FrancophonIA/ELRC3.0 huggingface dataset:
English: QUANTITY OF THE ACTIVE SUBSTANCE Live Streptococcus equi.
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) Levende Streptococcus equi
English: ROUTE OF ADMINISTRATION For submucosal use.
Danish: INDGIVELSESVEJ(E) Til submukøs anvendelse.
English: The vaccine strain is resistant to aminoglycosides, sulphonamides, flumequine and trimetroprim-sulfa combinations.
Danish: Vaccinestammen er resistent over for aminoglykosider, sulfonamider, flumequin og trimethoprim sulfa kombinationer.
English: Basic vaccination: Horses from 4 months of age onwards receive two vaccinations of one dose with a 4 week interval.
Danish: Basisvaccination: Heste fra 4 måneder vaccineres to gange med én dosis med 4 ugers mellemrum.
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Aktive bestanddele af biologisk oprindelse beregnet til at fremkalde aktiv eller passiv immunitet er ikke omfattet af lovgivningens område.
English: BATCH NUMBER Batch {number}
Danish: BATCHNUMMER <Lot> <Batch> {nummer}
English: This product contains a live auxotrophic deletion mutant Streptococcus equi vaccine strain with attenuated virulence.
Danish: Dette produkt indeholder en levende auxotrofisk deletions-mutant Streptococcus equi vaccine-stamme med svækket virulens.
English: Onset of immunity: 2 weeks after basic vaccination.
Danish: Immunitetens indtræden: Immuniteten indtræder 2 uger efter basisvaccination.
English: SPECIAL WARNING(S), IF NECESSARY
Danish: SÆRLIG(E) ADVARSEL/ADVARSLER OM NØDVENDIGT Ikke relevant.
English: Withdraw 0.2 ml of the reconstituted vaccine into the syringe provided (see Figure 1) and connect the applicator to the needle (see Figure 2).
Danish: Træk 0,2 ml opløst vaccine op med den vedlagte sprøjte (se figur 1) og sæt applikatoren på kanylen (se figur 2).
English: A slight cloudy discharge commonly occurs from the mucosal injection site at 3 or 4 days post vaccination.
Danish: Et lettere uklart eksudat ses almindeligvis fra injektionsstedet på slimhinden på 3. eller 4. dagen efter vaccination.
English: CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES 1 dose
Danish: PAKNINGSSTØRRELSE ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER
English: Intervet International B.V. Wim de Körverstraat 35 NL - 5831 AN Boxmeer The Netherlands
Danish: Wim de Körverstraat 35 Nl-5831 AN Boxmeer Holland
English: After reconstitution use within 4 hours.
Danish: Opløst vaccine skal anvendes inden for 4 timer.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE - solvent
Danish: VETERINÆRLÆGEMIDLETS NAVN Equilis StrepE - solvens
English: It is able to multiply locally at the submucosal injection site during a short period and is shed into the oro-nasal cavity during a few days, but the vaccine strain does not survive on the oro-nasal mucosa and does not disseminate systemically at the recommended dose.
Danish: Den kan i en kort periode multiplicere sig lokalt på det submukøse injektionssted og udskilles til næse- og mundhulen i nogle få dage, men vaccinenstammen overlever ikke på den oro-nasale slimhinde og spredes ikke systemisk ved brug af den anbefalede dosis.
English: This product contains a live bacterial deletion mutant with a limited growth potential in mammalian tissue.
Danish: Dette produkt indeholder en levende bakteriel deletions-mutant med begrænset vækstpotentiale i væv hos pattedyr.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Danish: BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG Lægemidlet må kun udleveres efter recept.
English: For any information about this veterinary medicinal product, please contact the marketing authorization holder.
Danish: De bedes kontakte indehaveren af markedsføringstilladelsen, hvis De ønsker yderligere oplysninger om dette lægemiddel.
English: Restrain the animal's head, lift the upper lip and insert the needle into the inside of the upper lip until the applicator rests on the lip. Administer the whole contents of the syringe into the inside of the upper lip (see Figure 3).
Danish: Fiksér dyrets hoved, løft overlæben og stik kanylen ind i overlæbens inderside indtil applikatoren hviler på læben.
English: 4.8 Interaction with other medicinal products and other forms of interaction
Danish: 4.8 Interaktion med andre lægemidler og andre former for interaktion Der foreligger kun begrænsede oplysninger om sikkerhed og effekt ved brug af vaccinen sammen med andre vacciner.
English: Aseptically reconstitute the freezedried vaccine with 0.3 ml of the sterile solvent provided.
Danish: Opløs den frysetørrede vaccine aseptisk med 0,3 ml af den medfølgende sterile solvens.
English: Aseptically reconstitute the lyophilisate with 0.3 ml of the sterile solvent provided.
Danish: Opløs lyofilisatet aseptisk med 0,3 ml af den medfølgende sterile solvens.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE
Danish: VETERINÆRLÆGEMIDLETS NAVN Equilis StrepE
English: The vaccine organism may establish a small suppurative inflammation locally at the injection site, leading to a disruption of the overlaying lip mucosa and subsequent discharge fluid and inflammatory cells.
Danish: Vaccineorganismen kan skabe et lille betændt område på injektionsstedet, hvilket forårsager en erosion af læbens slimhinde med efterfølgende udskillelse af væske og inflammatoriske celler.
English: The vaccine strain is a deletion mutant with a limited growth potential in mammalian tissue.
Danish: Vaccinestammen er en deletions-mutant med begrænset vækstpotientale i væv hos pattedyr.
English: MANUFACTURER'S BATCH NUMBER Batch {number}
Danish: FREMSTILLERENS BATCHNUMMER <Lot> <Batch> {nummer}
English: In case of accidental self-injection, seek medical advice immediately and show the package insert or the label to the physician even if only a very small amount is injected.
Danish: I tilfælde af selvinjektion skal der straks søges lægehjælp og indlægssedlen eller etiketten bør vises til lægen.
English: PHARMACEUTICAL FORM Lyophilisate for suspension for injection
Danish: LÆGEMIDDELFORM Lyofilisat til injektionsvæske, suspension
English: 4.2 Indications for use, specifying the target species For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Til immunisering af heste mod Streptococcus equi for at reducere kliniske symptomer og forekomst af lymfeknudeabscesser.
English: For immunisation of horses against Streptococcus equi to reduce clinical signs and occurrence of lymph node abscesses.
Danish: Til immunisering af heste mod Streptococcus equi for at reducere kliniske symptomer og forekomst af lymfeknudeabscesser.
English: Use during pregnancy, lactation or lay: Do not use in pregnant or lactating mares.
Danish: 4.7 Anvendelse under drægtighed, laktation eller æglægning Bør ikke anvendes til drægtige eller lakterende hopper.
English: However, the bacterial compounds of this product can cause an inflammatory reaction with intense and painful swelling after accidental injection.
Danish: Efter uforsætlig injektion kan dette produkts vaccinekomponenter imidlertid skabe en betændt reaktion med intens og smertefuld hævelse.
English: STATEMENT OF THE ACTIVE SUBSTANCE AND OTHER INGREDIENT(S) Per dose of 0.2 ml vaccine:
Danish: ANGIVELSE AF AKTIV STOFFER OG ANDRE STOFFER Pr. dosis af 0,2 ml vaccine:
English: The vaccine is intended for use in horses for which a risk of Streptococcus equi infection has been clearly identified, due to contact with horses from areas where this pathogen is known to be present, e.g. stables with horses that travel to shows and/or competitions in such areas, or stables that obtain or have livery horses from such areas.
Danish: Vaccinen er beregnet til brug til heste, som tydeligvis risikerer infektion med Streptococcus equi på grund af kontakt med heste fra områder med kendt forekomst af smitte.
English: C. STATEMENT OF THE MRLs
Danish: D. ANGIVELSE AF MRL-VÆRDIER Stof
English: Pharmacotherapeutic group: immunological for equidae, live bacterial vaccine, ATCvet code: QI05AE.
Danish: ATCvet-kode: QI05 AE levende bakterie vaccine
English: WITHDRAWAL PERIOD Zero days.
Danish: TILBAGEHOLDELSESTID 0 dage.
English: SPECIAL STORAGE CONDITIONS Store in a refrigerator (2 °C - 8 °C).
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares ved 2°C - 8°C (i køleskab).
English: MINIMUM PARTICULARS ON IMMEDIATE PACKAGING OF THE SOLVENT Solvent vial
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER SOLVENSETIKET
English: Lyophilisate: Store in a refrigerator (2 °C - 8 °C).
Danish: Lyofilisat: Opbevares ved 2°C - 8°C (i køleskab).
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCTS OR WASTE MATERIALS
Danish: 6.6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Carton box
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE VACCINE KARTON
English: PARTICULARS TO APPEAR ON THE INNER BOX WITH SOLVENT
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE SOLVENS KARTON
English: This swelling resolves completely within 3 weeks and normally has no effect on the appetite of the vaccinated animal and causes no apparent discomfort.
Danish: Hævelsen er på sit højeste 2-3 dage efter vaccination og kan have et areal på maksimalt 3 cm gange 8 cm. Hævelsen forsvinder fuldstændigt inden for 3 uger og påvirker normalt ikke det vaccinerede dyrs appetit og forårsager intet erkendeligt ubehag.
English: A priming response is maintained for up to six months after basic vaccination.
Danish: En priming-effekt varer i op til seks måneder efter basisvaccination, hvorfor der kun behøves en enkelt vaccinedosis for at gendanne immuniteten.
English: THE WORDS "FOR ANIMAL TREATMENT ONLY" For animal treatment only.
Danish: TEKSTEN ”TIL DYR” Til dyr.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Intervet International B.V.
Danish: Intervet International B.V.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vial
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER VACCINEETIKET
English: SPECIAL STORAGE CONDITIONS
Danish: EVENTUELLE, SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING
English: In rare cases, inappetence, fever, shivering and diffuse oedematous swellings (e.g. facial oedema, swollen muzzle/upper lip) may be observed.
Danish: I sjældne tilfælde kan der observeres appetitløshed, feber og kulderystelser.
English: CONTRAINDICATIONS
Danish: BIVIRKNINGER
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE, lyophilisate for suspension for injection, for horses
Danish: VETERINÆRLÆGEMIDLETS NAVN Equilis StrepE, lyofilisat til injektionsvæske, suspension, til hest
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Danish: Det frarådes derfor at anvende andre vacciner sideløbende eller samtidigt med denne.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For administration submucosally to the inside of the upper lip. Read the package leaflet before use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Se indlægssedlen.
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN, HERUNDER BEGRÆNSNINGER FOR UDLEVERING OG BRUG
English: WITHDRAWAL PERIOD
Danish: TILBAGEHOLDELSESTID 0 dage
English: The reaction is maximal at 2-3 days post vaccination with a maximum area of 3 cm by 8 cm.
Danish: Efter vaccination dannes der inden for 4 timer en diffus hævelse, der kan være varm eller smertefuld, på injektionsstedet.. Hævelsen er på sit højeste 2-3 dage efter vaccination og kan have et areal på maksimalt 3 cm gange 8 cm. Hævelsen forsvinder fuldstændigt inden for 3 uger og påvirker normalt ikke det vaccinerede dyrs appetit og forårsager intet tydeligt ubehag.
English: EXPIRY DATE Exp: {month/year}
Danish: UDLØBSDATO <Udløbsdato> <EXP> {MM/ÅÅÅÅ}
English: PACKAGE LEAFLET FOR: Equilis StrepE, lyophilisate and solvent for suspension for injection, for horses
Danish: Equilis StrepE, lyofilisat til injektionsvæske, suspension til hest
English: EXPIRY DATE EXP: {month/year}
Danish: UDLØBSDATO EXP {MM/ÅÅÅÅ}
English: Disposal: read package leaflet.
Danish: Læs indlægssedlen før brug.
English: DOSAGE FOR EACH SPECIES, ROUTES AND METHOD OF ADMINISTRATION Submucosal vaccination of 0.2 ml of reconstituted product.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Efter opløsning indgives 0,2 ml submukøst i overlæbens inderside.
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST REVISED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: De nævnte foranstaltningers virkninger for produktets risk/benefit-forhold skal overvåges nøje efter genindførelse af vaccinen på det europæiske marked.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Equilis StrepE, lyophilisate and solvent for suspension for injection
Danish: VETERINÆRLÆGEMIDLETS NAVN Equilis StrepE, lyofilisat til injektionsvæske, suspension til hest
English: ADVERSE REACTIONS
Danish: Bemærkninger
English: EXPIRY DATE EXP {month/year}
Danish: 10. UDLØBSDATO EXP {MM/ÅÅÅÅ}
English: Incompatibilities:
Danish: Ikke relevant
English: Poliovirus (Inactivated)4: Type 1 (Mahoney)
Danish: Poliovirus (inaktiveret)4 Type 1 (Mahoney)
English: 3 micrograms Conjugated to meningococcal protein2 50 micrograms adsorbed on aluminium phosphate (0.17 mg Al adsorbed on amorphous aluminium hydroxyphosphate sulfate (0.15 mg Al 3 produced in yeast (Saccharomyces cerevisiae) cells by recombinant DNA technology 4 produced in Vero cells or equivalent antigenic quantity determined by a suitable immunochemical method.
Danish: adsorberet på aluminiumphosphat (0,17 mg Al adsorberet på amorf aluminiumhydroxyphosphatsulfat (0,15 mg Al 3 fremstillet i gærceller (Saccharomyces cerevisiae) ved hjælp af rekombinant DNA-teknologi 4 fremstillet i Vero-celler eller en ækvivalent antigen-mængde, der er fastlagt efter en egnet immunokemisk metode.
English: Haemophilus influenzae type b polysaccharide (Polyribosylribitol Phosphate)
Danish: Haemophilus influenzae type b-polysaccharid (polyribosylribitolphosphat)
English: Hepatitis B surface antigen2,3:
Danish: Hepatitis B-overfladeantigen2,3
English: 50 (5x10) pre-filled syringes (multipack)
Danish: 50 (5 x 10) fyldte injektionssprøjter (multipakning)
English: --1 One dose (0.5 ml) contains: Diphtheria Toxoid1:
Danish: --1 En dosis (0,5 ml) indeholder: Difteritoksoid1
English: Bordetella pertussis antigens1: Pertussis Toxoid (PT)
Danish: Bordetella pertussis-antigener1 Pertussistoksoid (PT)
English: Tetanus Toxoid1:
Danish: Tetanustoksoid1
English: Filamentous Haemagglutinin (FHA) 20 micrograms Pertactin (PRN)
Danish: Pertactin (PRN)
English: This summary was last updated in 06-2014.
Danish: Dette sammendrag blev senest ajourført i 06-2014.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Entyvio on 22 May 2014.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Entyvio den 22. maj 2014.
English: This is a summary of the European public assessment report (EPAR) for Entyvio.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Entyvio.
English: Entyvio is given as an infusion that lasts 30 minutes.
Danish: Entyvio gives som en infusion, der varer 30 minutter.
English: The full EPAR and risk management plan summary for Entyvio can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR og resuméet af risikostyringsplanen for Entyvio findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: All patients are monitored for any reactions during the infusion and for at least one to two hours after the end of the infusion.
Danish: Alle patienter overvåges for eventuelle reaktioner under infusionen og i mindst 1-2 timer efter infusionen.
English: Other information about Entyvio
Danish: Andre oplysninger om Entyvio
English: A risk management plan has been developed to ensure that Entyvio is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Entyvio anvendes så sikkert som muligt.
English: What is Entyvio and what is it used for?
Danish: Hvad er Entyvio, og hvad anvendes det til?
English: Entyvio was also shown to be more effective than placebo at improving symptoms of Crohn's disease.
Danish: Entyvio var også mere effektivt end placebo til at bedre symptomerne på Crohns sygdom.
English: The recommended dose is 300 mg given at weeks zero, two and six, and then every eight weeks after that in patients who respond.
Danish: Den anbefalede dosis er 300 mg i uge nul, to og seks, derefter hver 8. uge til de patienter, lægemidlet virker hos.
English: Entyvio is a medicine that contains the active substance vedolizumab.
Danish: Entyvio er et lægemiddel, der indeholder det aktive stof vedolizumab.
English: Why is Entyvio approved?
Danish: Hvorfor blev Entyvio godkendt?
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Entyvio's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) afgjorde, at fordelene ved Entyvio overstiger risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: What measures are being taken to ensure the safe and effective use of Entyvio?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Entyvio?
English: Patients who receive Entyvio must be given a special alert card that summarises the safety information about the medicine.
Danish: Patienter, der får Entyvio, får udleveret et særligt advarselskort, der sammenfatter de vigtigste sikkerhedsoplysninger om lægemidlet.
English: Furthermore, the risks are considered manageable, despite the lack of long-term safety data, if recommendations in place are followed.
Danish: Risiciene menes at kunne styres, når de gældende anbefalinger overholdes, selv om der ikke var oplysninger om sikkerheden på lang sigt.
English: Entyvio was shown to be more effective than placebo: 47% (106 out of 225) of patients who received Entyvio showed an improvement in symptoms, compared with 26% (38 out of 149) of patients who received placebo.
Danish: Entyvio blev påvist at være mere effektivt end placebo: 47 % (106 ud af 225) af de patienter, der fik Entyvio, fik bedring i symptomerne, sammenholdt med 26 % (38 ud af 149) af dem, der fik placebo.
English: Entyvio is produced by a method known as ‘recombinant DNA technology'; it is made by cells into which a gene (DNA) has been introduced that makes them able to produce vedolizumab.
Danish: Entyvio fremstilles ved “rekombinant DNA-teknologi”: Det produceres af celler, som har fået indsat et gen (DNA), der gør dem i stand til at producere vedolizumab.
English: It is not intended to provide practical advice on how to use Entyvio.
Danish: Det er ikke en praktisk vejledning i, hvordan Entyvio bør anvendes.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Entyvio, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Entyvio, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: It can only be obtained with a prescription and treatment should be started and supervised by a specialist who has experience in the diagnosis and treatment of ulcerative colitis or Crohn's disease.
Danish: Entyvio fås kun på recept, og behandlingen bør indledes og overvåges af en speciallæge med erfaring i diagnose og behandling af ulcerøs kolitis eller Crohns sygdom.
English: The active substance in Entyvio, vedolizumab, is a monoclonal antibody.
Danish: Det aktive stof i Entyvio, vedolizumab, er et monoklonalt antistof.
English: For more information about treatment with Entyvio, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Entyvio, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: In ulcerative colitis and Crohn's disease these cells are involved in causing inflammation in the gut.
Danish: Ved ulcerøs kolitis og Crohns sygdom er disse celler medvirkende til inflammation i tarmen.
English: The most common side effects with Entyvio (which may affect more than 1 in 10 people) are nasopharyngitis (inflammation of the nose and throat such as a cold), headache and arthralgia (joint pain).
Danish: De hyppigste bivirkninger med Entyvio (som kan forekomme hos over 1 ud af 10 behandlede) er betændelse i næse og svælg såsom forkølelse (nasofaryngitis), hovedpine og ledsmerter (artralgi).
English: Entyvio must not be used in people with active serious infections such as tuberculosis, sepsis (infection in the blood), listeriosis (infection with bacteria called Listeria) or opportunistic infections (those seen in patients with a weakened immune system) such as progressive multifocal leukoencephalopathy (PML, a rare brain infection that usually leads to severe disability or death).
Danish: Entyvio må ikke anvendes ved aktive alvorlige infektioner såsom tuberkulose, blodforgiftning (sepsis), infektion med bakterien Listeria (listeriose) eller infektioner ved nedsat immunforsvar (opportunistiske infektioner) såsom den sjældne hjernebetændelse progressiv multifokal leukencefalopati (PML), der sædvanligvis fører til svær invaliditet eller død.
English: What are the risks associated with Entyvio?
Danish: Hvilke risici er der forbundet med Entyvio?
English: By blocking alfa-4-beta-7 integrin, vedolizumab reduces the inflammation in the gut and the symptoms of these diseases.
Danish: Vedolizumab blokerer alfa-4-beta-7 integrin og mindsker derved inflammationen i tarmen og symptomerne på disse sygdomme.
English: For the full list of all side effects reported with Entyvio, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger med Entyvio fremgår af indlægssedlen.
English: In Crohn's disease, the CHMP considered that although the time required for improvement of symptoms may be longer and the size of the effect limited when compared with anti-TNF-alfa therapy, Entyvio still offers a benefit for patients because of its different mechanism of action and safety profile.
Danish: Hvad angår Crohns sygdom fandt CHMP, at selv om virkningen af Entyvio indtræder senere og er mindre sammenlignet med anti-TNF-alfa-behandling, er Entyvio alligevel til fordel for patienterne med sin anderledes virkningsmekanisme og sikkerhedsprofil.
English: Vedolizumab has been designed to attach to ‘alfa-4-beta-7 integrin', a protein mostly found on the surface of certain white blood cells in the gut.
Danish: Vedolizumab er opbygget, så det genkender og bindes til det særlige protein alfa-4-beta-7 integrin på overfladen af hvide blodlegemer i tarmen.
English: How is Entyvio used?
Danish: Hvordan anvendes Entyvio?
English: In addition, the study also showed that Entyvio maintained the effect up to 52 weeks more effectively than placebo.
Danish: Desuden viste undersøgelsen, at Entyvio i op til 52 uger stadig var mere effektivt end placebo.