FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients were then re-treated with adalimumab 0.8 mg / kg eow for an additional 16 weeks and response rates observed during retreatment were similar to the previous double-blind period: PASI 75 response of 78.9 % (15 of 19 subjects) and PGA clear or minimal of 52.6 % (10 of 19 subjects).
Slovenian: Bolniki so bili nato znova zdravljeni z adalimumabom v odmerku 0,8 mg/kg vsak drugi teden še nadaljnjih 16 tednov, pri čemer so bile opažene stopnje odziva podobne kot v prejšnjem dvojno slepem obdobju: odziv PASI 75 pri 78,9 % (15 od 19 oseb) in PGA čisto ali minimalno pri 52,6 % (10 od 19 oseb).
English: Study HS-I (PIONEER I) evaluated 307 patients with 2 treatment periods.
Slovenian: V študiji HS-I (PIONEER I) je bilo ocenjenih 307 v dveh obdobjih zdravljenja.
English: Amongst those who responded at week 16 (n = 144), the paediatric ACR 30 / 50 / 70 /90 responses were maintained for up to six years in the OLE phase in patients who received adalimumab throughout the study.
Slovenian: Med bolniki, ki so se odzvali 16. teden (n = 144), so se odzivi »pediatric ACR« 30/50/70/90 v odprti podaljšani fazi ohranili do 6 let pri tistih, ki so ves čas študije dobivali adalimumab.
English: People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affect blood cells and bone marrow).
Slovenian: Pri bolnikih z resnejšim revmatoidnim artritisom, ki imajo bolezen že dolgo, obstaja povečana verjetnost, da zbolijo za limfomom in levkemijo (raka, ki prizadeneta krvne celice in kostni mozeg).
English: The mean (± SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 µg/ml for patients ≥ 40 kg (160 / 80 mg) and 10.6 ± 6.1 µg / ml for patients < 40 kg (80 / 40 mg).
Slovenian: Srednje (±SD) serumske koncentracije adalimumaba, dosežene v 4. tednu, so bile 15,7 ± 6,6 μg/ml pri bolnikih ≥ 40 kg (160/80 mg) in 10,6 ± 6,1 μg/ml pri bolnikih < 40 kg (80/40 mg).
English: • Do not use the syringe if it is broken or the needle guard is activated.
Slovenian: • Injekcijske brizge ne uporabite, če je poškodovana ali če je aktiviran ščitnik za iglo.
English: • ≥ 40 kg: 40 mg every week or 80 mg every other week Continued therapy should be carefully considered in a subject not responding by week 12.
Slovenian: • ≥ 40 kg: 40 mg vsak teden ali 80 mg vsak drugi teden Če se bolnik ne odzove na zdravljenje do 12. tedna, je potrebno skrbno premisliti o nadaljevanju zdravljenja.
English: Table 5.
Slovenian: Preglednica 5.
English: In controlled and open label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
Slovenian: V kontroliranih in odprtih študijah pri odraslih in otrocih z adalimumabom so poročali o resnih okužbah (vključno s smrtno nevarnimi okužbami, ki so se pojavile redko), med katerimi so bile tuberkuloza (tudi miliarna in zunajpljučna) in invazivne oportunistične okužbe (npr. diseminirana ali zunajpljučna histoplazmoza, blastomikoza, kokcidioidomikoza, pnevmocistoza, kandidaza, aspergiloza in listerioza).
English: • pleural effusion (abnormal collection of fluid in the pleural space);
Slovenian: • plevralna efuzija (nenormalno zbiranje tekočine v plevralnem prostoru);
English: The pivotal controlled studies involved 6,089 patients receiving adalimumab and 3,801 patients receiving placebo or active comparator during the controlled period.
Slovenian: ki podpirajo vlogo za pridobitev dovoljenja za promet, so vključevale 6089 bolnikov, ki so med kontroliranim obdobjem dobivali adalimumab, in 3801 bolnikov, ki so med tem obdobjem dobivali placebo ali primerjalno učinkovino.
English: Elderly
Slovenian: Starejši
English: Some of these hepatosplenic T-cell lymphomas with adalimumab have occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for inflammatory bowel disease.
Slovenian: Pri uporabi adalimumaba so se nekateri od hepatospleničnih limfomov celic T pojavili pri mladih odraslih bolnikih, ki so se sočasno zdravili z azatioprinom ali 6-merkaptopurinom, ki se uporabljata pri vnetni bolezni črevesa.
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (see table 29).
Slovenian: Klinični odziv Rezultati iz obeh študij kažejo statistično značilno zmanjšanje tveganja za neuspeh zdravljenja pri bolnikih, ki so prejemali adalimumab, v primerjavi z bolniki, ki so prejemali placebo (glejte preglednico 29).
English: If you stop using Hefiya
Slovenian: Če ste prenehali uporabljati zdravilo Hefiya
English: • inflammation of the pancreas which causes severe pain in the abdomen and back;
Slovenian: • vnetje trebušne slinavke, ki povzroča težjo bolečino v trebuhu in hrbtu;
English: If you are concerned with the appearance of the solution, then contact your pharmacist for assistance.
Slovenian: Če vas skrbi videz raztopine, se po pomoč obrnite na farmacevta.
English: Adalimumab has not been studied in patients with hepatic or renal impairment.
Slovenian: Adalimumaba niso proučili pri bolnikih z okvaro jeter ali ledvic.
English: • If you have or develop demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if you should receive or continue to receive Hefiya.
Slovenian: Demielinizirajoča bolezen • Če imate ali pa se pri vas razvija demielinizirajoča bolezen (bolezen, ki prizadene izolacijsko plast okrog živcev, kot je multipla skleroza), bo zdravnik presodil, ali lahko dobivate zdravilo Hefiya.
English: How to use Hefiya
Slovenian: Kako uporabljati zdravilo Hefiya
English: Available data suggest that the clinical response is usually achieved within 2-8 weeks of treatment.
Slovenian: Razpoložljivi podatki kažejo, da se klinični odziv po navadi doseže v 2-8 tednih zdravljenja.
English: • acid reflux disease;
Slovenian: • bolezen refluksa kisline;
English: The safety and efficacy of adalimumab were assessed in over 1500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Slovenian: Varnost in učinkovitost adalimumaba so ocenili pri več kot 1500 bolnikih z zmerno do zelo aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 in ≤ 450) v randomiziranih,
English: Hefiya in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Slovenian: Zdravilo Hefiya je v kombinaciji z metotreksatom indicirano za zdravljenje aktivnega poliartikularnega juvenilnega idiopatskega artritisa pri bolnikih od 2. leta starosti, ki se ne odzovejo ustrezno na eno ali več imunomodulirajočih antirevmatičnih zdravil.
English: The combination of adalimumab and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Slovenian: Kombinacija adalimumaba in abatacepta ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARD ali antagonistov TNF”).
English: The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7 %) in the adalimumab-treated women with RA and 5/74 (6.8 %) in the untreated women with RA (unadjusted OR 1.31, 95 % CI 0.38-4.52) and 16/152 (10.5 %) in the adalimumabtreated women with CD and 3/32 (9.4 %) in the untreated women with CD (unadjusted OR 1.14, 95 % CI 0.31-4.16).
Slovenian: Razmerje nosečnosti, ki so se končale vsaj z enim živorojenim otrokom z večjim defektom ob rojstvu je bilo 6/69 (8,7 %) pri nosečnicah, zdravljenih z adalimumabom z RA, in 5/74 (6,8 %) pri nezdravljenih nosečnicah z RA (neprilagojeno razmerje obetov 1.31, 95 % interval zaupanja 0.38-4.52), ter 16/152 (10,5 %) pri nosečnicah, zdravljenih z adalimumabom s CB, in 3/32 (9,4 %) pri nezdravljenih nosečnicah s CB (neprilagojeno razmerje obetov 1.14, 95 % interval zaupanja 0.31-4.16).
English: In the Phase 3 trial of adalimumab in patients with paediatric Crohn's disease which evaluated efficacy and safety of two body weight adjusted maintenance dose regimens following body weight adjusted induction therapy up to 52 weeks of treatment, ALT elevations ≥ 3 x ULN occurred in 2.6 % (5 / 192) of patients of whom 4 were receiving concomitant immunosuppressants at baseline.
Slovenian: V preskušanju faze 3 z adalimumabom pri bolnikih s pediatrično Crohnovo boleznijo, kjer so ocenjevali učinkovitost in varnost dveh telesni masi prilagojenih vzdrževalnih režimov odmerjanja, ki sta sledila telesni masi prilagojenemu začetnemu zdravljenju do 52 tednov zdravljenja, so se pojavila zvišanja ALT ≥ 3 x ULN pri 2,6 % (5/192) bolnikov, od katerih so štirje sočasno prejemali imunosupresive ob začetku preskušanja.
English: Hefiya is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Slovenian: Zdravilo Hefiya je indicirano za zdravljenje aktivne, zmerne do hude oblike hidradenitis suppurativa (acne inversa) pri odraslih in mladostnikih, starejših od 12 let, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS zdravljenje (glejte poglavji 5.1 in 5.2).
English: In RA study V, structural joint damage was assessed radiographically and expressed as change in modified total Sharp Score (see table 10).
Slovenian: V študiji revmatoidnega artritisa V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte preglednico 10).
English: Figure 1: Kaplan-Meier Curves summarizing time to flare in study nr-axSpA II
Slovenian: Slika 1: Kaplan-Meier-jeve krivulje povzemajo čas do ponovnega zagona bolezni v študiji nr-axSpA II
English: Do not remove the cap until you are ready to inject.
Slovenian: Pokrovčka ne odstranjujte, dokler niste pripravljeni na injiciranje.
English: The following list of adverse reactions is based on experience from clinical trials and on postmarketing experience and are displayed by system organ class (SOC) and frequency in table 6 below: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and not known (cannot be estimated from the available data).
Slovenian: zelo pogosti (≥1/10), pogosti (≥1/100 do <1/10), občasni (≥1/1.000 do <1/100), redki (≥1/10.000 do <1/1.000) in neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti) (<1/10.000).
English: In the controlled portions of clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
Slovenian: V kontroliranih delih kliničnih preizkušanj z antagonisti TNF je bilo opaženih več primerov malignomov, vključno z limfomi, tako pri bolnikih, ki so prejemali antagonist TNF, kot pri kontrolnih bolnikih.
English: • Keep the plunger fully pressed down while you carefully lift the needle straight out from the injection site and let go of your skin (see Figure J).
Slovenian: • Bat držite v najnižjem položaju, iglo pa previdno potegnite naravnost ven iz mesta injiciranja in spustite kožo (glejte sliko J).
English: • neuropathy (nerve damage);
Slovenian: • nevropatija (poškodba živcev);
English: Induction of clinical remission (defined as CDAI < 150) was evaluated in two studies, CD Study I (CLASSIC I) and CD Study II (GAIN).
Slovenian: Indukcijo klinične remisije (opredeljene kot CDAI < 150) so ocenili v dveh študijah, študiji pri
English: If these medicines do not work well enough, you will be given Hefiya.
Slovenian: Če ta zdravila ne bodo dovolj dobro delovala, boste dobili zdravilo Hefiya.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON OF MULTIPACK (WITHOUT BLUE BOX)
Slovenian: NOTRANJA ŠKATLA ZA VEČKRATNO PAKIRANJE (BREZ MODREGA OKVIRČKA)
English: Hefiya is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Slovenian: Zdravilo Hefiya je indicirano za zdravljenje zmerne do hude kronične psoriaze v plakih pri odraslih bolnikih, ki so kandidati za sistemsko zdravljenje.
English: Hospitalisation rates
Slovenian: Stopnja hospitalizacije
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 Hefiya and during treatment with Hefiya.
Slovenian: Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete zdravilo Hefiya in med zdravljenjem z njim.
English: Upon completion of both studies, 383 patients enrolled in an open-label extension study, in which 40 mg adalimumab was administered every other week.
Slovenian: Po koncu obeh študij so 383 bolnikov vključili v odprto nadaljevalno študijo, med katero so bolniki dobivali 40 mg adalimumab vsak drugi teden.
English: In the open-label lead in phase (OL LI) patients were stratified into two groups, MTX (methotrexate)-treated or non-MTXtreated.
Slovenian: V odprti uvajalni fazi so bolnike stratificirali v dve skupini: zdravljene z metotreksatom in zdravljene brez metotreksata.
English: After treatment with adalimumab, a rapid decrease in levels of acute phase reactants of inflammation (C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR)) and serum cytokines (IL-6) was observed, compared to baseline in patients with rheumatoid arthritis.
Slovenian: Po zdravljenju z adalimumabom so pri bolnikih z revmatoidnim artritisom opažali hitro znižanje reaktantov akutne faze vnetja (C-reaktivnega proteina (CRP) in hitrosti sedimentacije eritrocitov (SR)) in serumskih citokinov (IL-6) v primerjavi z izhodiščem.
English: If you forget to use Hefiya
Slovenian: Če ste pozabili uporabiti zdravilo Hefiya
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to ≥ 2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
Slovenian: 673 bolnikov z aktivnim nr-axSpA (srednja vrednost aktivnosti bolezni [BASDAI] je bila 7,0), ki so nezadostno reagirali na vsaj dva NSAID ali niso prenašali NSAID ali s kontraindikacijo za NSAID, je bilo vključenih v odprto fazo študije nr-axSpA II, v kateri so prejemali adalimumab 40 mg vsak drugi teden 28 tednov.
English: During the withdrawal period, symptoms of psoriasis returned over time with a median time to relapse (decline to PGA “moderate” or worse) of approximately 5 months.
Slovenian: Med obdobjem prenehanja uporabe so se simptomi psoriaze sčasoma znova pojavili; mediani čas do ponovitve simptomov psoriaze (relapsa) (poslabšanje na PGA
English: • Hefiya can be used during breast-feeding.
Slovenian: • Zdravilo Hefiya se lahko uporablja med dojenjem.
English: If you are unsure, contact your doctor.
Slovenian: Če niste gotovi, se posvetujte s svojim zdravnikom.
English: • The pen can now be removed.
Slovenian: • Injekcijski peresnik zdaj lahko odstranite.
English: Hefiya works by reducing this inflammation.
Slovenian: Zdravilo Hefiya deluje tako, da zmanjša tako vnetje.
English: A patient who requires surgery while on Hefiya should be closely monitored for infections, and appropriate actions should be taken.
Slovenian: Bolnika, ki med zdravljenjem z zdravilom Hefiya potrebuje operacijo, je treba natančno nadzirati glede okužb in ustrezno ukrepati.
English: Ask your pharmacist how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
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.
Slovenian: Od 542 bolnikov, ki so bili randomizirani na adalimumab 40 mg vsak drugi teden, jih je 170 nadaljevalo zdravljenje z adalimumabom 40 mg vsak drugi teden še 10 let.
English: A total of 233 PASI 75 responders at week 16 and week 33 received continuous adalimumab therapy for 52 weeks in Psoriasis Study I, and continued adalimumab in the open-label extension trial.
Slovenian: Skupno je 233 bolnikov, ki so imeli 16. in 33. teden odziv PASI 75, v študiji psoriaze I prejemalo stalno zdravljenje z adalimumabom 52 tednov ter so zdravljenje z adalimumabom nadaljevali v odprtem podaljšanem preskušanju.
English: RA study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Slovenian: V študiji revmatoidnega artritisa II je bilo ocenjeno 544 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, pri katerih zdravljenje z vsaj enim imunomodulirajočim antirevmatičnim zdravilom ni bilo uspešno.
English: The incidence of serious infections was 0.04 per patient year in adalimumab-treated patients and 0.03 per patient year in placebo and active control-treated patients.
Slovenian: Incidenca resnih okužb je bila 0,04 na bolnikov-let med bolniki, ki so dobivali adalimumab, in 0,03 na bolnikov-let med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
English: In paediatric uveitis, there is no experience in the treatment with adalimumab without concomitant treatment with methotrexate.
Slovenian: Izkušenj z adalimumabom pri zdravljenju uveitisa pri pediatričnih bolnikih brez sočasnega zdravljenja z metotreksatom ni.
English: Usually, Hefiya is used with methotrexate.
Slovenian: Zdravilo Hefiya ponavadi uporabljamo z metotreksatom.
English: If your doctor considers that methotrexate is inappropriate, Hefiya can be given alone.
Slovenian: Če vaš zdravnik presodi, da metotreksat ni primeren, lahko zdravilo Hefiya dobivate samo.
English: After two further weeks, continue with a dosage of 40 mg every week or 80 mg every other week, as prescribed by your doctor.
Slovenian: Čez nadaljnja dva tedna nadaljujte z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden, kot vam je predpisal zdravnik.
English: Leave it to dry before injecting (see Figure F).
Slovenian: Pustite, da se pred injiciranjem posuši (glejte sliko F).
English: After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.
Slovenian: Po indukcijskem zdravljenju je priporočeni odmerek 40 mg v subkutani injekciji vsak drugi teden.
English: Active tuberculosis or other severe infections such as sepsis, and opportunistic infections
Slovenian: Aktivna tuberkuloza ali druge hude okužbe, npr. sepsa, in oportunistične okužbe (glejte poglavje 4.4).
English: Table 7 ACR responses in placebo-controlled trials (percent of patients)
Slovenian: Preglednica 7 odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov)
English: For patients who stayed on their randomised therapy, the mean (± SD) adalimumab trough concentrations at week 52 were 9.5 ± 5.6 µg / ml for the Standard Dose group and 3.5 ± 2.2 µg / ml for the Low Dose group.
Slovenian: Pri bolnikih, ki so ostali na njihovi randomizirani terapiji, so bile srednje najmanjše koncentracije adalimumaba v 52. tednu 9,5 ± 5,6 μg/ml v skupini s standardnim odmerkom in 3,5 ± 2,2 μg/ml v skupini z majhnim odmerkom.
English: Figure 3: Kaplan-Meier curves summarizing time to treatment failure in the paediatric uveitis study
Slovenian: Slika 3: Kaplan-Meierjeve krivulje povzemajo čas do neuspeha zdravljenja v študiji uveitisa pri pediatričnih bolnikih
English: Hefiya is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS but with objective signs of inflammation by elevated CRP and / or MRI, who have had an inadequate response to, or are intolerant to nonsteroidal anti-inflammatory drugs.
Slovenian: Zdravilo Hefiya je indicirano za zdravljenje odraslih s hudim aksialnim spondiloartritisom brez radiografskega dokaza za AS, toda z objektivnimi znaki vnetja s povišanimi CRP in/ali MRI, ki so nezadostno reagirali na ali ne prenašajo nesteroidnih protivnetnih zdravil.
English: No patients developed lupus nephritis or central nervous system symptoms.
Slovenian: Pri nobenem bolniku se niso pojavili lupusni nefritis ali simptomi s strani osrednjega živčevja.
English: Most patients continued on adalimumab after the infection resolved.
Slovenian: Večina bolnikov je po ozdravitvi okužbe nadaljevala zdravljenje z adalimumabom.
English: The observed rate of non-melanoma skin cancers is approximately 9.6 per 1,000 patient years, and the observed rate of lymphomas is approximately 1.3 per 1,000 patient years.
Slovenian: Ugotovljeni delež nemelanomskih kožnih rakov je približno 9,6 na 1000 bolnikov-let, ugotovljeni delež limfomov pa približno 1,3 na 1000 bolnikov-let.
English: Antibiotics may be continued during treatment with Hefiya, if necessary.
Slovenian: Med zdravljenjem z zdravilom Hefiya lahko nadaljujete z antibiotičnim zdravljenjem, če je potrebno.
English: Table 26 paediatric CD study PCDAI clinical remission and response standard dose 40 / 20 mg eow N = 93
Slovenian: študija Crohnove bolezni pri pediatričnih bolnikih PCDAI klinična remisija in odziv standardni odmerek 40/20 mg vsak drugi teden N = 93
English: Prescribers should exercise caution in considering the use of Hefiya in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of Hefiya should be considered if any of these disorders develop.
Slovenian: Pri odločanju za uporabo zdravila Hefiya pri bolnikih z že prej obstoječimi ali nedavno nastalimi demielinizirajočimi boleznimi osrednjega ali perifernega živčevja je potrebna previdnost; če se razvije katera od teh bolezni, je treba razmisliti o prenehanju zdravljenja z zdravilom Hefiya.
English: • Do not give Hefiya to children with paediatric Crohn's disease below the age of 6 years.
Slovenian: • Zdravila Hefiya ne smete dati otroku s Crohnovo boleznijo, če je star manj kot 6 let.
English: If your doctor determines that methotrexate is inappropriate, Hefiya can be given alone.
Slovenian: Če vaš zdravnik ugotovi, da metotreksat ni primeren, lahko zdravilo Hefiya dobivate samo.
English: The serum adalimumab trough levels at steady-state increased roughly proportionally with dose following 20, 40 and 80 mg subcutaneous dosing every other week and every week.
Slovenian: Najmanjše koncentracije adalimumaba v serumu v stanju dinamičnega ravnovesja so naraščale približno sorazmerno odmerku po 20, 40 in 80 mg subkutano vsak drugi teden in vsak teden.
English: RA study III evaluated 619 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, and who had an ineffective response to methotrexate at doses of 12.5 to 25 mg or have been intolerant to 10 mg of methotrexate every week.
Slovenian: V študiji revmatoidnega artritisa III je bilo ocenjeno 619 bolnikov z zmerno do zelo aktivnim revmatoidnim artritisom, starih ≥ 18 let, ki se niso učinkovito odzvali na odmerke metotreksata od 12,5 do 25 mg ali niso prenašali 10 mg metotreksata vsak teden.
English: Injection site reaction (including injection site erythema)
Slovenian: zelo pogosti reakcija na mestu injiciranja (vključno z eritemom na mestu injiciranje)
English: Patients who experience insufficient response may benefit from an increase in dosage.
Slovenian: Pri bolnikih, ki se ne odzovejo zadostno, se lahko poveča odmerek: