natgillin/translations-raw huggingface dataset:
The efficacy of guselkumab was evaluated with respect to overall skin disease, regional disease (scalp, hand and foot and nails) and quality of life and patient reported outcomes. 
Djelotvornost guselkumaba ocjenjivala se s obzirom na ukupnu kožnu bolest, regionalnu bolest (vlasište, šake i stopala te nokti) te kvalitetu života i ishode koje su prijavljivali bolesnici.
Store in refrigerator at 2° to 8°C. 
Čuvati u hladnjaku na temperaturi od 2°C do 8°C.
Through Week 156, 0.5% of Tremfya injections were associated with injection site reactions. 
Kroz 156 tjedana, 0,5% injekcija lijeka Tremfya je bilo povezano s reakcijama na mjestu injiciranja.
Adverse reactions of injection site erythema and injection site pain were generally mild to moderate in severity; none were serious, and none led to discontinuation of Tremfya. 
Slučajevi eritema na mjestu injiciranja i boli na mjestu injiciranja bili su uglavnom blage do umjerene težine; nijedan nije bio ozbiljan i nijedan nije doveo do prekida liječenja lijekom Tremfya.
• if you have recently had a vaccination or if you are due to have a vaccination during treatment with Tremfya. 
• ako ste nedavno primili cjepivo ili ako trebate primiti neko cjepivo tijekom liječenja lijekom Tremfya
There were no preneoplastic changes observed in histopathology evaluations of animals treated up to 24-weeks, or following the 12-week recovery period during which drug was detectable in the serum. 
Nisu opažene predneoplastične promjene u histopatološkim ocjenama životinja liječenih do 24 tjedna kao ni nakon 12-tjednog razdoblja oporavka tijekom kojega su razine lijeka bile mjerljive u serumu.
After injection, the needle will retract into the body of the device and lock into place. 
Nakon injekcije igla će se povući u tijelo štrcaljke i ostati zaključana u tom položaju.
Levels of IL-23 are elevated in the skin of patients with plaque psoriasis. 
Razine IL-23 povišene su u koži bolesnika s plak psorijazom.
Please also read the Package Leaflet carefully before starting your injection and discuss any questions you may have with your doctor or nurse. 
Prije nego što započnete s injiciranjem pažljivo pročitajte i Uputu o lijeku te razgovarajte o svim pitanjima koja možda imate sa svojim liječnikom ili medicinskom sestrom.
Other medicines and Tremfya 
Drugi lijekovi i Tremfya
The improvements in SF-36, HADS and WLQ were all maintained through Week 48 and in the open-label phase through Week 156 among patients randomised to maintenance therapy at Week 28. 
Poboljšanja SF-36, HADS i WLQ rezultata održala su se do 48. tjedna i u otvorenom dijelu ispitivanja do 156. tjedna među bolesnicima randomiziranima za primanje terapije održavanja u 28. tjednu.
Table 1: List of adverse reactions System Organ Class 
Tablica 1: Popis nuspojava Organski sustav
Name and address of the manufacturers of the biological active substance Biogen Inc. (BIIB) 
Naziv(i) i adresa(e) proizvođača biološke(ih) djelatne(ih) tvari Biogen Inc. (BIIB)
A weekly subcutaneous dose of 50 mg/kg to monkeys resulted in exposure (AUC) and Cmax values that were at least 49-fold and >200-fold higher, respectively, than those measured in the human clinical PK study. 
Tjedna supkutana primjena doze od 50 mg/kg majmunima dovela je do izloženosti (AUC) i vrijednosti Cmax koje su bile najmanje 49 puta odnosno > 200 puta veće od onih zabilježenih u farmakokinetičkom ispitivanju provedenom u ljudi.
b, n (%) Week 16 21 (14.5) hf-PGA (N) hf-PGA 0/1 
b, n (%) 16. tjedan hf-PGA (N) hf-PGA 0/1
Prior to use, a visual inspection of the pre-filled syringe or pre-filled pen is recommended. 
Prije primjene preporučuje se vizualno pregledati napunjenu štrcaljku ili napunjenu brizgalicu.
Place thumb from the opposite hand on the plunger and press the plunger all the way down until it stops. 
Položite palac suprotne ruke na klip i pritisnite ga sve do kraja, dok se ne zaustavi.
Possible serious allergic reaction - the signs may include: - difficulty breathing or swallowing - swelling of the face, lips, tongue or throat - severe itching of the skin, with a red rash or raised bumps 
Moguća ozbiljna alergijska reakcija - znakovi mogu uključivati: - otežano disanje ili gutanje - oticanje lica, usana, jezika ili grla - jak svrbež kože praćen crvenim osipom ili izdignutim kvržicama
Pre-treatment evaluation for tuberculosis 
Testiranje na tuberkulozu prije liječenja
Hold syringe body below finger flange. 
Uhvatite tijelo štrcaljke ispod rubnika za prste.
If a serious hypersensitivity reaction occurs, administration of Tremfya should be discontinued immediately and appropriate therapy initiated. 
Ako dođe do ozbiljne reakcije preosjetljivosti, treba odmah prekinuti primjenu lijeka Tremfya i uvesti odgovarajuću terapiju.
If a patient develops a clinically important or serious infection or is not responding to standard therapy, the patient should be monitored closely and Tremfya should be discontinued until the infection resolves. 
Ako se kod bolesnika razvije klinički važna ili ozbiljna infekcija ili ako on ne odgovara na standardnu terapiju, treba ga pažljivo nadzirati, a primjenu lijeka Tremfya prekinuti dok se infekcija ne povuče.
Talk to your doctor or nurse if you have any questions about giving yourself an injection. 
Obratite se svom liječniku ili medicinskoj sestri ako imate bilo kakvih pitanja o samoinjiciranju.
Tremfya has no or negligible influence on the ability to drive and use machines. 
Tremfya ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
Before live viral or live bacterial vaccination, treatment with Tremfya should be withheld for at least 12 weeks after the last dose and can be resumed at least 2 weeks after vaccination. 
Prije primjene živih virusnih ili živih bakterijskih cjepiva potrebno je prekinuti liječenje lijekom Tremfya tijekom najmanje 12 tjedana nakon posljednje doze, a primjena se može nastaviti 2 tjedna nakon cijepljenja.
What Tremfya contains - The active substance is guselkumab. 
Što Tremfya sadrži - Djelatna tvar je guselkumab.
In both studies, 21% had received prior biologic therapy, including 11% who had received at least one anti-tumour necrosis factor alpha (TNFα) agent, and approximately 10% who had received an anti-IL-12/IL-23 agent. 
U oba je ispitivanja 21% bolesnika prethodno primalo biološku terapiju, uključujući 11% njih koji su primili najmanje jedan inhibitor faktora tumorske nekroze alfa (engl. tumour necrosis factor alpha, TNFα), dok ih je približno 10% primalo inhibitor IL-12/IL-23.
You must look out for signs of these conditions while you are taking Tremfya. 
Morate pripaziti na znakove tih pojava dok se liječite lijekom Tremfya.
The efficacy and safety of guselkumab was assessed in three randomised, double-blind, active controlled phase III studies in adult patients with moderate to severe plaque psoriasis, who were candidates for phototherapy or systemic therapy. 
Djelotvornost i sigurnost guselkumaba ocjenjivale su se u tri randomizirana, dvostruko slijepa, aktivnim lijekom kontrolirana ispitivanja faze III provedena u odraslih bolesnika s umjerenom do teškom plak psorijazom koji su bili kandidati za fototerapiju ili sistemsku terapiju.
Patients receiving Tremfya should be monitored for signs and symptoms of active TB during and after treatment. 
Bolesnike koji primaju lijek Tremfya treba pratiti zbog moguće pojave znakova i simptoma aktivne tuberkuloze tijekom i nakon liječenja.
After randomisation, the primary endpoint was the number of post-randomisation visits between Weeks 12 and 24 at which patients achieved an IGA score 0/1 and had ≥ 2 grade improvement. 
Nakon randomizacije, primarna mjera ishoda bio je broj posjeta nakon randomizacije između 12. i 24. tjedna pri kojima su bolesnici postigli IGA rezultat 0/1 i poboljšanje od ≥ 2 stupnja.
If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Tremfya. 
Ako niste sigurni odnosi li se nešto od navedenog na Vas, obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego što primijenite lijek Tremfya.
Treatment with guselkumab resulted in significant improvements in the measures of disease activity compared to placebo and adalimumab at Week 16 and compared to adalimumab at Weeks 24 and 48. 
Liječenje guselkumabom dovelo je do značajnog poboljšanja mjerila aktivnosti bolesti u odnosu na placebo i adalimumab u 16. tjednu te u odnosu na adalimumab u 24. i 48. tjednu.
b, n (%) Week 16 f-PGA (N) f-PGA 0/1, n (%) Week 16 14 (15.9) NAPSI (N) Percent Improvement, mean (SD) Week 16 -0.9 (57.9) 34.4 (42.4) 
16. tjedan f-PGA (N) f-PGA 0/1, n (%) 16. tjedan NAPSI (N) Postotno poboljšanje, srednja vrijednost (SD) 16. tjedan -0,9 (57,9) 34,4 (42,4)
Do not put the cap back on, this could damage the needle. 
Nemojte vraćati zatvarač nazad, to bi moglo oštetiti iglu.
Of all patients included in VOYAGE 1 and 2, 32% and 29% were naïve to both conventional systemic and biologic therapy, 54% and 57% had received prior phototherapy, and 62% and 64% had received prior conventional systemic therapy, respectively. 
Među svim bolesnicima uključenima u ispitivanja VOYAGE 1 i 2, njih 32% odnosno 29% prethodno nije primalo ni konvencionalnu sistemsku ni biološku terapiju, 54% odnosno 57% bolesnika prethodno je primalo fototerapiju, dok je 62% odnosno 64% bolesnika prethodno bilo liječeno konvencionalnom sistemskom terapijom.
Tremfya is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis. 
Tremfya je namijenjena za primjenu pod vodstvom i nadzorom liječnika koji ima iskustva u dijagnosticiranju i liječenju plak psorijaze.
Tremfya contains the active substance guselkumab which is a type of protein called a monoclonal antibody. 
Tremfya sadrži djelatnu tvar guselkumab, koji je vrsta proteina koja se zove ‘monoklonsko protutijelo'.
Guselkumab demonstrated rapid onset of efficacy, with a significantly higher percent improvement in PASI as compared with placebo as early as Week 2 (p < 0.001). 
Guselkumab je pokazao brz nastup djelovanja, uz značajno veće postotno poboljšanje PASI rezultata u usporedbi s placebom već u 2. tjednu (p < 0,001).
The recommended dose of Tremfya is 100 mg by subcutaneous injection at weeks 0 and 4, followed by a maintenance dose every 8 weeks. 
Preporučena doza lijeka Tremfya je 100 mg supkutanom injekcijom u 0. i 4. tjednu, nakon čega se primjenjuje doza održavanja svakih 8 tjedana.
Keep hands away from the needle guard after the cap is removed. 
Držite ruke dalje od štitnika igle nakon skidanja zatvarača.
If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Tremfya and for at least 12 weeks after the last Tremfya dose. 
Ako ste žena reproduktivne dobi, preporučuje se da izbjegavate trudnoću i stoga morate koristiti odgovarajuću kontracepciju dok primjenjujete lijek Tremfya i još najmanje 12 tjedana nakon posljednje doze lijeka Tremfya.
• After the first dose, you will have the next dose 4 weeks later, and then every 8 weeks. 
• Drugu dozu primit ćete 4 tjedna nakon prve, a zatim ćete nastaviti primati injekcije svakih 8 tjedana.
Among patients who inadequately responded to ustekinumab at the time of randomisation, significantly greater improvement of efficacy was observed in patients who switched to guselkumab treatment compared to patients who continued ustekinumab treatment. 
Među bolesnicima koji pri randomizaciji nisu imali dovoljno dobar odgovor na ustekinumab, značajno veće poboljšanje u djelotvornosti primijećeno je u bolesnika koji su prešli na guselkumab nego u onih koji su nastavili liječenje ustekinumabom.
Signs of improvement on patient-reported outcomes were maintained through Week 24 (VOYAGE 1 and 2) and Week 48 (VOYAGE 1). 
Znakovi poboljšanja ishoda koje prijavljuju bolesnici održali su se do 24. tjedna (VOYAGE 1 i 2) i 48. tjedna (VOYAGE 1).
In a Phase 1 study in subjects with moderate to severe plaque psoriasis, changes in systemic exposures (Cmax and AUCinf) of midazolam, S-warfarin, omeprazole, dextromethorphan, and caffeine after a single dose of guselkumab were not clinically relevant, indicating that drug interactions between guselkumab and substrates of various CYP enzymes (CYP3A4, CYP2C9, CYP2C19, CYP2D6, and CYP1A2) are unlikely. 
U jednom ispitivanju faze 1 provedenom u ispitanika s umjerenom do teškom plak psorijazom promjene u sistemskoj izloženosti (Cmax i AUCinf) midazolamu, S-varfarinu, omeprazolu, dekstrometorfanu i kofeinu nakon jedne doze guselkumaba nisu bile klinički značajne, što ukazuje na to da interakcije između guselkumaba i supstrata različitih CYP enzima (CYP3A4, CYP2C9, CYP2C19, CYP2D6 i CYP1A2) nisu vjerojatne.
Inject within 5 minutes of removing the needle cover. 
Injicirajte lijek unutar 5 minuta nakon skidanja pokrova igle.
It should be clear to slightly yellow and may contain tiny white or clear particles. 
Mora biti bistra do svijetložuta i može sadržavati sitne bijele ili prozirne čestice.
This medicine works by blocking the activity of a protein called IL-23, which is present at increased levels in people with psoriasis. 
Djeluje tako da blokira aktivnost proteina pod nazivom IL-23, čije su razine povećane u osoba s psorijazom.
Table 1 provides a list of adverse reactions from psoriasis clinical studies as well as from post-marketing experience. 
Tablici 1 navodi se popis nuspojava prijavljenih u kliničkim ispitivanjima kod psorijaze kao i nakon stavljanja lijeka u promet.
Comparative PASI response rates are presented in Table 6. 
Usporedne PASI stope odgovora prikazane su u tablici 6.
Treatment with Tremfya should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated. 
Liječenje lijekom Tremfya ne smije se započeti u bolesnika s bilo kakvom klinički važnom aktivnom infekcijom sve dok se ona ne povuče ili ne liječi na odgovarajući način.
Mean volume of distribution during the terminal phase (Vz) following a single intravenous administration to healthy subjects ranged from approximately 7 to 10 L across studies. 
Srednja vrijednost volumena distribucije tijekom terminalne faze (Vz) nakon jedne intravenske primjene zdravim ispitanicima kretala se u rasponu od približno 7 do 10 l u svim ispitivanjima.
There is no need for dose adjustment when co-administering guselkumab and CYP450 substrates. 
Nije potrebno prilagođavati dozu pri istodobnoj primjeni guselkumaba i supstrata CYP450.
Patients treated with Tremfya should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur. 
Bolesnike koji se liječe lijekom Tremfya treba uputiti da potraže liječničku pomoć ako se pojave znakovi ili simptomi klinički važne kronične ili akutne infekcije.
No specific study has been conducted to determine the effect of renal or hepatic impairment on the pharmacokinetics of guselkumab. 
Nije provedeno specifično ispitivanje kojim bi se ocijenio učinak oštećenja bubrežne ili jetrene funkcije na farmakokinetiku guselkumaba.
Do not inject into areas with scars or stretch marks. 
Nemojte injicirati lijek u područja prekrivena ožiljcima ili strijama.
Tremfya is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. 
Tremfya je indicirana za liječenje umjerene do teške plak psorijaze u odraslih koji su kandidati za sistemsku terapiju.
In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions and administer appropriate symptomatic treatment immediately. 
U slučaju predoziranja potrebno je nadzirati bolesnika zbog moguće pojave znakova ili simptoma nuspojava te odmah primijeniti odgovarajuće simptomatsko liječenje.
This may be given by your doctor or nurse. 
Injekciju Vam može dati liječnik ili medicinska sestra.
Through Week 156, 4.9% of all Tremfya-treated patients reported gastroenteritis. 
Kroz 156 tjedana, 4,9% od ukupnog broja bolesnika liječenih lijekom Tremfya prijavilo je gastroenteritis.
In two phase III clinical studies through the placebo-controlled period, gastroenteritis occurred more frequently in the Tremfya-treated group (1.1%) than in the placebo group (0.7%). 
U placebom kontroliranim razdobljima dvaju kliničkih ispitivanja faze III gastroenteritis se češće javljao u skupini liječenoj lijekom Tremfya (1,1%) nego u onoj koja je primala placebo (0,7%).
No mutagenicity or carcinogenicity studies were conducted with guselkumab. 
Nisu provedena ispitivanja mutagenosti ni kancerogenosti guselkumaba.
All patients (N=871) received open-label ustekinumab (45 mg ≤100 kg and 90 mg >100 kg) at Weeks 0 and 4. 
Svi su bolesnici (N=871) otvoreno primili ustekinumab (45 mg ≤ 100 kg i 90 mg > 100 kg) u 0. i 4. tjednu.
Patients should be instructed to inject the full amount of Tremfya according to the ‘Instructions for use' provided in the carton. 
Bolesnike treba uputiti da injiciraju punu dozu lijeka Tremfya u skladu s ‘Uputama za uporabu' koje dolaze u pakiranju lijeka.
IL-23, a regulatory cytokine, affects the differentiation, expansion, and survival of T cell subsets, (e.g., Th17 cells and Tc17 cells) and innate immune cell subsets, which represent sources of effector cytokines, including IL-17A, IL-17F and IL-22 that drive inflammatory disease. 
IL-23, koji je regulacijski citokin, utječe na diferencijaciju, ekspanziju i preživljenje podskupina T-stanica (npr. Th17 stanica i Tc17 stanica) i podskupina prirođenih imunosnih stanica, koje predstavljaju izvore izvršnih citokina, uključujući IL-17A, IL-17F i IL-22 - interleukina koji potiču upalnu bolest.
Do not use the Tremfya pre-filled syringe if it is dropped. 
Nemojte upotrijebiti Tremfya napunjenu štrcaljku ako je pala.
Tremfya is used to treat adults with moderate to severe “plaque psoriasis”, an inflammatory condition affecting the skin and nails. 
Tremfya se koristi za liječenje odraslih osoba s umjerenom do teškom ‘plak psorijazom' - upalnom bolešću koja zahvaća kožu i nokte.
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 
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
You and your doctor should decide if you will breast-feed or use Tremfya. 
Vi i Vaš liječnik trebate odlučiti hoćete li dojiti ili primjenjivati lijek Tremfya.
For detailed instructions on how to use Tremfya, carefully read the ‘Instructions for use' leaflet before use, which is included in the carton. 
Za detaljne upute o tome kako primjenjivati lijek Tremfya pažljivo pročitajte ‘Upute za uporabu', koje dolaze u pakiranju lijeka.
Sign score = 0, n (%) 
Rezultat za znakove = 0, n (%)
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. 
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.
The solution should be clear, colourless to light yellow, and may contain a few small white or clear particles. 
Otopina mora biti bistra i bezbojna do svijetložuta, a smije sadržavati nekoliko malih bijelih ili prozirnih čestica.
The exact pathway through which guselkumab is metabolized has not been characterized. 
Točan put kojim se guselkumab metabolizira nije okarakteriziran.
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). 
Guselkumab je bio superioran naspram sekukinumaba mjereno primarnom mjerom ishoda PASI 90 odgovora u 48. tjednu (84,5% naspram 70,0%, p < 0.001).
1 pre-filled syringe Component of a multipack, cannot be sold separately 
1 napunjena brizgalica Sastavnica višestrukog pakiranja, ne može se prodavati pojedinačno
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. 
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.
Guselkumab could not be detected in breast milk from cynomolgus monkeys as measured at post-natal day 28. 
Guselkumab nije pronađen u mlijeku ženki makaki majmuna pri mjerenju provedenom 28. dana nakon okota.
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. 
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.
Mean systemic clearance (CL) following a single intravenous administration to healthy subjects ranged from 0.288 to 0.479 L/day across studies. 
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.
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. 
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.
Check the liquid in the window. 
Pregledajte tekućinu kroz prozorčić.
The immunogenicity of Tremfya was evaluated using a sensitive and drug-tolerant immunoassay. 
Imunogenost lijeka Tremfya ocjenjivala se osjetljivim imunotestom otpornim na lijek.
Inject within 5 minutes of removing the cap. 
Injicirajte lijek unutar 5 minuta nakon skidanja zatvarača.
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). 
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).
The effect of guselkumab on human fertility has not been evaluated. 
Nije se ocjenjivao učinak guselkumaba na plodnost ljudi.
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. 
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.
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. 
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.
What you need to know before you use Tremfya 
Što morate znati prije nego počnete primjenjivati lijek Tremfya
Multipack: 2 (2 packs of 1) pre-filled pens 
Višestruko pakiranje: 2 (2 pakiranja od po 1) napunjene štrcaljke
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). 
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).