FrancophonIA/ELRC3.0 huggingface dataset:
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 × ULN pojavilo pri 2,4 % bolnikov, zdravljenih z adalimumabom, in pri 2,4 % bolnikov v kontrolni skupini.
English: • 1 alcohol swab
Slovenian: • 1 alkoholni zloženec;
English: Patients should be instructed to seek medical advice if signs/symptoms suggestive of a tuberculosis infection (e.g., persistent cough, wasting/weight loss, low grade fever, listlessness) occur during or after therapy with Hulio.
Slovenian: Bolnikom je treba naročiti, naj poiščejo zdravniško pomoč, če med zdravljenjem z zdravilom Hulio ali po njem doživijo znake ali simptome, ki nakazujejo tuberkulozno okužbo (npr. trdovraten kašelj, hujšanje/izgubljanje mase, nekoliko zvišano telesno temperaturo, apatijo).
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 19.
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 19.
English: • There have been cases of cancers, other than lymphoma, have been reported in patients with a specific type of lung disease called chronic obstructive pulmonary disease (COPD) treated with another TNFα blocker.
Slovenian: • Pri bolnikih s posebno boleznijo pljuč, t.i. kronično obstruktivno pljučno boleznijo (KOPB), zdravljenih z nekim drugim zaviralcem TNFα, so poročali o primerih rakov, ki niso bili limfomi.
English: Hulio 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 Hulio je indicirano za zdravljenje zmerno do hudo aktivnega ulceroznega kolitisa pri odraslih bolnikih, ki se ne odzovejo ustrezno na konvencionalno 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: • If you received Hulio during your pregnancy, your baby may have a higher risk for getting an infection.
Slovenian: Če ste prejeli zdravilo Hulio med nosečnostjo, ima lahko vaš dojenček povečano tveganje za okužbo.
English: • Always keep your sharps container out of the sight and reach of children.
Slovenian: • Vsebnik za ostre predmete vedno shranjujte nedosegljiv otrokom.
English: o DO NOT put the vial back in the fridge after it has reached room temperature.
Slovenian: ◦ Viale NE dajte nazaj v hladilnik, ko se segreje na sobno temperaturo.
English: For patients who dose escalated from eow to weekly regimen, the mean (±SD) serum concentrations of adalimumab at week 52 were 15.3 ± 11.4 μg/ml (40/20 mg, weekly) and 6.7 ± 3.5 μg/ml (20/10 mg, weekly).
Slovenian: Pri bolnikih, ki so prešli z režima vsak drugi teden na režim vsak teden, so bile povprečne (± SD) serumske koncentracije adalimumaba v 52. tednu 15,3 ± 11,4 µg/ml (40/20 mg tedensko) in 6,7 ± 3,5 µg/ml (20/10 mg tedensko).
English: For patients who are prescribed a full 40 mg dose of Hulio, a 40 mg pre-filled pen and a 40 mg prefilled syringe are also available from your pharmacist.
Slovenian: Bolnikom, ki jim je predpisan polni 40 mg odmerek zdravila Hulio, sta v lekarni na voljo tudi 40 mg napolnjen injekcijski peresnik in 40 mg napolnjena injekcijska brizga.
English: ***, ** Statistically significant at p < 0.001 and < 0.01, respectively, for all comparisons between adalimumab and placebo.
Slovenian: ***, ** Statistično značilno pri p < 0,001 in < 0,01 (v tem zaporedju) za vse primerjave med adalimumabom in placebom.
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 kožnimi raki je bil delež (95-% interval zaupanja) skvamocelularnega karcinoma 2,7 (1,4; 5,4) na 1000 bolnikov-let med bolniki, ki so prejemali adalimumab, in 0,6 (0,1; 4,5) na 1000 bolnikov-let v kontrolni skupini bolnikov.
English: o DO NOT use the vial if the solution is cloudy, discoloured, or has particles in it.
Slovenian: ◦ Viale NE uporabljajte, če je raztopina motna, obarvana ali vsebuje delce.
English: ALT elevations ≥ 3 x ULN occurred in 0.9% of adalimumab-treated patients and 0.9% of controlled-treated patients.
Slovenian: ≥ 3 × ULN pojavilo pri 0,3 % bolnikov, zdravljenih z adalimumabom, in pri 0,6 % bolnikov v kontrolni skupini.
English: Table 21: Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission
Slovenian: Preglednica 21: Študija Crohnove bolezni pri pediatričnih bolnikih - prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule
English: Gently set the connected vial and adapter down on a flat work surface.
Slovenian: Vialo z nameščenim adapterjem previdno odložite na ravno delovno površino.
English: Lymphoma**, solid organ neoplasm (including breast cancer, lung neoplasm and thyroid neoplasm), melanoma**
Slovenian: tumorji parenhimskih organov (vključno s tumorjem dojk, tumorjem pljuč in tumorjem ščitnice), melanom**
English: Keep this Patient Reminder Card with you at all times and for 4 months after your last injection of Hulio.
Slovenian: To opozorilno kartico za bolnika imejte vedno pri sebi, kar velja še 4 mesece po zadnji injekciji zdravila Hulio, ki jo prejmete.
English: Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab.
Slovenian: Pri bolnikih, ki so prejemali adalimumab, so poročali o resnih okužbah, vključno s sepso, zaradi bakterijskih, mikobakterijskih, invazivnih glivičnih, parazitskih, virusnih in drugih oportunističnih okužb, npr. listerioze, legioneloze in pnevmocistične okužbe.
English: Figure 1: Kaplan-Meier Curves Summarizing Time to Flare in Study nr-axSpA II
Slovenian: Slika 1: Kaplan-Meierjeve krivulje povzemajo čas do ponovnega zagona bolezni v študiji nr axSpA II
English: RA study I evaluated 271 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old, had failed therapy with at least one disease-modifying, anti rheumatic drug and had insufficient efficacy with methotrexate at doses of 12.5 to 25 mg (10 mg if methotrexate-intolerant) every week and whose methotrexate dose remained constant at 10 to 25 mg every week.
Slovenian: V študiji revmatoidnega artritisa I je bilo ocenjenih 271 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, pri katerih zdravljenje z vsaj enim imunomodulirajočim antirevmatičnim zdravilom ni bilo uspešno, pri katerih metotreksat v odmerkih od 12,5 do 25 mg (10 mg, če so bili intolerantni za metotreksat) vsak teden ni bil dovolj učinkovit in pri katerih je odmerek metotreksata od 10 do 25 mg ostal stalen vsak teden.
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 zdravljenja potreben posvet z zdravnikom specialistom za zdravljenje bolnikov z invazivnimi glivičnimi okužbami.
English: On the basis of clinical trial data in patients with JIA (pJIA and ERA), an exposure-response relationship was established between plasma concentrations and PedACR 50 response.
Slovenian: Na podlagi podatkov iz kliničnih preskušanj pri bolnikih z juvenilnim idiopatskim artritisom (JIA) (poliartikularnim idiopatskim artritisom (pJIA) in z artritisom, povezanim z entezitisom (ERA)) je bilo dokazano razmerje med izpostavljenostjo in odzivom med plazemskimi koncentracijami in Ped ACR 50 (Ped ACR - American College of Rheumatology pediatric) odzivom.
English: • DO NOT re-use the syringe.
Slovenian: • Injekcijske brizge NE uporabite ponovno.
English: It is recommended that, if possible, children be given all the scheduled vaccinations for their age before they start treatment with Hulio.
Slovenian: Za otroke je priporočljivo, da pred začetkom zdravljenja z zdravilom Hulio opravijo vsa predvidena cepljenja v skladu z veljavnimi smernicami za cepljenje, če je le mogoče.
English: P Value b
Slovenian: vrednost p
English: Step 10 - Flip down pink needle cover and remove needle cap Hold the syringe with the needle pointing up.
Slovenian: 10. korak - Obrnite rožnati pokrovček igle navzdol in odstranite pokrovček igle.
English: Carriers of HBV who require treatment with Hulio should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy.
Slovenian: Nosilce HBV, ki potrebujejo zdravljenje z zdravilom Hulio, je treba ves čas zdravljenja in več mesecev po koncu zdravljenja natančno spremljati glede znakov in simptomov aktivne okužbe s HBV. O zdravljenju nosilcev HBV s protivirusno terapijo v kombinaciji z antagonistom TNF za preprečitev reaktivacije HBV ni zadostnih podatkov.
English: Step 15 - End of injection, remove syringe, engage needle cover When the syringe is empty, remove syringe and needle from the skin.
Slovenian: 15. korak - Injiciranje je končano, odstranite brizgo, namestite pokrovček igle.
English: Pull the needle cover straight off the syringe.
Slovenian: Pokrovček igle povlecite naravnost z injekcijske brizge.
English: Step 5 - Attach vial adapter to vial
Slovenian: 5. korak - Namestite adapter za vialo na vialo.
English: For patients who stayed on their randomised therapy, the mean (±SD) adalimumab trough concentrations at week 52 were 9.5±5.6 μg/ml for the Standard Dose group and 3.5±2.2 μg/ml for the Low Dose group.
Slovenian: Pri bolnikih, ki so ostali na njihovi randomizirani terapiji, so bile povprečne (±SD) najmanjše koncentracije adalimumaba v 52. tednu 9,5 ± 5,6 µg/ml v skupini s standardnim odmerkom in 3,5 ± 2,2 µg/ml v skupini z majhnim odmerkom.
English: Talk to your doctor or pharmacist before using Hulio.
Slovenian: Pred začetkom uporabe zdravila Hulio se posvetujte z zdravnikom ali farmacevtom.
English: • DO NOT put the clear needle cap back on the needle.
Slovenian: • NE NAMEŠČAJTE prozornega pokrovčka igle nazaj na iglo.
English: Step 9 - Detach syringe from vial adapter and attach needle Remove the vial adapter by twisting it off the syringe.
Slovenian: 9. korak - Odstranite brizgo z adapterja za vialo in namestite iglo.
English: *** p < 0.001 for all comparisons between adalimumab and placebo * p < 0.05 for all comparisons between adalimumab and placebo N/A not applicable
Slovenian: *** p < 0,001 za vse primerjave med adalimumabom in placebom * p < 0,05 za vse primerjave med adalimumabom in placebom
English: • Take a single pre-filled syringe out of the fridge at least 30 minutes before you intend to use it to allow the contents to reach room temperature.
Slovenian: • Eno napolnjeno injekcijsko brizgo vzemite iz hladilnika najmanj 30 minut pred predvideno uporabo, da se vsebina segreje na sobno temperaturo.
English: In RA study V, the improvement in the HAQ disability index and the physical component of the SF 36 showed greater improvement (p < 0.001) for adalimumab /methotrexate combination therapy versus methotrexate monotherapy and adalimumab monotherapy at week 52, which was maintained through week 104.
Slovenian: V študiji revmatoidnega artritisa V sta se indeks invalidnosti HAQ in telesna komponenta SF 36 ob kombinirani terapiji z adalimumabom in metotreksatom po 52 tednih izboljšala bolj (p < 0,001) kot ob monoterapiji z metotreksatom ali ob monoterapiji z adalimumabom; to se je ohranilo do 104. tedna.
English: Hulio 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 Hulio 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: RA Study IIa**
Slovenian: Študija revmatoidnega artritisa IIa**
English: The double-blind period was followed by an openlabel period during which patients receive adalimumab 40 mg every other week subcutaneously for up to an additional 144 weeks.
Slovenian: Dvojno slepi fazi je sledila odprta faza, v kateri so bolniki prejemali adalimumab 40 mg vsak drugi teden subkutano do dodatnih 144 tednov.
English: Gently flip the pink needle cover over the needle and snap into place.
Slovenian: Previdno obrnite rožnati pokrovček igle navzgor, čez iglo, da se zaskoči na mestu.
English: < 40 kg • 40 mg at week 0 and 20 mg at week 2
Slovenian: < 40 kg • 40 mg v 0. tednu in 20 mg v 2. tednu
English: Hulio is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy (see section 5.1).
Slovenian: Zdravilo Hulio je indicirano za zdravljenje aktivnega artritisa, povezanega z entezitisom, pri bolnikih, starih 6 let in več, ki so se nanj neustrezno odzvali ali so intolerantni za običajno zdravljenje (glejte poglavje 5.1).
English: Table 28: Response, Remission and Mucosal Healing in Study UC-II (Percent of Patients) Placebo
Slovenian: Preglednica 28: Odziv, remisija in celjenje sluznice v študiji UC-II (odstotek bolnikov)
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 Hulio 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 Hulio.
English: If these medicines do not work well enough, you will be given Hulio 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 Hulio.
English: The combination of Hulio and abatacept is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Slovenian: Kombinacija zdravila Hulio in abatacepta ni priporočljiva (glejte poglavje 4.4 ''Sočasna uporaba bioloških DMARD ali antagonistov TNF'').
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 recommended dose.
Slovenian: Zdravnik lahko vašemu otroku predpiše začetni odmerek 40 mg, ki se ga lahko uporabi en teden pred začetkom zdravljenja z običajnim priporočenim odmerkom.
English: Fever, bruising, bleeding or looking pale
Slovenian: Zvišana telesna temperatura, podplutbe, krvavitve ali bledica
English: 506 (62.2)b a Percent of patients achieving PASI75 response was calculated as centre-adjusted rate b p<0.001, adalimumab vs. placebo
Slovenian: 506 (62,2)b a Odstotek bolnikov, ki so dosegli odziv PASI 75, je bil izračunan kot delež, korigiran za center.
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: Pri bolnikih, zdravljenih z adalimumabom, so v primerjavi s placebom 24. teden ugotovili statistično značilno izboljšanje telesnega delovanja, ocenjeno s HAQ in vprašalnikom SF-36 (Short Form Health Survey).
English: It is important that you tell the baby's doctors and other health care professionals about Hulio use during your child's pregnancy so they can decide when your child's baby should receive any vaccine.
Slovenian: Zato je pomembno, da obvestite zdravnika otrokovega dojenčka in druge zdravstvene delavce, da je vaš otrok med nosečnostjo prejemal zdravilo Hulio, da se lahko odločijo, kdaj bo dojenček vašega otroka lahko prejel katero koli cepivo.
English: • DO NOT hold the syringe by the plunger rod.
Slovenian: • NE DRŽITE brizge za nosilec bata.
English: Table 22: Proportion of Patientsa Achieving HiSCRb at weeks 24 and 36 After Treatment Reassignment from weekly Adalimumab at week 12
Slovenian: Preglednica 22: 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 placebo (ukinitev zdravljenja) N = 73
English: JSN score 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: Seštevek JSN 2,0 (1,2-2,8) 1,3 (0,5-2,1) a Vrednost p se nanaša na parno primerjavo monoterapije z metotreksatom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U. b Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in kombinirane terapije z adalimumabom/metotreksatom z Mann-Whitneyevim testom U. c Vrednost p se nanaša na parno primerjavo monoterapije z adalimumabom in monoterapije z metotreksatom z Mann-Whitneyevim testom U.
English: The recommended Hulio dose for patients with plaque psoriasis from 4 to 17 years of age is based on body weight (Table 3).
Slovenian: Priporočeni odmerek zdravila Hulio pri bolnikih s psoriazo v plakih, starih od 4 do 17 let, temelji na telesni masi (preglednica 3).
English: Hulio 40 mg/0.8 ml solution for injection adalimumab
Slovenian: Hulio 40 mg/0,8 ml raztopina za injiciranje adalimumab
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 in monoterapija z adalimumabom, odzivi pa so se ohranili do 104. tedna (glejte preglednico 10).
English: Placebo Adalimumab 40 mg weekly
Slovenian: placebo adalimumab 40 mg vsak teden placebo adalimumab 40 mg vsak teden
English: In the open-label extension of RA study V, the mean change from baseline at Year 10 in the modified Total Sharp Score was 10.8, 9.2 and 3.9 in patients originally randomised to methotrexate monotherapy, adalimumab monotherapy and adalimumab/methotrexate combination therapy, respectively.
Slovenian: V odprtem podaljšanju študije revmatoidnega artritisa V je bila povprečna sprememba celotne Sharpove ocene v 10. letu pri bolnikih, ki so jih na začetku randomizirali na monoterapijo z metotreksatom, monoterapijo z adalimumabom in kombinacijo adalimumaba/metotreksata, glede na izhodišče 10,8, 9,2 oz. 3,9.
English: Hulio is used to treat moderate to severe plaque psoriasis in adults.
Slovenian: Zdravilo Hulio se uporablja za zdravljenje zmerne do hude luskavice (psoriaze) v plakih pri odraslih.
English: Each pre-filled syringe or pre-filled pen contains 38.2 mg sorbitol (E420).
Slovenian: Ena napolnjena injekcijska brizga ali napolnjen injekcijski peresnik vsebuje 38,2 mg sorbitola (E420).
English: Solution for injection 1 pre-filled pen, 2 alcohol pads 2 pre-filled pens, 2 alcohol pads 6 pre-filled pens, 6 alcohol pads
Slovenian: 1 napolnjen injekcijski peresnik, 2 alkoholna zloženca 2 napolnjena injekcijska peresnika, 2 alkoholna zloženca 6 napolnjenih injekcijskih peresnikov, 6 alkoholnih zložencev
English: The mean steady-state trough concentration at week 12 through week 36 were approximately 8 to 10 μg/ml during adalimumab 40 mg every week treatment.
Slovenian: Najnižja koncentracija v stanju dinamičnega ravnovesja je bila približno 8 do 10 µg/ml med 12. tednom in 36. tednom pri zdravljenju z odmerkom 40 mg adalimumaba vsak teden.
English: In patients with polyarticular JIA who were 2 to <4 years old or aged 4 and above weighing <15 kg dosed with adalimumab 24 mg/m2, the mean trough steady-state serum adalimumab concentrations was 6.0 ± 6.1 μg/ml (101% CV) for adalimumab without concomitant methotrexate and 7.9 ± 5.6 μg/ml (71.2% CV) with concomitant methotrexate.
Slovenian: Pri bolnikih s poliartikularnim JIA, starih od 2 do < 4 leta ali starih 4 leta ali več in s telesno maso < 15 kg, ki so prejemali adalimumab v odmerku 24 mg/m², je bila povprečna najmanjša koncentracija adalimumaba v serumu v stanju dinamičnega ravnovesja 6,0 ± 6,1 µg/ml (KV 101 %) med uporabo adalimumaba brez metotreksata in 7,9 ± 5,6 µg/ml (KV 71,2 %) med sočasno uporabo metotreksata.
English: Patients received an initial dose of 80 mg adalimumab followed by 40 mg every other week (starting one week after the initial dose) or placebo for 26 weeks followed by open-label adalimumab treatment for an additional 26 weeks.
Slovenian: Bolniki so prejeli začetni odmerek 80 mg adalimumaba, ki mu je sledil odmerek 40 mg vsak drugi teden (z začetkom en teden po začetnem odmerku), ali pa placebo 26 tednov, čemur je sledilo odprto zdravljenje z adalimumabom dodatnih 26 tednov.
English: If your doctor considers that methotrexate is inappropriate, Hulio can be given alone.
Slovenian: Če vaš zdravnik meni, da metotreksat ni primeren, lahko zdravilo Hulio dobivate samo.
English: Hulio 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 Hulio 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: Hulio is also available as a vial for paediatric use or a pre-filled syringe.
Slovenian: Zdravilo Hulio je na voljo tudi v viali za uporabo pri otrocih ali napolnjeni injekcijski brizgi.
English: Hulio 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: Hulio is used to treat psoriatic arthritis in adults.
Slovenian: Zdravilo Hulio se uporablja za zdravljenje psoriatičnega artritisa pri odraslih.
English: If your doctor determines that methotrexate is inappropriate, Hulio can be given alone.
Slovenian: Če vaš zdravnik ugotovi, da metotreksat ni primeren, lahko zdravilo Hulio dobivate samo.