FrancophonIA/ELRC3.0 huggingface dataset:
English: The recommended Idacio dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at day 15 (given as two 40 mg injections in one day).
Slovenian: Priporočena shema odmerjanja zdravila Idacio pri odraslih bolnikih s hidradenitis suppurativa (HS) je 160 mg na 1. dan (aplicirano v obliki štirih 40 mg injiciranj na dan ali z dvema 40 mg injiciranjema na dan, dva dni zapored), ki mu sledi 80 mg dva tedna kasneje na 15. dan (aplicirano v obliki dveh 40 mg injiciranj v enem dnevu).
English: • Hold the syringe upward and pull the needle cap straight off (Figure N).
Slovenian: Injekcijsko brizgo držite obrnjeno navzgor in odstranite pokrovček na injekcijski igli (Slika N).
English: In adult patients with uveitis, a loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab every other week starting at week 1, resulted in mean steady-state concentrations of approximately 8 to 10 µg/mL.
Slovenian: Pri odraslih bolnikih z uveitisom je polnilni odmerek 80 mg adalimumaba v 0. tednu, ki mu je sledil odmerek 40 mg adalimumaba vsak drugi teden z začetkom v 1. tednu, povzročil srednjo koncentracijo v stanju dinamičnega ravnovesja približno 8 do 10 µg/ml.
English: Your healthcare provider should show you how to prepare and inject Idacio properly using the pre-filled pen before you use it for the first time.
Slovenian: Vaš zdravstveni delavec vam pokazati, kako pravilno pripraviti in injicirati zdravilo Idacio preden boste napolnjen injekcijsko peresnik prvič uporabili.
English: Adalimumab treated patients showed statistically significant improvements at week 26 compared with placebo in the DLQI.
Slovenian: Pri bolnikih, zdravljenih z adalimumabom, je prišlo do statistično značilnega izboljšanja dermatološkega indeksa kakovosti življenja (DLQI) po 26 tednih v primerjavi s placebom.
English: Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
Slovenian: Podatki, ki so na voljo, kažejo, da je klinični odziv po navadi dosežen v 12 tednih zdravljenja.
English: Solution for injection 2 pre-filled syringes 2 alcohol pads 6 pre-filled syringes 6 alcohol pads
Slovenian: raztopina za injiciranje 2 napolnjeni injekcijski brizgi 2 alkoholna zloženca 6 napolnjenih injekcijskih brizg 6 alkoholnih zložencev
English: There is no relevant use of Idacio in children aged less than 2 years in this indication.
Slovenian: Uporaba zdravila Idacio pri otrocih, mlajših od 2 let, za to indikacijo ni primerna.
English: • Lift the pre-filled pen from your skin (Figure Q).
Slovenian: • Injekcijski peresnik odmaknite od kože (Slika Q).
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 µg/mL (102% CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 µg/mL (47.7% CV) with concomitant methotrexate.
Slovenian: Po uporabi 24 mg/m2 (do največ 40 mg) subkutano vsak drugi teden pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom (pJIA), ki so bili stari od 4 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednosti merjene od 20. do 48.tedna) med uporabo adalimumaba brez metotreksata 5,6 ± 5,6 µg/ml (koeficient variacije 102 %) in med uporabo z metotreksatom 10,9 ± 5,2 µg/ml (koeficient variacije 47,7 %).
English: Idacio should be used with caution in patients with mild heart failure (NYHA class I/II).
Slovenian: Pri bolnikih z blagim srčnim popuščanjem (razred I/II po NYHA) je treba zdravilo Idacio uporabljati previdno.
English: Idacio dose for paediatric patients with uveitis
Slovenian: Odmerjanje zdravila Idacio pri pediatričnih bolnikih z uveitisom
English: In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with Idacio should be considered prior to initiating therapy (see Other opportunistic infections).
Slovenian: Pred začetkom zdravljenja je treba tveganja in koristi zdravljenja z zdravilom Idacio pretehtati pri bolnikih, ki so bili izpostavljeni tuberkulozi, in bolnikih, ki so potovali na območja, kjer obstaja veliko tveganje tuberkuloze ali endemičnih mikoz, npr. histoplazmoze, kokcidioidomikoze ali blastomikoze (glejte Druge oportunistične okužbe).
English: 5.1 Wipe the skin of your injection site with an alcohol pad to clean it (Figure K).
Slovenian: 5.1 Kožo na mestu injiciranja obrišite z zložencem, prepojenim z alkoholom, da jo očistite.
English: All patients, and in particular patients with a medical history of extensive immunosuppressant therapy or psoriasis patients with a history of PUVA treatment should be examined for the presence of nonmelanoma skin cancer prior to and during treatment with Idacio.
Slovenian: Pred zdravljenjem z zdravilom Idacio in med zdravljenjem z njim je treba za nemelanomskega kožnega raka pregledati vse bolnike, še zlasti pa bolnike z anamnezo intenzivne imunosupresivne terapije in bolnike s psoriazo, ki so kdaj prejemali PUVA.
English: If these medicines do not work well enough, patients will be given Idacio to treat their polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Slovenian: Če ta zdravila ne bodo delovala dovolj, boste za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa ali artritisa, povezanega z entezitisom dobili zdravilo Idacio.
English: If you do not respond well enough to these medicines, you will be given Idacio to reduce the signs and symptoms of your Crohn's disease.
Slovenian: Če se nanje ne boste odzvali dovolj dobro, boste za zmanjšanje znakov in simptomov Crohnove bolezni dobili zdravilo Idacio.
English: Sarcoidosis1), vasculitis
Slovenian: občasni sarkoidoza1), vaskulitis redki anafilaksa1)
English: Table 14 Efficacy response in placebo-controlled study nr-axSpA I Double-blind response at week 12
Slovenian: Preglednica 14 Odziv učinkovitosti v s placebom kontrolirani študiji nr-axSpA I
English: Note: P# = Placebo (Number of events/Number at risk); A# = Adalimumab (number of events/Number at risk).
Slovenian: Opomba: P# = placebo (število dogodkov/število rizičnih preiskovancev); A# = Adalimumab (število dogodkov/število rizičnih preiskovancev).
English: Initial dose of 160 mg (as four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by an 80 mg dose (as two 40 mg injections on the same day) two weeks later.
Slovenian: Začetni odmerek je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva zaporedna dneva), ki mu sledi 80 mg (kot dve 40 mg injekciji v istem dnevu) dva tedna kasneje.
English: Beyond 16 weeks, patients with inadequate response to Idacio 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week.
Slovenian: Od 16. tedna dalje lahko bolnikom z nezadostnim odzivom na zdravilo Idacio 40 mg vsak drugi teden koristi povečanje odmerka na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: • Only use Idacio Vial Kit if your healthcare professional has trained you how to use it correctly.
Slovenian: • Zdravilo Idacio komplet z vialo lahko uporabljate le, če vas je zdravstveni delavec naučil, kako pravilno uporabljati napolnjeno injekcijsko brizgo.
English: • Hold the -pre-filled pen so that you can see the transparent syringe housing.
Slovenian: • Napolnjen injekcijski peresnik držite tako, da vidite prozorno ohišje injekcijske brizge.
English: Idacio 40 mg/0.8 mL solution for injection (injection) for paediatric use is supplied as a sterile 0.8 mL clear, colourless solution of 40 mg adalimumab.
Slovenian: Zdravilo Idacio 40 mg/0,8 ml raztopine za injiciranje v vialah za pediatrično uporabo je na voljo kot 0,8 ml sterilna, bistra, brezbarvna raztopina z 40 mg adalimumaba.
English: The recommended dose of Idacio for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2).
Slovenian: Priporočeni odmerek zdravila Idacio pri bolnikih z artritisom, povezanim z entezitisom, starih 6 let in več, temelji na telesni masi (preglednica 2).
English: • Hold the syringe like a pencil.
Slovenian: • Injekcijsko brizgo držite tako kot pisalo.
English: • Keep Idacio pre-filled syringe and the sharps disposal container out of reach and sight of children.
Slovenian: • Zdravilo Idacio napolnjena injekcijsko brizgo in zbiralnik za ostre predmete shranjujte nedosegljivo otrokom.
English: In patients with Crohn's disease, the loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 5.5 µg/mL during the induction period.
Slovenian: Pri bolnikih s Crohnovo boleznijo doseže polnilni odmerek 80 mg adalimumab na 0. teden, ki mu sledi 40 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu približno 5,5 µg/ml.
English: In adolescent patients with inadequate response to Idacio 40 mg every other week, an increase in dosage to 40 mg every week or 80 mg every other week may be considered.
Slovenian: Pri mladostnikih z nezadostnim odzivom na zdravilo Idacio 40 mg vsak drugi teden je možno razmisliti o povečanju odmerka na 40 mg vsak teden ali 80 mg vsak drugi teden.
English: If a faster response is required, your child's doctor may prescribe an initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Slovenian: Če je potreben hitrejši odziv, lahko zdravnik vašemu otroku predpiše začetni odmerek 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva zaporedna dneva), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje.
English: In monotherapy, some patients who experience a decrease in their response to Idacio 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Slovenian: Med monoterapijo lahko nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Idacio 40 mg vsak drugi teden, koristi povečanje odmerka adalimumaba na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Some patients who experience decrease in their response to Idacio 40 mg every other week may benefit from an increase in dosage to 40 mg Idacio every week or 80 mg every other week.
Slovenian: Nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Idacio 40 mg vsak drugi teden, lahko koristi povečanje odmerka zdravila Idacio na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Vertigo and visual impairment may occur following administration of Idacio (see section 4.8).
Slovenian: Po dajanju zdravila Idacio se lahko pojavita vrtoglavica in poslabšanje vida (glejte poglavje 4.8).
English: Concomitant administration of adalimumab with other biologic DMARDs (e.g, anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
Slovenian: Sočasna uporaba adalimumaba z drugimi biološkimi DMARDs (tj.anakinra in abacept) ali z drugimi antagonisti TNF ni priporočljiva zaradi možnega povečanega tveganja za okužbe, vključno z resnimi okužbami in drugih potencialnih farmakoloških interakcij (glejte poglavje 4.5).
English: The recommended dose of Idacio for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5).
Slovenian: Priporočeni odmerek zdravila Idacio pri pediatričnih bolnikih z uveitisom, starih 2 leti ali več, temelji na telesni masi (preglednica 5).
English: Syringe Warning: Do not use if damaged.
Slovenian: Opozorilo: Če so pripomočki poškodovani, jih ne smete uporabljati.
English: Initial dose of 160 mg (as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg (as two 40 mg injections in one day) two weeks later.
Slovenian: Začetni odmerek je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored) nato sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje.
English: Adolescent hidradenitis suppurativa (from 12 years of age, weighing at least 30 kg) There are no clinical trials with adalimumab in adolescent patients with HS.
Slovenian: Hidradenitis suppurativa pri mladostnikih (starejših od 12 let, ki tehtajo najmanj 30 kg) Kliničnih študij z adalimumabom pri mladostnikih s HS ni. Odmerjanje adalimumaba pri teh bolnikih je bilo določeno na podlagi farmakokinetičnega modeliranja in simulacije (glejte poglavje 5.2).
English: Week 24 Week 36
Slovenian: 12. teden 4 % 24. teden 6 %
English: How to store Idacio
Slovenian: Shranjevanje zdravila Idacio
English: Table 7 Distribution of patients by age and adalimumab dose received during the OL LI phase Age Group
Slovenian: Porazdelitev bolnikov po starosti in odmerku adalimumaba, ki so ga dobivali med odprto uvajalno fazo
English: If these medicines do not work well enough, you will be given Idacio to reduce the signs and symptoms of your disease.
Slovenian: Če ta zdravila ne bodo dovolj delovala, boste dobili zdravilo Idacio za zmanjšanje znakov in simptomov vaše bolezni.
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10% BSA involvement and PASI ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Slovenian: Varnost in učinkovitost adalimumaba so raziskali v randomiziranih, dvojno slepih študijah pri odraslih bolnikih s kronično psoriazo v plakih (zajete ≥ 10 % telesne površine ter indeksom obsežnosti in izrazitosti psoriaze PASI ≥ 12 ali ≥ 10), ki so bili kandidati za sistemsko zdravljenje ali fototerapijo.
English: The recommended dose of Idacio for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose.
Slovenian: Priporočeni začetni odmerek zdravila Idacio za odrasle bolnike z uveitisom je 80 mg, čemur sledi 40 mg odmerek vsak drugi teden, ki se ga začne dajati en teden po začetnem odmerku.
English: Idacio is contraindicated in moderate to severe heart failure (see section 4.3).
Slovenian: Pri bolnikih z zmernim do hudim srčnim popuščanjem je zdravilo Idacio kontraindicirano (glejte poglavje 4.3).
English: Important Information Only use Idacio pre-filled pen if your healthcare professional has trained you how to use it correctly.
Slovenian: Zdravilo Idacio napolnjen injekcijski peresnik lahko uporabljate le, če vas je zdravstveni delavec naučil, kako pravilno uporabljati napolnjeno injekcijsko brizgo.
English: The benefit and risk of continued long-term treatment should be periodically evaluated (see section
Slovenian: Tveganja in koristi neprekinjenega dolgotrajnega zdravljenja je treba periodično pretehtati (glejte poglavje 5.1).
English: The recommended dose of Idacio for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
Slovenian: Priporočeno odmerjanje zdravila Idacio za odrasle bolnike je začetni odmerek 80 mg subkutano in nato 40 mg subkutano vsak drugi teden, začenši en teden po začetnem odmerku.
English: p-value
Slovenian: P vrednost1
English: SPARCCh MRI sacroiliac jointsd,i SPARCC MRI spined,j a Assessment of Spondyloarthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
Slovenian: d povprečna sprememba od začetka zdravljenja e n = 91 placebo in n = 87 adalimumab f hs-CRP = C-reaktivni protein z veliko občutljivostjo (high sensitivity C-Reactive Protein) (mg/L)
English: Read carefully these entire instructions before using your Idacio pre-filled syringe.
Slovenian: Pred uporabo zdravila Idacio napolnjena injekcijska brizga natančno preberite celotno navodilo.
English: In adult patients with ulcerative colitis, a loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 µg/mL during the induction period.
Slovenian: Pri odraslih bolnikih z ulceroznim kolitisom doseže polnilni odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu približno 12 µg/ml.
English: • The needle guard spring is not extended (Figure I).
Slovenian: Slika H • vzmet varovala za injekcijsko iglo ni raztegnjena (Slika I).
English: Idacio is available as a vial, a pre-filled syringe and a pre-filled pen.
Slovenian: Zdravilo Idacio je na voljo v viali, napolnjeni injekcijski brizgi in napolnjenem injekcijskem peresniku.
English: Adverse events of the haematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leucopenia) have been reported with adalimumab.
Slovenian: Med uporabo adalimumaba so poročali o neželenih učinkih na hematološki sistem, vključno z medicinsko pomembno citopenijo (npr. trombocitopenijo, levkopenijo).
English: Patients in steroid-free remission for >=90 daysa * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a
Slovenian: Klinična remisija Klinični odziv (CR-100) Bolniki v remisiji brez steroidov 5 % (3/66) za ≥ 90 dnia p < 0,001 za parne primerjave deležev med adalimumabom in placebom ** p < 0,02 za parne primerjave deležev med adalimumabom in placebom a Od tistih, ki so izhodiščno dobivali kortikosteroide
English: Table 22 Induction of clinical remission and response (percent of patients) CD study I: infliximab naive patients
Slovenian: Indukcija klinične remisije in odziv (Odstotek bolnikov) Študija pri Crohnovi bolezni I:
English: Table 14 Ps study I (REVEAL) efficacy results at 16 weeks
Slovenian: Preglednica 14: Študija pri psoriazi I (REVEAL) Rezultati učinkovitosti po 16 tednih Adalimumab placebo
English: ACR 50 Week 12 Week 24
Slovenian: 2. teden 12. teden 24. teden ASAS 50 2. teden 12. teden 24. teden ASAS 70 2. teden 12. teden 24. teden
English: Table 20: Paediatric plaque psoriasis efficacy results at 16 weeks MTXa
Slovenian: Preglednica 20: Rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
English: NAME OF THE MEDICINAL PRODUCT Idacio 40 mg solution for injection in pre-filled syringe Idacio 40 mg solution for injection in pre-filled pen
Slovenian: Idacio 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Idacio 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: Idacio 40 mg solution for injection in pre-filled syringe adalimumab
Slovenian: Idacio 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
English: STATEMENT OF ACTIVE SUBSTANCE(S) One 0.8 mL vial contains 40 mg adalimumab
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena 0,8 ml viala vsebuje 40 mg adalimumaba.
English: Sodium dihydrogen phosphate dihydrate Disodium phosphate dihydrate Mannitol
Slovenian: - Druge sestavine zdravila so natrijev dihidrogenfosfat dihidrat, natrijev hidrogenfosfat dihidrat,
English: Hypertension, flushing, haematoma
Slovenian: Žilne bolezni pogosti hipertenzija, zardevanje, hematom,
English: Solution for injection 2 pre-filled pens 2 alcohol pads 6 pre-filled pens 6 alcohol pads
Slovenian: raztopina za injiciranje 2 napolnjena injekcijska peresnika 2 alkoholna zloženca 6 napolnjenih injekcijskih peresnikov 6 alkoholnih zložencev
English: Discontinuation of Idacio therapy should be considered in patients with confirmed significant haematologic abnormalities.
Slovenian: Pri bolnikih s potrjenimi pomembnimi hematološkimi nepravilnostmi je treba razmisliti o prekinitvi terapije z zdravilom Idacio.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1356/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1356/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1356/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA(DOVOLJENJ) ZA PROMET EU/1/19/1356/001
English: Idacio 40 mg solution for injection in pre-filled pen Each 0.8 ml single dose pre-filled pen contains 40 mg of adalimumab.
Slovenian: Idacio 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku En 0,8 ml enoodmerni napolnjen injekcijski peresnik vsebuje 40 mg adalimumaba.
English: Note: P = Placebo (number at risk); A = Adalimumab (number at risk).
Slovenian: Opomba: P = placebo (število rizičnih preiskovancev); A = Adalimumab (število rizičnih preiskovancev).
English: In Psoriasis study I, 28% of patients who were PASI 75 responders and were re-randomised to placebo at week 33 compared to 5% continuing on adalimumab, p<0.001, experienced “loss of adequate response” (PASI score after week 33 and on or before week 52 that resulted in a <PASI 50 response relative to baseline with a minimum of a 6-point increase in PASI score relative to week 33).
Slovenian: 79 (73,1) a, b čisto/minimalno p < 0,001 adalimumab v primerjavi s placebom p < 0,001 adalimumab v primerjavi z metotreksatom p < 0,01 adalimumab v primerjavi s placebom p < 0,05 adalimumab v primerjavi z metotreksatom V študiji pri psoriazi I so 33. teden "izgubo ustreznega odziva" zabeležili pri 28 % bolnikov, ki so dosegli odziv PASI 75 in so bili ob ponovni randomizaciji razvrščeni na placebo, in pri 5 % bolnikov, ki so še naprej dobivali adalimumab (p < 0,001).
English: years.
Slovenian: (meseci)
English: The decision to stop using Idacio should be discussed with your child's doctor.
Slovenian: Če je vaš otrok prenehal uporabljati zdravilo Idacio O odločitvi, da bi prenehali uporabljati zdravilo Idacio, se morate posvetovati z otrokovim zdravnikom.
English: Idacio 40 mg solution for injection in pre-filled syringe
Slovenian: Idacio 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: Idacio 40 mg solution for injection (injection) in pre-filled syringe is supplied as a sterile 0.8 mL clear, colourless solution of 40 mg adalimumab.
Slovenian: Zdravilo Idacio 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku je na voljo kot 0,8 ml sterilna, bistra, brezbarvna raztopina z 40 mg adalimumaba.
English: Treatment with Idacio must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
Slovenian: Pri bolnikih, ki se jim na novo pojavijo simptomi kongestivnega srčnega popuščanja ali se jim takšni simptomi poslabšajo, je treba zdravljenje z zdravilom Idacio prekiniti.
English: 2.5 Wipe the entire vial top with an alcohol pad and throw the pad away.
Slovenian: 2.5 Očistite površino pod pokrovčkom z zložencem, prepojenim z alkoholom, ki ga nato zavržete.
English: Talk to your doctor or pharmacist before using Idacio
Slovenian: Pred začetkom uporabe zdravila Idacio se posvetujte z zdravnikom ali farmacevtom.
English: - 2 pre-filled pens, with 2 alcohol pads - 6 pre-filled pens, with 6 alcohol pads
Slovenian: Velikost pakiranj: - 2 napolnjeni injekcijski brizgi z 2 alkoholnima zložencema - 6 napolnjenih injekcijskih brizg s 6 alkoholnimi zloženci
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1356/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1356/003
English: ASASa partial remission ASDASc inactive disease Partial flared aAssessment of SpondyloArthritis international Society bBaseline is defined as open label baseline when patients have active disease.
Slovenian: ASASa delno izboljšanje ASDASc neaktivna bolezen Delni zagon boleznid a ocena spondiloartritičnega mednarodnega združenja (Assessment of Spondyloarthritis