FrancophonIA/ELRC3.0 huggingface dataset:
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: podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: Ilumetri 100 mg injection tildrakizumab SC
Slovenian: Ilumetri 100 mg injekcija tildrakizumab SC
English: 1 mL solution in a type I glass pre-filled syringe with stainless steel 29G x ½” needle, covered with a needle shield and rigid needle shield of polypropylene with a fluropolymer lamination, plunger stopper assembled in a passive safety device.
Slovenian: 1 ml raztopine v napolnjeni injekcijski brizgi iz stekla vrste I z iglo iz nerjavnega jekla 29G x ½”, prekrito s ščitnikom za iglo in togim ščitnikom iz polipropilena, prevlečenega s fluropolimerom, zamaškom z batom, sestavljenem v pasivnem zaščitnem pripomočku.
English: Improvements were maintained over time with at week 52, 63.7% (100 mg) and 73.3% (200 mg) in reSURFACE 1, and 68.8% (100 mg) and 72.4% (200 mg) in reSURFACE 2 of patients who were PASI 75 responders at week 28 having a DLQI of 0 or 1.
Slovenian: Izboljšanja so se s časom ohranila do 52. tedna, 63,7 % (100 mg) in 73,3 % (200 mg) v reSURFACE 1 in 68,8 % (100 mg) in 72,4 % (200 mg) v reSURFACE 2 bolnikov, ki so bili PASI 75 odzivni v 28. tednu, je imelo DLQI 0 ali 1.
English: - Choose a different location for the second injection.
Slovenian: - Za drugo injekcijo izberite drugo mesto injiciranja.
English: c No imputation for missing data.
Slovenian: c Brez imputacije za manjkajoče podatke.
English: What Ilumetri is and what it is used for What you need to know before you use Ilumetri How to use Ilumetri
Slovenian: Kaj je zdravilo Ilumetri in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ilumetri Kako uporabljati zdravilo Ilumetri Možni neželeni učinki
English: Ronda General Mitre, 151 08022 Barcelona, Spain
Slovenian: Ronda General Mitre, 151 08022 Barcelona, Španija
English: - Check the expiration date on the carton and pre-filled syringe and discard if the date has passed.
Slovenian: - Preverite datum izteka roka uporabnosti na škatli in napolnjeni injekcijski brizgi ter zdravilo zavrzite, če je datum potekel.
English: No formal trial of the effect of hepatic or renal impairment on the pharmacokinetics of tildrakizumab was conducted.
Slovenian: Formalnih preskušanj učinka jetrne ali ledvične okvare na farmakokinetiko tildrakizumaba niso izvedli.
English: o A complete dose is administered if the blue plunger cannot go any further, and there are no spills.
Slovenian: o Celotni odmerek ste uporabili, ko se modri bat ne more več premikati naprej in ni nič razlito.
English: The safety and efficacy of Ilumetri in children and adolescents under 18 years of age has not yet been established and therefore Ilumetri is not recommended for use in children or adolescents.
Slovenian: Varnost in učinkovitost zdravila Ilumetri pri otrocih in mladostnikih, starih do 18 let, še nista bili dokazani, zato se uporaba zdravila Ilumetri pri otrocih in mladostnikih ne priporoča.
English: Ilumetri 200 mg --> Placebo**
Slovenian: Zdravilo Ilumetri 200 mg --> placebo**
English: If you have administered more Ilumetri than you should or the dose has been administered sooner than according to your doctor's prescription, tell your doctor.
Slovenian: Če menite, da ste si dali več zdravila Ilumetri, kot bi smeli, ali pa da ste odmerek prejeli prej, kot vam je predpisal zdravnik, se posvetujte z zdravnikom.
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 28 weeks of treatment.
Slovenian: Pri bolnikih, ki se po 28 tednih niso odzvali na zdravljenje, je treba razmisliti o prekinitvi zdravljenja.
English: In a pre- and postnatal development toxicity study in monkeys, no related increase in pregnancy loss was observed at exposures up to 85 times the human exposure at the recommended dose.
Slovenian: V študiji razvojne toksičnosti pred rojstvom in po njem pri opicah niso opazili povezanega povečanja prekinitev nosečnosti pri izpostavljenostih, ki so za 85-krat presegale izpostavljenost priporočenim odmerkom pri ljudeh.
English: In case your dose is 200 mg, you will need to use 2 pre-filled syringes each time you administer the product.
Slovenian: Če potrebujete 200-mg odmerek, boste morali vsakič uporabiti 2 napolnjeni injekcijski brizgi.
English: If you are not sure if any of the above applies to you, talk to your doctor, pharmacist or nurse before using Ilumetri.
Slovenian: Če niste prepričani, ali katera od zgornjih trditev velja za vas, se pogovorite z zdravnikom ali medicinsko sestro, preden začnete uporabljati zdravilo Ilumetri.
English: Two neonatal deaths from monkeys administered tildrakizumab at maternal exposure of 85 times the human exposure at the recommended dose were attributed to possible viral infection and considered of uncertain relationship to the treatment.
Slovenian: Dve smrti novorojencev opic, ki so jim dajali tildrakizumab z izpostavljenostjo matere, ki je za 85-krat presegala izpostavljenost priporočenim odmerkom pri ljudeh, so pripisali možni virusni okužbi in smatrali, da je razmerje z zdravljenjem negotovo.
English: Prior to use, a visual inspection of the pre-filled syringe is recommended.
Slovenian: Pred uporabo je priporočljivo napolnjeno injekcijsko brizgo vizualno pregledati.
English: Patients should be instructed to seek medical advice if signs or symptoms suggestive of a clinically relevant chronic or acute infection occur.
Slovenian: Bolnikom je treba naročiti, da se posvetujejo z zdravnikom, če opazijo znake ali simptome, ki kažejo na klinično pomembne kronične ali akutne okužbe.
English: - If you currently have an infection or if you have long-term or repeated infections.
Slovenian: - če imate trenutno, dolgotrajno ali ponavljajočo okužbo; - če ste se nedavno cepili ali se nameravate cepiti.
English: • Clean the injection site with an alcohol wipe and allow the skin to dry.
Slovenian: • Mesto injiciranja očistite z alkoholnim zložencem; počakajte, da se koža osuši.
English: Animal studies do not indicate direct or indirect harmful effect with respect to reproductive toxicity (see section 5.3).
Slovenian: Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na sposobnost razmnoževanja (glejte poglavje 5.3).
English: Live vaccines should not be given concurrently with Ilumetri (see section 4.4).
Slovenian: Živih cepiv se ne sme dajati sočasno z zdravilom Ilumetri (glejte poglavje 4.4).
English: If a serious hypersensivity reaction occurs, administration of Ilumetri should be discontinued immediately and appropriate therapy initiated.
Slovenian: Če se pojavi resna preobčutljivostna reakcija, je treba zdravljenje z zdravilom Ilumetri prekiniti in takoj uvesti ustrezno zdravljenje.
English: Patients randomised to tildrakizumab 100 mg or tildrakizumab 200 mg in Part 1 who were PASI 75 responders at week 28 (reSURFACE1).
Slovenian: Bolniki, randomizirani tako, da so prejemali tildrakizumab 100 mg ali tildrakizumab 200 mg v 1. delu, ki so bili odzivni na PASI 75 v 28. tednu (reSURFACE1).
English: If you use more Ilumetri than you should
Slovenian: Če ste uporabili večji odmerek zdravila Ilumetri, kot bi smeli
English: The safety and efficacy of Ilumetri in children and adolescents below the age of 18 years have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Ilumetri pri otrocih in mladostnikih, starih do 18 let, še nista bili dokazani.
English: - DO NOT use if the liquid contains visible particles or the syringe is damaged.
Slovenian: - NE uporabljajte, če tekočina vsebuje vidne delce ali je injekcijska brizga poškodovana.
English: EU/1/18/1323/002 2 pre-filled syringes
Slovenian: EU/1/18/1323/002 2 napolnjeni injekcijski brizgi
English: Caution should be exercised when considering the use of Ilumetri in patients with a chronic infection or a history of recurrent or recent serious infection.
Slovenian: Pri presojanju uporabe zdravila Ilumetri pri bolnikih s kronično okužbo ali ponovljeno ali nedavno resno okužbo v anamnezi je potrebna previdnost.
English: The effect of Ilumetri on human fertility has not been evaluated.
Slovenian: Učinka zdravila Ilumetri na sposobnost razmnoževanja pri ljudeh niso ovrednotili.
English: Concomitant medicines affecting Ilumetri pharmacokinetics are not expected since it is cleared from the body by general protein catabolism processes with no contribution of cytochrome P450 (CYP450) enzymes, and it is not eliminated by renal or hepatic pathways.
Slovenian: Sočasno zdravljenje z zdravili, ki vplivajo na farmakokinetiko zdravila Ilumetri, se ne pričakuje, saj se iz telesa izloča v postopku splošne razgradnje beljakovin brez sodelovanja encimov citokroma P450 (CYP450), in se ne izloča skozi ledvice ali jetra.
English: a Long-term response in patients who were responders (had achieved at least PASI 75) to tildrakizumab at week 28. b No imputation for missing data.
Slovenian: a Dolgoročni odziv pri bolnikih, ki so se odzvali (dosegli vsaj PASI 75) na tildrakizumab v 28. tednu.
English: Following administration of 100 mg or 200 mg of tildrakizumab, subjects who are 65 years or older (n=81 and n=82, respectively) had a similar tildrakizumab clearance as compared to subjects less than 65 years old (n=884).
Slovenian: Po dajanju 100 mg ali 200 mg tildrakizumaba osebam, starim 65 let ali več (n = 81 oz. n = 82), je bil očistek tildrakizumaba primerljiv s tistim pri osebah, starih manj kot 65 let (n = 884).
English: Ilumetri has no or negligible influence on the ability to drive and use machines.
Slovenian: Zdravilo Ilumetri nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
English: The recommended dose of Ilumetri is 100 mg by subcutaneous injection at weeks 0, and 4 and every 12 weeks thereafter.
Slovenian: Priporočeni odmerek zdravila Ilumetri je 100 mg s subkutano injekcijo v 0. in 4. tednu, nato pa vsak 12 teden.
English: Inject the full amount of tildrakizumab according to the instructions for use provided in the package leaflet.
Slovenian: Injicirajte vso količino tildrakizumaba v skladu z navodili v navodilu za uporabo.
English: • While holding the body of the pre-filled syringe, remove the needle cover as shown and discard.
Slovenian: • Telo napolnjene injekcijske brizge držite in medtem odstranite pokrovček za iglo, kot je prikazano, in ga zavrzite.
English: Use the syringe within 30 days after taking it out of the refrigerator or by the expiry date whichever occurs first.
Slovenian: Injekcijsko brizgo uporabite v 30 dneh po tem, ko ste jo vzeli iz hladilnika, ali do dneva izteka roka uporabnosti, kar je prej.
English: In these studies, patients were randomised to either placebo or tildrakizumab (including 200 mg and 100 mg at 0, 4 and every twelve weeks thereafter [Q12W]), up to 52 or 64 weeks.
Slovenian: V teh študijah so bili bolniki randomizirani tako, da so prejemali placebo ali tildrakizumab (vključno z 200 mg in 100 mg v 0. in 4. tednu, nato pa vsaka dva tedna, do 52 ali 64 tednov.
English: Ilumetri should not be injected into areas where the skin is affected by plaque psoriasis or is tender, bruised, red, hard, thick, or scaly.
Slovenian: Zdravila Ilumetri se ne sme injicirati na mestih, kjer je koža občutljiva, poškodovana, pordela, trda, debela, luskasta ali prizadeta zaradi psoriaza v plakih.
English: Its colour may vary from colourless to slightly yellow.
Slovenian: Barva se lahko razlikuje od brezbarvne do rumenkaste.
English: If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use an effective method of contraception whilst having treatment with Ilumetri and for at least 17 weeks after treatment.
Slovenian: Če ste ženska v rodni dobi, vam odsvetujemo zanositev; med zdravljenjem z zdravilom Ilumetri in še vsaj 17 tednov po zdravljenju morate uporabljati učinkovito kontracepcijsko metodo.
English: Prior to initiating treatment with tildrakizumab, consider completion of all appropriate immunisations according to current immunisation guidelines.
Slovenian: Pred začetkom zdravljenja s tildrakizumabom je treba pretehtati možnost, da bolnik opravi vsa potrebna cepljenja v skladu z veljavnimi smernicami za cepljenje.
English: If you notice any of the following, contact your doctor immediately: - Swelling of the face, lips or throat - Breathing difficulties As these may be signs of an allergic reaction.
Slovenian: Če opazite kaj od naslednjega, se takoj posvetujte z zdravnikom: - otekanje obraza, ustnic ali žrela; - težave z dihanjem.
English: The multicentre, randomised, double-blind, placebo-controlled trials reSURFACE 1 and reSURFACE 2 studies enrolled a total of 1,862 patients 18 years of age and older with plaque psoriasis who had a minimum body surface area involvement of 10%, a Physician Global Assessment (PGA) score of ≥3 in the overall assessment (plaque thickness, erythema, and scaling) of psoriasis on a severity scale of 0 to 5, a
Slovenian: V multicentrični, randomizirani, dvojno slepi, s placebom nadzorovani preskušanji reSURFACE 1 in reSURFACE 2 je bilo skupaj vključenih 1.862 bolnikov, starih 18 let in več, s psoriazo s plaki, ki so imeli prizadete vsaj 10 % telesne površine, splošno oceno psoriaze po oceni raziskovalca (Physician Global Assessment, PGA) (debelina plaka, eritem in luščenje) ≥ 3 na lestvici resnosti od 0 do 5, rezultat ≥ 12 po indeksu izraženosti psoriaze in velikosti prizadete površine kože (Psoriasis Area and Severity Index, PASI) in so bili primerni kandidati za fototerapijo ali sistemsko zdravljenje.
English: If you forget to use Ilumetri
Slovenian: Če ste pozabili uporabiti zdravilo Ilumetri
English: Single use only.
Slovenian: Samo za enkratno uporabo.
English: A field for the date is provided on the carton to record the removal from refrigerator date.
Slovenian: Na škatli je okence, v katero se zabeleži datum, ko se zdravilo vzame iz hladilnika.
English: Summary of Response Rates in Studies reSURFACE 1 and reSURFACE 2
Slovenian: Povzetek stopenj odziva v študijah reSURFACE 1 in reSURFACE 2
English: *The number of doses administered refers only to tildrakizumab groups.
Slovenian: *Število danih odmerkov se nanaša le na skupine z tildrakizumabom.
English: 5347 JN Oss The Netherlands
Slovenian: Organon Veersemeer 4 5347 JN Oss Nizozemska
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Slovenian: Prilogi V. S tem, ko poročate o neželenih učinkih, lahko prispevate k zagotovitvi več informacij o varnosti tega zdravila.
English: Ilumetri is used to treat a skin condition called plaque psoriasis, in adults with moderate to severe disease.
Slovenian: Zdravilo Ilumetri se uporablja za zdravljenje bolezni kože, imenovane psoriaza s plaki, pri odraslih z zmerno do hudo boleznijo.
English: Almirall B.V. Tel: +31 (0)307991155
Slovenian: Tel: +31 (0)307991155
English: If you stop using Ilumetri
Slovenian: Če ste prenehali uporabljati zdravilo Ilumetri
English: L-Histidine hydrochloride monohydrate Polysorbate 80
Slovenian: L-histidinijev klorid monohidrat Polisorbat 80
English: Maintenance of Response in Studies reSURFACE 1 and reSURFACE 2
Slovenian: Vzdrževanje odziva v študijah reSURFACE 1 in reSURFACE 2
English: W4 W8 W12 W16 W22 W28 W32 W36 W40 W44 W48 W52 W56 W60 W64 Ilumetri 100 mg --> Placebo**
Slovenian: T4 T8 T12 T16 T22 T28 T32 T36 T40 T44 T48 T52 T56 T60 T64
English: Doses up to 10 mg/kg intravenously have been safely administered in clinical trials.
Slovenian: V kliničnih preskušanjih je bilo intravensko dajanje odmerkov do 10 mg/kg varno.
English: Choose an injection site
Slovenian: Izberite mesto injiciranja
English: Once taken out of the refrigerator, do not store tildrakizumab above 25ºC or refrigerate it again.
Slovenian: Tildrakizumaba, ki ste ga vzeli iz hladilnika, ne shranjujte pri temperaturi nad 25 °C in ne dajajte nazaj v hladilnik.
English: • After inserting the needle, let go of the skin gently.
Slovenian: • Po vstavitvi igle kožo nežno spustite.
English: What Ilumetri looks like and contents of the pack
Slovenian: Izgled zdravila Ilumetri in vsebina pakiranja
English: Excipients: L-Histidine, L-Histidine hydrochloride monohydrate, polysorbate 80, sucrose and water for injections.
Slovenian: Pomožne snovi: L-histidin, L-histidinijev klorid monohidrat, polisorbat 80, saharoza in voda za injekcije.
English: After proper training in subcutaneous injection technique, you may inject Ilumetri yourself if your doctor determines that it is appropriate.
Slovenian: Ko se naučite tehnike pravilnega subkutanega injiciranja, si lahko zdravilo Ilumetri injicirate sami, če zdravnik oceni, da je to ustrezno.
English: - If you have an infection which your doctor thinks is important, for example, active tuberculosis which is an infectious disease affecting mainly the lungs.
Slovenian: - če ste alergični na tildrakizumab ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če imate okužbo, za katero vaš zdravnik meni, da je pomembna, na primer aktivna tuberkuloza, ki je infekcijska bolezen, ki prizadene zlasti pljuča.
English: Furthermore, Ilumetri does not impact the pharmacokinetics of concomitant medicines metabolized by CYP450 enzymes either through direct or indirect mechanisms (see section 5.2).
Slovenian: Zdravilo Ilumetri prav tako ne vpliva na farmakokinetiko sočasnih zdravil, ki jih presnavljajo encimi CYP450, niti z neposrednimi niti s posrednimi mehanizmi (glejte poglavje 5.2).
English: In cynomolgus monkeys, there was negligible secretion of the product into breast milk.
Slovenian: Pri opicah cynomolgus se je zdravilo v zanemarljivi količini izločalo v materino mleko.
English: • Remove the pre-filled syringe from the carton when ready to inject.
Slovenian: • Napolnjeno injekcijsko brizgo vzemite iz škatle, ko ste pripravljeni na injiciranje.
English: Unopened pre-filled syringe of Ilumetri may be removed from the refrigeration and stored up to 25°C for a single period of up to 30 days.
Slovenian: Neodprta napolnjena injekcijska brizga zdravila Ilumetri se lahko vzame iz hladilnika in za 30-dnevno obdobje shrani pri temperaturi do 25 °C.
English: This is what Ilumetri pre-filled syringe looks like:
Slovenian: Zdravilo Ilumetri napolnjene injekcijske brizge je videti tako:
English: • Dispose of used syringe in a sharps disposal container right away after use and before injecting a second syringe.
Slovenian: • Uporabljeno injekcijsko brizgo zavrzite v zbiralnik za ostre predmete, preden si injicirate drugo injekcijsko brizgo.
English: How to use Ilumetri
Slovenian: Kako uporabljati zdravilo Ilumetri
English: Therefore, tildrakizumab does not impact the pharmacokinetics of concomitant medicines metabolized by CYP enzyme (see section 4.5).
Slovenian: Tildrakizumab tako ne vpliva na farmakokinetiko sočasnih zdravil, ki jih presnavlja encim CYP (glejte poglavje 4.5).
English: Ilumetri has no or little effect on the ability to drive and use machines.
Slovenian: Zdravilo Ilumetri nima vpliva ali ima blag vpliv na sposobnost vožnje in upravljanja strojev.
English: After taking a pre-filled syringe from the refrigerator, wait approximately 30 minutes to allow the Ilumetri solution in the syringe to reach room temperature (up to 25ºC).
Slovenian: Ko napolnjene injekcijske brizge vzamete iz hladilnika, počakajte približno 30 minut, da se zdravilo Ilumetri raztopina v injekcijski brizgi ogreje na sobno temperaturo (do 25 °C).
English: Clearance values range from 2.04 to 2.52 mL/day/kg and the half-life was 23.4 days (23% CV) in subjects with plaque psoriasis.
Slovenian: Pri osebah s psoriazo v plakih je razpon vrednosti očistka od 2,04 do 2,52 ml/dan/kg in razpolovni čas je bil 23,4 dni (23 % vrednosti očistka).
English: Do not use this medicine after the expiry date which is stated on the carton and the label of the pre-filled syringe after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki napolnjene injekcijske brizge poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: The pre-filled syringe should be taken out of the refrigerator 30 minutes before injecting to allow it to reach room temperature (up to 25ºC).
Slovenian: Injekcijsko brizgo vzemite iz hladilnika 30 minut pred injiciranjem, da se ogreje na sobno temperaturo (do 25 ºC).
English: It is preferable to avoid the use of Ilumetri in pregnancy.
Slovenian: Po možnosti se je treba uporabi zdravila Ilumetri med nosečnostjo izogniti.
English: Three placebo-controlled studies (Phase 2b and two Phase 3) were integrated to evaluate the safety of Ilumetri in comparison to placebo.
Slovenian: Za ocenitev varnosti zdravila Ilumetri v primerjavi s placebom so bile vključene tri s placebom nadzorovane študije (ena faze 2b in dve faze 3).
English: Once removed from the refrigerator and stored under these conditions, discard after 30 days or by the expiry date printed on the container, whichever occurs first.
Slovenian: Zdravilo, vzeto iz hladilnika in shranjeno v teh pogojih, je treba v 30 dneh ali do dneva izteka roka uporabnosti, kar je prej, zavreči.
English: Ilumetri is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Slovenian: Zdravilo Ilumetri je namenjeno za uporabo pod vodstvom in nadzorom zdravnika, ki ima izkušnje z diagnosticiranjem in zdravljenjem psoriaze.
English: If you feel the need, you can use a sticky plaster to cover the injection site.
Slovenian: Če menite, da je potrebno, lahko mesto injiciranja prekrijete z lepljivim obližem.
English: Tildrakizumab is catabolized into component amino acids by general protein degradation processes and is not eliminated by renal or hepatic pathways.
Slovenian: Tildrakizumab se katabolizira v sestavino aminokislin v procesu splošne razgradnje beljakovin in se ne izloča po ledvični ali jetrni poti.
English: Each pre-filled syringe contains 100 mg of tildrakizumab in 1 mL.
Slovenian: Ena napolnjena injekcijska brizga vsebuje 100 mg tildrakizumaba v 1 ml.
English: The maintenance of response in studies reSURFACE1 and reSURFACE2 are presented in Table 3.
Slovenian: Ohranjen odziv v študijah reSURFACE1 in reSURFACE2 je predstavljen v preglednici 3.
English: Tildrakizumab exhibited dose-proportional pharmacokinetics in subjects with plaque psoriasis over a dose range from 50 mg to 400 mg following subcutaneous administration, with clearance being independent of dose.
Slovenian: Pri osebah s psoriazo v plakih je bila farmakokinetika tildrakizumaba po subkutanem dajanju odvisna od odmerka v razponu odmerka od 50 mg do 400 mg, z očistkom, odvisnim od odmerka.
English: Common aIncluding nasopharyngitis.
Slovenian: Pogosti aVključno z nazofaringitisom.
English: As a precautionary measure, it is preferable to avoid the use of Ilumetri during pregnancy.
Slovenian: Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Ilumetri bolje izogibati.
English: At steady state, following administration of 100 mg of tildrakizumab in subjects with moderate to severe plaque psoriasis geometric means (% CV) of AUC0-τ and Cmax values were respectively 305 μg·day/mL (41%) and 8.1 μg/mL (34%), whereas they were 612 μg·day/mL (40%) and 16.3 μg/mL (33%) following administration of 200 mg.
Slovenian: V stanju dinamičnega ravnovesja so bile po dajanju 100 mg tildrakizumaba pri osebah z zmerno do hudo psoriazo v plakih geometrične srednje vrednosti (% CV) vrednosti AUC0-τ in Cmax 305 µg·dan/ml (41%) oz. 8,1 μg/ml (34 %), pri čemer so bile 612 μg·dan/ml (40 %) oz. 16,3 µg/ml (33 %) po dajanju 200 mg. Porazdelitev
English: Almirall N.V. Tél/Tel: +32 (0)2 771 86 37
Slovenian: Tél/Tel: +32 (0)2 771 86 37
English: PC: SN:
Slovenian: PC:
English: Maintenance and durability of PASI 90 response over time is presented in Figure 1.
Slovenian: Ohranjen odziv PASI 90 in njegovo vzdrževanje je predstavljeno na sliki 1.