FrancophonIA/ELRC3.0 huggingface dataset:
English: The Committee was of the opinion that the company had not shown that Contusugene Ladenovec Gendux was beneficial to patients.
Danish: CHMP var af den opfattelse, at virksomheden ikke havde påvist, at Contusugene Ladenovec Gendux var gavnligt for patienterne.
English: On 12 June 2009, Gendux Molecular Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Contusugene Ladenovec Gendux for the treatment of recurrent or refractory squamous cell carcinoma of the head and neck.
Danish: Den 12. juni 2009 meddelte Gendux Molecular Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Contusugene Ladenovec Gendux til behandling af recidiverende eller refraktær pladecellekræft i hoved og hals.
English: Based on the review of the data, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Contusugene Ladenovec Gendux could not have been approved for the treatment of recurrent or refractory squamous cell carcinoma of the head and neck.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Contusugene Ladenovec Gendux ikke kunne have været godkendt til behandling af recidiverende eller refraktær pladecellekræft i hoved og hals.
English: The virus in Contusugene Ladenovec Gendux is an ‘adenovirus' that has been modified so that it does not cause disease in humans.
Danish: Virus i Contusugene Ladenovec Gendux er en "adenovirus", som er blevet modificeret, så den ikke forårsager sygdom hos mennesker.
English: Contusugene Ladenovec Gendux was developed as a type of advanced therapy medicine called a ‘gene therapy product'.
Danish: Contusugene Ladenovec Gendux blev udviklet som et lægemiddel til avanceret terapi, kaldet et "genterapiprodukt".
English: By increasing the production of the p53 protein, Contusugene Ladenovec Gendux was expected to cure or slow down the growth of the cancer.
Danish: Ved at øge produktionen af p53-proteinet forventedes Contusugene Ladenovec Gendux at helbrede kræften eller hæmme dens udvikling.
English: Contusugene Ladenovec Gendux is a suspension for injection that contains the active substance contusugene ladenovec.
Danish: Contusugene Ladenovec Gendux er en injektionsvæske, suspension, der indeholder det aktive stof contusugen ladenovec.
English: What is Contusugene Ladenovec Gendux?
Danish: Hvad er Contusugene Ladenovec Gendux?
English: The active substance in Contusugene Ladenovec Gendux, contusugene ladenovec, is a type of virus that has been modified so that it can carry the p53 gene into the cells of the body.
Danish: Det aktive stof i Contusugene Ladenovec Gendux, contusugen ladenovec, er en virustype, som er blevet modificeret, så den kan transportere p53-genet ind i kroppens celler.
English: Once injected into the tumour, Contusugene Ladenovec Gendux was expected to carry the p53 gene into the cancer cells, where the gene was expected to make the cell increase the production of the p53 protein.
Danish: Efter at være blevet sprøjtet ind i tumoren, forventedes det, at Contusugene Ladenovec Gendux ville transportere p53-genet ind i kræftcellerne, og at genet fik cellen til at øge produktionen af p53proteinet.
English: What are the consequences of the withdrawal for patients in clinical trials or compassionate use programmes using Contusugene Ladenovec Gendux?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Contusugene Ladenovec Gendux eller i programmer for anvendelse af Contusugene Ladenovec Gendux med særlig udleveringstilladelse?
English: What was Contusugene Ladenovec Gendux expected to be used for?
Danish: Hvad forventedes Contusugene Ladenovec Gendux anvendt til?
English: The Company did not inform the Agency of any patients in clinical trials or compassionate use programmes using Contusugene Ladenovec Gendux.
Danish: Virksomheden har ikke informeret CHMP om patienter, som deltager i kliniske undersøgelser med Contusugene Ladenovec Gendux eller i programmer for anvendelse af Contusugene Ladenovec Gendux med særlig udleveringstilladelse.
English: The p53 protein normally contributes to the repair of damaged DNA, causes cell death when the DNA cannot be repaired and helps control the formation of blood vessels.
Danish: Dett medfører celledød, når DNA ikke kan repareres, og det er med til at kontrollere blodkardannelsen.
English: How is Contusugene Ladenovec Gendux expected to work?
Danish: Hvordan forventedes Contusugene Ladenovec Gendux at virke?
English: The following new adverse reactions were added during this procedure:
Danish: Følgende nye bivirkninger blev tilføjet under denne procedure:
English: Use during pregnancy was agreed to be kept in this section.
Danish: Anvendelse under graviditet blev bibeholdt i dette afsnit.
English: There are differences between Member States concerning the individual paragraphs in this section.
Danish: Der er forskelle mellem medlemsstaterne vedrørende de enkelte underafsnit i dette afsnit.
English: Overall summary of the scientific evaluation of Tavanic and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Tavanic og relaterede navne (se bilag I)
English: A harmonised Module 3 was also adopted.
Danish: Der blev ligeledes vedtaget et harmoniseret Modul 3.
English: Worldwide, levofloxacin was first approved in 1993 in Japan followed by the United States in 1996.
Danish: På verdensbasis blev levofloxacin først godkendt i 1993 i Japan, herefter i USA i 1996.
English: In conclusion, the CHMP adopted a harmonised wording for section 5.1
Danish: Som konklusion vedtog CHMP en harmoniseret ordlyd til afsnit 5.1.
English: The EUCAST information was aligned with the current EUCAST recommendations.
Danish: EUCAST-oplysningerne blev rettet ind efter de gældende EUCAST-anbefalinger.
English: Furthermore, the wording is misleading as it implies that standard treatment is monotherapy.
Danish: Desuden er ordlyden vildledende, idet den forudsætter, at standardbehandlingen er monoterapi.
English: These concentrations provide sufficient bactericidal activity on bacterial strains with sensitivity level up to 0.5-1 mg/l.
Danish: Disse koncentrationer giver tilstrækkelig baktericid virkning på bakteriestammer med følsomhed op til 0,5-1 mg/l.
English: However, the role of macrolides has dramatically decreased in many countries due to the increased level of S pneumoniae resistance.
Danish: Makrolidernes rolle er imidlertid i mange lande aftaget dramatisk på grund af det stigende resistensniveau hos S. pneumoniae.
English: Based on the review of data the CHMP adopted a harmonised Module 3.
Danish: På grundlag af gennemgangen af data vedtog CHMP et harmoniseret Modul 3.
English: The proposed harmonised indication wording was considered to better reflect the current overall European treatment recommendations.
Danish: Den foreslåede harmoniserede ordlyd af indikationen fandtes bedre at afspejle de nuværende overordnede europæiske behandlingsanbefalinger.
English: The SPC harmonisation considered all relevant therapeutic and regulatory guidelines in the EU.
Danish: Ved harmoniseringen af produktresuméerne blev alle relevante terapeutiske og regulatoriske retningslinjer i EU taget i betragtning.
English: The studies above mentioned do not permit to overcome this issue as no placebocontrolled studies were performed.
Danish: Ovennævnte undersøgelser løser ikke dette problem, da der ikke er udført placebokontrollerede undersøgelser.
English: The method and the statistical approach together with the data provided were reviewed and the CHMP considered the estimated frequency to be appropriate.
Danish: Metoden og den statistiske tilgang blev gennemgået sammen med de forelagte data, og CHMP fandt, at den estimerede hyppighed var passende.
English: No other discrepancies in this section were detected in regard to special populations: impaired renal function and/or elderly.
Danish: Der blev ikke fundet andre afvigelser i dette afsnit vedrørende særlige populationer: Nedsat nyrefunktion og/eller ældre patienter.
English: However, most MRSA isolates are resistant to levofloxacin.
Danish: De fleste isolater af MRSA er imidlertid resistente over for levofloxacin.
English: Three pivotal studies supported this indication, granted in the EU since 1997.
Danish: Denne indikation støttedes af tre hovedundersøgelser og har været godkendt i EU siden 1997.
English: Section 4.6 - Fertility, Pregnancy and Lactation
Danish: Afsnit 4.6 - Fertilitet, graviditet og amning
English: Based on the above, the CHMP considers the benefit/risk ratio of Tavanic and associated names to be favourable and the harmonised Product Information documents to be approvable.
Danish: På ovenstående grundlag finder CHMP, at benefit/risk-forholdet for Tavanic og relaterede navne er positivt, og at de harmoniserede produktinformationer kan godkendes.
English: • Hypoglycaemic coma, in line with the CCSI version 4 for levofloxacin submitted as part of the PSUR 27;
Danish: • Hypoglykæmisk koma, på linje med CCSI version 4 for levofloxacin, der blev indleveret som en del af PSUR 27
English: Antibiotic therapy may subsequently be changed in the light of culture results and clinical response.
Danish: Antibiotikabehandlingen kan herefter tilpasses dyrkningsresultater og klinisk respons.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Officielle retningslinjer for hensigtsmæssig brug af antibiotika bør følges.
English: The warning on prevention of photosensitisation was revised to further recommend precaution during treatment and 48 hours following treatment discontinuation.
Danish: Advarslen om forebyggelse af fotosensibilisering blevet yderligere revideret med en anbefaling om forsigtighed under behandlingen og 48 timer efter ophør af behandlingen.
English: Thus, the outcome of this referral procedure does not include any evaluation of levofloxacin 750 mg.
Danish: Denne henvisningsprocedure omfatter derfor ikke en vurdering af levofloxacin, 750 mg.
English: In addition, it was agreed to include precautions for use in case of treatment of anthrax in section 4.4 to include reference for consultation of national and/or international consensus documents.
Danish: Desuden bestemtes det at tilføje forholdsregler for anvendelse til behandling af miltbrand i afsnit 4.4 med henvisning til nationale og/eller internationale konsensus-dokumenter.
English: The gold standard for these pathogens remains penicillin (with the exception of MRSA - Methicillin-resistant staphylococcus aureus).
Danish: Den gyldne standard for disse patogener er fortsat penicillin (bortset fra MRSA (meticillinresistente Staphylococcus aureus)).
English: The results of tests carried out indicate satisfactory consistency and uniformity of important product quality characteristics, and these in turn lead to the conclusion that the products should have a satisfactory and uniform performance in the clinic.
Danish: Resultaterne af de udførte test viser tilfredsstillende overensstemmelse og ensartethed af produkternes vigtigste kvalitetsegenskaber, og det blev konkluderet, at produkterne må forventes at have tilfredsstillende og ensartede egenskaber i klinikken.
English: Since the granting of this indication in the EU, twenty two additional studies have become available including 4 recent trials of levofloxacin used as a comparator versus tigecycline (2 studies), docycycline (one study) and nemonoxacin (one study).
Danish: Siden godkendelsen af denne indikation i EU er yderligere 22 undersøgelser blevet tilgængelige, herunder fire nyere undersøgelser, hvor levofloxacin blev anvendt som sammenligningsstof over for tigecyclin (to undersøgelser), doxycyclin (én undersøgelse) og nemonoxacin (én undersøgelse).
English: In addition, the information on the combination treatment that may be required in case of nosocomial infections due to P. aeruginosa was deleted since it is considered not appropriate to be included in this section.
Danish: Desuden slettedes oplysningen om den kombinationsbehandling, der kan være nødvendig ved nosokomielle infektioner forårsaget af P. aeruginosa, da det ikke blevet anset for hensigtsmæssigt at lade den indgå i dette afsnit.
English: Antibiotic therapy is indicated and usually starts empirically, covering typical organisms with or without atypical organisms.
Danish: Antibiotikabehandling indiceres og påbegyndes sædvanligvis empirisk, således at behandlingen dækker typiske organismer med eller uden atypiske organismer.
English: • Ligament rupture, in line with a review provide by the MAH in which possible causal relationship in some cases without alternative explanations in combination with biological plausibility were identified.
Danish: • Ligamentruptur, i henhold til en oversigt, der blev fremlagt af indehaveren af markedsføringstilladelsen, hvori der konstateredes en mulig kausal sammenhæng, i nogle tilfælde uden alternative forklaringer, kombineret med biologisk plausibilitet.
English: Considering the extent of the harmonisation of the PL a Readability Testing was agreed to be submitted after the adoption of this referral procedure.
Danish: I betragtning af omfanget af harmoniseringen af indlægssedlen aftaltes det, at der skulle forelægges en læsbarhedstest efter vedtagelsen af denne henvisningsprocedure.
English: This section was further amended to clearly mention that treatment with levofloxacin is contraindicated during breastfeeding and to include information on fertility also in line with the CHMP Guideline on risk assessment of medicinal products on human reproduction and lactation: From data to labelling, January 2009.
Danish: Dette afsnit blev yderligere ændret med klar angivelse af, at behandling med levofloxacin er kontraindiceret under amning og med tilføjelse af oplysninger om fertilitet, ligeledes i overensstemmelse med CHMP's ”Guideline on risk assessment of medicinal products on human reproduction and lactation: From data to labelling”, januar 2009.
English: A cross reference to the warning sections with regards resistance patterns was agreed.
Danish: Det blev besluttet at indsætte en krydsreference til advarselsafsnittene om resistensmønsteret.
English: In this regard a recent published epidemiologic study revealed an increased risk (OR 4.5) of fluoroquinolones for retinal detachment.
Danish: Hvad dette angår, viste en nypubliceret epidemiologisk undersøgelse øget risiko (OR 4,5) for retinaløsning i forbindelse med fluorquinoloner.
English: Uncomplicated cystitis (see section 4.4)
Danish: Ukompliceret cystitis (se afsnit 4.4)
English: It was further agreed that consideration should be given to the European guidelines whereby quinolones are only recommended as first line therapy if the resistance rate for E. coli (responsible for 70-80% of all UTIs caused by Gram-negative) is below 10%.
Danish: Desuden blev det vedtaget at tage hensyn til de europæiske retningslinjer, der kun anbefaler quinoloner som førstevalgsbehandling, hvis resistensraten af E. coli (som er årsag til 70-80 % af alle urinvejsinfektioner forårsaget af gramnegative bakterier) er under 10 %.
English: A general consideration to be taken into account is that ABS is generally a non-severe infection associated with high spontaneous cure rates (90%).
Danish: Et almindeligt forhold, der må tages i betragtning, er, at akut bakteriel sinuitis sædvanligvis er en ikke svær infektion med høj spontan helbredelsesrate (90 %).
English: The MAH provided all data available for this indication namely, in vitro data, non-clinical data, pharmacokinetic data and data published by the US Centers of Disease Control and Prevention (CDC) and proposed an harmonised indication.
Danish: Indehaveren af markedsføringstilladelsen fremlagde alle foreliggende data for denne indikation, dvs. in vitro-data, ikkekliniske data, farmakokinetiske data og data fra amerikanske Centers of Disease Control and Prevention (CDC), og foreslog en harmoniseret indikation.
English: In particular, the table of the European Committee on Antimicrobial Susceptibility Testing (EUCAST) breakpoints and the table of susceptible species were revised.
Danish: Herunder revideredes tabellen over tærskelværdier fra European Committee on Antimicrobial Susceptibility Testing (EUCAST) og tabellen over følsomme arter.
English: Namely, the inclusion of bacteroides sp. other than B. fragilis was removed due to the natural intermediate susceptibility to levofloxacin.
Danish: Således blev Bacteroides sp. bortset fra B. fragilis slettet på grund af den naturlige intermediære følsomhed for det aktive stof.
English: The warning on pneumococcal pneumonia was deleted since it was considered covered by the information included in section 4.1 that levofloxacin should only be considered as alternative treatment in such cases.
Danish: Advarslen om pneumokokpneumoni blev slettet, da den blev anset for at være dækket af oplysningerne i afsnit 4.1 om, at levofloxacin i sådanne tilfælde kun bør overvejes som behandlingsalternativ.
English: Tavanic may also be used to complete a course of therapy in patients who have shown improvement during initial treatment with intravenous levofloxacin.
Danish: Tavanic kan desuden anvendes til at fuldføre et behandlingsforløb hos patienter, der har opnået bedring ved indledende behandling med intravenøst levofloxacin.
English: Section 4.4 - Special warnings and precautions for use
Danish: Afsnit 4.4 - Særlige advarsler og forsigtighedsregler vedrørende brugen
English: It is hereafter summarised the main points discussed for the harmonisation of the different sections of the SmPC.
Danish: Nedenstående er en sammenfatning af de drøftede hovedpunkter vedrørende harmoniseringen af de forskellige afsnit af produktresuméet.
English: Due to the divergent national decisions taken by Member States concerning the authorisation of the above-mentioned product (and its associated names), the European Commission notified the CHMP/EMA Secretariat of an official referral under Article 30 of Directive 2001/83/EC as amended in order to resolve divergences amongst the nationally authorised PIs and thus to harmonise its divergent PIs across the European Union.
Danish: På grund af de divergerende nationale afgørelser, der er truffet af medlemsstaterne ved godkendelsen af ovenstående produkt (og relaterede navne), anmeldte Europa-Kommissionen en officiel henvisning til CHMP/EMA's sekretariat i henhold til artikel 30 i direktiv 2001/83/EF, som ændret, med henblik på at ophæve divergenserne mellem de nationalt godkendte produktinformationer og dermed harmonisere de divergerende produktinformationer i EU.
English: Fluoroquinolones are particularly useful in severe cases due to their coverage of Gram-negative organisms as well as the more common H. influenzae and S. pneumoniae.
Danish: Fluorquinoloner er især nyttige i svære tilfælde, da de dækker gramnegative organismer foruden de mere almindelige H. influenzae og S. pneumoniae.
English: • “Palpitation” and “ventricular tachycardia which may result in cardiac arrest” supported by data from clinical trials and post-marketing data provided by the MAH;
Danish: • “Palpitationer” og “ventrikulær takykardi, som kan medføre hjertestop”, støttet af data fra kliniske undersøgelser og erfaringer efter markedsføring forelagt af indehaveren af markedsføringstilladelsen.
English: The major objections preventing the granting of this indication in one MS was the X-ray criteria for the corroboration of the clinical diagnosis of sinusitis which was not defined clearly in one of the studies.
Danish: Hovedindvendingen mod godkendelse af indikationen i én medlemsstat vedrørte røntgenundersøgelseskriterierne for den kliniske diagnose sinuitis, som ikke var klart defineret i den ene af undersøgelserne.
English: The warning on tendinitis and tendon rupture was amended to state that the risk of tendinitis and tendon rupture is increased in patients receiving daily doses of 1000 mg.
Danish: Advarslen om tendinitis og seneruptur blev rettet med angivelse af den øgede risiko for tendinitis og seneruptur hos patienter, der får en daglig dosis på 1000 mg.
English: The MAH was asked to evaluate all other sections of the nationally approved SPCs and suggested appropriate changes in the text where divergences exist and in some cases summarised the information already included in these sections (e.g. in section 5.2 of the SmPC information on tissue distribution was summarised).
Danish: Indehaveren af markedsføringstilladelsen blev anmodet om at vurdere alle øvrige afsnit af de nationalt godkendte produktresuméer, foreslog passende ændringer af teksten, hvor der var divergenser, og sammenfattede i nogle tilfælde de eksisterende oplysninger i disse afsnit (f.eks. oplysningerne i afsnit 5.2 af produktresuméet om fordelingen i væv).
English: Since Anthrax is life-threatening, especially when the route of infection is inhalation it was agreed the following harmonised wording for:
Danish: Da miltbrand er livstruende, navnlig ved smitte gennem inhalation, blev der fastlagt følgende harmoniserede ordlyd for:
English: Nine additional studies (and one reanalysis of data from the registration studies) have become available.
Danish: Yderligere ni undersøgelser er kommet til (foruden en reanalyse af data fra undersøgelserne i dokumentationen til ansøgningen om markedsføringstilladelse).
English: This review showed possible association within the fluoroquinolon class specifically the use of levofloxacin and exacerbation of myasthenia gravis although the reporting rate for this event remains extremely low.
Danish: Denne gennemgang viste en mulig sammenhæng med fluorquinoloner og specielt mellem anvendelse af levofloxacin og Myastenia gravis, skønt indberetningsfrekvensen af denne hændelse fortsat er ekstremt lav.
English: Following all the changes in the SPC there are several corresponding changes to the Package Leaflet.
Danish: Efter de mange ændringer i produktresuméet er der en række tilsvarende ændringer af indlægssedlen.
English: This indication has been approved in all MS based on four pivotal studies.
Danish: Denne indikation er godkendt i alle medlemsstater på grundlag af fire hovedundersøgelser.
English: The Core Safety Profile (CSP) approved as an outcome of the PSUR work-sharing procedure finalised on 1 April 2011 was considered.
Danish: Der blev taget hensyn til de centrale sikkerhedsoplysninger (CSP), der er godkendt som resultat af arbejdsdelingsproceduren vedrørende PSUR, som afsluttedes den 1. april 2011.
English: The proposed harmonised warning on G-6-PD deficiency was supported by a review provided by the MAH on all G6PD cases and no new safety information was found.
Danish: Den foreslåede harmoniserede advarsel om G-6-PD-mangel støttedes af en oversigt, der blev fremlagt af indehaveren af markedsføringstilladelsen vedrørende alle tilfælde af G6PD-mangel, og der blev ikke fundet nye sikkerhedsoplysninger.
English: The warning under sub-heading “Interference with laboratory tests” was updated mainly to include sentence on M. tuberculosis, which is considered class labelling and which is included in the Company Core Data Sheet (CCDS).
Danish: Advarslen under overskriften “Interferens med laboratorieprøver” blev opdateret, hovedsageligt med sætningen om M. tuberculosis, der anses for at være en klassebetegnelse og er indeholdt i virksomhedens centrale datablad (CCDS).
English: Information on development, manufacture and control of the film coated tablets and solution for infusion has been presented in a satisfactory manner.
Danish: Oplysningerne om udvikling, fremstilling og kontrol af filmovertrukne tabletter og infusionsvæske er tilfredsstillende.