FrancophonIA/ELRC3.0 huggingface dataset:
English: This means that it attaches to opioid receptors and acts like the body's natural opioids to calm down waves of contractions along the digestive system.
Danish: Det betyder, at det binder til opioidreceptorer og virker ligesom kroppens naturlige opioider ved at berolige bølgerne af muskelsammentrækninger i mave-tarm-kanalen.
English: In both studies Truberzi was compared with placebo (a dummy treatment) over 26 weeks of treatment during which patients kept a daily record of their irritable bowel syndrome symptoms.
Danish: I begge undersøgelser blev Truberzi sammenlignet med placebo (en uvirksom behandling) over 26 ugers behandling, hvor patienterne dagligt registrerede symptomer på irritabel tyktarm.
English: Truberzi contains the active substance eluxadoline.
Danish: Truberzi indeholder det aktive stof eluxadolin.
English: In the first study effectiveness was shown in 29% (125 out of 426) of patients taking Truberzi 100 mg twice a day compared with 19% (81 out of 427) in patients taking placebo.
Danish: I den første undersøgelse blev der påvist virkning hos 29 % (125 ud af 426) af de patienter, der fik 100 mg Truberzi to gange om dagen, mens dette kun var tilfældet hos 19 % (81 ud af 427) af de patienter, der fik placebo.
English: Serious side effects include pancreatitis (inflammation of the pancreas) and sphincter of Oddi spasm (a painful condition in which bile and digestive juices are blocked from flowing into the gut).
Danish: Alvorlige bivirkninger omfatter betændelse i bugspytkirtlen (pancreatitis) og kramper i Oddis sfinkter (en smertefuld tilstand, hvor galden og fordøjelsessafter er forhindret i at flyde ind i tarmsystemet).
English: In the second study symptoms improved in 33% (125 out of 382) of patients taking Truberzi 100 mg twice a day compared with 20% (77 out of 382) of patients taking placebo.
Danish: I den anden undersøgelse blev der påvist en forbedring af symptomerne hos 33 % (125 ud af 382) af de patienter, der fik 100 mg Truberzi to gange om dagen, mens dette kun var tilfældet hos 20 % (77 ud af 382) af de patienter, der fik placebo.
English: For practical information about using Truberzi, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Truberzi, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Irritable bowel syndrome is a long-term disorder of the gut with pain or discomfort in the abdomen (belly), bloating and altered bowel habit.
Danish: Irritabel tyktarm er en langvarig tarmsygdom med smerter eller ubehag i maven, oppustethed og ændret afføringsmønster.
English: For the full list of all side effects of Truberzi, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Truberzi fremgår af indlægssedlen.
English: What benefits of Truberzi have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Truberzi?
English: How is Truberzi used?
Danish: Hvordan anvendes Truberzi?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Truberzi have been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Truberzi.
English: How does Truberzi work?
Danish: Hvordan virker Truberzi?
English: Truberzi is a medicine that acts on the digestive system.
Danish: Truberzi er et lægemiddel, der virker i mave-tarm-kanalen.
English: • Risk management plan:
Danish: • Risikostyringsplan:
English: Efficacy data demonstrated an effect from 35 days after treatment.
Danish: Virkningsdata har vist, at virkning indtræder fra 35 dage efter behandling.
English: Pharmacotherapeutic group: Not yet assigned ATCvet code: Not yet assigned
Danish: Farmakoterapeutisk gruppe: endnu ikke tildelt ATCvet-kode: endnu ikke tildelt
English: Substantial improvement was shown in the next 48 hours and complete remission in the following two weeks.
Danish: Der blev observeret væsentlig bedring i de næste 48 timer og fuldstændig remission i de følgende to uger.
English: The first report shall be submitted 6 months after Day 0, and subsequently at 6-month intervals, until otherwise agreed by the CVMP.
Danish: Den første rapport skal indsendes seks måneder efter dag 0 og derefter med seks måneders intervaller, indtil andet er godkendt af CVMP.
English: The safety of the veterinary medicinal product has only been investigated in horses at least two years old.
Danish: Veterinærlægemidlets sikkerhed er kun undersøgt hos heste på mindst to år.
English: The onset of efficacy may be gradual.
Danish: Virkningen kan indtræde gradvist.
English: Swirl gently before use in order to ensure the contents are well mixed.
Danish: Slynges forsigtigt rundt inden brug for at sikre, at indholdet er godt blandet.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/226/001
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/18/226/001
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 1 ml dose contains:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver dosis på 1 ml indeholder:
English: The starting date of the reporting scheme (Day 0) shall be the date of first release of a batch that has been tested with the updated and validated potency assay.
Danish: Startdatoen for indberetningsplanen (dag 0) er datoen for første frigivelse af en batch, der er testet med den ajourførte og validerede styrkebestemmelse.
English: The product must be handled and injected following sterile techniques and in a clean environment.
Danish: Produktet skal håndteres og injiceres med sterile teknikker og i rene omgivelser.
English: MARKETING AUTHORISATION NUMBER(S) EU/2/18/226/001 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 19/06/2019
Danish: MARKEDSFØRINGSTILLADELSENS NUMMER (NUMRE) EU/2/18/226/001 DATO FOR FØRSTE UDSTEDELSE/FORNYELSE AF TILLADELSEN Dato for første markedsføringstilladelse: 19/06/2019
English: Do not use this veterinary medicinal product after the expiry date which is stated on the vial label.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på hætteglasetiketten.
English: Use a 20G needle.
Danish: Der skal anvendes en 20G-kanyle.
English: The active substance, mesenchymal stem cells, is considered as not falling within the scope of the MRL regulation, as it is covered by the entry for stem cells in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009.
Danish: Det aktive stof, mesenkymale stamceller, anses for ikke at falde ind under MRL-forordningens anvendelsesområde, da det er omfattet af posten stamceller på fortegnelsen over stoffer, der anses for ikke at falde ind under anvendelsesområdet for forordning (EF) nr. 470/2009.
English: In 5/6 horses, the adverse reactions were mild and resolved spontaneously within 28 days.
Danish: Hos 5/6 heste var bivirkningerne lette og svandt spontant inden for 28 dage.
English: EXPIRY DATE EXP: {day/month/year}
Danish: UDLØBSDATO EXP: {dag/måned/år}
English: Cloudy colourless suspension.
Danish: Uklar, farveløs suspension.
English: In one case, symptomatic treatment (NSAID) was required.
Danish: I ét tilfælde var symptomatisk behandling (NSAID) nødvendig.
English: Complete remission was observed within 3 days, without any symptomatic treatment.
Danish: Fuldstændig remission er iagttaget i løbet af tre dage uden nogen symptomatisk behandling.
English: Shelf life of the veterinary medicinal product as packaged for sale: 14 days.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 14 dage.
English: Shelf life after first opening the immediate packaging: Use immediately.
Danish: Opbevaringstid efter første åbning af den indre emballage: Anvendes straks.
English: Mesenchymal stem cells have immunomodulatory and anti-inflammatory properties that may be attributed to their paracrine activity, -e.g. prostaglandin (PGE2) secretion, and can possess tissue regenerative properties.
Danish: Mesenkymale stamceller har immunmodulerende og antiinflammatoriske egenskaber, der kan tilskrives deres parakrine aktivitet, f.eks. sekretion af prostaglandin (PGE2), og kan have vævsregenererende egenskaber.
English: Complete remission was observed over the following two weeks without any symptomatic treatment.
Danish: Fuldstændig remission er iagttaget i løbet af de følgende to uger uden nogen symptomatisk behandling.
English: The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne anført under punkt 6.1 i SPC'et, er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet, eller som ikke anses for at være omfattet af forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.
English: In order to further support the link between PGE2 production and a clinically-relevant therapeutic effect, the marketing authorisation holder shall conduct and submit an updated and validated potency assay (a product specific in vitro model) to the CVMP/EMA for evaluation before batch release and placing the product on the market.
Danish: For yderligere at underbygge sammenhængen mellem PGE2-produktion og en klinisk relevant terapeutisk virkning skal indehaveren af markedsføringstilladelsen udføre og for CVMP/EMA forelægge en ajourført og valideret styrkebestemmelse (en produktspecifik in vitro-model) til evaluering inden batchfrigivelse og markedsføring af produktet.
English: Administrative office and manufacturing site: EquiCord-YMAS
Danish: Administrativt kontor og fremstillingssted: EquiCord-YMAS
English: The marketing authorisation holder shall perform the required pharmacovigilance activities and interventions as detailed in the agreed risk management plan and any agreed subsequent updates of the risk management plan.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de nødvendige aktiviteter og indgreb til lægemiddelovervågning som beskrevet i den godkendte risikostyringsplan og eventuelle godkendte efterfølgende ajourføringer heraf.
English: Use only accordingly to the benefit/risk assessment by the responsible veterinarian.
Danish: Må kun anvendes i overensstemmelse med den ansvarlige dyrlæges vurdering af benefit/riskforholdet.
English: One horse required symptomatic treatment (NSAID) and its lameness resolved by day 14.
Danish: Én hest krævede symptomatisk behandling (NSAID), og dens halthed svandt på dag 14.
English: Adverse reactions in the other horses resolved spontaneously within a maximum of 21 days; lameness lasted for up to three days.
Danish: Bivirkningerne hos de andre heste svandt spontant i løbet af højst 21 dage; halthed persisterede i op til tre dage.
English: To what extent EUC-MSCs from this product persist after intraarticular administration to horses is not known as no proprietary biodistribution studies have been conducted with HorStem.
Danish: Det vides ikke, i hvilket omfang EUC-MSC fra dette produkt persisterer efter intraartikulær indgivelse til heste, da der ikke er udført interne studier af biodistribution med HorStem.
English: A second administration of the product at the recommended dose to healthy young horses in the same joint, 28 days after the first administration at the recommended dose, led to an increase in frequency and severity of inflammation related to the treated joint (8/8 horses) and to an increase in the severity of the lameness observed (3/8 horses; up to grade 4/5 according to the American Association of Equine Practitioners lameness scale (AAEP)) compared to the first treatment.
Danish: Endnu en indgivelse af produktet i den anbefalede dosis til raske unge heste i samme led 28 dage efter den første indgivelse af den anbefalede dosis medførte en stigning i hyppigheden og sværhedsgraden af inflammation i det behandlede led (8/8 heste) og en stigning i sværhedsgraden af haltheden (3/8 heste, op til grad 4/5 på American Association of Equine Practitioners' (AAEP) skala for halthed) i forhold til den første behandling.
English: No efficacy data are available regarding the treatment of other joints.
Danish: Der foreligger ingen virkningsdata vedrørende behandling af andre led.
English: These pharmacodynamic properties may be also relevant for equine umbilical cord derived MSCs (EUC-MSCs) but have not been demonstrated in proprietary studies conducted with the product.
Danish: Disse farmakodynamiske egenskaber kan også tænkes at være relevante for ekvine mesenkymale navlestrengsstamceller (EUC-MSC), men er ikke påvist i beskyttede studier udført med produktet.
English: The veterinary product must be administered intraarticularly, only by a veterinary surgeon, taking special precautions to ensure the sterility of the injection process.
Danish: Dette veterinærlægemiddel skal indgives intraartikulært af en dyrlæge, der træffer særlige forholdsregler til at sikre sterilitet af injektionen.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside: http://www.ema.europa.eu/
English: Trolox (6-hydroxyl-2,5,7,8- tetramethylchroman-2-carboxylic acid) Water for injections
Danish: Trolox (6-hydroxyl-2,5,7,8- tetramethylchroman-2-carboxylsyre) Vand til injektionsvæsker
English: In order to collect further field data, related to both safety and efficacy, from batches that have been released by use of the updated potency assay, the marketing authorisation holder shall conduct and submit the results of a surveillance study.
Danish: For at indsamle yderligere feltdata vedrørende både sikkerhed og virkning fra batcher, der er frigivet ved brug af den ajourførte styrkebestemmelse, skal indehaveren af markedsføringstilladelsen udføre et overvågningsstudie og forelægge resultaterne heraf.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES 1 ml
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1 ml
English: No efficacy data are available regarding the treatment in more than one arthritic joint at the same time.
Danish: Der foreligger ingen virkningsdata vedrørende samtidig behandling af mere end ét artritisk led.
English: Intraarticular administration of a 2x dose (30x106/2ml) of HorStem to 4 years old and older healthy horses led to lameness in 5/6 animals and to signs of inflammation in all animals.
Danish: Intraartikulær administration af en dobbeltdosis (30x106/2 ml) af HorStem til raske heste på fire år og derover medførte halten hos 5/6 dyr og tegn på inflammation hos alle dyr.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON
English: Intraarticular placement should be confirmed by the appearance of synovial fluid in the hub of the needle.
Danish: Intraartikulær placering bør bekræftes ved fremkomst af synovialvæske i kanylens hoved.
English: Correct placement of the needle is crucial to avoid accidental injection into blood vessels and an associated risk of thrombosis.
Danish: Korrekt placering af kanylen er afgørende for at undgå utilsigtet injektion i blodkar og dermed forbundet risiko for trombose.
English: HEPES N-(2-hydroxyethyl) piperazine-N´-(2-ethanesulfonic acid) Sodium hydroxide
Danish: HEPES N-(2-hydroxyethyl)-piperazin-N'-(2-ethansulfonsyre) Natriumhydroxid
English: In case of severe inflammation, administration of symptomatic treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) could be necessary.
Danish: Ved svær inflammation kan symptomatisk behandling med non-steroide anti-inflammatoriske lægemidler (NSAID) være nødvendig.
English: Phone: +34 (0) 914856756
Danish: Telefon: +34 (0) 914856756 E-mail: horstem@equicord.com
English: The veterinary medicinal product was demonstrated to be efficacious in horses affected by osteoarthritis in the metacarpo-phalangeal joint, distal interphalangeal joint, and tarsometatarsal/ distal intertarsal joint.
Danish: Veterinærlægemidlet er påvist at være effektivt hos heste med osteoartritis i metacarpophalangealleddet, det distale interphalangealled og tarsometatarsalleddet/det distale intertarsalled.
English: L- Glutathione
Danish: L-glutathion
English: Pack size: Cardboard box with 1 vial containing 1 ml.
Danish: Pakningsstørrelse: Kartonæske med 1 hætteglas indeholdende 1 ml.
English: Adenosine
Danish: Adenosin
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Route of administration:
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: In the absence of compatibility studies, this veterinary medicinal product must not be mixed with any other veterinary medicinal products.
Danish: Da der ikke foreligger studier vedrørende eventuelle uforligeligheder, bør dette veterinærlægemiddel ikke blandes med andre veterinærlægemidler.
English: Acute synovitis with an acute onset of severe lameness, joint effusion and pain on palpation was reported 24 hours after administration of the veterinary medicinal product.
Danish: Der er indberettet akut synovitis med akut indtrædende svær halthed, ledeffusion og smerte ved palpation 24 timer efter indgivelse af veterinærlægemidlet.
English: An increase in mild lameness was observed 24 hours after HorStem administration.
Danish: En stigning i let halthed er iagttaget 24 timer efter indgivelse af HorStem.
English: TARGET SPECIES Horses
Danish: DYREARTER Heste
English: STATEMENT OF ACTIVE SUBSTANCES Each vial contains:
Danish: ANGIVELSE AF AKTIVE STOFFER 1 hætteglas indeholder:
English: Reduction of lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in horses.
Danish: INDIKATION Reduktion af halthed ved let til moderat degenerativ ledsygdom (osteoartritis) hos heste.
English: ROUTE(S) OF ADMINISTRATION Intraarticular use
Danish: INDGIVELSESVEJ(E) Intraartikulær anvendelse
English: WITHDRAWAL PERIOD Withdrawal period(s): Zero days
Danish: TILBAGEHOLDELSESTID Tilbageholdelsestid(er): Nul dage
English: Industrial Ventorro del Cano
Danish: Industrial Ventorro del Cano Alcorcón
English: For intraarticular use.
Danish: Til intraartikulær anvendelse.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Swirl gently before use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Slynges forsigtigt rundt inden brug Læs indlægssedlen inden brug.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Intraarticular use.
Danish: Intraartikulær anvendelse.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/
Danish: DATO FOR ÆNDRING AF TEKSTEN Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu/).
English: Equine umbilical cord mesenchymal stem cells (EUC-MSCs)
Danish: Ekvine mesenkymale navlestrengsstamceller (EUC-MSC)
English: Cyclic olefin vial closed with a bromobutyl rubber stopper and a flip off aluminium cap.
Danish: Hætteglas af cyklisk olefin med prop af brombutylgummi og afrivningskapsel af aluminium.
English: WITHDRAWAL PERIOD Withdrawal period: zero days
Danish: TILBAGEHOLDELSESTID Tilbageholdelsestid: nul dage.
English: The product should only be administered by a veterinary surgeon.
Danish: Produktet må kun indgives af en dyrlæge.
English: Moderate joint effusion with no associated lameness has been observed 24 hours after HorStem administration.
Danish: Moderat ledeffusion uden ledsagende halthed er iagttaget 24 timer efter indgivelse af HorStem.
English: Each vial contains:
Danish: 1 hætteglas indeholder:
English: 4.2 Indications for use, specifying the target species Reduction of lameness associated with mild to moderate degenerative joint disease (osteoarthritis) in horses.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Reduktion af halthed ved let til moderat degenerativ ledsygdom (osteoartritis) hos heste.
English: Do not administer simultaneously with any other intraarticular veterinary medicinal product.
Danish: Må ikke indgives samtidig med andre intraartikulære veterinærmedicinske lægemidler.
English: PACKAGE LEAFLET: HorStem suspension for injection for horses
Danish: INDLÆGSSEDDEL: HorStem injektionsvæske, suspension, til heste
English: ADVICE ON CORRECT ADMINISTRATION Do not apply simultaneously with other intraarticular veterinary medicinal products.
Danish: OPLYSNINGER OM KORREKT ANVENDELSE Må ikke indgives samtidig med andre intraartikulære veterinærlægemidler.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT HorStem suspension for injection for horses
Danish: VETERINÆRLÆGEMIDLETS NAVN HorStem injektionsvæske, suspension, til heste
English: Dosage A single intraarticular injection of 1 ml (15x106 equine umbilical cord mesenchymal stem cells) into the affected joint.
Danish: Dosering En enkelt intraartikulær injektion på 1 ml (15x106 ekvine mesenkymale navlestrengsstamceller) i det berørte led.
English: Route of administration: Intraarticular use.
Danish: Indgivelsesvej: Intraartikulær anvendelse.
English: Magnesium chloride
Danish: Magnesiumchlorid
English: A single intraarticular injection of 1 ml (15x106 equine umbilical cord mesenchymal stem cells) into the affected joint.
Danish: En enkelt intraartikulær injektion på 1 ml (15x106 ekvine mesenkymale navlestrengsstamceller) i det berørte led.
English: MARKETING AUTHORISATION HOLDER EquiCord-YMAS S.L.
Danish: EquiCord-YMAS S.L.
English: The potential of EUC-MSCs to secrete PGE2 with and without stimulation by synovial fluid has been demonstrated in studies in vitro.
Danish: Det er påvist in vitro, at EUC-MSC har potentiale for at secernere PGE2 med og uden stimulation fra synovialvæsken.
English: Lactobionic acid
Danish: Lactobionsyre
English: 15x106 /ml Equine umbilical cord mesenchymal stem cells
Danish: 15x106/ml ekvine mesenkymale navlestrengsstamceller
English: AUTHORISATION
Danish: PRODUKTRESUMÉ
English: For animal treatment only.
Danish: TIL DYR Til dyr.
English: Calcium chloride
Danish: Calciumchlorid
English: PACKAGE SIZE One 1 ml vial.
Danish: PAKNINGSSTØRRELSE Ét hætteglas med 1 ml.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 15x106 /ml Equine umbilical cord mesenchymal stem cells
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) 15x106/ml ekvine mesenkymale navlestrengsstamceller
English: Active Substance: 15x106 Equine umbilical cord mesenchymal stem cells
Danish: Aktivt stof: 15x106 ekvine mesenkymale navlestrengsstamceller
English: To be administered only by a veterinary surgeon
Danish: Må kun indgives af en dyrlæge.
English: INDICATION
Danish: KONTRAINDIKATIONER
English: Potassium bicarbonate
Danish: Kaliumhydrogencarbonat
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forholdsregler, der skal træffes af personer, der administrerer lægemidlet til dyr: Der bør udvises forsigtighed for at undgå utilsigtet selvinjektion.
English: Handle it carefully.
Danish: Håndter den med forsigtighed.
English: There will be a loud click.
Danish: Der vil komme et højt klik.
English: DO NOT inject in the exact same spot every time.
Danish: Indsprøjt IKKE nøjagtig det samme sted hver gang.
English: - if you have Crohn's disease.
Danish: - hvis du har Crohns sygdom.
English: 1 GET READY
Danish: 1 GØR DIG KLAR
English: Clearance is independent of dose.
Danish: Clearance er uafhængig af dosis.
English: - if you have recently had or are due to have a vaccination.
Danish: - hvis du for nylig har fået eller skal have en vaccination.