FrancophonIA/ELRC3.0 huggingface dataset:
English: • the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
Slovenian: • zdravljenje hudega, aktivnega in progresivnega revmatoidnega artritisa pri odraslih, ki prej še niso dobivali metotreksata.
English: Polyarticular juvenile idiopathic arthritis and enthesitis-related arthritis are inflammatory diseases of the joints that usually first appear in childhood.
Slovenian: Poliartikularni juvenilni idiopatski artritis in artritis, povezan z entezitisom, sta vnetni bolezni sklepov, ki se običajno prvič pojavita v otroštvu.
English: Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with Hulio.
Slovenian: Bolnike je zato treba pred, med in po zdravljenju z zdravilom Hulio natančno spremljati glede okužb, vključno s tuberkulozo.
English: What you need to know before you use Hulio
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Hulio
English: Injection steps
Slovenian: Koraki za injiciranje
English: Patients requiring a dose less than 40 mg should use the 40 mg vial presentation of Hulio.
Slovenian: Bolniki, ki potrebujejo manj kot 40 mg odmerek, naj uporabijo 40 mg vialo zdravila Hulio.
English: Should treatment be interrupted, Hulio 40 mg every week or 80 mg every other week may be reintroduced (see section 5.1).
Slovenian: Če je potrebno z zdravljenjem prekiniti, lahko ponovno uvedete zdravljenje z zdravilom Hulio z odmerkom 40 mg vsak teden ali 80 mg vsak drugi teden (glejte poglavje 5.1).
English: N/A
Slovenian: (n/N)
English: • Do not give Hulio to children with polyarticular juvenile idiopathic arthritis and chronic non infectious uveitis below the age of 2 years.
Slovenian: • Zdravila Hulio ne smete dati otroku s poliartikularnim juvenilnim idiopatskim artritisom in kroničnim neinfekcijskim uveitisom, če je star manj kot 2 leti.
English: Hulio in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs).
Slovenian: Zdravilo Hulio je v kombinaciji z metotreksatom indicirano za zdravljenje aktivnega poliartikularnega juvenilnega idiopatskega artritisa pri bolnikih od 2. leta starosti, ki se ne odzovejo ustrezno na eno ali več imunomodulirajočih antirevmatičnih zdravil (DMARD).
English: There is limited experience in the initiation of treatment with adalimumab alone.
Slovenian: Izkušnje z uvedbo zdravljenja samo z adalimumabom so omejene.
English: • vertigo (sensation of the room spinning);
Slovenian: • vertigo (občutek vrtenja);
English: • DO NOT put the needle cap back on the needle after it has been removed.
Slovenian: • NE NAMEŠČAJTE pokrovčka igle nazaj na iglo, potem ko ste ga odstranili.
English: At week 12 and week 24, PedACR30 response was 93.5% and 90.0%, respectively, using the observed data approach.
Slovenian: 12. teden je bil odziv Ped ACR 30 93,5 % in 24. teden 90,0 % (z uporabo pristopa z opaženimi podatki).
English: • Check the solution in the vial is clear, colourless and has no particles.
Slovenian: • Prepričajte se, da je raztopina v viali bistra, brezbarvna in da ne vsebuje nobenih delcev.
English: urticaria, bruising (including purpura), dermatitis (including eczema), onychoclasis, hyperhydrosis, alopecia 1),
Slovenian: urtikarija, modrice (vključno s purpuro), dermatitis (vključno z ekcemom), lomljenje nohtov, čezmerno znojenje, alopecija1),
English: Your child may first be given other medicines.
Slovenian: Vaš otrok bo najprej prejel druga zdravila.
English: If you forget to use Hulio
Slovenian: Če ste pozabili uporabiti zdravilo Hulio
English: Erythema multiforme1), Stevens-Johnson syndrome1), angioedema1), cutaneous vasculitis1), lichenoid skin reaction1)
Slovenian: srbenje občasni nočno potenje, brazgotinjenje redki multiformni eritem1), Stevens-Johnsonov sindrom1), angioedem1), kožni vaskulitis1), lihenoidna reakcija1)
English: For storage information, see the package leaflet.
Slovenian: Za informacije o shranjevanju glejte navodilo za uporabo.
English: REMINDER STICKERS TEXT (included in pack)
Slovenian: BESEDILO ZA OPOZORILNE NALEPKE (vključeno v pakiranju)
English: Twist the syringe until the needle is firmly attached.
Slovenian: Brizgo sukajte, dokler ni igla trdno nameščena.
English: No ALT elevations ≥ 3 x ULN occurred in the Phase 3 trial of adalimumab in patients with polyarticular juvenile idiopathic arthritis who were 2 to <4 years.
Slovenian: Zvišanja ALT ≥ 3 × ULN se niso pojavila v preskušanju faze 3 z adalimumabom pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom, ki so bili stari od 2 do < 4 leta.
English: • the treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
Slovenian: • zdravljenje zmernega do hudega aktivnega revmatoidnega artritisa pri odraslih bolnikih, kadar odziv na imunomodulirajoča zdravila, vključno z metotreksatom, ni zadosten.
English: • As cases of tuberculosis have been reported in patients treated with adalimumab, your doctor will check you for signs and symptoms of tuberculosis before starting Hulio.
Slovenian: • Ker so bili pri bolnikih, zdravljenih z adalimumabom, opisani primeri tuberkuloze, vas bo zdravnik pred začetkom zdravljenja z zdravilom Hulio preiskal glede znakov in simptomov tuberkuloze.
English: When needed (for example when you are travelling), a single Hulio 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 zdravila Hulio hranite pri sobni temperaturi (do 25 °C) za največ 14 dni - zagotovite, da bo zaščitena pred svetlobo.
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 jih je 37 (56,9 %) po 12 tednih ponovnega odprtega zdravljenja ponovno doseglo remisijo (ASDAS
English: Total Sharp
Slovenian: Celotna Sharpova ocena
English: TNF-antagonists including adalimumab have been associated in rare instances with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome.
Slovenian: Antagonisti tumorje nekrotizirajočega faktorja (TNF), z adalimumabom vred, so bili v redkih primerih povezani z novim pojavom ali s poslabšanjem kliničnih simptomov in/ali rentgenoloških znakov demielinizirajoče bolezni osrednjega živčnega sistema, vključno z multiplo sklerozo in optičnim nevritisom, in periferne demielinizirajoče bolezni, vključno z Guillain-Barréjevim sindromom.
English: If your child has COPD, or is a heavy smoker, you should discuss with your child's doctor whether treatment with a TNFα blocker is appropriate for your child.
Slovenian: Če ima vaš otrok KOPB ali če veliko kadi, se morate z otrokovim zdravnikom posvetovati, ali je zdravljenje z zaviralcem TNFα za vašega otroka primerno.
English: Table 21: Efficacy Results at 12 weeks, HS Studies I and II
Slovenian: Preglednica 21: Rezultati učinkovitosti v 12. tednu, študiji HS I in II
English: Table 17: Efficacy Results at 12 weeks, HS Studies I and II
Slovenian: Preglednica 17: Rezultati učinkovitosti v 12. tednu, študiji HS I in II
English: SLOWLY pull the plunger rod to draw the Hulio solution into the syringe.
Slovenian: POČASI potegnite nosilec bata ven, da povlečete raztopino zdravila Hulio v brizgo.
English: Clinical remission and clinical response (defined as reduction in PCDAI score of at least 15 points from Baseline) rates are presented in Table 20.
Slovenian: Stopnji klinične remisije in kliničnega odziva (definiran kot zmanjšanje vrednosti PCDAI vsaj za 15 točk od začetne vrednosti) sta predstavljeni v preglednici 20.
English: Your child may first be given other disease-modifying medicines, such as methotrexate.
Slovenian: Vaš otrok bo morda najprej prejel druga imunomodulirajoča zdravila, kot je metotreksat.
English: Adalimumabb/ MTXc n=63
Slovenian: adalimumabb/M TXc n = 63
English: Step 8 - End of injection, remove syringe
Slovenian: 8. korak - Injiciranje je končano, odstranite brizgo.
English: A single Hulio pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of 25°C for a period of up to 14 days.
Slovenian: Posamezna napolnjena injekcijska brizga ali napolnjen injekcijski peresnik zdravila Hulio se lahko shranjuje pri temperaturi do 25 °C za obdobje do 14 dni.
English: Then give your child's next dose as you would have on your originally scheduled day, had you not forgotten a dose.
Slovenian: Nato dajte svojemu otroku naslednji odmerek, kot bi ga uporabili po prvotnem urniku injiciranja, če ne bi pozabili odmerka.
English: • lung diseases causing shortness of breath (including inflammation);
Slovenian: • pljučna bolezen, ki povzroči zadihanost (vključno z vnetjem);
English: • If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice about taking this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se z zdravnikom posvetujte o uporabi tega zdravila.
English: • symptoms of nerve problems such as tingling, numbness, double vision or arm or leg weakness;
Slovenian: • simptome težav živčevja, kot so mravljinčenje, odrevenelost, dvojni vid ali šibkost rok ali nog;
English: • If you have psoriasis, DO NOT inject into any raised, thick, red, or scaly skin patches, or lesions.
Slovenian: • Če imate psoriazo, NE injicirajte v izbočene, debele, pordele ali luskave predele kože ali lezije.
English: • 1 syringe (1)
Slovenian: • 1 injekcijsko brizgo (1);
English: • Check syringe to make sure the medication is at or near the Fill Marker (you may need to shake gently to see the liquid), and the liquid is clear, colourless and has no particles.
Slovenian: • V kontrolnem okencu preverite, da zdravilo sega do oznake napolnjenosti ali je v njeni bližini (morda boste morali peresnik malo pretresti, da boste videli tekočino) in da je tekočina čista, brezbarvna in ne vsebuje delcev.
English: People with more serious rheumatoid arthritis who have had the disease for a long time may have a higher than average risk of getting lymphoma and leukaemia (cancers that affect blood cells and bone marrow).
Slovenian: Pri bolnikih z resnejšim revmatoidnim artritisom, ki imajo bolezen že dolgo, obstaja morda povečano tveganje, da zbolijo za limfomom in levkemijo (vrsta raka, ki prizadene krvne celice in kostni mozeg).
English: Hulio is a biosimilar medicinal product.
Slovenian: Zdravilo Hulio je podobno biološko zdravilo.
English: • excessive fluid around the lung;
Slovenian: • čezmerna količina tekočine okrog pljuč;
English: No studies have been conducted that include patients with a history of malignancy or in whom treatment with adalimumab is continued following development of malignancy.
Slovenian: Študije, ki bi vključevale bolnike z anamnezo malignoma ali bolnike, pri katerih bi se zdravljenje z adalimumabom nadaljevalo po pojavu malignoma, niso bile izvedene.
English: If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with Hulio and is positive for antibodies against double-stranded DNA, further treatment with Hulio should not be given (see section 4.8).
Slovenian: Če se bolniku po zdravljenju z zdravilom Hulio pojavijo simptomi, ki nakazujejo lupusu podoben sindrom, in ima pozitivna protitelesa proti dvojnoverižni DNA, zdravljenja z zdravilom Hulio ne sme nadaljevati (glejte poglavje 4.8).
English: Pull the plunger to 0.1 ml beyond the prescribed dose (for example, if the prescribed dose is 0.5 ml, pull the white plunger rod to 0.6 ml).
Slovenian: Bat potegnite ven tako, da je 0,1 ml preko predpisanega odmerka (če je npr. predpisani odmerek 0,5 ml, potegnite beli nosilec bata do 0,6 ml).
English: Adalimumab showed statistically significantly greater improvement in the HAQ-S total score and the SF-36 Physical Component Score (PCS) from baseline to week 12 compared to placebo.
Slovenian: Adalimumab je pokazal statistično večje izboljšanje skupnega števila točk v vprašalniku HAQ-S in točk v telesni komponenti (Physical Component Score (PCS)) v vprašalniku SF-36 od začetka do 12. tedna v primerjavi s placebom.
English: Administration of live vaccines (e.g., BCG vaccine) to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Slovenian: Uporaba živih cepiv (npr. BCG cepivo) pri dojenčkih, ki so bili izpostavljeni adalimumabu in utero, ni priporočljiva še 5 mesecev po materini zadnji injekciji adalimumaba med nosečnostjo.
English: It is important to tell your doctor if your child has had or have a serious heart condition (see “Warnings and precautions”).
Slovenian: Pomembno je, da zdravniku poveste, če je vaš otrok imel ali ima resno bolezen srca (glejte ''Opozorila in previdnostni ukrepi'').
English: Patients who develop a new infection while undergoing treatment with Hulio, should be monitored closely and undergo a complete diagnostic evaluation.
Slovenian: Bolnike, pri katerih se med zdravljenjem z zdravilom Hulio pojavi nova okužba, je treba natančno nadzirati, pri njih je treba izvesti popolno diagnostično obravnavo.
English: Adalimumab, 40 mg every other week, was studied in patients with moderately to severely active psoriatic arthritis in two placebo-controlled studies, PsA studies I and II.
Slovenian: Uporabo adalimumaba 40 mg vsak drugi teden so pri bolnikih z zmernim do hudim aktivnim psoriatičnim artritisom proučili v dveh s placebom kontroliranih študijah, študijah psoriatičnega artritisa I in II.
English: The conduct and results of these tests should be recorded on child's Patient Reminder Card.
Slovenian: Izvedbo in rezultate teh preiskav je treba zabeležiti na otrokovi opozorilni kartici za bolnika.
English: • Hulio should only be used during a pregnancy if needed.
Slovenian: Zdravilo Hulio se lahko uporablja med nosečnostjo le v primeru, da je to potrebno.
English: When combining controlled portions of these trials and ongoing and completed open label extension studies with a median duration of approximately 3.3 years including 6,427 patients and over 26,439 patient-years of therapy, the observed rate of malignancies, other than lymphoma and nonmelanoma skin cancers is approximately 8.5 per 1,000 patient years.
Slovenian: Če vzamemo skupaj kontrolirane dele teh preskušanj ter potekajoče in zaključene podaljšane odprte študije z medianim trajanjem približno 3,3 leta s 6427 bolniki in več kot 26439 bolnikov-let zdravljenja, je ugotovljeni delež malignomov (razen limfoma in nemelanomskih kožnih rakov)
English: • abnormal blood results;
Slovenian: • nenormalne vrednosti krvnih preiskav;
English: The percent of adalimumab-treated patients achieving ACR 20, 50 and 70 responses was consistent across RA studies I, II and III.
Slovenian: Odstotek bolnikov, zdravljenih z adalimumabom, ki so dosegli odziv ACR 20, 50 in 70, se je v študijah revmatoidnega artritisa I, II in III skladal.
English: A modified Total Sharp Score (mTSS), which included distal interphalangeal joints (i.e. not identical to the TSS used for rheumatoid arthritis), was used.
Slovenian: Za oceno so uporabili modificirani celotni seštevek po Sharpu (modified Total Sharp Score, mTSS), ki je vključil distalne interfalangealne sklepe (tj. Ni bil enak TSS, ki se uporablja za revmatoidni artritis).
English: ACR 20 week 12 week 24
Slovenian: ACR 20 12. teden 24. teden
English: A total of 76.5% (218/285) of patients who entered the retreatment period had a response of PGA “clear” or “minimal” after 16 weeks of retreatment, irrespective of whether they relapsed during withdrawal (69.1%[123/178] and 88.8% [95/107] for patients who relapsed and who did not relapse during the withdrawal period, respectively).
Slovenian: Od bolnikov, deležnih ponovnega zdravljenja, jih je skupno 76,5 % (218/285) po 16 tednih ponovnega zdravljenja imelo odziv PGA ''čisto'' ali ''minimalno'', ne glede na to, ali je med prenehanjem uporabe prišlo do relapsa (69,1 % [123/178] bolnikov, pri katerih je med prenehanjem uporabe prišlo do relapsa, in 88,8 % [95/107] tistih, pri katerih ni prišlo do relapsa).
English: A 40 mg paediatric vial is available for patients who need to administer less than the full 40 mg dose.
Slovenian: 40 mg viala za otroke je na voljo bolnikom, ki jim je treba dati manjši odmerek od polnega 40 mg odmerka.
English: Peel the cover off the vial adapter package but DO NOT take the adapter out of the package.
Slovenian: Odlepite prekrivno folijo z ovojnine adapterja za vialo, vendar adapterja NE vzemite iz ovojnine.
English: Be careful to insert the needle so that it will not inject into your fingers holding the injection site.
Slovenian: Pazite, da iglo zabodete tako, da zdravila ne boste injicirali v prste, ki držijo injekcijsko mesto.
English: It is important to tell your doctor if you have had or have a serious heart condition (see “Warnings and precautions”).
Slovenian: Pomembno je, da zdravniku poveste, če ste imeli ali imate kakšno resno bolezen srca (glejte ''Opozorila in previdnostni ukrepi'').
English: Put the used syringe, needle, vial and vial adapter in a sharps disposal container after use.
Slovenian: Uporabljeno brizgo, iglo, vialo in adapter za vialo po uporabi odložite v vsebnik za odlaganje ostrih predmetov.
English: Hulio is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
Slovenian: Zdravilo Hulio je indicirano za zdravljenje zmerne do hude kronične psoriaze v plakih pri odraslih bolnikih, ki so kandidati za sistemsko zdravljenje.
English: 79 (73.1) a, b a p<0.001 adalimumab vs. placebo b p<0.001 adalimumab vs. methotrexate c p<0.01 adalimumab vs. placebo d p<0.05 adalimumab vs. methotrexate
Slovenian: 79 (73,1)a, b a p < 0,001 adalimumab v primerjavi s placebom b p < 0,001 adalimumab v primerjavi z metotreksatom c p < 0,01 adalimumab v primerjavi s placebom d p < 0,05 adalimumab v primerjavi z metotreksatom
English: Attach the needle to the syringe by inserting the syringe tip into the yellow syringe connector on the needle.
Slovenian: Namestite iglo na brizgo tako, da konico brizge vstavite v rumeni konektor za brizgo na igli.
English: 1 sterile vial adapter 2 alcohol pads
Slovenian: 1 sterilen adapter za vialo 2 alkoholna zloženca
English: • DO NOT over-tighten.
Slovenian: • NE PRIVIJTE je preveč.
English: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor) while on Hulio.
Slovenian: Vsem bolnikom je treba naročiti, naj nemudoma poiščejo zdravniško pomoč, če se jim med uporabo zdravila Hulio pojavijo znaki in simptomi krvnih diskrazij (npr. trajno zvišana telesna temperatura, podplutbe, krvavitve, bledica).
English: • nerve disorders (such as inflammation of the optic nerve to the eye, and Guillain-Barré syndrome, a condition that may cause muscle weakness, abnormal sensations, tingling in the arms and upper body);
Slovenian: • bolezni živčevja (kot je vnetje vidnega živca v očesu in Guillain-Barréjev sindrom, stanje, ki lahko povzroči šibkost mišic, nenormalna občutenja, mravljinčenje v rokah in zgornjem delu telesa);
English: Physicians should exercise caution when considering the use of Hulio in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
Slovenian: Pri odločanju za uporabo zdravila Hulio je potrebna previdnost pri bolnikih z anamnezo ponavljajoče se okužbe ali z osnovnimi boleznimi, ki lahko zvečajo nagnjenost k okužbam, vključno s sočasno uporabljenimi imunosupresivnimi zdravili.
English: Patients participating in all Phase 2 and Phase 3 psoriasis studies were eligible to enrol into an openlabel extension trial, where adalimumab was given for at least an additional 108 weeks.
Slovenian: Bolniki, ki so sodelovali v študijah psoriaze 2. in 3. faze, so bili primerni za vključitev v odprto podaljšano preskušanje, v katerem so adalimumab prejemali vsaj še dodatnih 108 tednov.
English: • inflammation of blood vessels in the skin;
Slovenian: • vnetje krvnih žil v koži;
English: What Hulio contains - The active substance is adalimumab.
Slovenian: Kaj vsebuje zdravilo Hulio - Učinkovina je adalimumab.
English: 1 sterile vial adapter
Slovenian: 1 sterilen adapter za vialo
English: Hulio 40 mg solution for injection in pre-filled syringe EU/1/18/1319/001
Slovenian: Hulio 40 mg raztopina za injiciranje v napolnjeni injekcijski brizgi EU/1/18/1319/001
English: Keep the pen held at a 90° angle to the injection site, and with the Viewing Window visible to you.
Slovenian: Injekcijski peresnik držite pod kotom 90° na injekcijsko mesto in tako, da vidite kontrolno okence.
English: Patients treated with adalimumab had significantly reduced risk of disease flare during the initial 12 weeks of treatment.
Slovenian: Bolniki, zdravljeni z adalimumabom, so imeli statistično pomembno zmanjšanje tveganja novega zagona bolezni v začetnih 12 tednih zdravljenja.
English: Among patients whose adalimumab treatment was withdrawn at week 12 in Studies HS-I and HS-II, the HiSCR rate 12 weeks after re-introduction of adalimumab 40 mg weekly returned to levels similar to that observed before withdrawal (56.0 %).
Slovenian: Med bolniki, pri katerih je bilo zdravljenje z adalimumabom ukinjeno v 12. tednu v študijah HS-I in HS-II, se je po ponovni uvedbi adalimumaba 40 mg enkrat na teden raven kliničnega odziva (HiSCR) v 12. tednu vrnila na podobno raven, kot so jo opazili pred ukinitvijo (56,0 %).
English: 673 patients with active nr-axSpA (mean baseline disease activity [BASDAI] was 7.0) who had an inadequate response to  2 NSAIDs, or an intolerance to or a contraindication for NSAIDs enrolled into the open-label period of Study nr-axSpA II during which they received adalimumab 40 mg eow for 28 weeks.
Slovenian: 673 bolnikov z aktivnim nr-axSpA (srednja vrednost aktivnosti bolezni [BASDAI] je bila 7,0), ki so nezadostno reagirali na ≥ 2 NSAID ali niso prenašali NSAID ali s kontraindikacijo za NSAID, je bilo vključenih v odprto fazo študije nr-axSpA II, v kateri so prejemali adalimumab 40 mg vsak drugi teden 28 tednov.
English: • If you are about to have surgery or dental procedures, tell your doctor that you are taking Hulio.
Slovenian: • Če boste imeli kirurški poseg ali poseg na zobeh, povejte svojemu zdravniku, da jemljete zdravilo Hulio.
English: In RA study III, most subjects who achieved improvement in physical function and continued treatment maintained improvement through week 520 (120 months) of open-label treatment.
Slovenian: V študiji revmatoidnega artritisa III se je pri večini bolnikov, ki so dosegli izboljšanje telesne funkcije in so nadaljevali zdravljenje, to izboljšanje ohranilo do 520. tedna (120. meseca) odprtega zdravljenja.
English: Hulio packs should be stored in the fridge (between 2 to 8°C) until needed for use.
Slovenian: Pakiranje zdravila Hulio shranjujte v hladilniku (pri temperaturi od 2 do 8 °C), dokler ga ne boste uporabili.
English: In the open-label extension, improvement in the signs and symptoms was maintained with adalimumab therapy through week 156.
Slovenian: Pri odprti podaljšani študiji se je pri zdravljenju z adalimumabom izboljšanje znakov in simptomov ohranjalo do 156. tedna.