FrancophonIA/ELRC3.0 huggingface dataset:
English: Bleeding events included serious bleeding events, bleeding events assessed as possibly study-drug related by the investigator, bleeding events associated with the need for a red blood cell transfusion, and bleeding events that led to permanent discontinuation of the study drug.
Danish: Blødningstilfælde inkluderer alvorlige tilfælde af blødning forbundet med et behov for transfusion med røde blodlegemer og tilfælde af blødninger, som medførte permanent seponering af forsøgsmedicinen.
English: After reconstitution with 10 ml of Water for Injection each ml contains 2 mg of Drotrecogin alfa (activated).
Danish: Efter rekonstitution med 10 ml vand til injektionsvæsker indeholder hver ml 2 mg drotrecogin alfa (aktiveret).
English: After reconstitution with 2.5 ml of Water for Injection each ml contains 2 mg of Drotrecogin alfa (activated).
Danish: Efter rekonstitution med 2,5 ml vand til injektionsvæsker indeholder hver ml 2 mg drotrecogin alfa (aktiveret).
English: b) history of severe head trauma that required hospitalization, intracranial or intraspinal surgery, or haemorrhagic stroke within the previous 3 months, or any history of intracerebral arteriovenous malformation, cerebral aneurysm, or central nervous system mass lesion; patients with an epidural catheter or who are anticipated to receive an c) history of congenital bleeding diatheses d) gastrointestinal bleeding within the last 6 weeks that has required medical intervention unless definitive surgery has been performed e) trauma patients at increased risk of bleeding
Danish: a) Enhver større operation, defineret som en operation, der kræver generel eller spinal anæstesi foretaget indenfor 12 timer før infusionen, enhver postoperativ patient, som viser tegn på aktiv blødning eller enhver patient med planlagt eller forventet operation b) Anamnese med svært hovedtraume, som har krævet hospitalsindlæggelse, intrakraniel eller intraspinal operation, hæmoragisk apopleksi indenfor de seneste 3 måneder, enhver intracerebral arteriovenøs misdannelse, cerebral aneurisme eller solid svulst i centralnervesystemet eller patienter der har epiduralkateter eller som forventes at få lagt d) Gastrointestinal blødning indenfor de seneste 6 uger, som har krævet medicinsk intervention, medmindre endelig operation har fundet sted e) Traumatiserede patienter med øget risiko for blødning
English: Paediatrics: Data from a placebo-controlled clinical trial which was stopped for futility after 477 patients 0 to 17 years-old had received the study treatment did not establish efficacy of Xigris in paediatric patients and showed a higher rate of central nervous system bleeding in the Xigris versus placebo group.
Danish: Børn: Data fra et placebokontrolleret klinisk forsøg med patienter i alderen 0 til 17 år har ikke fastslået effekten af Xigris hos børn.
English: The incidence of serious bleeding events during infusion (defined as study Day 0 through study Day 6) was 31 (2.4%) and 15 (1.2%) in drotrecogin alfa (activated)-treated and placebo-treated patients, respectively (p=0.02).
Danish: Forekomsten af tilfælde af alvorlige blødning i løbet af infusionsperioden (defineret som forsøgsdag 0 til og med forsøgsdag 6) var henholdsvis 31 (2,4 %) og 15 (1,2 %) af de drotrecogin alfa (aktiveret)-behandlede og placebobehandlede patienter (p=0,02).
English: Do not transport the infusion bag between locations using mechanical delivery
Danish: Transporter ikke infusionsposen mellem afdelinger ved
English: In a randomised study of heparin versus placebo (XPRESS) in 1935 adult severe sepsis patients, all treated with drotrecogin alfa (activated), prophylactic heparin did not adversely affect mortality (heparin 28.3% versus placebo 31.9% in the overall ITT population, and heparin 30.3% versus placebo 26.9% in patients with multiple organ dysfunction treated within 24 hours of their first sepsis-induced organ dysfunction (n=890)).
Danish: I forsøget påvirkede profylaktisk heparinbehandling ikke i nævneværdig grad dødeligheden (heparin 28,3 % mod placebo 31,9 %) i den samlede ITT population, og heparin 30,3 % mod placebo 26,9 % hos de patienter med multipel organdysfunktion, som havde modtaget behandling indenfor 24 timer efter deres første sepsisinducerede organ dysfunktion (n=890).
English: The solution of reconstituted Xigris should be diluted into an infusion bag containing sterile 0.9% Sodium Chloride Injection to a final concentration of between
Danish: Rekonstitueret Xigris skal fortyndes i en infusionspose indeholdende steril natriumchlorid injektionsvæske 0,9 % til en færdig koncentration på mellem
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Xigris 5 mg powder for infusion
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER INDGIVELSESVEJ(E) Xigris 5 mg pulver til infusionsvæske
English: Xigris may be restarted 12 hours after major invasive procedures or surgery if adequate haemostasis has been achieved.
Danish: Hvis adækvat hæmostase er opnået, kan Xigris genstartes 12 timer efter større invasive procedurer eller operationer.
English: Lot {number}
Danish: Batch {nummer}
English: After preparation, the intravenous infusion solution can be used at room temperature (15 to 30ºC) for a period up to 14 hours.
Danish: Efter tilberedning kan den intravenøse infusionsvæske bruges ved stuetemperatur (15°C til 30°C) i op til 14 timer.
English: - The other ingredients are sucrose, sodium chloride, sodium citrate, citric acid, hydrochloric acid
Danish: - Øvrige indholdsstoffer: saccharose, natriumchlorid, natriumcitrat, citronsyre, saltsyre og
English: Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder: Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, The Netherlands
Danish: Indehaver af markedsføringstilladelsen: Eli Lilly Nederland B.V., Grootslag 1-5, 3991 RA, Houten, Holland
English: It is recommended that the bag be labelled
Danish: Det anbefales, at infusionsposen mærkes i
English: For the other reports, the observed events were consistent with known undesirable effects of the drug (see section 4.8), effects of the drug on laboratory tests (see section 4.4), or consequences of the underlying condition of sepsis.
Danish: I de resterende tilfælde var de observerede hændelser i overensstemmelse med kendte bivirkninger for lægemidlet (se pkt.
English: In a Phase 3b international, single-arm, open-label clinical trial (ENHANCE), 2378 adult patients with severe sepsis received drotrecogin alfa (activated).
Danish: I et internationalt, enkelt-arm, open-label klinisk fase 3b forsøg (ENHANCE) modtog 2378 voksne patienter med svær sepsis drotrcogin alfa (aktiveret).
English: There was a higher rate of central nervous system (CNS) bleeding in the drotrecogin alfa (activated) versus the placebo group.
Danish: I infusionsperioden (forsøgsdag 0-6) var der en højere forekomst af blødninger i centralnervesystemet (CNS) i drotrecogin alfa (aktiveret)-gruppen i forhold til placebogruppen.
English: After preparation, the intravenous infusion solution can be used at room temperature (15 to
Danish: Efter tilberedning kan den intravenøse infusionsvæske bruges ved stuetemperatur (15 til 30°C) i
English: Excipient: Each vial contains approximately 17 mg sodium.
Danish: Hjælpestoffer: Hvert hætteglas indeholder ca. 17 mg natrium.
English: The incidence of CNS bleeds during infusion was 4 (0.3%) and 3 (0.2%) for drotrecogin alfa (activated)-treated and placebo-treated patients, respectively.
Danish: Hyppigheden af CNS-blødninger i løbet af infusionsperioden var henholdsvis 4 (0,3 %) og 3 (0,2 %) af de drotrecogin alfa (aktiveret)-behandlede og placebobehandlede patienter.
English: Excipient: Each vial contains approximately 68 mg sodium.
Danish: Hjælpestoffer: Hvert hætteglas indeholder ca. 68 mg natrium.
English: A total of 2640 adult patients with severe sepsis who were at low risk of death (e.g. patients with APACHE II<25 or with only one sepsis-induced organ failure) were enrolled in a randomised, doubleblind, placebo-controlled trial (ADDRESS).
Danish: I et randomiseret, dobbeltblindt, placebokontrolleret klinisk forsøg (ADDRESS) blev der i alt indrulleret 2640 voksne patienter med svær sepsis og en lav dødelighedsrisiko (APACHE II<25 eller kun med et sepsis-induceret organsvigt).
English: In the placebo-controlled ADDRESS study, the incidence of serious bleeding events during the 28-day study period was 51 (3.9%) and 28 (2.2%) in drotrecogin alfa (activated)-treated and placebo-treated patients, respectively (p=0.01).
Danish: I den 28-dages forsøgsperiode i det placebokontrollerede ADDRESS forsøg var hyppigheden af tilfælde af alvorlige blødning henholdsvis 51 (3,9 %) og 28 (2,2 %) af de drotrecogin alfa (aktiveret)behandlede og placebobehandlede patienter (p=0,01).
English: Manufacturer: Lilly Pharma Fertigung und Distribution GmbH & Co. KG, Teichweg 3, D- 35396 Giessen, Germany.
Danish: KG, Teichweg 3, D-35396 Giessen, Tyskland.
English: This means that for scientific reasons it has been impossible to get complete information on this medicine.
Danish: Det betyder, at det ikke har været muligt at opnå fuldstændig dokumentation for Xigris af videnskabelige årsager.
English: Skin/soft tissue
Danish: Genitourinary Hud/blødt væv Nasopharyngeal Led/knogler Ukendt sted2
English: In XPRESS serious bleeding rates were consistent with those observed in previous studies during the 28-day study period (days 0-28).
Danish: Hyppigheden af alvorlige blødninger stemte overens med den hyppighed, der var observeret i tidligere forsøg med en behandlingsperiode på 0-6 dage.
English: In the multiple organ dysfunction subgroup of ADDRESS the 28-day placebo mortality was 21.9%, similar to the single organ dysfunction subgroup of PROWESS (21.2%), confirming the lack of efficacy in patients with severe sepsis who are at low risk of death.
Danish: Hos undergruppen med flere organ dysfunktioner i ADDRESS-forsøget var 28-dages dødeligheden hos placebobehandlede patienter 21, 9 % i lighed med den fundne værdi hos undergruppen med en enkelt organdysfunktion i PROWESS-forsøget (21, 2 %).
English: • Recent administration (within 7 days) of aspirin or other platelet inhibitors
Danish: • Nylig (indenfor 7 dage) administration af acetylsalicylsyre eller andre trombocytfunktionshæmmende midler
English: Xigris is contraindicated in children below the age of 18 (see section 4.3 and 5.1).
Danish: Xigris er kontraindiceret til børn under 18 år (se pkt.
English: However, the reconstituted solution in the vial may be held for up to 3 hours at room temperature (15 to 30ºC).
Danish: Den rekonstituerede opløsning i hætteglasset kan dog holde sig i op til 3 timer ved stuetemperatur (15 til 30°C).
English: • Recent administration (within 3 days) of thrombolytic therapy
Danish: • Nylig (indenfor 3 dage) administration af trombolytisk behandling
English: The incidence of CNS bleeds during the 28-day study period was 0.2% and 0.1% for drotrecogin alfa (activated)treated and placebo-treated patients, respectively.
Danish: Hyppigheden af CNS-blødninger i løbet af den 28-dages forsøgsperiode var henholdsvis 0,2 % og 0,1 % af de drotrecogin alfa (aktiveret)-behandlede og placebobehandlede patienter.
English: However, the reconstituted solution in the vial may be held for up to 3 hours at room temperature (15ºC - 30ºC).
Danish: Den rekonstituerede opløsning i hætteglasset kan dog holde sig i op til 3 timer ved stuetemperatur (15°C - 30°C).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 5 mg of Drotrecogin alfa (activated).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas indeholder 5 mg drotrecogin alfa (aktiveret).
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 20 mg of Drotrecogin alfa (activated).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hvert hætteglas indeholder 20 mg drotrecogin alfa (aktiveret).
English: Chloride Injection.
Danish: Natrumhydroxid.
English: The incidence of CNS bleeds during the 28-day study period was 6 (0.5%) and 5 (0.4%) for drotrecogin alfa (activated)-treated and placebo-treated patients, respectively.
Danish: Hyppigheden af CNS-blødninger i den 28-dages forsøgsperiode var henholdsvis 6 (0,5 %) og 5 (0,4 %) af de drotrecogin alfa (aktiveret)-behandlede og placebobehandlede patienter.
English: Prior to administration, 20 mg vials of Xigris must be reconstituted with 10 ml of Sterile Water for Injection, resulting in a solution with a concentration of approximately 2 mg/ml drotrecogin alfa (activated).
Danish: Før administration skal 20 mg hætteglas med Xigris rekonstitueres med 10 ml sterilt vand til injektionsvæsker, hvilket resulterer i en opløsning med en koncentration på ca. 2 mg/ml drotrecogin alfa (aktiveret).
English: Xigris should be administered via a dedicated intravenous line or a dedicated lumen of a multilumen central venous catheter.
Danish: Xigris bør administreres igennem en infusionsslange, hvori kun dette lægemiddel administreres, eller i en adgang i et centralt venekateter med flere adgange, hvor den pågældende adgang er forbeholdt dette lægemiddel.
English: Xigris is a recombinant version of the natural plasma-derived activated Protein C, from which it differs only by unique oligosaccharides in the carbohydrate portion of the molecule.
Danish: Xigris er en rekombinant udgave af det naturlige aktiverede protein C, som findes i plasma.
English: A vial contains 5 mg of drotrecogin alfa (activated).
Danish: Et hætteglas indeholder 5 mg drotrecogin alfa (aktiveret).
English: Site of haemorrhage
Danish: TEKST PÅ HÆTTEGLAS
English: If Xigris is readministered to patients, caution should be employed.
Danish: Der bør udvises forsigtighed ved gentagen administration af Xigris til patienter.
English: Each Xigris vial contains 5 mg of drotrecogin alfa (activated).
Danish: Hvert Xigris hætteglas indeholder 5 mg drotrecogin alfa (aktiveret).
English: Each Xigris vial contains 20 mg of drotrecogin alfa (activated).
Danish: Hvert Xigris hætteglas indeholder 20 mg drotrecogin alfa (aktiveret).
English: A vial contains 20 mg of drotrecogin alfa (activated).
Danish: Et hætteglas indeholder 20 mg drotrecogin alfa (aktiveret).
English: Retroperitoneal
Danish: Natrumhydroxid
English: Powder for solution for infusion.
Danish: Pulver til infusionsvæske, opløsning.
English: Prior to administration, 5 mg vials of Xigris must be reconstituted with 2.5 ml of Sterile Water for Injection, resulting in a solution with a concentration of approximately 2 mg/ml drotrecogin
Danish: Før administration skal 5 mg hætteglas med Xigris rekonstitueres med 2,5 ml sterilt vand til injektionsvæsker, hvilket resulterer i en opløsning med en koncentration på ca. 2 mg/ml
English: What Xigris contains - The active substance is 20 mg of drotrecogin alfa (activated) in each vial.
Danish: Xigris indeholder: - Aktivt stof: 20 mg drotrecogin alfa (aktiveret) i hvert hætteglas.
English: What Xigris contains - The active substance is 5 mg of drotrecogin alfa (activated) in each vial.
Danish: Xigris indeholder: - Aktivt stof: 5 mg drotrecogin alfa (aktiveret) i hvert hætteglas.
English: 3 In ENHANCE six patients experienced multiple serious bleeding events during the study drug infusion period
Danish: 3 Seks patienter oplevede flere alvorlige tilfælde af blødning i perioden med infusion af forsøgsmedicin i ENHANCE forsøget (94 tilfælde er observeret hos 85 patienter).
English: Xigris 5 mg powder for solution for infusion Drotrecogin alfa (activated)
Danish: Xigris 5 mg pulver til infusionsvæske, opløsning Drotrecogin alfa (aktiveret)
English: Prior to administration, 20 mg vials of Xigris must be reconstituted with 10 ml of Sterile Water for Injection, resulting in a solution with a concentration of approximately 2 mg/ml drotrecogin
Danish: Før administration skal 20 mg hætteglas med Xigris rekonstitueres med 10 ml sterilt vand til injektionsvæsker, hvilket resulterer i en opløsning med en koncentration på ca. 2 mg/ml
English: NAME OF THE MEDICINAL PRODUCT Xigris 20 mg powder for solution for infusion drotrecogin alfa (activated)
Danish: LÆGEMIDLETS NAVN Xigris 20 mg pulver til infusionsvæske, opløsning Drotrecogin alfa (aktiveret)
English: NAME OF THE MEDICINAL PRODUCT Xigris 20 mg powder for solution for infusion
Danish: LÆGEMIDLETS NAVN Xigris 20 mg pulver til infusionsvæske, opløsning.
English: Xigris 20 mg powder for solution for infusion Drotrecogin alfa (activated)
Danish: Xigris 20 mg pulver til infusionsvæske, opløsning Drotrecogin alfa (aktiveret)
English: In addition, approximately 2 hours after terminating the infusion of the drug, there is virtually no measurable activity of drotrecogin alfa (activated) remaining in the circulation of the patient; blood samples drawn for APTT determination after this point are no longer affected by the drug.
Danish: Tilsvarende er der stort set ingen målbar aktivitet af drotrecogin alfa (aktiveret) i patientens kredsløb ca. 2 timer efter infusionens afslutning.
English: NAME OF THE MEDICINAL PRODUCT Xigris 5 mg powder for solution for infusion drotrecogin alfa (activated)
Danish: LÆGEMIDLETS NAVN Xigris 5 mg pulver til infusionsvæske, opløsning Drotrecogin alfa (aktiveret)
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 20 mg of Drotrecogin alfa (activated).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 20 mg Drotrecogin alfa (aktiveret).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial contains 5 mg of Drotrecogin alfa (activated).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas indeholder 5 mg Drotrecogin alfa (aktiveret).
English: Genitourinary
Danish: Børn
English: Over the infusion period (study days 0-6) the number of patients experiencing CNS bleeding was 5 versus 1 (2.1% versus 0.4%) for the overall population (drotrecogin alfa (activated) versus placebo), with 4 of the 5 events in the drotrecogin alfa (activated) group occurring in patients ≤ 60 days old or ≤ 3.5 kg bodyweight.
Danish: Antallet af patienter, som oplevede CNS-blødninger var 5 mod 1 (2,1 % mod 0,4 %) for hele forsøgspopulationen (drotrecogin alfa (aktiveret) mod placebo).
English: NAME OF THE MEDICINAL PRODUCT Xigris 5 mg powder for solution for infusion
Danish: LÆGEMIDLETS NAVN Xigris 5 mg pulver til infusionsvæske, opløsning.
English: It is not known whether drotrecogin alfa (activated) appears in human milk and therefore you should not breast-feed whilst treated with Xigris.
Danish: Det vides ikke, om drotrecogin alfa (aktiveret) findes i modermælk.
English: - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Danish: Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her.
English: Serious bleeding events during the 28-day study period In PROWESS, the incidence of serious bleeding events during the 28-day study period was 3.5% and 2.0% in drotrecogin alfa (activated)-treated and placebo-treated patients, respectively.
Danish: I PROWESS forsøget opstod der alvorlige tilfælde af blødning hos henholdsvis 3,5 % og 2,0 % af de drotrecogin alfa (aktiveret)-behandlede og placebobehandlede patienter i løbet af den 28-dages forsøgsperiode.
English: In XPRESS, a randomised study of prophylactic heparin versus placebo in adult severe sepsis patients, all treated with drotrecogin alfa (activated), serious bleeding rates were consistent with those observed in previous studies over the treatment period of 0-6 days, and prophylactic heparin did not increase the risk of serious bleeding compared to placebo (2.3% vs 2.5%, respectively), including CNS bleeding (0.3% on both arms).
Danish: Profylaktisk heparinbehandling forøgede ikke risikoen for alvorlig blødning sammenlignet med placebo (henholdsvis 2,3 % for heparinbehandling mod 2,5 % for placebo), dette inkluderer CNS-blødning (0,3 % for begge forsøgsarme).
English: A total of 2378 adult patients with severe sepsis received drotrecogin alfa (activated) in a Phase 3b, international, single-arm, open-label clinical trial (ENHANCE).
Danish: I et internationalt, enkelt arm, open-label fase 3b klinisk forsøg (ENHANCE) modtog i alt 2378 voksne patienter med svær sepsis drotrecogin alfa (aktiveret).
English: There are no risks for the user, the consumer or the environment.
Danish: Der er ingen risici for brugeren, forbrugeren eller miljøet.
English: Van den Berg T. P., Gonze M., Meulemans G. 1991.
Danish: T. P.Van den Berg, M. Gonze, G. Meulemans 1991.
English: Chettle N., Stuart J. C., Wyeth P. J. 1989.
Danish: N. Chettle, J. C. Stuart, P. J. Wyeth 1989.
English: It was considered that the risks associated with this immunosuppression were not sufficiently addressed in the application.
Danish: Man mente ikke, at risiciene forbundet med denne immunosuppression var behandlet tilstrækkeligt i ansøgningen.
English: • The field study supports the safety of the vaccine.
Danish: • Feltundersøgelsen støtter vaccinens sikkerhed.
English: GROUNDS FOR RECOMMENDATION OF THE GRANTING OF MARKETING AUTHORISATIONS
Danish: BEGRUNDELSE FOR ANBEFALING AF UDSTEDELSE AF EN MARKEDSFØRINGSTILLADELSE
English: THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, RECOMMENDED DOSE, WITHDRAWAL PERIOD, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Danish: LISTE OVER LÆGEMIDLETS NAVNE, LÆGEMIDDELFORM, STYRKE, DYREARTER, INDGIVELSESVEJ, ANBEFALET DOSIS, TILBAGEHOLDELSESTID, ANSØGER/INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: • Product Safety Update Reports in the UK, where the product has been authorised since 1998, have not indicated a problem with immunosuppression.
Danish: • Opdaterede produktsikkerhedsindberetninger i Det Forenede Kongerige, hvor produktet har været godkendt siden 1998, har ikke vist noget problem med immunosuppression.
English: Although the oral route is recommended, some safety studies have been carried out using the intraocular route.
Danish: Selv om den orale vej anbefales, er der blevet gennemført sikkerhedsundersøgelser, hvor den intraokulare vej er blevet anvendt.
English: Maximum doses of virus, at minimum passage level, were used in almost all the pivotal safety studies (4 out of 5).
Danish: Der blev anvendt maksimale virusdoser ved minimumspassageniveau i næsten alle de pivotale sikkerhedsundersøgelser (4 ud af 5).
English: Withdrawal period (meat)
Danish: Tilbageholdel sestid (kød)
English: Recommended dose
Danish: Indgivelsesvej Anbefalet dosis
English: Having considered all the overall submitted data in writing the CVMP concluded that:
Danish: Efter at have analyseret alle de indsendte skriftlige data konkluderede CVMP følgende:
English: Czech Republic
Danish: Tjekkiske Republik
English: In addition the intrinsic immunosuppressive nature of the vaccine strain is further evidenced in another study.
Danish: Vaccinestammens iboende immunosuppressive natur påvises desuden i en anden undersøgelse.
English: Applicant/ Marketing Authorisation Holder
Danish: Ansøger/ Indehaver af markedsførings tilladelse
English: There are sufficient recommendations and warnings provided to ensure that the veterinarian can determine whether the product is appropriate for use in an outbreak of vvIBD.
Danish: Der er fremsat tilstrækkelige anbefalinger og advarsler til at sikre, at dyrlægen kan afgøre, om produktet er egnet til brug i forbindelse med et udbrud af vvIBD.
English: The benefit/risk balance for the product is considered positive.
Danish: Benefit/risk-forholdet for produktet anses for at være positivt.
English: • There is no risk for the consumer of vaccinated chickens, nor is there any risk for the user of the vaccine or the environment.
Danish: • Vaccinerede kyllinger indebærer ikke nogen risiko for forbrugeren, og der er heller ingen risiko for brugeren af vaccinen eller miljøet.
English: Benefit/Risk assessment
Danish: Benefit/risk-vurdering
English: The vaccine is to be specifically used in case of outbreaks caused by very virulent IBDV (vvIBDV) strains.
Danish: Vaccinen skal specifikt anvendes i tilfælde af udbrud forårsaget af meget virulente IBDV-stammer (vvIBDV).