FrancophonIA/ELRC3.0 huggingface dataset:
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).
Danish: Taltz' virkning og sikkerhed blev vurderet i tre randomiserede, dobbeltblinde, placebokontrollerede fase III-studier hos voksne patienter med moderat til svær plaque-psoriasis, der var kandidater til lysbehandling eller systemisk behandling (UNCOVER-1, UNCOVER-2 og UNCOVER-3).
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.
Danish: Et randomiseret, dobbeltblindet, placebokontrolleret studie (IXORA-Q) blev udført hos 149 voksne patienter (24 % kvinder) med moderat til svær genital psoriasis (med sPGA of Genitalia-score ≥ 3), en minimumsinvolvering af kropsoverfladen (Body Surface Area - BSA) på 1 % (60,4 % havde en BSA ≥ 10 %) samt en anamnese med behandlingssvigt eller intolerans overfor mindst en topikal behandling af genital psoriasis.
English: Efficacy and safety of ixekizumab was also investigated in a double-blind study compared to ustekinumab with ixekizumab being superior on the primary study objective (PASI 90 response at week 12, Table 6).
Danish: Postmarketing fase 3b, direkte komparativt studie Ixekizumabs virkning og sikkerhed blev også undersøgt i et dobbeltblindt, komparativt studie med ustekinumab, hvor ixekizumab var superior på det primære studiemål (PASI 90 respons ved uge 12, tabel 6).
English: 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%).
Danish: Ved uge 12 opnåede signifikant flere patienter i Taltz-gruppen sammenlignet med placebogruppen en sPGA of Genitalia 0/1 og en sPGA 0/1 uafhængigt af baseline BSA (baseline BSA 1 % - < 10 % hhv. ≥ 10 %: sPGA of Genitalia ‘'0” eller “1”: Taltz 71 %, hhv. 75 %; placebo: 0 %, hhv. 13 %).
English: 53% of patients had concomitant use of MTX at a mean weekly dose of 15.8 mg. 67% of patients who had concomitant use of MTX had a dose of 15 mg or greater.
Danish: 53% af patienterne var i samtidig behandling med MTX med en gennemsnitlig ugentlig dosis på 15,8 mg. 67% af patienterne, som var i samtidig behandling med MTX, fik en dosis på 15 mg eller større.
English: In general, neutropenia did not require discontinuation of Taltz.
Danish: Generelt var seponering af Taltz ikke nødvendig pga. neutropeni.
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.
Danish: Du vil ikke få brug for at sætte den på igen - ved at gøre dette, kan nålen blive ødelagt, eller du kan komme til at stikke dig selv ved et uheld.
English: If you see any of the following, DO NOT USE the prefilled pen, and dispose of it as directed:
Danish: Hvis du ser noget af følgende, MÅ DU IKKE BRUGE den fyldte pen, og skal bortskaffe den som anvist:
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.
Danish: Taltz' sikkerhed og virkning hos børn og unge i alderen 6-18 år i behandlingen af moderat til svær plaque-psoriasis er endnu ikke klarlagt.
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.
Danish: Hos patienter med samtidig moderat til svær psoriasis og psoriasisartrit, viste Taltz Q2W doseringsregimet en signifikant højere responsrate for PASI 75, PASI 90 og PASI 100 sammenlignet med placebo (p<0,001), og demonstrerede en klinisk meningsfuld fordel over Q4W doseringsregimet.
English: 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.
Danish: Brug ikke lægemidlet, hvis du bemærker, at pennen er beskadiget, eller at medicinen er uklar, tydeligt brun eller indeholder partikler.
English: If you are breast-feeding or are planning to breast-feed, talk to your doctor before using this medicine.
Danish: Hvis du ammer eller planlægger at amme, skal du tale med lægen, før du bruger dette lægemiddel.
English: 1 ml solution in a type I clear glass syringe.
Danish: 1 ml injektionsvæske i en injektionssprøjte af klart glas (type I).
English: This medicine contains less than 1 mmol sodium (23 mg) per 80 mg dose, i.e., essentially “sodiumfree”.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. 80 mg dosis, dvs. den er i det væsentlige natriumfri.
English: When you dispose of syringes and the sharps container:
Danish: Når du bortskaffer injektionssprøjter og kanyleboks:
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.
Danish: Du kan indsprøjte i abdomen (maveområdet), i låret eller bag på armen.
English: • The pre-filled syringe contains 1 dose of Taltz.
Danish: • Den fyldte injektionssprøjte indeholder 1 dosis Taltz.
English: Other side effects that have been reported
Danish: Andre indberettede bivirkninger
English: 354 (81.8)a sPGA of “0” (clear)
Danish: 354 (81,8)a sPGA på “0” (clear)
English: For psoriatic arthritis patients with concomitant moderate to severe plaque psoriasis, the recommended dosing regimen is the same as for plaque psoriasis.
Danish: For patienter med psoriasisartrit og samtidig moderat til svær plaquepsoriasis, er den anbefalede dosis den samme som for plaque-psoriasis.
English: Inflammatory Bowel Disease
Danish: Inflammatorisk tarmsygdom
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.
Danish: Det er ikke relevant at anvende Taltz til børn under 6 år i behandlingen af moderat til svær plaquepsoriasis.
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.
Danish: Ved uge 52, var gennemsnitsændringen fra baseline i mTSS, 0,27 for placebo/Taltz Q4W, 0,54 for Taltz Q4W/Taltz Q4W, og 0,32 for adalimumab/Taltz Q4W.
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%]).
Danish: Taltz var superior til ADA i det primære studiemål: samtidig opnåelse af ACR 50 og PASI 100 respons ved uge 24 (Taltz 36,0% vs. ADA 27,9%; p=0,036; 95% konfidensinterval [0,5%; 15,8%]).
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 80 mg dose, i.e., essentially “sodium-free”.
Danish: Dette lægemiddel indeholder mindre end 1 mmol (23 mg) natrium pr. 80 mg dosis, dvs. det er i det væsentlige natriumfrit.
English: - The other ingredients are sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; water for injections.
Danish: - Øvrige indholdsstoffer: natriumcitrat; citronsyre, vandfri; natriumchlorid; polysorbat 80 og vand til injektionsvæsker.
English: From Week 12, you will use an 80 mg dose (one injection) every 4 weeks.
Danish: Fra uge 12 skal du have en 80 mg dosis (én indsprøjtning) hver 4. uge.
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).
Danish: På tværs af studierne var Taltz ved uge 12 forbundet med en statistisk signifikant forbedring i helbredsrelateret livskvalitet (Health-related Quality of Life) vurderet ved gennemsnitlige reduktionsintervaller fra baseline i Dermatology Life Quality Index (DLQI) (Taltz 80 mg Q2W fra10,2 til -11,1; Taltz 80 mg Q4W fra -9,4 til -10,7; etanercept fra -7,7 til -8,0 og placebo fra -1,0 til2,0).
English: Then gently let go of your skin.
Danish: Slip herefter langsomt huden.
English: Each syringe contains one dose of Taltz (80 mg).
Danish: Hver injektionssprøjte indeholder én dosis af Taltz (80 mg).
English: 1 GET READY 1a Take the syringe from the refrigerator.
Danish: 1a Tag injektionssprøjten ud af køleskabet.
English: Taltz can potentially cause serious side effects, including infections and allergic reactions.
Danish: Hold øje med infektioner og allergiske reaktioner Der er risiko for, at Taltz kan forårsage alvorlige bivirkninger, herunder infektioner og allergiske reaktioner.
English: Taltz is used to treat a condition called “psoriatic arthritis”, an inflammatory disease of the joints, often accompanied by psoriasis.
Danish: Taltz anvendes til behandling af en sygdom, der kaldes “psoriasisartrit”, en inflammatorisk sygdom i leddende, som ofte kommer med psoriasis.
English: Talk to your doctor, nurse or pharmacist before using Taltz:
Danish: Advarsler og forsigtighedsregler Kontakt lægen, sundhedspersonalet eller apotekspersonalet, før du tager Taltz:
English: 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.
Danish: Den anbefalede dosis er 160 mg som subkutan injektion (to injektioner a 80 mg) ved uge 0, efterfulgt af 80 mg (én injektion) ved uge 2, 4, 6, 8, 10 og 12 og herefter vedligeholdelsesdosis på 80 mg (én injektion) hver 4. uge.
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.
Danish: 363 patienter blev evalueret i SPIRIT-P2, hvoraf 41% var i samtidig behandling med MTX med en gennemsnitlig ugentlig dosis på 16,1 mg. 73,2% af patienterne, som var i samtidig behandling med MTX, fik en dosis på 15 mg eller mere.
English: - After the first dose you will use an 80 mg dose (one injection) every 4 weeks.
Danish: - Efter den første dosis skal du have en 80 mg dosis (én indsprøjtning) hver 4. uge.
English: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Danish: Indehaver af markedsføringstilladelsen Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Holland.
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.
Danish: Hos 3% af patienterne behandlet med Taltz ændrede trombocyttallet sig fra normalt ved baseline til 75.000-150.000 celler/mm3.
English: 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).
Danish: I alt blev 678 patienter vurderet (229 patienter fik 80 mg hver 4. uge (Q4W), 225 patienter fik 80 mg hver 2. uge (Q2W) og 224 patienter fik placebo).
English: The pharmacokinetic properties of Taltz observed in psoriatic arthritis patients were similar to those displayed in plaque psoriasis patients.
Danish: De farmakokinetiske egenskaber for Taltz, observeret i patienter med psoriasisartrit, var de samme som observeret hos patienter med plaque-psoriasis.
English: Etanercept 50 mg twice weekly (N = 358)
Danish: Etanercept 50 mg to gange ugentligt (N = 358)
English: Etanercept 50 mg twice weekly (N = 382)
Danish: Etanercept 50 mg to gange ugentligt (N = 382)
English: After the 160 mg starting dose, steady state was achieved by Week 8 with the 80 mg Q2W dosing regimen.
Danish: Efter startdosen på 160 mg blev steady state nået i uge 8 med doseringsregimet 80 mg hver anden uge.
English: 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).
Danish: I alt blev 3.119 patienter vurderet (1.161 patienter fik 80 mg hver 4. uge (Q4W), 1.167 patienter fik 80 mg hver 2. uge (Q2W) og 791 patienter fik placebo).
English: 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).
Danish: Andelen af patienter, der opnåede PASI 75, PASI 90, og PASI 100-respons ved uge 24, var større med Taltz Q4W sammenlignet med placebo (p<0,001).
English: The syringe is encased in a disposable, single-dose pen.
Danish: Injektionssprøjten er indkapslet i en engangspen med en enkelt dosis.
English: Remove the pre-filled pen from your skin.
Danish: Fjern pennen fra huden.
English: Excipients: sodium citrate; citric acid, anhydrous; sodium chloride; polysorbate 80; water for injections.
Danish: Hjælpestoffer: natriumcitrat; citronsyre, vandfri; natriumchlorid; polysorbat 80 og vand til injektionsvæsker.
English: After switching from the 80 mg Q2W dosing regimen to the 80 mg Q4W dosing regimen at Week 12, steady state would be achieved after approximately 10 weeks.
Danish: Ved et skift fra doseringsregimet 80 mg hver 2. uge til doseringsregimet 80 mg hver 4. uge ved uge 12 blev steady state nået efter ca. 10 uger.
English: Q. What if there is a drop of liquid on the tip of the needle when I remove the needle cap?
Danish: Hvad nu hvis der er en dråbe væske på spidsen af nålen, når jeg tager nålehætten af?
English: If you see any of the following, DO NOT USE the syringe, and dispose of it as directed:
Danish: Hvis du ser noget af følgende, MÅ DU IKKE BRUGE injektionssprøjten, og du skal bortskaffe den som anvist:
English: 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).
Danish: Hos patienter med ≥3% BSA, var forbedringen i heling af huden ved uge 12 (målt ved 75% forbedring i Psoriasis Area Severity Index (PASI 75)) 67% (94/141) for patienterne behandlet med Q4W doseringsregimet og 9% (12/134) for patienterne behandlet med placebo (p<0,001).
English: 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.
Danish: Den anbefalede dosis er 160 mg som subkutan injektion (to injektioner a 80 mg) ved uge 0 og herefter 80 mg (én injektion) hver 4. uge.
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.
Danish: Patienter randomiseret til Taltz, som opnåede sPGA (0,1)-respons (statisk Physicians Global Assessment) ved uge 12, blev randomiseret på ny til at få placebo eller Taltz i yderligere 48 uger (UNCOVER-1 og UNCOVER-2); patienter randomiseret til placebo, etanercept eller Taltz, som ikke opnåede et sPGA (0,1)-respons, fik Taltz i op til 48 uger.
English: • If you do not have a sharps container, ask your doctor, pharmacist or nurse about where you can get one.
Danish: • Hvis du ikke har en kanyleboks, så spørg lægen, sygeplejersken eller apotekspersonalet, hvor du kan få en.
English: The primary endpoint was the proportion of patients who achieved at least a "0" (clear) or "1" (minimal) response on the sPGA of Genitalia (sPGA of Genitalia 0/1).
Danish: Det primære endepunkt var andelen af patienter, der opnåede en sPGA of Genitalia-score (sPGA of Genitalia 0/1) på 0 (“clear” [ingen symptomer]) eller 1 (“minimal” [minimale symptomer]).
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.
Danish: Sikkerhedsprofilen observeret hos psoriasisartrit-patienter behandlet med Taltz er i overenstemmelse med sikkerhedsprofilen i plaque-psoriasis, med undtagelse af hyppighederne af bivirkningerne influenza og konjunktivitis, som var almindelige hos patienter med psoriasisartrit.
English: Push in the plunger.
Danish: Tryk stemplet i bund.
English: 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.
Danish: Brug ikke lægemidlet, hvis du bemærker, at injektionssprøjten er beskadiget, eller at medicinen er uklar, tydeligt brun eller indeholder partikler.
English: Maintained sPGA of “0” (clear) or “1” (minimal)
Danish: Opretholdt sPGA på “0” (clear) eller “1” (minimal)
English: Bottom/ End Needle minutes
Danish: Bund/nål espids minutter
English: 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.
Danish: Forkortelser: ADA = adalimumab; CI = konfidensinterval; Q4W = Taltz 80 mg hver 4. uge; Q2W = Taltz 80 mg hver 2. uge; LSM = least squares mean; N = antal patienter i analysepopulationen; PBO = placebo; SE = standard error; SD = standard deviation.
English: Patients were stratified at baseline based on concomitant cDMARD use and presence of moderate-to-severe psoriasis (PASI≥12,
Danish: Patienterne blev stratificeret ved baseline baseret på samtidig behandling med cDMARD og forekomst af moderat til svær psoriasis (PASI≥12, BSA≥10 og sPGA≥3).
English: 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.
Danish: Tre placebokontrollerede fase III-studier med plaque-psoriasis blev integreret for at vurdere sikkerheden af Taltz sammenlignet med placebo i op til 12 uger efter påbegyndt behandling.
English: Read the “Instructions for Use” for the syringe carefully before using Taltz.
Danish: Læs omhyggeligt “Brugervejledning” til injektionssprøjten, inden du bruger Taltz.
English: The frequency of neutropenia and thrombocytopenia in psoriatic arthritis clinical studies is similar to that observed in the plaque psoriasis studies.
Danish: Hyppigheden af neutropeni og trombocytopeni er den samme i kliniske studier med psoriasisartrit som i kliniske studier med plaque-psoriasis.
English: 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).
Danish: I Psoriatic Arthritis Study 1 (SPIRIT-P1) blev patienter med aktiv psoriasisartrit, der ikke tidligere havde fået biologisk behandling, randomiseret til subkutane injektioner med placebo, adalimumab 40 mg en gang hver 2. uge (aktiv reference kontrol-arm), Taltz 80 mg 1 gang hver 2. uge (Q2W) eller 80 mg 1 gang hver 4. uge (Q4W).
English: Efficacy results in SPIRIT-P1 and SPIRIT-P2 at week 24
Danish: Tabel 8 Effektresultater ved uge 24 i SPIRIT-P1 og SPIRIT-P2
English: When you dispose of the pre-filled pen and the sharps container:
Danish: Når du bortskaffer penne og kanyleboks:
English: sPGA of “0” (clear) or
Danish: sPGA på “0” (clear) eller
English: 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.
Danish: To placebokontrollerede fase III-studier med psoriasisartrit blev integreret for at vurdere sikkerheden af Taltz sammenlignet med placebo i op til 24 uger efter påbegyndt behandling.
English: DO NOT put the needle cap back on.
Danish: Sæt IKKE nålehætten på igen.
English: 23.4 % of patients had a history of psoriatic arthritis at baseline.
Danish: 23,4 % af patienterne havde psoriasisartrit ved baseline eller havde tidligere haft psoriasisartrit.
English: • The syringe must not be shaken.
Danish: • Injektionssprøjten må ikke rystes.
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.
Danish: ** Taltz 160 mg uge 0, så 80 mg hver 2. uge indtil uge 12 og derefter hver 4. uge for patienter med moderat til svær plaque-psoriasis eller 160 mg uge 0, så 80 mg hver 4. uge for andre patienter.
English: The pre-filled pen is for single use only.
Danish: Den fyldte pen er kun til engangsbrug.
English: What you need to know before you use Taltz Do not use Taltz
Danish: Det skal du vide, før du begynder at bruge Taltz
English: The instructions for using the pen, included with the leaflet, must be followed carefully.
Danish: Brugervejledningen til pennen er inkluderet i indlægssedlen og skal følges nøje.
English: Leave the base cap on until you are ready to inject.
Danish: Behold hætten på, indtil du er klar til at indsprøjte.
English: Urticaria, Rash, Eczema,
Danish: Urticaria, udslæt, eksem
English: Leave the needle cap on the syringe until you are ready to inject.
Danish: Behold nålehætten på injektionssprøjten, indtil du er klar til at insprøjte.
English: 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.
Danish: Effekt hos patienter, der ikke responderede på etanercept: Af de patienter, der ikke opnåede et sPGA (0,1)-respons på etanercept ved uge 12 i UNCOVER-2 (N = 200), og som overgik til Taltz 80 mg Q4W efter en udvaskningsperiode på 4 uger, opnåede henholdsvis 73 % og 83,5 % sPGA (0,1) og PASI 75 efter at være blevet behandlet med Taltz i 12 uger.
English: 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.
Danish: Reaktioner på injektionsstedetf aPlacebokontrollerede kliniske studier (fase III), hvor patienter med moderat til svær plaque-psoriasis blev eksponeret for ixekizumab 80 mg Q2W, ixekizumab 80 mg Q4W eller placebo i en behandlingsperiode på op til 12 uger, eller hvor patienter med aktiv psoriasisartrit blev eksponeret for ixekizumab 80 mg Q2W, ixekizumab 80 mg Q4W eller placebo i en behandlingsperiode på op til 24 uger.
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
Danish: Alvorlig infektion (kan forekomme hos op til 1 ud af 100 behandlede) - tegnene kan være: - feber, influenzalignende symptomer, nattesved - træthed eller åndenød, hoste, der ikke vil gå over - varm, rød og smertende hud eller et smertefuldt hududslæt med blærer.