FrancophonIA/ELRC3.0 huggingface dataset:
English: It can make birds more prone to other diseases and can interfere with effective vaccination.
Danish: Den kan gøre fugle mere udsatte for andre sygdomme og kan modvirke en effektiv vaccination.
English: In the future if the animals are exposed to similar proteins the immune system will be able to respond more quickly.
Danish: Hvis dyrene efterfølgende udsættes for de samme proteiner, vil immunsystemet være i stand til at reagere hurtigere.
English: Vaccinated birds had a protection level of between 81% and 95% against disease signs.
Danish: De vaccinerede fugle havde et beskyttelsesniveau på mellem 81 % og 95 % mod sygdomstegnene.
English: Innovax-ND-IBD received a marketing authorisation valid throughout the EU on 22 August 2017.
Danish: Innovax-ND-IBD modtog en markedsføringstilladelse med gyldighed i hele EU den 22. august 2017.
English: The withdrawal period for meat and eggs from chickens treated with Innovax-ND-IBD is ‘zero' days, which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød og æg fra kyllinger, der behandles med Innovax-ND-IBD, er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: The full EPAR for Innovax-ND-IBD can be found on the Agency's website: ema.europa.eu/medicines/veterinary/EPAR/innovax-nd-ibd.
Danish: Den fuldstændige EPAR for Innovax-ND-IBD findes på agenturets websted under: ema.europa.eu/medicines/veterinary/EPAR/innovax-nd-ibd.
English: The vaccine can be given to one-day-old chicks as a single injection under the skin in the neck or directly into 18 - 19-day-old chicken eggs containing embryos (unhatched developing chicks).
Danish: Vaccinen kan gives til daggamle kyllinger som en enkelt injektion under huden i nakken eller direkte i 18-19 dage gamle hønseæg med fostre (ikkeudklækkede kyllinger under udvikling).
English: Vaccinated chickens were taken from a field study and challenged (brought in contact with the viruses) in the laboratory to show protection after vaccination.
Danish: Vaccinerede kyllinger blev udtaget fra et feltstudie og belastet (udsat for virusserne) i laboratoriet for at påvise beskyttelse efter vaccination.
English: As the vaccine is stored in liquid nitrogen, it is important that any handling is done in a well-ventilated area and that precautions are taken when preparing the vaccine.
Danish: Da vaccinen opbevares i flydende kvælstof, er det vigtigt, at den håndteres i et velventileret rum, og at der træffes forsigtighedsregler ved klargøring af vaccinen.
English: The European Medicines Agency decided that Innovax-ND-IBD's benefits are greater than its risks and recommended it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur besluttede, at fordelene ved Innovax-ND-IBD opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Similar challenges were carried out after hatching to show the effects of vaccination of chicken eggs.
Danish: Lignende belastning blev foretaget efter klækningen for at påvise vaccinationens virkning på hønseæg.
English: For IBD, vaccinated birds were challenged at 3, 4, 6 and 8 weeks after vaccination.
Danish: Med hensyn til IBD blev vaccinerede fugle belastet tre, fire, seks og otte uger efter vaccinationen.
English: This will help protect the chickens against ND, IBD and herpesvirus infections like MD.
Danish: Dette hjælper med at beskytte kyllingerne mod ND, IBD og herpesvirusinfektioner som MD.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Innovax-ND-IBD, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Innovax-ND-IBD, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: Since Innovax-ND-IBD is a live vaccine, the vaccine strain can be passed into the environment from vaccinated chickens and may spread to turkeys.
Danish: Da Innovax-ND-IBD er en levende vaccine, kan vaccinestammen udledes til miljøet fra vaccinerede fugle og spredes til kalkuner.
English: An overview of Innovax-ND-IBD and why it is authorised in the EU
Danish: En oversigt over Innovax-ND-IBD, og hvorfor det er godkendt i EU
English: Other information about Innovax-ND-IBD
Danish: Andre oplysninger om Innovax-ND-IBD
English: Innovax-ND-IBD is a veterinary vaccine used to protect chickens against Newcastle disease (ND), infectious bursal disease (IBD) and Marek's disease (MD).
Danish: Innovax-ND-IBD er en veterinær vaccine, der anvendes til beskyttelse af kyllinger mod Newcastle disease (ND), Gumboro-syge (IBD) og Mareks syge (MD).
English: Innovax-ND-IBD contains a live modified strain of turkey herpesvirus called strain HVP360.
Danish: Innovax-ND-IBD indeholder en levende modificeret stamme af kalkunherpesvirus, der kaldes stamme HVP360.
English: When Innovax-ND-IBD is given to chickens, the animals' immune system recognises the virus as ‘foreign' and makes antibodies against its proteins.
Danish: Når Innovax-ND-IBD gives til kyllinger, registrerer dyrenes immunsystem virussen som "fremmed" og reagerer ved at danne antistoffer mod den.
English: The turkey herpesvirus strain HVP360 has been modified so that it will produce proteins from ND virus and IBD virus.
Danish: Kalkunherpesvirusstamme HVP360 er blevet modificeret, så den danner proteiner fra ND-virus og IBD-virus.
English: For MD, 87% of the vaccinated chickens were protected against challenge at 9 days after vaccination.
Danish: Med hensyn til MD var 87 % af de vaccinerede kyllinger beskyttet mod belastning ni dage efter vaccinationen.
English: For ND, 60% of vaccinated chickens did not develop ND when challenged at 4 weeks after vaccination and 95% of vaccinated chickens were protected 6 weeks after vaccination.
Danish: Med hensyn til ND udviklede 60 % af de vaccinerede kyllinger ikke ND, da de blev belastet fire uger efter vaccinationen, og 95 % af de vaccinerede kyllinger var beskyttet seks uger efter vaccinationen.
English: Birds infected with MD virus can be carriers and shedders of the virus for life.
Danish: Fugle, der er smittet med MD-virus, kan bære og udskille virussen for livstid.
English: What is Innovax-ND-IBD and what is it used for?
Danish: Hvad er Innovax-ND-IBD, og hvad anvendes det til?
English: Safety studies have shown that the strain is safe for turkeys, however, precautionary measures must be followed to avoid direct or indirect contact between vaccinated chickens and turkeys.
Danish: Det er dog nødvendigt at træffe forholdsregler for at undgå direkte eller indirekte kontakt mellem vaccinerede kyllinger og kalkuner.
English: Innovax-ND-IBD is available as a suspension and solvent to be made into a suspension for injection and can only be obtained with a prescription.
Danish: Innovax-ND-IBD fås som suspension og solvens, der anvendes til fremstilling af en injektionsvæske, suspension.
English: For IBD, 100% of vaccinated chickens did not develop IBD when challenged at 46 days after vaccination.
Danish: Med hensyn til IBD udviklede 100 % af de vaccinerede kyllinger ikke IBD ved belastning 46 dage efter vaccinationen.
English: For MD, 91% of chickens from vaccinated eggs did not develop MD when challenged at 8 days of age.
Danish: Med hensyn til MD udviklede 91 % af kyllingerne fra de vaccinerede æg ikke MD ved belastning i 8-dagesalderen.
English: Why is Innovax-ND-IBD authorised in the EU?
Danish: Hvorfor blev Innovax-ND-IBD godkendt i EU?
English: Protection against MD starts 9 days after vaccination and lasts for life.
Danish: Beskyttelsen mod MD indtræder ni dage efter vaccinationen og er livslang.
English: IBD, also known as Gumboro disease, is a viral infection of chickens associated with death at 3-6 weeks of age.
Danish: Gumboro-syge er en virusinfektion hos kyllinger, der forårsager død, når de er tre til seks uger gamle.
English: Innovax-ND-IBD is a vaccine containing turkey herpesvirus serotype 3, a type of herpesvirus which does not cause disease in chickens but which is similar to the virus that causes MD.
Danish: Innovax-ND-IBD er en vaccine, der indeholder kalkunherpesvirus af serotype 3, hvilket er en type herpesvirus, som ikke forårsager sygdom hos kyllinger, men som ligner det virus, der forårsager MD. Virusset i vaccinen er blevet modificeret, så det også danner proteiner fra ND- og IBD-virus.
English: Protection against IBD starts 3 weeks after vaccination and lasts 8 weeks.
Danish: Beskyttelsen mod IBD indtræder tre uger efter vaccinationen og varer i otte uger.
English: What are the risks associated with Innovax-ND-IBD?
Danish: Hvilke risici er der forbundet med Innovax-ND-IBD?
English: Protection against ND starts 4 weeks after vaccination and lasts 8 weeks.
Danish: Beskyttelsen mod ND indtræder fire uger efter vaccinationen og varer i otte uger.
English: For ND, 92% of chickens from vaccinated eggs did not develop ND when challenged at 46 days after vaccination.
Danish: Med hensyn til ND udviklede 92 % af kyllinger fra de vaccinerede æg ikke ND ved belastning 46 dage efter vaccinationen.
English: How is Innovax-ND-IBD used?
Danish: Hvordan anvendes Innovax-ND-IBD?
English: How does Innovax-ND-IBD work?
Danish: Hvordan virker Innovax-ND-IBD?
English: What benefits of Innovax-ND-IBD have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Innovax-ND-IBD?
English: List of the names, pharmaceutical form, strength of the medicinal products, route of administration and applicants in the Member States
Danish: Navneliste, lægemiddelform, medicinske produkters styrke, indgivelsesvej og ansøgere i medlemslande
English: This summary was last updated in 10-2012.
Danish: Dette sammendrag blev sidst ajourført i 10-2012.
English: The full EPAR for Sildenafil Teva can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Sildenafil Teva findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Sildenafil Teva on 30 November 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Sildenafil Teva den 30. november 2009.
English: This is a summary of the European public assessment report (EPAR) for Sildenafil Teva.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Sildenafil Teva.
English: Sildenafil Teva is used to treat adult men with erectile dysfunction (sometimes called impotence), when they cannot get or keep a hard penis (erection) sufficient for satisfactory sexual activity.
Danish: Sildenafil Teva anvendes til behandling af voksne mænd med erektil dysfunktion (undertiden kaldet impotens), når de ikke kan få eller fastholde en stiv penis (erektion), som er tilstrækkelig til tilfredsstillende seksuel aktivitet.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sildenafil Teva.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Sildenafil Teva.
English: The recommended dose of Sildenafil Teva is 50 mg taken as needed about one hour before sexual activity.
Danish: Den anbefalede dosis af Sildenafil Teva er 50 mg, som tages efter behov ca. 1 time før seksuel aktivitet.
English: For Sildenafil Teva to be effective, sexual stimulation is required.
Danish: For at Sildenafil Teva kan være effektiv er seksuel stimulering nødvendig.
English: For more information about treatment with Sildenafil Teva, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Sildenafil Teva, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: This means that Sildenafil Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called Viagra.
Danish: Det betyder, at Sildenafil Teva er identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU), og som hedder Viagra.
English: The CHMP concluded that, in accordance with EU requirements, Sildenafil Teva has been shown to have comparable quality and to be bioequivalent to Viagra.
Danish: CHMP konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Sildenafil Teva er af sammenlignelig kvalitet og er bioækvivalent med Viagra.
English: By blocking the breakdown of cGMP, Sildenafil Teva restores erectile function.
Danish: Ved at blokere nedbrydningen af cGMP genopretter Sildenafil Teva den erektile funktion.
English: What are the benefits and risks of Sildenafil Teva?
Danish: Hvilke fordele og risici er der forbundet med Sildenafil Teva?
English: The active ingredient in Sildenafil Teva, sildenafil, belongs to a group of medicines called phosphodiesterase type 5 (PDE5) inhibitors.
Danish: Det aktive indholdsstof i Sildenafil Teva, sildenafil, tilhører en gruppe af lægemidler kaldet phosphodiesterase type 5-(PDE5)-hæmmere.
English: Therefore, the CHMP's view was that, as for Viagra, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Viagra.
English: The dose may be increased to a maximum of 100 mg or decreased to 25 mg depending on the effectiveness and side effects.
Danish: nedsættes til 25 mg afhængig af effekt og bivirkninger.
English: kidney problems should start treatment with the 25 mg dose.
Danish: Patienter med leverproblemer eller svære nyreproblemer bør påbegynde behandlingen med en dosis på 25 mg.
English: Sildenafil Teva is a medicine that contains the active substance sildenafil.
Danish: Sildenafil Teva er et lægemiddel, der indeholder det aktive stof sildenafil.
English: Sildenafil Teva is a ‘generic medicine'.
Danish: Sildenafil Teva er et "generisk lægemiddel".
English: If Sildenafil Teva is taken with food, the onset of activity may be delayed compared with taking Sildenafil Teva without food.
Danish: Hvis Sildenafil Teva tages sammen med et måltid, kan virkningens indtræden forsinkes i forhold til, hvis Sildenafil Teva tages uden et måltid.
English: Because Sildenafil Teva is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Sildenafil Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Other information about Sildenafil Teva
Danish: Andre oplysninger om Sildenafil Teva
English: The Committee recommended that Sildenafil Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Sildenafil Teva.
English: Because Sildenafil Teva is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Viagra.
Danish: Da Sildenafil Teva er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Viagra.
English: Why has Sildenafil Teva been approved?
Danish: Hvorfor blev Sildenafil Teva godkendt?
English: What is Sildenafil Teva?
Danish: Hvad er Sildenafil Teva?
English: How has Sildenafil Teva been studied?
Danish: Hvordan blev Sildenafil Teva undersøgt?
English: What is Sildenafil Teva used for?
Danish: Hvad anvendes Sildenafil Teva til?
English: How is Sildenafil Teva used?
Danish: Hvordan anvendes Sildenafil Teva?
English: How does Sildenafil Teva work?
Danish: Hvordan virker Sildenafil Teva?
English: AT-1020 Vienna Austria
Danish: AT-1020 Vienna Østrig
English: 16904 Solna Sweden
Danish: 16904 Solna Sverige
English: 41470 Neuss Germany
Danish: 41470 Neuss Tyskland
English: 5026 RH Tilburg The Netherlands
Danish: 5026 RH Tilburg Holland
English: Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italy
Danish: Janssen-Cilag SpA Via M.Buonarroti, 23 I-20093 Cologno Monzese MI, Italien
English: Janssen-Cilag A/S Bregnerødvej 133 3460 Birkerød Denmark
Danish: Janssen-Cilag A/S Bregnerødvej 133 3460 Birkerød Danmark
English: Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgium
Danish: Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse Belgien
English: 56 Eirinis Ave, Pefki Athens GR-151 21 Greece
Danish: 56 Eirinis Ave, Pefki Athens GR-151 21 Grækenland
English: The Netherlands Janssen-Cilag BV Dr. Paul Janssenweg
Danish: Janssen-Cilag BV Dr. Paul Janssenweg
English: (cannot be estimated from the available data)
Danish: (kan ikke estimeres ud fra forhåndenværende data)
English: This results in protection against the disease.
Danish: Dette resulterer i beskyttelse mod sygdommen.
English: If this is the case, then vaccination will be postponed.
Danish: Hvis dette er tilfældet, vil vaccinationen blive udsat.
English: The following side effects may also occur after receiving this vaccine.
Danish: Følgende bivirkninger kan også forekomme efter modtagelse af denne vaccine.
English: These symptoms have been of mild and transient nature)
Danish: Disse symptomer har været af mild og forbigående karakter)
English: The use of this vaccine should be in accordance with official recommendations.
Danish: Brug af vaccinen bør ske i overensstemmelse med officielle anbefalinger.
English: This will help to reduce some of the side effects of Bexsero.
Danish: Dette vil bidrage til at mindske nogle af bivirkningerne af Bexsero.
English: The vaccine works by specifically stimulating the body's natural defense system of the vaccinated person.
Danish: Vaccinen virker ved specifikt at stimulere kroppens naturlige forsvarssystem hos den vaccinerede person.
English: In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
Danish: I tilfælde af overdosering anbefales overvågning af vitale funktioner og eventuelt symptomatisk behandling.
English: Kanamycin is used in early manufacturing process and is removed during the later stages of manufacture.
Danish: Kanamycin anvendes i begyndelsen af fremstillingsprocessen og fjernes under de senere trin af fremstillingen.
English: See section 5.1 for information on protection against specific group B strains.
Danish: 5.1 for oplysninger om beskyttelse mod specifikke gruppe B-stammer.
English: - This vaccine has been prescribed for you or your child only.
Danish: - Denne vaccine er ordineret til dig eller dit barn personligt.
English: An early immune response after the first dose was also evaluated.
Danish: Et tidligt immunrespons efter første dosis was også evalueret.
English: Most of the primary immunogenicity studies were conducted as randomized, controlled, multicenter, clinical trials.
Danish: De fleste af de primære studier af immunogenicitet blev udført som randomiserede, kontrollerede, multicenter, kliniske studier.
English: Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency and they are consequently listed with the frequency unknown.
Danish: Da disse bivirkninger er indberettet frivilligt af en population af ukendt størrelse, er det ikke altid muligt at estimere en pålidelig frekvens, og de er derfor opført med frekvens ikke kendt.
English: If present, kanamycin levels in the final vaccine are less than 0.01 micrograms per dose.
Danish: Hvis det er til stede, er kanamycin-niveauerne i den endelige vaccine mindre end 0,01 mikrogram pr. dosis.
English: 2, 3, 4, 12 months
Danish: 2, 3, 4, 12 måneder
English: The clinical significance of this observation and the need for additional booster doses to maintain longer term protective immunity has not been established.
Danish: Den kliniske signifikans af denne observation og behovet for yderligere boosterdoser med henblik på at opretholde langvarig beskyttende immunitet er ikke fastlagt.
English: Pack sizes of 1 or 10 syringes.
Danish: Pakningsstørrelser på 1 eller 10 sprøjter.
English: See section 5.1.
Danish: Se punkt 5.1.
English: Feeling faint or fainting.
Danish: Følelse af svaghed eller besvimelse.
English: The need for, and timing of, further booster doses has not yet been determined.
Danish: Behovet for og tidsplanen for yderligere boosterdoser er endnu ikke fastlagt.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium-free'.
Danish: Dette lægemiddel indeholder mindre end 1 mmol natrium (23 mg) pr. dosis og er derfor stort set ”natriumfrit”.
English: Adults above 50 years of age
Danish: Voksne på over 50 år
English: Separate injection sites must be used if more than one vaccine is administered at the same time.
Danish: Forskellige injektionssteder skal anvendes, såfremt der administreres mere end én vaccine på samme tid.
English: As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Danish: Da fordelene ved vaccination er store for denne gruppe spædbørn, bør vaccination ikke udelades eller udsættes.
English: Not less than 1 month
Danish: Ikke mindre end en måned
English: Immunogenicity in special populations
Danish: Immunogenicitet hos særlige populationer
English: It is important to follow the instructions from the doctor or nurse so that you or your child completes the course of injections.
Danish: Det er vigtigt at følge instruktionerne fra lægen eller sundhedspersonalet, så du eller dit barn fuldfører injektionsforløbet.
English: 0, 1 months
Danish: 0, 1 måneder
English: Date of latest renewal: 18 September 2017
Danish: Dato for første markedsføringstilladelse: 14. januar 2013 Dato for seneste fornyelse: 18 september 2017
English: Do NOT use Bexsero:
Danish: Brug IKKE Bexsero:
English: Insufficient clinical data on exposed pregnancies are available.
Danish: Der foreligger utilstrækkelige kliniske data om eksponering under graviditet.
English: - If you or your child are allergic to the active substances or any of the other ingredients of this vaccine (listed in section 6).
Danish: - hvis du eller dit barn er allergisk over for de aktive stoffer eller et af de øvrige indholdsstoffer i denne vaccine (angivet i punkt 6).
English: The tip cap of the syringe may contain natural rubber latex.
Danish: Låget på spidsen af sprøjten kan indeholde naturgummi-latex.
English: Care must be taken to ensure that the vaccine is injected intramuscularly only.
Danish: Der skal drages omsorg for at sikre, at vaccinen kun injiceres intramuskulært.
English: There are no data on fertility in humans.
Danish: Der foreligger ingen data om fertilitet hos mennesker.
English: Read all of this leaflet carefully before you or your child receive this medicine because it contains important information for you or your child.
Danish: Læs denne indlægsseddel grundigt, inden du eller dit barn begynder at bruge dette lægemiddel, da den indeholder vigtige oplysninger for dig eller dit barn.
English: Rare: urticaria
Danish: Sjældne: urticaria
English: - if you or your child receive treatment that blocks the part of the immune system known as complement activation, such as eculizumab.
Danish: - hvis du eller dit barn modtaget behandling, som blokerer den del af immunsystemet, kendt som komplement aktivering, såsom eculizumab.
English: As with many vaccines, healthcare professionals should be aware that a temperature elevation may occur following vaccination of infants and children (less than 2 years of age).
Danish: Som ved andre vacciner skal sundhedspersonalet være opmærksomt på, at temperaturstigning kan forekomme efter vaccination af spædbørn og småbørn (under to år).