FrancophonIA/ELRC3.0 huggingface dataset:
English: In VOYAGE 2, 88.6% of patients receiving guselkumab maintenance treatment at Week 48 were PASI 90 responders compared to 36.8% of patients who were withdrawn from treatment at Week 28 (p < 0.001).
Croatian: U 48. tjednu ispitivanja VOYAGE 2 odgovor PASI 90 postiglo je 88,6% bolesnika koji su primali guselkumab kao terapiju održavanja, u usporedbi s 36,8% onih kojima je terapija povučena u 28. tjednu (p < 0,001).
English: Patients were randomised to receive guselkumab (N=534; 100 mg at Week 0, 4 and q8w thereafter), or secukinumab (N=514; 300 mg at Week 0, 1, 2, 3, 4, and q4w thereafter).
Croatian: Bolesnici su randomizirani za primanje guselkumaba (N=534; 100 mg u 0. i 4. tjednu te zatim svakih 8 tjedana nakon toga) ili sekukinumaba (N=514; 300 mg u 0., 1., 2., 3., i 4. tjednu i nakon toga svaka 4 tjedna).
English: Summary of Regional Disease Responses in VOYAGE 1 and VOYAGE 2 VOYAGE 1
Croatian: Tablica 3: Sažetak rezultata za odgovore regionalne bolesti u ispitivanjima VOYAGE 1 i VOYAGE 2
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.
Croatian: Dodatno, među 95 bolesnika randomiziranih za primanje guselkumaba koji nisu uspjeli postići odgovor PASI 90 u 28. tjednu, 36% je postiglo PASI 90 odgovor uz dodatnih 20 tjedana nastavka liječenja guselkumabom, a 41% je postiglo PASI 90 odgovor uz dodatna 44 tjedana nastavka liječenja guselkumabom.
English: SINGLE-USE DEVICE
Croatian: ZA JEDNOKRATNU UPORABU
English: Major Secondary Endpoints PASI 75 response at both Week 12 and Week 48
Croatian: Primarna mjera ishoda PASI 90 odgovor u 48. tjednu Glavne sekundarne mjere ishoda PASI 75 odgovor u 12. tjednu i 48. tjednu
English: Of the patients who developed antidrug antibodies, approximately 7% had antibodies that were classified as neutralizing, which equates to 0.4% of all patients treated with Tremfya.
Croatian: Među bolesnicima u kojih su se razvila protutijela na lijek, njih približno 7% (što čini 0,4% svih bolesnika liječenih lijekom Tremfya) imalo je protutijela koja su klasificirana kao neutralizirajuća.
English: Excipients: sucrose, histidine, histidine monohydrochloride monohydrate, polysorbate 80, water for injections.
Croatian: Pomoćne tvari: saharoza, histidin, histidinklorid hidrat, polisorbat 80, voda za injekcije.
English: CARTON FOR 1 PRE-FILLED PEN (100 mg) AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Croatian: KUTIJA ZA 1 NAPUNJENU BRIZGALICU (100 mg) KAO INTERMEDIJERNO PAKIRANJE / SASTAVNICA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: Figure 2: Percent of Subjects Who Achieved a PASI 90 Response by Visit in the Open-Label Phase in VOYAGE 1
Croatian: Slika 2: Postotak ispitanika koji su postigli odgovor PASI 90 po posjetu u otvorenom dijelu ispitivanja VOYAGE 1
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: • The dose is 100 mg (the content of 1 pre-filled pen) given by injection under the skin
Croatian: • Doza je 100 mg (sadržaj 1 napunjene brizgalice), a daje se injekcijom pod kožu (supkutanom injekcijom).
English: Figure 4: Percent of Subjects Who Achieved a PASI 90 Response Through Week 48 by Visit (Subjects Randomised at Week 0) in ECLIPSE
Croatian: Slika 4: Postotak ispitanika koji su postigli PASI 90 odgovor do 48. tjedna prikazano po posjetu (ispitanici randomizirani u 0. tjednu) u ispitivanju ECLIPSE
English: Remove carton with the pre-filled syringe from the refrigerator.
Croatian: Izvadite kutiju s napunjenom štrcaljkom iz hladnjaka.
English: Check the expiration date (‘EXP') on the back panel of the carton.
Croatian: Provjerite rok valjanosti (‘Rok valjanosti') na stražnjoj strani kutije.
English: Do not use this medicine if you notice that the medicine is cloudy or discoloured, or contains large particles.
Croatian: Nemojte primijeniti lijek ako primijetite da je mutan, da je promijenio boju ili da sadrži velike čestice.
English: • 1 Cotton ball or gauze pad
Croatian: • 1 komad pamučne vate ili gaze
English: Guselkumab was efficacious in conventional systemic-naive, biologic-naive, and biologic-exposed patients.
Croatian: Guselkumab je bio djelotvoran u bolesnika koji prethodno nisu primali konvencionalnu sistemsku terapiju, onih koji prethodno nisu primali biološku terapiju i bolesnika prethodno izloženih biološkim lijekovima.
English: Tremfya is a clear, colourless to light yellow solution.
Croatian: Tremfya je bistra te bezbojna do svijetložuta otopina.
English: Choose injection site
Croatian: Odaberite mjesto za injiciranje
English: Check injection site
Croatian: Provjerite mjesto injiciranja
English: Do not hold or pull plunger at any time.
Croatian: Nemojte ni u jednom trenutku držati štrcaljku za klip niti povlačiti klip.
English: • The dose is 100 mg (the content of 1 pre-filled syringe) given by injection under the skin
Croatian: • Doza je 100 mg (sadržaj 1 napunjene štrcaljke), a daje se injekcijom pod kožu (supkutanom injekcijom).
English: It is normal to see a drop of liquid.
Croatian: Kapljica tekućine normalna je pojava.
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.
Croatian: U ispitivanju VOYAGE 2, od 112 bolesnika randomiziranih za primanje adalimumaba koji nisu uspjeli postići odgovor PASI 90 u 28. tjednu, njih 66% postiglo je odgovor PASI 90 nakon 20 tjedana liječenja guselkumabom, a njih 76% postiglo je odgovor PASI 90 nakon 44 tjedana liječenja guselkumabom.
English: Do not use the 5-centimetre area around your belly-button.
Croatian: Nemojte injicirati lijek unutar područja 5 cm oko pupka.
English: Throw the used pre-filled syringe away
Croatian: Bacite upotrijebljenu štrcaljku
English: In repeat-dose toxicity studies in cynomolgus monkeys, guselkumab was well tolerated via intravenous and subcutaneous routes of administration.
Croatian: U ispitivanjima toksičnosti ponovljenih doza na makaki majmunima guselkumab se dobro podnosio i nakon intravenske i nakon supkutane primjene.
English: Put your used pre-filled pen in a sharps disposal container right away after use.
Croatian: Odložite upotrijebljenu napunjenu brizgalicu u spremnik za odlaganje oštrih predmeta odmah nakon uporabe.
English: Twist and pull off bottom cap
Croatian: Zavrnite i skinite donji zatvarač
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.
Croatian: U bolesnika u kojih je prekinuta primjena guselkumaba, ponovno je započeta primjena guselkumaba (primili su dozu kod ponovnog započinjanja liječenja, 4 tjedna nakon toga, a zatim svakih 8 tjedana nakon toga) nakon najmanje 50%-tnog gubitka njihovog PASI poboljšanja iz 28. tjedna.
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.
Croatian: Ako Vaš liječnik odluči da Vi ili Vaš njegovatelj možete primjenjivati injekcije lijeka Tremfya kod kuće, prije nego što pokušate injicirati lijek morate proći obuku o tome kako pravilno pripremiti i injicirati lijek Tremfya napunjenom štrcaljkom.
English: Remove carton with the pre-filled pen from the refrigerator.
Croatian: Izvadite kutiju s napunjenom brizgalicom iz hladnjaka.
English: Serious hypersensitivity reactions have been reported in the post-marketing setting.
Croatian: Nakon stavljanja lijeka u promet prijavljene su ozbiljne reakcije preosjetljivosti.
English: If any of these side effects becomes severe, tell your doctor, pharmacist or nurse immediately.
Croatian: Ako bilo koja od njih postane teška, odmah o tome obavijestite svog liječnika, ljekarnika ili medicinsku sestru.
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.
Croatian: Prema analizama objedinjenih podataka iz ispitivanja faze II i faze III, protutijela na lijek su se tijekom najviše 52 tjedna liječenja razvila u manje od 6% bolesnika liječenih lijekom Tremfya.
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).
Croatian: U oba su ispitivanja (VOYAGE 1 i 2) u 16. tjednu opažena značajno veća poboljšanja kvalitete života vezane uz zdravlje, mjerene indeksom kvalitete života kod dermatoloških bolesti (DLQI), te simptoma (svrbež, bol, žarenje, peckanje i zatezanje kože) i znakova psorijaze (suhoća, pucanje, ljuskanje, ljuštenje ili perutanje, crvenilo i krvarenje kože) koje su prijavili bolesnici, mjerenih temeljem unosa u dnevnik simptoma i znakova psorijaze (engl.
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).
Croatian: Bolesnici randomizirani za liječenje adalimumabom (N=582) primili su 80 mg u 0. tjednu i 40 mg u 1. tjednu, a zatim 40 mg svaki drugi tjedan do 48. tjedna (VOYAGE 1) odnosno 23. tjedna (VOYAGE 2).
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.
Croatian: Tremfya 100 mg otopina za injekciju u napunjenoj štrcaljki 1 ml otopine u napunjenoj staklenoj štrcaljki s pričvršćenom iglom i zaštitnim pokrovom igle u automatskom štitniku za iglu.
English: If you are uncertain, call your doctor or pharmacist for a refill.
Croatian: Ako niste sigurni, nazovite svog liječnika ili ljekarnika za novi recept.
English: In addition, reduced serum IL-17A, IL-17F and IL-22 levels compared to placebo were observed in guselkumab treated patients in phase II and phase III studies.
Croatian: Osim toga, u ispitivanjima faze II i faze III primijećene su i smanjene serumske vrijednosti IL-17A, IL-17F i IL-22 u bolesnika liječenih guselkumabom u odnosu na one koji su primali placebo.
English: CARTON FOR PRE-FILLED SYRINGE MULTIPACK COMPRISING 2 PACKS (INCLUDING BLUE BOX)
Croatian: KUTIJA ZA VIŠESTRUKO PAKIRANJE NAPUNJENE ŠTRCALJKE KOJE SE SASTOJI OD 2 PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: Musculoskeletal and connective tissue disorders
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva često artralgija
English: Check the expiration date (‘EXP') on the carton.
Croatian: Provjerite rok valjanosti (‘Rok valjanosti') na kutiji.
English: Includes only subjects with ss-IGA, f-PGA, hf-PGA score ≥ 2 at baseline or baseline NAPSI score > 0.
Croatian: Uključuje samo ispitanike koji su na početku ispitivanja imali ss-IGA, f-PGA ili hf-PGA rezultat ≥ 2 ili NAPSI rezultat > 0.
English: Among patients who were withdrawn from treatment and subsequently re-initiated guselkumab, 80% regained a PASI 90 response when assessed 20 weeks after initiation of retreatment.
Croatian: U bolesnika kod kojih je primjena guselkumaba prekinuta pa nakon toga ponovno započeta, prema ocjeni 20 tjedana nakon ponovnog početka liječenja, 80% bolesnika ponovno je postiglo PASI 90 odgovor.
English: DLQI score > 1 at baseline, n Subjects with DLQI 0/1
Croatian: DLQI rezultat > 1 na početku liječenja, n Ispitanici s DLQI 0/1
English: Call your doctor or pharmacist for a refill.
Croatian: Nazovite svog liječnika ili ljekarnika za novi recept.
English: Change from baseline, mean (standard deviation)
Croatian: Promjena od početne vrijednosti, srednja vrijednost (standardno odstupanje) 16. tjedan
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.
Croatian: Osim toga, tijekom ispitivanja toksičnosti ponovljenih doza i ciljanog farmakološkog ispitivanja sigurnosti za kardiovaskularni sustav provedenog na makaki majmunima nisu primijećeni štetni imunotoksični ni kardiovaskularni učinci.
English: In VOYAGE 1, all patients, including those randomised to adalimumab at Week 0, started to receive open-label guselkumab q8w at Week 52.
Croatian: Svi bolesnici, uključujući one randomizirane za primanje adalimumaba u 0. tjednu ispitivanja VOYAGE 1, počeli su u 52. tjednu primati guselkumab svakih 8. tjedana u otvorenom ispitivanju.
English: Summary of Patient Reported Outcomes at Week 16 in VOYAGE 1 and VOYAGE 2 VOYAGE 1
Croatian: Tablica 4: Sažetak rezultata za ishode koje su prijavili bolesnici u 16. tjednu u ispitivanjima VOYAGE 1 i VOYAGE 2
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
Croatian: Osim toga, u 12. tjednu nakon randomizacije veći je udio bolesnika liječenih guselkumabom nego onih koji su primali ustekinumab postigao IGA rezultat 0/1 i poboljšanje za ≥ 2 stupnja (31,1% naspram 14,3%; p = 0,001) te odgovor PASI 90 (48% naspram 23%, p < 0,001).
English: CARTON FOR PRE-FILLED PEN MULTIPACK COMPRISING 2 PACKS (INCLUDING BLUE BOX)
Croatian: KUTIJA ZA VIŠESTRUKO PAKIRANJE NAPUNJENE BRIZGALICE KOJE SE SASTOJI OD 2 PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)
English: p < 0.001 for superiority p < 0.001 for non-inferiority, p=0.062 for superiority formal statistical testing was not performed
Croatian: PASI 75 odgovor u 12. tjednu PASI 90 odgovor u 12. tjednu PASI 100 odgovor u 48. tjednu p < 0.001 za superiornost p < 0.001 za neinferiornost, p=0.062 for superiornost službeno statističko testiranje nije provedeno
English: Do not inject if the liquid is cloudy or discoloured, or has large particles.
Croatian: Nemojte injicirati lijek ako je tekućina mutna, ako je promijenila boju ili ako sadrži velike čestice.
English: Call your doctor or pharmacist for a new pre-filled pen.
Croatian: Nazovite svog liječnika ili ljekarnika za novu napunjenu brizgalicu.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKE(IH) DJELATNE(IH) TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: How much Tremfya is given and for how long Your doctor will decide for how long you need to use Tremfya.
Croatian: Vaš će liječnik odlučiti koliko dugo trebate primjenjivati lijek Tremfya.
English: In both studies, patients randomised to placebo (N=422) received guselkumab 100 mg at Weeks 16, 20 and q8w thereafter.
Croatian: U oba su ispitivanja bolesnici randomizirani za primanje placeba (N=422) primili 100 mg guselkumaba u 16. i 20. tjednu, a zatim svakih 8 tjedana nakon toga.
English: p < 0.001 for comparison between guselkumab and adalimumab.
Croatian: p < 0,001 za usporedbu guselkumaba i adalimumaba.
English: In VOYAGE 2, guselkumab patients had significantly greater improvement from baseline compared to placebo in health-related quality of life, anxiety and depression, and work limitation measures at Week 16, as measured by the 36-item Short Form (SF-36) health survey questionnaire, Hospital Anxiety and Depression Scale (HADS), and Work Limitations Questionnaire (WLQ), respectively.
Croatian: U ispitivanju VOYAGE 2, bolesnici liječeni guselkumabom ostvarili su, u usporedbi s placebom, značajno veće poboljšanje rezultata za kvalitetu života vezanu uz zdravlje, tjeskobu i depresiju te mjerila ograničenja pri radu od početka ispitivanja do 16. tjedna, što se mjerilo kratkim upitnikom o zdravstvenom stanju od 36 pitanja (engl.
English: Skin and subcutaneous tissue disorders Common
Croatian: Poremećaji kože i potkožnog tkiva često urtikarija manje često osip
English: Do not shake the pre-filled syringe at any time.
Croatian: Nemojte ni u jednom trenutku tresti napunjenu brizgalicu.
English: Medication injects as you push.
Croatian: Pritisnite držač ravno prema dolje Lijek se injicira dok Vi pritišćete.
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
Croatian: Slika 1: Postotak ispitanika koji su postigli odgovor PASI 90 do 48. tjedna po posjetu (ispitanici randomizirani u 0. tjednu) u ispitivanju VOYAGE 1
English: If you are uncertain, call your doctor or pharmacist for a new pre-filled pen.
Croatian: Ako niste sigurni, nazovite svog liječnika ili ljekarnika za novu napunjenu brizgalicu.
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).
Croatian: Psoriasis Area and Severity Index, PASI) bili su ponovno randomizirani za nastavak liječenja guselkumabom svakih 8 tjedana (terapija održavanja) ili za primanje placeba (povlačenje terapije).
English: In VOYAGE 1, for patients receiving continuous guselkumab treatment, the PASI 90 response rate was maintained from Week 52 through Week 156.
Croatian: Kod bolesnika koji su kontinuirano primali guselkumab u ispitivanju VOYAGE 1, stopa PASI 90 odgovora održana je od 52. do 156. tjedna.
English: Patients randomised to adalimumab at Week 0 who were PASI 90 non-responders received guselkumab at Weeks 28, 32 and q8w thereafter.
Croatian: Bolesnici randomizirani za primanje adalimumaba u 0. tjednu koji nisu ostvarili odgovor PASI 90, primili su guselkumab u 28., 32. tjednu, a zatim svakih 8 tjedana nakon toga.
English: Place on skin
Croatian: Stavite je na kožu
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).
Croatian: Bolesnici randomizirani za liječenje guselkumabom (N=825) primili su 100 mg u 0. i 4. tjednu, a zatim svakih 8 tjedana do 48. tjedna (VOYAGE 1) odnosno 20. tjedna (VOYAGE 2).
English: Bottom Cap
Croatian: Donji zatvarač
English: Single intravenous doses of guselkumab up to 987 mg (10 mg/kg) have been administered in healthy volunteers and single subcutaneous doses of guselkumab up to 300 mg have been administered in patients with plaque psoriasis in clinical studies without dose-limiting toxicity.
Croatian: (10 mg/kg) u zdravih dobrovoljaca te jednokratne supkutane doze guselkumaba do 300 mg u bolesnika s plak psorijazom, bez znakova toksičnosti koja bi ograničila dozu.
English: The solution is clear and colourless to light yellow.
Croatian: Otopina je bistra te bezbojna do svijetložuta.
English: Tremfya 100 mg solution for injection in pre-filled pen 1 mL solution in a pre-filled glass syringe assembled in a pre-filled pen with an automatic needle guard.
Croatian: Tremfya 100 mg otopina za injekciju u napunjenoj brizgalici 1 ml otopine u napunjenoj staklenoj štrcaljki uklopljenoj u napunjenu brizgalicu s automatskimm štitnikom za iglu.
English: Keep the pre-filled syringe or pre-filled pen in the outer carton in order to protect from light.
Croatian: Napunjenu štrcaljku ili napunjenu brizgalicu čuvati u vanjskom pakiranju radi zaštite od svjetlosti.
English: Do not touch, fan or blow on the injection site after you have cleaned it.
Croatian: Nakon što očistite mjesto injiciranja, nemojte ga dodirivati, sušiti fenom ili puhati po njemu.
English: What Tremfya looks like and contents of the pack Solution for injection (injection).
Croatian: Kako Tremfya izgleda i sadržaj pakiranja
English: It is unknown whether guselkumab is excreted in human milk.
Croatian: Nije poznato izlučuje li se guselkumab u majčino mlijeko.
English: After removing the pre-filled syringe or pre-filled pen from the refrigerator, keep the pre-filled syringe or pre-filled pen inside the carton and allow to reach room temperature by waiting for 30 minutes before injecting Tremfya.
Croatian: Nakon vađenja iz hladnjaka napunjenu štrcaljku ili napunjenu brizgalicu treba ostaviti u kutiji i pričekati 30 minuta da se ugrije na sobnu temperaturu prije nego što se Tremfya injicira.
English: Take the pre-filled syringe out of the carton.
Croatian: Izvadite napunjenu štrcaljku iz kutije.
English: - The other ingredients are histidine, histidine monohydrochloride monohydrate, polysorbate 80,
Croatian: - Drugi sastojci su histidin, histidinklorid hidrat, polisorbat 80, saharoza i voda za injekcije.
English: p < 0.001 for comparison between guselkumab and placebo.
Croatian: p < 0,001 za usporedbu guselkumaba i placeba.
English: Tremfya is available in a pack containing one pre-filled syringe and in a multipack containing 2 (2 packs of 1) pre-filled syringes.
Croatian: Tremfya dolazi u pakiranju koje sadrži jednu napunjenu štrcaljku i u višestrukom pakiranju koje sadrži 2 (2 pakiranja od po 1) napunjene štrcaljke.
English: Tremfya is available in a pack containing one pre-filled pen and in a multipack containing 2 (2 packs of 1) pre-filled pens.
Croatian: Tremfya dolazi u pakiranju koje sadrži jednu napunjenu brizgalicu i u višestrukom pakiranju koje sadrži 2 (2 pakiranja od po 1) napunjene brizgalice.
English: Use your free hand to grasp the body of the syringe.
Croatian: Otpustite nabor i promijenite položaj ruke Slobodnom rukom uhvatite tijelo štrcaljke.
English: (subcutaneous injection).
Croatian: Otopina za injekciju (injekcija).
English: PSSD Symptom score, subjects with baseline score > 0
Croatian: PSSD rezultat za simptome, ispitanici s početnim rezultatom > 0
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.
Croatian: Ostavite napunjenu štrcaljku u kutiji i odložite je na ravnu površinu, a zatim pričekajte najmanje 30 minuta da se ugrije na sobnu temperaturu prije nego što je upotrijebite.
English: Renal elimination of intact guselkumab, an IgG mAb, is expected to be low and of minor importance; similarly, hepatic impairment is not expected to influence clearance of guselkumab as IgG mAbs are mainly eliminated via intracellular catabolism.
Croatian: Slično tome, IgG monoklonska protutijela uglavnom se eliminiraju unutarstaničnim katabolizmom, pa se ne očekuje da će oštećenje jetrene funkcije utjecati na klirens guselkumaba.
English: DLQI, subjects with baseline score
Croatian: DLQI, ispitanici s početnim rezultatom
English: Do not inject if perforations on the carton are broken.
Croatian: Nemojte injicirati lijek ako je kutija već otvorena na mjestu gdje se nalaze perforacije.
English: Do not shake your pre-filled pen at any time.
Croatian: Nemojte ni u jednom trenutku tresti napunjenu štrcaljku.
English: Pre-filled syringe
Croatian: - kožni osip
English: How to use Tremfya
Croatian: Kako primjenjivati lijek Tremfya
English: Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.
Croatian: Kada napunite spremnik, obavezno ga zbrinite u skladu s uputama liječnika ili medicinske sestre.
English: Keep pre-filled pen in the carton and let it sit on a flat surface at room temperature for at least 30 minutes before use.
Croatian: Ostavite napunjenu brizgalicu u kutiji i odložite je na ravnu površinu, a zatim pričekajte najmanje 30 minuta da se ugrije na sobnu temperaturu prije nego što je upotrijebite.
English: Push handle straight down
Croatian: Pritisnite klip
English: Inject Tremfya using the pre-filled syringe
Croatian: Injicirajte lijek Tremfya napunjenom štrcaljkom