natgillin/translations-raw huggingface dataset:
In PsA study 2, the proportion of patients achieving a modified PsA Response Criteria (PsARC) response was greater in the secukinumab-treated patients (59.0% and 61.0% for 150 mg and 300 mg, respectively) compared to placebo (26.5%) at week 24.
V PsA študiji 2 je bil delež bolnikov, ki so po 24 tednih zdravljenja dosegli odziv po spremenejenih kriterijih za psoriatični artritis (PsARC - modified PsA Response Criteria), večji v skupini s sekukinumabom (59,0 % oziroma 61,0 % pri odmerkih 150 mg oziroma 300 mg) v primerjavi z uporabo placeba (26,5 %).
Similar responses for primary and key secondary endpoints were seen in PsA patients regardless of whether they were on concomitant MTX treatment or not.
Pri bolnikih s psoriatičnim artritisom so opažali približno enake odzive pri primarnem cilju študije in glavnih sekundarnih ciljih študije ne glede na to, ali so sočasno prejemali metotreksat ali ne.
The co-primary endpoints in the placebo and active-controlled studies were the proportion of patients who achieved a PASI 75 response and IGA mod 2011 “clear” or “almost clear” response versus placebo at week 12 (see Tables 2 and 3).
V s placebom in aktivno kontroliranih študijah je bil primarni cilj študije sestavljen, in sicer iz deleža bolnikov, ki dosežejo odziv PASI 75 (izboljšanje indeksa PASI za najmanj 75 %, pri čemer PASI pomeni indeks izraženosti psoriaze in velikosti prizadete površine kože - PASI - Psoriasis Area and Severity Index), in iz deleža bolnikov, ki dosežejo odziv IGA mod 2011 (po oceni raziskovalca, IGAInvestigator's Global Assessment) z oceno "brez znakov" ali "skoraj brez znakov" v primerjavi z ustreznima deležema bolnikov, ki so prejemali placebo, po 12 tednih zdravljenja (glejte preglednici 2 in 3).
Instructions for use of the Cosentyx SensoReady pen
Navodila za uporabo injekcijskega peresnika SensoReady z zdravilom Cosentyx
You must look out for signs of these conditions while you are taking Cosentyx.
V času uporabe zdravila Cosentyx morate biti pozorni na znake teh bolezni.
At each timepoint you will receive a 300 mg dose given as two injections of 150 mg.
Vsakokrat boste prejeli odmerek 300 mg v obliki dveh injekcij po 150 mg.
Store in the refrigerator between 2°C and 8°C.
Shranjujte v hladilniku pri temperaturi od 2 °C in 8 °C.
Week 24 *p<0.05 based on nominal, but non adjusted, p-value 1secukinumab 150 mg or 300 mg s.c. at weeks 0, 1, 2, 3, and 4 followed by the same dose every month 10 mg/kg at weeks 0, 2 and 4 followed by subcutaneous doses of 75 mg or 150 mg
Skupna ocena izhodiščna ocena (SD) povprečna sprememba po 24 tednih *p<0,05 glede na absolutno vrednost, gre za neprilagojeno vrednost p 1sekukinumab 150 mg ali 300 mg subkutano v tednih 0, 1, 2, 3 in 4, nato enak odmerek enkrat na mesec 10 mg/kg v tednih 0, 2 in 4, nato subkutano odmerjanje 75 mg ali 150 mg
The onset of action of secukinumab 150 mg occurred as early as week 1 for ASAS 20 and week 2 for ASAS 40 (superior to placebo) in AS study 2.
V AS študiji 2 je sekukinumab v odmerku 150 mg glede na odziv ASAS 20 začelo delovati že v 1. tednu, glede na odziv ASAS 40 pa v 2. tednu (bilo je boljše od placeba).
Instructions for use of Cosentyx pre-filled syringe
Navodila za uporabo napolnjene injekcijske brizge z zdravilom Cosentyx
One vial contains 150 mg secukinumab.
Ena viala vsebuje 150 mg sekukinumaba.
Also contains: Sucrose, histidine, histidine hydrochloride monohydrate, polysorbate 80.
Vsebuje tudi: saharozo, histidin, histidinijev klorid monohidrat, polisorbat 80.
• after the expiry date which is stated on the outer box or the label on the syringe after “EXP”.
• po datumu izteka roka uporabnosti, ki je naveden na zunanji škatli in na nalepki injekcijske brizge poleg oznake "Uporabno do" oziroma "EXP",
Enthesitis resolution n (%) ‡ Week 16
odpravljen entezitis n (%) ‡ teden 16
At week 16, patients who were randomised to placebo at baseline were re-randomised to receive secukinumab (either 75 mg or 150 mg subcutaneously) every month.
Po 16 tednih so bolnike, ki so bili sprva randomizirani na prejemanje placeba, ponovno randomizirali, tako da so prejemali sekukinumab (bodisi 75 mg ali 150 mg subkutano) enkrat na mesec.
Week 24 *p<0.05 based on nominal, but non adjusted, p-value secukinumab 150 mg or 300 mg s.c. at weeks 0, 1, 2, 3, and 4 followed by the same dose every month 10 mg/kg at weeks 0, 2 and 4 followed by subcutaneous doses of 75 mg or 150 mg
Skupna ocena izhodiščna ocena (SD) povprečna sprememba po 24 tednih *p<0,05 glede na absolutno vrednost, gre za neprilagojeno vrednost p sekukinumab 150 mg ali 300 mg subkutano v tednih 0, 1, 2, 3 in 4, nato enak odmerek enkrat na mesec 10 mg/kg v tednih 0, 2 in 4, nato subkutano odmerjanje 75 mg ali 150 mg
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) - pre-filled syringe
VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ PODATKOV V t.i. MODREM OKENCU) - napolnjena injekcijska brizga
Greater efficacy of secukinumab compared to ustekinumab for the endpoints PASI 75/90/100 and IGA mod 2011 0 or 1 response (“clear” or “almost clear”) was observed early and continued through to week 52.
Pri doseganju odzivov PASI 75/90/100 in odzivov IGA mod 2011 "0" oziroma "1" ("brez znakov" ali "skoraj brez znakov" kožne prizadetosti) so večjo učinkovitost sekukinumaba v primerjavi z ustekinumabom opažali zgodaj v poteku zdravljenja, učinek pa je vztrajal vse do 52. tedna.
Stop using Cosentyx and tell your doctor or seek medical help immediately if you get any of the following side effects:
Če pride do katerega od naslednjih neželenih učinkov, prenehajte uporabljati zdravilo Cosentyx in takoj obvestite zdravnika ali poiščite zdravniško pomoč.
• discharge from the eye with itching, redness and swelling (conjunctivitis)
• izcedek iz očesa s srbenjem, rdečino in oteklino (vnetje očesne veznice, konjunktivitis)
Cosentyx 150 mg solution for injection is supplied in a single-use pre-filled syringe for individual use.
Zdravilo Cosentyx 150 mg raztopina za injiciranje je na voljo v napolnjeni injekcijski brizgi za enkratno uporabo za posameznega bolnika.
• itchy rash (urticaria)
• srbeč izpuščaj (urtikarija)
Statistically significant improvements (decreases) at week 12 from baseline in the scalp psoriasis study were demonstrated in patient reported signs and symptoms of scalp itching, pain and scaling compared to placebo.
V študiji psoriaze lasišča so od izhodišča do 12. tedna v primerjavi s placebom dokazali tudi statistično značilno izboljšanje (zmanjšanje izraženosti in pogostnosti) znakov in simptomov srbenja, bolečin in luščenja kože po navedbah bolnikov.
ASAS 20 responses were improved at week 16 in both anti-TNFα-naïve patients (68.2% versus 31.1%; p<0.05) and anti-TNFα-IR patients (50.0% versus 24.1%; p<0.05) for secukinumab 150 mg compared with placebo, respectively.
Pri uporabi odmerka 150 mg sekukinumaba je v primerjavi z uporabo placeba večji delež bolnikov dosegel odziv ASAS 20 po 16 tednih, in sicer tako med bolniki, ki predhodno še niso prejemali zaviralca TNFα (68,2 % v primerjavi z 31,1 %; p<0,05), kot med anti-TNFα neodzivnimi bolniki (50,0 % v primerjavi s 24,1 %; p<0,05).
In both study 3 and study 4, patients randomised to secukinumab received 150 mg or 300 mg doses at weeks 0, 1, 2, 3 and 4, followed by the same dose every month.
Tako v 3. kot v 4. študiji so bolniki, ki so bili randomizirani na prejemanje sekukinumaba, prejeli odmerke 150 mg oziroma 300 mg v tednih 0, 1, 2, 3 in 4, nato pa enak odmerek enkrat na mesec.
Stop using Cosentyx and tell your doctor or seek medical help immediately if you notice any signs indicating a possible serious infection or an allergic reaction.
Če opazite znake, ki kažejo na možnost pojava resne okužbe ali alergijske reakcije, takoj prenehajte uporabljati zdravilo Cosentyx in obvestite zdravnika oziroma poiščite zdravniško pomoč.
Cosentyx 150 mg solution for injection is supplied in a single-use pre-filled pen for individual use.
Zdravilo Cosentyx 150 mg raztopina za injiciranje je na voljo v napolnjenem injekcijskem peresniku za enkratno uporabo za posameznega bolnika.
• after the expiry date which is stated on the outer box or the label on the pen after “EXP”.
• po datumu izteka roka uporabnosti, ki je naveden na zunanji škatli in na nalepki injekcijskega peresnika poleg oznake "Uporabno do" oziroma "EXP",
How to use the Cosentyx pre-filled syringe
Kako uporabljati napolnjeno injekcijsko brizgo z zdravilom Cosentyx
Inspection window Internal needle cover
• zbiralnik za ostre predmete igla zapiralo igle pokrovček pregledno okence notranje pokrivalo igle
Cosentyx 150 mg powder for solution for injection
Cosentyx 150 mg prašek za raztopino za injiciranje
Most pharmacokinetics properties observed in patients with plaque psoriasis, psoriatic arthritis and ankylosing spondylitis were similar.
Pri bolnikih s psoriazo s plaki, s psoriatičnim artritisom in pri tistih z ankilozirajočim spondilitisom so bile farmakokinetične lastnosti večinoma podobne.
In Ankylosing Spondylitis study 1 (AS study 1), Ankylosing Spondylitis study 2 (AS study 2), and Ankylosing Spondylitis study 3 (AS study 3), 27.0%, 38.8%, and 23.5% of patients, respectively, were previously treated with an anti-TNFα agent and discontinued the anti-TNFα agent for either lack of efficacy or intolerance (anti-TNFα-IR patients).
V AS študiji 1, AS študiji 2 in AS študiji 3 je bilo 27,0 %, 38,8 % oziroma 23,5 % bolnikov predhodno zdravljenih z zaviralcem TNFα, zdravljenje z njim pa so prekinili bodisi zaradi neučinkovitosti ali neprenašanja zdravila (anti-TNFα neodzivni bolniki).
How to store Cosentyx
Shranjevanje zdravila Cosentyx
The powder is a white solid lyophilisate.
prašek za raztopino za injiciranje Prašek je bel liofilizat v trdni obliki.
Multipack: 6 (3 packs of 2) pre-filled syringes
Skupno pakiranje: 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg
In the GESTURE study, secukinumab was superior to placebo at week 16 (33.3% for 300 mg, 22.1% for 150 mg, and 1.5% for placebo) as assessed by significant improvement of ppIGA 0 or 1 response (“clear” or “almost clear”) for patients with moderate to severe palmoplantar plaque psoriasis.
V študiji GESTURE je bil pri bolnikih z zmerno do hudo palmoplantarno psoriazo s plaki sekukinumab boljši od placeba glede na oceno pomembnega izboljšanja od izhodišča do 16. tedna na osnovi ocene ppIGA (izraženost palmoplantarne psoriaze po oceni raziskovalca) oziroma doseganja odziva "0" oziroma "1" ("brez znakov" ali "skoraj brez znakov" prizadetosti) (33,3 % pri odmerku 300 mg, 22,1 % pri odmerku 150 mg in 1,5 % pri uporabi placeba).
Expel the air bubbles and advance the plunger to the 1.0 ml mark.
Iztisnite zračne mehurčke in potiskajte bat še naprej do oznake 1,0 ml. Z alkoholnim zložencem očistite mesto za injiciranje na koži.
Statistically significant improvements in patient-reported signs and symptoms of itching, pain and scaling at week 16 and week 52 (CLEAR) were demonstrated in the Psoriasis Symptom Diary©
Pri bolnikih, ki so prejemali sekukinumab, so v primerjavi s tistimi, ki so prejemali ustekinumab, s pomočjo dnevnika simptomov psoriaze (Psoriasis Symptom Diary©) dokazali statistično značilno izboljšanje znakov in simptomov srbenja, bolečin in luščenja kože po navedbah bolnikov v 16. in 52. tednu (študija CLEAR).
Each 300 mg dose is given as two subcutaneous injections of 150 mg.
Bolnik prejme vsak 300-miligramski odmerek v obliki dveh subkutanih injekcij po 150 mg.
The renal elimination of intact secukinumab, an IgG monoclonal antibody, is expected to be low and of minor importance.
Nespremenjen sekukinumab, torej monoklonsko protitelo IgG, naj bi se po pričakovanjih izločalo skozi ledvice v majhnem obsegu in tako ledvično izločanje nima velikega pomena.
Disposing of your Cosentyx SensoReady pen:
Odstranjevanje injekcijskega peresnika SensoReady z zdravilom Cosentyx:
For other patients, the recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Za druge bolnike je priporočeni odmerek 150 mg s subkutano injekcijo, in sicer z začetnim odmerjanjem enkrat na teden v tednih 0, 1, 2, 3 in 4.
Cosentyx contains the active substance secukinumab.
Zdravilo Cosentyx vsebuje zdravilno učinkovino sekukinumab.
Serious infections have been observed in patients receiving secukinumab in the post-marketing setting.
V okviru izkušenj po prihodu zdravila na trg so pri bolnikih, ki so prejemali sekukinumab, opažali resne okužbe.
The recommended dose is 300 mg of secukinumab by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Priporočeni odmerek je 300 mg sekukinumaba s subkutano injekcijo in sicer z začetnim odmerjanjem enkrat na teden v tednih 0, 1, 2, 3 in 4.
Dispose of the used syringe in a sharps container (closable, puncture resistant container).
Uporabljeno brizgo zavrzite v zbiralnik za ostre predmete (vsebnik, ki ga je mogoče zapreti, in je narejen iz materiala, ki ga ni mogoče prebosti).
Secukinumab-treated patients without concomitant MTX use had a higher ACR 20 response (53.6% and 53.6% for 150 mg and 300 mg, respectively, compared to placebo 10.4%) and ACR 50 response (37.5% and 32.1% for 150 mg and 300 mg, respectively, compared to placebo 6.3%).
Tudi tisti bolniki, ki so prejemali sekukinumab brez sočasne uporabe metotreksata, so v večjem deležu dosegali odziv ACR 20 (53,6 % oziroma 53,6 % pri odmerkih 150 mg oziroma 300 mg v primerjavi z 10,4 % pri uporabi placeba).
A caregiver may also give you your Cosentyx injection after proper training.
Zdravilo Cosentyx vam lahko po ustreznem usposabljanju injicira tudi vaš negovalec oziroma oseba, ki sicer skrbi za vas.
What Cosentyx looks like and contents of the pack Cosentyx solution for injection is a clear liquid.
Raztopina za injiciranje Cosentyx je bistra tekočina.
Patients randomised to secukinumab received 75 mg or 150 mg subcutaneously at weeks 0, 1, 2, 3 and 4, followed by the same dose every month.
Bolniki, ki so jih randomizirali na prejemanje sekukinumaba, so ga prejemali v odmerku 75 mg ali 150 mg subkutano enkrat na teden v tednih 0, 1, 2, 3 in 4, nato pa so enak odmerek prejemali vsak mesec.
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) - pre-filled pen
VMESNA ŠKATLA SKUPNEGA PAKIRANJA (BREZ PODATKOV V t.i. MODREM OKENCU) - napolnjen injekcijski peresnik
At week 16, patients who were randomised to placebo at baseline were re-randomised to receive secukinumab (either 150 mg or 300 mg subcutaneously) every month.
Po 16 tednih so bolnike, ki so bili sprva randomizirani na prejemanje placeba, ponovno randomizirali, tako da so prejemali sekukinumab bodisi 150 mg ali 300 mg subkutano enkrat na mesec.
The recommended dose is 150 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Priporočeni odmerek je 150 mg s subkutano injekcijo, in sicer z začetnim odmerjanjem enkrat na teden v tednih 0, 1, 2, 3 in 4.
Multipack containing 6 (3 x 2) pre-filled syringes
Skupno pakiranje: 6 (3 x 2) napolnjenih injekcijskih brizg
Do not use if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Tekočine ne uporabljajte, če vsebuje jasno vidne delce, če je motna ali izrazito rjave barve.
Patients randomised to secukinumab received 75 mg, 150 mg or 300 mg subcutaneously at weeks 0, 1, 2, 3 and 4, followed by the same dose every month.
Bolniki, ki so jih randomizirali na prejemanje sekukinumaba, so ga prejemali v odmerkih 75 mg, 150 mg ali 300 mg subkutano enkrat na teden v tednih 0, 1, 2, 3 in 4, nato pa so enak odmerek prejemali enkrat na mesec.
One pre-filled syringe contains 150 mg secukinumab in 1 ml of solution.
Ena napolnjena injekcijska brizga vsebuje 150 mg sekukinumaba v 1 ml raztopine.
Patients randomised to secukinumab received 150 mg or 300 mg doses at weeks 0, 1, 2, 3 and 4, followed by the same dose every month.
Bolniki, ki so bili randomizirani na prejemanje sekukinumaba, so prejeli odmerke 150 mg oziroma 300 mg v tednih 0, 1, 2, 3 in 4, nato pa enak odmerek enkrat na mesec.
Cosentyx is used in adults with active psoriatic arthritis and can be used alone or with another medicine called methotrexate.
Zdravilo lahko uporabljamo samostojno ali v kombinaciji z drugim zdravilom, ki se imenuje metotreksat.
In the TRANSFIGURE study, secukinumab was superior to placebo at week 16 (46.1% for 300 mg, 38.4% for 150 mg and 11.7% for placebo) as assessed by significant improvement from baseline in the Nail Psoriasis Severity Index (NAPSI %) for patients with moderate to severe plaque psoriasis with nail involvement.
V študiji TRANSFIGURE je bil pri bolnikih z zmerno do hudo psoriazo s prizadetostjo nohtov sekukinumab boljši od placeba glede na oceno pomembnega izboljšanja od izhodišča do 16. tedna na osnovi indeksa izraženosti psoriaze s prizadetostjo nohtov (NAPSI - Nail Psoriasis Severity Index (46,1 % pri odmerku 300 mg, 38,4 % pri odmerku 150 mg in 11,7 % pri uporabi placeba).
OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) - pre-filled syringe
ŠKATLA ZA SKUPNO PAKIRANJE (S PODATKI V t.i. MODREM OKENCU) - napolnjena injekcijska brizga
In PsA study 2, at week 24, secukinumabtreated patients with concomitant MTX use had a higher ACR 20 response (47.7% and 54.4% for 150 mg and 300 mg, respectively, compared to placebo 20.0%) and ACR 50 response (31.8% and 38.6% for 150 mg and 300 mg, respectively, compared to placebo 8.0%).
V PsA študiji 2 je po 24 tednih zdravljenja odziv ACR 20 doseglo več tistih bolnikov, ki so sočasno s sekukinumabom prejemali še metotreksat (47,7 % oziroma 54,4 % pri odmerkih 150 mg oziroma 300 mg v primerjavi z 20,0 % pri uporabi placeba).
Number of patients PASI 75 response n (%) PASI 90 response n (%) PASI 100 response n (%) IGA mod 2011 “clear” or “almost clear” response n (%)
PASI 100 n (%) odziv IGA mod 2011 "brez znakov" ali "skoraj brez znakov" n (%)
System Organ Class Frequency Adverse reaction Infections and infestations
Organski sistem pogostnost neželeni učinek
However, if you stop, your psoriasis, psoriatic arthritis or ankylosing spondylitis symptoms may come back.
Če ste prenehali uporabljati zdravilo Cosentyx Če prenehate uporabljati zdravilo Cosentyx, to ne predstavlja nobene nevarnosti, vendar se v tem primeru lahko ponovno pojavijo simptomi psoriaze, psoriatičnega artritisa ali ankilozirajočega spondilitisa.
Cosentyx 150 mg powder for solution for injection secukinumab
Cosentyx 150 mg prašek za raztopino za injiciranje sekukinumab
Patients randomised to placebo who were non-responders at week 16 (early rescue) and all other placebo patients at week 24 were crossed over to receive secukinumab (either 75 mg or 150 mg subcutaneously), followed by the same dose every month.
Bolniki, ki so bili randomizirani na prejemanje placeba in pri katerih ni prišlo do odziva do tedna 16, so takoj prešli na uporabo sekukinumaba (zgodnje reševanje), vsi drugi bolniki s placebom pa so prešli na uporabo sekukinumaba (bodisi 75 mg ali 150 mg subkutano) v tednu 24, nato pa so enak odmerek prejemali vsak mesec.
Patients randomised to receive placebo who were responders at week 16 were crossed over to receive secukinumab (either 150 mg or 300 mg subcutaneously) at week 24 followed by the same dose every month.
Bolniki, ki so bili randomizirani na prejemanje placeba in pri katerih je prišlo do odziva do tedna 16, so prešli na uporabo sekukinumaba (bodisi 150 mg ali 300 mg subkutano) v tednu 24, nato pa so enak odmerek prejemali vsak mesec.
ASAS 40 response, % hsCRP, (post-BSL/BSL ratio)
hsCRP (razmerje med kasnejšo in izhodiščno vrednostjo)
Patients randomised to placebo who were non-responders at week 16 (early rescue) and other placebo patients at week 24 were crossed over to receive secukinumab (either 75 mg or 150 mg subcutaneously) followed by the same dose every month.
Bolniki, ki so bili randomizirani na prejemanje placeba in pri katerih ni prišlo do odziva do tedna 16, so takoj prešli na uporabo sekukinumaba (zgodnje reševanje), drugi bolniki s placebom pa so prešli na uporabo sekukinumaba (bodisi 75 mg ali 150 mg subkutano) v tednu 24, nato pa so enak odmerek prejemali vsak mesec.
During the blinded period, the ASAS 20 and ASAS 40 responses were 69.7% and 47.6% for 150 mg and 74.3% and 57.4% for 300 mg at week 52, respectively.
V obdobju slepega zdravljenja je do 52. tedna v skupini z odmerkom 150 mg odziv ASAS 20 doseglo 69,7 % in odziv ASAS 40 47,6 % bolnikov, v skupini z odmerkom 300 mg pa je odziv ASAS 20 doseglo 74,3 % in odziv ASAS 40 57,4 % bolnikov.
CARTON OF UNIT PACK - pre-filled syringe
ŠKATLA ZA POSAMIČNO PAKIRANJE - napolnjena injekcijska brizga
Each pre-filled syringe contains 150 mg secukinumab.
Ena napolnjena injekcijska brizga vsebuje 150 mg sekukinumaba.
• Talk to your doctor if you are breast-feeding or are planning to breast-feed.
• Če dojite ali nameravate začeti z dojenjem, se pogovorite s svojim zdravnikom.
One pre-filled pen contains 150 mg secukinumab in 1 ml of solution.
En napolnjen injekcijski peresnik vsebuje 150 mg sekukinumaba v 1 ml raztopine.
All p-values are adjusted for multiplicity of testing based on pre-defined hierarchy at week 24 for PsA study 2, except for ACR70, Dactylitis and Enthesitis, which were exploratory endpoints and all endpoints at week 16.
* p<0,05, ** p<0,01, *** p<0,001; v primerjavi s placebom V PsA študiji 2 so za teden 24 vse vrednosti p prilagojene na večkratnost testiranja po vnaprej opredeljenem hierarhičnem redu, razen vrednosti p za odziv ACR 70, daktilitis in entezitis, ki so bile raziskovalni cilji študije, in vsi cilji študije za teden 16.
Finger grips
Gibljivost hrbtenice
Pack containing 2 pre-filled pens
Pakiranje vsebuje 2 napolnjena injekcijska peresnika.
ASAS partial remission, %
delna remisija po kriterijih ASAS, % 4,1
Each vial of powder contains 150 mg secukinumab.
Ena viala s praškom vsebuje 150 mg sekukinumaba.
Based on your response, your doctor may increase your dose to 300 mg.
Na osnovi vašega odziva vam bo zdravnik morda odmerek zvišal na 300 mg Ankilozirajoči spondilitis
Patients randomised to receive placebo who were non-responders at week 16 (early rescue) were then crossed over to receive secukinumab (either 150 mg or 300 mg subcutaneously) at week 16 followed by the same dose every month.
Bolniki, ki so bili randomizirani na prejemanje placeba in pri katerih ni prišlo do odziva do tedna 16, so po 16 tednih (zgodnje reševanje) prešli na uporabo sekukinumaba (bodisi 150 mg ali 300 mg subkutano), nato pa so enak odmerek prejemali vsak mesec.
Your Cosentyx SensoReady pen:
Injekcijski peresnik SensoReady z zdravilom Cosentyx:
Cosentyx 150 mg solution for injection in pre-filled syringe secukinumab
Cosentyx 150 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku sekukinumab
Table 7 Clinical response in AS study 2 at week 16
Preglednica 7 Klinični odziv v AS študiji 2 po 16 tednih izid (vrednost p za primerjavo z uporabo placeba)
CARTON OF UNIT PACK - pre-filled pen
ŠKATLA ZA POSAMIČNO PAKIRANJE - napolnjen injekcijski peresnik
Cosentyx 150 mg solution for injection in pre-filled syringe
Cosentyx 150 mg raztopina za injiciranje v napolnjeni injekcijski brizgi
Cosentyx is available in unit packs containing 1 or 2 pre-filled syringes and in multipacks containing 6 (3 packs of 2) pre-filled syringes.
Zdravilo Cosentyx je na voljo v posamičnem pakiranjih, ki vsebujejo 1 ali 2 napolnjeni injekcijski brizgi in v skupnem pakiranju, ki vsebuje 6 (3 pakiranja po 2) napolnjenih injekcijskih brizg.
PASI 50 response n (%) 5 (8.2%) 48
odziv ACR 50 n (%) teden 16
Keep the pre-filled syringes in the outer carton in order to protect from light.
Napolnjeni injekcijski brizgi shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
Store the syringes in the original package in order to protect from light.
Injekcijske brizge shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
PASI 90 response n (%) 3 (1.2%) 95
odziv PASI 90 n (%) teden 16
OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) - pre-filled pen
ŠKATLA ZA SKUPNO PAKIRANJE (S PODATKI V t.i. MODREM OKENCU) - napolnjen injekcijski peresnik
Storage of the Cosentyx pre-filled syringe
Napolnjena injekcijska brizga z zdravilom Cosentyx
BLISTER OF PRE-FILLED SYRINGE
PRETISNI OMOT NAPOLNJENE INJEKCIJSKE BRIZGE