FrancophonIA/ELRC3.0 huggingface dataset:
English: Serious infections were reported in 1.6 % of patients treated with Taltz (1.5 per 100 patient years).
Croatian: Ozbiljne infekcije prijavljene su u 1,6% bolesnika liječenih lijekom Taltz (1,5 na
English: Keep holding the clear base firmly against your skin.
Croatian: Nastavite držati prozirnu bazu čvrsto priljubljenom uz kožu.
English: Each pen contains one dose of Taltz (80 mg).
Croatian: Jedna brizgalica sadrži jednu dozu lijeka Taltz (80 mg).
English: Maintained sPGA of “0” (clear) or “1” (minimal)
Croatian: Održan sPGA rezultat "0" (čisto) ili "1" (minimalno)
English: Taltz is used to treat a condition called “psoriatic arthritis”, an inflammatory disease of the joints, often accompanied by psoriasis.
Croatian: Taltz se koristi za liječenje bolesti pod nazivom "psorijatični artritis", upalne bolesti zglobova koju često prati psorijaza.
English: In psoriatic arthritis patients treated with Taltz at the recommended dosing regimen up to 52 weeks, approximately 11% developed anti-drug antibodies, the majority of which were low titre, and approximately 8% had confirmed neutralising antibodies.
Croatian: Približno 11% bolesnika s psorijatičnim artritisom liječenih lijekom Taltz prema preporučenom režimu doziranja tijekom razdoblja do 52 tjedna razvilo je protutijela na lijek, koja su se u većini slučajeva javljala u niskom titru, dok je u približno 8% bolesnika potvrđena prisutnost neutralizirajućih protutijela.
English: Difference from Placebo (95% CI)
Croatian: Razlika u odnosu na placebo (95% CI)
English: In SPIRIT-P1, inhibition of progression of structural damage was assessed radiographically and expressed as the change in modified total Sharp Score (mTSS) and its components, the Erosion Score (ES) and the Joint Space Narrowing score (JSN) at Weeks 24 and 52, compared to baseline.
Croatian: U ispitivanju SPIRIT-P1, inhibicija progresije strukturnog oštećenja ocjenjivala se radiološki, a izražavala se kao promjena ukupnog rezultata prema modificiranoj Sharpovoj ljestvici (engl. modified total Sharp Score, mTSS) i rezultata za njegove pojedinačne sastavnice - eroziju i suženje zglobnog prostora u 24. odnosno 52. tjednu u odnosu na početnu vrijednost.
English: Across studies, Taltz was associated with statistically significant improvement of itching severity assessed by the Itch NRS score.
Croatian: Taltz bio povezan sa statistički značajnim poboljšanjem težine svrbeža, mjereno NRS rezultatom za svrbež.
English: 354 (81.8)a sPGA of “0” (clear)
Croatian: 354 (81,8)a sPGA "0"
English: From Week 12, you will use an 80 mg dose (one injection) every 4 weeks.
Croatian: Od 12. tjedna nadalje primjenjivat ćete dozu od 80 mg (jednu injekciju) svaka 4 tjedna.
English: ** Taltz 160 mg Week 0, then 80 mg every 2 weeks to Week 12 and every 4 weeks thereafter for patients with moderate to severe plaque psoriasis or 160 mg Week 0, then 80 mg every 4 week for other patients, ADA 80 mg Week 0, then 40 mg every 2 weeks from Week 1 for patients with moderate to severe plaque psoriasis or 40 mg Week 0, then 40 mg every 2 weeks for other patients.
Croatian: ** Taltz 160 mg u 0. tjednu, zatim 80 mg svaka 2 tjedna do 12. tjedna i nakon toga svaka 4 tjedna za bolesnike s umjerenom do teškom plak psorijazom ili 160 mg u 0. tjednu i zatim 80 mg svaka 4 tjedna za druge bolesnike, ADA 80 mg u 0. tjednu, a zatim 40 mg svaka 2 tjedna od 1. tjedna za bolesnike s umjerenom do teškom plak psorijazom ili 40 mg u 0. tjednu, a zatim 40 mg svaka 2 tjedna za druge bolesnike.
English: Efficacy results in SPIRIT-P1 and SPIRIT-P2 at week 24
Croatian: Rezultati za djelotvornost u 24. tjednu ispitivanja SPIRIT-P1 i SPIRIT-P2 SPIRIT-P1
English: 56% and 35% of patients were inadequate responders to 1 anti-TNF or 2 anti-TNF, respectively.
Croatian: Među bolesnicima njih 56% nije ostvarilo dovoljno dobar odgovor na 1 anti-TNF lijek, a njih 35% na ≥ 2 anti-TNF lijeka.
English: Among these patients, 71.5 % regained at least an sPGA (0,1) response within 12 weeks of restarting treatment with Taltz 80 mg Q4W.
Croatian: Od tih je bolesnika njih 71,5% povratilo barem sPGA odgovor (0, 1) unutar 12 tjedana nakon ponovnog uvođenja liječenja lijekom Taltz u dozi od 80 mg svaka 4 tjedna.
English: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska.
English: Patients in all treatment groups had a median baseline PASI score ranging from 17.4 to 18.3; 48.3 % to 51.2 % of patients had a baseline sPGA score of severe or very severe, and mean baseline itch Numeric Rating Scale (itch NRS) ranging from 6.3 to 7.1.
Croatian: Bolesnici u svim liječenim skupinama imali su medijan početnog PASI rezultata od 17,4 do 18,3; od 48,3% do 51,2% bolesnika imalo je početni sPGA rezultat „teško“ ili „vrlo teško“ te početnu srednju vrijednost rezultata na brojčanoj ocjenskoj ljestvici (engl.
English: However, ixekizumab is excreted at low levels in the milk of cynomolgus monkeys.
Croatian: Međutim, iksekizumab se u malim količinama izlučuje u mlijeko makaki majmuna.
English: Excipients: sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; water for injections.
Croatian: Pomoćne tvari: natrijev citrat; bezvodna citratna kiselina; natrijev klorid; polisorbat 80; voda za injekcije.
English: Solution for injection in pre-filled syringe (injection).
Croatian: OBLIK Otopina za injekciju u napunjenoj štrcaljki (injekcija).
English: The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg (one injection) at Weeks 2, 4, 6, 8, 10, and 12, then maintenance dosing of 80 mg (one injection) every 4 weeks.
Croatian: Preporučena doza je 160 mg supkutanom injekcijom (dvije injekcije od 80 mg) u 0. tjednu, zatim 80 mg (jedna injekcija) u 2., 4., 6., 8., 10. i 12. tjednu i nakon toga doza održavanja od 80 mg (jedna injekcija) svaka 4 tjedna.
English: Taltz is used to treat a skin condition called “plaque psoriasis” in adults with moderate to severe disease.
Croatian: Taltz se koristi za liječenje kožne bolesti pod nazivom "plak psorijaza" u odraslih osoba s umjerenim do teškim oblikom te bolesti.
English: Consider anti-TB therapy prior to initiation of Taltz in patients with latent TB.
Croatian: TBC-om treba razmotriti primjenu terapije za TBC prije početka liječenja lijekom Taltz.
English: Do not use this medicine after the expiry date which is stated on the syringe label and on the outer carton after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici brizgalice i kutiji iza oznake „Rok valjanosti“ ili „EXP“.
English: Gently remove the needle from your skin.
Croatian: Nježno izvadite iglu iz kože.
English: Then gently let go of your skin.
Croatian: Zatim nježno otpustite nabor kože.
English: Do not use this medicine if you notice that the syringe is damaged, or the medicine is cloudy, distinctly brown, or has particles in it.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je štrcaljka oštećena ili ako je lijek mutan, izrazito smeđe boje ili sadrži čestice.
English: Each pen delivers only one dose.
Croatian: Jednom štrcaljkom može se primijeniti samo jedna doza.
English: There is no relevant use of Taltz in children below the age of 6 years in the treatment of moderate to severe plaque psoriasis.
Croatian: Nema relevantne primjene lijeka Taltz u djece mlađe od 6 godina za liječenje umjerene do teške plak psorijaze.
English: Patients in these studies had a diagnosis of psoriatic arthritis (Classification Criteria for Psoriatic Arthritis [CASPAR] criteria) for a median of 5.33 years.
Croatian: Classification Criteria for Psoriatic Arthritis, CASPAR]) bio je 5,33 godine.
English: The mean elimination half-life, as estimated from population pharmacokinetic analysis, is 13 days in patients with plaque psoriasis.
Croatian: procijenjena na temelju populacijske farmakokinetičke analize, iznosi 13 dana.
English: In the 2 clinical studies that included an active comparator (UNCOVER-2 and UNCOVER-3), the rate of serious adverse events was 1.9 % for both etanercept and for Taltz, and the rate of discontinuation due to adverse events was 1.2 % for etanercept and 2.0 % for Taltz.
Croatian: UNCOVER-3), stopa ozbiljnih štetnih događaja iznosila je 1,9% i uz etanercept i uz Taltz, dok je stopa prekida liječenja zbog štetnih događaja iznosila 1,2% uz etanercept i 2,0% uz Taltz.
English: Gently pinch and hold a fold of skin where you will inject.
Croatian: Nježno uhvatite nabor kože na mjestu gdje ćete injicirati lijek.
English: Plaque psoriasis - The first dose is 160 mg (two 80 mg injections) by subcutaneous injection.
Croatian: Plak psorijaza - Prva doza je 160 mg (dvije injekcije od 80 mg), a primjenjuje se injekcijom pod kožu.
English: Ixekizumab administration to cynomolgus monkeys for 39 weeks at subcutaneous doses up to 50 mg/kg weekly produced no organ toxicity or undesirable effects on immune function (e.g. T-cell dependent antibody response and NK cell activity).
Croatian: Primjena iksekizumaba u supkutanim dozama do 50 mg/kg na tjedan tijekom 39 tjedana u makaki majmuna nije uzrokovala toksičnost za organe niti neželjene učinke na funkciju imunološkog sustava
English: Efficacy and safety of Taltz was investigated in a multicenter, randomized, open-label, rater-blinded, parallel-group study (SPIRIT-H2H) compared to adalimumab (ADA) in 566 patients with PsA who were naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).
Croatian: U multicentričnom, randomiziranom, otvorenom ispitivanju s paralelnim skupinama koje je bilo zaslijepljeno za ocjenitelja (SPIRIT-H2H) ispitivale su se djelotvornost i sigurnost lijeka Taltz u usporedbi s adalimumabom (ADA) u 566 bolesnika s psorijatičnim artritisom koji prethodno nisu primali biološke antireumatske lijekove koji modificiraju tijek bolesti (bDMARD).
English: A total of 3,119 patients were evaluated (1,161 patients on 80 mg every 4 weeks (Q4W), 1,167 patients on 80 mg every 2 weeks (Q2W) and 791 patients on placebo).
Croatian: Ukupno je ocijenjeno 3119 bolesnika (1161 bolesnik liječen dozom od 80 mg svaka 4 tjedna, 1167 bolesnika liječenih dozom od 80 mg svaka 2 tjedna i 791 bolesnik koji je primao placebo).
English: 1 pre-filled syringe of 1 ml solution 2 pre-filled syringes of 1 ml solution 3 pre-filled syringes of 1 ml solution
Croatian: 1 napunjena štrcaljka s 1 ml otopine 2 napunjene štrcaljke s 1 ml otopine 3 napunjene štrcaljke s 1 ml otopine
English: - hives.
Croatian: [engl.
English: The proportion of patients achieving a PASI 75, PASI 90, and PASI 100 response at Week 24 was greater with Taltz Q4W compared to placebo (p<0.001).
Croatian: Udio bolesnika koji su postigli odgovor PASI 75, PASI 90 i PASI 100 u 24. tjednu bio je veći pri primjeni lijeka Taltz svaka 4 tjedna u odnosu na placebo (p<0,001).
English: In SPIRIT-P1 and SPIRIT-P2, similar responses for ACR 20/50/70 were seen in patients with psoriatic arthritis regardless of whether they were on concomitant cDMARDs, including MTX treatment, or not.
Croatian: U ispitivanjima SPIRIT-P1 i SPIRIT-P2, u bolesnika s psorijatičnim artritisom opažene su slične stope odgovora ACR 20/50/70 neovisno o tome jesu li istodobno primali konvencionalne DMARD-ove,
English: There were also improvements demonstrated in fatigue as assessed by Fatigue severity NRS scores (p<0.001).
Croatian: Dokazana su i poboljšanja u pogledu umora, na temelju rezultata na brojčanoj ljestvici za ocjenu težine umora (p < 0,001).
English: Efficacy and safety of ixekizumab was also investigated in a double-blind study compared to ustekinumab with ixekizumab being superior on the primary study objective (PASI 90 response at week 12, Table 6).
Croatian: Izravno usporedno ispitivanje faze 3b nakon stavljanja lijeka u promet Djelotvornost i sigurnost iksekizumaba bile su ispitivane i u dvostruko slijepom ispitivanju u usporedbi s ustekinumabom, u kojem je iksekizumab ostvario superiornost s obzirom na primarni cilj ispitivanja (odgovor PASI 90 u 12. tjednu, tablica 6).
English: PASI-Response Rates from comparative study ixekizumab versus ustekinumab
Croatian: PASI - Stope odgovora usporednog ispitivanja iksekizumaba u odnosu na ustekinumab
English: Taltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies (see section 5.1).
Croatian: Taltz je sam ili u kombinaciji s metotreksatom indiciran za liječenje aktivnog psorijatičnog artritisa u odraslih bolesnika koji na jedan ili više lijekova koji modificiraju tijek bolesti (engl. disease-modifying anti-rheumatic drug, DMARD) nisu dovoljno dobro odgovorili ili ih ne podnose.
English: Difference from Placebo in Response Rate (95% CI)
Croatian: Razlika u stopi odgovora u odnosu na placebo (95% CI)
English: Other side effects that have been reported
Croatian: Ostale prijavljene nuspojave
English: Etanercept 50 mg twice weekly (N = 358)
Croatian: Etanercept 50 mg dvaput na tjedan (N = 358)
English: The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg (one injection) every 4 weeks thereafter.
Croatian: Preporučena doza je 160 mg supkutanom injekcijom (dvije injekcije od 80 mg) u 0. tjednu, a zatim 80 mg (jedna injekcija) svaka 4 tjedna nakon toga.
English: points at week 12 (84.6% for Taltz Q2W, 79.2% for Taltz Q4W and 16.5% for placebo) and the benefit was sustained over time up to Week 60 in patients treated with Taltz who were sPGA (0 or 1)
Croatian: ≥ 4 boda u 12. tjednu (84,6% uz Taltz svaka 2 tjedna; 79,2% uz Taltz svaka 4 tjedna i 16,5% uz placebo), a korisni su se učinci održali do 60. tjedna u bolesnika liječenih lijekom Taltz koji su ostvarili odgovor prema sPGA rezultatu (0 ili 1) u 12. tjednu.
English: Etanercept 50 mg twice weekly (N = 382)
Croatian: Etanercept 50 mg dvaput na tjedan (N = 382)
English: Finger grips minutes
Croatian: Hvatište za prste minuta
English: Contact your doctor, pharmacist or nurse.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
English: A. It is normal to have air bubbles in the pre-filled pen.
Croatian: O. Normalno je da se u napunjenoj brizgalici nalaze mjehurići zraka.
English: For both Taltz Q2W and Q4W: b p<0.01 and c p<0.001 compared with placebo.
Croatian: Za Taltz svaka 2 tjedna i Taltz svaka 4 tjedna: b p < 0,01 i c p < 0,001 u usporedbi s placebom.
English: For both studies, the primary endpoint was American College of Rheumatology (ACR) 20 response at Week 24.
Croatian: American College of Rheumatology, ACR) u 24. tjednu.
English: In the psoriatic arthritis studies, injection site reactions were more common in subjects with a body weight < 100 kg compared with the group with a body weight ≥ 100 kg (24 %
Croatian: U ispitivanjima primjene kod psorijatičnog artritisa, reakcije na mjestu injiciranja bile su češće u ispitanika tjelesne težine < 100 kg nego u onih tjelesne težine ≥ 100 kg (24% naspram 13% prema objedinjenim podacima iz skupina koje su primale lijek svaka 2 tjedna odnosno svaka 4 tjedna).
English: Postmarketing Phase 4, direct comparative study
Croatian: Izravno usporedno ispitivanje faze 4 nakon stavljanja lijeka u promet
English: decision should be made whether to discontinue breast-feeding or to discontinue Taltz taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Croatian: Uzimajući u obzir korist dojenja za dijete i dobrobit liječenja za ženu, mora se donijeti odluka hoće li se prekinuti dojenje ili liječenje lijekom Taltz.
English: List of adverse reactions in clinical studiesa and postmarketing reports System Organ Class
Croatian: Popis nuspojava iz kliničkih ispitivanjaa i prijava nakon stavljanja lijeka u promet
English: Inflammatory Bowel Disease
Croatian: Upalna bolest crijeva
English: Back of arm
Croatian: Stražnji dio nadlaktice
English: Q. What if there is a drop of liquid on the tip of the needle when I remove the needle cap?
Croatian: Što ako se na vrhu igle nalazi kapljica tekućine nakon što skinem zatvarač igle?
English: • 1 sharps container for disposal of syringes
Croatian: • 1 spremnik za oštre predmete za zbrinjavanje štrcaljki
English: 53% of patients had concomitant use of MTX at a mean weekly dose of 15.8 mg. 67% of patients who had concomitant use of MTX had a dose of 15 mg or greater.
Croatian: tom je ispitivanju 85,3% bolesnika prethodno primilo ≥ 1 konvencionalni DMARD, dok je 53% bolesnika istodobno primalo MTX u srednjoj tjednoj dozi od 15,8 mg; 67% bolesnika koji su istodobno primjenjivali MTX primalo je dozu od 15 mg ili više.
English: - if you currently have an infection or if you have long-term or repeated infections.
Croatian: - ako trenutno imate neku infekciju ili ako imate dugotrajne ili opetovane infekcije - ako imate Crohnovu bolest - ako imate ulcerozni kolitis
English: In Psoriatic Arthritis Study 1 (SPIRIT-P1), patients naive to biologic therapy with active psoriatic arthritis were randomised to subcutaneous injections of placebo, adalimumab 40 mg once every 2 weeks (active control reference arm), Taltz 80 mg once every 2 weeks (Q2W), or 80 mg once every 4 weeks (Q4W).
Croatian: U ispitivanju SPIRIT-P1 (Psoriatic Arthritis Study 1) bolesnici s aktivnim psorijatičnim artritisom koji nisu prethodno liječeni biološkom terapijom bili su randomizirani za primanje supkutanih injekcija placeba, adalimumaba u dozi od 40 mg jedanput svaka 2 tjedna (s ulogom aktivne kontrolne skupine ispitivanja), lijeka Taltz u dozi od 80 mg jedanput svaka 2 tjedna ili lijeka Taltz u dozi od 80 mg jedanput svaka 4 tjedna.
English: Taltz is given by injection under your skin (subcutaneous injection).
Croatian: Taltz se primjenjuje injekcijom pod kožu (supkutanom injekcijom).
English: The percentage of patients with no radiographic joint damage progression from randomisation to Week 52 was 90.9% for placebo/Taltz Q4W, 85.6% for Taltz Q4W/Taltz Q4W, and 89.4% for adalimumab/Taltz Q4W.
Croatian: Postotak bolesnika bez radiološke progresije oštećenja zglobova od randomizacije do 52. tjedna bio je 90,0% za placebo/Taltz svaka 4 tjedna, 85,6% za Taltz svaka 4 tjedna/Taltz svaka 4 tjedna te 89,4% za adalimumab/Taltz svaka 4 tjedna.
English: When you dispose of syringes and the sharps container:
Croatian: Pri zbrinjavanju štrcaljki i spremnika za oštre predmete:
English: Over 58.9% and 22.3% of the psoriatic arthritis patients had enthesitis and dactylitis at baseline, respectively.
Croatian: Više od 58,9% bolesnika s psorijatičnim artritisom je na početku ispitivanja imalo entezitis, a više od 22,3% njih daktilitis.
English: - The other ingredients are sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; water for injections.
Croatian: - Drugi sastojci su natrijev citrat, bezvodna citratna kiselina, natrijev klorid, polisorbat 80 i voda za injekcije.
English: The instructions for using the syringe, included with the package leaflet, must be followed carefully.
Croatian: Moraju se pažljivo slijediti upute za uporabu brizgalice, koje su priložene uz uputu o lijeku.
English: 23.4 % of patients had a history of psoriatic arthritis at baseline.
Croatian: Na početku ispitivanja, 23,4% bolesnika imalo je psorijatični artritis u anamnezi.
English: ONLY.
Croatian: Co.
English: • The syringe must not be shaken.
Croatian: • Štrcaljka se ne smije tresti.
English: Efficacy in Non-Responders to Etanercept: For patients identified as an sPGA (0,1) non-responder to etanercept at Week 12 in UNCOVER-2 (N = 200) and who were switched to Taltz 80 mg Q4W after a 4 week washout period, 73 % and 83.5 % of patients were able to achieve sPGA (0,1) and PASI 75, respectively, after 12 weeks of being treated with Taltz.
Croatian: Djelotvornost u bolesnika koji nisu odgovorili na etanercept: Među bolesnicima za koje se utvrdilo da nisu ostvarili odgovor na etanercept prema sPGA rezultatu (0, 1) u 12. tjednu ispitivanja UNCOVER-2 (N = 200) i koji su prebačeni na Taltz u dozi od 80 mg svaka 4 tjedna nakon 4-tjednog razdoblja ispiranja, 73% bolesnika ostvarilo je sPGA odgovor (0, 1), a njih 83,5% odgovor PASI 75 nakon
English: In patients with pre-existing dactylitis or enthesitis, treatment with Taltz Q4W resulted in improvement in dactylitis and enthesitis at Week 24 compared to placebo (resolution: 78% vs. 24%; p<0.001, and 39% vs. 21%; p<0.01, respectively).
Croatian: U bolesnika s od prije postojećim daktilitisom ili entezitisom, liječenje lijekom Taltz svaka 4 tjedna doveo je do poboljšanja daktilitisa i entezitisa u 24. tjednu, u usporedbi s placebom (povlačenje 78% u odnosu na 24%; p<0,001, te 39% u odnosu na 21%; p<0,01).
English: In psoriatic arthritis, two placebo-controlled phase III studies were integrated to evaluate the safety of Taltz in comparison to placebo up to 24 weeks after treatment initiation.
Croatian: Kod psorijatičnog artritisa, objedinjeni su podaci iz dva placebom kontrolirana ispitivanja faze III radi ocjene sigurnosti lijeka Taltz u usporedbi s placebom tijekom razdoblja do 24 tjedna nakon početka liječenja.
English: Abbreviations: ACR 20/50/70 = American College of Rheumatology 20%/50%/70% response rate; ADA = adalimumab; BSA = body surface area; CI = confidence interval; Q4W = Taltz 80 mg every 4 weeks; Q2W = Taltz 80 mg every 2 weeks; N = number of patients in the analysis population; n = number of patients in the specified category; NRI = non-responder imputation; PASI 100 = psoriasis area and severity index 100% improvement; PBO = placebo.
Croatian: Kratice: ACR 20/50/70 = stopa odgovora od 20%/50%/70% prema kriterijima Američkog reumatološkog društva; ADA = adalimumab; BSA = površina tijela (body surface area); CI = interval pouzdanosti; N = broj bolesnika u populaciji uključenoj u analizu; n = broj bolesnika u specificiranoj kategoriji; NRI = eng.
English: Physical function and health-related quality of life In both SPIRIT-P1 and SPIRIT-P2, patients treated with Taltz Q2W (p<0.001) and Q4W (p<0.001) showed significant improvement in physical function compared to patients treated with placebo as assessed by Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24, and maintained at Week 52 in SPIRIT-P1.
Croatian: U oba su ispitivanja (SPIRIT-P1 i SPIRIT P2) bolesnici liječeni lijekom Taltz svaka 2 tjedna (p < 0,001) odnosno svaka 4 tjedna (p < 0,001) ostvarili značajno poboljšanje tjelesne funkcije u odnosu na bolesnike koji su primali placebo, što se ocjenjivalo indeksom onesposobljenosti prema Upitniku za ocjenu zdravstvenog stanja (engl.
English: Twist off the base cap.
Croatian: Odvrnite i skinite zatvarač baze.
English: 1b Gather the supplies for your injection:
Croatian: 1b Prikupite pribor za primjenu injekcije: • 1 vatu natopljenu alkoholom
English: For sPGA (0,1) responders at Week 12 re-randomised to treatment withdrawal (i.e., placebo), the median time to relapse (sPGA ≥ 3) was 164 days in integrated UNCOVER-1 and UNCOVER-2 studies.
Croatian: Među bolesnicima koji su u 12. tjednu ostvarili odgovor prema sPGA rezultatu (0, 1) i kojima je ponovnom randomizacijom dodijeljen prekid liječenja (tj. primjena placeba), medijan vremena do relapsa (sPGA ≥ 3) iznosio je 164 dana prema objedinjenim podacima iz ispitivanja UNCOVER-1 i UNCOVER-2.
English: Infection rates observed in psoriatic arthritis clinical studies were similar to those observed in the plaque psoriasis studies with the exception of the frequencies of the adverse reactions of influenza and conjunctivitis which were common in patients with psoriatic arthritis.
Croatian: Stope infekcija opažene u kliničkim ispitivanjima kod psorijatičng artritisa bile su slične onima opaženima u ispitivanjima kod plak psorijaze, uz izuzetak učestalosti gripe i konjunktivitisa, koji su u bolesnika s psorijatičnim artritisom bile česte nuspojave.
English: - if you have recently had or are due to have a vaccination.
Croatian: - ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove - ako ste nedavno primili ili trebate primiti cjepivo.
English: Read the “Instructions for Use” for the pen carefully before using Taltz.
Croatian: "Upute za uporabu" brizgalice prije nego što primijenite Taltz.