FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual dose regimen for hidradenitis suppurativa is an initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections on the same day) two weeks later.
Icelandic: Venjulegur skammtur við graftarmyndandi svitakirtlabólgu er 160 mg í upphafi (gefið sem fjórar 40 mg inndælingar á sama degi eða sem tvær 40 mg inndælingar tvo daga í röð), fylgt eftir með 80 mg tveimur vikum síðar (gefið sem tvær 40 mg inndælingar á sama degi).
English: In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1 % of adalimumab-treated patients and 1.3 % of control-treated patients.
Icelandic: Í 3. stigs samanburðarrannsóknum á adalimumabi hjá sjúklingum á aldrinum 4 til 17 ára með sjálfvakta fjölliðagigt og hjá sjúklingum á aldrinum 6 til 17 ára með festumeinstengda liðagigt, var aukning
English: Correct
Icelandic: Rétt
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Icelandic: NAFN MARKAÐSLEYFISHAFA
English: Rheumatoid arthritis is an inflammatory disease of the joints.
Icelandic: Iktsýki er bólgusjúkdómur í liðum.
English: Clinical remission results remained relatively constant irrespective of previous TNF-antagonist exposure.
Icelandic: 24. Niðurstöður hvað varðar klínískt sjúkdómshlé voru til þess að gera lítið breytilegar, óháð fyrri meðferð með TNF-blokka.
English: • high blood sugar;
Icelandic: hár blóðsykur;
English: Adults with non-infectious uveitis
Icelandic: ASDASc óvirkur sjúkdómur
English: EXPIRY DATE
Icelandic: RA rannsóknir
English: In Study UV I statistically significant differences in favour of adalimumab versus placebo were observed for each component of treatment failure.
Icelandic: Marktækur munur sást í rannsókn UV I adalimumab í hag samanborið við lyfleysu fyrir hvern þátt meðferðarbrests.
English: Hypokalaemia, uric acid increased, blood sodium abnormal, hypocalcaemia hyperglycaemia, hypophosphataemia, dehydration
Icelandic: Blóðkalíumlækkun, blóðþvagsýruhækkun, óeðlilegt natríum í blóði, blóðkalsíumlækkun, blóðsykurshækkun, blóðfosfatskortur, vessaþurrð
English: Autoimmune processes
Icelandic: Aukaverkanir á íkomustað
English: No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of adalimumab in paediatric patients with plaque psoriasis.
Icelandic: ALT ≥ 3 föld eðlileg efri mörk kom fram í 3. stigs rannsókn á adalimumabi hjá börnum með skellusóra.
English: The recommended dose of Hefiya for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Icelandic: Ráðlagður skammtur af Hefiya fyrir fullorðna er 80 mg upphafsskammtur gefinn undir húð, fylgt eftir með 40 mg gefnum undir húð aðra hverja viku, einni viku eftir að upphafsskammtur er gefinn.
English: Radiographic changes were assessed in the psoriatic arthritis studies.
Icelandic: Svörun samkvæmt myndgreiningu var metin í rannsóknunum á sóraliðbólgu.
English: Autoantibodies
Icelandic: Nálabox
English: • double vision;
Icelandic: • tvísýni;
English: primary analysis (ITT) placebo adalimumab
Icelandic: Lyfleysa adalimumab
English: The safety and efficacy of adalimumab were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and / or foot psoriasis who were candidates for systemic therapy in a randomised double-blind study (Psoriasis Study III).
Icelandic: Öryggi og verkun adalimumabs var einnig rannsakað í slembaðri tvíblindri rannsókn (sóra rannsókn III) hjá fullorðnum sjúklingum, sem komu til greina fyrir altæka meðferð, með í meðallagi mikinn til mikinn langvinnan skellusóra auk sóra á höndum og/eða fótum.
English: • increased uric acid in the blood;
Icelandic: fosfat mælist lágt í blóði;
English: The primary endpoint was the percent change from Baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6 % (median percent change -88.9 %) in patients in the adalimumab group compared to -11.6 % (median percent change -50.0 %) in patients in the placebo group.
Icelandic: Það náðist vegna fækkunar um að meðaltali 62,6% (88,9% að miðgildi) í adalimumab hópnum samanborið við 11,6% (50,0% að miðgildi) í lyfleysuhópnum.
English: Reports of serious allergic reactions including anaphylaxis have been received following adalimumab administration.
Icelandic: Greint hefur verið frá alvarlegum ofnæmisviðbrögðum, þ. á m. bráðaofnæmi, í kjölfar notkunar adalimumabs.
English: • pulmonary embolism (blockage in an artery of the lung);
Icelandic: • blóðtappi í lungum (fyrirstaða í lungnaslagæð);
English: The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (as two 40 mg injections), followed by 40 mg given every other week starting one week after the initial dose.
Icelandic: Venjulegur skammtur hjá fullorðnum með æðahjúpsbólgu sem ekki er af völdum sýkingar er 80 mg í upphafi (sem tvær 40 mg inndælingar sama dag), fylgt eftir með 40 mg gefnum á tveggja vikna fresti sem hefst einni viku eftir upphafsskammtinn.
English: The third group received 40 mg of adalimumab every other week with placebo injections on alternate weeks.
Icelandic: 40 mg af adalimumabi aðra hverja viku og inndælingu lyfleysu hina vikuna.
English: Tachycardia
Icelandic: Brotthvarf
English: • do not remove the needle cap until just before you give the injection.
Icelandic: fjarlægir ekki nálarhettuna fyrr en rétt fyrir inndælinguna.
English: • stroke;
Icelandic: • brjóstverkur;
English: Psychiatric disorders
Icelandic: LYFJAFRÆÐILEGAR
English: Not known
Icelandic: Að beiðni
English: • abnormal blood measurements for sodium;
Icelandic: • óeðlilegar mælingar á natríum í blóði;
English: • hepatitis (liver inflammation);
Icelandic: • lifrarbólga (bólga í lifur);
English: In a developmental toxicity study conducted in monkeys, there was no indication of maternal toxicity, embryotoxicity or teratogenicity.
Icelandic: Engar vísbendingar um eiturverkanir á móður, fósturvísiseitrun eða fósturskemmdir komu fram í rannsókn á eiturverkunum á þroska, sem gerð var á öpum.
English: • fungal infections;
Icelandic: • vélindabakflæði;
English: One 0.8 ml pre-filled pen contains 40 mg adalimumab.
Icelandic: Einn 0,8 ml áfylltur penni inniheldur 40 mg adalimumab.
English: Hospitalisation rates
Icelandic: Tíðni sjúkrahúsinnlagna
English: Headache
Icelandic: Skammtar
English: Table 9 radiographic mean changes over 12 months in RA study III
Icelandic: á 12 mánuðum í RA rannsókn III
English: After subcutaneous administration of a single 40 mg dose, absorption and distribution of adalimumab was slow, with peak serum concentrations being reached about 5 days after administration.
Icelandic: Frásog og dreifing adalimumabs var hægt eftir gjöf staks 40 mg skammts undir húð og hámarksþéttni í sermi náðist um 5 dögum eftir gjöf.
English: 3 defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive post-Baseline visits
Icelandic: skilgreint sem lokun allra fistla sem láku við upphafsgildi, í a.m.k.
English: Before your injection
Icelandic: UM AÐ LYFIÐ
English: * Note: Hefiya is currently only available as 40 mg pre-filled syringe and 40 mg pre-filled pen.
Icelandic: Hefiya er sem stendur aðeins fáanlegt sem 40 mg áfyllt sprauta og 40 mg áfylltur penni.
English: clinical remission clinical response (CR-100) patients in steroid-free remission for > = 90 daysa * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a of those receiving corticosteroids at baseline
Icelandic: < 0,001 fyrir adalimumab samanborið við lyfleysu, parasamanburður á hlutföllum ** p < 0,02 fyrir adalimumab samanborið við lyfleysu, parasamanburður á hlutföllum a af þeim sem notuð barkstera í upphafi rannsóknar
English: The recommended dose of Hefiya for paediatric patients with uveitis from 2 years of age is based on body weight (table 5).
Icelandic: Ráðlagður skammtur af Hefiya fyrir börn með æðahjúpsbólgu frá 2 ára aldri er byggður á líkamsþyngd (tafla 5).
English: • fever;
Icelandic: • skjálfti;
English: Polyarticular juvenile idiopathic arthritis
Icelandic: Graftarmyndandi svitakirtlabólga hjá unglingum
English: Figure I: complete your injection
Icelandic: Mynd I: inndælingunni lokið
English: Table 16 ACR response in placebo-controlled psoriatic arthritis studies (percent of patients)
Icelandic: Tafla 16 ACR svörun í lyfleysustýrðum samanburðarrannsóknum hjá sjúklingum með sóraliðbólgu (hlutfall sjúklinga)
English: Ulcerative colitis
Icelandic: Klínísk svörun
English: Table 6 Undesirable effects
Icelandic: Tafla 6 Aukaverkanir
English: Hefiya dose for paediatric patients with plaque psoriasis Patient weight
Icelandic: Tafla 3. Hefiya skammtar fyrir börn með skellusóra Þyngd sjúklings
English: Adalimumab-treated patients showed statistically significant improvements at week 26 compared with placebo in the DLQI.
Icelandic: Sjúklingar sem fengu meðferð með adalimumabi sýndu tölfræðilega marktækan ávinning eftir 26 vikur samanborið við lyfleysu með mælikvarða á lífsgæðum einstaklinga með húðsjúkdóm (Dermatology Life Quality Index, DLQI).
English: The safety and efficacy of adalimumab were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3-month trial of systemic antibiotic therapy.
Icelandic: Öryggi og verkun adalimumabs var metið í slembuðum, tvíblindum samanburðarrannsóknum með lyfleysu og opinni framhaldsrannsókn hjá fullorðnum sjúklingum með miðlungs til alvarlegrar graftarmyndandi svitakirtlabólgu
English: Paediatric population
Icelandic: Sérstakir sjúklingahópar
English: primary analysis (ITT) placebo adalimumab time to treatment failure at or after week 2 in study UV II
Icelandic: HRa p-gildi b tími til meðferðarbrests við eða eftir viku 6 í rannsókn UV I
English: Hefiya is used to treat psoriatic arthritis in adults.
Icelandic: Hefiya er notað til meðferðar við sóraliðbólgu hjá fullorðnum.
English: Before your injection Preparing the pen
Icelandic: Sprautan innan í pennanum er úr gleri af tegund
English: Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis
Icelandic: Hryggikt, áslægur hryggbólgusjúkdómur, án vísbendinga um hryggikt samkvæmt myndgreiningu, og sóraliðbólga
English: Deafness, tinnitus
Icelandic: A. ÁLETRANIR
English: • impotence;
Icelandic: • getuleysi;
English: Each 0.8 ml single-dose pre-filled pen contains 40 mg of adalimumab.
Icelandic: Hver 0,8 ml stakur skammtur í áfylltum penna inniheldur 40 mg af adalimumabi.
English: fistula remission3
Icelandic: Tafla 9
English: The decision to stop using Hefiya should be discussed with your doctor.
Icelandic: Ræða skal við lækninn um hvort hætta eigi að nota Hefiya.
English: Keep the pre-filled pens in the outer carton in order to protect from light.
Icelandic: Geymið áfyllta pennann í ytri umbúðum til varnar gegn ljósi.
English: Significant improvements at week 16 from baseline compared to placebo (Studies I and II) and MTX (Study II) were demonstrated in the DLQI (Dermatology Life Quality Index).
Icelandic: 16 var samkvæmt mati með mælikvarða á lífsgæðum einstaklinga með húðsjúkdóm (Dermatology Life Quality Index) sýnt fram á marktækan árangur miðað við upphafsgildi samanborið við lyfleysu (rannsóknir
English: Myocardial infarction1), arrhythmia, congestive heart failure
Icelandic: Hjartadrep1), hjartsláttartruflun, hjartabilun
English: Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma) benign neoplasm
Icelandic: Húðkrabbamein fyrir utan sortuæxli (þ.m.t. grunnfrumukrabbamein og flöguþekjukrabbamein), góðkynja æxli
English: Hefiya is used to treat moderate to severe plaque psoriasis in adults.
Icelandic: Hefiya er notað til meðferðar við í meðallagi alvarlegum eða alvarlegum skellusóra hjá fullorðnum.
English: There are no clinical trials with adalimumab in adolescent patients with HS.
Icelandic: Engar klínískar rannsóknir hafa verið gerðar á adalimumabi hjá sjúklingum á unglingsaldri með graftarmyndandi svitakirtlabólgu.
English: After adjustment for weight differences, gender and age appeared to have a minimal effect on adalimumab clearance.
Icelandic: Kyn og aldur virtust hafa óveruleg áhrif á úthreinsun adalimumabs eftir að leiðrétt hafði verið fyrir þyngdarmuni.
English: • angioedema (localised swelling of the skin);
Icelandic: • ofnæmisbjúgur (staðbundin bólga í húðinni);
English: Adalimumab significantly delayed the time to treatment failure, as compared to placebo (See Figure 3, P < 0.0001 from log rank test).The median time to treatment failure was 24.1 weeks for subjects treated with placebo, whereas the median time to treatment failure was not estimable for subjects treated with adalimumab because less than one-half of these subjects experienced treatment failure.
Icelandic: Miðgildi tíma fram að meðferðarbresti var 24,1 vika hjá þeim sem fengu lyfleysu en ekki var hægt að meta miðgildi tíma fram að meðferðarbresti hjá þeim sem fengu adalimumab þar sem innan við helmingur þeirra varð fyrir meðferðarbresti.
English: • Keep the syringes in the original carton until ready to use to protect from light.
Icelandic: Geymið sprauturnar í upprunalegum umbúðum fram að notkun til varnar gegn ljósi.
English: Concurrent administration of biologic DMARDs or TNF-antagonists
Icelandic: Samtímis gjöf sjúkdómstemprandi líftæknigigtarlyfja eða TNF-blokka
English: • a sac in the wall of a major artery, inflammation and clot of a vein; blockage of a blood vessel;
Icelandic: • ósæðargúll, bólga og tappi í bláæð, lokun í æð;
English: Subjects had to have failed conventional therapy (including a corticosteroid and/or an immunomodulator) for CD.
Icelandic: Skilyrði fyrir þátttöku var að hefðbundin meðferð við Crohns sjúkdómi hafði brugðist (m.a. meðferð með barksterum og/eða ónæmistemprandi meðferð).
English: Inflammation
Icelandic: Inndælingin
English: N failure median time to HRa CI 95 % p Value b treatment
Icelandic: áhættuhlutfalla 95% öryggisbil
English: Heart failure
Icelandic: Hjartabilun
English: Adipic acid
Icelandic: Áslægur hryggbólgusjúkdómur
English: Hefiya dose for patients with polyarticular juvenile idiopathic arthritis
Icelandic: Hefiya skammtar fyrir sjúklinga með festumeinstengda liðagigt
English: In controlled Phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7 % of adalimumab-treated patients and 1.6 % of control-treated patients.
Icelandic: Í 3. stigs samanburðarrannsóknum á adalimumabi hjá sjúklingum með iktsýki og sóraliðbólgu, sem stóðu yfir í 4 til 104 vikur, var aukning á ALT ≥
English: • intestinal infections (including gastroenteritis);
Icelandic: • sýkingar í taugakerfi (þ.m.t. veirumengisbólga);
English: Lymphoma**, solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma**
Icelandic: Eitilæxli**, æxli í líffærum (þ.m.t. brjóstakrabbamein, lungnaæxli og æxli í skjaldkirtli), sortuæxli**
English: • high blood measurements for white blood cells;
Icelandic: hvít blóðkorn mælast mörg í blóði;
English: Juvenile idiopathic arthritis (JIA)
Icelandic: klínískt sjúkdómshlé klínísk svörun (CR-100)
English: Children, adolescents and adults with enthesitis-related arthritis Children, adolescents and adults from 6 years of age weighing 30 kg or more The recommended dose of Hefiya is 40 mg every other week.
Icelandic: 30 kg eða þyngri Ráðlagður skammtur af Hefiya er 40 mg aðra hverja viku Fullorðnir með sóra
English: • Do not give Hefiya to children with polyarticular juvenile idiopathic arthritis below the age of
Icelandic: Hefiya má ekki gefa börnum yngri en 4 ára með skellusóra eða sáraristilbólgu.
English: Keep the pre-filled syringes in the outer carton in order to protect from light.
Icelandic: Geymið áfylltu sprauturnar í ytri umbúðum til varnar gegn ljósi.
English: Each 0.8 ml single-dose pre-filled syringe contains 40 mg of adalimumab.
Icelandic: Hver 0,8 ml stakur skammtur í áfylltri sprautu inniheldur 40 mg af adalimumabi.
English: Gastrointestinal disorders
Icelandic: Í CD rannsókn
English: Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of adalimumab.
Icelandic: B og ýmsum illkynja sjúkdómum (m.a.hvítblæði, eitilæxli og T-frumueitilæxli í lifur og milta) við notkun adalimumabs.
English: Keep the pre-filled syringe in the outer carton in order to protect from light.
Icelandic: Geymið áfylltu sprautuna í ytri umbúðum til varnar gegn ljósi.
English: Adalimumab has not been studied in patients with hepatic or renal impairment.
Icelandic: Engar rannsóknir hafa verið gerðar á adalimumabi hjá sjúklingum með skerta lifrar- eða nýrnastarfsemi.
English: Among patients who had failed prior anti-TNF treatment, week 52 remission was achieved by 3 % on placebo and 10 % on adalimumab.
Icelandic: 52 hjá 3% sjúklinga sem fengu lyfleysu og 10% sjúklinga sem fengu adalimumab.
English: Other opportunistic infections
Icelandic: Aðrar tækifærissýkingar
English: Method and route of administration
Icelandic: AÐFERÐ VIÐ LYFJAGJÖF OG ÍKOMULEIÐ
English: This evaluation should include colonoscopy and biopsies per local recommendations.
Icelandic: Þetta mat skal fela í sér ristilsspeglun og vefjasýnatöku í samræmi við staðbundnar leiðbeiningar.
English: In monotherapy, some patients who experience a decrease in their response to Hefiya 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Icelandic: Þegar Hefiya er gefið eitt og sér gætu þeir sjúklingar, sem finna fyrir minnkandi svörun við Hefiya 40 mg aðra hverja viku, haft ávinning af því að auka skammtinn í 40 mg af adalimumabi vikulega eða 80 mg aðra hverja viku.
English: • Hefiya pre-filled syringe/s (see Figure A).
Icelandic: Það sem fylgir með í öskjunni er: • Hefiya áfyllt sprauta/ur (sjá mynd A).
English: Active tuberculosis or other severe infections such as sepsis, and opportunistic infections
Icelandic: Virkir berklar eða aðrar alvarlegar sýkingar eins og blóðsýking (sepsis) og tækifærissýkingar (sjá kafla 4.4).
English: Hidradenitis suppurativa (HS)
Icelandic: Samantektir um öryggi lyfsins (PSUR)
English: • It is important that you tell your baby's doctors and other health care professionals about your Hefiya use during your pregnancy before the baby receives any vaccine (for more information on vaccines see the “Warnings and precautions” section).
Icelandic: Mikilvægt er að upplýsa lækni barnsins og annað heilbrigðisstarfsfólk um notkun Hefiya á meðgöngu áður en barnið fær bóluefni.
English: • skin infections (including cellulitis and shingles);
Icelandic: • sýkingar í meltingarfærum (þ.m.t. maga- og þarmabólga);
English: ASASa partial remission ASDASc inactive disease partial flared a assessment of SpondyloArthritis International Society b baseline is defined as open label baseline when patients have active disease.
Icelandic: Sjúkdómur blossar upp að hluta tild a Assessment of SpondyloArthritis international Society b
English: • high blood measurements for lactate dehydrogenase;
Icelandic: laktat dehýdrogenasi mælist hár í blóði;
English: Immunogenicity
Icelandic: Taugakerfi
English: In paediatric patients with moderate to severe CD, the open-label adalimumab induction dose was 160 / 80 mg or 80 / 40 mg at weeks 0 and 2, respectively, dependent on a body weight cut-off of 40 kg. At week 4, patients were randomised 1:1 to either the Standard Dose (40 / 20 mg eow) or Low Dose (20 / 10 mg eow) maintenance treatment groups based on their body weight.
Icelandic: Hjá börnum með í meðallagi alvarlegan til alvarlegan Crohns sjúkdóm var upphafsskammtur adalimumab 160/80 mg eða 80/40 mg í viku 0 og viku 2 í opnu rannsókninni eftir því hvort líkamsþyngd var undir eða yfir 40 kg.
English: Sodium content
Icelandic: Í sórarannsókn
English: Reproductive system and breast disorders
Icelandic: Meðganga og brjóstagjöf
English: Psoriasis
Icelandic: LOTUNÚMER
English: • sensation disorders such as tingling, prickling or numbness;
Icelandic: • meltingartruflanir (þ.m.t. meltingartregða, uppþemba, brjóstsviði);
English: B. PACKAGE LEAFLET
Icelandic: C. AÐRAR FORSENDUR
English: • multiple sclerosis;
Icelandic: • sjóntruflanir;
English: Common (may affect up to 1 in 10 people)
Icelandic: Algengar (geta komið fyrir hjá 1 af 10 einstaklingum)
English: Subcutaneous use.
Icelandic: MERKIMIÐI SPRAUTU
English: Paraesthesias (including hypoaesthesia), migraine, nerve root compression
Icelandic: Náladofi (þ.m.t. snertiskynsminnkun) mígreni, þrýstingur á taugarót
English: Ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis
Icelandic: Hryggikt og áslægur hryggbólgusjúkdómur, án vísbendinga um hryggikt samkvæmt myndgreiningu
English: Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving adalimumab.
Icelandic: Greint hefur verið frá berklum, bæði endurvakningu berkla og nýjum tilvikum hjá sjúklingum sem nota adalimumab.
English: Paediatric Uveitis
Icelandic: Skurðaðgerðir
English: Lupus-like syndrome1)
Icelandic: Mjög sjaldgæfar Heilkenni sem líkist rauðum úlfum1)
English: Hefiya 40 mg solution for injection in a single-use pre-filled syringe Hefiya is supplied in a single-use clear type I glass syringe with a rubber stopper and a stainless steel needle with an automatic needle guard with finger flange, rubber needle cap and plastic plunger, containing 0.8 ml solution.
Icelandic: I með gúmmítappa og nál úr ryðfríu stáli með sjálfvirkri nálarhlíf með fingurkraga, nálarhettu úr gúmmíi og plaststimpli, sem inniheldur 0,8 ml af lausn.
English: Of 542 patients who were randomised to adalimumab 40 mg every other week, 170 patients continued on adalimumab 40 mg every other week for 10 years.
Icelandic: 2 fengu sjúklingar í báðum adalimumab hópunum 40 mg aðra hverja viku.
English: • low blood measurements for red blood cells;
Icelandic: rauð blóðkorn mælast fá í blóði;
English: Following the administration of 24 mg / m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg / ml for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg / ml with concomitant methotrexate.
Icelandic: adalimumabs í sermi 8.8 ± 6.6 μg/ml fyrir adalimumab án samliða notkunar metotrexats og 11.8 ± 4.3 μg/ml með samhliða notkun metotrexats.
English: • chest pain;
Icelandic: • húðkrabbamein;
English: The infections consisted primarily of nasopharyngitis, upper respiratory tract infection, and sinusitis.
Icelandic: Einkum var um að ræða nefkoksbólgu, sýkingar í efri hluta öndunarvegar og skútabólgu.
English: Subjects who flared during the double-blind period were allowed adalimumab 40 mg eow rescue therapy for at least 12 weeks.
Icelandic: Þátttakendur þar sem sjúkdómur blossaði upp á tvíblinda tímabilinu máttu fá adalimumab 40 mg björgunarmeðferð aðra hverja viku í a.m.k.
English: Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period.
Icelandic: Endurskoða skal vandlega áframhaldandi meðferð að loknum 16 meðferðarvikum, ef sjúklingur hefur ekki svarað meðferð á þeim tíma.
English: GI haemorrhage, dyspepsia, gastroesophageal reflux disease, sicca syndrome
Icelandic: Gallblöðrubólga og gallsteinar, fitulifur, aukið bilirúbín
English: See “4.
Icelandic: I og II.
English: adalimumab N=208
Icelandic: N=208
English: 30 months.
Icelandic: 30 mánuðir.