FrancophonIA/ELRC3.0 huggingface dataset:
English: Response over time
Slovenian: Časovni potek odzivov
English: Prepare for your injection
Slovenian: Pripravite vse za injiciranje
English: Tremfya is a clear, colourless to light yellow solution.
Slovenian: Zdravilo Tremfya je bistra, brezbarvna do svetlo rumena raztopina.
English: Guselkumab is a fully human immunoglobulin G1 lamda (IgG1λ) monoclonal antibody (mAb) to the interleukin (IL)-23 protein, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Slovenian: Guselkumab je povsem humano monoklonsko protitelo G1 lambda (IgG1λ) proti proteinu interlevkinu (IL)-23, izdelano na ovarijskih celicah kitajskega hrčka s tehnologijo rekombinantne DNK.
English: Inject within 5 minutes of removing the needle cover.
Slovenian: Zdravilo injicirajte v 5 minutah po snetju pokrovčka z igle.
English: 1 pre-filled syringe Component of a multipack, cannot be sold separately
Slovenian: 1 napolnjen injekcijski peresnik Sestavni del večjega pakiranja, Posamezni zavitki se ne smejo prodajati ločeno.
English: Tremfya has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Tremfya nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: Summary of Patient Reported Outcomes at Week 16 in VOYAGE 1 and VOYAGE 2 VOYAGE 1
Slovenian: Povzetek izidov po navedbah bolnikov v 16. tednu v študijah VOYAGE 1 in VOYAGE 2
English: As a precautionary measure, it is preferable to avoid the use of Tremfya in pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Tremfya bolje izogibati.
English: Please also read the Package Leaflet carefully before starting your injection and discuss any questions you may have with your doctor or nurse.
Slovenian: Preden začnete z injiciranjem, si skrbno preberite tudi Navodilo za uporabo in se o morebitnih vprašanjih pogovorite z zdravnikom ali medicinsko sestro.
English: In two phase III clinical studies through Week 48, 0.7% of Tremfya injections and 0.3% of placebo injections were associated with injection site reactions.
Slovenian: V dveh kliničnih študijah faze III so se do 48. tedna pri 0,7% injiciranj zdravila Tremfya in 0,3% injiciranj placeba pojavile reakcije na mestu injiciranja.
English: Single intravenous doses of guselkumab up to 987 mg (10 mg/kg) have been administered in healthy volunteers and single subcutaneous doses of guselkumab up to 300 mg have been administered in patients with plaque psoriasis in clinical studies without dose-limiting toxicity.
Slovenian: Zdravim prostovoljcem so dajali enkratne intravenske odmerke guselkumaba do 987 mg (10 mg/kg), bolnikom s psoriazo s plaki pa so v kliničnih študijah dajali enkratne subkutane odmerke guselkumaba do 300 mg brez toksičnih učinkov, ki bi omejevali odmerjanje zdravila.
English: The efficacy and safety of guselkumab was demonstrated regardless of age, gender, race, body weight, plaques location, PASI baseline severity, concurrent psoriatic arthritis, and previous treatment with a biologic therapy.
Slovenian: Učinkovitost in varnost guselkumaba sta bili dokazani neodvisno od starosti, spola, rase, telesne mase, lokacije plakov, izhodiščne ocene izraženosti bolezni (PASI), sočasnega psoriatičnega artritisa in predhodnega zdravljenja z biološkimi zdravili.
English: VOYAGE 1 and VOYAGE 2
Slovenian: Študiji VOYAGE 1 in VOYAGE 2
English: Patients receiving Tremfya should be monitored for signs and symptoms of active TB during and after treatment.
Slovenian: Bolnike, ki prejemajo zdravilo Tremfya, je treba med in po zaključku zdravljenja spremljati glede znakov in simptomov aktivne tuberkuloze.
English: If you think you may be allergic, ask your doctor for advice before using Tremfya
Slovenian: Če menite, da bi lahko bili alergični, se pred začetkom uporabe zdravila Tremfya posvetujte z zdravnikom.
English: Signs of improvement on patient-reported outcomes were maintained through Week 24 (VOYAGE 1 and 2) and Week 48 (VOYAGE 1).
Slovenian: Znaki izboljšanja izidov, ki so jih navedli bolniki, so vztrajali do konca 24. tedna (v študijah VOYAGE 1 in 2) in do konca 48. tedna (v študiji VOYAGE 1).
English: As a human IgG mAb, guselkumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Slovenian: Glede na to, da je guselkumab človeško monoklonsko protitelo, je mogoče pričakovati, da se razgradi na manjše peptide in aminokisline preko kataboličnih procesov tako kot endogena protitelesa IgG.
English: No specific study has been conducted to determine the effect of renal or hepatic impairment on the pharmacokinetics of guselkumab.
Slovenian: Za ugotavljanje vpliva okvare jeter ali ledvic na farmakokinetiko guselkumaba, niso opravili posebnih študij.
English: Check the expiration date (‘EXP') on the back panel of the carton.
Slovenian: Preverite datum izteka roka uporabnosti (EXP) na zadnji strani škatle.
English: In VOYAGE 2, 88.6% of patients receiving guselkumab maintenance treatment at Week 48 were PASI 90 responders compared to 36.8% of patients who were withdrawn from treatment at Week 28 (p < 0.001).
Slovenian: V študiji VOYAGE 2 je 88,6% bolnikov, ki so prejemali vzdrževalno zdravljenje z guselkumabom, do 48. tedna doseglo odziv PASI 90 v primerjavi 36,8% bolnikov, ki so po 28. tednu prekinili zdravljenje (p < 0,001).
English: In VOYAGE 1, for patients receiving continuous guselkumab treatment, these improvements were maintained in the open-label phase through Week 156 (Table 5).
Slovenian: V študiji VOYAGE 1 so se pri bolnikih, ki so neprekinjeno prejemali guselkumab, ta izboljšanja ohranila v odprti fazi študije do 156. tedna (glejte Preglednico5).
English: Do not use this medicine after the expiry date which is stated on the syringe label and on the outer carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki injekcijske brizge in na zunanji škatli poleg oznake "EXP".
English: If you stop using Tremfya
Slovenian: Če ste prenehali uporabljati zdravilo Tremfya
English: The exact pathway through which guselkumab is metabolized has not been characterized.
Slovenian: Natančna pot presnove guselkumaba ni bila opisana.
English: After proper training in subcutaneous injection technique, patients may inject Tremfya if a physician determines that this is appropriate.
Slovenian: Po ustreznem usposabljanju o subkutanem injiciranju si lahko bolniki sami injicirajo zdravilo Tremfya, če zdravnik presodi, da je to primerno in zagotovi tudi ustrezno spremljanje bolnika.
English: Following a single 100 mg subcutaneous injection in healthy subjects, guselkumab reached a mean (± SD) maximum serum concentration (Cmax) of 8.09 ± 3.68 mcg/mL by approximately 5.5 days post dose.
Slovenian: Po enkratni 100 mg subkutani injekciji je guselkumab pri zdravih preiskovancih dosegel povprečno najvišjo serumsko koncentracijo (Cmax) 8,09 μg/ml (s standardno deviacijo ± 3,68 μg/ml) približno 5,5 dni po odmerjanju.
English: These results are consistent with the clinical benefit observed with guselkumab treatment in plaque psoriasis.
Slovenian: Ti rezultati se ujemajo s kliničnimi koristmi, ki jih opažajo pri zdravljenju psoriaze s plaki z guselkumabom.
English: Treatment with guselkumab resulted in significant improvements in the measures of disease activity compared to placebo and adalimumab at Week 16 and compared to adalimumab at Weeks 24 and 48.
Slovenian: Zdravljenje z guselkumabom je privedlo do statistično značilnega večjega izboljšanja meril aktivnosti bolezni v primerjavi z bolniki s placebom v 16. tednu in v primerjavi z bolniki z adalimumabom v 24. oziroma v 48. tednu.
English: Serious allergic reactions, which can include symptoms of hives and shortness of breath, have occurred with Tremfya (see “Serious side effects” in section 4).
Slovenian: Pri uporabi zdravila Tremfya je prišlo do resnih alergijskih reakcij, ki so lahko vključevale simptome koprivnice in zadihanosti (glejte pod naslovom “Resni neželeni učinki” v poglavju 4).
English: Mean systemic clearance (CL) following a single intravenous administration to healthy subjects ranged from 0.288 to 0.479 L/day across studies.
Slovenian: Po enkratnem intravenskem odmerku je pri zdravih preiskovancih povprečni sistemski očistek (CL) v študijah znašal od 0,288 do 0,479 l/dan.
English: Guselkumab and secukinumab PASI 90 response rates through Week 48 are presented in Figure 4.
Slovenian: Stopnje odziva PASI 90 za guselkumab in sekukinumab do konca 48. tedna so prikazane na Sliki 4.
English: Do not put the cap back on, this could damage the needle.
Slovenian: Pokrovčka ne nameščajte nazaj, s tem bi lahko poškodovali iglo.
English: In in vitro models, guselkumab was shown to inhibit the bioactivity of IL-23 by blocking its interaction with cell surface IL-23 receptor, disrupting IL-23-mediated signaling, activation and cytokine cascades.
Slovenian: V modelih in vitro se je pokazalo, da guselkumab zavira biološko aktivnost IL-23, tako da zavira njegovo interakcijo z receptorji za IL-23 na celični površini, ovira signaliziranje, ki ga posreduje IL-23, aktivacijo in kaskadno pot nastajanja citokinov.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, toxicity to reproduction and pre- and post-natal development.
Slovenian: Neklinični podatki na osnovi konvencionalnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, toksičnega vpliva na sposobnost razmnoževanja in na prenatalni in postnatalni razvoj ne kažejo posebnega tveganja za človeka.
English: Driving and using machines Tremfya is unlikely to influence your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Za zdravilo Tremfya je malo verjetno, da bi vplivalo na vašo sposobnost vožnje in upravljanja strojev.
English: For additional assistance or to share your feedback refer to the Package Leaflet for your local representative contact information.
Slovenian: Če potrebujete dodatno pomoč ali bi radi povedali svoje mnenje, v Navodilu za uporabo poiščite kontaktne podatke predstavništva imetnika dovoljenja za promet z zdravilom v vaši državi.
English: There were no preneoplastic changes observed in histopathology evaluations of animals treated up to 24-weeks, or following the 12-week recovery period during which drug was detectable in the serum.
Slovenian: Pri histopatoloških preiskavah na živalih, zdravljenih do največ 24 tednov, ali po 12-tedenskem obdobju premora, v katerem so še vedno lahko zaznali koncentracijo zdravila v serumu, niso opazili nobenih prekancerogenih sprememb.
English: Check the liquid in the window.
Slovenian: Preverite tekočino v okencu
English: PASI 100 1 (0.6) IGA 0/1
Slovenian: IGA 0/1 12 (6,9) IGA 0
English: Mean volume of distribution during the terminal phase (Vz) following a single intravenous administration to healthy subjects ranged from approximately 7 to 10 L across studies.
Slovenian: Po enkratnem intravenskem odmerku je bil pri zdravih preiskovancih povprečni volumen porazdelitve v terminalni fazi (Vz) v študijah od približno 7 do 10 l.
English: Through Week 156, 0.5% of Tremfya injections were associated with injection site reactions.
Slovenian: Do konca 156. tedna je bilo z reakcijo na mestu injiciranja povezanih 0,5% injiciranj zdravila Tremfya.
English: Call your doctor to talk about any questions you may have.
Slovenian: Pokličite svojega zdravnika in pri njem poiščite odgovore na svoja vprašanja.
English: All patients (N=871) received open-label ustekinumab (45 mg ≤100 kg and 90 mg >100 kg) at Weeks 0 and 4.
Slovenian: Vsi bolniki (N=871) so v odprti študiji v tednih 0 in 4 prejeli ustekinumab (45 mg pri telesni masi ≤100 kg oziroma 90 mg pri telesni masi >100 kg).
English: EU/1/17/1234/004 (2 packs, each containing 1 pre-filled syringe)
Slovenian: EU/1/17/1234/003 (2 pakiranji, vsako vsebuje 1 napolnjem injekcijski peresnik)
English: It is unknown whether guselkumab is excreted in human milk.
Slovenian: Ni znano, ali se guselkumab izloča v materino mleko pri človeku.
English: Table 1 provides a list of adverse reactions from psoriasis clinical studies as well as from post-marketing experience.
Slovenian: V Preglednici 1 so navedeni neželeni učinki iz kliničnih študij s psoriazo in izkušenj uporabe zdravila po prihodu na trg.
English: Guselkumab demonstrated superiority compared to adalimumab for scalp and hand and foot psoriasis at Week 24 (VOYAGE 1 and 2) and Week 48 (VOYAGE 1) (p ≤ 0.001, except for hand and foot psoriasis at Week 24 [VOYAGE 2] and Week 48 [VOYAGE 1], p < 0.05).
Slovenian: Superiornost guselkumaba v primerjavi z adalimumabom so dokazali pri psoriazi lasišča in psoriazi dlani in podplatov v 24. tednu (v študijah VOYAGE 1 in 2) in v 48. tednu (v študiji VOYAGE 1) (p < 0,001), razen pri psoriazi dlani in podplatov v 24. tednu [v študiji VOYAGE 2] in v 48. tednu [v študiji VOYAGE 1], p < 0,05).
English: Between 12 and 24 weeks after randomisation, guselkumab patients achieved an IGA score 0/1 with ≥ 2 grade improvement twice as often as ustekinumab patients (mean 1.5 vs 0.7 visits, respectively, p < 0.001).
Slovenian: Od 12. do 24. tedna po randomizaciji so bolniki z guselkumabom dosegali oceno IGA 0/1 z izboljšanjem za ≥ 2 stopnji dvakrat pogosteje kot bolniki z ustekinumabom (s povprečnim številom takih obiskov 1,5 v primerjavi z 0,7, p < 0,001).
English: Secukinumab (N=514)
Slovenian: sekukinumab (N = 514)
English: Do not use this medicine after the expiry date which is stated on the pre-filled pen label and on the outer carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki napolnjenega injekcijskega peresnika in na zunanji škatli poleg oznake "EXP".
English: Hold syringe by the body and pull needle cover straight off.
Slovenian: Primite telo brizge in potegnite pokrovček naravnost stran.
English: Signs of infections may include fever or flu like symptoms; muscle aches; cough; shortness of breath; burning when you urinate or urinating more often than usual; blood in your phlegm (mucus); weight loss; diarrhoea or stomach pain; warm, red, or painful skin or sores on your body which are different from your psoriasis.
Slovenian: Med znaki okužbe so lahko zvišana telesna temperatura ali gripi podobni simptomi, bolečine v mišicah, kašelj, zadihanost, pekoč občutek pri uriniranju ali uriniranje, ki je pogostejše kot običajno, kri v izmečku (izkašljani sluzi), hujšanje, driska ali bolečine v trebuhu, vroča, rdeča ali boleča koža ali rane oziroma spremembe na koži, ki so drugačne od vaših psoriatičnih sprememb.
English: For patients randomised to adalimumab at Week 0 who crossed over to guselkumab at Week 52, the PASI 90 response rate increased from Week 52 through Week 76 and was then maintained through Week 156 (see Figure 2).
Slovenian: Pri bolnikih, randomiziranih na adalimumab v tednu 0, ki so prešli na guselkumab v 52. tednu, pa se je odziv PASI 90 izboljševal od 52. do 76. tedna in se ohranil vse do 156. tedna (Glejte Sliko 2).
English: Figure 3: Percent of Subjects Who Achieved an IGA Score of Cleared (0) or Minimal (1) and at least a 2-grade improvement in IGA from Week 0 Through Week 24 by Visit After Randomisation in NAVIGATE
Slovenian: Slika 3: Odstotek bolnikov, ki so dosegli oceno IGA brez znakov prizadetosti (0) ali z minimalnimi znaki prizadetosti kože (1) in izboljšanje ocene za najmanj 2 stopnji od tedna 0 do 24. tedna, po posameznih obiskih po randomizaciji v študiji NAVIGATE
English: Each Tremfya pack is provided with an ‘Instructions for use' leaflet that fully describes the preparation and administration of the pre-filled syringe or pre-filled pen.
Slovenian: Vsakemu pakiranju zdravila Tremfya so priložena "Navodila za injiciranje" s podrobnim opisom priprave in odmerjanja zdravila z napolnjeno injekcijsko brizgo oziroma napolnjenim injekcijskim peresnikom.
English: The efficacy of guselkumab was evaluated with respect to overall skin disease, regional disease (scalp, hand and foot and nails) and quality of life and patient reported outcomes.
Slovenian: Učinkovitost guselkumaba so ocenjevali glede na celokupno stanje kožne bolezni, prizadetost posameznih predelov pri lokalizirani obliki (prizadetost lasišča, dlani, podplatov in nohtov) ter glede na kakovost življenja in izide zdravljenja po oceni bolnikov (patient reported outcomes).
English: Position syringe at about a 45 degree angle to the skin.
Slovenian: Injekcijsko brizgo postavite proti koži pod kotom 45 stopinj.
English: Check the expiration date (‘EXP') on the carton.
Slovenian: Preverite datum izteka roka uporabnosti (EXP), ki je napisan na škatli.
English: • if you have recently had a vaccination or if you are due to have a vaccination during treatment with Tremfya.
Slovenian: • če ste bili pred kratkim cepljeni ali če morate prejeti cepivo v času zdravljenja z zdravilom
English: In both studies, patients randomised to placebo (N=422) received guselkumab 100 mg at Weeks 16, 20 and q8w thereafter.
Slovenian: V obeh študijah so bolniki, ki so bili randomizirani na placebo (N=422), prejeli odmerek 100 mg guselkumaba v tednih 16 in 20, nato pa vsakih 8 tednov.
English: Week 76
Slovenian: 76. teden
English: Excipients: sucrose, histidine, histidine monohydrochloride monohydrate, polysorbate 80, water for injections.
Slovenian: Pomožne snovi: saharoza, histidin, histidinijev klorid monohidrat, polisorbat 80, voda za injekcije.
English: In a Phase 1 study in subjects with moderate to severe plaque psoriasis, changes in systemic exposures (Cmax and AUCinf) of midazolam, S-warfarin, omeprazole, dextromethorphan, and caffeine after a single dose of guselkumab were not clinically relevant, indicating that drug interactions between guselkumab and substrates of various CYP enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) are unlikely.
Slovenian: Medsebojno delovanje s substrati citokroma P450 (CYP450) V študiji faze I pri bolnikih z zmerno do hudo psoriazo s plaki, zdravljenih z guselkumabom, spremembe v sistemski izpostavljenosti (Cmax in AUCinf) midazolamu, S-varfarinu, omeprazolu, dekstrometorfanu in kofeinu po enkratnem odmerku guselkumaba niso bile klinično pomembne, kar pomeni, da interakcije med guselkumabom in različnimi substrati CYP (CYP3A4, CYP2C9, CYP2C19, CYP2D6 in CYP1A2) niso verjetne.
English: CARTON FOR 1 PRE-FILLED SYRINGE (100 mg) AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Slovenian: ŠKATLA Z 1 NAPOLNJENO INJEKCIJSKO BRIZGO (100 mg) KOT VMESNO PAKIRANJE/DEL VEČJEGA PAKIRANJA (BREZ MODREGA OKENCA)
English: Baseline disease characteristics were consistent for the study populations in VOYAGE 1 and 2 with a median body surface area (BSA) of 22% and 24%, a median baseline PASI score of 19 for both studies, a median baseline dermatology quality of life index (DLQI) score of 14 and 14.5, a baseline investigator global assessment (IGA) score of severe for 25% and 23% of patients, and a history of psoriatic arthritis for 19% and 18% of patients, respectively.
Slovenian: Izhodiščne značilnosti bolezni so bile podobne med posameznimi študijskimi skupinami v študijah VOYAGE 1 in 2 z mediano vrednostjo ocene prizadete telesne površine (BSA - Body Surface Area) 22% oziroma 24%, z mediano izhodiščno oceno PASI 19 v obeh študijah, z mediano izhodiščno oceno dermatološkega indeksa kakovosti življenja (DLQI - Dermatology Life Quality Index) 14 oziroma 14,5, z izhodiščno oceno IGA (IGA - splošna ocena raziskovalca - Investigator's Global Assessment) hude prizadetosti s psoriazo pri 25% oziroma 23% bolnikov ter z anamnezo psoriatičnega artritisa pri 19% oziroma 18% bolnikov.
English: 1 mL solution.
Slovenian: 1 ml raztopine.
English: Hold pressure over your skin with a cotton ball or gauze pad until any bleeding stops.
Slovenian: Na kožo pritisnite kosem vate ali zloženec iz gaze in ga držite tako dolgo, da se morebitna krvavitev ustavi.
English: In VOYAGE 1, all patients, including those randomised to adalimumab at Week 0, started to receive open-label guselkumab q8w at Week 52.
Slovenian: V študiji VOYAGE 1 so vsi bolniki, vključno s tistimi, ki so bili v tednu 0 randomizirani na adalimumab, začeli v tednu 52 odprto prejemati guselkumab vsakih 8 tednov.
English: Steady-state serum guselkumab concentrations were achieved by Week 20 following subcutaneous administrations of 100 mg guselkumab at Weeks 0 and 4, and every 8 weeks thereafter.
Slovenian: Serumske koncentracije v stanju dinamičnega ravnovesja je guselkumab dosegel do konca 20. tedna po subkutanem odmerjanju 100 mg guselkumaba v tednih 0 in 4 in nato vsakih 8 tednov.
English: Do not inject into areas with scars or stretch marks.
Slovenian: Zdravila ne injicirajte v predele, kjer so brazgotine ali strije.
English: Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Slovenian: Zdravilo Tremfya je indicirano za zdravljenje zmerne do hude psoriaze s plaki pri odraslih, ki so primerni za sistemsko zdravljenje.
English: Treatment with Tremfya should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Slovenian: Bolnikom s katero koli klinično pomembno aktivno okužbo se zdravljenja z zdravilom Tremfya ne sme uvesti, dokler okužba ne izzveni oziroma ni ustrezno zdravljena.
English: Do not use this medicine if you notice that the medicine is cloudy or discoloured, or contains large particles.
Slovenian: Zdravila ne uporabljajte, če opazite, da je vsebina motna, obarvana ali vsebuje večje delce.
English: Do not put needle cover back on, as this may damage the needle.
Slovenian: Pokrovčka za iglo ne nameščajte nazaj, s tem bi lahko poškodovali iglo.
English: In VOYAGE 2, guselkumab patients had significantly greater improvement from baseline compared to placebo in health-related quality of life, anxiety and depression, and work limitation measures at Week 16, as measured by the 36-item Short Form (SF-36) health survey questionnaire, Hospital Anxiety and Depression Scale (HADS), and Work Limitations Questionnaire (WLQ), respectively.
Slovenian: V študiji VOYAGE 2 je pri bolnikih z guselkumabom do 16. tedna prišlo do pomembno večjega izboljšanja od izhodišča kot pri bolnikih s placebom na področjih z zdravjem povezane kakovosti življenja, tesnobe in depresije ter delovnih omejitev po ocenah, pridobljenih s 36-točkovnim zdravstvenim vprašalnikom SF-36 (36-item Short Form), z bolnišnično lestvico tesnobe in depresije HADS (Hospital Anxiety and Depression Scale) in vprašalnikom o delovnih omejitvah (WLQ - Work Limitations Questionnaire).
English: In a phase I study, treatment with guselkumab resulted in reduced expression of IL-23/Th17 pathway genes and psoriasis-associated gene expression profiles, as shown by analyses of mRNA obtained from lesional skin biopsies of patients with plaque psoriasis at Week 12 compared to baseline.
Slovenian: V študiji faze I je zdravljenje z guselkumabom zmanjšalo izražanje genov, ki omogočajo procesne poti v povezavi z IL-23 in limfociti Th17, in spremenilo profil izražanja genov, povezanih s psoriazo, kar so ugotavljali z analizo mRNK, pridobljeno z biopsijo kožnih lezij pri bolnikih s psoriazo s plaki v 12. tednu v primerjavi z izhodiščnimi vrednostmi.
English: Prescribers should consult the Summary of Product Characteristics of the specific vaccine for additional information and guidance on concomitant use of immunosuppressive agents post-vaccination.
Slovenian: Zdravniki morajo upoštevati dodatne informacije in smernice o sočasni uporabi imunosupresivnih zdravil po cepljenju, katere najdejo v povzetku glavnih značilnosti zdravila posameznega cepiva.
English: Use your other hand to pinch skin at the injection site.
Slovenian: Z drugo roko na mestu injiciranja stisnite kožo v gubo.
English: Patients were randomised to receive guselkumab (N=534; 100 mg at Week 0, 4 and q8w thereafter), or secukinumab (N=514; 300 mg at Week 0, 1, 2, 3, 4, and q4w thereafter).
Slovenian: Bolnike so randomizirali na guselkumab (N = 534; 100 mg v tednu 0, 4 nato pa vsakih 8 tednov ) ali sekukinumab (N = 514; 300 mg v tednu 0, 1, 2, 3, 4, in nato vsake 4 tedne).