FrancophonIA/ELRC3.0 huggingface dataset:
English: The patients received 24 mg/m body surface area (BSA) of adalimumab up to a maximum of 20 mg every other week as a single dose via SC injection for at least 24 weeks.
Slovenian: Bolniki so vsaj 24 tednov prejemali adalimumab v odmerku 24 mg/m telesne površine (in do največ 20 mg) vsak drugi teden kot enkraten odmerek v subkutani injekciji.
English: Figure B
Slovenian: Vrednost b
English: If these medicines do not work well enough, patients will be given Kromeya 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 Kromeya.
English: • paediatric Crohn's disease
Slovenian: • Crohnova bolezen pri pediatrični populaciji
English: Adult Uveitis
Slovenian: Uveitis pri odraslih (UV)
English: Kromeya 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 Kromeya uporabljati previdno.
English: a a a p < 0.001, adalimumab vs. placebo
Slovenian: a a a p < 0,001, adalimumab v primerjavi s placebom
English: a a a p<0.001, adalimumab vs. placebo
Slovenian: a a a p < 0,001, Adalimumab v primerjavi s placebom
English: Table 10 Radiographic mean changes at week 52 in RA study V
Slovenian: Preglednica 10: Povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
English: Kromeya 40 mg/0.8 mL solution for injection for paediatric use
Slovenian: Kromeya 40 mg/0,8 ml raztopina za injiciranje za pediatrično uporabo
English: 6 months 6.7% 12 months NA
Slovenian: 6 mesecev 12 mesecev
English: • a cotton ball or gauze, and
Slovenian: • kosem vate ali gazo in
English: If these medicines do not work well enough, your child will be given Kromeya to treat his/her polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Slovenian: Če ta zdravila ne delujejo dovolj dobro, bo vaš otrok za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa ali artritisa, povezanega z entezitisom dobil zdravilo Kromeya.
English: • enthesitis-related arthritis
Slovenian: • artritis, povezan z entezitisom
English: CD study II: Infliximab experienced patients
Slovenian: Študija pri Crohnovi bolezni II: Bolniki, ki so ţe dobivali infliksimab
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 Kromeya should be considered prior to initiating therapy (see Other opportunistic infections).
Slovenian: Pred začetkom zdravljenja je treba tveganja in koristi zdravljenja z zdravilom Kromeya 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: Yellow syringe connector
Slovenian: Rumen konektor za injekcijsko brizgo
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" zabeleţili 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: The recommended dose of Kromeya 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 Kromeya 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: You may see drops of liquid at the needle tip.
Slovenian: Na konici injekcijske igle so lahko vidne kapljice tekočine.
English: Warning: Do not take the needle out of its packaging.
Slovenian: Opozorilo: Injekcijske igle ne vzemite iz ovojnine.
English: JSN score 2.0 (1.2-2.8) 1.3 (0.5-2.1)
Slovenian: ICAM-1 z IC50 0,1-0,2 nM).
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: Across all treatment groups, the mean baseline PASI score was 19.7 and the baseline PGA score ranged from “mild” (< 1%) to “moderate” (48%) to “severe” (46%) to “very severe” (6%).
Slovenian: V vseh terapevtskih skupinah je bila povprečna izhodiščna ocena PASI 19,7, izhodiščna PGA pa je segala od "blage" (< 1 %), "zmerne" (48 %) in "hude" (46 %) do "zelo hude" (6 %).
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 doseţe polnilni odmerek 80 mg adalimumab na 0. teden, ki mu sledi 40 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu pribliţno 5,5 µg/ml.
English: Kromeya contains sodium
Slovenian: Zdravilo Kromeya vsebuje natrij
English: Table 7 Distribution of patients by age and adalimumab dose received during the OL LI phase
Slovenian: Porazdelitev bolnikov po starosti in odmerku adalimumaba, ki so ga dobivali med odprto uvajalno fazo
English: Children and adolescents from 6 years of age weighing 15 kg to less than 30 kg
Slovenian: Otroci in mladostniki, starejši od 6 let, ki tehtajo od 15 kg do manj kot 30 kg
English: (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: (do največ 40 mg) subkutano vsak drugi teden pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom (pJIA), starih 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: 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: Pediatric Uveitis
Slovenian: Uveitis pri pediatričnih bolnikih
English: Children and adolescents from 4 to 17 years of age weighing 30 kg or more
Slovenian: Otroci in mladostniki, stari od 4 do 17 let, ki tehtajo 30 kg ali več
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 doseţe polnilni odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, med obdobjem indukcije najmanjšo koncentracijo v serumu pribliţno 12 µg/ml.
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: • Hold the syringe upward and pull the needle cap straight off (Figure N).
Slovenian: Injekcijsko brizgo drţite obrnjeno navzgor in odstranite pokrovček na injekcijski igli (Slika N).
English: Each pre-filled syringe contains 40 mg of adalimumab in 0.8 ml of solution.
Slovenian: Vsaka napolnjena brizga vsebuje 40 mg adalimumaba in 0,8 ml raztopine.
English: • Throw away the needle cap.
Slovenian: • Pokrovček z injekcijske igle zavrzite.
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 Kromeya.
Slovenian: Pred zdravljenjem z zdravilom Kromeya in med zdravljenjem z njim je treba za nemelanomskega koţnega raka pregledati vse bolnike, še zlasti pa bolnike z anamnezo intenzivne imunosupresivne terapije in bolnike s psoriazo, ki so kdaj prejemali PUVA.
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 neţelenih učinkih na hematološki sistem, vključno z medicinsko pomembno citopenijo (npr. trombocitopenijo, levkopenijo).
English: Shaking can damage the pre-filled syringe and the medicine.
Slovenian: S tem bi lahko poškodovali napolnjeno injekcijsko brizgo ali zdravilo.
English: The distribution of patients by age and minimum, median and maximum dose received during the OL LI phase is presented in Table 7.
Slovenian: Preglednica 7 prikazuje porazdelitev bolnikov po starosti ter najmanjšem, srednjem in največjem odmerku, prejetem med odprto uvajalno fazo.
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 adalimumaba v začetnem odmerku 80 mg, ki mu je sledil odmerek 40 mg vsak drugi teden, z začetkom dajanja en teden po začetnem odmerku.
English: • cutaneous vasculitis (inflammation of blood vessels in the skin);
Slovenian: • koţni vaskulitis (vnetje krvnih ţil v koţi);
English: Nervous system disorders* Very common
Slovenian: Organski sistem po MedDRA Pogostnost
English: Paediatric uveitis Age or body weight
Slovenian: Pediatrični uveitis Starost ali telesna masa
English: • Hold the -pre-filled pen so that you can see the transparent syringe housing.
Slovenian: • Napolnjen injekcijski peresnik drţite tako, da vidite prozorno ohišje injekcijske brizge.
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: 3.1 Check the transparent syringe housing to make sure that:
Slovenian: 3.1 Injekcijsko brizgo preglejte in preverite, ali:
English: Lymphoma**, solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma**
Slovenian: ploščatoceličnim karcinomom), benigni tumor občasni limfom**, tumorji parenhimskih organov (vključno s tumorjem dojk, tumorjem pljuč in tumorjem ščitnice) maligni melanom**,
English: If you do not respond well enough to these medicines, you will be given Kromeya 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 Kromeya.
English: Renal and/or hepatic impairment
Slovenian: Okvara jeter in/ali ledvic
English: The distribution of patients by age and minimum, median and maximum dose received during the OL LI phase is presented in Table 11.
Slovenian: Preglednica 11 prikazuje porazdelitev bolnikov po starosti ter najmanjšem, srednjem in največjem odmerku, prejetem med odprto uvajalno fazo.
English: Kromeya 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 Kromeya 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: What you need to know before your child uses Kromeya 3.
Slovenian: Kaj morate vedeti, preden bo vaš otrok uporabil zdravilo Kromeya Ne uporabljajte zdravila Kromeya
English: CD study I and CD study II induction of remission and response rates are presented in Table 21.
Slovenian: Indukcijo remisije in deleţe odziva v študiji pri Crohnovi bolezni I in študiji pri Crohnovi bolezni II prikazuje preglednica 21.
English: Kromeya 40 mg/0.8 mL solution for injection for paediatric use adalimumab
Slovenian: Kromeya 40 mg/0,8 ml raztopina za injiciranje za pediatrično uporabo adalimumab
English: Warning: Do not reuse a syringe in case of partial injection.
Slovenian: Opozorilo: Če injicirate le del odmerka, ne smete ponovno uporabiti injekcijske brizge.
English: There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Slovenian: Psoriatični artritis in aksialni spondiloartritis, vključno z ankiloznim spondilitisom Uporaba adalimumaba pri pediatrični populaciji za indikaciji ankilozni spodilitis in psoriatični artritis ni primerna.
English: • Store the pre-filled syringe in its original box to protect it from light.
Slovenian: • Napolnjen injekcijski peresnik shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: The recommended dose of Kromeya for paediatric patients with uveitis from 2 years of age is based on body weight (Table 5).
Slovenian: Priporočeni odmerek zdravila Kromeya pri pediatričnih bolnikih z uveitisom, starih 2 leti ali več, temelji na telesni masi (preglednica 5).
English: - If you get any side effects, talk to your doctor or pharmacist.
Slovenian: - Če opazite kateri koli neţeleni učinek, se posvetujte z zdravnikom ali farmacevtom.
English: The recommended dose of Kromeya for patients with enthesitis-related arthritis from 6 years of age is based on body weight (Table 2).
Slovenian: Priporočeni odmerek zdravila Kromeya pri bolnikih z artritisom, povezanim z entezitisom, starih 6 let in več, temelji na telesni masi (preglednica 2).
English: Pack sizes of: - 2 pre-filled syringes, with 2 alcohol pads - 6 pre-filled syringes, with 6 alcohol pads.
Slovenian: Velikost pakiranj: - 2 napolnjena injekcijska peresnika z 2 alkoholnima zloţencema - 6 napolnjenih injekcijskih peresnikov s 6 alkoholnimi zloţenci
English: Step 6 Give Injection
Slovenian: 6. korak Injicirajte zdravilo
English: Erosion score
Slovenian: Ocena erozij Ocena ZSŠ
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 obseţnosti in izrazitosti psoriaze PASI ≥ 12 ali ≥ 10), ki so bili kandidati za sistemsko zdravljenje ali fototerapijo.
English: • Keep Kromeya pre-filled syringe and the sharps disposal container out of reach and sight of children.
Slovenian: • Zdravilo Kromeya napolnjena injekcijsko brizgo in zbiralnik za ostre predmete shranjujte nedosegljivo otrokom.
English: Possible side effects
Slovenian: Neţeleni učinki
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 moţnega povečanega tveganja za okuţbe, vključno z resnimi okuţbami, in drugih potencialnih farmakoloških interakcij (glejte poglavje 4.5).
English: In patients with polyarticular JIA who were 2 to <4 years old or aged 4 and above weighing <15 kg dosed with adalimumab 24 mg/m2 , the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 µg/mL (101% CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 µg/mL (71.2% CV) with concomitant methotrexate.
Slovenian: < 15 kg, ki so prejemali adalimumab v odmerku 24 mg/m2, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja 6,0 ± 6,1 µg/ml (KV 101 %) med uporabo adalimumaba brez metotreksata in 7,9 ± 5,6 µg/ml (KV 71,2 %) med sočasno uporabo metotreksata.
English: Children and adolescents from 2 years of age weighing 10 kg to less than 30 kg
Slovenian: Otroci in mladostniki, starejši od 2 let, ki tehtajo od 10 kg do manj kot 30 kg
English: 4.5 Place the syringe on a clean, flat surface.
Slovenian: 4.5 Injekcijsko brizgo poloţite na čisto, ravno površino.
English: Each vial contains 40 mg of adalimumab in 0.8 ml of solution.
Slovenian: Ena viala vsebuje 40 mg adalimumaba in 0,8 ml raztopine.
English: If these medicines do not work well enough, you will be given Kromeya to reduce the signs and symptoms of your disease.
Slovenian: Če ta zdravila ne bodo dovolj delovala, boste dobili zdravilo Kromeya za zmanjšanje znakov in simptomov vaše bolezni.
English: Table 12 Radiographic mean changes at week 52 in RA study V
Slovenian: Preglednica 12: Povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
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: Kromeya is contraindicated in moderate to severe heart failure (see section 4.3).
Slovenian: Pri bolnikih z zmernim do hudim srčnim popuščanjem je zdravilo Kromeya kontraindicirano (glejte poglavje 4.3).
English: Children and adolescents from 2 years of age weighing less than 30 kg
Slovenian: Otroci in mladostniki, starejši od 2 let, ki tehtajo manj kot 30 kg
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 bo deloval dovolj dobro, lahko otrokov zdravnik odmerek poveča na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Warning: Do not remove the needle cap while allowing syringe to reach room temperature.
Slovenian: Opozorilo: Medtem ko čakate, da se injekcijska brizga ogreje na sobno temperaturo, ne smete odstraniti pokrovčka na injekcijski igli.
English: Kromeya 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 Kromeya 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: If so, throw away the pre-filled pen in a sharps disposal container and contact your healthcare professional or pharmacist.
Slovenian: V tem primeru injekcijski peresnik zavrzite v zbiralnik za ostre predmete in se obrnite na svojega zdravstvenega delavca ali farmacevta.
English: Vertigo and visual impairment may occur following administration of Kromeya (see section 4.8).
Slovenian: Po dajanju zdravila Kromeya se lahko pojavita vrtoglavica in poslabšanje vida (glejte poglavje 4.8).
English: • muscle spasms;
Slovenian: • okuţbe sečil;
English: • reproductive tract infections;
Slovenian: • okuţbe reproduktivnih organov;
English: Kromeya therapy should not be continued in patients failing to respond within this time period.
Slovenian: Pri bolnikih, ki se v tem času ne odzovejo na zdravljenje z zdravilom Kromeya, zdravljenja ni priporočljivo nadaljevati.
English: Table 20 Induction of clinical remission and response (percent of patients)
Slovenian: Preglednica 20 Indukcija klinične remisije in odziv (Odstotek bolnikov)
English: • pulmonary fibrosis (scarring of the lung);
Slovenian: • pljučna fibroza (brazgotinjenje pljuč);
English: • It is important to tell your doctor if your child gets symptoms of infections, such as fever, wounds, feeling tired or dental problems.
Slovenian: • Pomembno je, da poveste zdravniku, če vaš otrok dobi znake okuţbe, kot so zvišana telesna temperatura, rane, utrujenost ali problemi z zobmi.
English: The safety guard will slide down and lock into place to protect you from the needle (Figure Q).
Slovenian: Varovalo se bo spustilo navzdol in ostalo na mestu, da se ne bi poškodovali z iglo.
English: Week 12 Week 24 ASAS 70 Week 2
Slovenian: 12. teden 4 % 24. teden 6 %
English: Back view
Slovenian: Zadnja stran
English: ≥ 40 kg • 80 mg at week 0 and 40 mg at week 2
Slovenian: < 40 kg • 40 mg v 0. tednu in 20 mg v 2. tednu
English: Kromeya dose for paediatric patients with uveitis
Slovenian: Odmerjanje zdravila Kromeya pri pediatričnih bolnikih z uveitisom
English: Pack sizes of: - 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 zloţencema - 6 napolnjenih injekcijskih brizg s 6 alkoholnimi zloţenci
English: • Top of the thighs or
Slovenian: • zgornjem delu stegen ali
English: Tabulated list of adverse reactions
Slovenian: Seznam neţelenih učinkov v preglednici
English: • polyarticular juvenile idiopathic arthritis
Slovenian: • poliartikularni juvenilni idiopatski artritis
English: Non-serious allergic reactions associated with adalimumab were uncommon during clinical trials.Reports of serious allergic reactions including anaphylaxis have been received following adalimumab administration.
Slovenian: Po uporabi adalimumaba so prejeli poročila o resnih alergijskih reakcijah, vključno z anafilaksijo.
English: 5.3 Remove the clear needle cap by pulling it straight off and throw it away.
Slovenian: 5.3 Odstranite prozoren pokrovček na injekcijski igli in ga zavrzite.
English: • paediatric plaque psoriasis
Slovenian: • luskavica (psoriaza) v plakih pri pediatričnih bolnikih
English: This will unlock the injection button (Figure O).
Slovenian: S tem boste odklenili gumb za injiciranje.
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 in 2. teden, na adalimumab 0. teden in 80 mg 2. teden, ali na 80 mg 0. teden in 40 mg 2. teden.
English: • any issue you had
Slovenian: • kakršnihkoli teţavah,