FrancophonIA/ELRC3.0 huggingface dataset:
English: In patients treated with Flixabi, an invasive fungal infection such as aspergillosis, candidiasis, pneumocystosis, histoplasmosis, coccidioidomycosis or blastomycosis should be suspected if they develop a serious systemic illness, and a physician with expertise in the diagnosis and treatment of invasive fungal infections should be consulted at an early stage when investigating these patients.
Slovenian: Če se pri bolnikih, zdravljenih z zdravilom Flixabi, razvije resna sistemska bolezen, je treba posumiti na invazivno glivično okužbo, kot so aspergiloza, kandidiaza, pnevmocistoza, histoplazmoza, kokcidioidomikoza ali blastomikoza, poleg tega pa je pri teh bolnikih že zgodaj v poteku preiskav potreben posvet z zdravnikom, ki ima strokovno znanje iz diagnostike in zdravljenja invazivnih glivičnih okužb.
English: The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of psoriasis have not been established.
Slovenian: Varnost in učinkovitost infliksimaba pri otrocih in mladostnikih, mlajših od 18 let, za indikacijo psoriaza nista bili dokazani.
English: Infliximab Maintenance 5 mg/kg (n=113) (p value)
Slovenian: vzdrževalno zdravljenje z infliksimabom 5 mg/kg (n = 113) (p vrednost)
English: Flixabi and Kineret should not be used together.
Slovenian: Zdravili Flixabi in Kineret se ne smeta uporabljati skupaj.
English: Flixabi contains sodium
Slovenian: Zdravilo Flixabi vsebuje natrij
English: If these medicines do not work well enough, you will be given Flixabi to treat your disease.
Slovenian: Če ta zdravila ne delujejo dovolj dobro, boste prejeli zdravilo Flixabi za zdravljenje vaše bolezni.
English: As this medicine is being given by your doctor or nurse, it is unlikely that you will be given too much.
Slovenian: Če ste prejeli večji odmerek zdravila Flixabi, kot bi smeli Ker boste zdravilo prejeli od zdravnika ali medicinske sestre, je zelo malo verjetno, da ga boste prejeli preveč.
English: • Tell your doctor if you have or have ever had a problem that affects your nervous system before you are given Flixabi.
Slovenian: • Povejte zdravniku, če imate ali ste kdaj prej že imeli kakršne koli nevrološke težave, preden se začnete zdraviti z zdravilom Flixabi.
English: Induction treatment in moderately to severely active Crohn's disease The efficacy of a single dose treatment with infliximab was assessed in 108 patients with active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 ≤ 400) in a randomised, double-blinded, placebocontrolled, dose-response study.
Slovenian: Začetno zdravljenje pri zmerno do močno aktivni Crohnovi bolezni Učinkovitost infliksimaba v enkratnem odmerku so ocenjevali pri 108 bolnikih z aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 ≤ 400) v randomizirani, dvojno slepi s placebom kontrolirani študiji odziva na različne odmerke zdravila.
English: Caution should be exercised when considering the use of Flixabi in patients with chronic infection or a history of recurrent infections, including concomitant immunosuppressive therapy.
Slovenian: Pri odločanju o uporabi zdravila Flixabi pri bolnikih s kroničnimi okužbami ali ponavljajočimi se okužbami v pretekli anamnezi, pa tudi pri tistih s sočasno imunosupresivno terapijo, je potrebna previdnost.
English: Infliximab Maintenance (5 mg/kg) (n=96)
Slovenian: vzdrževalno zdravljenje z infliksimabom (5 mg/kg) (n = 96)
English: The safety and efficacy of infliximab in children and adolescents younger than 18 years for the indication of juvenile rheumatoid arthritis have not been established.
Slovenian: Varnost in učinkovitost infliksimaba pri otrocih in mladostnikih, mlajših od 18 let, za indikacijo juvenilni revmatoidni artritis nista bili dokazani.
English: Rheumatoid arthritis1
Slovenian: Revmatoidni artritis1
English: In clinical studies delayed hypersensitivity reactions have been uncommon and have occurred after infliximab-free intervals of less than 1 year.
Slovenian: V kliničnih študijah so bile pozne preobčutljivostne reakcije občasne in so se pojavile po premoru brez prejemanja infliksimaba, krajšem od enega leta.
English: Patients who discontinue immunosuppressants prior to or during infliximab treatment are at greater risk of developing these antibodies.
Slovenian: Pri bolnikih, ki prekinejo zdravljenje z zdravili za zaviranje imunske odzivnosti bodisi pred uvedbo zdravljenja z infliksimabom ali med njim, je nevarnost za pojav teh protiteles večja.
English: The safety and efficacy of infliximab were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Slovenian: Varnost in učinkovitost infliksimaba so ocenili v dveh randomiziranih, dvojno slepih in s placebom kontroliranih kliničnih študijah (ACT 1 in ACT 2) pri odraslih bolnikih z zmerno do močno aktivnim ulceroznim kolitisom (ocena Mayo od 6 do 12; delna endoskopska ocena ≥ 2), ki so se nezadostno odzvali na običajno zdravljenje [s peroralnimi kortikosteroidi, aminosalicilati in/ali imunomodulatorji (6-MP, AZA)].
English: Peripheral ischaemia, thrombophlebitis, haematoma.
Slovenian: periferna ishemija, tromboflebitis, hematom redki:
English: Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia.
Slovenian: srčno popuščanje (novo nastalo ali poslabšanje), aritmija, sinkopa, bradikardija redki:
English: Infliximab with or without AZA was assessed in a randomised, double-blind, active comparator study (SONIC) of 508 adult patients with moderate to severe Crohn's disease (CDAI ≥ 220 ≤ 450) who were naive to biologics and immunosuppressants and had a median disease duration of 2.3 years.
Slovenian: Uporabo infliksimaba z ali brez AZA so ovrednotili v randomizirani, dvojno slepi študiji s kontrolno učinkovino (SONIC) pri 508 odraslih bolnikih z zmerno do hudo obliko Crohnove bolezni (CDAI ≥ 220 ≤ 450), ki pred tem niso še nikoli prejemali bioloških zdravil ali imunosupresivov in je bila pri njih mediana vrednost trajanja bolezni 2,3 leta.
English: Significantly fewer colectomies occurred within 3 months of study infusion in patients who received a single dose of 5 mg/kg infliximab compared to patients who received placebo (29.2% vs. 66.7% respectively, p=0.017).
Slovenian: V 3 mesecih infundiranja zdravila v okviru te študije je bilo pri bolnikih, ki so prejeli en sam odmerek infliksimaba 5 mg/kg, opravljenih bistveno manj kolektomij kot pri tistih, ki so prejemali placebo (29,2 % v primerjavi s 66,7 %, p = 0,017).
English: The educational programme consists of a patient reminder card to be held by the patient.
Slovenian: Dodatni ukrepi za zmanjševanje tveganjç Izobraževalni program obsega opozorilno kartico za bolnika, ki jo ima bolnik pri sebi.
English: In the second clinical study (ASSERT), 279 patients were randomised to receive either placebo (Group 1, n=78) or 5 mg/kg infliximab (Group 2, n=201) at 0, 2 and 6 weeks and every 6 weeks to week 24.
Slovenian: V drugem preskušanju (ASSERT) so 279 bolnikov naključno razporedili bodisi v skupino, ki bo prejemala placebo (1. skupina, n = 78), ali pa v skupino, ki bo prejemala infliksimab v odmerku 5 mg/kg (2. skupina, n = 201) v 0., 2. in 6. tednu in kasneje na vsakih 6 tednov, do 24. tedna.
English: • If you received Flixabi while you were pregnant, your baby may also be at higher risk for getting an infection with live vaccines for up to six months after birth.
Slovenian: • Če ste zdravilo Flixabi prejemali v času nosečnosti, lahko tudi pri vašem dojenčku še šest mesecev po rojstvu obstaja večje tveganje za okužbo z živimi cepivi.
English: Crohn's disease Crohn's disease is an inflammatory disease of the bowel.
Slovenian: Crohnova bolezen je vnetna bolezen črevesja.
English: a Reduction in CDAI ≥ 25% and ≥ 70 points.
Slovenian: Ohranjena remisija brez jemanja steroidov b a Zmanjšanje CDAI za ≥ 25 % oziroma ≥ 70 točk.
English: General disorders and administration site conditions Very common:
Slovenian: vaginitis Splošne težave in spremembe na mestu aplikacije zelo pogosti:
English: Dilute the total volume of the reconstituted Flixabi solution dose to 250 ml with sodium chloride 9 mg/ml (0.9%) solution for infusion.
Slovenian: Celoten volumen (odmerek) rekonstituirane raztopine zdravila Flixabi razredčite do 250 ml z 9 mg/ml (0,9 %) raztopino natrijevega klorida za infundiranje.
English: • Swelling of your pancreas (pancreatitis)
Slovenian: • otekanje trebušne slinavke (pankreatitis),
English: Chemical and physical in use stability of the reconstituted solution has been demonstrated for 24 hours at 25°C.
Slovenian: Dokazali so, da je rekonstituirana raztopina zdravila Flixabi kemično in fizikalno stabilna 24 ur pri 25 °C.
English: • Low platelet count, too many white blood cells
Slovenian: • nizko število trombocitov, preveliko število belih krvnih celic,
English: The median AUCss in paediatric patients aged 2 years to less than 6 years was predicted to be approximately 40% lower than that in adults, although the number of patients supporting this estimate is limited.
Slovenian: Pri pediatričnih bolnikih, starih od 2 leti do manj kot 6 let, je bila napovedana mediana vrednost AUCss 40 % nižja kot pri odraslih,
English: • Swelling of the liver (hepatitis) or gall bladder, liver damage
Slovenian: • otekanje jeter (hepatitis) ali žolčnika, okvara jeter,
English: * P-values represent each infliximab treatment group vs. AZA monotherapy
Slovenian: * P vrednosti predstavljajo vsako skupino, zdravljeno z infliksimabom, v primerjavi z monoterapijo z AZA.
English: Infusion-related reaction, pain.
Slovenian: reakcije povezane z infuzijo, bolečine pogosti:
English: • Eye problems including blurred or reduced vision, puffy eyes or sties
Slovenian: • težave z očmi, vključno z zamegljenim vidom ali slabovidnostjo, otečene oči ali ječmen na očesu,
English: Hepatitis, hepatocellular damage, cholecystitis.
Slovenian: hepatitis, hepatocelularna okvara, holecistitis redki:
English: • The medicine will be given as an infusion (drip) (over 2 hours) into one of your veins, usually in your arm. After the third treatment, your doctor may decide to give your dose of Flixabi over 1 hour.
Slovenian: • Zdravilo vam bodo dali v obliki infuzije (kapalne) (v času 2 ur) v eno od ven, običajno v roki.
English: Fewer subjects underwent colectomy in the 5 mg/kg infliximab group (28/242 or 11.6% [N.S.]) and the 10 mg/kg infliximab group (18/242 or 7.4% [p=0.011]) than in the placebo group (36/244; 14.8%).
Slovenian: Ugotovili so, da je bilo treba v terapevtskih skupinah, ki sta prejemali po 5 mg/kg infliksimaba (28/242 ali 11,6 % [neznačilno]) oziroma po 10 mg/kg infliksimaba (18/242 ali 7,4 % [p = 0,011]) pri manjšem številu preiskovancev opraviti kolektomijo kot pa v skupini, ki je prejemala placebo (36/244; 14,8 %).
English: If these medicines do not work well enough, you will be given Flixabi to:
Slovenian: Če ta zdravila ne delujejo dovolj dobro, boste prejeli zdravilo Flixabi za:
English: • Lung or chest infections such as bronchitis or pneumonia
Slovenian: • okužbe pljuč in prsnega koša, na primer bronhitis ali pljučnica,
English: Date of Flixabi therapy initiation:
Slovenian: Datum začetka zdravljenja z zdravilom Flixabi: Trenutno odmerjanje:
English: • Psoriasis, skin problems such as eczema and hair loss
Slovenian: • luskavica, kožne težave, kot na primer ekcem, in izpadanje las,
English: • Lung problems (such as oedema)
Slovenian: • težave s pljuči (na primer edem),
English: • Collection of blood outside the blood vessels (haematoma) or bruising
Slovenian: • kopičenje krvi izven krvnih žil (hematom) ali nastajanje podplutb,
English: Patients treated with Flixabi should be given the patient reminder card.
Slovenian: Bolniki, zdravljeni z zdravilom Flixabi, morajo prejeti opozorilno kartico za bolnika.
English: Change from baseline in total van der Heijde-modified Sharp score b
Slovenian: Sprememba z začetne vrednosti za skupni rezultat po metodi van der Heijde, modificirani po Sharpub Srednja vrednost ± SDa
English: Elevated concentrations of TNFα have been found in the joints of rheumatoid arthritis patients and correlate with elevated disease activity.
Slovenian: V sklepih bolnikov z revmatoidnim artritisom so ugotavljali povečano koncentracijo TNFα in ta je bila v korelaciji s povečano aktivnostjo bolezni.
English: Infliximab Maintenance 10 mg/kg (n=112) (p value)
Slovenian: vzdrževalno zdravljenje z infliksimabom 10 mg/kg (n = 112) (p vrednost)
English: Hepatic function abnormal, transaminases increased.
Slovenian: nenormalno delovanje jeter, zvišane vrednosti transaminaz občasni:
English: In Phase III clinical studies, 18% of infliximab-treated patients compared with 5% of placebo-treated patients experienced an infusion-related reaction.
Slovenian: V kliničnih študijah faze III se je pri 18 % bolnikov, zdravljenih z infliksimabom, med infundiranjem pojavila z infuzijo povezana reakcija, v primerjavi s 5 % bolnikov, ki so prejemali placebo.
English: In Group 2, starting with the week 36 infusion, patients who had a BASDAI ≥ 3 at 2 consecutive visits, received 7.5 mg/kg infliximab every 6 weeks thereafter through week 96.
Slovenian: 1. skupina je prejemala 5 mg/kg infliksimaba, v 2. skupini pa so od infuzije v 36. tednu vsi bolniki, ki so imeli BASDAI ≥ 3 pri 2 zaporednih obiskih, prejemali po 7,5 mg/kg infliksimaba na vsakih 6. tednov, do 96. tedna.
English: Before treatment with Flixabi
Slovenian: Pred zdravljenjem z zdravilom Flixabi
English: A greater proportion of patients in the combined infliximab treatment group were able to discontinue corticosteroids while remaining in clinical remission compared to the placebo treatment group at both week 30 (22.3% vs. 7.2%, p < 0.001, pooled ACT 1 & ACT 2 data) and week 54 (21.0% vs. 8.9%, p=0.022, ACT 1 data).
Slovenian: V (združeni) skupini, ki se je zdravila z infliksimabom, so pri večjem odstotku bolnikov lahko ukinili kortikosteroide ob ohranjeni klinični remisiji kot pri skupini, ki je prejemala placebo, kar velja tako za 30. teden (22,3 % v primerjavi s 7,2 %, p < 0,001, združeni podatki iz preskušanj ACT 1 in ACT 2) kot za 54. teden (21,0 % v primerjavi z 8,9 %, p = 0,022, podatki iz preskušanja ACT 1).
English: It is recommended that patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Flixabi therapy.
Slovenian: Priporočljivo je, da bolniki pred uvajanjem zdravila Flixabi, če je mogoče, opravijo vsa cepljenja v skladu s trenutnimi veljavnimi smernicami za cepljenje.
English: The safety and efficacy of infliximab have not been studied in children with Crohn's disease below the age of 6 years.
Slovenian: Varnost in učinkovitost infliksimaba pri otrocih s Crohnovo boleznijo, mlajših od 6 let, nista bili dokazani.
English: Children and adolescents who took infliximab for Crohn's disease showed some differences in side effects compared with adults who took infliximab for Crohn's disease.
Slovenian: Dodatni neželeni učinki pri otrocih in mladostnikih Neželeni učinki pri otrocih in mladostnikih, ki so prejemali infliksimab za zdravljenje Crohnove bolezni, so se nekoliko razlikovali od tistih pri odraslih, ki so prejemali infliksimab za zdravljenje Crohnove bolezni.
English: Hypotension, hypertension, ecchymosis, hot flush, flushing.
Slovenian: hipotenzija, hipertenzija, ekhimoza, vročinski oblivi, zardevanje občasni:
English: • Do not breast-feed when you are being treated with Flixabi or for 6 months after your last treatment with Flixabi.
Slovenian: • Med zdravljenjem z zdravilom Flixabi in še 6 mesecev po zadnjem zdravljenju z njim ne smete dojiti.
English: • Fluid around the lungs (pleural effusion)
Slovenian: • tekočina okrog pljuč (plevralni izliv),
English: Lower respiratory tract infection (e.g. bronchitis, pneumonia), dyspnoea, epistaxis.
Slovenian: okužbe spodnjih dihal (npr. bronhitis, pljučnica), dispneja, epistaksa občasni:
English: Infliximab prevented disease in transgenic mice that develop polyarthritis as a result of constitutive expression of human TNFα and when administered after disease onset, it allowed eroded joints to heal.
Slovenian: Infliksimab je preprečil razvoj poliartritisa pri transgenskih miših, pri katerih ta bolezen nastopi kot posledica konstitucijske ekspresije humanega TNFα.
English: • It is important that you tell your baby's doctors and other healthcare professionals about your Flixabi use before your baby is given any vaccine.
Slovenian: Pomembno je, da zdravniku vašega dojenčka in drugim zdravstvenim delavcem poveste, da ste prejemali zdravilo Flixabi, še preden dojenček dobi katero koli cepivo.
English: If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using Flixabi.
Slovenian: Če niste prepričani, ali kaj od naštetega velja za vas, se posvetujte z zdravnikom ali farmacevtom, preden boste prejeli zdravilo Flixabi.
English: You should not be given Flixabi if
Slovenian: Ne smete prejemati zdravila Flixabi:
English: Ankylosing spondylitis Psoriatic arthritis Plaque psoriasis
Slovenian: Ankilozirajoči spondilitis Psoriatični artritis
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age), including infliximab in the post-marketing setting.
Slovenian: Pri otrocih, mladostnikih in mlajših odraslih (do 22 let starosti), ki so se zdravili z zaviralci TNF (začetek zdravljenja je bil pri starosti ≤ 18 let), vključno z infliksimabom po začetku trženja, so poročali o pojavu malignomov, od katerih so bili nekateri smrtni.
English: • A rare blood cancer affecting mostly teenage boys or young men (hepatosplenic T-cell lymphoma)
Slovenian: • redka vrsta krvnega raka, ki prizadene predvsem najstniške fante in mlade moške
English: If active tuberculosis is diagnosed, Flixabi therapy must not be initiated (see section 4.3).
Slovenian: Če postavite diagnozo aktivne tuberkuloze, ne smete uvesti zdravljenja z zdravilom Flixabi (glejte poglavje 4.3).
English: 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 Flixabi treatment.
Slovenian: Vsem bolnikom morate naročiti, naj pridejo k zdravniku, če se v času zdravljenja z zdravilom Flixabi ali po njem pojavijo znaki ali simptomi, ki kažejo na tuberkulozo (npr. trdovraten kašelj, hujšanje ali nekoliko zvišana telesna temperatura).
English: If a patient shows no response after 14 weeks (i.e. after 4 doses), no additional treatment with Flixabi should be given.
Slovenian: Če bolnik ne pokaže nobenega odziva po 14 tednih (t. j. po 4 odmerkih), ga ne smete več zdraviti zdravilom Flixabi.
English: Mean ± SDd a p < 0.001, for each infliximab treatment group vs control b greater values indicate more joint damage.
Slovenian: d a p < 0,001 za vsako skupino, zdravljeno z infliksimabom, v primerjavi s kontrolno skupino b Večje vrednosti pomenijo večjo okvaro sklepov.
English: Flixabi is supplied as a glass vial containing a powder for concentrate for solution for infusion.
Slovenian: Zdravilo Flixabi je na voljo v steklenih vialah s praškom za koncentrat za raztopino za infundiranje.
English: Other uses of therapeutic infectious agents such as live attenuated bacteria (e.g., BCG bladder instillation for the treatment of cancer) could result in clinical infections, including disseminated infections.
Slovenian: Uporaba povzročiteljev okužb, kot so žive oslabljene bakterije (npr. instilacija BCG v sečni mehur za zdravljenje raka), v druge terapevtske namene lahko povzroči klinične okužbe, vključno z razsejanimi okužbami, zato priporočamo, da jih ne dajete sočasno z zdravilom Flixabi.
English: Crohn's disease2
Slovenian: Crohnova bolezen2
English: Tumour necrosis factor alpha (TNFα) mediates inflammation and modulates cellular immune responses.
Slovenian: Tumorje nekrotizirajoči faktor alfa (TNFα) je mediator vnetnega procesa in vpliva na celični imunski odziv.
English: Toxic epidermal necrolysis, Stevens-Johnson Syndrome, erythema multiforme, furunculosis, linear IgA bullous dermatosis (LABD), acute generalised exanthematous pustulosis (AGEP), lichenoid reactions.
Slovenian: toksična epidermalna nekroliza, Stevens-Johnsonov sindrom, multiformni eritem, furunkuloza, linearna IgA bulozna dermatoza (LABD), akutna generalizirana eksantematozna pustuloza (AGEP - acute generalised exanthematous pustulosis), lihenoidne reakcije neznana pogostnost: poslabšanje simptomov dermatomiozitisa Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti:
English: Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation.
Slovenian: meningitis, oportunistične okužbe (npr. invazivne glivične okužbe [pnevmocistoza, histoplazmoza, aspergiloza, kokcidioidomikoza, kriptokokoza, blastomikoza], bakterijske okužbe [okužbe z atipičnimi mikobakterijami, listerioza, salmoneloza] in virusne okužbe [s citomegalovirusom]), okužbe s paraziti, reaktivacija hepatitisa B neznana pogostnost: okužba po cepljenju (po in utero izpostavitvi infliksimabu)* Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi) redki:
English: If you were using Flixabi during pregnancy, tell your baby's doctor and other healthcare professionals caring for your baby about your Flixabi use before the baby receives any vaccines.
Slovenian: Če ste prejemali zdravilo Flixabi med nosečnostjo, je pomembno, da o tem obvestite otrokovega zdravnika in druge zdravstvene delavce, ki skrbijo za vašega dojenčka, preden vaš dojenček prejme katero koli cepivo.
English: Post-marketing spontaneous serious adverse reactions with infliximab in the paediatric population have included malignancies including hepatosplenic T-cell lymphomas, transient hepatic enzyme abnormalities, lupus-like syndromes, and positive auto-antibodies (see sections 4.4 and 4.8).
Slovenian: Med spontano poročanimi resnimi neželenimi učinki v okviru izkušenj z uporabo infliksimaba iz obdobja trženja pri pediatričnih bolnikih so bili tudi malignomi, vključno s T-celičnimi limfomi jeter in vranice, prehodno nenormalni izvidi jetrnih encimov, lupusu podobni sindromi in pozitivni izvidi na avtoprotitelesa (glejte poglavji 4.4 in 4.8).
English: Flixabi should be administered intravenously.
Slovenian: Zdravilo Flixabi je treba dajati intravensko.
English: Upper respiratory tract infection, sinusitis.
Slovenian: okužba zgornjih dihal, sinusitis pogosti:
English: Concurrent administration of TNF-alpha inhibitor and anakinra Serious infections and neutropenia 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.
Slovenian: Sočasno zdravljenje z zaviralcem TNF-alfa in anakinro V kliničnih študijah, v katerih so sočasno uporabljali anakinro in drug zaviralec TNFα - etanercept, so opažali resne okužbe in nevtropenijo, ni pa bilo nikakršnih dodatnih koristnih kliničnih učinkov v primerjavi z uporabo samega etanercepta.
English: Patients received 3 or 6 mg/kg infliximab as a 3-dose induction regimen (weeks 0, 2, 6 or weeks 14, 16, 20, respectively) followed by maintenance therapy every 8 weeks, in combination with methotrexate.
Slovenian: Ti bolniki so prejemali uvodno shemo iz treh odmerkov infliksimaba 3 mg/kg oziroma 6 mg/kg (v tednih 0, 2 in 6 oziroma v tednih 14, 16 in 20), potem pa je sledilo vzdrževalno zdravljenje na vsakih 8 tednov, v kombinaciji z metotreksatom.