natgillin/translations-raw huggingface dataset:
The primary endpoint was the percent change from baseline to week 12 in the number of active joints with arthritis (swelling not due to deformity or joints with loss of motion plus pain and/or tenderness), which was achieved with mean percent decrease of -62.6% (median percent change -88.9%) in patients in the adalimumab group compared to -11.6% (median percent change -50.0%) in patients in the placebo group.
Primarni opazovani dogodek je bil odstotek spremembe od izhodiščne vrednosti do 12. tedna v številu aktivnih sklepov z artritisom (oteklina, ki ni nastala zaradi deformacije ali sklepi z zmanjšano gibljivostjo ter bolečino in/ali občutljivostjo); slednji je bil dosežen s povprečnim zmanjšanjem za -62,6 % (mediana sprememba -88,9 %) pri skupini bolnikov, ki je prejemala adalimumab v primerjavi z -11,6 % (mediana sprememba -50,0 %) v skupini bolnikov, ki je prejemala placebo.
In RA study V, structural joint damage was assessed radiographically and expressed as change in modified Total Sharp Score (see table 10).
V študiji revmatoidnega artritisa V so strukturno okvaro sklepov ocenili rentgenografsko in jo izrazili kot razliko v modificirani celotni Sharpovi oceni (glejte preglednico 10).
The observed rate of nonmelanoma 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.
Ugotovljeni delež nemelanomskih kožnih rakov je približno 9,6 na 1000 bolnikov-let, ugotovljeni delež limfomov pa približno 1,3 na 1000 bolnikov-let.
Alternatively, if a patient has stopped AMGEVITA and signs and symptoms of disease recur, AMGEVITA may be re-administered.
Če bolnik neha uporabljati zdravilo AMGEVITA, pa se znaki in simptomi bolezni ponovijo, je mogoče zdravilo AMGEVITA znova uvesti.
In RA studies I-IV, adalimumab-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
V študijah revmatoidnega artritisa I - IV so z adalimumabom zdravljeni bolniki v primerjavi s prejemniki placeba dosegli statistično značilen odziv 20 in 50 po ACR že en do dva tedna po začetku zdravljenja.
● Do not recycle the pre-filled pen or sharps disposal container or throw them into the household waste.
● Ne reciklirajte napolnjenega injekcijskega peresnika ali vsebnika za ostre odpadke ter ju ne vrzite med gospodinjske odpadke.
Dermatitis (including eczema), Onychoclasis,
dermatitis (vključno z ekcemom),
The adjusted OR (accounting for baseline differences) was 1.10 (95% CI 0.45-2.73) with RA and CD
Prilagojeno razmerje obetov (z ozirom na izhodiščne razlike) je bilo 1,10 (95 % interval zaupanja 0,45-2,73) z RA in CB skupaj.
For a more comfortable injection, leave the pre-filled pen at room temperature for 15 to 30 minutes before injecting.
Da bo injiciranje bolj udobno, pustite napolnjen injekcijski peresnik za 15 do 30 minut na sobni temperaturi, preden začnete z injiciranjem.
Treatment with AMGEVITA may result in the formation of autoimmune antibodies.
Zdravljenje z zdravilom AMGEVITA lahko povzroči nastanek avtoimunskih protiteles.
Figure 1: Kaplan-Meier Curves Summarising 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
Physicians should exercise caution when considering the use of AMGEVITA in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Pri odločanju za uporabo zdravila AMGEVITA je potrebna previdnost pri bolnikih z anamnezo ponavljajoče se okužbe ali z osnovnimi boleznimi, ki lahko zvečajo nagnjenost k okužbam, vključno s sočasno uporabljenimi imunosupresivnimi zdravili.
• ≥ 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.
• ≥ 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.
What AMGEVITA looks like and contents of the pack
Izgled zdravila AMGEVITA in vsebina pakiranja
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.
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.
MTX N = 110 n (%)
metotreksat N = 110 n (%)
After week 2, patients in both adalimumab arms received 40 mg every other week.
Po 2. tednu so bolniki v obeh krakih z adalimumabom prejemali 40 mg vsak drugi teden.
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.
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.
Prescribers should exercise caution in considering the use of AMGEVITA in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of AMGEVITA should be considered if any of these disorders develop.
Pri odločanju za uporabo zdravila AMGEVITA 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 AMGEVITA.
In paediatric uveitis, there is no experience in the treatment with AMGEVITA without concomitant treatment with methotrexate.
Izkušenj z zdravilom AMGEVITA pri zdravljenju uveitisa pri pediatričnih bolnikih brez sočasnega zdravljenja z metotreksatom ni.
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.
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.
A patient who requires surgery while on AMGEVITA should be closely monitored for infections, and appropriate actions should be taken.
Bolnika, ki med zdravljenjem z zdravilom AMGEVITA potrebuje operacijo, je treba natančno nadzirati glede okužb in ustrezno ukrepati.
The mean trough concentrations were maintained in patients who continued to receive adalimumab treatment every other week for 52 weeks.
Srednje najmanjše koncentracije so se pri bolnikih, ki so 52 tednov še naprej prejemali zdravljenje z adalimumabom vsak drugi teden, ohranile.
AMGEVITA 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).
Zdravilo AMGEVITA 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).
The most commonly reported adverse reactions are infections (such as nasopharyngitis, upper respiratory tract infection and sinusitis), injection site reactions (erythema, itching, haemorrhage, pain or swelling), headache and musculoskeletal pain.
Najpogosteje poročani neželeni učinki so okužbe (kot je nazofaringitis, okužbe zgornjih dihal in sinusitis), reakcije na mestu injiciranja (eritem, srbenje, hemoragija, bolečina ali otekanje), glavobol in mišičnoskeletna bolečina.
Efficacy responses in placebo-controlled AS study - study I reduction of signs and symptoms
Odzivi učinkovitosti v študiji pri ankilozirajočem spondilitisu, kontrolirani s placebom - študija I zmanjšanje znakov in simptomov Odziv placebo N = 107
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.
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.
Serious infections were seen in clinical studies with concurrent use of anakinra and another TNFantagonist, etanercept, with no added clinical benefit compared to etanercept alone.
V kliničnih študijah s sočasno uporabo anakinre in drugega antagonista TNF, etanercepta, so opazili hude okužbe brez dodatnih kliničnih prednosti v primerjavi z etanerceptom samim.
ACR response in placebo-controlled psoriatic arthritis studies (percent of patients)
Odziv ACR v študijah pri psoriatičnem artritisu, kontroliranih s placebo (odstotek bolnikov)
Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of AMGEVITA therapy and regularly during treatment to assess for pre-existing or developing central demyelinating disorders.
Pri bolnikih z neinfekcijskim intermediarnim uveitisom je treba pred začetkom zdravljenja z zdravilom AMGEVITA in redno med zdravljenjem opravljati nevrološko oceno, da se oceni že obstoječe ali razvijajoče se demielinizirajoče bolezni osrednjega živčevja.
Patients received adalimumab 0.8 mg/kg every other week (up to 40 mg), 0.4 mg/kg every other week (up to 20 mg), or methotrexate 0.1-0.4 mg/kg weekly (up to 25 mg).
Bolniki so prejemali adalimumab v odmerkih 0,8 mg/kg vsak drugi teden (do največ 40 mg), 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).
In RA studies I-IV, all individual components of the ACR response criteria (number of tender and swollen joints, physician and patient assessment of disease activity and pain, disability index (HAQ) scores and CRP (mg/dL) values) improved at 24 or 26 weeks compared to placebo.
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 (mg/dl)).
Clinical remission Clinical response (CR-100) Patients in steroid-free remission for > = 90 daysa Week 56
Klinična remisija Klinični odziv (CR-100) Bolniki v remisiji brez steroidov za ≥ 90 dnia
With the yellow cap off, place the pre-filled pen on your skin at 90 degrees.
Rumeni pokrovček mora biti odstranjen; prislonite napolnjeni injekcijski peresnik na kožo pod kotom 90 stopinj.
● Do not put the needle cap back onto the syringe.
● Ne nameščajte pokrovčka igle nazaj na brizgo.
The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
Pokrovček igle na napolnjenem injekcijskem pereseniku vsebuje suho naravno gumo (derivat lateksa), ki lahko povzroči alergijske reakcije.
The safety and efficacy of adalimumab were assessed in two randomised, double-blind placebocontrolled studies in patients with non-radiographic axial spondyloarthritis (nr-axSpA).
Varnost in učinkovitost adalimumaba so ocenili v dveh randomiziranih dvojno slepih, s placebom kontroliranih študijah pri bolnikih z ne-radiografskim aksialnim spondiloartritisom (nr-axSpA).
Of the patients who lost adequate response after re-randomisation to placebo who then enrolled into the openlabel extension trial, 38% (25/66) and 55% (36/66) regained PASI 75 response after 12 and 24 weeks of retreatment, respectively.
Med bolniki, ki so izgubili ustrezen odziv ob ponovni randomizaciji na placebo med podaljšanim odprtim preskušanjem, je po 12 tednih ponovne terapije PASI 75 znova doseglo 38 % (25/66), po 24 tednih pa 55 % (36/66) bolnikov.
In the controlled portions of adalimumab clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.
V kontroliranih delih kliničnih preizkušanj z adalimumabom z antagonisti TNF je bilo opaženih več primerov malignomov, vključno z limfomi, tako pri bolnikih, ki so prejemali antagonist TNF, kot pri kontrolnih bolnikih.
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 adalimumab-treated women with CD and 3/32 (9.4%) in the untreated women with CD (unadjusted OR 1.14, 95% CI 0.31-4.16).
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).
During the controlled portions of pivotal adalimumab 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 adalimumab-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 adalimumab and 3.8 months for control-treated patients).
V kontroliranih delih preskušanj, ki podpirajo vlogo za pridobitev dovoljenja za promet adalimumaba 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 adalimumab, 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).
Administration of AMGEVITA should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Če se bolniku pojavi nova resna okužba ali sepsa, je treba uporabo zdravila AMGEVITA prekiniti in uvesti ustrezno protimikrobno ali protimikotično zdravljenje, dokler okužba ni obvladana.
Clinical response is decrease from baseline in Mayo score ≥ 3 points and ≥ 30% plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS of 0 or 1; * p < 0.05 for adalimumab versus placebo pairwise comparison of proportions ** p < 0.001 for adalimumab versus placebo pairwise comparison of proportions a Of those receiving corticosteroids at baseline
Klinični odgovor pomeni znižanje ocene Mayo od začetka za ≥ 3 in ≥ 30% ter znižanje podocene rektalne krvavitve [RBS] ≥ 1 ali absolutna RBS 0 ali 1; *p < 0,05 za parno primerjavo deležev med adalimumabom in placebom **p < 0,001 za parno primerjavo deležev med adalimumabom in placebom a Od tistih, ki so izhodiščno prejemali kortikosteroide
Important: Keep the skin stretched or pinched while injecting.
Pomembno: Kožo med injiciranjem držite raztegnjeno ali stisnjeno.
Important: Always hold the pre-filled syringe by the syringe barrel.
Pomembno: Napolnjeno injekcijsko brizgo vedno držite za valj brizge.
Paediatric CD study discontinuation of corticosteroids or immunomodulators and fistula remission
Študija Crohnove bolezni pri pediatričnih bolnikih: Prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule
Available adalimumab data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Razpoložljivi podatki o adalimumabu kažejo, da se klinični odziv običajno pojavi v 12 tednih zdravljenja.
Clear and colourless to slightly yellow solution.
Bistra in brezbarvna do rahlo rumena raztopina.
The safety and efficacy of adalimumab were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3month trial of systemic antibiotic therapy.
Varnost in učinkovitost adalimumaba so raziskali v randomiziranih, dvojno slepih študijah, kontroliranih s placebom in v odprti podaljšani študiji pri odraslih bolnikih z zmerno do hudo obliko hidradenitis suppurativa (HS), ki imajo intoleranco, kontraindikacijo ali se ne odzovejo zadovoljivo pri vsaj 3-mesečnem preskušanju sistemske antibiotične terapije.
For patients who dose escalated from every other week to weekly regimen, the mean (±SD) serum concentrations of adalimumab at week 52 were 15.3 ± 11.4 μg/mL (40/20 mg, weekly) and 6.7 ± 3.5 μg/mL (20/10 mg, weekly).
Pri bolnikih, ki so prešli iz režima vsak drugi teden na režim vsak teden, so bile srednje (±SD) serumske koncentracije adalimumaba v 52.tednu 15,3 ± 11,4 μg/ml (40/20 mg, tedensko) in 6,7 ± 3,5 μg/ml (20/10 mg, tedensko).
In study UC-II, 248 patients received 160 mg of adalimumab at week 0, 80 mg at week 2 and 40 mg every other week thereafter, and 246 patients received placebo.
V študiji UC-II je 248 bolnikov dobilo 160 mg adalimumaba 0. teden, 80 mg 2. teden in nato 40 mg vsak drugi teden, 246 bolnikov pa je dobivalo placebo.
At week 16, more patients randomised to adalimumab 0.8 mg/kg had positive efficacy responses (e.g. PASI 75) than those randomised to 0.4 mg/kg every other week or MTX.
V 16. tednu se je več bolnikov, ki so bili randomizirani na adalimumab 0,8 mg/kg, pozitivno odzvalo v smislu učinkovitosti (npr. PASI 75) kot tistih, ki so bili randomizirani na odmerek 0,4 mg/kg vsak drugi teden ali metotreksat.
b 2-sided P value from log rank test. c NE = not estimable.
b 2-stranska vrednost p testa log-rank.
Among patients who were not in response at week 4, 43% of adalimumab maintenance patients responded by week 12 compared to 30% of placebo maintenance patients.
Med bolniki, ki so bili 4. teden brez odziva, se je do 12. tedna odzvalo 43 % tistih, ki so vzdrževalno dobivali adalimumab, in 30 % tistih, ki so vzdrževalno dobivali placebo.
If you have rheumatoid arthritis and you do not receive methotrexate with your AMGEVITA therapy, your doctor may decide to give 40 mg every week or 80 mg every other week.
Če imate revmatoidni artritis in hkrati z zdravilom AMGEVITA ne dobivate metotreksata, vam bo zdravnik morda predpisal 40 mg vsak teden ali 80 mg vsak drugi teden.
c p = 0.031
** p < 0,01
Alopecia1),
čezmerno znojenje, alopecija1),
Multipack: 6 (3 packs of 2) SureClick pre-filled pens.
Skupno pakiranje: 6 (3 pakiranja po 2) napolnjenih injekcijskih peresnikov SureClick.
If you develop a fever that does not go away, bruise or bleed very easily or look very pale, call your doctor right away.
Če dobite zvišano telesno temperaturo, ki ne mine, če se vam pojavljajo podplutbe, zlahka zakrvavite ali ste zelo bledi, se takoj posvetujte s svojim zdravnikom.
The combination of AMGEVITA and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDS or TNF-antagonists”).
Kombinacija zdravila AMGEVITA in abatacepta ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDS ali antagonistov TNF”).
These trials included rheumatoid arthritis patients with short term and longstanding disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitisrelated arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
Ta preskušanja so vključila bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli že dolgo), juvenilnim idiopatskim artritisom (poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), aksialnim spondiloartritisom (ankilozirajočim spondilitisom in aksialnim spondiloartritisom brez radiografskega dokaza za AS), psoriatičnim artritisom, Crohnovo boleznijo, ulceroznim kolitisom, psoriazo, hidradenitis suppurativa in uveitisom.
Vaccinations: if possible children should be up to date with all vaccinations before using AMGEVITA.
• Cepljenja: če je mogoče, naj vaš otrok pred začetkom uporabe zdravila AMGEVITA opravi vsa potrebna cepljenja.
Pack size of one pre-filled syringe.
Velikost pakiranja z eno napolnjeno injekcijsko brizgo.
Placebo/MTXadalimumab /MTX (95% confidence intervalb)
placebo/MTXa adalimumab /MTX 40 mg vsak drugi teden placebo/MTXadalimumab/ MTX (95 % interval zaupanjab)
Methotrexate should be continued during treatment with AMGEVITA.
Med zdravljenjem z zdravilom AMGEVITA je treba še naprej uporabljati metotreksat.
Starting at Week 4
Vzdrževalni odmerek z začetkom v 4. tednu
Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Razpoložljivi podatki kažejo, da se klinični odziv ponavadi pojavi v 12 tednih zdravljenja.
● The needle cover of the AMGEVITA pre-filled pen is made from dry natural rubber, which contains latex.
● Pokrovček igle na napolnjenem injekcijskem peresniku zdravila AMGEVITA vsebuje suho naravno gumo, ki vsebuje lateks.
F. Pinch your injection site to create a firm surface.
F. Na mestu injiciranja kožo stisnite v kožno gubo, da boste ustvarili trdno površino.
a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test b p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
a Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U b Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U c Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in monoterapije z metotreksatom z Mann-Whitneyevim testom U
Do not give AMGEVITA to children with polyarticular juvenile idiopathic arthritis below the age of 2 years.
Zdravila AMGEVITA ne smete dati otroku s poliartikularnim juvenilnim idiopatskim artritisom, če je star manj kot 2 leti.