FrancophonIA/ELRC3.0 huggingface dataset:
English: In the placebo-controlled period of the psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies, the incidence of malignancies excluding non-melanoma skin cancer was 0.11 per 100 patient-years of follow-up for ustekinumab-treated patients (1 patient in 929 patient-years of follow-up) compared with 0.23 for placebo-treated patients (1 patient in 434 patient-years of follow-up).
Danish: I den placebokontrollerede periode af de kliniske studier af psoriasis, psoriasisartrit, Crohns sygdom og colitis ulcerosa var forekomsten af maligniteter, undtaget ikke-melanom hudkræft, 0,11 pr. 100 patientår i opfølgningsperioden for patienter behandlet med ustekinumab (1 patient i 929 patientår i opfølgningsperioden) sammenlignet med 0,23 patienter behandlet med placebo (1 patient i 434 patientår i opfølgningsperioden).
English: Stelara is not recommended for use in children with psoriasis under 6 years of age, or for use in children under 18 years of age with psoriatic arthritis, Crohn's disease, or ulcerative colitis because it has not been studied in this age group.
Danish: Det frarådes at give Stelara til børn med psoriasis under 6 år, og til børn under 18 år med psoriasisartrit, Crohns sygdom eller colitis ulcerosa, da det ikke er undersøgt hos denne aldersgruppe.
English: • A change in psoriasis with redness and new tiny, yellow or white skin blisters, sometimes accompanied by fever (pustular psoriasis)
Danish: • Forandringer i psoriasis med rødme og nye bittesmå gule eller hvide blærer i huden,
English: STELARA is however, diluted in sodium chloride 9 mg/ml (0.9%) solution for infusion.
Danish: STELARA fortyndes dog med natriumchlorid 9 mg/ml (0,9 %) infusionsvæske, opløsning.
English: STELARA should only be diluted with sodium chloride 9 mg/mL (0.9%) solution.
Danish: STELARA må kun fortyndes med natriumchlorid 9 mg/ml (0,9%) infusionsvæske, opløsning.
English: Patients randomised to receive placebo at Weeks 0 and 4 crossed over to receive ustekinumab (either 45 mg or 90 mg) at Weeks 12 and 16.
Danish: De patienter, der var randomiseret til at få placebo i uge 0 og 4, skiftede til at få ustekinumab (enten 45 mg eller 90 mg) i uge 12 og 16.
English: The safety and efficacy of STELARA in treatment of Crohn's disease or ulcerative colitis in children less than 18 years have not yet been established.
Danish: STELARAs sikkerhed og virkning ved behandling af Crohns sygdom eller colitis ulcerosa er endnu ikke klarlagt hos børn under 18 år.
English: The incidence of non-melanoma skin cancer was 0.49 per 100 patient-years of follow-up for ustekinumab-treated patients (56 patients in 11,545 patient-years of follow-up).
Danish: Incidensen af ikke-melanom hudkræft var 0,49 pr. 100 patientår i opfølgningsperioden for patienter, der fik ustekinumab (56 patienter pr. 11.545 patientår i opfølgningsperioden).
English: STELARA is indicated for the treatment of moderate to severe plaque psoriasis in children and adolescent patients from the age of 6 years and older, who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies (see section 5.1).
Danish: STELARA er indiceret til behandling af moderat til svær plaque-psoriasis hos børn og unge patienter i alderen 6 år og derover, som ikke kan opnå tilstrækkelig kontrol med eller som er intolerante over for andre systemiske behandlinger eller lysbehandling (se pkt.
English: Uncommon: Pustular psoriasis, skin exfoliation, acne Rare: Exfoliative dermatitis
Danish: Hud og subkutane væv Almindelig: Pruritus Ikke almindelig: Pustuløs psoriasis, hudeksfoliation, acne Sjælden: Eksfoliativ dermatitis
English: Uncommon: Hypersensitivity reactions (including rash, urticaria) Rare: Serious hypersensitivity reactions (including anaphylaxis, angioedema)
Danish: Sjælden: Alvorlige overfølsomhedsreaktioner (herunder anafylaksi, angioødem)
English: • Used syringes should be placed in a puncture-resistant container, like a sharps container (see
Danish: • Brugte sprøjter skal anbringes i en punktérfri beholder beregnet til skarpe ting (se figur 8).
English: The safety and efficacy of ustekinumab was assessed in two randomized, double-blind, placebocontrolled, multicenter studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥ 2).
Danish: Ustekinumabs sikkerhed og virkning blev vurderet i to randomiserede, dobbeltblinde, placebokontrollerede multicenterstudier hos voksne patienter med moderat til svær aktiv colitis ulcerosa (Mayo-score 6 til 12, endoskopisk subscore ≥ 2).
English: PBO 45 mg
Danish: PBO 45 mg 90 mg
English: STELARA concentrate for solution for infusion is intended for use under the guidance and supervision of physicians experienced in the diagnosis and treatment of Crohn's disease or ulcerative colitis.
Danish: STELARA koncentrat til infusionsvæske er beregnet til brug under vejledning og supervision af læger med erfaring i diagnosticering og behandling af Crohns sygdom eller colitis ulcerosa.
English: • Drooping eyelid and sagging muscles on one side of the face (‘facial palsy' or ‘Bell's palsy'), which is usually temporary
Danish: • Hængende øjenlåg og slappe muskler i den ene side af ansigtet (ansigtslammelse eller
English: • If you know, or think that it may have been exposed to extreme temperatures (such as accidentally frozen or heated).
Danish: • hvis du ved eller tror, at Stelara er blevet udsat for ekstreme temperaturer ved en fejltagelse
English: Efficacy was higher in the tiered dose group (6 mg/kg) compared to the 130 mg dose group in select endpoints, and tiered dosing is therefore the recommended intravenous induction dose.
Danish: Virkningen var bedre i den gruppe, som fik en vægtbaseret dosis (6 mg/kg), i forhold til den gruppe, som fik en dosis på 130 mg for udvalgte endepunkter.
English: • If you are taking, have recently taken or might take any other medicines.
Danish: • Hvis du tager anden medicin eller har gjort det for nylig.
English: At Week 44 maintenance of this effect was observed with significantly more patients in histologic healing in the every 12 week (54%) and every 8 week (59%) ustekinumab groups as compared to placebo (33%).
Danish: I uge 44 observeredes opretholdelse af denne virkning med signifikant flere patienter med histologisk heling i de grupper, der blev behandlet med ustekinumab hver 12. uge (54%) og hver 8. uge (59%) sammenlignet med placebo (33%).
English: Frequency: Adverse reaction
Danish: Hyppighed: bivirkning
English: Patients were randomised to receive either placebo (n = 37), or the recommended dose of ustekinumab (see section 4.2; n = 36) or half of the recommended dose of ustekinumab (n = 37) by subcutaneous injection at Weeks 0 and 4 followed by every 12 week (q12w) dosing.
Danish: 4.2; n = 36) eller halvdelen af den anbefalede dosis af ustekinumab (n = 37) som subkutan injektion i uge 0 og 4 efterfulgt af dosering hver 12. uge.
English: • Push the needle into the pinched skin
Danish: • Stik nålen ind i det sammenklemte hudområde.
English: Take the vial(s) out of the refrigerator.
Danish: Tag hætteglasset/hætteglassene ud af køleskabet.
English: All patients were followed for efficacy for up to 52 weeks following first administration of study agent.
Danish: Der blev gennemført opfølgning mht. virkning hos alle patienter i op til 52 uger efter den første administration af studielægemidlet.
English: Patients were randomized to receive a subcutaneous maintenance regimen of either 90 mg ustekinumab every 8 weeks, 90 mg ustekinumab every 12 weeks or placebo for 44 weeks (for recommended maintenance posology, see section 4.2).
Danish: Patienterne blev randomiseret til at få et subkutant vedligeholdelsesregime på enten 90 mg ustekinumab hver 8. uge, 90 mg ustekinumab hver 12. uge eller placebo i 44 uger (se pkt.
English: • the solution is not discoloured or cloudy and does not contain any foreign particles
Danish: • at opløsningen ikke er misfarvet eller uklar og at den ikke indeholder fremmede partikler
English: Live vaccines should not be given concurrently with STELARA (see section 4.4).
Danish: Levende vacciner bør ikke gives samtidig med STELARA (se pkt.
English: PGA of cleared (0) or minimal (1)
Danish: PGA clear (0) eller minimal (1) PGA clear (0)
English: • Psoriatic arthritis - in adults
Danish: • Psoriasisartrit hos voksne
English: Signs include:
Danish: Stelara indeholder:
English: • Back, muscle or joint pain
Danish: • Ryg-, muskel- eller ledsmerter
English: Stelara is not recommended for use in children under 18 years of age with Crohn's disease or ulcerative colitis because it has not been studied in this age group.
Danish: Det frarådes at give Stelara til børn under 18 år med Crohns sygdom eller colitis ulcerosa, da det ikke er undersøgt hos denne aldersgruppe.
English: Mucosal healing is defined as a Mayo endoscopic subscore of 0 or 1.
Danish: Slimhindeheling defineres som en endoskopisk Mayo-subscore på 0 eller 1.
English: Hospitalizations and ulcerative colitis (UC) related surgeries Through week 8 of UNIFI-I, the proportions of subjects with UC disease related hospitalizations were significantly lower for subjects in the ustekinumab recommended dose group (1.6%, 5/322) compared with subjects in the placebo group (4.4%, 14/319) and no subjects underwent UC disease related surgeries in subjects receiving ustekinumab at the recommended induction dose compared to 0.6% (2/319) subjects in the placebo group.
Danish: Hospitalsindlæggelser og colitis ulcerosa (UC)-relaterede kirurgiske indgreb Op til uge 8 i UNIFI-I var andelen af forsøgspersoner, der blev indlagt på grund af UC-relateret sygdom, signifikant lavere i den gruppe, der fik ustekinumab ved den anbefalede dosis (1,6%, 5/322) sammenlignet med forsøgspersoner i placebogruppen (4,4%, 14/319), og der var ingen forsøgspersoner, i gruppen der fik ustekinumab ved den anbefalede induktionsdosis, der måtte gennemgå kirurgiske indgreb relateret til UC-sygdom sammenlignet med 0,6% (2/319) af forsøgspersonerne i placebogruppen.
English: Each 26 mL vial of STELARA contains 130 mg of ustekinumab.
Danish: Hvert 26 ml hætteglas med Stelara indeholder 130 mg ustekinumab.
English: Common side effects (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 brugere):
English: The incidence of non-melanoma skin cancer was 0.43 per 100 patient-years of follow-up for ustekinumab-treated patients (4 patients in 929 patient-years of follow-up) compared to 0.46 for placebo-treated patients (2 patients in 433 patient-years of follow-up).
Danish: Forekomsten af ikke-melanom hudkræft var 0,43 pr. 100 patientår i opfølgningsperioden for patienter behandlet med ustekinumab (4 patienter i 929 patientår i opfølgningsperioden) sammenlignet med 0,46 for patienter behandlet med placebo (2 patienter i 433 patientår i opfølgningsperioden).
English: What Stelara looks like and contents of the pack Stelara is a clear, colourless to light yellow concentrate for solution for infusion.
Danish: Stelara er et klart, farveløst til lyst gult koncentrat til infusionsvæske.
English: • In a single and swift motion, insert the needle through the skin as far as it will go (see Figure 4)
Danish: • Tryk nålen igennem huden så langt, som den kan, med en enkelt, hurtig bevægelse (se figur 4).
English: Patients randomised to ustekinumab received 45 mg or 90 mg doses at Weeks 0 and 4 followed by an additional dose at 16 weeks.
Danish: De patienter, der var randomiseret til ustekinumab, fik doser på 45 mg eller 90 mg i uge 0 og 4 efterfulgt af en yderligere dosis efter 16 uger.
English: In PsA Study 2, ACR 20 responses at week 52 were achieved by 47% and 48%, for 45 mg and 90 mg, respectively.
Danish: I PsA-studie 1 opnåedes ACR 20 respons i uge 100 af 57% og 64% af patienterne på henholdsvis 45 mg og 90 mg. I PsA-studie 2 opnåedes ACR 20 respons i uge 52 af 47% og 48% af patienterne på henholdsvis 45 mg og 90 mg.
English: Detailed instructions for use are provided in the package leaflet.
Danish: Indlægssedlen indeholder detaljerede oplysninger om anvendelse.
English: STELARA 90 mg solution for injection in pre-filled syringe 1 mL solution in a type I glass 1 mL syringe with a fixed stainless steel needle and a needle cover containing dry natural rubber (a derivative of latex).
Danish: STELARA 90 mg injektionsvæske, opløsning i fyldt injektionssprøjte 1 ml opløsning i en 1 ml injektionssprøjte af type I glas med en fast kanyle af rustfrit stål og et kanylehylster indeholdende tørt naturgummi (et derivat af latex).
English: In Psoriasis Study 1, at week 2 and week 12, significantly greater improvements from baseline were demonstrated in the DLQI in each ustekinumab treatment group compared with placebo.
Danish: I psoriasisstudie 1 blev der påvist signifikante forbedringer i uge 2 og uge 12 af DLQI (Dermatology Life Quality Index) i forhold til baseline for hver behandlingsgruppe med ustekinumab sammenlignet med placebo.
English: • the number of vials and strength is correct o If your dose is 90 mg you will get one 90 mg vial of Stelara.
Danish: • at antallet af hætteglas og styrken er korrekt o Hvis din dosis er 90 mg, får du et hætteglas med 90 mg Stelara.
English: STELARA is indicated for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a TNFα antagonist or have medical contraindications to such therapies.
Danish: STELARA er indiceret til behandling af voksne patienter med moderat til svær aktiv Crohns sygdom, som ikke har responderet tilstrækkeligt på, ikke længere responderer på eller er intolerante over for enten konventionel behandling eller en TNF-alfa-antagonist eller har medicinske kontraindikationer over for sådanne behandlinger.
English: STELARA 45 mg solution for injection in pre-filled syringe 0.5 mL solution in a type I glass 1 mL syringe with a fixed stainless steel needle and a needle cover containing dry natural rubber (a derivative of latex).
Danish: STELARA 45 mg injektionsvæske, opløsning i fyldt injektionssprøjte 0,5 ml opløsning i en 1 ml injektionssprøjte af type I glas med en fast kanyle af rustfrit stål og et kanylehylster indeholdende tørt naturgummi (et derivat af latex).
English: VIAL LABEL TEXT (130 mg)
Danish: HÆTTEGLASSETS ETIKET (130 mg)
English: • If you are allergic to ustekinumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for ustekinumab eller et af de øvrige indholdsstoffer i Stelara
English: Tell your doctor straight away if you notice any of the following signs.
Danish: Kontakt straks lægen, hvis du bemærker nogle af følgende tegn.
English: • Clean the stopper with an antiseptic swab
Danish: • Rengør proppen med en desinficerende serviet.
English: During the placebo controlled period through week 12, the efficacy of both the recommended and half of the recommended dose groups were generally comparable at the primary endpoint (69.4% and 67.6% respectively) although there was evidence of a dose response for higher level efficacy criteria (e.g. PGA of cleared (0), PASI 90).
Danish: I den placebokontrollerede periode frem til uge 12 var virkningen hos den gruppe, der fik den anbefalede dosis, og den gruppe, der fik halvdelen af den anbefalede dosis, generelt sammenlignelig hvad angår det primære effektmål (hhv. 69,4% og 67,6%).
English: Patients randomised to ustekinumab received 45 mg or 90 mg doses at Weeks 0 and 4 and followed by the same dose every 12 weeks.
Danish: De patienter, der var randomiseret til ustekinumab, fik doser på 45 mg eller 90 mg i uge 0 og 4 efterfulgt af samme dosis hver 12. uge.
English: In patients with Crohn's disease and ulcerative colitis, following an intravenous dose of ~6 mg/kg, starting at week 8, subcutaneous maintenance dosing of 90 mg ustekinumab was administered every 8 or 12 weeks.
Danish: Patienter med Crohns sygdom og colitis ulcerosa fik en subkutan vedligeholdelsesdosis på 90 mg ustekinumab hver 8. eller 12. uge efter først at have fået en intravenøs dosis på ~6 mg/kg i uge 8.
English: Rare side effects (may affect up to 1 in 1000 people)
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 brugere):
English: CorticosteroidFree Clinical Remission Durable Remission
Danish: Kortikosteroidfri klinisk remission Vedvarende remission Symptomatisk remission Kombineret symptomatisk remission og slimhindeheling
English: Each vial contains 130 mg ustekinumab in 26 mL of concentrate for solution for infusion.
Danish: Hvert hætteglas indeholder 130 mg ustekinumab i 26 ml koncentrat til infusionsvæske.
English: In both UNITI-1 and UNITI-2, a significantly greater proportion of patients were in clinical response and remission in the ustekinumab treated group compared to placebo (Table 9).
Danish: I både UNITI-1 og UNITI-2 opnåede en signifikant større andel af de patienter, som blev behandlet med ustekinumab, et klinisk respons og var i remission sammenlignet med dem, som fik placebo (tabel 9).
English: At week 44, maintenance of this effect was observed with significantly more patients in histo-endoscopic mucosal healing in the every 12 week (39%) and every 8 week (46%) ustekinumab groups as compared to placebo (24%).
Danish: I uge 44 observeredes opretholdelse af denne virkning med signifikant flere patienter med histo-endoskopisk slimhindeheling i de grupper, der blev behandlet med ustekinumab hver 12. uge (39%) og hver 8. uge (46%) sammenlignet med placebo (24%).
English: Median half-life (t1/2) of ustekinumab was approximately 3 weeks in patients with psoriasis, psoriatic arthritis, Crohn's disease or ulcerative colitis, ranging from 15 to 32 days across all psoriasis and psoriatic arthritis studies.
Danish: Den mediane halveringstid (t1/2) for ustekinumab var ca. 3 uger hos patienter med psoriasis og/eller psoriasisartrit, med et interval mellem 15 og 32 dage for alle studier af psoriasis, psoriasisartrit, Crohns sygdom eller colitis ulcerosa.
English: 90mg ustekinumab every 12 Weeks N = 172
Danish: 90 mg ustekinumab hver 12. uge N = 172
English: 90mg ustekinumab every 8 Weeks N = 176
Danish: 90 mg ustekinumab hver 8. uge N = 176
English: Stelara is used in children and adolescents aged 6 years and older with moderate to severe plaque psoriasis who are unable to tolerate phototherapy or other systemic therapies or where these treatments did not work.
Danish: Stelara bruges til børn og unge på 6 år og derover med moderat til svær plaque-psoriasis, som ikke tåler lysbehandling eller andre systemiske behandlinger, eller hvis disse behandlinger ikke virker.
English: • The first dose of Stelara for treatment of Crohn's disease or ulcerative colitis is given by a doctor as a drip in the vein of an arm (intravenous infusion).
Danish: Ved behandling af Crohns sygdom eller colitis ulcerosa vil du få den første dosis Stelara af lægen som et drop i en blodåre i armen (intravenøs infusion).
English: This includes antiseptic wipes, a cotton ball or gauze, and a sharps container.
Danish: Det omfatter desinficerende servietter, en vattot eller et stykke gaze og en affaldsbeholder til skarpe genstande.
English: Table 2 provides a list of adverse reactions from adult psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies as well as adverse reactions reported from post-marketing experience.
Danish: Tabel 2 giver en oversigt over bivirkninger fra kliniske studier af psoriasis, psoriasisartrit, Crohns sygdom og colitis ulcerosa hos voksne og over bivirkninger indrapporteret efter markedsføringen.
English: PASI 50 response N (%)
Danish: PASI 50 respons N (%)
English: Table 10: Maintenance of Clinical Response and Remission in IM-UNITI (week 44; 52 weeks from initiation of the induction dose)
Danish: Tabel 10: Vedligeholdelse af klinisk respons og remission i IM-UNITI (uge 44, 52 uger fra initiering af induktionsdosen)
English: Calculate the dose and the number of STELARA vials needed based on patient weight (see section 3, Table 1).
Danish: Beregn dosis og det nødvendige antal Stelara-hætteglas på basis af patientens vægt (se pkt.
English: Some types of vaccines (live vaccines) should not be given while using Stelara.
Danish: (levende vacciner) må ikke gives, mens du er i behandling med Stelara.
English: If you use more Stelara than you should
Danish: Hvis du har brugt for meget Stelara
English: STELARA 45 mg solution for injection 0.5 mL solution in a type I glass 2 mL vial closed with a coated butyl rubber stopper.
Danish: STELARA 45 mg injektionsvæske, opløsning 0,5 ml opløsning i type 1-hætteglas med 2 ml lukket med en overtrukken butylgummiprop.
English: Table 3 provides a list of adverse reactions from adult psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis clinical studies as well as adverse reactions reported from post-marketing experience.
Danish: Tabel 3 giver en oversigt over bivirkninger fra kliniske studier af psoriasis, psoriasisartrit, Crohns sygdom og colitis ulcerosa hos voksne og over bivirkninger indrapporteret efter markedsføringen.
English: Table 4: Maintenance of Clinical Response and Remission in IM-UNITI (week 44; 52 weeks from initiation of the induction dose)
Danish: Tabel 4: Vedligeholdelse af klinisk respons og remission i IM-UNITI (uge 44, 52 uger fra initiering af induktionsdosen)
English: Check the number of pre-filled syringes and prepare the materials:
Danish: Kontrollér antallet af fyldte injektionssprøjter og forbered udstyret: Forberedelse til anvendelse af den fyldte injektionssprøjte
English: Stelara is intended for use under the guidance and supervision of a doctor experienced in the diagnosis and treatment of Crohn's disease or ulcerative colitis.
Danish: Stelara er beregnet til brug under vejledning og tilsyn af en læge med erfaring i at diagnosticere og behandle Crohns sygdom eller colitis ulcerosa.
English: 100 people)
Danish: 1 ud af 100 brugere)
English: Common: Fatigue, injection site erythema, injection site pain Uncommon: Injection site reactions (including haemorrhage, haematoma, induration, swelling and pruritus), asthenia
Danish: Ikke almindelig: Reaktioner på injektionsstedet (herunder blødning, hæmatom, induration, hævelse og pruritus), asteni
English: • Shingles (a type of painful rash with blisters) are uncommon (may affect up to 1 in 100 people)
Danish: • Helvedesild (et smertefuldt udslæt med blærer) er ikke almindeligt (kan forekomme hos op til 1 ud af 100 brugere).
English: STELARA is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic or have medical contraindications to such therapies (see section 5.1).
Danish: STELARA er indiceret til behandling af voksne patienter med moderat til svær aktiv colitis ulcerosa, som ikke har responderet tilstrækkeligt på, ikke længere responderer på eller er intolerante over for enten konventionel behandling eller et biologisk middel eller har medicinske kontraindikationer over for sådanne behandlinger (se pkt.
English: A beneficial effect was also observed in induction in patients who failed at least one prior TNFα antagonist therapy and vedolizumab, however the number of patients in this subgroup was too small to draw definitive conclusions about the beneficial effect in this group during maintenance.
Danish: Dog var antallet af patienter i denne undergruppe for lille til at drage endelige konklusioner vedrørende den gunstige effekt i denne gruppe under vedligeholdelse.
English: PASI 90 response N (%)
Danish: PASI 90 respons, N (%)
English: Once diluted, the infusion should be completed within eight hours of the dilution in the infusion bag.
Danish: Infusionen skal være gennemført senest otte timer efter fortynding i infusionsposen.
English: VIAL LABEL TEXT (45 mg)
Danish: HÆTTEGLASSETS ETIKET (45 mg)
English: Symptomatic remission is defined as a Mayo stool frequency subscore of 0 or 1 and a rectal bleeding subscore of 0.
Danish: Symptomatisk remission defineres som en Mayo-subscore for afføringshyppighed på 0 eller 1 og en subscore for rektal blødning på 0.