FrancophonIA/ELRC3.0 huggingface dataset:
English: When needed (for example when you are travelling), a single Kromeya pre-filled syringe may be stored at room temperature (up to 25°C) for a maximum period of 14 days - be sure to protect it from light.
Slovenian: Če je potrebno (na primer kadar potujete), lahko posamezno napolnjeno injekcijsko brizgo Kromeya hranite pri sobni temperaturi (do 25 ºC) za največ 14 dni - zagotovite, da bo zaščitena pred svetlobo.
English: Figure 3: Kaplan-Meier curves summarizing time to treatment failure in the paediatric uveitis study
Slovenian: Slika 3: Kaplan-Meier-jeve krivulje povzemajo čas do neuspeha zdravljenja v študiji uveitisa pri pediatričnih bolnikih
English: Of these skin cancers, squamous cell carcinomas occurred at rates (95% confidence interval) of 2.7 (1.4, 5.4) per 1,000 patient-years among adalimumab- treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Slovenian: Med temi koţnimi raki je bil deleţ (95 % interval zaupanja) skvamocelularnega karcinoma 2,7 (1,4; 5,4) na 1000 bolnikov-let med bolniki, ki so dobivali adalimumab, in 0,6 (0,1; 4,5) na 1000 bolnikov-let v kontrolni skupini bolnikov.
English: • If your child has or develops a demyelinating disease (a disease that affects the insulating layer around the nerves, such as multiple sclerosis), your doctor will decide if he/she should receive or continue to receive Kromeya.
Slovenian: • Če vaš otrok ima ali pa se pri njem razvija demielinizirajoča bolezen (bolezen, ki vpliva na izolacijsko plast okoli ţivcev, kot je multipla skleroza), bo zdravnik presodil, ali lahko dobiva zdravilo Kromeya.
English: Patients demonstrating a Pediatric ACR 30 response at week 16 were eligible to be randomised into the double blind (DB) phase and received either adalimumab 24 mg/m up to a maximum of 40 mg, or placebo every other week for an additional 32 weeks or until disease flare.
Slovenian: Bolniki, ki so 16. teden dosegli odziv »Pediatric ACR« 30, so bili primerni za randomizacijo v dvojno slepo fazo in so nadaljnjih 32 tednov ali do zagona bolezni vsak drugi teden dobili adalimumab 24 mg/m
English: Of 207 patients who were randomised to adalimumab 40mg every other week, 114 patients continued on adalimumab 40 mg every other week for 5 years.
Slovenian: Od 207 bolnikov, ki so bili randomizirani na adalimumab 40 mg vsak drugi teden, jih je 114 nadaljevalo zdravljenje z adalimumab 40 mg vsak drugi teden še 5 let.
English: Polyarticular juvenile idiopathic arthritis from 2 years of age
Slovenian: Poliartikularni juvenilni idiopatski artritis od 2. starosti.
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 8).
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 po ACR kot monoterapija z metotreksatom ali monoterapija z adalimumabom, odzivi pa so se ohranili do 104. tedna (glejte preglednico 8).
English: All doses/schedules of adalimumab in all four studies showed statistically significantly greater improvement in the disability index of the HAQ from baseline to Month 6 compared to placebo and in RA study III the same was seen at week 52.
Slovenian: V vseh štirih študijah se je indeks invalidnosti po vprašalniku HAQ od izhodišča do meseca z vsemi odmerki/shemami adalimumaba izboljšal statistično značilno bolj kot s placebom; v študiji revmatoidnega artritisa III so isto ugotovili po 52 tednih.
English: Kromeya is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
Slovenian: Zdravilo Kromeya je indicirano za zdravljenje zmerno do hudo aktivnega ulceroznega kolitisa pri odraslih bolnikih, ki so se ne odzovejo zadostno na običajno zdravljenje, na primer na kortikosteroide in 6-merkaptopurin (6-MP) ali azatioprin (AZA), ali pa takšnega zdravljenja ne prenesejo oz. imajo zanj medicinske kontraindikacije.
English: Pulmonary embolism interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion
Slovenian: pogosti astma, dispneja, kašelj občasni pljučni embolizem intersticijska pljučna bolezen, kronična obstruktivna pljučna bolezen, pnevmonitis, plevralna efuzija redki pljučna fibroza
English: In controlled trials of adalimumab (initial doses of 80 mg at week 0 followed by 40 mg every other week starting at week 1) in adult patients with uveitis up to 80 weeks with a median exposure of 166.5 days and 105.0 days in Adalimumab-treated and control-treated patients, respectively, ALT elevations ≥ 3 x ULN occurred in 2.4% of adalimumab-treated patients and 2.4% of control-treated patients.
Slovenian: V kontroliranih preskušanjih z adalimumabom (začetni odmerek 80 mg v 0. tednu, ki mu sledi odmerek 40 mg vsak drugi teden z začetkom v 1. tednu) pri odraslih bolnikih z uveitisom, ki so trajala do 80 tednov, z mediano izpostavljenostjo 166,5 dni pri bolnikih zdravljenih z adalimumabom in 105,0 dni pri bolnikih v kontrolni skupini, se je zvišanje ALT ≥ 3 x ULN pojavilo pri 2,4 % bolnikov zdravljenih z adalimumabom in pri 2,4 % bolnikov v kontrolni skupini.
English: Following the administration of 0.8 mg/kg (up to a maximum of 40 mg) subcutaneously every other week to paediatric patients with chronic plaque psoriasis, the mean ± SD steady-state adalimumab trough concentration was approximately 7.4 ± 5.8 µg/mL (79% CV).
Slovenian: Po dajanju adalimumaba 0,8 mg/kg (do največ 40 mg) subkutano vsak drugi teden pediatričnim bolnikom s kronično psoriazo v plakih, so bile povprečne koncentracije adalimumaba v stanju dinamičnega ravnovesja pribliţno 7,4 ± 5,8 µg/ml (79 % KV).
English: Serious adverse reactions have been reported for adalimumab.
Slovenian: Poročali so tudi o resnih neţelenih učinkih v zvezi z adalimumabom.
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: The rate (95% confidence interval) of lymphomas was 0.7 (0.2, 2.7) per 1,000 patient-years among adalimumab-treated patients and 0.6 (0.1, 4.5) per 1,000 patient-years among control patients.
Slovenian: Deleţ (95 % interval zaupanja) limfomov je bil 0,7 (0,2; 2,7) na 1000 bolnikov-let med bolniki, ki so dobivali adalimumab, in 0,6 (0,1; 4,5) na 1000 bolnikov-let v kontrolni skupini bolnikov.
English: Initial dose of 80 mg (as two 40 mg injections in one day), followed by 40 mg two weeks later.
Slovenian: Začetni odmerek je 80 mg (kot dve 40 mg injekciji v enem dnevu), ki mu sledi 40 mg dva tedna kasneje.
English: 6.3 Administer the Injection
Slovenian: 6.3 Vstavite injekcijsko iglo
English: • Tell your doctor if you have lived or travelled in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
Slovenian: • Zdravniku morate povedati, če ste ţiveli ali potovali v predele, kjer so pogoste glivične okuţbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
English: If your child becomes pregnant, you should see your child's doctor.
Slovenian: Če vaš otrok zanosi, mora obiskati zdravnika.
English: PGA: Clear/minimal b a
Slovenian: PGA: čisto/minimalno b a
English: The recommended dose of Kromeya for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 4).
Slovenian: Priporočeni odmerek zdravila Kromeya pri bolnikih s Crohnovo boleznijo, starih od 6 do 17 let, temelji na telesni masi (preglednica 4).
English: Kromeya is indicated for the treatment of paediatric chronic non-infectious anterior uveitis in patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.
Slovenian: Zdravilo Kromeya je indicirano za zdravljenje kroničnega neinfekcijskega anteriornega uveitisa pri bolnikih, starejših od 2 let, ki se niso ustrezno odzvali ali ne prenašajo konvencionalnega zdravljenja, ali pri katerih konvencionalno zdravljenje ni primerno.
English: • Continue to HOLD the pre-filled pen firmly.
Slovenian: • Napolnjen injekcijski peresnik močno DRŢITE še naprej.
English: Some patients who experience decrease in their response to Kromeya 40 mg every other week may benefit from an increase in dosage to 40 mg Kromeya every week or 80 mg every other week.
Slovenian: Nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Kromeya 40 mg vsak drugi teden, lahko koristi povečanje odmerka zdravila Kromeya na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: • enthesitis-related arthritis,
Slovenian: • artritis, povezan z entezitisom,
English: Once removed from the refrigerator for room temperature storage, your vial must be used within 14 days or discarded, even if it is later returned to the refrigerator.
Slovenian: Ko napolnjeno injekcijsko brizgo enkrat, namesto v hladilniku, shranjujete pri sobni temperaturi, morate brizgo porabiti v 14 dneh ali pa zavreči, tudi če jo kasneje vrnete v hladilnik.
English: This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal.
Slovenian: Pri bolnikih, zdravljenih z adalimumabom, je bil v redkih primerih med obdobjem trţenja identificiran hepatosplenični limfom celic T. Ta redka oblika limfoma celic T ima zelo agresiven potek bolezni in je običajno smrtna.
English: Initial dose of 20 mg, followed by 20 mg one week later.
Slovenian: Začetni odmerek 20 mg, ki mu sledi 20 mg en teden kasneje.
English: Figure K Warning: Do not use the syringe if:
Slovenian: Opozorilo: Injekcijske brizge ne uporabljajte, če:
English: In an open-label extension study, for patients who dose escalated from 40 mg every other week to 40 mg weekly due to a PASI response below 50%, 26.4% (92/349) and 37.8% (132/349) of patients achieved PASI 75 response at week 12 and 24, respectively.
Slovenian: V odprti podaljšani študiji je odziv PASI 75 v 12. tednu oziroma 24. tednu doseglo 92 od 349 (26,4 %) bolnikov oziroma 132 od 349 (37,8 %) bolnikov, katerim so zaradi odziva PASI pod 50 % odmerek povečali s 40 mg vsak drugi teden na 40 mg vsak teden.
English: Available data suggest that the clinical response is usually achieved within 12 weeks of treatment.
Slovenian: Podatki, ki so na voljo, kaţejo, da je klinični odziv ponavadi doseţen v 12 tednih zdravljenja.
English: Figure 1: Kaplan-Meier curves summarizing time to treatment failure in the paediatric uveitis study
Slovenian: Slika 1: Kaplan-Meierjeve krivulje povzemajo čas do neuspeha zdravljenja v študiji uveitisa pri pediatričnih bolnikih
English: Adalimumab was assessed in a multicenter, randomised, double-blind clinical trial designed to evaluate the efficacy and safety of induction and maintenance treatment with doses dependent on body weight (< 40 kg or ≥ 40 kg) in 192 paediatric subjects between the ages of 6 and 17 (inclusive) years, with moderate to severe Crohn´s disease (CD) defined as Paediatric Crohn's Disease Activity Index (PCDAI) score > 30.
Slovenian: Adalimumab je bil ocenjen v multicentrični, randomizirani, dvojno slepi klinični študiji, ki je bila zasnovana za oceno učinkovitosti in varnosti uvodnega in vzdrţevalnega zdravljenja z odmerki, odvisnimi od telesne mase (< 40 mg ali ≥ 40 mg) pri 192 pediatričnih bolnikih med 6. in 17.
English: * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a
Slovenian: * p < 0,001 za parne primerjave deleţev med adalimumabom in placebom ** p < 0,02 za parne primerjave deleţev med adalimumabom in placebom a
English: Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with increased risk for malignancy due to heavy smoking.
Slovenian: Zato je treba pri bolnikih s KOPB in bolnikih, ki jih zaradi hudega kajenja bolj ogroţa malignom, vsak antagonist TNF uporabljati previdno.
English: Kromeya is also used to treat severe plaque psoriasis in children and adolescents adolescents aged 4 to 17 years for whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.
Slovenian: Zdravilo Kromeya se uporablja tudi za zdravljenje hude luskavice v plakih pri otrocih in mladostnikih, starih od 4 do 17 let, pri katerih zdravila, ki se nanašajo na koţo in zdravljenje z UV svetlobo, nista dovolj dobro delovala ali pa nista primerna.
English: (up to a maximum of 40 mg) subcutaneously every other week to patients with enthesitis-related arthritis who were 6 to 17 years, the mean trough steady-state (values measured at week 24) serum adalimumab concentrations were 8.8 ± 6.6 μg/mL for adalimumab without concomitant methotrexate and 11.8 ± 4.3 μg/mL with concomitant methotrexate.
Slovenian: (do največ 40 mg) subkutano vsak drugi teden bolnikom z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja (vrednost merjena v 24. tednu) 8,8 ± 6,6 μg/ml med uporabo adalimumaba brez metotreksata in 11,8 ± 4,3 μg/ml med sočasno uporabo metotreksata.
English: Storage Information
Slovenian: Navodila za shranjevanje
English: Diagnosis and administration of empiric antifungal therapy in these patients should be made in consultation with a physician with expertise in the care of patients with invasive fungal infections.
Slovenian: Pri teh bolnikih je pri postavitvi diagnoze in izbiri empiričnega antimikotičnega zdravljena potreben posvet z zdravnikom, izkušenim v zdravljenju bolnikov z invazivnimi glivičnimi okuţbami.
English: • mouth infections (including tooth infections and cold sores);
Slovenian: • okuţbe ust (vključno z okuţbami zob in herpesom);
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 po ACR kot monoterapija z metotreksatom ali monoterapija z adalimumabom, odzivi pa so se ohranili do 104. tedna (glejte preglednico 10).
English: It is important that you tell your doctor if your child has symptoms of infections, e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
Slovenian: Pomembno je, da zdravniku poveste, če ima vaš otrok simptome okuţb, npr. zvišano telesno temperaturo, rane, občutek utrujenosti ali teţave z zobmi (glejte "Opozorila in previdnostni ukrepi").
English: 5.2 Clean the injection site with an alcohol pad and throw the pad away.
Slovenian: 5.2 Koţo na mestu injiciranja obrišite z zloţencem, prepojenim z alkoholom, in ga zavrzite.
English: In monotherapy, some patients who experience a decrease in their response to Kromeya 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
Slovenian: Med monoterapijo lahko nekaterim bolnikom, ki se jim zmanjša odziv na zdravilo Kromeya 40 mg vsak drugi teden, koristi povečanje odmerka adalimumaba na 40 mg vsak teden ali na 80 mg vsak drugi teden.
English: 3.3 Turn the vial upside down so it is vertical with the syringe still attached.
Slovenian: 3.3 Vialo obrnite na glavo, tako da gleda navzdol skupaj s pritrjeno injekcijsko brizgo.
English: What Kromeya contains
Slovenian: Kaj vsebuje zdravilo Kromeya
English: • Push and hold the pre-filled pen firmly against your skin until the safety guard is fully depressed.
Slovenian: • Napolnjen injekcijski peresnik močno pritisnite na koţo in ga drţite, da se varovalo popolnoma spusti.
English: Adalimumab treated patients demonstrated statistically significant improvement in physical function as assessed by HAQ and Short Form Health Survey (SF 36) compared to placebo at week 24.
Slovenian: Ob zdravljenju z adalimumabom so v primerjavi s placebom 24. teden ugotovili statistično značilno izboljšanje telesnega delovanja, ocenjeno z vprašalnikoma HAQ in SF 36 (Short Form Health Survey).
English: The recommended dose of Kromeya for patients with polyarticular juvenile idiopathic arthritis from 2 years of age is based on body weight (Table 1).
Slovenian: Priporočeni odmerek zdravila Kromeya pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, starih 2 leti in več, temelji na telesni masi (preglednica 1).
English: 3.7 Place the syringe on a clean, flat surface.
Slovenian: 3.7 Injekcijsko brizgo poloţite na čisto, ravno površino.
English: You are advised to avoid becoming pregnant and must use adequate contraception while using Kromeya and for at least 5 months after the last Kromeya injection.
Slovenian: Svetujemo vam, da preprečite nosečnost in uporabljate ustrezno kontracepcijsko zaščito, dokler uporabljate zdravilo Kromeya in še 5 mesecev po zadnjem injiciranju zdravila Kromeya.
English: ACR 20 Week 52 62.6% 54.4% 72.8% Week 104 56.0% 49.3% 69.4% ACR 50 Week 52 45.9% 41.2% 61.6% < 0.001 < 0.001 0.317 Week 104 42.8% 36.9% 59.0% < 0.001 < 0.001 0.162 ACR 70 Week 52 27.2% 25.9% 45.5% < 0.001 < 0.001 0.656 Week 104 28.4% 28.1% 46.6% < 0.001 < 0.001 0.864 a. p-value is from the pairwise comparison of methotrexate monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test. b. p-value is from the pairwise comparison of adalimumab monotherapy and adalimumab/methotrexate combination therapy using the Mann-Whitney U test c. p-value is from the pairwise comparison of adalimumab monotherapy and methotrexate monotherapy using the Mann-Whitney U test
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 ACR 70
English: It is important that you tell your doctor if you have symptoms of infections, e.g. fever, wounds, feeling tired, dental problems (see “Warnings and precautions”).
Slovenian: Pomembno je, da zdravniku poveste, če imate simptome okuţb, npr. zvišano telesno temperaturo, rane, občutek utrujenosti ali teţave z zobmi (glejte "Opozorila in previdnostni ukrepi").
English: 2.2 Check the label on the vial for Kromeya and expiration date.
Slovenian: Preglejte nalepko in preverite, ali je na njej ime Kromeya in če je rok uporabnosti ţe pretekel.
English: Initial dose of 20 mg, followed by 20 mg given every other week starting one week after the initial dose
Slovenian: Začetni odmerek 20 mg, ki mu sledi odmerek 20 mg vsak drugi teden, z začetkom en teden po začetnem odmerku
English: • If needed, for example when traveling, the Kromeya Vial Kit can be stored at room temperature for up to 14 days.
Slovenian: • Po potrebi lahko zdravilo Kromeya komplet z vialo shranjujete pri sobni temperaturi do 14 dni,
English: You should record the date when the pen is first removed from refrigerator, and the date after which it should be discarded.
Slovenian: Zapisati si morate datum, ko je bil peresnik vzet iz hladilnika in datum, po katerem ga je potrebno zavreči.
English: For patients who develop the signs and symptoms such as fever, malaise, weight loss, sweats, cough, dyspnoea, and/or pulmonary infiltrates or other serious systemic illness with or without concomitant shock an invasive fungal infection should be suspected and administration of Kromeya should be promptly discontinued.
Slovenian: Če se bolniku pojavijo znaki ali simptomi, kot so npr. zvišana telesna temperatura, splošno slabo počutje, hujšanje, znojenje, kašelj, dispneja in/ali pljučni infiltrati ali druga resna sistemska bolezen (s spremljajočim šokom ali brez njega), je treba posumiti na invazivno glivično okuţbo.
English: • systemic lupus erythematosus (an immune disorder including inflammation of skin, heart, lung,
Slovenian: • sistemski eritematozni lupus (imunske motnje vključno z vnetjem koţe, srca, pljuč, sklepov in drugih organskih sistemov);
English: Kromeya 40 mg injection adalimumab
Slovenian: Kromeya 40 mg injekcija adalimumab s.c.
English: Adalimumab 40 mg eow N=814 n (%)
Slovenian: Adalimumab 40 mg vsak 2. teden n = 814 n (%)
English: If you receive Kromeya during your pregnancy, your baby may have a higher risk for getting an infection.
Slovenian: Če prejemate zdravilo Kromeya med nosečnostjo, obstaja večje tveganje, da bo vaš dojenček dobil okuţbo.
English: A rapid decrease in CRP levels was also observed in patients with polyarticular juvenile idiopathic arthritis, Crohn's disease and ulcerative colitis after treatment with adalimumab.
Slovenian: Pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, Crohnovo boleznijo in ulceroznim kolitisom so opazili tudi naglo zniţanje koncentracij CRP po zdravljenju z adalimumabom.
English: • The needle cap is securely attached (Figure H).
Slovenian: • je pokrovček na injekcijski igli trdno pritrjen (Slika H).
English: Record injection and dispose components
Slovenian: Zabeleţite injiciranje in zavrzite pripomočke
English: Table 9 ACR responses in placebo-controlled trials (percent of patients)
Slovenian: Preglednica 9: Odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov)
English: Warning: Do not try to put the needle cap back on the needle.
Slovenian: Opozorilo: Pokrovčka ne poskušajte ponovno namestiti na injekcijsko iglo.
English: Table 7 ACR responses in placebo-controlled trials (percent of patients)
Slovenian: Preglednica 7: Odziv po ACR v študijah, kontroliranih s placebom (odstotek bolnikov)
English: Kromeya 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 Kromeya je indicirano za zdravljenje zmerno do hudo 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: Warning: Do not blow on or touch the injection site after cleaning.
Slovenian: Opozorilo: Na očiščeno mesto injiciranja ne pihajte ali se ga dotikajte.
English: • pull the syringe straight up and out of the packaging (Figure C).
Slovenian: • injekcijsko brizgo potegnite navzgor iz škatle (Slika C).
English: One 0.8 mL vial contains 40 mg adalimumab
Slovenian: Ena 0,8 ml viala vsebuje 40 mg adalimumaba.
English: Ulcerative colitis Age or body weight
Slovenian: Ulcerozni kolitis Starost ali telesna masa
English: Available data suggest that clinical response is usually achieved within 12 weeks of treatment.
Slovenian: Podatki, ki so na voljo, kaţejo, da je klinični odziv po navadi doseţen v 12 tednih zdravljenja.
English: Among the 68 patients who flared in the group allocated to treatment withdrawal, 65 completed 12 weeks of rescue therapy with adalimumab, out of which 37 (56.9%) had regained remission (ASDAS < 1.3) after 12 weeks of restarting the open-label treatment.
Slovenian: Med 68 bolniki iz skupine namenjene prenehanju zdravljenja, pri katerih je prišlo do ponovnega zagona bolezni, jih je 65 zaključilo 12 tednov trajajoče rešilno zdravljenje z adalimumabom, od tega