FrancophonIA/ELRC3.0 huggingface dataset:
English: SPARCC MRI Spined,j a Assessment of SpondyloArthritis international Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n = 91 placebo and n = 87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n = 73 placebo and n = 70 adalimumab h Spondyloarthritis Research Consortium of Canada i n = 84 placebo and adalimumab j n = 82 placebo and n = 85 adalimumab ***, **, * Statistically significant at p < 0.001, < 0.01, and < 0.05, respectively, for all comparisons between adalimumab and placebo
Slovenian: SPARCC MRI hrbtenjačed,j a ASAS = ocena v spondiloartritičnem mednarodnem združenju (Assessments in Spondyloarthritis International Society) b BASDAI = Bathov indeks bolezenske aktivnosti ankilozirajočega spondilitisa (Bath Ankylosing Spondylitis Disease Activity Index) c ASDAS = ocena bolezenske aktivnosti ankilozirajočega spondilitisa (Ankylosing Spondylitis Disease Activity Score) d povprečna sprememba od začetka zdravljenja e n=91 placebo in n=87 adalimumab f hs-CRP = C-reaktivni protein z veliko občutljivostjo (high sensitivity C-Reactive Protein) (mg/l) g n=73 placebo in n=70 adalimumab h SPARCC = Kanadski raziskovalni konzorcij za spondiloartritis (Spondyloarthritis Research Consortium of Canada) i n=84 placebo in adalimumab j n=82 placebo in n=85 adalimumab ***, **, * Statistično pomembno pri p < 0,001, < 0,01 in < 0,05, v tem zaporedju, za vse primerjave med adalimumabom in placebom.
English: AMGEVITA is used to treat hidradenitis suppurativa in adults and adolescents from 12 years of age.
Slovenian: Zdravilo AMGEVITA se uporablja za zdravljenje hidradenitis suppurativa pri odraslih in mladostnikih, starejših od 12 let.
English: During treatment with AMGEVITA, other concomitant therapies (e.g. corticosteroids and/or immunomodulatory agents) should be optimised.
Slovenian: Med zdravljenjem z zdravilom AMGEVITA je treba optimizirati druge sočasne terapije (npr. kortikosteroide in/ali imunomodulacijska zdravila).
English: Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-antagonists (initiation of therapy ≤ 18 years of age), including adalimumab in the post-marketing setting.
Slovenian: Med obdobjem trženja so bili opisani malignomi (nekateri s smrtnim izidom) pri otrocih, mladostnikih in mladih odraslih (starih do 22 let), ki so dobivali antagoniste TNF, vključno z adalimumabom (začetek zdravljenja v starosti ≤ 18 let).
English: How to store AMGEVITA Contents of the pack and other information
Slovenian: Shranjevanje zdravila AMGEVITA Vsebina pakiranja in dodatne informacije
English: All patients received a 2 week standardised dose of prednisone 60 mg/day at study entry followed by a mandatory taper schedule, with complete corticosteroid discontinuation by week 15.
Slovenian: Vsi bolniki so ob začetku študije prejeli 2-tedenski standardizirani odmerek prednizolona 60 mg/dan, čemur je sledil obvezen program postopnega zmanjševanja, s popolno ukinitvijo kortikosteroidov do 15. tedna.
English: Antibiotics may be continued during treatment with AMGEVITA if necessary.
Slovenian: Med zdravljenjem z zdravilom AMGEVITA lahko nadaljujete z antibiotičnim zdravljenjem, če je potrebno.
English: Efficacy Outcomes
Slovenian: Rezultati učinkovitosti
English: ● Do not try to warm the pre-filled pen by using a heat source such as hot water or microwave.
Slovenian: ● Ne poskušajte ogrevati napolnjenega injekcijskega peresnika z virom toplote, kot na primer z vročo vodo ali v mikrovalovni pečici.
English: ● Do not use the syringe if: - The medicine is cloudy or discoloured or contains flakes, or particles.
Slovenian: ● Ne uporabite brizge, če: - Je zdravilo motno ali obarvano ali vsebuje kosmiče ali delce.
English: Response, remission and mucosal healing in study UC-II (percent of patients)
Slovenian: Odziv, remisija in celjenje sluznice v študiji UC-II (odstotek bolnikov)
English: Clinical remission (defined as Mayo score ≤ 2 with no subscore > 1) was assessed at week
Slovenian: Klinično remisijo (opredeljeno kot ocena Mayo ≤ 2 in nobena podocena > 1) so ocenili 8. teden.
English: Proportion of patientsa achieving HiSCRb at weeks 24 and 36 after treatment reassignment from weekly adalimumab at week 12
Slovenian: Delež bolnikova, ki so dosegli klinični odziv (HiSCR)b v 24. in 36. tednu po spremembi zdravljenja na jemanje adalimumaba vsak teden v 12. tednu
English: Improvement in health-related quality of life and physical function was maintained during the open-label extension through week 156.
Slovenian: Izboljšanje z zdravjem povezane kakovosti življenja in telesne funkcije se je pri podaljšanih študijah brez placeba ohranjalo do 156. tedna.
English: With the needle cap off, insert the syringe into your skin at 45 to 90 degrees.
Slovenian: Brizgo, ki ste ji odstranili pokrovček z igle, zabodite z iglo v kožo pod kotom 45 do 90 stopinj.
English: Adalimumab-treated patients had significantly greater improvement at week 12 which was maintained through week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Slovenian: Bolniki, ki so dobivali adalimumab, so imeli po 12 tednih značilno večje izboljšanje (ki se je ohranilo do 24. tedna) SF36 in ASQoL (Vprašalnik o kakovosti življenja pri ankilozirajočem spondilitisuAnkylosing Spondylitis Quality of Life Questionnaire).
English: These infections have not consistently been recognised in patients taking TNFantagonists and this has resulted in delays in appropriate treatment, sometimes resulting in fatal outcomes.
Slovenian: Takšne okužbe se pri uporabnikih antagonistov TNF niso pojavljale vedno, zato je v primerih njihovega nastanka prihajalo do zamud pri ustreznem zdravljenju, kar je včasih povzročilo smrt.
English: AMGEVITA can also be used to treat severe, active and progressive rheumatoid arthritis without previous methotrexate treatment.
Slovenian: Zdravilo AMGEVITA je mogoče uporabljati tudi za zdravljenje hudega, aktivnega in napredujočega revmatoidnega artritisa brez predhodnega zdravljenja z metotreksatom.
English: Results from both studies demonstrated statistically significant reduction of the risk of treatment failure in patients treated with adalimumab versus patients receiving placebo (see table 29).
Slovenian: Rezultati iz obeh študij kažejo statistično značilno zmanjšanje tveganja za neuspeh zdravljenja pri bolnikih, ki so prejemali adalimumab, v primerjavi z bolniki, ki so prejemali placebo (glejte preglednico 29).
English: Improvement in number of active joints with arthritis was maintained during the OL period through week 156 for the 26 of 31 (84%) patients in the adalimumab group who remained in the study.
Slovenian: Izboljšanje v številu aktivnih sklepov z artritisom se je ohranilo v obdobju odprtega preskušanja po 156. tednu pri 26 od 31 (84 %) bolnikov, ki so prejemali adalimumab in so ostali v študiji.
English: If you take AMGEVITA the risk of getting lymphoma, leukaemia, or other cancers may increase.
Slovenian: Če uporabljate zdravilo AMGEVITA, se vam lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
English: - The expiration date printed on the label has passed.
Slovenian: - je že pretekel datum roka izteka uporabnosti, ki je naveden na nalepki.
English: Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0% versus 11.4%, respectively) and draining fistulas (30.0% versus 13.9%, respectively).
Slovenian: Približno dvakratni delež bolnikov v skupini, ki je prejemala placebo, je v primerjevi s tistimi, ki so bili v skupini z adalimumabom, je v prvih 12. tednih študije HS-I in HS-II, doživelo poslabšanje abscesov (23,0 % v primerjavi z 11,4 %, v tem zaporedju) in fistul z izcedkom (30,0 % v primerjavi s 13,9 %, v tem zaporedju).
English: Number of patients at baseline n (%)
Slovenian: Izhodiščno število bolnikov n (%)
English: Neither carcinogenicity studies, nor a standard assessment of fertility and postnatal toxicity, were performed with adalimumab due to the lack of appropriate models for an antibody with limited cross-reactivity to rodent TNF and to the development of neutralising antibodies in rodents.
Slovenian: Z adalimumabom niso bile narejene niti raziskave kancerogenosti, niti standardne ocene plodnosti ter poporodne toksičnosti, in sicer zato, ker ni ustreznih modelov za protitelo z omejeno navzkrižno reaktivnostjo z glodalskim TNF, in zaradi nastanka nevtralizirajočih protiteles pri glodalcih.
English: Patients induced with 160/80 mg adalimumab achieved clinical remission versus placebo at week 8 in statistically significantly greater percentages in study UC-I (18% versus 9% respectively, p = 0.031) and study UC-II (17% versus 9% respectively, p = 0.019).
Slovenian: Bolniki, ki so za indukcijo dobili 160/80 mg adalimumaba, so 8. teden v primerjavi s placebom dosegli klinično remisijo v statistično značilno večjem odstotku tako v študiji UC-I (18 % v primerjavi z 9 %, p = 0,031) kot v študiji UC-II (17 % v primerjavi z 9 %, p = 0,019).
English: AMGEVITA should only be used during pregnancy if clearly needed.
Slovenian: Zdravilo AMGEVITA se med nosečnostjo lahko uporablja samo, če je brez dvoma potrebno.
English: ASDAS Inactive Disease hs-CRPd,f,g
Slovenian: ASDAS neaktivna bolezen hs-CRP
English: No clinical data are available on the use of a AMGEVITA loading dose in children < 6 years of age (see section 5.2).
Slovenian: Klinični podatki o uporabi polnilnega odmerka zdravila AMGEVITA pri otrocih, mlajših od 6 let, niso na voljo (glejte poglavje 5.2).
English: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last AMGEVITA treatment.
Slovenian: Ženske v rodni dobi morajo premisliti o uporabi ustrezne kontracepcijske zaščite za preprečitev nosečnosti in z njo nadaljevati vsaj še pet mesecev po zadnjem zdravljenju z zdravilom AMGEVITA.
English: For a more comfortable injection, leave the syringe at room temperature for 15 to 30 minutes before injecting.
Slovenian: Da bo injiciranje bolj udobno, pustite brizgo za 15 do 30 minut na sobni temperaturi, preden začnete z injiciranjem.
English: L. Examine the injection site.
Slovenian: L. Preglejte mesto injiciranja.
English: ● Do not reuse the used syringe.
Slovenian: ● Uporabljene brizge ne uporabite ponovno.
English: At week 4, subjects were randomised 1:1 based on their body weight at the time to either the low dose or standard dose maintenance regimens as shown in table 25.
Slovenian: V 4.tednu so bili bolniki glede na njihovo telesno maso v tem času randomizirani v razmerju 1:1 bodisi v vzdrževalni režim z majhnim odmerkom ali vzdrževalni režim s standardnim odmerkom, kot kaže preglednica 25.
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: Med tistimi, ki so se odzvali (Pediatric ACR 30) 24. teden (n = 27 od 30 bolnikov), se je odziv Pediatric ACR 30 v odprti podaljšani fazi ohranil do 60 tednov pri bolnikih, ki so med tem celotnim obdobjem prejemali adalimumab.
English: Reduction of inflammatory lesions and prevention of worsening of abscesses and draining fistulas was assessed using Hidradenitis Suppurativa clinical response (HiSCR; at least a 50% reduction in total abscess and inflammatory nodule count with no increase in abscess count and no increase in draining fistula count relative to Baseline).
Slovenian: Zmanjšanje inflamatornih lezij in preprečevanje poslabšanja abscesov in fistul z izcedkom so ocenili z rezultatom kliničnega odziva pri hidradenitis suppurativa (HiSCR - Hidradenitis Suppurativa Clinical Response); najmanj 50 % zmanjšanje skupnega števila abscesov in inflamatornih nodulov brez povečanja števila abscesov in fistul z izcedkom glede na izhodiščno število.
English: Improved physical function continued during the open-label extension up to week 136.
Slovenian: Izboljšanje telesnega delovanja je trajalo še med odprto nadaljevalno študijo do 136. tedna.
English: In the post-marketing setting, cases of leukaemia have been reported in patients treated with a TNF-antagonist.
Slovenian: Med obdobjem trženja so bili opisani primeri levkemije pri bolnikih, zdravljenih z antagonistom TNF.
English: ● Do not touch this area again before injecting.
Slovenian: ● Tega predela se pred injiciranjem ne dotikajte več.
English: Standard dose
Slovenian: Standarden odmerek
English: If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting AMGEVITA.
Slovenian: • Če imate kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo zdravila AMGEVITA posvetujte s svojim zdravnikom.
English: Advise your doctor if you reside or travel in regions where fungal infections such as histoplasmosis coccidioidomycosis or blastomycosis are endemic.
Slovenian: • Zdravniku morate povedati, če živite na območju ali potujete v predele, kjer so endemične glivične okužbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
English: ● It is important that you do not try to give the injection unless you or your caregiver has received training.
Slovenian: ● Pomembno je, da vi ali oseba, ki za vas skrbi, zdravila ne poskušate injicirati sami, dokler vas ali osebo, ki za vas skrbi, tega ne nauči zdravstveni delavec.
English: After proper training in injection technique, patients may self-inject with AMGEVITA if their physician determines that it is appropriate and with medical follow-up as necessary.
Slovenian: Bolniki, ki se naučijo pravilnega postopka injiciranja, si zdravilo AMGEVITA lahko injicirajo sami, če zdravnik presodi, da je to primerno, in je zagotovljeno ustrezno medicinsko spremljanje.
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with AMGEVITA.
Slovenian: Bolnike je zato treba pred, med in po zdravljenju z zdravilom AMGEVITA natančno kontrolirati glede okužb, vključno s tuberkulozo.
English: If you do not respond well enough to these medicines, you will be given AMGEVITA to treat your polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Slovenian: Če se na ta zdravila ne odzovete dovolj dobro, boste za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa ali artritisa, povezanega z entezitisom, dobili zdravilo AMGEVITA.
English: AMGEVITA is used to treat
Slovenian: Zdravilo AMGEVITA se uporablja za zdravljenje
English: ● Sharps disposal container
Slovenian: ● Vsebnik za odlaganje ostrih odpadkov
English: • signs and symptoms suggestive of blood disorders such as persistent fever, bruising, bleeding,
Slovenian: • znaki in simptomi, ki nakazujejo bolezni krvi, npr. dolgotrajno zvišana telesna temperatura,
English: When combining controlled portions of these trials and ongoing and completed open-label extension studies of adalimumab, with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and non-melanoma skin cancers is approximately 8.5 per 1,000 patient-years.
Slovenian: Če vzamemo skupaj kontrolirane dele teh preskušanj in potekajoče in zaključene nadaljevalne študije z adalimumabom z medianim trajanjem približno 3,3 leta s 6427 bolniki in prek 26439 bolnikov-let zdravljenja, je ugotovljeni delež malignomov (razen limfoma in nemelanomskih kožnih rakov) približno 8,5 na 1000 bolnikov-let.
English: AMGEVITA may have a minor influence on the ability to drive and use machines.
Slovenian: Zdravilo AMGEVITA ima lahko blag vpliv na sposobnost vožnje in upravljanja s stroji.
English: The safety and efficacy of adalimumab were assessed in over 1,500 patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index (CDAI) ≥ 220 and ≤ 450) in randomised, double-blind, placebo-controlled studies.
Slovenian: Varnost in učinkovitost adalimumaba so ocenili pri več kot 1500 bolnikih z zmerno do hudo aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 in ≤ 450) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
English: If you experience allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or rash do not inject more AMGEVITA and contact your doctor immediately since, in rare cases, these reactions can be life threatening.
Slovenian: • Če doživite alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila AMGEVITA ne injicirajte več in se takoj posvetujte s svojim zdravnikom, saj so v redkih primerih te reakcije lahko življenje ogrožajoče.
English: AMGEVITA treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which AMGEVITA is indicated.
Slovenian: Zdravljenje z zdravilom AMGEVITA mora uvesti in nadzorovati zdravnik specialist, izkušen v diagnosticiranju in zdravljenju bolezenskih stanj, za katere je zdravilo AMGEVITA indicirano.
English: Week 36 a Patients with at least a partial response to adalimumab 40 mg weekly after 12 weeks of treatment b Patients meeting protocol-specified criteria for loss of response or no improvement were required to discontinue from the studies and were counted as non-responders
Slovenian: 24. teden 36. teden a Bolniki z vsaj delnim odzivom na odmerek 40 mg adalimumaba po 12. tednih zdravljenja b Bolniki, ki izpolnjujejo merila, določena v protokolu za izgubo odziva ali pri njih ni bilo izboljšanja, so bili izključeni iz študij in so se šteli kot bolniki brez odgovora (“nonresponders”)
English: AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
Slovenian: Zdravilo AMGEVITA je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno.
English: The symptoms described above can be signs of the below listed side effects, which have been observed with adalimumab.
Slovenian: Opisani simptomi so lahko znaki naslednjih neželenih učinkov, ugotovljenih med uporabo adalimumaba.
English: AMGEVITA can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate (for the efficacy in monotherapy see section 5.1).
Slovenian: Zdravilo AMGEVITA je mogoče uporabiti kot monoterapijo v primeru intolerance za metotreksat ali kadar nadaljnje zdravljenje z metotreksatom ni primerno (za učinkovitost monoterapije glejte poglavje 5.1).
English: AMGEVITA reduces the rate of progression of peripheral joint damage as measured by x-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and improves physical function.
Slovenian: Rentgensko slikanje je pokazalo, da zdravilo AMGEVITA upočasni hitrost napredovanja prizadetosti perifernih sklepov pri bolnikih s poliartikularnimi, simetričnimi podtipi bolezni (glejte poglavje 5.1) in izboljša telesno funkcijo.
English: Tell your doctor if you are taking azathioprine or 6-mercaptopurine with AMGEVITA.
Slovenian: Povejte zdravniku, če vaš otrok prejema azatioprin ali 6-merkaptopurin sočasno z zdravilom AMGEVITA.
English: Clinical response is usually achieved within 12 weeks of treatment.
Slovenian: Klinični odziv je ponavadi dosežen v 12 tednih zdravljenja.
English: Among patients whose adalimumab treatment was withdrawn at week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of adalimumab 40 mg weekly returned to levels similar to that observed before withdrawal (56.0%).
Slovenian: Med bolniki, pri katerih je bilo zdravljenje z adalimumabom ukinjeno v 12. tednu v študijah HS-I in HS-II, se je po ponovni uvedbi adalimumaba 40 mg enkrat na teden raven kliničnega odziva (HiSCR) po 12. tednih vrnila na podobno raven, kot so jo opazili pred ukinitvijo (56,0 %).
English: • 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: ● Do not recycle the syringe or sharps disposal container or throw them into the household waste.
Slovenian: ● Ne reciklirajte brizge ali vsebnika za ostre odpadke ter ju ne vrzite med gospodinjske odpadke.
English: PGA: Clear/minimalc a MTX = methotrexate b P = 0.027, adalimumab 0.8 mg/kg versus MTX c P = 0.083, adalimumab 0.8 mg/kg versus MTX
Slovenian: PASI 75b PGA: čisto/minimalnoc a MTX = methotrexate b P = 0,027, adalimumab 0,8 mg/kg v primerjavi z MTX c P = 0,083, adalimumab 0,8 mg/kg v primerjavi z MTX
English: ● Do not put the pre-filled pen back in the refrigerator once it has reached room temperature.
Slovenian: ● Ne vračajte napolnjenega injekcijskega peresnika nazaj v hladilnik, ko je le-ta dosegel sobno temperaturo.
English: In rheumatoid arthritis, methotrexate is continued while using AMGEVITA.
Slovenian: Pri revmatoidnem artritisu se uporaba metotreksata med uporabo zdravila AMGEVITA nadaljuje.
English: Your doctor will decide if you should receive AMGEVITA.
Slovenian: On se bo odločil, ali lahko dobivate zdravilo AMGEVITA.
English: ASASa,b 20
Slovenian: ASASa,b 20 ASASa,b 40 ASAS
English: TNF-antagonists including adalimumab have been associated in rare instances with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
Slovenian: Antagonisti tumorje nekrotizirajočega faktorja (TNF), z adalimumabom vred, so bili v redkih primerih povezani s pojavom ali poslabšanjem kliničnih simptomov in/ali rentgenoloških znakov demielinizirajoče bolezni osrednjega živčnega sistema, vključno z multiplo sklerozo in optičnim nevritisom, in periferne demielinizirajoče bolezni, vključno z Guillain-Barré- jevim sindromom.
English: In RA study IV, the ACR 20 response of patients treated with adalimumab plus standard of care was statistically significantly better than patients treated with placebo plus standard of care (p < 0.001).
Slovenian: V študiji revmatoidnega artritisa IV je bil odziv 20 po ACR pri bolnikih, zdravljenih z adalimumabom in standardno oskrbo, statistično značilno boljši kot pri bolnikih, zdravljenih s placebom in standardno oskrbo (p < 0,001).
English: If you stop using AMGEVITA
Slovenian: Če ste prenehali uporabljati zdravilo AMGEVITA
English: - The yellow cap is missing or not securely attached.
Slovenian: - manjka rumeni pokrovček igle ali ta ni varno nameščen.
English: This medicine contains less than 1 mmol of sodium (23 mg) per 0.8 mL dose, i.e. essentially ‘sodiumfree'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 0,8 ml odmerek, kar v bistvu pomeni 'brez natrija'.
English: Mood alterations (including depression), Anxiety,
Slovenian: Psihiatrične motnje pogosti spremembe razpoloženja (vključno z depresijo), anksioznost, nespečnost
English: Usually, AMGEVITA is used with methotrexate.
Slovenian: Zdravilo AMGEVITA ponavadi uporabljamo z metotreksatom.
English: Administration of live vaccines (e.g., BCG vaccine) to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Slovenian: Uporaba živih cepiv (npr. BCG cepiva) pri dojenčkih, ki so bili izpostavljeni adalimumabu in utero, ni priporočljiva 5 mesecev po zadnji injekciji adalimumaba, ki jo je mati prejela med nosečnostjo.
English: Efficacy Response in Placebo-Controlled Period for Study nr-axSpA II
Slovenian: Odziv učinkovitosti v s placebom kontroliranem obdobju študije nr-axSpA II