FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Tremfya in plaque psoriasis in one or more subsets of the paediatric population (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z zdravilom Tremfya pri psoriazi s plaki za eno ali več podskupin pediatrične populacije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih posodobitvah RMP.
English: • Front of thighs (recommended)
Slovenian: • sprednji del stegen (priporočljivo)
English: It is important to pinch enough skin to inject under the skin and not into the muscle.
Slovenian: Pomembno je, da naredite dovolj veliko kožno gubo, da boste zdravilo injicirali pod kožo in ne v mišico.
English: Name and address of the manufacturers of the biological active substance Biogen Inc. (BIIB)
Slovenian: Ime in naslov proizvajalcev biološke učinkovine Biogen Inc. (BIIB)
English: How much Tremfya is given and for how long Your doctor will decide for how long you need to use Tremfya.
Slovenian: Koliko zdravila Tremfya je treba dajati in kako dolgo Vaš zdravnik bo presodil, kako dolgo boste potrebovali zdravilo Tremfya.
English: For further instructions on preparation and special precautions for handling, see section 6.6 and the ‘Instructions for use' leaflet.
Slovenian: Za dodatna navodila za pripravo zdravila in posebna opozorila pri ravnanju z zdravilom glejte poglavje 6.6 in priložena "Navodila za injiciranje".
English: • 1 Sharps container (See Step 3)
Slovenian: • 1 posodo za odstranjevanje ostrih predmetov (glejte korak 3)
English: Wash hands
Slovenian: Umijte si roke
English: Concomitant immunosuppressive therapy or phototherapy The safety and efficacy of Tremfya in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
Slovenian: Sočasno imunosupresivno zdravljenje ali fototerapija Varnosti in učinkovitosti zdravila Tremfya v kombinaciji z imunosupresivi, vključno z biološkimi zdravili ali fototerapijo, niso ocenili.
English: This instruction guide does not take the place of talking with your doctor about your medical condition or your treatment.
Slovenian: To navodilo ne nadomešča pogovora o vaši bolezni in zdravljenju z zdravnikom.
English: The safety and efficacy of Tremfya in children and adolescents below the age of 18 years have not yet been established.
Slovenian: Varnosti in učinkovitosti zdravila Tremfya pri otrocih in mladostnikih, mlajših od 18 let, niso ugotovili.
English: Week 156
Slovenian: 156. teden
English: The last dose was at week 44 for both treatment groups.
Slovenian: Zadnji odmerek so bolniki obeh skupin prejeli v 44. tednu.
English: There may be new information.
Slovenian: V navodilih so lahko navedene nove informacije.
English: It is important not to try to inject yourself until you have been trained by your doctor or nurse.
Slovenian: Pomembno je, da si zdravila ne poskušate injicirati sami, dokler vas tega ne nauči zdravnik ali medicinska sestra.
English: 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.
Slovenian: Pred cepljenjem z živimi virusnimi ali bakterijskimi cepivi je treba zdravljenje z zdravilom Tremfya odložiti za najmanj 12 tednov po zadnjem odmerku in ga nato ponovno uvesti najmanj 2 tedna po cepljenju.
English: Position the pre-filled pen straight onto the skin (about 90 degrees relative to injection site).
Slovenian: Napolnjen injekcijski peresnik postavite navpično na kožo (približno pod kotom 90 stopinj na mesto injiciranja).
English: If you forget to use Tremfya If you have forgotten to inject a dose of Tremfya, inform your doctor.
Slovenian: Če ste pozabili uporabiti zdravilo Tremfya Če ste si pozabili injicirati odmerek zdravila Tremfya, obvestite zdravnika.
English: Select from the following areas for your injection:
Slovenian: Izberite med naslednjimi mesti za injiciranje:
English: Baseline characteristics for randomised patients were similar to those observed in VOYAGE 1 and 2.
Slovenian: Izhodiščne karakteristike so bile pri randomiziranih bolnikih podobne kot tiste opažene v študijah VOYAGE 1 in 2.
English: Women of childbearing potential should use effective methods of contraception during treatment and for at least 12 weeks after treatment.
Slovenian: Ženske v rodni dobi morajo med zdravljenjem in še najmanj 12 tednov po njem uporabljati učinkovite kontracepcijske metode.
English: • if you are being treated for an infection
Slovenian: • če se zdravite zaradi okužbe,
English: In humans, selective blockade of IL-23 was shown to normalize production of these cytokines.
Slovenian: Pri človeku selektivno zaviranje IL-23 dokazano normalizira nastajanje teh citokinov.
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.
Slovenian: Med bolniki, pri katerih so se razvila protitelesa proti zdravilu, jih je približno 7% imelo protitelesa, ki so bila opredeljena kot nevtralizacijska, kar ustreza 0,4% vseh bolnikov, ki so prejemali zdravilo Tremfya.
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC16.
Slovenian: Farmakoterapevtska skupina: zdravila za zaviranje imunske odzivnosti, zaviralci interlevkinov, oznaka ATC: L04AC16.
English: Table 1: List of adverse reactions System Organ Class
Slovenian: Preglednica 1:Seznam neželenih učinkov Organski sistem
English: No mutagenicity or carcinogenicity studies were conducted with guselkumab.
Slovenian: Študij mutagenosti ali kancerogenosti z guselkumabom niso izvajali.
English: Summary of the safety profile The most common adverse drug reaction (ADR) was upper respiratory infection.
Slovenian: Povzetek varnostnega profila Najpogostejši neželeni učinek so bile okužbe zgornjih dihal.
English: Of the 1384 plaque psoriasis patients exposed to guselkumab and included in the population pharmacokinetic analysis, 70 patients were 65 years of age or older, including 4 patients who were 75 years of age or older.
Slovenian: Med 1.384 bolniki s psoriazo s plaki, ki so bili izpostavljeni guselkumabu in vključeni v analizo populacijske farmakokinetike, je bilo 70 bolnikov starih 65 let ali več, vključno s 4 bolniki, ki so bili stari 75 let ali več.
English: EU/1/17/1234/001 1 pre-filled syringe EU/1/17/1234/002 1 pre-filled pen EU/1/17/1234/003 2 pre-filled pens EU/1/17/1234/004 2 pre-filled syringes
Slovenian: EU/1/17/1234/001 1 napolnjena injekcijska brizga EU/1/17/1234/002 1 napolnjen injekcijski peresnik EU/1/17/1234/003 2 napolnjena injekcijska peresnika EU/1/17/1234/004 2 napolnjeni injekcijski brizgi
English: There are no data from the use of guselkumab in pregnant women.
Slovenian: O uporabi guselkumaba pri nosečnicah ni podatkov.
English: Population pharmacokinetic analyses indicated there were no apparent changes in CL/F estimate in patients ≥ 65 years of age compared to patients < 65 years of age, suggesting no dose adjustment is needed for elderly patients.
Slovenian: Rezultati analize populacijske farmakokinetike so pokazali, da pri bolnikih, starih 65 let ali več, ni bilo očitnih sprememb ocene navideznega očistka (CL/F) v primerjavi z bolniki, ki so bili stari manj kot 65 let, kar nakazuje, da prilagajanje odmerkov pri starejših bolnikih ni potrebno.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. PROIZVAJALCI BIOLOŠKE UČINKOVINE IN PROIZVAJALEC, ODGOVOREN ZA SPROŠČANJE SERIJE
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or postnatal development (see section 5.3).
Slovenian: Študije na živalih niso pokazale neposrednih ali posrednih škodljivih vplivov na nosečnost, razvoj zarodka/plodu, porod ali postnatalni razvoj (glejte poglavje 5.3).
English: Efficacy and safety of guselkumab were also investigated in a double-blind study compared to secukinumab.
Slovenian: Učinkovitost in varnost guselkumaba so raziskovali tudi v dvojno slepi študiji in ga primerjali z sekukinumabom.
English: c -9.7 (6.8)
Slovenian: 16. teden c -9,7 (6,8)
English: Tremfya has not been studied in these patient populations.
Slovenian: Zdravila Tremfya pri teh dveh skupinah bolnikov niso preučevali.
English: • if you are using, have recently used or might use any other medicines.
Slovenian: • če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo,
English: A decision should be made whether to discontinue, or abstain from initiating treatment with Tremfya, taking into account the benefit of breast-feeding to the child and the benefit of Tremfya therapy to the woman.
Slovenian: Odločiti se je treba, ali je potrebno prenehati zdravljenje z zdravilom Tremfya oz. ga ne uvesti, ob upoštevanju koristi dojenja za otroka in koristi zdravljenja z zdravilom Tremfya za mater.
English: Hold syringe body below finger flange.
Slovenian: Telo brizge primite pod oprijemalom za prste.
English: Do not touch needle or let it touch any surface.
Slovenian: Ne dotikajte se igle in se z njo ne dotikajte drugih površin.
English: Name and address of the manufacturer responsible for batch release Janssen Biologics B.V.
Slovenian: Ime in naslov proizvajalca, odgovornega za sproščanje serije Janssen Biologics B.V.
English: The absolute bioavailability of guselkumab following a single 100 mg subcutaneous injection was estimated to be approximately 49% in healthy subjects.
Slovenian: Absolutna biološka razpoložljivost guselkumaba po enkratni 100 mg subkutani injekciji je bila pri zdravih preiskovancih ocenjena na približno 49%.
English: 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.
Slovenian: 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.
English: Two studies (VOYAGE 1 and VOYAGE 2) evaluated the efficacy and safety of guselkumab versus placebo and adalimumab in 1829 adult patients.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: PASI Response Rates in ECLIPSE
Slovenian: Stopnje odziva PASI v študiji ECLIPSE
English: If needed, cover injection site with a bandage.
Slovenian: Če je potrebno, pokrijte mesto injiciranja z obližem.
English: You should not stop using Tremfya without speaking to your doctor first.
Slovenian: Ne prenehajte uporabljati zdravila Tremfya, ne da bi se prej posvetovali z zdravnikom.
English: 2333CB Leiden
Slovenian: NL-2333 CB Leiden
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment.
Slovenian: Pri bolnikih, pri katerih po 16 tednih zdravljenja ne pride do odziva, je treba razmisliti o prenehanju zdravljenja.
English: 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.
Slovenian: 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.
English: Tremfya is not recommended for children and adolescents under 18 years of age because it has not been studied in this age group.
Slovenian: Uporaba zdravila Tremfya ni priporočljiva za otroke in mladostnike, mlajše od 18 let, ker je v tej starostni skupini niso preučevali.
English: The Tremfya pre-filled syringe is intended for injection under the skin, not into the muscle or vein.
Slovenian: Zdravilo Tremfya v napolnjeni injekcijski brizgi je namenjeno injiciranju pod kožo in ne v mišico ali v veno.
English: Talk to your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se pogovorite s svojim zdravnikom.
English: Tremfya can improve the condition of the skin and appearance of nails and reduce symptoms, such as scaling, shedding, flaking, itching, pain and burning.
Slovenian: 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.
English: In the event of overdosage, monitor the patient for any signs or symptoms of adverse reactions and administer appropriate symptomatic treatment immediately.
Slovenian: V primeru prevelikega odmerjanja je treba bolnika spremljati glede morebitnih znakov in simptomov neželenih učinkov ter uvesti ustrezno simptomatsko zdravljenje.
English: 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
Slovenian: 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
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.
Slovenian: 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.
English: If you stop treatment, symptoms of psoriasis may come back.
Slovenian: Če prenehate uporabljati zdravilo Tremfya, se lahko ponovno pojavijo simptomi psoriaze.
English: 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%).
Slovenian: 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%).
English: Keep Tremfya and all medicines out of reach of children.
Slovenian: Zdravilo Tremfya in vsa druga zdravila shranjujte nedosegljivo otrokom!
English: Do not touch plunger or area above finger flange as this may cause the needle safety device to activate.
Slovenian: Ne dotikajte se bata oziroma delov nad oprijemalom za prste, saj bi to lahko sprožilo varnostni mehanizem za zaščito igle.
English: 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.
Slovenian: 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.
English: Through Week 156, 4.9% of all Tremfya-treated patients reported gastroenteritis.
Slovenian: Do konca 156. tedna je 4,9% vseh bolnikov, zdravljenih z zdravilom Tremfya, poročalo o gastroenteritisu.
English: Adverse reactions of gastroenteritis were non-serious and did not lead to discontinuation of Tremfya through Week 156.
Slovenian: Gastroenteritisi niso bili resni in zaradi njih do konca 156. tedna ni bilo treba prekinjati zdravljenja z zdravilom Tremfya.
English: Herpes simplex infections
Slovenian: • okužba z virusom herpes simplex
English: 2333CB Leiden The Netherlands
Slovenian: NL-2333 CB Leiden Nizozemska
English: 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.
Slovenian: 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.
English: Patients treated with Tremfya should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.
Slovenian: Bolnikom, ki prejemajo zdravilo Tremfya, je treba naročiti, da se posvetujejo z zdravnikom, če opazijo znake ali simptome klinično pomembne kronične ali akutne okužbe.
English: After injection, the needle will retract into the body of the device and lock into place.
Slovenian: Po končanem injiciranju se bo igla pomaknila nazaj v telo brizge in se tam zaskočila.
English: What Tremfya is and what it is used for
Slovenian: Kaj je zdravilo Tremfya in za kaj ga uporabljamo
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: What you need to know before you use Tremfya
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Tremfya
English: 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.
Slovenian: 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.
English: Tremfya is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of plaque psoriasis.
Slovenian: Zdravilo Tremfya je namenjeno za uporabo pod vodstvom in nadzorom zdravnika z izkušnjami z diagnostiko in zdravljenjem psoriaze s plaki.
English: Other medicines and Tremfya
Slovenian: Druga zdravila in zdravilo Tremfya
English: Some side effects are very common (may affect more than 1 in 10 people): - upper respiratory infections
Slovenian: Nekateri neželeni učinki so pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): • okužbe zgornjih dihal
English: Number of patients (%) Guselkumab (N=534)
Slovenian: Število bolnikov (%) guselkumab (N = 534)
English: Place thumb from the opposite hand on the plunger and press the plunger all the way down until it stops.
Slovenian: Palec druge roke postavite na bat in ga potisnite čisto do konca, dokler se ne ustavi.
English: 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.
Slovenian: 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.
English: The effect of guselkumab on human fertility has not been evaluated.
Slovenian: Vpliva guselkumaba na plodnost pri ljudeh niso ovrednotili.
English: Inject within 5 minutes of removing the cap.
Slovenian: Zdravilo injicirajte v 5 minutah po odstranitvi pokrovčka.
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.
Slovenian: 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.
English: Patients should be instructed to inject the full amount of Tremfya according to the ‘Instructions for use' provided in the carton.
Slovenian: Bolnikom je treba naročiti, naj si injicirajo celotno količino zdravila Tremfya, skladno z "Navodili za injiciranje", ki so priložena v škatli z zdravilom.
English: The solution should be clear, colourless to light yellow, and may contain a few small white or clear particles.
Slovenian: Raztopina mora biti bistra, brezbarvna do svetlo rumena in lahko vsebuje nekaj majhnih belih ali prozornih delcev.
English: Prior to use, a visual inspection of the pre-filled syringe or pre-filled pen is recommended.
Slovenian: Pred uporabo je priporočljivo, da napolnjeno injekcijsko brizgo oziroma napolnjen injekcijski peresnik vizualno pregledate.
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.
Slovenian: 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.
English: The immunogenicity of Tremfya was evaluated using a sensitive and drug-tolerant immunoassay.
Slovenian: Imunogenost zdravila Tremfya so ocenjevali z občutljivo imunsko metodo s toleranco na zdravilo.
English: You should not be given certain types of vaccines (live vaccines) while using Tremfya.
Slovenian: Med uporabo zdravila Tremfya vam ne smejo dati nekaterih vrst cepiv (živa cepiva).
English: Summary of Patient Reported Outcomes in the Open-Label Phase in VOYAGE 1 Guselkumab
Slovenian: Povzetek izidov po navedbah bolnikov v odprti fazi študije VOYAGE 1 guselkumab adalimumab-guselkumab
English: Do not use Tremfya
Slovenian: Ne uporabljajte zdravila Tremfya
English: It should be clear to slightly yellow and may contain tiny white or clear particles.
Slovenian: Biti mora bistra do rahlo rumenkasta in lahko vsebuje drobne bele ali prosojne delce.