natgillin/translations-raw huggingface dataset:
56% and 35% of patients were inadequate responders to 1 anti-TNF or 2 anti-TNF, respectively.
56 % bolnikov se ni zadovoljivo odzvalo na 1 zaviralec TNF, 35 % bolnikov pa se ni zadovoljivo odzvalo na 2 zaviralca TNF.
Do not use this medicine after the expiry date which is stated on the pen label and on the outer carton after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki peresnika in na škatli poleg oznake "EXP".
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.
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.
Both Taltz regimens included a 160 mg starting dose.
Oba režima z zdravilom Taltz sta vključevala 160-miligramski začetni odmerek.
sPGA of “0” or “1” is equivalent to “clear” or “minimal”; NRS = Numeric Rating Scale
Ocena sPGA »0« ali »1« je enakovredna oceni »brez« ali »minimalno«; NRS = številčna ocenjevalna lestvica.
You and your doctor or nurse should decide if you should inject Taltz yourself.
Z zdravnikom ali medicinsko sestro se lahko dogovorite, da si boste zdravilo Taltz injicirali sami.
If you stop using Taltz
Če ste prenehali uporabljati zdravilo Taltz
If possible, areas of the skin that show psoriasis should be avoided as injection sites.
Če je mogoče, se je treba izogibati injiciranju na mestih, ki kažejo znake psoriaze.
An association between immunogenicity and treatment emergent adverse events has not been clearly established.
Povezave med imunogenostjo in neželenimi dogodki, nastalimi med zdravljenjem, niso zanesljivo ugotovili.
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.
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.
DO NOT inject into areas where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.
NE injicirajte zdravila na mesta, kjer je koža občutljiva, poškodovana, pordela ali trda ali na področja, kjer imate brazgotine ali strije.
If you forget to use Taltz
Če ste pozabili uporabiti zdravilo Taltz
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).
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).
85.3% of patients in this study had received prior treatment with ≥1 cDMARD.
85,3 % bolnikov v tej študiji je v preteklosti prejemalo zdravljenje z vsaj enim konvencionalnim imunomodulirajočim protirevmatičnim zdravilom.
The medicine inside should be clear.
Zdravilo v brizgi mora biti bistro.
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).
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).
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.
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.
Do not use this medicine after the expiry date which is stated on the syringe label and on the outer carton after “EXP”.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki brizge in na škatli poleg oznake "EXP".
Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Pri vsakem organskem sistemu so neželeni učinki zdravila navedeni po pogostnosti, pri čemer so najpogostejši neželeni učinki navedeni najprej.
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.
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.
Its colour may vary from colourless to slightly yellow.
Barva raztopine je lahko brezbarvna do svetlo rumena.
If you think you may be allergic, ask your doctor for advice before using Taltz.
Če menite, da ste morda alergični, se pred uporabo zdravila Taltz posvetujte z zdravnikom.
Alternate your injection sites.
Spreminjajte mesto injiciranja.
The most frequently reported adverse drug reactions (ADRs) were injection site reactions and upper respiratory tract infections (most frequently nasopharyngitis).
Neželeni učinki zdravila, o katerih so najpogosteje poročali, so bili reakcije na mestu injiciranja in okužbe zgornjih dihalnih poti (najpogosteje nazofaringitis).
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.
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.
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
Opomba: bolnike z manjkajočimi podatki smo šteli kot bolnike, ki se niso odzvali a p < 0,001 v primerjavi s placebom
After the 160 mg starting dose, steady state was achieved by Week 8 with the 80 mg Q2W dosing regimen.
Po začetnem odmerku 160 mg je bilo stanje dinamičnega ravnovesja doseženo do 8. tedna z režimom odmerjanja 80 mg Q2W.
DO NOT inject within 2.5 centimetres of the navel (belly button).
Zdravila ne smete injicirati manj kot 2,5 cm stran od popka.
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.
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.
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.
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.
Place the clear base flat and firmly against your skin.
Prozorno podnožje namestite plosko in trdno na kožo.
** 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.
** 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.
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
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.
How to use Taltz
Kako uporabljati zdravilo Taltz
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.
Če ste noseči, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom, preden vzamete to zdravilo.
What Taltz looks like and contents of the pack
Izgled zdravila Taltz in vsebina pakiranja
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.
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.
There is no relevant use of Taltz in children below 2 years for the indication of psoriatic arthritis.
Smotrne uporabe zdravila Taltz pri otrocih, mlajših od 2 let, za indikacijo psoriatičnega artritisa ni.
1a Take the pre-filled pen from the refrigerator.
1a Vzemite brizgo iz hladilnika.
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).
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).
Store in the original packaging in order to protect from light.
Shranjujte v originalni zunanji ovojnini za zagotovitev zaščite pred svetlobo.
A caregiver may also give you your Taltz injection after proper training.
Po ustreznem usposabljanju vam lahko vaše injekcije zdravila Taltz daje tudi negovalec.
DO NOT put the needle cap back on-you could damage the needle or injure yourself by accident.
NE nameščajte znova pokrovčka igle - lahko bi poškodovali iglo ali pa se po nesreči z njo ranili.
Across studies, Taltz was associated with statistically significant improvement of itching severity assessed by the Itch NRS score.
V vseh študijah so zdravilo Taltz povezali s statistično pomembnim zmanjšanjem jakosti srbenja, glede na oceno srbenja na lestvici srbenja NRS.
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.
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.
DO NOT rub the injection site, as this may cause bruising.
NE drgnite kože na mestu injiciranja, saj bi to povzročilo podplutbo.
As a precautionary measure, it is preferable to avoid the use of Taltz during pregnancy.
Iz previdnostnih ukrepov se je med nosečnostjo bolje izogibati uporabi zdravila Taltz.
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.
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.
354 (81.8)a sPGA of “0” (clear)
354 (81,8) a sPGA "0" (čisto)
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).
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
Doses up to 180 mg have been administered subcutaneously in clinical trials without dose-limiting toxicity.
V kliničnih študijah so bolnikom subkutano dajali odmerke do 180 mg, brez toksičnih učinkov, ki bi omejevali odmerek zdravila.
Thrombocytopenia may persist, fluctuate or be transient.
Trombocitopenija se lahko ohrani, niha ali pa je prehodna.
A. Do not remove the base cap.
O: Ne odstranjujte pokrovčka podnožja.
Difference from Placebo in Response Rate (95% CI)
Razlika od placeba v stopnji odziva (95 % IZ)
There were also improvements demonstrated in fatigue as assessed by Fatigue severity NRS scores (p<0.001).
Opazili so tudi izboljšanje pri oceni utrujenosti, kot so ocenili na lestvici NRS za komponento izraženosti utrujenosti (p<0,001).
Treatment with Taltz resulted in significant improvement in measures of disease activity compared to placebo at Week 24 (see Table 8).
Zdravljenje z zdravilom Taltz je v 24. tednu pomembno izboljšalo ocene za merjenje aktivnosti bolezni, v primerjavi s placebom (glejte Preglednico 8).
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.
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.
• The pre-filled syringe contains 1 dose of Taltz.
• Napolnjena injekcijska brizga vsebuje 1 odmerek zdravila Taltz.
23.4 % of patients had a history of psoriatic arthritis at baseline.
23,4 % bolnikov je imelo v izhodišču anamnezo psoriatičnega artritisa.
Subjects randomized to TALTZ received an initial dose of 160 mg followed by 80 mg every 2 weeks for 12 weeks.
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.
a p<0.05; b p<0.01; c p<0.001 compared with placebo.
a p<0,05; b p<0,01; c p<0,001 v primerjavi s placebom.
Safety tips
Varnostni nasveti
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.
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.
Inflammatory Bowel Disease
Vnetna črevesna bolezen
Baseline score, mean (SD) 17.6 (28.62) 19.2 (32.68) 15.2 (28.86) 15.9 (27.37)
17,6 (28,62) 19,2 (32,68) 15,2 (28,86) 15,9 (27,37) ni podatka ni podatka
The grey syringe plunger should be pushed all the way to the end of the syringe.
Sivi bat brizge morate potisniti vse do konca brizge.
Keep holding the clear base firmly against your skin.
Še naprej trdno držite prozorno podnožje na koži.
From Week 12, you will use an 80 mg dose (one injection) every 4 weeks.
Od 12. tedna dalje boste uporabljali odmerek 80 mg (ena injekcija) vsake 4 tedne.
Etanercept 50 mg twice weekly (N = 358)
etanercept 50 mg dvakrat na teden (N = 358)
Leave the needle cap on the syringe until you are ready to inject.
Pokrovčka igle ne snemajte z brizge, dokler niste pripravljeni na injiciranje.
A. It is normal to sometimes have air bubbles in the syringe.
O: Občasni zračni mehurčki v brizgi so normalen pojav.
b p<0.01; c p<0.001 compared with placebo.
b p<0,01; c p<0,001 v primerjavi s placebom.
• The grey syringe plunger should be pushed all the way to the end of the syringe.
• Sivi bat brizge morate potisniti vse do konca brizge.
Taltz is used to treat a skin condition called “plaque psoriasis” in adults with moderate to severe disease.
Zdravilo Taltz se uporablja za zdravljenje kožne bolezni, imenovane "psoriaza s plaki" pri odraslih z zmerno do hudo boleznijo.
However, ixekizumab is excreted at low levels in the milk of cynomolgus monkeys.
Iksekizumab pa se v majhnih količinah izloča v mleko opic vrste javanski makak (cynomolgus).
For psoriatic arthritis patients with concomitant moderate to severe plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis.
Za bolnike s psoriatičnim artritisom, ki imajo sočasno zmerno do hudo psoriazo s plaki, je priporočeni režim odmerjanja enak kot za bolnike s psoriazo s plaki.
Each syringe contains one dose of Taltz (80 mg).
Ena brizga vsebuje en odmerek zdravila Taltz (80 mg).
Taltz has no or negligible influence on the ability to drive and use machines.
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Taltz nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Etanercept 50 mg twice weekly (N = 382)
etanercept 50 mg dvakrat na teden (N = 382)
Taltz was associated with a fast onset of efficacy with > 50 % reduction in mean PASI by Week 2 (Figure 1).
Zdravilo Taltz je bilo povezano s hitrim nastopom učinkovitosti s > 50 % znižanjem povprečne ocene
Abbreviations: N = number of patients in the intent-to-treat population Note: patients with missing data were counted as non-responders.
Opomba: bolnike z manjkajočimi podatki smo šteli kot bolnike, ki se niso odzvali.
Plaque psoriasis - The first dose is 160 mg (two 80 mg injections) by subcutaneous injection.
Psoriaza s plaki - Prvi odmerek je 160 mg (dve injekciji po 80 mg) s subkutano injekcijo.
Taltz is used to treat a condition called “psoriatic arthritis”, an inflammatory disease of the joints, often accompanied by psoriasis.
Zdravilo Taltz se uporablja za zdravljenje bolezni, imenovane "psoriatični artritis", vnetne bolezni sklepov, ki jo pogosto spremlja psoriaza.
At Week 12, significantly more subjects in the TALTZ group than placebo group achieved a sPGA of Genitalia 0/1 and a sPGA 0/1 independent of baseline BSA (baseline BSA 1% - <10% resp. ≥10%: sPGA of Genitalia ‘'0” or “1”: Taltz 71%, resp. 75%; placebo: 0%, resp. 13%).
V 12. tednu je v skupini z zdravilom TALTZ bistveno več bolnikov doseglo oceno sPGA za genitalije 0/1 in sPGA 0/1 v primerjavi s skupino s placebom, neodvisno od izhodiščne BSA (izhodiščna BSA 1 % - < 10 % oziroma ≥ 10 %: sPGA za genitalije »0« ali »1«: Taltz 71 %, oziroma 75 %; placebo: 0 %, oziroma 13 %).
The majority of infections were non-serious and mild to moderate in severity, most of which did not necessitate treatment discontinuation.
Večina okužb ni bila resnih in je bila blage do zmerne jakosti.
You and your doctor should decide if you will breast-feed or use Taltz.
Skupaj se bosta odločila, ali boste dojili ali pa jemali zdravilo Taltz.
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Imetnik dovoljenja za promet z zdravilom Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska.
- After the first dose you will use an 80 mg dose (one injection) every 4 weeks.
- Po prvem odmerku boste uporabili odmerek 80 mg (ena injekcija) vsake 4 tedne.
Patients on Taltz Q2W or Q4W remained on their originally assigned dose of Taltz.
Bolniki, ki so prejemali Taltz Q2W ali Q4W, so obdržali svoj izvorno dodeljeni odmerek zdravila Taltz.
sPGA of Genitalia “0” or “1” sPGA “0” or “1” DLQI 0,1b
Ocena sPGA za genitalije »0« ali »1« sPGA »0« ali »1«
Mean (SD) Cmax,ss, and Ctrough,ss estimates are 14.6 (6.04) µg/ml, and 1.87 (1.30) µg/ml.
trough,ss so 14,6 (6,04) µg/ml in 1,87 (1,30) µg/ml.
In patients with ≥3% BSA, the improvement in skin clearance at Week 12 as measured by 75% improvement in Psoriasis Area Severity Index (PASI 75), was 67% (94/141) for those treated with the Q4W dosing regimen, and 9% (12/134) for those treated with placebo (p<0.001).
Pri bolnikih s ≥ 3 % BSA, je znašalo izboljšanje v čistosti kože v 12. tednu, merjeno s 75-odstotnim izboljšanjem indeksa PASI (PASI 75), 67 % (94/141) pri bolnikih, zdravljenih z režimom Q4W, in 9 % (12/134) pri bolnikih, ki so prejemali placebo (p<0,001).
This medicine contains less than 1 mmol sodium (23 mg) per 80 mg dose, i.e., essentially “sodiumfree”.
To zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na 80-miligramski odmerek, torej je v bistvu »brez natrija«.
Results from a drug-drug interaction study in patients with moderate-to-severe psoriasis determined that 12 weeks of administration of ixekizumab with drugs metabolized by CYP3A4 (i.e., midazolam), CYP2C9 (i.e., warfarin), CYP2C19 (i.e., omeprazole), CYP1A2 (i.e., caffeine) or CYP2D6 (i.e., dextromethorphan) does not have a clinically significant impact on the pharmacokinetics of these drugs.
Rezultati študije o medsebojnem delovanju zdravil pri bolnikih z zmerno do hudo psoriazo so pokazali, da 12 tednov dajanja iksekizumaba skupaj z drugimi zdravili, ki se presnavljajo prek CYP3A4 (tj. midazolam), CYP2C9 (tj. varfarin), CYP2C19 (tj. omeprazol), CYP1A2 (tj. kofein) ali
The efficacy and safety of Taltz was demonstrated regardless of age, gender, race, body weight, PASI baseline severity, plaques location, concurrent psoriatic arthritis, and previous treatment with a biologic.
Učinkovitost in varnost zdravila Taltz sta bili dokazani ne glede na starost, spol, raso, telesno maso, resnost izhodiščne ocene PASI, mesto plakov, sočasnost psoriatičnega artritisa in predhodno zdravljenje z biološkim zdravilom.
In SPIRIT-P1, efficacy was maintained up to Week 52 as assessed by ACR 20/50/70, MDA, enthesitis resolution, dactylitis resolution, and PASI 75/90/100 response rates.
V študiji SPIRIT-P1 se je učinkovitost ohranila do 52. tedna, ocenjeno po merilih ACR 20/50/70, minimalne aktivnosti bolezni (Minimal Disease Activity - MDA), odpravljanju entezitisa, odpravljanju daktilitisa in stopnjah odziva PASI 75/90/100.
A total of 3,119 patients were evaluated (1,161 patients on 80 mg every 4 weeks (Q4W), 1,167 patients on 80 mg every 2 weeks (Q2W) and 791 patients on placebo).
Skupno so ocenili 3119 bolnikov (1161 bolnikov, ki so prejemali odmerek 80 mg vsake 4 tedne (Q4W), 1167 bolnikov, ki so prejemali odmerek 80 mg vsaka 2 tedna (Q2W) in 791 bolnikov, ki so prejemali placebo).