FrancophonIA/ELRC3.0 huggingface dataset:
English: The bag of vaccine should be gently swirled frequently during vaccination to guarantee that the vaccine suspension remains homogenous and that the correct vaccine virus titre is administered (e.g. during long vaccination sessions).
Danish: Posen med vaccine bør forsigtigt roteres gentagne gange under vaccinationen for at sikre vaccinesuspensionen forbliver homogen og, at den korrekte vaccinevirus titer indgives (f.eks. ved vaccinationer af længere varighed).
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above.
Danish: Der foreligger ingen oplysninger om sikkerhed og virkning af vaccinen ved samtidig brug med andre lægemidler til dyr end de veterinærlægemidler, der er nævnt ovenfor.
English: Innovax-ND-IBD is a virus suspension packed in glass ampoules and stored in liquid nitrogen.
Danish: Innovax- ND-IBD er en virussuspension, som leveres i glasampuller, der opbevares i flydende kvælstof.
English: To allow a check on correct storage and transport the ampoules are placed upside down in the liquid nitrogen containers.
Danish: For at muliggøre kontrol af korrekt opbevaring og transport af ampullerne er disse placeret med bunden i vejret i beholderne med flydende kvælstof.
English: In ovo: One single injection of 0.05 ml per chicken egg.
Danish: In ovo: En enkelt injektion på 0,05 ml pr. æg.
English: After dilution, administer 1 dose of 0.2 ml vaccine per chicken by subcutaneous injection in the neck or 1 dose of 0.05 ml per egg by in ovo injection.
Danish: Efter fortynding administreres 1 dosis på 0,2 ml vaccine pr. kylling ved subkutan injektion i nakken eller 1 dosis på 0,05 ml pr. æg ved in ovo injektion.
English: CAUTION: The ampoules have been known to explode on exposure to sudden temperature changes.
Danish: ADVARSEL: Det er i nogle tilfælde set, at ampuller er eksploderet ved udsættelse for pludselige temperaturændringer.
English: Suspension and solvent for suspension for injection.
Danish: Suspension og solvens til injektionsvæske, suspension.
English: Use solvent for cell associated poultry vaccines for reconstitution.
Danish: Anvend solvens til celleassocierede kyllingevacciner til rekonstitution.
English: For active immunisation of one-day-old chicks or 18-19 day-old embryonated chicken eggs: - to reduce mortality and clinical signs caused by Newcastle disease (ND) virus, - to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease
Danish: Til aktiv immunisering af daggamle kyllinger eller 18-19 dage gamle æg med kyllingeembryoner: - For at reducere mortalitet og kliniske symptomer forårsaget af Newcastle disease virus (ND), - For at undgå mortalitet samt reducere kliniske symptomer og læsioner forårsaget af infektiøs bursal disease virus (IBD), - For at reducere mortalitet, kliniske symptomer og læsioner forårsaget af Marek's disease virus (MD).
English: Each dose of the reconstituted vaccine (0.2 ml for subcutaneous use or 0.05 ml for in ovo use) contains:
Danish: En dosis (0,2 ml til subkutan anvendelse eller 0,05 ml til in ovo anvendelse) rekonstitueret vaccine indeholder:
English: Gently swirl and invert the bag to mix the vaccine.
Danish: Rotér og vend posen forsigtigt for at blande vaccinen.
English: If you notice any serious effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Danish: Dette gælder også alvorlige bivirkninger, der ikke allerede er anført i denne indlægsseddel, eller hvis du mener, at dette lægemiddel ikke har virket efter anbefalingerne.
English: Suspension: - One Type I glass ampoule of 2 ml containing 2,000 or 4,000 doses.
Danish: Suspension: - Type I-glasampuller på 2 ml, der indeholder 2.000 eller 4.000 doser.
English: No information is available on the safety or possible adverse reactions following a 10-fold overdose applied in ovo.
Danish: Ingen information om sikkerheden eller mulige bivirkninger efter en 10-gange overdosering givet in ovo er tilgængelig.
English: No symptoms were observed after the administration of a 10-fold dose of vaccine when applied subcutaneously.
Danish: Der er ikke observeret nogen symptomer efter administration af 10 gange normal vaccinedosis ved subkutan anvendelse.
English: Pancreatic digest of casein Phenolsulfonphthalein (Phenol red) Potassium dihydrogen phosphate Water for injections
Danish: Kasein, enzymfordøjet Phenolsulfonphthalein (phenolrødt) Kaliumdihydrogenphosphat Vand til injektionsvæsker
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS AMPOULE
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER AMPUL
English: Subcutaneous: One single injection of 0.2 ml per chick.
Danish: Subkutant: En enkelt injektion på 0,2 ml pr. kylling.
English: Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer THE NETHERLANDS
Danish: Wim de Körverstraat 35 5831 AN Boxmeer HOLLAND
English: Do not thaw in hot water or ice cold water.
Danish: Ampullerne må ikke optøs i varmt vand eller iskoldt vand.
English: For subcutaneous use reconstitute the vaccine according to the table below:
Danish: Til subkutan anvendelse rekonstitueres vaccinen efter nedenstående tabel:
English: Withdraw a small quantity from the solvent bag into the syringe and rinse the ampoule.
Danish: Træk en lille mængde fra solvensposen op i sprøjten og skyl ampullen.
English: 1 ampoule containing 4000 doses For in ovo use reconstitute the vaccine according to the table below: Solvent bag
Danish: 1 ampul indeholdende 4000 doser Til in ovo brug rekonstitueres vaccine efter nedenstående tabel: Solvenspose
English: As this is a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Da dette er en levende vaccine, udskilles vaccinestammen fra vaccinerede fugle og kan spredes til kalkuner.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: For such associated use, an onset of immunity of 3 weeks (when used with Nobilis ND Clone 30) and 2 weeks (when used with Nobilis ND C2), has been demonstrated for ND.
Danish: Såfremt denne kombination anvendes, er det for ND påvist, at immunitet indtræder efter 3 uger (ved brug af Nobilis ND Clone 30) og efter 2 uger (ved brug med Nobilis ND C2).
English: In order to protect the cells, it is important that the suspension is mixed, immediately after thawing, with the solvent.
Danish: For at beskytte cellerne er det vigtigt, at suspensionen blandes i solvensen straks efter at være blevet optøet.
English: Ampoules are stored on a cane and attached to the cane is a coloured clip displaying the dose (2,000 doses: salmon-pink coloured clip, and 4,000 doses: yellow coloured clip).
Danish: Fastgjort på staven er en farvet klemme som viser antal doser (2.000 doser: laksepinkfarvet klemme og 4.000 doser: gulfarvet klemme).
English: Number of vaccine ampoules for subcutaneous use
Danish: Antal af vaccineampuller til subkutant brug
English: Shelf life of the solvent (polyethylene bags) as packaged for sale: 3 years.
Danish: Opbevaringstid for solvens (poser af polyethylen) i salgspakning: 3 år.
English: Insert the needle through the stopper of the solvent bag, and then slowly and gently add the contents of the syringe to the solvent.
Danish: Stik kanylen gennem proppen på posen med solvens, og tilsæt langsomt og forsigtigt indholdet af sprøjten til solvensen.
English: 1 ampoule, containing 2,000 or 4,000 doses.
Danish: 1 ampul, som indeholder 2.000 eller 4.000 doser.
English: PACKAGE LEAFLET: Innovax-ND-IBD suspension and solvent for suspension for injection for chickens
Danish: INDLÆGSSEDDEL: Innovax-ND-IBD, suspension og solvens til injektionsvæske, suspension, til kyllinger
English: Innovax-ND-IBD suspension and solvent for suspension for injection for chickens
Danish: Innovax-ND-IBD, suspension og solvens til injektionsvæske, suspension, til kyllinger
English: Solvent: Store below 25 °C.
Danish: Solvens: Må ikke opbevares over 25 °C.
English: Thaw the ampoules in clean water at 25-27 °C.
Danish: Ampullerne skal optøs i rent vand ved 25-27 °C.
English: Number of vaccine ampoules for in ovo use
Danish: Antal af vaccineampuller til in ovo brug
English: Safety and efficacy data are available which demonstrate that Nobilis IB Ma5 or Nobilis IB 4-91 can be administered to day-old chicks that are vaccinated either by the subcutaneous or in ovo route with the vaccine.
Danish: Der foreligger data vedrørende sikkerhed og virkning, som viser, at Nobilis IB Ma5 eller Nobilis IB 4-91 kan gives til daggamle kyllinger, der er vaccineret enten via subkutan eller in ovo administration af vaccinen.
English: After removing the ampoule(s), the remaining ampoules should be put back immediately into the canister in the liquid nitrogen container.
Danish: Efter udtagelse af en eller flere ampuller bør det resterende antal ampuller straks sættes tilbage i røret i beholderen med flydende kvælstof.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE SOLVENT BAG
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE POSE MED SOLVENS
English: Bag of 400 ml solvent or bag of 800 ml solvent.
Danish: Pose med 400 ml solvens eller pose med 800 ml solvens.
English: Store liquid nitrogen container securely in an upright position in a clean, dry and well-ventilated room separated from the hatching/chicken room.
Danish: Opbevar beholderen med flydende kvælstof sikkert, idet den placeres opretstående i et rent, tørt rum med god ventilation, som er adskilt fra ruge-/kyllingekasser.
English: Thaw the content of the ampoule(s) rapidly by immersing the ampoule in clean water at 2527 °C.
Danish: Optø indholdet af ampullerne hurtigt ved nedsænkning af ampullen i rent vand ved 25-27 °C.
English: Container: Store liquid nitrogen container securely in an upright position in a clean, dry and wellventilated room separated from the hatching/chicken room.
Danish: Beholder: Opbevar beholderen med flydende kvælstof sikkert, idet den placeres opretstående i et rent, tørt rum med god ventilation, som er adskilt fra ruge-/kyllingekasser.
English: Shelf life of the cell suspension as packaged for sale: 2 years.
Danish: Opbevaringstid for cellesuspensionen i salgspakning: 2 år.
English: Shelf life of the solvent (multilayer plastic bags) as packaged for sale: 2 years.
Danish: Opbevaringstid for solvens (flerlagsposer af plast) i salgspakning: 2 år.
English: Safety and efficacy data are available which demonstrate that Nobilis ND Clone 30 or Nobilis ND C2 can be administered to day-old chicks that are vaccinated either by the subcutaneous or in ovo route with Innovax-ND-IBD.
Danish: Der foreligger data vedrørende sikkerhed og virkning, som viser, at Nobilis ND Clone 30 eller Nobilis ND C2 kan gives til daggamle kyllinger, der er vaccineret enten via subkutan eller in ovo administration af Innovax-ND-IBD.
English: Pharmacotherapeutic group: Immunologicals for aves, live viral vaccines for domestic fowls.
Danish: Farmakoterapeutisk gruppe: Immunologica til hønsefugle, levende virale vacciner, hønsefugleherpes virus (Marek's disease)
English: Preparation of the vaccine shall be planned before the ampoules are taken from the liquid nitrogen and the exact amount of vaccine ampoules and amount of solvent needed shall be calculated first.
Danish: Først udregnes det rette antal vaccineampuller og den nødvendige mængde solvens.
English: Gently swirl the ampoule(s) to disperse the contents.
Danish: Rotér forsigtigt hver enkelt ampul for at få indholdet til at fordele sig.
English: Gently withdraw the contents of the ampoule into a sterile syringe, fitted with an 18 gauge needle.
Danish: Træk forsigtigt indholdet af ampullen op i en steril sprøjte, påsat en 18-G kanyle.
English: ND: 4 weeks of age, IBD: 3 weeks of age, MD: 9 days.
Danish: Immunitetens indtræden: ND: 4 ugers alderen, IBD: 3 ugers alderen,
English: The vaccine is a cell-associated live recombinant turkey herpesvirus (HVT) expressing the F protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus.
Danish: Vaccinen er en celleassocieret levende, rekombinant kalkunherpesvirus (HVT), der udviser F protein over for Newcastle disease virus og VP2 protein over for infektiøs bursal disease virus.
English: - One 800 ml polyethylene or multilayer plastic bag.
Danish: - 800 ml solvens i pose af polyethylen eller flerlagspose af plast.
English: - One 400 ml polyethylene or multilayer plastic bag.
Danish: - 400 ml solvens i pose af polyethylen eller flerlagspose af plast.
English: Bag of 400 ml solvent
Danish: Pose à 400 ml solvens
English: Inject the remaining contents of the ampoule gently into the solvent bag.
Danish: Injicer forsigtigt ampullens overskydende indhold i posen med solvens.
English: Bag of 800 ml solvent
Danish: Pose à800 ml solvens
English: There is no information available on the number of doses on the ampoules once they are removed from the cane, so special care has to be taken to ensure that the mix-ups of ampoules with different number of doses is avoided and the correct solvent is used.
Danish: Derfor skal man sikre sig at undgå at blande ampuller med forskelligt antal doser og at korrekt solvens anvendes.
English: When withdrawing a cane of ampoules from the canister in the liquid nitrogen container, expose only the ampoule(s) to be used immediately.
Danish: Sørg for at staven med ampuller, når den tages op af røret i beholderen med flydende kvælstof, kun trækkes så langt op, at det svarer til det antal ampuller, der skal bruges med det samme.
English: Cell-associated live recombinant turkey herpesvirus (strain HVP360), expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus: 103.3 - 104.6 PFU1.
Danish: Celleassocieret levende, rekombinant kalkunherpesvirus (stamme HVP360), der udviser fusionsprotein Newcastle disease virus og VP2 protein over for infektiøs bursal disease virus:
English: 4 ampoules containing 4000 doses
Danish: 4 ampuller indeholdende 4000 doser
English: 8 ampoules containing 2000 doses
Danish: 8 ampuller indeholdende 2000 doser
English: (gloved) hand holding the ampoule away from the body and face.
Danish: Når en ampul tages op af beholderen, skal den holdes i håndfladen iført handske væk fra krop og ansigt.
English: In order to prevent serious wounds, by either the liquid nitrogen or the ampoules when removing an ampoule from the canister, hold the palm of the (gloved) hand holding the ampoule away from the body and face.
Danish: Inden ampuller tages op af beholderen med flydende kvælstof skal man iklæde sig beskyttelsesudstyr bestående af handsker, lange ærmer, en ansigtsmaske eller beskyttelsesbriller.For at forebygge risikoen for alvorlige sår på grund af flydende kvælstof eller ampullerne; når en ampul tages op af beholderen, skal ampullen derfor holdes i håndfladen iført handske væk fra krop og ansigt.
English: Posology:
Danish: Beholder:
English: 2 ampoules containing 4000 doses
Danish: 2 ampuller indeholdende 4000 doser
English: 4 ampoules containing 2000 doses
Danish: 4 ampuller indeholdende 2000 doser
English: 1 ampoule containing 2000 doses
Danish: 1 ampul indeholdende 2000 doser
English: Before withdrawing ampoules from the liquid nitrogen canister, protective equipment consisting of gloves, long sleeves and a facemask or goggles should be worn.
Danish: Inden ampuller tages op af beholderen med flydende kvælstof skal man iklæde sig beskyttelsesudstyr bestående af handsker, lange ærmer, en ansigtsmaske eller beskyttelsesbriller.Det vigtigt at forebygge risikoen for alvorlige sår på grund af flydende kvælstof eller ampullerne; når en ampul tages op af beholderen, skal den derfor holdes i håndfladen iført handske væk fra kroppen og ansigtet.
English: 2 ampoules containing 2000 doses
Danish: 2 ampuller indeholdende 2000 doser
English: Solvent bag
Danish: Solvenspose
English: Inject the remaining contents of the ampoule and gently into the solvent bag.
Danish: Fjern skyllevæsken fra ampullen med sprøjten og injicér den forsigtigt i posen med solvens.
English: Blister (PA/Al/PVC//Al) 336 (3x112) tablets
Danish: 336 (3x112) tabletter
English: In such case, treatment must be stopped immediately.
Danish: I sådanne tilfælde skal behandlingen seponeres øjeblikkeligt.
English: [the wording below should be inserted in the relevant sections]
Danish: [nedenstående passager skal indsættes i de relevante afsnit]
English: What you need to know before you take <name of product>
Danish: Det skal du vide, før du begynder at tage <produktnavn>
English: Section 4.1 “Therapeutic indications”
Danish: 4.1 ”Terapeutiske indikationer”
English: The product information may be subsequently updated by the Member State competent authorities, in liaison with the Reference Member State, as appropriate, in accordance with the procedures laid down in Chapter 4 of Title III of Directive 2001/83/EC.
Danish: Produktinformationen kan efterfølgende opdateres af de relevante myndigheder i medlemsstaterne i samråd med referencemedlemsstaten og i henhold til procedurerne i Europa-Parlamentets og Rådets direktiv 2001/83/EC, kapitel 4, afsnit III.
English: Section 4.4 “Special Warnings and Precautions for Use”
Danish: 4.4 ”Særlige advarsler og forsigtighedsregler vedrørende brugen”
English: Currently, there is no consensus about age specific testosterone reference values.
Danish: Der er aktuelt ingen konsensus vedrørende aldersspecifikke referenceværdier for testosteron.
English: Testosterone level should be monitored at baseline and at regular intervals during treatment.
Danish: Testosteronniveauet skal kontrolleres ved baseline og med regelmæssige mellemrum under behandlingen.
English: There is limited experience on the safety and efficacy of the use of <name of product>in patients over 65 years of age.
Danish: Der er begrænset erfaring med <produktnavn>s sikkerhed og virkning hos mænd over 65 år.
English: Clinicians should adjust the dosage individually to ensure maintenance of eugonadal testosterone levels.
Danish: Lægen skal justere doseringen individuelt for at sikre opretholdelse af eugonadalt testosteronniveau.
English: Testosterone may cause a rise in blood pressure and <name of product> should be used with caution in men with hypertension.
Danish: Testosteron kan medføre en stigning i blodtrykket, og <produktnavn> skal anvendes med forsigtighed til mænd med hypertension.
English: However, it should be taken into account that physiologically testosterone serum levels are lower with increasing age.
Danish: Imidlertid skal der tages hensyn til, at det fysiologiske testosteronniveau falder med alderen.
English: Annex III Amendments to relevant sections of the summary of product characteristics and package leaflets
Danish: Bilag III Ændringer til de relevante afsnit i produktresuméet og indlægssedlen
English: These amendments to the relevant sections of the Summary of Product Characteristics and package leaflet are the outcome of the referral procedure.
Danish: Følgende ændringer til de relevante afsnit i produktresuméet og indlægssedlen er resultatet af referralproceduren.
English: Tell your doctor if you have high blood pressure or if you are treated for high blood pressure, as testosterone may cause a rise in blood pressure.
Danish: Fortæl det til lægen, hvis du har højt blodtryk, eller hvis du er i behandling for højt blodtryk, da testosteron kan medføre en stigning i blodtrykket.
English: In patients receiving long-term androgen therapy, the following laboratory parameters should also be monitored regularly: haemoglobin, and haematocrit, liver function tests and lipid profile.
Danish: Hos patienter, der får langvarig androgenbehandling, skal følgende laboratorieparametre også monitoreres regelmæssigt: hæmoglobin og hæmatokrit, leverfunktionsprøver og lipidprofil.
English: This should be confirmed by two separate blood testosterone measurements and also include clinical symptoms such as: impotence infertility low sex drive tiredness depressive moods bone loss caused by low hormone levels
Danish: Disse tilstande skal bekræftes ved to forskellige målinger af testosteron i blodet og af symptomer på tilstandene, som omfatter: impotens sterilitet lav kønsdrift træthed depression knogletab på grund af lave hormonniveauer
English: Section 4.8 Undesirable effects
Danish: 4.8 Bivirkninger
English: If you are suffering from severe heart, liver or kidney disease, treatment with <name of product> may cause severe complications in the form of water retention in your body sometimes accompanied by (congestive) heart failure.
Danish: Hvis du lider af alvorlig hjerte-, lever- eller nyresygdom, kan behandling med <produktnavn> give alvorlige komplikationer i form af væskeophobning i kroppen, nogle gange med (kongestivt) hjertesvigt.
English: Frequency common: Increase in red blood cell count, haematocrit (percentage of red blood cells in blood) and haemoglobin (the component of red blood cells that carries oxygen), identified by periodic blood tests.
Danish: Hyppighed almindelig: øget antal røde blodlegemer, forhøjet hæmatokrit (procentdelen af røde blodlegemer i blodet) og forhøjet hæmoglobin (det stof i de røde blodlegemer, som transporterer ilt), der konstateres ved regelmæssige blodprøver.
English: The following blood checks should be carried out by your doctor before and during the treatment: testosterone blood level, full blood count.
Danish: Din læge skal tage følgende blodprøver før og under behandlingen: koncentrationen af testosteron i blodet og komplet blodbillede.
English: In patients suffering from severe cardiac, hepatic, or renal insufficiency or ischaemic heart disease, treatment with testosterone may cause severe complications characterised by oedema with or without congestive cardiac failure.
Danish: Hos patienter, der lider af alvorlig hjerte-, lever- eller nyreinsufficiens eller iskæmisk hjertesygdom, kan behandling med testosteron forårsage svære komplikationer i form af ødem med eller uden kongestivt hjertesvigt.
English: What <name of product> is and what it is used for <name of product> is used in adult men for testosterone replacement to treat various health problems caused by a lack of testosterone (male hypogonadism).
Danish: Virkning og anvendelse <Produktnavn> anvendes til voksne mænd som erstatning for det testosteron, som kroppen ikke selv producerer, for at behandle forskellige helbredstilstande, der skyldes mangel på testosteron (hypogonadisme).
English: Haematocrit increased, Red blood cell count increased, Haemoglobin increased Frequency common.
Danish: Forhøjet hæmatokrit, øget antal røde blodlegemer, forhøjet hæmoglobin Hyppighed almindelig.
English: Testosterone replacement therapy for male hypogonadism, when testosterone deficiency has been confirmed by clinical features and biochemical tests.
Danish: Substitutionsbehandling ved mandlig hypogonadisme, hvor testosteronmangel er bekræftet af kliniske symptomer og ved laboratorieanalyser).
English: The reference authority for the worksharing procedure is Sweden.
Danish: Referencemyndigheden for arbejdsdelingsproceduren er Sverige.
English: A potential serious risk to public health was raised by the Netherlands.
Danish: Nederlandene pegede på en potentiel alvorlig risiko for den offentlige sundhed.
English: The relevant authorities of the concerned marketing authorisations are: AT, BE, DE, DK, ES, FI, FR, IE, IT, LU, NL, NO, PT.
Danish: De relevante myndigheder for de pågældende markedsføringstilladelser er: AT, BE, DE, DK, ES, FI, FR, IE, IT, LU, NL, NO og PT.
English: The CHMP noted that according to the ICH Quality Guidelines, none of the Member States of the EU is considered a Zone IV region.
Danish: CHMP bemærkede, at ifølge ICH-retningslinjerne for kvalitet kan ingen af EU-medlemsstaterne anses for at være en zone IV-region.
English: • The Committee considered the referral under Article 13 of Regulation (EC) No 1234/2008;
Danish: • Udvalget har behandlet indbringelsen i henhold til artikel 13 i forordning (EF) nr. 1234/2008.