FrancophonIA/ELRC3.0 huggingface dataset:
English: • As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check your child for signs and symptoms of tuberculosis before starting Humira.
Estonian: • Kuna Humira-ravi saanud patsientidel on kirjeldatud tuberkuloosi juhte, kontrollib arst teie last enne Humira-ravi alustamist tuberkuloosi nähtude ja sümptomite suhtes.
English: Table 15 Maintenance regimen Patient Weight
Estonian: Tabel 15 Säilitusravi skeem
English: Patients demonstrating a Pediatric ACR 30 response at Week 16 were eligible to be randomised into the double blind (DB) phase and received either Humira 24 mg/m up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Estonian: Patsiendid, kellel esines 16 ravinädalaks laste ACR 30 ravivastus, olid sobivad randomiseeritavaks topeltpimedasse faasi (DB) ning said, kas Humira't 24 mg/m2 kuni maksimaalselt 40 mg või platseebot igal teisel nädalal, järgneva 32 nädala jooksul või kuni haiguse ägenemiseni.
English: Patients received Humira 0.8 mg/kg eow (up to 40 mg), 0.4 mg/kg eow (up to 20 mg), or methotrexate 0.1 - 0.4 mg/kg weekly (up to 25 mg).
Estonian: Patsientidele manustati Humira't annuses 0,8 mg/kg igal teisel nädalal (kuni 40 mg), 0,4 mg/kg igal teisel nädalal (kuni 20 mg) või metotreksaati 0,1…0,4 mg/kg üks kord nädalas (kuni 25 mg).
English: Your child's doctor may increase the dose frequency to 20 mg every week.
Estonian: Teie lapse arst võib suurendada annuse sagedust 20 mg-ni igal nädalal.
English: Humira is used to treat children with chronic non-infectious uveitis from 2 years of age with inflammation affecting the front of the eye
Estonian: Humira't kasutatakse laste kroonilise mitteinfektsioosse soonkestapõletiku raviks vähemalt 2-aastastel lastel, kellel põletik haarab silma eesmist osa.
English: Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the open-label extension trial, 38% (25/66) and 55% (36/66) regained PASI 75 response after 12 and 24 weeks of re-treatment, respectively.
Estonian: Kõikidest patsientidest, kellel kadus adekvaatne ravivastus pärast rerandomiseerimist platseebole ülemineku tõttu, osalesid avatud jätku-uuringus 38% (25/66) ja 55% (36/66) saavutasid PASI 75 tulemuse vastavalt pärast 12 ja 24 nädalat kestnud korduvravikuuri.
English: • Do not use the pre-filled syringe if it has been dropped or crushed
Estonian: • Ärge kasutage eeltäidetud süstalt, kui see on maha kukkunud või vigastada saanud
English: • increased lipids in the blood
Estonian: • tõusnud lipiidide tase veres
English: Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with Humira, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Estonian: Neist 37 patsienti (56,9%) saavutasid taas remissiooni (ASDAS < 1,3) 12 nädalat pärast avatud ravi taasalustamist.
English: In patients with polyarticular juvenile idiopathic arthritis who were 2 to <4 years old or aged 4 and above weighing <15 kg, anti-adalimumab antibodies were identified in 7% (1/15) of patients, and the one patient was receiving concomitant methotrexate.
Estonian: Polüartikulaarse juveniilse idiopaatilise artriidiga 2 kuni < 4-aastastel või üle 4-aastastel, ent kehakaaluga < 15 kg patsientidel tuvastati adalimumabivastaseid antikehasid 7% (1/15) patsientidest ning see üks patsient sai kaasnevalt metotreksaati.
English: • low blood measurements for phosphate
Estonian: • madal fosfaatide tase veres
English: Your doctor may recommend temporary discontinuation.
Estonian: Teie arst võib soovitada ravi ajutiselt katkestada.
English: What the Humira vial looks like and contents of the pack
Estonian: Kuidas Humira viaal välja näeb ja pakendi sisu
English: In Psoriasis Study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at Week 33 compared to 5% continuing on Humira, p<0.001, experienced “loss of adequate response” (PASI score after Week 33 and on or before Week 52 that resulted in a <PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to Week 33).
Estonian: Psoriaasi uuringus I, 28% patsientidest, kes olid PASI 75 tulemustega, re-randomiseeriti platseebo suhtes 33. nädalal, võrreldes 5%-ga, kes jätkasid ravi Humira'ga, p<0,001, kogesid “adekvaatse ravivastuse kadumist” (PASI tulemus pärast 33. nädalat ja edaspidi või enne 52. nädalat põhjustas <PASI 50 tulemuse võrreldes algtasemega, minimaalselt 6-punktilise PASI tulemuse tõusu, võrreldes 33. nädalaga).
English: First dose of 40 mg, followed by 40 mg one week later.
Estonian: Algannus on 40 mg, millele järgneb 40 mg üks nädal hiljem.
English: Table 17 Maintenance regimen Patient Weight
Estonian: Tabel 17 Säilitusskeem
English: Week 8 and 52 Sustained Response Sustained Remission Sustained Mucosal Healing Clinical remission is Mayo score ≤ 2 with no subscore > 1; Clinical response is decrease from baseline in Mayo score ≥3 points and ≥30% plus a decrease in the rectal bleeding subscore [RBS] ≥1 or an absolute RBS of 0 or 1; p<0.05 for Humira vs. placebo pairwise comparison of proportions **p<0.001 for Humira vs. placebo pairwise comparison of proportions a
Estonian: 8. ja 52. nädal Püsiv ravivastus Püsiv paranemine Püsiv limaskesta paranemine Kliiniline paranemine: Mayo skoor ≤ 2 koos alamskooriga < 1; Kliiniline ravivastus on Mayo skoori vähenemine algväärtusest ≥ 3 punkti ja ≥ 30% pluss vähenemine rektaalveritsuste alamskooris [RBS, rectal bleeding subscore] ≥ 1 või RBS absoluutväärtus 0 või 1; p<0,05 Humira versus platseebo paariviisiline proportsioonide võrdlus **p<0,001 Humira versus platseebo paariviisiline proportsioonide võrdlus a
English: SYRINGE LABEL
Estonian: Luupuselaadne sündroom
English: Humira 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 (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Estonian: Humira on näidustatud mõõduka kuni raske aktiivse haavandilise koliidi raviks täiskasvanud patsientidel, kelle ravivastus konventsionaalsele ravile, sh kortikosteroididele ja 6-merkaptopuriinile (6-MP) või asatiopriinile (AZA) on ebapiisav või kes ei talu või kellel on meditsiiniline vastunäidustus selliste ravikuuride suhtes.
English: In CD Study II, 325 patients who had lost response or were intolerant to infliximab were randomised to receive either 160 mg Humira at Week 0 and 80 mg at Week 2 or placebo at Weeks 0 and 2.
Estonian: CD uuringus II randomiseeriti 325 patsienti, kellel oli ravivastus kadunud või kes ei talunud infliksimabi; manustati kas 160 mg Humira't 0-nädalal ja 80 mg 2. nädalal või platseebot 0- ja 2. nädalal.
English: Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Estonian: Humira on näidustatud raske aktiivse anküloseeriva spondüliidi raviks täiskasvanutel, kelle ravivastus konventsionaalsele ravile on olnud ebapiisav.
English: Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis
Estonian: Psoriaatiline artriit ja aksiaalne spondüloartriit, sh anküloseeriv spondüliit
English: In patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years, anti-adalimumab antibodies were identified in 15.8% (27/171) of patients treated with adalimumab.
Estonian: Polüartikulaarse juveniilse idiopaatilise artriidiga 4...17-aastastel patsientidel tuvastati adalimumabivastaseid antikehasid 15,8% (27/171) patsientidest, keda raviti adalimumabiga.
English: In adult patients with psoriasis, anti-adalimumab antibodies were identified in 77/920 subjects (8.4%) treated with adalimumab monotherapy.
Estonian: Psoriaasiga täiskasvanud patsientidel leiti adalimumabivastaseid antikehi 77/920 katsealusel (8,4%), keda raviti adalimumabi monoteraapiaga.
English: Humira 40 mg every other week N = 70
Estonian: Humira 40 mg igal teisel nädalal N = 70
English: There is no relevant use of Humira in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Estonian: Puudub Humira asjakohane kasutus lastel anküloseeriva spondüliidi ja psoriaatilise artriidi näidustusel.
English: Hold the grey body of the pre-filled pen with one hand.
Estonian: Hoidke ühe käega pensüstli hallist kehast.
English: Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the Humira group experienced worsening of abscesses (23.0% vs 11.4%, respectively) and draining fistulas (30.0% vs 13.9%, respectively).
Estonian: Patsientide osakaal, kellel abstsesside ja eritisega fistulite seisund uuringutes HS-I ja HS-II esimesel 12 ravinädalal halvenes, oli platseebo grupis ligikaudu kaks korda suurem kui Humira grupis (abstsessid vastavalt 23,0% vs 11,4% ja eritisega fistulid vastavalt 30,0% vs 13,9% ).
English: If you have rheumatoid arthritis and you do not receive methotrexate with your Humira therapy, your doctor may decide to give 40 mg adalimumab every week or 80 mg every other week.
Estonian: Kui teil on reumatoidartriit ning te ei saa Humira-ravi ajal metotreksaati, võib arst otsustada, et saate 40 mg adalimumabi igal nädalal või 80 mg igal teisel nädalal.
English: Two patients out of 3,441 treated with Humira in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
Estonian: 3441 patsiendist, keda raviti Humira'ga kõigis reumatoidartriidi ja psoriaatilise artriidi uuringutes, kahel ilmnesid esmaselt tekkinud luupusetaolisele sündroomile viitavad kliinilised nähud.
English: Humira 40 mg every other week was assessed in 393 patients in two randomised, 24 week double − blind, placebo − controlled studies in patients with active ankylosing spondylitis (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.3 in all groups) who have had an inadequate response to conventional therapy.
Estonian: Aktiivse anküloseeriva spondüliidiga 393 patsiendil, kelle vastus konventsionaalsele ravile oli olnud ebapiisav, hinnati Humira toimet (40 mg igal teisel nädalal) kahes randomiseeritud, 24-nädalases topeltpimedas, platseebokontrollitud uuringus [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) oli kõikides gruppides 6,3].
English: • Psoriasis,
Estonian: • psoriaas
English: Tell your doctor or pharmacist if your child is taking, has recently taken or might take any other medicines.
Estonian: Teatage oma arstile või apteekrile, kui teie laps võtab, on hiljuti võtnud või kavatseb võtta mis tahes muid ravimeid.
English: • pre-filled syringe has been dropped or crushed
Estonian: • eeltäidetud süstal on maha kukkunud või vigastada saanud
English: Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.
Estonian: Ärge püüdke ravimit ise süstida, kui te ei ole kindel, kas te saite aru, kuidas süstimiseks ettevalmistusi teha ja süstida.
English: Humira Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis
Estonian: Humira annus polüartikulaarse juveniilse artriidiga patsientidel
English: How to store Humira
Estonian: Kuidas Humira't säilitada
English: Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leukopenia) have been reported with Humira.
Estonian: Humira'ga seoses on teatatud hematoloogilise süsteemi kõrvaltoimetest, sh meditsiiniliselt olulisest tsütopeeniast (nt trombotsütopeenia, leukopeenia).
English: Table 8 ACR Responses in RA Study V (percent of patients)
Estonian: Tabel 8 ACR vastused RA uuringus V (protsent patsientidest)
English: The following instructions explain how to give yourself an injection of Humira using the pre-filled pen.
Estonian: Järgnevalt on selgitatud, kuidas süstida endale Humira't, kasutades pensüstlit.
English: Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis) urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhidrosis, alopecia pruritus
Estonian: Psoriaasi halvenemine või avaldumine (sh palmoplantaarne pustuloosne psoriaas) urtikaaria, verevalumid (sealhulgas purpur), dermatiit (sealhulgas ekseem), küünte murdumine, liighigistamine, alopeetsia sügelus
English: Some of those patients were also treated with azathioprine or 6- mercaptopurine.
Estonian: Mõningaid nendest patsientidest raviti samuti asatiopriini või 6-merkaptopuriiniga.
English: The recommended dose of Humira is 40 mg every other week.
Estonian: Soovitatav Humira annus on 40 mg igal teisel nädalal.
English: Psoriatic arthritis Psoriatic arthritis is an inflammatory disease of the joints that is usually associated with psoriasis.
Estonian: Psoriaatiline artriit Psoriaatiline artriit on liigeste põletikuline haigus, mis on tavaliselt seostatud psoriaasiga.
English: • Pick up the syringe with the needle pointing up.
Estonian: • Võtke süstal kätte, nõelaga ülespoole.
English: Table 20: Paediatric Plaque Psoriasis Efficacy Results at 16 Weeks
Estonian: Tabel 20: Naastuline psoriaas lastel: efektiivsustulemused 16. nädalal
English: Serious allergic reactions associated with Humira were rare during clinical trials.
Estonian: Kliinilistes uuringutes esines Humira kasutamisega seotud tõsiseid allergilisi reaktsioone harva.
English: • You should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Humira treatment.
Estonian: • Te peate teadlikult kasutama usaldusväärseid rasestumisvastaseid vahendeid raseduse vältimiseks ja jätkama nende kasutamist vähemalt 5 kuu jooksul pärast viimast Humira-ravi.
English: In patients not given concomitant methotrexate, the incidence was 16/185 (8.6%), compared to 1/19 (5.3%) when adalimumab was used as add-on to methotrexate.
Estonian: Patsientidel, kes ei saanud samaaegselt metotreksaati, oli esinemissagedus 8,6% (16/185), võrreldes 5,3%-ga (1/19), kui adalimumabi kasutati lisaks metotreksaadile.
English: • Your child should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after the last Humira treatment.
Estonian: • Teie laps peab teadlikult kasutama usaldusväärseid rasestumisvastaseid vahendeid raseduse vältimiseks ja jätkama nende kasutamist vähemalt 5 kuu jooksul pärast viimast Humira-ravi.
English: • autoimmune hepatitis (inflammation of the liver caused by the body's own immune system)
Estonian: • autoimmuunne hepatiit (organismi enda immuunsüsteemi põhjustatud maksapõletik)
English: It is important that you tell her baby's doctors and other health care professionals about your child's Humira use during her pregnancy so they can decide when her baby should receive any vaccine.
Estonian: On tähtis, et te räägiksite tema lapse arstile ja teistele arstidele teie lapse rasedusaegsest Humira-ravist, et nad saaksid otsustada, millal tema last vaktsineerida.
English: The recommended dose of Humira for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 1).
Estonian: Soovitatav Humira annus Crohni tõvega patsientidele vanuses 6 kuni 17 aastat põhineb kehakaalul (tabel 1).
English: The recommended dose of Humira for patients with polyarticular juvenile idiopathic arthritisfrom 2 years of age is based on body weight (Table 1).
Estonian: Soovitatav Humira annus polüartikulaarse juveniilse idiopaatilise artriidiga vähemalt 2-aastastele patsientidele põhineb kehakaalul (tabel 1).
English: Rheumatoid arthritis Age or body weight
Estonian: Reumatoidartriit Vanus või kehakaal
English: The recommended Humira dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Estonian: Soovitatav Humira annus naastulise psoriaasiga patsientidele vanuses 4 kuni 17 aastat põhineb kehakaalul (tabel 3).
English: Humira 40 mg solution for injection in pre-filled syringe and/or pre-filled pen is available for the maintenance dose.
Estonian: Säilitusannuse manustamiseks on saadaval Humira 40 mg süstelahus eeltäidetud süstlas ja/või pensüstlis.
English: Solution for injection 1 pre-filled syringe 1 alcohol pad
Estonian: Süstelahus 1 eeltäidetud süstal 1 alkoholipadjake
English: At Week 12, a significantly higher proportion of patients treated with Humira versus placebo achieved HiSCR.
Estonian: 12. ravinädalal saavutas platseeboga võrreldes oluliselt suurem hulk Humira'ga ravitud patsiente HiSCRi.
English: • Enthesitis-related arthritis
Estonian: • entesiidiga seotud artriit
English: Note: P = Placebo (Number at Risk (flared)); A = HUMIRA (Number at Risk (flared)).
Estonian: Märkus: P = platseebo (riskipatsientide arv (ägenemised)); A = HUMIRA (riskipatsientide arv (ägenemised)).
English: Among patients whose Humira treatment was withdrawn at Week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of Humira 40 mg weekly returned to levels similar to that observed before withdrawal (56.0 %).
Estonian: Patsientide hulgas, kellel uuringutes HS-I ja HS-II Humira-ravi 12. nädalal katkestati, taastus HiSCR määr 12 nädalat pärast Humira-ravi taasalustamist annusega 40 mg igal nädalal tasemeni, mida täheldati enne ravi katkestamist (56,0%).
English: If you accidentally inject a smaller amount of Humira liquid, or if you inject Humira less frequently than told to by your child's doctor or pharmacist, you should call your child's doctor or pharmacist and tell him/her that your child has taken less.
Estonian: Kui te kasutate Humira't vähem kui ette nähtud Kui te süstite kogemata vähem Humira't või harvemini kui teie lapse arst või apteeker on soovitanud, peate helistama oma lapse arstile või apteekrile ja rääkima talle, et teie laps on saanud vähem ravimit.
English: There is limited safety experience in patients undergoing arthroplasty while receiving Humira.
Estonian: Kogemus käimasoleva artroplastikaga Humira't saavate patsientide ohutusest on piiratud.
English: • Do not attempt to self-inject until you are sure that you understand how to prepare and give the injection.
Estonian: • Ärge püüdke ravimit ise süstida, kui te ei ole kindel, kas saite aru, kuidas süstimiseks ettevalmistusi teha ja süstida.
English: • Do not attempt to inject your child until you are sure that you understand how to prepare and give the injection.
Estonian: • Ärge püüdke ravimit ise oma lapsele süstida, kui te ei ole kindel, kas saite aru, kuidas süstimiseks ettevalmistusi teha ja süstida.
English: Humira/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 9).
Estonian: Humira/metotreksaadi patsientidel täheldati 6. ja 12. ravikuul märkimisväärselt vähem radiograafilist progressiooni kui patsientidel, kes said ainult metotreksaati (vt tabel 9).
English: Humira is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Estonian: Humira on näidustatud mõõduka kuni raske aktiivse Crohni tõve raviks lastel (alates 6 aasta vanusest), kelle ravivastus konventsionaalsele ravile, sh esmasele toitumisteraapiale ning kortikosteroididele ja/või immunomodulaatoritele on ebapiisav või kes ei talu või kellel on vastunäidustus selliste ravikuuride suhtes.
English: Psoriatic arthritis is an inflammation of the joints associated with psoriasis.
Estonian: Psoriaatiline artriit on liigeste põletik, mida seostatakse psoriaasiga.
English: Methotrexate should be continued during treatment with Humira.
Estonian: Humira-ravi ajal tuleb jätkata metotreksaadi manustamist.
English: • Do not recycle or throw the pre-filled syringe in the household waste
Estonian: • Ärge eeltäidetud süstalt taaskasutage ega visake seda olmejäätmete hulka
English: The recommended dose of Humira for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Estonian: Humira soovitatav annus reumatoidartriidiga täiskasvanud patsientidele on 40 mg adalimumabi, mida manustatakse igal teisel nädalal ühekordse annusena nahaaluse süste teel.
English: In controlled trials of Humira (initial doses of 80 mg at Week 0 followed by 40 mg every other week starting at Week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in Humira-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of Humira-treated patients and 2.4% of control-treated patients.
Estonian: Humira kontrollitud uuringutes (algannus 80 mg 0-nädalal, millele järgnes 40 mg manustamine igal teisel nädalal alates 1. nädalast) uveiidiga täiskasvanud patsientidel kestusega kuni 80 nädalat, kus kokkupuute kestuse mediaan oli 166,5 päeva ja 105,0 päeva vastavalt Humira-ravi saanud ja kontrollrühma patsientidel, tekkis ALAT aktiivsuse suurenemine ≥ 3 korda üle normi ülemise piiri 2,4% Humira'ga ravitud ja 2,4% kontrollrühma patsientidest.
English: Contains 2 cartons each for a single injection only Each carton contains:
Estonian: Sisaldab 2 karpi, mõlemad on ette nähtud ainult ühekordseks süsteks.
English: • Psoriatic arthritis
Estonian: • psoriaatiline artriit
English: Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before you are given Humira and during treatment with Humira.
Estonian: - Arst annab teile patsiendi teabekaardi, mis sisaldab tähtsat ohutusalast informatsiooni, millest peate teadlik olema enne Humira-ravi alustamist ja ravi ajal.
English: Humira is used to treat psoriatic arthritis in adults.
Estonian: Humira't kasutatakse psoriaatilise artriidi raviks täiskasvanutel.
English: The other ingredients are mannitol, polysorbate 80 and water for injections.
Estonian: Abiained on mannitool, polüsorbaat 80 ja süstevesi.
English: Placebo/ MTX n=60
Estonian: Platseebo/ MTX n=60
English: • Polyarticular juvenile idiopathic arthritis,
Estonian: • polüartikulaarne juveniilne idiopaatiline artriit,
English: In patients with Crohn's disease, the loading dose of 80 mg Humira on Week 0 followed by 40 mg Humira on Week 2 achieves serum adalimumab trough concentrations of approximately 5.5 g/ml during the induction period.
Estonian: Crohni tõvega patsientidel saavutatakse sissejuhatava perioodi jooksul küllastusannusega 80 mg Humira't 0-nädalal, millele järgneb annus 40 mg Humira't 2. nädalal, adalimumabi minimaalsed seerumi kontsentratsioonid ligikaudu 5,5 μg/ml.
English: Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before your child is given Humira and during treatment with Humira.
Estonian: - Arst annab teile patsiendi teabekaardi, mis sisaldab tähtsat ohutusalast informatsiooni, millest peate teadlik olema enne lapsel Humira-ravi alustamist ja ravi ajal.
English: In Psoriasis Study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at Week 33 compared to 5% continuing on Humira, p < 0.001, experienced “loss of adequate response” (PASI score after Week 33 and on or before Week 52 that resulted in a <PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to Week 33).
Estonian: Psoriaasi uuringus I 28% patsientidest, kes olid PASI 75 tulemustega ja rerandomiseeritud platseebo suhtes 33. nädalal, võrreldes 5%-ga, kes jätkasid ravi Humira'ga, p<0,001, kogesid „adekvaatse ravivastuse kadumist“ (PASI tulemus pärast 33. nädalat ja edaspidi või enne 52. nädalat põhjustas <PASI 50 tulemuse võrreldes algtasemega, minimaalselt 6-punktilise PASI tulemuse tõusu võrreldes 33. nädalaga).