natgillin/translations-raw huggingface dataset:
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.
Izmed vseh bolnikov, vključenih v študiji VOYAGE 1 in 2, jih 32% oziroma 29% predhodno še ni prejemalo niti konvencionalnega sistemskega zdravljenja niti bioloških zdravil, 54% oziroma 57% jih je predhodno prejemalo fototerapijo in 62% oziroma 64% jih je predhodno prejemalo konvencionalno sistemsko zdravljenje.
Two studies (VOYAGE 1 and VOYAGE 2) evaluated the efficacy and safety of guselkumab versus placebo and adalimumab in 1829 adult patients.
V dveh študijah (VOYAGE 1 in VOYAGE 2) so ocenjevali učinkovitost in varnost guselkumaba v primerjavi s placebom in adalimumabom pri 1.829 odraslih bolnikih.
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.
V obeh študijah se je 21% bolnikov predhodno že zdravilo z biološkimi zdravili, vključno z 11% bolnikov, ki so predhodno že prejeli najmanj en zaviralecfaktorja tumorske nekroze alfa (TNFα), in s približno 10% bolnikov, ki so že prejemali zaviralec IL-12/IL-23.
PASI Response Rates in ECLIPSE
Stopnje odziva PASI v študiji ECLIPSE
If needed, cover injection site with a bandage.
Če je potrebno, pokrijte mesto injiciranja z obližem.
You should not stop using Tremfya without speaking to your doctor first.
Ne prenehajte uporabljati zdravila Tremfya, ne da bi se prej posvetovali z zdravnikom.
2333CB Leiden
NL-2333 CB Leiden
Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment.
Pri bolnikih, pri katerih po 16 tednih zdravljenja ne pride do odziva, je treba razmisliti o prenehanju zdravljenja.
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.
Učinkovitost in varnost guselkumaba so ocenjevali v treh randomiziranih, dvojno slepih, aktivno nadzorovanih študijah faze III pri odraslih bolnikih z zmerno do hudo psoriazo s plaki, ki so bili primerni za fototerapijo ali sistemsko zdravljenje.
Tremfya is not recommended for children and adolescents under 18 years of age because it has not been studied in this age group.
Uporaba zdravila Tremfya ni priporočljiva za otroke in mladostnike, mlajše od 18 let, ker je v tej starostni skupini niso preučevali.
The Tremfya pre-filled syringe is intended for injection under the skin, not into the muscle or vein.
Zdravilo Tremfya v napolnjeni injekcijski brizgi je namenjeno injiciranju pod kožo in ne v mišico ali v veno.
Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se pogovorite s svojim zdravnikom.
Tremfya can improve the condition of the skin and appearance of nails and reduce symptoms, such as scaling, shedding, flaking, itching, pain and burning.
Zdravilo Tremfya lahko izboljša stanje kože in izgled nohtov ter zmanjša simptome psoriaze, kot so luščenje kože, drobno luščenje ali luščenje zaplat kože, srbenje, bolečina in skelenje.
In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions and administer appropriate symptomatic treatment immediately.
V primeru prevelikega odmerjanja je treba bolnika spremljati glede morebitnih znakov in simptomov neželenih učinkov ter uvesti ustrezno simptomatsko zdravljenje.
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
Možnost resne alergijske reakcije - znaki lahko vključujejo: - oteženo dihanje ali požiranje - otekanje v obraz, ustnice, jezik ali grlo oziroma žrelo - hudo srbenje kože z rdečim izpuščajem ali dvignjenimi kožnimi spremembami
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.
Izgubo odziva PASI 90 so opazili že 4 tedne po opustitvi zdravljenja z guselkumabom, pri čemer je bila mediana časa do izgube odziva PASI 90 približno 15 tednov.
If you stop treatment, symptoms of psoriasis may come back.
Če prenehate uporabljati zdravilo Tremfya, se lahko ponovno pojavijo simptomi psoriaze.
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%).
V dveh kliničnih študijah faze III se je v obdobju s placebom nadzorovanega zdravljenja gastroenteritis pojavljal pogosteje v skupini, ki je prejemala zdravilo Tremfya (1,1%) kot v skupini s placebom (0,7%).
Keep Tremfya and all medicines out of reach of children.
Zdravilo Tremfya in vsa druga zdravila shranjujte nedosegljivo otrokom!
Do not touch plunger or area above finger flange as this may cause the needle safety device to activate.
Ne dotikajte se bata oziroma delov nad oprijemalom za prste, saj bi to lahko sprožilo varnostni mehanizem za zaščito igle.
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.
Enkrat tedenski subkutani odmerki 50 mg/kg so pri opicah povzročili izpostavljenost zdravilu (AUC), ki je bila najmanj 49-krat večja, in vrednosti Cmax, ki so bile več kot 200-krat višje od vrednosti, ki so jih izmerili v farmakokinetični klinični študiji pri ljudeh.
Through Week 156, 4.9% of all Tremfya-treated patients reported gastroenteritis.
Do konca 156. tedna je 4,9% vseh bolnikov, zdravljenih z zdravilom Tremfya, poročalo o gastroenteritisu.
Adverse reactions of gastroenteritis were non-serious and did not lead to discontinuation of Tremfya through Week 156.
Gastroenteritisi niso bili resni in zaradi njih do konca 156. tedna ni bilo treba prekinjati zdravljenja z zdravilom Tremfya.
Herpes simplex infections
• okužba z virusom herpes simplex
2333CB Leiden The Netherlands
NL-2333 CB Leiden Nizozemska
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.
Med bolniki, ki se niso zadostno odzvali na ustekinumab do randomizacije, so opazili statistično značilno večje izboljšanje učinkovitosti pri tistih, ki so prešli na uporabo guselkumaba, kot pri tistih, ki so nadaljevali zdravljenje z ustekinumabom.
Patients treated with Tremfya should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.
Bolnikom, ki prejemajo zdravilo Tremfya, je treba naročiti, da se posvetujejo z zdravnikom, če opazijo znake ali simptome klinično pomembne kronične ali akutne okužbe.
After injection, the needle will retract into the body of the device and lock into place.
Po končanem injiciranju se bo igla pomaknila nazaj v telo brizge in se tam zaskočila.
What Tremfya is and what it is used for
Kaj je zdravilo Tremfya in za kaj ga uporabljamo
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.
Neželena učinka eritem in bolečina na mestu injiciranja sta bila na splošno blaga do zmerna, noben ni bil resen in zaradi njiju ni bilo treba prekiniti zdravljenja z zdravilom Tremfya.
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.
Če se pri bolniku pojavijo klinično pomembne ali resne okužbe ali če se ne odzove na običajno zdravljenje, je treba bolnika skrbno spremljati in prekiniti zdravljenje z zdravilom Tremfya dokler okužba ne izzveni.
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.
Po randomizaciji je bil primarni cilj opazovanja število tistih obiskov po randomizaciji od 12. do 24. tedna, pri katerih so bolniki dosegli oceno IGA 0/1 in izboljšanje za ≥ 2 stopnji.
What you need to know before you use Tremfya
Kaj morate vedeti, preden boste uporabili zdravilo Tremfya
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, regulatorni citokin, vpliva na diferenciacijo, rast in preživetje podvrst limfocitov T (kot so celice Th17 in celice Tc17) in podvrst celic prirojenega imunskega sistema, v katerih nastajajo efektorski citokini, med drugim IL-17A, IL-17F in IL-22, ki vodijo proces vnetne bolezni.
Tremfya is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis.
Zdravilo Tremfya je namenjeno za uporabo pod vodstvom in nadzorom zdravnika z izkušnjami z diagnostiko in zdravljenjem psoriaze s plaki.
Other medicines and Tremfya
Druga zdravila in zdravilo Tremfya
Some side effects are very common (may affect more than 1 in 10 people): - upper respiratory infections
Nekateri neželeni učinki so pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): • okužbe zgornjih dihal
Number of patients (%) Guselkumab (N=534)
Število bolnikov (%) guselkumab (N = 534)
Place thumb from the opposite hand on the plunger and press the plunger all the way down until it stops.
Palec druge roke postavite na bat in ga potisnite čisto do konca, dokler se ne ustavi.
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.
Če ste ženska v rodni dobi, vam svetujemo, da se zaščitite pred zanositvijo, zato morate med uporabo zdravila Tremfya in še najmanj 12 tednov po zadnjem odmerku tega zdravila uporabljati ustrezno kontracepcijo.
The effect of guselkumab on human fertility has not been evaluated.
Vpliva guselkumaba na plodnost pri ljudeh niso ovrednotili.
Inject within 5 minutes of removing the cap.
Zdravilo injicirajte v 5 minutah po odstranitvi pokrovčka.
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.
Povprečni razpolovni čas (T1/2) guselkumaba v študijah je bil pri zdravih preiskovancih približno 17 dni, pri bolnikih s psoriazo s plaki pa približno 15 do 18 dni.
Patients should be instructed to inject the full amount of Tremfya according to the ‘Instructions for use' provided in the carton.
Bolnikom je treba naročiti, naj si injicirajo celotno količino zdravila Tremfya, skladno z "Navodili za injiciranje", ki so priložena v škatli z zdravilom.
The solution should be clear, colourless to light yellow, and may contain a few small white or clear particles.
Raztopina mora biti bistra, brezbarvna do svetlo rumena in lahko vsebuje nekaj majhnih belih ali prozornih delcev.
Prior to use, a visual inspection of the pre-filled syringe or pre-filled pen is recommended.
Pred uporabo je priporočljivo, da napolnjeno injekcijsko brizgo oziroma napolnjen injekcijski peresnik vizualno pregledate.
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.
Med bolniki, ki so opustili zdravljenje in nato ponovno začeli prejemati guselkumab, jih je 80% ponovno doseglo odziv PASI 90 pri ocenjevanju 20 tednov po uvedbi ponovnega zdravljenja.
The immunogenicity of Tremfya was evaluated using a sensitive and drug-tolerant immunoassay.
Imunogenost zdravila Tremfya so ocenjevali z občutljivo imunsko metodo s toleranco na zdravilo.
You should not be given certain types of vaccines (live vaccines) while using Tremfya.
Med uporabo zdravila Tremfya vam ne smejo dati nekaterih vrst cepiv (živa cepiva).
Summary of Patient Reported Outcomes in the Open-Label Phase in VOYAGE 1 Guselkumab
Povzetek izidov po navedbah bolnikov v odprti fazi študije VOYAGE 1 guselkumab adalimumab-guselkumab
Do not use Tremfya
Ne uporabljajte zdravila Tremfya
It should be clear to slightly yellow and may contain tiny white or clear particles.
Biti mora bistra do rahlo rumenkasta in lahko vsebuje drobne bele ali prosojne delce.
Response over time
Časovni potek odzivov
Prepare for your injection
Pripravite vse za injiciranje
Tremfya is a clear, colourless to light yellow solution.
Zdravilo Tremfya je bistra, brezbarvna do svetlo rumena raztopina.
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.
Guselkumab je povsem humano monoklonsko protitelo G1 lambda (IgG1λ) proti proteinu interlevkinu (IL)-23, izdelano na ovarijskih celicah kitajskega hrčka s tehnologijo rekombinantne DNK.
Inject within 5 minutes of removing the needle cover.
Zdravilo injicirajte v 5 minutah po snetju pokrovčka z igle.
1 pre-filled syringe Component of a multipack, cannot be sold separately
1 napolnjen injekcijski peresnik Sestavni del večjega pakiranja, Posamezni zavitki se ne smejo prodajati ločeno.
Tremfya has no or negligible influence on the ability to drive and use machines.
Zdravilo Tremfya nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Summary of Patient Reported Outcomes at Week 16 in VOYAGE 1 and VOYAGE 2 VOYAGE 1
Povzetek izidov po navedbah bolnikov v 16. tednu v študijah VOYAGE 1 in VOYAGE 2
As a precautionary measure, it is preferable to avoid the use of Tremfya in pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Tremfya bolje izogibati.
Please also read the Package Leaflet carefully before starting your injection and discuss any questions you may have with your doctor or nurse.
Preden začnete z injiciranjem, si skrbno preberite tudi Navodilo za uporabo in se o morebitnih vprašanjih pogovorite z zdravnikom ali medicinsko sestro.
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.
V dveh kliničnih študijah faze III so se do 48. tedna pri 0,7% injiciranj zdravila Tremfya in 0,3% injiciranj placeba pojavile reakcije na mestu injiciranja.
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.
Zdravim prostovoljcem so dajali enkratne intravenske odmerke guselkumaba do 987 mg (10 mg/kg), bolnikom s psoriazo s plaki pa so v kliničnih študijah dajali enkratne subkutane odmerke guselkumaba do 300 mg brez toksičnih učinkov, ki bi omejevali odmerjanje zdravila.
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.
Učinkovitost in varnost guselkumaba sta bili dokazani neodvisno od starosti, spola, rase, telesne mase, lokacije plakov, izhodiščne ocene izraženosti bolezni (PASI), sočasnega psoriatičnega artritisa in predhodnega zdravljenja z biološkimi zdravili.
VOYAGE 1 and VOYAGE 2
Študiji VOYAGE 1 in VOYAGE 2
Patients receiving Tremfya should be monitored for signs and symptoms of active TB during and after treatment.
Bolnike, ki prejemajo zdravilo Tremfya, je treba med in po zaključku zdravljenja spremljati glede znakov in simptomov aktivne tuberkuloze.
If you think you may be allergic, ask your doctor for advice before using Tremfya
Če menite, da bi lahko bili alergični, se pred začetkom uporabe zdravila Tremfya posvetujte z zdravnikom.
Signs of improvement on patient-reported outcomes were maintained through Week 24 (VOYAGE 1 and 2) and Week 48 (VOYAGE 1).
Znaki izboljšanja izidov, ki so jih navedli bolniki, so vztrajali do konca 24. tedna (v študijah VOYAGE 1 in 2) in do konca 48. tedna (v študiji VOYAGE 1).
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.
Glede na to, da je guselkumab človeško monoklonsko protitelo, je mogoče pričakovati, da se razgradi na manjše peptide in aminokisline preko kataboličnih procesov tako kot endogena protitelesa IgG.
No specific study has been conducted to determine the effect of renal or hepatic impairment on the pharmacokinetics of guselkumab.
Za ugotavljanje vpliva okvare jeter ali ledvic na farmakokinetiko guselkumaba, niso opravili posebnih študij.
Check the expiration date (‘EXP') on the back panel of the carton.
Preverite datum izteka roka uporabnosti (EXP) na zadnji strani škatle.
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).
V študiji VOYAGE 2 je 88,6% bolnikov, ki so prejemali vzdrževalno zdravljenje z guselkumabom, do 48. tedna doseglo odziv PASI 90 v primerjavi 36,8% bolnikov, ki so po 28. tednu prekinili zdravljenje (p < 0,001).
In VOYAGE 1, for patients receiving continuous guselkumab treatment, these improvements were maintained in the open-label phase through Week 156 (Table 5).
V študiji VOYAGE 1 so se pri bolnikih, ki so neprekinjeno prejemali guselkumab, ta izboljšanja ohranila v odprti fazi študije do 156. tedna (glejte Preglednico5).
Do not use this medicine after the expiry date which is stated on the syringe label and on the outer carton after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki injekcijske brizge in na zunanji škatli poleg oznake "EXP".
If you stop using Tremfya
Če ste prenehali uporabljati zdravilo Tremfya
The exact pathway through which guselkumab is metabolized has not been characterized.
Natančna pot presnove guselkumaba ni bila opisana.
After proper training in subcutaneous injection technique, patients may inject Tremfya if a physician determines that this is appropriate.
Po ustreznem usposabljanju o subkutanem injiciranju si lahko bolniki sami injicirajo zdravilo Tremfya, če zdravnik presodi, da je to primerno in zagotovi tudi ustrezno spremljanje bolnika.
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.
Po enkratni 100 mg subkutani injekciji je guselkumab pri zdravih preiskovancih dosegel povprečno najvišjo serumsko koncentracijo (Cmax) 8,09 μg/ml (s standardno deviacijo ± 3,68 μg/ml) približno 5,5 dni po odmerjanju.
These results are consistent with the clinical benefit observed with guselkumab treatment in plaque psoriasis.
Ti rezultati se ujemajo s kliničnimi koristmi, ki jih opažajo pri zdravljenju psoriaze s plaki z guselkumabom.
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.
Zdravljenje z guselkumabom je privedlo do statistično značilnega večjega izboljšanja meril aktivnosti bolezni v primerjavi z bolniki s placebom v 16. tednu in v primerjavi z bolniki z adalimumabom v 24. oziroma v 48. tednu.
Serious allergic reactions, which can include symptoms of hives and shortness of breath, have occurred with Tremfya (see “Serious side effects” in section 4).
Pri uporabi zdravila Tremfya je prišlo do resnih alergijskih reakcij, ki so lahko vključevale simptome koprivnice in zadihanosti (glejte pod naslovom “Resni neželeni učinki” v poglavju 4).
Mean systemic clearance (CL) following a single intravenous administration to healthy subjects ranged from 0.288 to 0.479 L/day across studies.
Po enkratnem intravenskem odmerku je pri zdravih preiskovancih povprečni sistemski očistek (CL) v študijah znašal od 0,288 do 0,479 l/dan.
Guselkumab and secukinumab PASI 90 response rates through Week 48 are presented in Figure 4.
Stopnje odziva PASI 90 za guselkumab in sekukinumab do konca 48. tedna so prikazane na Sliki 4.
Do not put the cap back on, this could damage the needle.
Pokrovčka ne nameščajte nazaj, s tem bi lahko poškodovali iglo.
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.
V modelih in vitro se je pokazalo, da guselkumab zavira biološko aktivnost IL-23, tako da zavira njegovo interakcijo z receptorji za IL-23 na celični površini, ovira signaliziranje, ki ga posreduje IL-23, aktivacijo in kaskadno pot nastajanja citokinov.
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeat-dose toxicity, toxicity to reproduction and pre- and post-natal development.
Neklinični podatki na osnovi konvencionalnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, toksičnega vpliva na sposobnost razmnoževanja in na prenatalni in postnatalni razvoj ne kažejo posebnega tveganja za človeka.
Driving and using machines Tremfya is unlikely to influence your ability to drive and use machines.
Vpliv na sposobnost upravljanja vozil in strojev Za zdravilo Tremfya je malo verjetno, da bi vplivalo na vašo sposobnost vožnje in upravljanja strojev.
For additional assistance or to share your feedback refer to the Package Leaflet for your local representative contact information.
Če potrebujete dodatno pomoč ali bi radi povedali svoje mnenje, v Navodilu za uporabo poiščite kontaktne podatke predstavništva imetnika dovoljenja za promet z zdravilom v vaši državi.
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.
Pri histopatoloških preiskavah na živalih, zdravljenih do največ 24 tednov, ali po 12-tedenskem obdobju premora, v katerem so še vedno lahko zaznali koncentracijo zdravila v serumu, niso opazili nobenih prekancerogenih sprememb.
Check the liquid in the window.
Preverite tekočino v okencu
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.
Po enkratnem intravenskem odmerku je bil pri zdravih preiskovancih povprečni volumen porazdelitve v terminalni fazi (Vz) v študijah od približno 7 do 10 l.
Through Week 156, 0.5% of Tremfya injections were associated with injection site reactions.
Do konca 156. tedna je bilo z reakcijo na mestu injiciranja povezanih 0,5% injiciranj zdravila Tremfya.
Call your doctor to talk about any questions you may have.
Pokličite svojega zdravnika in pri njem poiščite odgovore na svoja vprašanja.
All patients (N=871) received open-label ustekinumab (45 mg ≤100 kg and 90 mg >100 kg) at Weeks 0 and 4.
Vsi bolniki (N=871) so v odprti študiji v tednih 0 in 4 prejeli ustekinumab (45 mg pri telesni masi ≤100 kg oziroma 90 mg pri telesni masi >100 kg).
EU/1/17/1234/004 (2 packs, each containing 1 pre-filled syringe)
EU/1/17/1234/003 (2 pakiranji, vsako vsebuje 1 napolnjem injekcijski peresnik)
It is unknown whether guselkumab is excreted in human milk.
Ni znano, ali se guselkumab izloča v materino mleko pri človeku.