FrancophonIA/ELRC3.0 huggingface dataset:
English: Table 18: Proportion of Patientsa Achieving HiSCRb at weeks 24 and 36 After Treatment Reassignment from weekly Adalimumab at week 12
Slovenian: Preglednica 18: Delež bolnikov, ki so dosegli klinični odziv (HiSCRb) v 24. in 36. tednu po spremembi zdravljenja na jemanje adalimumaba vsak teden v 12. tednu placebo (ukinitev zdravljenja) N = 73
English: Hulio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Slovenian: Zdravilo Hulio je indicirano za zdravljenje aktivne, zmerne do hude oblike hidradenitis suppurativa (acne inversa) pri odraslih in mladostnikih, starejših od 12 let, ki se ne odzovejo ustrezno na konvencionalno sistemsko HS-zdravljenje (glejte poglavji 5.1 in 5.2).
English: 4.5 Interaction with other medicinal products and other forms of interaction Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate.
Slovenian: Adalimumab so raziskali pri bolnikih z revmatoidnim artritisom, poliartikularnim juvenilnim idiopatskim artritisom in psoriatičnim artritisom, ki so adalimumab jemali v monoterapiji, kot pri tistih, ki so ga jemali hkrati z metotreksatom.
English: The blinded period was followed by an open − label period during which patients received adalimumab 40 mg every other week subcutaneously for up to an additional 28 weeks.
Slovenian: Slepljenemu obdobju je sledilo odprto obdobje, v katerem so bolniki dobivali 40 mg adalimumaba vsak drugi teden subkutano, do dodatnih 28 tednov.
English: Your doctor may recommend temporarily stopping Hulio.
Slovenian: Vaš zdravnik bo morda priporočil, da začasno prenehate z uporabo zdravila Hulio.
English: Do not use this medicine after the expiry date which is stated on the label/ carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki/škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Muscle spasms (including blood creatine phosphokinase increased)
Slovenian: Bolezni mišičnoskeletnega sistema in vezivnega tkiva zelo pogosti mišično-skeletne bolečine pogosti mišični spazmi (vključno s povišano kreatin fosfokinazo v krvi)
English: Their doctor may recommend temporarily stopping Hulio.
Slovenian: Zdravnik bo morda priporočil začasno prenehanje uporabe zdravila Hulio.
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 (v 24 tednu) in 0,0 ± 1,9; (p < 0,001) v skupini z adalimumabom (v 48 tednu).
English: Hulio is used to treat ulcerative colitis in adults.
Slovenian: Zdravilo Hulio se uporablja za zdravljenje ulceroznega kolitisa pri odraslih.
English: • DO NOT touch or pull back on the plunger at any time.
Slovenian: • Nikoli se NE dotikajte bata in ga ne vlecite nazaj.
English: Phase OL-LI 16 weeks Ped ACR 30 response (n/N)
Slovenian: Odziv »Ped ACR« 30 (n/N)
English: • Check the expiry date printed on the syringe.
Slovenian: • Preverite rok uporabnosti zdravila, ki je natisnjen na injekcijski brizgi.
English: Hulio is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy (see sections 5.1 and 5.2).
Slovenian: Zdravilo Hulio je indicirano za zdravljenje aktivne, zmerne do hude oblike hidradenitis suppurativa (acne inversa) pri mladostnikih, starejših od 12 let, ki se ne odzovejo zadovoljivo na konvencionalno sistemsko HS-zdravljenje (glejte poglavji 5.1 in 5.2).
English: Double-Blind Response at week 12
Slovenian: Dvojno slepa Odziv v 12. tednu placebo N = 94
English: Patients were randomised to receive either 24 mg/m body surface area (BSA) of adalimumab up to a maximum of 40 mg, or placebo every other week for 12 weeks.
Slovenian: Bolniki so bili randomizirani za prejemanje bodisi 24 mg/m² telesne površine adalimumaba do največjega posamičnega odmerka 40 mg ali placebo vsak drugi teden, 12 tednov.
English: Do not use this medicine after the expiry date which is stated on the label/blister/carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteku roka uporabnosti, ki je naveden na nalepki/pretisnem omotu/škatli poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: If your child gets any side effects, talk to your child's doctor or pharmacist.
Slovenian: Če vaš otrok dobi katerega koli izmed neželenih učinkov, se posvetujte z otrokovim zdravnikom ali farmacevtom.
English: Standard Dose 40/20 mg eow N = 93
Slovenian: Standardni odmerek 40/20 mg vsak drugi teden N = 93
English: Hulio is used to treat ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of ankylosing spondylitis in adults.
Slovenian: Zdravilo Hulio se uporablja za zdravljenje ankilozirajočega spondilitisa in aksialnega spondiloartritisa brez radiografskega dokaza o ankilozirajočem spondilitisu pri odraslih.
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 neradiografskim aksialnim spondiloartritisom je bila povprečna (± SD) najmanjša koncentracija v stanju dinamičnega ravnovesja (merjena v 68. tednu) 8,0 ± 4,6 µg/ml.
English: Injection syringe
Slovenian: raztopina za injiciranje
English: In adult patients with uveitis, a loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab every other week starting at week 1, resulted in mean steady-state concentrations of approximately 8 to 10 μg/ml.
Slovenian: Pri odraslih bolnikih z uveitisom je polnilni odmerek 80 mg adalimumaba v 0. tednu, ki mu je sledil odmerek 40 mg adalimumaba vsak drugi teden z začetkom v 1. tednu, povzročil povprečno koncentracijo v stanju dinamičnega ravnovesja približno 8 do 10 µg/ml.
English: You should rotate and change the injection site each time, staying at least 3 cm from the previous site used.
Slovenian: Ob vsakem injiciranju izberite drugo injekcijsko mesto, ki je vsaj 3 cm od mesta prejšnje injekcije.
English: Gently place the syringe on a clean, flat surface.
Slovenian: Brizgo previdno odložite na čisto, ravno delovno površino.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hulio 40 mg injection adalimumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Hulio 40 mg injekcija adalimumab s.c.
English: Adolescents with hidradenitis suppurativa from 12 to 17 years of age weighing at least 30 kg
Slovenian: Mladostniki s hidradenitis suppurativa, stari od 12 do 17 let, ki tehtajo najmanj 30 kg
English: If these medicines do not work well enough, your child will be given Hulio to treat his/her polyarticular juvenile idiopathic arthritis or enthesitis-related arthritis.
Slovenian: Če ta zdravila ne delujejo dovolj dobro, bo vaš otrok za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa ali artritisa, povezanega z entezitisom, prejel zdravilo Hulio.
English: Sustained Remission
Slovenian: Ohranjena remisija
English: • DO NOT inject into skin that is red, hard, bruised, or tender.
Slovenian: • NE injicirajte v pordelo, zatrdelo, podpluto ali občutljivo kožo.
English: NA 4.5% 23.2% a RA study I at 24 weeks, RA study II at 26 weeks , and RA study III at 24 and 52 weeks b 40 mg adalimumab administered every other week c MTX = methotrexate
Slovenian: a Študija revmatoidnega artritisa I po 24 tednih, študija revmatoidnega artritisa II po 26 tednih in študija revmatoidnega artritisa III po 24 in 52 tednih b 40 mg adalimumaba vsak drugi teden c MTX = metotreksat ** p < 0,01, adalimumab v primerjavi s placebom
English: ≥ 40 kg • 80 mg at week 0 and 40 mg at week 2
Slovenian: ≥ 40 kg • 80 mg v 0. tednu in 40 mg v 2. tednu
English: Hulio 40 mg solution for injection in pre-filled syringe Hulio 40 mg solution for injection in single-use pre-filled syringe with an automatic needle guard.
Slovenian: Hulio 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi Zdravilo Hulio 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi za enkratno uporabo, opremljeni s samodejnim ščitnikom za iglo.
English: Each Hulio vial contains 38.2 mg of sorbitol.
Slovenian: Vsaka viala zdravila Hulio vsebuje 38,2 mg sorbitola.
English: If these medicines do not work well enough your child will be given Hulio to reduce the signs and symptoms of his/her Crohn's disease.
Slovenian: Če ta zdravila ne delujejo dovolj dobro, bo vaš otrok za zmanjšanje znakov in simptomov Crohnove bolezni prejel zdravilo Hulio.
English: o DO NOT put the syringe back in the fridge after it has reached room temperature.
Slovenian: ◦ Injekcijske brizge NE dajte nazaj v hladilnik, ko se segreje na sobno temperaturo.
English: In the OL LI phase all patients received 24 mg/m2 up to a maximum of 40 mg adalimumab every other week for 16 weeks.
Slovenian: V odprti uvajalni fazi so vsi bolniki 16 tednov dobivali 24 mg/m² (do največ 40 mg) adalimumaba vsak drugi teden.
English: It is important that you tell your baby's doctors and other health care professionals about your Hulio use during your pregnancy so they can decide when your baby should receive any vaccine.
Slovenian: Zato je pomembno, da obvestite zdravnika svojega otroka in druge zdravstvene delavce, da ste med nosečnostjo prejemali zdravilo Hulio, da se lahko odločijo, kdaj bo vaš otrok lahko prejel katero koli cepivo.
English: o DO NOT use other heat sources such as a microwave oven or hot water to warm the syringe.
Slovenian: ◦ Za segrevanje injekcijske brizge NE uporabljajte nobenih drugih virov toplote, kot je mikrovalovna pečica ali vroča voda.
English: It is recommended that your child uses an antiseptic wash daily on the affected areas during treatment with Hulio.
Slovenian: Priporočljivo je, da vaš otrok med zdravljenjem z zdravilom Hulio na prizadetih predelih vsak dan uporabi antiseptično milo.
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: Your child's doctor may also prescribe an initial dose of 80 mg which may be administered one week prior to the start of the usual recommended dose.
Slovenian: Zdravnik lahko vašemu otroku predpiše začetni odmerek 80 mg, ki se ga lahko uporabi en teden pred začetkom zdravljenja z običajnim priporočenim odmerkom.
English: The third group received 40 mg of adalimumab every other week with placebo injections on alternate weeks.
Slovenian: Tretja pa je vsak drugi teden dobivala 40 mg adalimumaba in injekcije placeba vsak vmesni teden.
English: Place the Orange Activator end of the pen onto the injection site.
Slovenian: Del injekcijskega peresnika z oranžnim aktivatorjem postavite na injekcijsko mesto.
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 16 weeks.
Slovenian: Bolniki so prejeli začetni odmerek 80 mg adalimumaba, ki mu je sledil 40 mg odmerek vsak drugi teden (z začetkom en teden po začetnem odmerku) ali placebo 16 tednov.
English: At a 45° angle to the injection site, use a quick, short motion and push the needle all the way into skin.
Slovenian: S hitrim, kratkim gibom zabodite iglo v celoti v kožo pod kotom 45° na injekcijsko mesto.
English: The pre-filled syringes should be stored in the fridge (between 2°C to 8°C).
Slovenian: Napolnjene injekcijske peresnike shranjujte v hladilniku (pri temperaturi od 2 do 8 °C).
English: • Your child should consider the use of adequate contraception to prevent pregnancy and continue its use for at least 5 months after their last Hulio injection.
Slovenian: Vaš otrok naj premisli o uporabi ustrezne kontracepcije za preprečitev nosečnosti in naj nadaljuje z njeno uporabo še najmanj 5 mesecev po tem, ko prejme zadnjo injekcijo zdravila Hulio.
English: The safety and efficacy of adalimumab were studied in adult patients with chronic plaque psoriasis (≥ 10% BSA involvement and Psoriasis Area and Severity Index (PASI) ≥ 12 or ≥ 10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Slovenian: Varnost in učinkovitost adalimumaba so raziskali v randomiziranih, dvojno slepih študijah pri odraslih bolnikih s kronično psoriazo v plakih (zajete  10 % telesne površine ter indeksom obsežnosti in izrazitosti psoriaze (PASI - Psoriasis Area and Severity Index)  12 ali  10), ki so bili kandidati za sistemsko zdravljenje ali fototerapijo.
English: Injecting Hulio
Slovenian: Injiciranje zdravila Hulio
English: Hulio 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 Hulio uporabljati previdno.
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 je bila povprečna (± SD) najmanjša koncentracija adalimumaba v stanju dinamičnega ravnovesja približno 7,4 ± 5,8 µg/ml (79 % KV).
English: If you are unsure, contact your child's doctor.
Slovenian: Če niste gotovi, se posvetujte z otrokovim zdravnikom.
English: Table 22: Induction of Clinical Remission and Response (Percent of Patients)
Slovenian: Preglednica 22: Indukcija klinične remisije in odziva (odstotek bolnikov)
English: The Hulio vial is a glass vial with a rubber stopper.
Slovenian: Viala zdravila Hulio je steklena viala z gumijasto zaporko.
English: Patients who maintained ≥PASI 75 response at week 33 and were originally randomised to active therapy in period A, were re-randomised in period C to receive 40 mg adalimumab every other week or placebo for an additional 19 weeks.
Slovenian: Bolnike, ki so imeli 33. teden ohranjen odziv PASI ≥ 75 in so bili v obdobju A randomizirani na aktivno terapijo, so v obdobju C ponovno randomizirali tako, da so dodatnih 19 tednov dobivali bodisi 40 mg adalimumaba vsak drugi teden bodisi placebo.
English: All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at week 0 and 80 mg at week 2 for subjects ≥ 40 kg, and 80 mg and 40 mg, respectively, for subjects < 40 kg.
Slovenian: Vsi bolniki so prejeli odprto indukcijsko zdravljenje v odmerku glede na njihovo začetno telesno maso: 160 mg v 0. tednu in 80 mg v 2. tednu bolniki z ≥ 40 kg ter 80 mg in 40 mg, v tem vrstnem redu, bolniki z < 40kg.
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/m² (do največ 40 mg) ali placebo.
English: Your doctor will test you for HBV. Hulio can reactivate HBV infection in people who carry this virus.
Slovenian: Zdravilo Hulio lahko pri nosilcih HBV povzroči reaktivacijo tega virusa.
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 trženja identificiran hepatosplenični limfom celic T. Ta redka oblika limfoma celic T ima zelo agresiven potek bolezni, običajno s smrtnim izidom.
English: Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
Slovenian: V študiji 226 odraslih preiskovancev z revmatoidnim artritisom, ki so prejemali adalimumab ali placebo, so ugotovili podobne odzive protiteles na standardno 23-valentno pnevmokokno cepivo in trivalentno virusno cepivo proti influenci.
English: If symptoms of tuberculosis (persistent cough, weight loss, listlessness, mild fever), or any other infection appear during or after therapy tell your child's doctor immediately.
Slovenian: Če se med zdravljenjem ali po njem pojavijo simptomi tuberkuloze (trdovraten kašelj, hujšanje, brezvoljnost, rahlo zvišana telesna temperatura) ali kakšne druge okužbe, to takoj povejte otrokovemu zdravniku.
English: The Patient Reminder Cards (adult and paediatric) should contain the following key elements:
Slovenian: Opozorilna kartica za bolnika (za odrasle in za otroke) mora vsebovati naslednje ključne elemente: hude okužbe tuberkulozo rak težave z živčnim sistemom cepljenja
English: Plaque psoriasis in adults and children
Slovenian: Psoriaza v plakih pri odraslih
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, bodisi na adalimumab v odmerku 160 mg 0. teden, ki mu sledi odmerek 80 mg 2. teden bodisi na adalimumab v odmerku 80 mg 0. teden, ki mu sledi odmerek 40 mg 2. teden.
English: Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Hulio.
Slovenian: Med zdravljenjem z zdravilom Hulio je mogoče nadaljevati z uporabo glukokortikoidov, salicilatov, nesteroidnih protivnetnih zdravil ali analgetikov.
English: Adolescents with hidradenitis suppurativa from 12 years of age, weighing at least 30 kg
Slovenian: Mladostniki s hidradenitis suppurativa, starejši od 12 let, ki tehtajo najmanj 30 kg
English: * p < 0.001 for adalimumab versus placebo pairwise comparisons of proportions ** p < 0.02 for adalimumab versus placebo pairwise comparisons of proportions a Of those receiving corticosteroids at baseline
Slovenian: * p < 0,001 za parne primerjave deležev med adalimumabom in placebom ** p < 0,02 za parne primerjave deležev med adalimumabom in placebom a od tistih, ki so izhodiščno dobivali kortikosteroide
English: • blockage in an artery of the lung;
Slovenian: • zamašitev arterije v pljučih;
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 v plakih in s trajanjem kontrolnega obdobja od 12 do 24 tednov se je zvišanje ALT ≥ 3 × ULN pojavilo pri 1,8 % bolnikov, zdravljenih z adalimumabom, in pri 1,8 % bolnikov v kontrolni skupini.
English: In adult patients with psoriasis, the mean steady-state trough concentration was 5 μg/ml during adalimumab 40 mg every other week monotherapy treatment.
Slovenian: Pri odraslih bolnikih s psoriazo je bila povprečna najmanjša koncentracija v stanju dinamičnega ravnovesja med monoterapijo s 40 mg adalimumaba vsak drugi teden 5 µg/ml.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hulio 40 mg/0.8 ml injection adalimumab
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Hulio 40 mg/0,8 ml injekcija adalimumab s.c.
English: • Check the expiry date printed on the pen.
Slovenian: • Preverite rok uporabnosti zdravila, ki je natisnjen na injekcijskem peresniku.
English: Placebo/MTXAdalimumab /MTX (95% Confidence Intervalb)
Slovenian: 40 mg vsak drugi teden placebo/MTXadalimumab/MTX (95-% interval zaupanjab)
English: Dose Preparation
Slovenian: Priprava odmerka
English: The combination of Hulio and anakinra is not recommended (see section 4.4 “Concurrent administration of biologic DMARDs or TNF-antagonists”).
Slovenian: Kombinacija zdravila Hulio in anakinre ni priporočljiva (glejte poglavje 4.4 ''Sočasna uporaba bioloških DMARD ali antagonistov TNF'').
English: Following subcutaneous administration of 40 mg of adalimumab every other week in adult rheumatoid arthritis (RA) patients the mean steady-state trough concentrations were approximately 5 μg/ml (without concomitant methotrexate) and 8 to 9 μg/ml (with concomitant methotrexate), respectively.
Slovenian: Po subkutani uporabi 40 mg adalimumaba vsak drugi teden pri odraslih bolnikih z revmatoidnim artritisom (RA) so bile povprečne najmanjše koncentracije v stanju dinamičnega ravnovesja približno 5 µg/ml (brez sočasne uporabe metotreksata) in od 8 do 9 µg/ml (s sočasno uporabo metotreksata).
English: Table 9: Radiographic Mean Changes Over 12 Months in RA Study III
Slovenian: Preglednica 9: Povprečne rentgenografske spremembe v 12 mesecih študije revmatoidnega artritisa III
English: • It is important that you tell your baby's doctors and other health care professionals about your Hulio use during your pregnancy before the baby receives any vaccine.
Slovenian: Pomembno je, da poveste dojenčkovemu zdravniku in drugim zdravstvenim delavcem o uporabi zdravila Hulio med nosečnostjo, preden dojenček dobi cepivo.
English: Step 8 - Pull plunger to draw dose + 0.1 ml Keep the plunger rod pressed down and turn the connected syringe and vial upside down.
Slovenian: 8. korak - Povlecite bat, da izvlečete odmerek +0,1 ml.
English: Table 8: Ped ACR 30 Responses in the JIA study
Slovenian: Preglednica 8: Odzivi »Ped ACR« 30 v študiji juvenilnega idiopatskega artritisa Stratum
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 Hulio should be considered prior to initiating therapy (see Other opportunistic infections).
Slovenian: Pred začetkom zdravljenja je treba tveganja in koristi zdravljenja z zdravilom Hulio pretehtati pri bolnikih, ki so bili izpostavljeni tuberkulozi, in bolnikih, ki so potovali na območja, kjer obstaja veliko tveganje tuberkuloze ali endemičnih mikoz, npr. histoplazmoze, kokcidioidomikoze ali blastomikoze (glejte Druge oportunistične okužbe).
English: Table 13: Paediatric Plaque Psoriasis Efficacy Results at 16 weeks
Slovenian: Preglednica 13: Rezultati učinkovitosti v 16. tednu pri pediatričnih bolnikih s psoriazo v plakih
English: If this dose does not work well enough, your child's doctor may increase the dose frequency to 20 mg every week.
Slovenian: Če ta odmerek ne deluje dovolj dobro, lahko otrokov zdravnik poveča pogostnost odmerjanja na 20 mg vsak teden.
English: The recommended Hulio 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 Hulio je 80 mg v 0. tednu, ki mu sledi 40 mg vsak drugi teden z začetkom v 1. tednu, v obliki subkutane injekcije.
English: CD Study I and CD Study II induction of remission and response rates are presented in Table 22.
Slovenian: Indukcijo remisije in deleže odziva v študiji Crohnove bolezni I in študiji Crohnove bolezni II prikazuje preglednica 22.