FrancophonIA/ELRC3.0 huggingface dataset:
English: Mean systemic clearance (CL) following a single intravenous administration to patients with plaque psoriasis ranged from 0.13 to 0.36 l/day.
Slovenian: Po odmerjanju enkratnega intravenskega odmerka bolnikom s psoriazo s plaki je povprečen sistemski očistek (CL) znašal od 0,13 do 0,36 l/dan.
English: All p-values are adjusted for multiplicity of testing based on pre-defined hierarchy at week 16 for PsA study 3, except for ACR70 which was an exploratory endpoint and all endpoints at week 24.
Slovenian: V PsA študiji 3 so za teden 16 vse vrednosti p prilagojene na večkratnost testiranja po vnaprej opredeljenem hierarhičnem redu, razen vrednosti p za odziv ACR 70, ki je bil raziskovalni cilji študije, in za vse cilje študije za teden 24.
English: For all studies, the primary endpoint was American College of Rheumatology (ACR) 20 response.
Slovenian: V vseh študijah je bil primarni cilj študije odziv ACR 20 (20-odstotno izboljšanje po merilih Ameriške akademije za revmatologijo, ACR - American College of Rheumatology).
English: Renal impairment / hepatic impairment Cosentyx has not been studied in these patient populations.
Slovenian: Zdravila Cosentyx pri teh dveh skupinah bolnikov niso proučevali.
English: Remove the syringe from the outer box and take it out of the blister.
Slovenian: Injekcijsko brizgo vzemite iz zunanje škatle in iz pretisnega omota.
English: Based on population pharmacokinetic analysis, following a single subcutaneous dose of either 150 mg or 300 mg in plaque psoriasis patients, secukinumab reached peak serum concentrations of 13.7±4.8 µg/ml or 27.3±9.5 µg/ml, respectively, between 5 and 6 days post dose.
Slovenian: Po rezultatih analize populacijske farmakokinetike je po enkratnem subkutanem odmerku bodisi 150 mg ali 300 mg sekukinumab pri bolnikih s psoriazo s plaki dosegel najvišjo koncentracijo v plazmi 13,7±4,8 µg/ml oziroma 27,3±9,5 µg/ml v času med 5. in 6. dnem po odmerjanju.
English: In a population pharmacokinetic analysis, the mean systemic clearance (CL) was 0.19 l/day in plaque psoriasis patients.
Slovenian: Po rezultatih analize populacijske farmakokinetike je pri bolnikih s psoriazo s plaki povprečen sistemski očistek (CL) znašal 0,19 l/dan.
English: Solution for injection in pre-filled pen (SensoReady pen)
Slovenian: raztopina za injiciranje v napolnjenem injekcijskem peresniku (injekcijskem peresniku SensoReady)
English: The frequency of IL-17-producing cells was also significantly higher in the subchondral bone marrow of facet joints from patients with ankylosing spondylitis.
Slovenian: Koncentracija celic, v katerih nastaja IL-17A, je bila prav tako bistveno večja v subhondralnem kostnem mozgu pod fasetnimi sklepi pri bolnikih z ankilozirajočim spondilitisom.
English: PsA study 1
Slovenian: PsA študija 1
English: Included in the carton:
Slovenian: V škatli najdete:
English: For psoriatic arthritis patients who also have moderate to severe plaque psoriasis or patients who did not respond well to medicines called tumour necrosis factor (TNF) blockers:
Slovenian: Za bolnike s psoriatičnim artritisom, ki imajo poleg tega zmerno do hudo psoriazo s plaki, in za bolnike z nezadostnim odzivom na predhodno zdravljenje z zdravili, ki jih imenujemo zaviralci tumorje nekrotizirajočega faktorja:
English: The primary endpoint was ASAS 20 at week 16.
Slovenian: Primarni cilj študije je bil dosežen odziv ASAS 20 po 16 tednih.
English: Do not use this medicine if you notice that the powder has not fully dissolved or if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Slovenian: Zdravila ne uporabljajte, če opazite, da se prašek ni raztopil v celoti ali če tekočina vsebuje jasno vidne delce, je motna ali izrazito rjave barve.
English: Weeks of treatment n = number of patients evaluable secukinumab 150 mg (n=243)
Slovenian: odstotek spremembe vrednosti indeksa PASI od izhodišča tedni zdravljenja n = število bolnikov, primernih za ocenjevanje number of patients evaluable sekukinumab 150 mg (n=243)
English: PsA study 3 (FUTURE 5) evaluated 996 patients, of whom 50.1% had concomitant MTX.
Slovenian: V PsA študiji 3 (študiji FUTURE 5) so ocenjevali 996 bolnikov, od katerih jih je 50,1 % sočasno prejemalo še metotreksat.
English: Cosentyx is given via injection under your skin (known as a subcutaneous injection).
Slovenian: Zdravilo Cosentyx je treba dajati z injekcijo pod kožo (kar imenujemo subkutano injiciranje).
English: Using Cosentyx in psoriatic arthritis will benefit you by reducing the signs and symptoms of the disease, slowing down the damage to the cartilage and bone of the joints and improving your ability to do normal daily activities.
Slovenian: Pri psoriatičnem artritisu vam bo uporaba zdravila Cosentyx koristila, saj bo zmanjševala znake in simptome bolezni, zavirala napredovanje okvar hrustanca in kostnine v sklepih in izboljševala vašo zmogljivost za opravljanje običajnih vsakodnevnih dejavnosti.
English: Week 52 Placebo 150 mg 300 mg 150 mg 300 mg 150 mg 300 mg
Slovenian: po 12 tednih po 16 tednih po 52 tednih placebo 150 mg 300 mg 150 mg 300 mg 150 mg 300 mg
English: Secukinumab 300 mg met the primary and secondary endpoints by showing superiority to ustekinumab based on PASI 90 response at week 16 (primary endpoint), speed of onset of PASI 75 response at week 4, and long-term PASI 90 response at week 52.
Slovenian: Za odmerek 300 mg sekukinumaba so tako pri primarnem kot pri sekundarnih ciljih študije lahko dokazali boljše rezultate (superiornost) v primerjavi z ustekinumabom pri doseganju odziva PASI 90 v 16. tednu (primarni cilj študije), hitrosti nastopa odziva PASI 75 v 4. tednu in dolgoročnem odzivu PASI 90 v 52. tednu.
English: Before reconstitution: Store the vial in the refrigerator between 2°C and 8°C.
Slovenian: Pred rekonstitucijo: Vialo shranjujte v hladilniku pri temperaturi od 2 °C do 8 °C.
English: Cosentyx 150 mg powder for solution for injection must be prepared by a healthcare professional.
Slovenian: Zdravilo Cosentyx 150 mg prašek za raztopino za injiciranje mora pripraviti zdravstveni delavec.
English: In PsA study 1, inhibition of structural damage was maintained with secukinumab treatment up to week 52.
Slovenian: V PsA študiji 1 se je zaviranje napredovanja strukturnih okvar pri uporabi sekukinumaba ohranilo do konca 52. tedna.
English: Live vaccines should not be given concurrently with secukinumab (see also section 4.4).
Slovenian: Bolniki v času zdravljenja s sekukinumabom ne smejo prejeti živih cepiv (glejte tudi poglavje 4.4).
English: IGA mod 2011 “clear” or “almost clear” response n (%) * The IGA mod 2011 is a 5-category scale including “0 = clear”, “1 = almost clear”, “2 = mild”, “3 = moderate” or “4 = severe”, indicating the physician's overall assessment of the psoriasis severity focusing on induration, erythema and scaling.
Slovenian: * IGA mod 2011 je lestvica s 5 kategorijami možne ocene, in sicer "0 = brez znakov", "1 = skoraj brez znakov", "2 = blaga", "3 = zmerna" in "4 = huda", ki se nanašajo na zdravnikovo oceno celotne izraženosti psoriaze s poudarkom na oceni zadebelitve, rdečine in luščenja kože.
English: Do not use this medicine if either the seal on the outer box or the seal of the blister is broken, as it may not be safe for you to use.
Slovenian: Če zunanja škatla ali pretisni omot nista originalno zaprta, ne uporabljajte tega zdravila, saj morda ni varno za uporabo.
English: Compared with exposure after a single dose, the population pharmacokinetic analysis showed that patients exhibited a 2-fold increase in peak serum concentrations and area under the curve (AUC) following repeated monthly dosing during maintenance.
Slovenian: Pri rednem odmerjanju enkrat na mesec v času vzdrževalnega zdravljenja so po rezultatih analize populacijske farmakokinetike v primerjavi z izpostavljenostjo zdravilu po enkratnem odmerku pri bolnikih izmerili 2-krat višje vrednosti najvišje koncentracije v serumu in površine pod krivuljo časovnega poteka koncentracije (AUC).
English: Cosentyx is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Slovenian: Zdravilo Cosentyx je indicirano za zdravljenje zmerne do hude psoriaze s plaki pri odraslih, ki so primerni za sistemsko zdravljenje.
English: The onset of action of secukinumab occurred as early as week 2.
Slovenian: Sekukinumab je začel delovati že v 2. tednu zdravljenja.
English: If you forget to use Cosentyx If you have missed a Cosentyx injection, talk to your doctor.
Slovenian: Če ste izpustili injiciranje zdravila Cosentyx, se posvetujte z zdravnikom.
English: Using Cosentyx in plaque psoriasis will benefit you by leading to improvements of skin clearance and reducing your symptoms such as scaling, itching and pain.
Slovenian: Pri psoriazi s plaki vam bo uporaba zdravila Cosentyx koristila, saj bo odpravljala kožne spremembe in zmanjševala simptome, kot so luščenje, srbenje in bolečine.
English: In clinical studies, rare cases of anaphylactic reactions have been observed in patients receiving secukinumab.
Slovenian: V kliničnih študijah so pri bolnikih, ki so prejemali sekukinumab, v redkih primerih opažali anafilaktične reakcije.
English: If you do not respond well enough to these medicines, you will be given Cosentyx to reduce the signs and symptoms of the disease, reduce inflammation and improve your physical function.
Slovenian: Če se na zdravljenje s temi zdravili ne bi dobro odzvali, boste dobili zdravilo Cosentyx za zmanjševanje znakov in simptomov bolezni, za zmanjševanje vnetja in izboljšanje telesne zmogljivosti.
English: • if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Slovenian: • če raztopina vsebuje jasno vidne delce, je motna ali izrazito rjave barve.
English: Using Cosentyx in ankylosing spondylitis will benefit you by reducing the signs and symptoms of your disease and improving your physical function.
Slovenian: Pri ankilozirajočem spondilitisu vam bo uporaba zdravila Cosentyx koristila, saj bo zmanjševala znake in simptome bolezni ter izboljševala vašo telesno zmogljivost.
English: Figure 2 ACR20 response in PsA study 2 over time up to week 52
Slovenian: Slika 2 Časovni potek doseganja odziva ACR 20 v PsA študiji 2 do 52. tedna
English: The removable needle cap of the Cosentyx pre-filled syringe contains a derivative of natural rubber latex.
Slovenian: Snemljiv pokrovček igle napolnjene injekcijske brizge z zdravilom Cosentyx vsebuje derivat naravnega lateksa.
English: In PsA study 2, among 200 patients initially randomised to secukinumab 150 mg and 300 mg, 178 (89%) patients were still on treatment at week 52.
Slovenian: V PsA študiji 2 je med 200 bolniki, ki so bili že takoj randomizirani na zdravljenje s sekukinumabom 150 mg in 300 mg, 178 bolnikov (89 %) ob koncu 52. tedna še vedno prejemalo zdravilo.
English: In AS study 2, treatment with secukinumab 150 mg resulted in greater improvement in measures of disease activity compared with placebo at week 16 (see Table 7).
Slovenian: V AS študiji 2 je zdravljenje s sekukinumabom 150 mg po 16 tednih povzročilo večje izboljšanje po merilih aktivnosti bolezni kot uporaba placeba (glejte preglednico 7).
English: Week 52 Placebo 150 mg 300 mg Etanercept 150 mg 300 mg Etanercept 150 mg 300 mg Etanercept
Slovenian: po 12 tednih po 16 tednih po 52 tednih placebo 150 mg 300 mg etanercept 150 mg 300 mg etanercept 150 mg 300 mg etanercept število bolnikov odziv
English: In AS study 1 and AS study 2, secukinumab-treated patients (150 mg in AS study 2 and both regimens in AS study 1) demonstrated significantly improved signs and symptoms at week 16, with comparable magnitude of response and efficacy maintained up to week 52 in both anti-TNFα-naive and anti-TNFα-IR patients.
Slovenian: V AS študiji 1 in AS študiji 2 je pri bolnikih, ki so prejemali sekukinumab (v odmerku 150 mg v AS študiji 2 in pri obeh režimih zdravljenja v AS študiji 1), po 16 tednih prišlo do statistično značilnega izboljšanja znakov in simptomov, pri čemer je bila izraženost odziva primerljiva med skupinama predhodno nezdravljenih in z zaviralci TNFα neodzivnih bolnikov, učinkovitost pa se je v obeh podskupinah ohranila do konca 52 tedna.
English: Patients treated with ustekinumab received 45 mg or 90 mg at weeks 0 and 4, then every 12 weeks until week 52 (dosed by weight as per approved posology) ** p values versus ustekinumab: p<0.0001 for primary endpoint of PASI 90 at week 16 and secondary endpoint of PASI 75 at week 4 *** p values versus ustekinumab: p=0.0001 for secondary endpoint of PASI 90 at week 52
Slovenian: Bolniki, ki so prejemali ustekinumab, so prejeli odmerek 45 mg ali 90 mg (glede na telesno maso v skladu z odobrenim odmerjanjem) v tednih 0 in 4 in nato enkrat na 12 tednov do 52. tedna.. ** p- vrednost v primerjavi z ustekinumabom: p<0,0001 za primarni cilj študije PASI 90 v 16. tednu in sekundarni cilj študije PASI 75 v 4. tednu *** p- vrednost v primerjavi z ustekinumabom: p=0,0001 za sekundarni cilj študije PASI 90 v 52. tednu
English: The frequency of neutropenia in psoriatic arthritis and ankylosing spondylitis is similar to psoriasis.
Slovenian: Pogostnost nevtropenije je pri psoriatičnem artritisu in ankilozirajočem spondilitisu podobna kot pri psoriazi.
English: Psoriasis study 3 (FEATURE) evaluated 177 patients using a pre-filled syringe compared with placebo after 12 weeks of treatment to assess the safety, tolerability, and usability of secukinumab self-administration via the pre-filled syringe.
Slovenian: V 3. študiji psoriaze (študiji FEATURE) so pri 177 bolnikih, ki so uporabljali napolnjeno injekcijsko brizgo za primerjavo s placebom, po 12 tednih zdravljenja ocenjevali varnost, prenašanje in uporabnost sekukinumaba, ki so si ga bolniki odmerjali sami z napolnjeno injekcijsko brizgo.
English: Patients treated with secukinumab 150 mg showed improvements in spinal mobility as measured by change from baseline in BASMI at week 16 for both AS study 1 (-0.40 versus -0.12 for placebo; p=0.0114) and AS study 2 (-0.51 versus -0.22 for placebo; p=0.0533).
Slovenian: Pri bolnikih, ki so prejemali sekukinumab v odmerku 150 mg, je prišlo do izboljšanja gibljivosti hrbtenice, kar so ocenjevali s spremembo vrednosti Bachovega indeksa gibljivosti hrbtenice BASMI od izhodišča po 16 tednih, in sicer tako v AS študiji 1 (-0,40 v primerjavi z -0,12 pri uporabi placeba; p=0,0114) kot v AS študiji 2 (-0,51 v primerjavi z -0,22 pri uporabi placeba; p=0,0533).
English: In PsA study 2 and PsA study 3, patients treated with secukinumab 150 mg (p=0.0555 and p<0.0001) and 300 mg (p=0.0040 and p<0.0001) showed improvement in physical function compared to patients treated with placebo as assessed by Health Assessment Questionnaire-Disability Index (HAQ-DI) at week 24 and week 16, respectively.
Slovenian: Telesna zmogljivost in z zdravjem povezana kakovost življenja V PsA študiji 2 in v PsA študiji 3 so pri bolnikih, ki so prejemali sekukinumab 150 mg (p=0,0555 in p<0,0001) oziroma 300 mg (p=0,0040 in p<0,0001) opažali večje izboljšanje telesne zmogljivosti kot pri bolnikih, ki so prejemali placebo, glede na indeks invalidnosti pri vprašalniku za oceno zdravstvenega stanja (HAQ-DI - Health Assessment Questionnaire-Disability Index), ki so ga ocenjevali po 24 tednih oziroma po 16 tednih.
English: What Cosentyx contains - The active substance is secukinumab.
Slovenian: Kaj vsebuje zdravilo Cosentyx - Učinkovina je sekukinumab.
English: Dactylitis resolution n (%) † Week 16
Slovenian: odpravljen daktilitis n (%) † teden 16
English: • if you have recently had or are due to have a vaccination.
Slovenian: • če ste bili pred kratkim cepljeni ali pa se nameravate cepiti.
English: Non-serious infections with usual response to standard care and not requiring discontinuation of secukinumab were reported in the remaining 3 cases.
Slovenian: V preostalih 3 primerih so poročali o okužbah, ki niso bile opredeljene kot resne in pri katerih je prišlo do običajnega odziva na standardno zdravljenje, prekinitev uporabe sekukinumaba pa ni bila potrebna.
English: - The other ingredients are trehalose dihydrate, histidine, histidine hydrochloride monohydrate,
Slovenian: - Druge sestavine zdravila so trehaloza dihidrat, histidin, histidinijev klorid monohidrat, metionin,
English: After the first dose you will receive further weekly injections at weeks 1, 2, 3 and 4 followed by monthly injections.
Slovenian: Po prvem odmerku boste zdravilo prejemali enkrat na teden, in sicer po 1, 2, 3 in 4 tednih zdravljenja, nato pa enkrat na mesec.
English: The pre-filled syringe inside the pen is a 1 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid needle shield of styrene butadiene rubber.
Slovenian: Napolnjena injekcijska brizga znotraj peresnika je 1-mililitrska steklena injekcijska brizga z batnim zamaškom iz brombutilne gume s silikonsko prevleko, z nameščeno iglo debeline 27 G in dolžine pol palca (12,7 mm) ter z neupogljivim ščitnikom igle iz stiren-butadienske gume.
English: Remember to take the syringe out of the refrigerator and allow it to reach room temperature before preparing it for injection (15-30 minutes).
Slovenian: Pred pripravljanjem za injiciranje ne pozabite injekcijske brizge vzeti iz hladilnika in jo pustiti, da doseže sobno temperaturo (15-30 minut).
English: Cosentyx is supplied in a pre-filled 1 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid needle shield of styrene butadiene rubber assembled in a passive safety device of polycarbonate.
Slovenian: Zdravilo Cosentyx je na voljo v napolnjeni 1-mililitrski stekleni injekcijski brizgi z batnim zamaškom iz brombutilne gume s silikonsko prevleko, z nameščeno iglo debeline 27 G in dolžine pol palca (12,7 mm) ter z neupogljivim ščitnikom igle iz stiren-butadienske gume, ki je vgrajen v pasivni varnostni mehanizem iz polikarbonata.
English: Cosentyx is used to treat a condition called “psoriatic arthritis”.
Slovenian: Zdravilo Cosentyx uporabljamo za zdravljenje bolezni, ki jo imenujemo "psoriatični artritis".
English: As a direct consequence treatment with secukinumab reduces erythema, induration and desquamation present in plaque psoriasis lesions.
Slovenian: Zdravljenje s sekukinumabom neposredno zmanjšuje rdečino, zadebelitev in luščenje kože v predelu lezij pri psoriazi s plaki.
English: 1 pre-filled syringe 2 pre-filled syringes
Slovenian: 1 napolnjena injekcijska brizga 2 napolnjeni injekcijski brizgi
English: Over 17,900 patients have been treated with secukinumab in blinded and open-label clinical studies in various indications (plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and other autoimmune conditions), representing 29,978 patient years of exposure.
Slovenian: V slepih in odprtih kliničnih študijah z različnimi indikacijami (psoriaza s plaki, psoriatični artritis, ankilozirajoči spondilitis in druge avtoimunske bolezni) je bilo s sekukinumabom zdravljenih več kot 17.900 bolnikov, kar predstavlja 29.978 bolnikov-let izpostavljenosti zdravilu.
English: Tell your doctor or pharmacist before using Cosentyx:
Slovenian: Pred začetkom uporabe zdravila Cosentyx obvestite zdravnika ali farmacevta:
English: For patients with concomitant moderate to severe plaque psoriasis or who are anti-TNFα inadequate responders (IR), the recommended dose is 300 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Slovenian: Za bolnike s sočasno zmerno do hudo psoriazo s plaki in za tiste z nezadostnim odzivom na zdravljenje z zaviralci TNFα je priporočeni odmerek 300 mg s subkutano injekcijo, in sicer z začetnim odmerjanjem enkrat na teden v tednih 0, 1, 2, 3 in 4.
English: AS study 2 (MEASURE 2) evaluated 219 patients, of whom 11.9% and 14.2% used concomitant MTX or sulfasalazine, respectively.
Slovenian: V AS študiji 2 (študiji MEASURE 2) so ocenjevali 219 bolnikov, med katerimi jih je 11,9 % sočasno prejemalo metotreksat, 14,2 % pa jih je sočasno prejemalo sulfasalazin.
English: Mean decreases (improvements) in DLQI from baseline ranged from -10.4 to -11.6 with secukinumab 300 mg, from -7.7 to -10.1 with secukinumab 150 mg, versus -1.1 to -1.9 for placebo at week 12.
Slovenian: Povprečno znižanje (izboljšanje) vrednosti indeksa DLQI od izhodišča je po 12 tednih znašalo od -10,4 do -11,6 pri uporabi sekukinumaba 300 mg in od -7,7 do -10,1 pri uporabi sekukinumaba 150 mg v primerjavi z znižanjem za -1,1 do -1,9 pri uporabi placeba.
English: This is followed by a slow decrease due to reduced clearance of secukinumab-bound IL-17A, indicating that secukinumab selectively captures free IL-17A, which plays a key role in the pathogenesis of plaque psoriasis.
Slovenian: Tak potek kaže, da sekukinumab selektivno veže prosti IL-17A, ki ima pomembno vlogo v patogenezi psoriaze s plaki.
English: Cosentyx is used to treat a condition called “ankylosing spondylitis”.
Slovenian: Zdravilo Cosentyx uporabljamo za zdravljenje bolezni, ki jo imenujemo "ankilozirajoči spondilitis".
English: Based on your response, your doctor may increase your dose to 300 mg. Each 300 mg dose is given as two injections of 150 mg.
Slovenian: Na osnovi vašega odziva vam bo zdravnik morda odmerek zvišal na 300 mg. Vsak odmerek 300 mg prejmete v obliki dveh injekcij po 150 mg.
English: PsA study 2
Slovenian: PsA študija 2
English: Cosentyx has no or negligible influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Cosentyx nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: The resulting solution should be clear and colourless to slightly yellow.
Slovenian: Dobljena raztopina mora biti bistra in brezbarvna do nekoliko rumenkasta.
English: On the basis of simulated data, peak concentrations at steady-state (Cmax,ss) following subcutaneous administration of 150 mg or 300 mg were 27.6 µg/ml and 55.2 µg/ml, respectively.
Slovenian: Na osnovi simulacijskih podatkov je po subkutanem odmerjanju 150 mg oziroma 300 mg v stanju dinamičnega ravnovesja najvišja koncentracija (Cmax,ss) znašala 27,6 µg/ml oziroma 55,2 µg/ml.
English: Of the 72 patients randomised to secukinumab 150 mg, 45 and 35 had an ASAS 20/40 response, respectively.
Slovenian: Med 72 bolniki, ki so bili randomizirani na prejemanje sekukinumaba 150 mg, jih je 45 oziroma 35 doseglo odziv ASAS 20 oziroma ASAS 40.
English: An effect of inhibition of structural damage was observed in anti-TNFα-naïve and anti-TNFα-IR patients and in patients treated with and without concomitant MTX.
Slovenian: Zaviralni učinek na napredovanje strukturnih okvar so opažali tako pri tistih, ki predhodno še niso prejemali zaviralcev TNFα, kot pri tistih z nezadostnim odzivom na zdravljenje z zaviralci TNFα, pa tudi pri bolnikih, ki so sočasno prejemali metotreksat, in pri tistih, ki niso sočasno prejemali metotreksata.
English: Patients were randomised to receive secukinumab 150 mg, 300 mg or placebo subcutaneously at weeks 0, 1, 2, 3 and 4, followed by the same dose every month, or a once monthly injection of secukinumab 150 mg (without loading).
Slovenian: Bolnike so randomizirali na prejemanje sekukinumaba 150 mg ali 300 mg ali placeba, in sicer subkutano v tednih 0, 1, 2, 3 in 4, nato pa v enakem odmerku enkrat na mesec, ali na prejemanje injekcij sekukinumaba 150 mg enkrat na mesec (brez polnitvenega režima).
English: Instructions for administration of Cosentyx solution Tilt the vial to an angle of approximately 45° and position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe.
Slovenian: Navodila za apliciranje raztopine zdravila Cosentyx Vialo nagnite pod kotom približno 45° in pri vlečenju raztopine v brizgo držite konico igle čisto na dnu raztopine v viali.