FrancophonIA/ELRC3.0 huggingface dataset:
English: * p<0.05, ***p<0.001, adalimumab versus placebo a Among all randomised patients b Among patients with baseline HS-related skin pain assessment ≥ 3, based on Numeric Rating Scale 0
Slovenian: * p < 0,05, ***p < 0,001, adalimumab v primerjavi s placebom a Med vsemi randomiziranimi bolniki b Med bolniki z izhodiščnim rezultatom 3 ali več pri ocenjevanju bolečine, povezane s hidradenitis suppurativa, po numerični ocenjevalni lestvici od 0 do 10; 0 = brez bolečin na koži, 10 = najhujša možna bolečina na koži
English: RA study IIa**
Slovenian: Študija revmatoidnega artritisa IIa**
English: Table 25 Maintenance regimen
Slovenian: Vzdrževalni režim
English: The double-blind period is followed by an open-label (OL) period during which patients received 24 mg/m2 BSA of adalimumab up to a maximum of 40 mg every other week subcutaneously for up to an additional 192 weeks.
Slovenian: Obdobju dvojno slepega preskušanja je sledilo obdobje odprtega preskušanja, v katerem so bolniki prejemali 24 mg/m telesne površine adalimumaba do največjega posamičnega odmerka 40 mg vsak drugi teden subkutano do največ 192 tednov.
English: Worsening or new onset of psoriasis (including palmoplantar pustular psoriasis)1),
Slovenian: pogosti poslabšanje ali pojav psoriaze (vključno s palmoplantarno pustularno psoriazo) urtikarija, modrice (vključno s purpuro), dermatitis (vključno z ekcemom),
English: 4 pre-filled pens 4 alcohol pads
Slovenian: 4 alkoholni zloženci
English: Week 26 Placebo-Controlled
Slovenian: Kontrolirana s placebom26.
English: Table 10 Radiographic Mean Changes at Week 52 in RA Study V
Slovenian: Povprečne rentgenografske spremembe po 52 tednih študije revmatoidnega artritisa V
English: Table 18 Ps Study II (CHAMPION) Efficacy Results at 16 Weeks
Slovenian: Študija pri psoriazi II (CHAMPION) - rezultati učinkovitosti po 16 tednih Placebo
English: Absorption and distribution Following the administration of 24 mg/m
Slovenian: Po uporabi 24 mg/m
English: In RA study V with early rheumatoid arthritis patients who were methotrexate naïve, combination therapy with adalimumab and methotrexate led to faster and significantly greater ACR responses than methotrexate monotherapy and adalimumab monotherapy at week 52 and responses were sustained at week 104 (see Table 10).
Slovenian: V študiji revmatoidnega artritisa V pri bolnikih z zgodnjim revmatoidnim artritisom, ki še niso dobivali metotreksata, je kombinirana terapija z adalimumabom in metotreksatom po 52 tednih prinesla hitrejše in značilno večje odzive ACR kakor monoterapija z metotreksatom ali monoterapija z adalimumabom, odzivi pa so se ohranili do 104. tedna (glejte preglednico 10).
English: The usual dose regimen is 40 mg initially followed by 20 mg two weeks later.
Slovenian: Običajni začetni odmerek je 40 mg, ki mu sledi 20 mg dva tedna kasneje.
English: In controlled Phase 3 trials of adalimumab in patients with plaque psoriasis with a control period duration ranging from 12 to 24 weeks, ALT elevations ≥3 × ULN occurred in 1.8% of adalimumab-treated patients and 1.8 % of control-treated patients.
Slovenian: V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih s psoriazo s plaki in s trajanjem kontrolnega obdobja od 12 do 24 tednov, se je zvišanje ALT ≥ 3 × ULN pojavilo pri 1,8 % bolnikov,
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult nonradiographic axial spondyloarthritis patients, the mean (±SD) trough steady-state concentration at Week 68 was 8.0 ± 4.6 μg/ml.
Slovenian: Po subkutanem dajanju 40 mg adalimumaba vsak drugi teden odraslim bolnikom z ne-radiografskim aksialnim spondiloartritisom je bila povprečna (±SD) najmanjša koncentracija v stanju dinamičnega ravnovesja (merjena v 68. tednu) 8,0 ± 4,6 µg/ml.
English: Imraldi is given by injection under the skin (by subcutaneous injection).
Slovenian: Zdravilo Imraldi se daje v obliki injekcije pod kožo (subkutana uporaba).
English: There is no relevant use of Imraldi in children aged less than 4 years for this indication.
Slovenian: Uporaba zdravila Imraldi pri otrocih, starih manj kot 4 leta, za to indikacijo ni primerna.
English: 104 Week 42.8% 36.9% 59.0% <0.001 <0.001 0.162
Slovenian: 52. teden 45,9 % 41,2 % 61,6 % < 0,001 < 0,001 0,317 104. teden 42,8 % 36,9 % 59,0 % < 0,001 < 0,001 0,162
English: Placebo/MTXa
Slovenian: Placebo/MTXadalimumab/MTX
English: Muscle spasms (including blood creatine phosphokinase increased)
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva zelo pogosti mišičnoskeletne bolečine pogosti mišični spazmi (vključno s povišano kreatin fosfokinazo v krvi)
English: Imraldi is used to treat ulcerative colitis in adults.
Slovenian: Zdravilo Imraldi se uporablja za zdravljenje ulceroznega kolitisa pri odraslih.
English: EU/1/17/1216/005 1 pre-filled pen EU/1/17/1216/006 2 pre-filled pens EU/1/17/1216/007 4 pre-filled pens EU/1/17/1216/008 6 pre-filled pens
Slovenian: EU/1/17/1216/005 1 napolnjen injekcijski peresnik EU/1/17/1216/006 2 napolnjena injekcijska peresnika EU/1/17/1216/007 4 napolnjeni injekcijski peresniki EU/1/17/1216/008 6 napolnjenih injekcijskih peresnikov
English: The recommended Imraldi dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Slovenian: Priporočeni odmerek zdravila Imraldi pri bolnikih s psoriazo v plakih, starih od 4 do 17 let, temelji na telesni masi (preglednica 3).
English: A 40 mg pre-filled pen and a 40 mg pre-filled syringe are also available for patients to administer a full 40 mg dose.
Slovenian: Za bolnike sta na voljo tudi 40 mg napolnjen injekcijski peresnik in 40 mg napolnjena injekcijska brizga za apliciranje polnega 40 mg odmerka.
English: Imraldi is used to treat psoriatic arthritis in adults.
Slovenian: Zdravilo Imraldi se uporablja za zdravljenje psoriatičnega artritisa pri odraslih.
English: The patients received 24 mg/m2 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: I − V. In these trials, 11.9 % of patients treated with adalimumab and 8.1% of placebo and active control treated patients that had negative baseline anti-nuclear antibody titres reported positive titres at week 24.
Slovenian: V teh preskušanjih so pozitivne titre protijedrnih protiteles po 24 tednih ugotovili pri 11,9 % prejemnikov adalimumaba in 8,1 % prejemnikov placeba in kontrolne učinkovine, ki so imeli izhodiščno negativne titre teh protiteles.
English: Adalimumab 160/80 mg N=76
Slovenian: Adalimumab 160/80 mg
English: The recommended dose of Imraldi for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1).
Slovenian: Priporočeni odmerek zdravila Imraldi pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih 2 leti in več, temelji na telesni masi (preglednica 1).
English: The safety and efficacy of adalimumab were also studied in adult patients with moderate to severe chronic plaque psoriasis with concomitant hand and/or foot psoriasis who were candidates for systemic therapy in a randomised doubleblind study (Psoriasis study III).
Slovenian: Varnost in učinkovitost adalimumaba so raziskali tudi v randomizirani dvojno slepi študiji pri odraslih bolnikih z zmerno do hudo kronično psoriazo v plakih s sočasno psoriazo na dlaneh in/ali stopalih, ki so bili kandidati za sistemsko zdravljenje (študija pri psoriazi III).
English: Your doctor should test you for HBV. Imraldi can reactivate HBV infection in people who carry this virus.
Slovenian: Zdravilo Imraldi lahko pri nosilcih HBV reaktivira okužbo s HBV.
English: Icepharma hf. Sími: + 354 800 9836
Slovenian: Sími: + 354 800 9836
English: Therapy continued beyond 12 weeks did not result in significantly more responses (see section
Slovenian: 12. tedna ni prineslo značilno več odzivov (glejte poglavje 4.2).
English: This risk may increase if his/her lung function is impaired.
Slovenian: Tveganje je lahko večje, če ima vaš otrok okvarjeno delovanje pljuč.
English: Caring for your pre-filled syringe
Slovenian: Skrb za vaš napolnjen injekcijski peresnik
English: 104 Week 56.0% 49.3% 69.4% 0.002 <0.001 0.140
Slovenian: 52. teden 62,6 % 54,4 % 72,8 % 0,013 < 0,001 0,043 104. teden 56,0 % 49,3 % 69,4 % 0,002 < 0,001 0,140
English: Children and adolescents with chronic non-infectious uveitis from 2 years of age Children and adolescents from 2 years of age weighing less than 30 kg The usual dose of Imraldi is 20 mg every other week with methotrexate.
Slovenian: Otroci in mladostniki s kroničnim neinfekcijskim uveitisom, starejši od 2 let Otroci in mladostniki, starejši od 2 let, ki tehtajo manj kot 30 kg Običajni odmerek zdravila Imraldi je 20 mg vsak drugi teden z metotreksatom.
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 povprečne koncentracije v stanju dinamičnega ravnovesja približno 8 do 10 μg/ml.
English: Dosing Regimen
Slovenian: Režim odmerjanja
English: arrhythmia, congestive heart failure
Slovenian: Neželeni učinki kongestivno srčno popuščanje redki zastoj srca
English: NEVER pull past the 0.9 ml position regardless of prescribed dose.
Slovenian: Ne glede na predpisani odmerek pa nosilca bata NIKOLI ne potegnite preko položaja 0,9 ml.
English: Excipients: Sodium citrate, citric acid monohydrate, histidine, histidine hydrochloride monohydrate, sorbitol, polysorbate 20, and water for injections.
Slovenian: Pomožne snovi: natrijev citrat, citronska kislina monohidrat, histidin, histidinijev klorid monohidrat, sorbitol, polisorbat 20 in voda za injekcije.
English: In adult patients with hidradenitis suppurativa, a dose of 160 mg adalimumab on week 0 followed by 80 mg on week 2 achieved serum adalimumab trough concentrations of approximately 7 to 8 μg/ml at week 2 and week 4.
Slovenian: Pri odraslih bolnikih s hidradenitis suppurativa doseže odmerek 160 mg adalimumaba na 0. teden, ki mu sledi 80 mg adalimumaba 2. teden, najnižjo koncentracijo adalimumaba v serumu pred naslednjim odmerkom približno 7 do 8 μg/ml v 2. tednu in v 4. tednu.
English: DO NOT use if the liquid is not clear or not free of particles.
Slovenian: Zdravila NE UPORABLJAJTE, če je tekočina motna ali vsebuje kosmiče ali delce.
English: The double-blind period was followed by an open-label period during which patients receive adalimumab 40 mg every other week subcutaneously for up to an additional 144 weeks.
Slovenian: Dvojno slepi periodi je sledila odprta perioda, v kateri so bolniki prejemali 40 mg adalimumaba vsak drugi teden subkutano do dodatnih
English: N=53 n (%)
Slovenian: n (%)
English: Discontinuation of Imraldi 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 Imraldi.
English: Imraldi is used to treat moderate to severe plaque psoriasis in adults.
Slovenian: Zdravilo Imraldi se uporablja za zdravljenje zmerne do hude luskavice (psoriaze) v plakih pri odraslih.
English: Children and adolescents from 2 years of age weighing 30 kg or more The usual dose of Imraldi is 40 mg every other week with methotrexate.
Slovenian: Otroci in mladostniki, starejši od 2 let, ki tehtajo 30 kg ali več Običajni odmerek zdravila Imraldi je 40 mg vsak drugi teden z metotreksatom.
English: Depending on your response, your doctor may increase the dosage to 40 mg every week or 80 mg every other week.
Slovenian: Glede na vaš odziv vam bo zdravnik lahko povečal odmerek na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Hepatitis reactivation of hepatitis B1)
Slovenian: zvišana vrednost bilirubina v krvi redki hepatitis reaktivacija hepatitisa B avtoimunski hepatitis1)
English: Imraldi 40 mg injection adalimumab SC
Slovenian: Imraldi 40 mg injekcija adalimumab s.c.
English: • signs of infection such as fever, feeling sick, wounds, dental problems, burning on urination;
Slovenian: • znake okužbe, npr. zvišano telesno temperaturo, splošno slabo počutje, rane, težave z zobmi,
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 Imraldi should be considered prior to initiating therapy (see Other opportunistic infections).
Slovenian: Pred začetkom zdravljenja je treba tveganja in koristi zdravljenja z zdravilom Imraldi 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: Amongst those who responded (Paediatric ACR 30) at week 24 (n=27 out of 30 patients), the Paediatric ACR 30 responses were maintained for up to 60 weeks in the OLE phase in patients who received adalimumab throughout this time period.
Slovenian: od 30 bolnikov), se je odziv Paediatric ACR 30 v odprti podaljšani fazi ohranil do 60 tednov pri bolnikih, ki so med tem celotnim obdobjem prejemali adalimumab.
English: Subjects who flared during the double-blind period were allowed adalimumab 40 mg eow rescue therapy for at least 12 weeks.
Slovenian: Preiskovanci, pri katerih je v dvojno slepem obdobju prišlo do ponovnega zagona bolezni, so kot rešilno zdravljenje prejemali zdravilo adalimumab 40 mg vsak drug teden vsaj 12 tednov.
English: Low Dose 20/10 mg eow P value1
Slovenian: Majhni odmerek 20/10 mg vsak P vrednost1
English: In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/ml during adalimumab 40 mg every other week monotherapy treatment.
Slovenian: Pri odraslih bolnikih s psoriazo je bila povprečna najmanjša koncentracija v stanju dinamičnega ravnovesja med monoterapijo s 40 mg adalimumaba vsak drugi teden 5 μg/ml.
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Slovenian: Če vaš otrok opazi katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom svojega otroka ali farmacevtom.
English: Imraldi is indicated for the treatment of moderately to severely active Crohn's disease in paediatric patients (from 6 years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and a corticosteroid and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies.
Slovenian: Zdravilo Imraldi je indicirano za zdravljenje zmerno do hudo aktivne Crohnove bolezni pri pediatričnih bolnikih (od 6. leta starosti), ki se ne odzovejo zadovoljivo na konvencionalno zdravljenje, vključno s primarno prehransko terapijo in kortikosteroidom in/ali imunomodulatorjem,
English: 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a PGA ≥4 or >20% BSA involvement or >10 % BSA involvement with very thick lesions or 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: zajete telesne površine ali > 10 % zajete telesne površine z zelo grobimi lezijami ali indeksom obsežnosti in izrazitosti psoriaze (PASI - Psoriasis Area and Severity Index) ≥ 20 ali ≥ 10 s klinično pomembnim zajetjem obraza, genitalij ali dlani/stopal), ki ni bila ustrezno nadzorovana s topikalnim zdravljenjem in helioterapijo ali fototerapijo.
English:  Avoid skin that's sore, bruised, scarred, scaly, or has red patches.
Slovenian:  Izogibajte se injiciranja na mestih, kjer je koža boleča, zabrazgotinjena ali luskasta ali pa so na njej modrice ali rdeče lise.
English: Imraldi is administered via subcutaneous injection.
Slovenian: Zdravilo Imraldi se uporablja kot subkutana injekcija.
English: Across all treatment groups, the mean baseline PASI score was 18.9 and the baseline PGA score ranged from “moderate” (53 % of subjects included) to “severe” (41 %) to “very severe” (6 %).
Slovenian: V vseh terapevtskih skupinah je bila povprečna izhodiščna ocena PASI 18,9, izhodiščna ocena PGA pa je segala od "zmerne" (53 % vključenih preiskovancev) do "hude" (41 %) in "zelo hude" (6 %).
English: MTX N=110 n (%)
Slovenian: MTX N = 110
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, 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: Contact your doctor if symptoms such as persistent unexplained rash, fever, joint pain or tiredness occur.
Slovenian: Obvestite zdravnika, če se pojavijo simptomi, kot so vztrajen nepojasnjen izpuščaj, zvišana telesna temperatura, bolečine v sklepih ali utrujenost.
English: - If your child gets any side effects, talk to your child's doctor or pharmacist.
Slovenian: - Če vaš otrok opazi kateri koli neželeni učinek, se posvetujte z otrokovim zdravnikom ali farmacevtom.
English: Table 8 ACR Responses in RA Study V (Percent of Patients)
Slovenian: Odzivi ACR v študiji revmatoidnega artritisa V (odstotek bolnikov)
English: Your child's doctor may also prescribe an initial dose of 40 mg which may be administered one week prior to the start of the usual dose.
Slovenian: Zdravnik vašega otroka lahko predpiše začetni odmerek 40 mg, ki se ga lahko uporabi en teden pred začetkom zdravljenja z običajnim odmerkom.
English: Table 23 Induction of Clinical Remission and Response (Percent of Patients)
Slovenian: Indukcija klinične remisije in odziva (odstotek bolnikov)
English: Imraldi 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 Imraldi uporabljati previdno.
English: • arm or leg weakness;
Slovenian: • šibkost rok ali nog;
English: The recommended Imraldi dose is 80 mg at week 0 followed by 40 mg every other week starting at week 1 via subcutaneous injection.
Slovenian: Priporočeni odmerek zdravila Imraldi je 80 mg v 0. tednu, ki mu sledi 40 mg vsak drugi teden z začetkom v 1. tednu, v obliki subkutane injekcije.
English: If these medicines do not work well enough, you will be given Imraldi to reduce the signs and symptoms of your disease.
Slovenian: Če ta zdravila ne bodo delovala dovolj dobro, boste dobili zdravilo Imraldi za zmanjšanje znakov in simptomov vaše bolezni.
English: RA studies III and V had an additional primary endpoint at 52 weeks of retardation of disease progression (as detected by X-ray results).
Slovenian: 52 tednih upočasnitev napredovanja bolezni (ugotovljena z izvidi rentgenskega slikanja).
English: • paediatric plaque psoriasis,
Slovenian: • luskavice (psoriaze),
English: Room spinning sensation (vertigo) and vision disturbances may occur after taking Imraldi.
Slovenian: Po dajanju zdravila Imraldi se lahko pojavita vrtoglavica (vertigo) in poslabšanje vida.
English: In controlled trials of adalimumab (initial doses of 160 mg at week 0 and 80 mg at week 2, followed by 40 mg every week starting at week 4), in patients with hidradenitis suppurativa with a control period duration ranging from 12 to 16 weeks, ALT elevations ≥3 × ULN occurred in 0.3 % of adalimumabtreated patients and 0.6 % of control-treated patients.
Slovenian: V kontroliranih preskušanjih z adalimumabom (v začetnem odmerku 160 mg, ki mu sledi odmerek 80 mg v 2. tednu in potem 40 mg vsak teden z začetkom v 4. tednu) pri bolnikih s hidradenitis suppurativa in s trajanjem kontrolnega obdobja od 12 do 16 tednov se je zvišanje ALT ≥ 3 × ULN
English: Imraldi Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis Patient Weight
Slovenian: Odmerjanje zdravila Imraldi pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom
English: Table 12 Paed ACR 30 Responses in the JIA study
Slovenian: Odzivi Paed ACR 30 v študiji pri juvenilnem idiopatskem artritisu Stratum
English: Vertigo and visual impairment may occur following administration of Imraldi (see section 4.8).
Slovenian: Po dajanju zdravila Imraldi se lahko pojavita vrtoglavica in poslabšanje vida (glejte poglavje 4.8).
English: Low Dose 20/10 mg eow N=95
Slovenian: Majhni odmerek 20/10 mg vsak drugi teden N = 95
English: • inflammation of the eyelid and eye swelling;
Slovenian: • vnetje veke in otekanje oči;
English: Tachycardia Uncommon Myocardial infarction1),
Slovenian: pogosti tahikardija občasni miokardni infarkt aritmija,
English: A 40 mg pre-filled syringe and pre-filled pen are available for patients to administer a full 40 mg dose.
Slovenian: Za bolnike sta na voljo 40 mg napolnjena injekcijska brizga in napolnjen injekcijski peresnik za apliciranje polnega 40 mg odmerka.
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 Imraldi.
Slovenian: Pred zdravljenjem z zdravilom Imraldi 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: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥10% BSA involvement and Psoriasis Area and Severity Index (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 indeksom obsežnosti in izrazitosti psoriaze (PASI - Psoriasis Area and Severity Index) ≥ 12 ali ≥ 10), ki so bili kandidati za sistemsko zdravljenje ali fototerapijo.
English: • chest pain;
Slovenian: • edem obraza;
English: • Hold the vial with the vial stopper facing up.
Slovenian: • Držite vialo tako, da je zamašek viale obrnjen navzgor.
English: CD study I and CD study II induction of remission and response rates are presented in Table 22.
Slovenian: Indukcijo remisije in deleže odziva v študiji pri Crohnovi bolezni I in študiji pri Crohnovi bolezni II prikazuje preglednica 22.
English: In controlled Phase 3 trials of adalimumab in patients with Crohn's disease and ulcerative colitis with a control period ranging from 4 to 52 weeks.
Slovenian: V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih s Crohnovo boleznijo in ulceroznim kolitisom s kontrolnim obdobjem od 4 do 52 tednov se je zvišanje ALT ≥ 3 × ULN pojavilo pri 0,9 %
English: Children and adolescents from 6 to 17 years of age weighing 40 kg or more:
Slovenian: Otroci in mladostniki, stari od 6 do 17 let, ki tehtajo 40 kg ali več:
English: Adalimumab has not been studied in these patient populations.
Slovenian: Zdravilo adalimumaba pri teh populacijah bolnikov še ni bila preskušena, zato priporočil za odmerjanje ni mogoče dati.