natgillin/translations-raw huggingface dataset:
Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.
Bolnikom je treba naročiti, da se posvetujejo z zdravnikom, če opazijo znake ali simptome, ki kažejo na okužbo.
How much Cosentyx is given and for how long Your doctor will decide how much Cosentyx you need and for how long.
Koliko zdravila Cosentyx je treba dajati in kako dolgo Koliko zdravila Cosentyx potrebujete in kako dolgo, bo določil vaš zdravnik.
If you think you may be allergic, ask your doctor for advice before using Cosentyx.
Če menite, da bi lahko bili alergični, se pred začetkom uporabe zdravila Cosentyx posvetujte z zdravnikom.
What you need to know before you use Cosentyx
Kaj morate vedeti, preden boste uporabili zdravilo Cosentyx
methionine, polysorbate 80 and water for injections.
polisorbat 80 in voda za injekcije.
Table 6 Change in modified Total Sharp Score in psoriatic arthritis
Preglednica 6 Sprememba modificirane skupne Sharpove ocene pri psoriatičnem artritisu
Approximately 15 to 25% of patients in phase III studies had psoriatic arthritis (PsA) at baseline.
Približno 15 do 25 % bolnikov v študijah faze III je imelo ob izhodišču psoriatični artritis.
Patient Instructions for Use
Navodila za uporabo za bolnike
Secukinumab has been shown to lower (within 1 to 2 weeks of treatment) levels of C-reactive protein, which is a marker of inflammation.
Dokazali so, da sekukinumab (v roku 1 do 2 tednov zdravljenja) zniža koncentracijo C-reaktivnega proteina, ki je označevalec vnetja.
Prepare the required number of vials (2 vials for the 300 mg dose).
Pripravite potrebno število vial (2 viali za odmerek 300 mg).
After using Cosentyx you should not breast-feed for at least 20 weeks after the last dose.
Po prenehanju uporabe zdravila Cosentyx še najmanj 20 tednov po zadnjem odmerku ne smete dojiti.
Table 1 List of adverse reactions in clinical studies and post-marketing experience
Preglednica 1 Seznam neželenih učinkov v kliničnih študijah in na osnovi izkušenj uporabe zdravila po prihodu na trg
Cosentyx is available in packs containing one vial.
Zdravilo Cosentyx je na voljo v pakiranju, ki vsebuje eno vialo.
DO NOT invert the vial.
Viale NE obračajte na glavo.
IGA mod 2011 “clear” or “almost clear” response n (%)
odziv IGA mod 2011 "brez znakov" ali "skoraj brez znakov" n (%)
Patients in these studies had a diagnosis of PsA of at least five years.
Diagnozo psoriatičnega artritisa so imeli bolniki v teh študijah že najmanj 5 let.
Preparing the Cosentyx pre-filled syringe ready for use Note: For a 300 mg dose, prepare 2 pre-filled syringes and inject the contents of both.
Priprava napolnjene injekcijske brizge z zdravilom Cosentyx na injiciranje Opomba: Za odmerek 300 mg pripravite 2 napolnjeni injekcijski brizgi in injicirajte vsebino obeh.
No pharmacokinetic data are available in patients with renal or hepatic impairment.
Pri bolnikih z okvaro ledvic ali jeter ni na voljo nobenih farmakokinetičnih podatkov.
Patients with each subtype of PsA were enrolled in these studies, including polyarticular arthritis with no evidence of rheumatoid nodules, spondylitis with peripheral arthritis, asymmetric peripheral arthritis, distal interphalangeal involvement and arthritis mutilans.
V ti dve študiji so bili vključeni bolniki z vsemi podtipi psoriatičnega artritisa, vključno s poliartikularnim artritisom brez revmatoidnih vozličev, s spondilitisom, s perifernim artritisom, z asimetričnim perifernim artritisom, s prizadetostjo distalnih interfalangealnih sklepov in z mutilirajočim artritisom.
After initial weekly dosing during the first month, time to reach the maximum concentration was between 31 and 34 days based on population pharmacokinetic analysis.
Po začetnem odmerjanju enkrat na teden v prvem mesecu je bilo po rezultatih analize populacijske farmakokinetike potrebno 31 do 34 dni za doseg najvišje koncentracije v plazmi.
• low blood pressure, which can cause dizziness or light-headedness
• nizek krvni tlak, ki lahko povzroča omotičnost ali slabost pred izgubo zavesti,
Slowly depress the plunger as far as it will go so that the plunger head is completely between the syringe guard wings.
Počasi potiskajte bat, dokler gre, tako da se na koncu glava bata povsem usede med krila zapirala brizge.
You should not be given certain types of vaccines (live vaccines) while using Cosentyx.
V času uporabe zdravila Cosentyx ne smete prejeti nekaterih vrst cepiv (živih cepiv).
In psoriasis studies, the safety and efficacy of secukinumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
V študijah niso ocenjevali varnosti in učinkovitosti sekukinumaba v kombinaciji z imunosupresivnim zdravljenjem, kar vključuje tudi biološka zdravila in fototerapijo.
Statistically significant difference in ACR 20 versus placebo was reached at week 3.
Do statistično značilne razlike pri doseganju odziva ACR 20 v primerjavi z uporabo placeba je prišlo v 3. tednu.
Cases of new or exacerbations of Crohn's disease and ulcerative colitis have been reported.
Poročani so bili primeri poslabšanja ter na novo nastale Crohnove bolezni in ulceroznega kolitisa.
Secukinumab works by targeting IL-17A and inhibiting its interaction with the IL-17 receptor, which is expressed on various cell types including keratinocytes.
Sekukinumab usmerjeno deluje proti IL-17A in zavira njegovo interakcijo z receptorjem za IL-17A, ki je prisoten na različnih vrstah celic, med drugim tudi na keratinocitih.
After reconstitution: The solution can be used immediately or can be stored at 2°C to 8°C for up to 24 hours.
Po rekonstituciji: Raztopino je mogoče uporabiti takoj, mogoče pa jo je do 24 ur shranjevati pri temperaturi od 2 °C do 8 °C.
Psoriasis study 2 (FIXTURE) evaluated 1,306 patients.
V 2. študiji psoriaze (študiji FIXTURE) so ocenjevali 1.306 bolnikov.
By touching them, the syringe guard may be activated too early.
Z dotikom lahko namreč prezgodaj aktivirate zapiralo brizge.
If necessary, Cosentyx can be left out of the refrigerator for a single period of up to 4 days at room temperature, not above 30°C.
Če je potrebno, je zdravilo Cosentyx mogoče pustiti izven hladilnika samo enkrat za največ 4 dni pri sobni temperaturi, ki ne presega 30 °C.
There are no adequate data from the use of secukinumab in pregnant women.
O uporabi sekukinumaba pri nosečnicah ni na voljo ustreznih podatkov.
Slowly release the plunger and allow the syringe guard to automatically cover the exposed needle.
Počasi spustite bat in pustite, da zapiralo brizge samodejno pokrije izpostavljeno iglo.
• upper respiratory tract infections with symptoms such as sore throat and stuffy nose
• okužbe zgornjih dihal s simptomi, kot sta vneto grlo oziroma žrelo in zamašen nos
Never leave the syringe lying around where others might tamper with it. Do not shake the syringe.
Injekcijske brizge nikoli ne puščajte ležati naokoli, da ne bi nanjo naleteli drugi ljudje.
Caution should be exercised when prescribing secukinumab to patients with inflammatory bowel disease, including Crohn's disease and ulcerative colitis.
Pri predpisovanju sekukinumaba bolnikom z vnetno črevesno boleznijo, kar vključuje Crohnovo bolezen in ulcerozni kolitis, je potrebna previdnost.
After storage at 2°C to 8°C, the solution should be allowed to come to room temperature for approximately 20 minutes before administration.
Po shranjevanju pri temperaturi med 2 °C in 8 °C je treba raztopino pred apliciranjem približno 20 minut pustiti na sobni temperaturi.
Its colour may vary from colourless to slightly yellow.
Njena barva lahko variira od brezbarvne do nekoliko rumenkaste.
Tilt the vial to an angle of approx. 45° and gently rotate between the fingertips for approx. 1 minute.
Vialo nagnite pod kotom približno 45° in jo rahlo sukajte med konicami prstov približno 1 minuto.
If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Cosentyx and for at least 20 weeks after the last Cosentyx dose.
Če ste ženska v rodni dobi, vam svetujemo, da se zaščitite pred zanositvijo, zato morate v času uporabe zdravila Cosentyx in še najmanj 20 tednov po zadnjem odmerku tega zdravila uporabljati primerno kontracepcijo.
As a precautionary measure, it is preferable to avoid the use of Cosentyx during pregnancy.
Iz previdnostnih razlogov se je med nosečnostjo uporabi zdravila Cosentyx bolje izogibati.
• abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems)
• trebušni krči in bolečine, driska, hujšanje ali kri v blatu (znaki težav s črevesjem).
Most of these were mild or moderate upper respiratory tract infections such as nasopharyngitis and did not require treatment discontinuation.
Večinoma je šlo za blage ali zmerne okužbe zgornjih dihal, kot je nazofaringitis, in zaradi njih ni bilo treba prekiniti zdravljenja.
Patients were blinded to the treatment regimen up to week 52, and the study continued to week 156.
Bolniki do 52. tedna niso vedeli, kateri režim zdravljenja prejemajo (slepo zdravljenje), študija pa je za njih trajala 156 tednov.
** p values versus placebo and adjusted for multiplicity: p<0.0001.
** vrednost p v primerjavi s placebom, prilagojena na številčnost primerjav: p<0,0001.
If possible, areas of the skin that show psoriasis should be avoided as injection sites.
Če je mogoče, se je treba pri izbiri mesta za injiciranje izogniti predelom kože, ki so prizadeti zaradi psoriaze.
Improvements in the PASI 75 response were seen in both subgroups and the 300 mg dose showed statistically significant benefit in the anti-TNFα-IR patients.
Izboljšanje pri doseganju odziva PASI 75 so opažali v obeh podskupinah, do statistično značilne prednosti pa je prišlo pri uporabi odmerka 300 mg pri anti-TNFα neodzivnih bolnikih.
• runny nose (rhinorrhoea)
• izcedek iz nosu (rinoreja).
• cold sores (oral herpes)
• herpes (oralni herpes),
After proper training in subcutaneous injection technique, patients may self-inject Cosentyx if a physician determines that this is appropriate.
Ko se bolniki naučijo tehnike subkutanega injiciranja, si lahko zdravilo Cosentyx injicirajo sami, če zdravnik presodi, da je to primerno, in bolnikom zagotovi ustrezne kontrolne preglede.
A new and unused Cosentyx SensoReady pen (2 pens are needed for a 300 mg dose).
nov in neuporabljen injekcijski peresnik SensoReady z zdravilom Cosentyx (za odmerek 300 mg potrebujete 2 injekcijska peresnika).
If a patient develops a serious infection, the patient should be closely monitored and secukinumab should not be administered until the infection resolves.
Če pride do resne okužbe, je treba bolnika skrbno spremljati in prekiniti odmerjanje sekukinumaba, dokler okužba ni odpravljena.
• It is preferable to avoid the use of Cosentyx in pregnancy.
• Najbolje je, da v času nosečnosti ne uporabljate zdravila Cosentyx.
Radiographs of hands, wrists, and feet were obtained at baseline, week 16 and/or week 24 and scored independently by at least two readers who were blinded to treatment group and visit number.
Rentgenske posnetke rok, zapestij in stopal so pridobili ob izhodišču, v tednu 16 in/ali tednu 24, ocenila pa sta jih neodvisno najmanj dva ocenjevalca, in sicer slepo, brez dostopa do podatkov o zdravljeni skupini in zaporedni številki obiska.
In an additional psoriasis study (CLEAR) 676 patients were evaluated.
V dodatni študiji psoriaze (študiji CLEAR) so ocenjevali 676 bolnikov.
If you forget to use Cosentyx
Če ste pozabili uporabiti zdravilo Cosentyx
Treatment success of “clear” or “almost clear” consisted of no signs of psoriasis or normal to pink colouration of lesions, no thickening of the plaque and none to minimal focal scaling.
Uspeh zdravljenja, ki je ocenjen z ocenama "brez znakov" oziroma "skoraj brez znakov", pomeni, da na koži ni nobenih znakov psoriaze oziroma da so lezije normalne do rožnate barve, brez zadebelitev v plake in brez luščenja ali z minimalnim luščenjem na posameznih mestih.
What Cosentyx is and what it is used for What you need to know before you use Cosentyx How to use Cosentyx
Kaj je zdravilo Cosentyx in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Cosentyx Kako uporabljati zdravilo Cosentyx Možni neželeni učinki
Caution should be exercised when considering the use of secukinumab in patients with a chronic infection or a history of recurrent infection.
Pri odločanju za uporabo sekukinumaba pri bolnikih s kronično okužbo ali z anamnezo ponavljajoče se okužbe je potrebna previdnost.
ACR: American College of Rheumatology; PASI: Psoriasis Area and Severity Index; DAS: Disease Activity Score; BSA: Body Surface Area
ACR: po kriterijih Ameriške akademije za revmatologijo (ACR - American College of Rheumatology); PASI: indeks izraženosti psoriaze in velikosti prizadete površine kože (PASI - Psoriasis Area and Severity Index); DAS: ocena aktivnosti bolezni (DAS - Disease Activity Score)
Make sure you discuss with your doctor when you will have your injections and your follow-up appointments.
Poskrbite, da se boste z zdravnikom dogovorili, kdaj boste prejemali injekcije in kdaj morate prihajati na kontrolne preglede.
You and your doctor should decide if you should inject Cosentyx yourself.
Skupaj z zdravnikom se lahko odločita, da si boste zdravilo Cosentyx injicirali sami.
Do not inject into areas where the skin is tender, bruised, red, scaly or hard.
Zdravila ne injicirajte v predele, kjer je koža bolj občutljiva, podpluta, rdeča, luskasta ali trda.
Clinically relevant levels of secukinumab reach the skin and reduce local inflammatory markers.
Sekukinumab v klinično pomembni koncentraciji doseže kožo in zmanjša koncentracijo lokalnih označevalcev vnetja.
Bring the vial of powder to room temperature and ensure that the sterile water for injections is at room temperature.
Pustite, da se viala s praškom ogreje na sobno temperaturo, in poskrbite, da bo tudi sterilna voda za injekcije sobne temperature.
Improvement in both endpoints was sustained for secukinumab patients who continued treatment through to week 24.
Pri obeh ciljih študije je pri bolnikih, ki so prejemali sekukinumab in nadaljevali z zdravljenjem, izboljšanje vztrajalo do 24. tedna.
Instructions for reconstitution of Cosentyx 150 mg powder for solution for injection: Bring the vial of powder to room temperature and ensure that the sterile water for injections is at room temperature.
Navodila za rekonstitucijo zdravila Cosentyx 150 mg prašek za raztopino za injiciranje: Pustite, da se viala s praškom ogreje na sobno temperaturo, in poskrbite, da bo tudi sterilna voda za injekcije sobne temperature.
Secukinumab is a monoclonal antibody which belongs to a group of medicines called interleukin (IL) inhibitors.
Sekukinumab je monoklonsko protitelo in sodi v skupino zdravil, ki jih imenujemo zaviralci interlevkina (IL).
Replace the attached needle with a 27G x ½″ needle.
Nameščeno iglo zamenjajte z iglo 27G x ½″ (12,7 mm).
Cosentyx, alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate (see section 5.1).
Zdravilo Cosentyx je kot samostojno zdravilo ali v kombinaciji z metotreksatom indicirano za zdravljenje aktivnega psoriatičnega artritisa pri odraslih bolnikih z nezadostnim odzivom na predhodno zdravljenje z imunomodulirajočimi antirevmatičnimi zdravili (DMARD - Disease Modifying Anti-Rheumatic Drugs) (glejte poglavje 5.1).
Secukinumab is a fully human IgG1/κ monoclonal antibody that selectively binds to and neutralises the proinflammatory cytokine interleukin-17A (IL-17A).
Sekukinumab je popolnoma humano monoklonsko protitelo IgG/κ, ki se selektivno veže na provnetni citokin interlevkin-17A (IL-17A) in ga nevtralizira.
Caution should be exercised when considering concomitant use of other immunosuppressants and secukinumab (see also section 4.5).
Pri odločanju za sočasno uporabo drugih imunosupresivnih zdravil in sekukinumaba je potrebna previdnost (glejte tudi poglavje 4.5).
• severe itching of the skin, with a red rash or raised bumps.
• hudo srbenje kože z rdečim izpuščajem ali bulicami.
Carefully withdraw slightly more than 1.0 ml of the solution for subcutaneous injection from the vial into a 1 ml graduated disposable syringe using a suitable needle (e.g. 21G x 2″).
Iz viale v 1-mililitrsko brizgo z merilnimi oznakami za enkratno uporabo previdno potegnite nekoliko več kot 1,0 ml raztopine za subkutano injiciranje s pomočjo ustrezne igle (na primer igle 21G x 2 ″).
If you have received more Cosentyx than you should or the dose has been administered sooner than according to your doctor's prescription, inform your doctor.
Če ste uporabili večji odmerek zdravila Cosentyx, kot bi smeli Če se prejeli več zdravila Cosentyx, kot bi smeli, ali ste odmerek prejeli prezgodaj glede na to, kar vam je predpisal zdravnik, obvestite zdravnika.
Patients randomised to etanercept received 50 mg doses twice per week for 12 weeks followed by 50 mg every week.
Bolniki, ki so bili randomizirani na prejemanje etanercepta, so prejemali odmerek 50 mg dvakrat na teden 12 tednov, nato pa odmerek 50 mg enkrat na teden.
In clinical studies, infections have been observed in patients receiving secukinumab (see section 4.8).
V kliničnih študijah so pri bolnikih, ki so prejemali sekukinumab, opažali pojavljanje okužb (glejte poglavje 4.8).
Psoriasis study 1 (ERASURE) evaluated 738 patients.
V 1. študiji psoriaze (študiji ERASURE) so ocenjevali 738 bolnikov.
Do not open the sealed outer box until you are ready to use this medicine.
Originalno zaprto zunanjo škatlo odprite šele takrat, ko boste pripravljeni za injiciranje zdravila.
Serious infections occurred in 0.14% of patients treated with secukinumab and in 0.3% of patients treated with placebo (see section 4.4).
Do resnih okužb je prišlo pri 0,14 % bolnikov, ki so prejemali sekukinumab, in pri 0,3 % bolnikov, ki so prejemali placebo (glejte poglavje 4.4).
With the needle pointing upward, gently tap the syringe to move any air bubbles to the top.
Konico igle usmerite navzgor in nežno potrkajte po brizgi, da se bodo morebitni zračni mehurčki premaknili proti vrhu.
Greater response rates favouring 300 mg were also observed for ASAS partial remission (ASAS PR) response at week 16 and were maintained up to week 156.
Večje deleže bolnikov z odzivom v prid odmerku 300 mg so opažali tudi pri delni remisiji po kriterijih ASAS (ASAS partial remission, ASAS PR) do 16. tedna in to se je ohranilo do 156. tedna.
Over the entire treatment period (a total of 3,430 patients treated with secukinumab for up to 52 weeks for the majority of patients), infections were reported in 47.5% of patients treated with secukinumab (0.9 per patient-year of follow-up).
V celotnem obdobju zdravljenja (ko je skupno 3.430 bolnikov prejemalo sekukinumab, večinoma do 52 tednov) so o okužbah poročali pri 47,5 % bolnikov, ki so prejemali sekukinumab (0,9 na enoto bolnik-leto spremljanja).
As a result, secukinumab inhibits the release of proinflammatory cytokines, chemokines and mediators of tissue damage and reduces IL-17A-mediated contributions to autoimmune and inflammatory diseases.
Na ta način sekukinumab posredno zavira sproščanje provnetnih citokinov, kemokinov in mediatorjev, ki povzročajo poškodbe tkiva, in zmanjša delovanje ter vpletenost IL-17A pri avtoimunskih in vnetnih boleznih.
The mean elimination half-life, as estimated from population pharmacokinetic analysis, was 27 days in plaque psoriasis patients, ranging from 18 to 46 days across psoriasis studies with intravenous administration.
Povprečni razpolovni čas izločanja je bil pri bolnikih s psoriazo s plaki po rezultatih analize populacijske farmakokinetike ocenjen na 27 dni in se je v študijah psoriaze z intravenskim odmerjanjem gibal v obsegu od 18 do 46 dni.
Table 5 Clinical response in PsA study 2 and PsA study 3 at week 16 and week 24
Preglednica 5 Klinični odziv v PsA študiji 2 in PsA študiji 3 po 16 in 24 tednih
ASAS: Assessment of SpondyloArthritis International Society Criteria; BASDAI: Bath Ankylosing Spondylitis Disease Activity Index; hsCRP: high-sensitivity C-reactive protein; ASDAS: Ankylosing Spondylitis Disease Activity Score; BSL: baseline
ASAS: ocena po kriterijih Mednarodnega združenja za spondiloartritis (ASAS - Assessment of Spondyloarthritis International Society); BASDAI: ocena Bathovega indeksa aktivnosti bolezni (BASDAI- Bath Ankylosing Spondylitis Disease Activity Index); hsCRP: C reaktivni protein visoke občutljivosti (hsCRP: C - high-sensitivity C-reactive protein); ASDAS: ocena aktivnosti ankilozirajočega spondilitisa (ASDAS - Ankylosing Spondylitis Disease Activity Score)
Keep the vial standing at room temperature for a minimum of 10 minutes to allow for dissolution.
Vialo pustite stati na sobni temperaturi najmanj 10 minut, da se vsebina lahko raztopi.
Rare cases of neutropenia <0.5x10
V redkih primerih so poročali o nevtropeniji z vrednostmi <0,5 x 10
After the medicine has been injected the syringe guard will be activated to cover the needle.
Po injiciranju zdravila se zapiralo brizge aktivira in pokrije iglo.
For Psoriatic Arthritis study 1 (PsA study 1) and Psoriatic Arthritis study 2 (PsA study 2), the primary endpoint was at week 24.
V 1. študiji psoriatičnega artritisa (PsA študiji 1) in v 2. študiji psoriatičnega artritisa (PsA študiji 2) so primarni cilj opazovali po 24 tednih.
1 pre-filled SensoReady pen 2 pre-filled SensoReady pens
1 napolnjen injekcijski peresnik SensoReady 2 napolnjena injekcijska peresnika SensoReady
There was an increase in mucosal or cutaneous candidiasis, consistent with the mechanism of action, but the cases were mild or moderate in severity, non-serious, responsive to standard treatment and did not necessitate treatment discontinuation.
Pogosteje je prihajalo do kandidoze sluznic in kože, kar je v skladu z mehanizmom delovanja zdravila, primeri pa so bili blago ali zmerno izraženi, niso bili opredeljeni kot resni, odzivali so se na običajno zdravljenje in zaradi njih ni bilo treba prekiniti zdravljenja psoriaze.
What Cosentyx looks like and contents of the pack Cosentyx powder for solution for injection is a white solid powder in a glass vial.
Izgled zdravila Cosentyx in vsebina pakiranja Cosentyx prašek za raztopino za injiciranje je bel trden prašek v stekleni viali.
The European Medicines Agency has waived the obligation to submit the results of studies with Cosentyx in plaque psoriasis in paediatric patients aged from birth to less than 6 years and in chronic idiopathic arthritis for paediatric patients aged from birth to less than 2 years (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Cosentyx pri psoriazi s plaki pri pediatričnih bolnikih v starostnem obdobju od rojstva do manj kot 6 let in pri kroničnem idiopatskem artritisu pri pediatričnih bolnikih v starostnem obdobju od rojstva do manj kot 2 leti (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
Inhibition of progression of structural damage was also assessed in PsA study 1 at weeks 24 and 52, compared to baseline.
Zaviranje napredovanja strukturnih okvar so ocenjevali tudi v PsA študiji 1 po 24 in po 52 tednih v primerjavi z izhodiščno vrednostjo.
Psoriasis study 5 (SCULPTURE) evaluated 966 patients.
V 5. študiji psoriaze (študiji SCULPTURE) so ocenjevali 966 bolnikov.
The number of PsA patients with axial involvement was too small to allow meaningful assessment.
Število bolnikov s psoriatičnim artritisom z aksialno prizadetostjo je bilo premajhno za ločeno ocenjevanje te podskupine.
In clinical studies, urticaria and rare cases of anaphylactic reaction to secukinumab were observed (see also section 4.4).
V kliničnih študijah so opažali pojavljanje urtikarije in redke primere anafilaktične reakcije na sekukinumab (glejte tudi poglavje 4.4).
ADRs from clinical studies and post-marketing reports (Table 1) are listed by MedDRA system organ class.
Neželeni učinki zdravila iz kliničnih študij ter poročil iz obdobja uporabe zdravila po prihodu na trg (preglednica 1) so navedeni po organskih sistemih klasifikacije MedDRA.