FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypersensitivity, allergies (including seasonal allergy) Uncommon Sarcoidosis1),
Slovenian: pogosti preobčutljivost, alergije (vključno s sezonsko alergijo)
English: Patients received an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) or placebo for 16 weeks.
Slovenian: Bolniki so prejeli začetni odmerek 80 mg adalimumaba, ki mu je sledil 40 mg odmerek, ali placebo vsak drugi teden (z začetkom en teden po začetnem odmerku) naslednjih 16 tednov.
English: Insomnia
Slovenian: nespečnost
English: • eye infections;
Slovenian: • okužba očesa;
English: Week 12 Week 24 *** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo
Slovenian: *** p < 0,001 za vse primerjave med adalimumabom in placebom * p < 0,05 za vse primerjave med adalimumabom in placebom
English: Adalimumab treatment reduced the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS (mean ± SD) 0.8 ± 2.5 in the placebo group (at week 24) compared with 0.0 ± 1.9; (p<0.001) in the adalimumab group (at week 48).
Slovenian: Sprememba je bila (povprečje ± standardni odklon) 0,8 ± 2,5 v skupini s placebom (po 24 tednih) in 0,0 ± 1,9; (p < 0,001) v skupini z adalimumabom (po 48 tednih).
English: Heart Failure
Slovenian: Srčne bolezni*
English: In adolescent patients with inadequate response to Imraldi 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 Imraldi 40 mg vsak drugi teden je možno razmisliti o povečanju odmerka na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Patients received placebo or adalimumab at an initial dose of 80 mg followed by 40 mg every other week starting one week after the initial dose.
Slovenian: Bolniki so prejeli placebo ali adalimumab v začetnem odmerku 80 mg, ki mu je sledil odmerek 40 mg vsak drugi teden, z začetkom dajanja en teden po začetnem odmerku.
English: Imraldi Dose for Patients with Enthesitis-Related Arthritis Patient Weight
Slovenian: Odmerjanje zdravila Imraldi pri bolnikih z artritisom, povezanim z entezitisom
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 adalimumaba na 0. teden, ki mu sledi 40 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu približno 5,5 μg/ml.
English: Imraldi Dose for Paediatric Patients with Plaque Psoriasis Patient Weight
Slovenian: Odmerjanje zdravila Imraldi pri pediatričnih bolnikih s psoriazo v plakih Masa bolnika
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: 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: Keep the pre-filled syringe or pre-filled pen in outer carton in order to protect from light.
Slovenian: Napolnjeno injekcijsko brizgo ali napolnjen injekcijski peresnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Two patients out of 3,441 treated with adalimumab in all rheumatoid arthritis and psoriatic arthritis studies developed clinical signs suggestive of new-onset lupus-like syndrome.
Slovenian: V vseh študijah revmatoidnega artritisa in psoriatičnega artritisa so se klinični znaki, ki so nakazovali novonastali lupusni sindrom, pojavili pri 2 od
English: - If your child is allergic to adalimumab or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Kaj morate vedeti, preden bo vaš otrok uporabil zdravilo Imraldi Ne uporabljajte zdravila Imraldi - če je vaš otrok alergičen na adalimumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Imraldi 40 mg/0.8 ml solution for injection
Slovenian: Imraldi 40 mg/0,8 ml raztopina za injiciranje
English: Children and adolescents with polyarticular juvenile idiopathic arthritis Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg The recommended dose of Imraldi is 20 mg every other week.
Slovenian: Otroci in mladostniki s poliartikularnim juvenilnim idiopatskim artritisom Otroci in mladostniki, starejši od 2 let, ki tehtajo od 10 kg do manj kot 30 kg Priporočeni odmerek zdravila Imraldi je 20 mg vsak drugi teden.
English: Children, adolescents and adults from 6 years of age weighing 30 kg or more
Slovenian: Otroci, mladostniki in odrasli, starejši od 6 let, ki tehtajo 30 kg ali več
English: Patient Weight
Slovenian: Masa bolnika
English: ALT elevations ≥3 × ULN occurred in 0.9% of adalimumabtreated patients and 0.9 % of controlled-treated patients.
Slovenian: pojavilo pri 0,3 % bolnikov, zdravljenih z adalimumabom, in pri 0,6 % bolnikov v kontrolni skupini.
English: Contents of the pack and other information What Imraldi contains
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo Imraldi - Učinkovina je adalimumab.
English: CD Study II: Infliximab Experienced Patients
Slovenian: Študija pri Crohnovi bolezni II: Bolniki, ki so že dobivali infliksimab
English: The usual dose regimen for Crohn's disease is 80 mg (as two 40 mg injections in one day) initially followed by 40 mg every other week starting two weeks later.
Slovenian: Običajna shema odmerjanja pri Crohnovi bolezni je 80 mg (kot dve 40 mg injekciji v enem dnevu) na začetku, čemur sledi 40 mg vsak drugi teden z začetkom dva tedna kasneje.
English: Some patients who experience decrease in their response to Imraldi 40 mg every other week may benefit from an increase in dosage to 40 mg Imraldi every week or 80 mg every other week.
Slovenian: Nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Imraldi 40 mg vsak drugi teden, lahko koristi povečanje odmerka zdravila Imraldi na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Uncommon Erectile dysfunction
Slovenian: Motnje reprodukcije in dojk občasni erektilna disfunkcija
English: In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥3 × ULN occurred in 6.1 % of adalimumab-treated patients and 1.3 % of control-treated patients.
Slovenian: ki so bili stari od 4 do 17 let, in bolnikih z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, so se zvišanja ALT ≥ 3 × ULN pojavila pri 6,1 % bolnikov, zdravljenih z adalimumabom, in pri
English: Beyond 16 weeks, patients with inadequate response to Imraldi 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 Imraldi 40 mg vsak drugi teden koristi povečanje odmerka na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: pruritus
Slovenian: Dojenje
English: 1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe, 1 needle, 1 vial adapter and 2 alcohol pads.
Slovenian: 1 pakiranje z 2 škatlama, od katerih vsaka vsebuje: 1 vialo (0,8 ml sterilne raztopine), 1 prazno sterilno injekcijsko brizgo, 1 iglo, 1 adapter za vialo in
English: Imraldi can reduce the number of nodules and abscesses you have, and the pain that is often associated with the disease.
Slovenian: Zmanjša lahko tudi bolečino, ki je pogosto povezana s to boleznijo.
English: Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate.
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Adalimumab so raziskali pri bolnikih z revmatoidnim artritisom, poliartikularnim juvenilnim idiopatskim artritisom in psoriatičnim artritisom, ki so adalimumab jemali v monoterapiji, kot pri tistih, ki so ga jemali hkrati z metotreksatom.
English: In Period A, patients received placebo or adalimumab at an initial dose of 160 mg at week 0, 80 mg at week 2, and 40 mg every week starting at week 4 to week 11.
Slovenian: V obdobju A so bolniki prejeli placebo ali adalimumab v začetnem odmerku 160 mg v 0. tednu, nato 80 mg v 2. tednu in 40 mg vsak teden od vključno 4. tedna do 11. tedna.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INNER CARTON (VIAL PACK)
Slovenian: PODATKI NA ZUNANJI OVOJNINI NOTRANJA ŠKATLA (PAKIRANJE Z VIALO)
English: In study UC-I, 390 TNF-antagonist naïve patients were randomised to receive either placebo at weeks 0 and 2, 160 mg adalimumab at week 0 followed by 80 mg at week 2, or 80 mg adalimumab at week 0 followed by 40 mg at week 2.
Slovenian: V študiji UC-I so 390 bolnikov, ki še niso prejemali antagonista TNF, randomizirali bodisi na placebo 0. in 2. teden, na adalimumab 0. teden in 80 mg 2. teden, ali na 80 mg 0. teden in 40 mg
English: 0.8 ml solution for injection in single-use pre-filled pen for patient use containing a pre-filled syringe.
Slovenian: Imraldi 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku 0,8 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku za enkratno uporabo, ki vsebuje napolnjeno injekcijsko brizgo, za bolnikovo uporabo.
English: • Pick up the syringe with the needle pointing up.
Slovenian: • Primite brizgo tako, da je igla obrnjena navzgor.
English: This medicinal product contains 20 mg sorbitol in each vial.
Slovenian: To zdravilo vsebuje 20 mg sorbitola v eni viali.
English: Each 0.8 ml vial contains 40 mg adalimumab.
Slovenian: Ena 0,8 ml viala z enim odmerkom vsebuje 40 mg adalimumaba.
English: CD study I and CD study II induction of remission and response rates are presented in Table 23.
Slovenian: Indukcijo remisije in deleže odziva v študiji pri Crohnovi bolezni I in študiji pri Crohnovi bolezni II prikazuje preglednica 23.
English: If you dropped your syringe with the cap OFF, do not use it.
Slovenian: Če vam je injekcijska brizga padla, ko je bil pokrovček že ODSTRANJEN, je ne uporabite.
English: Imraldi contains the active substance adalimumab, a medicine that acts on your body's immune (defence) system.
Slovenian: Kaj je zdravilo Imraldi in za kaj ga uporabljamo Zdravilo Imraldi vsebuje učinkovino adalimumab, ki je zdravilo, ki učinkuje na imunski (obrambni)
English: 6 pre-filled pens 6 alcohol pads
Slovenian: 6 alkoholnih zložencev
English: How to store Imraldi
Slovenian: Shranjevanje zdravila Imraldi
English: Leukaemia1) Not known Hepatosplenic T-cell lymphoma1),
Slovenian: redki levkemija neznana pogostnost hepatosplenični T-celični limfom karcinom Merklovih celic (nevroendokrini karcinom kože)
English: Standard Dose 40/20 mg eow
Slovenian: Standardni odmerek 40/20 mg vsak
English: * p<0.05, ***p<0.001, adalimumab versus placebo a
Slovenian: * p < 0,05, ***p < 0,001, adalimumab v primerjavi s placebom a Med vsemi randomiziranimi bolniki b
English: a, b
Slovenian: Vrednost b
English: 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: Polnilni odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, doseže med obdobjem indukcije najmanjšo koncentracijo v serumu približno 12 μg/ml.
English: Imraldi has not been studied in these patient populations.
Slovenian: Zdravilo Imraldi pri teh populacijah bolnikov še ni bilo preskušeno, zato priporočil za odmerjanje ni mogoče dati.
English: Excess liquid may come out of the needle while the white plunger rod is being pushed.
Slovenian: Med pritiskanjem belega nosilca bata lahko iz igle steče odvečna tekočina.
English: Week 12 Week 24
Slovenian: 12. teden 24. teden
English: Crohn's disease is an inflammatory disease of the digestive tract.
Slovenian: Crohnova bolezen je vnetna bolezen prebavil.
English: The recommended dose of Imraldi for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5).
Slovenian: Priporočeni odmerek zdravila Imraldi pri pediatričnih bolnikih z uveitisom, starih 2 leti ali več, temelji na telesni masi (preglednica 5).
English: In controlled trials of adalimumab (initial doses of 80 mg at week 0 followed by 40 mg every other week starting at week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in adalimumab-treated and control-treated patients, respectively, ALT elevations ≥3 × ULN occurred in 2.4 % of adalimumab-treated patients and 2.4 % of control-treated patients.
Slovenian: V kontroliranih preskušanjih z adalimumabom (začetni odmerek 80 mg v 0. tednu, ki mu sledi odmerek 40 mg vsak drugi teden z začetkom v 1. tednu) pri odraslih bolnikih z uveitisom, ki so trajala do 80 tednov, z mediano izpostavljenostjo 166,5 dni pri bolnikih, zdravljenih z adalimumabom, in
English: Week 26 Week 52
Slovenian: 26. teden 52. teden
English: SC
Slovenian: MTXc
English: Primary analysis (ITT) Placebo
Slovenian: Odziv placebo
English: 2 pre-filled pens 2 alcohol pads
Slovenian: 2 alkoholna zloženca
English: interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1)
Slovenian: Sjögrenov sindrom občasni pankreatitis, disfagija, edem obraza redki intestinalna perforacija1)
English: Immunogenicity
Slovenian: tromboflebitis
English: These results suggest that some patients who have not responded by week 4 benefit from continued maintenance therapy through week 12.
Slovenian: To kaže, da lahko nadaljnje zdravljenje do 12. tedna koristi nekaterim bolnikom, ki se ne odzovejo do 4. tedna.
English: Patients demonstrating a Paediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg/m2 up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Slovenian: Bolniki, ki so 16. teden dosegli odziv»Paediatric ACR« 30, so bili primerni za randomizacijo v dvojno slepo fazo in so nadaljnjih 32 tednov ali do zagona bolezni vsak drugi teden dobili adalimumab
English: If these medicines do not work well enough, you will be given Imraldi to reduce the signs and symptoms of your Crohn's disease.
Slovenian: Če ta zdravila ne bodo delovala dovolj dobro, boste za zmanjšanje znakov in simptomov Crohnove bolezni dobili zdravilo Imraldi.
English: Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections.
Slovenian: Pri teh bolnikih je pri postavitvi diagnoze in izbiri empiričnega antimikotičnega zdravljenja potreben posvet z zdravnikom, izkušenim v zdravljenju bolnikov z invazivnimi glivičnimi okužbami.
English: In CD study I, 299 TNF-antagonist naive patients were randomised to one of four treatment groups; placebo at weeks 0 and 2, 160 mg adalimumab at week 0 and 80 mg at week 2, 80 mg at week 0 and 40 mg at week 2, and 40 mg at week 0 and 20 mg at week 2.
Slovenian: V študiji pri Crohnovi bolezni I so 299 bolnikov, ki pred tem še niso dobivali antagonistov TNF, randomizirali v eno od štirih skupin: placebo 0. in 2. teden, 160 mg adalimumaba 0. teden in 80 mg 2. teden, 80 mg 0. teden in
English: Packs of:  1 pre-filled syringe, with 2 alcohol pads  2 pre-filled syringes, each with 1 alcohol pad
Slovenian:  1 napolnjeno injekcijsko brizgo z 2 alkoholnima zložencema  2 napolnjenih injekcijskih brizg, vsak z 1 alkoholnim zložencem
English: Table 23 Maintenance of Clinical Remission and Response (Percent of Patients)
Slovenian: Vzdrževanje klinične remisije in odziva (odstotek bolnikov)
English: Adalimumab /methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 9).
Slovenian: Pri bolnikih, ki so dobivali adalimumab in metotreksat, je bilo po 6 in 12 mesecih (glejte preglednico 9) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
English: • myocardial infarction;
Slovenian: • miokardni infarkt;
English: Children, adolescents and adults from 6 years of age weighing 30 kg or more The recommended dose of Imraldi is 40 mg every other week.
Slovenian: Otroci in mladostniki, starejši od 6 let, ki tehtajo 30 kg ali več Priporočeni odmerek zdravila Imraldi je 40 mg vsak drugi teden.
English: This medicinal product contains 20 mg sorbitol in each pre-filled syringe/pre-filled pen.
Slovenian: To zdravilo vsebuje 20 mg sorbitola v napolnjeni injekcijski brizgi/napolnjenem injekcijskem peresniku.
English: The recommended dose of Imraldi for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2).
Slovenian: Priporočeni odmerek zdravila Imraldi pri bolnikih z artritisom, povezanim z entezitisom, starih 6 let in več, temelji na telesni masi (preglednica 2).
English: OL-LI 16 weeks
Slovenian: 16. teden
English: Imraldi is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Slovenian: (acne inversa) pri odraslih in mladostnikih, starejših od 12 let, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS zdravljenje (glejte poglavji 5.1 in 5.2).
English: Imraldi therapy should not be continued in patients failing to respond within this time period.
Slovenian: Pri bolnikih, ki se v tem času ne odzovejo, se zdravljenja ne sme nadaljevati.
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 v randomiziranih, dvojno slepih študijah raziskali pri odraslih bolnikih s kronično psoriazo v plakih (zajete ≥ 10 % telesne površine ter PASI ≥ 12 ali ≥ 10), ki so bili kandidati za sistemsko zdravljenje ali fototerapijo.
English: A statistically significant decrease in fatigue as measured by functional assessment of chronic illness therapy (FACIT) scores was seen in all three studies in which it was assessed (RA studies I, III, IV).
Slovenian: V vseh treh študijah (študije revmatoidnega artritisa I, III in IV), v katerih so ocenjevali utrujenost s funkcijsko oceno terapije kronične bolezni (Functional assessment of chronic illness therapy (FACIT)), so ugotovili statistično značilno zmanjšanje utrujenosti.
English: There is limited safety experience in patients undergoing arthroplasty while receiving adalimumab.
Slovenian: Izkušnje z varnostjo pri bolnikih, ki so jim med zdravljenjem z adalimumabom opravili artroplastiko,
English: Adalimumabb N=113
Slovenian: N = 113
English: The recommended Imraldi induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg injections in one day).
Slovenian: Priporočena shema odmerjanja zdravila Imraldi med indukcijo je pri odraslih bolnikih z zmerno do hudo aktivnim ulceroznim kolitisom 160 mg 0. teden (aplicirano kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva dni zapored) in 80 mg 2. teden (aplicirano kot dve 40 mg injekciji v enem dnevu).
English: • paediatric uveitis.
Slovenian: • uveitisa pri pediatrični populaciji.
English: Uncommon Lymphoma**, solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma**
Slovenian: pogosti karcinom kože, ki ne vključuje malignega melanoma (vključno z bazalnoceličnim karcinomom in ploščatoceličnim karcinomom), benigni tumor občasni limfom**, tumorji parenhimskih organov (vključno s tumorjem dojk, tumorjem pljuč in tumorjem ščitnice), maligni melanom**
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/ml for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/ml with concomitant methotrexate.
Slovenian: (do največ 40 mg) subkutano vsak drugi teden bolnikom z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednost merjena v 24. tednu) 8,8 ± 6,6 μg/ml med uporabo adalimumaba brez metotreksata in 11,8 ± 4,3 μg/ml med sočasno uporabo metotreksata.
English: Carefully pull off the clear needle cap with a metal center from the pen.
Slovenian: Z injekcijskega peresnika previdno snemite prozorni pokrovček za iglo s kovinsko sredico.
English: Imraldi is contraindicated in moderate to severe heart failure (see section 4.3).
Slovenian: Pri bolnikih z zmernim ali hudim srčnim popuščanjem je zdravilo Imraldi kontraindicirano (glejte poglavje 4.3).
English: Talk to your doctor or pharmacist before using Imraldi.
Slovenian: Pred začetkom uporabe zdravila Imraldi se posvetujte z zdravnikom ali farmacevtom.
English: Imraldi is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Slovenian: (acne inversa) pri mladostnikih, starejših od 12 let, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS zdravljenje (glejte poglavji 5.1 in 5.2).
English: Adalimumab /methotrexate patients demonstrated significantly less radiographic progression than patients receiving methotrexate alone at 6 and 12 months (see Table 11).
Slovenian: Pri bolnikih, ki so dobivali adalimumab in metotreksat, je bilo po 6 in 12 mesecih (glejte preglednico 11) statistično značilno manj rentgenografskih znakov napredovanja kot pri bolnikih, ki so dobivali samo metotreksat.
English: Imraldi may have a minor influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Imraldi ima lahko blag vpliv na sposobnost vožnje in upravljanja strojev.
English: Do not pass it on to others.
Slovenian: NE PRIVIJTE je preveč.
English: Adults with rheumatoid arthritis
Slovenian: Revmatoidni artritis pri odraslih
English: 20 weeks
Slovenian: ≥ 90 dnia
English: Patients who experience insufficient response may benefit from an increase in dosage:  < 40 kg: 20 mg every week  ≥ 40 kg: 40 mg every week or 80 mg every other week
Slovenian: • < 40 kg: 20 mg vsak teden • ≥ 40 kg: 40 mg vsak teden ali 80 mg vsak drugi teden
English: You will be instructed by your child's doctor or his/her assistant on the technique of injection and the amount to give to your child. Do not attempt to give your child an injection until you are sure that you understand how to prepare and give the injection.
Slovenian: Otrokov zdravnik ali njegovo osebje vas bodo naučili, kako in koliko zdravila injicirate vašemu otroku.
English:  2 pre-filled pens, each with 1 alcohol pad  4 pre-filled pens, each with 1 alcohol pad  6 pre-filled pens, each with 1 alcohol pad
Slovenian: Pakiranja po:  1 napolnjen injekcijski peresnik z 2 alkoholnima zložencema  2 napolnjena injekcijska peresnika, vsak z 1 alkoholnim zložencem  4 napolnjeni injekcijski peresniki, vsak z 1 alkoholnim zložencem  6 napolnjenih injekcijskih peresnikov, vsak z 1 alkoholnim zložencem