FrancophonIA/ELRC3.0 huggingface dataset:
English: How Skyrizi works
Danish: Sådan virker Skyrizi
English: What Skyrizi contains
Danish: Skyrizi indeholder:
English: The clearance of risankizumab was not significantly influenced by gender or race in adult subjects with plaque psoriasis.
Danish: Køn og etnisk oprindelse har ikke signifikant betydning for risankizumabs clearance hos voksne patienter med plaque-psoriasis.
English: Do not use this medicine if the liquid is cloudy or contains flakes or large particles.
Danish: Du må ikke anvende dette lægemiddel, hvis opløsningen er uklar eller indeholder flager eller store partikler.
English: No specific studies were conducted to assess the effect of hepatic or renal impairment on the pharmacokinetics of Skyrizi.
Danish: Der er ikke gennemført specifikke studier til vurdering af, hvorvidt nedsat lever- eller nyrefunktion har betydning for Skyrizis farmakokinetik.
English: Among subjects with sPGA of clear or almost clear at week 28 in IMMHANCE, 81.1% (90/111) of subjects re-randomised to continued treatment with risankizumab maintained this response at week 104 compared to 7.1% (16/225) who were re-randomised to withdrawal from risankizumab.
Danish: Blandt de patienter, der havde en sPGA-score svarende til "clear" eller "almost clear" hud i uge 28 i IMMHANCE, og som var genrandomiseret til at fortsætte behandling med risankizumab, fastholdt 81,1 % (90 ud af 111) deres respons i uge 104, sammenholdt med 7,1 % (16 ud af 225) af de patienter, der blev genrandomiseret til at få seponereret risankizumab.
English: What you need to know before you use Skyrizi
Danish: Det skal du vide, før du begynder at bruge Skyrizi
English: The liquid should look clear to slightly yellow and may contain tiny white or clear particles
Danish: Opløsningen skal være klar til let gul og kan eventuelt indeholde små hvide eller klare partikler.
English: Pre-filled glass syringe with a fixed needle and needle cover, assembled in an automatic needle guard.
Danish: Fyldt glassprøjte med fastgjort kanyle med kanylehætte og automatisk kanylebeskyttelse.
English: Skyrizi 75 mg solution for injection in pre-filled syringe
Danish: Skyrizi 75 mg injektionsvæske, opløsning i fyldt injektionssprøjte
English: Areas to inject
Danish: Områder, hvor der kan injiceres
English: - The other ingredients are disodium succinate hexahydrate, succinic acid, sorbitol, polysorbate
Danish: - Øvrige indholdsstoffer: dinatriumsuccinathexahydrat, ravsyre, sorbitol, polysorbat 20 og vand til injektionsvæsker.
English: Risankizumab is not expected to undergo metabolism by hepatic enzymes or renal elimination.
Danish: Risankizumab forventes ikke at blive metaboliseret af leverenzymer eller elimineret gennem nyrerne.
English: STEP 3
Danish: TRIN 3
English: • <PASI 50 were switched to risankizumab
Danish: • Patienter med < PASI 50 skiftede til risankizumab
English: • if you have recently received or plan to receive an immunisation (vaccine).
Danish: • du for nylig er blevet vaccineret (immuniseret) eller planlægger at blive det. Du skal undgå visse typer vaccine, mens du bruger Skyrizi.
English: You should not be given certain types of vaccines while using Skyrizi.
Danish: Du skal undgå visse typer vaccine,
English: Percent of Subjects
Danish: Procentdel af patienter
English: Two pre-filled syringes should be injected for the full 150 mg dose.
Danish: Der skal injiceres to fyldte sprøjter for at opnå den fulde dosis på 150 mg. Der er en detaljeret brugsvejledning i indlægssedlen.
English: Talk to your doctor, pharmacist or nurse if you need help
Danish: apotekspersonalet eller sundhedspersonalet, hvis du har brug for hjælp.
English: • Do not inject if the liquid is cloudy or contains flakes or large particles.
Danish: • Du må ikke injicere opløsningen, hvis den er uklar eller indeholder flager eller store partikler.
English: Skyrizi 75 mg solution for injection in pre-filled syringe risankizumab
Danish: Skyrizi 75 mg injektionsvæske, opløsning i fyldt injektionssprøjte risankizumab
English: How to use Skyrizi
Danish: Sådan skal du bruge Skyrizi
English: Each pre-filled syringe contains 75 mg of risankizumab in 0.83 ml solution.
Danish: Hver fyldt sprøjte indeholder 75 mg risankizumab i 0,83 ml opløsning.
English: Disodium succinate hexahydrate Succinic acid
Danish: Dinatriumsuccinathexahydrat Ravsyre
English: Week 16 89 (29.3) Week 52 173 (56.9) All comparisons of risankizumab versus ustekinumab and placebo achieved p<0.001 except for PASI 75 at week 52 in ULTIMMA-2 where p=0.001
Danish: Ved alle sammenligninger af risankizumab vs. ustekinumab og placebo opnåedes p < 0,001, bortset fra for PASI 75 i uge 52 i ULTIMMA-2, hvor p = 0,001 a Co-primære endepunkter vs. Placebo
English: Skyrizi 75 mg injection risankizumab SC
Danish: væske) risankizumab s.c.
English: PASI Percent Change from Baseline
Danish: Procentvis PASI-ændring ift.
English: • Do not use if the liquid is cloudy or contains flakes or large particles
Danish: • Du må ikke anvende opløsningen, hvis den er uklar eller indeholder flager eller store partikler.
English: • feeling tired
Danish: • Træthed
English: - The active substance is risankizumab.
Danish: - Aktivt stof: risankizumab.
English: Comprehensive instructions for use are provided in the package leaflet.
Danish: Alle hjælpestoffer er anført under pkt.
English: • difficulty breathing or swallowing
Danish: • vejrtræknings- eller synkebesvær
English: nd dose
Danish: 2. dosis
English: SUMMARY OF PRODUCT CHARACTERISTICS
Danish: Oversigt over bivirkninger
English: • front of right thigh
Danish: • Fortil på højre lår
English: Tinea infections
Danish: Tinea-infektioner
English: If you use more Skyrizi than you should
Danish: Hvis du har taget for meget Skyrizi
English: NAPSI:
Danish: SN:
English: • Throw away the needle cover
Danish: • Kassér kanylehætten.
English: • front of left thigh
Danish: • Fortil på venstre lår
English: Pharmaceutical Form
Danish: Lægemiddelform Indgivelsesvej Emballage Pakningsstørrelse
English: List of the names, pharmaceutical forms, strengths of the medicinal products, routes of administration, applicants / marketing authorisation holders in the Member States
Danish: Fortegnelse over lægemidlernes navne, lægemiddelform, styrker, indgivelsesvej, ansøgere, indehavere af markedsføringstilladelser i medlemsstaterne
English: This summary was last updated in April 2013.
Danish: Dette sammendrag blev sidst ajourført den 04-2013.
English: TruScient should only be used by a veterinarian.
Danish: TruScient bør kun anvendes af en dyrlæge.
English: Other information about TruScient:
Danish: Andre oplysninger om TruScient:
English: The European Commission granted a marketing authorisation valid throughout the European Union, for TruScient on 14 December 2011.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for TruScient den 14-12-2011.
English: TruScient has been developed for use in dogs based on the approved use of the InductOs product in humans (EU/1/02/226/001).
Danish: TruScient er blevet udviklet til brug hos hunde på baggrund af den godkendte brug af lægemidlet InductOs hos mennesker (EU/1/02/226/001).
English: Only the amount of prepared sponge needed to cover the affected area of the bone should be used.
Danish: Kun den mængde forberedt svamp, der er nødvendig for at dække det berørte knogleområde, bør anvendes.
English: The benefit/risk balance may be found in the scientific discussion module of this EPAR.
Danish: Risk/benefit-forholdet fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
English: The prepared collagen sponges are then cut, if needed, to the correct size before use.
Danish: De forberedte kollagensvampe skæres derefter om nødvendigt til, så de får den rette størrelse før brug.
English: TruScient was investigated in one main field study in 126 dogs with fractures of the diaphysis.
Danish: TruScient blev undersøgt i en hovedfeltundersøgelse af 126 hunde med diafysefrakturer.
English: It must not be used in young dogs whose bones are not fully developed, have an active infection at the site of operation, pathological fracture (caused by a disease), or any active malignancy (cancerous growth).
Danish: Det må ikke anvendes til unge hunde, hvis knogler endnu ikke er fuldt udviklede, eller til hunde, der har en aktiv infektion på operationsstedet, patologisk fraktur (fraktur, som skyldes en sygdom) eller enhver aktiv malignitet (kræftvækst).
English: After 18 weeks, the fractures of all the dogs treated with TruScient together with standard surgical care (84) were seen to have healed, compared with 95% of the dogs treated with standard surgical care alone (40 out of 42).
Danish: Efter 18 uger var det påvist, at frakturerne hos alle hunde behandlet med TruScient sammen med kirurgisk standardbehandling (84) var helet, sammenlignet med 95 % af de hunde, der blev behandlet med kirurgisk standardbehandling alene (40 ud af 42).
English: TruScient is a medicine that contains the active substance dibotermin alfa.
Danish: TruScient er et lægemiddel, der indeholder det aktive stof dibotermin alfa.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of TruScient exceed the risks for the treatment of diaphyseal bone fractures in dogs and recommended that TruScient be given a marketing authorisation.
Danish: Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved TruScient opvejer risiciene til behandling af diafysefrakturer hos hunde og anbefalede udstedelse af markedsføringstilladelse for TruScient.
English: The main side effects with TruScient (seen in more than 1 dog in 10) were lameness, and firm and soft swelling during the first three weeks after surgery.
Danish: De mest almindelige bivirkninger ved TruScient (som optræder hos flere end 1 ud af 10 hunde) er halthed samt hårde og bløde hævelser, som forekommer inden for de første tre uger efter operationen.
English: Dibotermin alfa is produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA) which makes them able to produce dibotermin alfa.
Danish: Dibotermin alfa fremstilles ved hjælp af en metode, der kaldes "rekombinant DNA-teknologi", dvs. det fremstilles af celler, der har modtaget et gen (DNA), som gør dem i stand til at danne dibotermin alfa.
English: The kit allows the user to make a solution containing the active substance (0.2 mg/ml) to be applied onto collagen sponges which are implanted during surgery.
Danish: Sættet gør det muligt for brugeren at fremstille en opløsning, der indeholder det aktive stof (0,2 mg/ml), og som påføres kollagensvampe, der implanteres under operationen.
English: It is a copy of a protein called ‘bone morphogenetic protein 2' (BMP-2), which is produced naturally by the body and helps with the formation of new bone tissue.
Danish: Det er en kopi af et protein ved navn "knogle-morfogenetisk protein-2" (BMP-2), som dannes naturligt i kroppen og er medvirkende ved dannelsen af nyt knoglevæv.
English: What is the risk associated with TruScient?
Danish: Hvilken risiko er der forbundet med TruScient?
English: If TruScient is accidentally spilled onto the skin or eyes, it should be rinsed off immediately.
Danish: Hvis TruScient ved et uheld kommer i kontakt med hud eller øjne, skylles der omgående.
English: TruScient is available as a kit for implant.
Danish: TruScient fås som et sæt til implantation.
English: Time to radiographic fracture healing was less when the dogs were treated with TruScient together with standard surgical care.
Danish: Tiden til radiografisk frakturheling var mindre, når hundene blev behandlet med TruScient sammen med kirurgisk standardbehandling.
English: The main measure of effectiveness was the time until the fracture was seen to have healed using an X-ray (time to radiographic fracture healing).
Danish: Det primære effektmål var den tid, der gik, indtil det ved hjælp af røntgen blev påvist, at frakturen var helet (tid til radiografisk frakturheling).
English: Why has TruScient been approved?
Danish: Hvorfor blev TruScient godkendt?
English: The replacement dibotermin alfa acts in the same way as BMP-2 produced naturally by the body.
Danish: Det kunstigt tilførte dibotermin alfa virker på samme måde som det BMP-2, der dannes naturligt af kroppen.
English: The study assessed TruScient used together with standard surgical care, compared with standard surgical care alone.
Danish: I undersøgelsen vurderede man TruScient anvendt sammen med kirurgisk standardbehandling sammenlignet med kirurgisk standardbehandling alene.
English: When the collagen sponge is implanted into the bone fracture, dibotermin alfa stimulates the bone tissue around the sponge to make new bone.
Danish: Når kollagensvampen implanteres i knoglefrakturen, stimulerer dibotermin alfa knoglevævet omkring svampen til at danne nyt knoglevæv.
English: The active substance in TruScient, dibotermin alfa, acts on the bone structure.
Danish: Det aktive stof i TruScient, dibotermin alfa, virker på knoglestrukturen.
English: The newly formed bone grows into the collagen sponge, which then dissolves away.
Danish: Det nydannede knoglevæv gror ind i kollagensvampen, som herefter opløses og forsvinder.
English: What is TruScient?
Danish: Hvad er TruScient?
English: TruScient is made up into a solution before use, applied to the collagen sponges and left for at least 15 minutes (but no more than two hours).
Danish: Opløsningen påføres kollagensvampe og skal trække i mindst 15 minutter (dog højst to timer).
English: For a full list of all side effects reported with TruScient, see the package leaflet.
Danish: Den fuldstændige liste over de indberettede bivirkninger ved TruScient fremgår af indlægssedlen.
English: TruScient must not be used in dogs that are hypersensitive (allergic) to dibotermin alfa or any of the other ingredients.
Danish: TruScient må ikke anvendes til hunde, der er overfølsomme (allergiske) over for dibotermin alfa eller et eller flere af hjælpestofferne i tabletterne.
English: How has TruScient been studied?
Danish: Hvordan blev TruScient undersøgt?
English: What is TruScient used for?
Danish: Hvad anvendes TruScient til?
English: The prepared collagen sponges are implanted during surgery by placing them directly onto the bone fracture and leaving them in place when the surgical wound is stitched up.
Danish: De forberedte kollagensvampe implanteres under operationen, idet de placeres direkte på knoglefrakturen og skal blive der, mens operationssåret syes.
English: TruScient is used in combination with standard surgical care to treat diaphyseal bone fractures (affecting the diaphysis, the main section of long bone) in dogs.
Danish: TruScient anvendes som supplement til kirurgisk standardbehandling for at behandle diafysefrakturer (som vedrører diafysen, dvs. skaftet af en lang rørknogle) hos hunde.
English: What benefit has TruScient shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved TruScient?
English: How does TruScient work?
Danish: Hvordan virker TruScient?
English: The Reference Member State was Finland and the Concerned Member States were Austria, Denmark, Germany and Sweden.
Danish: Referencemedlemsstaten var Finland, og de berørte medlemsstater var Østrig, Danmark, Tyskland og Sverige.
English: Germany referred the reasons for disagreement to the EMEA on 15 December 2004.
Danish: Tyskland fremsendte begrundelserne for uenigheden til EMEA den 15. december 2004.
English: Hexal AG in Finland on 7 November 2003.
Danish: AG i Finland den 7. november 2003.
English: The Marketing Authorisation Holder provided written explanations on 13 April 2005.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 13. april 2005.
English: The arbitration procedure started on 20 January 2005.
Danish: Voldgiftsproceduren indledtes den 20. januar 2005.
English: The final opinion was converted into a Decision by the European Commission on 15 September 2005.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 15.
English: International Non-Proprietary Name (INN): Lansoprazole
Danish: Internationalt fællesnavn ( INN): Lansoprazol
English: The Concerned Member States have not been able to reach an agreement in respect of the Mutual Recognition of the Marketing Authorisation granted by the
Danish: De berørte medlemsstater har ikke kunnet nå til enighed om en gensidig anerkendelse af den af referencemedlemsstaten udstedte markedsføringstilladelse.
English: The Rapporteur and Co-Rapporteur appointed were Sif Ormarsdottir/Tomas Salmonson, Gottfried Kreutz/Julia Dunne respectively.
Danish: Den udpegede rapportør og medrapportør var henholdsvis Sif Ormarsdottir/Tomas Salmonson og Gottfried Kreutz/Julia Dunne.
English: A Mutual Recognition Procedure was started on 16 September 2004.
Danish: En gensidig anerkendelsesprocedure blev indledt den 16.
English: The list of product names concerned is given in Annex I. The scientific conclusions are provided in Annex II, together with the Summary of Product Characteristics in Annex III.
Danish: Listen over de pågældende lægemiddelnavne fremgår af bilag I. De faglige konklusioner findes i bilag II og produktresuméet i bilag III.
English: Significant differences in comparison to the reference product have been identified with regard to the indications' section of the SPCs.
Danish: Der er identificeret signifikante forskelle i forhold til referenceproduktet i afsnittet om indikationer i produktresuméet.
English: A Marketing Authorisation for Lansoprazol HEXAL (15 mg and 30 mg) was previously granted to
Danish: Der er tidligere udstedt en markedsføringstilladelse for Lansoprazol Hexal (15 mg og 30 mg) til Hexal
English: OPINION FOLLOWING AN ARTICLE 29(2)1 REFERRAL FOR Lansoprazol HEXAL 15 mg and 30 mg
Danish: UDTALELSE SOM FØLGE AF EN SAG INDBRAGT I HENHOLD TIL ARTIKEL 29, STK. 21, OM Lansoprazol Hexal 15 mg og 30 mg
English: During its June 2005 meeting, the CHMP, in the light of the overall data submitted and the scientific discussion within the Committee, was of the opinion that the benefit/risk ratio is favourable for
Danish: På sit møde i juni 2005 var CHMP på grundlag af de samlede forelagte oplysninger og den faglige drøftelse i udvalget af den opfattelse, at benefit/risk-forholdet var gunstigt for Lansoprazol Hexal.
English: 15 September 2005 EMEA/CHMP/230471/2005
Danish: EMEA/CHMP/230471/2005 UDVALGET FOR HUMANMEDICINSKE LÆGEMIDLER
English: The SPC of the reference product in Germany does not contain the indications related to the concomitant use of NSAIDs and the treatment and prevention of gastric and duodenal ulceration caused by these compounds.
Danish: Produktresuméet for referenceproduktet i Tyskland indeholder ikke indikationerne for samtidig anvendelse af NSAID'er og behandling og forebyggelse af gastrisk og duodenal ulceration forårsaget af disse præparater.
English: The indications related to the concomitant use of NSAIDs and the treatment and prevention of gastric and duodenal ulceration caused by these compounds were supported.
Danish: Indikationerne for samtidig anvendelse af NSAID'er samt behandling og forebyggelse af gastrisk og duodenal ulceration forårsaget af disse præparater blev understøttet.
English: Lansoprazol HEXAL.
Danish: Lansoprazol Hexal (lansoprazol) er en protonpumpe-hæmmer.
English: Lansoprazol HEXAL (lansoprazole) is a proton pump inhibitor that inhibits gastric acid secretion and is used for treatment of duodenal and gastric ulcer, reflux oesophagitis, gastro-oesophageal reflux disease, treatment and prophylaxis of NSAID-associated gastric and duodenal ulcers, Zollinger-Ellison syndrome, and in combination with appropriate antibacterial therapeutic regimens for the eradication of Helicobacter pylori and prevention of relapse of peptic ulcers in patients with H. pylori associated ulcers.
Danish: Den hæmmer sekretion af mavesyre og anvendes til behandling af duodenalt og gatrisk ulcus, reflux øsofagitis, gastro-øsofageal reflukssygdom, behandling og profylakse af NSAID-relaterede gastriske og duodenale ulcera,
English: Overall, the following should be taken into account:
Danish: Samlet set skal der tages højde for følgende:
English: The corresponding decision from the commission was issued on 12 May 2011.
Danish: Kommissionen traf en afgørelse i den forbindelse den 12. maj 2011.
English: In particular, the peritoneal dialysis (PD) Dianeal, Extraneal and Nutrineal were affected by this procedure.
Danish: Navnlig peritonealdialysevæskerne (PD) Dianeal, Extraneal og Nutrineal blev berørt af denne procedure.
English: The conditions affecting the marketing authorisations are set out in Annex IV of the opinion.
Danish: De betingelser, der berører markedsføringstilladelserne, fremgår af udtalelsens bilag IV.
English: The CHMP reviewed all the data available for each of the sites concerned.
Danish: CHMP gennemgik alle de tilgængelige data for hvert af de pågældende produktionssteder.
English: - The current minimum standards for critical process parameters and limits e.g. for terminal sterilisation should be reviewed and improved, in compliance with process capabilities and best practice.
Danish: - De aktuelle minimumsstandarder for kritiske procesparametre og begrænsninger for f.eks. terminalsterilisering skal evalueres og forbedres i overensstemmelse med proceskapaciteter og bedste praksis.
English: Consequently bioburden specifications of the filled containers should also be harmonised.
Danish: Følgelig skal specifikationerne for de fyldte beholderes mikrobielle belastning ligeledes harmoniseres.
English: The necessary data packages to support the inclusion of one more additional manufacturing site located in Europe (Poland) which is expected to become fully operational soon, was also expedited.
Danish: De nødvendige datapakker til støtte for medtagelsen af et yderligere produktionssted i Europa (Polen), som forventes snart at blive fuldt operationelt, blev ligeledes fremskyndet.
English: - All starting materials (including excipients) should be subject to satisfactory routine control of microbial contamination and, unless justified, endotoxin testing.
Danish: - Alle udgangsmaterialer (herunder hjælpestoffer) skal være genstand for en tilfredsstillende rutinekontrol af mikrobiel kontaminering og, medmindre andet er begrundet, test for endotoksin.
English: The coordinated review of the conditions by the CHMP will enable the appropriate harmonious adjustments with minimum impact on supply of PD solutions to the EU market.
Danish: CHMP's koordinerede gennemgang af betingelserne vil muliggøre hensigtsmæssige, harmoniske justeringer med en minimal indvirkning på leveringen af PD-væsker til EU's marked.
English: Additional measures may be requested subsequently for these sites, but pending conclusion of the ongoing article 31 these cannot be identified.
Danish: Der kan kræves yderligere foranstaltninger efterfølgende for disse produktionssteder, men de kan ikke identificeres, så længe den igangværende procedure i henhold til artikel 31 ikke er afsluttet.
English: The present opinion is the second of a series of entwined opinions, which may result subsequently in additional measures being requested for the site subject of the current opinion.
Danish: Nærværende udtalelse er den anden i en række sammenhængende udtalelser, som efterfølgende kan resultere i et krav om yderligere foranstaltninger for det produktionssted, der er genstand for denne udtalelse.
English: A harmonised European approach to supply has been in place since identification of the concern at Castlebar and the article 31 procedure remains ongoing pending resolution of the outstanding issues.
Danish: Der har eksisteret en harmoniseret europæisk tilgang til forsyningen, siden problemet blev identificeret i Castlebar, og proceduren i henhold til artikel 31 fortsætter, indtil de tilbageværende spørgsmål er blevet afklaret.
English: The sterilisation process should be re-validated using biological indicators as per Ph. Eur..
Danish: Sterilisationsprocessen skal valideres på ny ved hjælp af biologiske indikatorer i henhold til Den Europæiske Farmakopé.