natgillin/translations-raw huggingface dataset:
ADRs from clinical studies and postmarketing reports (Table 1) are listed by MedDRA system organ class.
Tabelarični prikaz neželenih učinkov Neželeni učinki zdravila iz kliničnih študij in poročil iz obdobja trženja zdravila (Preglednica 1) so navedeni po organskih sistemih klasifikacije MedDRA.
The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg (one injection) at Weeks 2, 4, 6, 8, 10, and 12, then maintenance dosing of 80 mg (one injection) every 4 weeks.
Priporočeni odmerek je 160 mg s subkutano injekcijo (dve injekciji po 80 mg) v tednu 0, ki mu sledi 80 mg (ena injekcija) v tednih 2, 4, 6, 8, 10 in 12, nato pa vzdrževalno odmerjanje 80 mg (ena injekcija) vsake 4 tedne.
Serious infections were reported in 1.6 % of patients treated with Taltz (1.5 per 100 patient years).
Pri 1,6 % bolnikov, zdravljenih z zdravilom Taltz (1,5 na 100 bolnik-let), so poročali o resnih okužbah.
A. Do not touch the needle or replace the base cap.
O: Ne dotikajte se igle in ne nameščajte pokrovčka podnožja nazaj.
A total of 678 patients were evaluated (229 patients on 80 mg every 4 weeks (Q4W), 225 patients on 80 mg every 2 weeks (Q2W) and 224 patients on placebo).
Skupno so ocenili 678 bolnikov (229 bolnikov, ki so prejemali odmerek 80 mg vsake 4 tedne (Q4W), 225 bolnikov, ki so prejemali odmerek 80 mg vsaka 2 tedna (Q2W) in 224 bolnikov, ki so prejemali placebo).
Injection site reactionsf a Placebo-controlled clinical studies (phase III) in moderate to severe plaque psoriasis patients exposed to ixekizumab 80 mg Q2W, ixekizumab 80 mg Q4W or placebo for up to 12 weeks of treatment duration, or in active psoriatic arthritis patients exposed to ixekizumab 80 mg Q2W, ixekizumab 80 mg Q4W or placebo for up to 24 weeks of treatment duration.
Zelo pogosti reakcije na mestu injiciranjaf a S placebom nadzorovane klinične študije (3. faze) pri bolnikih z zmerno do hudo psoriazo s plaki, ki so bili izpostavljeni iksekizumabu 80 mg Q2W, iksekizumabu 80 mg Q4W ali placebu v obdobju zdravljenja do 12. tedna, ali pri bolnikih z aktivnim psoriatičnim artritisom, ki so bili izpostavljeni iksekizumabu 80 mg Q2W, iksekizumabu 80 mg Q4W ali placebu v obdobju zdravljenja do 24. tedna.
Taltz is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
Zdravilo Taltz je indicirano za zdravljenje zmerne do hude psoriaze s plaki pri odraslih, ki so primerni za sistemsko zdravljenje.
- The active substance is ixekizumab.
- Učinkovina je iksekizumab.
The recommended dose is 160 mg by subcutaneous injection (two 80 mg injections) at Week 0, followed by 80 mg (one injection) every 4 weeks thereafter.
Priporočeni odmerek je 160 mg, dan s subkutano injekcijo (dve injekciji po 80 mg) v tednu 0, ki mu sledi odmerek 80 mg (ena injekcija) vsake 4 tedne po tem.
Significant improvements in itch severity were seen at Week 1 in patients treated with Taltz.
Pomembno zmanjšanje v jakosti srbenja so opazili v 1. tednu pri bolnikih, zdravljenih z zdravilom Taltz.
You should not be given certain types of vaccines while using Taltz.
Med uporabo zdravila Taltz vam ne smejo dati nekaterih cepiv.
Contact your doctor, pharmacist or nurse.
Obvestite zdravnika, farmacevta ali medicinsko sestro.
In psoriatic arthritis, two placebo-controlled phase III studies were integrated to evaluate the safety of Taltz in comparison to placebo up to 24 weeks after treatment initiation.
Za psoriatični artritis sta bili dve študiji 3. faze, nadzorovani s placebom, vključeni za oceno varnosti zdravila Taltz v primerjavi s placebom do 24 tednov po uvedbi zdravljenja.
• It is past the expiry date.
• Rok uporabnosti je pretečen.
1 pre-filled syringe of 1 ml solution 2 pre-filled syringes of 1 ml solution 3 pre-filled syringes of 1 ml solution
1 napolnjeni injekcijski peresnik z 1 ml raztopine 2 napolnjena injekcijska peresnika z 1 ml raztopine 3 napolnjeni injekcijski peresniki z 1 ml raztopine
A higher incidence of postnatal mortality occurred in the offspring of monkeys given ixekizumab compared to concurrent controls.
Pri potomcih opic, ki so prejemale iksekizumab, so opazili višjo incidenco poporodnega pogina, v primerjavi s sočasnimi kontrolami.
A total of 7,339 patients have been treated with Taltz in blinded and open-label clinical studies in plaque psoriasis, psoriatic arthritis, and other autoimmune conditions.
V slepih in odprtih kliničnih študijah so z zdravilom Taltz zdravili skupno 7339 bolnikov, ki so imeli psoriazo s plaki, psoriatični artritis in druge avtoimune bolezni.
- The other ingredients are sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; water for injections.
- Druge sestavine zdravila so natrijev citrat, brezvodna citronska kislina, natrijev klorid, polisorbat 80, voda za injekcije.
(nasopharyngitis).
(subkutano injiciranje).
As a direct consequence treatment with ixekizumab reduces erythema, induration and desquamation present in plaque psoriasis lesions.
Na ta način zdravljenje z iksekizumabom zmanjšuje eritem, debelino epidermija in luščenje, ki so prisotni pri lezijah psoriaze s plaki.
It is preferable to avoid the use of Taltz in pregnancy.
Med nosečnostjo se je bolje izogibati uporabi zdravila Taltz.
- low blood platelet count (thrombocytopenia).
- nizko število krvnih ploščic (trombocitopenija),
Excipients: sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; water for injections.
Pomožne snovi: natrijev citrat, brezvodna citronska kislina, natrijev klorid, polisorbat 80, voda za injekcije.
TALTZ Placebo Difference from placebo (95% CI)
TALTZ Placebo Razlika od placeba (95-odstotni interval zaupanja)
Commonly asked questions Q. What if I see air bubbles in my syringe?
V: Kaj moram narediti, če v svoji brizgi opazim zračne mehurčke?
Abbreviations: ADA = adalimumab; CI = confidence interval; Q4W = Taltz 80 mg every 4 weeks; Q2W = Taltz 80 mg every 2 weeks; LSM = least squares mean; N = number of patients in the analysis population; PBO = placebo; SE = standard error; SD = standard deviation.
Okrajšave: ADA = adalimumab; IZ = interval zaupanja; Q4W = Taltz 80 mg vsake 4 tedne; Q2W = Taltz 80 mg vsaka 2 tedna; LSM = povprečna vrednost najmanjših kvadratov; N = število bolnikov v analizirani populaciji; PBO = placebo; SE = standardna napaka; SD = standardni odklon.
Do not use this medicine if you notice that the syringe is damaged, or the medicine is cloudy, distinctly brown, or has particles in it.
Ne uporabljajte tega zdravila, če opazite, da je brizga poškodovana, ali da je zdravilo motno, izrazito rjave barve ali da v njem plavajo delci.
Concomitant cDMARDs included MTX, leflunomide and sulfasalazine.
MTX, leflunomid in sulfasalazin.
Renal or hepatic impairment Taltz has not been studied in these patient populations.
Zdravila Taltz v tej skupini bolnikov niso proučevali.
Gently remove the needle from your skin.
Nežno izvlecite iglo iz kože.
In patients with pre-existing dactylitis or enthesitis, treatment with Taltz Q4W resulted in improvement in dactylitis and enthesitis at Week 24 compared to placebo (resolution: 78% vs. 24%; p<0.001, and 39% vs. 21%; p<0.01, respectively).
Pri bolnikih z že obstoječim daktilitisom ali entezitisom je zdravljenje z režimom Taltz Q4W v primerjavi s placebom povzročilo izboljšanje daktilitisa in entezitisa v 24. tednu (odprava: 78 % v primerjavi s 24 %; p < 0,001 in 39 % v primerjavi z 21 %; p < 0,01).
points at week 12 (84.6% for Taltz Q2W, 79.2% for Taltz Q4W and 16.5% for placebo) and the benefit was sustained over time up to Week 60 in patients treated with Taltz who were sPGA (0 or 1)
12. tednu (84,6 % za zdravilo Taltz Q2W, 79,2 % za zdravilo Taltz Q4W in 16,5% za placebo), učinek pa se je ohranil daljši čas, do 60. tedna pri bolnikih, zdravljenih z zdravilom Taltz, ki do imeli v 12.
Consider anti-TB therapy prior to initiation of Taltz in patients with latent TB.
Pri bolnikih z latentno tuberkulozo je treba pred začetkom zdravljenja z zdravilom Taltz razmisliti o zdravljenju proti tuberkulozi.
(Based on adverse reactions data from 4,204 patients with moderate to severe plaque psoriasis [4,729.7 patient years] and 1,117 patients with active psoriatic arthritis [1,050.6 patient years] who have received at least 1 dose of ixekizumab.)
Opis izbranih neželenih učinkov (Na podlagi podatkov o neželenih učinkih pri 4204 bolnikih z zmerno do hudo psoriazo s plaki [4729,7 bolnik-let] in pri 1117 bolnikih z aktivnim psoriatičnim artritisom [1050,6 bolnik-let], ki so prejeli najmanj 1 odmerek iksekizumaba.)
The proportion of patients achieving a PASI 75, PASI 90, and PASI 100 response at Week 24 was greater with Taltz Q4W compared to placebo (p<0.001).
PASI 75, PASI 90 in PASI 100 v 24. tednu, je bil večji pri režimu Taltz Q4W v primerjavi s placebom (p<0,001).
- Eczema - Rash - Rapid swelling of the tissues of the neck, face, mouth or throat (angioedema)
- hitro otekanje tkiv vratu, obraza, ust ali grla (angioedem).
Over 58.9% and 22.3% of the psoriatic arthritis patients had enthesitis and dactylitis at baseline, respectively.
V izhodišču je imelo več kot 58,9 % bolnikov s psoriatičnim artritisom entezitis, 22,3 % bolnikov s psoriatičnim artritisom pa daktilitis.
Do not use this medicine if you notice that the pen is damaged, or the medicine is cloudy, distinctly brown, or has particles in it.
Ne uporabljajte tega zdravila, če opazite, da je peresnik poškodovan, ali da je zdravilo motno, izrazito rjave barve ali da v njem plavajo delci.
Taltz should not be used if particles appear or if the solution is cloudy and/or distinctly brown.
Zdravila Taltz ne smete uporabljati, če so v raztopini vidni delci ali če je raztopina motna in/ali izrazito rjave barve.
In plaque psoriasis, three placebo-controlled phase III studies were integrated to evaluate the safety of Taltz in comparison to placebo up to 12 weeks after treatment initiation.
Za psoriazo s plaki so bile tri študije 3. faze, nadzorovane s placebom, vključene za oceno varnosti zdravila Taltz v primerjavi s placebom do 12 tednov po uvedbi zdravljenja.
In Psoriatic Arthritis Study 1 (SPIRIT-P1), patients naive to biologic therapy with active psoriatic arthritis were randomised to subcutaneous injections of placebo, adalimumab 40 mg once every 2 weeks (active control reference arm), Taltz 80 mg once every 2 weeks (Q2W), or 80 mg once every 4 weeks (Q4W).
V študiji psoriatičnega artritisa 1 (SPIRIT-P1) so bili bolniki z aktivnim psoriatičnim artritisom, ki še niso bili zdravljeni z biološkimi zdravili, randomizirani za prejemanje subkutanih injekcij placeba, adalimumaba 40 mg enkrat na vsaka 2 tedna (referenčna skupina z aktivno kontrolo), zdravila Taltz 80 mg enkrat na vsaka 2 tedna (Q2W) ali 80 mg enkrat na vsake 4 tedne (Q4W).
significantly greater proportion of patients treated with Taltz achieved a reduction of Itch NRS ≥ 4
Bistveno večji delež bolnikov, zdravljenih z zdravilom Taltz, je dosegel znižanje ocene na lestvici srbenja NRS ≥ 4 točk v
“1” (rarely limited) a Abbreviations: NRI = Non-Responder Imputation; sPGA = static Physician Global Assessment; GPSS = Genital Psoriasis Symptom Scale; SFQ = Sexual Frequency Questionnaire; DLQI = Dermatology Quality of Life Index; b Total DLQI score of 0,1 indicates skin condition has no effect at all on patient's life.
Postavka 2 vprašalnika SFQ »0« (nikoli omejeno) ali »1« (redko omejeno) aOkrajšave: NRI = imputacija manjkajočih podatkov za bolnike, ki se niso odzvali (Non-Responder Imputation); sPGA = statična globalna ocena zdravnika (static Physician Global Assessment); GPSS = lestvica simptomov genitalne psoriaze (Genital Psoriasis Symptom Scale); SFQ = vprašalnik o pogostnosti spolne aktivnosti (Sexual Frequency Questionnaire); DLQI = dermatološki indeks kakovosti življenja (Dermatology Quality of Life Index); bSkupna ocena DLQI 0,1 kaže na stanje kože, ki nima nobenega vpliva na bolnikovo življenje.
Onset of response was superior on PASI 75 as early as week 2 (p < 0.001) and on PASI 90 and PASI 100 by week 4 (p < 0.001).
Hitrost odziva za opazovani dogodek PASI 75 je bila superiorna že v 2. tednu (p < 0,001) in za opazovani dogodek PASI 90 ter PASI 100 v 4. tednu
After proper training in subcutaneous injection technique, patients may self-inject Taltz if a healthcare professional determines that it is appropriate.
Po ustreznem usposabljanju o subkutanem injiciranju si lahko bolniki sami injicirajo zdravilo
Q. What if I unlocked the pre-filled pen and pressed the green injection button before I twisted off the base cap?
V: Kaj če odklenem napolnjeni injekcijski peresnik in pritisnem zeleni gumb za injiciranje,
- Cold sores of mouth, skin and mucous membranes (herpes simplex, mucocutaneous)
- herpes na ustih, koži in sluznicah (mukokutani herpes simpleks).
Efficacy in Non-Responders to Etanercept: For patients identified as an sPGA (0,1) non-responder to etanercept at Week 12 in UNCOVER-2 (N = 200) and who were switched to Taltz 80 mg Q4W after a 4 week washout period, 73 % and 83.5 % of patients were able to achieve sPGA (0,1) and PASI 75, respectively, after 12 weeks of being treated with Taltz.
Učinkovitost pri bolnikih, ki se niso odzvali na etanercept: Pri bolnikih, ki se niso odzvali na etanercept, so imeli oceno sPGA (0,1) v 12. tednu v študiji UNCOVER-2 (N = 200) in so prešli na zdravljenje z zdravilom Taltz 80 mg Q4W po 4-tedenskem obdobju izpiranja, je 73 % in 83,5 % bolnikov doseglo oceno sPGA (0,1) oziroma PASI 75, po 12. tednih zdravljenja z zdravilom Taltz.
For sPGA (0,1) responders at Week 12 re-randomised to treatment withdrawal (i.e., placebo), the median time to relapse (sPGA ≥ 3) was 164 days in integrated UNCOVER-1 and UNCOVER-2 studies.
Bolniki, ki so se odzvali z oceno sPGA (0,1) v 12. tednu in so bili znova randomizirani v skupino brez zdravljenja (tj. placebo), je bil mediani čas do ponovnega pojava znakov (sPGA ≥ 3) 164 dni v integriranih študijah UNCOVER-1 in UNCOVER-2.
The frequency of neutropenia and thrombocytopenia in psoriatic arthritis clinical studies is similar to that observed in the plaque psoriasis studies.
Pogostnost nevtropenije in trombocitopenije v kliničnih študijah psoriatičnega artritisa je podobna pogostnosti, ki so jo opazili v študijah psoriaze s plaki.
Q. What if there is a drop of liquid on the tip of the needle when I remove the base cap?
V: Kaj če opazim kapljico tekočine na konici igle, ko odstranim pokrovček podnožja?
The pharmacokinetic properties of Taltz observed in psoriatic arthritis patients were similar to those displayed in plaque psoriasis patients.
Psoriatični artritis Farmakokinetične lastnosti zdravila Taltz pri bolnikih s psoriatičnim artritisom so bile podobne tistim pri bolnikih s psoriazo s plaki.
• If you do not have a sharps container, ask your doctor, pharmacist or nurse about where you can get one.
• Če nimate zbiralnika za ostre predmete, se pri zdravniku, farmacevtu ali medicinski sestri pozanimajte, kje ga lahko dobite.
Taltz is a solution in a clear glass syringe.
Zdravilo Taltz je raztopina v brizgi iz prozornega stekla.
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.
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.
sPGA of “0” (clear) or “1” (minimal)
sPGA "0" (čisto) ali "1" (minimalno)
Leave the base cap on until you are ready to inject.
Pokrovčka ohišja ne snemajte, dokler niste pripravljeni na injiciranje.
Oropharyngeal pain
Navojni pokrovček ohišja
Let the injection site dry naturally before you inject your medicine.
Injekcijsko mesto se mora pred injiciranjem zdravila posušiti na zraku.
- signs of low levels of white blood cells, such as fever, sore throat or mouth ulcers due to infections
- 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),
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.
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.
Inspect the pre-filled syringe for damage to the outside.
Preglejte napolnjeno injekcijsko brizgo, ali so na njeni zunanjosti kakršne koli poškodbe.
Q. What if there is a drop of liquid on the tip of the needle when I remove the needle cap?
V: Kaj če opazim kapljico tekočine na konici igle, ko odstranim pokrovček igle?
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.
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.
How much Taltz is given and for how long
Koliko zdravila Taltz je treba uporabiti in koliko časa ga uporabljamo
Tell your doctor, pharmacist or nurse - if you are using, have recently used or might use any other medicine.
- če uporabljate, ste pred kratkim uporabljali ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
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.
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.
Patients were randomised to subcutaneous injections of placebo, Taltz 80 mg once every 2 weeks (Q2W), or 80 mg once every 4 weeks (Q4W).
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).
A
h
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]).
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
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).
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
• Read the Taltz Package Leaflet inside this box to learn more about your medicine.
• Preberite Navodilo za uporabo zdravila Taltz v tej škatli, da boste izvedeli več o vašem zdravilu.
Some side effects are common (may affect up to 1 in 10 people): - nausea (feeling sick).
Nekateri neželeni učinki so pogosti (pojavijo se lahko pri največ 1 od 10 bolnikov): - navzea (občutek slabosti),
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.
Zdravilo lahko injicirate v trebuh (abdominalno področje), v stegno ali v nadlaket (hrbtno stran roke).
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
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).
Remove the pre-filled pen from your skin.
Umaknite peresnik s kože.
• The green plunger rod should show through the body of the syringe.
• Zeleni potisni bat mora biti viden skozi ohišje brizge.
PASI-Response Rates from comparative study ixekizumab versus ustekinumab
Rezultati primerjalne študije iksekizumaba v primerjavi z ustekinumabom glede na odziv PASI
• 1 sharps container for disposal of syringes
• 1 zbiralnik za ostre predmete za odstranjevanje brizg
Throw the base cap in the bin.
Odvrzite pokrovček podnožja v koš za odpadke.
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]).
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]).
Maintained or Achieved sPGA 0 (clear)
Vzdrževana ali zabeležena ocena sPGA 0
Syringe body with medicine
Ohišje brizge z zdravilom
Maintained or Achieved PASI 100
Vzdrževana ali zabeležena ocena PASI
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.
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.
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 %
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).
Among these patients, 71.5 % regained at least an sPGA (0,1) response within 12 weeks of restarting treatment with Taltz 80 mg Q4W.
Od teh bolnikov jih je 71,5 % znova doseglo oceno sPGA najmanj (0,1) v 12. tednih od ponovnega začetka zdravljenja z zdravilom