FrancophonIA/ELRC3.0 huggingface dataset:
English: Prior to initiating therapy with Tremfya, completion of all appropriate immunisations should be considered according to current immunisation guidelines.
Slovenian: Pred začetkom zdravljenja z zdravilom Tremfya je treba pretehtati možnost, da bolnik opravi vsa potrebna cepljenja v skladu z veljavnimi smernicami.
English: Differences in response rates between guselkumab and ustekinumab treated patients were noted as early as 4 weeks after randomisation (11.1% and 9.0%, respectively) and reached a maximum 24 weeks after randomisation (see Figure 3).
Slovenian: Razliko v deležih bolnikov z odzivom med tistimi, ki so prejemali guselkumab, in tistimi, ki so prejemali ustekinumab, so opazili že 4 tedne po randomizaciji (11,1% v primerjavi z 9,0%), do največje razlike pa je prišlo 24 tednov po randomizaciji (glejte Sliko 3).
English: After injection
Slovenian: Po injiciranju
English: If you have received more Tremfya than you should or the dose has been given sooner than prescribed, inform your doctor.
Slovenian: Če ste prejeli večji odmerek zdravila Tremfya kot bi smeli Če se prejeli več zdravila Tremfya, kot bi smeli, ali ste odmerek prejeli pred predvidenim rokom, obvestite zdravnika.
English: At the start, your doctor or nurse will inject Tremfya.
Slovenian: Na začetku vam bo zdravilo Tremfya injiciral zdravnik ali medicinska sestra.
English: Do not hold or pull plunger at any time.
Slovenian: Brizge nikoli ne držite za bat in bata ne vlecite.
English: At Week 16, 268 patients with an IGA ≥ 2 score were randomised to either continue ustekinumab treatment (N=133) q12w, or to initiate guselkumab treatment (N=135) at Weeks 16, 20, and q8w thereafter.
Slovenian: V 16. tednu so 268 bolnikov z oceno IGA ≥ 2 randomizirali tako, da so bodisi še naprej prejemali ustekinumab (N=133) vsakih 12 tednov ali pa so začeli zdravljenje z guselkumabom (N=135), ki so ga prejeli v tednih 16 in 20, nato pa vsakih 8 tednov.
English: • Back of upper arms (if a caregiver is giving you the injection) Do not inject into skin that is tender, bruised, red, scaly or hard.
Slovenian: • zadnji del nadlakti (če vam zdravilo injicira negovalec) Zdravila ne injicirajte v mesta, kjer je koža občutljiva, podpluta, rdeča, trda ali se lušči.
English: Guselkumab demonstrated rapid onset of efficacy, with a significantly higher percent improvement in PASI as compared with placebo as early as Week 2 (p < 0.001).
Slovenian: Guselkumab je začel učinkovati hitro, statistično značilno večji odstotek bolnikov z izboljšanjem ocene PASI kot pri bolnikih s placebom so opazili že po 2. tednu (p < 0,001).
English: Do this at a speed that is comfortable for you.
Slovenian: Držalo potiskajte tako hitro, kot vam najbolj ustreza.
English: The co-primary endpoints in VOYAGE 1 and 2 were the proportion of patients who achieved an IGA score of cleared or minimal (IGA 0/1) and a PASI 90 response at Week 16 versus placebo (see Table 2).
Slovenian: Druga dva primarna cilja opazovanja v študijah VOYAGE 1 in 2 sta bila delež bolnikov, ki doseže oceno IGA "brez znakov" ali "skoraj brez znakov prizadetosti" (IGA 0/1) in odziv PASI 90 do 16. tedna, v primerjavi z bolniki s placebom (glejte Preglednico 2).
English: Musculoskeletal and connective tissue disorders
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva pogosti artralgija
English: If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Tremfya.
Slovenian: Če ste negotovi, ali karkoli od naštetega velja za vas, se pred začetkom uporabe zdravila Tremfya posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Baseline disease characteristics were consistent with a population of moderate to severe plaque psoriasis with a median BSA of 20%, a median PASI score of 18, and an IGA score of severe for 24% of patients.
Slovenian: Izhodiščne značilnosti bolezni so bile skladne s populacijo zmerne do hude psoriaze s plaki z mediano BSA 20%, z mediano izhodiščno oceno PASI 18 in z izhodiščno oceno IGA hude prizadetosti s psoriazo pri 24% bolnikih.
English: If your doctor decides that you or a caregiver may be able to give your injections of Tremfya at home, you should receive training on the right way to prepare and inject Tremfya using the pre-filled syringe before attempting to inject.
Slovenian: Če vaš zdravnik presodi, da ste si sposobni zdravilo Tremfya injicirati sami oziroma da vam ga lahko doma injicira vaš negovalec, vas mora naučiti, kako pravilno pripraviti in injicirati zdravilo Tremfya z napolnjeno injekcijsko brizgo, preden si ga poskušate injicirati.
English: In pooled phase II and phase III analyses, fewer than 6% of patients treated with Tremfya developed antidrug antibodies in up to 52 weeks of treatment.
Slovenian: Po rezultatih analize združenih podatkov študij faze II in faze III je v 52 tednih zdravljenja prišlo do nastanka protiteles proti zdravilu pri manj kot 6% bolnikov, ki so prejemali zdravilo Tremfya.
English: Do not use the 5-centimetre area around your belly-button.
Slovenian: Ne injicirajte v področje manj kot 5 cm stran od popka.
English: Guselkumab is a human IgG1λ monoclonal antibody (mAb) that binds selectively to the interleukin 23 (IL-23) protein with high specificity and affinity.
Slovenian: Guselkumab je humano monoklonsko protitelo vrste IgG1λ, ki se z visoko specifičnostjo in afiniteto selektivno veže na protein interlevkin 23 (IL-23).
English: If a serious hypersensitivity reaction occurs, administration of Tremfya should be discontinued immediately and appropriate therapy initiated.
Slovenian: Če se pojavi resna preobčutljivostna reakcija, je treba zdravljenje z zdravilom Tremfya prekiniti in bolniku uvesti ustrezno zdravljenje.
English: See section 5.3 for information on the excretion of guselkumab in animal (cynomolgus monkey) milk.
Slovenian: Za podatke o izločanju guselkumaba v mleko pri živalih (opicah Cynomolgus) glejte poglavje 5.3.
English: Remove carton with the pre-filled syringe from the refrigerator.
Slovenian: Škatlo z napolnjenim injekcijskim peresnikom vzemite iz hladilnika.
English: For detailed instructions on how to use Tremfya, carefully read the ‘Instructions for use' leaflet before use, which is included in the carton.
Slovenian: Pred uporabo zdravila, za natančna navodila za uporabo zdravila Tremfya skrbno preberite "Navodila za injiciranje", ki so priložena v škatli.
English: Choose injection site
Slovenian: Izberite mesto injiciranja
English: Tremfya should not be used if the solution is cloudy or discoloured, or contains large particles.
Slovenian: Zdravila Tremfya ne smete uporabljati, če je raztopina motna, obarvana ali vsebuje večje delce.
English: There is no need for dose adjustment when co-administering guselkumab and CYP450 substrates.
Slovenian: Pri sočasnem odmerjanju guselkumaba in substratov CYP450 odmerka ni treba prilagajti.
English: In addition, among 95 patients randomised to guselkumab who failed to achieve a PASI 90 response at Week 28, 36% and 41% achieved a PASI 90 response with an additional 20 and 44 weeks of continued treatment with guselkumab, respectively.
Slovenian: Dodatno je izmed 95 bolniki, randomiziranimi na guselkumab, ki niso dosegli odziva PASI 90 do 28. tedna, 36% bolnikov doseglo odziv PASI 90 v nadaljnih 20 tednih zdravljenja in 41% bolnikov v nadaljnih 44 tednih zdravljenja z guselkumabom.
English: In VOYAGE 2, among 112 patients randomised to adalimumab who failed to achieve a PASI 90 response at Week 28, 66% and 76% achieved a PASI 90 response after 20 and 44 weeks of treatment with guselkumab, respectively.
Slovenian: V študiji VOYAGE 2 je izmed 112 bolnikov, randomiziranih na adalimumab, ki niso dosegli odziva PASI 90 do 28. tedna, 66% doseglo odziv PASI 90 po 20 tednih zdravljenja z guselkumabom,76% pa jih je doseglo odziv PASI 90 po 44 tednih zdravljenja.
English: Do not inject if the liquid is cloudy or discoloured, or has large particles.
Slovenian: Ne injicirajte zdravila, če je tekočina motna ali obarvana ali če vsebuje večje delce.
English: The NAVIGATE study examined the efficacy of guselkumab in patients who had an inadequate response (ie, who had not achieved a ‘cleared' or ‘minimal' response defined as IGA ≥ 2) to ustekinumab at Week 16.
Slovenian: V študiji NAVIGATE so po 16 tednih primerjali učinkovitost guselkumaba in ustekinumaba pri bolnikih, ki se niso zadostno odzvali (kar pomeni, da niso dosegli odziva "brez znakov" ali "z minimalnimi znaki prizadetosti kože", ki jih označuje ocena IGA ≥ 2).
English: • Back of upper arms (if a caregiver is giving you the injection) Do not inject into skin that is tender, bruised, red, scaly, hard or has scars or stretch marks.
Slovenian: • zadnji del nadlakti (če vam zdravilo injicira negovalec) Zdravila ne injicirajte v mesta, kjer je koža občutljiva, podpluta, rdeča, trda ali se lušči oziroma kjer so brazgotine ali strije.
English: b, n (%) Week 16 f-PGA (N) f-PGA 0/1, n (%) Week 16 14 (15.9) NAPSI (N) Percent Improvement, mean (SD) Week 16 -0.9 (57.9) 34.4 (42.4)
Slovenian: b, n (%) 16. teden f-PGA (N) f-PGA 0/1, n (%) 16. teden NAPSI (N) odstotno izboljšanje, povprečje (standardna deviacija)
English: In repeat-dose toxicity studies in cynomolgus monkeys, guselkumab was well tolerated via intravenous and subcutaneous routes of administration.
Slovenian: V študijah toksičnosti pri ponavljajočih odmerkih pri opicah cinomolgus so živali dobro prenašale intravensko ali subkutano dani guselkumab.
English: Additionally, there were no adverse immunotoxicity or cardiovascular safety pharmacology effects noted during the conduct of the repeat-dose toxicity studies or in a targeted cardiovascular safety pharmacology study in cynomolgus monkeys.
Slovenian: Poleg tega pri izvajanju študij toksičnosti pri ponavljajočih odmerkih in v usmerjeni farmakološki študiji kardiovaskularne varnosti pri opicah cinomolgus niso opazili neželenih imunotoksičnih učinkov ali neželenih farmakoloških učinkov na varnost kardiovaskularnega sistema.
English: The solution is clear and colourless to light yellow.
Slovenian: Raztopina je bistra in brezbarvna do svetlorumena.
English: How to use Tremfya
Slovenian: Kako uporabljati zdravilo Tremfya
English: If any of these side effects becomes severe, tell your doctor, pharmacist or nurse immediately.
Slovenian: Če kateri od navedenih neželenih učinkov postane resen, nemudoma obvestite zdravnika, farmacevta ali medicinsko sestro.
English: Figure 4: Percent of Subjects Who Achieved a PASI 90 Response Through Week 48 by Visit (Subjects Randomised at Week 0) in ECLIPSE
Slovenian: Slika 4: Odstotek preiskovancev, ki si dosegli odziv PASI 90 do konca 48. tedna, po posameznih obiskih (preiskovanci, randomizirani v tednu 0) v študiji ECLIPSE
English: Tremfya can potentially cause serious side effects, including allergic reactions and infections.
Slovenian: Bodite pozorni na okužbe in alergijske reakcije Zdravilo Tremfya lahko povzroča resne neželene učinke, vključno z alergijskimi reakcijami in okužbami.
English: Guselkumab was efficacious in conventional systemic-naive, biologic-naive, and biologic-exposed patients.
Slovenian: Guselkumab je bil učinkovit tako pri bolnikih, ki še niso prejemali konvencionalnega sistemskega zdravljenja ali bioloških zdravil, kot pri tistih, ki so že prejemali biološka zdravila.
English: The percentage of patients achieving a PASI 90 response was numerically higher for guselkumab than adalimumab starting at Week 8 with the difference reaching a maximum around Week 20 (VOYAGE 1 and 2) and maintained through Week 48 (VOYAGE 1) (see Figure 1).
Slovenian: Odstotek bolnikov, ki so dosegli odziv PASI 90, je bil številčno večji pri bolnikih z guselkumabom kot pri bolnikih z adalimumabom že od 8. tedna dalje, pri čemer je bila razlika med njima največja približno v 20. tednu (v študijah VOYAGE 1 in 2) in je vztrajala do konca 48. tedna (v študiji VOYAGE 1) (glejte Sliko 1).
English: The recommended dose of Tremfya is 100 mg by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks.
Slovenian: Priporočeni odmerek zdravila Tremfya je 100 mg s subkutano injekcijo v tednih 0 in 4.
English: d 1.8 (53.8) 39.6 (45.6)
Slovenian: 16. teden e 38,0 (53,9)
English: If your doctor decides that you or a caregiver may be able to give your injections of Tremfya at home, you should receive training on the right way to prepare and inject Tremfya using the pre-filled pen.
Slovenian: Če vaš zdravnik presodi, da ste si sposobni zdravilo Tremfya injicirati sami oziroma da vam ga lahko doma injicira vaš negovalec, vas mora naučiti, kako pravilno pripraviti in injicirati zdravilo Tremfya z napolnjenim injekcijskim peresnikom.
English: Patients randomised to adalimumab (N=582) received 80 mg at Week 0 and 40 mg at Week 1, followed by 40 mg every other week (q2w) through Week 48 (VOYAGE 1) and Week 23 (VOYAGE 2).
Slovenian: Bolniki, ki so bili randomizirani na adalimumab, (N=582) so prejeli 80 mg adalimumaba v tednu 0 in 40 mg v tednu 1, nato pa 40 mg vsak drugi teden do konca 48. tedna (v študiji VOYAGE 1) oziroma do konca 23. tedna (v študiji VOYAGE 2).
English: Health-related quality of life / Patient reported outcomes Across VOYAGE 1 and 2 significantly greater improvements in health-related quality of life as measured by Dermatology Life Quality Index (DLQI) and in patient-reported psoriasis symptoms (itching, pain, burning, stinging and skin tightness) and signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) as measured by the Psoriasis Symptoms and Signs Diary (PSSD) were observed in guselkumab patients compared to placebo patients at Week 16 (Table 4).
Slovenian: Z zdravjem povezana kakovost življenja/izidi zdravljenja po oceni bolnikov V študijah VOYAGE 1 in 2 so v 16. tednu opazili pomembno večje izboljšanje pri bolnikih z guselkumabom kot pri bolnikih s placebom ali adalimumabom kar zadeva z zdravjem povezano kakovost življenja po oceni DLQI, po navedbah bolnikov glede simptomov psoriaze (srbenja, bolečin, skelenja, zbadanja in občutka zategovanja kože) in ocene znakov (suhosti kože, razpok na koži, luščenja kože, drobnega luščenja ali luščenja zaplat kože, rdečine in krvavitev) s pomočjo beleženja v dnevnik znakov in simptomov psoriaze (PSSD - Psoriasis Symptoms and Signs Diary) (Preglednica 4).
English: Guselkumab was superior to secukinumab as measured by the primary endpoint of PASI 90 response at Week 48 (84.5% versus 70.0%, p < 0.001).
Slovenian: Glede na primarni cilj opazovanja, odziv PASI 90 v 48. tednu, je bil guselkumab superiornejši kot adalimumab (84,5% proti 70,0%, p < 0,001).
English: In VOYAGE 2, patients randomised to guselkumab at Week 0 who were Psoriasis Area and Severity Index (PASI) 90 responders at Week 28 were re-randomised to either continue treatment with guselkumab q8w (maintenance treatment) or receive placebo (withdrawal treatment).
Slovenian: V študiji VOYAGE 2 so tiste bolnike, ki so bili v tednu 0 randomizirani na guselkumab, v 28. tednu pa so pri njih opazili odziv PASI 90 (tj. indeks jakosti psoriaze in telesne površine, prizadete s psoriazo - Psoriasis Area and Severity Index), ponovno randomizirali bodisi na nadalnje prejemanje guselkumaba vsakih 8 tednov (vzdrževalno zdravljenje) ali na prejemanje placeba (opustitev zdravljenja).
English: The pre-filled syringe or pre-filled pen should not be shaken.
Slovenian: Napolnjene injekcijske brizge oziroma napolnjenega injekcijskega peresnika ne smete stresati.
English: Use your free hand to grasp the body of the syringe.
Slovenian: Sprostite kožno gubo in premestite roko S prosto roko primite telo injekcijske brizge.
English: Some side effects are uncommon (may affect up to 1 in 100 people): - pain at the injection site - allergic reaction - skin rash
Slovenian: Nekateri neželeni učinki so občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): • bolečina na mestu injiciranja zdravila
English: In VOYAGE 1, for patients receiving continuous guselkumab treatment, the PASI 90 response rate was maintained from Week 52 through Week 156.
Slovenian: V študiji VOYAGE 1 se je pri bolnikih, ki so neprekinjeno prejemali guselkumab, odziv PASI 90 ohranil od 52. do 156. tedna.
English: NAVIGATE
Slovenian: Študija NAVIGATE
English: Patients randomised to adalimumab at Week 0 who were PASI 90 non-responders received guselkumab at Weeks 28, 32 and q8w thereafter.
Slovenian: Bolniki, ki so bili v tednu 0 randomizirani na prejemanje adalimumaba in niso dosegli odziva PASI 90, so prejeli guselkumab v 28. in 32. tednu ter nato vsakih 8 tednov.
English: Call your doctor or pharmacist for a new pre-filled pen.
Slovenian: Pokličite zdravnika ali farmacevta, da vam priskrbita nov napolnjen injekcijski peresnik.
English: • if you have an infection that does not go away or that keeps coming back
Slovenian: • če imate okužbo, ki je dolgotrajna ali ponavljajoča,
English: • if you recently had or are due to have a vaccination.
Slovenian: • če ste bili pred kratkim cepljeni oziroma boste cepljeni.
English: Prior to initiating treatment with Tremfya, patients should be evaluated for tuberculosis (TB) infection.
Slovenian: Ugotavljanje prisotnosti tuberkuloze pred zdravljenjem Pred začetkom zdravljenja z zdravilom Tremfya je treba bolnike pregledati in opraviti preiskave na prisotnost tuberkuloze.
English: There is limited information in subjects aged ≥ 65 years.
Slovenian: Podatki o uporabi zdravila pri starejših (starih 65 let ali več) so omejeni.
English: Withdrawal patients re-initiated guselkumab (dosed at time of retreatment, 4 weeks later and q8w thereafter) when they experienced at least a 50% loss of their Week 28 PASI improvement.
Slovenian: Bolniki so po opustitvi zdravljenja ponovno začeli prejemati guselkumab (z odmerjanjem ob začetku ponovne uvedbe, po 4 tednih in nato vsakih 8 tednov), če je pri njih prišlo do najmanj 50-odstotne izgube tistega izboljšanja odziva PASI 90, ki so ga dosegli v 28. tednu.
English: Tremfya 100 mg solution for injection in pre-filled syringe 1 mL solution in a pre-filled glass syringe with a fixed needle and a needle shield, assembled in an automatic needle guard.
Slovenian: Tremfya 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi 1 ml raztopine v napolnjeni stekleni injekcijski brizgi s pritrjeno iglo in ščitnikom igle, ki je vstavljen v avtomatsko varovalo.
English: • 1 Cotton ball or gauze pad
Slovenian: • 1 kosem vate ali zloženec iz gaze
English: Additionally, at 12 weeks after randomisation a higher proportion of guselkumab patients compared to ustekinumab patients achieved an IGA score 0/1 and ≥ 2 grade improvement (31.1% vs. 14.3%, respectively; p = 0.001) and a
Slovenian: Poleg tega je bil 12 tednov po randomizaciji večji delež bolnikov z guselkumabom, ki so dosegli oceno IGA 0/1 in izboljšanje za ≥ 2 stopnji (31,1% v primerjavi s 14,3%, p = 0,001) in odziv PASI 90 (48% v primerjavi s 23%, p < 0,001), kot delež bolnikov z ustekinumabom.
English: Serious side effects Tell your doctor or seek medical help immediately if you get any of the following side effects:
Slovenian: Če opazite katerega od naslednjih neželenih učinkov, takoj obvestite zdravnika ali poiščite zdravniško pomoč:
English: Guselkumab exerts clinical effects in plaque psoriasis through blockade of the IL-23 cytokine pathway.
Slovenian: Klinični učinki guselkumaba pri psoriazi s plaki so posledica zaviranja signalnih poti v katere je vpleten citokin IL-23.
English: Figure 1: Percent of Subjects Who Achieved a PASI 90 Response Through Week 48 by Visit (Subjects Randomised at Week 0) in VOYAGE 1
Slovenian: Slika 1: Odstotek preiskovancev, ki so dosegli odziv PASI 90 do konca 48. tedna po posameznih obiskih (glede na randomizacijo v tednu 0) v študiji VOYAGE 1
English: In pooled phase III analyses, approximately 9% of patients treated with Tremfya developed antidrug antibodies in up to 156 weeks of treatment.
Slovenian: Po rezultatih analize združenih podatkov študije faze III je v 156 tednih zdravljenja prišlo do nastanka protiteles proti zdravilu pri približno 9% bolnikov, zdravljenih z zdravilom Tremfya.
English: The mean (± SD) steady-state trough serum guselkumab concentrations in two phase III studies were 1.15 ± 0.73 mcg/mL and 1.23 ± 0.84 mcg/mL.
Slovenian: V dveh študijah faze III sta bili povprečni najnižji serumski koncentraciji guselkumaba v stanju dinamičnega ravnovesja 1,15 μg/ml s standardno deviacijo ± 0,73 μg/ml oziroma 1,23 μg/ml s standardno deviacijo ± 0,84 μg/ml.
English: Remove needle cover
Slovenian: Snemite pokrovček z igle
English: You and your doctor should decide if you will breast-feed or use Tremfya.
Slovenian: Skupaj se bosta odločila, ali boste dojili ali pa prejemali zdravilo Tremfya.
English: Symptom score = 0, n (%) PSSD Sign score, subjects with baseline score > 0
Slovenian: ocena simptomov PSSD, preiskovanci z izhodiščno oceno > 0 ocena simptomov = 0, n (%) ocena znakov PSSD, preiskovanci z izhodiščno oceno > 0 ocena znakov = 0, n (%)
English: Take the pre-filled syringe out of the carton.
Slovenian: Napolnjeno injekcijsko brizgo vzemite iz škatle.
English: Patients randomised to guselkumab (N=825) received 100 mg at Weeks 0 and 4, and every 8 weeks (q8w) thereafter through Week 48 (VOYAGE 1) and Week 20 (VOYAGE 2).
Slovenian: Bolniki, ki so bili randomizirani na guselkumab, (N=825) so prejeli 100 mg guselkumaba v tednih 0 in 4, nato pa vsakih 8 tednov do konca 48. tedna (v študiji VOYAGE 1) oziroma do konca 20. tedna (v študiji VOYAGE 2).
English: Summary of Regional Disease Responses in VOYAGE 1 and VOYAGE 2 VOYAGE 1
Slovenian: Povzetek odzivov pri lokalizirani obliki bolezni v študijah VOYAGE 1 in VOYAGE 2
English: In VOYAGE 1 and 2, significant improvements were seen in scalp, hand and foot, and nail psoriasis (as measured by the Scalp-specific Investigator Global Assessment [ss-IGA], Physician's Global Assessment of Hands and/or Feet [hf-PGA], Fingernail Physician's Global Assessment [f-PGA] and Nail Psoriasis Severity Index [NAPSI], respectively) in guselkumab treated patients compared to placebo treated patients at Week 16 (p < 0.001, Table 3).
Slovenian: V študijah VOYAGE 1 in 2 so v 16. tednu (p < 0,001, Preglednica 3) pri bolnikih z guselkumabom opazili pomembno večje izboljšanje psoriaze lasišča, dlani in podplatov ter nohtov v primerjavi z bolniki s placebom (po merilih za psoriazo lasišča po oceni raziskovalca, Scalp-specific Investigator Global Assessment [ss-IGA], za palmoplantarno psoriazo po oceni raziskovalca, Physician's Global Assessment of Hands and/or Feet [hf-PGA], za psoriazo nohtov na rokah po oceni raziskovalca, Fingernail Physician's Global Assessment [f-PGA] in indeksa izraženosti psoriaze nohtov, Nail Psoriasis Severity Index [NAPSI]).
English: - The other ingredients are histidine, histidine monohydrochloride monohydrate, polysorbate 80,
Slovenian: • Druge sestavine zdravila so histidin, histidinijev klorid monohidrat, polisorbat 80, saharoza in voda za injekcije.
English: If you are uncertain, call your doctor or pharmacist for a new pre-filled pen.
Slovenian: Če ste v dvomu, pokličite zdravnika ali farmacevta, da vam priskrbita nov napolnjen injekcijski peresnik.
English: Guselkumab could not be detected in breast milk from cynomolgus monkeys as measured at post-natal day 28.
Slovenian: V mleku opic cinomolgus 28 dni po porodu niso zaznali prisotnosti guselkumaba.
English: Serious hypersensitivity reactions have been reported in the post-marketing setting.
Slovenian: Po prihodu zdravila na trg so poročali o resnih preobčutljivostnih reakcijah.
English: Check injection site
Slovenian: Preglejte mesto injiciranja
English: This medicine works by blocking the activity of a protein called IL-23, which is present at increased levels in people with psoriasis.
Slovenian: To zdravilo deluje tako, da nevtralizira aktivnost beljakovine, ki jo imenujemo IL-23.
English: In VOYAGE 2, all patients started to receive open-label guselkumab q8w at Week 76.
Slovenian: V študiji VOYAGE 2 so vsi bolniki začeli v tednu 76 odprto prejemati guselkumab vsakih 8 tednov.
English: Keep the pre-filled syringe in the carton and let it sit on a flat surface at room temperature for at least 30 minutes before use.
Slovenian: Napolnjen injekcijski peresnik pustite v škatli na ravni površini.Pred uporabo naj stoji na sobni temperaturi najmanj 30 minut.