FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety profile observed in patients with psoriatic arthritis treated with Taltz is consistent with the safety profile in plaque psoriasis with the exception of the frequencies of the adverse reactions of influenza and conjunctivitis which were common in patients with psoriatic arthritis.
Slovenian: Varnostni profil, ki so ga opazili pri bolnikih s psoriatičnim artritisom, zdravljenih z zdravilom Taltz, je skladen z varnostnim profilom pri psoriazi s plaki, z izjemo pogostnosti neželenih učinkov gripe in konjunktivitisa, ki sta bila pogosta neželena učinka pri bolnikih s psoriatičnim artritisom.
English: sPGA of “0” (clear) or “1” (minimal)
Slovenian: sPGA "0" (čisto) ali "1" (minimalno)
English: Leave the base cap on until you are ready to inject.
Slovenian: Pokrovčka ohišja ne snemajte, dokler niste pripravljeni na injiciranje.
English: Oropharyngeal pain
Slovenian: Navojni pokrovček ohišja
English: Let the injection site dry naturally before you inject your medicine.
Slovenian: Injekcijsko mesto se mora pred injiciranjem zdravila posušiti na zraku.
English: - signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections
Slovenian: - izcedek iz oči s srbenjem, pordelostjo in otekanjem (konjunktivitis), - znaki nizkih ravni belih krvničk, kot so povišana telesna temperatura, boleče grlo ali razjede v ustih zaradi okužb (nevtropenija),
English: Abbreviations: ACR 20/50/70 = American College of Rheumatology 20%/50%/70% response rate; ADA = adalimumab; BSA = body surface area; CI = confidence interval; Q4W = Taltz 80 mg every 4 weeks; Q2W = Taltz 80 mg every 2 weeks; N = number of patients in the analysis population; n = number of patients in the specified category; NRI = non-responder imputation; PASI 100 = psoriasis area and severity index 100% improvement; PBO = placebo.
Slovenian: Okrajšave: ACR 20/50/70 = Stopnja odziva 20 %/50 %/70 % glede na lestvico Ameriškega združenja za revmatologijo (American College of Rheumatology); ADA = adalimumab; BSA = telesna površina (body surface area); IZ = interval zaupanja; Q4W = Taltz 80 mg vsake 4 tedne; Q2W = Taltz 80 mg vsaka 2 tedna; N = število bolnikov v analizirani populaciji; n = število bolnikov v posamezni kategoriji; NRI = imputacija manjkajočih podatkov za bolnike, ki se niso odzvali.
English: Inspect the pre-filled syringe for damage to the outside.
Slovenian: Preglejte napolnjeno injekcijsko brizgo, ali so na njeni zunanjosti kakršne koli poškodbe.
English: Q. What if there is a drop of liquid on the tip of the needle when I remove the needle cap?
Slovenian: V: Kaj če opazim kapljico tekočine na konici igle, ko odstranim pokrovček igle?
English: Patients randomised to Taltz who were sPGA (0,1) responders (static Physicians Global Assessment) at Week 12 were re-randomised to receive placebo or Taltz for an additional 48 weeks (UNCOVER-1 and UNCOVER-2); patients randomised to placebo, etanercept or Taltz who were sPGA (0,1) nonresponders received Taltz for up to 48 weeks.
Slovenian: Bolniki, ki so bili randomizirani za uporabo zdravila Taltz, in ki so se odzvali z oceno sPGA (0,1) (static Physicians Global Assessment - statična zdravnikova splošna ocena) v 12. tednu, so bili randomizirani za prejemanje placeba ali zdravila Taltz dodatnih 48 tednov (UNCOVER-1 in UNCOVER-2); bolniki, ki so bili randomizirani za uporabo placeba, etanercepta ali zdravila Taltz, ki se niso odzvali z oceno sPGA (0,1), so prejemali zdravilo Taltz še največ 48 tednov.
English: How much Taltz is given and for how long
Slovenian: Koliko zdravila Taltz je treba uporabiti in koliko časa ga uporabljamo
English: Tell your doctor, pharmacist or nurse - if you are using, have recently used or might use any other medicine.
Slovenian: - če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
English: The safety and efficacy of Taltz in children and adolescents aged 6 to 18 years in the treatment of moderate to severe plaque psoriasis have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Taltz pri otrocih in mladostnikih, starih od 6 do 18 let, za zdravljenje zmerne do hude psoriaze s plaki, še nista bili dokazani.
English: Patients were randomised to subcutaneous injections of placebo, Taltz 80 mg once every 2 weeks (Q2W), or 80 mg once every 4 weeks (Q4W).
Slovenian: Bolniki so bili randomizirani za prejemanje subkutanih injekcij placeba, zdravila Taltz 80 mg enkrat na vsaka 2 tedna (Q2W) ali 80 mg enkrat na vsake 4 tedne (Q4W).
English: A
Slovenian: h
English: Significantly greater improvements at Week 12 from baseline compared to placebo and etanercept were demonstrated in nail psoriasis (as measured by the Nail Psoriasis Severity Index [NAPSI]), in scalp psoriasis (as measured by Psoriasis Scalp Severity Index [PSSI]) and in palmoplantar psoriasis (as measured by Psoriasis Palmoplantar Severity Index [PPASI]).
Slovenian: Bistveno večja izboljšanja v 12. tednu od izhodišča so v primerjavi s placebom in etanerceptom dokazali pri psoriazi nohtov (merjeno z indeksom jakosti psoriaze nohtov NAPSI (Nail Psoriasis
English: At Week 12 and across studies, Taltz was associated with statistically significant improvement in Health-related Quality of Life as assessed by mean decrease ranges from baseline in the Dermatology Life Quality Index (DLQI) (Taltz 80 mg Q2W from -10.2 to -11.1, Taltz 80 mg Q4W from -9.4 to10.7, etanercept from -7.7 to -8.0 and placebo -1.0 to -2.0).
Slovenian: V 12. tednu in v vseh študijah so zdravilo Taltz povezali s statistično pomembnim izboljšanjem kakovosti življenja, povezane z zdravjem, ocenjene s povprečnimi stopnjami zmanjšanja od izhodišča po dermatološkem indeksu kakovosti življenja (Dermatology Life Quality Index - DLQI) (zdravilo Taltz 80 mg Q2W od -10,2 do -11,1, zdravilo Taltz 80 mg Q4W od -9,4 do -10,7, etanercept od -7,7
English: • Read the Taltz Package Leaflet inside this box to learn more about your medicine.
Slovenian: • Preberite Navodilo za uporabo zdravila Taltz v tej škatli, da boste izvedeli več o vašem zdravilu.
English: Some side effects are common (may affect up to 1 in 10 people): - nausea (feeling sick).
Slovenian: Nekateri neželeni učinki so pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): - navzea (občutek slabosti),
English: You may inject in your abdomen (stomach area), in your thigh, or in the back of your arm. To inject in your arm, you will need someone to help you.
Slovenian: Zdravilo lahko injicirate v trebuh (abdominalno področje), v stegno ali v nadlaket (hrbtno stran roke).
English: Some side effects are very common (may affect more than 1 in 10 people): - upper respiratory tract infections with symptoms such as sore throat and stuffy nose
Slovenian: Nekateri neželeni učinki so zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov): - okužbe zgornjih dihalnih poti s simptomi, kot sta boleče grlo in zamašen nos (nazofaringitis), - reakcije na mestu injiciranja (npr. pordela koža, bolečina).
English: Remove the pre-filled pen from your skin.
Slovenian: Umaknite peresnik s kože.
English: • The green plunger rod should show through the body of the syringe.
Slovenian: • Zeleni potisni bat mora biti viden skozi ohišje brizge.
English: PASI-Response Rates from comparative study ixekizumab versus ustekinumab
Slovenian: Rezultati primerjalne študije iksekizumaba v primerjavi z ustekinumabom glede na odziv PASI
English: • 1 sharps container for disposal of syringes
Slovenian: • 1 zbiralnik za ostre predmete za odstranjevanje brizg
English: Throw the base cap in the bin.
Slovenian: Odvrzite pokrovček podnožja v koš za odpadke.
English: Patients originally randomised to Taltz and who were responders at Week 12 (i.e., sPGA score of 0,1) in UNCOVER-1 and UNCOVER-2 were re-randomised to an additional 48 weeks of one of the following treatment regimens: placebo, or Taltz (80 mg every four or twelve weeks [Q4W or Q12W]).
Slovenian: Bolniki, ki so bili najprej randomizirani za zdravljenje z zdravilom Taltz in ki so se v 12. tednu odzivali na zdravljenje (tj., ocena sPGA 0,1) v študijah UNCOVER-1 in UNCOVER-2, so bili znova randomizirani za dodatnih 48 tednov zdravljenja z enim od naslednjih režimov: placebo ali zdravilo Taltz (80 mg vsake štiri ali dvanajst tednov [Q4W ali Q12W]).
English: Maintained or Achieved sPGA 0 (clear)
Slovenian: Vzdrževana ali zabeležena ocena sPGA 0
English: Syringe body with medicine
Slovenian: Ohišje brizge z zdravilom
English: Maintained or Achieved PASI 100
Slovenian: Vzdrževana ali zabeležena ocena PASI
English: The efficacy and safety of Taltz was demonstrated regardless of age, gender, race, disease duration, baseline body weight, baseline psoriasis involvement, baseline CRP, baseline DAS28-CRP, concomitant corticosteroid use, and previous treatment with a biologic.
Slovenian: Učinkovitost in varnost zdravila Taltz je bila dokazana ne glede na starost, spol, raso, trajanje bolezni, izhodiščno telesno maso, izhodiščno prizadetost kože, izhodiščni C-reaktivni protein, izhodiščno oceno na lestvici DAS28-CRP, sočasno uporabo kortikosteroidov in predhodno zdravljenje z biološkim zdravilom.
English: In the psoriatic arthritis studies, injection site reactions were more common in subjects with a body weight < 100 kg compared with the group with a body weight ≥ 100 kg (24 %
Slovenian: V študijah psoriatičnega artritisa so bile reakcije na mestu injiciranja bolj pogoste pri bolnikih s telesno maso < 100 kg, v primerjavi s skupino, ki je imela telesno maso ≥ 100 kg (24 % v primerjavi s 13 % za kombinirani skupini Q2W in Q4W).
English: Among these patients, 71.5 % regained at least an sPGA (0,1) response within 12 weeks of restarting treatment with Taltz 80 mg Q4W.
Slovenian: Od teh bolnikov jih je 71,5 % znova doseglo oceno sPGA najmanj (0,1) v 12. tednih od ponovnega začetka zdravljenja z zdravilom
English: Press a cotton ball or gauze over the injection site.
Slovenian: Na mesto injiciranja pritisnite kroglico vate ali kos gaze.
English: Patients were stratified at baseline based on concomitant cDMARD use and presence of moderate-to-severe psoriasis (PASI≥12,
Slovenian: Bolnike so ob izhodišču stratificirali glede na sočasno uporabo cDMARD in prisotnost zmerne do hude psoriaze (PASI ≥ 12, BSA ≥ 10 in sPGA ≥ 3).
English: Taltz is for subcutaneous injection.
Slovenian: Zdravilo Taltz je namenjeno za subkutano injiciranje.
English: Other medicines and Taltz
Slovenian: Shranjevanje zdravila Taltz
English: Taltz was superior to ADA on the primary study objective: simultaneous achievement of ACR 50 and PASI 100 response at Week 24 (Taltz 36.0% vs ADA 27.9%; p=0.036; 95% confidence interval [0.5%, 15.8%]).
Slovenian: ACR 50 in PASI 100 v 24. tednu (zdravilo Taltz 36,0 % v primerjavi z ADA 27,9 %; p = 0,036; 95 % interval zaupanja [0,5 %, 15,8 %]).
English: There is limited information in subjects aged ≥ 75 years.
Slovenian: Podatki za bolnike, stare 75 let in več, so omejeni.
English: sPGA of “0” (clear) or
Slovenian: sPGA "0" (čisto)
English: At Week 24 the proportion of patients achieving a modified Psoriatic Arthritis Response Criteria (PsARC) response was greater in the Taltz-treated patients compared to placebo.
Slovenian: V 24. tednu je delež bolnikov, ki so dosegli odziv glede na prilagojene kriterije odzivnosti bolnikov s psoriatičnim artritisom (PsARC - Psoriatic Arthritis
English: • If you have questions or need help with your pre-filled syringe, call your doctor, pharmacist or nurse.
Slovenian: • Če imate vprašanja ali če potrebujete pomoč v zvezi s svojo napolnjeno injekcijsko brizgo, se obrnite na zdravnika, farmacevta ali medicinsko sestro.
English: Ixekizumab administration to cynomolgus monkeys for 39 weeks at subcutaneous doses up to 50 mg/kg weekly produced no organ toxicity or undesirable effects on immune function (e.g. T-cell dependent antibody response and NK cell activity).
Slovenian: 39 tednov ni povzročilo nobene toksičnosti za organe ali neželenih učinkov na delovanje imunskega sistema (npr. na odziv s protitelesi, odvisen od celic T in dejavnost celic NK).
English: Taltz also showed non-inferiority (pre-specified margin of -12%) to ADA on ACR 50 (ITT analysis: Taltz 50.5% vs ADA 46.6%; 3.9% difference vs. ADA; 95% confidence interval [4.3%; 12.1%] ; PPS analysis Taltz: 52.3%, ADA: 53.1%, difference: -0.8% [CI: -10.3%; 8.7%]) and superiority on PASI 100 at Week 24 (60.1 % with Taltz vs 46.6% with ADA, p=0.001), which were the major secondary endpoints in the study.
Slovenian: Pokazali so tudi neinferiornost zdravila Taltz (predhodno določena meja -12 %) glede na ADA pri odzivu ACR 50 (analiza ITT: zdravilo Taltz 50.5% v primerjavi z ADA 46.6%; 3,9-odstotna razlika v primerjavi z ADA; 95 % interval zaupanja [-4,3 %; 12,1 %]; analiza PPS za zdravilo Taltz; 52,3 %, ADA: 53,1%, razlika -0,8 % [IZ: -10,3 %; 8,7 %] ) in superiornost pri odzivu PASI 100 v 24. tednu (60,1 % pri zdravilu Taltz v primerjavi s 46,6 % pri ADA, p = 0,001), ki sta bila glavna sekundarna opazovana dogodka v študiji.
English: Injection button Lock ring Lock/unlock symbols
Slovenian: Simbol za zaklep/odklep
English: Infection rates observed in psoriatic arthritis clinical studies were similar to those observed in the plaque psoriasis studies with the exception of the frequencies of the adverse reactions of influenza and conjunctivitis which were common in patients with psoriatic arthritis.
Slovenian: Stopnje okužb, ki so jih opazili v kliničnih študijah psoriatičnega artritisa, so bile podobne stopnjam, ki so jih opazili v študijah psoriaze s plaki, z izjemo pogostnosti neželenih učinkov gripe in konjunktivitisa, ki sta bila pogosta neželena učinka pri bolnikih s psoriatičnim artritisom.
English: Contents of the pack and other information
Slovenian: Shranjevanje zdravila Taltz Vsebina pakiranja in dodatne informacije
English: • The syringe must not be shaken.
Slovenian: • Brizge ne smete stresati.
English: No interaction was seen when Taltz was administered concomitantly with methotrexate (MTX) and/or corticosteroids in patients with psoriatic arthritis.
Slovenian: Ob sočasnem dajanju zdravila Taltz z metotreksatom (MTX) in/ali kortikosteroidi pri bolnikih s psoriatičnim artritisom niso opazili medsebojnega delovanja zdravil.
English: a p < 0.001 compared with placebo b p < 0.001 compared with etanercept c p < 0.01 compared with placebo d Patients with Itch NRS > = 4 at baseline: placebo N = 135, Taltz 80 mg Q4W N = 293, Taltz 80 mg Q2W N = 303, Etanercept N = 306
Slovenian: a p < 0,001 v primerjavi s placebom b p < 0,001 v primerjavi z etanerceptom c p < 0,01 v primerjavi s placebom d Bolniki z oceno srbenja na lestvici NRS > = 4 v izhodišču: placebo N = 135, zdravilo Taltz 80 mg Q4W N = 293, zdravilo Taltz 80 mg Q2W N = 303, etanercept N = 306
English: There is no relevant use of Taltz in children below the age of 6 years in the treatment of moderate to severe plaque psoriasis.
Slovenian: Smotrne uporabe zdravila Taltz pri otrocih, mlajših od 6 let, za zdravljenje zmerne do hude psoriaze s plaki, ni.
English: Taltz was efficacious in the maintenance of response in systemic treatment-naive, biologic-naive, biologic/anti-TNF-exposed and biologic/anti-TNF-failure patients.
Slovenian: Zdravilo Taltz je bilo učinkovito pri vzdrževanju odziva pri bolnikih, ki še niso bili zdravljeni s sistemsko terapijo ali biološkimi zdravili, niso bili izpostavljeni biološkim zdravilom/zaviralcem TNF oziroma pri bolnikih, pri katerih je bilo zdravljenje z biološkimi zdravili/zaviralci TNF neuspešno.
English: Placebo (N = 168)
Slovenian: Opazovani dogodki placebo (N = 168)
English: Some side effects are uncommon (may affect up to 1 in 100 people): - oral thrush (oral candidiasis).
Slovenian: Nekateri neželeni učinki so občasni (pojavijo se lahko pri največ 1 od 100 bolnikov): - glivična okužba v ustih (ustna kandidaza),
English: • If you have questions or need help with your pre-filled pen, call your doctor, pharmacist or nurse.
Slovenian: • Če imate vprašanja ali če potrebujete pomoč v zvezi s svojim napolnjenim injekcijskim peresnikom, se obrnite na zdravnika, farmacevta ali medicinsko sestro.
English: DO NOT put the base cap back on.
Slovenian: NE nameščajte znova pokrovčka podnožja.
English: They will not harm you or affect your dose.
Slovenian: Ne bodo vam škodili, niti ne bodo vplivali na vaš odmerek.
English: Taltz contains sodium
Slovenian: Zdravilo Taltz vsebuje natrij
English: Maintained sPGA of “0” (clear) or “1” (minimal)
Slovenian: Vzdrževana ocena sPGA "0" (čisto) ali "1" (minimalno)
English: DO NOT put the needle cap back on.
Slovenian: NE nameščajte znova pokrovčka igle.
English: Package leaflet: Information for the patient Taltz 80 mg solution for injection in pre-filled syringe ixekizumab This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo: informacije za bolnika Taltz 80 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku iksekizumab Za to zdravilo se izvaja dodatno spremljanje varnosti.
English: No effects on reproductive organs, menstrual cycles or sperm were observed in sexually mature cynomolgus monkeys that received ixekizumab for 13 weeks at a weekly subcutaneous dose of 50 mg/kg.
Slovenian: Pri spolno zrelih opicah vrste javanski makak, ki so 13 tednov prejemale iksekizumab v tedenskih subkutanih odmerkih po 50 mg/kg, niso opazili učinkov na reproduktivne organe, menstrualni cikel ali spermo.
English: INFORMATION IN BRAILLE
Slovenian: PODATKI V BRAILLOVI PISAVI Taltz
English: Patients receiving adalimumab or placebo were re-randomised 1:1 to Taltz Q2W or Q4W at week 16 or 24 based on responder status.
Slovenian: Bolniki, ki so prejemali adalimumab ali placebo, so bili znova randomizirani v razmerju 1 : 1 v skupini z zdravilom Taltz Q2W ali Q4W v 16. ali 24. tednu glede na svoj odziv na zdravljenje.
English: In all three studies, the co-primary endpoints were the proportion of patients who achieved a PASI 75 response (Psoriasis Area and Severity Index) and an sPGA of 0 (“clear”) or 1 (“minimal”) response at Week 12 versus placebo.
Slovenian: PASI 75 (Psoriasis Area and Severity Index - indeks jakosti psoriaze in telesne površine, prizadete s psoriazo) in odziv sPGA 0 ("čisto") ali 1 ("minimalno") v 12. tednu v primerjavi s placebom.
English: At Week 52, the mean change from baseline in mTSS was 0.27 for placebo/Taltz Q4W, 0.54 for Taltz Q4W/Taltz Q4W, and 0.32 for adalimumab/Taltz Q4W.
Slovenian: Q4W, 0,54 za Taltz Q4W/Taltz Q4W in 0,32 za adalimumab/Taltz Q4W.
English: Read the full Instructions for Use and the Patient Information Leaflet for Taltz inside this box to learn more about your medicine.
Slovenian: Preberite celotno Navodila za uporabo zdravila Taltz, ki je priloženo v tej škatli, da boste izvedeli več o vašem zdravilu.
English: ACR 20 response, n (%) Week 24
Slovenian: Odziv ACR 20, n (%) 24. teden
English: 80 mg Q4W (induction) / Placebo (maintenance) (N = 191)
Slovenian: 80 mg Q4W (indukcijsko zdravljenje) / placebo (vzdrževalno zdravljenje) (N=191)
English: Taltz is unlikely to influence your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo Taltz najverjetneje nima vpliva na sposobnost upravljanja vozil in strojev.
English: Dispose of the pre-filled pen in a closable, puncture-resistant sharps container.
Slovenian: Zavrzite peresnik v zbiralnik za ostre predmete, ki je odporen proti vbodom s pokrovom in ga je mogoče zapreti.
English: 80 mg Q2W (induction) / Placebo (maintenance) (N = 211)
Slovenian: 80 mg Q2W (indukcijsko zdravljenje) / placebo (vzdrževalno zdravljenje) (N=211)
English: Patients receiving placebo were re-randomised 1:1 to Taltz Q2W or Q4W at week 16 or 24 based on responder status.
Slovenian: Bolniki, ki so prejemali placebo, so bili znova randomizirani v razmerju 1 : 1 v skupini z zdravilom Taltz Q2W ali Q4W v 16. ali 24. tednu glede na svoj odziv na zdravljenje.
English: Ask your doctor, nurse or pharmacist how to throw away medicines you no longer use.
Slovenian: O načinu odstranjevanja zdravila, ki ga ne uporabljate več, se posvetujte s farmacevtom.
English: Renal elimination of intact ixekizumab, an IgG MAb, is expected to be low and of minor importance; similarly, IgG MAbs are mainly eliminated via intracellular catabolism and hepatic impairment is not expected to influence clearance of ixekizumab.
Slovenian: Pričakujemo lahko, da je izločanje nespremenjenega iksekizumaba IgG MAb prek ledvic majhno in manj pomembno; protitelesa IgG
English: When you dispose of syringes and the sharps container:
Slovenian: Ko zavržete brizge v zbiralnik za ostre predmete:
English: However, approximately 1% of patients treated with Taltz had confirmed neutralising antibodies associated with low drug concentrations and reduced clinical response.
Slovenian: Kljub temu pa je imel približno 1 % bolnikov, zdravljenih z zdravilom Taltz, potrjena nevtralizirajoča protitelesa,
English: ACR 50 response, n (%) Week 24
Slovenian: Odziv ACR 50, n (%) 24. teden
English: do not use it. Use a new pre-filled pen for your injection.
Slovenian: Za injiciranje uporabite nov napolnjeni injekcijski peresnik.
English: If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.
Slovenian: Če dojite ali načrtujete dojenje, se posvetujte z zdravnikom, preden boste uporabili to zdravilo.
English: Store in the original package in order to protect from light.
Slovenian: Shranjujte v originalni zunanji ovojnini, da bo zdravilo zaščiteno pred svetlobo.
English: Upper respiratory tract infectionb
Slovenian: Zelo pogosti okužbe zgornjih dihalnih potib
English: If you do not respond well enough to these medicines, you will be given Taltz to reduce the signs and symptoms of the disease.
Slovenian: Če se na ta zdravila ne boste dovolj dobro odzvali, boste prejeli zdravilo
English: Taltz was efficacious in systemic treatment-naive, biologic-naive, biologic/anti-TNFexposed and biologic/anti-TNF-failure patients.
Slovenian: Zdravilo Taltz je bilo učinkovito pri bolnikih, ki še niso bili zdravljeni s sistemsko terapijo ali biološkimi zdravili, niso bili izpostavljeni biološkim zdravilom/zaviralcem TNF oziroma pri bolnikih, pri katerih je bilo zdravljenje z biološkimi zdravili/zaviralci TNF neuspešno.
English: ACR 70 response, n (%) Week 24
Slovenian: Odziv ACR 70, n (%) 24. teden
English: 80 mg Q2W (induction) / 80 mg Q4W (maintenance) (N = 221)
Slovenian: 80 mg Q2W (indukcijsko zdravljenje) / 80 mg Q4W (vzdrževalno zdravljenje) (N=221)
English: A. It is okay to see a drop of liquid on the tip of the needle.
Slovenian: O: Kapljica tekočine na konici igle je povsem običajna.
English: A. It is normal to have air bubbles in the pre-filled pen.
Slovenian: O: Zračni mehurčki v napolnjenem injekcijskem peresniku so normalen pojav.
English: 3 FINISH 3a
Slovenian: 3a
English: Blood and lymphatic system disorders
Slovenian: Bolezni krvi in limfatičnega sistema Občasni nevtropenijag, trombocitopenijag
English: Efficacy and safety of Taltz was investigated in a multicenter, randomized, open-label, rater-blinded, parallel-group study (SPIRIT-H2H) compared to adalimumab (ADA) in 566 patients with PsA who were naïve to biologic disease-modifying anti-rheumatic drugs (bDMARD).
Slovenian: slepi za ocenjevalca, z vzporednima skupinama (SPIRIT-HSH), v kateri so zdravilo Taltz primerjali z adalimumabom (ADA) pri 566 bolnikih s PsA, ki se še niso zdravili z biološkimi imunomodulirajočimi protirevmatičnimi zdravili (bDMARD- biologic disease-modifying antirheumatic drugs).
English: Taltz 80 mg Q2W
Slovenian: zdravilo Taltz 80 mg Q2W
English: Push in the plunger.
Slovenian: Zavrzite peresnik.
English: Change in modified Total Sharp Score in SPIRIT-P1
Slovenian: Sprememba modificirane celotne Sharpove ocene v študiji SPIRIT-P1 Razlika v primerjavi s placebom (95-odstotni IZ)
English: Gently pinch and hold a fold of skin where you will inject.
Slovenian: Nežno primite kožno gubo na mestu injiciranja in jo držite.
English: Patients were randomised (1:1:1) to receive either placebo or Taltz (80 mg every two or four weeks [Q2W or Q4W] following a 160 mg starting dose) for 12 weeks.
Slovenian: Bolniki so bili randomizirani (1:1:1) za prejemanje placeba ali zdravila Taltz (80 mg vsaka dva ali štiri tedne [Q2W ali Q4W] po 160
English: Itch NRS reduction
Slovenian: Znižanje ocene srbenja na lestvici NRS