FrancophonIA/ELRC3.0 huggingface dataset:
English: Following 52 weeks and 104 weeks of treatment, the percentage of patients without progression (change from baseline in modified Total Sharp Score ≤ 0.5) was significantly higher with adalimumab /methotrexate combination therapy (63.8% and 61.2% respectively) compared to methotrexate monotherapy (37.4% and 33.5% respectively, p < 0.001) and adalimumab monotherapy (50.7%, p < 0.002 and 44.5%, p < 0.001 respectively).
Slovenian: Po 52 oz. 104 tednih zdravljenja je bil v skupini s kombinirano terapijo z adalimumabom in metotreksatom odstotek bolnikov brez napredovanja bolezni (sprememba prilagojene Sharpove ocene od izhodišča ≤ 0,5) značilno večji (63,8 % oz. 61,2 %) kot v skupinah, ki sta prejemali monoterapijo z metotreksatom (37,4 % in 33,5 %, p < 0,001) ali monoterapijo z adalimumabom (50,7 %, p < 0,002, oz. 44,5 %, p < 0,001).
English: If you have mild heart failure and you are being treated with Hulio your heart failure status must be closely monitored by your doctor.
Slovenian: Če imate blago srčno popuščanje in se zdravite z zdravilom Hulio, mora zdravnik natančno nadzorovati stanje vašega srčnega popuščanja.
English: Patients who had been randomised to placebo in Period A were assigned to receive adalimumab 40 mg every week in period B.
Slovenian: Bolniki, ki so jih randomizirali na placebo v obdobju A, so v obdobju B prejemali adalimumab 40 mg vsak teden.
English: The efficacy of adalimumab was assessed in a randomised, double-blind, controlled study of 114 paediatric patients from 4 years of age with severe chronic plaque psoriasis (as defined by a Physician's Global Assessment (PGA) ≥ 4 or > 20% BSA involvement or > 10% BSA involvement with very thick lesions or Psoriasis Area and Severity Index (PASI) ≥ 20 or ≥ 10 with clinically relevant facial, genital, or hand/ foot involvement) who were inadequately controlled with topical therapy and heliotherapy or phototherapy.
Slovenian: Učinkovitost adalimumaba je bila ocenjena v randomizirani, dvojno slepi, kontrolirani študiji, v katero je bilo vključenih 114 pediatričnih bolnikov od 4. leta starosti, s hudo kronično psoriazo v plakih (definirano z zdravnikovo globalno oceno (PGA - Physician's Global Assessment) ≥ 4 ali > 20 % zajete telesne površine ali > 10 % zajete telesne površine z zelo grobimi lezijami ali indeksom obsežnosti in izrazitosti psoriaze (PASI - Psoriasis Area and Severity Index) ≥ 20 ali ≥ 10 s klinično pomembnim zajetjem obraza, genitalij ali dlani/stopal), ki ni bila ustrezno nadzorovana s topikalnim zdravljenjem in helioterapijo ali fototerapijo.
English: Table 16: ACR Response in Placebo-Controlled Psoriatic Arthritis Studies (Percent of Patients)
Slovenian: Preglednica 16: Odziv ACR v študijah psoriatičnega artritisa, kontroliranih s placebom (odstotek bolnikov)
English: The mean (±SD) serum adalimumab trough concentrations achieved at week 4 were 15.7±6.6 μg/ml for patients ≥ 40 kg (160/80 mg) and 10.6±6.1 μg/ml for patients < 40 kg (80/40 mg).
Slovenian: Povprečne (± SD) serumske koncentracije adalimumaba, dosežene v 4. tednu, so bile 15,7 ± 6,6 µg/ml pri bolnikih ≥ 40 kg (160/80 mg) in 10,6 ± 6,1 µg/ml pri bolnikih < 40 kg (80/40 mg).
English: SPARCCh MRI Sacroiliac Jointsd,i
Slovenian: SPARCCh MRI sakroiliakalnih sklepovd, i
English: If you have allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or a rash, do not inject more Hulio and contact your doctor immediately since, in rare cases, these reactions can be life-threatening.
Slovenian: Če imate alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Hulio ne injicirajte več in se takoj posvetujte z zdravnikom, saj so v redkih primerih te reakcije lahko življenjsko ogrožajoče.
English: Hulio is used to treat severe plaque psoriasis in children and adolescents aged 4 to 17 years whom medicines applied to the skin and treatment with UV light have either not worked very well or are not suitable.
Slovenian: Zdravilo Hulio se uporablja za zdravljenje hude luskavice v plakih pri otrocih in mladostnikih, starih od 4 do 17 let, pri katerih zdravila, nanesena na kožo, in zdravljenje z UV-svetlobo niso dovolj dobro delovali ali pa niso primerni.
English: • Do not give Hulio to children with plaque psoriasis below the age of 4 years.
Slovenian: • Zdravila Hulio ne smete dati otroku s psoriazo v plakih, če je star manj kot 4 leta.
English: The usual dose regimen is 40 mg initially, followed by 20 mg two weeks later.
Slovenian: Običajni začetni odmerek je 40 mg, ki mu sledi 20 mg dva tedna kasneje.
English: • If your child receives Hulio during her pregnancy, her baby may have a higher risk for getting an infection.
Slovenian: Če vaš otrok prejema zdravilo Hulio med nosečnostjo, ima lahko njegov dojenček povečano tveganje za okužbo.
English: Each pre-filled syringe is for single-use only and contains one 40 mg dose of adalimumab.
Slovenian: Vsaka napolnjena injekcijska brizga je namenjena samo za enkratno uporabo in vsebuje en 40 mg odmerek adalimumaba.
English: Placebo / MTXc n=60
Slovenian: placebo/M TXc n = 60
English: If these medicines do not work well enough, you will be given Hulio to treat your rheumatoid arthritis.
Slovenian: Če ta zdravila ne delujejo dovolj dobro, boste za zdravljenje revmatoidnega artritisa dobili zdravilo Hulio.
English: The following side effects have been observed with adalimumab:
Slovenian: Pri uporabi adalimumaba so bili ugotovljeni naslednji neželeni učinki:
English: Adalimumab has not been studied in patients aged less than 2 years.
Slovenian: Študije z adalimumabom pri bolnikih, mlajših od 2 let, niso bile izvedene.
English: o DO NOT use the vial if past the expiry date.
Slovenian: ◦ Viale NE uporabljajte, če je rok uporabnosti že potekel.
English: • If you have an infection, including long-term or localised infection (for example, leg ulcer) consult your doctor before starting Hulio.
Slovenian: • Če imate kakšno okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo zdravila Hulio posvetujte s svojim zdravnikom.
English: In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see Table 18).
Slovenian: Pri bolnikih z vsaj delnim odzivom na adalimumab v odmerku 40 mg vsak teden v 12. tednu je bila stopnja kliničnega odziva (HiSCR) v 36. tednu višja pri bolnikih, ki so nadaljevali zdravljenje z adalimumabom vsak teden, kot pri bolnikih, pri katerih so pogostnost odmerjanja zmanjšali na vsak drugi teden ali pri katerih je bilo zdravljenje ukinjeno (glejte preglednico 18).
English: o DO NOT use other heat sources such as a microwave oven or hot water to warm the vial.
Slovenian: ◦ Za segrevanje viale NE uporabljajte nobenih drugih virov toplote, kot je mikrovalovna pečica ali vroča voda.
English: Statistically and clinically significant improvements from Baseline were also observed in both treatment groups for quality of life parameters (including IMPACT III).
Slovenian: Opazili so tudi statistično in klinično pomembno izboljšanje parametrov kakovosti življenja (vključno z IMPACT III) glede na začetek študije.
English: Rhabdomyolysis, systemic lupus erythematosus
Slovenian: občasni rabdomioliza, sistemski eritematozni lupus redki sindrom, podoben lupusu1)
English: Patients received adalimumab 0.8 mg/kg eow (up to 40 mg), 0.4 mg/kg eow (up to 20 mg), or methotrexate 0.1 - 0.4 mg/kg weekly (up to 25 mg).
Slovenian: Bolniki so prejemali adalimumab v odmerkih 0,8 mg/kg vsak drugi teden (do 40 mg), 0,4 mg/kg vsak drugi teden (do 20 mg) ali 0,1-0,4 mg/kg metotreksata na teden (do 25 mg).
English: Step 6 - Insert needle into site
Slovenian: 6. korak - Iglo zabodite v mesto.
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 v 12. tednu odziv PASI 75 doseglo 92 od 349 (26,4 %) bolnikov in v 24. tednu 132 od 349 (37,8 %) bolnikov, ki so jim zaradi odziva PASI pod 50 % odmerek povečali s 40 mg vsak drugi teden na 40 mg vsak teden.
English: Anti-adalimumab antibodies may develop during adalimumab treatment.
Slovenian: Med zdravljenjem z adalimumabom lahko nastanejo protitelesa proti adalimumabu.
English: • If your child have an infection, including long-term or localised infection (for example, leg ulcer) consult your child's doctor before starting Hulio.
Slovenian: • Če ima vaš otrok okužbo, vključno z dolgotrajno ali omejeno okužbo (npr. razjedo na nogi), se pred uporabo zdravila Hulio posvetujte z otrokovim zdravnikom.
English: In Study nr-axSpA I, adalimumab 40 mg every other week was assessed in 185 patients in a randomised, 12 week double - blind, placebo - controlled study in patients with active nr-axSpA (mean baseline score of disease activity [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] was 6.4 for patients treated with adalimumab and 6.5 for those on placebo) who have had an inadequate response to or intolerance to ≥ 1 NSAIDs, or a contraindication for NSAIDs.
Slovenian: Uporabo adalimumaba 40 mg vsak drugi teden so proučili v randomizirani, 12 tednov trajajoči, dvojno slepi, s placebom kontrolirani študiji nr-axSpA I pri 185 bolnikih z aktivnim nr-axSpA (srednja vrednost aktivnosti bolezni [Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)] je bila 6,4 pri bolnikih, zdravljenih z adalimumabom, in 6,5 pri bolnikih na placebu), ki so nezadostno reagirali na ali niso prenašali ≥ 1 NSAID ali s kontraindikacijo za NSAID.
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: Consequently, adalimumab can be used during breastfeeding.
Slovenian: Posledično se zdravilo Hulio lahko uporablja med dojenjem.
English: TIME (WEEKS) Treatment
Slovenian: ČAS (TEDNI)
English: - Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before your child is given Hulio and during treatment with Hulio.
Slovenian: Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden vaš otrok prejme zdravilo Hulio in med zdravljenjem z njim.
English: Table 27: Paediatric CD Study Discontinuation of Corticosteroids or Immunomodulators and Fistula Remission
Slovenian: Preglednica 27: Študija Crohnove bolezni pri pediatričnih bolnikih Prenehanje zdravljenja s kortikosteroidi ali imunomodulatorji in remisija fistule
English: • 1 gauze pad or cotton ball (not included in Hulio pack)
Slovenian: • 1 blazinico gaze ali kosem vate (ni priložen pakiranju zdravila Hulio).
English: In patients with at least a partial response to adalimumab 40 mg weekly at week 12, the HiSCR rate at week 36 was higher in patients who continued weekly adalimumab than in patients in whom dosing frequency was reduced to every other week, or in whom treatment was withdrawn (see Table 22).
Slovenian: Pri bolnikih z vsaj delnim odzivom na adalimumab v odmerku 40 mg vsak teden v 12. tednu je bila stopnja kliničnega odziva (HiSCR) v 36. tednu višja pri bolnikih, ki so nadaljevali zdravljenje z adalimumabom vsak teden, kot pri bolnikih, pri katerih so pogostnost odmerjanja zmanjšali na vsak drugi teden ali pri katerih je bilo zdravljenje ukinjeno (glejte preglednico 22).
English: 1 box of Hulio vial for paediatric use
Slovenian: • 1 škatlo vial zdravila Hulio za pediatrično uporabo;
English: It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Hulio.
Slovenian: Priporočljivo je, da med zdravljenjem z zdravilom Hulio bolnik vsak dan uporablja topikalno antiseptično čistilno sredstvo za čiščenje lezij HS.
English: At week 4, patients were randomised 1:1 to either the Standard Dose (40/20 mg eow) or Low Dose (20/10 mg eow) maintenance treatment groups based on their body weight.
Slovenian: V 4. tednu so bili bolniki randomizirani 1 : 1 bodisi v skupino s standardnim vzdrževalnim odmerkom (40/20 mg vsak drugi teden) ali v skupino z majhnim vzdrževalnim odmerkom (20/10 mg vsak drugi teden), odvisno od njihove telesne mase.
English: Your doctor, nurse or other healthcare professional will first show you how to inject Hulio pre-filled syringe.
Slovenian: Zdravnik, medicinska sestra ali drug zdravstveni delavec vam bo pokazal, kako si zdravilo Hulio v injekcijski brizgi injicirate sami.
English: If your child has allergic reactions with symptoms such as chest tightness, wheezing, dizziness, swelling or a rash do not inject them more Hulio and contact their doctor immediately since, in rare cases, these reactions can be life-threatening.
Slovenian: Če ima vaš otrok alergijske reakcije s simptomi, kot so tiščanje v prsih, piskajoče dihanje, omotica, otekanje ali izpuščaj, zdravila Hulio ne injicirajte več in se takoj posvetujte z otrokovim zdravnikom, saj so v redkih primerih te reakcije lahko življenjsko ogrožujoče.
English: The syringe is made from cyclo olefin polymer plastic with a stopper (chlorobutyl rubber) and a needle (stainless steel) with a needle cap (butyl /diene blend polymer and polypropylene).
Slovenian: Injekcijska brizga je narejena iz cikličnih olefinskih polimerov z zaporko (klorobutilni kavčuk) in z iglo (nerjavno jeklo) z varovalnim pokrovčkom (mešanica butil/dienskih polimerov ter polipropilen).
English: Step 7 - Inject Hulio
Slovenian: 7. korak - Injicirajte zdravilo Hulio.
English: A 40 mg pen and a 40 mg prefilled syringe are also available for patients to administer a full 40 mg dose.
Slovenian: Bolnikom sta na voljo tudi 40 mg injekcijski peresnik in 40 mg napolnjena injekcijska brizga za odmerjanje celotnega odmerka 40 mg.
English: Hulio is used to treat rheumatoid arthritis in adults.
Slovenian: Zdravilo Hulio se uporablja za zdravljenje revmatoidnega artritisa pri odraslih.
English: Psoriasis Study IV compared efficacy and safety of adalimumab versus placebo in 217 adult patients with moderate to severe nail psoriasis.
Slovenian: Študija psoriaze IV je primerjala učinkovitost in varnost adalimumaba v primerjavi s placebom pri 217 odraslih bolnikih z zmerno do hudo psoriazo nohtov.
English: Psoriatic arthritis is an inflammatory disease of the joints associated with psoriasis.
Slovenian: Psoriatični artritis je vnetje sklepov, povezano s kožno luskavico.
English: Hulio is used to treat: - adults with non-infectious uveitis with inflammation affecting the back of the eye. - children and adolescents aged 2 to 17 years with chronic non-infectious uveitis who have inflammation affecting the front of the eye.
Slovenian: Zdravilo Hulio se uporablja za zdravljenje: - odraslih z neinfekcijskim uveitisom, kjer vnetje prizadene zadnji del očesa, - otrok in mladostnikov, starih od 2 do 17 let, s kroničnim neinfekcijskim uveitisom, kjer vnetje prizadene sprednji del očesa.
English: Pulmonary embolism1), interstitial lung disease, chronic obstructive pulmonary disease, pneumonitis, pleural effusion1)
Slovenian: pogosti astma, dispneja, kašelj občasni pljučna embolija1), intersticijska pljučna bolezen, kronična obstruktivna pljučna bolezen, pnevmonitis, plevralni izliv1)
English: The safety and efficacy of adalimumab was assessed in a randomized, double-masked, controlled study of 90 paediatric patients from 2 to < 18 years of age with active JIA-associated noninfectious anterior uveitis who were refractory to at least 12 weeks of methotrexate treatment.
Slovenian: Varnost in učinkovitost adalimumaba sta bili ocenjeni v randomizirani, dvojno slepi, kontrolirani študiji pri 90 pediatričnih bolnikih, starih od 2 do < 18 let, z aktivnim neinfekcijskim anteriornim uveitisom, povezanim z juvenilnim idiopatskim artritisom, ki se niso odzvali na zdravljenje z metotreksatom, ki je trajalo vsaj 12 tednov.
English: You should not take Hulio with medicines containing the active substances anakinra or abatacept.
Slovenian: Zdravila Hulio ne smete jemati z zdravili, ki vsebujejo učinkovini anakinra ali abatacept.
English: These trials included rheumatoid arthritis patients with short term and long standing disease, juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and enthesitisrelated arthritis) as well as axial spondyloarthritis (ankylosing spondylitis and axial spondyloarthritis without radiographic evidence of AS), psoriatic arthritis, Crohn's disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis patients.
Slovenian: Ta preskušanja so vključila bolnike z revmatoidnim artritisom (tako tiste, ki so imeli bolezen kratek čas, kot tiste, ki so jo imeli že dolgo), juvenilnim idiopatskim artritisom (poliartikularnim juvenilnim idiopatskim artritisom in artritisom, povezanim z entezitisom), aksialnim spondiloartritisom (ankilozirajočim spondilitisom in aksialnim spondiloartritisom brez radiografskega dokaza za AS), psoriatičnim artritisom, Crohnovo boleznijo, ulceroznim kolitisom, psoriazo, hidradenitis suppurativa in uveitisom.
English: Solution for injection 1 pre-filled syringe, 2 alcohol pads 2 pre-filled syringes, 2 alcohol pads 6 pre-filled syringes, 6 alcohol pads
Slovenian: 1 napolnjena injekcijska brizga, 2 alkoholna zloženca 2 napolnjeni injekcijski brizgi, 2 alkoholna zloženca 6 napolnjenih injekcijskih brizg, 6 alkoholnih zložencev
English: Pharmacotherapeutic group: Immunosuppressants, Tumour Necrosis Factor alpha (TNF-α) inhibitors.
Slovenian: Farmakoterapevtska skupina: Zdravila za zaviranje imunske odzivnosti, zaviralci tumorje nekrotizirajočega faktorja alfa (TNF-α), oznaka ATC: L04AB04
English: Sustained Response
Slovenian: Ohranjen odziv
English: The recommended dose of Hulio for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
Slovenian: Priporočeni odmerek zdravila Hulio za odrasle bolnike z revmatoidnim artritisom je 40 mg adalimumaba vsak drugi teden v enkratnem odmerku v subkutani injekciji.
English: The recommended dose of Hulio for patients with Crohn's disease from 6 to 17 years of age is based on body weight (Table 4).
Slovenian: Priporočeni odmerek zdravila Hulio pri bolnikih s Crohnovo boleznijo, starih od 6 do 17 let, temelji na telesni masi (preglednica 4).
English: If your child develops a fever that does not go away, or bruises or bleeds very easily or look very pale, call your child's doctor right away.
Slovenian: Če vaš otrok dobi zvišano telesno temperaturo, ki ne mine, če se mu pojavljajo podplutbe, zlahka zakrvavi ali je zelo bled, se takoj posvetujte z njegovim zdravnikom.
English: • nausea and vomiting;
Slovenian: • siljenje na bruhanje in bruhanje;
English: Ulcerative Colitis
Slovenian: Ulcerozni kolitis
English: The syringe inside the pen is made from cyclo olefin polymer plastic with a stopper (chlorobutyl rubber) and a needle (stainless steel) with a needle cap (butyl /diene blend polymer and polypropylene).
Slovenian: Injekcijska brizga v injekcijskem peresniku je narejena iz cikličnih olefinskih polimerov z zaporko (klorobutilni kavčuk) in z iglo (nerjavno jeklo) z varovalnim pokrovčkom (mešanica butil/dienskih polimerov ter polipropilen).
English: - Your doctor will also give you a Patient Reminder Card, which contains important safety information that you need to be aware of before you are given Hulio and during treatment with Hulio.
Slovenian: Ta vsebuje pomembne varnostne informacije, s katerimi morate biti seznanjeni, preden prejmete zdravilo Hulio in med zdravljenjem z njim.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - VIAL SINGLE UNIT PACK
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA ŠKATLA - ENOJNO PAKIRANJE VIAL
English: Needle Safety Feature
Slovenian: Varnostni sistem igle
English: Table 15: Ps Study II (CHAMPION) Efficacy Results at 16 weeks Placebo N=53 n (%)
Slovenian: Preglednica 15: Študija psoriaze II (CHAMPION) - rezultati učinkovitosti po 16 tednih placebo n = 53 n (%)
English: Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma), benign neoplasm
Slovenian: pogosti karcinom kože, ki ne vključuje melanoma (vključno z bazalnoceličnim karcinomom in ploščatoceličnim karcinomom), benigni tumor občasni limfom**,
English: If these medicines do not work well enough, you will be given Hulio to reduce the signs and symptoms of your disease.
Slovenian: Če ta zdravila ne delujejo dovolj dobro, boste za zmanjšanje znakov in simptomov bolezni dobili zdravilo Hulio.
English: The incidence of serious infections was 0.04 per patient year in adalimumab treated patients and 0.03 per patient year in placebo and active control - treated patients.
Slovenian: Incidenca resnih okužb je bila 0,04 na bolnikov-let med bolniki, ki so prejemali adalimumab, in 0,03 na bolnikov-let med bolniki, ki so dobivali placebo oziroma primerjalno zdravilo.
English: a a a p<0.001, adalimumab vs. placebo
Slovenian: b p < 0,001, adalimumab v primerjavi s placebom
English: Fatal and life-threatening infections (including sepsis, opportunistic infections and TB), HBV reactivation and various malignancies (including leukaemia, lymphoma and HSTCL) have also been reported with use of adalimumab.
Slovenian: Poročali so tudi o smrtnih in življenjsko ogrožajočih okužbah (vključno s sepso, oportunističnimi okužbami in TB), HBV reaktivaciji in različnih malignih obolenjih (vključno z levkemijo, limfomom in HSTCL).
English: If you develop a fever that does not go away, or you bruise or bleed very easily or look very pale, call your doctor right away.
Slovenian: Če dobite zvišano telesno temperaturo, ki ne mine, če se vam pojavljajo podplutbe, zlahka zakrvavite ali ste zelo bledi, se takoj posvetujte s svojim zdravnikom.
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: Delež (95-% interval zaupanja) limfomov je bil 0,7 (0,2; 2,7) 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: Your doctor, nurse or other healthcare professional will first show you how to inject Hulio pre-filled pen.
Slovenian: Zdravnik, medicinska sestra ali drug zdravstveni delavec vam bo pokazal, kako si zdravilo Hulio v injekcijskem peresniku injicirate sami.
English: In controlled Phase 3 trials of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 4 to 17 years and enthesitis-related arthritis who were 6 to 17 years, ALT elevations ≥ 3 x ULN occurred in 6.1% of adalimumab-treated patients and 1.3% of control-treated patients.
Slovenian: V kontroliranih preskušanjih faze 3 z adalimumabom pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, ki so bili stari od 4 do 17 let, in bolnikih z artritisom, povezanim z entezitisom, ki so bili stari od 6 do 17 let, so se zvišanja ALT ≥ 3 × ULN pojavila pri 6,1 % bolnikov, zdravljenih z adalimumabom, in pri 1,3 % bolnikov v kontrolni skupini.
English: With the vial adapter still in the clear package, attach it to the vial stopper by pushing the adapter over the vial until it snaps in place.
Slovenian: Medtem ko je adapter za vialo še v prozorni ovojnini, ga namestite na zaporko viale tako, da ga potiskate navzdol, dokler se ne zaskoči na mestu.
English: If you do not respond well enough to these medicines, you will be given Hulio to reduce the signs and symptoms of your Crohn's disease.
Slovenian: Če se nanje ne boste odzvali dovolj dobro, boste za zmanjšanje znakov in simptomov Crohnove bolezni dobili zdravilo Hulio.