FrancophonIA/ELRC3.0 huggingface dataset:
English: Number of patients (%)
Danish: Antal patienter (%)
English: Such signs are listed under “Serious side effects” in section 4.
Danish: Sådanne tegn er anført under “Alvorlige bivirkninger” i afsnit 4.
English: However, the physician should ensure appropriate follow-up of patients.
Danish: Lægen bør dog sikre relevant opfølgning af patienterne.
English: The effects of this medicine in pregnant women are not known.
Danish: Virkningerne af dette lægemiddel hos gravide kvinder kendes ikke.
English: Maintenance of Response at Week 60
Danish: Opretholdelse af respons ved uge 60
English: You will hear a second loud click in about 5 to 10 seconds after the first one.
Danish: Du vil høre endnu et højt klik ca. 5 til 10 sekunder efter det første.
English: Air bubbles are not a problem in this type of injection.
Danish: Luftbobler er ikke noget problem ved denne form for indsprøjtning.
English: You are now ready to inject.
Danish: Du er nu klar til at indsprøjte.
English: This will not harm you or affect your dose.
Danish: Dette vil ikke skade dig eller påvirke din dosis.
English: - if you currently have an infection or if you have long-term or repeated infections.
Danish: - hvis du har en infektion for øjeblikket, eller hvis du har langvarige eller tilbagevendende infektioner.
English: Your doctor will decide if and when you may restart the treatment:
Danish: Lægen vil afgøre, om og hvornår du kan genoptage behandlingen.
English: Significance level only provided for endpoint that was pre-defined and multiplicity tested.
Danish: Signifikansniveau er kun angivet for endepunkt som var prædefineret og testet for multiplicitet.
English: Clinical response at 12 weeks
Danish: Klinisk respons efter 12 uger
English: Back of arm
Danish: Bag på arm
English: There is limited information in subjects aged ≥ 75 years.
Danish: Der er begrænsede oplysninger for personer ≥ 75 år.
English: - if you have ulcerative colitis.
Danish: - hvis du har colitis ulcerosa.
English: Taltz that has been frozen must not be used.
Danish: Taltz, der har været nedfrosset, må ikke anvendes.
English: - if you have an infection which your doctor thinks is important (for example, active tuberculosis).
Danish: - hvis du har en infektion, som lægen mener er væsentlig (f.eks. aktiv tuberkulose).
English: Each pen delivers only one dose.
Danish: Hver pen afgiver kun én dosis.
English: Do not remove the pre-filled pen from your skin until you hear the second loud click.
Danish: Tag ikke pennen væk fra huden, før du hører det andet høje klik.
English: Insert the needle at a 45-degree angle.
Danish: Stik nålen ind i en vinkel på 45 grader.
English: 1d Wash your hands before you inject your medicine.
Danish: 1d Vask hænder, før du indsprøjter medicinen.
English: Postmarketing Phase 4, direct comparative study
Danish: Postmarketing fase 4, direkte komparativt studie
English: • It is past the expiry date.
Danish: • Udløbsdatoen er overskredet.
English: Some patients with initially partial response may subsequently improve with continued treatment beyond 20 weeks.
Danish: Patienter med partielt respons initialt kan i visse tilfælde efterfølgende opnå bedring ved fortsat behandling ud over 20 uger.
English: For both studies, the primary endpoint was American College of Rheumatology (ACR) 20 response at Week 24.
Danish: For begge studier, var det primære endepunkt American College of Rheumatology (ACR) 20-respons ved uge 24.
English: Taltz must not be given to patients with active tuberculosis (TB).
Danish: Taltz må ikke gives til patienter med aktiv tuberkulose (TB).
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 16 to 20 weeks of treatment.
Danish: Det bør overvejes at seponere behandlingen hos patienter, der ikke har vist respons efter 16 til 20 ugers behandling.
English: Such levels of neutropenia may persist, fluctuate or be transient.
Danish: Sådanne niveauer af neutropeni kan være vedvarende, svingende eller forbigående.
English: 1f Prepare your skin.
Danish: 1f Klargør huden.
English: There is a limited amount of data from the use of ixekizumab in pregnant women.
Danish: Der er begrænsede data vedrørende anvendelse af ixekizumab til gravide kvinder.
English: Clean your skin with an alcohol wipe.
Danish: Rens huden med en alkoholserviet.
English: A. This is not necessary, but it may help you keep the pre-filled pen steady and firm against your skin.
Danish: Det er ikke nødvendigt, men det kan gøre det lettere at holde den fyldte pen roligt og fast mod huden.
English: A. After you press the green injection button, you will hear 2 loud clicks.
Danish: Når du har trykket på den grønne injektionsknap, vil du høre 2 høje klik.
English: Week 52 Ixekizumab* Ustekinumab** Ixekizumab* Ustekinumab** Ixekizumab* Ustekinumab**
Danish: Uge 52 Ixekizumab* Ustekinumab** Ixekizumab* Ustekinumab** Ixekizumab* Ustekinumab*
English: Cytochrome P450 Substrates
Danish: Cytokrom P450 substrater
English: Taltz is for long-term treatment.
Danish: Taltz er beregnet til længerevarende behandling.
English: Make sure to keep the needle in place.
Danish: Sørg for at holde nålen på plads.
English: Influenzai, Rhinitis, Oral candidiasisd, Conjunctivitisi, Cellulitise
Danish: Influenzai, rhinitis, oral candidiasisd, konjunktivitisi, cellulitise
English: 2 INJECT 2a
Danish: 2 INDSPRØJT 2a
English: Use a reminder method such as notes in a calendar or diary to help you remember your next dose so that you avoid missing or repeating doses.
Danish: Brug en huskemetode, f.eks. noter i en kalender eller dagbog, som kan hjælpe dig med at huske din næste dosis, så du undgår at springe en dosis over eller tage for mange doser.
English: This was related primarily to early delivery or maternal neglect of offspring, common findings in nonhuman primate studies, and considered clinically irrelevant.
Danish: Dette var primært relateret til tidlig fødsel eller maternel forsømmelse af afkommet, hvilket er almindelige fund i studier hos ikke-humane primater, og blev ikke anset for at være klinisk relevant.
English: A. If the plunger is stuck or damaged:
Danish: Hvis stemplet sidder fast eller er beskadiget:
English: Change from baseline at Week 24, LSM (SE)
Danish: Ændring fra baseline ved uge 24, LSM (SE)
English: Your doctor or nurse will regularly monitor your condition to check that the treatment is having the desired effect.
Danish: Lægen eller sygeplejersken vil undersøge dig regelmæssigt for at kontrollere, at behandlingen virker, som den skal.
English: However, the data concerning immunisation were insufficient to conclude on an adequate immune response to these vaccines following administration of Taltz.
Danish: Data vedrørende immunisering var imidlertid ikke tilstrækkelige til at konkludere, om immunresponset på disse vacciner, givet efter administration af Taltz, var tilstrækkeligt.
English: Taltz can be used alone or with another medicine named methotrexate.
Danish: Taltz kan gives alene eller sammen med et andet lægemiddel kaldet methotrexat.
English: 56% and 35% of patients were inadequate responders to 1 anti-TNF or 2 anti-TNF, respectively.
Danish: 56% og 35% af patienterne responderede utilstrækkeligt på henholdsvis 1 anti-TNF eller 2 anti-TNF.
English: The most frequent injection site reactions observed were erythema and pain.
Danish: De hyppigst observerede reaktioner på injektionsstedet var erytem og smerte.
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.
Danish: Der var ikke evidens for forværring af depression efter op til 60 ugers behandling med Taltz, vurderet ved Quick Inventory of Depressive Symptomatology Self Report.
English: • It looks damaged.
Danish: • Pennen ser beskadiget ud.
English: If possible, areas of the skin that show psoriasis should be avoided as injection sites.
Danish: Hvis det er muligt, skal hudområder med psoriasis undgås som injektionssteder.
English: Did I get my complete injection?
Danish: Har jeg så fået hele min dosis?
English: In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.
Danish: I tilfælde af overdosering anbefales det, at patienten monitoreres for tegn eller symptomer på bivirkninger, og at relevant symptomatisk behandling omgående indledes.
English: From population pharmacokinetic analyses, the mean total volume of distribution at steady state was 7.11 L.
Danish: Populationsfarmakokinetiske analyser viste, at det gennemsnitlige samlede fordelingsvolumen ved steady state var 7,11 l.
English: The effect of ixekizumab on human fertility has not been evaluated.
Danish: Virkningen af ixekizumab på fertiliteten hos mennesker er ikke blevet undersøgt.
English: For example, if your last injection was in your left thigh, your next injection should be in your right thigh, your abdomen, or the back of either arm.
Danish: Hvis din sidste indsprøjtning for eksempel var i venstre lår, bør din næste indsprøjtning være i højre lår, i abdomen eller bag på en af armene.
English: Make sure the name Taltz appears on the label.
Danish: Vær opmærksom på, at der skal stå Taltz på etiketten.
English: You should not stop using Taltz without speaking to your doctor first.
Danish: Du må ikke stoppe med at bruge Taltz uden først at have talt med lægen.
English: You must look out for signs of these conditions while you are using Taltz.
Danish: Du skal holde øje med tegn på disse tilstande, mens du bruger Taltz.
English: Quality of Life/Patient-Reported Outcomes
Danish: Livskvalitet/patientrapporterede resultater
English: • Your doctor, pharmacist or nurse may help you decide where on your body to inject your dose.
Danish: • Lægen, sygeplejersken eller apotekspersonalet kan hjælpe dig med afgøre, hvor på kroppen du skal indsprøjte din dosis.
English: Slowly push the plunger all the way in until all the medicine is injected.
Danish: Tryk langsomt stemplet helt i bund, indtil al medicin er sprøjtet ind.
English: You may have slight bleeding.
Danish: Det kan bløde en lille smule.
English: Press the green injection button.
Danish: Tryk på den grønne injektionsknap.
English: If you have psoriatic arthritis you will first be given other medicines.
Danish: Hvis du har psoriasisartrit vil du først få anden medicin.
English: Taltz reduces the signs and symptoms of the disease.
Danish: Taltz mindsker tegnene og symptomerne på sygdommen.
English: 85.3% of patients in this study had received prior treatment with ≥1 cDMARD.
Danish: I studiet havde 85,3% af patienterne tidligere været i behandling med ≥ 1 cDMARD.
English: The average bioavailability of ixekizumab after subcutaneous administration was 54 % to 90 % across analyses.
Danish: Den gennemsnitlige biotilgængelighed af ixekizumab efter subkutan administration var 54-90 % på tværs af analyserne.
English: If a serious hypersensitivity reaction occurs, administration of Taltz should be discontinued immediately and appropriate therapy initiated.
Danish: Hvis der opstår en alvorlig overfølsomhedsreaktion, skal administration af Taltz omgående ophøre og relevant behandling indledes.
English: It is not known whether ixekizumab is excreted in human milk or absorbed systemically after ingestion.
Danish: Det vides ikke, om ixekizumab udskilles i human mælk eller absorberes systemisk efter indtagelse.
English: DO NOT inject within 2.5 centimetres of the navel (belly button).
Danish: Indsprøjt IKKE inden for 2,5 centimeter fra navlen.
English: Comprehensive instructions for administration are given in the package leaflet.
Danish: I indlægssedlen gives der en udførlig vejledning i administration.
English: Of all patients, 14.9 % had received at least one anti-TNF alpha agent, and 8.7 % had received an anti-IL-12/IL-23.
Danish: Af alle patienter havde 14,9 % fået mindst ét anti-TNF-alfa-middel, og 8,7 % havde fået et anti-IL-12/IL-23.
English: Taltz is not recommended for children and adolescents under 18 years of age because it has not been studied in this age group.
Danish: Taltz anbefales ikke til børn og unge under 18 år, da lægemidlet ikke er blevet undersøgt hos denne aldersgruppe.
English: A caregiver may also give you your Taltz injection after proper training.
Danish: En omsorgsperson kan også give dig din Taltz-indsprøjtning efter grundig oplæring.
English: If you do not respond well enough to these medicines, you will be given Taltz to reduce the signs and symptoms of the disease.
Danish: Hvis disse lægemidler ikke virker tilstrækkeligt for dig, vil du få Taltz for at mindske tegn og symptomer på sygdommen.
English: Note: patients who were rescued at week 16 or discontinued or with missing data were imputed as non-responders for week 24 analyses.
Danish: Bemærk: Patienter, som modtog supplerende behandling ved uge 16, eller afbrød behandlingen, eller med manglende data, blev talt med som ikke-responderende ved uge 24 analyser.
English: Make sure the lock ring is in the lock position.
Danish: Sørg for, at låseringen er i position 'låst'.
English: Taltz has been shown to lower (within 1 week of treatment) levels of C-reactive protein, which is a marker of inflammation.
Danish: Det er vist, at Taltz sænker (inden for 1 uges behandling) koncentrationen af C-reaktivt protein, som er en markør for inflammation.
English: 1b Gather the supplies for your injection:
Danish: 1b Find de ting frem, som du skal bruge til indsprøjtningen:
English: If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using Taltz and for at least 10 weeks after the last Taltz dose.
Danish: Hvis du er en kvinde, der kan blive gravid, bør du undgå at blive gravid, og du skal bruge sikker prævention, mens du er i behandling med Taltz og i mindst 10 uger efter den sidste dosis.
English: Keep the base on your skin, and then turn the lock ring to the unlock position.
Danish: Hold endefladen mod huden, og drej herefter låseringen til position 'ulåst'.
English: Superiority of ixekizumab versus ustekinumab was also demonstrated in the subgroups stratified by weight.
Danish: Ixekizumabs superioritet versus ustekinumab blev også vist i de vægtstratificerede subgrupper.
English: Taltz should be used with caution in patients with clinically important chronic infection.
Danish: Taltz bør anvendes med forsigtighed hos patienter med en klinisk vigtig kronisk infektion.
English: • 1 alcohol wipe
Danish: • 1 alkoholserviet
English: Of these, 4,500 patients were exposed to Taltz for at least one year, cumulatively representing 13,645.6 patient years of exposure.
Danish: Af disse blev 4.500 patienter eksponeret for Taltz i mindst ét år, hvilket kumulativt repræsenterer eksponering i 13.645,6 patientår.
English: Taltz should not be used with live vaccines.
Danish: Taltz bør ikke anvendes sideløbende med levende vacciner.
English: Ixekizumab modulates biological responses that are induced or regulated by IL-17A.
Danish: Ixekizumab modulerer biologiske responser, der induceres eller reguleres af IL-17A.
English: Maintained or Achieved sPGA 0 (clear)
Danish: Opretholdt eller opnået sPGA 0 (clear)
English: No apparent association between the presence of neutralising antibodies and impact on drug concentration or efficacy was observed.
Danish: Der blev ikke observeret nogen klar sammenhæng mellem tilstedeværelsen af neutraliserende antistoffer og påvirkning af lægemiddelkoncentration eller lægemiddelvirkning.
English: If you think you may be allergic, ask your doctor for advice before using Taltz.
Danish: Hvis du tror, at du kan være allergisk, så spørg lægen til råds, før du bruger Taltz.
English: Taltz was associated with a fast onset of efficacy with > 50 % reduction in mean PASI by Week 2 (Figure 1).
Danish: Taltz var forbundet med en hurtigt indsættende virkning med en reduktion i gennemsnitlig PASI på > 50 % i uge 2 (figur 1).
English: do not use it. Use a new pre-filled pen for your injection.
Danish: Brug en ny fyldt pen til din indsprøjtning.
English: Across studies, Taltz was associated with statistically significant improvement of itching severity assessed by the Itch NRS score.
Danish: På tværs af studierne var Taltz forbundet med en statistisk signifikant forbedring af sværhedsgraden af kløe vurderet ved Itch NRS-score.
English: Treatment with Taltz resulted in significant improvement in measures of disease activity compared to placebo at Week 24 (see Table 8).
Danish: Behandling med Taltz resulterede i en signifikant forbedring af sygdomsaktivitetsmålinger sammenlignet med placebo ved uge 24 (se tabel 8).
English: These reactions were predominantly mild to moderate in severity and did not lead to discontinuation of Taltz.
Danish: Disse reaktioner var overvejende lette til moderate i sværhedsgrad og førte ikke til seponering af Taltz.
English: Store in a refrigerator (2 ºC - 8 ºC).
Danish: Opbevares i køleskab (2ºC - 8ºC).
English: Taltz should not be resumed until the infection resolves.
Danish: Behandlingen med Taltz må ikke genoptages, før infektionen er i bedring.
English: Women of childbearing potential should use an effective method of contraception during treatment and for at least 10 weeks after treatment.
Danish: Fertile kvinder skal anvende sikker kontraception under behandlingen og i mindst 10 uger efter endt behandling.
English: • The pre-filled pen contains glass parts.
Danish: • Den fyldte pen indeholder dele af glas.
English: The efficacy and safety of Taltz were also evaluated versus etanercept (UNCOVER-2 and UNCOVER-3).
Danish: Taltz' virkning og sikkerhed blev også vurderet versus etanercept (UNCOVER-2 og UNCOVER-3).
English: Using Taltz will benefit you by reducing the signs and symptoms of the disease, improving physical function (ability to do normal daily activities), and slowing down the damage to the joints.
Danish: Taltz hjælper ved at mindske tegn og symptomer på sygdommen, forbedre den fysiske funktion (evnen til at udføre sædvanlige daglige aktiviteter) og nedsætte skader på leddende.
English: • The medicine is cloudy, is distinctly brown, or has small particles.
Danish: • Medicinen er uklar, den er tydeligt brun, eller den indeholder små partikler.
English: The bioavailability of Taltz in psoriatic arthritis patients was in the range of 61-84% on the basis of the population pharmacokinetic model.
Danish: Biotilgængeligheden af Taltz hos patienter med psoriasisartrit lå i området 61-84%, baseret på populationsfarmakokinetik-modellen.
English: The majority of infections were non-serious and mild to moderate in severity, most of which did not necessitate treatment discontinuation.
Danish: Størstedelen af infektionerne var ikke alvorlige og lette til moderate i sværhedsgrad og krævede i de fleste tilfælde ikke seponering af behandlingen.
English: Animal studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger, hvad angår fertilitet (se pkt.
English: Number of patients (N) randomized
Danish: Antal randomiserede patienter (N)
English: A higher incidence of postnatal mortality occurred in the offspring of monkeys given ixekizumab compared to concurrent controls.
Danish: Der var en højere incidens af postnatal mortalitet hos afkommet af aber, der fik ixekizumab, sammenlignet med samstemmende kontroller.
English: Taltz is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of conditions for which Taltz is indicated.
Danish: Taltz skal anvendes under vejledning og supervision af en læge med erfaring i diagnosticering og behandling af sygdomme, for hvilke Taltz er indiceret.
English: No interaction was seen when Taltz was administered concomitantly with methotrexate (MTX) and/or corticosteroids in patients with psoriatic arthritis.
Danish: Der blev ikke set interaktioner, når Taltz blev administreret sammen med methotrexat (MTX) og/eller kortikosteroider hos patienter med psoriasisartrit.
English: Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonic/foetal development, parturition or post-natal development (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår graviditet, embryonal/føtal udvikling, fødsel eller postnatal udvikling (se pkt.
English: Taltz-treated patients reported improvements in health-related quality of life as measured by the Physical Component Summary of the Short Form-36 Health Survey (SF-36 PCS) score (p<0.001).
Danish: Patienter behandlet med Taltz rapporterede forbedringer i helbredsrelateret livskvalitet, målt ved Physical Component Summary of the Short Form-36 Health Survey (SF-36 PCS)-score (p<0,001).
English: Before using your pre-filled pen:
Danish: Før du bruger din fyldte pen:
English: Neutralisation of IL-17A by ixekizumab inhibits these actions.
Danish: Neutralisering af IL-17A med ixekizumab hæmmer disse virkninger.
English: Change in modified Total Sharp Score in SPIRIT-P1
Danish: Tabel 9 Ændring i modificeret total Sharp-score i SPIRIT-P1
English: Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Danish: Inden for hver systemorganklasse er bivirkningerne opstillet efter hyppighed med de hyppigste bivirkninger anført først.
English: In most cases, the blood neutrophil count was ≥1,000 cells/mm3.
Danish: I de fleste tilfælde var neutrofiltallet ≥1.000 celler/mm3.
English: Doses up to 180 mg have been administered subcutaneously in clinical trials without dose-limiting toxicity.
Danish: Doser på op til 180 mg er blevet administreret subkutant i kliniske studier uden dosisbegrænsende toksicitet.
English: Cases of new or exacerbations of Crohn's disease and ulcerative colitis have been reported.
Danish: Tilfælde af nyopstået samt forværring af Crohns sygdom og colitis ulcerosa er blevet indberettet.
English: ADRs from clinical studies and postmarketing reports (Table 1) are listed by MedDRA system organ class.
Danish: Bivirkninger fra kliniske studier og postmarketing rapporter (tabel 1) er anført efter MedDRAsystemorganklasse.
English: Figure 2.
Danish: Figur 2
English: to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000).
Danish: < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), sjælden (≥ 1/10.000 til < 1/1.000) og meget sjælden
English: Ixekizumab does not bind to ligands IL-17B, IL-17C, IL-17D, IL-17E or IL-17F.
Danish: Ixekizumab binder sig ikke til liganderne IL-17B, IL-17C, IL-17D, IL-17E eller IL-17F.
English: If you stop treatment, symptoms of psoriasis or psoriatic arthritis may come back.
Danish: Hvis du stopper behandlingen, kan der igen komme symptomer på psoriasis eller psoriasisartrit.
English: In vitro binding assays confirmed that ixekizumab does not bind to human Fcγ receptors I, IIa, and IIIa or to complement component C1q.
Danish: Bindingsanalyser in vitro bekræftede, at ixekizumab ikke binder sig til human Fcγ-receptor I, IIa og IIIa eller til komplementkomponent C1q.
English: Finger grips minutes
Danish: Fingergreb minutter
English: The rate of serious infections was 0.4 % for etanercept and 0.5 % for Taltz.
Danish: Forekomsten af alvorlige infektioner var 0,4 % for etanercept og 0,5 % for Taltz.
English: If you have received more Taltz than you should or the dose has been given sooner than prescribed, inform your doctor.
Danish: Hvis du har fået mere Taltz end foreskrevet, eller hvis dosen er givet før det ordinerede tidspunkt, skal du informere lægen.
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]**
Danish: Figur 3 Primær endepunkt (samtidig ACR 50 & PASI 100) og største sekundære endepunkter (ACR 50; PASI 100) responsrater uge 0 - 24 [ITT population, NRI]**
English: Renal or hepatic impairment Taltz has not been studied in these patient populations.
Danish: Nedsat nyre- eller leverfunktion Taltz er ikke blevet undersøgt hos disse patientpopulationer.