FrancophonIA/ELRC3.0 huggingface dataset:
English: Idacio 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 Idacio 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: * P < 0.05, ***P < 0.001, adalimumab versus placebo a Among all randomised patients.
Slovenian: * P < 0,05, ***P < 0,001, adalimumab v primerjavi s placebom a Med vsemi randomiziranimi bolniki.
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 delež nemelanomskih kožnih rakov je približno 9,6 na 1000 bolnikovlet, ugotovljeni delež limfomov pa približno 1,3 na 1000 bolnikov-let.
English: The combination of Idacio and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Slovenian: Kombinacija zdravila Idacio in anakinre ni priporočljiva (glejte poglavje 4.4 “Sočasna uporaba bioloških DMARDs ali antagonistov TNF”).
English: Hidradenitis suppurativa Age or body weight
Slovenian: Hidradentis suppurativa Starost ali telesna masa
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 življenjsko ogrožajočih okužbah (vključno s sepso, oportunističnimi okužbami in TB), HBV reaktivaciji in različnih malignih obolenjih (vključno z levkemijo, limfomom in HSTCL) v zvezi z adalimumabom.
English: Hepatosplenic T-cell lymphoma1), Merkel cell carcinoma (neuroendocrine carcinoma of the skin)1)
Slovenian: karcinom Merklovih celic (nevroendokrini karcinom kože)1)
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 delež bolnikov, ki so od izhodišča do 16. tedna dosegli PASI 75 (glejte preglednici 17 in 18).
English: 1.1 Remove the Idacio Vial Kit from the refrigerator.
Slovenian: 1.1 Komplet z vialo vzemite iz hladilnika.
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 režima vsak drugi teden na režim 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: Placebo/MTXAdalimumab/MTX (95% confidence intervalb)
Slovenian: Adalimumab placebo/MTXAdalimumab/MTX (95 % interval zaupanjab)
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 40 mg/0.8 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 40 mg/0,8 ml
English: • Place the pre-filled pen against your skin at a 90° angle (Figure N).
Slovenian: Slika M • Napolnjen injekcijski peresnik postavite na kožo pod kotom 90° (Slika N).
English: Idacio can be used during breast-feeding.
Slovenian: Zdravilo Idacio se lahko uporablja med dojenjem.
English: -56.2a a p<0.001, adalimumab vs. placebo
Slovenian: -56,2a a p < 0,001, Adalimumab v primerjavi s placebom
English: Idacio is used to treat hidradenitis suppurativa in adolescents from 12 years of age.
Slovenian: Zdravilo Idacio se uporablja za zdravljenje hidradenitis suppurativa pri mladostnikih, starejših od 12 let.
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 že en do dva tedna po začetku zdravljenja.
English: Based on the observed data approach, 216 (80.3%) 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 178 (66.2 %) were in steroid-free quiescence.
Slovenian: Na osnovi pristopa z opaženimi podatki je bilo 216 (80,3 %) 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 178 bolnikov (66,2 %), ki so bili v remisiji in brez steroidov.
English: The Idacio pre-filled syringe is supplied in a glass syringe with needle guard and finger flanges.
Slovenian: Napolnjena injekcijska brizga Idacio je steklena brizga s ščitnikom za iglo in prirobnico za prste.
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor) while on Idacio.
Slovenian: Vsem bolnikom je treba naročiti, naj nemudoma poiščejo zdravniško pomoč, če se jim med uporabo zdravila Idacio pojavijo znaki ali simptomi krvnih diskrazij (npr. trajno zvišana telesna temperatura, podplutbe, krvavitve, bledica).
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related 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.
Slovenian: Ta preskušanja so vključevala 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.
English: Non-clinical data reveal no special hazard for humans based on studies of single dose toxicity, repeated dose toxicity and genotoxicity.
Slovenian: Predklinični podatki na osnovi študij toksičnosti posameznih odmerkov, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: If you take Idacio the risk of getting lymphoma, leukaemia, or other cancers may increase.
Slovenian: Če uporabljate zdravilo Idacio, se vam lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
English: Idacio 40 mg/0.8 mL solution for injection for paediatric use in single-use vial 0.8 mL solution in vial (type I glass) with a rubber stopper (synthetic rubber) and aluminium crimp seal.
Slovenian: Idacio 40 mg /0,8 ml raztopina za injiciranje za pediatrično uporabo v enoodmerni viali 0,8 ml raztopine v viali (steklo tipa I), z gumijastim zamaškom (sintetična guma) in obrobno zaporko iz aluminija.
English: Idacio is administered every other week via subcutaneous injection.
Slovenian: Zdravilo Idacio se odmerja vsak drugi teden v obliki subkutane injekcije.
English: • Use your thumb to gently push plunger all the way down (Figure Q).
Slovenian: • S palcem nežno potisnite bat do konca navzdol (Slika Q).
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, dosežene 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: Usually, Idacio is used with methotrexate.
Slovenian: Zdravilo Idacio ponavadi uporabljamo z metotreksatom.
English: > 32 weeks 14 weeks a Ped ACR 30/50/70 responses week 48 significantly greater than those of placebo treated patients b p = 0.015 c p = 0.031
Slovenian: 14 tednov a Odzivi »Ped ACR« 30/50/70 so bili 48. teden značilno večji kot pri bolnikih, ki so dobivali placebo b p = 0,015 c p = 0,031
English: Polyarticular juvenile idiopathic arthritis from 2 years of age The recommended dose of Idacio for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1).
Slovenian: Poliartikularni juvenilni idiopatski artritis od 2. leta starosti Priporočeni odmerek zdravila Idacio pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih 2 leti in več, temelji na telesni masi (preglednica 1).
English: Impaired healing * further information is found elsewhere in sections 4.3, 4.4 and 4.8 ** including open label extension studies
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih pogosti slabše celjenje *Nadaljnje informacije v zvezi s tem najdete v poglavjih 4.3, 4.4 in 4.8 **Vključno pri podaljšanih študijah brez placeba
English: Idacio dose for paediatric patients with Crohn's disease
Slovenian: Odmerjanje zdravila Idacio pri pediatričnih bolnikih s Crohnovo boleznijo
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 okužbe.
English: There is insufficient evidence of the efficacy of Idacio in patients with ankylosing spondylitis-like psoriatic arthropathy due to the small number of patients studied.
Slovenian: Zaradi majhnega števila bolnikov ni dovolj dokazov o učinkovitosti zdravila Idacio pri bolnikih s psoriatično artropatijo, podobno ankilozirajočemu spondilitisu.
English: Step 1 Prepare for your injection
Slovenian: 1. korak Pripravite se za injiciranje
English: • Do not use the Idacio pre-filled syringe if liquid appears cloudy or discolored, or has -particles or flakes in it.
Slovenian: • Zdravilo Idacio napolnjeno injekcijsko brizgo ne uporabljajte, če je tekočina motna ali obarvana ali če so v njej delci ali kosmiči.
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 zloženci.
English: In controlled and open label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, ,blastomycosis, coccidioidomycosis, pneumocystis, candidiasis, aspergillosis and listeriosis).
Slovenian: V kontroliranih in odprtih študijah pri odraslih in otrocih z adalimumabom so poročali o resnih okužbah (vključno s smrtno nevarnimi okužbami, ki so se pojavile redko), med katerimi so bile tuberkuloza (tudi miliarna in zunajpljučna) in invazivne oportunistične okužbe (npr. diseminirana ali zunajpljučna histoplazmoza, blastomikoza, kokcidioidomikoza, pnevmocistoza, kandidaza, aspergiloza in listerioza).
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 14 and 15).
Slovenian: V študijah pri psoriazi I in II je bil primarna končna točka delež bolnikov, ki so od izhodišča do 16. tedna dosegli PASI 75 (glejte preglednici 14 in 15).
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 okužbe.
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Slovenian: Če vaš otrok dobi katerega koli izmed neželenih učinkov, se posvetujte z otrokovim zdravnikom ali s farmacevtom.
English: Idacio is used to treat polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis.
Slovenian: Zdravilo Idacio se uporablja za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa in artritisa, povezanega z entezitisom.
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 nežno pritisnite kosem vate ali gazo.
English: Figure Q Warning: Call your healthcare professional or pharmacist if you have any problem.
Slovenian: Opozorilo: V primeru težav pokličite vašega zdravstvenega delavca ali farmacevta.
English: Idacio 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 Idacio je indicirano za zdravljenje aktivnega in napredujočega psoriatičnega artritisa pri odraslih, če odziv na predhodno zdravljenje z imunomodulirajočimi antirevmatiki ni bil ustrezen.
English: OTHER For single use only
Slovenian: DRUGI PODATKI Samo za enkratno uporabo.
English: The conduct and results of these tests should be recorded on your patient reminder card.
Slovenian: Izvedbo in rezultate teh preiskav je treba zabeležiti na opozorilni kartici.
English: 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0% vs 11.4%, respectively) and draining fistulas (30.0% vs 13.9%, respectively).
Slovenian: Približno dvakratni delež bolnikov v skupini, ki je prejemala placebo, je v primerjavi s tistimi, ki so bili v skupini z adalimumabom, v prvih 12 tednih študije HS-I in HS-II, 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).
English: The incidence of serious infections was 0.04 per patient year in adalimumab treated patients and 0.03 per patient year in placebo and active control − treated patients.
Slovenian: Incidenca resnih okužb je bila 0,04 na bolnikov-let med bolniki, ki so dobivali adalimumab, in 0,03 na bolnikov-let med bolniki, ki so dobivali placebo oziroma kontrolno učinkovino.
English: • The name on the syringe says Idacio (Figure K).
Slovenian: • je na injekcijski brizgi ime Idacio (Slika K).
English: Erythema multiforme1), Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1), lichenoid skin reaction1)
Slovenian: srbenje občasni nočno potenje, brazgotinjenje redki multiformni eritem1), sindrom Stevens-Johnson, angioedem1), kožni vaskulitis1), lihenoidna reakcija neznana pogostnost poslabšanje simptomov dermatomiozitisa1)
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 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 mesece in pri drugih 3,8 meseca).
English: Idacio is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Slovenian: Zdravilo Idacio je indicirano za zdravljenje hudega aktivnega ankilozirajočega spondilitisa pri odraslih, ki se na konvencionalno terapijo ne odzovejo ustrezno.
English: When Idacio 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.
Slovenian: Na začetku zdravljenja z zdravilom Idacio se lahko pri bolnikih < 30 kg uporabi polnilni odmerek 40 mg in pri bolnikih ≥ 30 kg polnilni odmerek 80 mg en teden pred začetkom vzdrževalnega zdravljenja.
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 zložencev.
English: The recommended Idacio induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Slovenian: Priporočena shema odmerjanja zdravila Idacio med indukcijo je pri odraslih bolnikih z zmerno do hudo, aktivno Crohnovo boleznijo 80 mg 0. teden in nato 40 mg 2. teden.
English: • Certain vaccines contain living but weakened forms of disease-causing bacteria or viruses and should not be given during treatment with Idacio in case they cause infections.
Slovenian: • Določena cepiva lahko vsebujejo žive ampak oslabljene oblike povzročitelja bolezni (bakterije ali viruse), zato se jih v primerih, ko lahko povzročijo okužbo, ne sme dajati med zdravljenjem z zdravilom Idacio.
English: Among patients who were at least partial responders at week 12, and who received continuous weekly adalimumab therapy, the HiSCR rate at week 48 was 68.3% and at week 96 was 65.1%.
Slovenian: Pri bolnikih z vsaj delnim odzivom na adalimumab v odmerku 40 mg v 12. tednu, in ki so prejemali neprekinjeno tedensko terapijo adalimumaba, je bila stopnja kliničnega odziva (HiSCR) v 48. tednu 68,3 % in v 96. tednu 65,1 %.
English: By Week 68, patients receiving continuous Idacio 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 Idacio v primerjavi z bolniki, ki so bili v skupini za prenehanje zdravljenja v dvojno slepem obdobju študije (preglednica 15).
English: Be sure that you read, understand, and follow these Instructions for Use before injecting Idacio.
Slovenian: Pred injiciranjem zdravila Idacio, bodite prepričani, da ste prebrali, razumeli in sledili tem Navodilom za uporabo.
English: If you have mild heart failure and you are being treated with Idacio, your heart failure status must be closely monitored by your doctor.
Slovenian: Če imate blago srčno popuščanje in se zdravite z zdravilom Idacio, mora zdravnik natančno nadzorovati stanje vašega srčnega popuščanja.
English: Adalimumab exposure in paediatric uveitis patients was predicted using population pharmacokinetic modelling and simulation based on cross-indication pharmacokinetics in other paediatric patients (paediatric psoriasis, juvenile idiopathic arthritis, paediatric Crohn's disease, and enthesitis-related arthritis).
Slovenian: Izpostavljenost adalimumabu pri pediatričnih bolnikih z uveitisom je bila napovedana z uporabo populacijskega farmakokinetičnega modeliranja in simulacije, ki temelji na farmakokinetiki navzkrižnih indikacij pri drugih pediatričnih bolnikih (psoriaza pri pediatričnih bolnikih, juvenilni idiopatski artritis, Crohnova bolezen pri pediatričnih bolnikih in artritis, povezan z entezitisom) .
English: • Push and hold the pre-filled pen firmly against your skin until the safety guard is fully depressed.
Slovenian: • Napolnjen injekcijski peresnik močno pritisnite na kožo in ga držite, da se varovalo popolnoma spusti.
English: Idacio is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Slovenian: Zdravilo Idacio je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri pediatričnih bolnikih (od 6. leta starosti), ki se ne odzovejo zadovoljivo na konvencionalno zdravljenje, vključno s primarno prehransko terapijo in kortikosteroidom in/ali imunomodulatorjem, ali pri tistih, ki imajo intoleranco ali kontraindikacije za tako zdravljenje.
English: 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).
Slovenian: Razmerje nosečnosti, ki so se končale vsaj z enim živorojenim 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).
English: 1.6 Place the remaining pre-filled pen(s) in its (their) original box back in the refrigerator (Figure E).
Slovenian: 1.6 Drug injekcijski peresnik (druge injekcijske peresnike) položite nazaj v hladilnik v originalni ovojnini (Slika E).
English: • Idacio is a pre-filled syringe for single use only.
Slovenian: • Zdravilo Idacio je napolnjena injekcijska brizga za zgolj enkratno uporabo.
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 okužbo povezanih neželenih dogodkov kot pri zdravljenju samo z adalimumabom.
English: Syringe plunger final position
Slovenian: Končni položaj bata
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 nežno pritisnite kosem vate ali gazo (Slika T).
English: Idacio is indicated for the treatment of Crohn's disease in children aged 6 to 17 years.
Slovenian: Zdravilo Idacio je namenjeno za zdravljenje Crohnove bolezni pri otrocih, starih 6 do 17 let.
English: It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Idacio.
Slovenian: Priporočljivo je, da med zdravljenjem z zdravilom Idacio bolnik vsak dan uporablja topikalno antiseptično čistilno sredstvo za čiščenje lezij HS.
English: CI 95% for HRa p Value b
Slovenian: N Neuspeh Srednji čas do RTa IZ 95 % p vrednost b