FrancophonIA/ELRC3.0 huggingface dataset:
English: Simponi has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease (see section 5.1) and to improve physical function.
Slovenian: Pokazalo se je, da zdravilo Simponi zmanjša hitrost napredovanja okvare perifernih sklepov, kar so merili z rentgenskim slikanjem pri bolnikih s poliartikularnimi simetričnimi podtipi bolezni (glejte poglavje 5.1), in izboljša telesno funkcijo.
English: • Hair loss
Slovenian: • izguba las,
English: The pre-filled pen is a manual injection pen that allows you to set a specific, prescribed dose.
Slovenian: Napolnjeni injekcijski peresnik je peresnik za ročno injiciranje, ki omogoča, da nastavite svoj specifični predpisani odmerek zdravila.
English: Placebo-controlled efficacy data were collected and analysed through week 24.
Slovenian: S placebom nadzorovani podatki o učinkovitosti zdravila so bili zbrani in analizirani za čas do 24. tedna.
English: If you do not respond well enough to these medicines, you may be given Simponi which you will take in combination with another medicine called methotrexate to:
Slovenian: Če se nanje ne boste dovolj dobro odzvali, pa vam bodo lahko predpisali zdravilo Simponi, ki ga boste jemali v kombinaciji z drugim zdravilom, imenovanim metotreksat:
English: • If you are more than 2 weeks late, inject the forgotten dose as soon as you remember and talk to your doctor or pharmacist to ask when you need to take the next dose.
Slovenian: • če zamujate več kot 2 tedna, injicirajte pozabljeni odmerek takoj, ko se spomnite, in se posvetujte z zdravnikom ali farmacevtom, kdaj morate vzeti naslednji odmerek.
English: • Increase in blood cholesterol levels
Slovenian: • zvišanje koncentracije holesterola v krvi,
English: Out of 146 patients who were randomised to Simponi 50 mg, 52 week X-ray data were available for 126 patients, of whom 77% showed no progression compared to baseline.
Slovenian: Od 146 bolnikov, ki so bili naključno razvrščeni v skupino za prejemanje zdravila Simponi v odmerku 50 mg, so bili rentgenski podatki za 52. teden na voljo pri 126 bolnikih, od katerih jih 77 % ni kazalo nikakršnega napredovanja bolezni v primerjavi z začetnimi vrednostmi.
English: This appearance is not unusual for solutions containing protein.
Slovenian: Pri raztopinah, ki vsebujejo beljakovine, tak videz ni neobičajen.
English: Approximately 93% of patients who were receiving Simponi at the beginning of the open-label extension (week 16) remained on treatment through the end of the study (week 52).
Slovenian: Približno 93 % bolnikov, ki so prejemali zdravilo Simponi na začetku obdobja odprtega zdravljenja v podaljšanju študije (16. teden), je nadaljevalo zdravljenje do konca študije (52. teden).
English: Patients enrolled in this study had active disease (defined as a BASDAI ≥ 4 and a Visual Analogue Scale (VAS) for total back pain of ≥ 4, each on a scale of 0-10 cm) despite current or previous NSAID therapy and had not previously been treated with any biological agents including anti-TNF therapy.
Slovenian: Bolniki, vključeni v to študijo, so imeli aktivno bolezen (opredeljeno z BASDAI ≥ 4 in oceno vseh bolečin v hrbtu na vizualni analogni skali (VAS) ≥ 4, vsako na lestvici od 0 do 10 cm) kljub trenutnemu ali predhodnemu zdravljenju z NSAID ter se predhodno niso zdravili z nobenim biološkim zdravilom, vključno z zdravili proti TNF.
English: If you have used or been given too much Simponi (either by injecting too much on a single occasion, or by using it too often), talk to your doctor or pharmacist straight away.
Slovenian: Če ste uporabili večji odmerek zdravila Simponi, kot bi smeli Če ste uporabili ali dobili preveč zdravila Simponi (bodisi z enkratnim injiciranjem prevelike količine zdravila ali zaradi prepogoste uporabe zdravila), se takoj posvetujte z zdravnikom ali farmacevtom.
English: Responses observed in the Simponi treated groups were similar in patients receiving and not receiving concomitant MTX.
Slovenian: Odzivi, ki so jih opazili v skupini bolnikov, zdravljenih z zdravilom Simponi, so bili podobni kot pri bolnikih, ki so sočasno prejemali MTX oziroma ga niso prejemali.
English: Consistent efficacy was seen in patients regardless of use of DMARDs (MTX, sulfasalazine and/or hydroxychloroquine), HLA-B27 antigen status or baseline CRP levels as assessed by ASAS 20 responses at week 14.
Slovenian: Pri bolnikih so ugotovili stalno učinkovitost ne glede na uporabo terapije DMARD (MTX, sulfasalazin in/ali hidroksiklorokvin), izvid antigena HLA-B27 ali vrednosti CRP na začetku študije, ki so jih določili na podlagi odziva ASAS 20 v 14. tednu.
English: Please read this Instructions for Use before using the Simponi pre-filled pen and each time you get a new pre-filled pen.
Slovenian: Prosimo, da ta navodila za uporabo preberete pred začetkom uporabe napolnjenega injekcijskega peresnika zdravila Simponi, ter vsakokrat, kot dobite nov napolnjen injekcijski peresnik, saj so lahko na voljo nove informacije.
English: Effect of weight on pharmacokinetics
Slovenian: Učinek telesne mase na farmakokinetiko
English: The diagram below (see figure 1) shows what the pre-filled syringe looks like.
Slovenian: Spodnji diagram (glejte sliko 1) prikazuje, kako izgleda napolnjena injekcijska brizga.
English: Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period.
Slovenian: O nadaljevanju zdravljenja je treba premisliti pri bolnikih, pri katerih v tem obdobju ni opaznih terapevtskih koristi.
English: CHAQ: Child Health Assessment Questionaire ESR (mm/h): erythrocyte sedimentation rate (millimetres per hour)
Slovenian: ESR (erythrocyte sedimentation rate) (mm/h): hitrost sedimentacije eritrocitov (milimetri na uro)
English: Do not share the pre-filled pen with anyone.
Slovenian: Ne delite si napolnjenega injekcijskega peresnika z nikomer.
English: Due to the higher sensitivity and the improved drug tolerance, a higher incidence of antibodies to golimumab was expected to be detected with the drug-tolerant EIA method compared to the EIA method.
Slovenian: Zaradi višje občutljivosti in izboljšane tolerance za zdravilo je bilo pri metodi EIA, ki je tolerantna za zdravilo, pričakovati detekcijo večjega obsega protiteles proti golimumabu, v primerjavi z metodo EIA.
English: In a fertility and general reproductive function study in mouse, using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, the number of pregnant mice was reduced.
Slovenian: V študiji plodnosti in splošne sposobnosti razmnoževanja pri miših je bilo ob uporabi analognega protitelesa, ki selektivno zavira funkcionalno aktivnost mišjega TNFα, število brejih miši zmanjšano.
English: Psoriatic arthritis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis Simponi 50 mg given once a month, on the same date each month.
Slovenian: Psoriatični artritis, ankilozirajoči spondilitis ali neradiografski aksialni spondiloartritis Zdravilo Simponi 50 mg dajemo enkrat na mesec, vsak mesec na isti datum.
English: Among the children who tested positive for antibodies to golimumab, 39% (25/65) had neutralising antibodies.
Slovenian: Med otroki, ki so bili pozitivni na protitelesa proti golimumabu, jih je imelo 39 % (25/65) nevtralizirajoča protitelesa.
English: Gently, press the plunger until it stops.
Slovenian: Nežno pritisnite bat, dokler se ne ustavi.
English: Change from baseline n reflects randomised patients * p = 0.015
Slovenian: Začetna vrednost Sprememba glede na začetno vrednost n odraža randomizirane bolnike * p = 0,015
English: Check the expiration date (‘EXP') printed or written on the back panel of the carton.
Slovenian: Preverite datum izteka roka uporabnosti ("EXP"), ki je natisnjen ali napisan na zadnji strani škatle.
English: Patients were assessed for UC disease activity by partial Mayo score every 4 weeks (loss of response was confirmed by endoscopy).
Slovenian: Aktivnost UK so ocenili z oceno Mayo na 4 tedne (izginotje odziva so potrdili endoskopsko).
English: It is not known whether golimumab is excreted in human milk or absorbed systemically after ingestion.
Slovenian: Ni znano, ali se golimumab izloča v materino mleko pri človeku in ali se po zaužitju absorbira v sistemski krvni obtok.
English: Approximately 63% of patients who were receiving Simponi at the beginning of the study extension (week 56), remained on treatment through the end of the study (last golimumab administration at week 212).
Slovenian: Približno 63 % bolnikov, ki je prejemalo zdravilo Simponi na začetku podaljšanja študije (56. teden), je nadaljevalo zdravljenje do konca študije (zadnji odmerek golimumaba v 212. tednu).
English: While you are waiting you can get the rest of your equipment ready, including an alcohol swab, a cotton ball or gauze and a sharps container.
Slovenian: Med čakanjem si lahko pripravite vse ostale potrebščine, vključno z alkoholnim zložencem, kosmom vate ali zložencem iz gaze ter posodo za odlaganje ostrih odpadkov.
English: The safety of golimumab has been studied in a phase III study of 173 pJIA patients from 2 to 17 years of age.
Slovenian: Varnost golimumaba so preučevali v študiji faze III pri 173 bolnikih s pJIA, starih od 2 do 17 let.
English: Malignancies other than lymphoma
Slovenian: Drugi malignomi razen limfoma
English: • Pain and ulcers in the mouth
Slovenian: • bolečine in razjede v ustih,
English: However, you and your doctor may decide that you may inject Simponi to yourself or to your child.
Slovenian: Vendar se lahko skupaj z zdravnikom odločite, da boste zdravilo Simponi sebi ali svojemu otroku injicirali sami.
English: • Lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes)
Slovenian: • lihenoidne reakcije (srbeč rdeče-vijoličast kožni izpuščaj in/ali belo-sive nitaste črte na sluznicah),
English: Insert needle and hold in place
Slovenian: Zabodite iglo in držite pri miru
English: Do not inject if the perforations on the carton are broken.
Slovenian: Ne injicirajte, če je perforacija na škatli poškodovana/pretrgana.
English: A generally greater effect of Simponi 50 mg + MTX versus MTX alone was demonstrated in the indicated population compared with the overall population.
Slovenian: Na splošno se je pokazal večji učinek zdravila Simponi 50 mg z MTX v primerjavi s samim MTX pri navedeni populaciji v primerjavi s celotno populacijo.
English: • Do not warm the pre-filled pen in any other way (for example, do not warm it in a microwave or in hot water).
Slovenian: • Napolnjenega injekcijskega peresnika ne smete segrevati na noben drug način (na primer v mikrovalovni pečici ali v vroči vodi).
English: defined as a decrease from baseline in the Mayo score by ≥ 30% and ≥ 3 points, accompanied by a decrease in the rectal bleeding subscore of ≥ 1 or a rectal bleeding subscore of 0 or 1.
Slovenian: Opredeljeno kot zmanjšanje ocene Mayo za ≥ 30 % in ≥ 3 točke v primerjavi z izhodiščem ob hkratnem zmanjšanju ocene rektalne krvavitve za ≥ 1 ali ob hkratni oceni rektalne krvavitve 0 ali
English: The majority of lymphomas occurred in study GO-AFTER, which enrolled patients previously exposed to anti-TNF agents who had longer disease duration and more refractory disease (see section 4.4).
Slovenian: Večina limfomov se je pojavila v študiji GO-AFTER, v katero so bili vključeni bolniki, ki so bili že prej izpostavljeni zdravilom proti TNF in pri katerih je bilo trajanje bolezni daljše in je bila le-ta bolj odporna na zdravljenje (glejte poglavje 4.4).
English: Simponi contains sorbitol (E420).
Slovenian: Zdravilo Simponi vsebuje sorbitol (E420).
English: • Inflammation of blood vessels in internal organs
Slovenian: • vnetje krvnih žil v notranjih organih,
English: Each 0.05 mL medicine contains 2.05 mg sorbitol (E420).
Slovenian: 0,05 ml zdravila vsebuje 2,05 mg sorbitola (E420).
English: Dose Lines
Slovenian: Črte z odmerki
English: • serious infections (including TB, bacterial infections including serious blood infections and pneumonia, severe fungal infections and other opportunistic infections) (common).
Slovenian: • resne okužbe (vključno s TB, bakterijskimi okužbami, vključno z resnimi okužbami krvi in pljučnico, hudimi glivnimi okužbami in drugimi oportunističnimi okužbami) (pogosto).
English: • the treatment of moderate to severe, active rheumatoid arthritis in adults when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate.
Slovenian: • zdravljenje zmernega do hudega, aktivnega revmatoidnega artritisa pri odraslih, če je bil odziv na zdravljenje z antirevmatiki, ki vplivajo na potek bolezni (disease-modifying anti-rheumatic drug - DMARD), vključno z MTX, nezadosten;
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).
Slovenian: Vsem bolnikom je treba svetovati, naj nemudoma poiščejo zdravniško pomoč, če se pri njih pojavijo znaki in simptomi, ki kažejo na pojav krvne diskrazije (npr. dolgotrajno zvišana telesna temperatura, podplutbe, krvavitve in bledica).
English: Table 1: Simponi dose in millilitres (mL) by height and weight of patients with pJIA Total Body Weight (kg)
Slovenian: Preglednica 1: Odmerek zdravila Simponi v mililitrih (ml) glede na telesno višino in telesno maso bolnikov s pJIA Celotna telesna masa (kg)
English: • blood disease (common).
Slovenian: • bolezni krvi (pogosto).
English: Week 24 5% 20%*
Slovenian: 24. teden 5 % 20 %*
English: If you feel that something has gone wrong with the injection or if you are not sure, talk to your doctor or pharmacist.
Slovenian: Če menite, da je prišlo do napake pri injiciranju, ali ste negotovi, se posvetujte z zdravnikom ali farmacevtom.
English: If you would like to self inject Simponi, you must be trained by a healthcare professional to prepare an injection and give it to yourself.
Slovenian: Če si želite sami injicirati zdravilo Simponi, vas mora zdravstveni delavec poučiti, kako si pravilno pripravite in date injekcijo.
English: • You may notice an air bubble in the pre-filled syringe or a drop of liquid at the end of the needle.
Slovenian: • V napolnjeni injekcijski brizgi boste morda opazili zračni mehurček ali kapljico tekočine na koncu igle.
English: Although concomitant use of MTX results in higher steady-state trough concentrations of golimumab in patients with RA, PsA or AS, the data do not suggest the need for dose adjustment of either golimumab or MTX (see section 5.2).
Slovenian: Čeprav sočasna uporaba MTX vodi do večjih najnižjih koncentracij golimumaba v stanju dinamičnega ravnovesja pri bolnikih z RA, PsA ali AS, podatki, ki so na voljo, ne kažejo potrebe po prilagoditvi odmerka, bodisi pri golimumabu ali pri MTX (glejte poglavje 5.2).
English: The efficacy of Simponi was evaluated in two randomised, double-blind, placebo-controlled clinical studies in adult patients.
Slovenian: Učinkovitost zdravila Simponi so ocenili v dveh randomiziranih, dvojno slepih, s placebom kontroliranih kliničnih študijah pri odraslih bolnikih.
English: If your doctor decides that you or a caregiver may be able to give your injections of Simponi at home, you should receive training on the right way to prepare and inject Simponi.
Slovenian: Če zdravnik presodi, da si lahko injekcije zdravila Simponi dajete doma sami (oziroma vam jih lahko da vaš skrbnik), morate opraviti usposabljanje za pravilno pripravo in injiciranje zdravila Simponi.
English: It is very important that you tell your doctor if you have ever had TB, or if you have been in close contact with someone who has had TB.
Slovenian: Zelo pomembno je, da poveste zdravniku, če ste imeli kadar koli v preteklosti TB ali ste bili v tesnem stiku s tuberkuloznim bolnikom.
English: • Flu
Slovenian: • gripa,
English: Patients in clinical remission at week 6
Slovenian: Bolniki v klinični remisiji v 6. tednu
English: The solution can be used if it contains a few small translucent or white particles of protein.
Slovenian: Raztopina se lahko uporablja, če vsebuje nekaj majhnih prozornih ali belih delcev beljakovin.
English: Appropriate screening tests, i.e. tuberculin skin or blood test and chest X-ray, should be performed in all patients (local recommendations may apply).
Slovenian: Pri vseh bolnikih je treba opraviti ustrezne presejalne teste, npr. tuberkulinski kožni test ali krvno preiskavo ter slikanje prsnega koša (v skladu z lokalnimi priporočili).
English: Use the space above to record your prescribed dose.
Slovenian: Poznati morate svoj odmerek V zgornji prostor vpišite svoj predpisani odmerek.
English: Children in this study demonstrated ACR Ped 30, 50, 70, and 90 responses from week 4.
Slovenian: V tej študiji so otroci že od 4. tedna pokazali odzive ACR Ped 30, 50, 70 in 90.
English: Patients enrolled in this study had active disease despite current or previous NSAID or DMARD therapy and had not previously been treated with anti-TNF therapy.
Slovenian: Bolniki, ki so bili vključeni v to študijo, so imeli aktivno bolezen kljub obstoječemu ali prejšnjemu zdravljenju z nesteroidnimi antirevmatiki ali terapijo DMARD in se pred tem niso zdravili z zaviralci TNF.
English: The majority of cases have occurred in adolescent and young adult males with nearly all on concomitant treatment with azathioprine (AZA) or 6-mercaptopurine (6-MP) for inflammatory bowel disease.
Slovenian: Večina primerov se je pojavila pri mladostnikih in mladih odraslih moškega spola, od katerih so skoraj vsi sočasno prejemali azatioprin (AZA) ali 6-merkaptopurin (6-MP) za zdravljenje vnetne črevesne bolezni.
English: Each pack is provided with instructions for use that fully describe the use of the pen or the syringe.
Slovenian: V vsakem pakiranju so navodila za uporabo, v katerih je podrobno opisana uporaba peresnika ali brizge.
English: The safety and efficacy of golimumab have not been established in patients with pJIA below the age of 2 years.
Slovenian: Varnost in učinkovitost golimumaba pri bolnikih s pJIA, mlajših od 2 let, nista bili ugotovljeni.
English: Patients were allowed to continue concomitant DMARD therapy with MTX, sulfasalazine (SSZ), and/or hydroxychloroquine (HCQ) during the study.
Slovenian: Bolnikom so dovolili, da v času študije nadaljujejo s sočasno DMARD terapijo z MTX, sulfasalazinom (SSZ) in/ali hidroksiklorokvinom (HCQ).
English: GO-AFTER Active RA, previously treated with one or more anti-TNF agent(s)
Slovenian: GO-AFTER aktiven RA, ki je bil pred tem zdravljen z enim ali več zaviralci TNF
English: Injection site selection for caregivers if you are not administering the injection yourself (see figure 3)
Slovenian: Izbira mesta za injiciranje za negovalce, če si injekcije ne dajete sami (glejte sliko 3)
English: The dose should be given once a month, on the same date each month.
Slovenian: Odmerek je treba dati enkrat na mesec, vsak mesec na isti datum.
English: The pharmacokinetics of golimumab were determined in 173 children with pJIA with an age range from 2 to 17 years of age.
Slovenian: Farmakokinetiko golimumaba so določili pri 173 otrocih s pJIA, starih od 2 do 17 let.
English: Simponi has not been studied in these patient populations.
Slovenian: Zdravilo Simponi pri teh populacijah bolnikov ni bilo raziskano.
English: The pen or the syringe should not be shaken.
Slovenian: Peresnika ali brizge se ne sme stresati.
English: • Wipe the injection site with an alcohol swab.
Slovenian: • Obrišite mesto injiciranja z alkoholnim zložencem.
English: • Psoriasis (including on the palms of your hand and/or the soles of your feet and/or in the form of skin blisters)
Slovenian: • luskavica (vključno na dlaneh in/ali podplatih in/ali v obliki mehurjev na koži),
English: Patients should be advised of, and avoid exposure to, potential risk factors for infection as appropriate.
Slovenian: Bolnike je treba ustrezno poučiti o potencialnih dejavnikih tveganja za okužbe ter o izogibanju izpostavljenosti le-tem.
English: Cancer and lymphoma Tell your doctor if you have ever been diagnosed with lymphoma (a type of blood cancer) or any other cancer before you use Simponi.
Slovenian: Rak in limfom Preden uporabite zdravilo Simponi, zdravnika obvestite, če ste kdaj imeli limfom (vrsto krvnega raka) ali kakršno koli drugo vrsto raka.
English: If a patient forgets to inject Simponi on the planned date, the forgotten dose should be injected as soon as the patient remembers.
Slovenian: Če si bolnik pozabi injicirati zdravilo Simponi na načrtovani datum, si mora pozabljeni odmerek injicirati takoj, ko se spomni.
English: • heart failure (rare).
Slovenian: • srčno popuščanje (redko).
English: • The yellow indicator is connected to the plunger of the pre-filled pen.
Slovenian: • Rumeni kazalnik je povezan z batom napolnjenega injekcijskega peresnika.
English: The possibility exists for TNF-blocking agents, including golimumab, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
Slovenian: Obstaja možnost, da bodo zaviralci TNF, vključno z golimumabom, vplivali na obrambo osebe proti okužbam in malignim boleznim, saj je TNF mediator vnetja in spremeni celični imunski odziv.
English: Each pack is provided with instructions for use that fully describe the use of the pen.
Slovenian: V vsakem pakiranju so navodila za uporabo, v katerih je podrobno opisana uporaba peresnika.
English: • Merkel cell carcinoma (a type of skin cancer)
Slovenian: • karcinom Merklovih celic (vrsta kožnega raka),
English: Percentage of patients Patients in clinical response at week 6
Slovenian: Odstotek bolnikov Bolniki s kliničnim odzivom v 6. tednu
English: Based on the subset of patients with ≥ 3% BSA involvement at baseline, 79 patients (69.9%) in the placebo group and 109 (74.3%) in the Simponi 50 mg group.
Slovenian: Na podlagi podskupine bolnikov z ≥ 3 % prizadete telesne površine (BSA) na začetku študije, 79 bolnikov (69,9 %) v skupini za prejemanje placeba in 109 (74,3 %) v skupini za prejemanje zdravila Simponi v odmerku 50 mg.
English: Symptoms of skin cancer can include changes in the appearance of your skin or growths on your skin.
Slovenian: Simptomi kožnega raka lahko vključujejo spremembe izgleda kože ali izrastke na koži.
English: Do not attempt to use any leftover medicine in the pre-filled pen.
Slovenian: Ne poskušajte uporabiti morebitnega preostanka zdravila v napolnjenem injekcijskem peresniku.
English: The safety and efficacy of Simponi in patients aged less than 18 for indications other than pJIA have not been established.
Slovenian: Varnost in učinkovitost zdravila Simponi pri bolnikih, starih manj kot 18 let, nista bili ugotovljeni za nobeno indikacijo razen za pJIA.
English: If possible, it is recommended that prior to initiating golimumab therapy, paediatric patients be brought up to date with all immunisations in agreement with current immunisation guidelines (see Vaccinations/therapeutic infectious agents above).
Slovenian: Priporočljivo je, da se pred uvedbo zdravljenja z golimumabom, če je le mogoče, pri pediatričnih bolnikih opravijo vsa cepljenja v skladu s trenutno veljavnimi smernicami za cepljenje (glejte poglavje Cepljenja/povzročitelji okužb v terapevtske namene zgoraj).
English: If you are not sure what to do, talk to your doctor or pharmacist.
Slovenian: Če niste prepričani, kaj storiti, se posvetujte z zdravnikom ali farmacevtom.
English: Dates of Simponi treatment
Slovenian: Datumi zdravljenja z zdravilom Simponi
English: Patients with body weight less than 80 kg
Slovenian: Bolniki s telesno maso manj kot 80 kg
English: o If you weigh more than 100 kg, the dose might be increased to 100 mg (the content of
Slovenian: o Če tehtate več kot 100 kg, vam bo zdravnik morda povečal odmerek na 100 mg (vsebina
English: Patients who completed the maintenance study through week 54 continued treatment in a study extension, with efficacy evaluated through week 216.
Slovenian: Bolniki, ki so do 54. tedna zaključili vzdrževalno študijo, so nadaljevali z zdravljenjem v podaljšanju študije, kjer so ocenili učinkovitost do 216. tedna.