FrancophonIA/ELRC3.0 huggingface dataset:
English: START was a randomised, multicenter, double-blind, 3-arm, parallel-group safety study.
Slovenian: Študija START je bila randomizirana, multicentrična, dvojno slepa študija varnosti zdravila pri vzporednih skupinah in je imela tri krake.
English: Twenty four of these patients (75.0%) regained clinical response after crossing over.
Slovenian: Po tem prehodu se je pri 24 bolnikih (75,0 %) klinični odziv ponovno pojavil.
English: If you have active rheumatoid arthritis you will first be given other medicines.
Slovenian: Če imate aktivni revmatoidni artritis, boste najprej prejeli druga zdravila.
English: At week 14, 282 patients were assessed for clinical response and randomised to receive either placebo or 5 mg/kg infliximab every 8 weeks through week 46.
Slovenian: V štirinajstem tednu zdravljenja so pri 282 bolnikih ocenili klinični odziv in jih naključno razvrstili v skupino zdravljeno s placebom ali skupino ki je prejemala infliksimab 5 mg/kg vsakih 8 tednov skupaj 46 tednov.
English: Patients may be pre-treated with e.g., an antihistamine, hydrocortisone and/or paracetamol to prevent mild and transient effects.
Slovenian: Za preprečevanje blagih in prehodnih učinkov lahko bolnikom pred zdravljenjem z zdravilom Remicade daste premedikacijo, npr. antihistaminik, hidrokortizon in/ali paracetamol.
English: During the 24-week double-blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, 14, and 22 (100 patients in each group).
Slovenian: V 24-tedenski dvojno slepi fazi študije so bolniki prejemali bodisi 5 mg/kg infliksimaba ali pa placebo v 0., 2., 6., 14. in 22. tednu (100 bolnikov v vsaki skupini).
English: Uncommon: Amnesia, agitation, confusion, somnolence, nervousness.
Slovenian: Psihiatrične motnje pogosti: depresija, nespečnost občasni: amnezija, vznemirjenost, zmedenost, zaspanost, živčnost redki: apatija
English: The antibody titres were notably higher for the 3 mg/kg compared to the 6 mg/kg group.
Slovenian: Titri protiteles v skupini, ki je prejemala odmerek 3 mg/kg, so bili opazno višji kot v tisti, ki je prejemala 6 mg/kg.
English: Re-administration for psoriasis
Slovenian: Ponovna uporaba zdravila pri psoriazi
English: • Severely decreased numbers of white blood cells have been reported in infants born to women treated with Remicade during pregnancy.
Slovenian: • Pri dojenčkih, rojenih materam, ki so bile med nosečnostjo zdravljenje z zdravilom Remicade, so poročali o močnem znižanju števila belih krvnih celic.
English: Some cases of active tuberculosis have been reported in patients treated with Remicade during and after treatment for latent tuberculosis.
Slovenian: Pri bolnikih, zdravljenih z zdravilom Remicade, so med in po zdravljenju latentne tuberkuloze poročali o nekaj primerih pojava aktivne tuberkuloze.
English: The safety and efficacy of re-administration, other than every 8 weeks, has not been established (see sections 4.4 and 4.8).
Slovenian: Ponovna uporaba zdravila pri ulceroznem kolitisu Varnosti in učinkovitosti ponovne uporabe, razen na vsakih 8 tednov, še niso ugotovili (glejte poglavji 4.4 in 4.8).
English: • Bleeding in the stomach or intestines, diarrhoea, indigestion, heartburn, constipation
Slovenian: • krvavitev v želodcu ali črevesju, driska, prebavne motnje, zgaga, zaprtje
English: Do not use if visibly opaque particles, discolouration or foreign particles are observed.
Slovenian: Če opazite vidne neprosojne delce, obarvanje ali tuje delce, ga ne smete uporabiti.
English: Caution should be exercised when considering TNF-blocking therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy.
Slovenian: Previdnost je potrebna tudi pri odločanju o uvedbi zdravljenja z zaviralci TNF pri bolnikih z rakavimi boleznimi v pretekli anamnezi ter pri odločanju o tem, ali naj nadaljujete z zdravljenjem pri bolnikih, pri katerih se pojavi nov nova rakava bolezen.
English: Clinical response at week 30
Slovenian: Klinični odziv v 30. tednu
English: Of the 22 subjects that had fistulas at baseline, 63.6% (14/22), 59.1% (13/22) and 68.2% (15/22) were in complete fistula response at week 10, 30 and 54, respectively, in the combined q8 weeks and q12 weeks maintenance groups.
Slovenian: Od 22 preiskovancev, ki so imeli fistule na začetku preskušanja, so pri 63,6 % (14/22) ugotovili popoln odziv fistule na zdravljenje v 10. tednu, pri 59,1 % (13/22) v 30. tednu in pri 68,2 % (15/22) v 54. tednu, kar velja za združeni skupini za vzdrževalno zdravljenje z infuzijami na vsakih 8 in 12 tednov.
English: Signs include persistent cough, weight loss, feeling tired, fever, night sweats.
Slovenian: Znaki vključujejo trdovraten kašelj, hujšanje, utrujenost, zvišano telesno temperaturo, nočno potenje.
English: Adult Crohn's disease
Slovenian: Crohnova bolezen pri odraslih bolnikih
English: Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Slovenian: Z infuzijo povezane 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 ).
English: The number of ulcerative colitis-related surgical procedures was also lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of surgical procedures per 100 subject-years: 22 and 19 vs. 34; p = 0.145 and p = 0.022, respectively).
Slovenian: Tudi število kirurških posegov zaradi ulceroznega kolitisa je bilo manjše v obeh terapevtskih skupinah, ki sta prejemali po 5 mg/kg oziroma 10 mg/kg infliksimaba, kot pa v skupini, ki je prejemala placebo (srednje število kirurških posegov na 100 preiskovancev x let je bilo 22 za 5 mg/kg infliksimaba in 19 za 10 mg/kg infliksimaba, v primerjavi s 34 za placebo; p = 0,145 in p = 0,022).
English: Had treatment with Remicade before
Slovenian: Predhodno ste se že zdravili z zdravilom Remicade
English: During the 16-week double-blind phase, patients received either 5 mg/kg infliximab or placebo at weeks 0, 2, 6, and 14 (52 patients in each group).
Slovenian: Med 16-tedensko dvojno slepo fazo študije so bolniki prejemali bodisi 5 mg/kg infliksimaba ali placebo v 0., 2., 6. in 14. tednu (52 bolnikov v vsaki skupini).
English: • Tell your doctor if you have an infection even if it is a very minor one
Slovenian: • Zdravniku povejte, če imate kakršno koli, tudi najmanjšo okužbo.
English: Infliximab + AZA Combination Therapy
Slovenian: AZA v monoterapiji infliksimab v monoterapiji infliksimab + AZA v kombinirani terapiji
English: Sustained Steroid-Free Remission
Slovenian: Ohranjena remisija brez jemanja steroidov
English: • Re-administration: Infusion of 5 mg/kg if signs and symptoms of the disease recur (see
Slovenian: • Ponovna uporaba zdravila: Infuzija v odmerku 5 mg/kg, če se ponovijo znaki in simptomi bolezni (glejte poglavje “Ponovna uporaba zdravila” spodaj in poglavje 4.4).
English: It is recommended that the conduct of these tests should be recorded in the patient's reminder card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Slovenian: Zdravnike opozarjamo, da so izvidi tuberkulinskega kožnega testa lahko lažno negativni, še posebej pri bolnikih, ki so močno bolni ali imajo zmanjšan imunski odziv.
English: A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.
Slovenian: Pri otrocih in mladostnikih, ki se zdravijo z zaviralci TNF, tveganja za nastanek malignomov ni mogoče izključiti.
English: If a patient does not respond after 3 doses, no additional treatment with infliximab should be given.
Slovenian: Če se bolnik ne odzove na zdravilo po 3 odmerkih, ga ne smete več zdraviti z infliksimabom.
English: Ulcerative colitis
Slovenian: • ulcerozni kolitis
English: A reduction in the rate of the progression of structural joint damage (erosions and joint space narrowing) was observed in all infliximab groups at 54 weeks (Table 3).
Slovenian: V 54. tednu so v vseh skupinah, ki so prejemale infliksimab, ugotavljali zmanjšanje hitrosti napredovanja strukturne okvare sklepov (erozije in zožitev sklepne špranje) (preglednica 3).
English: p = 0.030 and < 0.001 for the 3 mg/kg and 6 mg/kg treatment groups respectively vs. placebo + MTX.
Slovenian: HAQ = vprašalnik za oceno zdravstvenega stanja; večje vrednosti pomenijo manjšo okvaro sklepov p = 0,030 in < 0,001 za terapevtski skupini, ki sta prejemali 3 mg/kg in 6 mg/kg v primerjavi s placebom + MTX
English: If a patient does not respond after 2 doses, no additional treatment with infliximab should be given.
Slovenian: Če se bolnik ne odzove na zdravljenje po 2 odmerkih zdravila, ga ne smete več zdraviti z infliksimabom.
English: How much Remicade is given
Slovenian: Koliko zdravila Remicade uporabiti
English: • Fungal infections such as yeast infection or fungal infection of the nails
Slovenian: • glivične okužbe, na primer okužba s kvasovkami ali glivična okužba nohtov
English: Table 4 Effects on ACRn, Structural Joint Damage and Physical Function at week 54, ASPIRE Infliximab + MTX Placebo + MTX 3 mg/kg 6 mg/kg Combined
Slovenian: Preglednica 4 Učinki na ACRn, strukturno poškodbo sklepov in funkcijo sklepov v 54. tednu, ASPIRE placebo + MTX
English: If you have ankylosing spondylitis you will first be given other medicines.
Slovenian: Če imate ankilozirajoči spondilitis, boste najprej prejeli druga zdravila.
English: Clinical remission and mucosal healing occurred in a greater proportion of patients in the combined infliximab treatment group compared to the placebo treatment group at week 54 (34.6% vs. 16.5%, p < 0.001 and 46.1% vs. 18.2%, p < 0.001, respectively).
Slovenian: Klinično remisijo in celjenje sluznice v 54. tednu so ugotovili pri večjem odstotku bolnikov v (združeni) skupini, ki se je zdravila z infliksimabom, kot pa v skupini, ki je prejemala placebo (34,6 % v primerjavi s 16,5 %; p < 0,001, in 46,1 % v primerjavi z 18,2 %; p < 0,001).
English: At week 8, 45 patients were randomised and received 5 mg/kg infliximab at either q8 weeks or q12 weeks as a maintenance treatment regimen.
Slovenian: Po 8. tednih so 45 bolnikov randomizirali in so za vzdrževalno zdravljenje prejemali 5 mg/kg infliksimaba bodisi na 8, bodisi na 12 tednov.
English: Tell your doctor straight away if you notice any of the following:
Slovenian: Če opazite katerega od naslednjih učinkov, nemudoma obvestite zdravnika:
English: At week 54, the figures were 55.8% (29/52) and 23.5% (12/51) in the q8 weeks and q12 weeks maintenance groups, respectively (p < 0.001).
Slovenian: V 54. tednu so bili ti rezultati naslednji: 55,8 % (29/52) za skupino, ki je za vzdrževalno zdravljenje prejemala infuzije infliksimaba na vsakih 8 tednov, in 23,5 % (12/51) za skupino, ki jih je prejemala na vsakih 12 tednov (p < 0,001).
English: • Severe allergic reactions (e.g. anaphylaxis), an immune system disorder called lupus, allergic reactions to foreign proteins
Slovenian: • hude alergijske reakcije (npr. anafilaksija), motnja v delovanju imunskega sistema (lupus),
English: Week 30 Clinical Response
Slovenian: 30. teden Klinični odziv
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
Slovenian: Ugotovili so, da je bilo treba v terapevtskih skupinah, ki sta prejemali po 5 mg/kg infliksimaba (28/242 ali 11,6 % [nesignifikantno]) 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: Infliximab was administered at a dose of 5 mg/kg at weeks 0, 2, 6, and then every 8 weeks.
Slovenian: Infliksimab so bolniki prejemali v odmerku 5 mg/kg v tednih 0, 2 in 6 ter nato na vsakih 8 tednov.
English: After reconstitution one ml contains 10 mg of infliximab.
Slovenian: Po rekonstituciji en ml vsebuje 10 mg infliksimaba.
English: Ankylosing spondylitis (Bechterew's disease)
Slovenian: Ankilozirajoči spondilitis (Bechterew sindrom)
English: • You are allergic (hypersensitive) to proteins that come from mice.
Slovenian: • če ste alergični (preobčutljivi) na glodalske proteine,
English: Cases of jaundice and non-infectious hepatitis, some with features of autoimmune hepatitis, have been observed in the post-marketing experience of Remicade.
Slovenian: Med izkušnjami z zdravilom Remicade v obdobju trženja so opažali primere zlatenice in neinfekcijskega hepatitisa in nekateri od njih so imeli značilnosti avtoimunskega hepatitisa.
English: 5.7% [95% CI 2.65%-10.6%].
Slovenian: Mediana dolžine spremljanja bolnikov je bila 0,8 let (incidenca 5,7 % [95 % IZ 2,65 %-10,6 %].
English: Reduction in the rate of progression of structural damage was observed at weeks 30 and 54 in the infliximab + methotrexate groups compared to methotrexate alone.
Slovenian: V skupinah, ki sta prejemali infliksimab in metotreksat, so opažali zmanjšanje hitrosti napredovanja strukturne poškodbe v 30. in 54. tednu v primerjavi s samim metotreksatom.
English: It is also recommended that live vaccines not be given to infants after in utero exposure to infliximab for at least 6 months following birth (see section 4.4).
Slovenian: Poleg tega priporočamo, da dojenčkom, ki so bili in utero izpostavljeni infliksimabu, vsaj 6 mesecev po rojstvu ne dajete živih cepiv (glejte poglavje 4.4).
English: A total of 306 patients received 3 doses of infliximab 5 mg/kg at week 0, 2 and 6.
Slovenian: Skupaj 306 bolnikov je prejelo 3 odmerke infliksimaba v odmerku 5 mg/kg na začetku, po 2 tednih in po 6 tednih.
English: Infliximab (week 98)
Slovenian: Infliksimab (98. teden)
English: Ulcerative colitis is an inflammatory disease of the bowel.
Slovenian: Ulcerozni kolitis je vnetna bolezen črevesja.
English: Tell your doctor straight away if you get signs of infection during treatment with Remicade.
Slovenian: Zdravniku takoj povejte, če ste dobili simptome okužbe med zdravljenjem z zdravilom Remicade.
English: If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before using Remicade.
Slovenian: Če niste prepričani, ali kaj od naštetega velja za vas, se posvetujte z zdravnikom, preden boste prejeli zdravilo Remicade.
English: • Crohn's disease
Slovenian: • Crohnovo bolezen
English: Infliximab (week 24)
Slovenian: Infliksimab (24. teden)
English: • You should avoid getting pregnant when you are being treated with Remicade and for 6 months after you stop being treated with it.
Slovenian: • Če prejemate zdravilo Remicade, je treba preprečiti nosečnost med zdravljenjem in še vsaj 6 mesecev po prenehanju zdravljenja.
English: Please read the Remicade ‘Package Leaflet' carefully before you start using this medicine.
Slovenian: Preden začnete uporabljati to zdravilo, natančno preberite navodilo za uporabo.
English: Signs include persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
Slovenian: Znaki vključujejo dolgotrajno zvišano telesno temperaturo, večjo nagnjenost h krvavitvam ali k nastanku podplutb, majhne rdeče ali vijolične pike, ki jih povzroči podkožna krvavitev, ali bledico.
English: The safety and efficacy of re-administration, other than every 6 to 8 weeks, has not been established (see sections 4.4 and 4.8).
Slovenian: Ponovna uporaba zdravila pri ankilozirajočem spondilitisu Varnosti in učinkovitosti ponovne uporabe zdravila, razen na vsakih 6 do 8 tednov, še niso ugotovili (glejte poglavji 4.4 in 4.8).
English: • Treatment with TNF blockers such as Remicade may result in reactivation of hepatitis B
Slovenian: • Zdravljenje z zaviralci TNF, kot je zdravilo Remicade, lahko vodi do reaktivacije virusa hepatitisa B pri bolnikih, ki prenašajo ta virus, kar je lahko v nekaterih primerih življenjsko nevarno.
English: Thirty one of these patients were treated with infliximab 5 mg/kg.
Slovenian: 31 bolnikov je prejemalo infliksimab v odmerku 5 mg/kg.
English: Live vaccines such as BCG should not be given to your baby within 6 months after birth.
Slovenian: Živih cepiv, kot je cepivo BCG, se ne sme dati dojenčkom v obdobju 6 mesecev po rojstvu (za več informacij glejte poglavje o cepljenjih).
English: Excipients: sucrose, polysorbate 80, monobasic sodium phosphate and dibasic sodium phosphate.
Slovenian: Pomožne snovi: saharoza, polisorbat 80, natrijev dihidrogenfosfat, natrijev hidrogenfosfat.
English: Nervous system disease
Slovenian: Bolezni imunskega sistema
English: • Signs of low blood counts such as persistent fever, bleeding or bruising more easily, small red or purple spots caused by bleeding under the skin, or looking pale.
Slovenian: • znaki znižanega števila krvnih celic, na primer dolgotrajno zvišana telesna temperatura, večja nagnjenost h krvavitvam ali k nastanku podplutb, majhne rdeče ali vijolične pike zaradi podkožne krvavitve ali bledica;
English: All patients had experienced an inadequate response to prior conventional therapies.
Slovenian: Predhodno konvencionalno zdravljenje je bilo pri vseh teh bolnikih neučinkovito.
English: Mean baseline NAPSI scores were 4.6 and 4.3 in infliximab and placebo group.
Slovenian: Srednji oceni po lestvici NAPSI na začetku študije sta bili naslednji: 4,6 za skupino, zdravljeno z infliksimabom, in 4,3 za skupino, zdravljeno s placebom.
English: If you are not sure, talk to your doctor before you are given Remicade.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom, preden začnete prejemati zdravilo Remicade.
English: There is limited safety experience of Remicade treatment in patients who have undergone surgical procedures, including arthroplasty.
Slovenian: Izkušnje glede varnosti kirurških posegov vključno z artroplastiko pri bolnikih, zdravljenih z zdravilom Remicade, so omejene.
English: Dizziness may occur following administration of Remicade (see section 4.8).
Slovenian: Pri uporabi zdravila Remicade se lahko pojavi omotica (glejte poglavje 4.8).
English: Furthermore, improved quality of life as measured by IBDQ was observed with infliximab.
Slovenian: Podobne trende pri doseganju klinične remisije brez jemanja kortikosteroidov so opazili tudi v 50. tednu, poleg tega pa so pri uporabi infliksimaba opazili še izboljšanje kakovosti življenja, merjene z vprašalnikom IBDQ.
English: Cases of malignancies, including lymphoma, have also been reported in the post-marketing setting (see section 4.4).
Slovenian: Tudi v obdobju trženja so poročali o primerih malignih bolezni, vključno z limfomom (glejte poglavje 4.4).
English: Signs include a fever, feeling tired, (persistent) cough, shortness of breath, weight loss, night sweats, diarrhea, wounds, dental problems, burning when urinating or ‘flu-like' signs.
Slovenian: Ti znaki so zvišana telesna temperatura, utrujenost, (trdovraten) kašelj, kratka sapa, izguba telesne mase, nočno potenje, driska, rane, težave z zobmi, pekoče uriniranje ali gripi podobni znaki.
English: Remicade 100 mg powder for concentrate for solution for infusion.
Slovenian: Remicade 100 mg prašek za koncentrat za raztopino za infundiranje
English: The number of ulcerative colitis-related hospitalisations was significantly lower in the 5 and 10 mg/kg infliximab treatment groups than in the placebo group (mean number of hospitalisations per 100 subject-years: 21 and 19 vs. 40 in the placebo group; p = 0.019 and p = 0.007, respectively).
Slovenian: V obeh terapevtskih skupinah, ki sta prejemali 5 mg/kg oziroma 10 mg/kg infliksimaba, je bilo število hospitalizacij zaradi ulceroznega kolitisa bistveno manjše kot pa v skupini, ki je prejemala placebo (srednje število hospitalizacij na 100 preiskovancev x let je znašalo 21 v skupini, ki je prejemala 5 mg/kg infliksimaba in 19 v skupini, ki je prejemala 10 mg/kg infliksimaba, medtem ko je v skupini za placebo znašalo kar 40; p = 0,019 in p = 0,007).
English: Patients treated with Remicade should be given the package leaflet and the patient reminder card.
Slovenian: Bolniki, zdravljeni z zdravilom Remicade, morajo prejeti navodilo za uporabo in opozorilno kartico za bolnika.
English: In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with Remicade administration (see section 4.4).
Slovenian: V okviru izkušenj v obdobju trženja je bila uporaba zdravila Remicade povezana s primeri anafilaktoidnih reakcij, vključno z edemom grla ali žrela in hudega bronhospazma, ter epileptičnimi napadi (glejte poglavje 4.4).
English: No dose recommendations can be made (see section 5.2).
Slovenian: Zdravila Remicade pri teh skupinah bolnikov niso proučevali, zato ni mogoče podati priporočil za odmerjanje (glejte poglavje 5.2)
English: • The other ingredients are sucrose, polysorbate 80, monobasic sodium phosphate and dibasic sodium phosphate.
Slovenian: • Pomožne snovi so saharoza, polisorbat 80, natrijev dihidrogenfosfat, natrijev hidrogenfosfat.
English: Paediatric Crohn's disease patients
Slovenian: Crohnova bolezen pri pediatričnih bolnikih
English: Radiographs of hands and feet were collected at baseline, weeks 24 and 54.
Slovenian: Na začetku študije ter v 24. in 54. tednu so posneli rentgenske slike dlani in stopal.
English: Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving Remicade.
Slovenian: Pri bolnikih, zdravljenih z infliksimabom, so ugotavljali tuberkulozo, bakterijske okužbe vključno s sepso in pljučnico, invazivne glivične, virusne in druge oportunistične okužbe.
English: • Fluid in the lining of the heart (pericardial effusion)
Slovenian: • tekočina v srčni ovojnici (perikardni izliv)
English: Each vial contains 100 mg of infliximab.
Slovenian: Ena viala vsebuje 100 mg infliksimaba (infliximabum).
English: • Kidney infections
Slovenian: • okužbe nožnice
English: Infliximab (week 16)
Slovenian: Infliksimab (16. teden)
English: Discontinuation of Remicade therapy should be considered in patients with confirmed significant haematologic abnormalities.
Slovenian: Pri bolnikih s potrjenimi bistvenimi hematološkimi anomalijami lahko tudi ukinete zdravljenje z zdravilom Remicade.
English: Remicade contains sodium
Slovenian: Zdravilo Remicade vsebuje natrij
English: If there are any changes in your skin or growths on the skin during or after therapy, tell your doctor.
Slovenian: Povejte zdravniku, če med ali po zdravljenju opazite na koži kakršne koli spremembe ali izrastke.
English: Discontinuation of Remicade should be considered if these disorders develop.
Slovenian: Če se pojavijo te motnje, je potrebno razmisliti o ukinitvi zdravila Remicade.
English: The following side effects have been observed with Remicade:
Slovenian: Pri uporabi zdravila Remicade so opazili naslednje neželene učinke:
English: • Heart attack
Slovenian: • srčni zastoj
English: All patients received an induction regimen of 5 mg/kg infliximab at weeks 0, 2, and 6.
Slovenian: Vsi bolniki so prejeli indukcijsko shemo 5 mg/kg infliksimaba, in sicer na začetku (teden 0) ter 2. in 6. teden.
English: AZA Monotherapy
Slovenian: optični nevritis.
English: No physical biochemical compatibility studies have been conducted to evaluate the co-administration of Remicade with other agents.
Slovenian: Študije za ovrednotenje fizikalno biokemične združljivosti zdravila Remicade z drugimi zdravili niso bile izvedene, zato ga ne smete dati sočasno v isti intravenski liniji z drugimi zdravili.
English: In one of the study arms (group 2, n = 329), patients with an inadequate response were allowed to dose titrate with 1.5 mg/kg increments from 3 up to 9 mg/kg.
Slovenian: V enem kraku študije (skupina 2, n = 329) so bolnikom z nezadostnim odzivom na zdravilo omogočili titracijo t.j.
English: Steroid-Free Remission
Slovenian: Remisija brez jemanja steroidov
English: Each Remicade vial contains 100 mg infliximab.
Slovenian: Ena viala vsebuje 100 mg infliksimaba.
English: Paediatric ulcerative colitis patients
Slovenian: Ulcerozni kolitis pri pediatričnih bolnikih