FrancophonIA/ELRC3.0 huggingface dataset:
English: Tremfya is used to treat adults with moderate to severe “plaque psoriasis”, an inflammatory condition affecting the skin and nails.
Croatian: Tremfya se koristi za liječenje odraslih osoba s umjerenom do teškom ‘plak psorijazom' - upalnom bolešću koja zahvaća kožu i nokte.
English: Some side effects are common (may affect up to 1 in 10 people): - headache - joint pain (arthralgia) - diarrhoea - stomach flu (gastroenteritis) - redness at the injection site - hives - fungal infection of the skin, for instance between the toes (e.g., athlete's foot) - herpes simplex infections
Croatian: Neke su nuspojave česte (mogu se javiti u do 1 na 10 osoba): - glavobolja - bol u zglobovima (artralgija) - proljev - želučana viroza (gastroenteritis) - crvenilo na mjestu injiciranja - koprivnjača - gljivična infekcija kože, primjerice između nožnih prstiju (npr. atletsko stopalo) - herpes simpleks
English: You and your doctor should decide if you will breast-feed or use Tremfya.
Croatian: Vi i Vaš liječnik trebate odlučiti hoćete li dojiti ili primjenjivati lijek Tremfya.
English: For detailed instructions on how to use Tremfya, carefully read the ‘Instructions for use' leaflet before use, which is included in the carton.
Croatian: Za detaljne upute o tome kako primjenjivati lijek Tremfya pažljivo pročitajte ‘Upute za uporabu', koje dolaze u pakiranju lijeka.
English: Sign score = 0, n (%)
Croatian: Rezultat za znakove = 0, n (%)
English: Prescribers should consult the Summary of Product Characteristics of the specific vaccine for additional information and guidance on concomitant use of immunosuppressive agents post-vaccination.
Croatian: Liječnici koji propisuju lijek trebaju pročitati Sažetak opisa svojstava lijeka za određeno cjepivo za dodatne informacije i smjernice o istodobnoj primjeni imunosupresivnih lijekova nakon cijepljenja.
English: The solution should be clear, colourless to light yellow, and may contain a few small white or clear particles.
Croatian: Otopina mora biti bistra i bezbojna do svijetložuta, a smije sadržavati nekoliko malih bijelih ili prozirnih čestica.
English: The exact pathway through which guselkumab is metabolized has not been characterized.
Croatian: Točan put kojim se guselkumab metabolizira nije okarakteriziran.
English: Guselkumab was superior to secukinumab as measured by the primary endpoint of PASI 90 response at Week 48 (84.5% versus 70.0%, p < 0.001).
Croatian: Guselkumab je bio superioran naspram sekukinumaba mjereno primarnom mjerom ishoda PASI 90 odgovora u 48. tjednu (84,5% naspram 70,0%, p < 0.001).
English: 1 pre-filled syringe Component of a multipack, cannot be sold separately
Croatian: 1 napunjena brizgalica Sastavnica višestrukog pakiranja, ne može se prodavati pojedinačno
English: Mean half-life (T1/2) of guselkumab was approximately 17 days in healthy subjects and approximately 15 to 18 days in patients with plaque psoriasis across studies.
Croatian: Srednja vrijednost poluvijeka (T1/2) guselkumaba u svim je ispitivanjima iznosila približno 17 dana u zdravih ispitanika te približno 15 do 18 dana u bolesnika s plak psorijazom.
English: Guselkumab could not be detected in breast milk from cynomolgus monkeys as measured at post-natal day 28.
Croatian: Guselkumab nije pronađen u mlijeku ženki makaki majmuna pri mjerenju provedenom 28. dana nakon okota.
English: As a human IgG mAb, guselkumab is expected to be degraded into small peptides and amino acids via catabolic pathways in the same manner as endogenous IgG.
Croatian: Budući da je guselkumab humano IgG monoklonsko protutijelo, očekuje se da će se kataboličkim putovima razgraditi na male peptide i aminokiseline na isti način kao i endogeni IgG.
English: Mean systemic clearance (CL) following a single intravenous administration to healthy subjects ranged from 0.288 to 0.479 L/day across studies.
Croatian: Srednja vrijednost sistemskog klirensa (CL) nakon jedne intravenske primjene zdravim ispitanicima kretala se u rasponu od 0,288 do 0,479 l/dan u svim ispitivanjima.
English: Loss of PASI 90 response was noted as early as 4 weeks after withdrawal of guselkumab treatment with a median time to loss of PASI 90 response of approximately 15 weeks.
Croatian: Gubitak odgovora PASI 90 zabilježen je već 4 tjedna nakon povlačenja terapije guselkumabom, a medijan vremena do gubitka odgovora PASI 90 iznosio je približno 15 tjedana.
English: Check the liquid in the window.
Croatian: Pregledajte tekućinu kroz prozorčić.
English: The immunogenicity of Tremfya was evaluated using a sensitive and drug-tolerant immunoassay.
Croatian: Imunogenost lijeka Tremfya ocjenjivala se osjetljivim imunotestom otpornim na lijek.
English: Inject within 5 minutes of removing the cap.
Croatian: Injicirajte lijek unutar 5 minuta nakon skidanja zatvarača.
English: Guselkumab demonstrated superiority compared to adalimumab for scalp and hand and foot psoriasis at Week 24 (VOYAGE 1 and 2) and Week 48 (VOYAGE 1) (p ≤ 0.001, except for hand and foot psoriasis at Week 24 [VOYAGE 2] and Week 48 [VOYAGE 1], p < 0.05).
Croatian: Guselkumab se pokazao superiornim adalimumabu kod psorijaze vlasišta te šaka i stopala u 24. tjednu (VOYAGE 1 i 2) i 48. tjednu (VOYAGE 1) (p ≤ 0,001, osim za psorijazu šaka i stopala u 24. tjednu [VOYAGE 2] i 48. tjednu [VOYAGE 1], p < 0,05).
English: The effect of guselkumab on human fertility has not been evaluated.
Croatian: Nije se ocjenjivao učinak guselkumaba na plodnost ljudi.
English: In the same phase I study, treatment with guselkumab resulted in improvement of histological measures of psoriasis at Week 12, including reductions in epidermal thickness and T-cell density.
Croatian: U istom je ispitivanju faze I liječenje guselkumabom dovelo do poboljšanja histoloških mjerila psorijaze u 12. tjednu, uključujući smanjenje debljine epiderme i gustoće T-stanica.
English: Following a single 100 mg subcutaneous injection in healthy subjects, guselkumab reached a mean (± SD) maximum serum concentration (Cmax) of 8.09 ± 3.68 mcg/mL by approximately 5.5 days post dose.
Croatian: Nakon jedne supkutane injekcije guselkumaba od 100 mg u zdravih ispitanika, srednja vrijednost (± SD) vršnih serumskih koncentracija (Cmax) guselkumaba od 8,09 ± 3,68 μg/ml postignuta je približno 5,5 dana nakon primjene doze.
English: What you need to know before you use Tremfya
Croatian: Što morate znati prije nego počnete primjenjivati lijek Tremfya
English: Multipack: 2 (2 packs of 1) pre-filled pens
Croatian: Višestruko pakiranje: 2 (2 pakiranja od po 1) napunjene štrcaljke
English: The co-primary endpoints in VOYAGE 1 and 2 were the proportion of patients who achieved an IGA score of cleared or minimal (IGA 0/1) and a PASI 90 response at Week 16 versus placebo (see Table 2).
Croatian: Koprimarne mjere ishoda u ispitivanjima VOYAGE 1 i 2 bile su udio bolesnika koji su postigli IGA rezultat 0/1 (bez bolesti ili minimalna bolest) i odgovor PASI 90 u 16. tjednu u odnosu na placebo (vidjeti Tablicu 2).
English: Concomitant immunosuppressive therapy or phototherapy The safety and efficacy of Tremfya in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Croatian: Nisu se ocjenjivale sigurnost i djelotvornost lijeka Tremfya u kombinaciji s imunosupresivima (uključujući biološke lijekove) ili fototerapijom.
English: Some cases occurred several days after treatment with guselkumab, including cases with urticaria and dyspnoea.
Croatian: Neki su slučajevi nastupili više dana nakon liječenja guselkumabom, uključujući slučajeve praćene urtikarijom i dispnejom.
English: Figure 3: Percent of Subjects Who Achieved an IGA Score of Cleared (0) or Minimal (1) and at least a 2-grade improvement in IGA from Week 0 Through Week 24 by Visit After Randomisation in NAVIGATE
Croatian: Slika 3: Postotak ispitanika koji su postigli IGA rezultat 0 (‘bez bolesti') ili 1 (‘minimalna bolest') te poboljšanje IGA rezultata za najmanje 2 stupnja od 0. tjedna do 24. tjedna po posjetu nakon randomizacije u ispitivanju NAVIGATE
English: Each Tremfya pack is provided with an ‘Instructions for use' leaflet that fully describes the preparation and administration of the pre-filled syringe or pre-filled pen.
Croatian: U svakoj kutiji lijeka Tremfya nalaze se ‘Upute za uporabu', u kojima se detaljno opisuje postupak pripreme i primjene lijeka napunjenom štrcaljkom ili napunjenom brizgalicom.
English: Instructions for use Tremfya
Croatian: Upute za uporabu lijeka Tremfya
English: Name and address of the manufacturer responsible for batch release Janssen Biologics B.V.
Croatian: Naziv(i) i adresa(e) proizvođača odgovornog(ih) za puštanje serije lijeka u promet Janssen Biologics B.V.
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment.
Croatian: U bolesnika koji ne ostvare odgovor nakon 16 tjedana liječenja treba razmotriti prekid liječenja.
English: Includes only subjects achieving ≥ 2-grade improvement from baseline in ss-IGA and/or hf-PGA.
Croatian: Uključuje samo ispitanike koji su ostvarili poboljšanje početnog ss-IGA i/ili hf-PGA rezultata za ≥ 2 stupnja.
English: The NAVIGATE study examined the efficacy of guselkumab in patients who had an inadequate response (ie, who had not achieved a ‘cleared' or ‘minimal' response defined as IGA ≥ 2) to ustekinumab at Week 16.
Croatian: U ispitivanju NAVIGATE ocjenjivala se djelotvornost guselkumaba u bolesnika s nedovoljno dobrim odgovorom na ustekinumab u 16. tjednu (tj. bolesnika koji nisu ostvarili odgovor ‘bez bolesti' ili ‘minimalna bolest', definiran IGA rezultatom ≥ 2).
English: Number of patients (%) Guselkumab (N=534)
Croatian: Broj bolesnika (%) Guselkumab (N=534)
English: The absolute bioavailability of guselkumab following a single 100 mg subcutaneous injection was estimated to be approximately 49% in healthy subjects.
Croatian: Procijenjena apsolutna bioraspoloživost guselkumaba nakon jedne supkutane injekcije doze od 100 mg u zdravih ispitanika iznosila je približno 49%.
English: Week 16
Croatian: 16. tjedan
English: Please read these Instructions for use before using the Tremfya pre-filled pen and each time you get a new pre-filled pen.
Croatian: Pročitajte ove ‘Upute za uporabu' prije nego što upotrijebite Tremfya napunjenu brizgalicu i svaki put kad dobijete novu napunjenu brizgalicu.
English: PASI 100 1 (0.6) IGA 0/1
Croatian: IGA 0/1 12 (6,9) IGA 0
English: Efficacy and safety of guselkumab were also investigated in a double-blind study compared to secukinumab.
Croatian: Djelotvornost i sigurnost guselkumaba u usporedbi sa sekukinumabom također su ispitivane u dvostruko slijepom ispitivanju.
English: Prior to initiating therapy with Tremfya, completion of all appropriate immunisations should be considered according to current immunisation guidelines.
Croatian: Prije početka liječenja lijekom Tremfya potrebno je razmotriti primjenu svih potrebnih cjepiva u skladu s važećim smjernicama za cijepljenje.
English: Serious side effects Tell your doctor or seek medical help immediately if you get any of the following side effects:
Croatian: Odmah se obratite svom liječniku ili potražite liječničku pomoć ako se pojavi bilo koja od sljedećih nuspojava:
English: Guselkumab is a fully human immunoglobulin G1 lamda (IgG1λ) monoclonal antibody (mAb) to the interleukin (IL)-23 protein, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
Croatian: Guselkumab je potpuno humano imunoglobulinsko G1 lambda (IgG1λ) monoklonsko protutijelo na protein interleukin 23 (IL-23), proizvedeno u stanicama jajnika kineskog hrčka tehnologijom rekombinantne DNK.
English: comparisons between guselkumab and adalimumab were not performed.
Croatian: Nisu provedene usporedbe guselkumaba i adalimumaba.
English: The efficacy and safety of guselkumab was demonstrated regardless of age, gender, race, body weight, plaques location, PASI baseline severity, concurrent psoriatic arthritis, and previous treatment with a biologic therapy.
Croatian: Djelotvornost i sigurnost guselkumaba dokazana je neovisno o dobi, spolu, rasi, tjelesnoj težini, lokaciji lezija, početnoj težini bolesti prema PASI rezultatu, istodobnom psorijatičnom artritisu i prethodnom liječenju biološkom terapijom.
English: In VOYAGE 1, for patients receiving continuous guselkumab treatment, these improvements were maintained in the open-label phase through Week 156 (Table 5).
Croatian: U bolesnika koji su kontinuirano primali guselkumab u ispitivanju VOYAGE 1, ova poboljšanja održana su u otvorenom dijelu ispitivanja do 156. tjedna (Tablica 5).
English: If you stop using Tremfya
Croatian: Ako prestanete primjenjivati lijek Tremfya
English: Differences in response rates between guselkumab and ustekinumab treated patients were noted as early as 4 weeks after randomisation (11.1% and 9.0%, respectively) and reached a maximum 24 weeks after randomisation (see Figure 3).
Croatian: Razlike u stopama odgovora između bolesnika liječenih guselkumabom i onih koji su primali ustekinumab bile su primjetne već 4 tjedna nakon randomizacije (11,1% odnosno 9,0%), a najveće su bile 24 tjedna nakon randomizacije (vidjeti Sliku 3).
English: Guselkumab is a human IgG1λ monoclonal antibody (mAb) that binds selectively to the interleukin 23 (IL-23) protein with high specificity and affinity.
Croatian: Guselkumab je humano IgG1λ monoklonsko protutijelo koje se selektivno vezuje za protein interleukin 23 (IL-23) s velikom specifičnošću i afinitetom.
English: In in vitro models, guselkumab was shown to inhibit the bioactivity of IL-23 by blocking its interaction with cell surface IL-23 receptor, disrupting IL-23-mediated signaling, activation and cytokine cascades.
Croatian: Pokazalo se da u in vitro modelima guselkumab inhibira biološku aktivnost IL-23 blokiranjem njegove interakcije s receptorom za IL-23 na staničnoj površini, čime ometa signalizaciju, aktivaciju te citokinske kaskade posredovane IL-23.
English: In pooled phase III analyses, approximately 9% of patients treated with Tremfya developed antidrug antibodies in up to 156 weeks of treatment.
Croatian: Prema analizama objedinjenih podataka iz ispitivanja faze III, približno 9% bolesnika liječenih lijekom Tremfya je razvilo protutijela na lijeka u razdoblju do 156-og tjedna liječenja.
English: Serious allergic reactions, which can include symptoms of hives and shortness of breath, have occurred with Tremfya (see “Serious side effects” in section 4).
Croatian: Kod liječenja lijekom Tremfya zabilježene su ozbiljne alergijske reakcije, čiji simptomi mogu uključivati koprivnjaču i nedostatak zraka (pogledajte dio ‘Ozbiljne nuspojave' u dijelu 4.).
English: EU/1/17/1234/003 (2 packs, each containing 1 pre-filled pen)
Croatian: EU/1/17/1234/003 (2 pakiranja od kojih svaki sadrži 1 napunjenu brizgalicu)
English: Signs of infections may include fever or flu like symptoms; muscle aches; cough; shortness of breath; burning when you urinate or urinating more often than usual; blood in your phlegm (mucus); weight loss; diarrhoea or stomach pain; warm, red, or painful skin or sores on your body which are different from your psoriasis.
Croatian: Znakovi infekcija mogu uključivati vrućicu ili simptome nalik gripi, bolove u mišićima, kašalj, nedostatak zraka, žarenje pri mokrenju ili učestalije mokrenje nego inače, krv u iskašljaju (sluzi), gubitak tjelesne težine, proljev ili bol u trbuhu, toplu, crvenu ili bolnu kožu ili ranice na tijelu koje se razlikuju od onih koje uzrokuje psorijaza.
English: Before injection
Croatian: Prije injekcije
English: Do not use Tremfya
Croatian: Nemojte primijeniti lijek Tremfya
English: Guselkumab and secukinumab PASI 90 response rates through Week 48 are presented in Figure 4.
Croatian: Stope PASI 90 odgovora guselkumaba i sekukinumaba do 48. tjedna prikazane su na slici 4.
English: Baseline disease characteristics were consistent with a population of moderate to severe plaque psoriasis with a median BSA of 20%, a median PASI score of 18, and an IGA score of severe for 24% of patients.
Croatian: Značajke bolesti s početka ispitivanja odgovarale su populaciji s umjerenom do teškom plak psorijazom s medijanom BSA od 20%, medijanom PASI rezultata od 18 i IGA rezultatom teška bolest za 24% bolesnika.
English: Please read these Instructions for use before using the Tremfya pre-filled syringe and each time you get a refill.
Croatian: Pročitajte ove ‘Upute za uporabu' prije nego što upotrijebite Tremfya napunjenu štrcaljku i svaki put kad dobijete novo pakiranje lijeka.
English: Do not put needle cover back on, as this may damage the needle.
Croatian: Nemojte vraćati pokrov na iglu jer biste je mogli oštetiti.
English: Position fingers and insert needle
Croatian: Namjestite prste i ubodite iglu
English: EU/1/17/1234/004 (2 packs, each containing 1 pre-filled syringe)
Croatian: EU/1/17/1234/004 (2 pakiranja od kojih svako sadrži 1 napunjenu štrcaljku)
English: • Back of upper arms (if a caregiver is giving you the injection) Do not inject into skin that is tender, bruised, red, scaly or hard.
Croatian: • stražnja strana nadlaktica (ako Vam injekciju daje njegovatelj) Nemojte injicirati lijek u kožu koja je osjetljiva na dodir, prekrivena modricama, crvena, koja se ljušti ili je tvrda.
English: Some side effects are uncommon (may affect up to 1 in 100 people): - pain at the injection site - allergic reaction - skin rash
Croatian: Neke su nuspojave manje česte (mogu se javiti u do 1 na 100 osoba): - bol na mjestu injiciranja - alergijska reakcija
English: PASI Response Rates in ECLIPSE
Croatian: Tablica 6: PASI stope odgovora u ispitivanju ECLIPSE
English: The mean (± SD) steady-state trough serum guselkumab concentrations in two phase III studies were 1.15 ± 0.73 mcg/mL and 1.23 ± 0.84 mcg/mL.
Croatian: Srednja vrijednost (± SD) najnižih serumskih koncentracija guselkumaba u stanju dinamičke ravnoteže u dvama ispitivanjima faze III iznosila je 1,15 ± 0,73 μg/ml odnosno 1,23 ± 0,84 μg/ml.
English: In a phase I study, treatment with guselkumab resulted in reduced expression of IL-23/Th17 pathway genes and psoriasis-associated gene expression profiles, as shown by analyses of mRNA obtained from lesional skin biopsies of patients with plaque psoriasis at Week 12 compared to baseline.
Croatian: U jednom je ispitivanju faze I liječenje guselkumabom smanjilo ekspresiju gena za signalizaciju putem IL-23/Th17 i profile genske ekspresije povezane s psorijazom, što su pokazale analize mRNK iz biopsijskih uzoraka kožnih lezija bolesnika s plak psorijazom uzetih u 12. tjednu u odnosu na one uzete na početku ispitivanja.
English: Secukinumab (N=514)
Croatian: Sekukinumab (N=514)
English: For additional assistance or to share your feedback refer to the Package Leaflet for your local representative contact information.
Croatian: Ako Vam treba dodatna pomoć ili želite dati povratne informacije, potražite kontaktne podatke lokalnog predstavnika u Uputi o lijeku.
English: Needle retracts into the body
Croatian: Igla se povlači u tijelo štrcaljke
English: Between 12 and 24 weeks after randomisation, guselkumab patients achieved an IGA score 0/1 with ≥ 2 grade improvement twice as often as ustekinumab patients (mean 1.5 vs 0.7 visits, respectively, p < 0.001).
Croatian: Između 12. i 24. tjedna nakon randomizacije bolesnici liječeni guselkumabom postizali su IGA rezultat 0/1 uz poboljšanje za ≥ 2 stupnja dvostruko češće nego bolesnici liječeni ustekinumabom (srednja vrijednost: 1,5 naspram 0,7 posjeta; p < 0,001).
English: At Week 16, 268 patients with an IGA ≥ 2 score were randomised to either continue ustekinumab treatment (N=133) q12w, or to initiate guselkumab treatment (N=135) at Weeks 16, 20, and q8w thereafter.
Croatian: U 16. tjednu, 268 bolesnika s IGA rezultatom ≥ 2 bilo je randomizirano za nastavak liječenja ustekinumabom (N=133) svakih 12 tjedana ili za početak liječenja guselkumabom (N=135), s primjenom u 16. i 20. tjednu, a zatim svakih 8 tjedana nakon toga.
English: If your doctor decides that you or a caregiver may be able to give your injections of Tremfya at home, you should receive training on the right way to prepare and inject Tremfya using the pre-filled pen.
Croatian: Ako Vaš liječnik odluči da Vi ili Vaš njegovatelj možete primjenjivati injekcije lijeka Tremfya kod kuće, morate proći obuku o tome kako pravilno pripremiti i injicirati lijek Tremfya napunjenom brizgalicom.
English: Tremfya should not be used if the solution is cloudy or discoloured, or contains large particles.
Croatian: Tremfya se ne smije primijeniti ako je otopina mutna, ako je promijenila boju ili ako sadrži velike čestice.
English: The systemic exposure of guselkumab (Cmax and AUC) increased in an approximately dose-proportional manner following a single subcutaneous injection at doses ranging from 10 mg to 300 mg in healthy subjects or patients with plaque psoriasis.
Croatian: Sistemska izloženost guselkumabu (Cmax i AUC) nakon jedne supkutane injekcije doza u rasponu od 10 mg do 300 mg u zdravih ispitanika ili bolesnika s plak psorijazom povećavala se približno proporcionalno dozi.
English: These results are consistent with the clinical benefit observed with guselkumab treatment in plaque psoriasis.
Croatian: Ti su rezultati u skladu s kliničkom korišću primijećenom kod liječenja plak psorijaze guselkumabom.
English: Guselkumab exerts clinical effects in plaque psoriasis through blockade of the IL-23 cytokine pathway.
Croatian: Guselkumab svoje kliničke učinke kod plak psorijaze ostvaruje blokadom signalnog puta citokina IL-23.
English: The percentage of patients achieving a PASI 90 response was numerically higher for guselkumab than adalimumab starting at Week 8 with the difference reaching a maximum around Week 20 (VOYAGE 1 and 2) and maintained through Week 48 (VOYAGE 1) (see Figure 1).
Croatian: Postotak bolesnika koji su postigli odgovor PASI 90 bio je brojčano veći uz guselkumab nego uz adalimumab počevši od 8. tjedna, a razlika je bila najveća oko 20. tjedna (VOYAGE 1 i 2) i održala se do 48. tjedna (VOYAGE 1) (vidjeti sliku 1).
English: Driving and using machines Tremfya is unlikely to influence your ability to drive and use machines.
Croatian: Nije vjerojatno da će lijek Tremfya utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
English: For patients randomised to adalimumab at Week 0 who crossed over to guselkumab at Week 52, the PASI 90 response rate increased from Week 52 through Week 76 and was then maintained through Week 156 (see Figure 2).
Croatian: Kod bolesnika randomiziranih za primanje adalimumaba u 0. tjednu, koji su prešli na guselkumab u 52. tjednu, stopa PASI 90 odgovora se povećala od 52. do 76. tjedna i održana je do 156. tjedna (vidjeti sliku 2).
English: At the start, your doctor or nurse will inject Tremfya.
Croatian: Na početku će Vam lijek Tremfya injicirati Vaš liječnik ili medicinska sestra.
English: Do not use the pre-filled pen if it is dropped after removing the cap.
Croatian: Nemojte upotrijebiti napunjenu brizgalicu ako je pala nakon skidanja zatvarača.
English: In two phase III clinical studies through Week 48, 0.7% of Tremfya injections and 0.3% of placebo injections were associated with injection site reactions.
Croatian: U dvama kliničkim ispitivanjima faze III reakcije na mjestu injiciranja su se tijekom 48 tjedana javile kod 0,7% injekcija lijeka Tremfya i 0,3% injekcija placeba.
English: Symptom score = 0, n (%) PSSD Sign score, subjects with baseline score > 0
Croatian: Rezultat za simptome = 0, n (%) PSSD rezultat za znakove, ispitanici s početnim rezultatom > 0
English: CARTON FOR 1 PRE-FILLED SYRINGE (100 mg) AS INTERMEDIATE PACK / COMPONENT OF A MULTIPACK (WITHOUT BLUE BOX)
Croatian: KUTIJA ZA 1 NAPUNJENU ŠTRCALJKU (100 mg) KAO INTERMEDIJERNO PAKIRANJE / SASTAVNICA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA)
English: Put your used syringe in a sharps disposal container right away after use.
Croatian: Odložite upotrijebljenu štrcaljku u spremnik za odlaganje oštrih predmeta odmah nakon uporabe.
English: Remove needle cover
Croatian: Skinite pokrov igle
English: Prior to initiating treatment with Tremfya, patients should be evaluated for tuberculosis (TB) infection.
Croatian: Prije uvođenja lijeka Tremfya potrebno je utvrditi imaju li bolesnici tuberkulozu.