifically abscess, has been excluded (see section 4.3).
Pri bolnikih s fistulirajočo Crohnovo boleznijo z akutnimi gnojnimi fistulami ne smete uvesti terapije z zdravilom Remicade, dokler ne izključite možnosti, da obstaja nekje vir okužbe, na primer absces (glejte poglavje 4. 3).
7 Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Remicade, who are chronic carriers of this virus.
Reaktivacija hepatitisa B Pri bolnikih, ki so prejemali antagonist TNF, na primer zdravilo Remicade, in ki so bili kronični prenašalci virusa hepatitisa B, je prišlo do reaktivacije hepatitisa B.
Some cases have had fatal outcome.
V nekaterih primerih je prišlo celo do smrti bolnika.
Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating Remicade therapy.
Bolnike, pri katerih obstaja tveganje za okužbo z virusom hepatitisa B (HBV), je torej treba oceniti, ali imajo znake okužbe s HBV, preden smete pri njih uvesti zdravljenje z zdravilom Remicade.
Carriers of HBV who require treatment with Remicade should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Prenašalce virusa HBV, ki potrebujejo zdravljenje z zdravilom Remicade, je treba ves čas zdravljenja in še več mesecev po prekinitvi oz. zaključku zdravljenja skrbno spremljati, da pri njih ugotovite morebitne znake in simptome aktivne okužbe z virusom HBV.
Adequate data of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available.
Ni zadostnih podatkov o zdravljenju prenašalcev virusa HBV s protivirusno terapijo ob uporabi antagonista TNF za preprečevanje reaktivacije hepatitisa B.
In patients who develop HBV reactivation, Remicade should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Pri bolnikih, pri katerih se ponovno aktivira okužba s HBV, je treba zdravilo Remicade ukiniti in uvesti učinkovito protivirusno terapijo z ustreznimi podpornimi ukrepi.
Hepatobiliary events Very rare cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of Remicade.
Sopojavi na jetrih, žolčniku in žolčevodih Med postmarketinškimi izkušnjami z zdravilom Remicade so opažali zelo redke primere zlatenice in neinfekcijskega hepatitisa in nekateri od njih so imeli značilnosti avtoimunskega hepatitisa.
If jaundice and/ or ALT elevations ≥ 5 times the upper limit of normal develop(s), Remicade should be discontinued, and a thorough investigation of the abnormality should be undertaken.
Če se pojavi zlatenica in/ ali zvišanje vrednosti ALT ≥ 5 - kratno zgornjo mejo normale, prenehajte z uporabo zdravila Remicade in temeljito raziščite vzroke za nenormalne izvide.
Concurrent administration of TNF-alpha inhibitor and anakinra Serious infections were seen in clinical studies with concurrent use of anakinra and another TNFα - blocking agent, etanercept, with no added clinical benefit compared to etanercept alone.
Sočasno zdravljenje z zaviralcem TNFα in anakinro V kliničnih študijah, v katerih so sočasno uporabljali anakinro in drug zaviralec TNFα - etanercept, so opažali resne okužbe, ni pa bilo nikakršnih dodatnih koristnih kliničnih učinkov v primerjavi z uporabo samega etanercepta.
Because of the nature of the adverse events seen with combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNFα -blocking agents.
Glede na vrsto neželenih sopojavov, ki so jih opažali pri kombinirani terapiji z etanerceptom in anakinro, lahko podobni toksični učinki nastopijo tudi kot posledica kombiniranja anakinre in drugih zaviralcev TNFα.
Vaccinations No data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines in patients receiving anti-TNF therapy.
Cepljenja Ni podatkov o odzivu na cepljenje z živimi cepivi ali o sekundarnem prenosu okužbe z živimi cepivi pri bolnikih, ki prejemajo anti- TNF terapijo.
It is recommended that live vaccines not be given concurrently.
Priporočamo, da živih cepiv ne dajete sočasno.
It is recommended that paediatric Crohn’ s disease patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Remicade therapy.
Priporočamo, da pri pediatričnih bolnikih s Crohnovo boleznijo če je le mogoče opravite vsa cepljenja, v skladu s tekočimiz veljavnimi smernicami za cepljenje otrok, preden pri njih uvedete zdravljenje z zdravilom Remicade.
Autoimmune processes The relative deficiency of TNFα caused by anti-TNF therapy may result in the initiation of an autoimmune process.
Avtoimunski procesi Relativno pomanjkanje TNFα kot posledica anti- TNF terapije lahko sproži avtoimunski proces.
If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Remicade and is positive for antibodies against double-stranded DNA, further treatment with Remicade must not be given (see section 4.8: “ Anti-nuclear antibodies (ANA)/ Double- stranded DNA (dsDNA) antibodies”).
Če se po zdravljenju z zdravilom Remicade pri bolniku pojavijo simptomi, ki kažejo na lupusu podoben sindrom, in je bolnik pozitiven na protitelesa proti dvojnoverižni DNA, ne sme več prejeti tega zdravila (glejte poglavje 4. 8: “ Protitelesa proti celičnemu jedru (ANA - anti- nuclear antibodies) / protitelesa proti dvojnoverižni DNA (dsDNA) ”).
Neurological events Infliximab and other agents that inhibit TNFα have been associated in rare cases with optic neuritis, seizure and new onset or exacerbation of clinical symptoms and/ or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis, and peripheral demyelinating disorders, including Guillain-Barré syndrome.
Nevrološki pojavi Infliksimab in druga zdravila, ki zavirajo TNFα, so bila v redkih primerih povezana z nevritisom vidnega živca, epileptičnimi napadi in novim pojavom ali poslabšanjem kliničnih simptomov in/ ali z rentgenskimi znaki demielinizirajoče bolezni osrednjega živčevja, vključno z multiplo sklerozo in demielinizirajoče bolezni perifernega živčevja, vključno z Guillain- Barréjevim sindromom.
In patients with pre-existing or recent onset of demyelinating disorders, the benefits and risks of Remicade treatment should be carefully considered before initiation of Remicade therapy.
Pri 8 bolnikih z obstoječo ali nedavno nastalo demielinizirajočo boleznijo morate pred uvedbo terapije z zdravilom Remicade skrbno pretehtati razmerje med tveganji in koristmi zdravljenja za bolnika.
Malignancies and lymphoproliferative disorders In the controlled portions of clinical studies of TNF-blocking agents, more cases of malignancies including lymphoma have been observed among patients receiving a TNF blocker compared with control patients.
Maligne in limfoproliferativne bolezni V kontroliranih delih kliničnih študij zaviralcev TNF so opažali več primerov rakavih bolezni, vključno z limfomom med bolniki, ki so prejemali zaviralec TNF, kot pri kontrolni skupini.