FrancophonIA/ELRC3.0 huggingface dataset:
English: ● Do not grasp the plunger rod.
Slovenian: ● Ne prijemajte bata brizge.
English: 2 Immunosuppressant therapy could only be discontinued at or after week 26 at the investigator's discretion if the subject met the clinical response criterion
Slovenian: 1p vrednost za primerjavo standardnega odmerka proti majhnemu odmerku 2Zdravljenje z imunosupresivi je bilo lahko prekinjeno v 26. tednu ali po njem po raziskovalčevi diskreciji, če je bolnik izpolnjeval kriterije kliničnega odziva 3definiran kot zaprtje vseh fistul, ki so bile prisotne ob začetku študije na vsaj 2 zaporednih obiskih po začetku
English: Discontinuation of AMGEVITA 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 AMGEVITA.
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 x ULN occurred in 1.8% of adalimumabtreated 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 x ULN pojavilo pri 1,8 % bolnikov, zdravljenih z adalimumabom, in pri 1,8 % bolnikov v kontrolni skupini.
English: AMGEVITA is a biosimilar medicinal product.
Slovenian: Zdravilo AMGEVITA je biološko podobno zdravilo.
English: • abnormal muscle breakdown;
Slovenian: • razpad trebušnih mišic;
English: Finger flange
Slovenian: Oprijemalo za prste
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 uvajalni odmerek 80 mg adalimumaba v 0. tednu, ki mu je sledil odmerek 40 mg adalimumaba vsak drugi teden z začetkom v 1. tednu, povzročil srednjo koncentracijo v stanju dinamičnega ravnovesja približno 8 do 10 µg/ml.
English: Muscle spasms (including blood creatine phosphokinase increased)
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva zelo pogosti mišičnoskeletne bolečine pogosti mišični spazmi (vključno s povišano kreatin fosfokinazo v krvi)
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 160 mg adalimumaba 0. teden, ki mu je sledil odmerek 80 mg 2. teden, ali na 80 mg adalimumaba 0. teden, ki mu je sledil odmerek 40 mg 2. teden.
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 g/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: There have been very rare cases of certain kinds of cancer in children and adult patients taking adalimumab or other TNF blockers.
Slovenian: • Med bolniki (otroci in odraslimi), ki so jemali adalimumab ali druge zaviralce TNF, so se pojavili zelo redki primeri določenih vrst raka.
English: Adalimumab 40 mg every other week N = 70
Slovenian: adalimumab 40 mg vsak drugi teden N = 70
English: AMGEVITA is used to treat psoriatic arthritis in adults.
Slovenian: Zdravilo AMGEVITA se uporablja za zdravljenje psoriatičnega artritisa pri odraslih.
English: 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 protiteles proti jedrnim antigenom 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: 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, lahko zdravnik predpiše začetni odmerek 80 mg (kot dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg dva tedna kasneje.
English: AMGEVITA 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: When AMGEVITA therapy is initiated, a loading dose of 40 mg for patients < 30 kg or 80 mg for patients ≥ 30 kg may be administered one week prior to the start of maintenance therapy.
Slovenian: 40 mg vsak drugi teden v kombinaciji z metotreksatom Na začetku zdravljenja z zdravilom AMGEVITA se lahko pri bolnikih < 30 kg uporabi polnilni odmerek 40 mg in pri bolnikih ≥ 30 kg polnilni odmerek 80 mg en teden pred začetkom vzdrževalnega zdravljenja.
English: AMGEVITA 40 mg solution for injection in pre-filled syringe 0.8 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a stainless steel needle with a needle shield (thermoplastic elastomer).
Slovenian: AMGEVITA 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi 0,8 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z batno zaporko (bromobutilni kavčuk) in z iglo iz nerjavečega jekla z varovalnim pokrovčkom (termoplastični elastomer).
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 trdovraten nepojasnjen izpuščaj, zvišana telesna temperatura, bolečine v sklepih ali utrujenost.
English: 2 pre-filled syringes.
Slovenian: 2 napolnjeni injekcijski brizgi.
English: No malignancies were observed in 77 paediatric patients with an exposure of 80.0 patient-years during an adalimumab trial in paediatric patients with chronic plaque psoriasis.
Slovenian: Pri 77 pediatričnih bolnikih v preskušanju adalimumaba pri pediatričnih bolnikih s kronično psoriazo v plakih z izpostavljenostjo 80,0 bolnikov-let niso opazili malignomov.
English: AMGEVITA 20 mg solution for injection in pre-filled syringe 0.4 mL solution in pre-filled syringe (type I glass) with a plunger stopper (bromobutyl rubber) and a stainless steel needle with a needle shield (thermoplastic elastomer).
Slovenian: AMGEVITA 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi 0,4 ml raztopine v napolnjeni injekcijski brizgi (steklo tipa I) z batno zaporko (bromobutilni kavčuk) in z iglo iz nerjavečega jekla z varovalnim pokrovčkom (termoplastični elastomer).
English: AMGEVITA is used to treat ulcerative colitis in adults.
Slovenian: Zdravilo AMGEVITA se uporablja za zdravljenje ulceroznega kolitisa pri odraslih.
English: Ps study I (REVEAL) - efficacy results at 16 weeks
Slovenian: Študija pri psoriazi I (REVEAL) - Rezultati učinkovitosti po 16 tednih placebo N = 398
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 AMGEVITA is 20 mg every other week.
Slovenian: Otroci, mladostniki in odrasli z artritisom, povezanim z entezitisom Otroci in mladostniki, starejši od 6 let, ki tehtajo od 15 kg do manj kot 30 kg Priporočeni odmerek zdravila AMGEVITA je 20 mg vsak drugi teden.
English: ● Do not put the yellow cap back onto the pre-filled pen.
Slovenian: ● Ne nameščajte rumenega pokrovčka igle nazaj na napolnjen injekcijski peresnik.
English: Patients who were in the non-MTX stratum were either naïve to or had been withdrawn fromMTX at least two weeks prior to study drug administration.
Slovenian: Bolniki v stratumu brez metotreksata le-tega sploh še niso dobivali ali so ga nehali dobivati vsaj dva tedna pred uporabo raziskovanega zdravila.
English: Hypokalaemia, Uric acid increased, Blood sodium abnormal, Hypocalcaemia, Hyperglycaemia, Hypophosphatemia, Dehydration
Slovenian: Presnovne in prehranske motnje zelo pogosti zvišanje lipidov pogosti hipokalemija, hiperurikemija, nenormalni nivo natrija v krvi, hipokalcemija, hiperglikemija, hipofosfotemija, dehidracija
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: AMGEVITA is used to treat moderate to severe plaque psoriasis in adults.
Slovenian: Zdravilo AMGEVITA se uporablja za zdravljenje zmerne do hude luskavice (psoriaze) v plakih pri odraslih.
English: ● Do not remove the yellow cap from the pre-filled pen until you are ready to inject.
Slovenian: ● Ne odstranjujte rumenega pokrovčka igle z napolnjenega injekcijskega peresnika, dokler niste pripravljeni za injiciranje.
English: AMGEVITA 40 mg solution for injection in pre-filled pen 0.8 mL solution for injection in pre-filled pen for patient use containing a pre-filled syringe (type I glass).
Slovenian: Zdravilo AMGEVITA 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku 0,8 ml raztopine v napolnjenem injekcijskem peresniku za uporabo pri bolnikih, ki vsebuje napolnjeno injekcijsko brizgo (steklo tipa I).
English: Sodium hydroxide (for pH adjustment)
Slovenian: Ledocet saharoza polisorbat 80 natrijev hidroksid (za prilagoditev pH) voda za injekcije
English: Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs, or analgesics can be continued during treatment with AMGEVITA.
Slovenian: Med zdravljenjem z zdravilom AMGEVITA je mogoče nadaljevati z uporabo glukokortikoidov, salicilatov, nesteroidnih protivnetnih zdravil ali analgetikov.
English: Adalimumab 40 mg weekly N = 70
Slovenian: adalimumab 40 mg vsak teden N = 70
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/m2 telesne površine (in do največ 20 mg) vsak drugi teden kot enkraten odmerek v subkutani injekciji.
English: B. Inspect the AMGEVITA pre-filled pen.
Slovenian: B. Preglejte napolnjeno injekcijsko brizgo zdravila AMGEVITA.
English: AMGEVITA is indicated for treatment of moderately to severely active Crohn's disease, in adult patients who have not responded despite a full and adequate course of therapy with a corticosteroid and/or an immunosuppressant; or who are intolerant to or have medical contraindications for such therapies.
Slovenian: Zdravilo AMGEVITA je indicirano za zdravljenje zmerne do hude aktivne Crohnove bolezni pri odraslih bolnikih, ki se ne odzovejo na popoln in ustrezen ciklus zdravljenja s kortikosteroidom in/ali imunosupresivom, ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
English: The recommended dose of AMGEVITA for paediatric patients with uveitis from 2 years of age is based on body weight (table 5).
Slovenian: Priporočeni odmerek zdravila AMGEVITA pri pediatričnih bolnikih z uveitisom, starih 2 leti ali več, temelji na telesni masi (preglednica 5).
English: Adalimumab treated patients showed statistically significant improvements at week 26 compared with placebo in the DLQI.
Slovenian: Pri bolnikih, zdravljenih z adalimumabom, je prišlo do statistično značilnega izboljšanja dermatološkega indeksa kakovosti življenja (DLQI) po 26 tednih v primerjavi z placebom.
English: A single AMGEVITA pre-filled syringe may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Slovenian: Posamezno napolnjeno injekcijsko brizgo zdravila AMGEVITA lahko shranite pri temperaturi do največ 25 °C za obdobje do 14 dni.
English: 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: AMGEVITA is a clear and colourless to slightly yellow solution.
Slovenian: Zdravilo AMGEVITA je bistra in brezbarvna do rahlo rumena raztopina.
English: The recommended dose of AMGEVITA for patients with enthesitis-related arthritis from 6 years of age is based on body weight (table 2).
Slovenian: Priporočeni odmerek zdravila AMGEVITA pri bolnikih z artritisom, povezanim z entezitison, starih 6 let in več, temelji na telesni masi (preglednica 2).
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 adalimubaba v serumu pred naslednjim odmerkom približno 7 do 8 µg/ml v 2. tednu in v 4. tednu.
English: AMGEVITA is administered by subcutaneous injection.
Slovenian: Zdravilo AMGEVITA se uporablja kot subkutana injekcija.
English: There have been cases of cancers, other than lymphoma in patients with a specific type of lung disease called Chronic Obstructive Pulmonary Disease (COPD) treated with another TNF blocker.
Slovenian: • Pri bolnikih s posebno boleznijo pljuč, t.i. kronično obstruktivno pljučno boleznijo (KOPB), zdravljenih z nekim drugim zaviralcem TNF, so bili primeri rakov, ki niso bili limfomi.
English: ● Do not shake the syringe.
Slovenian: ● Ne stresajte brizge.
English: 4 SureClick pre-filled pens.
Slovenian: 4 napolnjeni injekcijski peresniki SureClick.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL PRE-FILLED PEN
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH NALEPKA ZA NAPOLNJEN INJEKCIJSKI PERESNIK
English: Myocardial infarction1), Arrhythmia, Congestive heart failure
Slovenian: pogosti tahikardija občasni miokardni infarkt aritmija, kongestivno srčno popuščanje redki zastoj srca
English: In controlled phase 3 trials of adalimumab in patients with rheumatoid arthritis and psoriatic arthritis with a control period duration ranging from 4 to 104 weeks, ALT elevations ≥ 3 x ULN occurred in 3.7% of adalimumab-treated patients and 1.6% of control-treated patients.
Slovenian: V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih z revmatoidnim artritisom in psoriatičnim artritisom s trajanjem kontrolnega obdobja od 4 do 104 tedne, so se zvišanja ALT ≥ 3 x ULN (Upper Limits of Normal - zgornja normalna meja) pojavila pri 3,7 % bolnikov, zdravljenih z adalimumabom, in pri 1,6 % bolnikov v kontrolni skupini.
English: Vertigo and visual impairment may occur following administration of AMGEVITA (see section 4.8).
Slovenian: Po dajanju zdravila AMGEVITA se lahko pojavita vrtoglavica in poslabšanje vida (glejte poglavje 4.8).
English: 1 SureClick pre-filled pen.
Slovenian: 1 napolnjen injekcijski peresnik SureClick.
English: P Value b
Slovenian: Vrednost p
English: 2 SureClick pre-filled pens.
Slovenian: 2 napolnjena injekcijska peresnika SureClick.
English: Placebo N = 162
Slovenian: Odziv placebo n = 162
English: - Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before you are given AMGEVITA and during treatment with AMGEVITA.
Slovenian: Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete zdravilo AMGEVITA in med zdravljenjem z zdravilom AMGEVITA.
English: • Polyarticular juvenile idiopathic arthritis
Slovenian: • poliartikularnega juvenilnega idiopatskega artritisa
English: Aortic aneurysm, Vascular arterial occlusion, Thrombophlebitis
Slovenian: Žilne bolezni pogosti hipertenzija, zardevanje, hematom občasni aortna anevrizma, zapora arterijskega žilja, tromboflebitis
English: Marketing Authorisation Holder and Manufacturer Amgen Europe B.V.
Slovenian: Imetnik dovoljenja za promet in izdelovalec Amgen Europe B.V.
English: AMGEVITA 20 mg solution for injection in pre-filled syringe AMGEVITA 40 mg solution for injection in pre-filled syringe Solution for injection (injection).
Slovenian: AMGEVITA 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi AMGEVITA 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi raztopina za injiciranje (injekcija).
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: The recommended AMGEVITA 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 AMGEVITA je 80 mg v 0. tednu, ki mu sledi 40 mg vsak drugi teden z začetkom v 1. tednu, v obliki subkutane injekcije.
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 AMGEVITA.
Slovenian: Pred zdravljenjem z zdravilom AMGEVITA 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: ASASa Partial Remission
Slovenian: a delno izboljšanje ASDAS
English: ● Cotton ball or gauze pad
Slovenian: ● Kosem vate ali zloženec iz gaze
English: Week 2 Week 12 Week 24 BASDAIb 50
Slovenian: 2. teden 12. teden 24. teden ASAS 50
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 v primerjavi s 5 % bolnikov, ki so še naprej dobivali adalimumab (p < 0,001).
English: No malignancies were observed in 249 paediatric patients with an exposure of 655.6 patient-years during adalimumab trials in patients with juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis).
Slovenian: Pri 249 pediatričnih bolnikih z juvenilnim idiopatskim artritisom (s poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), ki so bili med preskušanji adalimumaba zdravilu izpostavljeni 655,6 bolnikov-let, niso ugotovili nobenega malignoma.
English: Adalimumabb / MTXc n = 63
Slovenian: adalimumab b/ MTXc n = 63
English: Adalimumab 40 mg eow N = 814 n (%)
Slovenian: adalimumab 40 mg vsak 2. teden N = 814 n (%)
English: Following the administration of 24 mg/m2 (up to a maximum of 40 mg) subcutaneously every other week to patients with polyarticular juvenile idiopathic arthritis (JIA) who were 4 to 17 years the mean trough steady-state (values measured from week 20 to 48) serum adalimumab concentration was 5.6 ± 5.6 μg/mL (102% CV) for adalimumab without concomitant methotrexate and 10.9 ± 5.2 μg/mL (47.7% CV) with concomitant methotrexate.
Slovenian: (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: AMGEVITA 20 mg solution for injection in pre-filled syringe AMGEVITA 40 mg solution for injection in pre-filled syringe adalimumab
Slovenian: AMGEVITA 20 mg raztopina za injiciranje v napolnjeni injekcijski brizgi AMGEVITA 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi adalimumab
English: AMGEVITA single use SureClick pre-filled pen For subcutaneous use
Slovenian: AMGEVITA napolnjen injekcijski peresnik SureClick za enkratno uporabo Za subkutano uporabo.
English: • Enthesitis-related arthritis
Slovenian: • artritisa, povezanega z entezitisom
English: Children, adolescents and adults from 6 years of age weighing 30 kg or more The recommended dose of AMGEVITA is 40 mg every other week.
Slovenian: Otroci in mladostniki, starejši od 6 let, ki tehtajo 30 kg ali več Priporočeni odmerek zdravila AMGEVITA je 40 mg vsak drugi teden.
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 AMGEVITA should be considered prior to initiating therapy (see Other opportunistic infections).
Slovenian: Pred začetkom zdravljenja je treba tveganja in koristi zdravljenja z zdravilom AMGEVITA 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 Oportunistične okužbe).
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias
Slovenian: Vsem bolnikom je treba naročiti, naj nemudoma poiščejo zdravniško pomoč, če se jim med uporabo zdravila AMGEVITA pojavijo znaki ali simptomi krvnih diskrazij (npr. trajno zvišana telesna temperatura, podplutbe, krvavitve, bledica).
English: Beyond 16 weeks, patients with inadequate response to AMGEVITA 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 AMGEVITA 40 mg vsak drugi teden koristi povečanje odmerka na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: In adolescent patients with inadequate response to AMGEVITA 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 AMGEVITA 40 mg vsak drugi teden je možno razmisliti o povečanju odmerka na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: Adalimumab 40 mg eow N = 108 n (%)
Slovenian: adalimumab 40 mg vsak 2. teden N = 108 n (%)
English: AMGEVITA is contraindicated in moderate to severe heart failure (see section 4.3).
Slovenian: Pri bolnikih z zmernim ali hudim srčnim popuščanjem je zdravilo AMGEVITA kontraindicirano (glejte poglavje 4.3).
English: AMGEVITA contains the active substance adalimumab.
Slovenian: Zdravilo AMGEVITA vsebuje zdravilno učinkovino adalimumab.
English: AMGEVITA 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 AMGEVITA uporabljati previdno.
English: Yellow cap on
Slovenian: Snet rumeni pokrovček
English: Always hold the syringe by the syringe barrel.
Slovenian: Napolnjeno injekcijsko brizgo vedno držite za valj brizge.