natgillin/translations-raw huggingface dataset:
Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
Zdravljenja z risankizumabom se ne sme začeti pri bolnikih s klinično pomembno aktivno okužbo, dokler okužba ni obravnavana ali ustrezno zdravljena.
It may contain a few translucent to white product-related particles.
Vsebuje lahko nekaj prosojnih do belih z zdravilom povezanih delcev.
Table 4: Efficacy and quality of life results at week 16 in adults with plaque psoriasis in IMMVENT
Preglednica 4: Rezultati učinkovitosti in kakovosti življenja v 16. tednu pri odraslih s psoriazo v plakih v študiji IMMVENT
Co-primary endpoints No impact on health-related quality of life
Ni vpliva na kakovost življenja, povezano z zdravjem
For a full dose, two injections are needed, one after the other.
Za celoten odmerek sta potrebni dve injekciji, ena za drugo.
For a full dose, 2 injections are required, one after the other.
Za celoten odmerek sta potrebni 2 injekciji, ena za drugo.
• fungal skin infection
• glivična okužba kože
Women of childbearing potential should use an effective method of contraception during treatment and for at least 21 weeks after treatment.
Ženske v rodni dobi morajo med zdravljenjem in vsaj še 21 tednov po zdravljenju uporabljati učinkovito kontracepcijo.
Examination of age, gender, race, body weight ≤130 kg, baseline PASI score, concurrent psoriatic arthritis, previous non-biologic systemic treatment, previous biologic treatment, and previous failure of a biologic did not identify differences in response to risankizumab among these subgroups.
Analize starosti, spola, rase, telesne mase ≤130 kg, izhodiščne ocene PASI, sočasnega psoriatičnega artritisa, predhodnega nebiološkega sistemskega zdravljenja, predhodnega biološkega zdravljenja in predhodnega neuspeha bioloških zdravil niso pokazale razlik v odzivu na risankizumab med temi podskupinami.
Enrolled subjects were 18 years of age and older with plaque psoriasis who had a body surface area (BSA) involvement of ≥10%, a static Physician Global Assessment (sPGA) score of ≥3 in the overall assessment (plaque thickness/induration, erythema, and scaling) of psoriasis on a severity scale of 0 to 4, a Psoriasis Area and Severity Index (PASI) score ≥12, and who were candidates for systemic therapy or phototherapy.
Vključeni preiskovanci so bili stari 18 let ali več in so imeli psoriazo v plakih z zajetostjo ≥ 10 % telesne površine (BSA - Body Surface Area), statično zdravnikovo globalno oceno (sPGA - static Physician Global Assessment) ≥ 3 v celokupni oceni psoriaze (debelina/induracija plakov, eritem in luščenje) na lestvici izrazitosti od 0 do 4, oceno PASI (Psoriasis Area and Severity Index) ≥ 12 in so bili kandidati za sistemsko zdravljenje ali fototerapijo.
Throw away used syringes in a special disposal container.
Porabljeni injekcijski brizgi odvrzite v poseben vsebnik za odlaganje.
Nonclinical data revealed no special hazard for humans based on repeat-dose toxicity studies including safety pharmacology evaluations, and a reproductive and developmental toxicity study in cynomolgus monkeys at doses of up to 50 mg/kg/week (producing exposures of about 70 times the clinical exposure at maximum recommended human dose [MRHD]).
Predklinični podatki niso pokazali posebne ogroženosti pri človeku na podlagi študij toksičnosti ponavljajočih se odmerkov, vključno z varnostnimi farmakološkimi ocenami, ter študije reproduktivne in razvojne toksičnosti pri opicah cynomolgus v odmerkih do 50 mg/kg/teden (ki povzročijo približno 70-kratno klinično izpostavljenost ob največjem priporočenem odmerku za človeka).
Please read all of section 7 before using Skyrizi
Prosimo vas, da v celoti preberete poglavje 7, preden začnete uporabljati zdravilo Skyrizi.
Patients treated with risankizumab should be instructed to seek medical advice if signs or symptoms of clinically important chronic or acute infection occur.
Bolnikom, ki se zdravijo z risankizumabom je treba naročiti, naj poiščejo zdravniško pomoč, če se jim pojavijo znaki ali simptomi klinično pomembnih kroničnih ali akutnih okužb.
What Skyrizi is and what it is used for
Kaj je zdravilo Skyrizi in za kaj ga uporabljamo
If a serious hypersensivity reaction occurs, administration of risankizumab should be discontinued immediately and appropriate therapy initiated.
Če se pojavi resna preobčutljivostna reakcija, je treba uporabo risankizumaba nemudoma prekiniti in uvesti ustrezno zdravljenje.
• 2 pre-filled syringes and 2 alcohol pads (included in the carton)
• 2 napolnjeni injekcijski brizgi in 2 alkoholna zloženca (priložena v škatli)
The results for the co-primary and other endpoints are presented in Table 2 and Figure 1.
Rezultati soprimarnega in drugih opazovanih dogodkov so prikazani v preglednici 2 in na sliki 1.
In 270 patients who switched from adalimumab to risankizumab without a washout period, the safety profile of risankizumab was similar to that in patients who initiated risankizumab after wash out of any prior systemic therapies.
Pri 270 bolnikih, ki so prešli z adalimumaba na risankizumab brez obdobja izpiranja, so bile varnostne značilnosti risankizumaba podobne kot pri bolnikih, ki so začeli zdravljenje z risankizumabom po obdobju izpiranja katerega koli predhodnega sistemskega zdravljenja.
What you need to know before you use Skyrizi 3.
Kaj morate vedeti, preden boste uporabili zdravilo Skyrizi 3.
For each dose, the injections should be administered at different anatomic locations (such as thighs or abdomen), and not into areas where the skin is tender, bruised, erythematous, indurated or affected by psoriasis.
Za vsak odmerek je treba injekciji dati na drugem anatomskem mestu (npr. na stegnu ali na trebuhu); injicirati se ne sme v predele kože, ki je občutljiva, podpluta, eritematozna, zatrdela ali prizadeta zaradi psoriaze.
Mutagenicity and carcinogenicity studies have not been conducted with risankizumab.
Študij mutagenosti in karcinogenosti z risankizumabom niso izvedli.
• severe itching of the skin, with a red rash or raised bumps
• hudo srbenje kože z rdečim izpuščajem ali dvignjenimi bulicami.
IMMVENT enrolled 605 subjects (301 randomised to risankizumab and 304 to adalimumab).
Študija IMMVENT je zajela 605 preiskovancev (301 randomiziranega na risankizumab in 304 na adalimumab).
• Keep Skyrizi in the original carton to protect the medicine from light until it is time to use it
• Shranjujte zdravilo Skyrizi v originalni škatli za zagotovitev zaščite pred svetlobo, dokler ni čas za njegovo uporabo.
Upper respiratory infections
Okužbe zgornjih dihal
If you have used more Skyrizi than you should or the dose has been given sooner than prescribed, talk to your doctor.
Če ste uporabili večji odmerek zdravila Skyrizi, kot bi smeli Če ste uporabili večji odmerek zdravila Skyrizi, kot bi smeli, ali če ste odmerek uporabili prej, kot je predpisano, se posvetujte z zdravnikom.
Tell your doctor, pharmacist or nurse:
Obvestite zdravnika, farmacevta ali medicinsko sestro:
The effect of risankizumab on human fertility has not been evaluated.
Vpliva risankizumaba na plodnost pri človeku niso ocenili.
The injection site reactions were all mild to moderate in severity, none were serious, and none led to discontinuation of risankizumab.
Vse reakcije na mestu injiciranja so bile blage do zmerne, resnih ni bilo, in niso povzročile prenehanja uporabe risankizumaba.
Nail Psoriasis Severity Index (NAPSI), Palmoplantar Psoriasis Severity Index (PPASI), Psoriasis Scalp Severity Index (PSSI), and Standard Error (SE) ** P < 0.01 comparing to risankizumab *** P < 0.001 comparing to risankizumab
Indeks jakosti psoriaze nohtov (Nail Psoriasis Severity Index, NAPSI), indeks jakosti palmoplantarne psoriaze (Psoriasis Palmoplantar Severity Index, PPASI), indeks jakosti psoriaze lasišča (Psoriasis Scalp Severity Index, PSSI) in Standardna Napaka (SN) ** P < 0,01 v primerjavi z risankizumabom *** P < 0,001 v primerjavi z risankizumabom
The exposure of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), metoprolol (CYP2D6 substrate) and midazolam (CYP3A substrate) following risankizumab treatment were comparable to their exposures prior to risankizumab treatment, indicating no clinically meaningful drug interactions through these enzymes.
Izpostavljenost kofeinu (substratu CYP1A2), varfarinu (substratu CYP2C9), omeprazolu (substratu CYP2C19), metoprololu (substratu CYP2D6) in midazolamu (substratu CYP3A) po zdravljenju z risankizumabom je bila primerljiva z izpostavljenostjo pred zdravljenjem z risankizumabom; to kaže, da ni klinično pomembnih medsebojnih delovanj zdravil preko teh encimov.
ULTIMMA-1 and ULTIMMA-2 enrolled 997 subjects (598 randomised to risankizumab 150 mg, 199 to ustekinumab 45 mg or 90 mg [according to baseline weight], and 200 to placebo).
Študiji ULTIMMA-1 in ULTIMMA-2 sta zajeli 997 preiskovancev (598 randomiziranih na risankizumab 150 mg, 199 na ustekinumab 45 mg ali 90 mg [glede na izhodiščno telesno maso] in 200 na placebo).
• With the other hand, gently pull the needle cover straight off
• Z drugo roko previdno potegnite pokrovček igle naravnost dol.
Patients receiving risankizumab should be monitored for signs and symptoms of active TB.
Bolnike, ki prejemajo risankizumab, je potrebno nadzirati za znake in simptome aktivne TB.
Animal studies do not indicate direct or indirect harmful effects with respect to fertility.
Študije na živalih ne kažejo neposrednih ali posrednih škodljivih učinkov na plodnost.
The mean terminal elimination half-life of risankizumab ranged from 28 to 29 days in Phase 3 studies in subjects with psoriasis.
Povprečni terminalni eliminacijski razpolovni čas risankizumaba je v študijah 3. faze pri preiskovancih s psoriazo segal od 28 do 29 dni.
Change at Week 16 (SE)
Sprememba v 16. tednu (SN)
Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking Skyrizi such as:
Nemudoma obvestite zdravnika ali poiščite zdravniško pomoč, če med uporabo zdravila Skyrizi opazite kakšne znake alergijske reakcije, na primer:
Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment.
Pri bolnikih, ki se v 16 tednih ne odzovejo na zdravljenje, je treba razmisliti o prenehanju zdravljenja.
Skyrizi is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Zdravilo Skyrizi je indicirano za zdravljenje zmerne do hude psoriaze v plakih pri odraslih, ki so kandidati za sistemsko zdravljenje.
QR code to be included
Vstaviti je treba QR-kodo
Pre-filled glass syringe with a fixed needle and needle cover, assembled in an automatic needle guard.
Napolnjena injekcijska brizga s fiksno iglo in pokrovčkom igle, sestavljeno z avtomatičnim ščitnikom igle.
Overall, subjects had a median baseline PASI score of 17.8, a median BSA of 20.0%, and a median baseline DLQI score of 13.0.
Na splošno so imeli preiskovanci mediano izhodiščno oceno PASI 17,8, mediano prizadetost telesne površine 20,0 % in mediano izhodiščno oceno DLQI 13,0.
Risankizumab may increase the risk of infection.
Risankizumab lahko poveča tveganje za okužbo.
If you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of Skyrizi.
Če ste ženska, ki lahko zanosi, morate med uporabo zdravila Skyrizi in vsaj še 21 tednov po zadnjem odmerku tega zdravila uporabljati kontracepcijsko zaščito.
For a more comfortable injection: Take the carton out of the refrigerator and leave it at room temperature, out of direct sunlight, for 15 to 30 minutes before injecting.
Da injiciranje ne bo neprijetno: Vzemite škatlo iz hladilnika in jo za 15 do 30 minut pred injiciranjem pustite na sobni temperaturi zaščiteno pred neposredno sončno svetlobo.
Important information to know before you inject Skyrizi
Pomembne informacije, s katerimi morate biti seznanjeni, preden injicirate zdravilo Skyrizi
• Mark the dates on your calendar so you know when to inject Skyrizi
• Na koledarju označite datume, tako da boste vedeli, kdaj naslednjič uporabiti zdravilo Skyrizi.
Fatigue Injection site reactions
Utrujenost Reakcije na mestu injiciranja
• PASI 50 to <PASI 90 were re-randomised to either continue adalimumab or switch to risankizumab
• PASI 50 do < PASI 90 so bili ponovno randomizirani bodisi na nadaljevanje adalimumaba ali na prehod na risankizumab,
• Hold the syringe in one hand
• Primite injekcijsko brizgo z eno roko.
Drug interactions between risankizumab and inhibitors, inducers, or substrates of drug metabolising enzymes are not expected and no dose adjustment is needed (see section 5.2).
Prav tako ni pričakovati medsebojnih delovanj med risankizumabom in zaviralci, induktorji ali substrati encimov, ki presnavljajo zdravila, tako da prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
There is limited safety information in subjects aged ≥65 years.
Podatki o varnosti pri preiskovancih, starih ≥ 65 let, so omejeni.
IMMHANCE enrolled 507 subjects (407 randomised to risankizumab 150 mg and 100 to placebo).
Študija IMMHANCE je zajela 507 preiskovancev (407 randomiziranih na risankizumab 150 mg in 100 na placebo).
Reductions in epidermal thickness, infiltration of inflammatory cells, and expression of psoriatic disease markers were also observed in psoriatic lesions.
Na psoriatičnih lezijah so opažali tudi zmanjšanje debeline epidermisa, infiltracije z vnetnimi celicami in izraženosti označevalcev psoriatične bolezni.
Starting at week 16, subjects who were receiving adalimumab continued or switched treatment based on response:
Preiskovanci, ki so prejemali adalimumab, so od 16. tedna naprej zdravljenje nadaljevali ali ga zamenjali glede na odziv:
Do not rub the skin where you have injected.
Ne drgnite kože na mestu injiciranja.
In a 26-week chronic toxicology study in cynomolgus monkeys at doses of up to 50 mg/kg/week (about 70 times the clinical exposure at the MRHD), there were no pre-neoplastic or neoplastic lesions observed and no adverse immunotoxicity or cardiovascular effects were noted .
V 26-tedenski kronični toksikološki študiji pri opicah cynomolgus v odmerkih do 50 mg/kg/teden (približno 70-kratna klinična izpostavljenost ob največjem priporočenem odmerku za človeka) niso opažali predneoplastičnih ali neoplastičnih sprememb in nobenih neželenih imunotoksičnih ali srčno-žilnih učinkov.
Subjects randomised to adalimumab received 80 mg at week 0, 40 mg at week 1 and 40 mg every other week through week 15.
Preiskovanci, randomizirani na adalimumab, so dobili 80 mg 0. teden, 40 mg 1. teden in nato po 40 mg vsak drugi teden do 15. tedna.
Name and address of the manufacturer(s) of the biological active substance(s)
Ime in naslov proizvajalca (proizvajalcev) biološke učinkovine
Press a cotton ball or gauze pad where you have injected and hold for 10 seconds.
S kosmom vate ali zložencem gaze 10 sekund pritiskajte na mesto, kamor ste injicirali.
• Wait to remove the needle cover until just before the injection
• Pokrovček igle odstranite šele tik pred injiciranjem.
If you stop using Skyrizi
Če ste prenehali uporabljati zdravilo Skyrizi
Patients may self-inject Skyrizi after training in subcutaneous injection technique.
Bolniki si smejo zdravilo Skyrizi injicirati sami, potem ko se usposobijo za postopek subkutanega injiciranja.
Population pharmacokinetic analyses indicated that risankizumab exposure was not impacted by concomitant medications (metformin, atorvastatin, lisinopril, amlodipine, ibuprofen, acetylsalicylate and levothyroxine) used by some subjects with plaque psoriasis during the clinical studies.
Populacijske farmakokinetične analize so pokazale, da na izpostavljenost risankizumaba niso vplivala sočasno uporabljena zdravila (metformin, atorvastatin, lizinopril, amlodipin, ibuprofen, acetilsalicilat in levotiroksin), ki so jih v kliničnih študijah uporabljali nekateri preiskovanci s psoriazo v plakih.
Subjects who were originally on risankizumab and had a sPGA response of clear or almost clear at week 28 were rerandomised to continue risankizumab every 12 weeks or have treatment withdrawn.
Preiskovance, ki so prvotno prejemali risankizumab in so imeli v 28. tednu odziv sPGA čisto ali skoraj čisto, so ponovno randomizirali na nadaljevanje zdravljenja z risankizumabom na 12 tednov ali na prenehanje tega zdravljenja.
For subjects treated with risankizumab at the recommended clinical dose for up to 52 weeks in psoriasis clinical trials, treatment-emergent anti-drug antibodies and neutralising antibodies were detected in 24% (263/1,079) and 14% (150/1,079) of evaluated subjects, respectively.
Med preiskovanci, zdravljenimi z risankizumabom v priporočenih kliničnih odmerkih do 52 tednov v kliničnih preskušanjih pri psoriazi so med zdravljenjem ugotovili nastanek protiteles proti zdravilu pri 24 % (263/1 079) in nevtralizirajočih protiteles pri 14 % (150/1 079) ovrednotenih preiskovancev.
Risankizumab has no or negligible influence on the ability to drive and use machines.
Risankizumab nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
sPGA of clear or almost clear PASI 75
Ocena sPGA čista ali skoraj čista
• Do not throw away used syringes in the household waste
• Uporabljenih injekcijskih brizg ne smete odvreči med gospodinjske odpadke.
Skyrizi contains sorbitol and sodium This medicine contains 68 mg sorbitol per 150 mg dose.
Zdravilo Skyrizi vsebuje sorbitol in natrij To zdravilo vsebuje 68 mg sorbitola na 150-mg odmerek.
Skyrizi is administered by subcutaneous injection.
Zdravilo Skyrizi se uporablja s subkutanim injiciranjem.
Excipients: disodium succinate hexahydrate, succinic acid, sorbitol, polysorbate 20 and water for injections.
Pomožne snovi: dinatrijev sukcinat heksahidrat, sukcinska kislina, sorbitol, polisorbat 20 in voda za injekcije.
This medicinal product contains less than 1 mmol sodium (23 mg) per 150 mg dose, that is to say essentially ‘sodium free'.
To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 150-mg odmerek; to pomeni, da je praktično "brez natrija".
Risankizumab exhibited linear pharmacokinetics with dose-proportional increase in exposure across dose ranges of 18 to 300 mg and 0.25 to 1 mg/kg administered subcutaneously, and 200 to 1,200 mg and 0.01 to 5 mg/kg administered intravenously.
Risankizumab je imel linearno farmakokinetiko z odmerku sorazmernim povečanjem izpostavljenosti v razponu odmerkov od 18 do 300 mg in od 0,25 do 1 mg/kg subkutano ter od 200 do 1200 mg in od 0,01 do 5 mg/kg intravensko.
Skyrizi is not recommended for children and adolescents under 18 years of age.
Zdravilo Skyrizi ni priporočljivo za otroke in mladostnike, mlajše od 18 let, ker v tej starostni skupini ni raziskano.
ADA/ADA: Subjects randomised to adalimumab and continued on adalimumab ADA/RZB: Subjects randomised to adalimumab and switched to risankizumab p<0.05 at week 4 and p<0.001 at each time point beginning at week 8
ADA/RZB: Preiskovanci, randomizirani na adalimumab, ki so prešli na risankizumab p < 0,05 4. teden in p < 0,001 na vseh časovnih točkah, začenši z 8. tednom
Week 52 262 (86.2) sPGA of clear (0) Week 16 112 (36.8) Week 52 175 (57.6) PASI 75
52. teden 262 (86,2) Ocena sPGA čisto (0) 16. teden 112 (36,8) 52. teden 175 (57,6) PASI 75
In a study of subjects with psoriasis, expression of genes associated with the IL-23/IL-17 axis was decreased in the skin after single doses of risankizumab.
V študiji preiskovancev s psoriazo se je v koži izraženost genov, povezanih z osjo IL-23/IL-17, zmanjšala že po enkratnih odmerkih risankizumaba.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC (PROIZVAJALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJ
There is limited information in subjects aged ≥65 years.
Podatki pri preiskovancih, starih ≥ 65 let, so omejeni.
Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds with high affinity to the p19 subunit of human interleukin 23 (IL-23) cytokine without binding to IL12 and inhibits its interaction with the IL-23 receptor complex.
Risankizumab je humaniziran imunoglobulin G1 (IgG1), monoklonsko protitelo, ki se selektivno in z visoko afiniteto veže na podenoto p19 človeškega citokina interlevkina 23 (IL-23), brez vezave na IL12, ter zavre njegovo medsebojno delovanje z receptorskim kompleksom IL-23.
Table 2: Efficacy and quality of life results in adults with plaque psoriasis in ULTIMMA-1 and ULTIMMA-2
Preglednica 2: Rezultati učinkovitosti in kakovosti življenja pri odraslih s psoriazo v plakih v študijah ULTIMMA-1 in ULTIMMA-2
Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody selective to the interleukin (IL)-23 protein produced in Chinese Hamster Ovary cells using recombinant DNA technology.
Risankizumab je humaniziran imunoglobulin G1 (IgG1), monoklonsko protitelo, selektivno za beljakovino interlevkin (IL)-23; pridobljen je s tehnologijo rekombinantne DNA v celicah jajčnikov kitajskega hrčka.
solution for injection 2 pre-filled syringes 2 alcohol pads
raztopina za injiciranje 2 napolnjeni injekcijski brizgi 2 alkoholna zloženca
Before each injection, wipe where you will inject in a circular motion with an alcohol pad.
Pred vsakim injiciranjem s krožnim gibom z alkoholnim zložencem obrišite mesto, kamor boste injicirali.
A caregiver may also give your injections after they have been trained.
Injekcije vam lahko daje tudi oseba, ki za vas skrbi (vaš negovalec), potem ko se za to usposobi.
If you are not sure, talk to your doctor, pharmacist or nurse before and during the use of Skyrizi.
Če ste negotovi, se pred uporabo in med uporabo zdravila Skyrizi posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
A drug interaction study was conducted in subjects with plaque psoriasis to assess the effect of repeated administration of risankizumab on the pharmacokinetics of cytochrome P450 (CYP) sensitive probe substrates.
Pri preiskovancih s psoriazo v plakih so izvedli študijo medsebojnega delovanja zdravil za oceno vpliva ponavljajoče se uporabe risankizumaba na farmakokinetiko testnih substratov, občutljivih za citokrom P450 (CYP).
The dose is 150 mg given as two 75 mg injections.
Odmerek je 150 mg in se ga uporabi v dveh 75-mg injekcijah.
As an IgG1 monoclonal antibody, risankizumab is not expected to be filtered by glomerular filtration in the kidneys or to be excreted as an intact molecule in the urine.
Risankizumab je monoklonsko protitelo IgG1, zato ni pričakovati, da bi se v ledvicah filtriral z glomerulno filtracijo ali da bi se izločal v urinu kot intaktna molekula.
What you need to know before you use Skyrizi
Kaj morate vedeti, preden boste uporabili zdravilo Skyrizi
For the second syringe, inject at least 3 cm away from the first injection.
Z drugo injekcijsko brizgo injicirajte vsaj 3 cm proč o mesta, kamor ste dali prvo injekcijo.
You should not be given certain types of vaccines while using Skyrizi.
Med uporabo zdravila Skyrizi ne smete dobiti določenih vrst cepiv.
Change at Week 52 (SE)
Sprememba v 52. tednu (SN)
• Keep the syringes in the carton until ready to inject
• Injekcijske brizge shranjujte v škatli, dokler niste pripravljeni za injiciranje.
Keep the syringe steady at the same angle.
Injekcijsko brizgo mirno držite pod istim kotom.
Week 12 264 (86.8) Week 52 279 (91.8) PASI 90
12. teden 264 (86,8) 52. teden 279 (91,8) PASI 90
If you forget to use Skyrizi
Če ste pozabili uporabiti zdravilo Skyrizi
For PASI 90 responders at week 16, 88.4% (398/450) of subjects maintained the response at week 52.
Med preiskovanci z odzivom PASI 90 v 16. tednu se je odziv v 52. tednu ohranil pri 88,4 % (398/450).
Place the following items on a clean, flat surface:
Na čisto, ravno površino položite:
By blocking IL-23 from binding to its receptor, risankizumab inhibits IL-23-dependent cell signalling and release of proinflammatory cytokines.
Z blokado vezave IL-23 na njegov receptor risankizumab zavre od IL-23 odvisno celično signaliziranje in sproščanje vnetnih citokinov.
• if the syringe paper tray cover is broken or missing
• če je papirnat podstavek injekcijske brizge poškodovan ali manjka.