FrancophonIA/ELRC3.0 huggingface dataset:
English: Volume of one dose (ml)
Danish: Volumen af 1 dosis (ml)
English: Name and address of the manufacturer of the biological active substance
Danish: Navn og adresse på fremstilleren af den biologisk aktive substans
English: For the full list of excipients, see section 6.1.
Danish: Fortegnelse over alle hjælpestoffer findes i afsnit 6.1.
English: Be familiar with all safety and precautionary measures for handling liquid nitrogen in order to prevent personal injury.
Danish: Vær bekendt med alle sikkerhedsbestemmelser og andre forholdsregler i forbindelse med håndtering af flydende kvælstof for at undgå personskade.
English: The safety and efficacy of the mixed vaccines are not different from those described for the vaccines administered separately.
Danish: Sikkerheden og virkningen af den blandede vaccine er ikke forskellig fra det beskrevne ved anvendelse af de to vacciner separat.
English: Repeat one or two times.
Danish: Gentag proceduren 2-3 gange.
English: Store and transport frozen in liquid nitrogen (-196 °C).
Danish: Opbevares og transporteres i flydende kvælstof (-196 °C).
English: Sterile solvent
Danish: Steril solvent
English: Personnel involved in the treatment of vaccinated birds should follow hygiene principles and take particular care in handling litter from vaccinated chickens.
Danish: Personer der er involveret i behandling af vaccinerede fugle bør overholde hygiejneforskrifterne, og være særligt omhyggelige ved håndtering af hold med vaccinerede kyllinger.
English: Special precautions should be taken to avoid spreading of the vaccine strain to turkeys.
Danish: Der bør tages særlige forholdsregler for at undgå, at vaccinestammen spredes til kalkuner.
English: The canes with ampoules are stored in a liquid nitrogen container.
Danish: Stænger med ampuller opbevares i en beholder med flydende kvælstof.
English: Personal protective equipment consisting of protective gloves, spectacles and boots should be worn when handling the veterinary medicinal product, before withdrawing from liquid nitrogen, during the ampoule thawing and opening operations.
Danish: Personligt beskyttelsesudstyr bestående af beskyttelseshandsker, -briller og -fodtøj bør anvendes når veterinærlægemidlet bliver håndteret, før optagelse fra det flydende kvælstof, ved optøning af ampuller og under åbningsprocessen.
English: As soon as they are completely thawed, open ampoules holding them at arms length in order to prevent any risk of injury should the ampoule break.
Danish: Når indholdet er helt optøet, åbnes ampullerne holdt i strakt arm for at undgå risikoen for skader i tilfælde af, at ampullen går i stykker.
English: Safety trials show the excreted vaccine strain is not harmful in turkeys; however, special precautions should be taken to avoid spreading of the vaccine strain to turkeys.
Danish: Sikkerhedsstudier har vist, at ekskretion af vaccinestammen ikke er skadelig for kalkuner; imidlertid bør der tages særlige forholdsregler for at undgå, at vaccinestammen spredes til kalkuner.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: 6.1 i Produktresuméet anses ikke for at være omhandlet af Kommisionens forordning (EU) Nr. 470/2009, når de anvendes som i dette veterinærlægemiddel.
English: Casein hydrolisate Sorbitol
Danish: Kaseinhydrolisat Sorbitol
English: For active immunisation of 18 day-old embryonated chicken eggs or one-day-old chicks to reduce mortality and clinical signs caused by Newcastle disease virus and to reduce mortality, clinical signs and lesions caused by Marek's disease virus with a phenotype “virulent”.
Danish: Til aktiv immunisering af 18-dage gamle embryonerede hønseæg eller daggamle kyllinger for at reducere dødeligheden og kliniske symptomer forårsaget af Newcastle disease virus, og for at reducere dødeligheden, kliniske symptomer og læsioner forårsaget af virulente stammer af Marek's disease virus.
English: Solvent presentation (ml)
Danish: Solvent pakning (ml)
English: Vaccinated chicks may excrete the vaccine strain.
Danish: Vaccinerede kyllinger kan udskille vaccinevirus.
English: Official control authority batch release is required for this product.
Danish: For dette produkt kræves en Officiel batchfrigivelse.
English: A slow spread to turkeys which was not detectable at 35 days but was detectable after 42 days of a contact study.
Danish: En langsom spredning til kalkuner, hvor virus ikke kunne påvises efter 35 dage, men var påviselige efter 42 dage er påvist i et kontaktforsøg.
English: Laying birds: Do not use in birds in lay and within 4 weeks before the start of the laying period.
Danish: Må ikke anvendes til æglæggende fugle og senere end 4 uger før æglægningsperiodens begyndelse.
English: Use the vaccine immediately, slowly mix regularly to ensure uniform suspension of cells and use within a period not exceeding 2 hours.
Danish: Vaccinen anvendes straks og indholdet vendes jævnligt, for at sikre en ensartet fordeling af celler i opløsningen, som anvendes indenfor en periode på højst 2 timer.
English: Shelf life of the veterinary medicinal product as packaged for sale: suspension: 2 years, solvent: 30 months.
Danish: Holdbarhed af veterinærlægemidlet i salgspakning: suspension: 2 år,
English: Overview table for dilution possibilities of different presentations:
Danish: Oversigtstabel til fortynding af forskellige pakningsstørrelser:
English: The 200 ml presentation may be used for manual vaccination.
Danish: Solvent pakning med 200 ml kan anvendes til manuel vaccination.
English: Thaw rapidly the contents of the ampoules by gentle agitation in water at 27-39 °C.
Danish: Ampullens indhold tøes hurtigt op ved forsigtig omrøring i 27-39°C lunkent vand.
English: In-ovo and subcutaneous use.
Danish: Til in-ovo og subkutan anvendelse.
English: The vaccine strain was shown to be excreted by chickens and there was a slow spread to turkeys which was not detectable at 35 days but was detectable after 42 days of a contact study.
Danish: Det er påvist, at vaccinestammen udskilles fra kyllinger og der skete en langsom spredning til kalkuner i et kontaktstudie, hvor virus ikke kunne påvises efter 35 dage, men var påviselige efter 42 dage.
English: The liquid nitrogen containers must be checked regularly for liquid nitrogen level and must be refilled as needed.
Danish: Mængden af flydende kvælstof i beholdere med flydende kvælstof skal kontrolleres jævnligt, og påfyldning skal ske efter behov.
English: Dipotassium hydrogen phosphate Potassium dihydrogen phosphate Phenol red
Danish: Dikaliumhydrogenfosfat Kaliumdihydrogenfosfat Fenol rødt
English: Liquid nitrogen containers and vaccine ampoules should be handled only by properly trained personnel.
Danish: Beholdere med flydende kvælstof og vaccine bør kun håndteres af særligt uddannet personale.
English: After matching the dose size of the vaccine with the solvent size, quickly remove the exact number of ampoules needed from the liquid nitrogen container.
Danish: Når forholdet mellem antal vaccinedoser og mængden af solvent er fastlagt, tages det eksakte antal nødvendige ampuller hurtigt op af beholderen med flydende kvælstof.
English: Suspension and solvent for suspension for injection.
Danish: Suspension og solvent til opløsning til injektion.
English: The speed of automatic injection is at least 2,500 eggs per hour, therefore solvent presentation of at least or more than 400 ml is recommended to prime and inject for longer than 10 minutes.
Danish: Ved automatisk injektion er hastigheden mindst 2.500 æg pr. time, og derfor anbefales at anvende solvent pakninger med mindst 400 ml for at forberede og injicere i længere tid end 10 minutter.
English: For inovo application an automatic in-ovo egg injector can be used.
Danish: Ved in-ovo applikation kan anvendes en automatisk in-ovo æginjektor.
English: Name and address of the manufacturer responsible for batch release
Danish: Navn og adresse på fremstiller ansvarlig for batch frigivelse
English: Pharmacotherapeutic group: Immunologicals for Aves, live viral vaccines for domestic fowls.
Danish: Farmakoterapeutisk gruppe: Immunologisk produkt til fjerkræ, levende virusvaccine til tamfugle.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE OR OUTER PACKAGES Solvent bags of 200 ml, 400 ml or 800 ml
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Solventposer med 200 ml, 400 ml eller 800 ml
English: In-ovo equipment should be calibrated to ensure that a 0.05 ml dose is applied to each egg.
Danish: In-ovo udstyr bør kalibreres for at sikre, at en dosis på 0,05 ml anvendes til hvert æg.
English: The vaccine may be applied by an automatic syringe.
Danish: Vaccinen kan indgives med automatsprøjte.
English: The efficacy of the vaccine was challenged with the Marek virus strain MD70 which has a phenotype “virulent”.
Danish: Vaccinens effektivitet blev testet med den virulente Marek virusstamme MD70.
English: Veterinary medicinal product subject to prescription.
Danish: Receptpligtigt, veterinært lægemiddel.
English: For in-ovo administration:
Danish: Til administration in-ovo:
English: Shelf life after reconstitution according to directions: 2 hours.
Danish: Holdbarhed efter opblanding som anvist: 2 timer.
English: Vectormune ND suspension and solvent for suspension for injection for chickens
Danish: Vectormune ND, suspension og solvent til suspension til injektion til kyllinger.
English: Do not mix with any other veterinary medicinal product, except Cevac Transmune (where it is marketed) and the solvent (Cevac Solvent Poultry) supplied for use with the veterinary medicinal product.
Danish: Må ikke blandes med andre veterinærlægemidler, undtagen med Cevac Transmune (hvor denne er markedsført) og med den solvent (Cevac Solvent Poultry) som leveres med dette veterinære lægemiddel.
English: Store and use liquid nitrogen only in a dry and well-ventilated place.
Danish: Opbevaring og brug af flydende kvælstof kræver et tørt og velventileret område.
English: Repeat the operations in point 2-7 for the appropriate number of ampoules to be thawed.
Danish: 2-7 indtil den passende mængde ampuller er optøede.
English: Bovine serum Dimethyl sulfoxide Water for injection
Danish: Dimethylsulfoxid Vand til injektionsvæsker
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product, except Cevac Transmune (where it is marketed).
Danish: Der findes ingen tilgængelig information om sikkerhed og virkning af vaccinen, når den anvendes sammen med andre veterinære lægemidler, med undtagelse af Cevac Transmune (hvor denne er markedsført).
English: Duration of immunity for broilers and layers: A single vaccination is sufficient to provide protection during the risk period of infection with Marek's disease.
Danish: Varighed af beskyttende immunitet for slagtekyllinger og æglæggende høns: En enkelt vaccination er tilstrækkelig for at opnå beskyttelse i risikoperioden for infektion med Marek's disease virus.
English: Cell-associated live recombinant viral turkey herpes virus (rHVT/ND) expressing the fusion protein of Newcastle disease virus D-26 lentogenic strain: 2,500-8,000 PFU*/dose
Danish: Celle-associeret, levende, recombinant kalkun herpesvirus (rHVT/ND), der udtrykker fusionsprotein med Newcastle Disease Virus, avirulent stamme D-26: 2.500 - 8.000 PFU
English: Type I glass ampoule containing 1,000, 2,000 or 4,000 doses of the vaccine.
Danish: Type I glasampul indeholdende 1000, 2000 eller 4000 doser vaccine.
English: Transfer the suspension into the solvent bag.
Danish: Overfør opløsningen til posen med solvent.
English: It should be ensured that the vaccine suspension is mixed regularly in a gentle way during the vaccination session to guarantee that the vaccine suspension remains homogenous and that the correct vaccine virus titer is administered (e.g. when automatic inovo injection machines are used or during long vaccination sessions).
Danish: Det bør sikres, at vaccineopløsningen jævnligt blandes forsigtigt i løbet af vaccinationsforløbet så vaccinen forbliver homogen og der til stadighed administreres den korrekte mængde vaccinevirus (f.eks. ved anvendelse af automatisk injektionsmaskine ved in-ovo injektion, eller hvor vaccinationsforløbet strækker sig over lang tid).
English: Once the ampoule is open slowly draw up the content into the 5 ml sterile syringe already containing 2 ml solvent with a needle of at least 18 gauge diameter.
Danish: Så snart ampullen er åbnet trækkes indholdet op i den sterile 5-ml sprøjte, som allerede indeholder 2 ml solvent, med en ikke mindre end 18 gauge (G) kanyle.
English: Company logo or
Danish: logo eller
English: Draw up 2 ml of solvent into a 5 ml syringe.
Danish: Træk 2 ml steril solvent op i en 5 ml sprøjte.
English: Withdraw a portion of the diluted vaccine into the syringe to rinse the ampoule.
Danish: Træk en smule af den opløste vaccine op i sprøjten og skyl ampullen.
English: It should be ensured that the vaccine suspension is mixed regularly in a gentle way during the vaccination session to guarantee that the vaccine suspension remains homogenous and that the correct vaccine virus titer is administered (e.g. when automatic in-ovo injection machines are used or during long vaccination sessions).
Danish: Det bør sikres, at vaccinesuspensionen bliver opblandet regelmæssigt ved forsigtig omrystning undervejs i vaccinationsprocessen, så suspensionen forbliver homogen og administrationen af den korrekte dosering af vaccinens antigener bibeholdes (f.eks. når der anvendes in-ovo vaccinationsmaskine eller varigheden af vaccinationsprocessen er lang).
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Preparation of vaccine suspension for injection:
Danish: Fremstilling af vaccineopløsning til injektion: 1.
English: Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with Cevac Transmune by in ovo or subcutaneous vaccination.
Danish: Der findes tilgængelig information om sikkerheden og virkningen, der viser, at denne vaccine kan blandes og anvendes sammen med Cevac Transmune ved in-ovo eller subkutan vaccination.
English: The mixed products protect against Newcastle disease virus, Marek's disease virus with a phenotype “virulent” and Avian Infectious Bursal Disease (IBD) viruses.
Danish: Denne blandede vaccine beskytter mod Newcastle disease virus, virulente stammer af Mareks disease virus og Avian Infectious Bursal disease (IBD) virus.
English: Match the dose size of the vaccines and the sterile solvent according to the table below.
Danish: Tilpas mængden af vacciner med den sterile opløsningsvæske (solvent) efter følgende skema:
English: Solvent presentation smaller than 400 ml are not recommended to be used for in-ovo application by an automated machine as it may not be enough to prime the machine and to inject for longer than 10 minutes.
Danish: Solvent pakninger mindre end 400 ml anbefales ikke til in-ovo applikation med en automatisk maskine, da det ikke nødvendigvis er tilstrækkeligt til at forberede maskinen og til vaccination i længere tid end 10 minutter.
English: {MM/YYYY}
Danish: [Dato]
English: Vaccine ampoule presentation (No. of vaccine ampoules multiplied by doses needed)
Danish: Vaccineampul pakning (antal ampuller gange nødvendige antal doser)
English: Solvent presentation smaller than 400 ml is not recommended to be used for in-ovo application as it may not be enough to prime the machine and to inject longer than 10 minutes.
Danish: Solventpakninger mindre end 400 ml anbefales ikke til in-ovo applikation med en automatisk maskine, da det ikke nødvendigvis er tilstrækkeligt til at forberede maskinen og til vaccination i længere tid end 10 minutter.
English: The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
Danish: Den fortyndede vaccine opløst som beskrevet vendes forsigtigt i posen, og er klar til brug.
English: Draw up 2 ml of sterile solvent into a 5 ml syringe then draw up the thawed content of Vectormune ND ampoule in it.
Danish: Træk 2 ml steril solvent op i en 5 ml sprøjte og træk derefter det optøede indhold i Vectormune ND ampullen op i sprøjten.
English: One single dose of 0.05 ml is injected into each 18-day-old embryonated broiler chicken egg.
Danish: En enkelt dosis på 0,05 ml injiceres i hver af de 18-dage-gamle embryonerede æg med slagtekyllinger.
English: Duration of immunity for broilers and layers: A single vaccination is sufficient to provide protection during the risk period of infection with Marek's disease virus with a phenotype “virulent”.
Danish: Varighed af beskyttende immunitet for slagtekyllinger og æglæggende høns: En enkelt vaccination er tilstrækkelig for at opnå beskyttelse i risikoperioden for infektion med virulente stammer af Marek's disease virus.
English: Zero days.
Danish: Slagtning: 0 døgn
English: Do not re-use opened containers of diluted vaccine.
Danish: Åbne beholdere med fortyndet vaccine må ikke genanvendes.
English: L-glutamine Sodium bicarbonate Hepes
Danish: Natriumbikarbonat Hepes
English: Draw up 2 ml of sterile solvent into another 5 ml syringe then dissolve the content of Cevac Transmune vial in it.
Danish: Træk 2 ml steril solvent op i en anden 5 ml sprøjte, og opløs derefter indholdet i Cevac Transmune hætteglasset og træk hele indholdet op i sprøjten.
English: Glass ampoule of 1,000; 2,000 or 4,000 doses of the vaccine.
Danish: Glasampuller indeholdende 1000, 2000 eller 4000 doser vaccine.
English: Transfer the dissolved vaccines into the solvent bag and mix by gentle agitation.
Danish: Overfør de opløste vacciner til posen med solvent og bland indholdet ved forsigtigt at vende posen flere gange.
English: Discard any ampoules that have been accidentally thawed.
Danish: Alle ampuller, der fejlagtigt er optøede, skal bortskaffes.
English: Repeat it one or two times.
Danish: Gentag proceduren 23 gange.
English: Duration of immunity against Newcastle disease for layers: 18 week of age.
Danish: Varighed af immunitet mod Newcastle disease for æglæggende høns: til 18-ugers alderen.
English: Do not use Vectormune ND if you notice visible signs of unacceptable decolourisation in the vials.
Danish: Hvis du bemærker synlige tegn på uacceptable farveændringer af flaskens indhold må Vectormune ND ikke anvendes.
English: Solvent: Polyvinylchloride bag containing 200 ml, 400 ml or 800 ml in individual over-pouch.
Danish: Polyvinylkloridpose indeholdende 200 ml, 400 ml eller 800 ml i individuel overtrækspose.
English: Duration of immunity against Newcastle disease for broilers: 9 weeks of age.
Danish: Varighed af immunitet mod Newcastle disease for slagtekyllinger: til 9-ugers alderen.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Ampoules of 1,000, 2,000 or 4,000 doses
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Ampul med 1.000, 2.000 eller 4.000 doser VETERINÆRLÆGEMIDLETS NAVN Vectormune ND
English: Excipients:
Danish: Æglægning:
English: For subcutaneous administration:
Danish: Ved subkutan anvendelse:
English: One single injection of 0.2 ml per chick is applied for broilers at one day of age.
Danish: En enkelt injektion af 0,2 ml pr. kylling anvendes til daggamle slagtekyllinger.
English: Special warnings for each target species: Vaccinate healthy chicks only.
Danish: Vaccinér kun sunde kyllinger.
English: The diluted vaccine prepared as described is mixed by gentle agitation.
Danish: Den fortyndede vaccine, der er forberedt som beskrevet, blandes ved forsigtigt at vende posen flere gange indtil opløsningen er klar til brug.
English: Suspension: EMEM
Danish: EMEM
English: Remove the washing from the ampoule and inject it gently into the solvent bag.
Danish: Sug op i sprøjten og overfør forsigtigt indholdet til posen med solvent.
English: Onset of immunity against Marek's disease for broilers and layers: 1 week of age.
Danish: Beskyttende immunitet mod Marek's disease for slagtekyllinger og kommende æglæggende høns er påvist hos 1 uge gamle kyllinger.
English: Polyvinylchloride bag containing 200 ml of solvent in individual over-pouch.
Danish: Polyvinylkloridpose indeholdende 200 ml solvent i individuel overtrækspose.
English: Polyvinylchloride bag containing 800 ml of solvent in individual over-pouch.
Danish: Polyvinylkloridpose indeholdende 800 ml solvent i individuel overtrækspose.
English: Polyvinylchloride bag containing 400 ml of solvent in individual over-pouch.
Danish: Polyvinylkloridpose indeholdende 400 ml solvent i individuel overtrækspose.
English: Onset of immunity against Newcastle disease for broilers and layers: 3 weeks of age.
Danish: Beskyttende immunitet mod Newcastle disease for slagtekyllinger og kommende æglæggende høns er påvist: ved 3-ugers alderen.
English: 1,000 doses 2,000 doses 4,000 doses
Danish: 2.000 doser
English: MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Danish: Indehaver af markedsføringstilladelse og fremstiller ansvarlig for batch frigivelse: CEVA- Phylaxia Co. Ltd.
English: One single injection of 0.2 ml per chick is applied for broilers or layers at one day of age.
Danish: Én enkelt dosis på 0,2 ml pr. slagtekylling eller kommende æglæggende høne anvendes til daggamle kyllinger.
English: Aranesp has been authorised since June 2001.
Danish: Aranesp har været godkendt siden juni 2001.
English: Further information on Aranesp's current uses can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om de nuværende anvendelser af Aranesp findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: It contains the active substance darbepoetin alfa.
Danish: Det indeholder det aktive stof darbepoetin alfa.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i et klinisk studie og har behov for yderligere information om din behandling, kan du kontakte den læge, der behandler dig.
English: This means that darbepoetin alfa has a longer duration of action, and can be given less often than natural erythropoietin.
Danish: Det betyder, at darbepoetin alfa virker i længere tid og kan gives mindre hyppigt end naturligt erythropoietin.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 March 2018 EMA/165563/2018 EMEA/H/C/000332
Danish: marts 2018 EMA/165563/2018 EMEA/H/C/000332
English: The CHMP was of the opinion that changes to the study design of one study and the exclusion of a high number of patients from the analysis of the results raise questions about the validity of the data.
Danish: CHMP var af den opfattelse, at ændringerne i det ene studies udformning og udelukkelsen af et stort antal patienter fra analysen af resultaterne rejser spørgsmål om dataenes gyldighed.
English: The first study compared Aranesp with placebo (a dummy treatment) over 24 weeks.
Danish: I det første studie blev Aranesp sammenlignet med virkningsløs behandling (placebo) i 24 uger.
English: There are no consequences for the use of Aranesp in its authorised uses.
Danish: Der er ingen konsekvenser for brugen af Aranesp til de godkendte indikationer.
English: The main measure of effectiveness was a reduction in the number of transfusions of red blood cells.
Danish: Virkningen blev hovedsageligt målt på reduktionen i antallet af transfusioner af røde blodlegemer.
English: • adults who are receiving chemotherapy for ‘non-myeloid' cancer (cancer not originating in the bone marrow).
Danish: • voksne, der får kemoterapi for kræft, der ikke udgår fra knoglemarven (ikke-myeloid kræft).
English: In addition, one study conducted in the United States was not in line with EU recommendations for treatment of patients with myelodysplastic syndromes.
Danish: Desuden var det ene studie, der var udført i USA, ikke i overensstemmelse med EU's anbefalinger for behandling af patienter med myelodysplastisk syndrom.