FrancophonIA/ELRC3.0 huggingface dataset:
English: Tell your doctor immediately if your child experiences symptoms like changes in vision, weakness in arms or legs or numbness or tingling in any part of the body.
Slovenian: Zdravniku takoj povejte, če se pri vašem otroku pojavijo simptomi, kot so spremembe vida, šibkost rok ali nog ali pa odrevenelost ali mravljinčenje v katerem koli delu telesa.
English: Time to Treatment Failure At or After Week 6 in Study UV I Primary analysis (ITT) Placebo Adalimumab 110 60 (54.5) 5.6 Time to Treatment Failure At or After Week 2 in Study UV II Primary analysis (ITT) Placebo Adalimumab 115 45 (39.1) NE Note: Treatment failure at or after Week 6 (Study UV I), or at or after Week 2 (Study UV II), was counted as event.
Slovenian: Primarna analiza (ITT) Placebo Adalimumab 115 45 (39,1) NEc Opomba: Neuspeh zdravljenja v ali po 6. tednu (študija UV I) ali v ali po 2. tednu (študija UV II) je bil štet kot dogodek.
English: When combining controlled portions of these trials and ongoing and completed open label extension studies with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and nonmelanoma skin cancers is approximately 8.5 per 1,000 patient years.
Slovenian: Če vzamemo skupaj kontrolirane dele teh preskušanj in potekajoče in zaključene odprte nadaljevalne študije z medianim trajanjem približno 3,3 leta s 6427 bolniki in prek 26439 bolnikov-let zdravljenja, je ugotovljeni delež malignomov (razen limfoma in nemelanomskih kožnih rakov) približno 8,5 na 1000 bolnikov-let.
English: Patients who maintained PASI 75 response at Week 33 and were originally randomised to active therapy in Period A, were re-randomised in period C to receive 40 mg Humira every other week or placebo for an additional 19 weeks.
Slovenian: Bolnike, ki so imeli 33. teden ohranjen odziv PASI ≥ 75 in so bili v obdobju A randomizirani na aktivno terapijo, so med obdobjem C ponovno randomizirali tako, da so dodatnih 19 tednov dobivali 40 mg zdravila Humira vsak drugi teden ali placebo.
English: Humira 40 mg every other week N = 70
Slovenian: Humira 40 mg vsak drugi teden N = 70
English: This study evaluated the efficacy of Humira 40 mg every other week/methotrexate combination therapy, Humira 40 mg every other week monotherapy and methotrexate monotherapy in reducing the signs and symptoms and rate of progression of joint damage in rheumatoid arthritis for 104 weeks.
Slovenian: Ta študija je ocenila učinkovitost treh shem (kombinirano zdravljenje z zdravilom Humira 40 mg vsak drugi teden/metotreksatom, monoterapija z zdravilom Humira 40 mg vsak drugi teden in monoterapija z metotreksat) za zmanjšanje znakov in simptomov ter hitrosti napredovanja sklepne okvare pri revmatoidnem artritisu v obdobju 104 tednov.
English: • signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,
Slovenian: • znaki in simptomi, ki nakazujejo bolezni krvi, npr. dolgotrajno zvišana telesna temperatura, modrice, krvavitve, bledica
English: In patients with enthesitis-related arthritis, anti-adalimumab antibodies were identified in 10.9% (5/46) of patients treated with adalimumab.
Slovenian: Pri bolnikih z artritisom, povezanim z entezitisom so protitelesa proti adalimumabu ugotovili pri 10,9 % (5/46) bolnikov, ki so dobivali adalimumab.
English: • Ankylosing spondylitis
Slovenian: • ankilozirajočega spondilitisa
English: • angioedema (localized swelling of the skin)
Slovenian: • angioedem (lokalizirano otekanje kože)
English: Of 207 patients, 81 patients continued on Humira 40 mg every other week for 10 years.
Slovenian: Od 207 bolnikov jih je 81 nadaljevalo zdravljenje z zdravilom Humira 40 mg vsak drugi teden še 10 let.
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).
Slovenian: Približno dvakratni delež bolnikov v skupini, ki je prejemala placebo, je v primerjevi s tistimi, ki so bili v skupini z zdravilom Humira, je v prvih 12. tednih študije HS-I in HSII, doživelo poslabšanje abscesov (23,0 % v primerjavi z 11,4 %, v tem zaporedju) in fistul z izcedkom (30,0 % v primerjavi s 13,9 %, v tem zaporedju).
English: The Humira pre-filled syringe is available in a pack containing 1 pre-filled syringe for patient use with 1 alcohol pad.
Slovenian: Napolnjena injekcijska brizga zdravila Humira je na voljo v pakiranju, ki vsebuje 1 napolnjeno injekcijsko brizgo z 1 alkoholnim zložencem.
English: Hold the pre-filled pen with the grey cap (labelled ‘1') pointing up.
Slovenian: Napolnjeni injekcijski peresnik držite tako, da bo sivi pokrovček (označen z '1') obrnjen navzgor.
English: The usual dose for adults with rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of ankylosing spondylitis and for patients with psoriatic arthritis is 40 mg adalimumab given every other week as a single dose.
Slovenian: Običajni odmerek za odrasle z revmatoidnim artritisom, ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez radiografskega dokaza za ankilozirajoči spondilitis in za bolnike s psoriatičnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku.
English: Of 207 patients who were randomised to Humira 40 mg every other week, 114 patients continued on Humira 40 mg every other week for 5 years.
Slovenian: Od 207 bolnikov, ki so bili randomizirani na zdravilo Humira 40 mg vsak drugi teden, jih je 114 nadaljevalo zdravljenje z zdravilom Humira 40 mg vsak drugi teden še 5 let.
English: The usual dose of Humira is 20 mg every other week with methotrexate.
Slovenian: Običajni odmerek zdravila Humira je 20 mg vsak drugi teden z metotreksatom.
English: UNIQUE INDENTIFIER - 2D BARCODE
Slovenian: EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
English: Humira 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 non-steroidal anti-inflammatory drugs (NSAIDs).
Slovenian: Aksialni spondiloartritis brez radiografskega dokaza za AS Zdravilo Humira 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: • leukemia (cancer affecting the blood and bone marrow);
Slovenian: • levkemija (rak, ki prizadene kri in kostni mozeg);
English: Psoriatic arthritis is an inflammatory disease of the joints that is usually associated with psoriasis.
Slovenian: Psoriatični artritis je vnetna bolezen sklepov, ki je običajno povezana s kožno luskavico.
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: The rate (95% confidence interval) of non-melanoma skin cancers was 8.8 (6.0, 13.0) per 1,000 patient-years among Humira-treated patients and 3.2 (1.3, 7.6) per 1,000 patient-years among control patients.
Slovenian: Delež (95 % interval zaupanja) nemelanomskih kožnih rakov je bil 8,8 (6,0; 13,0) na 1000 bolnikovlet med bolniki, ki so dobivali zdravilo Humira, in 3,2 (1,3; 7,6) na 1000 bolnikov-let med kontrolnimi bolniki.
English: In patients with psoriatic arthritis, anti-adalimumab antibodies were identified in 38/376 subjects (10%) treated with adalimumab.
Slovenian: Med bolniki s psoriatičnim artritisom so protitelesa proti adalimumabu ugotovili pri 38/376 (10 %) tistih, ki so dobivali adalimumab.
English: Rheumatoid arthritis Age or body weight
Slovenian: Revmatoidni artritis Starost ali telesna masa
English: Plaque psoriasis is a skin condition that causes red, flaky, crusty patches of skin covered with silvery scales.
Slovenian: Luskavica v plakih je bolezen kože, pri kateri nastajajo rdeče, kosmičaste, krastave lise na koži, pokrite s srebrnimi luskami.
English: • Your child's belly (abdomen) at least 5 cm from his/her belly button (navel)
Slovenian: • na trebuhu vašega otroka; najmanj 5 cm oddaljeno od popka
English: • Using your thumb or a piece of gauze, apply pressure over the injection site for 10 seconds.
Slovenian: • S palcem ali koščkom gaze 10 sekund pritiskajte na injekcijsko mesto.
English: Do not remove the needle cover until just before injection.
Slovenian: Pokrovček igle odstranite šele tik pred injiciranjem.
English: Pulmonary fibrosis
Slovenian: pljučna fibroza1)
English: Tell your doctor immediately if you experience symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Slovenian: Zdravniku takoj povejte, če se pri vas pojavijo simptomi, kot so spremembe vida, šibkost rok ali nog ali pa odrevenelost ali mravljinčenje v katerem koli delu telesa.
English: MTX N=37
Slovenian: MTXa N = 37
English: In subjects treated with Humira with no radiographic progression from baseline to Week 48 (n=102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Slovenian: Pri 84 % preiskovancev, ki so dobivali zdravilo Humira in od izhodišča do 48. tedna niso imeli rentgenografsko vidnega napredovanja (n = 102), se takšno napredovanje tudi do 144. tedna zdravljenja ni pojavilo.
English: • intestinal infections (including gastroenteritis)
Slovenian: • črevesne okužbe (vključno z gastroenteritisom)
English: • cancer that affects the lymph system
Slovenian: • rak, ki zajame limfni sistem
English: If the remaining volume is less than the prescribed dose volume, DO NOT use the syringe and contact your healthcare provider.
Slovenian: Če je preostala količina manjša od količine predpisanega odmerka, brizge, NE
English: Patients with at least a partial response to Humira 40 mg weekly after 12 weeks of treatment.
Slovenian: 36. teden a Bolniki z vsaj delnim odzivom na odmerek 40 mg Humira po 12. tednih zdravljenja.
English: The posology of Humira in these patients has been determined from pharmacokinetic modelling and simulation (see section 5.2).
Slovenian: Kliničnih študij z zdravilom Humira pri mladostnikih s HS ni. Odmerjanje zdravila Humira pri teh bolnikih je bilo določeno na podlagi farmakokinetičnega modeliranja in simulacije (glejte poglavje 5.2).
English: STEP 5
Slovenian: KORAK 5
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.
Slovenian: Med bolniki s poliartikularnim juvenilnim idiopatskim artritisom, ki so bili stari od 2 do < 4 let ali 4 leta in več in so tehtali <15 kg, so protitelesa proti adalimumabu ugotovili pri 7 % (1/15) bolnikov, en bolnik je sočasno prejemal metotreksat.
English: >32 weeks
Slovenian: > 32 tednov 20 tednov
English: Humira is administered every other week via subcutaneous injection.
Slovenian: Zdravilo Humira se odmerja vsak drugi teden v obliki subkutane injekcije.
English: • Do not recycle or throw the pre-filled syringe in the household waste
Slovenian: • Uporabljene napolnjene injekcijske brizge ne reciklirajte ali zavrzite med gospodinjske odpadke.
English: At Week 52, 42.9% of patients who received Humira/methotrexate combination therapy achieved clinical remission (DAS28 (CRP) < 2.6) compared to 20.6% of patients receiving methotrexate monotherapy and 23.4% of patients receiving Humira monotherapy.
Slovenian: Po 52. tednih je klinično remisijo (DAS28 (CRP)< 2,6) doseglo 42,9 % bolnikov, ki so dobivali kombinirano terapijo z zdravilom Humira/metotreksatom, 20,6 % bolnikov, ki so dobivali metotreksat v monoterapiji, in 23,4 % bolnikov, ki so dobivali zdravilo Humira v monoterapiji.
English: Fever, bruising, bleeding or looking pale
Slovenian: modrice, krvavitve, bledica
English: • acid reflux disease
Slovenian: • bolezen refluksa kisline
English: • People with more serious rheumatoid arthritis that have had the disease for a long time may have a higher than average risk of getting lymphoma (a cancer that affects the lymph system) and leukaemia (a cancer that affects the blood and bone marrow).
Slovenian: • Pri bolnikih z resnejšim revmatoidnim artritisom, ki imajo bolezen že dolgo, obstaja povečana verjetnost, da zbolijo za limfomom (rak, ki prizadene limfatični sistem) in levkemijo (rak, ki prizadene kri in kostni mozeg).
English: With automatic needle guard.
Slovenian: S ščitnikom za iglo.
English: 2-sided P value from log rank test. NE = not estimable.
Slovenian: 2-stranska vrednost p testa log-rank.
English: • severe rash, hives or other signs of allergic reaction
Slovenian: • hud izpuščaj, koprivnico ali druge znake alergijske reakcije
English: For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough concentrations at Week 52 were 9.5±5.6g/ml for the Standard Dose group and 3.5±2.2 g/ml for the Low Dose group.
Slovenian: Pri bolnikih, ki so ostali na njihovi randomizirani terapiji, so bile povprečne 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: • hepatosplenic T-cell lymphoma (a rare blood cancer that is often fatal)
Slovenian: • jetrnovranični limfom celic T (redka oblika krvnega raka, ki je pogosto smrtna)
English: Place the white end of the pre-filled pen at a right angle (90 degrees) to the skin, so that you can see the window.
Slovenian: Namestite beli konec napolnjenega injekcijskega peresnika pravokotno (90 stopinj) na kožo,
English: c Inactive Disease Partial Flare Assessment of SpondyloArthritis international Society Baseline is defined as open label baseline when patients have active disease.
Slovenian: Delni zagon boleznid a ocena spondiloartritičnega mednarodnega združenja (Assessment of Spondyloarthritis International Society b izhodišče je določeno kot izhodišče odprte faze, ko imajo bolniki aktivno bolezen c ocena bolezenske aktivnosti ankilozirajočega spondilitisa (Ankylosing Spondylitis Disease
English: Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Slovenian: Zdravilo Humira je indicirano za zdravljenje zmerne do hude kronične psoriaze v plakih pri odraslih bolnikih, ki so kandidati za sistemsko zdravljenje.
English: This risk may increase if your child has problems with his/her lungs.
Slovenian: Tveganje je lahko večje, če ima vaš otrok okvarjeno delovanje pljuč.
English: Humira has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking Humira as monotherapy and those taking concomitant methotrexate.
Slovenian: Zdravilo Humira so raziskali pri bolnikih z revmatoidnim artritisom, poliartikularnim juvenilnim idiopatskim artritisom in psoriatičnim artritisom, ki so zdravilo Humira jemali v monoterapiji, kot pri tistih, ki so jo jemali hkrati z metotreksatom.
English: • gallbladder inflammation, gallbladder stones
Slovenian: • vnetje žolčnika, žolčni kamni
English: • Using a piece of gauze, apply pressure over the injection site for 10 seconds.
Slovenian: • S koščkom gaze 10 sekund pritiskajte na injekcijsko mesto.
English: Your doctor may recommend temporary discontinuation.
Slovenian: Vaš zdravnik bo morda priporočil začasno prenehanje uporabe zdravila
English: The safety profile for patients with uveitis treated with Humira every other week was consistent with the known safety profile of Humira.
Slovenian: Varnostni profil za bolnike z uveitisom, ki so bili vsak drugi teden zdravljeni z zdravilom Humira, je v skladu z znanim varnostnim profilom zdravila Humira.
English: • a bump or open sore that doesn't heal
Slovenian: • bula ali odprta rana, ki se ne zaceli
English: • Keep pushing the pre-filled pen down firmly against the injection site until the injection is complete.
Slovenian: • Trdno potiskajte napolnjen injekcijski peresnik proti mestu injiciranja, dokler injiciranje ni končano.
English: During the controlled portions of pivotal Humira trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 6.8 (4.4, 10.5) per 1,000 patient-years among 5,291 Humira treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient-years among 3,444 control patients (median duration of treatment was 4.0 months for Humira and 3.8 months for control-treated patients).
Slovenian: V kontroliranih delih preskušanj, ki podpirajo vlogo za pridobitev dovoljenja za promet zdravila Humira pri odraslih, ki so trajala vsaj 12 tednov, pri bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez radiografskega dokaza za AS, psoriatičnim artritisom, psoriazo, hidradenitis suppurativa, Crohnovo boleznijo, ulceroznim kolitisom in uveitisom so malignome (razen limfoma in nemelanomskega kožnega raka) opažali z deležem (95 % interval zaupanja) 6,8 (4,4; 10,5) na 1000 bolnikov-let med 5291 bolniki, ki so dobivali zdravilo Humira, in 6,3 (3,4; 11,8) na 1000 bolnikov-let med 3444 kontrolnimi bolniki (pri prvih je zdravljenje mediano trajalo 4,0 meseca in pri drugih 3,8 meseca).
English: - infections, including tuberculosis - cancer - nervous system problems - vaccinations
Slovenian: - okužbe, vključno s tuberkulozo, - rak,
English: Myocardial infarction arrhythmia, congestive heart failure
Slovenian: pogosti tahikardija občasni miokardni infarkt1) aritmija kongestivno srčno popuščanje redki zastoj srca
English: • lung diseases causing shortness of breath (including inflammation)
Slovenian: • pljučna bolezen, ki povzroči kratko sapo (vključno z vnetjem)
English: Do not put either of the caps back on the pre-filled pen.
Slovenian: Ne enega ne drugega pokrovčka ne natikajte nazaj na napolnjeni injekcijski peresnik.
English: It is important to tell your doctor if your child has had or has a serious heart condition (see “Warnings and precautions”).
Slovenian: Pomembno je, da zdravniku poveste, če je vaš otrok imel ali ima resno bolezen srca (glejte "Opozorila in previdnostni ukrepi").
English: STEP 9
Slovenian: KORAK 9
English: In controlled and open label adult and paediatric studies with Humira, 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,
Slovenian: V kontroliranih in odprtih študijah pri odraslih in otrocih z zdravilom Humira 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,
English: Each pack contains 1, 2, 4 or 6 pre-filled syringes for patient use with 1, 2, 4 or 6 alcohol pads, respectively.
Slovenian: Eno pakiranje vsebuje 1, 2, 4 oz. 6 napolnjenih injekcijskih brizg za bolnikovo uporabo z 1, 2, 4 oz. 6 alkoholnimi zloženci.
English: Your doctor may prescribe another strength of Humira if your child needs a different dose.
Slovenian: Zdravnik lahko predpiše vašemu otroku drugo jakost zdravila Humira, če vaš otrok potrebuje drugačen odmerek.
English: Patients were randomised to receive either 24 mg/m2 body surface area (BSA) of Humira up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Slovenian: Bolniki so bili randomizirani za prejemanje bodisi 24 mg/m2 telesne površine zdravila Humira do največjega posamičnega odmerka 40 mg ali placebo vsak drugi teden, 12 tednov.
English: * P < 0.05, ***P < 0.001, Humira versus placebo Among all randomised patients.
Slovenian: * P < 0,05, ***P < 0,001, zdravilo Humira v primerjavi s placebom a Med vsemi randomiziranimi bolniki.
English: Maintenance of remission and response rates are presented in Table 23.
Slovenian: Stopnje vzdrževanja remisije in odziva so prikazani v preglednici 23.
English: Do not recap.
Slovenian: Ne nameščajte ga nazaj.
English: • If new skin lesions appear during or after therapy or if existing lesions change appearance, tell your doctor.
Slovenian: • Če se vam med zdravljenjem ali po njem pojavijo nove spremembe na koži, ali če se vam spremeni videz obstoječih sprememb, morate to povedati zdravniku.
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.
Slovenian: Bolniki, ki so 16. teden dosegli odziv »Pediatric ACR« 30, so bili primerni za randomizacijo v dvojno slepo fazo in so nadaljnjih 32 tednov ali do zagona bolezni vsak drugi teden dobili zdravilo Humira 24 mg/m2 (do največ 40 mg) ali placebo.
English: 5 How to store Humira Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila Humira Vsebina pakiranja in dodatne informacije
English: Humira is used to treat enthesitis-related arthritis in patients from 6 years of age.
Slovenian: Zdravilo Humira se uporablja za zdravljenje artritisa, povezanega z entezitisom pri bolnikih od 6. leta starosti.
English: Your doctor will decide if your child should receive Humira.
Slovenian: On se bo odločil, ali lahko vaš otrok dobiva zdravilo Humira.
English: Humira is used to treat children from 2 years of age with chronic non-infectious uveitis with inflammation affecting the front of the eye.
Slovenian: Zdravilo Humira se uporablja za zdravljenje otrok, starejših od 2 let, s kroničnim neinfekcijskim uveitisom, kjer vnetje prizadene sprednji del očesa.
English: In the larger AS study I with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with Humira compared to placebo.
Slovenian: Rezultati obsežnejše študije pri ankilozirajočem spondilitisu I pri 315 bolnikih so pri bolnikih, ki so dobivali zdravilo Humira, pokazali statistično značilno izboljšanje znakov in simptomov ankilozirajočega spondilitisa v primerjavi s placebom.
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: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in Table 16.
Slovenian: Stopnja klinične remisije in kliničnega odziva (definiran kot zmanjšanje vrednosti PCDAI vsaj za 15 točk od začetne vrednosti) sta predstavljena v preglednici 16.
English: Children and adolescents from 2 years of age weighing less than 30 kg The usual dose of Humira is 20 mg every other week with methotrexate.
Slovenian: Otroci in mladostniki, starejši od 2 let, ki tehtajo 30 kg ali več Običajni odmerek zdravila Humira je 40 mg vsak drugi teden z metotreksatom.