natgillin/translations-raw huggingface dataset:
• As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check your child for signs and symptoms of tuberculosis before starting Humira.
• Ker so bili pri bolnikih, zdravljenih z zdravilom Humira, opisani primeri tuberkuloze, bo zdravnik vašega otroka pred začetkom zdravljenja z zdravilom Humira preiskal glede znakov in simptomov tuberkuloze.
Assessment of SpondyloArthritis international Society Bath Ankylosing Spondylitis Disease Activity Index Ankylosing Spondylitis Disease Activity Score mean change from baseline n=91 placebo and n=87 Humira high sensitivity C-Reactive Protein (mg/L) n=73 placebo and n=70 Humira Spondyloarthritis Research Consortium of Canada n=84 placebo and Humira n=82 placebo and n=85 Humira ***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between Humira and placebo.
d povprečna sprememba od začetka zdravljenja e n = 91 placebo in n = 87 zdravilo Humira f hs-CRP = C-reaktivni protein z veliko občutljivostjo (high sensitivity C-Reactive Protein) (mg/L) g n = 73 placebo in n = 70 zdravilo Humira h SPARCC = Kanadski raziskovalni konzorcij za spondiloartritis (Spondyloarthritis Research Consortium of Canada) i n = 84 placebo in zdravilo Humira j n = 82 placebo in n = 85 zdravilo Humira
• You will need a special container for waste, such as a sharps container or as instructed by your nurse, doctor or pharmacist.
• Potrebovali boste poseben vsebnik za odpadke, kot je vsebnik za ostre predmete ali, kot so vam naročili medicinska sestra, zdravnik ali farmacevt.
Humira contains sodium
Zdravilo Humira vsebuje natrij
Excipients with known effects
Pomožne snovi z znanim delovanjem
• You will be instructed by your doctor, nurse or pharmacist on the technique of self-injection.
• Zdravnik, farmacevt ali medicinska sestra vas bodo naučili, kako si zdravilo injicirate sami.
Squeeze the skin at your injection site with your other hand to make a raised area and hold it firmly until the injection is complete.
Kožo na mestu injiciranja stisnite z drugo roko, tako da se površina dvigne, in jo držite čvrsto, dokler injiciranje ni končano.
• It is important that you tell your baby's doctors and other health care professionals about your Humira use during your pregnancy before the baby receives any vaccine (for more information on vaccines see the “Warnings and precautions” section).
• Pomembno je, da obvestite zdravnika vašega dojenčka in druge zdravstvene delavce, da ste med nosečnostjo prejemali zdravilo Humira, preden bo vaš dojenček prejel katerokoli cepivo (za več informacij o cepljenju glejte poglavje "Opozorila in previdnostni ukrepi").
Efficacy Outcomes Double Blind 32 weeks Humira / MTX (N = 38)
Dvojno slepa 32 tednov Zdravilo Humira / MTX (n = 38)
For storage information, see package leaflet.
Za informacije o shranjevanju glejte navodilo za uporabo.
• diverticulitis (inflammation and infection of the large intestine)
• divertikulitis (vnetje in okužba debelega črevesa)
Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate.
Zdravilo Humira je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, če odziv na predhodno zdravljenje z imunomodulirajočimi antirevmatiki ni bil ustrezen.
• Do not rub • Slight bleeding at the injection site is normal
• Rahla krvavitev na mestu injiciranja je normalna.
What the Humira vial looks like and contents of the pack
Izgled zdravila Humira in vsebina pakiranja
No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of Humira in patients with polyarticular juvenile idiopathic arthritis who were 2 to <4 years.
Zvišanja ALT ≥ 3 x ULN se niso pojavila v preskušanju faze 3 z zdravilom Humira pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, ki so bili stari od 2 do < 4 leta.
• bacterial infections
• bakterijske okužbe
• Do not give Humira to children with polyarticular juvenile idiopathic arthritis below the age of 2
• Zdravila Humira ne smete dati otroku s poliartikularnim juvenilnim idiopatskim artritisom, če je star manj kot 2 leti.
Keep pushing down to prevent the pre-filled pen from moving away from the skin during the injection.
Potiskajte navzdol, da se napolnjeni injekcijski peresnik med injiciranjem ne odmakne od kože.
Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score  0.5) was significantly higher with Humira/methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and Humira monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Po 52 oz. 104 tednih zdravljenja je bil v skupini s kombinirano terapijo z zdravilom Humira in metotreksatom odstotek bolnikov brez napredovanja bolezni (sprememba prilagojene Sharpove ocene od izhodišča ≤ 0,5) značilno večji (63,8 % oz. 61,2 %) kot v skupinah, ki sta prejemali monoterapijo z metotreksatom (37,4 % in 33,5 %, p < 0,001) ali monoterapijo z zdravilom Humira (50,7 %, p < 0,002, oz. 44,5 %, p < 0,001).
At Week 16, a statistically significantly greater proportion of patients who received Humira achieved PGA of 'clear' or 'almost clear' for the hands and/or feet compared to patients who received placebo (30.6% versus 4.3%, respectively [P = 0.014]).
V 16. tednu je statistično pomembno večji delež bolnikov, ki so prejemali zdravilo Humira, doseglo PGA ‘'čisto'' ali ‘'skoraj čisto'' za dlani in/ali stopala, v primerjavi z bolniki, ki so prejemali placebo
Concomitant administration of adalimumab with other biologic DMARDS (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Sočasna uporaba adalimumaba z drugimi biološkimi DMARDS (tj.anakinra in abacept) ali z drugimi antagonisti TNF ni priporočljiva zaradi možnega povečanega tveganja za okužbe, vključno z resnimi okužbami in drugih potencialnih farmakoloških interakcij (glejte poglavje 4.5).
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 Humira.
Poročali so tudi o smrtnih in življenjsko ogrožajočih okužbah (vključno s sepso, oportunističnimi okužbami in TB), HBV reaktivaciji in različnih malignih obolenjih (vključno z levkemijo, limfomom in HSTCL).
In study UC-II, 248 patients received 160 mg of Humira at Week 0, 80 mg at Week 2 and 40 mg eow thereafter, and 246 patients received placebo.
V študiji UC-II je 248 bolnikov dobilo 160 mg zdravila Humira 0. teden, 80 mg 2. teden in nato 40 mg vsak drugi teden, 246 bolnikov pa je dobivalo placebo.
The safety and efficacy of Humira were assessed in adult patients with non-infectious intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two randomised, doublemasked, placebo-controlled studies (UV I and II).
Varnost in učinkovitost zdravila Humira sta bili ocenjeni pri odraslih bolnikih z neinfekcijskim intermediarnim, posteriornim uveitisom in panuveitisom v dveh randomiziranih, dvojno slepih, s placebom kontroliranih študijah (UV I in UV II), ki nista vključevali bolnikov z izoliranim anteriornim uveitisom.
A single Humira pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Posamezna napolnjena injekcijska brizga ali napolnjen injekcijski peresnik zdravila Humira se lahko shranjuje pri temperaturi največ do 25 ºC za obdobje do 14 dni.
The target of adalimumab is a protein called tumour necrosis factor (TNFα), which is involved in the immune (defence) system and is present at increased levels in the inflammatory diseases listed above.
Tarča adalimumaba je beljakovina ki se imenuje tumor nekrotizirajoči faktor (TNF), ki je vključen v imunski (obrambni) sistem in je prisoten v povečanih koncentracijah pri zgoraj navedenih vnetnih boleznih.
• benign tumours
• benigni tumorji
• Tuberculosis can develop during therapy even if you have received treatment for the prevention of tuberculosis.
• Tuberkuloza se lahko razvije med zdravljenjem, tudi če ste prejeli zdravljenje za preprečevanje tuberkuloze.
Should treatment be interrupted, Humira 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1).
Če je potrebno z zdravljenjem prekiniti, lahko ponovno uvedete zdravljenje z zdravilom Humira z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden (glejte poglavje 5.1).
***, ** Statistically significant at p < 0.001 and < 0.01, respectively, for all comparisons between Humira and placebo.
***, ** Statistično značilno pri p < 0,001 in < 0,01 (v tem zaporedju) za vse primerjave med zdravilom Humira in placebom.
Excipients: mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.
Pomožne snovi: manitol, citronska kislina monohidrat, natrijev citrat, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, natrijev klorid, polisorbat 80, natrijev hidroksid in voda za injekcije.
Humira Dose for Paediatric Patients with Crohn's disease
Odmerjanje zdravila Humira pri pediatričnih bolnikih s Crohnovo boleznijo
Antibody formation was lower when Humira was given together with methotrexate in comparison with use as monotherapy.
Če je bilo zdravilo Humira uporabljeno skupaj z metotreksatom, je bilo nastajanje protiteles v primerjavi z monoterapijo manjše.
In people who carry HBV, Humira can cause the virus to become active again.
Zdravilo Humira lahko pri nosilcih HBV povzroči, da virus znova postane aktiven.
Patients taking TNF-antagonists are more susceptible to serious infections.
Okužbe Bolniki, ki uporabljajo antagoniste tumor nekrotizirajočega faktorja (TNF), so bolj dovzetni za resne okužbe.
For the pooled crossover RA studies VI and VII, a statistically significant difference for injection site pain immediately after dosing was observed between Humira 40 mg/0.8 ml and Humira 40 mg/0.4 ml (mean VAS of 3.7 cm versus 1.2 cm, scale of 0-10 cm, P < 0.001).
Pri združenih navzkrižnih študijah revmatoidnega artritisa VI in VII, so opazili statistično pomembne razlike pri bolečini na mestu injiciranja takoj po injiciranju med zdravilom Humira 40 mg/0,8 ml in zdravilom Humira 40 mg/0,4 ml (povprečna vrednost na vizualni analogni lestvici 3,7 cm, v primerjavi z 1,2 cm, na lestvici od 0 do10 cm, p <0,001).
Your child's symptoms may return upon discontinuation.
Simptomi vašega otroka se lahko po prekinitvi zdravljenja povrnejo.
• inflammation of the skin (such as eczema)
• vnetje kože (kot je ekcem)
The other ingredients are mannitol, citric acid monohydrate, sodium citrate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, sodium chloride, polysorbate 80, sodium hydroxide and water for injections.
Druge sestavine zdravila so manitol, citronska kislina monohidrat, natrijev citrat, natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat, natrijev klorid, polisorbat 80, natrijev hidroksid in voda za injekcije.
Table 18:
Preglednica 16:
There is insufficient evidence of the efficacy of Humira in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied.
Zaradi majhnega števila bolnikov ni dovolj dokazov o učinkovitosti zdravila Humira pri bolnikih s psoriatično artropatijo, podobno ankilozirajočemu spondilitisu.
• As cases of tuberculosis have been reported in patients treated with Humira, your doctor will check you for signs and symptoms of tuberculosis before starting Humira.
• Ker so bili pri bolnikih, zdravljenih z zdravilom Humira, opisani primeri tuberkuloze, vas bo zdravnik pred začetkom zdravljenja z zdravilom Humira preiskal glede znakov in simptomov tuberkuloze.
The safety and efficacy of Humira were assessed in a multicentre, randomised, double-blind, parallel − group study in 171 children (4-17 years old) with polyarticular JIA.
Varnost in učinkovitost zdravila Humira so ocenili v multicentrični randomizirani dvojno slepi študiji vzporednih skupin pri 171 otrocih (starih od 4 do 17 let) s poliartikularnim juvenilnim idiopatskim artritisom.
Upon completion of the first 52 weeks, 457 patients enrolled in an open-label extension phase in which 40 mg of Humira/MTX was administered every other week up to 10 years.
Po zaključenih prvih 52 tednih so 457 bolnikov vključili v odprto nadaljevalno fazo, med katero so dobivali 40 mg zdravilo Humira/MTX vsak drugi teden v obdobju do 10 let.
Methotrexate should be continued during treatment with Humira.
Med zdravljenjem z zdravilom Humira je treba še naprej uporabljati metotreksat.
In an analysis in which all patients who dropped out of the study for adverse events or lack of efficacy, or who dose-escalated, were considered non-responders, PASI 75 and PGA of clear or minimal response rates in these patients were 69.6% and 55.7%, respectively, after an additional 108 weeks of open-label therapy (total of 160 weeks).
Opravljena je bila analiza, v kateri so vse bolnike, ki so izpadli iz študije zaradi neželenih učinkov ali nezadostne učinkovitosti, ali jim je bil povečan odmerek, obravnavali kot neodzivne; pri teh bolnikih sta bila po dodatnih 108 tednih odprtega zdravljenja (skupaj 160 tednov) delež odziva
• elevated bilirubin measurement (liver blood test).
• povišane vrednosti bilirubina (test jetrne krvi).
In the open-label extension, improvement in the signs and symptoms was maintained with Humira therapy through Week 156.
Pri podaljšanih odprtih študijah se je pri zdravljenju z zdravilom Humira izboljšanje znakov in simptomov ohranjalo do 156. tedna.
RA studies VI and VII each evaluated 60 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old.
Študiji revmatoidnega artritisa VI in VII sta vsaka ocenili po 60 bolnikov z zmernim do hudim revmatoidnim artritisom, starih ≥ 18 let.
• leukaemia (cancer affecting the blood and bone marrow)
• levkemija (rak, ki prizadene kri in kostni mozeg)
Placebo/ MTX
placebo/ MTXa
95% confidence intervals for the differences in change scores between methotrexate and Humira.
Ocena ZSŠd ametotreksat b95 % intervali zaupanja za razlike v spremembi ocen med metotreksatom in zdravilom Humira cna podlagi analize rangov dzožitev sklepne špranje
Week 26 Placebo-Controlled
teden Kontrolirana s placebom
In patients with paediatric psoriasis, anti-adalimumab antibodies were identified in 5/38 subjects (13%) treated with 0.8 mg/kg adalimumab monotherapy.
Pri pediatričnih bolnikih s psoriazo so bila protitelesa proti adalimumabu odkrita pri 5/38 oseb (13 %), ki so bile zdravljene z monoterapijo adalimumaba 0,8 mg/kg.
5) Injecting Humira
5) Injiciranje zdravila Humira
Ask your doctor or pharmacist how to throw away medicines you no longer use.
O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
Table 15 Efficacy Response in Placebo-Controlled Period for Study nr-axSpA II
Odziv učinkovitosti v s placebom kontroliranem obdobju študije nr-axSpA II
Humira 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).
Zdravilo Humira 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.
The safety and efficacy of Humira were assessed in two randomized, double-blind placebo controlled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Varnost in učinkovitost zdravila Humira so ocenili v dveh randomiziranih dvojno slepih, s placebom kontroliranih študijah pri bolnikih z ne-radiografskim aksialnim spondiloartritisom (nr-axSpA).
Some of these hepatosplenic T-cell lymphomas with Humira have occurred in young adult patients on concomitant treatment with azathioprine or 6-mercaptopurine used for inflammatory bowel disease.
Pri uporabi zdravila Humira 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.
It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Humira.
Priporočljivo je, da med zdravljenjem z zdravilom Humira bolnik vsak dan uporablja topikalno antiseptično čistilno sredstvo za čiščenje lezij HS.
• Humira is a liquid that is clear and colourless.
• Zdravilo Humira je bistra in brezbarvna tekočina.
Do not rub the injection site.
Injekcijskega mesta NE DRGNITE.
Humira Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis
Odmerjanje zdravila Humira pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom
Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma),
pogosti karcinom kože, ki ne vključuje malignega melanoma (vključno z bazalnoceličnim karcinomom in ploščatoceličnim karcinomom),
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.
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.
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.
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.
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.
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.
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.
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.
Humira 40 mg every other week N = 70
Humira 40 mg vsak drugi teden N = 70
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.
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.
• signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,
• znaki in simptomi, ki nakazujejo bolezni krvi, npr. dolgotrajno zvišana telesna temperatura, modrice, krvavitve, bledica
In patients with enthesitis-related arthritis, anti-adalimumab antibodies were identified in 10.9% (5/46) of patients treated with adalimumab.
Pri bolnikih z artritisom, povezanim z entezitisom so protitelesa proti adalimumabu ugotovili pri 10,9 % (5/46) bolnikov, ki so dobivali adalimumab.
• Ankylosing spondylitis
• ankilozirajočega spondilitisa
• angioedema (localized swelling of the skin)
• angioedem (lokalizirano otekanje kože)
Of 207 patients, 81 patients continued on Humira 40 mg every other week for 10 years.
Od 207 bolnikov jih je 81 nadaljevalo zdravljenje z zdravilom Humira 40 mg vsak drugi teden še 10 let.
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).
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).
The Humira pre-filled syringe is available in a pack containing 1 pre-filled syringe for patient use with 1 alcohol pad.
Napolnjena injekcijska brizga zdravila Humira je na voljo v pakiranju, ki vsebuje 1 napolnjeno injekcijsko brizgo z 1 alkoholnim zložencem.
Hold the pre-filled pen with the grey cap (labelled ‘1') pointing up.
Napolnjeni injekcijski peresnik držite tako, da bo sivi pokrovček (označen z '1') obrnjen navzgor.
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.
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.
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.
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.
The usual dose of Humira is 20 mg every other week with methotrexate.
Običajni odmerek zdravila Humira je 20 mg vsak drugi teden z metotreksatom.
UNIQUE INDENTIFIER - 2D BARCODE
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
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).
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.
• leukemia (cancer affecting the blood and bone marrow);
• levkemija (rak, ki prizadene kri in kostni mozeg);
Psoriatic arthritis is an inflammatory disease of the joints that is usually associated with psoriasis.
Psoriatični artritis je vnetna bolezen sklepov, ki je običajno povezana s kožno luskavico.
Figure 1: Kaplan-Meier Curves Summarizing Time to Flare in Study nr-axSpA II
Slika 1: Kaplan-Meier-jeve krivulje povzemajo čas do ponovnega zagona bolezni v študiji nr-axSpA II