FrancophonIA/ELRC3.0 huggingface dataset:
English: The product is considered as bioequivalent to the originator, and the benefit-risk balance is considered positive.
Danish: Lægemidlet betragtes som bioækvivalent med originalpræparatet, og benefit/risk-forholdet betragtes som positivt.
English: The CHMP considered the chemicalpharmaceutical documentation and Expert Report, of Betahistine, of sufficient quality in view of the present European regulatory requirements.
Danish: CHMP fandt, at den kemisk-farmaceutiske dokumentation af og ekspertudtalelse om betahistin var af tilstrækkelig høj kvalitet i forhold til de aktuelle europæiske lovbestemmelser.
English: The control tests and specifications for drug product are adequately drawn up.
Danish: Kontrolprøverne og specifikationerne for lægemidlet er affattet på hensigtsmæssig vis.
English: Efficacy and safety of betahistine dihydrochloride in the treatment of symptoms associated with Menière's disease have been demonstrated in preclinical-and clinical trials.
Danish: Virkningen og sikkerheden af betahistindihydrochlorid i behandling af symptomer forbundet med Menières sygdom er blevet påvist i prækliniske og kliniske undersøgelser.
English: As betathistine is a widely used, well-known active substance, no further studies are required and the MAH provides none.
Danish: Idet betahistin er et almindeligt anvendt, velkendt aktivt stof, er der ikke behov for yderligere undersøgelser, og indehaveren af markedsføringstilladelsen forelægger ingen sådan undersøgelse.
English: Betahistine is excreted in breast milk in concentrations similar to those found in plasma.
Danish: Betahistin udskilles i brystmælk i koncentrationer, der svarer til koncentrationerne i plasma.
English: The MAH has demonstrated that Betavert N (Hennig Arzneimittel GmbH, Germany) and the originator, Betaserc® 8 (Duphar, UK), are bioequivalent after single administration.
Danish: Indehaveren af markedsføringstilladelsen har påvist, at Betavert N (Hennig Arzneimittel GmbH, Tyskland) og originalpræparatet, Betaserc® 8 (Duphar, Det Forenede Kongerige), er bioækvivalente efter indgift af enkeltdosis.
English: The determination of 2-Pyridylacetic acid (PAA), the active metabolite of betahistine, from urine samples was not considered as up-to-date method, the measurement of PAA in human plasmas would have considered more appropriate.
Danish: Bestemmelse af 2-pyridyleddikesyre (PAA), den aktive metabolit i betahistin, fra urinprøver blev betragtet som en forældet metode, og måling af PAA i humant plasma blev betragtet som en mere hensigtsmæssig metode.
English: Distribution: The human volume of distribution of betahistine dihydrochloride is not known.
Danish: Distribution: Den humane distributionsvolumen for betahistindihydrochlorid er ukendt.
English: The BCS-studies of betahistine substance and formulations presented herein along with the properties of the drug substance (therapeutic index, safety and complete absorption) and the formulations (composition) provided robust support for waiving in vivo BE studies for Betavert N. Moreover, betahistine fulfils the regulatory requirements for granting a biowaver, being assigned to the group of compounds with high solubility and complete absorption - accordant with Class I of BCS.
Danish: BCS-undersøgelserne af betahistins substans og formulering, der præsenteres heri, sammen med lægemiddelstoffets egenskaber (terapeutisk indeks, sikkerhed og fuldstændig absorption) og formuleringerne (sammensætning) gav dokumentation for at undlade at foretage in vivo-bioækvivalensundersøgelser for Betavert N. Betahistin opfylder endvidere det lovmæssige krav til dispensation for bioækvivalensundersøgelse, idet betahistin henføres til en gruppe af forbindelser med høj opløselighed og fuldstændig absorption - i overensstemmelse med BCS-klasse I.
English: Only traces of desmethylbetahistine dihydrochloride are recovered in the urine.
Danish: Kun spor af demethylbetahistindihydrochlorid genfindes i urinen.
English: This was done by a bioequivalence study investigating urine levels of the main metabolite and by supportive in vitro studies, performed in the course of the national authorisation procedure, leading to the conclusion that it is justified to waive for further bioequivalence studies in human volunteers.
Danish: Dette blev gjort gennem en bioækvivalensundersøgelse, hvori man undersøgte urinkoncentrationen af hovedmetabolitten, og gennem understøttende in vitro-undersøgelser foretaget under den nationale godkendelsesprocedure, på baggrund af hvilke det blev fundet berettiget at opgive yderligere bioækvivalensundersøgelser på forsøgspersoner.
English: Betahistine is an analogue of histamine, which is indicated in the treatment of vertigo associated with functional disorders of the vestibular apparatus in the context of Meniere's symptom complex.
Danish: Betahistin er en histaminanalog, som er indiceret til behandling af svimmelhed forbundet med funktionelle lidelser i det vestibulære apparat i forbindelse med Menières symptomkompleks.
English: The Marketing Authorisation Holder of Betavert N is Hennig Arzneimittel GmbH & Co.KG
Danish: Indehaveren af markedsføringstilladelsen for Betavert N er Hennig Arzneimittel GmbH & Co.KG.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS / MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: The MAH has provided documents that set out a detailed description of the system of pharmacovigilance.
Danish: Indehaveren af markedsføringstilladelsen har fremsendt dokumenter med detaljeret beskrivelse af lægemiddelovervågningssystemet.
English: Elimination: Excretion of Betahistine is almost entirely (85 % - 90 %) in the urine within 24 hours Betahistin is excreted almost completely as the major metabolite in the urine.
Danish: Udskillelse: Betahistin udskilles næsten helt (85-90 %) i urin inden for 24 timer.
English: The results of solubility study showed a high solubility of the active substance about a broad pH range.
Danish: Resultaterne af undersøgelsen vedrørende opløselighed viste, at det aktive stof har en høj opløselighed inden for et bredt pH-område.
English: The MAH demonstrated the bioequivalence with two types of data: an in vivo BE-study (bioequivalence study) with urine measurement and in vitro studies on BA/BE based on Biopharmaceutics Classification System (BCS).
Danish: Indehaveren af markedsføringstilladelsen påviste bioækvivalensen ved hjælp af to typer data: en in vivoBE-undersøgelse (bioækvivalensundersøgelse) med urinmåling og in vitro-undersøgelser af BA/BE på baggrund af Biopharmaceutics Classification System (BCS).
English: The active substance Betahistine hydrochloride is described in Ph.Eur.
Danish: Det aktive stof betahistinhydrochlorid er beskrevet i Den Europæiske Farmakopé.
English: The RMS considers that the Pharmacovigilance system as described by the MAH fulfils the requirements as described in Volume 9A of the Rules Governing Medicinal Products in the European Union and provides adequate evidence that the MAH has the services of a qualified person responsible for pharmacovigilance and has the necessary means for the notification of any adverse reaction suspected of occurring either in the Community or in a third country.
Danish: Referencemedlemsstaten vurderer, at lægemiddelovervågningssystemet, som det er beskrevet af indehaveren af markedsføringstilladelsen, opfylder kravene i henhold til bind 9A i Bestemmelser om lægemidler i Den Europæiske Union og tilvejebringer tilstrækkelig dokumentation for, at indehaveren af markedsføringstilladelsen har adgang til en sagkyndig med ansvar for lægemiddelovervågning og råder over de nødvendige midler til indberetning af eventuelle bivirkninger, der er formodning om i Fællesskabet eller tredjelande.
English: The absolute bioavailability of betahistine dihydrochloride is not known.
Danish: Den absolutte biotilgængelighed for betahistindihydrochlorid er ukendt.
English: The Marketing Authorisation Holder of the originator is Solvay Pharma B.V. settled in Netherlands.
Danish: Indehaveren af markedsføringstilladelsen for originalpræparatet er Solvay Pharma B.V.
English: Germany HENNIG ARZNEIMITTEL GmbH & Co. KG
Danish: Tyskland HENNIG ARZNEIMITTEL GmbH & Co.
English: The CHMP concluded that betahistine dihydrochloride can be classified as Class I according to Biopharmaceutics Classification System.
Danish: CHMP konkluderede, at betahistindihydrochlorid kan klassificeres som klasse I i overensstemmelse med Biopharmaceutics Classification System.
English: The CHMP asked the MAH to clearly prove the bioequivalence between Betavert N and the originator.
Danish: CHMP anmodede indehaveren af markedsføringstilladelsen om klart at påvise bioækvivalensen mellem Betavert N og originalpræparatet.
English: The evaluation of the permeability and the absorption of the active substance was derived from a bioequivalence and a mass balance study in vivo.
Danish: Vurderingen af det aktive stofs permeabilitet og absorption blev afledt fra en in vivobioækvivalensundersøgelse og en in vivo-massebalanceundersøgelse.
English: Non-clinical pharmacodynamic, pharmacokinetic and toxicological properties of betahistine dihydrochloride are also well known.
Danish: De ikke-kliniske farmakodynamiske, farmakokinetiske og toksikologiske egenskaber ved betahistindihydrochlorid er også velkendte.
English: The originator product is Betaserc® 8 available in 8 mg tablets.
Danish: Originalpræparatet er Betaserc® 8, der kan fås som 8 mg-tabletter.
English: Pharmacodynamic, pharmacokinetic and toxicological properties of betahistine are well known.
Danish: De farmakodynamiske, farmakokinetiske og toksikologiske egenskaber ved betahistin er velkendte.
English: Bioequivalence
Danish: Bioækvivalens
English: The solubility of the drug substance and the fast dissolution rate of the drug product were already unquestionably proven.
Danish: Lægemiddelstoffets opløselighed og lægemidlets høje opløsningshastighed var allerede påvist med sikkerhed.
English: The solubility of the drug substance and the fast dissolution rate of the drug product have been proven.
Danish: Lægemiddelstoffets opløselighed og lægemidlets høje opløsningshastighed er blevet påvist.
English: The bioequivalence between Betavert N and the originator is based on Biopharmaceutics Classification System (BCS) approach (biowaiver).
Danish: Bioækvivalensen mellem Betavert N og originalpræparatet er baseret på metoden i Biopharmaceutics Classification System (dispensation for bioækvivalensundersøgelse).
English: A statement signed by the MAH and the qualified person for pharmacovigilance, indicating that the MAH has the services of a qualified person responsible for pharmacovigilance and the necessary means for the notification of any adverse reaction occurring either in the Community or in a third country has been provided.
Danish: Det fremgik af en erklæring fra indehaveren af markedsføringstilladelsen og den sagkyndige inden for lægemiddelovervågning, at indehaveren af markedsføringstilladelsen har adgang til en sagkyndig med ansvar for lægemiddelovervågning og råder over de nødvendige midler til indberetning af eventuelle bivirkninger i Fællesskabet eller i et tredjeland.
English: The CHMP, considered these data, concluded that betahistine dihydrochloride can be assigned to the highly soluble class according to Biopharmaceutics Classification System, Class I.
Danish: CHMP vurderede disse data og konkluderede, at betahistindihydrochlorid kunne henføres til klassen for høj opløselighed i henhold til BCS-klasse I.
English: Drug Product
Danish: Lægemiddelstoffet
English: In conclusuion, considering the absorption correlated with high permeability, the allocation of betahistine dihydrochloride to BCS Class I is considered justified by the CHMP.
Danish: I betragtning af at absorptionen er korreleret med en høj permeabilitet, finder CHMP det således berettiget, at betahistindihydrochlorid klassificeres som BCS-klasse I. Lægemidlet er således egnet til en BCS-baseret tilgang med dispensation for bioækvivalensundersøgelse.
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: Markedsføringstilladelsens (EU)-nummer
English: This summary was last updated in August 2016.
Danish: Dette sammendrag blev sidst ajourført i august 2016.
English: This does not affect the health or performance of the animal.
Danish: Dette påvirker ikke dyrets helbred eller præstationer.
English: If pain persists for more than 12 hours after medical examination, the doctor should be contacted again.
Danish: Hvis smerten fortsætter i over 12 timer efter lægeundersøgelsen, skal der søges lægehjælp igen.
English: The virus in the vaccine has also been modified to allow vaccinated animals to be distinguished from naturally infected animals so allowing better disease management.
Danish: Virussen i vaccinen er også blevet ændret for at kunne skelne vaccinerede dyr fra naturligt smittede dyr og for derved bedre at kunne behandle sygdommen.
English: The vaccine is given into the neck at the front of the shoulder.
Danish: Vaccinen injiceres i halsregionen foran skulderen.
English: Accidental injection may cause severe pain and swelling, particularly if injected into a joint or finger -this could result in the loss of a finger if prompt medical attention is not given.
Danish: Utilsigtet selvinjektion kan medføre svære smerter og hævelse, navnlig hvis der injiceres i et led eller en finger - dette kan medføre tab af en finger, medmindre der straks iværksættes lægelig behandling.
English: The full EPAR for Bovalto Ibraxion can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Bovalto Ibraxion findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: The name of the medicine was changed to Bovalto Ibraxion on 10 August 2016.
Danish: Lægemidlets navn blev ændret til Bovalto Ibraxion den 10. august 2016.
English: The European Commission granted a marketing authorisation valid throughout the EU for Bovalto Ibraxion on 9 March 2000.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Bovalto Ibraxion den 9. marts 2000.
English: The withdrawal period for meat and milk from cattle treated with Bovalto Ibraxion is ‘zero' days, which means there is no mandatory waiting time.
Danish: Tilbageholdelsestiden for kød og mælk fra kvæg, der behandles med Bovalto Ibraxion , er "nul" dage, hvilket vil sige, at der ikke er nogen påkrævet ventetid.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Bovalto Ibraxion's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Bovalto Ibraxion opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: A booster injection is given at 6 month intervals.
Danish: Der gives en booster-injektion med 6 måneders mellemrum.
English: In the future, if the animals are exposed to the active virus the immune system will be able to respond more quickly.
Danish: Hvis dyret efterfølgende udsættes for den inaktive virus, vil immunsystemet reagere hurtigere.
English: This is a summary of the European public assessment report (EPAR) for Bovalto Ibraxion.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Bovalto Ibraxion.
English: When there are antibodies the vaccine should be given to calves from age 3 months.
Danish: Hvis der findes antistoffer, skal vaccinen gives fra 3 måneders alderen.
English: Field studies were conducted in around 300 cattle of various ages in both an IBR contaminated and an IBR free environment.
Danish: Der blev gennemført feltundersøgelser hos 300 stykker kvæg i forskellige aldersgrupper både i et IBR-inficeret og et IBR-frit område.
English: Cattle vaccinated with Bovalto Ibraxion had protective levels of antibodies to IBR virus at 2 weeks after vaccination and the duration of protection was shown to last 6 months.
Danish: Kvæg vaccineret med Bovalto Ibraxion havde beskyttelsesniveauer af antistoffer mod IBR-virus 2 uger efter vaccinationen, og beskyttelsen varede i 6 måneder.
English: Protection starts 2 weeks after vaccination and lasts for 6 months.
Danish: Beskyttelsen opnås 14 dage efter vaccinationen og varer i 6 måneder.
English: Bovalto Ibraxion is an emulsion containing mineral oil.
Danish: Bovalto Ibraxion er en emulsion, der indeholder mineralsk olie.
English: Bovalto Ibraxion is a veterinary vaccine used to protect cattle against infectious bovine rhinotracheitis (IBR) virus.
Danish: Bovalto Ibraxion er en veterinær vaccine til beskyttelse af kvæg mod infektiøs bovin rhinotracheitis (IBR)-virus.
English: Two injections are given 3 weeks apart to calves from age 2 weeks provided they have not acquired antibodies against IBR virus from the mother.
Danish: Der gives 2 injektioner med 21 dages mellemrum hos kvæg i alderen 2 uger og derover, som ikke har antistoffer mod IBR-virus fra moderen.
English: It is not intended to provide practical advice on how to use Bovalto Ibraxion.
Danish: Det er ikke en praktisk vejledning i, hvordan Bovalto Ibraxion bør anvendes.
English: IBR virus infections affect the airways with nasal discharge, conjunctivitis (inflammation of the eye) and coughing.
Danish: IBR-virusinfektioner påvirker luftvejene i form af udflåd fra næsen, konjuktivitis (øjenbetændelse) og hoste.
English: When Bovalto Ibraxion is given to cattle the animals' immune system recognises the inactive virus as ‘foreign' and makes antibodies against it.
Danish: Når Bovalto Ibraxion gives til kvæg, registrerer dyrenes immunsystem den inaktive virus som "fremmed" og reagerer ved at danne antistoffer mod den.
English: Bovalto Ibraxion is a vaccine containing a version of the IBR virus that has been made inactive so it cannot cause infection.
Danish: Bovalto Ibraxion er en vaccine, der indeholder en version af IBR-virus, som er blevet inaktiv, så den ikke kan forårsage infektion.
English: Bovalto Ibraxion is available as an emulsion and can only be obtained with a prescription.
Danish: Bovalto Ibraxion fås som en emulsion og udleveres kun efter recept.
English: Why is Bovalto Ibraxion approved?
Danish: Hvorfor blev Bovalto Ibraxion godkendt?
English: Ibraxion may cause a slight rise in body temperature (less than 1°C) for less than 48 hours after injection.
Danish: Injektion med Bovalto Ibraxion kan forårsage en forbigående vævsreaktion på injektionsstedet, som kan vare ved i tre uger og i sjældne tilfælde op til fem uger Ibraxion kan medføre en let forhøjelse af kropstemperaturen (under 1° C) inden for 48 timer efter injektionen.
English: Bovalto Ibraxion contains the adjuvant light paraffin oil to enhance the immune response.
Danish: Bovalto Ibraxion indeholder let paraffinolie, for at fremme immunreaktionen.
English: For more information about treatment with Bovalto Ibraxion, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Bovalto Ibraxion, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Bovalto Ibraxion contains the active substance inactivated gene deleted IBR virus.
Danish: Bovalto Ibraxion indeholder det aktive stof inaktiveret IBR-virus, hvor det specifikke gen er fjernet.
English: What are the risks associated with Bovalto Ibraxion?
Danish: Hvilke risici er der forbundet med Bovalto Ibraxion?
English: For practical information about using Bovalto Ibraxion, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Bovalto Ibraxion, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Other information about Bovalto Ibraxion?
Danish: Andre oplysninger om Bovalto Ibraxion:
English: Bovine rhinotracheitis vaccine (inactivated)
Danish: Bovalto Ibraxion bovin rhinotracheitis (IBR)-vaccine (inaktiveret)
English: What benefits of Bovalto Ibraxion have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Bovalto Ibraxion?
English: How is Bovalto Ibraxion used?
Danish: Hvordan anvendes Bovalto Ibraxion?
English: How does Bovalto Ibraxion work?
Danish: Hvordan virker Bovalto Ibraxion?
English: This product contains mineral oil.
Danish: Dette produkt indeholder mineralolie.
English: 1 year.
Danish: 1 år.
English: An alternative solution could be to retain only one production site.
Danish: En alternativ løsning, der kunne beholde kun ét produktionsanlæg.
English: If pain persists for more than 12 hours after medical examination, seek medical advice again.
Danish: Hvis smerten fortsætter i over 12 timer efter lægeundersøgelsen, skal De søge lægehjælp igen.
English: Duration of immunity in chickens has not been established yet.
Danish: Immunitetsvarigheden hos kyllinger er endnu ikke fastslået.
English: The entire content of the bottle should be used within 2 hours after broaching the container.
Danish: Hele flaskens indhold bør anvendes inden for 2 timer efter anbrud.
English: With regard to the differences in production and control, harmonization of the production process and the controls between both manufacturing site is strongly suggested.
Danish: Med hensyn til forskellene i produktion og kontrol, harmonisering af produktionsprocessen og kontrol mellem både produktionsstedet kraftigste foreslås.
English: Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Danish: Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur http://www.ema.europa.eu/.
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 virksomme stof, der er en aktiv bestanddel af biologisk oprindelse beregnet til at fremkalde aktiv immunitet, er ikke omfattet af forordning (EC) No 470/2009.
English: For use only as a preservative in multidose vaccines at a concentration not exceeding
Danish: Må kun anvendes som konserveringsmiddel i multidosisvacciner i en koncentration, der ikke overstiger
English: The vaccination schedule should be completed at least 4 weeks before the start of laying.
Danish: Vaccinationen skal være afsluttet mindst 4 uger før æglægningsperiodens begyndelse.
English: 1381 CP Weesp
Danish: 1381 Weesp
English: QUALITY ASPECTS
Danish: KVALITETSASPEKTER
English: > 1:40 HI Units
Danish: > 1:40 HI1 enheder
English: Keep in the original container in order to protect from light.
Danish: Opbevares i den originale pakning for at beskytte mod lys.
English: Water in oil adjuvant
Danish: Vand i olie adjuvans
English: Do not mix with any other medicinal product.
Danish: Må ikke blandes med andre lægemidler.
English: Avoid stress in the birds around the time of vaccination.
Danish: Undgå at stresse fuglene ved vaccinationen.
English: To induce serological response against N3 neuraminidase which can act as a marker to Differentiate Infected from Vaccinated Animals (DIVA strategy).
Danish: Inducerer et serologiske respons mod neuraminidase N3, som tillader differentiering mellem inficerede og vaccinerede dyr (DIVA strategi).
English: Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ United Kingdom
Danish: Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ Storbritannien
English: The vaccine is presented in boxes of 1 or 10 bottles of 500 ml.
Danish: Vaccinen markedsføres i kartonæsker med 1 eller 10 flasker indholdende 500 ml.
English: Food additives (substances with a valid E number approved as additives in
Danish: Fødevaretilsætningsstoffer (stoffer med et gyldigt Enummer, der er godkendt som tilsætningsstoffer i fødevarer)