natgillin/translations-raw huggingface dataset:
Table 7 Clinical response in AS study 2 at week 16
Tablica 7 Klinički odgovor u 2. ispitivanju AS-a u 16. tjednu
If you do not respond well enough to these medicines, you will be given Cosentyx to reduce the signs and symptoms of the disease, reduce inflammation and improve your physical function.
Ako ne budete dovoljno dobro reagirali na te lijekove, dobit ćete Cosentyx za smanjivanje znakova i simptoma bolesti, smanjivanje upale i poboljšanje tjelesne funkcije.
If you forget to use Cosentyx
Ako ste zaboravili primijeniti Cosentyx
Cosentyx SensoReady pen 150 mg
Cosentyx SensoReady brizgalica 150 mg
Solution for injection in pre-filled pen (SensoReady pen)
Otopina za injekciju u napunjenoj brizgalici (SensoReady brizgalici)
If you think you may be allergic, ask your doctor for advice before using Cosentyx.
Ako mislite da biste mogli biti alergični, upitajte svog liječnika za savjet prije nego što primijenite Cosentyx. ako imate aktivnu infekciju za koju Vaš liječnik smatra da je važna.
Tilt the vial to an angle of approx. 45° and gently rotate between the fingertips for approx. 1 minute.
7. Nagnite bočicu pod kutem od otprilike 45° i nježno je rotirajte između prstiju otprilike 1 minutu.
Based on population pharmacokinetic analysis, following a single subcutaneous dose of either 150 mg or 300 mg in plaque psoriasis patients, secukinumab reached peak serum concentrations of 13.7±4.8 µg/ml or 27.3±9.5 µg/ml, respectively, between 5 and 6 days post dose.
Na temelju populacijske farmakokinetičke analize, nakon jednokratne supkutane doze od 150 mg ili 300 mg u bolesnika s plak psorijazom, sekukinumab je dosegao vršne koncentracije u serumu od 13,7±4,8 µg/ml odnosno 27,3±9,5 µg/ml, između 5 i 6 dana nakon doze.
• upper respiratory tract infections with symptoms such as sore throat and stuffy nose
• infekcije gornjeg dijela dišnog sustava sa simptomima kao što su grlobolja i začepljen nos
If you stop using Cosentyx
Ako prestanete primjenjivati Cosentyx
Cosentyx is available in packs containing one vial.
Cosentyx je dostupan u pakiranjima koja sadrže jednu bočicu.
The safety and efficacy of secukinumab were assessed in four randomised, double-blind, placebo-controlled phase III studies in patients with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy [ERASURE, FIXTURE, FEATURE, JUNCTURE].
Sigurnost i djelotvornost sekukinumaba ocjenjivali su se u četiri randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze III u bolesnika s umjerenom do teškom plak psorijazom koji su bili kandidati za fototerapiju ili sistemsku terapiju [ERASURE, FIXTURE, FEATURE, JUNCTURE].
Live vaccines should not be given concurrently with secukinumab (see also section 4.4).
Živa cjepiva ne smiju se davati istodobno sa sekukinumabom (vidjeti također dio 4.4).
Important safety checks before you inject:
Važne sigurnosne provjere prije nego što si date injekciju: Tekućina treba biti bistra.
No natural rubber latex has to date been detected in the removable cap.
Do danas u poklopcu nije pronađen prirodni gumeni lateks.
Choose a different site each time an injection is administered.
Odaberite drugo mjesto svaki put kad primjenjujete injekciju.
• burning sensation when passing urine.
• osjećaj peckanja pri mokrenju.
Instructions for use of Cosentyx powder for solution for injection
Upute za uporabu Cosentyx praška za otopinu za injekciju
The majority of infections consisted of non-serious and mild to moderate upper respiratory tract infections, such as nasopharyngitis, which did not necessitate treatment discontinuation.
Većina infekcija sastojala se od blagih do umjerenih infekcija gornjeg dijela dišnog sustava koje nisu bile ozbiljne, kao što je nazofaringitis, zbog kojih nije bilo potrebno prekinuti liječenje.
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).
U 1. ispitivanju ankilozantnog spondilitisa (1. ispitivanje AS-a), 2. ispitivanju ankilozantnog spondilitisa (2. ispitivanje AS-a), odnosno 3. ispitivanju ankilozantnog spondilitisa (3. ispitivanje AS-a), 27,0%, 38,8%, odnosno 23,5%, bolesnika bilo je prethodno liječeno anti-TNFα lijekom i prekinulo je primjenu anti-TNFα ili zbog nedostatka djelotvornosti ili zbog intolerancije (anti-TNFαNO bolesnici).
On the basis of simulated data, peak concentrations at steady-state (Cmax,ss) following subcutaneous administration of 150 mg or 300 mg were 27.6 µg/ml and 55.2 µg/ml, respectively.
Na temelju simuliranih podataka, vršne koncentracije u stanju dinamičke ravnoteže (Cmax,dr) nakon supkutane primjene 150 mg ili 300 mg bile su 27,6 µg/ml odnosno 55,2 µg/ml.
Prepare the required number of syringes (2 syringes for the 300 mg dose).
Pripremite potreban broj štrcaljki (2 štrcaljke za dozu od 300 mg).
Insert the syringe needle into the vial containing the powder through the centre of the rubber stopper and reconstitute the powder by slowly injecting 1.0 ml of sterile water for injections into the vial.
Uvedite iglu štrcaljke u bočicu koja sadrži prašak kroz središte gumenog čepa i rekonstituirajte prašak polako ubrizgavajući 1,0 ml sterilne vode za injekcije u bočicu.
Cosentyx is supplied in a pack containing one vial.
Cosentyx se isporučuje u pakiranju koje sadrži jednu bočicu.
Psoriasis study 3 (FEATURE) evaluated 177 patients using a pre-filled syringe compared with placebo after 12 weeks of treatment to assess the safety, tolerability, and usability of secukinumab self-administration via the pre-filled syringe.
Treće ispitivanje psorijaze (FEATURE) ocjenjivalo je 177 bolesnika uz korištenje napunjene štrcaljke u usporedbi s placebom nakon 12 tjedana liječenja da bi se ocijenile sigurnost, podnošljivost i mogućnost samoprimjene sekukinumaba pomoću napunjene štrcaljke.
secukinumab 150 mg n=185
sekukinumab 150 mg n=185
2 pre-filled syringes.
2 napunjene brizgalice.
Mean decreases (improvements) in DLQI from baseline ranged from -10.4 to -11.6 with secukinumab 300 mg, from -7.7 to -10.1 with secukinumab 150 mg, versus -1.1 to -1.9 for placebo at week 12.
Srednja smanjenja (poboljšanja) u DLQI-ju od početne vrijednosti bila su u rasponu od -10,4 do -11,6 uz sekukinumab 300 mg, od -7,7 do -10,1 uz sekukinumab 150 mg, u odnosu na -1,1 do -1,9 za placebo u 12. tjednu.
Psoriasis study 2 (FIXTURE) evaluated 1,306 patients.
Drugo ispitivanje psorijaze (FIXTURE) ocjenjivalo je 1306 bolesnika.
Improvements in PASI 75 in patients with concurrent psoriatic arthritis at baseline were similar to those in the overall plaque psoriasis population.
Poboljšanja u odgovoru PASI 75 u bolesnika s istodobnim psorijatičnim artritisom na početku bila su slična onima u cjelokupnoj populaciji s plak psorijazom.
In clinical studies, infections have been observed in patients receiving secukinumab (see section 4.8).
U kliničkim ispitivanjima u bolesnika koji su primali sekukinumab bile su uočene infekcije (vidjeti dio 4.8).
Patients treated with secukinumab 150 mg showed improvements in spinal mobility as measured by change from baseline in BASMI at week 16 for both AS study 1 (-0.40 versus -0.12 for placebo; p=0.0114) and AS study 2 (-0.51 versus -0.22 for placebo; p=0.0533).
Bolesnici liječeni sekukinumabom 150 mg pokazali su poboljšanja u spinalnoj mobilnosti mjerenoj promjenom od početne vrijednosti u BASMI-ju u 16. tjednu i u 1. ispitivanju AS-a (-0,40 u odnosu na -0,12 za placebo; p=0,0114) i u 2. ispitivanju AS-a (-0,51 u odnosu na -0,22 za placebo; p=0,0533).
The condition is an inflammatory disease of the joints, often accompanied by psoriasis.
To je upalna bolest zglobova, često popraćena psorijazom.
The single-use vial contains 150 mg secukinumab for reconstitution with sterile water for injections.
Bočica za jednokratnu uporabu sadrži 150 mg sekukinumaba za rekonstituciju sa sterilnom vodom za injekcije.
The powder is a white solid lyophilisate.
Prašak za otopinu za injekciju Prašak je bijeli čvrsti liofilizat.
In AS study 1 and AS study 2, secukinumab-treated patients (150 mg in AS study 2 and both regimens in AS study 1) demonstrated significantly improved signs and symptoms at week 16, with comparable magnitude of response and efficacy maintained up to week 52 in both anti-TNFα-naive and anti-TNFα-IR patients.
U 1. i 2. ispitivanju AS-a bolesnici liječeni sekukinumabom (150 mg u 2. ispitivanju AS-a i oba režima u 1. ispitivanju AS-a) imali su značajno ublažene znakove i simptome u 16. tjednu, s usporedivom veličinom odgovora i djelotvornošću održanom do 52. tjedna i u bolesnika koji nisu ranije primali anti-TNFα i u anti-TNFα-NO bolesnika.
For patients with concomitant moderate to severe plaque psoriasis or who are anti-TNFα inadequate responders (IR), the recommended dose is 300 mg by subcutaneous injection with initial dosing at weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
Za bolesnike s istodobnom umjerenom do teškom plak psorijazom ili one koji imaju neodgovarajući odgovor (NO) na anti-TNFα, preporučena doza je 300 mg supkutanom injekcijom s početnom dozom u 0., 1., 2., 3. i 4. tjednu, nakon čega slijedi mjesečna doza održavanja.
What you additionally need for your injection:
Što Vam još treba za injekciju:
The resulting solution should be clear and colourless to slightly yellow.
Otopina koja se dobije treba biti bistra i bezbojna do žućkasta.
In AS study 2, among 72 patients initially randomised to secukinumab 150 mg, 61 (84.7%) patients were still on treatment at week 52.
U 2. ispitivanju AS-a, među 72 bolesnika prvobitno randomiziranih na sekukinumab 150 mg, 61 (84,7%) bolesnik bio je još uvijek na terapiji u 52. tjednu.
SensoReady pen
SensoReady brizgalica
All patients received secukinumab 150 mg or 300 mg doses at weeks 0, 1, 2, 3, 4, 8 and 12 and then were randomised to receive either a maintenance regimen of the same dose every month starting at week 12 or a “retreatment as needed” regimen of the same dose.
Svi su bolesnici primali doze sekukinumaba od 150 mg ili 300 mg u 0., 1., 2., 3., 4., 8. i 12. tjednu, a zatim su bili randomizirani na primanje ili režima održavanja u istoj dozi svakoga mjeseca počevši od 12. tjedna ili režima „ponovnog liječenja prema potrebi“ u istoj dozi.
In AS study 3, patients treated with secukinumab (150 mg and 300 mg) demonstrated improved signs and symptoms, and had comparable efficacy responses regardless of dose that were superior to placebo at week 16 for the primary endpoint (ASAS 20).
U 3. ispitivanju AS-a bolesnici liječeni sekukinumabom (150 mg i 300 mg) imali su poboljšanja znakova i simptoma te usporedive odgovore u pogledu djelotvornosti bez obzira na dozu, koji su bili superiorni u odnosu na placebo u 16. tjednu za mjeru primarnog ishoda (ASAS 20).
• The recommended dose is 300 mg by subcutaneous injection.
• Preporučena doza je 300 mg potkožnom injekcijom.
PsA study 3 (FUTURE 5) evaluated 996 patients, of whom 50.1% had concomitant MTX.
Treće ispitivanje PsA (FUTURE 5) ocjenjivalo je 996 bolesnika, od kojih je 50,1% istodobno primalo MTX.
To prepare Cosentyx 150 mg powder for solution for injection, please adhere to the following instructions:
Za pripremu Cosentyx 150 mg praška za otopinu za injekciju slijedite sljedeće upute:
Overall, the efficacy response rates for the 300 mg group were consistently greater compared to the 150 mg group for the secondary endpoints.
Općenito su stope odgovora u pogledu djelotvornosti za skupinu koja je primala 300 mg bile dosljedno veće u usporedbi sa skupinom koja je primala 150 mg za mjere sekundarnih ishoda.
The percentage of patients with no disease progression from week 24 to week 52 for secukinumab 10 mg/kg intravenous load - followed by 150 mg subcutaneous maintenance and for placebo patients who switched to 75 mg or 150 mg subcutaneous every 4 weeks at week 16 or week 24 was 85.7% and 86.8%, respectively.
Postotak bolesnika bez progresije bolesti od 24. tjedna do 52. tjedna uz sekukinumab 10 mg/kg intravensku fazu - nakon koje je slijedilo 150 mg supkutano održavanje te za bolesnike na placebu koji su se prebacili na 75 mg ili 150 mg supkutane primjene svaka 4 tjedna u 16. tjednu ili 24. tjednu bio je 85,7% odnosno 86,8%.
The removable needle cap of the Cosentyx pre-filled syringe contains a derivative of natural rubber latex.
Poklopac igle Cosentyx napunjene štrcaljke sadrži derivat prirodnog gumenog lateksa.
The syringe should be taken out of the refrigerator 20 minutes before injecting to allow it to reach room temperature.
Štrcaljka se treba izvaditi iz hladnjaka 20 minuta prije ubrizgavanja kako bi mogla doseći sobnu temperaturu.
In PsA study 2, among 200 patients initially randomised to secukinumab 150 mg and 300 mg, 178 (89%) patients were still on treatment at week 52.
U 2. ispitivanju PsA među 200 bolesnika prvobitno randomiziranih na sekukinumab 150 mg i 300 mg, 178 (89%) bolesnika bilo je još uvijek na terapiji u 52. tjednu.
secukinumab 300 mg (n=245)
sekukinumab 300 mg (n=245)
Patients were also randomised to receive placebo at weeks 0, 1, 2, 3 and 4, followed by the same dose every month.
Bolesnici su također bili randomizirani na primanje placeba u 0., 1., 2., 3. i 4. tjednu, nakon čega je slijedila ista doza svakoga mjeseca.
ASAS 20 response, %
Odgovor ASAS 20, %
Over 61% and 42% of the PsA patients had enthesitis and dactylitis at baseline, respectively.
Više od 61%, odnosno 42%, bolesnika s PsA-om imalo je entezitis, odnosno daktilitis, na početku ispitivanja.
Most of these were mild or moderate upper respiratory tract infections such as nasopharyngitis and did not require treatment discontinuation.
Većinom se radilo o blagim do umjerenim infekcijama gornjeg dijela dišnog sustava, kao što je nazofaringitis, koje nisu zahtijevale prekid liječenja.
The ASAS 20 and ASAS 40 responses were maintained up to week 156 (69.5% and 47.6% for 150 mg versus 74.8% and 55.6% for 300 mg).
Odgovori ASAS 20 i ASAS 40 održali su se do 156. tjedna (69,5% i 47,6% za 150 mg u odnosu na 74,8% i 55,6% za 300 mg).
Psoriasis study 4 (JUNCTURE) evaluated 182 patients using a pre-filled pen compared with placebo after 12 weeks of treatment to assess the safety, tolerability, and usability of secukinumab self-administration via the pre-filled pen.
Četvrto ispitivanje psorijaze (JUNCTURE) ocjenjivalo je 182 bolesnika uz korištenje napunjene brizgalice u usporedbi s placebom nakon 12 tjedana liječenja da bi se ocijenile sigurnost, podnošljivost i mogućnost samoprimjene sekukinumaba pomoću napunjene brizgalice.
Cosentyx contains the active substance secukinumab.
Cosentyx sadrži djelatnu tvar sekukinumab.
Histidine hydrochloride monohydrate Polysorbate 80
Histidinklorid hidrat Polisorbat 80
Cosentyx 150 mg powder for solution for injection must be prepared by a healthcare professional.
Cosentyx 150 mg prašak za otopinu za injekciju mora pripremiti zdravstveni radnik.
Secukinumab 150 mg or 300 mg s.c. at weeks 0, 1, 2, 3, and 4 followed by the same dose every month †In patients with dactylitis at baseline (n=27, 32, 46, respectively for PsA study 2 and n=124, 80, 82, respectively for PsA study 3) ‡In patients with enthesitis at baseline (n=65, 64, 56, respectively for PsA study 2 and n=192, 141, 140, respectively for PsA study 3)
Sekukinumab 150 mg ili 300 mg s.c. u 0., 1., 2., 3. i 4. tjednu nakon čega slijedi ista doza svaki mjesec †U bolesnika s daktilitisom na početku (n=27, 32, 46 redom za 2. ispitivanje PsA te n=124, 80, 82 redom za 3. ispitivanje PsA) ‡U bolesnika s entezitisom na početku (n=65, 64, 56 redom za 2. ispitivanje PsA te n=192, 141, 140 redom za 3. ispitivanje PsA)
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.
U GESTURE ispitivanju, sekukinumab je bio superioran nad placebom u 16. tjednu (33,3% za 300 mg, 22,1% za 150 mg, i 1,5% za placebo) što je pokazano značajnim poboljšanjem ppIGA 0 ili 1 odgovora (“čista” ili “gotovo čista”) za bolesnike s umjerenom do teškom palmoplantarnom plak psorijazom.
Infection rates observed in psoriatic arthritis and ankylosing spondylitis clinical studies were similar to those observed in the psoriasis studies.
Stope infekcije opažene u kliničkim ispitivanjima psorijatičnog artritisa i ankilozantnog spondilitisa bile su slične stopama opaženima u ispitivanjima psorijaze.
No natural rubber latex has to date been detected in the removable needle cap.
Do danas u poklopcu igle nije pronađen prirodni gumeni lateks.
• Plaque psoriasis
• Plak psorijaze
Read ALL the way through these instructions before injecting.
Pročitajte ove upute DO KRAJA prije nego što primijenite injekciju.
The pre-filled syringe inside the pen is a 1 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid needle shield of styrene butadiene rubber.
Napunjena štrcaljka unutar brizgalice je staklena štrcaljka od 1 ml s čepom klipa od bromobutilne gume obložen silikonom, pričvršćenom iglom 27G x ½″ i čvrstim štitnikom igle od stiren-butadien gume.
• The recommended dose is 150 mg by subcutaneous injection.
• Preporučena doza je 150 mg potkožnom injekcijom.
Secukinumab-treated patients reported significant improvements in health-related quality of life as measured by the Short Form-36 Health Survey Physical Component Summary (SF-36 PCS) score (p<0.001).
Short Form-36 Health Survey Physical Component Summary, SF-36 PCS) (p<0,001).
How to use Cosentyx
Kako primjenjivati Cosentyx
Cosentyx is supplied in a pre-filled 1 ml glass syringe with a silicone-coated bromobutyl rubber plunger stopper, staked 27G x ½″ needle and rigid needle shield of styrene butadiene rubber assembled in a passive safety device of polycarbonate.
Cosentyx se isporučuje u napunjenoj staklenoj štrcaljki od 1 ml s čepom klipa od bromobutilne gume obložen silikonom, pričvršćenom iglom 27G x ½″ i čvrstim štitnikom igle od stiren-butadien gume, postavljenoj u pasivnom sigurnosnom uređaju od polikarbonata.
The removable cap of the Cosentyx pre-filled pen contains a derivative of natural rubber latex.
Poklopac Cosentyx napunjene brizgalice sadrži derivat prirodnog gumenog lateksa.
Remove the plastic cap from the vial.
Skinite plastični poklopac s bočice.
Elderly patients (aged 65 years and over) No dose adjustment is required (see section 5.2).
Nije potrebno prilagođavanje doze (vidjeti dio 5.2).
In AS study 2, treatment with secukinumab 150 mg resulted in greater improvement in measures of disease activity compared with placebo at week 16 (see Table 7).
U 2. ispitivanju AS-a liječenje sekukinumabom 150 mg rezultiralo je većim poboljšanjem u mjerama aktivnosti bolesti u usporedbi s placebom u 16. tjednu (vidjeti Tablicu 7).
Cosentyx is used in adults with moderate to severe plaque psoriasis.
Cosentyx se koristi u odraslih osoba s umjerenom do teškom plak psorijazom.
Viewing window, label & expiry date
Kontrolni prozorčić, naljepnica i rok valjanosti
Secukinumab 150 mg and 300 mg treatment significantly inhibited the rate of progression of peripheral joint damage compared with placebo treatment as measured by change from baseline in mTSS at week 24 (Table 6).
Liječenje sekukinumabom 150 mg i 300 mg značajno je inhibiralo stopu progresije oštećenja perifernih zglobova u usporedbi s placebom, mjereno promjenom u mTSS-u nakon 24. tjedna, u odnosu na početni (Tablica 6).
In PsA study 2 and PsA study 3, patients treated with secukinumab 150 mg (p=0.0555 and p<0.0001) and 300 mg (p=0.0040 and p<0.0001) showed improvement in physical function compared to patients treated with placebo as assessed by Health Assessment Questionnaire-Disability Index (HAQ-DI) at week 24 and week 16, respectively.
U 2. i 3. ispitivanju PsA bolesnici liječeni sekukinumabom 150 mg (p=0,0555 i p<0,0001) i 300 mg (p=0,0040 i p<0,0001) imali su poboljšanje tjelesne funkcije u usporedbi s bolesnicima koji su primali placebo, što je procijenjeno Upitnikom za procjenu zdravlja - Indeksom onesposobljenosti (engl.
Cosentyx is used to treat a condition called “psoriatic arthritis”.
Cosentyx se koristi za liječenje bolesti koja se zove „psorijatični artritis“.
The frequency of neutropenia in psoriatic arthritis and ankylosing spondylitis is similar to psoriasis.
Učestalost neutropenije kod psorijatičnog artritisa i ankilozantnog spondilitisa slična je kao i kod psorijaze.
PsA study 1 (FUTURE 1) evaluated 606 patients, of whom 60.7% had concomitant MTX.
Prvo ispitivanje PsA (FUTURE 1) ocjenjivalo je 606 bolesnika, od kojih je 60,7% istodobno primalo MTX.
Store your boxed pen in a refrigerator between 2°C and 8°C and out of the reach of children.
Čuvajte kutiju sa svojom brizgalicom u hladnjaku na temperaturi između 2 °C i 8 °C te izvan dohvata djece.
PASI 75 response n (%) 2 (3.3%) 43
Odgovor PASI 75 n (%) 2 (3,3%) 43
Exfoliative dermatitis Placebo-controlled clinical studies (phase III) in plaque psoriasis, PsA and AS patients exposed to 300 mg, 150 mg, 75 mg or placebo up to 12 weeks (psoriasis) or 16 weeks (PsA and AS) treatment duration Cases were reported in patients with psoriasis diagnosis
Poremećaji kože i potkožnog tkiva manje često urtikarija rijetko eksfolijativni dermatitis Placebom kontrolirana klinička ispitivanja (faze III) u bolesnika s plak psorijazom, psorijatičnim artritisom i ankilozantnim spondilitisom izloženih dozama od 300 mg, 150 mg, 75 mg ili placebu do 12 tjedana (psorijaza) ili 16 tjedana (psorijatični artritis i ankilozantni spondilitis) liječenja Prijavljeni su slučajevi u bolesnika s dijagnosticiranom psorijazom
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.
Tijekom maskiranog razdoblja, odgovori ASAS 20 i ASAS 40 bili su 69,7%, odnosno 47,6%, za 150 mg te 74,3%, odnosno 57,4%, za 300 mg u 52. tjednu.
DO NOT invert the vial.
NEMOJTE preokretati bočicu.
There were also statistically significant improvements demonstrated in exploratory endpoints assessed by the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) scores for 150 mg and 300 mg compared to placebo (7.97, 5.97 versus 1.63, respectively) and these improvements were maintained up to week 104 in PsA study 2.
Functional Assessment of Chronic Illness Therapy - Fatigue, FACIT-F) za 150 mg i 300 mg u usporedbi s placebom (7,97, odnosno 5,97 u odnosu na 1,63), a ta poboljšanja održala su se do 104. tjedna u 2. ispitivanju PsA.
Instructions for use of the Cosentyx SensoReady pen
Upute za uporabu Cosentyx SensoReady brizgalice
Also contains: Trehalose dihydrate, histidine, histidine hydrochloride monohydrate, methionine, polysorbate 80, water for injections.
Također sadrži: trehalozu dihidrat, histidin, histidinklorid hidrat, metionin, polisorbat 80, vodu za injekcije.
Solution for injection in a pre-filled pen
Otopina za injekciju u napunjenoj brizgalici
Note that foaming of the solution may occur.
Napominjemo da bi se otopina mogla zapjeniti.
• Ankylosing spondylitis
• Ankilozantnog spondilitisa
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.
Odgovori ASAS 20 bili su bolji u 16. tjednu i u bolesnika koji nisu ranije primali anti-TNFα (68,2% u odnosu na 31,1%; p<0,05) i anti-TNFα-NO bolesnika (50,0% u odnosu na 24,1%; p<0,05) za sekukinumab 150 mg u usporedbi s placebom.
Histidine hydrochloride monohydrate Methionine
Histidinklorid hidrat Metionin
Of the 100 patients randomised to secukinumab 300 mg, 64, 44 and 24 had an ACR 20/50/70 response, respectively.
Od 100 bolesnika randomiziranih na sekukinumab 300 mg, 64, 44 odnosno 24 imalo je odgovor ACR 20/50/70.
• If a caregiver or healthcare professional is giving you your injection, they may also inject into your outer upper arm.
• Ako Vam njegovatelj ili zdravstveni radnik daju injekciju, mogu