FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious infections occurred in 13 (0.6 %) of patients treated with Taltz and in 3 (0.4 %) of patients treated with placebo (see section 4.4).
Croatian: 3 (0,4%) bolesnika koja su primala placebo (vidjeti dio 4.4).
English: In plaque psoriasis, three placebo-controlled phase III studies were integrated to evaluate the safety of Taltz in comparison to placebo up to 12 weeks after treatment initiation.
Croatian: Kod plak psorijaze, objedinjeni su podaci iz tri placebom kontrolirana ispitivanja faze III radi ocjene sigurnosti lijeka Taltz u usporedbi s placebom tijekom razdoblja do 12 tjedana nakon početka liječenja.
English: The pharmacokinetic properties of Taltz observed in psoriatic arthritis patients were similar to those displayed in plaque psoriasis patients.
Croatian: Farmakokinetička svojstva lijeka Taltz opažena u bolesnika s psorijatičnim artritisom bila su slična onima u bolesnika s plak psorijazom.
English: • Keep the pre-filled pen out of the reach and sight of children.
Croatian: • Čuvajte napunjenu brizgalicu izvan dohvata i pogleda djece.
English: Of the 3,866 patients enrolled in these placebo-controlled studies, 64 % had received prior systemic therapy (biologic, conventional systemic or psoralen and ultraviolet A (PUVA)), 43.5 % had received prior phototherapy, 49.3 % had received prior conventional systemic therapy, and 26.4 % had received prior biologic therapy for the treatment of psoriasis.
Croatian: Od 3866 bolesnika uključenih u ta placebom kontrolirana ispitivanja, njih 64% prethodno je za liječenje psorijaze primalo sistemsku terapiju (biološku terapiju, konvencionalnu sistemsku terapiju ili terapiju psoralenom i ultraljubičastim
English: (Based on adverse reactions data from 4,204 patients with moderate to severe plaque psoriasis [4,729.7 patient years] and 1,117 patients with active psoriatic arthritis [1,050.6 patient years] who have received at least 1 dose of ixekizumab.)
Croatian: Opis odabranih nuspojava (Na temelju podataka o nuspojavama zabilježenim u 4204 bolesnika s umjerenom do teškom plak psorijazom [4729,7 bolesnik-godina] i 1117 bolesnika s aktivnim psorijatičnim artritisom
English: Frequency
Croatian: Sexual Frequency
English: Renal or hepatic impairment Taltz has not been studied in these patient populations.
Croatian: Taltz nije ispitivan u tim populacijama bolesnika.
English: Patients were randomised (1:2:2:2) to receive either placebo, or Taltz (80 mg every two or four weeks [Q2W or Q4W] following a 160 mg starting dose) or etanercept 50 mg twice weekly for 12 weeks.
Croatian: Bolesnici su bili randomizirani (1:2:2:2) za primanje placeba, lijeka Taltz (80 mg svaka dva ili četiri tjedna nakon početne doze od 160 mg) ili etanercepta u dozi od 50 mg dvaput na tjedan tijekom 12 tjedana.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED SYRINGE
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - NAPUNJENA ŠTRCALJKA
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED PEN
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA - NAPUNJENA BRIZGALICA
English: The frequency of neutropenia and thrombocytopenia in psoriatic arthritis clinical studies is similar to that observed in the plaque psoriasis studies.
Croatian: Učestalost neutropenije i trombocitopenije u kliničkim ispitivanjima kod psorijatičnog artritisa slična je onoj opaženoj u ispitivanjima kod plak psorijaze.
English: At Week 52, the mean change from baseline in mTSS was 0.27 for placebo/Taltz Q4W, 0.54 for Taltz Q4W/Taltz Q4W, and 0.32 for adalimumab/Taltz Q4W.
Croatian: U 52. tjednu srednja vrijednost promjene u usporedbi s početnom vrijednošću mTSS rezultata bila je 0,27 za placebo/Taltz svaka 4 tjedna, 0,54 za Taltz svaka 4 tjedna/Taltz svaka 4 tjedna te 0,32 za adalimumab/Taltz svaka 4 tjedna.
English: Taltz was efficacious in the maintenance of response in systemic treatment-naive, biologic-naive, biologic/anti-TNF-exposed and biologic/anti-TNF-failure patients.
Croatian: Taltz je bio djelotvoran u održavanju odgovora u bolesnika prethodno neliječenih sistemskom terapijom, bolesnika prethodno neliječenih biološkom terapijom, bolesnika prethodno izloženih biološkim/anti-TNF lijekovima i bolesnika koji nisu odgovorili na prethodno liječenje biološkim/anti-TNF lijekovima.
English: • Keep the syringe out of the reach and sight of children.
Croatian: • Čuvajte štrcaljku izvan dohvata i pogleda djece.
English: Read the “Instructions for Use” for the syringe carefully before using Taltz.
Croatian: "Upute za uporabu" štrcaljke prije nego što primijenite Taltz.
English: Taltz contains the active substance ixekizumab.
Croatian: Taltz sadrži djelatnu tvar iksekizumab.
English: Patients randomised to Taltz who were sPGA (0,1) responders (static Physicians Global Assessment) at Week 12 were re-randomised to receive placebo or Taltz for an additional 48 weeks (UNCOVER-1 and UNCOVER-2); patients randomised to placebo, etanercept or Taltz who were sPGA (0,1) nonresponders received Taltz for up to 48 weeks.
Croatian: Bolesnici randomizirani za liječenje lijekom Taltz koji su u 12. tjednu ostvarili odgovor prema sPGA (od engl. static Physician's Global Assessment; statična opća ocjena liječnika) rezultatu (0, 1) bili su ponovno randomizirani za primanje placeba ili lijeka Taltz tijekom dodatnih 48 tjedana (UNCOVER-1 i UNCOVER-2); bolesnici randomizirani za primanje placeba, etanercepta ili lijeka Taltz koji nisu ostvarili odgovor prema sPGA rezultatu (0, 1) primali su lijek Taltz tijekom razdoblja do 48 tjedana.
English: Dispose of the pre-filled pen in a closable, puncture-resistant sharps container.
Croatian: Zbrinite brizgalicu u neprobojan spremnik za oštre predmete koji se može zatvoriti.
English: In SPIRIT-P1and SPIRIT-P2, improvements were shown in all components of the ACR scores including patient assessment of pain.
Croatian: U ispitivanjima SPIRIT-P1 i SPIRIT-P2 zabilježena su poboljšanja svih sastavnica ACR odgovora,
English: After the 160 mg starting dose, steady state was achieved by Week 8 with the 80 mg Q2W dosing regimen.
Croatian: Nakon početne doze od 160 mg, stanje dinamičke ravnoteže uz režim doziranja 80 mg svaka 2 tjedna postignuto je do 8. tjedna.
English: At Week 12 and across studies, Taltz was associated with statistically significant improvement in Health-related Quality of Life as assessed by mean decrease ranges from baseline in the Dermatology Life Quality Index (DLQI) (Taltz 80 mg Q2W from -10.2 to -11.1, Taltz 80 mg Q4W from -9.4 to10.7, etanercept from -7.7 to -8.0 and placebo -1.0 to -2.0).
Croatian: Dermatology Life Quality Index, DLQI) od početnog rezultata (Taltz 80 mg svaka 2 tjedna: od -10,2 do -11,1; Taltz 80 mg svaka 4 tjedna: od -9,4 do -10,7; etanercept: od -7,7 do -8,0; placebo: od -1,0 do -2,0).
English: 3 FINISH 3a
Croatian: 3a
English: The solution/the syringe must not be shaken.
Croatian: Otopina/brizgalica se ne smije tresti.
English: Comprehensive instructions for administration are given in the package leaflet.
Croatian: Opsežne upute za primjenu navode se u uputi o lijeku.
English: Patients receiving adalimumab or placebo were re-randomised 1:1 to Taltz Q2W or Q4W at week 16 or 24 based on responder status.
Croatian: Bolesnici koji su primali adalimumab ili placebo bili su ponovno randomizirani u omjeru 1:1 za primanje lijeka Taltz svaka 2 tjedna ili svaka 4 tjedna u 16. ili 24. tjednu, ovisno o statusu postignutog odgovora.
English: Read the full Instructions for Use and the Patient Information Leaflet for Taltz inside this box to learn more about your medicine.
Croatian: Za više informacije o ovom lijeku, pročitajte cjelovite upute za uporabu i uputu o lijeku Taltz koja se nalazi u ovoj kutiji.
English: • If you have questions or need help with your pre-filled syringe, call your doctor, pharmacist or nurse.
Croatian: • Ako imate pitanja ili trebate pomoć s napunjenom štrcaljkom, obratite se svom liječniku,
English: Patients (n) PASI 75, n (%) 120 (88.2 %) 114 (68.7 %) PASI 90, n (%) PASI 100, n (%) 49 (36.0 %) * Ixekizumab 160 mg was given as a loading dose followed by 80 mg at week 2,4,6,8,10 and 12, and 80 mg Q4W thereafter ** Weight based dosing: 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 < 0.001 versus ustekinumab (p value only provided for primary endpoint)
Croatian: PASI 100, n (%) 49 (36,0%) * Iksekizumab se primjenjivao u udarnoj dozi od 160 mg, a zatim u dozi od 80 mg u 2., 4., 6., 8., 10. i 12. tjednu te u dozi od 80 mg svaka 4 tjedna nakon toga ** Doziranje na temelju tjelesne težine: Bolesnici liječeni ustekinumabom primali su dozu od 45 mg ili 90 mg u 0. i 4. tjednu, a zatim svakih 12 tjedana do 52. tjedna (doza prema tjelesnoj težini u skladu s odobrenim doziranjem) § p < 0,001 u odnosu na ustekinumab (p-vrijednost dana je samo za primarnu mjeru ishoda)
English: Significantly greater improvements at Week 12 from baseline compared to placebo and etanercept were demonstrated in nail psoriasis (as measured by the Nail Psoriasis Severity Index [NAPSI]), in scalp psoriasis (as measured by Psoriasis Scalp Severity Index [PSSI]) and in palmoplantar psoriasis (as measured by Psoriasis Palmoplantar Severity Index [PPASI]).
Croatian: Značajno veća poboljšanja od početka ispitivanja do 12. tjedna u odnosu na placebo i etanercept primijećena su kod psorijaze noktiju (prema indeksu za ocjenjivanje težine psorijaze noktiju [engl.
English: In patients with ≥3% BSA, the improvement in skin clearance at Week 12 as measured by 75% improvement in Psoriasis Area Severity Index (PASI 75), was 67% (94/141) for those treated with the Q4W dosing regimen, and 9% (12/134) for those treated with placebo (p<0.001).
Croatian: U bolesnika kojima je psorijazom zahvaćeno ≥3% površine tijela, poboljšanje čistoće kože u 12. tjednu mjereno kao 75% poboljšanje indeksa zahvaćenosti i težine psorijaze (PASI 75) bilo je 67% (94/141)
English: Patients were randomised to subcutaneous injections of placebo, Taltz 80 mg once every 2 weeks (Q2W), or 80 mg once every 4 weeks (Q4W).
Croatian: Bolesnici su bili randomizirani za primanje supkutanih injekcija placeba, lijeka Taltz u dozi od 80 mg jedanput svaka 2 tjedna ili lijeka Taltz u dozi od 80 mg jedanput svaka 4 tjedna.
English: Dispose of the syringe in a sharps container or as directed by your doctor, pharmacist or nurse.
Croatian: Zbrinite štrcaljku u spremnik za oštre predmete ili sukladno uputama svog liječnika, ljekarnika ili medicinske sestre.
English: - bacterial skin infection.
Croatian: - gripa - curenje iz nosa - bakterijska kožna infekcija
English: In SPIRIT-P1, efficacy was maintained up to Week 52 as assessed by ACR 20/50/70, MDA, enthesitis resolution, dactylitis resolution, and PASI 75/90/100 response rates.
Croatian: ACR 20/50/70, minimalnoj aktivnosti bolesti, povlačenju entezitisa, povlačenju daktilitisa i stopama odgovora PASI 75/90/100.
English: Taltz was efficacious in systemic treatment-naive, biologic-naive, biologic/anti-TNFexposed and biologic/anti-TNF-failure patients.
Croatian: Taltz se pokazao djelotvornim u bolesnika prethodno neliječenih sistemskom terapijom, bolesnika prethodno neliječenih biološkom terapijom, bolesnika prethodno izloženih biološkim/anti-TNF lijekovima i bolesnika koji nisu odgovorili na prethodno liječenje biološkim/anti-TNF lijekovima.
English: You may give or get an infection
Croatian: Moglo bi doći do prijenosa infekcije.
English: Patients originally randomised to Taltz and who were responders at Week 12 (i.e., sPGA score of 0,1) in UNCOVER-1 and UNCOVER-2 were re-randomised to an additional 48 weeks of one of the following treatment regimens: placebo, or Taltz (80 mg every four or twelve weeks [Q4W or Q12W]).
Croatian: Bolesnici izvorno randomizirani za primanje lijeka Taltz koji su ostvarili odgovor u 12. tjednu (tj. sPGA rezultat od 0, 1) u ispitivanjima UNCOVER-1 i UNCOVER-2 bili su ponovno randomizirani za dodatnih 48 tjedana primjene jednoga od sljedećih režima: placeba ili lijeka Taltz (80 mg svaka
English: Respiratory, thoracic and mediastinal disorders
Croatian: Laboratorijska ocjena neutropenije i trombocitopenije
English: • 1 sharps container for disposal of pre-filled pen
Croatian: • 1 spremnik za oštre predmete za zbrinjavanje brizgalica
English: For psoriatic arthritis patients with concomitant moderate to severe plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis.
Croatian: Preporučeni režim doziranja za bolesnike s psorijatičnim artritisom koji istodobno imaju i umjerenu do tešku plak psorijazu jednak je onome za plak psorijazu.
English: Pack sizes of 1, 2, or 3 pre-filled syringes.
Croatian: Veličine pakiranja: 1, 2 ili 3 napunjene brizgalice.
English: At Week 12, significantly more subjects in the TALTZ group than placebo group achieved a sPGA of Genitalia 0/1 and a sPGA 0/1 independent of baseline BSA (baseline BSA 1% - <10% resp. ≥10%: sPGA of Genitalia ‘'0” or “1”: Taltz 71%, resp. 75%; placebo: 0%, resp. 13%).
Croatian: U 12. je tjednu značajno više ispitanika u skupini koja je primala Taltz nego u skupini koja je primala placebo postiglo sPGA rezultat za genitalije 0/1 i sPGA rezultat 0/1, neovisno o zahvaćenoj površini tijela na početku ispitivanja (početna zahvaćena površina 1% - <10%, odgovor
English: Laboratory assessment of neutropenia and thrombocytopenia In plaque psoriasis studies, 9% of patients receiving Taltz developed neutropenia.
Croatian: U 9% bolesnika koji su primali Taltz u ispitivanjima plak psorijaze razvila se neutropenija.
English: Efficacy results at Week 12 in UNCOVER-1
Croatian: Rezultati za djelotvornost u 12. tjednu ispitivanja UNCOVER-1
English: Efficacy results at Week 12 in UNCOVER-3
Croatian: Rezultati za djelotvornost u 12. tjednu ispitivanja UNCOVER-3
English: ACR 50 and PASI 100 in patients with ≥3% BSA psoriasis skin involvement at baseline, n (%)
Croatian: ACR 50 i PASI 100 u bolesnika kojima je na početku ispitivanja koža zahvaćena psorijazom iznosila
English: Injection site reactionsf a Placebo-controlled clinical studies (phase III) in moderate to severe plaque psoriasis patients exposed to ixekizumab 80 mg Q2W, ixekizumab 80 mg Q4W or placebo for up to 12 weeks of treatment duration, or in active psoriatic arthritis patients exposed to ixekizumab 80 mg Q2W, ixekizumab 80 mg Q4W or placebo for up to 24 weeks of treatment duration.
Croatian: Placebom kontrolirana klinička ispitivanja (faze III) provedena u bolesnika s umjerenom do teškom plak psorijazom izloženih iksekizumabu u dozi od 80 mg svaka 2 tjedna, iksekizumabu u dozi od 80 mg svaka 4 tjedna ili placebu tijekom liječenja u trajanju do 12 tjedana, ili u bolesnika s aktivnim psorijatičnim artritisom izloženih iksekizumabu u dozi od 80 mg svaka 2 tjedna, iksekizumabu u dozi od 80 mg svaka 4 tjedna ili placebu tijekom liječenja u trajanju do 24 tjedna.
English: The efficacy and safety of Taltz was demonstrated regardless of age, gender, race, disease duration, baseline body weight, baseline psoriasis involvement, baseline CRP, baseline DAS28-CRP, concomitant corticosteroid use, and previous treatment with a biologic.
Croatian: početnoj tjelesnoj težini, početnoj zahvaćenosti psorijazom, početnoj vrijednosti CRP-a, početnom DAS28-CRP rezultatu, istodobnoj primjeni kortikosteroida i prethodnom liječenju biološkim lijekom.
English: The pre-filled syringe is for single use only.
Croatian: Napunjena brizgalica namijenjena je samo za jednokratnu uporabu.
English: • DO NOT share or reuse your Taltz pre-filled syringe.
Croatian: • NEMOJTE dijeliti Taltz napunjenu štrcaljku s drugim osobama i nemojte je ponovno upotrijebiti.
English: You should see the green plunger rod showing through the syringe body when the injection is complete.
Croatian: Kada injiciranje završi, trebali biste vidjeti zeleni potisnik klipa kroz tijelo štrcaljke.
English: Possible serious infection (may affect up to 1 in 100 people) - the signs may include: - fever, flu-like symptoms, night sweats - feeling tired or short of breath, cough which will not go away - warm, red and painful skin, or a painful skin rash with blisters
Croatian: Moguća ozbiljna infekcija (može se javiti u do 1 na 100 osoba) - znakovi mogu uključivati: - vrućicu, simptome nalik gripi, noćno znojenje
English: SFQ-item 2 score, “0” (never limited) or
Croatian: Rezultat za 2. pitanje SFQ upitnika, "0" (nikada nisu ograničili) ili "1" (rijetko su ograničili) a Kratice: NRI (engl.
English: Solution for injection in pre-filled pen.
Croatian: OBLIK Otopina za injekciju u napunjenoj brizgalici.
English: Itch NRS reduction
Croatian: Smanjenje NRS rezultata za svrbež od
English: • Read the Taltz Package Leaflet inside this box to learn more about your medicine.
Croatian: • Za više informacija o lijeku pročitajte uputu o lijeku Taltz koja se nalazi u ovoj kutiji.
English: EU/1/15/1085/001 EU/1/15/1085/002 EU/1/15/1085/003
Croatian: EU/1/15/1085/002
English: Radiographic joint damage progression was inhibited by Taltz (Table 9) at Week 24, and the percentage of patients with no radiographic joint damage progression (defined as a change from baseline in mTSS of ≤0.5) from randomisation to Week 24 was 94.8% for Taltz Q2W(p<0.001),
Croatian: Taltz je inhibirao radiološku progresiju oštećenja zglobova (Tablica 9.) u 24. tjednu, te je postotak bolesnika bez radiološke progresije oštećenja zglobova (koja se definirala kao promjena početnog mTSS rezultata za ≤ 0,5 bodova) od randomizacije do 24. tjedna iznosio je 94,8% uz Taltz svaka 2 tjedna (p<0.001), 89,0% uz Taltz svaka 4 tjedna (p=0,026), 95,8% uz adalimumab (p<0,001), sve u usporedbi sa 77,4% uz placebo.
English: Renal elimination of intact ixekizumab, an IgG MAb, is expected to be low and of minor importance; similarly, IgG MAbs are mainly eliminated via intracellular catabolism and hepatic impairment is not expected to influence clearance of ixekizumab.
Croatian: Očekuje se da će bubrežna eliminacija nepromijenjenog iksekizumaba, koji je IgG monoklonsko protutijelo, biti niska i od neznatne važnosti.
English: Patients were stratified at baseline based on concomitant cDMARD use and presence of moderate-to-severe psoriasis (PASI≥12,
Croatian: Bolesnici su na početku ispitivanja bili stratificirani prema istodobnoj primjeni konvencionalnih DMARD-ova (cDMARD) i prisutnosti umjerene do teške psorijaze (PASI ≥ 12, zahvaćenost ≥ 10% površine tijela i sPGA ≥ 3).
English: • If you have questions or need help with your pre-filled pen, call your doctor, pharmacist or nurse.
Croatian: • Ako imate pitanja ili trebate pomoć s napunjenom brizgalicom, obratite se svom liječniku,
English: The safety profile observed in patients with psoriatic arthritis treated with Taltz is consistent with the safety profile in plaque psoriasis with the exception of the frequencies of the adverse reactions of influenza and conjunctivitis which were common in patients with psoriatic arthritis.
Croatian: Sigurnosni profil zabilježen u bolesnika s psorijatičnim artritisom liječenih lijekom Taltz u skladu je sa sigurnosnim profilom kod plak psorijaze, uz izuzetak učestalosti gripe i konjunktivitisa,
English: Taltz Q4W (N = 107)
Croatian: Taltz svaka 4 tjedna (N = 107)
English: In patients with concomitant moderate to severe psoriasis and psoriatic arthritis, Taltz Q2W dose regimen showed significantly higher response rate for PASI75, PASI 90 and PASI 100 compared to placebo (p<0.001) and demonstrated clinically meaningful benefit over the Q4W dose regimen.
Croatian: 2 tjedna doveo je do značajno viših stopa odgovora PASI 75, PASI 90 i PASI 100 u usporedbi s placebom (p < 0,001) te je pokazao klinički značajnu korist u odnosu na režim primjene svaka
English: They will not harm you or affect your dose.
Croatian: Neće Vam naškoditi niti utjecati na dozu.
English: The treatment responses on Taltz were significantly greater than those on placebo as early as week 1 for ACR 20, week 4 for ACR 50 and week 8 for ACR 70 and persisted through week 24.
Croatian: 4. tjednu prema ACR 50 te u 8. tjednu prema ACR 70, a održali su se do kraja 24. tjedna.
English: Baseline score, mean (SD) 17.6 (28.62) 19.2 (32.68) 15.2 (28.86) 15.9 (27.37)
Croatian: Odgovor ACR 20, n (%) tjedan 32 (30,2) 62 (57,9) 64 (62,1) 58 (57,4)
English: Efficacy results at Week 12 in UNCOVER-2
Croatian: Rezultati za djelotvornost u 12. tjednu ispitivanja UNCOVER-2
English: Significant improvements in itch severity were seen at Week 1 in patients treated with Taltz.
Croatian: U bolesnika liječenih lijekom Taltz primijećena su značajna poboljšanja svrbeža u 1. tjednu.
English: • The pre-filled pen must not be shaken.
Croatian: • Napunjena brizgalica ne smije se tresti.
English: What Taltz looks like and contents of the pack
Croatian: Kako Taltz izgleda i sadržaj pakiranja Taltz je otopina u prozirnoj staklenoj štrcaljki.
English: Taltz Q2W (N = 103)
Croatian: Taltz svaka 2 tjedna (N = 103)
English: Some side effects are common (may affect up to 1 in 10 people): - nausea (feeling sick).
Croatian: Neke nuspojave su česte (mogu se javiti u do 1 na 10 osoba):
English: - Cold sores of mouth, skin and mucous membranes (herpes simplex, mucocutaneous)
Croatian: - gljivične infekcije (tinea) poput atletskog stopala - bol u stražnjem dijelu grla - herpes usta, na koži i na sluzinci (herpes simpleks, mukokutani)
English: The pen must not be shaken.
Croatian: Štrcaljka se ne smije tresti.
English: Taltz 80 mg Q4W
Croatian: Taltz 80 mg svaka 4 tjedna
English: INFORMATION IN BRAILLE
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Taltz
English: Read the full Patient Information Leaflet for Taltz inside this box to learn more about your medicine.
Croatian: Za više informacija o ovom lijeku, pročitajte cjelovitu uputu o lijeku Taltz koja se nalazi u ovoj kutiji.
English: Immune system disorders
Croatian: Poremećaji dišnog sustava,
English: Abbreviations: N = number of patients in the intent-to-treat population Note: patients with missing data were counted as non-responders a p < 0.001 compared with placebo b Patients with Itch NRS >= 4 at baseline: placebo N = 374, Taltz 80 mg Q4W N = 379, Taltz 80 mg Q2W N = 391
Croatian: Kratice: N = broj bolesnika u populaciji koju se namjeravalo liječiti (engl. intent-to-treat, ITT) Napomena: bolesnici za koje su nedostajali podaci klasificirali su se kao bolesnici koji nisu ostvarili odgovor a p < 0,001 u usporedbi s placebom b Bolesnici s početnim NRS rezultatom za svrbež od ≥ 4: placebo N = 374, Taltz 80 mg svaka 4 tjedna N = 379, Taltz 80 mg svaka 2 tjedna N = 391
English: At Week 24 the proportion of patients achieving a modified Psoriatic Arthritis Response Criteria (PsARC) response was greater in the Taltz-treated patients compared to placebo.
Croatian: Psoriatic Arthritis Response Criteria, PsARC) bio je veći među bolesnicima liječenima lijekom Taltz nego među onima koji su primali placebo.
English: EU/1/15/1085/004 EU/1/15/1085/005 EU/1/15/1085/006
Croatian: EU/1/15/1085/006
English: How to store Taltz
Croatian: Moguće nuspojave Kako čuvati Taltz
English: In all three studies, the co-primary endpoints were the proportion of patients who achieved a PASI 75 response (Psoriasis Area and Severity Index) and an sPGA of 0 (“clear”) or 1 (“minimal”) response at Week 12 versus placebo.
Croatian: Psoriasis Area and Severity Index; indeks proširenosti i težine psorijaze) i odgovor sPGA 0 („čisto“) ili 1 („minimalno“) u odnosu na placebo.
English: Abbreviations: N = number of patients in the intent-to-treat population Note: patients with missing data were counted as non-responders a p < 0.001 compared with placebo b p < 0.001 compared with etanercept c Patients with Itch NRS >= 4 at baseline: placebo N = 158, Taltz 80 mg Q4W N = 313, Taltz 80 mg Q2W N = 320, Etanercept N = 312
Croatian: Napomena: bolesnici za koje su nedostajali podaci klasificirali su se kao bolesnici koji nisu ostvarili odgovor a p < 0,001 u usporedbi s placebom b p < 0,001 u usporedbi s etanerceptom c Bolesnici s početnim NRS rezultatom za svrbež od ≥ 4: placebo N = 158, Taltz 80 mg svaka 4 tjedna N = 313, Taltz 80 mg svaka 2 tjedna N = 320, etanercept N = 312
English: Sodium citrate Citric acid, anhydrous Sodium chloride Polysorbate 80
Croatian: 6.1 Popis pomoćnih tvari natrijev citrat citratna kiselina, bezvodna natrijev klorid polisorbat 80 voda za injekcije