FrancophonIA/ELRC3.0 huggingface dataset:
English: Bottle 1: Total Proteins 100-130 mg/ml; dont clottable protein 75-115 mg/ml, Factor XIII 10-50 UI/ml; Plasminogen 0.04-0.12 mg/ml; Bottle 2: Aprotinin bovine 3000 UIK/ml (1.67 UPE/ml);
Danish: Flaske 1: Proteiner i alt 100-130 mg/ml; koagulerbart protein 75-115 mg/ml, Faktor XIII 10-50 IE/ml; Plasminogen 0,04-0,12 mg/ml; Flaske 2: Bovint aprotinin 3000 KIE/ml (1,67 PEU/ml);
English: Syringe TISSUCOL-APROTININ: Total Proteins 100-130 mg/ml; clottable protein 75-115 mg/ml, of which fibrinogen 70-110 mg/ml and plasmatic fibronectin 2-9 mg/ml: Factor XIII 10-50 UI/ml; Plasminogen 0.04-0.12 mg/ml; Aprotinin 3000 UIK/ml (1.67 UPE/ml); Syringe THROMBIN-CALCIUM CHLORIDE: Proteins 50mg/ml; Thrombin 500 UI/ml; calcium chloride 40 µmol/ml
Danish: Sprøjte TISSUCOL-APROTININ: Proteiner i alt 100-130 mg/ml; koagulerbart protein 75-115 mg/ml, heraf fibrinogen 70-110 mg/ml og plasmafibronectin 2-9 mg/ml; Faktor XIII 10-50 IE/ml; Plasminogen 0,040,12 mg/ml; Aprotinin 3000 KIE/ml (1,67 PEU/ml); Sprøjte THROMBINCALCIUMCHLORID: Proteiner 50 mg/ml; Thrombin 500 IE/ml; calciumchlorid 40 µmol/ml
English: Fibrinogen: 70-110mg/ml Plasmafibronectin (CIG): 2-9mg/ml Factor XIII: 10-50 U/ml Plasminogen: 0.04 - 0.12mg/ml
Danish: Fibrinogen: 70-110 mg/ml Plasmafibronectin (CIG): 2-9 mg/ml Faktor XIII: 10-50 E/ml Plasminogen: 0,04-0,12 mg/ml
English: Combi-Set 1: fibrinogen: 90 mg/ml coagulation factor XIII: 60 U/ml aprotinin: 1000 KIU/ml=0.56 PEU/ml
Danish: Combi-Set 1: fibrinogen: 90 mg/ml Koagulationsfaktor XIII: 60 U/ml aprotinin: 1000 KIU/ml = 0,56 PEU/ml
English: Plasminogen 0.08-0.24 mg; Aprotinin 6000 KIU;
Danish: Plasminogen 0,08-0,24 mg;
English: Factor XIII ≤ 10 UI/ml Aprotinin: 3000 UIK/ml Human Thrombin: 500 UI/ml Calcium chloride: 40 μmol/ml
Danish: Faktor XIII ≤10 IE/ml Aprotinin: 3000 KIE/ml Humant thrombin: 500 IE/ml Calciumchlorid: 40 μmol/ml
English: UI/ml; Plasminogen 0.04-0.12 mg/ml;
Danish: Plasminogen 0,04-0,12 mg;
English: ARTISS LYOPulver und Lösungsmittel für einen
Danish: ARTISS LYO - Pulver und Lösungsmittel für einen Gewebekleber
English: Fibrinogen: 90 mg/ml Coagulation factor XIII: 60 U/ml Aprotinin: 1000 KIU/ml=0.56 PEU/ml
Danish: Fibrinogen: 90 mg/ml Koagulationsfaktor XIII: 60 U/ml Aprotinin: 1000 KIU/ml = 0,56 PEU/ml
English: Total Protein 100-130 mg; Clottable protein: 75-115 mg, thereof Fibrinogen 70-110 mg; Plasma Fibronectin 2-9 mg; Factor XIII 10-50 UI;
Danish: Koagulerbart protein: 75-115 mg, hvoraf fibrinogen 70-110 mg; Plasmafibronectin 2-9 mg;
English: Human fibrinogen (72-110 mg/ml) Factor xiii (≤10 UI) Aprotinin (3000 KUI2/ml) Human thrombin (500 UI3/ml) Calcium chloride (40micromol/ml)
Danish: Humant fibrinogen (72-110 mg/ml) Faktor xiii (≤10 IE) Aprotinin (3000 KIE2/ml) Humant thrombin (500 IE3/ml) Calciumchlorid (40 mikromol/ml)
English: Human fibrinogen: 90 mg/ml Coagulation factor XIII: 60 e/ml Aprotinin: 1000 EIK/ml Thrombin: 7,6 mg/ml Calcium chloride: 5,9 mg/ml
Danish: Human fibrinogen: 90 mg/ml Koagulationsfaktor XIII: 60 e/ml Aprotinin: 1000 EIK/ml Thrombin: 7,6 mg/ml Calcium chloride: 5,9 mg/ml
English: Human Fibrinogen 91 gm/ml Human Factor XIII 10 IU/ml Bovine Aprotinin 3000 IU/ml Human Thrombin 500 IU/ml Calcium Chloride 40 micromol/ml
Danish: Humant fibrinogen 91 mg/ml Human faktor XIII 10 IE/ml Bovint aprotinin 3000 KIE/ml Humant thrombin 500 IE/ml Calciumchlorid (40 mikromol/ml)
English: Aprotinin 3000KIE/ml Coagulation Factor XIII 30IE/ml Plasminogen 80 μg/ml Thrombin human 500 IE/ml Calcium Chloride Dihydrate 40 μg/ml
Danish: enhed/ml Koagulationsfaktor XIII 30 mg/ml Plasminogen 80 μg/ml Thrombin, humant 500 IE/ml Plasmaprotein, humant 50 mg/ml Calciumchloriddihydrat 40 μg/ml
English: Human fibrinogen 72-110 mg/ml Aprotinin 3000 KIU/ml Human Thrombin 500 IU/ml Calcium Chloride 40 µmol/ml
Danish: Humant fibrinogen 72-110 mg/ml Aprotinin 3000 KIE/ml Humant thrombin 500 IE/ml Calciumchlorid 40 µmol/ml
English: Fibrinogen: 90 mg/ml Aprotinin (bovine): 1000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 5,9 mg/ml Factor XIII: 60 U/ml
Danish: Fibrinogen: 90 mg/ml Aprotinin (bovint): 1000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 5,9 mg/ml Koagulationsfaktor XIII: 60 U/ml
English: Fibrinogen:70-110 mg/ml Coagulation factor XIII: 10-50 I.E./ml Plasmafibronectin: 2-9 mg/ml Aprotinin (bovin): 3000 KIE/ml
Danish: Fibrinogen: 70-110 mg/ml Koagulationsfaktor XIII: 10-50 IE/ml Plasmafibronectin: 2-9 mg/ml Aprotinin (bovint): 3000 KIE/ml
English: Human fibrinogen 91 mg/ml Aprotinin 3000 KIU/ml Human Thrombin 4 IU/ml Calcium Chloride 40 µmol/ml
Danish: Humant fibrinogen 91 mg/ml Aprotinin 3000 KIE/ml Humant thrombin 4 IE/ml Calciumchlorid 40 µmol/ml
English: Sealant
Danish: Topisk
English: Fibrinogen: 70 - 110 mg/ml Plasmafibronectin: 2 - 9 mg/ml Coagulation factor XIII: 10 - 50 I.E/ml Aprotininsolution: 3000 KIE/ml
Danish: Fibrinogen: 70-110 mg/ml Plasmafibronectin: 2-9 mg/ml Koagulationsfaktor XIII: 10-50 IE/ml Aprotininopløsning: 3000 KIE/ml
English: Fibrinogen: 70 - 110 mg/ml Fibronectine 2 - 9 mg/ml Thrombin: 500 IU/ml Calcium chloride: 40 µmol/ml Factor XIII: 10-50 IU/ml Aprotinine (bovine): 3000 KIU/ml
Danish: Fibrinogen: 70-110 mg/ml Fibronectin: 2-9 mg/ml Thrombin: 500 IE/ml Calciumchlorid: 40 µmol/ml Faktor XIII: 10-50 IE/ml Aprotinin (bovint): 3000 KIE/ml
English: Fibrinogen: 90 mg/ml Coagulation factor XIII: 60 U/ml Aprotinin: 1000 KIU = 0,56 EPU Thrombin: 500 IU /ml Calcium chloride (dihydrate): 5,9 mg/ml
Danish: Fibrinogen: 90 mg/ml Koagulationsfaktor XIII: 60 U/ml Aprotinin: 1000 KIU = 0,56 EPU Thrombin: 500 IU/ml Calciumchloriddihydrat : 5,9 mg/ml
English: Human fibrinogen: 72-110 mg/ml Factor xiii: ≤10 UI Aprotinin: 3000 KU12/ml Human thrombin: 500 UI3/ml Calcium chloride: 40 micromol/ml
Danish: Humant fibrinogen: 72-110 mg/ml Faktor xiii: ≤10 IE Aprotinin: 3000 KIE2/ml Humant thrombin: 500 IE3/ml Calciumchlorid: 40 micromol/ml
English: Human Fibrinogen: 72-110 mg/ml Aprotinin: 3000 KIU/ml Human Thrombin: 4 IU/ml Calcium Chloride: 40 μmol/ml
Danish: Humant fibrinogen: 72-110 mg/ml Aprotinin: 3000 KIE/ml Humant thrombin: 4 IE/ml Calciumchlorid: 40 μmol/ml
English: Human Fibrinogen: 91 mg1/ml Aprotinin: 3000 KIU2/ml Human Thrombin: 500 IU3/ml Calcium Chloride: 40 µmol/ml
Danish: Humant fibrinogen: 91 mg1/ml Aprotinin: 3000 KIE2/ml Humant thrombin: 500 IE3/ml Calciumchlorid: 40 µmol/ml
English: Fibrinogen: 90 mg/ml Factor XIII: 60 U/ml Aprotinin: 1000 KIU/ml Thrombin: 500 IU/ml Calcium Chloride: 5.9 mg/ml
Danish: Fibrinogen: 90 mg/ml Koagulationsfaktor XIII: 60 U/ml Aprotinin: 1000 KIU/ml Thrombin: 500 IU/ml Calcium Chloride: 5,9 mg/ml
English: Fibrinogen: 90 mg/ml Factor XIII: 60 U/ml Aprotinin: 1000 UIC/ml Thrombin: 500 UI/ml Calcium chloride dihydrate: 5,9 mg/ml
Danish: Fibrinogen: 90 mg/ml Koagulationsfaktor XIII: 60 U/ml Aprotinin: 1000 UIC/ml Thrombin: 500 UI/ml Calciumchloriddihydrat : 5,9 mg/ml
English: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 40 µmol/ml Factor XIII: 10 IU/ml
Danish: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIE/ml Thrombin: 500 IE/ml Calciumchlorid: 40 µmol/ml Faktor XIII: 10 IE/ml
English: Fibrinogen: 75mg Human thrombin: 500 IU Aprotinin: 3000KIU Calcium chloride: 40 mcmol/ml
Danish: Fibrinogen: 75 mg/ml Humant thrombin: 500 IE/ml Aprotinin: 3000 KIE/ml Calciumchlorid: 40 µmol/ml
English: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU/ml Thrombin: 500 IU/ml Calcium chloride: 40 µmol/ml
Danish: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIE/ml Thrombin: 500 IE/ml Calciumchlorid: 40 µmol/ml
English: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU/ml Thrombin: 4 IU/ml Calcium chloride: 40 µmol/ml
Danish: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIE/ml Thrombin: 4 IE/ml Calciumchlorid: 40 µmol/ml
English: Human Fibrinogen 91 mg/ml Aprotinum INN 3000 KIU/ml (bovine) Human Thrombin 4 ae^3/ml Calcium Chloride 40 micromol/ml
Danish: Humant fibrinogen 91 mg/ml Aprotinin 3000 KIE/ml (bovint) Humant thrombin, 4 IE^3/ml Calciumchlorid (40 mikromol/ml)
English: Human fibrinogen: 110mg/ml Aprotinin: 3750KIU/ml Human thrombin: 6.5IU/ml Calcium chloride: 44mcmol/ml
Danish: Humant fibrinogen: 110 mg/ml Aprotinin: 3750 KIE/ml Humant thrombin: 5 IE/ml Calciumchlorid: 44 µmol/ml
English: Aprotinin (bovel) 3000 KIU Plasminogen 80 microgram Thrombin solution per ml Human thrombin 500 ae Calcium chloridum 40 micromol
Danish: Tisseel-opløsning per mlFibrinogen 90 mg Fibronectin 5,5 mg Faktor XIII 30 IE Aprotinin (bovint) 3000 KIE Plasminogen 80 mikrogram Thrombinopløsning per ml Humant thrombin 500 IE Calciumchlorid 40 mikromol
English: Human fibrinogen: 91 mg/ml Aprotinin: 3000 KUI2/ml Human thrombin: 4 UI3/ml Calcium chloride: 40 mmol/ml
Danish: Humant fibrinogen: 91 mg/ml Aprotinin: 3000 KIE2/ml Humant thrombin: 4 IE3/ml Calciumchlorid: 40 micromol/ml
English: Human Fibrinogen: 72/110 mg/ml Aprotinin:3000 KIU/ml Human Thrombin: 500 IU/ml Calcium Chloride: 40 μmol/ml
Danish: Humant fibrinogen: 72-110 mg/ml Aprotinin: 3000 KIE/ml Humant thrombin: 500 IE/ml Calciumchlorid: 40 μmol/ml
English: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU Thrombin: 500 UI/ML Calcium Chloride: 40 MMO LI/L Factor XIII ≤ 10 UI/ml
Danish: Fibrinogen: 91 mg/ml Aprotinin: 3000 KIE Thrombin: 500 IE/ml Calciumchlorid: 40 μmol/ml Faktor XIII ≤10 IE/ml
English: Beriplast P CombiSet 0,5 ml, Beriplast P CombiSet 1 ml,
Danish: Combi-Set 0,5 ml, Beriplast P
English: Human Fibrinogen: 91mg1/ ml Aprotinin: 3000 KIU2/ml Human Thrombin: 4IU3/ml Calcium Chloride:40μmol/ml
Danish: Humant fibrinogen: 91 mg1/ml Aprotinin: 3000 KIE2/ml Humant thrombin: 4 IE3/ml Calciumchlorid: 40 μmol/ml
English: BAXTER, S.L.
Danish: Baxter B.V.
English: Human fibrinogen: 110mg/ml Aprotinin: 3000KU/ml Human thrombin: 500 iu/ml Calcium chloride: 40mcmol/ml
Danish: Humant fibrinogen: 110 mg/ml Aprotinin: 3000 KIE/ml Humant thrombin: 500 IE/ml Calciumchlorid: 40 µmol/ml
English: Slovak Republic CSL Behring GmbH, Emil-von-Behring-Strasse 76 35041 Marburg
Danish: CSL Behring GmbH, Emil-von-Behring-Strasse 7
English: TISSEEL LYO Fibrinogen: 91 mg/ml Aprotinin: 3000 KIU/ml Thrombin: 500 IU/ml
Danish: Tisseel (RVG 35050/1/2) Fibrinogen: 91 mg/ml Aprotinin (syntetisk): 3000 KIE/ml Thrombin: 500 IE/ml
English: Tissucol Duo 500 Syringe TISSUCOL-APROTININ: Total Proteins 100-130 mg/ml; clottable protein 75-115 mg/ml, of which fibrinogen 70-110 mg/ml and plasmatic fibronectin 2-9 mg/ml: Factor XIII 10-50
Danish: Sprøjte TISSUCOL-APROTININ: Proteiner i alt 100-130 mg/ml; koagulerbart protein 75-115 mg/ml, heraf fibrinogen 70-110 mg/ml og plasmafibronectin 2-9 mg/ml; Faktor XIII 10-50 IE/ml; Plasminogen 0,04-0,12 mg/ml; Aprotinin 3000 KIE/ml (1,67 PEU/ml); Sprøjte THROMBINCALCIUMCHLORID: Proteiner 50 mg/ml; Thrombin 500 IE/ml; calciumchlorid 40 µmol/ml
English: The following side effects have also been reported:
Danish: Følgende bivirkninger er også blevet rapporteret:
English: Adopted at the 8-11 January 2018 PRAC
Danish: Vedtaget på PRAC's møde 8.-11. januar 2018
English: Not known: frequency cannot be estimated from the available data Increased urine output
Danish: Ikke kendt: hyppigheden kan ikke estimeres ud fra forhåndenværende data Øget urinproduktion
English: If you experience symptoms of spitting or coughing up blood you should contact your doctor immediately.
Danish: Hvis du oplever symptomer på blodigt spyt eller blodig hoste, bør du kontakte din læge med det samme.
English: Patients should be informed of the risk of pneumonitis and advised to contact their doctor immediately should they develop persistent cough or dyspnoea.
Danish: Patienterne skal informeres om risikoen for pneumonitis og tilrådes straks at kontakte lægen, hvis de får vedvarende hoste eller dyspnø.
English: Dulaglutide - Gastrointestinal stenosis and obstruction (EPITT no 18931)
Danish: Dulaglutid - Gastrointestinal stenose og obstruktion (EPITT nr. 18931)
English: Frequency ‘not known'
Danish: Hyppighed "ikke kendt"
English: The following side effects have also been reported: Frequency not known (cannot be estimated from the available data): bleeding from the lungs
Danish: Følgende bivirkninger er også blevet rapporteret: Hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data): blødning i lungerne
English: Symptoms typically include dyspnoea, cough (especially a dry nonproductive cough), thoracic pain and fever for which patients should be monitored at each follow-up visit.
Danish: Symptomerne omfatter typisk dyspnø, hoste (især tør, uproduktiv hoste), brystsmerter og feber, som patienterne skal spørges om ved hvert kontrolbesøg.
English: Pemetrexed - Nephrogenic diabetes insipidus (EPITT no
Danish: Pemetrexed - Nefrogen diabetes insipidus (EPITT nr.
English: Frequency ‘not known': Non-mechanical intestinal obstruction
Danish: Hyppighed "ikke kendt": Ikke-mekanisk tarmobstruktion
English: Acute bleeding from the lungs in patients with underlying rheumatologic disease has been reported with methotrexate.
Danish: Der er rapporteret om tilfælde af akut blødning i lungerne hos patienter med underliggende reumatologiske lidelser ved brug af methotrexat.
English: Bowel obstruction - a severe form of constipation with additional symptoms such as stomach ache, bloating or vomiting
Danish: Tarmobstruktion - en svær form for forstoppelse med yderligere symptomer som f.eks. mavesmerter, oppustethed eller opkastning
English: Acute or chronic interstitial pneumonitis, often associated with blood eosinophilia, may occur and deaths have been reported.
Danish: Der kan opstå akut eller kronisk interstitiel pneumonitis, ofte forbundet med eosinofili, og dødelige tilfælde er rapporteret.
English: Frequency not known (cannot be estimated from the available data): bleeding from the lungs* *(has been reported for methotrexate used in patients with underlying rheumatologic disease).
Danish: Hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data): blødning i lungerne* *(er indberettet ved anvendelse af methotrexat hos patienter med underliggende reumatologisk sygdom).
English: Assessment of respiratory system
Danish: Vurdering af luftveje
English: Questioning the patient with regard to possible pulmonary dysfunctions, if necessary lung function test.
Danish: Patienten skal udspørges om eventuelle lungedysfunktioner.
English: Respiratory, thoracic and mediastinal disorders Not known: Epistaxis, Pulmonary alveolar haemorrhage
Danish: Luftveje, thorax og mediastinum Ikke kendt: Epistaxis, pulmonal alveolær blødning
English: For methotrexate-containing medicinal products with both nononcologic and oncologic indications
Danish: For methotrexat-holdige lægemidler med både ikke-onkologiske og onkologiske indikationer
English: Thirst and increased water consumption Hypernatraemia - increased sodium in blood
Danish: Øget koncentration af natrium i blodet (hypernatriæmi)
English: Respiratory, thoracic and mediastinal disorders Not known: Epistaxis, Pulmonary alveolar haemorrhage* *(has been reported for methotrexate used in rheumatologic and related indications)
Danish: Ikke kendt: Epistaxis, pulmonal alveolær blødning* *(er indberettet ved anvendelse af methotrexat i reumatologiske og relaterede indikationer)
English: For methotrexate-containing medicinal products with oncologic indications
Danish: For methotrexat-holdige lægemidler med onkologiske indikationer
English: For methotrexate-containing medicinal products with non-oncologic indications
Danish: For methotrexat-holdige lægemidler med ikke-onkologiske indikationer
English: Methotrexate - Pulmonary alveolar haemorrhage (EPITT no 18850)
Danish: Methotrexat - Pulmonal alveolær blødning (EPITT nr.
English: If you develop any of the following side effects, contact your doctor immediately: - inflammation of the lungs (symptoms may be general illness, dry, irritating cough, shortness of breath, breathlessness at rest, chest pain, or fever) - spitting or coughing blood
Danish: − betændelse i lungerne (symptomerne kan være generel sygdomsfølelse, tør, generende hoste,
English: Respiratory system
Danish: Luftveje
English: Gastrointestinal disorders
Danish: Mave-tarm-kanalen
English: MD: entire risk period.
Danish: MD: hele risikoperioden.
English: SC In ovo
Danish: s.c. In ovo
English: The vaccine is now ready for use.
Danish: Vaccinen er nu klar til brug.
English: ATCvet code: QI01AD16.
Danish: ATCvet-kode: QI01AD.
English: Date of first authorisation: 22/08/2017
Danish: Dato for første markedsføringstilladelse: 22/08/2017
English: Official control authority batch release is required for this product.
Danish: Officiel batchfrigivelse af kontrolmyndighed er krævet for dette produkt.
English: please note; the sentence ‘for animal treatment only' will only appear in the English and will not be translated
Danish: Vær opmærksom på, at sætningen “Til dyr” kun vil stå på engelsk og ikke vil blive oversat
English: The usual aseptic precautions should be applied to all preparation and administration procedures.
Danish: Sædvanlige aseptiske forholdsregler skal benyttes ved fremstillings- og administrationsprocedurer.
English: Suspension: off-red to red suspension.
Danish: Suspension: rødlig til rød suspension.
English: However, precautionary measures have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Danish: Imidlertid skal der tages forholdsregler for at undgå direkte eller indirekte kontakt mellem vaccinerede kyllinger og kalkuner.
English: Safety trials have shown that the strain is safe for turkeys.
Danish: Sikkerhedsstudier har vist, at stammen er sikker for kalkuner.
English: Control of correct storage:
Danish: Kontrol af korrekt opbevaring:
English: The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Danish: Det aktive stof, som principielt er af biologisk oprindelse, hvis formål er at udvikle aktiv immunitet, falder ikke inden for anvendelsesområdet af Forordning (EF) nr. 470/2009.
English: Preparation of the vaccine:
Danish: Fremstilling af vaccinen:
English: Any person intending to manufacture, import, possess, sell, supply and use this veterinary medicinal product must first consult the relevant Member State's competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
Danish: Enhver, som har til hensigt at fremstille, indføre, besidde, sælge, levere og anvende dette veterinære lægemiddel skal forinden rådføre sig med den relevante medlemsstats kompetente myndighed vedrørende gældende vaccinationspolitik, da disse aktiviteter kan være forbudt i en medlemsstat på hele eller en del af dens område i henhold til nationale lovgivning.
English: It is recommended to handle a maximum of 5 ampoules (from one cane only) at a time.
Danish: Det anbefales højst at håndtere 5 ampuller (fra kun en stav) ad gangen.
English: 1 PFU - plaque forming units.
Danish: 1 PFU: plaquedannende enheder.
English: A 3-fold overdose was tested in ovo, which was regarded as safe.
Danish: En 3-dobbelt overdosis blev testet in ovo, og blev vurderet som sikker.
English: According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Danish: I henhold til artikel 71 i Europa-Parlamentets og Rådets direktiv 2001/82/EF, med senere ændringer, kan et medlemsland i overensstemmelse med medlemslandets nationale lovgivning forbyde fremstilling, indførsel, besiddelse salg, levering og/eller anvendelse af veterinærlægemidlet på hele eller en del af landets område, hvis det godtgøres:
English: Bovine serum Veggie medium Dimethyl sulfoxide
Danish: Bovint serum Veggie medium Dimethylsulfoxid
English: 29160 Intervet Lane PO Box 318, Millsboro Delaware 19966-0318
Danish: 29160 Intervet Lane PO Box 318, Millsboro Delaware 19966-0318 USA
English: Remove the syringe and invert the bag (6-8 times) to mix the vaccine.
Danish: Fjern sprøjten og vend posen (6-8 gange) for at blande vaccinen.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu/).
Danish: Yderligere information om dette veterinære lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Duration of immunity: ND: 8 weeks, IBD: 8 weeks,
Danish: Immunitetens varighed: ND: 8 uger, IBD: 8 uger,
English: Suspension: Store and transport frozen in liquid nitrogen (below -140 °C).
Danish: Suspension: Opbevares og transporteres nedfrosset i flydende kvælstof (under -140 °C).
English: Care should be exercised to prevent contaminating the hands, eyes and clothing with the suspension.
Danish: Der bør træffes passende foranstaltninger for at undgå at udsætte hænder, øjne og tøj for kontakt med suspensionen.
English: Name and address of the manufacturers of the biological active substance
Danish: Navn og adresse på fremstillere af det biologisk aktive stof
English: THE NETHERLANDS
Danish: HOLLAND
English: After adding the contents of the ampoule to the solvent, the ready to use product is a clear, red coloured suspension for injection.
Danish: Efter at have tilsat indholdet af ampullen til solvensen, er det klargjorte produkt en klar, rødfarvet suspension til injektion.
English: {DD/MM/YYYY}
Danish: DD/MM/ÅÅÅÅ
English: Solvent: clear, red solution.
Danish: Solvens: klar, rød opløsning.
English: If frozen suspension is situated in the tip of the ampoule this indicates that the suspension has been thawed and must not be used.
Danish: Hvis der forekommer frossen suspension i spidsen af ampullen, er det tegn på, at suspensionen har været optøet, og den må derfor ikke anvendes.
English: (number of doses per ampoule is presented on the colour coded clip attached to each cane containing the ampoule)
Danish: (Antal doser pr. ampul er angivet på den farvekodede klemme, som er fastgjort på hver stav med ampuller.)
English: The solvent must be clear, red coloured, without sediment and at room temperature (15-25 °C) at the time of mixing.
Danish: Solvensen skal være klar, rødfarvet, uden bundfald og have opnået stuetemperatur (15-25 °C), når blandingen foretages.
English: Intervet International B.V. Ambachtstraat 2, 4, 5a 3732 CN De Bilt THE NETHERLANDS
Danish: Ambachtstraat 2, 4, 5a 3732 CN De Bilt HOLLAND
English: Solvent for cell associated poultry vaccines.
Danish: Solvens til celleassocierede fjerkrævacciner.
English: Dry the ampoule, then break the ampoule at its neck and immediately proceed as described below.
Danish: Tør ampullen, åbn derefter ampullen ved at knække halsen og fortsæt straks som beskrevet nedenfor.
English: The vaccine is administered by subcutaneous injection in the neck or by in ovo injection.
Danish: Vaccinen administreres ved subkutan injektion i nakken eller ved in ovo injektion.
English: The vaccine induces active immunity against Newcastle disease, infectious bursal disease (Gumboro disease) and Marek's disease in chickens.
Danish: Vaccinen stimulerer aktiv immunitet mod Newcastle disease, infektiøs bursal disease (Gumboro disease) og Marek's disease hos kyllinger.
English: Subcutaneous use and in ovo use.
Danish: Til subkutan anvendelse og in ovo anvendelse.
English: The handling of liquid nitrogen should take place in a well-ventilated area.
Danish: Håndteringen af flydende kvælstof bør foregå på et sted med god ventilation.
English: Do not mix with any other veterinary medicinal product, except the solvent supplied for use with this medicinal product.
Danish: Må ikke blandes med andre lægemidler til dyr, undtagen den solvens, der leveres til brug sammen med dette veterinærlægemiddel.
English: Major incompatibilities:
Danish: Væsentlige uforligeligheder: