FrancophonIA/ELRC3.0 huggingface dataset:
English: […] Kentera should be used with caution in elderly patients, who may be more sensitive to the effects of centrally acting anticholinergics and exhibit differences in pharmacokinetics.
Danish: […] Kentera bør anvendes med forsigtighed hos ældre patienter, som kan være mere følsomme for virkningerne af centralt virkende antikolinergika og kan udvise forskelle i farmakokinetikken.
English: There is no dose adjustment necessary in this population.
Danish: Dosisjustering er ikke nødvendig hos ældre.
English: Panic reaction#, delirium#, hallucinations#, disorientation#
Danish: Panikreaktion#, delirium#, hallucinationer#, desorientering#
English: Psychiatric and CNS anticholinergic events like sleep disorders (e.g. insomnia) and cognitive disorders have been associated with oxybutynin use, especially in elderly patients.
Danish: Antikolinerge psykiske og CNS-bivirkninger såsom søvnforstyrrelser (f.eks. søvnløshed) og kognitive forstyrrelser er sat i forbindelse med oxybutynin, navnlig hos ældre.
English: During post-marketing use in this age group, cases of hallucinations (associated with anxiety manifestations) and sleep disorders correlated with oxybutynin have been reported.
Danish: Hos denne aldersgruppe er der efter markedsføring rapporteret hallucinationer (forbundet med angstmanifestationer) og søvnforstyrrelser med sammenhæng med oxybutynin.
English: Anxiety, confusion, nervousness, agitation, insomnia
Danish: Angst, konfusion, nervøsitet, agitation, søvnløshed
English: Caution should be exercised when oxybutynin is administrated concomitantly with other anticholinergic medicines (see also section 4.5).
Danish: Der bør udvises forsigtighed, hvis oxybutynin anvendes sammen med andre antikolinerge lægemidler (se også pkt.
English: Other psychiatric events implying an anticholinergic mechanism have been reported during postmarketing use (see section 4.8).
Danish: Andre psykiske bivirkninger, der antyder en antikolinerg mekanisme, er rapporteret efter markedsføring (se pkt.
English: Kentera should be used with caution in elderly patients, who may be more sensitive to the effects of centrally acting anticholinergics and exhibit differences in pharmacokinetics (see section 4.4).
Danish: Kentera bør anvendes med forsigtighed hos ældre patienter, som kan være mere følsomme for virkningerne af centralt virkende antikolinergika og kan udvise forskelle i farmakokinetikken (se pkt.
English: KENTERA (oxybutynin) - Psychiatric disorders (EPITT no
Danish: KENTERA (oxybutynin) - psykiske lidelser (EPITT nr. 18342)
English: Rare side effects: - panic reaction - mental confusion - hallucinations - disorientation - memory impairment - loss of memory - abnormal tiredness
Danish: Sjældne bivirkninger: - panikreaktion - delirium - hallucinationer - desorientering - hukommelsesbesvær - hukommelsestab
English: Memory impairment#, amnesia#, lethargy#, disturbance in attention#
Danish: Hukommelsesbesvær#, amnesi #, letargi#, opmærksomhedsforstyrrelse#
English: - anxiety - confusion - nervousness - agitation - difficulty in sleeping
Danish: - angst - forvirring - nervøsitet - sindsbevægelse - søvnbesvær
English: # post-marketing adverse reactions from post-marketing reports only (not seen in clinical trials), with the frequency category estimated from clinical trial safety data, and reported in association with oxybutynin topical use (anticholinergic class effects).
Danish: # bivirkninger, der kun er set efter markedsføring (ikke i kliniske studier); hyppighedskategori er beregnet fra kliniske sikkerhedsdata.
English: […] Tabulated list of adverse reactions
Danish: […] Tabel over bivirkninger
English: Applicable to all formulations: Kentera 3.9 mg / 24 hours transdermal patch, Kentera 90.7 mg/g gel in sachet and Kentera 90.7 mg/g gel in a metering pump
Danish: For alle formuleringer: Kentera depotplaster 3,9 mg/24 timer, Kentera gel i brev 90,7 mg/g, og Kentera gel i doseringspumpe 90,7 mg/g
English: 90.7 mg/g gel in sachet and Kentera 90.7 mg/g gel in a metering pump 4.2 Posology and method of administration […] Elderly population
Danish: 90,7 mg/g og Kentera gel i doseringspumpe 90,7 mg/g 4.2.
English: Applicable to all formulations: Kentera 3.9 mg / 24 hours transdermal patch, Kentera
Danish: For alle formuleringer: Kentera depotplaster 3,9 mg/24 timer, Kentera gel i brev
English: Applicable to Kentera 3.9 mg / 24 hours transdermal patch only
Danish: Kun Kentera depotplaster 3,9 mg/24 timer
English: Kentera is not recommended for use in the paediatric population.
Danish: Kentera anbefales ikke til børn og unge <18 år.
English: - poor concentration
Danish: - abnorm træthed - nedsat koncentrationsevne
English: How much?
Danish: Hvor meget?
English: • It is normal to see bubbles in the window
Danish: • Det er normalt at se bobler i vinduet.
English: Date of first authorisation: 26 April 2019
Danish: Dato for første markedsføringstilladelse: 26. april 2019
English: If you stop treatment, your symptoms may come back.
Danish: Hvis du holder op med behandlingen, kan dine symptomer komme tilbage.
English: However, this observation is based on a limited number of subjects.
Danish: Denne observation er imidlertid baseret på et begrænset antal patienter.
English: Wash and dry your hands.
Danish: Vask dine hænder, og tør dem.
English: Elderly (aged 65 years and over)
Danish: Ældre (65 år og derover)
English: • if the expiry date (EXP) has passed
Danish: • hvis udløbsdatoen (EXP) er overskredet
English: Open here
Danish: Åbnes her
English: DLQI 0 or 1
Danish: DLQI 0 eller 1
English: Week 16
Danish: Uge 16
English: • Skyrizi should not be warmed in any other way (for example, in a microwave or in hot water)
Danish: • Skyrizi må ikke opvarmes på anden måde (f.eks. i en mikrobølgeovn eller i varmt vand).
English: • if you have tuberculosis (TB).
Danish: • du har tuberkulose (TB)
English: Campoverde di Aprilia (LT) ITALY
Danish: Campoverde di Aprilia (LT) Italien
English: No dose adjustment based on body weight is currently recommended.
Danish: Dosisjustering baseret på legemsvægt anbefales ikke på nuværende tidspunkt.
English: • if you have an infection, including active tuberculosis, which your doctor thinks is important.
Danish: • hvis du har en infektion, herunder aktiv tuberkulose, som lægen mener er væsentlig.
English: System Organ Class Frequency
Danish: Systemorganklasse Hyppighed
English: QR code to be included
Danish: QR-kode skal anføres
English: • Do not inject through clothes
Danish: • Du må ikke injicere gennem tøjet.
English: Weeks After Re-Randomisation
Danish: Uger efter genrandomisering
English: Return this medicine to the pharmacy
Danish: Returnér lægemidlet til apoteket:
English: As with all therapeutic proteins, there is the potential for immunogenicity with risankizumab.
Danish: Som med alle terapeutiske proteiner er der en potentiel mulighed for immunogenicitet ved risankizumab.
English: Do not stop using Skyrizi without talking to your doctor first.
Danish: Du må ikke holde op med at tage Skyrizi uden først at tale med lægen.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Danish: Da der ikke foreligger undersøgelser af eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler.
English: Human IgGs are known to be excreted in breast milk during the first few days after birth, which decreases to low concentrations soon afterwards; consequently, a risk to the breast-fed infant cannot be excluded during this short period.
Danish: Man ved, at humane IgG'er udskilles i brystmælk i de første få dage efter fødslen, og at koncentrationen falder til et lavt niveau kort tid derefter; en risiko for det ammede barn kan således ikke udelukkes i denne korte periode.
English: Place the following items on a clean, flat surface:
Danish: Anbring følgende på en ren, plan flade:
English: Hold the body of the syringe in one hand between the thumb and index finger, like you would a pencil.
Danish: Tag fat om sprøjtens krop med den ene hånd mellem tommel- og pegefinger, som når du holder om en blyant.
English: Maintenance of response
Danish: Opretholdelse af respons
English: All comparisons achieved p<0.001
Danish: Ved alle sammenligninger opnåedes p < 0,001
English: Start with one syringe for the first injection.
Danish: Start med den ene sprøjte til den første injektion.
English: The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
Danish: Den additive virkning af samtidigt administrerede produkter, der indeholder sorbitol (eller fruktose), og dagligt indtag af sorbitol (eller fruktose) bør tages i betragtning.
English: Choose from these 3 areas to inject:
Danish: Vælg et af disse 3 områder, hvor der kan injiceres:
English: • Do not touch the needle with your fingers or let the needle touch anything
Danish: • Du må ikke røre ved kanylen med fingrene eller lade kanylen røre ved noget.
English: Slowly take your thumb off the plunger.
Danish: Fjern langsomt tommelfingeren fra stemplet.
English: Consideration should be given to discontinuing treatment in patients who have shown no response after 16 weeks of treatment.
Danish: Det bør overvejes at seponere behandlingen hos patienter, der ikke har responderet efter 16 ugers behandling.
English: • Hold the syringe in one hand
Danish: • Hold sprøjten i den ene hånd.
English: The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.
Danish: Detektion af antistofdannelse afhænger i høj grad af analysens følsomhed og specificitet.
English: The results for the co-primary and other endpoints are presented in Table 2 and Figure 1.
Danish: Resultaterne for co-primære og andre endepunkter er vist i tabel 2 og figur 1.
English: Table 1: List of adverse reactions in clinical studies
Danish: Tabel 1: Oversigt over bivirkninger i kliniske studier
English: The safety and efficacy of Skyrizi in children and adolescents aged 6 to 18 years have not yet been established.
Danish: Skyrizis sikkerhed og virkning hos børn og unge i alderen 6-18 år er endnu ikke klarlagt.
English: If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab.
Danish: Hvis patienten har fået en levende vaccine (viral eller bakteriel), anbefales det at vente mindst 4 uger før påbegyndelse af behandling med risankizumab.
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of risankizumab in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 graviditeter med eksponering for risankizumab) fra anvendelse af risankizumab til gravide kvinder.
English: Slowly push the plunger all the way in until all of the liquid is injected.
Danish: Tryk langsomt stemplet helt i bund, indtil al opløsningen er injiceret.
English: RZB = risankizumab UST = ustekinumab PBO = placebo p<0.001 at each time point
Danish: RZB = risankizumab UST = ustekinumab PBO = placebo p < 0,001 ved hvert tidspunkt
English: The same information is also available at the following URL: www.skyrizi.eu
Danish: Disse oplysninger er også tilgængelige via følgende URL: www.skyrizi.eu
English: Figure 2: Time course of PASI 90 after re-randomisation in IMMVENT
Danish: Figur 2: Tidsforløb for PASI 90 efter genrandomisering i IMMVENT
English: As a precautionary measure, it is preferable to avoid the use of risankizumab during pregnancy.
Danish: For en sikkerheds skyld er det bedst at undgå brug af risankizumab under graviditet.
English: The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13% of patients.
Danish: De hyppigst indberettede bivirkninger var infektioner i de øvre luftveje, som sås hos 13 % af patienterne.
English: Some patients with initial partial response may subsequently improve with continued treatment beyond 16 weeks.
Danish: Nogle patienter med initialt delvist respons kan have gavn af fortsat behandling efter de første 16 uger.
English: • if the liquid has ever been frozen (even if thawed)
Danish: • hvis opløsningen på noget tidspunkt har været frossen (selv efter optøning)
English: Each pre-filled syringe is for single use only.
Danish: Hver fyldt sprøjte er kun til engangsbrug.
English: • if you currently have an infection or if you have an infection that keeps coming back.
Danish: • du har en aktuel infektion eller en infektion, der bliver ved med at komme tilbage
English: sPGA of clear or almost clear (0 or 1)
Danish: sPGA "clear" eller "almost clear" hud (0 eller 1)
English: For more information and support on Skyrizi go to www.skyrizi.eu or scan this code.
Danish: Du kan finde flere oplysninger om Skyrizi ved at gå ind på www.skyrizi.eu eller scanne denne kode.
English: Keep the syringe steady at the same angle.
Danish: Hold kanylen stabilt i samme vinkel.
English: • injection site reactions (such as redness or pain)
Danish: • Reaktioner på injektionsstedet (f.eks. rødme eller smerter)
English: This medicine is given as 2 injections under your skin (called ‘subcutaneous injections').
Danish: Dette lægemiddel gives som 2 såkaldt subkutane injektioner (under huden).
English: Tell your doctor or seek medical help immediately if you notice any signs of an allergic reaction while you are taking Skyrizi such as:
Danish: Sig det til lægen eller søg læge med det samme, hvis du bemærker tegn på en allergisk reaktion, mens du bruger Skyrizi, f.eks.:
English: Your doctor will decide if you can keep using Skyrizi.
Danish: Lægen vil vurdere, om du kan fortsætte med at tage Skyrizi.
English: Do not use this medicine after the expiry date which is stated on the syringe label and outer carton after ‘EXP'.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken efter 'EXP'.
English: This is normal
Danish: Det er helt normalt.
English: • if you are allergic to risankizumab or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for risankizumab eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i punkt 6)
English: Prior to use, a visual inspection of each pre-filled syringe is recommended.
Danish: Inden anvendelse anbefales det at foretage visuel inspektion af den enkelte fyldte sprøjte.
English: Pharmacotherapeutic group: Immunosuppressants, interleukin inhibitors, ATC code: L04AC18
Danish: Farmakoterapeutisk klassifikation: Immunosuppressiva, interleukinhæmmere, ATC-kode: L04AC18
English: The rate of serious infections was 1.7 events per 100 subject-years (see section 4.4).
Danish: Graden af alvorlige infektioner var 1,7 hændelser pr. 100 patientår (se pkt.
English: If you are a woman who can become pregnant, you should use contraception while using this medicine and for at least 21 weeks after your last dose of Skyrizi.
Danish: Hvis du er en kvinde, der kan blive gravid, skal du bruge prævention, mens du tager dette lægemiddel og i mindst 21 uger efter din sidste dosis Skyrizi.
English: Follow the steps below each time you use Skyrizi
Danish: Følg nedenstående trin, hver gang du tager Skyrizi
English: Results 28 weeks after re-randomisation are presented in Table 5 and Figure 2.
Danish: Resultaterne 28 uger efter genrandomisering er vist i tabel 5 og figur 2.
English: Do not inject into the same place.
Danish: Du må ikke injicere det samme sted begge gange.
English: • Mark the dates on your calendar so you know when to inject Skyrizi
Danish: • Markér datoerne i din kalender, så du ved, hvornår du skal tage Skyrizi.
English: • You may see a drop of liquid at the end of the needle.
Danish: • Du kan muligvis se en dråbe ved kanylespidsen.
English: IL-23 is a cytokine that is involved in inflammatory and immune responses.
Danish: IL-23 er et cytokin, der er involveret i inflammatorisk respons og immunrespons.
English: Risankizumab clearance and volume of distribution increase as body weight increases which may result in reduced efficacy in subjects with high body weight (>130 kg).
Danish: Risankizumabs clearance og fordelingsvolumen øges med øget legemsvægt som kan resultere i nedsat virkning hos patienter med høj legemsvægt (>130 kg).
English: Detailed and updated information on this product is available by scanning the QR code included below or on the outer carton with a smartphone.
Danish: Du kan også finde detaljerede og opdaterede oplysninger om dette lægemiddel ved at scanne den QRkode, der er angivet nedenfor eller på den ydre æske, ved brug af en smartphone.
English: Administration of Skyrizi in the upper, outer arm may only be performed by a healthcare professional or caregiver.
Danish: Administration af Skyrizi på ydersiden af overarmen må kun udføres af en sundheds- eller omsorgsperson.
English: For most subjects, antibodies to risankizumab including neutralising antibodies were not associated with changes in clinical response or safety.
Danish: For de fleste patienters vedkommende var antistoffer mod risankizumab, herunder neutraliserende antistoffer, ikke forbundet med ændringer i klinisk respons eller sikkerhed.
English: It also reduces symptoms of psoriasis such as burning, itching, pain, redness and scaling.
Danish: Det reducerer også symptomer på psoriasis som f.eks. brændende fornemmelse, kløe, smerter, rødme og afskalning.
English: • Do not inject into areas affected by psoriasis
Danish: • Du må ikke injicere i hudområder, der er påvirket af psoriasis.
English: Clinically important active infections (e.g. active tuberculosis, see section 4.4).
Danish: Klinisk væsentlige aktive infektioner (f.eks. aktiv tuberkulose, se pkt.
English: • Keep Skyrizi in the original carton to protect the medicine from light until it is time to use it
Danish: • Opbevar Skyrizi i den originale æske for at beskytte lægemidlet mod lys, indtil det skal bruges.
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Sundhedsperson anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Talk to your doctor or get medical help immediately if you have symptoms of a serious infection such as:
Danish: Tal med lægen eller søg læge med det samme, hvis du oplever symptomer på alvorlig infektion, f.eks.:
English: • Repeat Steps 2 through 6 with the second syringe
Danish: • Gentag trin 2-6 med den anden sprøjte.
English: • fever, flu-like symptoms, night sweats
Danish: • Feber, influenza-lignende symptomer, nattesved
English: Table 5: Efficacy results 28 weeks after re-randomisation in IMMVENT Switched to Risankizumab (N=53) n (%)
Danish: Tabel 5: Effektresultater 28 uger efter genrandomisering i IMMVENT Skiftede til risankizumab (N = 53) n (%)
English: The injection site reactions were all mild to moderate in severity, none were serious, and none led to discontinuation of risankizumab.
Danish: Reaktionerne på injektionsstedet var alle milde til moderate i sværhedsgrad, ingen var alvorlige og ingen førte til seponering af risankizumab.
English: Skyrizi is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
Danish: Skyrizi er beregnet til anvendelse under vejledning og tilsyn af en læge med erfaring i diagnosticering og behandling af psoriasis.
English: Skyrizi is administered by subcutaneous injection.
Danish: Skyrizi administreres ved subkutan injektion.
English: It reduces the inflammation.
Danish: Lægemidlet reducerer betændelsen.
English: Reductions in epidermal thickness, infiltration of inflammatory cells, and expression of psoriatic disease markers were also observed in psoriatic lesions.
Danish: Reduktioner i epidermis-tykkelse, infiltration af inflammatoriske celler og ekspression af psoriasismarkører sås også i psoriasislæsionerne.
English: Co-primary endpoints No impact on health-related quality of life
Danish: Ingen indvirkning på den helbredsrelaterede livskvalitet
English: The majority of cases were non-serious and mild to moderate in severity and did not lead to discontinuation of risankizumab.
Danish: De fleste tilfælde var ikke-alvorlige og milde til moderate i sværhedsgrad og førte ikke til seponering af risankizumab.
English: Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection.
Danish: Inden behandling med risankizumab påbegyndes, bør patienterne undersøges for infektion med tuberkulose (TB).
English: In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution.
Danish: Hos patienter med kronisk infektion, en anamnese med tilbagevendende infektion eller kendte risici for infektion, skal risankizumab anvendes med forsigtighed.
English: The safety profile of risankizumab with up to 77 weeks of exposure was consistent with the profile observed up to 16 weeks.
Danish: Sikkerhedsprofilen for risankizumab ved op til 77 ugers eksponering svarede til sikkerhedsprofilen ved 16 ugers eksponering.
English: • You should receive training on how to inject Skyrizi before giving an injection.
Danish: • Du skal oplæres i, hvordan du skal injicere Skyrizi, før du indgiver en injektion.
English: To listen to or request a copy of this leaflet in <Braille>, <large print> or <audio>, please contact the local representative of the Marketing Authorisation Holder.
Danish: Hvis du ønsker at rekvirere denne indlægsseddel som <lydfil> eller <i brailleskrift> eller <magnaprint>, kan du kontakte den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: This medicine works by stopping a protein in the body called ‘IL-23', which causes inflammation.
Danish: Dette lægemiddel virker ved at blokere et specifikt protein i kroppen, IL-23, som forårsager betændelse.
English: Before each injection, wipe where you will inject in a circular motion with an alcohol pad.
Danish: Før hver injektion skal du rense injektionsstedet med en spritserviet i en cirkulær bevægelse.
English: Adverse reactions for risankizumab from clinical studies (Table 1) are listed by MedDRA system organ class and are based on the following convention: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); and very rare (< 1/10,000).
Danish: Bivirkninger fra kliniske studiermed risankizumab er opstillet efter MedDRA's systemorganklasse (tabel 1) og er baseret på følgende konvention: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100); sjælden (≥ 1/10.000 til < 1/1.000) og meget sjælden
English: The effect of risankizumab on human fertility has not been evaluated.
Danish: Risankizumabs indvirkning på menneskers fertilitet er ikke undersøgt.
English: • Inject the second syringe straight after the first injection but at least 3 cm away from the first injection
Danish: • Injicér indholdet af den anden sprøjte umiddelbart efter den første injektion, men mindst i 3 cm væk fra den første injektion.
English: Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines.
Danish: Inden påbegyndelse af behandling med risankizumab bør alle relevante immuniseringer tages i betragtning i henhold til de gældende retningslinjer for immunisering.
English: Check the liquid in the syringe.
Danish: Tjek opløsningen i sprøjten.
English: Very common: may affect more than 1 in 10 people • upper respiratory infections with symptoms such as sore throat and stuffy nose
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter): • Infektioner i de øvre luftveje med symptomer som f.eks. ondt i halsen og tilstoppet næse