FrancophonIA/ELRC3.0 huggingface dataset:
English: control = All patients had active RA despite treatment with stable methotrexate doses for 6 months prior to enrolment and were to remain on stable doses throughout the study.
Slovenian: Kontrolna skupina: Vsi bolniki so imeli aktivni revmatoidni artritis kljub zdravljenju s stalnimi odmerki metotreksata že 6 mesecev pred vključitvijo v študijo; te odmerke so prejemali še naprej ves čas študije.
English: Infliximab is a chimeric human-murine IgG1 monoclonal antibody produced in murine hybridoma cells by recombinant DNA technology.
Slovenian: Infliksimab je himerno človeško-glodalsko monoklonsko protitelo IgG1, pridobljeno iz celic glodalskega hibridoma s tehnologijo rekombinantne DNK.
English: Ask your doctor to record the type and date of last screening(s) for tuberculosis (TB) below: Test
Slovenian: Zdravnik naj zabeleži tip in datum zadnjega presejalnega(ih) testa(ov) za tuberkulozo (TBC):
English: All patients were required to be on a stable dose of 6-MP, AZA or MTX (35% were also receiving corticosteroids at baseline).
Slovenian: Vsi bolniki so morali prejemati stalen odmerek 6-MP, AZA ali MTX (35 % jih je na začetku prejemalo tudi kortikosteroide).
English: • Inflammation of the lining of the brain (meningitis)
Slovenian: • vnetje možganskih ovojnic (meningitis)
English: Lung disease or heavy smoking
Slovenian: Pljučna bolezen ali bolniki, ki veliko kadijo
English: The combination of Remicade and abatacept is not recommended.
Slovenian: Kombiniranje zdravila Remicade in abatacepta torej ni priporočljivo.
English: Infliximab-treated patients demonstrated significant improvement in physical function as assessed by HAQ.
Slovenian: Pri bolnikih, zdravljenih z infliksimabom, so ugotovili bistveno izboljšanje funkcije sklepov, kar so ocenjevali z vprašalnikom HAQ.
English: • Circulation problems such as low or high blood pressure
Slovenian: • težave s krvnim obtokom, na primer nizek ali visok krvni tlak
English: Invasive fungal infections
Slovenian: Invazivne glivične okužbe
English: Remicade has been studied only in combination with conventional immunosuppressive therapy.
Slovenian: Zdravilo so preučevali le v kombinaciji z običajno imunosupresivno terapijo.
English: • The active substance is infliximab.
Slovenian: • Učinkovina je infliksimab.
English: Remicade 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.
Slovenian: Zdravljenje z zdravilom Remicade mora uvesti in nadzorovati kvalificiran zdravnik, ki je izkušen v diagnostiki in zdravljenju revmatoidnega artritisa, vnetnih bolezni črevesa, ankilozirajočega spondilitisa, psoriatičnega artritisa ali psoriaze.
English: Due to methodological limitations, a negative assay did not exclude the presence of antibodies to infliximab.
Slovenian: Zaradi pomanjkljivosti uporabljene metode pa negativen izvid ni izključil možnosti za prisotnost protiteles proti infliksimabu.
English: Significant improvements in health-related quality of life were also demonstrated as measured by the physical and mental component summary scores of the SF-36 in IMPACT 2.
Slovenian: Ugotovili so tudi bistveno izboljšanje kakovosti življenja v zvezi z zdravjem, kar so merili na podlagi delnih ocen, to je seštevkov za telesne in duševne komponente SF-36 v študiji IMPACT 2.
English: • Re-administration: 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).
Slovenian: • Ponovna uporaba zdravila: Infuzija v odmerku 5 mg/kg, če se ponovijo znaki in simptomi bolezni, čemur naj sledijo infuzije v odmerku 5 mg/kg na vsakih 8 tednov (glejte poglavje “Ponovna uporaba zdravila” spodaj in poglavje 4.4).
English: 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.
Slovenian: (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.
English: Heart problems
Slovenian: Težave s srcem
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 prevelik odmerek zdravila Remicade Ker boste zdravilo prejeli od zdravnika ali medicinske sestre, je zelo malo verjetno, da ga boste prejeli preveč.
English: Structural joint damage (erosions and joint space narrowing) in both hands and feet was measured by the change from baseline in the total van der Heijde-modified Sharp score (0-440).
Slovenian: Strukturne okvare sklepov (erozije in zožitev sklepne špranje) tako na rokah kot na stopalih so merili na podlagi spremembe skupnega rezultata po metodi van der Heijde, modificirani po Sharpu (0 - 440) glede na začetne vrednosti.
English: Caution should also be exercised in patients with psoriasis and a medical history of extensive immunosuppressant therapy or prolonged PUVA treatment.
Slovenian: Previdnost je potrebna tudi pri bolnikih s psoriazo in obsežno imunosupresivno terapijo ali daljšim zdravljenjem s PUVA v anamnezi.
English: 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.
Slovenian: Pri Crohnovi bolezni je malo izkušenj s ponovnim dajanjem zdravila po ponovitvi znakov in simptomov bolezni, primerjalnih podatkov o razmerju med koristmi in tveganji drugih možnosti nadaljnjega zdravljenja pa ni.
English: Care should be taken and patients should continue to be monitored when switching from one biologic to another, since overlapping biological activity may further increase the risk for adverse reactions, including infection.
Slovenian: Prehod na zdravljenje z drugim biološkim zdravilom tipa DMARD Pri prehodu z enega biološkega zdravila na drugega je potrebna previdnost, bolnike pa je treba še naprej spremljati, ker se zaradi prekrivanja biološke učinkovitosti lahko še poveča tveganje za neželene učinke, vključno z okužbami.
English: • Low blood counts, including a severely decreased number of white blood cells
Slovenian: • nizko število krvnih celic, vključno z močnim znižanjem števila belih kvnih celic
English: Because of the nature of the adverse reactions seen with combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNF-blocking agents.
Slovenian: Glede na vrsto neželenih učinkov, ki so jih opažali pri kombinirani terapiji z etanerceptom in anakinro, lahko podobni toksični učinki nastopijo tudi kot posledica kombiniranja anakinre in drugih zaviralcev TNF.
English: • Blood problems such as anaemia or low white blood cell count
Slovenian: • težave s krvjo kot na primer anemija ali nizko število belih krvnih celic
English: In carefully selected adult patients who have tolerated at least 3 initial 2-hour infusions of Remicade (induction phase) and are receiving maintenance therapy, consideration may be given to administering subsequent infusions over a period of not less than 1 hour.
Slovenian: Skrajšane infuzije pri indikacijah za odrasle bolnike Pri skrbno izbranih odraslih bolnikih, ki so dobro prenesli vsaj 3 začetne 2-urne infuzije zdravila Remicade (uvajalna faza zdravljenja) in so trenutno na vzdrževalnem zdravljenju, lahko razmislite o skrajšanju naslednjih infuzij, vendar ne na manj kot 1 uro.
English: 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).
Slovenian: 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).
English: Of these 108 patients, 27 were treated with the recommended dosage of infliximab 5 mg/kg.
Slovenian: 27 od teh 108 bolnikov so zdravili s priporočenim odmerkom infliksimaba, 5 mg/kg.
English: After infliximab treatment, patients exhibited decreased levels of serum interleukin 6 (IL-6) and C-reactive protein (CRP), and increased haemoglobin levels in rheumatoid arthritis patients with reduced haemoglobin levels, compared with baseline.
Slovenian: Po zdravljenju z infliksimabom se je pri bolnikih zmanjšala serumska koncentracija interlevkina 6 (IL-6) in C-reaktivnega proteina (CRP) in zviša nivo hemoglobina pri bolnikih z revmatoidnim artritisom, ki imajo ta nivo sicer znižan, v primerjavi z izhodiščno vrednostjo.
English: Upon removal from refrigerated storage, Remicade must not be returned to refrigerated storage.
Slovenian: Ko zdravilo Remicade enkrat vzamete iz hladilnika, ga ne smete vrniti nazaj v hladilnik.
English: The efficacy of infliximab was assessed in two multicenter, randomised, double-blind studies: SPIRIT and EXPRESS.
Slovenian: Učinkovitost infliksimaba so ocenjevali v dveh multicentričnih, randomiziranih, dvojno slepih študijah: SPIRIT in EXPRESS.
English: • Small red or purple spots caused by bleeding under the skin
Slovenian: • majhne rdeče ali vijolične pike zaradi podkožnih krvavitev
English: Warnings and precautions Talk to your doctor before or during treatment with Remicade if you have:
Slovenian: Opozorila in previdnostni ukrepi Pred ali med zdravljenjem z zdravilom Remicade se v naslednjih primerih posvetujte z zdravnikom:
English: In psoriatic arthritis, short term treatment with Remicade reduced the number of T-cells and blood vessels in the synovium and psoriatic skin.
Slovenian: Pri psoriatičnem artritisu je kratkotrajno zdravljenje z zdravilom Remicade zmanjšalo število celic T in krvnih žil v sinovialni ovojnici in v psoriatično spremenjeni koži.
English: Week 10
Slovenian: 10. teden
English: Isolated cases of liver failure resulting in liver transplantation or death have occurred.
Slovenian: V osamljenih primerih je prišlo do odpovedi jeter, ki je zahtevala transplantacijo jeter ali povzročila smrt.
English: Cases of transient visual loss occurring during or within 2 hours of Remicade infusion have been reported.
Slovenian: Poročali so o primerih prehodne izgube vida, ki je nastopila med infundiranjem ali v roku 2 ur po prejemu infuzije zdravila Remicade.
English: It is recommended that paediatric patients, if possible, be brought up to date with all vaccinations in agreement with current vaccination guidelines prior to initiating Remicade therapy.
Slovenian: Priporočljivo je, da se pri pediatričnih bolnikih pred uvajanjem zdravila Remicade, če je mogoče, opravijo vsa cepljenja v skladu s trenutnimi smernicami za cepljenje.
English: In the re-treatment arm, 4% (8/219) of patients experienced a serious infusion reaction versus < 1% (1/222) on maintenance therapy.
Slovenian: V kraku za ponovno zdravljenje so imeli 4 % bolnikov (8/219) resno z infuzijo povezano reakcijo, v primerjavi z < 1 % bolnikov (1/222) na vzdrževalnem zdravljenju.
English: The elimination pathways for infliximab have not been characterised.
Slovenian: Poti izločanja infliksimaba niso bile ugotovljene.
English: Secondary endpoints included the proportion of patients in clinical remission at week 4 (CDAI < 150) and clinical response over time.
Slovenian: Sekundarna cilja študije sta bila odstotek bolnikov v klinični remisiji v 4. tednu (CDAI < 150) in klinični odziv po času.
English: The primary endpoint of the study was corticosteroid-free clinical remission at week 26, defined as patients in clinical remission (CDAI of < 150) who, for at least 3 weeks, had not taken oral systemic corticosteroids (prednisone or equivalent) or budesonide at a dose > 6 mg/day.
Slovenian: Primarni končni opazovani dogodek študije je bila klinična remisija bolezni brez jemanja kortikosteroidov v 26. tednu, ki je bila opredeljena z bolniki v klinični remisiji (vrednost CDAI < 150), ki najmanj 3 tedne niso jemali peroralnih sistemskih kortikosteroidov (prednizona oziroma njemu enakovrednih kortikosteroidov) ali budezonida v odmerku > 6 mg/dan.
English: Infusion reactions occurred in 35% of patients with juvenile rheumatoid arthritis receiving 3 mg/kg compared with 17.5% of patients receiving 6 mg/kg.
Slovenian: Z infuzijo povezane reakcije so se pojavile pri 35 % bolnikov z juvenilnim revmatoidnim artritisom, ki so prejemali odmerek 3 mg/kg, v primerjavi s 17,5 % tistih, ki so prejemali odmerek 6 mg/kg.
English: Remicade will generally be stored by the health professionals.
Slovenian: V glavnem bodo za shranjevanje zdravila Remicade poskrbeli zdravstveni delavci.
English: • You should receive recommended vaccinations before starting Remicade treatment.
Slovenian: • Vsa priporočena cepljenja morate prejeti pred začetkom zdravljenja z zdravilom Remicade.
English: In this study 150 patients with NYHA Class III-IV CHF (left ventricular ejection fraction ≤ 35%) were treated with 3 infusions of Remicade 5 mg/kg, 10 mg/kg, or placebo over 6 weeks.
Slovenian: 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: zdravilo Remicade v odmerkih 5 mg/kg, 10 mg/kg ali s placebom več kot 6 tednov.
English: Cancer and lymphoma
Slovenian: Rak in limfom
English: Psoriasis is an inflammatory disease of the skin.
Slovenian: Psoriaza (luskavica) je vnetna bolezen kože.
English: Of the patients who required a dose titration, 80% achieved clinical response and the majority (64%) of these required only one adjustment of 1.5 mg/kg.
Slovenian: Pri večini (67 %) teh bolnikov ni bila potrebna nikakršna titracija odmerka, med tistimi, pri katerih pa je bila titracija odmerka potrebna, jih je kar 80 % doseglo klinični odziv in večina njih (64 %) je potrebovala le eno prilagoditev odmerka za 1,5 mg/kg.
English: In patients receiving anti-TNF therapy, limited data are available on the response to vaccination with live vaccines or on the secondary transmission of infection by live vaccines.
Slovenian: Živa cepiva/povzročitelji okužb v terapevtske namene Pri bolnikih, ki prejemajo anti-TNF terapijo, je na voljo malo podatkov o odzivu na cepljenje z živimi cepivi ali o sekundarnem prenosu okužbe, povzročene z živimi cepivi.
English: In a 6-month repeated dose toxicity study in mice, using the same analogous antibody against mouse TNF, crystalline deposits were observed on the lens capsule of some of the treated male mice.
Slovenian: V 6-mesečni študiji toksičnosti pri ponavljajočih se odmerkih pri miših z uporabo istega analognega protitelesa proti mišjem TNF so opažali kopičenje kristalov na lečni kapsuli nekaterih mišjih samcev, ki so prejemali zdravilo.
English: This includes multiple sclerosis, Guillain-Barre syndrome, if you have fits or have been diagnosed with ‘optic neuritis'.
Slovenian: To vključuje bolezni, kot so multipla skleroza, Guillain-Barréjev sindrom, če ste imeli napade krčev ali so vam diagnosticirali
English: Signs include joint pain or a rash on cheeks or arms that is sensitive to the sun.
Slovenian: Znaki vključujejo bolečino v sklepih ali izpuščaj na licih ali rokah, ki je občutljiv na sončno svetlobo.
English: p-value
Slovenian: p vrednost
English: Among patients classified as non-responders at week 2, 32% (26/81) in the placebo maintenance group and 42% (68/163) in the infliximab group achieved clinical response by week 6.
Slovenian: Med bolniki, uvrščenimi v skupino brez odziva v 2. tednu, pa jih je 32 % (26/81) iz skupine za vzdrževalno zdravljenje s placebom in 42 % (68/163) iz skupine za prejemanje infliksimaba doseglo klinični odziv v 6. tednu.
English: In rheumatoid arthritis, treatment with infliximab reduced infiltration of inflammatory cells into inflamed areas of the joint as well as expression of molecules mediating cellular adhesion, chemoattraction and tissue degradation.
Slovenian: Pri revmatoidnem artritisu je zdravljenje z infliksimabom zmanjšalo infiltracijo vnetnih celic v vnete dele sklepov, pa tudi ekspresijo molekul, ki sodelujejo pri celični adheziji, kemotaksi in razgradnji tkiva.
English: At week 24, the placebo group crossed over to infliximab induction therapy (5 mg/kg) followed by infliximab maintenance therapy (5 mg/kg).
Slovenian: V 24. tednu je skupina za placebo prešla na uvodno terapijo z infliksimabom (5 mg/kg), potem pa je sledila vzdrževalna terapija z infliksimabom (5 mg/kg).
English: • A statement that the brand name and batch number should be recorded
Slovenian: • Navedba glede potrebnega beleženja imena ter številke serije zdravila.
English: In ASSERT, improvement in signs and symptoms was observed as early as week 2.
Slovenian: V študiji ASSERT so že v 2. tednu opazili izboljšanje znakov in simptomov bolezni.
English: • It is important that you tell your baby's doctors and other healthcare professionals about your Remicade use before your baby is given any vaccine.
Slovenian: • Pomembno je, da zdravniku vašega dojenčka in drugim zdravstvenim delavcem poveste, da ste prejemali zdravilo Remicade, še preden dojenček dobi katero koli cepivo.
English: • Talk to your doctor if you recently have had or are due to have a vaccine.
Slovenian: • Obvestite zdravnika, če ste bili pred kratkim cepljeni ali boste cepljeni.
English: 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).
Slovenian: 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).
English: Additionally, closure of all fistulae was achieved in 55% of infliximab-treated patients compared with 13% of placebo-treated patients (p = 0.001).
Slovenian: Dodatno so pri 55 % bolnikov zdravljenih z infliksimabom dosegli zapiranje vseh fistul, v primerjavi s 13 % bolnikov, ki so prejemali placebo (p = 0,001).
English: Can be stored at room temperature (up to 25 °C) for a single period up to 6 months, but not exceeding the original expiry date.
Slovenian: Lahko se shranjuje pri sobni temperaturi (do 25 °C) za enkratno obdobje do 6 mesecev, vendar ne dlje od originalnega datuma izteka roka uporabnosti.
English: Abnormal skin openings
Slovenian: Nenormalne odprtine na koži
English: 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 Remicade treatment should be carefully considered before initiation of Remicade therapy.
Slovenian: 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.
English: • treatment of fistulising, active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with conventional treatment (including antibiotics, drainage and immunosuppressive therapy).
Slovenian: • zdravljenje aktivne Crohnove bolezni s fistulami pri odraslih bolnikih, ki se niso odzvali na celoten in ustrezen ciklus konvencionalnega zdravljenja (vključno z antibiotiki, drenažo in imunosupresivno terapijo).
English: In this study, there were more patients in the 12 to 17 year age group than in the 6 to 11 year age group (45/60 [75.0%]) vs.15/60 [25.0%]).
Slovenian: V tej študiji je bilo več bolnikov v starostni skupini od 12 do 17 let (45/60 [75,0 %]) kot v starostni skupini od 6 do 11 let 15/60 [25,0 %]).
English: The effects observed at 54 weeks were maintained through 102 weeks.
Slovenian: Učinki, ki so jih opažali v 54. tednu zdravljenja, so bili še vedno prisotni tudi v 102. tednu.
English: Currently available data are described in sections 4.8 and 5.2 but no recommendation on a posology can be made.
Slovenian: Podatki, ki so trenutno na voljo, so podani v poglavjih 4.8 in 5.2, vendar ni mogoče podati priporočil za odmerjanje.
English: Patients with moderate or severe heart failure (NYHA class III/IV) (see sections 4.4 and 4.8).
Slovenian: Bolniki z zmernim do hudim srčnim popuščanjem (razred III/IV po NYHA) (glejte poglavji 4.4 in
English: Infections were reported in 31 (51.7%) of 60 treated patients in C0168T72 and 22 (36.7%) required oral or parenteral antimicrobial treatment.
Slovenian: O okužbah so v preskušanju C0168T72 poročali pri 31 (51,7 %) od 60 zdravljenih bolnikov in 22 (36,7 %) jih je potrebovalo peroralno ali parenteralno protimikrobno zdravljenje.
English: • Balance problems or feeling dizzy
Slovenian: • težave z ravnotežjem ali občutek omotice
English: In the first clinical study (IMPACT), efficacy and safety of infliximab were studied in 104 patients with active polyarticular psoriatic arthritis.
Slovenian: V prvi študiji (IMPACT) so proučevali učinkovitost in varnost infliksimaba pri 104 bolnikih z aktivnim poliartikularnim psoriatičnim artritisom.
English: • It is very important that you tell your doctor if you have ever had TB or if you have been in close contact with someone who has had or has TB.
Slovenian: • Zelo pomembno je, da zdravniku poveste, če ste imeli kdaj v preteklosti tuberkulozo ali če ste bili v tesnejšem stiku z osebo s tuberkulozo ali z osebo, ki je v preteklosti imela tuberkulozo.
English: In this study, there were more patients in the 12 to 17 year age group than in the 6 to 11 year age group (45/60 vs.15/60).
Slovenian: V tej študiji je bilo več bolnikov v starostni skupini od 12 do 17 let (45/60) kot v starostni skupini od 6 do 11 let (15/60).
English: Available data do not support further infliximab treatment, in patients not responding within 6 weeks of the initial infusion.
Slovenian: Podatki, ki so na voljo, ne govorijo v prid nadaljevanju zdravljenja z infliksimabom pri bolnikih, ki se niso odzvali na zdravilo v roku 6 tednov po prvi infuziji.
English: Sustained remission (in remission at both week 8 and week 30)
Slovenian: Trajnejša remisija (remisija tako v 8. tednu kot v
English: A patient who requires surgery while on Remicade should be closely monitored for infections, and appropriate actions should be taken.
Slovenian: Bolnika, pri katerem je med zdravljenjem z zdravilom Remicade potreben kirurški poseg, morate skrbno spremljati, da ugotovite morebitne okužbe, in uvesti ustrezne ukrepe.
English: With the current knowledge, a risk for the development of lymphomas or other malignancies in patients treated with a TNF-blocking agent cannot be excluded (see section 4.8).
Slovenian: Glede na sedanje znanje ni mogoče izključiti tveganja za pojav limfomov ali drugih malignih bolezni pri bolnikih, zdravljenih z zaviralci TNF (glejte poglavje 4.8).
English: In both studies concurrent use of stable doses of folic acid, oral corticosteroids (≤ 10 mg/day) and/or non-steroidal antiinflammatory drugs (NSAIDs) was permitted.
Slovenian: V obeh študijah je bilo dovoljeno sočasno jemanje stalnih odmerkov folne kisline, peroralnih kortikosteroidov (≤ 10 mg/dan) in/ali nesteroidnih protivnetnih zdravil (NSAID).
English: Anti-dsDNA antibodies were newly detected in approximately 17% of infliximab-treated patients compared with 0% of placebo-treated patients.
Slovenian: Protitelesa anti-dsDNA so na novo ugotovili pri približno 17 % bolnikov, zdravljenih z infliksimabom, v primerjavi z 0 % bolnikov, ki so prejemali placebo.
English: Patients should be closely monitored and Remicade must not be continued in patients who develop new or worsening symptoms of heart failure (see sections 4.3 and 4.8).
Slovenian: Zdravljenja z zdravilom Remicade ne smete nadaljevati pri bolnikih, pri katerih se pojavijo ali poslabšajo simptomi srčnega popuščanja (glejte poglavji 4.3 in 4.8).
English: Re-administration across indications
Slovenian: Ponovna uporaba zdravila za vse indikacije