FrancophonIA/ELRC3.0 huggingface dataset:
English: The most frequently reported adverse drug reactions (ADRs) were injection site reactions and upper respiratory tract infections (most frequently nasopharyngitis).
Croatian: Najčešće prijavljene nuspojave lijeka bile su reakcije na mjestu injiciranja i infekcije gornjih dišnih putova (najčešće nazofaringitis).
English: Syringe body with medicine
Croatian: Tijelo štrcaljke ispunjeno lijekom
English: Figure 3: Primary Endpoint (Simultaneous ACR 50 & PASI 100) and Major Secondary Endpoints (ACR 50; PASI 100) Response Rates Week 0 - 24 [ITT population, NRI]**
Croatian: Slika 3: Stope odgovora primarne mjere ishoda (istodobni odgovori ACR 50 i PASI 100) i glavnih sekundarnih mjera ishoda (ACR 50; PASI 100) od 0. do 24. tjedna [ITT populacija, NRI]**
English: Taltz may be stored unrefrigerated for up to 5 days at a temperature not above 30 ºC.
Croatian: Taltz se može čuvati izvan hladnjaka najviše 5 dana na temperaturi do 30ºC.
English: Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Croatian: Unutar svakog organskog sustava nuspojave su razvrstane prema učestalosti, na način da se prvo navode najčešće nuspojave.
English: Results from a drug-drug interaction study in patients with moderate-to-severe psoriasis determined that 12 weeks of administration of ixekizumab with drugs metabolized by CYP3A4 (i.e., midazolam), CYP2C9 (i.e., warfarin), CYP2C19 (i.e., omeprazole), CYP1A2 (i.e., caffeine) or CYP2D6 (i.e., dextromethorphan) does not have a clinically significant impact on the pharmacokinetics of these drugs.
Croatian: Na temelju rezultata ispitivanja interakcija s drugim lijekovima u bolesnika s umjerenom do teškom psorijazom utvrđeno je da primjena iksekizumaba tokom 12 tjedana, s lijekovima koji se metaboliziraju putem CYP3A4 (npr. midazolam), CYP2C9 (npr. varfarin), CYP2C19 (npr. omeprazol), CYP1A2 (npr. kofein) ili CYP2D6 (npr. dekstrometorfan) nema klinički značajnog utjecaja na farmakokinetiku tih lijekova.
English: Alternate your injection sites.
Croatian: Mijenjajte mjesto za injiciranje.
English: do not use it. Use a new pre-filled pen for your injection.
Croatian: Upotrijebite novu napunjenu brizgalicu da biste primijenili injekciju.
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 16 to 20 weeks of treatment.
Croatian: U bolesnika koji ne ostvare nikakav odgovor nakon 16 do 20 tjedana liječenja treba razmotriti prekid liječenja.
English: • If you have vision problems, DO NOT use the pre-filled syringe without help from a person trained to use it.
Croatian: • Ako imate problema s vidom, NEMOJTE koristiti napunjenu brizgalicu bez pomoći osobe koja je obučena za njezinu uporabu.
English: The second loud click tells you that your injection is complete.
Croatian: Drugi glasan klik znak je da je injekcija završena.
English: Of the 1,118 psoriatic arthritis patients exposed to Taltz in clinical studies, a total of 122 patients were 65 years of age or older and 6 patients were 75 years of age or older.
Croatian: Od 1118 bolesnika s psorijatičnim artritisom izloženih lijeku Taltz u kliničkim ispitivanjima, ukupno su 122 bolesnika imala 65 ili više godina, dok je 6 bolesnika imalo 75 ili više godina.
English: In a study in healthy subjects, no safety concerns were identified of two inactivated vaccines (tetanus and pneumococcal), received after two doses of ixekizumab (160 mg followed by a second dose of 80 mg two weeks later).
Croatian: U ispitivanju provedenom u zdravih ispitanika nisu utvrđeni sigurnosni problemi kod primjene dvaju inaktiviranih cjepiva (cjepiva protiv tetanusa i pneumokokne bolesti) nakon dviju doza iksekizumaba (doza od 160 mg i druga doza od 80 mg dva tjedna kasnije).
English: Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Croatian: Taltz je indiciran za liječenje umjerene do teške plak psorijaze u odraslih koji su kandidati za sistemsku terapiju.
English: DO NOT inject into areas where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.
Croatian: NEMOJTE injicirati lijek u područja na kojima je koža osjetljiva na dodir, prekrivena modricama, crvena ili tvrda niti u područja prekrivena ožiljcima ili strijama.
English: UNCOVER-3 enrolled 1,346 patients.
Croatian: U ispitivanje UNCOVER-3 bilo je uključeno 1346 bolesnika.
English: These improvements in nail, scalp and palmoplantar psoriasis were maintained at Week 60 in patients treated with Taltz who were sPGA (0,1) responders at Week 12.
Croatian: Ta poboljšanja psorijaze noktiju, psorijaze vlasišta i palmoplantarne psorijaze bila su održana u 60. tjednu u bolesnika liječenih lijekom Taltz koji su ostvarili odgovor prema sPGA rezultatu (0,1) u 12. tjednu.
English: In the population PK analysis, mean serum clearance was 0.0161 L/hr.
Croatian: U populacijskoj farmakokinetičkoj analizi srednja vrijednost serumskog klirensa iznosila je 0,0161 l/h.
English: Taltz is for subcutaneous injection.
Croatian: Taltz se primjenjuje supkutanom injekcijom.
English: Ixekizumab is a monoclonal antibody and is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous immunoglobulins.
Croatian: Budući da je iksekizumab monoklonsko protutijelo, očekuje se da će se kataboličkim putovima razgraditi na male peptide i aminokiseline na isti način kao i endogeni imunoglobulini.
English: UNCOVER-1 enrolled 1,296 patients.
Croatian: U ispitivanje UNCOVER-1 bilo je uključeno 1296 bolesnika.
English: Leave the base cap on until you are ready to inject.
Croatian: Ostavite zatvarač baze na brizgalici dok ne budete spremni injicirati lijek.
English: Mean (SD) Cmax,ss, and Ctrough,ss estimates are 14.6 (6.04) µg/ml, and 1.87 (1.30) µg/ml.
Croatian: Srednja procijenjena vrijednost (SD) Cmax,ss i Ctrough,ss iznosi 14,6 (6,04) µg/ml odnosno 1,87 (1,30) µg/ml.
English: The grey syringe plunger should be pushed all the way to the end of the syringe.
Croatian: Sivi klip štrcaljke treba potisnuti sve do kraja štrcaljke.
English: Randomised patients also had current plaque psoriasis skin lesions (94.0%) or a documented history of plaque psoriasis, with 12.1% of patients with moderate to severe plaque psoriasis at baseline.
Croatian: Randomizirani bolesnici također su imali prisutne kožne lezije uzrokovane plak psorijazom (94,0%) ili dokumentiranu plak psorijazu u anamnezi, a njih 12,1% imalo je umjerenu do tešku plak psorijazu na početku ispitivanja.
English: - low blood platelet count (thrombocytopenia).
Croatian: - nizak broj krvnih pločica (trombocitopenija)
English: Doses up to 180 mg have been administered subcutaneously in clinical trials without dose-limiting toxicity.
Croatian: U kliničkim su se ispitivanjima primjenjivale supkutane doze do 180 mg, bez nastupa toksičnosti koja bi ograničila dozu.
English: Make sure to keep the needle in place.
Croatian: Pazite da se igla ne pomakne.
English: - injection site reactions (e.g. red skin, pain).
Croatian: (nazofaringitis) - reakcije na mjestu injiciranja (npr. crvenilo kože, bol)
English: Neutralisation of IL-17A by ixekizumab inhibits these actions.
Croatian: Iksekizumab neutralizira IL-17A, čime inhibira takvo njegovo djelovanje.
English: Maintained or Achieved PASI 90
Croatian: Održan ili ostvaren odgovor PASI 90
English: Place the clear base flat and firmly against your skin.
Croatian: Položite prozirnu bazu ravno i čvrsto na kožu.
English: b p<0.01; c p<0.001 compared with placebo.
Croatian: b p < 0,01; c p < 0,001 u usporedbi s placebom.
English: Injection button Lock ring Lock/unlock symbols
Croatian: Simboli za zaključavanje/otključavanje
English: If you forget to use Taltz
Croatian: Ako ste zaboravili primijeniti Taltz
English: How to use Taltz
Croatian: Kako primjenjivati Taltz
English: As a direct consequence treatment with ixekizumab reduces erythema, induration and desquamation present in plaque psoriasis lesions.
Croatian: Izravna posljedica liječenja iksekizumabom je smanjenje eritema, induracije i deskvamacije koji su prisutni u lezijama plak psorijaze.
English: Leave the needle cap on the syringe until you are ready to inject.
Croatian: Ostavite zatvarač igle na štrcaljki dok ne budete spremni injicirati lijek.
English: Approximately 9-17% of plaque psoriasis patients treated with Taltz at the recommended dosing regimen developed anti-drug antibodies, the majority of which were low titres and not associated with reduced clinical response up to 60 weeks of treatment.
Croatian: Približno 9 - 17% bolesnika s plak psorijazom liječenih lijekom Taltz prema preporučenom režimu doziranja razvilo je protutijela na lijek, koja su se u većini slučajeva javljala u niskim titrima te nisu bila povezana sa smanjenim kliničkim odgovorom tijekom razdoblja do 60 tjedana liječenja.
English: Taltz contains sodium
Croatian: Taltz sadrži natrij
English: The safety and efficacy of Taltz were assessed in two randomised, double-blind, placebo-controlled phase III studies in 780 patients with active psoriatic arthritis (≥3 swollen and ≥3 tender joints).
Croatian: Sigurnost i djelotvornost lijeka Taltz ocjenjivale su se u dva randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze III provedena u 780 bolesnika s aktivnim psorijatičnim artritisom (≥ 3 otečena i ≥ 3 bolna zgloba).
English: UNCOVER-2 enrolled 1,224 patients.
Croatian: U ispitivanje UNCOVER-2 bila su uključena 1224 bolesnika.
English: The efficacy and safety of Taltz were assessed in three randomised, double-blind, placebo-controlled phase III studies in adult patients with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy (UNCOVER-1, UNCOVER-2, and UNCOVER-3).
Croatian: Djelotvornost i sigurnost lijeka Taltz ocjenjivala se u tri randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze III, provedena u odraslih bolesnika s umjerenom do teškom plak psorijazom koji su bili kandidati za fototerapiju ili sistemsku terapiju (UNCOVER-1, UNCOVER-2 i UNCOVER-3).
English: Taltz should not be used with live vaccines.
Croatian: Taltz se ne smije primjenjivati zajedno sa živim cjepivima.
English: Mean (SD) Cmax,ss, and C trough,ss estimates are 21.5 (9.16) µg/ml, and 5.23 (3.19) µg/ml.
Croatian: Srednja procijenjena vrijednost (SD) Cmax,ss i Ctrough,ss iznosi 21,5 (9,16) µg/ml odnosno 5,23 (3,19) µg/ml.
English: 1 GET READY 1a Take the syringe from the refrigerator.
Croatian: 1a Izvadite štrcaljku iz hladnjaka.
English: A. Do not touch the needle or replace the base cap.
Croatian: Nemojte dodirivati iglu niti vraćati zatvarač na bazu.
English: If you stop using Taltz
Croatian: Ako prestanete primjenjivati Taltz
English: Taltz was superior to ADA on the primary study objective: simultaneous achievement of ACR 50 and PASI 100 response at Week 24 (Taltz 36.0% vs ADA 27.9%; p=0.036; 95% confidence interval [0.5%, 15.8%]).
Croatian: Taltz je bio superioran u odnosu na ADA s obzirom na primarni cilj ispitivanja: istodobno postizanje i odgovora ACR 50 i PASI 100 u 24. tjednu (Taltz 36,0% naspram ADA 27,9%; p=0,036; 95%-tni interval pouzdanosti [0,5%, 15,8%]).
English: These reactions were predominantly mild to moderate in severity and did not lead to discontinuation of Taltz.
Croatian: Te su reakcije pretežno bile blage do umjerene težine i nisu zahtijevale prekid liječenja lijekom Taltz.
English: • The green plunger rod should show through the body of the syringe.
Croatian: • Zeleni potisnik klipa trebao bi se vidjeti kroz tijelo štrcaljke.
English: 159 (41.6)a sPGA of “0” (clear)
Croatian: 159 (41,6)a sPGA "0"
English: Push in the plunger.
Croatian: Potisnite klip.
English: In the placebo-controlled period of the phase III clinical studies in plaque psoriasis, infections were reported in 27.2 % of patients treated with Taltz for up to 12 weeks compared with 22.9 % of patients treated with placebo.
Croatian: U placebom kontroliranom razdoblju kliničkih ispitivanja faze III kod plak psorijaze, infekcije su prijavljene u 27,2% bolesnika liječenih lijekom Taltz tijekom razdoblja do 12 tjedana u usporedbi s 22,9% bolesnika koji su primali placebo.
English: The primary endpoint was the proportion of patients who achieved at least a "0" (clear) or "1" (minimal) response on the sPGA of Genitalia (sPGA of Genitalia 0/1).
Croatian: Primarna mjera ishoda bio je udio bolesnika koji su postigli odgovor prema sPGA rezultatu za genitalije (sPGA za genitalije 0/1) od najmanje "0" (čisto) ili "1" (minimalno).
English: Based on psoriatic skin biopsy data from a phase I study, there was a dose-related trend towards decreased epidermal thickness, number of proliferating keratinocytes, T cells, and dendritic cells, as well as reductions in local inflammatory markers from baseline to day 43.
Croatian: Podaci dobiveni biopsijom psorijatične kože u jednom ispitivanju faze I ukazali su na dozom uvjetovanu tendenciju smanjenja debljine epidermisa, smanjenja broja proliferirajućih keratinocita, T-stanica i dendritičkih stanica, kao i sniženja vrijednosti markera lokalne upale od početka ispitivanja do 43. dana.
English: Throw the base cap in the bin.
Croatian: Bacite zatvarač baze u smeće.
English: The mean (SD) maximum plasma concentration (Cmax) of ixekizumab, after the 160 mg starting dose, was 19.9 (8.15) µg/ml.
Croatian: Srednja vrijednost (standardno odstupanje [engl. standard deviation, SD]) maksimalne plazmatske koncentracije (Cmax) iksekizumaba nakon početne doze od 160 mg iznosila je 19,9 (8,15) µg/ml.
English: Each syringe contains one dose of Taltz (80 mg).
Croatian: Jedna štrcaljka sadrži jednu dozu lijeka Taltz (80 mg).
English: Approximately 25 % of patients treated with Taltz achieved a PASI score < 5 by Week 2, more than 55 % achieved the PASI score < 5 by Week 4, and increased to 85 % by Week 12 (compared to 3 %, 14 % and 50 % for etanercept).
Croatian: više od 55% njih ostvarilo je PASI rezultat < 5 do 4. tjedna, a udio se povećao na 85% do 12. tjedna (u usporedbi s 3%, 14% odnosno 50% uz etanercept).
English: significantly greater proportion of patients treated with Taltz achieved a reduction of Itch NRS ≥ 4
Croatian: Značajno veći udio bolesnika liječenih lijekom Taltz ostvario je smanjenje NRS rezultata za svrbež za
English: • Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use.
Croatian: • Pitajte svoga liječnika, ljekarnika ili medicinsku sestru kako zbrinuti lijekove koje više ne koristite.
English: Psoriatic Arthritis Study 2 (SPIRIT-P2) enrolled patients who were previously treated with an anti-TNF agent and discontinued the anti-TNF agent for either lack of efficacy or intolerance (anti-TNF-IR patients).
Croatian: Psoriatic Arthritis Study 2) sudjelovali su bolesnici koji su se prethodno liječili anti-TNF lijekom i koji su prekinuli primjenu tog lijeka zbog izostanka djelotvornosti ili nepodnošenja (bolesnici s nedovoljno dobrim odgovorom na anti-TNF lijek).
English: The safety and efficacy of Taltz in children and adolescents aged 2 to less than 18 years in the treatment of psoriatic arthritis (a category of juvenile idiopathic arthritis) have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Taltz u djece i adolescenata u dobi od navršene 2 godine do manje od 18 godina, za liječenje psorijatičnog artritisa (kategorija juvenilni idiopatski artritis) nisu još ustanovljene.
English: Maintained or Achieved sPGA 0 (clear)
Croatian: Održan ili ostvaren sPGA rezultat "0" (čisto)
English: 292 (83.2)a sPGA of “0” (clear)
Croatian: 292 (83,2)a sPGA "0"
English: TALTZ Placebo Difference from placebo (95% CI)
Croatian: Taltz Placebo Razlika u odnosu na placebo (95% CI)
English: Maintained or Achieved PASI 100
Croatian: Održan ili ostvaren odgovor PASI 100
English: If possible, areas of the skin that show psoriasis should be avoided as injection sites.
Croatian: Ako je moguće, treba izbjegavati injiciranje u područja na koži zahvaćena psorijazom.
English: Thumb pad Green plunger rod
Croatian: Oslonac za palac Zeleni potisnik klipa
English: • The grey syringe plunger should be pushed all the way to the end of the syringe.
Croatian: • Sivi klip štrcaljke trebao bi biti potisnut sve do kraja štrcaljke.
English: PASI score, percent improvement at each post baseline visit (mBOCF)) in the Intentto-Treat Population during the Induction Dosing Period - UNCOVER-2 and UNCOVER-3
Croatian: Slika 1. PASI rezultat, postotno poboljšanje pri svakom posjetu nakon početka ispitivanja (modificiran prijenos početno zabilježene vrijednosti [engl. modified baseline observation carried forward, mBOCF]) u ITT populaciji tijekom razdoblja uvodnog doziranja - UNCOVER-2 i UNCOVER-3
English: The safety and efficacy of Taltz in children and adolescents aged 6 to 18 years in the treatment of moderate to severe plaque psoriasis have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Taltz u djece i adolescenata u dobi od 6 do 18 godina za liječenje umjerene do teške plak psorijaze nisu još ustanovljene.
English: 3% of patients exposed to Taltz had a shift from a normal baseline platelet value to <150,000 platelet cells/mm3 to ≥75,000 cells/mm3.
Croatian: 3% bolesnika izloženih lijeku Taltz došlo je do promjene broja trombocita od početne normalne vrijednosti na < 150 000 stanica/mm3 do ≥ 75 000 stanica/mm3.
English: Onset of response was superior on PASI 75 as early as week 2 (p < 0.001) and on PASI 90 and PASI 100 by week 4 (p < 0.001).
Croatian: Superioran je bio nastup odgovora PASI 75 već u 2. tjednu (p < 0,001) te odgovora PASI 90 i PASI 100 do 4. tjedna (p < 0,001).
English: Inspect the pre-filled pen.
Croatian: Pregledajte napunjenu brizgalicu.
English: Ixekizumab is a recombinant humanised monoclonal antibody produced in CHO cells.
Croatian: Iksekizumab je rekombinantno humanizirano monoklonsko protutijelo proizvedeno u stanicama jajnika kineskog hrčka (engl.
English: Taltz also showed non-inferiority (pre-specified margin of -12%) to ADA on ACR 50 (ITT analysis: Taltz 50.5% vs ADA 46.6%; 3.9% difference vs. ADA; 95% confidence interval [4.3%; 12.1%] ; PPS analysis Taltz: 52.3%, ADA: 53.1%, difference: -0.8% [CI: -10.3%; 8.7%]) and superiority on PASI 100 at Week 24 (60.1 % with Taltz vs 46.6% with ADA, p=0.001), which were the major secondary endpoints in the study.
Croatian: Taltz se također pokazao neinferiornim (unaprijed specificirana granica neinferiornosti od -12%) u odnosu na ADA s obzirom na ACR 50 (ITT analiza: Taltz 50,5% naspram ADA 46,6%; razlika od 3,9% u odnosu na ADA; 95%-tni interval pouzdanosti [-4,3%; 12,1%]; PPS analiza Taltz: 52,3%, ADA: 53,1%, razlika: -0,8% [CI: -10,3%; 8,7%]) te superiornim s obzirom na odgovor PASI 100 u 24. tjednu (60,1% uz Taltz naspram 46,6% uz ADA, p=0,001), što su bile glavne sekundarne mjere ishoda u ispitivanju.
English: Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic impairment on the PK of ixekizumab have not been conducted.
Croatian: Nisu provedena specifična klinička farmakološka ispitivanja kojima bi se ocijenili učinci oštećenja funkcije bubrega i jetre na farmakokinetiku iksekizumaba.
English: Abbreviations: N = number of patients in the analysis population Note: patients with missing data were counted as non-responders a p < 0.001 compared with placebo
Croatian: Kratice: N = broj bolesnika u populaciji uključenoj u analizu Napomena: bolesnici za koje su nedostajali podaci klasificirali su se kao bolesnici koji nisu ostvarili odgovor a p < 0,001 u usporedbi s placebom
English: Taltz-treated patients reported improvements in health-related quality of life as measured by the Physical Component Summary of the Short Form-36 Health Survey (SF-36 PCS) score (p<0.001).
Croatian: Short Form36 Health Survey Physical Component Summary, SF-36 PCS) (p < 0,001).
English: ACR 20 response in SPIRIT-P1 over time up to Week 24
Croatian: Odgovor ACR 20 tijekom vremena do 24. tjedna u ispitivanju SPIRIT-P1
English: • The pre-filled syringe contains 1 dose of Taltz.
Croatian: • Napunjena brizgalica sadrži 1 dozu lijeka Taltz.
English: A total of 678 patients were evaluated (229 patients on 80 mg every 4 weeks (Q4W), 225 patients on 80 mg every 2 weeks (Q2W) and 224 patients on placebo).
Croatian: Ukupno je ocijenjeno 678 bolesnika (229 bolesnika liječenih dozom od 80 mg svaka 4 tjedna, 225 bolesnika liječenih dozom od 80 mg svaka 2 tjedna i 224 bolesnika koja su primala placebo).
English: • If you do not have a sharps container, ask your doctor, pharmacist or nurse where you can get one.
Croatian: • Ako nemate spremnik za oštre predmete, pitajte svog liječnika, ljekarnika ili medicinsku sestru gdje ga možete nabaviti.
English: This medicine contains less than 1 mmol sodium (23 mg) per 80 mg dose, i.e., essentially “sodiumfree”.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi od 80 mg, tj. zanemarive količine natrija.
English: A significantly greater proportion of patients treated with TALTZ achieved a reduction in the PROs of severity of genital pain, genital itch, impact of genital psoriasis on sexual activity, and Dermatology Quality of Life Index (DLQI).
Croatian: Prema ishodima koje su prijavili bolesnici (PRO), kod značajno većeg udjela bolesnika liječenih lijekom Taltz zabilježeno je smanjenje težine genitalne boli, genitalnog svrbeža, utjecaja genitalne psorijaze na spolnu aktivnost i indeksa za ocjenu kvalitete života kod dermatoloških bolesti (DLQI).
English: Within each frequency grouping, adverse drug reactions are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: There is no relevant use of Taltz in children below 2 years for the indication of psoriatic arthritis.
Croatian: Nema relevantne primjene lijeka Taltz u djece mlađe od 2 godine, u indikaciji psorijatičnog artritisa.
English: Overdoses up to 240 mg, subcutaneously, as a single administration in clinical trials, have been reported without any serious adverse events.
Croatian: U kliničkim su ispitivanjima prijavljena predoziranja jednokratnom supkutanom dozom do 240 mg, bez ozbiljnih štetnih događaja.
English: SPIRIT-P2 evaluated 363 patients, of whom 41% had concomitant use of MTX at a mean weekly dose of 16.1 mg. 73.2% of patients who had concomitant use of MTX had a dose of 15 mg or greater.
Croatian: U ispitivanju SPIRIT-P2 ocjenjivala su se 363 bolesnika, od kojih je njih 41% istodobno primalo MTX u srednjoj tjednoj dozi od 16,1 mg; 73,2% bolesnika koji su istodobno primjenjivali MTX primalo je dozu od
English: Efficacy in Genital Psoriasis A randomized, double-blind, placebo-controlled study (IXORA-Q) was conducted in 149 adult subjects (24% females) with moderate to severe genital psoriasis (sPGA of Genitalia score of ≥3), a minimum body surface area (BSA) involvement of 1% (60.4% had a BSA ≥ 10%) and previous failure of or intolerance to at least one topical therapy for genital psoriasis.
Croatian: Randomizirano, dvostruko slijepo, placebom kontrolirano ispitivanje (IXORA-Q) provedeno je u 149 odraslih ispitanika (24% žena) s umjerenom do teškom genitalnom psorijazom (rezultat statične opće ocjene liječnika (sPGA) za genitalije ≥ 3), kojima je psorijazom bilo zahvaćeno najmanje 1% površine tijela (u 60,4% ispitanika bilo je zahvaćeno ≥ 10% površine tijela), a koji prethodno nisu uspješno odgovorili na najmanje jednu topikalnu terapiju za genitalnu psorijazu ili nisu podnosili takvu terapiju.
English: - After the first dose you will use an 80 mg dose (one injection) every 4 weeks.
Croatian: - Nakon prve doze primjenjivat ćete dozu od 80 mg (jednu injekciju) svaka 4 tjedna.
English: UNIQUE IDENTIFIER - 2D BARCODE
Croatian: 17. JEDINSTVENI IDENTIFIKATOR - 2D BARKOD Sadrži 2D barkod s jedinstvenim identifikatorom..
English: The percentage of patients achieving PASI 75 was significantly greater for Taltz compared with placebo and etanercept as early as Week 1.
Croatian: Postotak bolesnika koji su ostvarili rezultat PASI 75 bio je značajno veći u skupini koja je primala Taltz nego u onima koje su primale placebo i etanercept, i to već od 1. tjedna.