FrancophonIA/ELRC3.0 huggingface dataset:
English: Gastrointestinal signs (potentially due to the indigestible blister material) have been reported in dogs following accidental ingestion of the bait.
Danish: Gastrointestinale tegn (potentielt forårsaget af det ufordøjelige blistermateriale) har været indberettet hos hunde efter utilsigtet indtagelse af lokkemaden.
English: Water for injections Sucrose
Danish: Vand til injektionsvæsker Sukrose
English: b) the disease to which product is intended to confer immunity is largely absent from the territory in question.
Danish: b) at den sygdom, som veterinærlægemidlet er beregnet til at fremkalde immunitet mod, stort set ikke forekommer i det pågældende område.
English: A differentiation of this vaccine virus from any other rabies virus strains is possible, including its parental strain, for example by PCR methods.
Danish: Det er muligt at differentiere denne vaccinevirus fra andre rabiesvaccinevira, herunder moderstammen, f.eks. ved hjælp af PCR.
English: The genome carries mutations in the G-protein (glycoprotein) located at 2 independent loci of the genome (at amino acid positions 194 and 333 in Gprotein), where all three nucleotides ‘codon' were exchanged resulting in amino acid changes at both positions.
Danish: Genomet indeholder mutationer i G-proteinet (glykoprotein), der findes på 2 uafhængige loci i genomet (ved aminosyrepositionerne 194 og 333 i G-proteinet), hvor alle tre nukleotiders 'codon' blev udskiftet, hvilket resulterede i aminosyreændringer ved begge positioner.
English: Pharmacotherapeutic group: Immunologicals for canidae, live viral vaccines.
Danish: Farmakoterapeutisk gruppe: Immunologiske midler til canidae, levende virusvacciner.
English: Shelf life of the veterinary medicinal product as packaged for sale: 2 years at/below -15 °C.
Danish: Opbevaringstid for veterinærlægemidlet i salgspakning: 2 år ved/under -15°C.
English: As each of these modifications on the genome were shown to further attenuate the SAD B19 virus strain, their multiple effect helps to avoid the reversion to the parental strain.
Danish: Da hver af disse modifikationer af genomet har vist sig at svække SAD B19virusstammen yderligere, hjælper deres kombinerede effekt med at undgå reversion til moderstammen.
English: Stability after distribution in the environment was shown for 7 days at temperatures up to 25 °C.
Danish: Det er påvist, at produktet er stabilt efter distribution i miljøet i 7 dage ved temperaturer op til 25°C.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION 1 dose (1.7 ml) contains:
Danish: 1 dosis (1,7 ml) indeholder:
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/eller 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 national lovgivning.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS PVC/Aluminium blister
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ BLISTERKORT PVC/aluminiumsblister
English: The safety of the veterinary medicinal product has not been established during lactation.
Danish: Lægemidlets sikkerhed under laktation er ikke fastlagt.
English: Immunized animals are protected against field rabies virus infection and do not transmit rabies.
Danish: Immuniserede dyr er beskyttet mod rabiesvirusinfektion i felten og overfører ikke rabies.
English: No adverse reactions have been observed.
Danish: Der er ikke observeret nogen bivirkninger.
English: Vaccination should not be attempted when temperatures are expected to reach 25 °C or more, and never during the summer season.
Danish: Vaccinationen bør ikke forsøges udført, når temperaturen kan forventes at overstige 25°C og aldrig i sommersæsonen.
English: The suspension has a yellow colour in a frozen state and a reddish colour in the liquid state.
Danish: Suspensionen er gul i farven i frossen tilstand og en rødlig farve i flydende tilstand.
English: The intake of single bait is sufficient to ensure active immunisation to prevent infection by rabies virus.
Danish: Indtagelsen af et enkelt stykke lokkemad er tilstrækkeligt til at sikre aktiv immunisering til forebyggelse af infektion med rabiesvirus.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard box containing 800 baits (1 x 800 units, 4 x 200 units or 40 x 20 units)
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Kartonæske indeholdende 800 lokkemadsenheder (1 x 800 enheder, 4 x 200 enheder eller
English: HAZARD WARNING Rabies vaccine.
Danish: ADVARSEL OM FARE Rabiesvaccine.
English: Aerial distribution of the baits by any suitable flight devices (such as airplane, helicopter, drones or similar) is recommended for open or sparsely populated areas, and manual distribution in areas with a high human population.
Danish: Distribution af lokkemaden fra luften ved hjælp af egnede flyvende enheder (som f.eks. fly, helikopter, droner eller tilsvarende) anbefales i åbne og tyndt befolkede områder, mens manuel udbringning anbefales i tætbefolkede områder.
English: The active ingredient is a quadruple highly attenuated genetically modified rabies virus construct, derived from the SAD B19 vaccine strain.
Danish: Det aktive indholdsstof er et firdobbelt, kraftigt svækket, genetisk modificeret rabiesvirus, der er afledt fra SAD B19-vaccinestammen.
English: In contrast to its parental strain SAD B19, the Rabitec vaccine's active ingredient proved to be apathogenic for immunocompetent mice, the most sensitive species for rabies virus infection.
Danish: I modsætning til moderstammen SAD B19 har det aktive indholdsstof i Rabitec-vaccinen vist sig ikke at være patogent for immunkompetente mus, der er den mest følsomme art over for rabiesvirusinfektion.
English: In addition, the genome carries an exact duplicate of the modified immune-relevant Gprotein (glycoprotein) gene, which results in the significant higher expression of the G protein gene.
Danish: Hertil kommer, at genomet indeholder et præcist duplikat af genet for det modificerede immunrelevante G-protein (glykoprotein), hvilket resulterer i en signifikant højere udtrykkelse af Gproteingenet.
English: SPECIAL STORAGE CONDITIONS Store and transport frozen.
Danish: Opbevares og transporteres nedfrosset.
English: Rabitec is used for the induction of the protective immunity in foxes and raccoon dogs by the oral route characterised by the induction of rabies virus specific (neutralising) antibodies induced primarily by the G-protein (glycoprotein).
Danish: Rabitec anvendes til induktion af beskyttende immunitet hos ræve og mårhunde via oral administration, kendetegnet ved induktion af rabiesvirusspecifikke (neutraliserende) antistoffer induceret primært af G-proteinet (glykoprotein).
English: Name and address of the manufacturer responsible for batch release IDT Biologika GmbH
Danish: Navn og adresse på fremstilleren ansvarlig for batchfrigivelse IDT Biologika GmbH
English: Gelatin (porcine) Disodium phosphate dihydrate Potassium dihydrogen phosphate Neomycin sulfate
Danish: Gelatine (porcin) Dinatriumphosphatdihydrat Kaliumdihydrogenphosphat Neomycinsulfat
English: Since this vaccine has been prepared with live, attenuated microorganisms, appropriate measures should be taken to prevent contamination of the handler and other people that collaborate in the process.
Danish: Da vaccinen er fremstillet med levende, svækkede mikroorganismer, bør der træffes passende foranstaltninger for at udgå kontaminering af den, der indgiver lægemidlet, og andre, der medvirker ved denne proces.
English: Since this vaccine has been prepared with live, attenuated microorganisms, appropriate measures should be taken to prevent contamination of the handler and other people that collaborate in the process, e.g. by wearing appropriate protective clothes.
Danish: Da vaccinen er fremstillet med levende, svækkede mikroorganismer, bør der træffes passende foranstaltninger for at udgå kontaminering af den, der indgiver lægemidlet, og andre, der medvirker ved denne proces, f.eks. ved at anvende passende personligt beskyttelsesudstyr.
English: Aerial baiting is not recommended in the vicinity of water (lakes, rivers, water reservoirs,) neither in densely populated areas.
Danish: Udbringning fra luften frarådes i nærheden af vandområder (søer, floder, vandreservoirer) samt i tætbefolkede områder.
English: IDT Biologika (Riems) GmbH & Co. KG An der Wiek 7
Danish: IDT Biologika (Riems) GmbH & Co.
English: For the active immunization of foxes and raccoon dogs against rabies to prevent infection and mortality.
Danish: Til aktiv immunisering af ræve og mårhunde mod rabies med henblik på forebyggelse af infektion og dødelighed.
English: Baits should be distributed immediately after thawing.
Danish: Lokkemaden skal distribueres øjeblikkeligt efter optøning.
English: Fishmeal Palm fat Coconut fat Paraffin
Danish: Lokkemad: Fiskemel Palmefedt Kokosfedt Paraffin
English: If you notice any side effects, even those not listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Danish: Dette gælder også bivirkninger, der ikke er anført i denne indlægsseddel eller hvis du mener, at dette lægemiddel ikke har virket efter anbefalingerne.
English: The import, possession, sale, supply and/or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory, see package insert for further information.
Danish: Indførsel, besiddelse, salg, levering og/eller anvendelse af dette veterinærlægemiddel er eller kan være forbudt i en medlemsstat på dele af eller hele deres område.
English: EU/2/17/219/002
Danish: EU/2/17/219/001 EU/2/17/219/002 EU/2/17/219/003
English: Do not refreeze.
Danish: Må ikke fryses igen efter optøning.
English: MANUFACTURER'S BATCH NUMBER Lot: {number}
Danish: FREMSTILLERENS BATCHNUMMER
English: Plastic foil sleeves or bags in cardboard boxes of:
Danish: Omslag eller poser af plastfolie i kartonæsker med:
English: Handle the baits with care.
Danish: Lokkemaden skal håndteres med forsigtighed.
English: Foxes, raccoon dogs
Danish: Ræve, mårhunde
English: The vaccine suspension is filled in polymer/aluminium blisters which are embedded in a bait matrix attractive for the target species.
Danish: Vaccinesuspensionen er fyldt i polymer/aluminiumblistere, som er indeholdt i en lokkemadsmatrix, der tiltrækker målarterne.
English: The vaccination campaigns in rabies-free areas should be designed in such a way that the area covers a 50 km belt ahead of the rabies front.
Danish: Vaccinationsområdet skal være så stort som muligt (gerne større end 5000 km Vaccinationskampagner i rabiesfri områder skal arrangeres på en sådan måde, at området dækker et bælte på 50 km grænsende op til rabiesfronten.
English: Liquid vaccine contained in a polymer/aluminium blisters which are embedded in a bait matrix attractive for the target species.
Danish: Flydende vaccine indeholdt i polymer/aluminiumblistere, som er indeholdt i en lokkemadsmatrix, der tiltrækker målarterne.
English: As an exception, the thawed vaccine may be stored for up to 7 days at 2 °C - 8 °C before use.
Danish: Den optøede vaccine kan undtagelsesvist opbevares i op til 7 dage ved 2°C - 8°C før brug.
English: The baits are rectangular, brown coloured and have an intensive smell.
Danish: Lokkemadsenhederne er rektangulære, brune i farven og har en kraftig lugt.
English: Rabitec is a live modified rabies vaccine for oral administration to foxes and raccoon dogs.
Danish: Rabitec er en levende, modificeret rabiesvaccine til oral indgivelse til ræve og mårhunde.
English: WITHDRAWAL PERIOD (S)
Danish: TILBAGEHOLDELSESTID(er)
English: Baits are packed in plastic foil sleeves or bags in cardboard boxes of:
Danish: Lokkemadsenhederne er pakket i omslag eller poser af plastfolie i kartonæsker med:
English: 1 x 800 units 4 x 200 units 40 x 20 units
Danish: 1 x 800 enheder 4 x 200 enheder 40 x 20 enheder
English: STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S) 1 dose (1.7 ml) embedded in bait contains:
Danish: 1 dosis (1,7 ml) indeholdt i lokkemad indeholder:
English: PACKAGE LEAFLET Rabitec oral suspension, for foxes and raccoon dogs
Danish: INDLÆGSSEDDEL Rabitec oral suspension, til ræve og mårhunde
English: Vaccine baits are not intended for vaccination of domestic animals.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr Vaccinelokkemad er ikke beregnet til vaccination af husdyr.
English: The vaccination should be preferably carried out biannually (e.g. in spring and autumn), for a number of consecutive years, for at least two years after the last confirmed case of rabies in the region; however vaccination should not be attempted when temperatures are expected to reach 25 °C or more, and never during the summer season.
Danish: Vaccinationen bør udføres to gange om året (f.eks. om foråret og efteråret) i flere år efter hinanden og i mindst to år efter det sidst bekræftede tilfælde af rabies i regionen.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Lokkemaden skal håndteres med forsigtighed.
English: 40 x 20 units
Danish: 40 x 20 enheder)
English: NAME OF THE MARKETING AUTHORISATION HOLDER IDT Biologika, Germany
Danish: IDT Biologika, Germany
English: MINIMUM PARTICULARS TO APPEAR ON BAITS
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ LOKKEMADEN
English: Vaccine baits are not suitable for vaccination of domestic animals.
Danish: Særlige forsigtighedsregler vedrørende brug til dyr: Vaccinelokkemad er ikke egnet til vaccination af husdyr.
English: 4.11 Withdrawal period (s)
Danish: 4.11 Tilbageholdelsestid
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: Attenuated live rabies vaccine virus, strain SPBN GASGAS: 106.8 FFU* - 108.1 FFU* (* Focus Forming Units)
Danish: Svækket, levende rabiesvaccinevirus, stamme SPBN GASGAS FFU* - 10
English: BATCH NUMBER Lot: {number}
Danish: Lot: {nummer}
English: PACKAGE SIZE 1 x 800 units
Danish: 1 x 800 enheder
English: The thawed vaccine bait may be stored for 7 days between 2 °C- 8 °C before use; however baits for which the cooling chain was disrupted, because they were not stored in a refrigerator, should be destroyed.
Danish: Lokkemadsenheder, der har været udsat for et brud i kølekæden, f.eks. fordi de ikke har været opbevaret i køleskab, skal dog destrueres.
English: Bait:
Danish: FFU*
English: DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED {DD/MM/YYYY}
Danish: DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN
English: PHARMACEUTICAL PARTICULARS
Danish: VETERINÆRLÆGEMIDLETS NAVN
English: Attenuated live rabies vaccine virus, strain SPBN GASGAS 106.8 FFU*/dose - 108.1 FFU*/dose (* Focus Forming Units)
Danish: FFU*/dosis (*Fokusdannende enheder - Focus Forming Units)
English: Oral use blister (PCTFE/PVC/alu) 28 capsules
Danish: Oral anvendelse Blister (PCTFE/PVC/aluminium)
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration Immediate Packaging Pack size EU/1/08/443/001 Thalidomide Celgene 50 mg Capsule, hard
Danish: (Særnavn) Navn Styrke Lægemiddelform Administration Emballage
English: The European Commission granted a marketing authorisation valid throughout the EU for Clopidogrel Sandoz to Acino Pharma GmbH on 21 september 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Clopidogrel Sandoz til Acino Pharma GmbH den 21. september 2009.
English: The standard dose of Clopidogrel Sandoz is one 75 mg tablet once a day, taken with or without food.
Danish: Standarddosis af Clopidogrel Sandoz er én 75 mg -tablet én gang dagligt med eller uden et måltid.
English: This means that Clopidogrel Sandoz is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Danish: Det betyder, at Clopidogrel Sandoz er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union (EU), og som hedder Plavix.
English: Clopidogrel Sandoz can be given to the following groups of patients:
Danish: Clopidogrel Sandoz kan gives til følgende patientgrupper:
English: Clopidogrel Sandoz is used in adults to prevent atherothrombotic events (problems caused by blood clots and hardening of the arteries).
Danish: Clopidogrel Sandoz anvendes til forebyggelse af aterotrombotiske hændelser hos voksne (problemer forårsaget af blodpropper og åreforkalkning).
English: Clopidogrel Sandoz clopidogrel EPAR summary for the public
Danish: Clopidogrel Sandoz clopidogrel EPAR - sammendrag for offentligheden
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Clopidogrel Sandoz has been shown to have comparable quality and to be bioequivalent to Plavix.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Clopidogrel Sandoz i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med Plavix.
English: Other information about Clopidogrel Sandoz:
Danish: Andre oplysninger om Clopidogrel Sandoz:
English: The full EPAR for Clopidogrel Sandoz can be found here.
Danish: Den fuldstændige EPAR for Clopidogrel Sandoz findes her.
English: Clopidogrel Sandoz is a ‘generic medicine'.
Danish: Clopidogrel Sandoz er et ‘generisk lægemiddel'.
English: The Committee recommended that Clopidogrel Sandoz be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Clopidogrel Sandoz.
English: Clopidogrel Sandoz can be started between seven days and six months after the
Danish: Behandling med Clopidogrel Sandoz kan påbegyndes syv dage efter slagtilfældet og indtil seks måneder efter,
English: Because Clopidogrel Sandoz is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Clopidogrel Sandoz er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Clopidogrel Sandoz can be started between a few days and 35 days after the attack;
Danish: Sandoz kan påbegyndes få dage efter anfaldet og indtil 35 dage efter,
English: Because Clopidogrel Sandoz is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine, Plavix.
Danish: Da Clopidogrel Sandoz er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Plavix.
English: What are the benefit and risk of Clopidogrel Sandoz?
Danish: Hvilken fordel og risiko er der forbundet med Clopidogrel Sandoz?
English: Clopidogrel Sandoz is a medicine that contains the active substance clopidogrel.
Danish: Clopidogrel Sandoz er et lægemiddel, der indeholder det aktive stof clopidogrel.
English: The active substance in Clopidogrel Sandoz, clopidogrel, is an inhibitor of platelet aggregation.
Danish: Det aktive stof i Clopidogrel Sandoz, clopidogrel, er en trombocytfunktionshæmmer.
English: Why has Clopidogrel Sandoz been approved?
Danish: Hvorfor blev Clopidogrel Sandoz godkendt?
English: What is Clopidogrel Sandoz?
Danish: Hvad er Clopidogrel Sandoz?
English: How has Clopidogrel Sandoz been studied?
Danish: Hvordan blev Clopidogrel Sandoz undersøgt?
English: What is Clopidogrel Sandoz used for?
Danish: Hvad anvendes Clopidogrel Sandoz til?
English: How is Clopidogrel Sandoz used?
Danish: Hvordan anvendes Clopidogrel Sandoz?
English: How does Clopidogrel Sandoz work?
Danish: Hvordan virker Clopidogrel Sandoz?
English: 5 were from Canada and 5 from the USA, with no reports coming from Europe.
Danish: Fem var fra Canada, og fem fra USA, mens der ikke var nogen rapporter fra Europa.
English: All three facilities became part of Cetero Research.
Danish: Alle disse tre virksomheder blev en del af Cetero Research.
English: Overall summary of the scientific evaluation of Leflunomide Apotex (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Leflunomide Apotex (se bilag I)
English: The dissolution testing data submitted was not considered complete as it was performed with a surfactant and only done in water and was therefore considered to be only of limited value.
Danish: Den forelagte opløselighedstest blev ikke anset for at være fuldstændig, da den var fremkommet ved brug af en surfaktant og kun blev udført i vand, hvorfor den blev anset for at være af begrænset værdi.
English: It is used in the treatment of adults with active moderate to severe rheumatoid arthritis and psoriatic arthritis.
Danish: Det anvendes til behandling af voksne med aktiv, moderat til svær reumatoid arthritis og psoriatrisk arthritis.
English: In all 4 studies, the 90% confidence intervals for AUC0-72 and Cmax were within the 80% to 125% limits.
Danish: I alle fire undersøgelser lå 90-%-konfidensintervallerne for AUC0-72 og Cmax inden for grænserne på mellem 80 % og 125 %.
English: The studies had a cross-over design with 2 weeks wash-out in between the study periods.
Danish: Undersøgelserne var tilrettelagt som et overkrydsningsdesign med to ugers udvaskningsperiode mellem undersøgelsesperioderne.
English: However, according to the new bioequivalence guideline, such studies should be performed without the addition of surfactants and in media pH 1.2, 4.5, 6.8 and with the quality control method.
Danish: I henhold til de nye retningslinjer for bioækvivalens skal sådanne undersøgelser imidlertid udføres uden tilsætning af surfaktanter, ved anvendelse af medier med pH 1,2, 4,5 og 6,8 og ved anvendelse af kvalitetskontrolmetoden.
English: The clinical phase of the study was performed in January and February 2006 at Gateway Medical Research Inc. in St. Charles (USA) while the analytical phase was performed at BA Research International LP in Houston (USA) and the statistical phase was performed at BA Research International LP in Austin (USA) in February and March 2006.
Danish: Undersøgelsens kliniske fase blev udført i januar og februar 2006 hos Gateway Medical Research Inc. i St. Charles (USA), mens den analytiske fase blev udført hos BA Research International LP i Houston (USA), og den statistiske fase blev udført hos BA Research International LP i Austin (USA) i februar og marts 2006.
English: For ten of these cases, the potential involvement of Leflunomide Apotex was ruled out.
Danish: I 10 af disse tilfælde blev mulig involvering af Leflunomide Apotex udelukket.
English: • The Committee considered the procedure under Article 31 of Directive 2001/83/EC for Leflunomide Apotex and associated names.
Danish: • udvalget behandlede proceduren i henhold til artikel 31 i direktiv 2001/83/EF for Leflunomide Apotex og relaterede navne,
English: The CHMP agreed that the generic formulation is qualitative and quantitatively the same for the markets referred to and that the products are manufactured in the same manufacturing site, via the same manufacturing process.
Danish: CHMP medgav, at den generiske formulering kvalitativt og kvantitativt er den samme for de omtalte markeder, og at lægemidlerne fremstiles på samme fremstillingssted efter samme fremstillingsproces.
English: The studies with the US and Canadian products were performed by Apotex Research Inc., Toronto, Canada.
Danish: Undersøgelserne med de amerikanske og canadiske lægemidler blev udført af Apotex Research Inc. i Toronto, Canada.