FrancophonIA/ELRC3.0 huggingface dataset:
English: A third study in 906 adults with melanoma who had undergone surgery and who were at high risk of the cancer coming back compared Opdivo with ipilimumab.
Danish: I et tredje studie med 906 voksne med melanom, som var blevet opereret, og hos hvem der var stor risiko for, at kræften vendte tilbage, blev Opdivo sammenlignet med ipilimumab.
English: Opdivo used on its own was studied in two main studies in adults with advanced melanoma who had not undergone surgery.
Danish: Opdivo anvendt som enebehandling var genstand for to hovedstudier hos voksne med fremskredent melanom, som ikke var blevet opereret.
English: Improvements in the time patients lived without their disease getting worse when treated with Opdivo plus ipilimumab relative to Opdivo used on its own were only seen for patients whose cancer cells produced low levels of PD-L1.
Danish: Den tid, patienterne levede, uden at deres sygdom forværredes, når de blev behandlet med Opdivo og ipilimumab sammenlignet med Opdivo alene, blev kun forbedret hos de patienter, hvis kræftceller producerede et lavt antal PD-L1.
English: The second study looked at 405 advanced melanoma patients whose disease had got worse despite previous treatment with a cancer medicine.
Danish: I det andet studie deltog 405 patienter med fremskredent melanom, hvis sygdom var forværredes trods tidligere behandling med et kræftlægemiddel.
English: • advanced renal cell carcinoma, a kidney cancer.
Danish: • fremskredent renalcellekarcinom, en form for nyrekræft.
English: Opdivo was compared with everolimus (another cancer medicine) in one main study involving 821 patients with advanced renal cell carcinoma whose disease advanced despite previous treatment.
Danish: Opdivo blev sammenlignet med everolimus (et andet kræftlægemiddel) i et hovedstudie, der omfattede 821 patienter med fremskredent nyrecellekarcinom, hvis sygdom forværredes på trods af tidligere behandling.
English: Patients given Opdivo survived for 25.0 months, compared with 19.6 months for patients given everolimus.
Danish: De patienter, der fik Opdivo, overlevede i 25,0 måneder sammenlignet med 19,6 måneder for de patienter, der fik everolimus.
English: Opdivo is used on its own in patients who have previously been treated with other cancer medicines (chemotherapy);
Danish: Opdivo anvendes alene hos patienter, der tidligere har været behandlet med andre kræftlægemidler (kemoterapi)
English: The most common side effects with Opdivo (which may affect more than 1 in 10 people) include tiredness, diarrhoea, nausea (feeling sick), rash and itching, pain in joints, muscles and bones, and hypothyroidism (an underactive thyroid gland), most of which are mild to moderate in severity.
Danish: De hyppigste bivirkninger ved Opdivo (som optræder hos mere end 1 ud af 10 patienter) er træthed, diarré, kvalme, udslæt, kløe (pruritus) smerte i led, muskler og knogler og nedsat aktivitet i skjoldbruskkirtlen (hypothyreoidisme).
English: What benefits of Opdivo have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Opdivo?
English: By attaching to the receptor, nivolumab prevents PD-L1 and PD-L2 from switching off the T cells, thereby increasing the ability of the immune system to kill cancer cells.
Danish: Ved at binde sig til receptoren forhindrer nivolumab PD-L1 og PD-L2 kræftcellerne i at afbryde T-cellerne.
English: Opdivo is used on its own in patients whose cancer is progressing despite treatment with platinum-based cancer medicines;
Danish: Opdivo anvendes alene til patienter, hvis kræft forværres trods behandling med platinholdige kræftlægemidler
English: Opdivo is used on its own in patients who have been previously treated with other cancer medicines; it is used in combination with ipilimumab (another cancer medicine) in patients with previously untreated disease that is considered to be at moderate or high risk of worsening;
Danish: Det anvendes i kombination med ipilimumab (et andet kræftlægemiddel) hos patienter med en tidligere ubehandlet sygdom, der anses for at have en moderat eller høj risiko for forværring
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Opdivo have also been included in the summary of product characteristics and the package leaflet.
Danish: I produktresuméet og indlægssedlen er der desuden indføjet anbefalinger og forholdsregler, som sundhedspersonale og patienter skal følge med henblik på sikker og effektiv anvendelse af Opdivo.
English: Opdivo is used on its own or with another cancer medicine, ipilimumab, to treat adults whose cancer has spread to other parts of the body or cannot be surgically removed.
Danish: Opdivo er et lægemiddel til behandling af voksne, hvis kræft har spredt sig til andre dele af kroppen eller ikke kan fjernes ved operation.
English: Opdivo was investigated in one main study involving 270 adults with urothelial cancer whose cancer got worse or returned despite previous treatment with platinum medicines.
Danish: Opdivo blev undersøgt i et hovedstudie med 270 voksne med urotelial kræft, hvis kræft forværredes eller vendte tilbage trods tidligere behandling med platinholdige lægemidler.
English: For non-squamous NSCLC, one main study involved 582 adults whose disease had progressed despite previous treatments.
Danish: Et hovedstudie vedrørende ikkeskvamøs NSCLC omfattede 582 voksne, hvis sygdom var forværret trods tidligere behandlinger.
English: Opdivo was investigated in one main study involving 361 adults with SCCHN whose cancer progressed despite previous treatment with platinum medicines.
Danish: Opdivo blev undersøgt i et hovedstudie med 361 voksne med SCCHN, hvis kræft forværredes trods tidligere behandling med platinholdige lægemidler.
English: • urothelial cancer, a cancer of the bladder and urinary tract, that has spread locally and cannot be surgically removed or has spread to other parts of the body.
Danish: • blære- og urinvejskræft (urotelial kræft), som har spredt sig og ikke kan fjernes ved operation, eller som har spredt sig til andre dele af kroppen.
English: How does Opdivo work?
Danish: Hvordan virker Opdivo?
English: Date of first authorisation: 10/02/2015.
Danish: Dato for første markedsføringstilladelse: 10/02/2015.
English: Council Directive 2001/89/EC and Commission Decision 2002/106 prohibit prophylactic vaccination within the European Union.
Danish: Rådets direktiv 2001/89/EC og Kommissionens forordninger 2002/106 forbyder profylaktisk vaccination inden for den Europæiske Union.
English: Sorbitol 70% (solution)
Danish: Sorbitol 70 % (opløsning)
English: The virus is grown in porcine cells.
Danish: Virus er dyrket i porcine celler.
English: According to Community Legislation on classical swine fever (Council Directive 2001/89/EC, as amended), in the European Union:
Danish: I henhold til Kommissionens lovgivning for klassisk svinefeber (Rådets direktiv 2001/89/EC, som ændret) i den Europæiske Union:
English: Each dose of 1 ml contains:
Danish: En dosis på 1 ml indeholder:
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton after EXP {month/year}.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten efter EXP {måned/år}.
English: EU/2/14/179/001 (10 doses) EU/2/14/179/002 (50 doses)
Danish: EU/2/14/179/001 (10 doser) EU/2/14/179/002 (50 doser)
English: After reconstitution, the suspension should be slightly pink clear liquid.
Danish: Efter rekonstitueringen bør suspensionen være en svag lyserød, klar væske.
English: Shelf-life of the veterinary medicinal product as packaged for sale: 2 years.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år.
English: However, the use of vaccines may be authorised in the framework of an emergency vaccination plan, implemented by the competent authority of a Member State following confirmation of disease, in accordance with Community Legislation on control and eradication of classical swine fever.
Danish: Anvendelsen af vaccinen kan dog autoriseres indenfor rammerne af en nødvaccinationsplan, der er implementeret af den kompetente myndighed af medlemsstaten efter at sygdommen er bekræftet i henhold til Kommissionens lovgivning for kontrol og udryddelse af klassisk svinefeber.
English: * min 100 PD50 ** Tissue culture infectious dose
Danish: * min 100 PD50 ** Vævskulturinficerende dosis
English: Shedding of vaccine virus has however not been detected but cannot be excluded.
Danish: Spredning af vaccinevirus er dog ikke blevet påvist, men kan ikke udelukkes.
English: Specific derogation is required to use this vaccine in an outbreak situation.
Danish: Der er påkrævet en særlig dispensation for at anvende denne vaccine i en udbrudssituation
English: Onset of immunity: 14 days after vaccination Duration of immunity: at least 6 months after vaccination
Danish: Varighed af immunitet: Mindst 6 måneder efter vaccination.
English: The excipients (including adjuvants) 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 considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inklusive adjuvanter) som er anført i punkt 6.1 af 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: Limited studies in young pigs support protection against CSF1045 (genotype 2, Germany 2009) and CSF1047 (genotype 2, Israel 2009) field strains.
Danish: Et begrænset antal studier med unge svin understøtter beskyttelse mod CSF1045 (genotype 2, Tyskland 2009) og CSF1047 (genotype 2, Israel 2009) vildstammer.
English: 10 doses 50 doses
Danish: 10 doser 50 doser
English: Challenge studies were conducted with the Koslov strain (genotype 1) of CSFV.
Danish: Eksponeringsstudier blev udført med Koslovstammen (genotype 1) af CSFV.
English: Diagnostic tools targeted to detection of antibody responses could enable DIVA strategies.
Danish: Diagnostiseringsmetoder, der er beregnet til at detektere antistof-respons kan muliggøre DIVA-strategier.
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) Active substance:
Danish: ANGIVELSE AF DE(T) AKTIVE STOF(FER) OG ANDRE INDHOLDSSTOFFER Aktivt stof:
English: c) special provisions regulate the movement of pigs from areas where classical swine fever vaccine is being or has been used and the processing or marking of pig meat from vaccinated pigs.
Danish: c) Særlige bestemmelser regulerer flytning af svin fra områder hvor vaccine mod klassisk svinefeber anvendes eller er blevet anvendt og fremstilling eller mærkning/salg af svinekød fra vaccinerede svin.
English: Persistently infected immunotolerant piglets represent a very high risk since they are shedding field virus and they cannot be identified serologically due to their seronegative status.
Danish: Vedvarende inficerede immuntolerante smågrise udgør en meget høj risiko fordi de kan sprede vildtypevirus og de kan ikke identificeres serologisk på grund af deres seronegative status.
English: Solvent for Suvaxyn CSF Marker
Danish: Solvens til Suvaxyn CSF Marker
English: 6.2 Major Incompatibilities
Danish: 6.2 Væsentlige uforligeligheder
English: a) the use of classical swine fever vaccines is prohibited.
Danish: a) Anvendelse af en vaccination mod klassisk svinefeber er forbudt.
English: L2 Freeze-drying Stabilizer composed as follows Dextran 40
Danish: L2 lyofiliseringsstabilisator indeholdende følgende Dextran 40
English: Documentation provided for this vaccine supports that it is only to be used in an outbreak situation in herds within restricted control zones.
Danish: Dokumentationen for denne vaccine understøtter, at den kun må anvendes i tilfælde af udbrud i besætninger indenfor afgrænsede kontrolzoner.
English: Live recombinant CP7-E2Alf:
Danish: Levende, rekombinant CP7_E2alf:
English: Therefore, the decision to vaccinate breeding boars and piglets with maternally derived antibodies should be taken based on the actual outbreak case and associated control zones.
Danish: Derfor skal beslutning om at vaccinere avlsorner og smågrise med maternelle antistoffer baseres på det aktuelle udbrud og associerede kontrolzoner.
English: Vaccine virus genome is rarely detectable by RT-PCR in tonsils and lymph nodes for up to 63 days after vaccination and vaccine virus is very rarely detectable by virus isolation in tonsil for the first week after vaccination.
Danish: Vaccinevirus-genom er sjældent påviselig ved RT-PCR i tonsiller og lymfeknuder i op til 63 dage efter vaccinationen og vaccine-virus er meget sjældent påviselig via virusisolation i tonsillen i den første uge efter vaccinationen.
English: Use of the vaccine in experimental studies in breeding boars has not revealed safety concerns.
Danish: Brug af vaccinen i eksperimentelle studier med avlsorner påviste ingen sikkerhedsproblemer.
English: b) the manipulation, manufacture, storage, supply, distribution and sale of classical swine fever vaccines must be carried out under supervision and in accordance with the eventual instructions established by the competent authority of the Member State.
Danish: b) Manipulation, fremstilling, opbevaring, levering, distribution og salg af klassiske svinefebervacciner må kun udføres under overvågning af den kompetente myndighed i medlemsstaten.
English: The recombinant vaccine virus has potential marker properties for use in DIVA (differentiation between field virus infected and solely vaccinated animals).
Danish: Det rekombinante vaccinevirus har potentielle markør-egenskaber, som kan anvendes i DIVA (differentiering mellem dyr, der er inficeret med vildtypevirus og dyr, som udelukkende er vaccineret).
English: The vaccine has shown reduced protection in studies of piglets with maternally derived antibodies compared to studies of piglets without maternally derived antibodies.
Danish: Vaccinen har vist nedsat beskyttelse i studier med smågrise med maternelle antistoffer sammenlignet med studier med smågrise uden maternelle antistoffer/
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: Active substance: Lyophilisate:
Danish: Aktivt stof: Lyofilisat:
English: Detailed information on this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/.
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: 104.8* to 106.5 TCID**50
Danish: 104,8* til 106,5 TCID**50
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Danish: TEKSTEN “ KUN TIL DYR” SAMT BETINGELSER ELLER BEGRÆNSNINGER FOR UDLEVERING OG BRUG, OM NØDVENDIGT
English: To stimulate active immunity to Classical Swine Fever virus.
Danish: Den skal stimulere aktiv immunitet mod klassisk svinefeber-virus.
English: Therefore, sows should not be vaccinated, due to the risk of birth of immunotolerant persistently infected offspring.
Danish: Derfor bør søer ikke vaccineres, på grund af risikoen for fødsel af immuntolerant vedvarende inficeret afkom.
English: Incompatibilities: Do not mix with any other veterinary medicinal product.
Danish: Uforligeligheder: Må ikke blandes med lægemidler til dyr.
English: Sodium chloride 9 mg/ml Water for injections q.s.p.
Danish: Natriumchlorid 9 mg/ml Vand til injektionsvæsker q.s.p.
English: Challenge studies have shown lack of protection against transplacental transmission of CSFV.
Danish: Eksponeringsstudier har vist, at vaccinen ikke beskytter mod transplacental overførsel af CSFV.
English: A single 1 ml dose should be administered to pigs from 7 weeks of age.
Danish: En enkelt 1 ml dosis bør administreres intramuskulært til svin fra 7-ugers alderen.
English: Shelf-life after reconstitution according to directions: use immediately.
Danish: Opbevaringstid efter rekonstituering ifølge anvisning: Anvendes straks.
English: Serological DIVA concept has been shown in principle, while actual DIVA tools remain to be tested on large panels of samples from emergency vaccination in outbreak situations.
Danish: I princippet er det serologiske DIVA koncept demonstreret, mens aktuelle DIVA-metoder stadig skal testes på et stort antal prøver fra nødvaccinationer i udbrudsituationer.
English: Basic vaccination A single 1 ml dose should be administered intramuscularly to pigs from 7 weeks of age.
Danish: Basisvaccination En enkelt 1 ml dosis bør administreres intramuskulært til svin fra 7-ugers alderen.
English: Solvent: Clear colourless liquid
Danish: Solvens: Klar, farveløs væske.
English: For active immunisation of pigs from 7 weeks of age onwards to prevent mortality and reduce infection and disease caused by classical swine fever virus (CSFV).
Danish: Til aktiv immunisering af svin fra 7-ugers alderen og frem for at forebygge dødelighed og reducere infektion og sygdom, forårsaget af klassisk svinefebervirus (CSFV).
English: DIVA efficiency depends on the performance of tests related to fitness for purpose in outbreak situations.
Danish: Virkning af DIVA afhænger af gennemførelse af tests relateret til formålet i udbrud-situationer.
English: For active immunisation of pigs from 7 weeks of age onwards to prevent mortality and reduce infection and disease caused by classical swine fever virus.
Danish: Til aktiv immunisering af svin fra 7-ugers alderen og frem for at forebygge dødelighed og reducere infektion og sygdom, forårsaget af klassisk svinefebervirus.
English: Casein hydrolysate
Danish: Caseinhydrolysat
English: Sodium chloride solution 9 mg/ml
Danish: Natriumchlorid opløsning 9 mg/ml
English: Studies in vaccinated breeding boars addressing potential shedding of virulent challenge virus in semen have not been conducted.
Danish: Der er ikke udført studier med vaccinerede avlsorner med henblik på spredning af virulent provokationsvirus i sæd.
English: RT-PCR tools could be used in outbreak situations to differentiate between the vaccine virus genome and those of fields strains based on sequences unique to the CP7_E2alf.
Danish: RT-PCR identifikations-metoder kan anvendes ved et udbrud til at differentiere mellem vaccine-virusgenomer og vildtypestammer baseret på de sekvenser, der er unikke for CP7_E2alf.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Boxes of 1 vial of 10 or 50 doses
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æsker med 1 hætteglas med 10 eller 50 doser
English: Type I hydrolytic glass vials containing 10 or 50 doses of lyophilisate and 10 or 50 ml of solvent.
Danish: Hætteglas af hydrolytisk type I glas, som indeholder 10 eller 50 doser af lyofilisat og 10 eller 50 ml solvens.
English: Basic vaccination
Danish: Basisvaccination
English: EXP {month/year} Once reconstituted use immediately.
Danish: EXP {måned/år} Efter rekonstituering anvendes straks.
English: Reconstitute the lyophilisate aseptically with the solvent to obtain a suspension for injection.
Danish: Lyofilisatet rekonstitueres aseptisk med solvens for at få en suspension til injektion.
English: The vaccine is a live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene.
Danish: Vaccinen er en levende rekombinant E2 gen-deleteret bovin viral diarré virus indeholdende klassisk svinefeber E2 gen.
English: Do not mix with any other veterinary medicinal product.
Danish: Må ikke blandes med lægemidler til dyr.
English: Serological DIVA tools based on detection of CSFV antibodies other than those raised against E2, such as Erns antibody detection should be able to differentiate between antibody responses after solely herd vaccination with CP7_E2alf from responses after natural field CSFV infection.
Danish: Serologiske DIVA metoder baseret på detektering af CSFV antistoffer andre end dem, som opstår mod E2, såsom Erns antistof-detektering, bør være i stand til at differentiere mellem antistof-responser efter vaccination af kun en besætning med CP7_E2alf fra responset efter en naturlig felt-CSFV-infektion.
English: If you notice any side effects, whether or not listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon..
Danish: Dette gælder også bivirkninger, der ikke allerede er anført i denne indlægsseddel eller hvis du mener, at dette lægemiddel ikke har virket efter anbefalingerne.
English: Serological DIVA tools based on detection of CSFV antibodies other than those raised against E2, such as Erns antibody detection should be able to differentiate between antibody responses against Erns-BVDV after solely herd vaccination with CP7_E2alf from responses against Erns-CSFV after natural field CSFV infection.
Danish: Serologiske DIVA metoder baseret på detektering af CSFV antistoffer andre end dem, som opstår mod E2, såsom Erns antistof-detektering, bør være i stand til at differentiere mellem antistof-responser mod Erns BVDV efter kun vaccination af en besætning med CP7_E2alf fra responset mod Erns-CSFV efter en naturlig vildtype-CSFV-infektion.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial (10 and 50 ml)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Hætteglas med solvens (10 og 50 ml)
English: Date of last renewal:
Danish: Dato for seneste fornyelse af markedsføringstilladelse:
English: EXP {month/year} Once broached, use immediately.
Danish: EXP {måned/år} Anvendes straks efter anbrud
English: MARKETING AUTHORISATION NUMBER(S)
Danish: MARKEDSFØRINGSTILLADELSENS NUMRE
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Lyophilisate vial label (10 and 50 doses)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Etiket til hætteglas med lyofilisat (10 og 50 doser)
English: Cardboard box containing 1 vial with 50 doses of lyophilisate and 1 vial with 50 ml solvent.
Danish: Karton som indeholder 1 hætteglas med 50 doser lyofilisat og 1 hætteglas med 50 ml solvens.
English: Cardboard box containing 1 vial with 10 doses of lyophilisate and 1 vial with 10 ml solvent.
Danish: Karton som indeholder 1 hætteglas med 10 doser lyofilisat og 1 hætteglas med 10 ml solvens.
English: Pharmacotherapeutic group: live viral vaccines, live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene, ATC vet code: QI09AD04
Danish: Farmakoterapeutisk gruppe: Levende virale vacciner, levende rekombinant E2-gen-deleteret bovin viral diarré virus, indeholdende klassisk svinefeber E2 gen.
English: Lyophilisate and solvent for suspension for injection for pigs
Danish: Lyofilisat og solvens til injektionsvæske, suspension til svin
English: Live recombinant E2 gene deleted Bovine Viral Diarrhoea Virus containing Classical Swine Fever E2 gene (CP7_E2alf)
Danish: indeholdende klassisk svinefeber E2 gen (CP7_E2alf)
English: Lyophilisate: Off-white pellet
Danish: Lyofilisat: Råhvide pellets.
English: Lyophilisate
Danish: Lyofilisat
English: Suvaxyn CSF Marker lyophilisate for suspension for injection for pigs
Danish: Suvaxyn CSF Marker, lyofilisat til injektionsvæske, suspension til svin
English: Suvaxyn CSF Marker lyophilisate and solvent for suspension for injection for pigs
Danish: Suvaxyn CSF Marker, lyofilisat og solvens til injektionsvæske, suspension til svin
English: PACKAGE LEAFLET: Suvaxyn CSF Marker lyophilisate and solvent for suspension for injection for pigs
Danish: INDLÆGSSEDDEL Suvaxyn CSF Marker, lyofilisat og solvens til injektionsvæske, suspension til svin
English: Lyophilisate: bromobutyl rubber stoppers and aluminium caps Solvent: chlorobutyl rubber stoppers and aluminium caps Cardboard box containing 1 vial with 10 doses of lyophilisate and 1 vial with 10 ml solvent.
Danish: Lyofilisat: Bromobutyl gummilukke og aluminiumslåg.
English: 1ml
Danish: i.m.