natgillin/translations-raw huggingface dataset:
Patients were randomized to receive a subcutaneous maintenance regimen of either 90 mg ustekinumab every 8 weeks, 90 mg ustekinumab every 12 weeks or placebo for 44 weeks (for recommended maintenance posology, see section 4.2 of the STELARA Solution for injection (vial) and Solution for injection in pre filled syringe SmPC).
Bolniki so bili randomizirani v skupine, v katerih so 44 tednov prejemali subkutani vzdrževalni odmerek 90 mg ustekinumaba na 8 tednov, 90 mg ustekinumaba na 12 tednov ali placebo (za priporočeno vzdrževalno odmerjanje glejte poglavje 4.2 v SmPC zdravila STELARA raztopina za injiciranje (viala) in STELARA raztopina za injiciranje v napolnjeni injekcijski brizgi).
• Hold the pre-filled syringe with one hand between the middle and index fingers and place the thumb on top of the plunger head and use the other hand to gently pinch the cleaned skin between your thumb and index finger.
Palec položite na vrh glave bata, z drugo roko nežno stisnite kožo v gubo na predelu, ki ste ga pred tem očistili.
• Drooping eyelid and sagging muscles on one side of the face (‘facial palsy' or ‘Bell's palsy'), which is usually temporary
• povešena veka in mlahave mišice na eni strani obraza (‘paraliza obraznega živca' ali
In Psoriasis Study 1, improvements in nail psoriasis (Nail Psoriasis Severity Index), in the physical and mental component summary scores of the SF-36 and in the Itch Visual Analogue Scale (VAS) were also significant in each ustekinumab treatment group compared with placebo.
V 1. študiji psoriaze so bila tudi izboljšanja psoriaze na nohtih (indeks jakosti psoriaze na nohtih - Nail Psoriasis Severity Index), skupni oceni telesnega in duševnega stanja z vprašalnikom SF-36 in vizualni analogni lestvici (Visual Analogue Scale - VAS) statistično značilna v obeh terapevtskih skupinah z ustekinumabom v primerjavi s placebom.
• If there are air bubbles, tap the side gently until the air bubbles go to the top of the syringe (see
• Če so v brizgi vidni zračni mehurčki, nežno potrkajte po njej od strani, da bodo zračni mehurčki splavali na vrh (glejte Sliko 5).
• If you have recently had or are going to have a vaccination.
• če ste bili pred kratkim cepljeni oziroma boste cepljeni.
Psoriasis Study 3 (ACCEPT) evaluated 903 patients with moderate to severe psoriasis who inadequately responded to, were intolerant to, or had a contraindication to other systemic therapy and compared the efficacy of ustekinumab to etanercept and evaluated the safety of ustekinumab and etanercept.
V 3. študiji psoriaze (ACCEPT) so ocenjevali 903 bolnike z zmerno do hudo psoriazo, ki se na druge sistemske terapije niso odzvali v zadostni meri, jih niso prenašali ali so bile le-te kontraindicirane.
Clinical presentations included cough, dyspnoea, and interstitial infiltrates following one to three doses.
Po enem do treh odmerkih je klinična slika vključevala kašelj, dispnejo in intersticijske infiltrate.
70 Point Response, week 6
Klinični odziv (70 točk), 6. teden
During the controlled periods of the psoriasis and psoriatic arthritis clinical studies of ustekinumab, rash and urticaria have each been observed in < 1% of patients (see section 4.4).
Med nadzorovanim obdobjem kliničnih študij psoriaze in psoriatičnega artritisa z ustekinumabom so izpuščaje in urtikarijo opazili pri < 1% bolnikov.
The first subcutaneous administration of 90 mg STELARA should take place at week 8 after the intravenous dose.
Prvi subkutani 90 mg odmerek zdravila STELARA je treba injicirati 8 tednov po intravenskem odmerku.
Solution for injection 45 mg/0.5 mL 1 vial
raztopina za injiciranje 45 mg/0,5 ml 1 viala
Solution for injection 90 mg/1 mL 1 vial
raztopina za injiciranje 90 mg/1 ml 1 viala
• Stelara is given as an injection under the skin (‘subcutaneously').
• Zdravilo Stelara dajemo s podkožno injekcijo (‘subkutano').
PASI 90 response N (%)
odziv PASI 90 N (%)
The maintenance study (IM-UNITI), evaluated 388 patients who achieved 100 point clinical response at week 8 of induction with ustekinumab in studies UNITI-1 and UNITI-2.
V študijo, ki je ocenjevala vzdrževalno obdobje zdravljenja (IM-UNITI), je bilo vključenih 388 bolnikov, ki so v študijah UNITI-1 in UNITI-2 dosegli klinični odziv na ustekinumab (izboljšanje indeksa CDAI za vsaj 100 točk ) po 8 tednih.
Improvement in HAQ-DI score from baseline was maintained through Weeks 52 and 100.
Izboljšanje od izhodiščne ocene HAQ-DI se je ohranilo do 52. in do 100. tedna.
In patients with Crohn's disease and ulcerative colitis, following an intravenous dose of ~6 mg/kg, starting at week 8, subcutaneous maintenance dosing of 90 mg ustekinumab was administered every 8 or 12 weeks.
Bolniki s Crohnovo boleznijo in ulceroznim kolitisom so od 8. tedna po intravenskemu odmerku približno 6 mg/kg ustekinumaba prejemali 90 mg vzdrževalni odmerek ustekinumaba na 8 ali 12 tednov.
In patients with ulcerative colitis, median steady-state trough concentrations ranged from 2.69 μg/mL to 3.09 μg/mL and from 0.92 μg/mL to 1.19 μg/mL for 90 mg ustekinumab every 8 weeks or every 12 weeks.
Pri bolnikih z ulceroznim kolitisom se je mediana vrednost najmanjše koncentracije v stanju dinamičnega ravnovesja pri 90 mg odmerku ustekinumaba gibala od 2,69 μg/ml do 3,09 μg/ml (ob injiciranju na 8 tednov) in od 0,92 μg/ml do 1,19 μg/ml (ob injiciranju na 12 tednov).
• However, you and your doctor may decide that you may inject Stelara yourself.
• Z zdravnikom se lahko dogovorite, da si boste zdravilo Stelara injicirali sami.
* Clinical remission is defined as Mayo score ≤2 points, with no individual subscore > 1.
*Klinična remisija je definirana kot ocenaMayo ≤2, pri čemer nobena od podocen ni >1.
70 Point Response, week 3
Klinični odziv (70 točk), 3. teden
Significant differences in partial Mayo score and symptomatic remission were observed between ustekinumab and placebo as early as Week 2.
Glede parcialne ocene Mayo in simptomatske remisije so statistično značilne razlike med skupino, ki je prejemala ustekinumab in skupino, ki je prejemala placebo, opazili že po 2 tednih.
Stelara is for single use only.
Ena viala je namenjena le za enkratno uporabo.
Plaque psoriasis (Adults)
Psoriaza s plaki (odrasli bolniki)
Through week 44 of UNIFI-M, a significantly lower number of UC-related hospitalizations was observed in subjects in the combined ustekinumab group (2.0%, 7/348) as compared with subjects in the placebo group (5.7%, 10/175).
Do 44. tedna v študiji UNIFI-M je bilo število bolnikov, ki so bili hospitalizirani zaradi ulceroznega kolitisa, statistično značilno manjše v kombinirani skupini, ki je prejemala ustekinumab (2,0%, 7/348) kot med bolniki v skupini, ki je prejemala placebo (5,7%, 10/175).
• Do not touch the needle or allow it to touch any surface
• Ne dotikajte se igle in pazite, da se z njo ničesar ne dotaknete.
The safety and efficacy of ustekinumab was assessed in three randomized, double-blind, placebo-controlled, multicenter studies in adult patients with moderately to severely active Crohn's disease (Crohn's Disease Activity Index [CDAI] score of ≥ 220 and ≤ 450).
Varnost in učinkovitost ustekinumaba so ocenjevali v treh randomiziranih, dvojno slepih, s placebom nadzorovanih, multicentričnih študijah pri odraslih bolnikih z zmerno do močno aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI] ≥ 220 in ≤ 450).
• Pick up the syringe and remove the needle cover
• Vzemite brizgo in snemite pokrovček z igle.
If you forget a dose, contact your doctor or pharmacist.
Če pozabite vzeti odmerek zdravila, se posvetujte z zdravnikom ali farmacevtom.
Solution for injection in pre-filled syringe 90 mg/1 mL
raztopina za injiciranje v napolnjeni injekcijski brizgi 90 mg/1 ml
Improvements in FACIT scores were maintained through week 52.
Izboljšanje v FACIT-F se je ohranilo do 52. tedna.
At week 8, patients receiving ustekinumab showed statistically significantly greater and clinically meaningful improvements on IBDQ total score and SF-36 Mental Component Summary Score in both UNITI-1 and UNITI-2, and SF-36 Physical Component Summary Score in UNITI-2, when compared to placebo.
Pri bolnikih, zdravljenih z ustekinumabom, je bilo v študijah UNITI-1 in UNITI-2 po 8 tednih statistično značilno večje in klinično pomembno izboljšanje po vprašalniku IBDQ in SF-36 povzetek ocene duševnih komponent (SF-36 Mental Component Summary Score); ter SF-36 povzetek ocene telesnih komponent (SF-36 Physical Component Summary Score) v študiji UNITI-2, v primerjavi s placebom.
Symptomatic remission is defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
Simptomatska remisija je definirana kot podocena frekvence odvajanja blata Mayo 0 ali 1 in podocena krvavitve iz danke 0.
Dose levels in animal studies were up to approximately 45-fold higher than the highest equivalent dose intended to be administered to psoriasis patients and resulted in peak serum concentrations in monkeys that were more than 100-fold higher than observed in humans.
V študijah na živalih so bili odmerki do približno 45-krat večji kot so največji ekvivalentni odmerki namenjeni injiciranju bolnikom s psoriazo.
For further instructions on preparation and special precautions for handling, see section 6.6.
Za dodatne previdnostne ukrepe pri ravnanju z zdravilom glejte poglavje 6.6.
• the solution is not discoloured or cloudy and does not contain any foreign particles
• da raztopina ni spremenila barve ali je motna, da ne vsebuje tujih delcev in
Uncommon: Hypersensitivity reactions (including rash, urticaria) Rare: Serious hypersensitivity reactions (including anaphylaxis, angioedema)
Redki: hude preobčutljivostne reakcije (vključno z anafilaksijo in angioedemom)
STELARA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
Zdravilo STELARA je indicirano za zdravljenje zmerno do močno aktivne Crohnove bolezni pri odraslih bolnikih, ki se niso ustrezno odzvali, so izgubili odziv na zdravljenje, ali niso prenašali konvencionalnega zdravljenja ali zdravljenja z zaviralci faktorja tumorske nekroze alfa (TNFα) oziroma je takšno zdravljenje kontraindicirano.
The incidence of non-melanoma skin cancer was 0.49 per 100 patient-years of follow-up for ustekinumab-treated patients (56 patients in 11,545 patient-years of follow-up).
Pogostnost nemelanomskega kožnega raka za bolnike, zdravljene z ustekinumabom, je bila 0,49 na 100 bolnikov-let spremljanja (56 bolnikov na 11.545 bolnikov-let spremljanja).
Mucosal healing is defined as a Mayo endoscopic sub-score of 0 or 1.
Zacelitev sluznice je definirana kot endoskopska podocena Mayo 0 ali 1.
Infusion dose of ustekinumab using the weight-based dosage regimen specified in Table 1.
Kombinacija simptomatske remisije in zacelitve sluznice infuzijski odmerek ustekinumaba v skladu z režimom odmerjanja glede na telesno maso, opisanem v Preglednici 1.
• A 45 mg vial is available for children who need to receive less than the full 45 mg dose.
• Za otroke, ki morajo prejeti odmerek, manjši od 45 mg, je na voljo 45 mg viala.
Common: Diarrhoea, nausea, vomiting
Pogosti: driska, navzea, bruhanje
Stelara is not recommended for use in children under 18 years of age with Crohn's disease or ulcerative colitis because it has not been studied in this age group.
Zdravilo Stelara ni priporočljivo za otroke s Crohnovo boleznijo ali ulceroznim kolitisom, mlajše od 18 let, ker ga pri tej starostni skupini še niso preučili.
90 mg ustekinumab every 12 weeks N = 129
90 mg ustekinumaba na 12 tednov n = 129†
PGA of Cleared (0) PASI
PGA čisto (0) PASI
In PsA Study 2 there was a significant improvement in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scores in the ustekinumab groups when compared with placebo at week 24.
V 2. študiji PsA so v skupini, ki je 24 tednov prejemala ustekinumab, dokazali značilno izboljšanje funkcijske ocene zdravljenja kronične bolezni - utrujenosti (FACIT-FFunctional Assessment of Chronic Illness Therapy - Fatigue) v primerjavi s skupino, ki je prejemala placebo.
The safety and efficacy of ustekinumab was assessed in two randomized, double-blind, placebocontrolled, multicenter studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2).
Varnost in učinkovitost ustekinumaba so ocenjevali v dveh randomiziranih, dvojno slepih, s placebom nadzorovanih, multicentričnih študijah pri odraslih bolnikih z zmerno do močno aktivnim ulceroznim kolitisom (z oceno Mayo od 6 do 12 in endoskopsko podoceno ≥ 2).
There was no apparent accumulation in serum ustekinumab concentration over time when given subcutaneously every 12 weeks.
Pri subkutani uporabi ustekinumaba na 12 tednov ni bilo opaznega povečevanja njegove serumske koncentracije s časom.
• Then press the plunger until all of the air (but none of the liquid) has been removed • Do not lay the syringe down or allow the needle to touch anything.
• Potem potisnite bat noter, da boste iz brizge iztisnili ves zrak (ampak nič tekočine).
Solution for injection in pre-filled syringe 45 mg/0.5 mL
raztopina za injiciranje v napolnjeni injekcijski brizgi 45 mg/0,5 ml
STELARA is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) (see section 5.1).
Zdravilo STELARA je indicirano za zdravljenje zmerne do hude psoriaze s plaki pri odraslih, ki se niso odzvali na drugo sistemsko zdravljenje, vključno z zdravljenjem s ciklosporinom, metotreksatom (MTX) ali PUVA (psoralen in obsevanje z UVA svetlobo), pri katerih je drugo sistemsko zdravljenje kontraindicirano ali ga ne prenašajo (glejte poglavje 5.1).
In patients with Crohn's disease, median steady-state trough concentrations ranged from 1.97 μg/mL to 2.24 μg/mL and from 0.61 μg/mL to 0.76 μg/mL for 90 mg ustekinumab every 8 weeks or every 12 weeks respectively.
Pri bolnikih s Crohnovo boleznijo se je mediana vrednost najmanjše koncentracije v stanju dinamičnega ravnovesja pri 90 mg odmerku ustekinumaba gibala od 1,97 μg/ml do 2,24 μg/ml (ob injiciranju na 8 tednov) in od 0,61 μg/ml do 0,76 μg/ml (ob injiciranju na 12 tednov).
Infuse the diluted solution over a period of at least one hour.
Razredčeno raztopino infundirajte bolniku v času, ki naj ne bo krajši od ene ure.
Psoriatic arthritis (PsA) (Adults)
Psoriatični artritis (PsA) (odrasli bolniki)
The steady-state trough ustekinumab levels resulting from 90 mg ustekinumab every 8 weeks were associated with higher clinical remission rates as compared to the steady-state trough levels following 90 mg every 12 weeks.
Vrednosti najmanjše koncentracije v stanju dinamičnega ravnovesja po injiciranju 90 mg ustekinumaba na 8 tednov so bile povezane z večjo stopnjo klinične remisije kot vrednosti po injiciranju 90 mg ustekinumaba na 12 tednov.
Baseline disease characteristics were generally consistent across all treatment groups in Psoriasis Studies 1 and 2 with a median baseline PASI score from 17 to 18, median baseline Body Surface Area (BSA) ≥ 20, and median Dermatology Life Quality Index (DLQI) range from 10 to 12.
Mediana vrednost indeksa PASI na začetku študije je bila od 17 do 18, mediana vrednost ocene prizadete telesne površine (Body Surface Area-BSA) na začetku študije je bila ≥ 20, mediana vrednost dermatološkega indeksa kakovosti življenja (Dermatology Life Quality Index - DLQI) se je gibala v razponu od 10 do 12.
Table 5 Summary of clinical response at week 12 in Psoriasis Study 3 (ACCEPT) Psoriasis Study 3
Preglednica 5 Povzetek rezultatov kliničnega odziva po 12 tednih v 3. študiji psoriaze (ACCEPT) 3. študija psoriaze etanercept 24 odmerkov (50 mg dvakrat na teden)
No specific studies have been conducted with intravenous ustekinumab in elderly or paediatric patients.
Pri starejših ali pediatričnih bolnikih specifične študije z intravensko danim ustekinumabom niso bile opravljene.
The solution in the STELARA vial or pre-filled syringe should not be shaken.
Raztopine v viali ali napolnjeni injekcijski brizgi zdravila STELARA ne smete stresati.
VIAL LABEL TEXT (45 mg)
BESEDILO NA NALEPKI VIALE (45 mg)
When using the single-dose vial, a 1 mL syringe with a 27 gauge, ½ inch (13 mm) needle is recommended.
Pri uporabi viale z enim odmerkom se priporoča uporaba 1-ml brizge z iglo velikosti G27 x 13 mm.
The median trough serum concentrations of ustekinumab in patients with higher weight (> 100 kg) in the 90 mg group were comparable to those in patients with lower weight (≤ 100 kg) in the 45 mg group.
Mediana vrednost CL/F pri bolnikih s telesno maso > 100 kg je bila za približno 55% večja kot pri tistih s telesno maso ≤ 100 kg, medtem ko je bila mediana vrednost V/F za približno 37% večja pri bolnikih s telesno maso > 100 kg kot pri tistih s telesno maso ≤ 100 kg. Mediana vrednost najnižje serumske koncentracije ustekinumaba pri bolnikih z večjo telesno maso (> 100 kg) v skupini za odmerek 90 mg je bila podobna kot pri bolnikih z manjšo telesno maso (≤ 100 kg) v skupini za prejemanje 45 mg odmerka.
Calculate the dose and the number of STELARA vials needed based on patient weight (see section 3, Table 1).
Odmerek in potrebno število vial zdravila STELARA izračunajte na osnovi bolnikove telesne mase (glejte poglavje 4.1, Preglednica 1).
PASI 75 response N (%)
odziv PASI 75 r N (%)
Visually inspect the diluted solution before infusion.
Pred odmerjanjem preverite izgled razredčene raztopine.
You may cover the injection site with a small adhesive bandage, if necessary.
Če je potrebno, lahko na mesto injiciranja prilepite majhen obliž.
90mg ustekinumab every 12 Weeks N = 172
90 mg ustekinumaba na 12 tednov N = 172
Each vial contains 130 mg ustekinumab in 26 mL of concentrate for solution for infusion.
Ena viala vsebuje 130 mg ustekinumaba v 26 ml koncentrata za raztopino za infundiranje.
What Stelara looks like and contents of the pack Stelara is a clear to slightly opalescent (having a pearl-like shine), colourless to light yellow solution for injection.
Zdravilo Stelara je bistra do rahlo opalescentna (z bisernim sijajem), brezbarvna do svetlo rumena raztopina za injiciranje.
Stelara is intended for use under the guidance and supervision of a doctor experienced in the diagnosis and treatment of Crohn's disease or ulcerative colitis.
Zdravilo Stelara boste uporabljali pod vodstvom in nadzorom zdravnika, ki ima izkušnje z diagnostiko in zdravljenjem Crohnove bolezni oziroma ulceroznega kolitisa.
Never re-use needles and syringes, for your safety and health, and for the safety of others.
Te posode odstranite skladno z lokalnimi predpisi Zaradi vaše varnosti in zdravja in varnosti drugih, uporabljene igle ali brizge ne smete ponovno uporabiti.
Approximately 6 mg/kg
520 mg približno 6 mg/kg
Recommended dose of ustekinumab N = 209
Priporočeni odmerek ustekinumaba n = 209
During the placebo controlled period through week 12, the efficacy of both the recommended and half of the recommended dose groups were generally comparable at the primary endpoint (69.4% and 67.6% respectively) although there was evidence of a dose response for higher level efficacy criteria (e.g. PGA of cleared (0), PASI 90).
Do 12. tedna zdravljenja, nadzorovanega s placebom je bila učinkovitost primarnih ciljev pri skupini, ki je prejemala priporočeni odmerek in pri skupini, ki je prejemala polovico priporočenega odmerka v splošnem primerljiva (69,4% oziroma 67,6%).
If you have used or been given too much Stelara, talk to a doctor or pharmacist straight away.
Če ste uporabili večji odmerek zdravila Stelara, kot bi smeli Če ste sami uporabili prevelik odmerek zdravila Stelara oziroma so vam ga dali drugi, se morate nemudoma posvetovati z zdravnikom ali farmacevtom.
90mg ustekinumab every 8 Weeks N = 176
90 mg ustekinumaba na 8 tednov N=176
The systemic exposure of ustekinumab (Cmax and AUC) increased in an approximately dose-proportional manner after a single intravenous administration at doses ranging from 0.09 mg/kg to 4.5 mg/kg.
Sistemska izpostavljenost ustekinumabu (Cmax in AUC) po enkratni intravenski injekciji odmerkov od 0,09 mg/kg do 4,5 mg/kg je naraščala približno sorazmerno z odmerkom.
The solution in the STELARA vial should not be shaken.
Raztopine v viali zdravila STELARA ne smete stresati.
• Inject the dose promptly after removing the needle cover.
• Po odstranitvi pokrovčka z igle takoj injicirajte zdravilo.
Recommended dose of ustekinumab N = 322
Priporočeni odmerek ustekinumaba N =322
STELARA should only be diluted with sodium chloride 9 mg/mL (0.9%) solution.
Zdravilo STELARA se lahko redči samo z 9 mg/ml (0,9%) raztopino natrijevega klorida.
• Hold the pre-filled syringe by the body of the syringe with the covered needle pointing upward
• Primite telo brizge tako, da pokrovček igle gleda navzgor.
Patients who were not in clinical response to ustekinumab induction at week 8 of the UNFI-I study but were in response at week 16 (157 patients) entered into the non-randomized portion of UNIFI-M and continued to receive maintenance dosing every 8 weeks; among these patients, a majority (62%) maintained response and 30% achieved remission at week 44.
Bolniki, ki niso dosegli kliničnega odziva na indukcijski odmerek ustekinumaba v 8. tednu študije UNFI-I, so pa dosegli odziv v 16. tednu (157 bolnikov), so vstopili v nerandomiziran del študije UNIFI-M in nadaljevali s prejamanjem vzdrževalnega odmerjanja vsakih 8 tednov.
STELARA 45 mg solution for injection 2 years
STELARA 45 mg raztopina za injiciranje 2 leti
Patients randomised to receive placebo at Weeks 0 and 4 crossed over to receive ustekinumab (either 45 mg or 90 mg) at Weeks 12 and 16.
Bolniki, ki so bili najprej naključno uvrščeni v skupino za prejemanje placeba v 0. ali 4. tednu, pa so prešli v skupino za prejemanje ustekinumaba (bodisi v odmerku 45 mg ali 90 mg) v 12. in 16. tednu.
The median tmax values of ustekinumab following a single subcutaneous administration of either 45 mg or 90 mg in patients with psoriasis were comparable to those observed in healthy subjects.
po enkratni subkutani injekciji bodisi 45 mg ali 90 mg zdravila, pri bolnikih s psoriazo so bile podobne kot pri zdravih preizkušancih.
Keep the vial or pre-filled syringe in the outer carton in order to protect from light.
Vialo ali napolnjeno injekcijsko brizgo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo.
• Inflammation of tissue under the skin (‘cellulitis') is uncommon (may affect up to 1 in
• Občasno je vnetje podkožnega tkiva (‘celulitis') (pojavi se lahko pri največ 1 od
• You can press a cotton ball or gauze over the injection site and hold for 10 seconds.
• Na mesto injiciranja lahko za 10 sekund pritisnete vato ali gazo.
STELARA is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Zdravilo STELARA se redči z 9 mg/ml (0,9%) raztopino natrijevega klorida.
In both UNITI-1 and UNITI-2, a significantly greater proportion of patients were in clinical response and remission in the ustekinumab treated group compared to placebo (Table 9).
V študijah UNITI-1 in UNITI-2 je v skupini, ki je prejemala ustekinumab, statistično značilno večji delež bolnikov dosegel klinični odziv in remisijo, v primerjavi s skupino, ki je prejemala placebo (Preglednica 9).
• Slow down the damage to your joints.
• upočasnitev napredovanja sprememb v sklepih.
Eight weeks later, 50.5% of the patients achieved clinical response and continued to receive maintenance dosing every 8 weeks; among these patients with continued maintenance dosing, a majority maintained response (68.1%) and achieved remission (50.2%) at week 44, at proportions that were similar to the patients who initially responded to ustekinumab induction.
Med bolniki, ki so nadaljevali z vzdrževalnim odmerjanjem, jih je večina vzdrževala odziv na zdravljenje (68,1%) oz. so dosegli remisijo (50,2%) v 44. tednu.
Recommended dose of ustekinumab N = 249
Priporočeni odmerek ustekinumaba n = 249