FrancophonIA/ELRC3.0 huggingface dataset:
English: New onset or worsening psoriasis including pustular psoriasis (primarily palm & soles), urticaria, rash, pruritus, hyperhidrosis,
Estonian: psoriaasi teke või halvenemine, sealhulgas mädavilliline psoriaas (peamiselt pihud ja tallad), urtikaaria, lööve, sügelus, hüperhidroos, nahakuivus, fungaaldermatiit, ekseem, alopeetsia
English: Further treatment with Flixabi must not be given if a patient develops a serious infection or sepsis.
Estonian: Ravi Flixabi'ga ei tohi jätkata raske infektsiooni või sepsise ilmnemisel.
English: After preparation each mL contains 10 mg of infliximab.
Estonian: Pärast ettevalmistamist sisaldab iga ml lahust 10 mg infliksimabi.
English: If you feel tired, dizzy, or unwell after having Flixabi, do not drive or use any tools or machines.
Estonian: Ärge juhtige autot ega käsitsege tööriistu või masinaid, kui te tunnete pärast Flixabi saamist väsimust, pearinglust või tunnete end halvasti.
English: Transient visual loss occurring during or within 2 hours of infusion.
Estonian: lühiajaline nägemise kaotus, mis tekib infusiooni ajal või 2 tunni jooksul pärast seda
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.
Estonian: Infliksimabi ohutus ja efektiivsus juveniilse reumatoidartriidi näidustusel lastel ja noorukitel alla 18 eluaasta ei ole veel tõestatud.
English: If a patient does not respond after 2 doses, no additional treatment with Flixabi should be given.
Estonian: Kui patsient ei reageeri ravile pärast 2 annust, Flixabi-raviga ei jätkata.
English: How to store Flixabi
Estonian: Kuidas Flixabi't säilitada
English: Flixabi is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Estonian: Flixabi'i lahjendamiseks kasutatakse aga 9 mg/ml (0,9%) naatriumkloriidi infusioonilahust.
English: Flixabi should be used with caution in patients with mild heart failure (NYHA class I/II).
Estonian: Kerge südamepuudulikkusega (NYHA klass I/II) patsientidel peab Flixabi't kasutama ettevaatlikult.
English: Infliximab has been associated with acute infusion-related reactions, including anaphylactic shock, and delayed hypersensitivity reactions (see section 4.8).
Estonian: Infliksimabi kasutamisel võib tekkida äge infusioonireaktsioon, kaasa arvatud anafülaktiline šokk, ja hilist tüüpi ülitundlikkusreaktsioon (vt lõik 4.8).
English: There are no known side effects of having too much of Flixabi.
Estonian: Liiga suure koguse Flixabi manustamisel puuduvad teadaolevalt kõrvaltoimed.
English: Flixabi is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Estonian: Flixabi on näidustatud mõõduka kuni raske aktiivse haavandilise koliidi raviks täiskasvanud patsientidel, kelle ravivastus tavapärasele ravile, sh kortikosteroididele ja 6-merkaptopuriinile (6-MP) või asatiopriinile (AZA) on ebapiisav, või juhul, kui sellise ravi suhtes esineb talumatus või vastunäidustus.
English:  adult patients with severe, active and progressive disease not previously treated with methotrexate or other DMARDs.
Estonian: • eelnevalt metotreksaadi või teiste HMR-idega ravimata raske, ägeda ja progresseeruva haigusega täiskasvanud patsientidel.
English: Maintenance treatment in moderately to severely active Crohn's disease in adults The efficacy of repeated infusions with infliximab was studied in a 1-year clinical study (ACCENT I).
Estonian: Mõõduka kuni raske Crohni tõve aktiivse vormi säilitusravi täiskasvanutel Infliksimabi korduvate infusioonide efektiivsust hinnati 1-aastases kliinilises uuringus (ACCENT I).
English: Post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with TNFblocking agents including infliximab.
Estonian: Turuletulekujärgselt on teatatud hepatospleenilise T-rakulise lümfoomi juhtudest patsientidel, kes on saanud ravi TNF-blokaatoritega, sh infliksimabiga.
English: Cases of malignancies, including lymphoma, have also been reported in the post-marketing setting (see section 4.4).
Estonian: Ka turuletulekujärgselt on teatatud pahaloomulistest kasvajatest, sh lümfoomist (vt lõik 4.4).
English: The concurrent administration of live vaccines with Flixabi is not recommended.
Estonian: Elusvaktsiinide manustamine samaaegselt Flixabi'ga ei ole soovitatav.
English: Depression, insomnia.
Estonian: depressioon, unetus
English: In responding patients, the alternative strategies for continued treatment are:  Maintenance: Additional infusions of 5 mg/kg every 8 weeks or  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).
Estonian: • Kordusravi: infusioon annusega 5 mg/kg, kui haiguse sümptomid taastekivad, ning seejärel infusioonid annusega 5 mg/kg iga 8 nädala järel (vt “kordusravi” allpool ja lõik 4.4).
English: Tell your doctor straight away if you get new or worsening signs of heart failure during treatment with Flixabi.
Estonian: Rääkige kohe oma arstile kui teil tekivad uued südamepuudulikkuse nähud või olemasolevate nähtude halvenemine Flixabi-ravi ajal.
English: Fistulising, active Crohn's disease
Estonian: Fistulitega Crohni tõve aktiivne vorm
English: Administration of live vaccines (e.g. BCG vaccine) to infants exposed to infliximab in utero is not recommended for at least 6 months after birth (see sections 4.4 and 4.5).
Estonian: Üsasiseselt infliksimabiga kokku puutunud imikutele ei ole elusvaktsiinide (nt BCG-vaktsiin) manustamine soovitatav vähemalt 6 kuu jooksul pärast sündi (vt lõigud 4.4 ja 4.5).Teatatud on ka agranulotsütoosi juhtudest (vt lõik 4.8).
English: If a patient does not respond by 6 weeks (i.e. after 2 doses), no additional treatment with Flixabi should be given.
Estonian: Kui patsient ei reageeri ravile esimese 6 nädala jooksul (s.o. pärast kahte annust), Flixabi-raviga ei jätkata.
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.
Estonian: Lahjendage kogu manustamiskõlblikuks muudetud Flixabi-lahuse annus 250 ml-s 9 mg/ml (0,9%) naatriumkloriidi infusioonilahuses.
English: Sustained response (clinical response at both week
Estonian: Püsiv ravivastus (kliiniline ravivastus, nii 8. nädal kui ka
English: Tuberculosis, bacterial infections, including sepsis and pneumonia, invasive fungal, viral, and other opportunistic infections have been observed in patients receiving infliximab.
Estonian: Infliksimabiga ravitud patsientidel on täheldatud tuberkuloosi, bakteriaalseid infektsioone, sh sepsist ning pneumooniat, invasiivseid seen-, viirus- ning teisi oportunistlikke infektsioone.
English: Heart problems
Estonian: Südamehaigused
English: In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with infliximab administration (see section 4.4).
Estonian: Ravimi turuletulekujärgse perioodi kogemuste põhjal on infliksimabi manustamisega seostatud anafülaksia sarnaste reaktsioonide, sh larüngaalse/farüngaalse turse ja ägeda bronhospasmi ning krambihoogude teket (vt lõik 4.4).
English: Cases of transient visual loss occurring during or within 2 hours of infliximab infusion have been reported.
Estonian: On teatatud ka lühiajalisest nägemise kaotusest, mis tekib infliksimabi infusiooni ajal või kahe tunni jooksul pärast seda.
English: Adult Crohn's disease Flixabi is indicated for:  treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Estonian: • mõõduka kuni raske Crohni tõve aktiivse vormi raviks täiskasvanud patsientidel, kui vaatamata täielikule ja küllaldasele kortikosteroid- ja/või immunosupressiivsele ravile puudub ravivastus; või juhul, kui nende suhtes esineb talumatus või vastunäidustused.
English: Flixabi 100 mg powder for concentrate infliximab
Estonian: Flixabi 100 mg kontsentraadi pulber infliksimab
English: Tuberculosis, fungal infections (e.g. candidiasis, onychomycosis).
Estonian: tuberkuloos, seeninfektsioonid (nt kandidiaas, ohühhomükoos)
English: All patients received an induction regimen of 5 mg/kg infliximab at weeks 0, 2, and 6.
Estonian: Kõik patsiendid said 5 mg/kg infliksimabi induktsioonrežiimina nädalatel 0, 2 ja 6.
English: Crohn's disease2
Estonian: Crohni tõbi
English: Infliximab (week 16)
Estonian: Infliksimab (16. nädal
English: c a 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.
Estonian: HAQ muutus algtasemest aja jooksule (hinnatud patsiendid) Keskmine ± SDc a kontroll = kõik patsiendid aktiivse RA-ga vaatamata metotreksaatravile stabiilsete annustega 6 kuud enne uuringusse lülitamist.
English: How Flixabi is given
Estonian: Kuidas Flixabi't manustatakse
English: Infliximab was administered at a dose of 5 mg/kg at weeks 0, 2, 6, and then every 8 weeks.
Estonian: Infliksimabi manustati annusena 5 mg/kg 0., 2., 6. nädalal ja seejärel iga 8 nädala tagant.
English: Worsening of symptoms of dermatomyositis.
Estonian: dermatomüosiidi sümptomite halvenemine Lihas-skeleti ja sidekoe kahjustused Sage:
English: In a subset of 90 adult patients with rheumatoid arthritis from the ASPIRE study a similar proportion of patients in each treatment group (methotrexate plus: placebo [n = 17], 3 mg/kg [n = 27] or 6 mg/kg infliximab [n = 46]) mounted an effective two-fold increase in titers to a polyvalent pneumococcal vaccine, indicating that infliximab did not interfere with T-cell independent humoral immune responses.
Estonian: Uuringus ASPIRE osalenud 90 reumatoidartriidiga täiskasvanud patsiendi alarühmas saavutati igas raviharus (metotreksaat pluss: platseebo [n = 17], infliksimaab 3 mg/kg [n = 27] või infliksimaab
English: Flixabi contains the active substance infliximab.
Estonian: Flixabi toimeaine on, infliksimab.
English: Intravenous use.
Estonian: Täiendavalt anti folaati.
English: A risk for the development for hepatosplenic T-cell lymphoma in patients treated with Flixabi cannot be excluded (see section 4.8).
Estonian: Flixabi-ravi saavatel patsientidel ei saa välistada hepatospleenilise T-rakulise lümfoomi tekkeriski (vt lõik 4.8).
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodiumfree'.However, before Flixabi is given to you, it is mixed with a solution that contains sodium.
Estonian: Ravim sisaldab vähem kui 1 mmol naatriumi (23 mg) annuse kohta, see tähendab põhimõtteliselt naatriumivaba.
English: 3 Number of patients evaluated for ALT.
Estonian: Patsientide hulk, kellel hinnati ALAT väärtusi.
English: Pulmonary oedema, bronchospasm, pleurisy, pleural effusion.
Estonian: kopsuturse, bronhospasm, pleuriit, pleura efusioon
English: Flixabi is indicated for treatment of severely active ulcerative colitis in children and adolescents aged 6 to 17 years, who have had an inadequate response to conventional therapy including corticosteroids and 6-MP or AZA, or who are intolerant to or have medical contraindications for such therapies.
Estonian: Flixabi on näidustatud raske aktiivse haavandilise koliidi raviks 6- kuni 17-aastastel lastel ja noorukitel, kelle ravivastus tavapärasele ravile, sh kortikosteroididele ja 6-merkaptopuriinile (6-MP) või asatiopriinile (AZA) on ebapiisav, või juhul, kui sellise ravi suhtes esineb talumatus või vastunäidustus.
English: Patients with ACR20 response/ Patients evaluated (%) Total scored (van der Heijde-modified Sharp score) Change from baseline (Mean ± SD
Estonian: Patsiendid ACR20 vastusega/ hinnatud patsiendid (%)c
English: Conjunctivitis.
Estonian: konjunktiviit
English: 10 mg/kg q 8 wks
Estonian: 10 mg/kg 1 × 8 näd
English: Common: may affect up to 1 10 people
Estonian: Sage: võivad esineda kuni 1 inimesel 10-st
English: Chest pain, fatigue, fever, injection site reaction, chills, oedema.
Estonian: valu rinnus, väsimus, palavik, süstekoha reaktsioon, külmavärinad, turse
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.
Estonian: 8. nädalal randomiseeriti 45 patsienti saama säilitusravina infliksimabi 5 mg/kg iga 8 või 12 nädala järel.
English: Keratitis, periorbital oedema, hordeolum.
Estonian: keratiit, periorbitaalne turse, odraiva
English: Melanoma and Merkel cell carcinoma have been reported in patients treated with TNF blocker therapy, including infliximab (see section 4.8).
Estonian: Tuumorinekroosifaktori inhibiitoriga, sh infliksimabiga, ravi saanud patsientidel on teatatud melanoomist ja Merkeli raku kartsinoomist (vt lõik 4.8).
English: Neutropenia, leucopenia, anaemia, lymphadenopathy.
Estonian: artralgia, müalgia, seljavalu
English: Hepatobiliary events
Estonian: Hepatobiliaarsed kõrvaltoimed
English: Peripheral blood mononuclear cells (PBMC) from infliximab-treated patients showed undiminished proliferative responsiveness to stimuli compared with untreated patients, and no substantial changes in cytokine production by stimulated PBMC were observed following treatment with infliximab.
Estonian: Infliksimabravi saanud patsientide perifeerse vere mononukleaarsete rakkude (PBMC) proliferatiivne vastus ärritusele ei vähenenud võrreldes ravi mittesaavate patsientidega.
English: • Serious nervous system disorders such as transverse myelitis, multiple sclerosis-like disease, optic neuritis and Guillain-Barré syndrome
Estonian: • tõsised närvisüsteemi häired, nagu transversaalskleroos, hulgiskleroosi sarnane haigus,
English: Flixabi, in combination with methotrexate, is indicated for the reduction of signs and symptoms as well as the improvement in physical function in:  adult patients with active disease when the response to disease-modifying antirheumatic drugs
Estonian: Flixabi kombinatsioonis metotreksaadiga on näidustatud sümptomaatiliseks raviks ja füüsilise funktsiooni parandamiseks:
English: Abnormal skin openings • Tell your doctor if you have any abnormal skin openings (fistulae) before you are given Flixabi.
Estonian: • Rääkige oma arstile, kui teil on nahas mis tahes ebanormaalseid uuriseid (fistulid), enne kui teile manustatakse Flixabi't.
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).
Estonian: 24-nädalase topeltpimeda faasi käigus said patsiendid 0, 2, 6, 14 ja 22. nädalal kas 5 mg/kg kohta infliksimabi või platseebot (mõlemas grupis oli 100 patsienti).
English: The dilution can be accomplished by withdrawing a volume of the sodium chloride 9 mg/ml (0.9%) solution for infusion from the 250-ml glass bottle or infusion bag equal to the volume of reconstituted Flixabi.
Estonian: Lahjendamiseks eemaldage esmalt 9 mg/ml (0,9%) naatriumkloriidi sisaldavast 250 ml-st klaaspudelist või infusioonikotist manustamiskõlblikuks muudetud Flixabi-lahusega võrdne maht naatriumkloriidi infusioonilahust.
English: It is recommended that live vaccines not be given concurrently with Flixabi.
Estonian: Soovitatav on elusvaktsiine samaaegselt Flixabi'ga mitte manustada.
English: In a Phase II study aimed at evaluating infliximab in CHF, higher incidence of mortality due to worsening of heart failure were seen in patients treated with infliximab, especially those treated with the higher dose of 10 mg/kg (i.e. twice the maximum approved dose).
Estonian: II faasi uuringus, kus hinnati infliksimabi CHF korral, esines infliksimabiga ravitud patsientide hulgas sagedamini südamepuudulikkuse süvenemisest tingitud surmajuhtumeid.
English: * P-values represent each infliximab treatment group vs. AZA monotherapy
Estonian: (p < 0,001)* * P-väärtus esindab iga infliksimabi ravirühma vs. rühm, kus saadi AZA-t monoteraapiana.
English: After reconstitution one mL contains 10 mg infliximab.
Estonian: Pärast lahustamist sisaldab üks milliliiter 10 mg infliksimabi.
English: Each vial contains 100 mg of infliximab.
Estonian: Iga viaal sisaldab 100 mg infliksimabi.
English: Change from baseline in total van der Heijde-modified Sharp score b
Estonian: Van der Heijde modifitseeritud Sharpi koguskoori muutus algtasemest Keskmine ± SDa
English: Tell your doctor straight away if you get symptoms of liver problems during treatment with Flixabi.
Estonian: Rääkige kohe oma arstile, kui teil tekivad maksaprobleemide sümptomid ravi ajal Flixabi'ga.
English: 5 mg/kg given as an intravenous infusion followed by additional 5 mg/kg infusion doses at 2 and 6 weeks after the first infusion, then every 8 weeks thereafter.
Estonian: 5 mg/kg manustada intravenoosse infusioonina, seejärel lisaannused 5 mg/kg 2 ja 6 nädalat pärast esimest infusiooni ning iga 8 nädala järel pärast seda.
English: In the post-marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist.
Estonian: TNF-i antagonistidega ravitud patsientidel on turuletulekujärgselt teatatud leukeemia juhtudest.
English: At least a six month waiting period following birth is recommended before the administration of live vaccines to infants exposed in utero to infliximab (see section 4.6).
Estonian: Enne üsasiseselt infliksimabiga kokkupuutunud imikutele elusvaktsiinide manustamist on soovitatav oodata vähemalt kuus kuud (vt lõik 4.6).
English: The safety and efficacy of infliximab have not been studied in children with ulcerative colitis below the age of 6 years.
Estonian: Infliksimabi ohutust ja efektiivsust alla 6-aastastel haavandilise koliidiga lastel ei ole uuritud.
English: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including infliximab, who are chronic carriers of this virus.
Estonian: Patsientidel, kes on kroonilised B-hepatiidi viiruskandjad, on ilmnenud TNF-antagonisti ning sh infliksimabi manustamise järgselt B-hepatiidi reaktivatsioon.
English: 10 mg/kg q 4 wks
Estonian: 10 mg/kg 1 × 4 näd
English: 3 mg/kg q 4 wks
Estonian: 3 mg/kg 1 × 4 näd
English: Women of childbearing potential
Estonian: Haavandilise koliidiga lapsed
English: Tell your doctor straight away if you get symptoms of a nerve disease during treatment with Flixabi.
Estonian: Rääkige kohe oma arstile, kui teil tekivad närvihaiguse sümptomid Flixabi-ravi ajal.
English: Thirty one of these patients were treated with infliximab 5 mg/kg.
Estonian: 94-st patsiendist 31 said infliksimabi annusega 5 mg/kg.
English: Patients should be tested for HBV infection before initiating treatment with Flixabi.
Estonian: Enne ravi alustamist Flixabi'ga tuleb patsiente kontrollida HBV infektsiooni suhtes.
English: Percentage of subjects with mucosal healing Mucosal healing at week 8
Estonian: Paranenud limaskestaga uuringus osalejate protsent Limaskesta paranemine, 8. nädala
English: • Infections of the vagina.
Estonian: • tupeinfektsioonid.
English: • Signs of a lung problem such as coughing, breathing difficulties or tightness in the chest
Estonian: • kopsuhaiguse nähud, nagu köhimine, hingamisraskused või pitsitustunne rinnus;
English: Flixabi 100 mg powder for concentrate for solution for infusion.
Estonian: Flixabi 100 mg infusioonilahuse kontsentraadi pulber.
English: Flixabi 100 mg powder for concentrate for solution for infusion infliximab
Estonian: Flixabi 100 mg infusioonilahuse kontsentraadi pulber infliksimab
English: Combined
Estonian: KÕLBLIKKUSAEG
English: Reproductive system and breast disorders Uncommon:
Estonian: püelonefriit Reproduktiivse süsteemi ja rinnanäärme häired Aeg-ajalt:
English: a a p < 0.001, for each infliximab treatment group vs. placebo
Estonian: Limaskesta paranemine, 30. nädala a p < 0,001, igas infliksimabi ravirühmas vs. platseebo.
English: * ITT-analysis where subjects with missing data were included as non-responders a Week 98 data for IMPACT includes combined placebo crossover and infliximab patients who entered the open-label extension b Based on patients with PASI ≥ 2.5 at baseline for IMPACT, and patients with ≥ 3% BSA psoriasis skin involvement at baseline in IMPACT 2 ** PASI 75 response for IMPACT not included due to low N; p < 0.001 for infliximab vs. placebo at week 24 for IMPACT 2
Estonian: ** PASI 75 ravivastus uuringus IMPACT, mitte arvestatud madala N väärtuse tõttu; p < 0,001 infliksimab vs. platseebo 24. nädalal uuringus IMPACT 2.
English: Live vaccines such as BCG should not be given to your baby within 6 months after birth.
Estonian: 6 kuu jooksul pärast sündi ei tohi teie laps saada elusvaktsiine, nagu BCG-vaktsiin.
English: Ulcerative colitis Paediatric Ulcerative colitis
Estonian: Haavandilin e koliit Haavandilin e koliit lastel
English: 3 mg/kg q 8 wks
Estonian: Kontrolla 3 mg/kg 1 × 8 näd
English: Week 24
Estonian: 26. nädal
English: Vascular disorders
Estonian: Vaskulaarsed häired Sage:
English: Tell your doctor straight away if you get signs of infection during treatment with Flixabi.
Estonian: Rääkige kohe oma arstile, kui teil tekivad Flixabi-ravi ajal infektsiooni nähud.
English: Vertigo, dizziness, hypoaesthesia, paraesthesia.
Estonian: pearinglus, peapööritus, hüpesteesia, paresteesia
English: Thrombocytopenia, lymphopenia, lymphocytosis.
Estonian: trombotsütopeenia, lümfopeenia, lümfotsütoos
English: Visually inspect Flixabi for particulate matter or discolouration prior to administration.
Estonian: Enne ravimi manustamist kontrollige Flixabi't visuaalselt, et neis ei esineks tahkeid osakesi ja värvuse muutusi.
English: Number of patients
Estonian: Patsientide erirühmad
English: Respiratory, thoracic and mediastinal disorders Very common:
Estonian: Infektsioonid ja infestatsioonid Väga sage:
English: Hepatitis, hepatocellular damage, cholecystitis.
Estonian: hepatiit, maksarakkude kahjustus, sapipõiepõletik
English: Impaired healing.
Estonian: paranemise aeglustumine
English: N/A 49.4
Estonian: allpool ja lõik 4.4).
English: Instructions for use and handling - reconstitution, dilution and administration In order to improve the traceability of biological medicinal products, the tradename and batch number of the administered medicinal product should be clearly recorded.
Estonian: Kasutamise ja käsitsemise juhend - manustamiskõlblikuks muutmine, lahjendamine ja manustamine
English: METHOD OF ADMINISTRATION
Estonian: • kombinatsioonis metotreksaadiga
English: Test:
Estonian: Sage:
English: Tell your doctor straight away if you get signs of TB during treatment with Flixabi.
Estonian: Rääkige kohe oma arstile, kui teil tekivad tuberkuloosi nähud Flixabi-ravi ajal.
English: Mean ± SDd a p < 0.001, for each infliximab treatment group vs control b greater values indicate more joint damage.
Estonian: Nädal 50 a p < 0,001, iga infliksimabi ravigrupi kohta võrreldes kontrolliga.
English: Induction treatment in fistulising active Crohn's disease The efficacy was assessed in a randomised, double-blinded, placebo-controlled study in 94 patients with fistulising Crohn's disease who had fistulae that were of at least 3 months' duration.
Estonian: Fistulitega Crohni tõve aktiivse vormi induktsioonravi Vähemalt 3 kuud väldanud fistulitega Crohni tõve patsientidel jälgiti ravi efektiivsust randomiseeritud, topeltpimedas, platseebokontrolliga kliinilises uuringus.
English: Patients must be monitored closely for infections including tuberculosis before, during and after treatment with Flixabi.
Estonian: Enne Flixabi-ravi alustamist, selle ajal ning pärast ravi lõppu tuleb patsiente kontrollida infektsioonide, k.a tuberkuloosi suhtes.
English: Upper respiratory tract infection, sinusitis.
Estonian: ülemiste hingamisteede infektsioon, sinusiit
English: Abdominal pain, nausea.
Estonian: kõhuvalu, iiveldus
English: Ankylosing spondylitis
Estonian: Anküloseeri v spondüliit