FrancophonIA/ELRC3.0 huggingface dataset:
English: Injection of the vaccine to dogs already infected by Leishmania infantum did not show any specific adverse reactions other than those described in section 4.6.
Danish: Injektion af vaccinen i hunde, der allerede er inficeret med Leishmania infantum, har ikke påvist specifikke bivirkninger ud over dem, der er beskrevet i afsnit 4.6.
English: No adverse reactions other than those mentioned in section 6 were observed after the administration of a double-dose of the vaccine.
Danish: Ingen bivirkninger ud over dem, der er beskrevet i afsnittet ”Bivirkninger” blev observeret efter indgivelse af en dobbelt dosis af vaccinen.
English: CaniLeish lyophilisate and solvent for suspension for injection for dogs
Danish: CaniLeish lyofilisat og solvens til injektionsvæske, suspension til hunde
English: Purified extract of Quillaja saponaria (QA-21): 60 µg
Danish: Renset ekstrakt af Quillaja saponaria (QA-21): 60 µg
English: Vial with 1 dose of solvent
Danish: Hætteglas med 1 dosis solvens
English: Purified extract of Quillaja saponaria (QA-21) Trometamol
Danish: Renset ekstrakt af Quillaja saponaria (QA-21) Trometamol
English: Vial with 1 dose of lyophilisate
Danish: Hætteglas med 1 dosis lyofilisat
English: Therefore, the use is not recommended during pregnancy and lactation.
Danish: Anvendelse frarådes derfor under drægtighed og diegivning.
English: A symptomatic treatment should be rapidly implemented and clinical monitoring should be maintained until symptoms resolve.
Danish: Symptomatisk behandling bør indsættes hurtigt og de kliniske symptomer følges indtil disse ophører.
English: Type I glass vial containing 1 dose of lyophilisate and type I glass vial containing 1 ml of solvent, both closed with a butyl elastomer closure and sealed with an aluminium cap.
Danish: Type I-hætteglas indeholdende 1 dosis lyofilisat og type I-hætteglas indeholdende 1 ml solvens, begge lukket med en butylelastomerprop og forseglet med en aluminiumskapsel.
English: In case of anaphylactic reaction appropriate symptomatic treatment should be administered and clinical monitoring should be maintained until symptoms resolve.
Danish: I tilfælde af anafylaktisk reaktion bør passende symptomatisk behandling iværksættes og overvågning bør fortsætte indtil symptomerne ophører.
English: Purified extract of Quillaja saponaria (QA-21)
Danish: Renset ekstrakt af Quillaja saponaria (QA-21):
English: Injection of the vaccine to dogs already infected by Leishmania infantum did not show any specific adverse reactions other than those described in section 6.
Danish: Injektion af vaccinen i hunde, der allerede er inficeret med Leishmania infantum, har ikke påvist specifikke bivirkninger ud over dem, der er beskrevet under ”Bivirkninger”.
English: Lyophilisate:
Danish: Uforligeligheder:
English: The detection of Leishmania infection using a rapid serological diagnostic test is recommended prior to vaccination.
Danish: Det anbefales at udføre en test for tilstedeværelse af Leishmania-infektion før vaccination ved at bruge en hurtig serologisk diagnostisk test.
English: Box of 3 vials of lyophilisate and 3 vials of solvent Box of 5 vials of lyophilisate and 5 vials of solvent
Danish: Æske med 3 hætteglas med lyofilisat og 3 hætteglas med solvens Æske med 5 hætteglas med lyofilisat og 5 hætteglas med solvens
English: In dogs developing a leishmaniosis (active infection and/or disease) despite vaccination, proceeding with vaccine injections showed no benefit.
Danish: Der har ikke været påvist nogen fordel ved injektion af vaccinen hos hunde, der udvikler leishmaniasis (aktiv infektion og/eller sygdom) på trods af vaccination.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: 3 doses.
Danish: 3 doser.
English: 10 doses.
Danish: 10 doser.
English: The appearance of the reconstituted product is reddish-brown.
Danish: Den rekonstituerede vaccine fremtræder med rødbrun farve.
English: 30 doses.
Danish: 30 doser.
English: 1 dose.
Danish: 1 dosis.
English: In order to facilitate the quick implementation of such treatment, should an anaphylactic reaction occur, an observation of the dog by the owner during the hours following vaccination is recommended.
Danish: Det anbefales, at ejeren holder hunden under opsyn i timerne efter vaccination.
English: 25 doses.
Danish: 25 doser.
English: 5 doses.
Danish: 5 doser.
English: 50 doses.
Danish: 50 doser.
English: 15 doses.
Danish: 15 doser.
English: Marketing authorisation holder and manufacturer:
Danish: Indehaver af markedsføringstilladelsen og fremstiller ansvarlig for batchfrigivelse:
English: Plastic box containing 1 vial of 1 dose of lyophilisate, 1 vial of 1 ml of solvent, 1 syringe and 1 needle.
Danish: Æske af plast indeholdende 1 hætteglas med 1 dosis lyofilisat og 1 hætteglas med 1 ml solvens, 1 sprøjte og 1 kanyle.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Danish: FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG FREMSTILLER(E) ANSVARLIG FOR BATCHFRIGIVELSE
English: The frequency of adverse reactions is defined using the following convention: Very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment),
Danish: Hyppigheden af bivirkninger er defineret som: - Meget almindelig (mere end 1 ud af 10 dyr, der viser bivirkninger i løbet af en behandling) - Almindelige (mere end 1, men mindre end 10 dyr i 100 dyr) - Ualmindelige (mere end 1, men mindre end 10 dyr i 1.000 dyr) - Sjældne (mere end 1, men mindre end 10 dyr ud af 10.000 dyr) - Meget sjælden (mindre end 1 dyr ud af 10.000 dyr, herunder isolerede rapporter)
English: Box of 1 vial of lyophilisate and 1 vial of solvent Box of 1 vial of lyophilisate, 1 vial of solvent, 1 syringe and 1 needle.
Danish: Æske med 1 hætteglas med lyofilisat og 1 hætteglas med solvens, 1 sprøjte og 1 kanyle.
English: Plastic box containing 30 vials of 1 dose of lyophilisate and 30 vials of 1 ml of solvent.
Danish: Æske af plast indeholdende 30 hætteglas med 1 dosis lyofilisat og 30 hætteglas med 1 ml solvens.
English: Plastic box containing 3 vials of 1 dose of lyophilisate and 3 vials of 1 ml of solvent.
Danish: Æske af plast indeholdende 3 hætteglas med 1 dosis lyofilisat og 3 hætteglas med 1 ml solvens.
English: Plastic box containing 10 vials of 1 dose of lyophilisate and 10 vials of 1 ml of solvent.
Danish: Æske af plast indeholdende 10 hætteglas med 1 dosis lyofilisat og 10 hætteglas med 1 ml solvens.
English: Pregnancy and lactation
Danish: Drægtighed og diegivning:
English: Plastic box containing 25 vials of 1 dose of lyophilisate and 25 vials of 1 ml of solvent.
Danish: Æske af plast indeholdende 25 hætteglas med 1 dosis lyofilisat og 25 hætteglas med 1 ml solvens.
English: Plastic box containing 1 vial of 1 dose of lyophilisate and 1 vial of 1 ml of solvent.
Danish: Æske af plast indeholdende 1 hætteglas med 1 dosis lyofilisat og 1 hætteglas med 1 ml solvens.
English: Plastic box containing 15 vials of 1 dose of lyophilisate and 15 vials of 1 ml of solvent.
Danish: Æske af plast indeholdende 15 hætteglas med 1 dosis lyofilisat og 15 hætteglas med 1 ml solvens.
English: Lyophilisate
Danish: PRODUKTRESUME
English: Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of 1 ml of solvent.
Danish: Æske af plast indeholdende 5 hætteglas med 1 dosis lyofilisat og 5 hætteglas med 1 ml solvens.
English: Plastic box containing 50 vials of 1 dose of lyophilisate and 50 vials of 1 ml of solvent.
Danish: Æske af plast indeholdende 50 hætteglas med 1 dosis lyofilisat og 50 hætteglas med 1 ml solvens.
English: nd injection.
Danish: Kræver recept.
English: The antibiotics were given for up to 14 days.
Danish: Der blev givet antibiotika i op til 14 dage.
English: What is Vibativ?
Danish: Hvad er Vibativ?
English: The studies were carried out at sites where infection with MRSA is common.
Danish: Undersøgelserne blev udført på lokaliteter, hvor infektioner med MRSA er almindelige.
English: International non-proprietary name (INN): telavancin
Danish: Internationalt fællesnavn (INN): telavancin
English: Ref. EMEA/586612/2008
Danish: EMEA/650794/2008
English: The effects of Vibativ were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Vibativ blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The main measure of effectiveness was the number of patients whose infection had been cured after the end of treatment.
Danish: Det primære effektmål var antallet af patienter, hvis infektion var blevet kureret efter behandlingen.
English: The application was at day 201 when the company withdrew.
Danish: Ansøgningsproceduren var ved dag 201, da virksomheden trak sin ansøgning tilbage.
English: Questions and answers on the withdrawal of the marketing application for Vibativ
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Vibativ
English: It contains the active substance telavancin.
Danish: Det indeholder det aktive stof telavancin.
English: The CHMP also had concerns regarding the production of the medicine, its stability and the possible presence of impurities.
Danish: CHMP havde også betænkeligheder med hensyn til produktionen af medicinen, dens stabilitet samt den mulige tilstedeværelse af urenheder.
English: What was Vibativ expected to be used for?
Danish: Hvad forventedes Vibativ anvendt til?
English: ‘Complicated' means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment.
Danish: "Kompliceret" betyder, at infektionen er vanskelig at behandle, fordi den har bredt sig til det dybe væv under huden, operativ behandling kan være nødvendig, eller fordi patienten har andre tilstande, der påvirker responsen på behandlingen.
English: These include Staphylococcus aureus (including ‘methicillin-resistant' forms known as ‘MRSA') and Streptococcus pyogenes.
Danish: Herunder hører Staphylococcus aureus (deriblandt methicillin-resistente typer kendt som MRSA) og Streptococcus pyogenes.
English: Together, the cell wall and membrane form a barrier between the bacterial cell contents and the external environment.
Danish: Cellevæggen og membranen danner tilsammen en barriere mellem bakteriecellens indhold og det omgivende miljø.
English: The Committee was also concerned that Vibativ may cause ‘QTc prolongation' (an alteration of the electrical activity of the heart).
Danish: Udvalget fandt også grund til betænkelighed ved, at Vibativ kan forårsage QTc-forlængelse (en ændring i den elektriske aktivitet i hjertet).
English: The active substance in Vibativ, telavancin, is an antibiotic that belongs to the group ‘glycopeptides'.
Danish: Det aktive stof i Vibativ, telavancin, er et antibiotikum, som tilhører gruppen "glycopeptider".
English: It is expected to work in two ways, both by stopping the bacteria making their cell walls and by disrupting their cell membranes.
Danish: Det forventes at virke på to måder ved dels at hindre bakterierne i at opbygge deres cellevægge, dels at opløse deres cellemembraner.
English: By disrupting this barrier, telavancin is expected to kill the bacteria that are causing the infection.
Danish: Fordi telavancin opløser denne barriere, forventes det at dræbe de bakterier, der forårsager infektionen.
English: How is Vibativ expected to work?
Danish: Hvordan forventes Vibativ at virke?
English: Vibativ was compared with vancomycin (another antibiotic) in two main studies involving a total of 2,079 adults with complicated skin and soft tissue infections due to Gram-positive bacteria.
Danish: Vibativ blev sammenlignet med vancomycin (et andet antibiotikum) i to hovedundersøgelser, som omfattede i alt 2.079 voksne med komplicerede infektioner i hud og bløddele forårsaget af grampositive bakterier.
English: The CHMP was concerned that there was no additional benefit of Vibativ over vancomycin, and could cause more kidney damage than vancomycin.
Danish: CHMP fandt grund til betænkelighed ved, at der ikke var ekstra fordele ved Vibativ i forhold til vancomycin, og at det kunne forårsage mere nyreskade end vancomycin.
English: Hence, the CHMP recommended that Vibativ be refused marketing authorisation.
Danish: CHMP anbefalede derfor at give afslag på ansøgningen om markedsføringstilladelse for Vibativ.
English: What are the consequences of the refusal for patients in clinical trials or compassionate use programmes using Vibativ?
Danish: Hvilke konsekvenser har afslaget for patienter, der deltager i kliniske undersøgelser med Vibativ eller i programmer for anvendelse af Vibativ med særlig udleveringstilladelse?
English: Based on the review of the data and the company's responses to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Vibativ could not have been approved for the treatment of complicated skin and soft tissue infections in adults.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelser af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Vibativ ikke kunne have været godkendt til behandling af komplicerede infektioner i hud og bløddele hos voksne.
English: Vibativ was to be used only when the infection was known or thought to be caused by types of bacteria that are classified as ‘Gram-positive'.
Danish: Vibativ skulle kun anvendes, hvis infektionen var påvist eller ment at være opstået på baggrund af grampositive bakterietyper.
English: The company informed the CHMP that there are currently no clinical trials or compassionate use programmes ongoing with Vibativ.
Danish: Virksomheden har informeret CHMP om, at der ikke er nogen igangværende kliniske undersøgelser med Vibativ eller programmer for anvendelse af Vibativ med særlig udleveringstilladelse.
English: Vibativ is a powder to be made up into a solution for infusion (drip into a vein).
Danish: Vibativ er et pulver til fremstilling af en infusionsopløsning (intravenøst drop).
English: Vibativ was expected to be used to treat adults with complicated infections of the skin and the ‘soft tissues' below the skin.
Danish: Vibativ forventedes anvendt til behandling af voksne med komplicerede infektioner i huden og det underliggende bløde væv.
English: At that point in time, the CHMP was of the opinion that the benefits of Vibativ in the treatment of complicated skin and soft tissue infections in adults did not outweigh its risks.
Danish: CHMP var på daværende tidspunkt af den opfattelse, at fordelene ved Vibativ ikke opvejede risiciene til behandling af komplicerede infektioner i hud og bløddele hos voksne.
English: On 20 October 2008, Astellas Pharma Europe B. V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vibativ, for the treatment of complicated skin and soft tissue infections in adults.
Danish: officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønskede at tilbagetrække sin ansøgning om markedsføringstilladelse for Vibativ til behandling af komplicerede infektioner i hud og bløddele (det underliggende væv) hos voksne.
English: Once the company has supplied responses to the questions, the CHMP reviews them and may, before
Danish: Når virksomheden har besvaret spørgsmålene, gennemgår CHMP besvarelsen og kan, inden udvalget afgiver en udtalelse, stille eventuelle supplerende spørgsmål til virksomheden på dag 180.
English: • The Committee considered (Co-)Rapporteur's assessment report;
Danish: • Udvalget har taget hensyn til (med)rapportørens vurderingsrapport.
English: This justification was accepted by the CHMP.
Danish: Denne begrundelse blev godkendt af CHMP.
English: This minor difference in concentration (5.93%) is expected to be reduced even more by the available saliva in the mouth.
Danish: Den lille koncentrationsforskel (5,93 %) forventes at blive reduceret yderligere via det spyt, der er i munden.
English: First, the lower amount of cyclodextrins is preferable from a safety point of view.
Danish: For det første er en lavere mængde cyclodextriner at foretrække ud fra et sikkerhedsmæssigt synspunkt.
English: The benefit-risk balance of the applied medicinal product is considered positive.
Danish: Benefit/risk-forholdet for det omhandlede lægemiddel vurderes at være positivt.
English: • The Committee considered the totality of the data submitted by the applicant in relation to the objections raised as potential serious risk to public health and the questions asked by the CHMP;
Danish: • Udvalget har gennemgået alle de data, som ansøgeren har fremsendt, i forhold til indvendingerne vedrørende en mulig alvorlig risiko for folkesundheden og spørgsmålene fra CHMP.
English: The applicant has requested a waiver of the need to conduct clinical studies.
Danish: Ansøgeren har anmodet om dispensation fra at skulle gennemføre kliniske studier.
English: • The Committee was of the view that the submitted in-vitro studies and bibliographical data demonstrate sufficiently the safety and efficacy of the medicinal product.
Danish: • Udvalget vurderer, at de fremlagte in vitro-studier og bibliografiske data i tilstrækkelig grad påviser lægemidlets sikkerhed og virkning.
English: The drug inhibits the synthesis of prostaglandins by mixed inhibition of the enzymes COX-1/COX-2 with some selectivity towards COX-1.
Danish: Lægemidlet hæmmer syntesen af prostaglandiner ved blandet hæmning af enzymerne COX-1/COX-2 med en vis selektivitet over for COX-1.
English: Therefore, this difference in concentration is considered insignificant and clinically irrelevant, taking into consideration that eventually the same dose is administered locally.
Danish: Derfor vurderes koncentrationsforskellen at være ubetydelig og klinisk irrelevant i betragtning af, at det i sidste ende er den samme dosis, der administreres lokalt.
English: The product information remains as per the final version achieved during the Coordination group procedure as mentioned in Annex III of the CHMP opinion.
Danish: Produktinformationen fastholdes i den endelige version som aftalt under koordinationsgruppens sagsbehandling, jf. bilag 3 til CHMP's udtalelse.
English: The CHMP also considered that the different amount of cyclodextrins is not of concern.
Danish: CHMP vurderer også, at forskellen i mængden af cyclodextriner ikke er noget problem.
English: Grounds for the CHMP opinion
Danish: Begrundelse for CHMP's udtalelse
English: Second, flurbiprofen is moderately bound to the cyclodextrins and the release of the active substance is immediate when it comes in contact with the buccal membrane.
Danish: For det andet binder flurbiprofen moderat til cyclodextrinerne, og frigivelsen af det aktive stof sker med det samme, når det kommer i kontakt med mundslimhinden.
English: However, there are some quantitative and qualitative differences among the products which concern:
Danish: Der er dog nogle kvantitative og kvalitative forkelle på produkterne med hensyn til:
English: The originator product is Strepflam 8.75 Lozenges by Crookes Healthcare/Reckitt Benckiser Healthcare, which has been registered since June 2001.
Danish: Originalpræparatet er Strepflam 8,75 sugetabletter fra Crookes Healthcare/Reckitt Benckiser Healthcare, der har været godkendt siden juni 2001.
English: On the top of that, flurbiprofen is a highly permeable and passively absorbed drug of which the permeability is not altered by a difference in concentration.
Danish: Derudover er flurbiprofen et højpermeabelt lægemiddel, der absorberes passivt, og hvis permeabilitet ikke ændres af en koncentrationsforskel.
English: The therapeutic equivalence has been claimed to be demonstrated based on in-vitro data only.
Danish: Den terapeutiske ækvivalens hævdes at være påvist på baggrund af in vitro-data alene.
English: The proposed indication is ‘pain relief of mild to moderate symptoms of acute sore throat'.
Danish: Den anførte indikation er "smertelindring ved lette til moderate symptomer på akut ondt i halsen".
English: The CHMP considered that the removal of the mint flavour is considered clinically irrelevant in this specific case.
Danish: CHMP vurderer, at fjernelsen af myntevarianten må anses for være klinisk irrelevant i det foreliggende tilfælde.
English: No clinical studies have been contacted and instead the applicant requested a biowaiver.
Danish: Der er ikke fremlagt kliniske studier, idet ansøgeren i stedet har anmodet om en biowaiver (afkald på biotilgængelighedsundersøgelse).
English: So in the hypothetical scenario of a difference in the amount of produced saliva this would not impact on the absorbed amount of the active substance.
Danish: Hvis det således antages, at der er en forskel i mængden af produceret spyt, vil dette ikke have nogen betydning for den absorberede mængde af det aktive stof.
English: The Committee, as a consequence, considers that the benefit-risk balance of Flurbiprofen Geiser 8,75 mg oromucosal spray, solution and associated names is favourable and therefore recommends the granting of the marketing authorisation(s) for the medicinal products referred to in Annex I of the CHMP opinion.
Danish: Udvalget finder følgelig, at benefit/risk-forholdet for Flurbiprofen Geiser 8,75 mg mundhulespray, opløsning, og relaterede navne er positivt, og anbefaler derfor udstedelse af markedsføringstilladelse for de lægemidler, der er anført i bilag 1 til CHMP's udtalelse.
English: The proposed indication is short-term symptomatic relief of sore throat.
Danish: Den anførte indikation er kortsigtet symptomlindring ved ondt i halsen.
English: If bioequivalence has been established among such different formulations, the minor differences in the present case will not affect the pharmacokinetic and clinical profile of the test product.
Danish: Hvis der er påvist bioækvivalens for så forskellige formuleringer, vil de mindre forskelle i nærværende tilfælde ikke have nogen betydning for testproduktets farmakokinetik og kliniske profil.
English: The CHMP considered that the noted differences between the reference and test product are minor and the applicant has sufficiently demonstrated why these differences do not affect the local efficacy, safety or the systemic absorption of the product.
Danish: CHMP vurderer, at de anførte forskelle mellem referencelægemidlet og testproduktet er små, og at ansøgeren i tilstrækkeligt omfang har påvist, at disse forskelle ikke har nogen betydning for produktets lokale virkning, sikkerhed eller systemiske absorption.
English: Literature data (Radkova et al., 2017, Imai et al., 1988) demonstrate that different formulations of flurbiprofen (spray and lozenges) displayed comparable efficacy and safety profiles, despite the lack of cycloextrins from lozenges, and were also taken into consideration.
Danish: Der er også taget hensyn til data fra litteraturen (Radkova et al., 2017, Imai et al., 1988), hvoraf det fremgår, at forskellige formuleringer af flurbiprofen (spray og sugetabletter) har udvist sammenlignelige virknings- og sikkerhedsprofiler på trods af manglen på cyclodextriner i sugetabletter.
English: Moreover, it was emphasised that the originator has demonstrated bioequivalence between the oromucosal spray (Strefen Direct 8,75 mg Oromucosal spray) and lozenges (Strepflam 8,75 mg Lozenges), for which more significant formulation differences exist.
Danish: Desuden er det blevet understreget, at der for originalpræparatet er påvist bioækvivalens mellem mundhulespray (Strefen Direct 8,75 mg mundhulespray) og sugetabletter (Strepflam 8,75 mg sugetabletter), hvor der er mere signifikante formuleringsforskelle.