natgillin/translations-raw huggingface dataset:
The combination of Kromeya and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Kombinacija zdravila Kromeya in anakinre ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDs ali antagonistov TNF”).
• The expiration date on the vial has passed.
• se je rok uporabnosti iztekel.
The safety and efficacy of adalimumab were assessed in adult patients with non-infectious intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two randomised, double- masked, placebo-controlled studies (UV I and II).
Varnost in učinkovitost adalimumaba 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.
Your child's doctor should test your child for HBV. Adalimumab can reactivate HBV infection in people who carry this virus.
Zdravnik vašega otroka mora vašega otroka testirati na HBV. Adalimumab lahko pri nosilcih virusa povzroči reaktivacijo HBV okuţbe.
a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test.
Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U.
Crohn's disease Age or body weight
Crohnova bolezen Starost ali telesna masa
Step 1 Prepare for your Injection
1. korak Pripravite se za injiciranje
In CD study I and CD study II, statistically significant improvement in the disease-specific inflammatory bowel disease questionnaire (IBDQ) total score was achieved at week 4 in patients randomised to adalimumab 80/40 mg and 160/80 mg compared to placebo and was seen at weeks 26 and 56 in CD study III as well among the adalimumab treatment groups compared to the placebo group.
Študiji pri Crohnovi bolezni I in II sta pokazali statistično značilno izboljšanje celotnega seštevka po vprašalniku IBDQ (vprašalnik, specifičen za vnetno bolezen črevesa) do 4. tedna pri bolnikih, randomiziranih na shemi z adalimumabom 80/40 mg in 160/80 mg, v primerjavi s placebom; razliko 26. in 56. teden je v skupinah, zdravljenih z adalimumabom, v primerjavi s placebom pokazala tudi študija pri Crohnovi bolezni III.
Total sharp score
Celotna Sharpova ocena
Kromeya is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Zdravilo Kromeya je indicirano za zdravljenje aktivnega artritisa, povezanega z entezitisom pri bolnikih, starih 6 let in več, ki so se neustrezno odzvali ali so intolerantni za običajno zdravljenje (glejte poglavje 5.1).
Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (See Table 27).
Rezultati iz obeh študij kaţejo statistično značilno zmanjšanje tveganja za neuspeh zdravljenja pri bolnikih, ki so prejemali adalimumab, v primerjavi z bolniki, ki so prejemali placebo (glejte preglednico 27).
a partial remission ASDAS
a delno izboljšanje ASDAS
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 re-treatment, 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.
• Abdomen (inject at least 5 centimeters away from the belly button).
• trebuhu (zdravilo injicirajte vsaj 5 centimetrov stran od popka).
Study UV II evaluated 226 patients with inactive uveitis requiring chronic corticosteroid treatment (oral prednisone 10 to 35 mg/day) at baseline to control their disease.
Študija UV II je ovrednotila 226 bolnikov z inaktivnim uveitisom, ki je ţe na začetku zahteval kronično zdravljenje s kortikosteroidi (prednizolon peroralno 10 do 35 mg/dan) za nadzor njihove bolezni.
Kromeya is used to treat polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.
Zdravilo Kromeya se uporablja za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa in artritisa, povezanega z entezitisom.
In the pivotal controlled trials in adults and children, the rate of infection was 1.51 per patient year in the adalimumab treated patients and 1.46 per patient year in the placebo and active control-treated patients.
V kontroliranih preskušanjih, ki podpirajo vlogo za pridobitev dovoljenja za promet, pri odraslih in otrocih je bil deleţ okuţb 1,51 na bolnikov-let med bolniki, ki so dobivali adalimumab, in 1,46 na bolnikov-let med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
Of those receiving corticosteroids at baseline
Od tistih, ki so izhodiščno prejemali kortikosteroide
Over all 19 subjects, of which 11 of the baseline age group 4 to 12 and 8 of the baseline age group 13 to 17 years were treated 6 years or longer.
6 let ali več zdravljenih 19 preiskovancev, od tega 11 iz izhodiščne starostne skupine od 4 do 12 let in 8 iz izhodiščne starostne skupine od 13 do 17 let.
Rhabdomyolysis, systemic lupus erythematosus
občasni rabdomioliza, sistemski eritematozni lupus redki sindrom podoben lupusu
• The clear needle guard does not activate after injecting.
• če se prozorno varovalo za injekcijsko iglo po injiciranju ne aktivira.
• ulcerative colitis and
• ulcerozni kolitis in
Among those, 154 patients (90.6%) had ACR 20 responses; 127 patients (74.7%) had ACR 50 responses; and 102 patients (60.0%) had ACR 70 responses.
Med temi je 154 bolnikov (90,6 %) imelo odziv 20 po ACR; 127 bolnikov (74,7 %) je imelo odziv 50 po ACR; in 102 bolnika (60,0 %) sta imela odziv 70 po ACR.
Table 14 Efficacy response in placebo-controlled study nr-axSpA I
Preglednica 14 Odziv učinkovitosti v s placebom kontrolirani študiji nr-axSpA I
Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (See Table 22).
Rezultati iz obeh študij kaţejo statistično značilno zmanjšanje tveganja za neuspeh zdravljenja pri bolnikih, ki so prejemali adalimumab, v primerjavi z bolniki, ki so prejemali placebo (glejte preglednico 22).
Time to treatment failure at or after week 6 in study UV I Primary analysis (ITT)
Čas do neuspeha zdravljenja v ali po 6. tednu v študiji UV I Primarna analiza (ITT)
Based on the observed data approach, 222 (80.4%) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 184 (66.7 %) were in steroid-free quiescence.
Na osnovi pristopa z opaţenimi podatki je bilo 222 (80,4 %) bolnikov v remisiji (brez aktivnih vnetnih lezij, ocena celic sprednje očesne komore ≤ 0,5+, motnost steklovine ≤ 0,5+) ob sočasnem jemanju steroidov v odmerku ≤7,5 mg na dan in pa 184 bolnikov (66,7 %), ki so bili v remisiji in brez steroidov.
• Top of the thighs.
• zgornjem delu stegen.
By Week 68, patients receiving continuous Kromeya treatment showed statistically significant greater improvement of the signs and symptoms of active nr-axSpA as compared to patients allocated to treatment withdrawal during the double-blind period of the study (Table 15).
Rezultati do 68. tedna so pokazali statistično značilno izboljšanje znakov in simptomov aktivnega nraxSpA pri bolnikih, ki so neprekinjeno prejemali zdravilo Kromeya v primerjavi z bolniki, ki so bili v skupini za prenehanje zdravljenja v dvojno slepem obdobju študije (preglednica 15).
Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 19).
Ocena psoriaze nohtov je vključevala prilagojeni indeks izrazitosti psoriaze nohtov (mNAPSI - Modified Nail Psoriasis Severity Index), zdravnikovo globalno oceno psoriaze nohtov (PGA-F - Physician‟s Global Assessment of Fingernail Psoriasis) in indeks izrazitosti psoriaze nohtov (NAPSI - Nail Psoriasis Severity Index) (glejte preglednico 19).
Kromeya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Zdravilo Kromeya je indicirano za zdravljenje hudega aktivnega ankilozirajočega spondilitisa priodraslih, ki se na konvencionalno terapijo ne odzovejo ustrezno.
Nail psoriasis assessments included the Modified Nail Psoriasis Severity Index (mNAPSI), the Physician's Global Assessment of Fingernail Psoriasis (PGA-F) and the Nail Psoriasis Severity Index (NAPSI) (see Table 16).
Ocena psoriaze nohtov je vključevala prilagojeni indeks izrazitosti psoriaze nohtov (mNAPSI - Modified Nail Psoriasis Severity Index), zdravnikovo globalno oceno psoriaze nohtov (PGA-F - Physician‟s Global Assessment of Fingernail Psoriasis) in indeks izrazitosti psoriaze nohtov (NAPSI - Nail Psoriasis Severity Index) (glejte preglednico 16).
Among those, 40 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Med njimi 40 bolnikov ni pokazalo napredovanja strukturne prizadetosti izraţene s spremembo srednje Sharpove ocene 0,5 ali manj od začetka študije.
Patients requiring a dose less than 40 mg should use the 40 mg vial presentation of Kromeya.
Pri bolnikih, pri katerih se mora uporabiti odmerek manjši od 40 mg lahko uporabimo 40 mg vialo zdravila Kromeya.
Your doctor should test you for HBV. Adalimumab can reactivate HBV infection in people who carry this virus.
Zdravnik vas mora testirati na HBV. Adalimumab lahko pri nosilcih virusa povzroči reaktivacijo HBV okuţbe.
Warning: Do not recycle your used sharps disposal container.
Opozorilo: Uporabljenega vsebnika za ostre predmete ne smete reciklirati.
• Use your thumb to gently push plunger all the way down (Figure Q).
• S palcem neţno potisnite bat do konca navzdol (Slika Q).
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 adalimumab compared to placebo.
Rezultati obseţnejše študije pri ankilozirajočem spondilitisu I pri 315 bolnikih so pri bolnikih, ki so dobivali adalimumab, pokazali statistično značilno izboljšanje znakov in simptomov ankilozirajočega spondilitisa v primerjavi s placebom.
Kromeya can be used during breast-feeding.
Zdravilo Kromeya se lahko uporablja med dojenjem.
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 ţe en do dva tedna po začetku zdravljenja.
A patient who requires surgery while on Kromeya should be closely monitored for infections, and appropriate actions should be taken.
Bolnika, ki med zdravljenjem z zdravilom Kromeya potrebuje operacijo, je treba natančno nadzirati glede okuţb in ustrezno ukrepati.
• There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers.
• Med bolniki (otroci in odraslimi), ki so jemali adalimumab ali druge zaviralce TNFα, so se pojavili zelo redki primeri določenih vrst raka.
• low blood measurements for red blood cells;
• nizke krvne vrednosti za rdeče krvne celice;
RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b
RA 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
2D barcode carrying the unique identifier included.
<Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.>
> 32 weeks 14 weeks a
14 tednov a
Kromeya may have a minor influence on the ability to drive and use machines.
Zdravilo Kromeya ima lahko blag vpliv na sposobnost voţnje in upravljanja strojev.
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 adalimumab.
Poročali so tudi o smrtnih in ţivljenjsko ogroţajočih okuţbah (vključno s sepso, oportunističnimi okuţbami in TB), HBV reaktivaciji in različnih malignih obolenjih (vključno z levkemijo, limfomom in HSTCL) v zvezi z adalimumabom.
In Psoriasis Studies I and II, a primary endpoint was the proportion of patients who achieved a PASI 75 response from baseline at week 16 (see Tables 17 and 18).
V študijah pri psoriazi I in II je bil primarna končna točka deleţ bolnikov, ki so od izhodišča do 16. tedna dosegli PASI 75 (glejte preglednici 17 in 18).
Reporting of side effects
Poročanje o neţelenih učinkih
1.6 Place the remaining syringe(s) in its (their) original box back in the refrigerator (Figure D).
1.6 Drugo injekcijsko brizgo (druge injekcijske brizge) poloţite nazaj v hladilnik v originalni ovojnini (Slika D).
Bath Ankylosing Spondylitis Disease Activity Index
Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis Disease Activity Index)
Kromeya is administered every other week via subcutaneous injection.
Zdravilo Kromeya se odmerja vsak drugi teden v obliki subkutane injekcije.
In adult Crohn's disease studies, higher incidences of malignant and serious infection-related adverse events were seen with the combination of adalimumab and azathioprine/6-mercaptopurine compared with adalimumab alone.
V študijah Crohnove bolezni pri odraslih so pri sočasni uporabi adalimumaba in azatioprina/6merkaptopurina opazili večjo incidenco malignih in resnih z okuţbo povezanih neţelenih dogodkov kot pri zdravljenju samo z adalimumabom.
Serious allergic reactions associated with adalimumab were rare during clinical trials.
Z adalimumabom povezane alergijske reakcije, ki niso bile resne, so se v kliničnih študijah pojavljale občasno.
Kromeya is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Zdravilo Kromeya se uporablja za zdravljenje Crohnove bolezni pri odraslih in otrocih, starih 6 do 17 let.
6.5 If there is blood or liquid on the injection site, gently press a cotton ball or gauze on the skin (Figure T).
6.5 Če je na mestu injiciranja kri ali tekočina, nanj neţno pritisnite kosem vate ali gazo (Slika T).
The Kromeya pre-filled pen contains a pre-filled syringe with Kromeya.
Napolnjeni injekcijski peresnik zdravila Kromeya vsebuje napolnjeno injekcijsko brizgo z zdravilom Kromeya.
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 koţnega raka) opaţali z deleţem (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 mesece in pri drugih 3,8 meseca).
Step 8 Record your Injection
8. korak Zabeleţite injiciranje
In subjects treated with adalimumab with no radiographic progression from baseline to week 48 (n=102), 84% continued to show no radiographic progression through 144 weeks of treatment.
Pri 84 % preiskovancev, ki so dobivali adalimumab in od izhodišča do 48. tedna niso imeli rentgenografsko vidnega napredovanja (n = 102), se takšno napredovanje tudi do 144. tedna zdravljenja ni pojavilo.
Clinical remission
Klinična remisija
6.7 If there is blood or liquid on the injection site, gently press a clean cotton ball or gauze on the skin for 10 seconds.
6.7 Če je na mestu injiciranja kri ali tekočina, nanj za 10 sekund neţno pritisnite kosem vate ali gazo.
Each pack contains 2 or 6 pre-filled syringes, and 2 or 6 alcohol pads.
Eno pakiranje vsebuje 2 ali 6 napolnjenih injekcijskih brizg in 2 ali 6 alkoholnih zloţencev.
Tell your doctor immediately if you get symptoms like changes in your vision, weakness in your arms or legs or numbness or tingling in any part of your body.
Zdravniku takoj povejte, če ste dobili simptome, kot so spremembe vida, šibkost rok ali nog ali pa odrevenelost ali mravljinčenje v katerem koli delu telesa.
Polyarticular juvenile idiopathic arthritis Age or body weight
Poliartikularni juvenilni idiopatski artritis Starost ali telesna masa
If your child gets any side effects, talk to your child's doctor or pharmacist.
Če vaš otrok dobi katerega koli izmed neţelenih učinkov, se posvetujte z otrokovim zdravnikom ali s farmacevtom.
• adults with non-infectious uveitis with inflammation affecting the back of the eye
• odraslih z neinfekcijskim uveitisom, kjer vnetje prizadene zadnji del očesa,
• vasculitis (inflammation of blood vessels);
• vaskulitis (vnetje krvnih ţil);
40 mg Adalimumab every week
40 mg adalimumaba vsak teden
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 so spontano poročali o okuţbah (kot je nazofaringitis, okuţbe zgornjih dihal in sinusitis), reakcijah na mestu injiciranja (eritem, srbenje, hemoragija, bolečina ali otekanje), glavobolu in mišičnoskeletni bolečini.
The observed rate of non-melanoma skin cancers is approximately 9.6 per 1,000 patient years, and the observed rate of lymphomas is approximately 1.3 per 1,000 patient years.
Ugotovljeni deleţ nemelanomskih koţnih rakov je pribliţno 9,6 na 1000 bolnikovlet, ugotovljeni deleţ limfomov pa pribliţno 1,3 na 1000 bolnikov-let.
Of 342 subjects originally randomised to adalimumab monotherapy or adalimumab/methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of adalimumab treatment.
Od 342 oseb, ki so bile od začetka randomizirane na monoterapijo z adalimumabom ali kombinirano zdravljenje z adalimumabom/metotreksat in so bile vključene v odprto podaljšanje študije, je 171 bolnikov zaključilo 10-letno zdravljenje z adalimumabom.
1.5 Caution: Do not pick up the syringe by the plunger or the needle cap.
1.5 Pozor: Injekcijske igle ne smete prijeti za bat ali pokrovček na injekcijski igli.
The safety and efficacy of adalimumab were assessed in a multicentre, randomised, double-blind, parallel − group study in 171 children (4-17 years old) with polyarticular JIA.
Varnost in učinkovitost adalimumaba so ocenili v multicentrični randomizirani dvojno slepi študiji vzporednih skupin pri 171 otrocih (starih od 4 do 17 let) s poliartikularnim juvenilnim idiopatskim artritisom.
If your child develops a fever that does not go away, bruises or bleeds very easily or looks very pale, call your doctor right away.
Če vaš otrok dobi zvišano telesno temperaturo, ki ne mine, če se mu pojavljajo podplutbe, zlahka zakrvavi ali je zelo bled, se takoj posvetujte s svojim zdravnikom.
Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome)
Neţeleni učinki tremor, nevropatija redki multipla skleroza, demielinizirajoče bolezni (npr. optični nevritis, sindrom Guillain-Barré)
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 ţivorojenim otrokom z večjim defektom ob rojstvu, je bilo 6/69 (8,7 %) pri nosečnicah z RA, zdravljenih z adalimumabom, 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).
When Kromeya therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.
Na začetku zdravljenja z zdravilom Kromeya se lahko pri bolnikih < 30 kg uporabi polnilni odmerek 40 mg in pri bolnikih ≥ 30 kg polnilni odmerek 80 mg en teden pred začetkom vzdrţevalnega zdravljenja.
Median time to failure (months)
N (%) neuspeha (meseci)
Gather supplies and check for damages
Pripravite pripomočke in preverite ali so nepoškodovani
Anti-adalimumab antibodies may develop during adalimumab treatment.
Med zdravljenjem z adalimumabom se lahko razvijejo protitelesa proti adalimumabu.
bleeding, paleness.
modrice, krvavitve, bledica.
0.8 mL solution in pre-filled syringe (type I glass) with a 29G Thin-Wall, ½ inch needle with a latex-free needle cap, a plunger stopper (synthetic rubber), extended finger flanges and a passive needle shield.
0,8 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I), z iglo (29G s tanko steno, 12,7 mm) in pokrovčkom za iglo, ki ne vsebuje lateksa, z batno zaporko (sintetična guma), s podaljšano prirobnico za prste in pasivnim ščitnikom za iglo.
PGA: Clear/minimal a, b a p<0.001 adalimumab vs. placebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. placebo d p<0.05 adalimumab vs. methotrexate
PGA: čisto/minimalno a, b a p < 0,001 adalimumab v primerjavi s placebom b p < 0,001 adalimumab v primerjavi z metotreksatom c p < 0,01 adalimumab v primerjavi s placebom d p < 0,05 adalimumab v primerjavi z metotreksatom
It is important that you tell your baby's doctors and other health care professionals about your Kromeya use during your pregnancy before the baby receives any vaccine (for more information see section on vaccination).
Pomembno je, da obvestite zdravnika dojenčka in druge zdravstvene delavce, da je vaš otrok med nosečnostjo prejemal zdravilo Kromeya, preden bo dojenček prejel katerokoli cepivo (za več informacij glejte poglavje o cepljenju).
P=0.027, adalimumab 0.8 mg/kg versus MTX
P = 0,027, adalimumab 0,8 mg/kg v primerjavi z MTX
Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion defined as a closure of all fistulas that were draining at Baseline for at least 2 consecutive postBaseline visits
Zdravljenje z imunosupresivi je bilo lahko prekinjeno v 26. tednu ali po njem po raziskovalčevi diskreciji, če je bolnik izpolnjeval kriterije kliničnega odziva.
The conduct and results of these tests should be recorded on your patient reminder card.
Izvedbo in rezultate teh preiskav je priporočljivo vpisati v bolnikovo opozorilno kartico.