FrancophonIA/ELRC3.0 huggingface dataset:
English: Taltz, alone or in combination with methotrexate, is indicated for the treatment of active psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapies (see section 5.1).
Slovenian: Zdravilo Taltz je samo ali v kombinaciji z metotreksatom indicirano za zdravljenje aktivnega psoriatičnega artritisa pri odraslih bolnikih, ki so se nezadostno odzvali na zdravljenje z enim ali večimi imunomodulirajočimi protirevmatičnimi zdravili (DMARD) ali pa takega zdravljenja ne prenašajo (glejte poglavje 5.1).
English: In the placebo-controlled period of the phase III clinical studies in plaque psoriasis, infections were reported in 27.2 % of patients treated with Taltz for up to 12 weeks compared with 22.9 % of patients treated with placebo.
Slovenian: V s placebom nadzorovanem obdobju kliničnih študij 3. faze, ki so proučevale psoriazo s plaki, so o okužbah poročali pri 27,2 % bolnikov, zdravljenih z zdravilom Taltz do 12 tednov, v primerjavi z 22,9 % bolnikov, zdravljenih s placebom.
English: These reactions were predominantly mild to moderate in severity and did not lead to discontinuation of Taltz.
Slovenian: Te reakcije so bile po jakosti v glavnem blage do zmerne in niso povzročile prekinitve zdravljenja z zdravilom Taltz.
English: The treatment responses on Taltz were significantly greater than those on placebo as early as week 1 for ACR 20, week 4 for ACR 50 and week 8 for ACR 70 and persisted through week 24.
Slovenian: Odzivi na zdravljenje z zdravilom Taltz so bili pomembno večji kot pri placebu že v 1. tednu za ACR 20, 4. tednu za ACR 50 in 8. tednu za ACR 70 in so se ohranili do 24. tedna.
English: Q. What if the needle did not retract after my injection?
Slovenian: V: Kaj pa, če se igla po injiciranju ni umaknila?
English: If a serious hypersensitivity reaction occurs, administration of Taltz should be discontinued immediately and appropriate therapy initiated.
Slovenian: Če se pri bolniku pojavi resna preobčutljivostna reakcija, je treba dajanje zdravila Taltz takoj prekiniti in uvesti ustrezno zdravljenje.
English: UNCOVER-2 enrolled 1,224 patients.
Slovenian: Študija UNCOVER-2 je vključevala 1224 bolnikov.
English: There was not any evidence of worsening of depression up to 60 weeks treatment with Taltz as assessed by the Quick Inventory of Depressive Symptomatology Self Report.
Slovenian: Dokazov o poslabšanju depresije pri zdravljenju z zdravilom Taltz, ki je trajalo do 60 tednov, glede na kratko lestvico depresivne simptomatologije za samoporočanje (Quick
English: Approximately 9-17% of plaque psoriasis patients treated with Taltz at the recommended dosing regimen developed anti-drug antibodies, the majority of which were low titres and not associated with reduced clinical response up to 60 weeks of treatment.
Slovenian: Pri približno 9-17 % bolnikov s psoriazo s plaki, zdravljenih z zdravilom Taltz po priporočenem režimu odmerjanja, so se razvila protitelesa proti zdravilu, od katerih je imela večina nizke titre in niso bila povezana z zmanjšanim kliničnim odzivom v obdobju zdravljenja do 60. tedna.
English: Postmarketing Phase 4, direct comparative study
Slovenian: Neposredna primerjalna študija 4. faze v obdobju trženja
English: Figure 3: Primary Endpoint (Simultaneous ACR 50 & PASI 100) and Major Secondary Endpoints (ACR 50; PASI 100) Response Rates Week 0 - 24 [ITT population, NRI]**
Slovenian: Slika 3: Stopnje odziva med 0. in 24. tednom za primarni opazovani dogodek (hkratni odziv ACR 50 in PASI 100) ter glavne sekundarne opazovane dogodke (ACR 50; PASI 100) [populacija ITT, NRI]**
English: 0.1% of patients receiving Taltz developed a neutrophil count <1000 cells/mm3.
Slovenian: 0,1 % bolnikov, ki so prejemali zdravilo Taltz, je imelo število nevtrofilcev < 1000 celic/mm3.
English: Specific clinical pharmacology studies to evaluate the effects of renal impairment and hepatic impairment on the PK of ixekizumab have not been conducted.
Slovenian: Specifične klinične farmakološke študije za oceno vpliva okvare jeter in okvare ledvic na farmakokinetiko iksekizumaba niso bile opravljene.
English: Patients in all treatment groups had a median baseline PASI score ranging from 17.4 to 18.3; 48.3 % to 51.2 % of patients had a baseline sPGA score of severe or very severe, and mean baseline itch Numeric Rating Scale (itch NRS) ranging from 6.3 to 7.1.
Slovenian: Bolniki v vseh skupinah zdravljenja so imeli mediano izhodiščno oceno PASI od 17,4 do 18,3; 48,3 % do 51,2 % bolnikov je imelo izhodiščno oceno sPGA hudo ali zelo hudo, povprečna izhodiščna ocena srbenja na številčni lestvici NRS pa je bila od 6,3 do 7,1.
English: Using Taltz will benefit you by improvements of skin clearance and reducing your symptoms such as scaling, itching and pain.
Slovenian: Zdravilo Taltz vam bo pomagalo izboljšati videz kože in zmanjšati vaše simptome, npr. luščenje, srbenje in bolečine.
English: For both Taltz Q2W and Q4W: b p<0.01 and c p<0.001 compared with placebo.
Slovenian: Za režima Taltz Q2W in Q4W: b p<0,01 in c p<0,001 v primerjavi s placebom.
English: • The pre-filled pen contains glass parts.
Slovenian: • Napolnjeni injekcijski peresnik vsebuje steklene dele.
English: List of adverse reactions in clinical studiesa and postmarketing reports System Organ Class
Slovenian: Seznam neželenih učinkov v kliničnih študijaha in poročilih iz obdobja trženja zdravila Organski sistem
English: UNCOVER-1 enrolled 1,296 patients.
Slovenian: Študija UNCOVER-1 je vključevala 1296 bolnikov.
English: The mean (SD) maximum plasma concentration (Cmax) of ixekizumab, after the 160 mg starting dose, was 19.9 (8.15) µg/ml.
Slovenian: Povprečna največja koncentracija (SD) iksekizumaba v plazmi (Cmax) je po začetnem odmerku 160 mg znašala 19,9 (8,15) µg/ml.
English: You will not need to put the base cap back on-doing so could damage the needle or cause you to injure yourself by accident.
Slovenian: Pokrovčka podnožja vam ne bo treba znova namestiti - s tem bi lahko poškodovali iglo ali pa se po nesreči z njo ranili.
English: 56% and 35% of patients were inadequate responders to 1 anti-TNF or 2 anti-TNF, respectively.
Slovenian: 56 % bolnikov se ni zadovoljivo odzvalo na 1 zaviralec TNF, 35 % bolnikov pa se ni zadovoljivo odzvalo na 2 zaviralca TNF.
English: Do not use this medicine after the expiry date which is stated on the pen label and on the outer carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki peresnika in na škatli poleg oznake "EXP".
English: In SPIRIT-P1, inhibition of progression of structural damage was assessed radiographically and expressed as the change in modified total Sharp Score (mTSS) and its components, the Erosion Score (ES) and the Joint Space Narrowing score (JSN) at Weeks 24 and 52, compared to baseline.
Slovenian: V študiji SPIRIT-P1 je bilo zaviranje napredovanja strukturnih poškodb ocenjeno rentgenografsko in je bilo izraženo kot sprememba modificirane celotne Sharpove ocene (modified total Sharp score - mTSS) in njenih komponent, ocene erozije (Erosion Score - ES) in ocene zožitve sklepne špranje (Joint Space Narrowing score - JSN) v 24. in 52. tednu, v primerjavi z izhodiščem.
English: Both Taltz regimens included a 160 mg starting dose.
Slovenian: Oba režima z zdravilom Taltz sta vključevala 160-miligramski začetni odmerek.
English: sPGA of “0” or “1” is equivalent to “clear” or “minimal”; NRS = Numeric Rating Scale
Slovenian: Ocena sPGA »0« ali »1« je enakovredna oceni »brez« ali »minimalno«; NRS = številčna ocenjevalna lestvica.
English: You and your doctor or nurse should decide if you should inject Taltz yourself.
Slovenian: Z zdravnikom ali medicinsko sestro se lahko dogovorite, da si boste zdravilo Taltz injicirali sami.
English: If you stop using Taltz
Slovenian: Če ste prenehali uporabljati zdravilo Taltz
English: If possible, areas of the skin that show psoriasis should be avoided as injection sites.
Slovenian: Če je mogoče, se je treba izogibati injiciranju na mestih, ki kažejo znake psoriaze.
English: An association between immunogenicity and treatment emergent adverse events has not been clearly established.
Slovenian: Povezave med imunogenostjo in neželenimi dogodki, nastalimi med zdravljenjem, niso zanesljivo ugotovili.
English: In psoriatic arthritis patients treated with Taltz at the recommended dosing regimen up to 52 weeks, approximately 11% developed anti-drug antibodies, the majority of which were low titre, and approximately 8% had confirmed neutralising antibodies.
Slovenian: Pri bolnikih s psoriatičnim artritisom, zdravljenih z zdravilom Taltz po priporočenem režimu odmerjanja do 52 tednov, so se pri približno 11 % razvila protitelesa na zdravilo, od katerih je imela večina nizek titer, pri približno 8 % bolnikov pa so potrdili nevtralizirajoča protitelesa.
English: DO NOT inject into areas where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.
Slovenian: NE injicirajte zdravila na mesta, kjer je koža občutljiva, poškodovana, pordela ali trda ali na področja, kjer imate brazgotine ali strije.
English: If you forget to use Taltz
Slovenian: Če ste pozabili uporabiti zdravilo Taltz
English: The safety and efficacy of Taltz were assessed in two randomised, double-blind, placebo-controlled phase III studies in 780 patients with active psoriatic arthritis (≥3 swollen and ≥3 tender joints).
Slovenian: Varnost in učinkovitost zdravila Taltz so ocenjevali v dveh randomiziranih, dvojno slepih, s placebom nadzorovanih študijah 3. faze pri 780 bolnikih z aktivnim psoriatičnim artritisom (≥ 3 otekli in ≥ 3 boleči sklepi).
English: 85.3% of patients in this study had received prior treatment with ≥1 cDMARD.
Slovenian: 85,3 % bolnikov v tej študiji je v preteklosti prejemalo zdravljenje z vsaj enim konvencionalnim imunomodulirajočim protirevmatičnim zdravilom.
English: The medicine inside should be clear.
Slovenian: Zdravilo v brizgi mora biti bistro.
English: In a study in healthy subjects, no safety concerns were identified of two inactivated vaccines (tetanus and pneumococcal), received after two doses of ixekizumab (160 mg followed by a second dose of 80 mg two weeks later).
Slovenian: V študiji z zdravimi preiskovanci, ki so prejeli dve inaktivirani cepivi (proti tetanusu in pnevmokokom), niso ugotovili nobenih varnostnih zadržkov za ti cepivi, ki so ju preiskovanci prejeli po dveh odmerkih iksekizumaba (160 mg, ki mu je sledil drugi odmerek 80 mg dva tedna kasneje).
English: 3% of patients exposed to Taltz had a shift from a normal baseline platelet value to <150,000 platelet cells/mm3 to ≥75,000 cells/mm3.
Slovenian: Pri 3 % bolnikov, izpostavljenih zdravilu Taltz, je prišlo do spremembe od normalne izhodiščne vrednosti trombocitov do < 150.000 trombocitov/mm3 do ≥ 75.000 celic /mm3.
English: Do not use this medicine after the expiry date which is stated on the syringe label and on the outer carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki brizge in na škatli poleg oznake "EXP".
English: Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Slovenian: Pri vsakem organskem sistemu so neželeni učinki zdravila navedeni po pogostnosti, pri čemer so najpogostejši neželeni učinki navedeni najprej.
English: Of the 1,118 psoriatic arthritis patients exposed to Taltz in clinical studies, a total of 122 patients were 65 years of age or older and 6 patients were 75 years of age or older.
Slovenian: Od 1118 bolnikov s psoriatičnim artritisom, ki so bili izpostavljeni zdravilu Taltz v kliničnih študijah, je bilo skupaj 122 bolnikov starih 65 let ali več, 6 bolnikov pa je bilo starih 75 let ali več.
English: Its colour may vary from colourless to slightly yellow.
Slovenian: Barva raztopine je lahko brezbarvna do svetlo rumena.
English: If you think you may be allergic, ask your doctor for advice before using Taltz.
Slovenian: Če menite, da ste morda alergični, se pred uporabo zdravila Taltz posvetujte z zdravnikom.
English: Alternate your injection sites.
Slovenian: Spreminjajte mesto injiciranja.
English: The most frequently reported adverse drug reactions (ADRs) were injection site reactions and upper respiratory tract infections (most frequently nasopharyngitis).
Slovenian: Neželeni učinki zdravila, o katerih so najpogosteje poročali, so bili reakcije na mestu injiciranja in okužbe zgornjih dihalnih poti (najpogosteje nazofaringitis).
English: Of the 4,204 plaque psoriasis patients exposed to Taltz in clinical studies, a total of 301 were 65 years of age or older and 36 patients were 75 years of age or older.
Slovenian: Od 4204 bolnikov s psoriazo s plaki, ki so bili izpostavljeni zdravilu Taltz v kliničnih študijah, je bil skupaj 301 bolnik star 65 let ali več, 36 bolnikov pa je bilo starih 75 let ali več.
English: Abbreviations: N = number of patients in the analysis population Note: patients with missing data were counted as non-responders a p < 0.001 compared with placebo
Slovenian: Opomba: bolnike z manjkajočimi podatki smo šteli kot bolnike, ki se niso odzvali a p < 0,001 v primerjavi s placebom
English: After the 160 mg starting dose, steady state was achieved by Week 8 with the 80 mg Q2W dosing regimen.
Slovenian: Po začetnem odmerku 160 mg je bilo stanje dinamičnega ravnovesja doseženo do 8. tedna z režimom odmerjanja 80 mg Q2W.
English: DO NOT inject within 2.5 centimetres of the navel (belly button).
Slovenian: Zdravila ne smete injicirati manj kot 2,5 cm stran od popka.
English: SPIRIT-P2 evaluated 363 patients, of whom 41% had concomitant use of MTX at a mean weekly dose of 16.1 mg. 73.2% of patients who had concomitant use of MTX had a dose of 15 mg or greater.
Slovenian: Študija SPIRIT-P2 je ocenjevala 363 bolnikov, od katerih je 41 % sočasno uporabljalo MTX v povprečnem tedenskem odmerku 16,1 mg. 73,2 % bolnikov, ki so sočasno uporabljali MTX, je prejemalo odmerek 15 mg ali več.
English: Physical function and health-related quality of life In both SPIRIT-P1 and SPIRIT-P2, patients treated with Taltz Q2W (p<0.001) and Q4W (p<0.001) showed significant improvement in physical function compared to patients treated with placebo as assessed by Health Assessment Questionnaire-Disability Index (HAQ-DI) at Week 24, and maintained at Week 52 in SPIRIT-P1.
Slovenian: Telesna zmogljivost in z zdravjem povezana kakovost življenja V obeh študijah, SPIRIT-P1 in SPIRIT-P2, se je pri bolnikih, zdravljenih z zdravilom Taltz Q2W (p<0,001) in Q4W (p<0,001), pokazalo pomembno izboljšanje telesne zmogljivosti v primerjavi z bolniki, ki so prejemali placebo, kot so ocenili z vprašalnikom za oceno zdravja HAQ-DI (Health Assessment Questionnaire-Disability Index) v 24. tednu, in se je v študiji SPIRIT-P1 ohranilo do 52. tedna.
English: Place the clear base flat and firmly against your skin.
Slovenian: Prozorno podnožje namestite plosko in trdno na kožo.
English: ** Taltz 160 mg Week 0, then 80 mg every 2 weeks to Week 12 and every 4 weeks thereafter for patients with moderate to severe plaque psoriasis or 160 mg Week 0, then 80 mg every 4 week for other patients, ADA 80 mg Week 0, then 40 mg every 2 weeks from Week 1 for patients with moderate to severe plaque psoriasis or 40 mg Week 0, then 40 mg every 2 weeks for other patients.
Slovenian: ** Zdravilo Taltz 160 mg v 0. tednu, nato 80 mg vsaka 2 tedna do 12. tedna in potem vsake 4 tedne pri bolnikih z zmerno do hudo psoriazo s plaki ali 160 mg v 0. tednu, nato 80 mg vsake 4 tedne pri drugih bolnikih; ADA 80 mg v 0. tednu, nato 40 mg vsaka 2 tedna od 1. tedna dalje pri bolnikih z zmerno do hudo psoriazo s plaki ali 40 mg v 0. tednu in nato 40 mg vsaka 2 tedna pri drugih bolnikih.
English: Possible serious infection (may affect up to 1 in 100 people) - the signs may include: - fever, flu-like symptoms, night sweats - feeling tired or short of breath, cough which will not go away - warm, red and painful skin, or a painful skin rash with blisters
Slovenian: Možne resne okužbe (pojavijo se lahko pri največ 1 od 100 bolnikov) - znaki lahko vključujejo: - zvišano telesno temperaturo, gripi podobne simptome, nočno potenje, - občutek utrujenosti ali oteženega dihanja, kašelj, ki ne mine, - toplo, rdečo in bolečo kožo ali boleč kožni izpuščaj z mehurčki.
English: How to use Taltz
Slovenian: Kako uporabljati zdravilo Taltz
English: If you are pregnant, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Slovenian: Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
English: What Taltz looks like and contents of the pack
Slovenian: Izgled zdravila Taltz in vsebina pakiranja
English: Randomised patients also had current plaque psoriasis skin lesions (94.0%) or a documented history of plaque psoriasis, with 12.1% of patients with moderate to severe plaque psoriasis at baseline.
Slovenian: Randomizirani bolniki so imeli tudi trenutne spremembe na koži zaradi psoriaze s plaki (94,0 %) ali dokumentirano anamnezo psoriaze s plaki, pri tem pa je imelo 12,1 % bolnikov zmerno do hudo psoriazo s plaki v izhodišču.
English: There is no relevant use of Taltz in children below 2 years for the indication of psoriatic arthritis.
Slovenian: Smotrne uporabe zdravila Taltz pri otrocih, mlajših od 2 let, za indikacijo psoriatičnega artritisa ni.
English: 1a Take the pre-filled pen from the refrigerator.
Slovenian: 1a Vzemite brizgo iz hladilnika.
English: Psoriatic Arthritis Study 2 (SPIRIT-P2) enrolled patients who were previously treated with an anti-TNF agent and discontinued the anti-TNF agent for either lack of efficacy or intolerance (anti-TNF-IR patients).
Slovenian: Študija psoriatičnega artritisa 2 (SPIRIT-P2) je vključevala bolnike, ki so bili v preteklosti že zdravljeni z zaviralcem TNF in so zdravljenje z zaviralcem TNF prekinili zaradi nezadostne učinkovitosti ali zaradi neprenašanja zdravila (bolniki z nezadostnim odzivom na zaviralce TNF).
English: Store in the original packaging in order to protect from light.
Slovenian: Shranjujte v originalni zunanji ovojnini za zagotovitev zaščite pred svetlobo.
English: A caregiver may also give you your Taltz injection after proper training.
Slovenian: Po ustreznem usposabljanju vam lahko vaše injekcije zdravila Taltz daje tudi negovalec.
English: DO NOT put the needle cap back on-you could damage the needle or injure yourself by accident.
Slovenian: NE nameščajte znova pokrovčka igle - lahko bi poškodovali iglo ali pa se po nesreči z njo ranili.
English: Across studies, Taltz was associated with statistically significant improvement of itching severity assessed by the Itch NRS score.
Slovenian: V vseh študijah so zdravilo Taltz povezali s statistično pomembnim zmanjšanjem jakosti srbenja, glede na oceno srbenja na lestvici srbenja NRS.
English: In patients with concomitant moderate to severe psoriasis and psoriatic arthritis, Taltz Q2W dose regimen showed significantly higher response rate for PASI75, PASI 90 and PASI 100 compared to placebo (p<0.001) and demonstrated clinically meaningful benefit over the Q4W dose regimen.
Slovenian: Pri bolnikih s sočasno zmerno do hudo psoriazo in psoriatičnim artritisom je režim odmerjanja zdravila Taltz Q2W pokazal pomembno večjo stopnjo odziva za PASI 75, PASI 90 in PASI 100 v primerjavi s placebom (p<0,001), in dokazal klinično pomembno korist v primerjavi z režimom odmerjanja Q4W.
English: DO NOT rub the injection site, as this may cause bruising.
Slovenian: NE drgnite kože na mestu injiciranja, saj bi to povzročilo podplutbo.
English: As a precautionary measure, it is preferable to avoid the use of Taltz during pregnancy.
Slovenian: Iz previdnostnih ukrepov se je med nosečnostjo bolje izogibati uporabi zdravila Taltz.
English: The safety and efficacy of Taltz in children and adolescents aged 2 to less than 18 years in the treatment of psoriatic arthritis (a category of juvenile idiopathic arthritis) have not yet been established.
Slovenian: Varnost in učinkovitost zdravila Taltz pri otrocih in mladostnikih, starih od 2 do 18 let, za zdravljenje psoriatičnega artritisa (kategorija juvenilnega idiopatskega artritisa), še nista bili dokazani.
English: 354 (81.8)a sPGA of “0” (clear)
Slovenian: 354 (81,8) a sPGA "0" (čisto)
English: The efficacy and safety of Taltz were assessed in three randomised, double-blind, placebo-controlled phase III studies in adult patients with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy (UNCOVER-1, UNCOVER-2, and UNCOVER-3).
Slovenian: Učinkovitost in varnost zdravila Taltz so preučevali v treh randomiziranih, dvojno slepih, s placebom nadzorovanih študijah 3. faze pri odraslih bolnikih z zmerno do hudo psoriazo s plaki, ki so bili primerni za zdravljenje s fototerapijo ali sistemsko terapijo (UNCOVER-1, UNCOVER-2, in
English: Doses up to 180 mg have been administered subcutaneously in clinical trials without dose-limiting toxicity.
Slovenian: V kliničnih študijah so bolnikom subkutano dajali odmerke do 180 mg, brez toksičnih učinkov, ki bi omejevali odmerek zdravila.
English: Thrombocytopenia may persist, fluctuate or be transient.
Slovenian: Trombocitopenija se lahko ohrani, niha ali pa je prehodna.
English: A. Do not remove the base cap.
Slovenian: O: Ne odstranjujte pokrovčka podnožja.
English: Difference from Placebo in Response Rate (95% CI)
Slovenian: Razlika od placeba v stopnji odziva (95 % IZ)
English: There were also improvements demonstrated in fatigue as assessed by Fatigue severity NRS scores (p<0.001).
Slovenian: Opazili so tudi izboljšanje pri oceni utrujenosti, kot so ocenili na lestvici NRS za komponento izraženosti utrujenosti (p<0,001).
English: 292 (83.2)a sPGA of “0” (clear)
Slovenian: 292 (83,2)a sPGA "0"
English: Treatment with Taltz resulted in significant improvement in measures of disease activity compared to placebo at Week 24 (see Table 8).
Slovenian: Zdravljenje z zdravilom Taltz je v 24. tednu pomembno izboljšalo ocene za merjenje aktivnosti bolezni, v primerjavi s placebom (glejte Preglednico 8).
English: 159 (41.6)a sPGA of “0” (clear)
Slovenian: 159 (41,6)a sPGA "0"
English: Efficacy in Genital Psoriasis A randomized, double-blind, placebo-controlled study (IXORA-Q) was conducted in 149 adult subjects (24% females) with moderate to severe genital psoriasis (sPGA of Genitalia score of ≥3), a minimum body surface area (BSA) involvement of 1% (60.4% had a BSA ≥ 10%) and previous failure of or intolerance to at least one topical therapy for genital psoriasis.
Slovenian: Randomizirano, dvojno slepo, s placebom nadzorovano študijo (IXORA-Q) so opravili pri 149 odraslih bolnikih (24 % žensk) z zmerno do hudo genitalno psoriazo (ocena sPGA za genitalije ≥ 3), najmanjšo vključenostjo površine telesa (BSA; body surface area - telesna površina) 1 % (60,4 % jih je imelo BSA ≥ 10 %) in preteklim neuspešnim zdravljenjem ali intoleranco na najmanj eno topično zdravljenje genitalne psoriaze.
English: • The pre-filled syringe contains 1 dose of Taltz.
Slovenian: • Napolnjena injekcijska brizga vsebuje 1 odmerek zdravila Taltz.
English: 23.4 % of patients had a history of psoriatic arthritis at baseline.
Slovenian: 23,4 % bolnikov je imelo v izhodišču anamnezo psoriatičnega artritisa.
English: Subjects randomized to TALTZ received an initial dose of 160 mg followed by 80 mg every 2 weeks for 12 weeks.
Slovenian: Bolniki, ki so bili randomizirani v skupino z zdravilom TALTZ, so prejeli začetni odmerek 160 mg, ki mu je sledil odmerek 80 mg vsaka 2 tedna v obdobju 12 tednov.
English: a p<0.05; b p<0.01; c p<0.001 compared with placebo.
Slovenian: a p<0,05; b p<0,01; c p<0,001 v primerjavi s placebom.
English: Safety tips
Slovenian: Varnostni nasveti
English: The percentage of patients with no radiographic joint damage progression from randomisation to Week 52 was 90.9% for placebo/Taltz Q4W, 85.6% for Taltz Q4W/Taltz Q4W, and 89.4% for adalimumab/Taltz Q4W.
Slovenian: Odstotek bolnikov brez rentgenografskega napredovanja poškodb sklepov od randomizacije do 52. tedna je znašal 90,9 % za placebo/Taltz Q4W, 85,6 % za Taltz Q4W/Taltz Q4W in 89,4% za adalimumab/Taltz Q4W.