FrancophonIA/ELRC3.0 huggingface dataset:
English: Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Slovenian: Psoriatični artritis je vnetna bolezen sklepov, povezana s koţno luskavico.
English: Kromeya 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.
Slovenian: Zdravilo Kromeya je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, če odziv na predhodno zdravljenje z imunomodulirajočimi antirevmatiki ni bil ustrezen.
English: The mean (±SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 µg/mL for patients ≥ 40 kg (160/80 mg) and 10.6±6.1 µg/mL for patients < 40 kg (80/40 mg).
Slovenian: Povprečne (±SD) serumske koncentracije adalimumaba, doseţene v 4. tednu, so bile 15,7 ± 6,6 μg/ml pri bolnikih ≥ 40 kg (160/80 mg) in 10,6 ± 6.1 μg/ml pri bolnikih < 40 kg (80/40 mg).
English: • Do not use the Kromeya pre-filled syringe if liquid appears cloudy or discolored, or has -particles or flakes in it.
Slovenian: • Zdravilo Kromeya napolnjeno injekcijsko brizgo ne uporabljajte, če je tekočina motna ali obarvana ali če so v njej delci ali kosmiči.
English: Significant improvement of signs of inflammation as measured by hs-CRP and MRI of both Sacroiliac Joints and the Spine was maintained in adalimumab-treated patients through week 156 and week 104, respectively.
Slovenian: Statistično izboljšanje znakov vnetja, merjenih s C-reaktivnim proteinom z veliko občutljivostjo (hsCRP) in z magnetno resonanco (MRI) sakroiliakalnih sklepov in hrbtenice, se je ohranilo pri bolnikih, zdravljenih z adalimumabom, do 156. tedna oz. do 104. tedna, v tem zaporedju.
English: Kromeya is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
Slovenian: Zdravilo Kromeya je indicirano za zdravljenje neinfekcijskega intermediarnega, posteriornega uveitisa in panuveitisa pri odraslih bolnikih, ki se niso zadostno odzvali na zdravljenje s kortikosteroidi, pri bolnikih s potrebo po zmanjšani uporabi kortikosteroidov ali pri bolnikih, pri katerih je zdravljenje s kortikosteroidi neprimerno.
English: • signs and symptoms of infection such as fever, feeling sick, wounds, dental problems, burning on urination, feeling weak or tired or coughing;
Slovenian: • znake ali simptome okuţbe, npr. zvišano telesno temperaturo, splošno slabo počutje, rane, teţave z zobmi, pekoč občutek med uriniranjem; občutek šibkosti ali utrujenosti; ali kašelj;
English: If you have mild heart failure and you are being treated with Kromeya, your heart failure status must be closely monitored by your doctor.
Slovenian: Če imate blago srčno popuščanje in se zdravite z zdravilom Kromeya, mora zdravnik natančno nadzorovati stanje vašega srčnega popuščanja.
English: For patients who dose escalated from eow 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).
Slovenian: Pri bolnikih, ki so prešli iz reţima vsak drugi teden na reţim vsak teden, so bile povprečne (±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).
English: Each pack contains 2 or 6 pre-filled pens with 2 or 6 alcohol pads.
Slovenian: Vsako pakiranje vsebuje 2 ali 6 napolnjenih injekcijskih peresnikov z 2 ali 6 alkoholnimi zloţenci.
English: The combination of Kromeya and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Slovenian: Kombinacija zdravila Kromeya in anakinre ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDs ali antagonistov TNF”).
English: • The expiration date on the vial has passed.
Slovenian: • se je rok uporabnosti iztekel.
English: 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).
Slovenian: 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.
English: Your child's doctor should test your child for HBV. Adalimumab can reactivate HBV infection in people who carry this virus.
Slovenian: Zdravnik vašega otroka mora vašega otroka testirati na HBV. Adalimumab lahko pri nosilcih virusa povzroči reaktivacijo HBV okuţbe.
English: a p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test.
Slovenian: Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U.
English: Crohn's disease Age or body weight
Slovenian: Crohnova bolezen Starost ali telesna masa
English: Step 1 Prepare for your Injection
Slovenian: 1. korak Pripravite se za injiciranje
English: 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.
Slovenian: 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.
English: Total sharp score
Slovenian: Celotna Sharpova ocena
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: a partial remission ASDAS
Slovenian: a delno izboljšanje ASDAS
English: 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.
Slovenian: 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.
English: • Abdomen (inject at least 5 centimeters away from the belly button).
Slovenian: • trebuhu (zdravilo injicirajte vsaj 5 centimetrov stran od popka).
English: 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.
Slovenian: 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.
English: Kromeya is used to treat polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.
Slovenian: Zdravilo Kromeya se uporablja za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa in artritisa, povezanega z entezitisom.
English: 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.
Slovenian: 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.
English: Of those receiving corticosteroids at baseline
Slovenian: Od tistih, ki so izhodiščno prejemali kortikosteroide
English: 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.
Slovenian: 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.
English: Rhabdomyolysis, systemic lupus erythematosus
Slovenian: občasni rabdomioliza, sistemski eritematozni lupus redki sindrom podoben lupusu
English: • The clear needle guard does not activate after injecting.
Slovenian: • če se prozorno varovalo za injekcijsko iglo po injiciranju ne aktivira.
English: • ulcerative colitis and
Slovenian: • ulcerozni kolitis in
English: 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.
Slovenian: 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.
English: Table 14 Efficacy response in placebo-controlled study nr-axSpA I
Slovenian: Preglednica 14 Odziv učinkovitosti v s placebom kontrolirani študiji nr-axSpA I
English: 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).
Slovenian: 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).
English: Time to treatment failure at or after week 6 in study UV I Primary analysis (ITT)
Slovenian: Čas do neuspeha zdravljenja v ali po 6. tednu v študiji UV I Primarna analiza (ITT)
English: 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.
Slovenian: 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.
English: • Top of the thighs.
Slovenian: • zgornjem delu stegen.
English: 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).
Slovenian: 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).
English: 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).
Slovenian: 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).
English: Kromeya is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Slovenian: Zdravilo Kromeya je indicirano za zdravljenje hudega aktivnega ankilozirajočega spondilitisa priodraslih, ki se na konvencionalno terapijo ne odzovejo ustrezno.
English: 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).
Slovenian: 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).
English: Among those, 40 patients showed no progression of structural damage defined by a change from baseline in the mTSS of 0.5 or less.
Slovenian: Med njimi 40 bolnikov ni pokazalo napredovanja strukturne prizadetosti izraţene s spremembo srednje Sharpove ocene 0,5 ali manj od začetka študije.
English: Patients requiring a dose less than 40 mg should use the 40 mg vial presentation of Kromeya.
Slovenian: Pri bolnikih, pri katerih se mora uporabiti odmerek manjši od 40 mg lahko uporabimo 40 mg vialo zdravila Kromeya.
English: Your doctor should test you for HBV. Adalimumab can reactivate HBV infection in people who carry this virus.
Slovenian: Zdravnik vas mora testirati na HBV. Adalimumab lahko pri nosilcih virusa povzroči reaktivacijo HBV okuţbe.
English: Warning: Do not recycle your used sharps disposal container.
Slovenian: Opozorilo: Uporabljenega vsebnika za ostre predmete ne smete reciklirati.
English: • Use your thumb to gently push plunger all the way down (Figure Q).
Slovenian: • S palcem neţno potisnite bat do konca navzdol (Slika Q).
English: In the larger AS study I with 315 patients, results showed statistically significant improvement of the signs and symptoms of ankylosing spondylitis in patients treated with adalimumab compared to placebo.
Slovenian: 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.
English: Kromeya can be used during breast-feeding.
Slovenian: Zdravilo Kromeya se lahko uporablja med dojenjem.
English: 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.
Slovenian: 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.
English: A patient who requires surgery while on Kromeya should be closely monitored for infections, and appropriate actions should be taken.
Slovenian: Bolnika, ki med zdravljenjem z zdravilom Kromeya potrebuje operacijo, je treba natančno nadzirati glede okuţb in ustrezno ukrepati.
English: • There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers.
Slovenian: • Med bolniki (otroci in odraslimi), ki so jemali adalimumab ali druge zaviralce TNFα, so se pojavili zelo redki primeri določenih vrst raka.
English: • low blood measurements for red blood cells;
Slovenian: • nizke krvne vrednosti za rdeče krvne celice;
English: RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b
Slovenian: 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
English: 2D barcode carrying the unique identifier included.
Slovenian: <Vsebuje dvodimenzionalno črtno kodo z edinstveno oznako.>
English: > 32 weeks 14 weeks a
Slovenian: 14 tednov a
English: Kromeya may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo Kromeya ima lahko blag vpliv na sposobnost voţnje in upravljanja strojev.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: Reporting of side effects
Slovenian: Poročanje o neţelenih učinkih
English: 1.6 Place the remaining syringe(s) in its (their) original box back in the refrigerator (Figure D).
Slovenian: 1.6 Drugo injekcijsko brizgo (druge injekcijske brizge) poloţite nazaj v hladilnik v originalni ovojnini (Slika D).
English: Bath Ankylosing Spondylitis Disease Activity Index
Slovenian: Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis Disease Activity Index)
English: Kromeya is administered every other week via subcutaneous injection.
Slovenian: Zdravilo Kromeya se odmerja vsak drugi teden v obliki subkutane injekcije.
English: 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.
Slovenian: 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.
English: Serious allergic reactions associated with adalimumab were rare during clinical trials.
Slovenian: Z adalimumabom povezane alergijske reakcije, ki niso bile resne, so se v kliničnih študijah pojavljale občasno.
English: Kromeya is used to treat Crohn's disease in adults and children aged 6 to 17 years.
Slovenian: Zdravilo Kromeya se uporablja za zdravljenje Crohnove bolezni pri odraslih in otrocih, starih 6 do 17 let.
English: 6.5 If there is blood or liquid on the injection site, gently press a cotton ball or gauze on the skin (Figure T).
Slovenian: 6.5 Če je na mestu injiciranja kri ali tekočina, nanj neţno pritisnite kosem vate ali gazo (Slika T).
English: The Kromeya pre-filled pen contains a pre-filled syringe with Kromeya.
Slovenian: Napolnjeni injekcijski peresnik zdravila Kromeya vsebuje napolnjeno injekcijsko brizgo z zdravilom Kromeya.
English: 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).
Slovenian: 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).
English: Step 8 Record your Injection
Slovenian: 8. korak Zabeleţite injiciranje
English: 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.
Slovenian: 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.
English: Clinical remission
Slovenian: Klinična remisija
English: 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.
Slovenian: 6.7 Če je na mestu injiciranja kri ali tekočina, nanj za 10 sekund neţno pritisnite kosem vate ali gazo.
English: Each pack contains 2 or 6 pre-filled syringes, and 2 or 6 alcohol pads.
Slovenian: Eno pakiranje vsebuje 2 ali 6 napolnjenih injekcijskih brizg in 2 ali 6 alkoholnih zloţencev.
English: 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.
Slovenian: 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.
English: Polyarticular juvenile idiopathic arthritis Age or body weight
Slovenian: Poliartikularni juvenilni idiopatski artritis Starost ali telesna masa
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Slovenian: Če vaš otrok dobi katerega koli izmed neţelenih učinkov, se posvetujte z otrokovim zdravnikom ali s farmacevtom.
English: • adults with non-infectious uveitis with inflammation affecting the back of the eye
Slovenian: • odraslih z neinfekcijskim uveitisom, kjer vnetje prizadene zadnji del očesa,
English: • vasculitis (inflammation of blood vessels);
Slovenian: • vaskulitis (vnetje krvnih ţil);
English: 40 mg Adalimumab every week
Slovenian: 40 mg adalimumaba vsak teden
English: 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.
Slovenian: 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.
English: 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.
Slovenian: Ugotovljeni deleţ nemelanomskih koţnih rakov je pribliţno 9,6 na 1000 bolnikovlet, ugotovljeni deleţ limfomov pa pribliţno 1,3 na 1000 bolnikov-let.