natgillin/translations-raw huggingface dataset:
Sikkerheden og virkningen af den blandede vaccine er ikke forskellig fra det beskrevne ved anvendelse af de to vacciner separat.
The safety and efficacy of the mixed vaccines are not different from those described for the vaccines administered separately.
Gentag proceduren 2-3 gange.
Repeat one or two times.
Opbevares og transporteres i flydende kvælstof (-196 °C).
Store and transport frozen in liquid nitrogen (-196 °C).
Steril solvent
Sterile solvent
Personer der er involveret i behandling af vaccinerede fugle bør overholde hygiejneforskrifterne, og være særligt omhyggelige ved håndtering af hold med vaccinerede kyllinger.
Personnel involved in the treatment of vaccinated birds should follow hygiene principles and take particular care in handling litter from vaccinated chickens.
Der bør tages særlige forholdsregler for at undgå, at vaccinestammen spredes til kalkuner.
Special precautions should be taken to avoid spreading of the vaccine strain to turkeys.
Stænger med ampuller opbevares i en beholder med flydende kvælstof.
The canes with ampoules are stored in a liquid nitrogen container.
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.
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.
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.
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.
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.
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.
6.1 i Produktresuméet anses ikke for at være omhandlet af Kommisionens forordning (EU) Nr. 470/2009, når de anvendes som i dette veterinærlægemiddel.
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.
Kaseinhydrolisat Sorbitol
Casein hydrolisate Sorbitol
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.
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”.
Solvent pakning (ml)
Solvent presentation (ml)
Vaccinerede kyllinger kan udskille vaccinevirus.
Vaccinated chicks may excrete the vaccine strain.
For dette produkt kræves en Officiel batchfrigivelse.
Official control authority batch release is required for this product.
En langsom spredning til kalkuner, hvor virus ikke kunne påvises efter 35 dage, men var påviselige efter 42 dage er påvist i et kontaktforsøg.
A slow spread to turkeys which was not detectable at 35 days but was detectable after 42 days of a contact study.
Må ikke anvendes til æglæggende fugle og senere end 4 uger før æglægningsperiodens begyndelse.
Laying birds: Do not use in birds in lay and within 4 weeks before the start of the laying period.
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.
Use the vaccine immediately, slowly mix regularly to ensure uniform suspension of cells and use within a period not exceeding 2 hours.
Holdbarhed af veterinærlægemidlet i salgspakning: suspension: 2 år,
Shelf life of the veterinary medicinal product as packaged for sale: suspension: 2 years, solvent: 30 months.
Oversigtstabel til fortynding af forskellige pakningsstørrelser:
Overview table for dilution possibilities of different presentations:
Solvent pakning med 200 ml kan anvendes til manuel vaccination.
The 200 ml presentation may be used for manual vaccination.
Ampullens indhold tøes hurtigt op ved forsigtig omrøring i 27-39°C lunkent vand.
Thaw rapidly the contents of the ampoules by gentle agitation in water at 27-39 °C.
Til in-ovo og subkutan anvendelse.
In-ovo and subcutaneous use.
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.
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.
Mængden af flydende kvælstof i beholdere med flydende kvælstof skal kontrolleres jævnligt, og påfyldning skal ske efter behov.
The liquid nitrogen containers must be checked regularly for liquid nitrogen level and must be refilled as needed.
Dikaliumhydrogenfosfat Kaliumdihydrogenfosfat Fenol rødt
Dipotassium hydrogen phosphate Potassium dihydrogen phosphate Phenol red
Beholdere med flydende kvælstof og vaccine bør kun håndteres af særligt uddannet personale.
Liquid nitrogen containers and vaccine ampoules should be handled only by properly trained personnel.
Når forholdet mellem antal vaccinedoser og mængden af solvent er fastlagt, tages det eksakte antal nødvendige ampuller hurtigt op af beholderen med flydende kvælstof.
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.
Suspension og solvent til opløsning til injektion.
Suspension and solvent for suspension for injection.
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.
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.
Ved in-ovo applikation kan anvendes en automatisk in-ovo æginjektor.
For inovo application an automatic in-ovo egg injector can be used.
Navn og adresse på fremstiller ansvarlig for batch frigivelse
Name and address of the manufacturer responsible for batch release
Farmakoterapeutisk gruppe: Immunologisk produkt til fjerkræ, levende virusvaccine til tamfugle.
Pharmacotherapeutic group: Immunologicals for Aves, live viral vaccines for domestic fowls.
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Solventposer med 200 ml, 400 ml eller 800 ml
PARTICULARS TO APPEAR ON THE IMMEDIATE OR OUTER PACKAGES Solvent bags of 200 ml, 400 ml or 800 ml
In-ovo udstyr bør kalibreres for at sikre, at en dosis på 0,05 ml anvendes til hvert æg.
In-ovo equipment should be calibrated to ensure that a 0.05 ml dose is applied to each egg.
Vaccinen kan indgives med automatsprøjte.
The vaccine may be applied by an automatic syringe.
Vaccinens effektivitet blev testet med den virulente Marek virusstamme MD70.
The efficacy of the vaccine was challenged with the Marek virus strain MD70 which has a phenotype “virulent”.
Receptpligtigt, veterinært lægemiddel.
Veterinary medicinal product subject to prescription.
Til administration in-ovo:
For in-ovo administration:
Holdbarhed efter opblanding som anvist: 2 timer.
Shelf life after reconstitution according to directions: 2 hours.
Vectormune ND, suspension og solvent til suspension til injektion til kyllinger.
Vectormune ND suspension and solvent for suspension for injection for chickens
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.
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.
Opbevaring og brug af flydende kvælstof kræver et tørt og velventileret område.
Store and use liquid nitrogen only in a dry and well-ventilated place.
2-7 indtil den passende mængde ampuller er optøede.
Repeat the operations in point 2-7 for the appropriate number of ampoules to be thawed.
Dimethylsulfoxid Vand til injektionsvæsker
Bovine serum Dimethyl sulfoxide Water for injection
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).
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).
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.
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.
Celle-associeret, levende, recombinant kalkun herpesvirus (rHVT/ND), der udtrykker fusionsprotein med Newcastle Disease Virus, avirulent stamme D-26: 2.500 - 8.000 PFU
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
Type I glasampul indeholdende 1000, 2000 eller 4000 doser vaccine.
Type I glass ampoule containing 1,000, 2,000 or 4,000 doses of the vaccine.
Overfør opløsningen til posen med solvent.
Transfer the suspension into the solvent bag.
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).
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).
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.
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.
logo eller
Company logo or
Træk 2 ml steril solvent op i en 5 ml sprøjte.
Draw up 2 ml of solvent into a 5 ml syringe.
Træk en smule af den opløste vaccine op i sprøjten og skyl ampullen.
Withdraw a portion of the diluted vaccine into the syringe to rinse the ampoule.
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).
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).
FREMSTILLER AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Fremstilling af vaccineopløsning til injektion: 1.
Preparation of vaccine suspension for injection:
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.
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.
Denne blandede vaccine beskytter mod Newcastle disease virus, virulente stammer af Mareks disease virus og Avian Infectious Bursal disease (IBD) virus.
The mixed products protect against Newcastle disease virus, Marek's disease virus with a phenotype “virulent” and Avian Infectious Bursal Disease (IBD) viruses.
Tilpas mængden af vacciner med den sterile opløsningsvæske (solvent) efter følgende skema:
Match the dose size of the vaccines and the sterile solvent according to the table below.
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.
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.
[Dato]
{MM/YYYY}
Vaccineampul pakning (antal ampuller gange nødvendige antal doser)
Vaccine ampoule presentation (No. of vaccine ampoules multiplied by doses needed)
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.
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.
Den fortyndede vaccine opløst som beskrevet vendes forsigtigt i posen, og er klar til brug.
The diluted vaccine prepared as described is mixed by gentle agitation so as to be ready for use.
Træk 2 ml steril solvent op i en 5 ml sprøjte og træk derefter det optøede indhold i Vectormune ND ampullen op i sprøjten.
Draw up 2 ml of sterile solvent into a 5 ml syringe then draw up the thawed content of Vectormune ND ampoule in it.
En enkelt dosis på 0,05 ml injiceres i hver af de 18-dage-gamle embryonerede æg med slagtekyllinger.
One single dose of 0.05 ml is injected into each 18-day-old embryonated broiler chicken egg.
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.
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”.
Slagtning: 0 døgn
Zero days.
Åbne beholdere med fortyndet vaccine må ikke genanvendes.
Do not re-use opened containers of diluted vaccine.
Natriumbikarbonat Hepes
L-glutamine Sodium bicarbonate Hepes
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.
Draw up 2 ml of sterile solvent into another 5 ml syringe then dissolve the content of Cevac Transmune vial in it.
Glasampuller indeholdende 1000, 2000 eller 4000 doser vaccine.
Glass ampoule of 1,000; 2,000 or 4,000 doses of the vaccine.
Overfør de opløste vacciner til posen med solvent og bland indholdet ved forsigtigt at vende posen flere gange.
Transfer the dissolved vaccines into the solvent bag and mix by gentle agitation.
Alle ampuller, der fejlagtigt er optøede, skal bortskaffes.
Discard any ampoules that have been accidentally thawed.
Gentag proceduren 23 gange.
Repeat it one or two times.
Varighed af immunitet mod Newcastle disease for æglæggende høns: til 18-ugers alderen.
Duration of immunity against Newcastle disease for layers: 18 week of age.
Hvis du bemærker synlige tegn på uacceptable farveændringer af flaskens indhold må Vectormune ND ikke anvendes.
Do not use Vectormune ND if you notice visible signs of unacceptable decolourisation in the vials.
Polyvinylkloridpose indeholdende 200 ml, 400 ml eller 800 ml i individuel overtrækspose.
Solvent: Polyvinylchloride bag containing 200 ml, 400 ml or 800 ml in individual over-pouch.
Varighed af immunitet mod Newcastle disease for slagtekyllinger: til 9-ugers alderen.
Duration of immunity against Newcastle disease for broilers: 9 weeks of age.
MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Ampul med 1.000, 2.000 eller 4.000 doser VETERINÆRLÆGEMIDLETS NAVN Vectormune ND
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Ampoules of 1,000, 2,000 or 4,000 doses
Æglægning:
Excipients:
Ved subkutan anvendelse:
For subcutaneous administration:
En enkelt injektion af 0,2 ml pr. kylling anvendes til daggamle slagtekyllinger.
One single injection of 0.2 ml per chick is applied for broilers at one day of age.
Vaccinér kun sunde kyllinger.
Special warnings for each target species: Vaccinate healthy chicks only.
Den fortyndede vaccine, der er forberedt som beskrevet, blandes ved forsigtigt at vende posen flere gange indtil opløsningen er klar til brug.
The diluted vaccine prepared as described is mixed by gentle agitation.
Sug op i sprøjten og overfør forsigtigt indholdet til posen med solvent.
Remove the washing from the ampoule and inject it gently into the solvent bag.
Beskyttende immunitet mod Marek's disease for slagtekyllinger og kommende æglæggende høns er påvist hos 1 uge gamle kyllinger.
Onset of immunity against Marek's disease for broilers and layers: 1 week of age.
Polyvinylkloridpose indeholdende 200 ml solvent i individuel overtrækspose.
Polyvinylchloride bag containing 200 ml of solvent in individual over-pouch.
Polyvinylkloridpose indeholdende 800 ml solvent i individuel overtrækspose.
Polyvinylchloride bag containing 800 ml of solvent in individual over-pouch.
Polyvinylkloridpose indeholdende 400 ml solvent i individuel overtrækspose.
Polyvinylchloride bag containing 400 ml of solvent in individual over-pouch.
Beskyttende immunitet mod Newcastle disease for slagtekyllinger og kommende æglæggende høns er påvist: ved 3-ugers alderen.
Onset of immunity against Newcastle disease for broilers and layers: 3 weeks of age.
2.000 doser
1,000 doses 2,000 doses 4,000 doses
Indehaver af markedsføringstilladelse og fremstiller ansvarlig for batch frigivelse: CEVA- Phylaxia Co. Ltd.
MANUFACTURER RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE C. STATEMENT OF THE MRLs
Én enkelt dosis på 0,2 ml pr. slagtekylling eller kommende æglæggende høne anvendes til daggamle kyllinger.
One single injection of 0.2 ml per chick is applied for broilers or layers at one day of age.
Aranesp har været godkendt siden juni 2001.
Aranesp has been authorised since June 2001.
Yderligere information om de nuværende anvendelser af Aranesp findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
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.
Det indeholder det aktive stof darbepoetin alfa.
It contains the active substance darbepoetin alfa.
Hvis du deltager i et klinisk studie og har behov for yderligere information om din behandling, kan du kontakte den læge, der behandler dig.
If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Det betyder, at darbepoetin alfa virker i længere tid og kan gives mindre hyppigt end naturligt erythropoietin.
This means that darbepoetin alfa has a longer duration of action, and can be given less often than natural erythropoietin.
marts 2018 EMA/165563/2018 EMEA/H/C/000332
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom23 March 2018 EMA/165563/2018 EMEA/H/C/000332
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.
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.
I det første studie blev Aranesp sammenlignet med virkningsløs behandling (placebo) i 24 uger.
The first study compared Aranesp with placebo (a dummy treatment) over 24 weeks.
Der er ingen konsekvenser for brugen af Aranesp til de godkendte indikationer.
There are no consequences for the use of Aranesp in its authorised uses.
Virkningen blev hovedsageligt målt på reduktionen i antallet af transfusioner af røde blodlegemer.
The main measure of effectiveness was a reduction in the number of transfusions of red blood cells.
• voksne, der får kemoterapi for kræft, der ikke udgår fra knoglemarven (ikke-myeloid kræft).
• adults who are receiving chemotherapy for ‘non-myeloid' cancer (cancer not originating in the bone marrow).
Desuden var det ene studie, der var udført i USA, ikke i overensstemmelse med EU's anbefalinger for behandling af patienter med myelodysplastisk syndrom.
In addition, one study conducted in the United States was not in line with EU recommendations for treatment of patients with myelodysplastic syndromes.
Ansøgeren fremlagde data fra to hovedstudier hos 356 patienter med anæmi og myelodysplastisk syndrom.
The applicant presented data from two main studies in 356 anaemic patients with myelodysplastic syndromes.
Hvad er Aranesp?
What is Aranesp?
Hvad forventedes Aranesp anvendt til?
What was Aranesp expected to be used for?
• voksne og børn med langsigtet gradvist fald i nyrefunktionen (kronisk nyresvigt)
• adults and children with ‘chronic renal failure' (long-term, progressive decrease in the ability of the kidneys to work properly);
Lægemidlet skulle have været anvendt hos patienter, som ikke behøvede hyppige blodtransfusioner, og som havde lav eller mellemstor risiko for, at deres sygdom udviklede sig til en type kræft, der udgår fra de hvide blodlegemer (akut myeloid leukæmi, AML).
The medicine was to be used in patients who did not need frequent blood transfusions and who had a low or intermediate risk of their condition progressing to acute myeloid leukaemia (AML, a type of cancer affecting white blood cells).
Virksomheden har til CHMP oplyst, at der ikke er igangværende Amgen-sponsorerede kliniske studier med Aranesp.
The company informed the Agency that there are no Amgen-sponsored ongoing clinical trials with Aranesp.
Aranesp er et lægemiddel, der i forvejen anvendes til behandling af lavt antal røde blodlegemer (anæmi), som medfører symptomer hos følgende patientgrupper:
Aranesp is a medicine already used to treat anaemia (low red-blood-cell count) that is causing symptoms in the following groups of patients:
I det andet studie fik alle patienter Aranesp i 13 uger, og her måltes blodets indhold af hæmoglobin, der er hovedbestanddelen i de røde blodlegemer.
In the second study, all patients received Aranesp for 13 weeks and the study measured the level of haemoglobin, the main constituent of red blood cells, in the blood.
Ved behandling af anæmi hos patienter med myelodysplastisk syndrom forventedes Aranesp at fungere på samme måde som ved de eksisterende anvendelser (indikationer).
In the treatment of anaemia in patients with myelodysplastic syndromes, Aranesp was expected to work in the same way as it does in its existing indications.