natgillin/translations-raw huggingface dataset:
Renal impairment / hepatic impairment Cosentyx has not been studied in these patient populations.
Cosentyx nije bio ispitivan u tim populacijama bolesnika.
PsA study 2 (FUTURE 2) evaluated 397 patients, of whom 46.6% had concomitant MTX.
Drugo ispitivanje PsA (FUTURE 2) ocjenjivalo je 397 bolesnika, od kojih je 46,6% istodobno primalo MTX.
Cosentyx is used to treat a condition called “ankylosing spondylitis”.
Cosentyx se koristi za liječenje bolesti koja se zove „ankilozantni spondilitis“.
ACR70 response n (%)
Odgovor ACR70 n (%)
AS study 1 (MEASURE 1) evaluated 371 patients, of whom 14.8% and 33.4% used concomitant MTX or sulfasalazine, respectively.
Prvo ispitivanje AS-a (MEASURE 1) ocjenjivalo je 371 bolesnika, od kojih je 14,8% odnosno 33,4% istodobno koristilo MTX odnosno sulfasalazin.
• discharge from the eye with itching, redness and swelling (conjunctivitis)
• iscjedak iz oka uz svrbež, crvenilo i oticanje (konjunktivitis)
How to store Cosentyx
Kako čuvati Cosentyx
Before reconstitution: Store the vial in the refrigerator between 2°C and 8°C.
Prije rekonstitucije: Bočicu čuvajte u hladnjaku na temperaturi između 2 °C i 8 °C.
Secukinumab was efficacious in systemic treatment-naive, biologic-naive, biologic/anti-TNF-exposed and biologic/anti-TNF-failure patients.
Sekukinumab je bio djelotvoran u bolesnika koji nisu ranije primali sistemsku terapiju, nisu ranije primali biološke lijekove, u onih koji su bili izloženi biološkim/anti-TNF lijekovima te u onih u kojih je liječenje biološkim/anti-TNF lijekovima bilo neuspješno.
Of the 100 patients randomised to secukinumab 150 mg, 64, 39 and 20 had an ACR 20/50/70 response, respectively.
Od 100 bolesnika randomiziranih na sekukinumab 150 mg, 64, 39 odnosno 20 imalo je odgovor ACR 20/50/70.
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.
Statistički značajna poboljšanja (smanjenja) u 12. tjednu u odnosu na početnu vrijednost u ispitivanju psorijaze vlastišta dokazana su za znakove i simptome svrbeži, boli i ljuskanja vlasišta prema izvješćima bolesnika, u usporedbi s placebom.
The pen should be taken out of the refrigerator 20 minutes before injecting to allow it to reach room temperature.
Brizgalica se treba izvaditi iz hladnjaka 20 minuta prije ubrizgavanja kako bi mogla doseći sobnu temperaturu.
Do not use this medicine if you notice that the powder has not fully dissolved or if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Nemojte koristiti ovaj lijek ako primijetite da se prašak nije u potpunosti otopio ili ako tekućina sadrži lako vidljive čestice, ako je zamućena ili izrazito smeđa.
PASI 50 response n (%) 5 (8.2%) 48
Odgovor PASI 50 n (%) 5 (8,2%) 48
Driving and using machines Cosentyx is unlikely to influence your ability to drive and use machines.
Mala je vjerojatnost da će Cosentyx utjecati na Vašu sposobnost upravljanja vozilima i rada sa strojevima.
PASI 50 response n (%) 3 (5.1%) 51
Odgovor PASI 50 n (%) 3 (5,1%) 51
PASI 90 response n (%) 3 (1.2%) 95
Odgovor PASI 90 n (%) 3 (1,2%) 95
• Psoriatic arthritis
• Psorijatičnog artritisa
Your Cosentyx pre-filled syringe
Vaša Cosentyx napunjena štrcaljka
Non-serious infections with usual response to standard care and not requiring discontinuation of secukinumab were reported in the remaining 3 cases.
U preostala 3 slučaja zabilježene infekcije nisu bile ozbiljne, odgovarale su na uobičajeno standardno liječenje i nisu zahtijevale prekid liječenja sekukinumabom.
AS study 2 (MEASURE 2) evaluated 219 patients, of whom 11.9% and 14.2% used concomitant MTX or sulfasalazine, respectively.
Drugo ispitivanje AS-a (MEASURE 2) ocjenjivalo je 219 bolesnika, od kojih je 11,9% odnosno 14,2% istodobno uzimalo MTX odnosno sulfasalazin.
After using Cosentyx you should not breast-feed for at least 20 weeks after the last dose.
Ne smijete dojiti najmanje 20 tjedana nakon primjene zadnje doze Cosentyxa.
After reconstitution, 1 ml of solution contains 150 mg secukinumab.
Nakon rekonstitucije, 1 ml otopine sadrži 150 mg sekukinumaba.
secukinumab 150 mg n=213
sekukinumab 150 mg n=213
Of the 72 patients randomised to secukinumab 150 mg, 45 and 35 had an ASAS 20/40 response, respectively.
Od 72 bolesnika randomiziranih na sekukinumab 150 mg, 45 odnosno 35 imalo je odgovor ASAS 20/40.
Your Cosentyx SensoReady pen:
Vaša Cosentyx SensoReady brizgalica:
A placebo-controlled study evaluated 102 patients with moderate to severe scalp psoriasis, defined as having a Psoriasis Scalp Severity Index (PSSI) score of ≥12, an IGA mod 2011 scalp only score of 3 or greater and at least 30% of the scalp surface area affected.
Psoriasis Scalp Severity Index, PSSI) od ≥12, rezultat za IGA mod 2011 samo za vlasište od 3 ili veći i zahvaćenost najmanje 30% površine vlasišta.
How to use the Cosentyx pre-filled syringe
Kako se koristi Cosentyx napunjena štrcaljka
Patients were randomised to receive secukinumab 150 mg, 300 mg or placebo subcutaneously at weeks 0, 1, 2, 3 and 4, followed by the same dose every month, or a once monthly injection of secukinumab 150 mg (without loading).
Bolesnici su bili randomizirani na primanje sekukinumaba 150 mg, 300 mg ili placeba supkutano u 0., 1., 2., 3. i 4. tjednu, nakon čega je slijedila ista doza svaki mjesec, ili injekcija sekukinumaba 150 mg jedanput mjesečno (bez početne faze s tjednom primjenom lijeka).
Cosentyx is given via injection under your skin (known as a subcutaneous injection).
Cosentyx se daje injekcijom potkožno (što se naziva supkutanom injekcijom).
PASI 100 response n (%) 2 (0.8%) 31
Odgovor PASI 100 n (%) 2 (0,8%) 31
Number of patients PASI 50 response n (%)
Broj bolesnika Odgovor PASI 50 n (%)
The safety and efficacy of secukinumab were assessed in 1,999 patients in three randomised, double-blind, placebo-controlled phase III studies in patients with active psoriatic arthritis (≥3 swollen and ≥3 tender joints) despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid or disease-modifying anti-rheumatic drug (DMARD) therapy.
Sigurnost i djelotvornost sekukinumaba ocijenjene su u 1999 bolesnika u tri randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze III u bolesnika s aktivnim psorijatičnim artritisom (≥3 otečena i ≥3 osjetljiva zgloba) unatoč nesteroidnom protuupalnom lijeku (engl. non-steroidal anti-inflammatory drug, NSAID), kortikosteroidu ili terapiji antireumatskim lijekom koji modificira tijek bolesti (DMARD).
secukinumab 300 mg n=217
sekukinumab 300 mg n=217
ACR50 response n (%)
Odgovor ACR50 n (%)
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.
U 2. ispitivanju PsA, udio bolesnika koji su postigli odgovor prema modificiranim kriterijima odgovora kod PsA (PsARC) bio je veći među bolesnicima liječenim sekukinumabom (59,0% odnosno 61,0% za 150 mg odnosno 300 mg) u usporedbi s placebom (26,5%) u 24. tjednu.
In PsA study 1, PsA study 2 and PsA study 3, 29%, 35% and 30% 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 PsA, 2. ispitivanju PsA, odnosno 3. ispitivanju PsA, redom je 29%, 35%, odnosno 30%, bolesnika prethodno bilo liječeno anti-TNFα lijekom i prekinulo je primjenu anti-TNFα lijeka ili zbog nedostatka djelotvornosti ili zbog intolerancije (anti-TNFα-NO bolesnici).
Store in the refrigerator between 2°C and 8°C.
Čuvati u hladnjaku na temperaturi između 2 °C i 8 °C.
The solution is clear and colourless to slightly yellow.
Otopina je bistra i bezbojna do žućkasta.
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%).
Bolesnici liječeni sekukinumabom bez istodobne primjene MTX-a imali su viši odgovor ACR 20 (53,6% odnosno 53,6% za 150 mg odnosno 300 mg, u usporedbi s placebo 10,4%) i odgovor ACR 50 (37,5% odnosno 32,1% za 150 mg odnosno 300 mg, u usporedbi s placebom 6,3%).
Dispose of the used syringe in a sharps container (closable, puncture resistant container).
Odložite upotrijebljenu štrcaljku u spremnik za oštre predmete (spremnik koji se može zatvoriti i otporan je na bušenje).
• if the liquid contains easily visible particles, is cloudy or is distinctly brown.
• ako tekućina sadrži lako vidljive čestice, ako je zamućena ili izrazito smeđa.
AS study 3 (MEASURE 3) evaluated 226 patients, of whom 13.3% and 23.5% used concomitant MTX or sulfasalazine, respectively.
Treće ispitivanje AS-a (MEASURE 3) ocjenjivalo je 226 bolesnika, od kojih je 13,3%, odnosno 23,5%, istodobno koristilo MTX, odnosno sulfasalazin.
1 pre-filled syringe 2 pre-filled syringes
1 napunjena štrcaljka 2 napunjene štrcaljke
In PsA study 1, the percentage of patients with no disease progression (defined as a change from baseline in mTSS of ≤0.5) from randomisation to week 24 was 82.3% in secukinumab 10 mg/kg intravenous load - 150 mg subcutaneous maintenance and 75.7% in placebo.
U 1. ispitivanju PsA, postotak bolesnika bez progresije bolesti (definirano kao promjena u odnosu na početnu vrijednost mTSS-a ≤0,5) od randomizacije do 24. tjedna bio je 82,3% uz sekukinumab 10 mg/kg intravensku fazu - 150 mg supkutano održavanje i 75,7% kod placeba.
If any of these side effects becomes severe, tell your doctor, pharmacist or nurse.
Ako bilo koja od ovih nuspojava postane teška, obratite se svom liječniku, ljekarniku ili medicinskoj sestri.
Most of the following side effects are mild to moderate.
Većina nuspojava navedenih u nastavku blage je do umjerene prirode.
In PsA study 2, both anti-TNFα-naive and anti-TNFα-IR secukinumab-treated patients had a significantly higher ACR 20 response compared to placebo at week 24, with a slightly higher response in the anti-TNFα-naive group (anti-TNFα-naive: 64% and 58% for 150 mg and 300 mg, respectively, compared to placebo 15.9%; anti-TNFα-IR: 30% and 46% for 150 mg and 300 mg, respectively, compared to placebo 14.3%).
U 2. ispitivanju PsA, i bolesnici koji nisu ranije primali anti-TNFα i anti-TNFα-NO bolesnici liječeni sekukinumabom imali su značajno viši odgovor ACR 20 u usporedbi s placebom u 24. tjednu, uz nešto viši odgovor u skupini koja nije ranije primala anti-TNFα (bez prethodnog primanja anti-TNFα: 64% odnosno 58% za 150 mg odnosno 300 mg, u usporedbi s placebom 15,9%; s neodgovarajućim odgovorom na anti-TNFα: 30% odnosno 46% za 150 mg odnosno 300 mg, u usporedbi s placebom 14,3%).
Do not use this medicine after the expiry date which is stated on the outer box or vial after “EXP”.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili bočici iza oznake „Rok valjanosti“ ili „EXP“.
In PsA study 3, the percentage of patients with no disease progression (defined as a change from baseline in mTSS of ≤0.5) from randomisation to week 24 was 80.3%, 88.5% and 73.6% for secukinumab 150 mg, 300 mg and placebo, respectively.
U 3. ispitivanju PsA, postotak bolesnika bez progresije bolesti (definirano kao promjena u odnosu na početni mTSS od ≤0,5) od randomizacije do 24. tjedna bio je 80,3%, 88,5% i 73,6% za redom sekukinumab 150 mg, 300 mg i placebo.
At each timepoint you will receive a 300 mg dose given as two injections of 150 mg.
U svakoj od tih vremenskih točaka dobit ćete dozu od 300 mg koja će se davati kao dvije injekcije od po 150 mg.
Cosentyx is available in unit packs containing 1 or 2 pre-filled pens and in multipacks containing 6 (3 packs of 2) pre-filled pens.
Cosentyx je dostupan u jediničnim pakiranjima koja sadrže 1 ili 2 napunjene brizgalice i u višestrukim pakiranjima koja sadrže 6 (3 pakiranja po 2) napunjenih brizgalica.
Patients randomised to secukinumab received 10 mg/kg intravenously at weeks 0, 2, and 4, followed by either 75 mg or 150 mg subcutaneously every month starting at week 8.
Bolesnici randomizirani na sekukinumab primali su 10 mg/kg intravenski u 0., 2. i 4. tjednu, nakon čega je slijedilo ili 75 mg ili 150 mg supkutano svaki mjesec počevši od 8. tjedna.
PASI 75 response n (%) 11
Odgovor PASI 75 n (%) 11
PASI 75 response n (%) 0 (0.0%) 41
Odgovor PASI 75 n (%) 0 (0,0%) 41
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.
Cosentyx je dostupan u jediničnim pakiranjima koja sadrže 1 ili 2 napunjene štrcaljke i u višestrukim pakiranjima koja sadrže 6 (3 pakiranja po 2) napunjenih štrcaljki.
Cosentyx 150 mg solution for injection is supplied in a single-use pre-filled syringe for individual use.
Cosentyx 150 mg otopina za injekciju isporučuje se u napunjenoj štrcaljki za jednokratnu primjenu namijenjenoj individualnoj uporabi.
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.
U TRANSFIGURE ispitivanju, sekukinumab je bio superioran nad placebom u 16. tjednu (46,1% za 300 mg, 38,4% za 150 mg i 11,7% za placebo) što je pokazano značajnim poboljšanjem u odnosu na početnu vrijednost prema indeksu težine psorijaze noktiju (engl.
PASI 90 response n (%)
Odgovor PASI 90 n (%)
• itchy rash (urticaria)
• osip sa svrbežom (koprivnjača)
Non-responder imputation used for missing binary endpoint.
Imputacija bolesnika bez odgovora upotrijebljena je za binarnu mjeru ishoda koja nedostaje.
* Patients treated with secukinumab received 300 mg doses at weeks 0, 1, 2, 3 and 4, followed by the same dose every 4 weeks until week 52.
* Bolesnici liječeni sekukinumabom primili su doze od 300 mg u 0., 1., 2., 3. i 4. tjednu, nakon čega su primali istu dozu svaka 4 tjedna do 52. tjedna.
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%).
U 2. ispitivanju PsA, u 24. tjednu bolesnici liječeni sekukinumabom uz istodobnu primjenu MTX-a imali su viši odgovor ACR 20 (47,7% odnosno 54,4% za 150 mg odnosno 300 mg, u usporedbi s placebom 20,0%) i odgovor ACR 50 (31,8% odnosno 38,6% za 150 mg odnosno 300 mg, u usporedbi s placebom 8,0%).
PASI 100 response n (%)
Odgovor PASI 100 n (%)
Patients treated with ustekinumab received 45 mg or 90 mg at weeks 0 and 4, then every 12 weeks until week 52 (dosed by weight as per approved posology) ** p values versus ustekinumab: p<0.0001 for primary endpoint of PASI 90 at week 16 and secondary endpoint of PASI 75 at week 4 *** p values versus ustekinumab: p=0.0001 for secondary endpoint of PASI 90 at week 52
4. tjednu, a zatim svakih 12 tjedana do 52. tjedna (doziranje po tjelesnoj težini prema odobrenom doziranju) ** p vrijednosti u odnosu na ustekinumab: p<0,0001 za mjeru primarnog ishoda PASI 90 odgovor u 16. tjednu i sekundarnu mjeru ishoda PASI 75 odgovor u 4. tjednu *** p vrijednosti u odnosu na ustekinumab: p=0,0001 za mjeru sekundarnog ishoda PASI 90 odgovor u 52. tjednu
In both study 1 and study 2, patients randomised to receive placebo who were non-responders at week 12 then crossed over to receive secukinumab (either 150 mg or 300 mg) at weeks 12, 13, 14, and 15, followed by the same dose every month starting at week 16.
I u 1. i 2. ispitivanju bolesnici randomizirani na primanje placeba koji nisu imali odgovor u 12. tjednu su prešli u skupinu koja je primala sekukinumab (ili 150 mg ili 300 mg) u 12., 13., 14. i 15. tjednu, nakon čega je slijedila ista doza svakoga mjeseca počevši od 16. tjedna.
Syringe guard
Štitnik štrcaljke
PASI 75 response n (%)
Odgovor PASI 75 n (%)
Also contains: Sucrose, histidine, histidine hydrochloride monohydrate, polysorbate 80.
Također sadrži: saharozu, histidin, histidinklorid hidrat, polisorbat 80.
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava manje često neutropenija
- The other ingredients are sucrose, histidine, histidine hydrochloride monohydrate and polysorbate 80.
- Drugi sastojci su saharoza, histidin, histidinklorid hidrat i polisorbat 80.
Cosentyx is given via injection under your skin (known as a subcutaneous injection) by a healthcare professional.
Cosentyx daje zdravstveni radnik potkožno pomoću injekcije (što se naziva supkutanom injekcijom).
Cosentyx 150 mg solution for injection is supplied in a single-use pre-filled pen for individual use.
Cosentyx 150 mg otopina za injekciju isporučuje se u napunjenoj brizgalici za jednokratnu primjenu namijenjenoj individualnoj uporabi.
• Each 300 mg dose is given as two injections of 150 mg.
• Svaka doza od 300 mg daje se kao dvije injekcije od po 150 mg.
Disposing of your Cosentyx SensoReady pen:
Odlaganje Cosentyx SensoReady brizgalice:
PsA study 1
1. ispitivanje PsA
Using Cosentyx in ankylosing spondylitis will benefit you by reducing the signs and symptoms of your disease and improving your physical function.
Primjena Cosentyxa za ankilozantni spondilitis koristit će Vam tako što će smanjiti znakove i simptome
INTERMEDIATE CARTON OF MULTIPACK (WITHOUT BLUE BOX) - pre-filled syringe
SREDNJA KUTIJA VIŠESTRUKOG PAKIRANJA (BEZ PLAVOG OKVIRA) - napunjena štrcaljka
Patients randomised to secukinumab received 10 mg/kg intravenously at weeks 0, 2, and 4, followed by either 150 mg or 300 mg subcutaneously every month.
Bolesnici randomizirani na sekukinumab primali su 10 mg/kg intravenski u 0., 2. i 4. tjednu, nakon čega je slijedila supkutana doza od 150 mg ili 300 mg svakoga mjeseca.
The safety and efficacy of secukinumab were assessed in 816 patients in three randomised, double-blind, placebo-controlled phase III studies in patients with active ankylosing spondylitis (AS) with a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4 despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid or disease-modifying anti-rheumatic drug (DMARD) therapy.
Sigurnost i djelotvornost sekukinumaba bile su procijenjene u 816 bolesnika u tri randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja faze III u bolesnika s aktivnim ankilozantnim spondilitisom (AS) koji su imali Bath indeks aktivnosti ankilozantnog spondilitisa (engl.
Enthesitis resolution n (%) ‡ Week 16
Povlačenje entezitisa n (%) ‡ 16. tjedan
Pack containing 2 pre-filled pens
Pakiranje sadrži 2 napunjene brizgalice
Do not use if the lyophilised powder has not fully dissolved or if the liquid contains easily visible particles, is cloudy or is distinctly brown.
Ne upotrebljavajte ako se liofilizirani prašak nije potpuno rastopio ili ako tekućina sadrži lako vidljive čestice, ako je zamućena ili izrazito smeđa.
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 ostale bolesnike preporučena doza je 150 mg supkutanom injekcijom s početnom dozom u 0., 1., 2., 3. i 4. tjednu, nakon čega slijedi mjesečna doza održavanja.
Multipack containing 6 (3 x 2) pre-filled syringes
Višestruko pakiranje sadrži 6 (3 x 2) napunjenih štrcaljki
• if you have recently had or are due to have a vaccination.
• ako ste se nedavno cijepili ili se trebate cijepiti.
Non-responder imputation used for missing binary endpoint
Imputacija bolesnika bez odgovora upotrijebljena je za binarnu mjeru ishoda koja nedostaje
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.
Preporučena doza je 300 mg sekukinumaba supkutanom injekcijom s početnom dozom u 0., 1., 2., 3. i 4. tjednu, nakon čega slijedi mjesečna doza održavanja.
Do not use the syringe after the expiry date which is stated on the outer box or syringe label after “EXP”.
Štrcaljka se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji ili naljepnici na štrcaljki iza „Rok valjanosti“.
Pack containing 1 pre-filled pen
Pakiranje sadrži 1 napunjenu brizgalicu
• after the expiry date which is stated on the outer box or the label on the syringe after “EXP”.
• nakon isteka roka valjanosti navedenog na kutiji ili naljepnici na brizgalici iza „Rok valjanosti“
PsA study 2
2. ispitivanje PsA
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
Srednja vrijednost promjene u 24. tjednu *p<0,05 temeljeno na nominalnoj, ali ne prilagođenoj, p-vrijednosti Sekukinumab 150 mg ili 300 mg s.c. u 0., 1., 2., 3. i 4. tjednu nakon čega je slijedila ista doza svaki mjesec
OUTER CARTON OF MULTIPACK (INCLUDING BLUE BOX) - pre-filled syringe
VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA (UKLJUČUJUĆI PLAVI OKVIR)napunjena štrcaljka
Pack containing 1 pre-filled syringe
Pakiranje sadrži 1 napunjenu štrcaljku
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.
U 16. tjednu su bolesnici randomizirani na primanje placebo na početku ponovno bili randomizirani na primanje sekukinumaba (75 mg ili 150 mg supkutano) svakoga mjeseca.
Cosentyx 150 mg powder for solution for injection
Cosentyx 150 mg prašak za otopinu za injekciju
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.
Preporučena doza je 150 mg supkutanom injekcijom s početnom dozom u 0., 1., 2., 3. i 4. tjednu, nakon čega slijedi mjesečna doza održavanja.
Patients treated with secukinumab 150 mg also showed statistically significant improvements on exploratory endpoints in physical function as assessed by the Bath Ankylosing Spondylitis Functional Index (BASFI) compared to placebo (-2.15 versus -0.68), and in fatigue as assessed by the Functional Assessment of Chronic Illness TherapyFatigue (FACIT-Fatigue) scale compared to placebo (8.10 versus 3.30).
Bath Ankylosing Spondylitis Functional Index, BASFI) u usporedbi s placebom (-2,15 u odnosu na -0,68) i u umoru ocijenjenom putem ljestvice za funkcionalnu procjenu umora u kroničnim bolestima (engl.
Allow the vial to stand undisturbed at room temperature for approximately 5 minutes.
Ostavite bočicu na sobnoj temperaturi otprilike 5 minuta i ne dirajte je.
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.
U 16. tjednu su bolesnici randomizirani na primanje placeba na početku ponovno bili randomizirani na primanje sekukinumaba (150 mg ili 300 mg supkutano) svakoga mjeseca.
Multipack containing 6 (3 x 2) pre-filled pens
Višestruko pakiranje sadrži 6 (3 x 2) napunjenih brizgalica
CARTON - vial
KUTIJA - bočica
Pack containing 2 pre-filled syringes
Pakiranje sadrži 2 napunjene štrcaljke
Multipack: 6 (3 packs of 2) pre-filled pens
Višestruko pakiranje: 6 (3 pakiranja po 2) napunjenih brizgalica
PASI 100 response n (%) 0 (0.0%) 5
Odgovor PASI 100 n (%) 0 (0,0%) 5
Cosentyx 150 mg injection secukinumab
Cosentyx 150 mg injekcija sekukinumab s.c.
Store the syringes in the original package in order to protect from light.
Čuvati brizgalice u originalnom pakiranju radi zaštite od svjetlosti.
Each 300 mg dose is given as two subcutaneous injections of 150 mg.
Svaka doza od 300 mg daje se u obliku dvije supkutane injekcije od 150 mg.
PASI 90 response n (%) 0 (0.0%) 27
Odgovor PASI 90 n (%) 0 (0,0%) 27
PASI 90 response n (%) 0 (0.0%) 24
Odgovor PASI 90 n (%) 0 (0,0%) 24