FrancophonIA/ELRC3.0 huggingface dataset:
English: Maintenance of remission and response rates are presented in Table 21.
Slovenian: Vzdrževanje remisije in deleže odziva prikazuje preglednica 21.
English: • lichenoid skin reaction (itchy reddish-purple skin rash)
Slovenian: • lihenoidna reakcija kože (srbeč rdeče-vijolični kožni izpuščaj)
English: • reproductive tract infections
Slovenian: • okužbe reproduktivnih organov
English: Only remove both the grey cap and the plum cap immediately before injection.
Slovenian: Siv pokrovček in škrlaten pokrovček odstranite šele tik pred injiciranjem.
English: 20 weeks
Slovenian: 26.teden
English: If these medicines do not work well enough, your child will be given Humira to treat his/her enthesitis-related arthritis.
Slovenian: Če ta zdravila ne delujejo dovolj dobro, bo vaš otrok za zdravljenje artritisa, povezanega z entezitisom, prejel zdravilo Humira.
English: • Do NOT shake the syringe.
Slovenian: • Brizge NE STRESAJTE.
English: • If your child is about to have surgery or dental procedures please inform your doctor that your child is taking Humira.
Slovenian: • Če bo vaš otrok imel kirurški poseg ali poseg na zobeh, prosimo, povejte svojemu zdravniku, da jemlje zdravilo Humira.
English: Inflammation
Slovenian: Injiciranje
English: X-ray) should be performed in all patients (local recommendations may apply).
Slovenian: (veljajo lahko lokalna priporočila).
English: • increased sweating
Slovenian: čezmerno znojenje,
English: It is recommended that children, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Humira therapy.
Slovenian: Za otroke je priporočljivo, da pred začetkom zdravljenja z zdravilom Humira opravijo vsa cepljenja v skladu z veljavnimi smernicami za cepljenje, če je le mogoče.
English: In monotherapy, some patients who experience a decrease in their response to Humira 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Slovenian: Med monoterapijo lahko nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Humira 40 mg vsak drugi teden, koristi povečanje odmerka adalimumaba na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Humira 40 mg solution for injection in pre-filled syringe Humira 40 mg solution for injection in single-use pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a needle with a needle shield (thermoplastic elastomer).
Slovenian: Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Zdravilo Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi (steklo tipa I) z batno zaporko (bromobutilni kavčuk) in z iglo z varovalnim pokrovčkom (termoplastični elastomer).
English: The recommended dose of Humira for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2).
Slovenian: Priporočeni odmerek zdravila Humira pri bolnikih z artritisom, povezanim z entezitisom, starih 6 let in več, temelji na telesni masi (preglednica 2).
English: Children and adolescents from 6 to 17 years of age weighing less than 40 kg
Slovenian: Otroci in mladostniki od 6. do 17. leta starosti, ki tehtajo manj kot 40 kg
English: In patients with at least a partial response to Humira 40 mg weekly at Week 12, the HiSCR rate at Week 36 was higher in patients who continued weekly Humira than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see Table 22).
Slovenian: Pri bolnikih z vsaj delnim odzivom na zdravilo Humira v odmerku 40 mg vsak teden v 12. tednu, je bila stopnja kliničnega odziva (HiSCR) v 36. tednu višja pri bolnikih, ki so nadaljevali zdravljenje z zdravilom Humira vsak teden kot pri bolnikih, pri katerih so pogostnost odmerjanja zmanjšali na vsak drugi teden, ali pri katerih je bilo zdravljenje ukinjeno (glejte preglednico 22).
English: • If you have a severe infection, including active tuberculosis (see “Warnings and precautions”).
Slovenian: • če imate hudo okužbo, vključno z aktivno tuberkulozo (glejte "Opozorila in previdnostni ukrepi").
English: Room spinning sensation and vision disturbances may occur after taking Humira.
Slovenian: Po uporabi zdravila Humira se lahko pojavita vrtoglavica in poslabšanje vida.
English: Cap 2
Slovenian: Preglednica 2.
English: pleural effusion
Slovenian: Zaviranje vnetja
English: Table 17 Maintenance regimen Patient Weight
Slovenian: Preglednica 17 Vzdrževalni režim Bolnikova telesna masa Majhni odmerek Standardni odmerek
English: First dose of 40 mg, followed by 20 mg two weeks later.
Slovenian: Prvi odmerek je 40 mg, čemur sledi 20 mg dva tedna kasneje.
English: Humira Dose for Patients with Enthesitis-Related Arthritis
Slovenian: Odmerjanje zdravila Humira pri bolnikih z artritisom, povezanim z entezitisom Masa bolnika
English: • If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if he/she should receive or continue to receive Humira.
Slovenian: Demielinizirajoča bolezen • Če vaš otrok ima ali pa se pri njem razvija demielinizirajoča bolezen (bolezen, ki prizadene izolacijsko plast okoli živcev, kot je multipla skleroza), bo zdravnik presodil, ali lahko prejema zdravilo Humira.
English: Table 6 Radiographic Mean Changes Over 12 Months in RA Study III
Slovenian: Preglednica 6: Povprečne radioografske spremembe v 12 mesecih študije revmatoidnega artritisa III
English: UNIQUE INDENTIFIER - HUMAN READABLE DATA
Slovenian: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI
English: Immune system disorders* Common
Slovenian: Bolezni imunskega sistema*
English: Humira/methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 6).
Slovenian: Pri bolnikih, ki so dobivali zdravilo Humira in metotreksat, je bilo po 6 in 12 mesecih (glejte preglednico 6) statistično značilno manj radiografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
English: In adolescent patients with inadequate response to Humira 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.
Slovenian: Pri mladostnikih z nezadostnim odzivom na zdravilo Humira 40 mg vsak drugi teden je možno razmisliti o povečanju odmerka na 40 mg vsak teden ali 80 mg vsak drugi teden.
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.
Slovenian: Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete zdravilo Humira in med zdravljenjem z njim.
English: • pre-filled syringe has been dropped or crushed
Slovenian: • je napolnjena injekcijska brizga padla ali se zdrobila
English: The usual Humira dose for adults with ulcerative colitis is 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days) at Week 0 and 80 mg (as two 40 mg injections in one day) at Week 2 and thereafter 40 mg every other week.
Slovenian: Običajni odmerek zdravila Humira pri odraslih z ulceroznim kolitisom je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored) 0. teden in 80 mg (kot dve 40 mg injekciji v enem dnevu) 2. teden, nato pa 40 mg vsak drugi teden.
English: Reports of serious allergic reactions including anaphylaxis have been received following Humira administration.
Slovenian: Po uporabi zdravila Humira so prejeli poročila o resnih alergijskih reakcijah, vključno z anafilaksijo.
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).
Slovenian: 0,4 mg/kg vsak drugi teden (do največ 20 mg) ali 0,1 - 0,4 mg/kg metotreksata na teden (do največ 25 mg).
English: Humira 40 mg/0.8 ml injection adalimumab
Slovenian: Humira 40 mg/0,8 ml raztopina za injiciranje adalimumab
English: Discontinuation of Humira therapy should be considered in patients with confirmed significant haematologic abnormalities.
Slovenian: Pri bolnikih s potrjenimi pomembnimi hematološkimi nepravilnostmi je treba razmisliti o prekinitvi terapije z zdravilom Humira.
English: First dose of 80 mg, followed by 40 mg two weeks later.
Slovenian: Začetni odmerek je 80 mg, ki mu sledi 40 mg dva tedna kasneje.
English: • pleural effusion (abnormal collection of fluid in the pleural space)
Slovenian: • plevralna efuzija (nenormalno zbiranje tekočine v plevralnem prostoru)
English: There is no relevant use of Humira in children aged less than 6 years for this indication.
Slovenian: Uporaba zdravila Humira pri otrocih, starih manj kot 6 let, za to indikacijo ni primerna.
English: The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (as two injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Slovenian: Običajni začetni odmerek za odrasle z neinfekcijskim uveitisom je 80 mg (kot dve injekciji v enem dnevu), čemur sledi odmerek 40 mg, ki se ga daje vsak drugi teden, z začetkom en teden po začetnem odmerku.
English: Humira N=151
Slovenian: Zdravilo Humira n = 151
English: The mean steady-state trough concentration at Week 12 through Week 36 were approximately 8 to 10 μg/ml during adalimumab 40 mg every week treatment.
Slovenian: 12. tednom in 36. tednom pri zdravljenju z odmerkom 40 mg adalimumaba vsak teden.
English: If you have rheumatoid arthritis and you do not receive methotrexate with your Humira therapy, your doctor may decide to give Humira 40 mg every week or 80 mg every other week.
Slovenian: Če imate revmatoidni artritis in hkrati z zdravilom Humira ne dobivate metotreksata, vam bo zdravnik morda predpisal 40 mg zdravila Humira vsak teden ali 80 mg vsak drugi teden.
English: Humira 0.8 mg/kg eow N=38
Slovenian: Humira 0,8 mg/kg vsak drugi teden N = 38
English: • ear infections
Slovenian: • okužbe ušesa
English: • Paediatric Crohn's disease
Slovenian: • Crohnova bolezen pri pediatrični populaciji
English: One 0.8 ml pre-filled syringe with automatic needle guard contains 80 mg adalimumab.
Slovenian: Ena 0,8 ml napolnjena injekcijska brizga z avtomatskim ščitnikom za iglo vsebuje 80 mg adalimumaba.
English: • inflammation of the eye lid and eye swelling
Slovenian: • vnetje očesne veke in otekanje oči
English: Paediatric plaque psoriasis Age or body weight
Slovenian: Luskavica (psoriaza) v plakih Starost ali telesna masa
English: Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg
Slovenian: Otroci in mladostniki od 6. leta starosti, ki tehtajo od 15 kg do manj kot 30 kg
English: Table 19 Time to Treatment Failure in Studies UV I and UV II
Slovenian: Čas do neuspeha zdravljenja v študijah UV I in UV II
English: Humira 40 mg eow N=814 n (%)
Slovenian: Zdravilo Humira 40 mg vsak 2. teden n = 814 n (%)
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 and frequency in Table 3 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: Naslednji seznam neželenih učinkov je osnovan na izkušnjah iz kliničnih preskušanj in iz obdobja trženja zdravila in jih razvršča po organskih sistemih in pogostnosti v preglednici 3, spodaj: 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).
English: • low blood measurements for white blood cells
Slovenian: • nizke krvne vrednosti za bele krvne celice
English: Solution for injection 2 pre-filled syringes 2 alcohol pads
Slovenian: raztopina za injiciranje 2 napolnjeni injekcijski brizgi 2 alkoholna zloženca
English: o Wipe the injection site with the enclosed alcohol pad, using a circular motion.
Slovenian: Mesto injiciranja obrišite z alkoholnim zložencem s krožnimi gibi.
English: Adolescents from 12 to 17 years of age weighing 30 kg or more
Slovenian: Mladostniki stari od 12 do 17 let, ki tehtajo 30 kg ali več
English: Each 0.2 ml single dose pre-filled syringe contains 20 mg of adalimumab.
Slovenian: Ena 0,2 ml napolnjena injekcijska brizga vsebuje 20 mg adalimumaba.
English: Pulmonary embolism interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis,
Slovenian: pogosti astma, dispneja, kašelj občasni redki pljučni embolizem1) intersticijska pljučna bolezen, kronična obstruktivna pljučna bolezen,
English: • pre-filled pen has been dropped or crushed
Slovenian: • je napolnjen peresnik padel ali se zdrobil
English: What you need to know before you use Humira
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Humira Ne uporabljajte zdravila Humira
English: What is in this leaflet
Slovenian: V tej študiji je
English: • moderate to severe chronic plaque psoriasis in adults and
Slovenian: • zmerne do hude kronične luskavice pri odraslih in
English: Hidradenitis Suppurativa Clinical Response (HiSCR)
Slovenian: Humira 40 mg vsak teden klinični odziv pri hidradenitis suppurativa (HiSCR)a
English: Humira n=113
Slovenian: Zdravilo Humirab n = 113
English: • Check with your doctor before you receive any vaccines.
Slovenian: • Preden opravite kakršno koli cepljenje, se posvetujte z zdravnikom.
English: In CD Study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at Weeks 0 and 2, 160 mg Humira at Week 0 and 80 mg at Week 2, 80 mg at Week 0 and 40 mg at Week 2, and 40 mg at Week 0 and 20 mg at Week 2.
Slovenian: V študiji Crohnove bolezni I je bilo 299 bolnikov, ki še niso prejemali TNF antagonistov, randomiziranih v eno od štirih skupin; placebo v 0. in 2. tednu, 160 mg zdravila Humira v 0. tednu in 80 mg v 2. tednu, 80 mg v 0. tednu in 40 mg v 2. tednu in 40 mg v 0. tednu in 20 mg v 2. tednu.
English: Week 12 Week 24
Slovenian: 26.teden 52.teden
English: Humira is used to treat moderate to severe plaque psoriasis in adults.
Slovenian: Zdravilo Humira se uporablja za zdravljenje zmerne do hude luskavice (psoriaze) v plakih pri odraslih.
English: The recommended dose of Humira 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.
Slovenian: Priporočeno odmerjanje zdravila Humira za odrasle bolnike je začetni odmerek 80 mg subkutano in nato 40 mg subkutano vsak drugi teden, začenši en teden po začetnem odmerku.
English: Patients received placebo or Humira at an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose.
Slovenian: Bolniki so prejeli placebo ali zdravilo Humira v začetnem odmerku 80 mg, ki mu je sledil odmerek 40 mg vsak drugi teden, z začetkom dajanja ene teden po začetnem odmerku.
English: Table 15 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Slovenian: Preglednica 15: Študija pri psoriazi II (CHAMPION)
English: Placebo/ MTX n=60
Slovenian: placebo/ MTXc n = 60
English: NA NA 4.5% 23.2% RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks 40 mg Humira administered every other week MTX = methotrexate **p < 0.01, Humira versus placebo
Slovenian: NP 4,5 % 23,2 % a Študija revmatoidnega artritisa I po 24 tednih, študija revmatoidnega artritisa II po 26 tednih in študija revmatoidnega artritisa III po 24 in 52 tednih b 40 mg zdravilo Humira vsak drugi teden c MTX = metotreksat **p < 0,01, zdravilo Humira v primerjavi s placebom; V študijah revmatoidnega artritisa I-IV so se v primerjavi s placebom po 24 oz. 26 tednih izboljšali vsi posamezni elementi meril odziva po ACR (število bolečih in oteklih sklepov, zdravnikova in bolnikova ocena aktivnosti bolezni in bolečin, vrednost indeksa invalidnosti (HAQ) in vrednost CRP
English: Set up the following items on a clean surface.
Slovenian: Na čisto, ravno površino položite naslednje:
English: Humira 20 mg solution for injection in pre-filled syringe
Slovenian: Humira 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Your child's symptoms may return if you stop using Humira.
Slovenian: Simptomi vašega otroka se lahko po prekinitvi zdravljenja z zdravilom Humira povrnejo.
English: Humira 40 mg injection adalimumab SC
Slovenian: Humira 40 mg injekcija adalimumab s.c.
English: Humira N=51
Slovenian: Zdravilo Humira n = 51
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).
Slovenian: V študiji pri psoriazi I so 33. teden "izgubo ustreznega odziva" zabeležili pri 28 % bolnikov, ki so dosegli odziv PASI 75 in so bili ob ponovni randomizaciji razvrščeni na placebo, in pri 5 % bolnikov, ki so še naprej dobivali zdravilo Humira (p < 0,001).
English: The recommended Humira induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at Week 0 (given as two 80 mg injections in one day or as one 80 mg injection per day for two consecutive days) and 80 mg at Week 2.
Slovenian: Priporočena shema odmerjanja zdravila Humira med indukcijo je pri odraslih bolnikih z zmerno do hudo aktivnim ulceroznim kolitisom 160 mg 0. teden (odmerek se lahko da v dveh 80 mg injekcijah v enem dnevu ali v eni 80 mg injekciji na dan dva dni zapored) in 80 mg 2. teden.
English: • DO NOT inject in an area where the skin is reddened, bruised, or hard.
Slovenian: • NE INJICIRAJTE v pordelo, podpluto ali zatrdelo kožo.
English: Table 3 Undesirable Effects
Slovenian: Pogostnost Neželeni učinki
English: Humira is contraindicated in moderate to severe heart failure (see section 4.3).
Slovenian: Pri bolnikih z zmernim do hudim srčnim popuščanjem je zdravilo Humira kontraindicirano (glejte poglavje 4.3).
English: Humira can reduce the number of nodules and abscesses you have and the pain that is often associated with the disease.
Slovenian: Zdravilo Humira lahko zmanjša število vozličev in ognojkov, ki jih imate.
English: Table 9 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Slovenian: Preglednica 9: Študija pri psoriazi II (CHAMPION)
English: Humira may have a small effect on your child's ability to drive, cycle or use machines.
Slovenian: Zdravilo Humira ima lahko blag vpliv na otrokovo sposobnost vožnje, kolesarjenja ali upravljanja strojev.
English: • Enthesitis-related arthritis
Slovenian: • artritis, povezan z entezitisom
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 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: Naslednji seznam neželenih učinkov je osnovan na izkušnjah iz kliničnih preskušanj in iz obdobja trženja zdravila in jih razvršča po organskih sistemih in pogostnosti v preglednici 6, spodaj: 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: What Humira contains
Slovenian: Kaj vsebuje navodilo
English: Do not use the pre-filled syringe if expiry (EXP) date has passed.
Slovenian: Ne uporabljajte napolnjenega peresnika, če je pretekel rok uporabnosti
English: Table 25 Maintenance regimen Patient Weight
Slovenian: Preglednica 25 Vzdrževalni režim Bolnikova telesna masa Majhni odmerek Standardni odmerek
English: Humira 40 mg solution for injection in pre-filled syringe and/or pre-filled pen is available for the maintenance dose.
Slovenian: Za vzdrževalni odmerek je na voljo zdravilo Humira 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi in/ali napolnjenem peresniku.
English: • Tell your doctor if you are a carrier of the hepatitis B virus (HBV), if you have active HBV or if you think you might be at risk of getting HBV.
Slovenian: • Zdravniku morate povedati, če ste nosilec virusa hepatitisa B (HBV), če imate aktiven HBV ali če mislite, da bi lahko dobili HBV.
English: • low blood measurements for white blood cells, red blood cells and platelet count
Slovenian: • nizke vrednosti za bele krvne celice, rdeče krvne celice in trombocite
English: Patients received an initial dose of 80 mg Humira followed by 40 mg every other week (starting one week after the initial dose) or placebo for 16 weeks.
Slovenian: Bolniki so prejeli začetni odmerek 80 mg zdravila Humira, ki mu je sledil 40 mg odmerek ali placebo vsak drugi teden ( z začetkom en teden po začetnem odmerku) naslednjih 16 tednov.
English: Clear, colourless solution.
Slovenian: Benigne, maligne in neopredeljene novotvorbe
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly presenting as sarcoidosis)
Slovenian: • imunske bolezni, ki lahko prizadenejo pljuča, kožo in limfne vozle (najpogosteje kot sarkoidoza)
English: A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (RA studies I, III, IV).
Slovenian: V vseh treh študijah (študije revmatoidnega artritisa I, III in IV), v katerih so ocenjevali utrujenost s funkcijsko oceno terapije kronične bolezni (functional assessment of chronic illness therapy (FACIT)),
English: Maintenance of remission and response rates are presented in Table 14.
Slovenian: Vzdrževanje remisije in deleže odziva prikazuje preglednica 14.
English: If these medicines do not work well enough, your child will be given Humira to reduce the signs and symptoms of his/her disease.
Slovenian: Če ta zdravila ne delujejo dovolj dobro, bo vaš otrok dobil zdravilo Humira za zmanjšanje znakov in simptomov Crohnove bolezni.
English: Humira Dose for Paediatric Patients with Uveitis
Slovenian: Odmerjanje zdravila Humira pri pediatričnih bolnikih z uveitisom
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).
Slovenian: Crohnova bolezen pri pediatričnih bolnikih Priporočeni odmerek zdravila Humira pri bolnikih s Crohnovo boleznijo, starih od 6 do 17 let, temelji na telesni masi (preglednica 1).
English: • moderate to severe Crohn's disease in children and adolescents aged 6 to 17 years
Slovenian: • zmerne do hude Crohnove bolezni pri otrocih in mladostnikih, starih 6 do 17 let.
English: Some patients who experience decrease in their response to 40 mg every other week may benefit from an increase in dosage to 40 mg Humira every week or 80 mg every other week.
Slovenian: Nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Humira 40 mg vsak drugi teden, lahko koristi povečanje odmerka zdravila Humira na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: 40 mg at Week 2.
Slovenian: 40 mg vsak drugi teden.
English: Table 9 ACR Responses in Placebo-Controlled Trials (Percent of Patients)
Slovenian: Preglednica 9: Odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov)
English: Note: P = Placebo (Number at Risk (flared)); A = HUMIRA (Number at Risk (flared)).
Slovenian: Opomba: P = Placebo (število rizičnih preiskovancev (zagon bolezni)); A = HUMIRA (število rizičnih preiskovancev (zagon bolezni)).
English: First dose of 80 mg (one 80 mg injection), followed by 40 mg every other week starting one week after the first dose.
Slovenian: Prvi odmerek je 80 mg (ena 80 mg injekcija), čemur sledi 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.
English: Aortic aneurysm, vascular arterial occlusion, thrombophlebitis
Slovenian: Pogostnost Neželeni učinki občasni aortna anevrizma, zapora arterijskega žilja, tromboflebitis