FrancophonIA/ELRC3.0 huggingface dataset:
English: • fungal infections;
Slovenian: • glivične okužbe;
English: Pull off the clear needle cap
Slovenian: Snemite prozorni pokrovček za iglo
English: Imraldi in combination with methotrexate, is indicated for: - the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Slovenian: - Zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih bolnikih, kadar odziv na imunomodulirajoča antirevmatična zdravila, vključno z metotreksatom, ni zadosten.
English: Multiple sclerosis, demyelinating disorders (e.g. optic neuritis, Guillain-Barré syndrome)1)
Slovenian: stisnjenje živčnih korenin občasni možgansko-žilni dogodki tremor, nevropatija redki multipla skleroza, demielinizirajoče bolezni (npr. optični nevritis, sindrom Guillain-Barré)
English: The recommended dose of Imraldi 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 Imraldi za odrasle bolnike je začetni odmerek 80 mg subkutano in nato 40 mg subkutano vsak drugi teden, začenši en teden po začetnem odmerku.
English: • Keep your vial in its carton, and away from light.
Slovenian: • Vialo shranite v njeni kartonski škatli in zaščiteno pred svetlobo.
English: Imraldi 40 mg solution for injection in vial is supplied as a 0.8 ml clear and colourless solution.
Slovenian: Zdravilo Imraldi 40 mg raztopina za injiciranje v viali je na voljo v obliki 0,8 ml bistre in brezbarvne raztopine.
English: Imraldi 40 mg/0.8 ml injection adalimumab
Slovenian: Imraldi 40 mg/0,8 ml raztopina za injiciranje adalimumab
English: • Throw away your used vial in a special container as instructed by your doctor, nurse or pharmacist.
Slovenian: • Uporabljeno vialo zavrzite v poseben vsebnik, kot so vam naročili zdravnik, medicinska sestra ali farmacevt.
English: The recommended dose of Imraldi 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 Imraldi 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: This medicinal product contains 20 mg sorbitol in each pre-filled syringe.
Slovenian: To zdravilo vsebuje 20 mg sorbitola v napolnjeni injekcijski brizgi.
English: Imraldi 40 mg solution for injection in pre-filled syringe is supplied as a 0.8 ml clear and colourless solution.
Slovenian: Zdravilo Imraldi 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku je na voljo v obliki 0,8 ml bistre in brezbarvne raztopine.
English: Syringe disposal
Slovenian: Odstranjevanje injekcijske brizge
English: Treatment with Imraldi 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 Imraldi prekiniti.
English: Your child's doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual dose.
Slovenian: Zdravnik lahko vašemu otroku predpiše začetni odmerek 80 mg, ki se ga uporabi en teden pred začetkom zdravljenja z običajnim odmerkom.
English: Adalimumab /MTX N=268
Slovenian: Adalimumab/MTX
English: Pull off needle cap
Slovenian: Snemite pokrovček za iglo
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (PRE-FILLED SYRINGE PACK)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (PAKIRANJE Z NAPOLNJENIM INJEKCIJSKIM PERESNIKOM)
English: If a faster effect is required your doctor may prescribe an 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 80 mg (as two 40 mg injections in one day) two weeks later, and thereafter as 40 mg every other week.
Slovenian: Če je potreben hitrejši učinek, vam zdravnik lahko predpiše začetni odmerek 160 mg (kot štiri 40 mg injekcije na en dan ali kot dve 40 mg injekciji na dan dva dni zapored), ki mu sledi 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje in potem 40 mg vsak drugi teden.
English: • Throw away your used syringe in a special container as instructed by your doctor, nurse or pharmacist.
Slovenian: • Uporabljeni injekcijski peresnik zavrzite v poseben vsebnik, kot so vam naročili zdravnik, medicinska sestra ali farmacevt.
English: The usual dose for adults with non-infectious uveitis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Slovenian: Običajni začetni odmerek za odrasle z neinfekcijskim uveitisom je 80 mg (kot dve 40 mg injekciji v enem dnevu), čemur sledi odmerek 40 mg, ki se ga daje vsak drugi teden, z začetkom en teden po začetnem odmerku.
English: RA study IIIa**
Slovenian: Študija revmatoidnega artritisa IIIa**
English: Imraldi 40 mg solution for injection in pre-filled syringe adalimumab
Slovenian: Imraldi 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku adalimumab
English: The usual Imraldi dose for adults with ulcerative colitis is 160 mg initially (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 and thereafter 40 mg every other week.
Slovenian: Običajno odmerjanje zdravila Imraldi pri odraslih z ulceroznim kolitisom je 160 mg (kot štiri 40 mg injekcije v enem dnevu ali kot dve 40 mg injekciji na dan dva zaporedna dneva) 0. teden in 80 mg (kot dve 40 mg injekciji v enem dnevu) 2. teden, nato pa 40 mg vsak drugi teden.
English: and uveitis patients.
Slovenian: 3.000 bolnikih.
English: The recommended dose of Imraldi is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg every other week starting one week later.
Slovenian: Priporočeno odmerjanje zdravila Imraldi je začetni odmerek 80 mg (dve 40 mg injekciji v enem dnevu), čemur sledi 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.
English: Table 6 Undesirable Effects
Slovenian: Neželeni učinki
English: Adalimumab/methotrexate combination therapy was clinically and statistically superior to methotrexate (p <0.001) and adalimumab monotherapy (p <0.001) in achieving a low disease state in patients with recently diagnosed moderate to severe rheumatoid arthritis.
Slovenian: Za doseganje nizkega stanja bolezni pri bolnikih z nedavno diagnosticiranim zmernim do hudim revmatoidnim artritisom je bila kombinirana terapija z adalimumabom in metotreksatom klinično in statistično boljša od monoterapije z metotreksatom (p < 0,001) in monoterapije z adalimumabom (p < 0,001).
English: • kidney problems;
Slovenian: • težave z ledvicami;
English: ACR 50 52 Week
Slovenian: 52. tedna dosegli odziv ACR 50.
English: There is no relevant use of adalimumab in children aged below 6 years for this indication.
Slovenian: Uporaba adalimumaba pri otrocih, starih manj kot 6 let, za to indikacijo ni primerna.
English: Citric acid monohydrate Histidine
Slovenian: Pomožne snovi: natrijev citrat, citronska kislina monohidrat, histidin, histidinijev klorid monohidrat,
English: Adalimumab Δ Censored Note: P = Placebo (Number at Risk (flared)); A = Adalimumab (Number at Risk (flared)).
Slovenian: Opomba: P = placebo (število rizičnih preiskovancev (zagon bolezni)); A = adalimumab (število rizičnih preiskovancev (zagon bolezni)).
English: The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a Physician's Global Assessment (PGA) ≥4 or >20% BSA involvement or >10 % BSA involvement with very thick lesions or Psoriasis Area and Severity Index (PASI) ≥20 or ≥10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Slovenian: Učinkovitost adalimumaba je bila ocenjena v randomizirani, dvojno slepi, kontrolirani študiji, v katero je bilo vključenih 114 pediatričnih bolnikov od 4. leta starosti, s hudo kronično psoriazo v plakih (definirano z zdravnikovo globalno oceno (PGA - Physician's Global Assessment) ≥ 4 ali > 20 %
English: If a faster response is required, your child's doctor may prescribe an initial dose of 80 mg (as two 40-mg injections in 1 day) followed by 40 mg two weeks later.
Slovenian: Če je potreben hitrejši odziv, lahko zdravnik vašemu otroku predpiše začetni odmerek 80 mg (kot dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg dva tedna kasneje.
English: Uncommon Rhabdomyolysis, systemic lupus erythematosus
Slovenian: sistemski eritematozni lupus redki sindrom, podoben lupusu
English: Very common Lipids increased Common
Slovenian: Presnovne in prehranske motnje zelo pogosti zvišanje lipidov pogosti hipokaliemija,
English: In 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 bolnikih z ulceroznim kolitisom doseže polnilni odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 40 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu približno 12 µg/ml.
English: Imraldi 40 mg solution for injection in pre-filled syringe EU/1/17/1216/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET Z ZDRAVILOM EU/1/17/1216/009
English: Imraldi is also used to treat severe plaque psoriasis in children and adolescents weighing 30 kg or greater for whom topical therapy and phototherapies have either not worked very well or are not suitable.
Slovenian: ki tehtajo 30 kg ali več, pri katerih lokalno zdravljenje in fototerapija nista dovolj dobro delovala ali pa nista primerna.
English: • When the syringe is empty, remove the needle from skin, being careful to pull it out at the same angle as when it was inserted.
Slovenian: • Ko je brizga prazna, iglo potegnite iz kože.
English: If a faster response is required, your doctor may prescribe an initial dose of 80 mg (as two 40 mg injections in one day) followed by 40 mg two weeks later.
Slovenian: Če je potreben hitrejši odziv, vam zdravnik lahko predpiše začetni odmerek 80 mg (kot dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg dva tedna kasneje.
English: The usual dose regimen for hidradenitis suppurativa is an 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 in one day) two weeks later.
Slovenian: Običajni 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 odmerek 80 mg (kot dve 40 mg injekciji v enem dnevu) dva tedna kasneje.
English: Of 207 patients, 81 patients continued on adalimumab 40 mg every other week for 10 years.
Slovenian: 81 nadaljevalo zdravljenje s 40 mg adalimumaba vsak drugi teden še 10 let.
English: Stratum
Slovenian: RTa
English: * p <0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p <0.02 for adalimumab versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline
Slovenian: Bolniki v remisiji brez steroidov ≥ 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: Check with your doctor before your child receives any vaccines.
Slovenian: Preden vaš otrok opravi kakršnokoli cepljenje, se posvetujte z zdravnikom.
English: It is important to tell your doctor if your child gets symptoms such as fever, wounds, feeling tired or dental problems.
Slovenian: Pomembno je, da zdravniku poveste, če vaš otrok doživi simptome, kot so npr. zvišana telesna temperatura, rane, občutek utrujenosti ali težave z zobmi.
English: **p <0.01, adalimumab versus placebo - Not applicable
Slovenian: c MTX = metotreksat **p < 0,01, adalimumab v primerjavi s placebom - Ne pride v poštev
English: Skin Painb
Slovenian: ali stegna.
English: • adolescent hidradenitis suppurativa,
Slovenian: • hidradenitis suppurativa pri mladostnikih,
English: It is important that you tell your doctor if your child has symptoms of infections, e.g. fever, wounds, feeling tired, dental problems.
Slovenian: Pomembno je, da zdravniku poveste, če ima vaš otrok simptome okužb, npr. zvišano telesno temperaturo, rane, občutek utrujenosti ali težave z zobmi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (VIAL PACK)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA (PAKIRANJE Z VIALO)
English: CD study I: Infliximab Naive Patients
Slovenian: Študija pri Crohnovi bolezni I: Bolniki, ki še niso dobivali infliksimaba
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN
English: and were originally randomised to active therapy in Period A, were re-randomised in period C to receive 40 mg adalimumab every other week or placebo for an additional 19 weeks.
Slovenian: Bolnike, ki so imeli 33. teden ohranjen odziv PASI ≥ 75 in so bili v obdobju A randomizirani na aktivno terapijo, so med obdobjem C ponovno randomizirali tako, da so dodatnih 19 tednov dobivali 40 mg adalimumaba vsak drugi teden ali placebo.
English: Keep the syringe in the outer carton in order to protect from light.
Slovenian: Brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: Imraldi is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years in whom topical therapy and phototherapies have either not worked very well or are not suitable.
Slovenian: 4 leta do 17 let, pri katerih lokalno zdravljenje in fototerapija nista dovolj dobro delovala ali pa nista primerna.
English: Week 16 Placebo-Controlled
Slovenian: Kontrolirana s placebom
English: If these medicines do not work well enough, patients will be given Imraldi to reduce the signs and symptoms of your disease.
Slovenian: Če ta zdravila ne bodo delovala dovolj dobro, bodo bolniki za zmanjšanje znakov in simptomov bolezni dobili zdravilo Imraldi.
English: In monotherapy, some patients who experience a decrease in their response to Imraldi 40 mg every other week dosing 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 odziv na zdravilo zmanjša, koristi zvečanje odmerka adalimumaba na 40 mg vsak teden.
English: Talk to your child's doctor or pharmacist before using Imraldi.
Slovenian: Pred začetkom uporabe zdravila Imraldi se posvetujte z zdravnikom vašega otroka ali farmacevtom.
English: Inhibition of inflammation
Slovenian: Shranjevanje injekcijske brizge
English: Autoantibodies Patients had serum samples tested for autoantibodies at multiple time points in rheumatoid arthritis studies
Slovenian: V študijah revmatoidnega artritisa I−V so pri bolnikih ob več različnih časih testirali protitelesa v serumu.
English: solution for injection 1 pre-filled syringe 2 alcohol pads
Slovenian: raztopina za injiciranje 1 napolnjena injekcijska brizga
English: Your child's doctor should test your child for HBV. Imraldi can reactivate HBV infection in people who carry this virus.
Slovenian: Zdravnik mora vašega otroka testirati na HBV.
English: paleness.
Slovenian: Imraldi.
English: The usual dose for adults with psoriasis is an initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg given every other week starting one week after the initial dose.
Slovenian: Običajni začetni odmerek za odrasle z luskavico (psoriazo) je 80 mg (kot dve 40 mg injekciji v enem dnevu), nato pa 40 mg vsak drugi teden z začetkom en teden po začetnem odmerku.
English: • ear infections;
Slovenian: • okužbe ušesa;
English: If this dose does not work well enough, your child's doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Slovenian: Če ta odmerek ne deluje dovolj dobro, lahko zdravnik vašega otroka odmerek poveča na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Children and adolescents from 4 to 17 years of age weighing 15 kg to less than 30 kg The recommended dose of Imraldi is an initial dose of 20 mg, followed by 20 mg one week later.
Slovenian: Otroci in mladostniki, starejši od 6 let, ki tehtajo od 15 kg do manj kot 30 kg Priporočeni odmerek zdravila Imraldi je 20 mg vsak drugi teden.
English: There is no relevant use of adalimumab in children aged less than 2 years in this indication.
Slovenian: Uporaba adalimumaba pri otrocih, mlajših od 2 let, za to indikacijo ni primerna.
English: DO NOT touch the vial stopper after wiping with the alcohol pad.
Slovenian: Potem, ko ste zamašek viale obrisali z alkoholnim zložencem, se zamaška NE DOTIKAJTE.
English: Adalimumab was evaluated in over 3,000 patients in all rheumatoid arthritis clinical trials.
Slovenian: V vseh kliničnih preskušanjih revmatoidnega artritisa so adalimumab ocenili pri več kot
English: RA study Ia**
Slovenian: Študija revmatoidnega artritisa Ia**
English: Rare
Slovenian: adalimumabb
English: If a faster response is required, your child's doctor may prescribe an initial dose of 160 mg initially (as four 40 mg injections in one day or 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: This medicinal product contains 20 mg sorbitol in each pre-filled pen.
Slovenian: To zdravilo vsebuje 20 mg sorbitola v napolnjenem injekcijskem peresniku.
English: 7.2 % of patients receiving placebo or active control.
Slovenian: 1,3 % bolnikov v kontrolni skupini.
English: Biogen Inc.
Slovenian: Icepharma hf.
English: The primary endpoint in RA study V was the percent of patients who achieved an ACR 50 response at week 52.
Slovenian: Primarna končna točka študije revmatoidnega artritisa V je bil odstotek bolnikov, ki so do
English: If this dose does not work well enough to Imraldi 40 mg every other week, your doctor may increase the dosage to 40 mg every week or 80 mg every other week .
Slovenian: Če odziv na zdravilo Imraldi 40 mg vsak drugi teden ne bo zadosten, bo zdravnik odmerek lahko povečal na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: μg/ml (95% CI: 1-6 μg/ml).
Slovenian: ICAM-1 z IK50 0,1-0,2 nM).
English: • 40 mg at week 0 and 20 mg at week 2
Slovenian: 40 mg 2. teden oziroma 40 mg 0. teden in 20 mg 2. teden.
English: EU/1/17/1216/008
Slovenian: EU/1/17/1216/007 EU/1/17/1216/008
English: Imraldi 40 mg solution for injection in pre-filled syringe
Slovenian: Imraldi 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
English: • If you dropped your syringe with the cap ON, it is okay to use the syringe.
Slovenian: • Če vam je injekcijska brizga padla, ko je bil pokrovček še NAMEŠČEN, jo smete uporabiti.
English: Children, adolescents and adults with enthesitis-related arthritis Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg The recommended dose of Imraldi is 20 mg every other week.
Slovenian: Otroci, mladostniki in odrasli 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: • psoriasis,
Slovenian: oniholiza,
English: 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: > 32 tednov 20 tednov > 32 tednov 14 tednov a Odzivi »Paed ACR« 30/50/70 so bili 48. teden značilno večji kot pri bolnikih, ki so dobivali placebo.
English: Confirm completion & dispose
Slovenian: Prepričajte se, da je injiciranje zaključeno, in zavrzite
English: Each 0.8 ml pre-filled syringe contains 40 mg adalimumab.
Slovenian: Ena 0,8 ml napolnjena injekcijska brizga z enim odmerkom vsebuje 40 mg adalimumaba.
English: • Keep your syringe in its carton, and away from light.
Slovenian: • Injekcijsko brizgo shranite v njeni kartonski škatli in zaščiteno pred svetlobo.
English: It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems.
Slovenian: Pomembno je, da zdravniku poveste, če imate simptome okužb, npr. zvišano telesno temperaturo, rane, občutek utrujenosti ali težave z zobmi.
English: EU/1/17/1216/006
Slovenian: EU/1/17/1216/005 EU/1/17/1216/006
English: It is important to tell your doctor if you get symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Slovenian: Pomembno je, da poveste zdravniku, če dobite znake okužbe, kot so zvišana telesna temperatura, rane, utrujenost ali problemi z zobmi.
English: Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1) lichenoid skin reaction1)
Slovenian: brazgotinjenje redki multiformni eritem sindrom Stevens-Johnson angioedem kožni vaskulitis lihenoidna reakcija neznana poslabšanje simptomov dermatomiozitisa
English: • You might get infections more easily while you are receiving Imraldi treatment.
Slovenian: • Med zdravljenjem z zdravilom Imraldi se lahko poveča dovzetnost za okužbe.
English: If this dose does not work well enough, your doctor may increase the dose to 40 mg every week or 80 mg every other week.
Slovenian: Če ta odmerek ne deluje dovolj dobro, lahko zdravnik poveča odmerek na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: OTHER
Slovenian: Znova
English: Injection site care
Slovenian: Shranjevanje injekcijskega peresnika
English: No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during an adalimumab trial in paediatric patients with uveitis.
Slovenian: ki so bili med preskušanjem adalimumaba izpostavljeni 58,4 bolnikov-let, niso ugotovili nobenega malignoma.
English: Imraldi 40 mg solution for injection in pre-filled syringe Each 0.8 ml single dose pre-filled syringe contains 40 mg of adalimumab.
Slovenian: En 0,8 ml napolnjen injekcijski peresnik z enim odmerkom vsebuje 40 mg adalimumaba.
English: If this dose does not work well enough, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Slovenian: Če ta odmerek ne deluje dovolj dobro, lahko zdravnik odmerek poveča na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: There is no relevant use of adalimumab in children aged less than 4 years for this indication.
Slovenian: Uporaba adalimumaba pri bolnikih, starih manj kot 4 leta, za to indikacijo ni primerna.
English: Adverse Reaction alopecia1), pruritus
Slovenian: Zdravljenje placebo adalimumab Δ anonimizirano
English: • autoantibodies present in the blood;
Slovenian: • avtoprotitelesa prisotna v krvi; • nizke krvne vrednosti za kalij.
English: Solution for injection (injection).
Slovenian: raztopina za injiciranje (injekcija) bistra, brezbarvna raztopina
English: Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to <4 years.
Slovenian: V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih z juvenilnim idiopatskim artritisom,
English: In case there is a need for a more rapid response to therapy with the awareness that the risk for adverse events may be higher with use of the higher induction dose, the following dose may be used:
Slovenian: • 40 mg v 0. tednu in 20 mg v 2. tednu V primeru, ko je potreben hitrejši odgovor na zdravljenje, z zavedanjem, da je tveganje za pojav neželenih učinkov povečano ob uporabi večjega začetnega odmerka, se lahko uporabi odmerek: