natgillin/translations-raw huggingface dataset:
Health-related quality of life / Patient reported outcomes Across VOYAGE 1 and 2 significantly greater improvements in health-related quality of life as measured by Dermatology Life Quality Index (DLQI) and in patient-reported psoriasis symptoms (itching, pain, burning, stinging and skin tightness) and signs (skin dryness, cracking, scaling, shedding or flaking, redness and bleeding) as measured by the Psoriasis Symptoms and Signs Diary (PSSD) were observed in guselkumab patients compared to placebo patients at Week 16 (Table 4).
Z zdravjem povezana kakovost življenja/izidi zdravljenja po oceni bolnikov V študijah VOYAGE 1 in 2 so v 16. tednu opazili pomembno večje izboljšanje pri bolnikih z guselkumabom kot pri bolnikih s placebom ali adalimumabom kar zadeva z zdravjem povezano kakovost življenja po oceni DLQI, po navedbah bolnikov glede simptomov psoriaze (srbenja, bolečin, skelenja, zbadanja in občutka zategovanja kože) in ocene znakov (suhosti kože, razpok na koži, luščenja kože, drobnega luščenja ali luščenja zaplat kože, rdečine in krvavitev) s pomočjo beleženja v dnevnik znakov in simptomov psoriaze (PSSD - Psoriasis Symptoms and Signs Diary) (Preglednica 4).
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).
Glede na primarni cilj opazovanja, odziv PASI 90 v 48. tednu, je bil guselkumab superiornejši kot adalimumab (84,5% proti 70,0%, p < 0,001).
In VOYAGE 2, patients randomised to guselkumab at Week 0 who were Psoriasis Area and Severity Index (PASI) 90 responders at Week 28 were re-randomised to either continue treatment with guselkumab q8w (maintenance treatment) or receive placebo (withdrawal treatment).
V študiji VOYAGE 2 so tiste bolnike, ki so bili v tednu 0 randomizirani na guselkumab, v 28. tednu pa so pri njih opazili odziv PASI 90 (tj. indeks jakosti psoriaze in telesne površine, prizadete s psoriazo - Psoriasis Area and Severity Index), ponovno randomizirali bodisi na nadalnje prejemanje guselkumaba vsakih 8 tednov (vzdrževalno zdravljenje) ali na prejemanje placeba (opustitev zdravljenja).
The pre-filled syringe or pre-filled pen should not be shaken.
Napolnjene injekcijske brizge oziroma napolnjenega injekcijskega peresnika ne smete stresati.
Use your free hand to grasp the body of the syringe.
Sprostite kožno gubo in premestite roko S prosto roko primite telo injekcijske brizge.
Some side effects are uncommon (may affect up to 1 in 100 people): - pain at the injection site - allergic reaction - skin rash
Nekateri neželeni učinki so občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): • bolečina na mestu injiciranja zdravila
In VOYAGE 1, for patients receiving continuous guselkumab treatment, the PASI 90 response rate was maintained from Week 52 through Week 156.
V študiji VOYAGE 1 se je pri bolnikih, ki so neprekinjeno prejemali guselkumab, odziv PASI 90 ohranil od 52. do 156. tedna.
NAVIGATE
Študija NAVIGATE
Patients randomised to adalimumab at Week 0 who were PASI 90 non-responders received guselkumab at Weeks 28, 32 and q8w thereafter.
Bolniki, ki so bili v tednu 0 randomizirani na prejemanje adalimumaba in niso dosegli odziva PASI 90, so prejeli guselkumab v 28. in 32. tednu ter nato vsakih 8 tednov.
Call your doctor or pharmacist for a new pre-filled pen.
Pokličite zdravnika ali farmacevta, da vam priskrbita nov napolnjen injekcijski peresnik.
• if you have an infection that does not go away or that keeps coming back
• če imate okužbo, ki je dolgotrajna ali ponavljajoča,
• if you recently had or are due to have a vaccination.
• če ste bili pred kratkim cepljeni oziroma boste cepljeni.
Prior to initiating treatment with Tremfya, patients should be evaluated for tuberculosis (TB) infection.
Ugotavljanje prisotnosti tuberkuloze pred zdravljenjem Pred začetkom zdravljenja z zdravilom Tremfya je treba bolnike pregledati in opraviti preiskave na prisotnost tuberkuloze.
There is limited information in subjects aged ≥ 65 years.
Podatki o uporabi zdravila pri starejših (starih 65 let ali več) so omejeni.
Withdrawal patients re-initiated guselkumab (dosed at time of retreatment, 4 weeks later and q8w thereafter) when they experienced at least a 50% loss of their Week 28 PASI improvement.
Bolniki so po opustitvi zdravljenja ponovno začeli prejemati guselkumab (z odmerjanjem ob začetku ponovne uvedbe, po 4 tednih in nato vsakih 8 tednov), če je pri njih prišlo do najmanj 50-odstotne izgube tistega izboljšanja odziva PASI 90, ki so ga dosegli v 28. tednu.
Tremfya 100 mg solution for injection in pre-filled syringe 1 mL solution in a pre-filled glass syringe with a fixed needle and a needle shield, assembled in an automatic needle guard.
Tremfya 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi 1 ml raztopine v napolnjeni stekleni injekcijski brizgi s pritrjeno iglo in ščitnikom igle, ki je vstavljen v avtomatsko varovalo.
• 1 Cotton ball or gauze pad
• 1 kosem vate ali zloženec iz gaze
Additionally, at 12 weeks after randomisation a higher proportion of guselkumab patients compared to ustekinumab patients achieved an IGA score 0/1 and ≥ 2 grade improvement (31.1% vs. 14.3%, respectively; p = 0.001) and a
Poleg tega je bil 12 tednov po randomizaciji večji delež bolnikov z guselkumabom, ki so dosegli oceno IGA 0/1 in izboljšanje za ≥ 2 stopnji (31,1% v primerjavi s 14,3%, p = 0,001) in odziv PASI 90 (48% v primerjavi s 23%, p < 0,001), kot delež bolnikov z ustekinumabom.
Serious side effects Tell your doctor or seek medical help immediately if you get any of the following side effects:
Če opazite katerega od naslednjih neželenih učinkov, takoj obvestite zdravnika ali poiščite zdravniško pomoč:
Guselkumab exerts clinical effects in plaque psoriasis through blockade of the IL-23 cytokine pathway.
Klinični učinki guselkumaba pri psoriazi s plaki so posledica zaviranja signalnih poti v katere je vpleten citokin IL-23.
Figure 1: Percent of Subjects Who Achieved a PASI 90 Response Through Week 48 by Visit (Subjects Randomised at Week 0) in VOYAGE 1
Slika 1: Odstotek preiskovancev, ki so dosegli odziv PASI 90 do konca 48. tedna po posameznih obiskih (glede na randomizacijo v tednu 0) v študiji VOYAGE 1
In pooled phase III analyses, approximately 9% of patients treated with Tremfya developed antidrug antibodies in up to 156 weeks of treatment.
Po rezultatih analize združenih podatkov študije faze III je v 156 tednih zdravljenja prišlo do nastanka protiteles proti zdravilu pri približno 9% bolnikov, zdravljenih z zdravilom Tremfya.
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.
V dveh študijah faze III sta bili povprečni najnižji serumski koncentraciji guselkumaba v stanju dinamičnega ravnovesja 1,15 μg/ml s standardno deviacijo ± 0,73 μg/ml oziroma 1,23 μg/ml s standardno deviacijo ± 0,84 μg/ml.
Remove needle cover
Snemite pokrovček z igle
You and your doctor should decide if you will breast-feed or use Tremfya.
Skupaj se bosta odločila, ali boste dojili ali pa prejemali zdravilo Tremfya.
Symptom score = 0, n (%) PSSD Sign score, subjects with baseline score > 0
ocena simptomov PSSD, preiskovanci z izhodiščno oceno > 0 ocena simptomov = 0, n (%) ocena znakov PSSD, preiskovanci z izhodiščno oceno > 0 ocena znakov = 0, n (%)
Take the pre-filled syringe out of the carton.
Napolnjeno injekcijsko brizgo vzemite iz škatle.
Patients randomised to guselkumab (N=825) received 100 mg at Weeks 0 and 4, and every 8 weeks (q8w) thereafter through Week 48 (VOYAGE 1) and Week 20 (VOYAGE 2).
Bolniki, ki so bili randomizirani na guselkumab, (N=825) so prejeli 100 mg guselkumaba v tednih 0 in 4, nato pa vsakih 8 tednov do konca 48. tedna (v študiji VOYAGE 1) oziroma do konca 20. tedna (v študiji VOYAGE 2).
Summary of Regional Disease Responses in VOYAGE 1 and VOYAGE 2 VOYAGE 1
Povzetek odzivov pri lokalizirani obliki bolezni v študijah VOYAGE 1 in VOYAGE 2
In VOYAGE 1 and 2, significant improvements were seen in scalp, hand and foot, and nail psoriasis (as measured by the Scalp-specific Investigator Global Assessment [ss-IGA], Physician's Global Assessment of Hands and/or Feet [hf-PGA], Fingernail Physician's Global Assessment [f-PGA] and Nail Psoriasis Severity Index [NAPSI], respectively) in guselkumab treated patients compared to placebo treated patients at Week 16 (p < 0.001, Table 3).
V študijah VOYAGE 1 in 2 so v 16. tednu (p < 0,001, Preglednica 3) pri bolnikih z guselkumabom opazili pomembno večje izboljšanje psoriaze lasišča, dlani in podplatov ter nohtov v primerjavi z bolniki s placebom (po merilih za psoriazo lasišča po oceni raziskovalca, Scalp-specific Investigator Global Assessment [ss-IGA], za palmoplantarno psoriazo po oceni raziskovalca, Physician's Global Assessment of Hands and/or Feet [hf-PGA], za psoriazo nohtov na rokah po oceni raziskovalca, Fingernail Physician's Global Assessment [f-PGA] in indeksa izraženosti psoriaze nohtov, Nail Psoriasis Severity Index [NAPSI]).
- The other ingredients are histidine, histidine monohydrochloride monohydrate, polysorbate 80,
• Druge sestavine zdravila so histidin, histidinijev klorid monohidrat, polisorbat 80, saharoza in voda za injekcije.
If you are uncertain, call your doctor or pharmacist for a new pre-filled pen.
Če ste v dvomu, pokličite zdravnika ali farmacevta, da vam priskrbita nov napolnjen injekcijski peresnik.
Guselkumab could not be detected in breast milk from cynomolgus monkeys as measured at post-natal day 28.
V mleku opic cinomolgus 28 dni po porodu niso zaznali prisotnosti guselkumaba.
Serious hypersensitivity reactions have been reported in the post-marketing setting.
Po prihodu zdravila na trg so poročali o resnih preobčutljivostnih reakcijah.
Check injection site
Preglejte mesto injiciranja
This medicine works by blocking the activity of a protein called IL-23, which is present at increased levels in people with psoriasis.
To zdravilo deluje tako, da nevtralizira aktivnost beljakovine, ki jo imenujemo IL-23.
In VOYAGE 2, all patients started to receive open-label guselkumab q8w at Week 76.
V študiji VOYAGE 2 so vsi bolniki začeli v tednu 76 odprto prejemati guselkumab vsakih 8 tednov.
Keep the pre-filled syringe in the carton and let it sit on a flat surface at room temperature for at least 30 minutes before use.
Napolnjen injekcijski peresnik pustite v škatli na ravni površini.Pred uporabo naj stoji na sobni temperaturi najmanj 30 minut.
You must look out for signs of these conditions while you are taking Tremfya.
V času prejemanja zdravila Tremfya morate biti pozorni na znake takih težav.
Tremfya 100 mg solution for injection in pre-filled pen 1 mL solution in a pre-filled glass syringe assembled in a pre-filled pen with an automatic needle guard.
Tremfya 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku 1 ml raztopine v napolnjeni stekleni brizgi, vstavljeni v napolnjen injekcijski peresnik z avtomatskim varovalom igle.
CARTON FOR PRE-FILLED SYRINGE MULTIPACK COMPRISING 2 PACKS (INCLUDING BLUE BOX)
BESEDILO NA ŠKATLI Z VEČJIM PAKIRANJEM, KI VSEBUJE 2 NAPOLNJENA INJEKCIJSKA PERESNIKA (VKLJUČNO Z MODRIM OKENCOM)
Call your doctor or pharmacist for a refill.
Pokličite zdravnika ali farmacevta, da vam zdravilo zamenja z novim.
Major Secondary Endpoints PASI 75 response at both Week 12 and Week 48
primarni cilj opazovanja odziv PASI 90 v 48. tednu glavni sekundarni cilji opazovanja odziv PASI 75 v 12. tednu in v
Figure 2: Percent of Subjects Who Achieved a PASI 90 Response by Visit in the Open-Label Phase in VOYAGE 1
Slika 2: Odstotek preiskovancev, ki so dosegli odziv PASI 90 od 52. do 156. tedna po posameznih obiskih v odprti fazi študije VOYAGE 1
Inspect liquid
Študija ECLIPSE
After removing the pre-filled syringe or pre-filled pen from the refrigerator, keep the pre-filled syringe or pre-filled pen inside the carton and allow to reach room temperature by waiting for 30 minutes before injecting Tremfya.
Ko vzamete napolnjeno injekcijsko brizgo ali napolnjen injekcijski peresnik iz hladilnika, ju pustite v škatli in pred injiciranjem zdravila Tremfya počakajte 30 minut, da zdravilo doseže sobno temperaturo.
The safety guard will cover the needle and lock into place, removing the needle from your skin.
Prenehajte pritiskati na bat Varnostni ščitnik bo potegnil iglo iz kože, jo pokril in se zaskočil.
Renal elimination of intact guselkumab, an IgG mAb, is expected to be low and of minor importance; similarly, hepatic impairment is not expected to influence clearance of guselkumab as IgG mAbs are mainly eliminated via intracellular catabolism.
Podobno tudi okvara jeter predvidoma ne vpliva na izločanje guselkumaba iz telesa, ker se monoklonska protitelesa IgG izločajo predvsem z znotrajceličnim katabolizmom.
Multipack: 2 (2 packs of 1) pre-filled syringes
Večje pakiranje: 2 napolnjeni ijnekcijski brizgi (2 pakiranji po 1 napolnjeno injekcijsko brizgo)
Before use, remove the carton from the refrigerator and keep the pre-filled syringe inside the carton and allow to reach room temperature by waiting for 30 minutes.
Pred uporabo vzemite škatlo iz hladilnika in napolnjen injekcijski peresnik pustite v škatli ter počakajte 30 minut, da zdravilo doseže sobno temperaturo.
Put your used syringe in a sharps disposal container right away after use.
Zavrzite uporabljen napolnjen injekcijski peresnik Uporabljen napolnjen injekcijski peresnik takoj po uporabi odložite v posodo za odstranjevanje ostrih predmetov.
Levels of IL-23 are elevated in the skin of patients with plaque psoriasis.
Pri bolnikih s psoriazo s plaki je koncentracija IL-23 v koži povečana.
What Tremfya looks like and contents of the pack Solution for injection (injection).
Izgled zdravila Tremfya in vsebina pakiranja
Skin and subcutaneous tissue disorders Common
Bolezni kože in podkožja pogosti urtikarija občasni izpuščaj
Tremfya is available in a pack containing one pre-filled syringe and in a multipack containing 2 (2 packs of 1) pre-filled syringes.
Zdravilo Tremfya je na voljo v pakiranju, ki vsebuje en napolnjen injekcijski peresnik in v večjem pakiranju, ki vsebuje 2 napolnjena injekcijska peresnika (2 pakiranji po 1 injekcijski peresnik).
p < 0.001 for superiority p < 0.001 for non-inferiority, p=0.062 for superiority formal statistical testing was not performed
48. tednu odziv PASI 75 v 12. tednu odziv PASI 90 v 12. tednu odziv PASI 100 v 48. tednu p < 0,001 za superiornost p < 0,001 za neinferiornost, p=0,062 za superiornost formalno statistično testiranje ni bilo izvedeno
Insert needle with a quick, dart-like motion.
Iglo potisnite v kožo s hitrim sunkovitim gibom.
Histidine monohydrochloride monohydrate Polysorbate 80
6.1 Seznam pomožnih snovi histidin histidinijev klorid monohidrat polisorbat 80 saharoza voda za injekcije
Tremfya 100 mg solution for injection in pre-filled syringe guselkumab
Tremfya 100 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku guselkumab
PASI 90 response at Week 48
48. teden PASI 75 PASI 90 PASI
Symptom score = 0, n (%)
ocena simptomov PSSD, preiskovanci z izhodiščno oceno > 0 ocena simptomov = 0, n (%)
Talk to your doctor, pharmacist or nurse before using Tremfya:
Pred začetkom uporabe zdravila Tremfya se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
• The dose is 100 mg (the content of 1 pre-filled syringe) given by injection under the skin
• Prvi odmerek 100 mg (vsebino enega napolnjenega injekcijskega peresnika) boste prejeli s podkožno injekcijo (subkutano), ki vam jo bo injiciral vaš zdravnik ali medicinska sestra.
(subcutaneous injection).
Raztopina za injiciranje (injekcija).
SINGLE-USE DEVICE
ZA ENKRATNO UPORABO
If you are uncertain, call your doctor or pharmacist for a refill.
Če ste v dvomu, pokličite zdravnika ali farmacevta, da vam zdravilo zamenja z novim.
Please read these Instructions for use before using the Tremfya pre-filled syringe and each time you get a refill.
Pred uporabo napolnjene injekcijske brizge zdravila Tremfya in vsakokrat, ko obnovite zalogo zdravil, preberite to Navodilo za injiciranje.
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.
Pri bolnikih, ki so bili v 28. tednu randomizirani na vzdrževalno zdravljenje, so izboljšanja ocen pri vseh treh vprašalnikih (SF-36, HADS in WLQ) vztrajala do konca 48. tedna in pri odpti fazi študije do 156. tedna.
Make sure you dispose of the bin as instructed by your doctor or nurse when the container is full.
Ko bo posoda za odstranjevanje ostrih predmetov polna, poskrbite, da jo boste zavrgli v skladu z navodili zdravnika ali medicinske sestre.
Your injection is now complete!
S tem ste zaključili injiciranje.
Each pre-filled syringe contains 100 mg of guselkumab in
Ena napolnjena injekcijska brizga vsebuje 100 mg guselkumaba v
Keep the pre-filled syringe or pre-filled pen in the outer carton in order to protect from light.
Napolnjeno injekcijsko brizgo ali napolnjen injekcijski peresnik shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
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.
Po enkratni subkutani injekciji odmerkov od 10 mg do 300 mg se je pri zdravih preiskovancih in pri bolnikih s psoriazo s plaki sistemska izpostavljenost guselkumabu (Cmax in AUC) povečevala približno sorazmerno z odmerkom.
Do not use the Tremfya pre-filled syringe if it is dropped.
Če vam napolnjena injekcijska brizga z zdravilom Tremfya pade iz rok, je ne uporabite.
Do not inject if perforations on the carton are broken.
Če je perforacija na škatli pretrgana, ne injicirajte zdravila.
However, you may decide together with your doctor to give Tremfya yourself in which case you will get the appropriate training on how to inject Tremfya.
Skupaj z zdravnikom se lahko odločita, da si boste zdravilo Tremfya injicirali sami.
Tremfya is used to treat adults with moderate to severe “plaque psoriasis”, an inflammatory condition affecting the skin and nails.
Psoriaza s plaki je vnetna bolezen, ki prizadane kožo in nohte.
Instructions for use Tremfya
Shranjevanje zdravila Tremfya
What Tremfya contains - The active substance is guselkumab.
• Učinkovina je guselkumab.
The yellow band indicates that the needle guard is locked.
zeleno telo okence pokrovček peresnika varovalo igle držalo
PRE-FILLED SYRINGE LABEL TEXT (100 mg)
BESEDILO NA NALEPKI NAPOLNJENE INJEKCIJSKE BRIZGE (100 mg)
Do not use if the expiration date has passed.
Če je rok uporabnosti potekel, zdravila ne uporabite.
Do not shake the pre-filled syringe at any time.
Napolnjene injekcijske brizge nikoli ne stresajte.
Each pre-filled pen contains 100 mg of guselkumab in
En napolnjen injekcijski peresnik vsebuje 100 mg guselkumaba v
Summary of Clinical Responses in VOYAGE 1 and VOYAGE 2 Number of patients (%)
Preglednica 2:Povzetek kliničnih odzivov v študijah VOYAGE 1 in VOYAGE 2
Some cases occurred several days after treatment with guselkumab, including cases with urticaria and dyspnoea.
V nakaterih primerih, vključno z urtikarijo in dispnejo, je do preobčutljivostne reakcije prišlo več dni po zdravljenju z guselkumabom.
Position fingers and insert needle
opazovalno okence pokrovček za iglo
Anti-TB therapy should be considered prior to initiating Tremfya in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.
Pri bolnikih, z latentno ali aktivno tuberkulozo v anamnezi, ki nimajo dokumentiranega ustreznega poteka zdravljenja, je treba pred začetkom zdravljenja z zdravilom Tremfya razmisliti o zdravljenju tuberkuloze.
Please read these Instructions for use before using the Tremfya pre-filled pen and each time you get a new pre-filled pen.
Pred uporabo napolnjenega injekcijskega peresnika z zdravilom Tremfya in vsakokrat, ko dobite nov napolnjen injekcijski peresnik, preberite to Navodilo za injiciranje.
It is supplied as a carton pack containing one single-dose glass syringe and as a multipack containing 2 (2 packs of 1) single-dose pre-filled syringes.
Na voljo je v škatli, ki vsebuje eno stekleno injekcijsko brizgo za enkratno odmerjanje in v večjem pakiranju, ki vsebuje 2 napolnjeni injekcijski brizgi za enkratno uporabo (2 pakiranji po 1 napolnjeno injekcijsko brizgo).
Diarrhoea
Cepljenja
In addition, reduced serum IL-17A, IL-17F and IL-22 levels compared to placebo were observed in guselkumab treated patients in phase II and phase III studies.
V isti študiji faze I je zdravljenje z guselkumabom omogočilo izboljšanje histoloških meril za psoriazo, ki so jih ocenjevali v 12. tednu in so vključevala zmanjšanje debeline epidermisa in gostote limfocitov T. Poleg tega so v študijah faze II in faze III pri bolnikih, ki so prejemali guselkumab, opazili manjše koncentracije IL-17A, IL-17F in IL-22 v serumu kot pri bolnikih s placebom.
Before injection
Pred injiciranjem bat
No new safety findings were observed in patients who switched from adalimumab to guselkumab.
Pri bolnikih, ki so prešli z adalimumaba na guselkumab, niso opazili nobenih novih ugotovitev v povezavi z varnostjo zdravila.
Do not pass it on to others.
Ne ogrevajte ga na noben drug način.
• Talk to your doctor if you are breast-feeding or are planning to breast-feed.
• Če dojite ali načrtujete dojenje, se posvetujte z zdravnikom.
1 pre-filled pen
• 1 samolepilni obliž
Inject Tremfya using the pre-filled syringe
Injicirajte zdravilo Tremfya z napolnjeno injekcijsko brizgo
Each pre-filled syringe contains 100 mg of guselkumab in 1 mL.
Ena napolnjena injekcijska brizga vsebuje 100 mg guselkumaba v 1 ml raztopine.
Keep hands away from the needle guard after the cap is removed.
Ko je pokrovček odstranjen, pazite, da se z rokami ne dotaknete varovala igle.
Do not lift the pre-filled pen during the injection.
Napolnjenega injekcijskega peresnika nikoli ne stresajte.
Stop using Tremfya and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious allergic reaction or an infection.
Če opazite katerekoli znake, ki bi lahko pomenili, da je prišlo do resne alergijske reakcije ali okužbe, prenehajte uporabljati zdravilo Tremfya in takoj obvestite zdravnika oziroma poiščite zdravniško pomoč.
The needle guard will lock and the full dose will not be delivered.
Med injiciranjem ne dvigujte napolnjenega injekcijskega peresnika, sicer se varovalo igle lahko zaskoči in ne boste prejeli celotnega odmerka.
Live vaccines should not be used concurrently in patients treated with Tremfya.
Bolniki, ki prejemajo zdravilo Tremfya, ne smejo sočasno prejeti živih cepiv.
1 pre-filled pen Component of a multipack, cannot be sold separately
Posamezni deli se ne smejo prodajati ločeno.
Histidine
Tremfya.
Tremfya contains the active substance guselkumab which is a type of protein called a monoclonal antibody.
To je vrsta beljakovine, ki jo imenujemo monoklonsko protitelo.
No new safety findings were observed in patients who switched from ustekinumab to guselkumab.
Pri bolnikih, ki so prešli z ustekinumaba na guselkumab, niso opazili nobenih novih težav v povezavi z varnostjo zdravila.
Injection site erythema Uncommon Injection site pain
Splošne težave in spremembe na mestu aplikacije pogosti eritem na mestu injiciranja občasni bolečina na mestu injiciranja
It is supplied as a carton pack containing one single-dose pre-filled pen and as a multipack containing 2 (2 packs of 1) single-dose pre-filled pens.
Na voljo je v škatli, ki vsebuje en napolnjen injekcijski peresnik za enkratno odmerjanje in v večjem pakiranju, ki vsebuje 2 napolnjena injekcijska peresnika za enkratno odmerjanje (2 pakiranji po 1 napolnjen injekcijski peresnik.
Tremfya 100 mg solution for injection in pre-filled syringe.
Tremfya 100 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
DLQI score > 1 at baseline, n Subjects with DLQI 0/1
156. teden indeks DLQI, preiskovanci z izhodiščno oceno > 1, n Preiskovanci z indeksom DLQI
Complete injection
Zaključek injiciranja
Throw the used pre-filled syringe away
Napolnjen injekcijski peresnik postavite na kožo
Inject Tremfya using the pre-filled pen
Injicirajte zdravilo Tremfya z napolnjenim injekcijskim peresnikom