FrancophonIA/ELRC3.0 huggingface dataset:
English: For the riluzole-containing medicinal product affected by the review (Riluzole Alkem), the MAH provided some comparative dissolution data to claim that, as the multi-media dissolution profiles of cefuroxime and riluzole are similar to those of the reference products, the probability of the products being bioequivalent is high.
Danish: For det riluzol-indeholdende lægemiddel berørt af gennemgangen (Riluzol Alkem) frembragte indehaveren af markedsføringstilladelsen nogle komparative opløsningsdata til understøttelse af, at multimedieopløsningsprofilerne for cefuroxim og riluzol svarer til referencelægemidlernes profiler, hvilket antyder at sandsynligheden for at lægemidlerne er bioækvivalente er høj.
English: Having assessed the alternative data, the CHMP recommends the maintenance of the marketing authorisations for Cefuroxime Alkem and Cefuroxime Krka and concludes that, with regards to the Cefuroxime Ingen Pharma marketing authorisation application, bioequivalence has been demonstrated vis-à-vis the EU reference medicinal product using alternative data.
Danish: Efter vurdering af de alternative data anbefaler CHMP opretholdelse af markedsføringstilladelserne for Cefuroxim Alkem og Cefuroxim Krka og konkluderer, at med hensyn til ansøgningen om markedsføringstilladelse for Cefuroxim Ingen Pharma, er der påvist bioækvivalens med EU-referencelægemidlet med anvendelse af alternative data.
English: Taking the above into account, the benefit-risk balance of medicinal products for which bioequivalence is not established cannot be considered positive, as the possibility of safety/tolerability or efficacy issues cannot be excluded.
Danish: Under hensyntagen til ovenstående har et lægemiddel, hvis bioækvivalens ikke er påvist, derfor ikke et positivt benefit/risk-forhold, da det ikke kan udelukkes, at dette vil medføre problemer vedrørende sikkerhed/tolerabilitet eller virkning.
English: As the quality management system covered all parts of the trial and a failure of the system in particular in relation to the ECGs monitoring was detected and acknowledged by the site, this system was considered by BfArM to be insufficient and severe failures in other areas of the trial could not be excluded even if not detected.
Danish: Da kvalitetskontrolsystemet dækkede alle dele af forsøget, og der blev påvist systemsvigt i forbindelse med EKG-overvågning, hvilket det inspicerede sted erkendte, blev systemet anset for at være utilstrækkeligt af BfArM.
English: If the bioavailability of the generic product is higher than the bioavailability of the reference medicinal product, this may result in a higher than intended exposure of patients to the active substance, leading potentially to an increase in the incidence or severity of adverse effects.
Danish: Hvis lægemidlet havde større biotilgængelighed end referencelægemidlet, ville det medføre højere eksponering af patienterne for det aktive stof end tilsigtet, hvilket potentielt kunne føre til hyppigere eller sværere bivirkninger.
English: The bioequivalence to the EU reference medicinal product is therefore not established.
Danish: Bioækvivalensen med EU-referencelægemidlet er derfor ikke fastlagt.
English: c. Marketing authorisations for medicinal products for which the bioequivalence vis-à-vis the EU reference medicinal product has been established (annex IA) should be maintained, as the benefit risk balance of these marketing authorisation is considered favourable.
Danish: c. opretholdelse af markedsføringstilladelserne for lægemidler, som er påvist at være bioækvivalente med EU-referencelægemidlet (bilag IA), da benefit/risk-forholdet for disse markedsføringstilladelser anses for positivt.
English: − Authorised medicinal products for which alternative bioequivalence data or a justification was submitted but considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB);
Danish: − Godkendte lægemidler, for hvilke alternative bioækvivalensdata eller begrundelse var forelagt, men hvor CHMP ikke fandt, at disse var fyldestgørende til at godtgøre bioækvivalens med EUreferencelægemidlet (bilag IB).
English: In the absence of the demonstration of bioequivalence vis-à-vis the EU reference medicinal product, the requirements of Article 10 of Directive 2001/83/EC cannot be considered fulfilled, the efficacy and safety of the concerned medicinal products cannot be established, hence the benefit-risk balance of these medicinal products cannot be considered positive.
Danish: Konklusioner Som følge af manglende påvisninger af bioækvivalens med EU-referencelægemidlet kan kravene i artikel 10 i direktiv 2001/83/EF ikke anses som opfyldte, og de pågældende lægemidlers virkning og sikkerhed kan ikke fastlægges.
English: In addition, the MAH presented data to demonstrate that the US and Australian reference medicinal products are similar to the EU reference medicinal product, and that bioequivalence studies comparing the riluzole generic product under discussion to the US and Australian originators concluded in bioequivalence, therefore it is very likely that the product is also bioequivalent to the EU reference medicinal product.
Danish: Indehaveren af markedsføringstilladelsen præsenterede desuden data til påvisning af, at referencelægemidlerne i USA og Australien svarer til EU-referencelægemidlet, og at bioækvivalensundersøgelser, der sammenligner det omtalte generiske produkt riluzol med de oprindelige produkter i USA og Australien, fastslog bioækvivalens.
English: a. Marketing authorisations for medicinal products for which bioequivalence data or justification were not submitted or considered insufficient by the CHMP to establish bioequivalence vis-à-vis the EU reference medicinal product (annex IB) should be suspended, as the particulars supporting the marketing authorisations are incorrect and the benefit-risk balance of these marketing authorisation is considered not favourable pursuant to Article 116 of Directive 2001/83/EC.
Danish: b. suspendering af ansøgningerne om markedsføringstilladelser for lægemidler, for hvilke bioækvivalensdata eller begrundelse ikke er forelagt eller af CHMP ikke findes fyldestgørende til at godtgøre bioækvivalens med EU-referencelægemidlet (bilag IB), da oplysningerne til dokumentation for markedsføringstilladelserne er urigtige, og benefit/risk-forholdet for disse markedsføringstilladelser ikke er positivt i henhold til artikel 116 i direktiv 2001/83/EF.
English: • Revaccination Annual.
Danish: • Revaccination Årligt.
English: (as hydroxide)
Danish: (som hydroxid)
English: Date of first authorisation: 17/12/2010 Date of last renewal: 08/09/2015
Danish: Dato for første markedsføringstilladelse: 17/12/2010 Dato for seneste fornyelse af markedsføringstilladelse: 08/09/2015
English: Adjuvants: Al
Danish: Adjuvanser: Al
English: The entire content of the bottle should be used immediately after broaching and during the same procedure.
Danish: Hele flaskens indhold skal anvendes umiddelbart efter anbrud og i samme arbejdsgang.
English: Avoid bubble formation, as this can be irritating at the site of injection.
Danish: Undgå dannelse af luftbobler, da det kan virke irriterende på injektionsstedet.
English: - Second injection: after 3-4 weeks.
Danish: - Anden injektion: efter 3-4 uger.
English: (**) Antigen content (VP2 protein) by immuno-assay
Danish: (**) Antigenindhold (VP2 protein) fastsat ved immuno-assay
English: Sheep and cattle.
Danish: Får og kvæg.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required.
Danish: Hjælpestofferne (inklusive adjuvanter), som er anført i punkt 6.1 af SPC'et er tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer, at MRL-værdier ikke er påkrævet.
English: Apply usual aseptic procedures.
Danish: Anvend sædvanlig aseptik.
English: No other adverse reactions except those mentioned in section 4.6 were observed.
Danish: Der er ikke observeret andre bivirkninger end dem, der er nævnt i sektion 4.6.
English: Special precautions for use in animals: Not applicable.
Danish: Særlige forholdsregler til brug hos dyr: Ikke relevant.
English: The type of strain(s) (two strains at most) included in the final product will be selected based on the epidemiological situation at the time of manufacturing and will be stated on the label.
Danish: Den eller de stammer (højst to stammer), som inkluderes i den endelige vaccine, vil blive udvalgt baseret på den givne epidemiologiske situation på fremstillingstidspunktet og vil blive deklareret i mærkningen.
English: The level of efficacy for other species may differ from that observed in sheep and cattle.
Danish: Effektiviteten hos andre dyrearter kan variere fra den, der er observeret hos får og kvæg.
English: Any person intending to manufacture, import, possess, sell, supply and use of BTVPUR containing serotypes 1, 2, 4 and 8 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 BTVPUR, som indeholder serotyperne 1, 2, 4 og 8 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: Administer one dose of 1 ml subcutaneously according to the following vaccination scheme:
Danish: Administrer en dosis på 1 ml subkutant i henhold til følgende vaccinationsprogram:
English: For viral culture, inactivation and concentration steps only: MERIAL
Danish: Kun for viruskultur, inaktiverings- og koncentreringstrin: MERIAL
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: Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke inden for anvendelsesområdet af Forordning (EF) nr. 470/2009, når det anvendes som i dette veterinære lægemiddel.
English: Withdrawal period: zero days.
Danish: Tilbageholdelsestid: 0 dage.
English: Subcutaneous use.
Danish: Subkutan brug.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton after EXP.
Danish: Må ikke anvendes efter den udløbsdato, der er angivet på æsken efter EXP.
English: BOEHRINGER INGELHEIM Animal Health UK Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ United Kingdom
Danish: BOEHRINGER INGELHEIM Animal Health UK Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Storbritannien
English: 1 ml dose*:
Danish: 1 ml dosis*:
English: Store and transport refrigerated (2 ºC - 8 ºC).
Danish: Opbevares og transporteres nedkølet (2 °C-8 °C).
English: Pregnancy and lactation: Can be used during pregnancy and lactation.
Danish: Drægtighed og laktation: Kan anvendes under drægtighed og laktation.
English: FRANCE
Danish: FRANKRIG
English: It induces an active and specific immunity against Bluetongue Virus in the vaccinated animal.
Danish: Den inducerer en aktiv og specifik immunitet over for bluetonguevirus i vaccinerede dyr.
English: Detailed information of this product is available on the website of the European Medicines Agency (http://www.ema.europa.eu).
Danish: Yderligere information om dette lægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Pharmacotherapeutic group: bluetongue virus vaccine, ATC vet code QI04AA02 (sheep) and QI02AA08 (cattle).
Danish: Farmakoterapeutisk gruppe: Vaccine mod bluetonguevirus, ATC vet kode QI04AA02 (får) og QI02AA08 (kvæg).
English: Do not mix with any other veterinary medicinal product.
Danish: Bør ikke blandes med andre veterinære lægemidler.
English: Silicon antifoam Phosphate buffer Glycine buffer Aluminium hydroxide Saponin
Danish: Silikone antifoam Fosfatbuffer Glycinbuffer Aluminiumhydroxid Saponin
English: Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest France
Danish: Laboratory of Lyon Porte des Alpes Rue de l'Aviation, 69800 Saint-Priest Frankrig
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 veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: 100 doses (100 ml)
Danish: 100 doser (100 ml)
English: The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Bluetongue.
Danish: Anvendelse af dette veterinære lægemiddel er kun tilladt under de særlige omstændigheder, der er fastsat af EU-lovgivning vedr.
English: Each dose of 1 ml contains: Active substances *:
Danish: Hver dosis på 1 ml indeholder: Aktive stoffer*:
English: The duration of immunity for cattle and sheep is 1 year after primary vaccination course.
Danish: Varighed af immunitet hos kvæg og får er 1 år efter basisvaccinationsprogrammet.
English: Manufacturer responsible for batch release: MERIAL
Danish: Fremstiller ansvarlig for batchfrigivelse: MERIAL
English: Shake gently immediately before use.
Danish: Omrystes forsigtigt umiddelbart før brug.
English: Shelf life after first opening the immediate packaging: use immediately.
Danish: Opbevaringstid efter første åbning af beholderen: anvendes straks.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Danish: TEKSTEN “TIL DYR”
English: EXP {month/year} Once broached, use immediately.
Danish: EXP {måneder/år} Efter anbrud anvendes straks.
English: 10 doses (10 ml) 50 doses (50 ml)
Danish: 10 doser (10 ml) 50 doser (50 ml)
English: *below the level of detection by the validated RT-PCR method at 3.68 log10 RNA copies/ml, indicating no infectious virus transmission.
Danish: * under detektionsgrænsen for den validerede RT-PCR-metode på 3,68 log10 RNA-kopier/ml, der indikerer, at der ikke er nogen infektiøs virustransmission.
English: The vaccine contains inactivated Bluetongue Virus with aluminium hydroxide and saponin adjuvants.
Danish: Vaccinen indeholder inaktiveret bluetonguevirus med aluminiumhydroxid og saponin som adjuvans.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DE BIOLOGISK AKTIVE STOFFER OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: For purification and bottling steps only: MERIAL Laboratory of Lyon Porte des Alpes Rue de l'Aviation,
Danish: Kun for oprensnings- og flaskefyldningstrin: MERIAL, Laboratory of Lyon Porte des Alpes Rue de l'Aviation,
English: Each dose of 1 ml contains:
Danish: Hver dosis på 1 ml indeholder:
English: • Primary vaccination
Danish: • Basisvaccination
English: Onset of immunity has been demonstrated 3 weeks (or 5 weeks in sheep for BTV2) after the primary vaccination course for BTV-1, BTV-2 (cattle), BTV-4 and BTV-8 serotypes.
Danish: Immunitet er påvist 3 uger (eller 5 uger hos får for BTV-2) efter basisvaccinationsprogrammet for BTV-1, BTV-2 (kvæg), BTV-4 og BTV-8 serotyper.
English: Incompatibilities: Do not mix with any other veterinary medicinal product.
Danish: Uforligeligheder: Bland ikke vaccinen med andre veterinære lægemidler.
English: Active substance*:
Danish: Aktive stoffer *:
English: A confirmatory final potency test by seroneutralisation in rats is conducted when a batch is released.
Danish: Ved frigivelsen af en batch bliver der foretaget en seroneutraliseringstest i rotter, som skal bekræfte den endelige styrke.
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
Danish: Anvend derfor kun vaccinen til denne kategori af dyr i henhold til en benefit/risk vurdering foretaget af den ansvarlige dyrlæge og/eller de nationale myndigheder, der er ansvarlige for den foreliggende vaccinationspolitik for bluetonguevirus (BTV).
English: In this category of animals the vaccine should be used only according to the benefit/risk assessment by the responsible veterinarian and/ or national Competent Authorities on the current vaccination policies against Bluetongue Virus (BTV).
Danish: Anvend derfor kun vaccinen til denne kategori af dyr i henhold til en benefit/risk-vurdering foretaget af den ansvarlige dyrlæge og/eller de nationale myndigheder, der er ansvarlige for den foreliggende vaccinationspolitik for bluetonguevirus (BTV).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE Box of 1 bottle of 10 ml,
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske med 1 flaske à 10 ml
English: B. CONDITIONS OR RESTRICTIONS OF REGARDING SUPPLY OR USE
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER FOR MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG
English: The safety and the efficacy of the vaccine have not been established in breeding males.
Danish: Sikkerhed og virkning af vaccinen er endnu ikke fastlagt hos væddere og tyre.
English: PACKAGE LEAFLET: BTVPUR suspension for injection for sheep and cattle
Danish: INDLÆGSSEDDEL: BTVPUR injektionsvæske, suspension til får og kvæg
English: (**)Strain-specific pass levels
Danish: (**)Serotypepecifikke grænseværdier
English: In very rare cases it has been observed a small local swelling at the injection site (at most 32 cm² in cattle and 24 cm² in sheep) which becomes residual 35 days later (≤ 1 cm In very rare cases a transient increase in body temperature, normally not exceeding an average of 1.1 ºC, may occur within 24 hours after vaccination.
Danish: I meget sjældne tilfælde er der observeret en mindre lokal hævelse på injektionsstedet (max. 32 cm hos kvæg og 24 cm hos får), der tilbagedannes efter 35 dage (≤ 1 cm Inden for 24 timer efter vaccination kan der i meget sjældne tilfælde forekomme forbigående temperaturforhøjelse, der normalt ikke overstiger et gennemsnit på 1,1 °C.
English: For a monovalent vaccine containing an inactivated Bluetongue Virus serotype 2 or 4, or for a bivalent vaccine containing both serotypes 2 and 4 together, one injection is sufficient.
Danish: For en monovalent vaccine, som indeholder inaktiveret bluetonguevirus serotype 2 eller 4, eller for en bivalent vaccine, som både indeholder serotype 2 og 4, er én injektion tilstrækkelig.
English: Very rare and transient apathy can be observed after the administration of a double-dose of the vaccine.
Danish: Efter administration af en dobbeltdosis af vaccinen kan der meget sjældent ses forbigående apati.
English: Bottle of 10 and 50 ml
Danish: Flaske à 10 og 50 ml
English: 10 doses (10 ml) 50 doses (50 ml) 10 x 50 doses (10 x 50 ml) 100 doses (100 ml) 10 x 100 doses (10 x100 ml)
Danish: 10 doser (10 ml) 50 doser (50 ml) 10 x 50 doser (10 x 50 ml) 100 doser (100 ml) 10 x 100 doser (10 x 100 ml)
English: Shelf life of monovalent or bivalent formulation with Bluetongue Virus serotypes 1, 8 (100 ml, 50 ml and 10 ml bottles) and/or 4 (100 ml and 50 ml bottles): 2 years.
Danish: Opbevaringstid for monovalent eller bivalent formulering af bluetonguevirus med serotyperne 1, 8 (flasker à 100 ml, 50 ml og 10 ml) og/eller 4 (flasker à 100 ml og 50 ml): 2 år.
English: For a monovalent vaccine containing an inactivated Bluetongue Virus serotypes 2 or 4, or for a bivalent vaccine containing both serotypes 2 and 4 together, one injection is sufficient.
Danish: For en monovalent vaccine, som indeholder inaktiveret bluetonguevirus serotyper 2 eller 4, eller for en bivalent vaccine, som både indeholder serotype 2 og 4 er én injektion tilstrækkelig.
English: BTVPUR suspension for injection for sheep and cattle.
Danish: BTVPUR injektionsvæske, suspension til får og kvæg.
English: Suspension for injection Appearance: homogeneous milky white .
Danish: Injektionsvæske, suspension Udseende: Homogen, mælkehvid
English: Active immunisation of cattle to prevent viraemia* caused by bluetongue virus serotypes 1, 2, 4 and/or 8, and to reduce clinical signs caused by bluetongue virus serotypes 1, 4 and/or 8 (combination of maximum 2 serotypes).
Danish: Aktiv immunisering af kvæg for at forebygge viræmi* forårsaget af bluetonguevirus serotype 1, 2, 4 og/eller 8 og nedsætte kliniske symptomer forårsaget af bluetonguevirus serotype 1, 4 og/eller 8 (kombination af højst 2 serotyper).
English: Active immunisation of sheep to prevent viraemia* and to reduce clinical signs caused by bluetongue virus serotypes 1, 2, 4 and/or 8 (combination of maximum 2 serotypes).
Danish: Aktiv immunisering af får for at forebygge viræmi* og nedsætte kliniske symptomer forårsaget af bluetonguevirus serotype 1, 2, 4 og/eller 8 (kombination af højst 2 serotyper).
English: Inactivated BTV1 ..................................................................................................... ≥ 1.9 log10 pixels Inactivated BTV2 ................................................................................................... ≥ 1.82 log10 pixels Inactivated BTV4 ................................................................................................... ≥ 1.86 log10 pixels Inactivated BTV8 ................................................................................................... ≥ 2.12 log10 pixels (*) maximum of two different inactivated bluetongue virus serotypes.
Danish: Inaktiveret BTV1 ..............................................................................................................  1,9 log10 pixel Inaktiveret BTV2 ............................................................................................................  1,82 log10 pixel Inaktiveret BTV4 ..........................................................................................................  1,86 log10 pixel Inaktiveret BTV8 ..........................................................................................................  2,12 log10 pixel * højst 2 forskellige inaktiverede bluetonguevirus serotyper
English: Inactivated Bluetongue Virus ......................................... strain specific pass level (log10 pixels) ** * maximum of two different inactivated bluetongue virus serotypes
Danish: Inaktiveret Bluetonguevirus ....................................... serotypespecifik grænseværdi (log10 pixel)** * højst 2 forskellige inaktiverede bluetonguevirus serotyper
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ INDERPAKNING
English: Inactivated bluetongue virus ........................................ strain specific pass level (log10 pixels) ** (*) maximum of two different inactivated bluetongue virus serotypes
Danish: Inaktiveret Bluetonguevirus .......................................  serotypespecifik grænseværdi (log10 pixel)** * højst 2 forskellige inaktiverede bluetonguevirus serotyper
English: Bottle of 100 ml
Danish: Flaske à 100 ml
English: Al3+ (as hydroxide) .................................................................................................................. 2.7 mg Saponin ................................................................................................................................... 30 HU** (**)Haemolytic units
Danish: (som hydroxid) .................................................................................................................. 2,7 mg Saponin ................................................................................................................................... 30 HU** hæmolytiske enheder
English: Disposal: read package leaflet
Danish: Bortskaffelse: Se indlægssedlen.
English: No other adverse reactions except those mentioned in section ‘Adverse Reactions' were observed.
Danish: Der er ikke observeret andre bivirkninger efter en dobbeltdosis med vaccinen end de, der er nævnt i afsnittet Bivirkninger.