FrancophonIA/ELRC3.0 huggingface dataset:
English: Note: P# = Placebo (Number of Events/Number at Risk); A# = adalimumab (Number of Events/Number at Risk).
Slovenian: Opomba: P# = Placebo (število dogodkov/število rizičnih preiskovancev); A# = adalimumab (število dogodkov/število rizičnih preiskovancev).
English: Based on the observed data approach, 222 (80.4%) were in quiescence (no active inflammatory lesions, AC cell grade ≤ 0.5+, VH grade ≤ 0.5+) with a concomitant steroid dose ≤ 7.5 mg per day, and 184 (66.7 %) were in steroid-free quiescence.
Slovenian: Na osnovi pristopa z opaženimi podatki je bilo 222 (80,4 %) bolnikov v remisiji (brez aktivnih vnetnih lezij, ocena celic sprednje očesne komore ≤ 0,5+, motnost steklovine ≤ 0,5+) ob sočasnem jemanju steroidov v odmerku 7,5 mg na dan in pa 184 bolnikov (66,7 %), ki so bili v remisiji in brez steroidov.
English: INFORMATION IN BRAILLE Hulio 40 mg/0.8 ml
Slovenian: PODATKI V BRAILLOVI PISAVI Hulio 40 mg/0,8 ml
English: It is very important that you tell your child's doctor if he/she have ever had tuberculosis, or if he/she have been in close contact with someone who has had tuberculosis.
Slovenian: Zelo pomembno je, da zdravniku poveste, če je vaš otrok kadar koli imel tuberkulozo ali je bil v tesnem stiku s kom, ki jo je imel.
English: Patients participating in Studies HS-I and HS-II were eligible to enrol into an open-label extension study in which adalimumab 40 mg was administered every week.
Slovenian: Bolniki, vključeni v študiji HS-I in HS-II, so bili primerni za vključitev v odprto podaljšano študijo, v okviru katere so prejemali adalimumab 40 mg vsak teden.
English: Table 29: Time to Treatment Failure in Studies UV I and UV II
Slovenian: Preglednica 29: Čas do neuspeha zdravljenja v študijah UV I in UV II Analiza
English: Flip down the pink needle cover and remove the needle cap by pulling it straight up.
Slovenian: Rožnati pokrovček igle obrnite navzdol in odstranite pokrovček igle tako, da ga potegnete naravnost navzgor.
English: • DO NOT hold the syringe by the white plunger rod.
Slovenian: • NE DRŽITE brizge za beli nosilec bata.
English: • Tell your doctor if you reside or travel in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
Slovenian: • Zdravniku povejte, če živite na območju ali potujete v predele, kjer so pogoste glivične okužbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
English: Tell your child's doctor if your child is taking azathioprine or mercaptopurine with Hulio.
Slovenian: Povejte otrokovemu zdravniku, če vaš otrok prejema azatioprin ali merkaptopurin sočasno z zdravilom Hulio.
English: Each single pack containing 1 vial (0.8 ml sterile solution), 1 empty sterile injection syringe, 1 sterile needle, 1 sterile vial adapter and 2 alcohol pads.
Slovenian: Vsako enojno pakiranje vsebuje 1 vialo (0,8 ml sterilne raztopine), 1 prazno sterilno injekcijsko brizgo, 1 sterilno iglo, 1 sterilen adapter za vialo in 2 alkoholna zloženca.
English: Each vial contains 38.2 mg sorbitol (E420).
Slovenian: Ena viala vsebuje 38,2 mg sorbitola (E420).
English: Each vial contains one 40 mg dose of adalimumab.
Slovenian: Ena viala vsebuje en 40 mg odmerek adalimumaba.
English: • DO NOT use the pen if it has been dropped onto a hard surface.
Slovenian: • NE uporabljajte injekcijskega peresnika, če je padel na trdo površino.
English: Tell your doctor if you are taking azathioprine or mercaptopurine with Hulio.
Slovenian: Povejte zdravniku, če jemljete azatioprin ali merkaptopurin sočasno z zdravilom Hulio.
English: If you have rheumatoid arthritis and you do not receive methotrexate with your Hulio therapy, your doctor may decide to give you 40 mg adalimumab every week or 80 mg every other week.
Slovenian: Če imate revmatoidni artritis in hkrati z zdravilom Hulio ne dobivate metotreksata, vam bo zdravnik morda predpisal 40 mg adalimumaba vsak teden ali 80 mg vsak drugi teden.
English: • immune disorders that could affect the lungs, skin and lymph nodes (most commonly as a condition called sarcoidosis);
Slovenian: • imunske bolezni, ki lahko prizadenejo pljuča, kožo ali limfne vozle (najpogosteje kot stanje,
English: • DO NOT use the pre-filled syringe if dropped after uncapping.
Slovenian: • NE uporabljajte napolnjene injekcijske brizge, če vam je padla, potem ko ste odstranili pokrovček.
English: Among those, 154 patients (90.6%) had ACR 20 responses; 127 patients (74.7%) had ACR 50 responses; and 102 patients (60.0%) had ACR 70 responses.
Slovenian: Med temi je 154 bolnikov (90,6 %) imelo odziv 20 po ACR; 127 bolnikov (74,7 %) je imelo odziv 50 po ACR in 102 bolnika (60,0 %) sta imela odziv 70 po ACR.
English: Table 19: Ps Study IV Efficacy Results at 16, 26 and 52 weeks
Slovenian: Preglednica 19: Študija pri psoriazi IV Rezultati učinkovitosti po 16, 26 in 52 tednih
English: If you stop using Hulio
Slovenian: Če ste prenehali uporabljati zdravilo Hulio
English: It should be injected into the thigh or abdomen.
Slovenian: Injicirati ga je treba v stegno ali trebuh.
English: After 16 weeks of therapy, patients who achieved at least a PASI 75 response (PASI score improvement of at least 75% relative to baseline), entered period B and received open-label 40 mg adalimumab every other week.
Slovenian: Po 16 tednih zdravljenja so bolniki, ki so dosegli vsaj odziv PASI 75 (izboljšanje ocene PASI za vsaj 75 % glede na izhodišče), vstopili v obdobje B, v katerem so odprto dobivali 40 mg adalimumaba vsak drugi teden.
English: Hulio is used to treat Crohn's disease in children aged 6 to 17 years.
Slovenian: Zdravilo Hulio je namenjeno za zdravljenje Crohnove bolezni pri otrocih, starih od 6 do 17 let.
English: Prescribers should exercise caution in considering the use of Hulio in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of Hulio should be considered if any of these disorders develop.
Slovenian: Pri odločanju za uporabo zdravila Hulio pri bolnikih z že prej obstoječimi ali nedavno nastalimi demielinizirajočimi boleznimi osrednjega ali perifernega živčevja je potrebna previdnost; če se razvije katera od teh bolezni, je treba razmisliti o prenehanju zdravljenja z zdravilom Hulio.
English: Greater improvements at week 12 from baseline compared to placebo were demonstrated in skinspecific health-related quality of life, as measured by the Dermatology Life Quality Index (DLQI; Studies HS-I and HS-II), patient global satisfaction with medication treatment as measured by the Treatment Satisfaction Questionnaire - medication (TSQM; Studies HS-I and HS-II), and physical health as measured by the physical component summary score of the SF-36 (Study HS-I).
Slovenian: Večje izboljšanje v 12. tednu so pokazali glede na izhodiščno vrednost v primerjavi s placebom glede z zdravjem povezane kakovosti življenja, specifične za kožo, merjene z dermatološkim indeksom kakovosti življenja (''Dermatology life quality index'' (DLQI), v študijah HS-I in HS-II), glede bolnikovega splošnega zadovoljstva z zdravljenjem z zdravilom, merjenega z vprašalnikom o zadovoljstvu z zdravljenjem z zdravilom (''Treatment Satisfaction Questionnaire - medication'' (TSQM), v študijah HS-I in HS-II), in glede telesnega zdravja, merjenega s seštevkom telesnih komponent v vprašalniku SF-36 (''Short Form Health Survey'' (SF-36) v študiji HS-I).
English: The observed rate of nonmelanoma skin cancers is approximately 9.6 per 1,000 patient years, and the observed rate of lymphomas is approximately 1.3 per 1,000 patient years.
Slovenian: Ugotovljeni delež nemelanomskih kožnih rakov je približno 9,6 na 1000 bolnikov-let, ugotovljeni delež limfomov pa približno 1,3 na 1000 bolnikov-let.
English: • Do not give Hulio to children with hidradenitis suppurativa below the age of 12 years.
Slovenian: • Zdravila Hulio ne smete dati otroku s hidradenitis suppurativa, če je star manj kot 12 let.
English: Peel the clear plastic just far enough to expose the yellow connector, but DO NOT take the needle out of the package.
Slovenian: Odlepite prozorno plastiko ravno toliko, da odkrijete rumeni konektor, vendar igle NE vzemite iz ovojnine.
English: There are no data available comparing adalimumab and MTX beyond 16 weeks of therapy.
Slovenian: Podatkov za primerjavo adalimumaba in metotreksata za več kot 16-tedensko zdravljenje ni.
English: Hulio can slow down the damage to the cartilage and bone of the joints caused by the disease and improve physical function.
Slovenian: Zdravilo Hulio lahko upočasni okvaro sklepnega hrustanca in kosti, ki jo povzroča ta bolezen, in izboljšuje telesno delovanje.
English: In the pivotal controlled trials in adults and children, the rate of infection was 1.51 per patient year in the adalimumab treated patients and 1.46 per patient year in the placebo and active control-treated patients.
Slovenian: V kontroliranih osrednjih preskušanjih pri odraslih in otrocih je bil delež okužb 1,51 na bolnikov-let med bolniki, ki so prejemali adalimumab, in 1,46 na bolnikov-let med bolniki, ki so prejemali placebo oziroma primerjalno zdravilo.
English: For patients who are prescribed a dose less than 40 mg, Hulio 40 mg/0.8 ml solution for injection in a vial (available from your pharmacist) should be used.
Slovenian: Bolniki, ki jim je predpisan manjši odmerek od 40 mg, naj uporabijo Hulio 40 mg/0,8 ml raztopino za injiciranje v viali (na voljo pri farmacevtu).
English: SPARCC MRI Spined,j a Assessment of Spondyloarthritis International Society b Bath Ankylosing Spondylitis Disease Activity Index c Ankylosing Spondylitis Disease Activity Score d mean change from baseline e n=91 placebo and n=87 adalimumab f high sensitivity C-Reactive Protein (mg/L) g n=73 placebo and n=70 adalimumab h Spondyloarthritis Research Consortium of Canada i n=84 placebo and adalimumab j n=82 placebo and n=85 adalimumab
Slovenian: Disease Activity Score) d povprečna sprememba od začetka zdravljenja e n = 91 placebo in n = 87 adalimumab f hs-CRP = C-reaktivni protein z veliko občutljivostjo (high sensitivity C-Reactive Protein) (mg/l) g n = 73 placebo in n = 70 adalimumab h SPARCC = kanadski raziskovalni konzorcij za spondiloartritis (Spondyloarthritis Research
English: How to use Hulio
Slovenian: Kako uporabljati zdravilo Hulio
English: • Tell your child's doctor if you reside or travel in regions where fungal infections such as histoplasmosis, coccidioidomycosis or blastomycosis are common.
Slovenian: • Otrokovemu zdravniku povejte, če živite na območju ali potujete v predele, kjer so pogoste glivične okužbe, npr. histoplazmoza, kokcidioidomikoza ali blastomikoza.
English: • hepatosplenic T-cell lymphoma (a rare blood cancer);
Slovenian: • jetrnovranični limfom celic T (redka oblika krvnega raka);
English: Approximately twice the proportion of patients in the placebo group in the first 12 weeks of Studies HS-I and HS-II, compared with those in the adalimumab group experienced worsening of abscesses (23.0% vs 11.4%, respectively) and draining fistulas (30.0% vs 13.9%, respectively).
Slovenian: Približno dvakratni delež bolnikov v skupini, ki je prejemala placebo, je v primerjavi s tistimi, ki so bili v skupini z adalimumabom, v prvih 12 tednih študij HS-I in HS-II doživel poslabšanje abscesov (23,0 % v primerjavi z 11,4 %, v tem zaporedju) in fistul z izcedkom (30,0 % v primerjavi s 13,9 %, v tem zaporedju).
English: Insert the syringe tip into the vial adapter and twist it clockwise until firmly attached.
Slovenian: Konico brizge vstavite v adapter za vialo in jo sukajte v smeri urnega kazalca, dokler ni trdno nameščena.
English: RA study II evaluated 544 patients with moderately to severely active rheumatoid arthritis who were ≥ 18 years old and had failed therapy with at least one disease-modifying, anti-rheumatic drugs.
Slovenian: V študiji revmatoidnega artritisa II je bilo ocenjenih 544 bolnikov z zmerno do hudo aktivnim revmatoidnim artritisom, starih ≥ 18 let, pri katerih zdravljenje z vsaj enim imunomodulirajočim antirevmatičnim zdravilom ni bilo uspešno.
English: Psoriasis Study II (CHAMPION) compared the efficacy and safety of adalimumab versus methotrexate and placebo in 271 patients.
Slovenian: Študija psoriaze II (CHAMPION) je primerjala učinkovitost in varnost adalimumaba v primerjavi z metotreksatom in placebom pri 271 bolnikih.
English: After proper training in injection technique, patients may self-inject with Hulio if their physician determines that it is appropriate and with medical follow-up as necessary.
Slovenian: Bolniki, ki se naučijo pravilnega postopka injiciranja, si zdravilo Hulio lahko injicirajo sami, če zdravnik presodi, da je to primerno, in je zagotovljeno ustrezno medicinsko spremljanje.
English: • Do not give Hulio to children with enthesitis-related arthritis and Crohn's disease below the age of 6 years.
Slovenian: • Zdravila Hulio ne smete dati otroku z artritisom, povezanim z entezitisom, in s Crohnovo boleznijo, če je star manj kot 6 let.
English: Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of Hulio therapy and regularly during treatment to assess for pre-existing or developing central demyelinating disorders.
Slovenian: Pri bolnikih z neinfekcijskim intermediarnim uveitisom je treba pred začetkom zdravljenja z zdravilom Hulio in redno med zdravljenjem opravljati nevrološko oceno, da se oceni že obstoječe ali razvijajoče se demielinizirajoče bolezni osrednjega živčevja.
English: • DO NOT throw the sharps container in your household bin.
Slovenian: • Vsebnika za ostre predmete NE ODLAGAJTE v koš za gospodinjske odpadke.
English: Partially peel open the needle package from the end closest to the yellow syringe connector.
Slovenian: Delno odprite ovojnino igle tako, da jo odlepite od konca, ki je najbližji rumenemu konektorju za brizgo.
English: Adalimumab treated patients had significantly greater improvement at week 12 which was maintained through week 24 in both the SF36 and Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL).
Slovenian: Bolniki, ki so dobivali adalimumab, so imeli po 12 tednih statistično značilno večje izboljšanje (ki se je ohranilo do 24. tedna) glede na SF-36 in ASQoL (Vprašalnik o kakovosti življenja pri ankilozirajočem spondilitisu - Ankylosing Spondylitis Quality of Life Questionnaire).
English: If you forget to give yourself an injection, you should inject the next dose of Hulio as soon as you remember.
Slovenian: Če si pozabite dati injekcijo, si morate naslednji odmerek zdravila Hulio injicirati, čim se spomnite.
English: Administration of Hulio should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled.
Slovenian: Če se bolniku pojavi nova resna okužba ali sepsa, je treba uporabo zdravila Hulio prekiniti in uvesti ustrezno protimikrobno ali protimikotično zdravljenje, dokler okužba ni obvladana.
English: Do not use Hulio
Slovenian: Ne uporabljajte zdravila Hulio
English: This risk may increase if your child lung function is reduced.
Slovenian: Tveganje je lahko večje, če ima vaš otrok oslabljeno delovanje pljuč.
English: Be careful to place the pen so that it will not inject into your fingers holding the injection site.
Slovenian: Pazite, da injekcijski peresnik postavite tako, da zdravila ne boste injicirali v prste, ki držijo injekcijsko mesto.
English: • There have been very rare cases of certain kinds of cancer in children and adults taking adalimumab or other TNFα blockers.
Slovenian: • Pri otrocih in odraslih, ki so jemali adalimumab ali druge zaviralce TNFα, so se pojavili zelo redki primeri določenih vrst raka.
English: In controlled and open label adult and paediatric studies with adalimumab, serious infections (including fatal infections, which occurred rarely) have been reported, which include reports of tuberculosis (including miliary and extra-pulmonary locations) and invasive opportunistic infections (e.g. disseminated or extrapulmonary histoplasmosis, blastomycosis, coccidioidomycosis, pneumocystis candidiasis, aspergillosis and listeriosis).
Slovenian: V kontroliranih in odprtih študijah pri odraslih in otrocih z adalimumabom so poročali o resnih okužbah (vključno s smrtno nevarnimi okužbami, ki so se pojavile redko), med katerimi so bile tuberkuloza (tudi miliarna in zunajpljučna) in invazivne oportunistične okužbe (npr. diseminirana ali zunajpljučna histoplazmoza, blastomikoza, kokcidioidomikoza, pnevmocistoza, kandidoza, aspergiloza in listerioza).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1319/007 2 vials (2 packs of 1)
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1319/007 2 viali (2 pakiranji s po 1 vialo)
English: Neither carcinogenicity studies, nor a standard assessment of fertility and postnatal toxicity, were performed with adalimumab due to the lack of appropriate models for an antibody with limited cross-reactivity to rodent TNF and to the development of neutralising antibodies in rodents.
Slovenian: Z adalimumabom niso bile narejene niti raziskave kancerogenosti niti standardne ocene plodnosti ter poporodne toksičnosti, in sicer zato, ker ni ustreznih modelov za protitelo z omejeno navzkrižno reaktivnostjo z glodavskim TNF, in zaradi nastanka nevtralizirajočih protiteles pri glodavcih.
English: If you accidentally inject Hulio more frequently than you should, call your doctor or pharmacist and explain that you have taken more than required.
Slovenian: Če ste uporabili večji odmerek zdravila Hulio, kot bi smeli Če pomotoma injicirate zdravilo Hulio pogosteje, kot bi morali, se posvetujte s svojim zdravnikom ali farmacevtom in mu povejte, da ste uporabili večji odmerek, kot je potreben.
English: p-value
Slovenian: P-vrednostb
English: During the controlled portions of pivotal adalimumab trials in adults of at least 12 weeks in duration in patients with moderately to severely active rheumatoid arthritis, ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS, psoriatic arthritis, psoriasis, hidradenitis suppurativa, Crohn's disease, ulcerative colitis and uveitis, malignancies, other than lymphoma and non-melanoma skin cancer, were observed at a rate (95% confidence interval) of 6.8 (4.4, 10.5) per 1,000 patient-years among 5,291 adalimumab treated patients versus a rate of 6.3 (3.4, 11.8) per 1,000 patient-years among 3,444 control patients (median duration of treatment was 4.0 months for adalimumab and 3.8 months for control-treated patients).
Slovenian: V kontroliranih delih osrednjih preskušanj adalimumaba pri odraslih, ki so trajala vsaj 12 tednov, pri bolnikih z zmerno do hudo aktivnim revmatoidnim artritisom, ankilozirajočim spondilitisom, aksialnim spondiloartritisom brez radiografskega dokaza za AS, psoriatičnim artritisom, psoriazo, hidradenitis suppurativa, Crohnovo boleznijo, ulceroznim kolitisom in uveitisom so malignome (razen limfoma in nemelanomskega kožnega raka) opažali z deležem (95-% interval zaupanja) 6,8 (4,4; 10,5) na 1000 bolnikov-let med 5291 bolniki, ki so prejemali adalimumab, v primerjavi s 6,3 (3,4; 11,8) na 1000 bolnikov-let med 3444 kontrolnimi bolniki (pri prvih je zdravljenje mediano trajalo 4,0 meseca in pri drugih 3,8 meseca).
English: If new areas of damaged skin appear during or after treatment or if existing marks or areas of damage change appearance, tell your doctor.
Slovenian: Če se vam med zdravljenjem ali po njem pojavijo nova območja poškodovane kože ali če se spremeni videz obstoječih znamenj ali poškodovanih območij, morate to povedati zdravniku.
English: • If your child is pregnant, thinks she may be pregnant or is planning to have a baby, ask her doctor for advice about taking this medicine.
Slovenian: Če je vaš otrok noseč, meni, da bi lahko bil noseč ali načrtuje zanositev, se z otrokovim zdravnikom posvetujte o uporabi tega zdravila.
English: 1 sterile injection syringe
Slovenian: 1 sterilna injekcijska brizga
English: Table 1: Hulio Dose for Patients with Polyarticular Juvenile Idiopathic Arthritis
Slovenian: Preglednica 1: Odmerjanje zdravila Hulio pri bolnikih s poliartikularnim juvenilnim idiopatskim artritisom
English: PGA: Clear/minimalc a MTX = methotrexate b P=0.027, adalimumab 0.8 mg/kg versus MTX c P=0.083, adalimumab 0.8 mg/kg versus MTX
Slovenian: PASI 75b PGA: čisto/minimalnoc a MTX = metotreksat b P = 0,027, adalimumab 0,8 mg/kg v primerjavi z MTX c P = 0,083, adalimumab 0,8 mg/kg v primerjavi z MTX
English: If your child takes Hulio the risk of getting lymphoma, leukaemia, or other cancers may increase.
Slovenian: Če vaš otrok uporablja zdravilo Hulio, se mu lahko poveča tveganje za pojav limfoma, levkemije ali drugih vrst raka.
English: Hulio is used to treat polyarticular juvenile idiopathic arthritis in children and adolescents aged 2 to 17 years, and enthesitis-related arthritis in children and adolescents aged 6 to 17 years.
Slovenian: Zdravilo Hulio se uporablja za zdravljenje poliartikularnega juvenilnega idiopatskega artritisa pri otrocih in mladostnikih, starih 2 do 17 let, in artritisa, povezanega z entezitisom, pri otrocih in mladostnikih starih od 6 do 17 let.
English: The rate of pregnancies ending with at least one live born infant with a major birth defect was 6/69 (8.7%) in the adalimumab-treated women with RA and 5/74 (6.8%) in the untreated women with RA (unadjusted OR 1.31, 95% CI 0.38-4.52) and 16/152 (10.5%) in the adalimumab-treated women with CD and 3/32 (9.4%) in the untreated women with CD (unadjusted OR 1.14, 95% CI 0.31-4.16).
Slovenian: Razmerje nosečnosti, ki so se končale vsaj z enim živorojenim otrokom z večjim defektom ob rojstvu je bilo 6/69 (8,7 %) pri nosečnicah, zdravljenih z adalimumabom z RA, in 5/74 (6,8 %) pri nezdravljenih nosečnicah z RA (neprilagojeno razmerje obetov 1.31, 95 % interval zaupanja 0.38-4.52), ter 16/152 (10,5 %) pri nosečnicah, zdravljenih z adalimumabom s CB, in 3/32 (9,4 %) pri nezdravljenih nosečnicah s CB (neprilagojeno razmerje obetov 1.14, 95 % interval zaupanja 0.31-4.16).
English: No ALT elevations ≥3 X ULN occurred in the Phase 3 trial of adalimumab in paediatric patients with plaque psoriasis.
Slovenian: Do nobenih zvišanj ALT ≥ 3 × ULN ni prišlo v preskušanju faze 3 z adalimumabom pri pediatričnih bolnikih s psoriazo v plakih.
English: Peel the clear plastic just far enough to expose the white plunger rod, but DO NOT take the syringe out of the package.
Slovenian: Odlepite prozorno plastiko ravno toliko, da odkrijete beli nosilec bata, vendar brizge NE vzemite iz ovojnine.
English: Hulio is administered by injection under the skin (subcutaneous use).
Slovenian: Zdravilo Hulio se injicira pod kožo (subkutana uporaba).
English: Hulio 40 mg solution for injection in pre-filled pen EU/1/18/1319/004
Slovenian: Hulio 40 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku EU/1/18/1319/004
English: At week 12, a significantly higher proportion of patients in Study HS-II experienced a clinically relevant decrease in HS-related skin pain (see Table 17).
Slovenian: V 12. tednu je statistično pomembno večji delež bolnikov v študiji HS-II občutil klinično pomembno zmanjšanje bolečine kože, povezane s HS (glejte preglednico 17).
English: Of 342 subjects originally randomised to adalimumab monotherapy or adalimumab/methotrexate combination therapy who entered the open-label extension study, 171 subjects completed 10 years of adalimumab treatment.
Slovenian: Od 342 oseb, ki so bile od začetka randomizirane na monoterapijo z adalimumabom ali kombinirano zdravljenje z adalimumabom/metotreksatom in so bile vključene v odprto podaljšano študijo, je 171 bolnikov zaključilo 10-letno zdravljenje z adalimumabom.
English: If you received Hulio while you are pregnant, your baby may be at higher risk for getting an infection for up to about five months after the last dose you received during pregnancy.
Slovenian: Če ste prejemali zdravilo Hulio med nosečnostjo, obstaja večje tveganje, da bo vaš otrok dobil takšno okužbo do približno pet mesecev po zadnjem odmerku, ki ste ga prejeli med nosečnostjo.
English: • If your child is about to have surgery or dental procedures, tell your child's doctor that your child is taking Hulio.
Slovenian: • Če bo vaš otrok imel kirurški poseg ali poseg na zobeh, otrokovemu zdravniku povejte, da jemlje zdravilo Hulio.