FrancophonIA/ELRC3.0 huggingface dataset:
English: In this regard, it is noted that the 500 mg dosage given once daily by oral route allow to reach a plasmatic peak concentration (Cmax) as of 5 to 6 mg/l and a Cmax/MIC ratio of 10-12 and an AUC of approximately 50 mg.h/l corresponding to an AUC/MIC ratio as of 50-100.
Danish: I denne forbindelse bemærkes det, at doseringen 500 mg oralt én gang dagligt resulterer i en maksimal plasmakoncentration (Cmax) på 5-6 mg/l, et forhold Cmax/MIC på 10-12 og en AUC-værdi på cirka 50 mg.h/l svarende til et forhold AUC/MIC på of 50-100.
English: The harmonised SmPC wording agreed for the prostatitis indication was: “Chronic bacterial prostatitis”.
Danish: Den vedtagne harmoniserede ordlyd i produktresuméet for prostatitisindikationen var: ”Kronisk bakteriel prostatitis”.
English: • The committee reviewed the data submitted by the MAH from the existing clinical studies, the pharmacovigilance data and the published literature justifying the proposed harmonisation of the product information
Danish: • udvalget gennemgik de data, der er forelagt indehaverne af markedsføringstilladelsen fra eksisterende kliniske undersøgelser, data vedrørende lægemiddelovervågning og den publicerede litteratur som begrundelse for den foreslåede harmonisering af produktinformationen,
English: The committee noted that for another fluoroquinolon agent a placebo-controlled study failed to show superiority over placebo in terms of clinical response.
Danish: Udvalget bemærkede, at en placebokontrolleret undersøgelse for et andet fluorquinolon ikke havde vist superioritet over placebo i klinisk respons.
English: It is noted that fluoroquinolones, including levofloxacin are not recognised as reference treatment for staphylococci and streptococci.
Danish: Det blev bemærket, at fluorquinoloner, herunder levofloxacin, ikke anerkendes som referencebehandling for stafylokokker og streptokokker.
English: The discrepancies in this section regarded the use during pregnancy and in patients with glucose-6phosphate dehydrogenase (G6PD) deficiency (divergence in one MS).
Danish: Afvigelserne i dette afsnit vedrørte anvendelsen ved graviditet og ved glukose-6-fosfatdehydrogenase (G6PD)-mangel (afvigende i én medlemsstat).
English: In the EU the approval of levofloxacin was first granted in the United Kingdom (UK) in 1997 followed by eleven other Member States (MS): Austria, Belgium, Denmark, Finland, Germany, Ireland, Italy, Luxembourg, the Netherlands, Portugal and Spain through the mutual recognition procedure (MRP) with UK as reference MS. Tavanic is also approved nationally in thirteen other MS: Bulgaria, Cyprus, Czech Republic, Estonia, France, Greece, Hungary, Lithuania, Malta, Poland, Slovakia, Slovenia and Sweden.
Danish: I EU blev levofloxacin først godkendt i Det Forenede Kongerige i 1997, efterfulgt af 11 andre medlemsstater: Østrig, Belgien, Danmark, Finland, Tyskland, Irland, Italien, Luxembourg, Nederlandene, Portugal og Spanien ved den gensidige anerkendelsesprocedure (MRP) med Det Forenede Kongerige som referencemedlemsstat.
English: Monitoring cases of haemolytic anaemia in these patients is recommended.
Danish: Hos disse patienter anbefales overvågning for hæmolytisk anæmi.
English: The pivotal study was study LOFBO-UTI-060: A multicenter, double-blind, randomized study to compare the safety and efficacy of oral levofloxacin with that of Floxin (ofloxacin) in the treatment of uncomplicated urinary tract infections in women.
Danish: Hovedundersøgelsen var undersøgelse LOFBO-UTI-060: En dobbeltblindet, randomiseret multicenterundersøgelse af sikkerheden og virkningen af oralt levofloxacin sammenlignet med Floxin (ofloxacin) til behandling af ukomplicerede urinvejsinfektioner hos kvinder.
English: The harmonised warning on QT interval prolongation was amended in line with the updated recommendation from the CHMP' pharmacovigilance working party dated 16 April 2012 with regards fluoroquinolones and risk of QT-interval prolongation.
Danish: Den harmoniserede advarsel om forlænget QT-interval blev rettet ind efter den opdaterede anbefaling fra CHMP's arbejdsgruppe vedrørende lægemiddelovervågning af 16. april 2012 vedrørende fluorquinoloner og risikoen for forlænget QT-interval.
English: The general text of frequencies classification, and the adverse reaction obtained from post-marketing experience were clarified, and the frequency of a number of events was revised.
Danish: Der blev foretaget en præcisering af den generelle tekst om klassificering af bivirkningers hyppighed samt af bivirkningen udledt af erfaringerne efter markedsføring, og for en række bivirkninger blev hyppigheden revideret.
English: Precaution for use in inhalation of anthrax was moved from section 5.1 to this section to warn prescribers on the need to refer to further guidance in this situation.
Danish: Forsigtighedsreglen vedrørende anvendelse ved lunge-miltbrand blev flyttet fra afsnit 5.1 til dette afsnit for at advare den ordinerende læge om, at der kræves yderligere vejledning i denne situation.
English: Section 4.1 - Therapeutic Indications
Danish: Afsnit 4.1 - Terapeutiske indikationer
English: The European Society of Clinical Microbiology and Infectious Diseases (ESCMID) endorses the “Guideline for the management of adult lower respiratory tract infections” that establishes quinolones as second-choice treatment in case of clinically relevant pneumococcal resistance against amoxicillin and tetracyclines, or major intolerance.
Danish: European Society of Clinical Microbiology and Infectious Diseases (ESCMID) tilslutter sig “Guideline for the management of adult lower respiratory tract infections”, der udpeger quinoloner som andetvalgsbehandling ved klinisk relevant resistens af pneumokokker mod amoxicillin og tetracykliner og ved væsentlig intolerans.
English: The harmonised warning on dysglycaemia was further amended in light of the recent reported cases of hypoglycaemic coma with fluoroquinolon agents.
Danish: Den harmoniserede advarsel om dysglykæmi blev korrigeret yderligere på baggrund af de nyligt indberettede tilfælde af hypoglykæmisk koma med fluorquinoloner.
English: In addition, information on the hepatotoxicity was complemented to refer that reported cases of jaundice and severe liver injury with levofloxacin, include cases with fatal acute liver failure, primarily in patients with severe underlying diseases.
Danish: Desuden blev oplysningen om hepatotoksicitet suppleret med angivelse af, at de indberettede tilfælde af ikterus og svær leverskade med levofloxacin omfatter tilfælde med fatalt akut leversvigt, hovedsagelig hos patienter med svær underliggende sygdom.
English: Tavanic is indicated in adults for the treatment of the following infections (see sections 4.4 and 5.1):
Danish: Tavanic er indiceret til behandling af følgende infektioner hos voksne (se afsnit 4.4 og 5.1):
English: This is adequate for most infective diseases (respiratory and skin) listed in the levofloxacin indications.
Danish: Dette er tilstrækkeligt ved de fleste luftvejs- og hudinfektioner som anført under indikationerne for levofloxacin.
English: Tavanic (levofloxacin) is a synthetic antibacterial agent of the fluoroquinolone class and is the S(-) enantiomer of the racemic drug substance ofloxacin.
Danish: Tavanic (levofloxacin) er et syntetisk antibiotikum af fluorquinolon-klassen og er S(-)-enantiomeren af det racemiske lægemiddelstof ofloxacin.
English: A new warning was agreed by the MAH to be included on the potential occurrence of vision disorders and that in such cases an eye specialist should be consulted immediately.
Danish: Indehaveren af markedsføringstilladelsen tilsluttede sig, at der indsættes en ny advarsel om potentielle synsforstyrrelser og nødvendigheden af øjeblikkelig konsultation af øjenlæge i sådanne tilfælde.
English: In particular, the indications and their associated posology recommendations were harmonised.
Danish: Herunder blev indikationerne og de tilhørende doseringsanbefalinger harmoniseret.
English: A warning on severe bullous reactions was proposed by the MAH due to the seriousness of these reactions and considering that bullous eruptions were already included in section 4.8 of the SmPC.
Danish: Indehaveren af markedsføringstilladelsen foreslog en advarsel om svære bulløse reaktioner, dels på grund af sådanne reaktioners alvorlighed, dels fordi bulløse erosioner i forvejen er indeholdt i afsnit 4.8 af produktresuméet.
English: • The committee considered the identified divergences for Tavanic and associated names regarding the therapeutic indications and the posology and method of administration sections, as well as in the remaining sections of the SmPCs
Danish: • udvalget behandlede de konstaterede divergenser for Tavanic og relaterede navne vedrørende terapeutiske indikationer, dosering, administrationsvej og de øvrige afsnit af produktresuméerne,
English: The main differences in this section accepted by the CHMP are listed below.
Danish: Hovedforskellene i dette afsnit er angivet nedenfor.
English: Therefore a specific warning for the pattern of resistance to fluoroquinolones resistance to E. coli is included in section 4.4 of the SmPC.
Danish: Derfor indsættes en særlig advarsel vedrørende resistensmønstret af E. coli over for fluorquinoloner i produktresuméets afsnit 4.4.
English: In this case, “alternative” is defined as: to be used in case of hypersensitivity to a preferred drug or widespread prevalence of clinically relevant resistance in the population being treated.
Danish: Ved “behandlingsalternativ” forstås her: anvendes ved hypersensitivitet over for det foretrukne lægemiddel eller ved udbredt, klinisk relevant resistens i den behandlede population.
English: The warning on the superinfection was amended in line with the standard wording on this point included in the PI for all antibacterial agents.
Danish: Advarslen om superinfektion blev rettet ind efter standardordlyden herom i produktinformationen for alle antibiotika.
English: For the majority of the approved indications, the posology was overall harmonised in practically all MS, the MAH proposed the following dosing recommendations:
Danish: For størstedelen af de godkendte indikationer var doseringen i det store hele harmoniseret i praktisk talt alle medlemsstater, og indehaveren af markedsføringstilladelsen foreslog følgende dosisanbefalinger:
English: In the European guidelines, levofloxacin is recommended as an alternative antibiotic, with the possibility of use as a first-line agent in countries with a high level of clinically relevant resistance to the first-line drugs.
Danish: I de europæiske retningslinjer anbefales levofloxacin som alternativt antibiotisk behandlingsvalg med mulighed for anvendelse som førstevalgsbehandling i lande med høj forekomst af klinisk relevant resistens over for førstevalgspræparaterne.
English: The MAH agreed that the harmonised wording for levofloxacin should also be in line with wording for other fluoroquinolones.
Danish: Indehaveren af markedsføringstilladelsen tilsluttede sig, at den harmoniserede ordlyd for levofloxacin også skal være på linje med ordlyden for andre fluorquinoloner.
English: Further amendment was agreed with regards the duration of treatment for pyelonephritis and for cUTIs to be in line with the European Association of Urology (EAU) guidelines 2010 recommendations for levofloxacin treatment duration of 7-10 days for acute uncomplicated pyelonephritis, and 7-14 days (IV followed by possible oral switch) for severe cases (EAU guidelines 2010).
Danish: Desuden rettedes behandlingsvarigheden ved pyelonefritis og ved komplicerede urinvejsinfektioner ind efter anbefalingerne fra European Association of Urology (EAU) for 2010, dvs. en behandlingsvarighed på 7-10 dage ved akut ukompliceret pyelonefritis og i svære tilfælde 7-14 dage (i.v., evt. efterfulgt af oral behandling) (EAU guidelines 2010).
English: Levofloxacin has a broad in vitro antibacterial spectrum that includes Gram-positive organisms such as Streptococcus pneumoniae regardless of resistance phenotype, methicillin-susceptible Staphylococcus aureus and Streptococci spp., fastidious Gram-negative bacteria such as Haemophilus influenzae, Moraxella catarrhalis and Enterobacteriaceae such as Escherichia coli and Klebsiella spp., and organisms responsible for atypical infection such as Legionella, Mycoplasma and Chlamydophila.
Danish: Levofloxacin har et bredt antibakterielt spektrum in vitro, som omfatter grampositive organismer som Streptococcus pneumoniae uanset resistensfænotype, methicillinfølsomme Staphylococcus aureus og Streptococcus spp., kræsne gramnegative bakterier som Haemophilus influenzae, Moraxella catarrhalis og Enterobacteriaceae som Escherichia coli og Klebsiella spp., samt organismer, der er årsag til atypiske infektioner, såsom Legionella, Mycoplasma og Chlamydophila.
English: The CHMP noted the MAH proposal for an harmonised text for this section.
Danish: CHMP noterede sig forslaget fra indehaveren af markedsføringstilladelsen til en harmoniseret tekst til dette afsnit.
English: Guidelines for CAP are more complex than those for other respiratory infections as they take into account several criteria like age and / or comorbidities, severity of the disease and the management as out- or in-patients.
Danish: Retningslinjerne for samfundserhvervet pneumoni er mere komplekse end for andre luftvejsinfektioner, da de tager hensyn til en række kriterier såsom alder og/eller komorbiditet, sygdommens sværhed og om de anvendes ambulant eller under indlæggelse.
English: Pyelonephritis and complicated urinary tract infections (see section 4.4) Chronic bacterial prostatitis
Danish: Pyelonefritis og komplicerede urinvejsinfektioner (se afsnit 4.4) Kronisk bakteriel prostatitis
English: This study included only acute cystitis patients and not uncomplicated pyelonephritis, even those might be encompassed within the classification of “uncomplicated UTI”.
Danish: Undersøgelsen omfattede kun akut cystitis og ikke ukompliceret pyelonefritis, selv om begge kan klassificeres som “ukomplicerede urinvejsinfektioner”.
English: Taking into account these considerations, and that the limited number of available guidelines currently recommend fluoroquinolones only in specific and complicated conditions e.g. polymicrobial infections involving Gram-negative organisms, the MAH agreed to amend the initially proposal for (“Skin and soft tissue infections when commonly recommended antibacterial agents are considered inappropriate for the treatment of this infection”) to reflect the current practice that levofloxacin should be indicated only for complicated SSTIs as an alternative (i.e. second line treatment) when recommended antibacterial agents are considered inappropriate for the treatment of this infection.
Danish: Ud fra disse overvejelser og det forhold, at de få gældende retningslinjer kun anbefaler fluorquinoloner i specifikke og komplicerede tilfælde, f.eks. polymikrobielle infektioner med gramnegative organismer, tilsluttede indehaveren af markedsføringstilladelsen sig at ændre det indledende forslag (“infektioner i hud og underliggende væv, når sædvanligt anbefalede antibiotika anses for uegnede til behandling af infektionen”), så det afspejler den nuværende praksis, dvs. levofloxacin er kun indiceret ved komplicerede infektioner i hud og underliggende væv som behandlingsalternativ (andetvalgsbehandling), når de anbefalede antibiotika anses for uegnede til behandling af infektionen.
English: Levofloxacin has been studied in large AECB controlled trials with an active comparator but no placebo-controlled study has been conducted.
Danish: Levofloxacin er blevet undersøgt i store kontrollerede undersøgelser ved akut eksacerbation af kronisk bronkitis med aktivt sammenligningspræparat, men der er ikke udført nogen placebokontrolleret undersøgelse.
English: Overall, levofloxacin showed to be at least as effective as other treatment recommended as first-line options, e.g. intravenous ceftriaxone and/or oral cefuroxime axetil plus macrolides and also to amoxicillin/clavulanic acid.
Danish: Overordnet har levofloxacin vist sig at være mindst ligeså effektivt som andre førstevalgsbehandlinger, f.eks. intravenøst ceftriaxon og/eller oralt cefuroximaxetil plus makrolider samt amoxicillin/clavulansyre.
English: The warning on exacerbation of myasthenia gravis included in the CSP was revised based on the cumulative safety review presented by the MAH during this referral procedure.
Danish: Advarslen om eksacerbation af myasthenia gravis, der indgår i de centrale sikkerhedsoplysninger (CSP), blev revideret på grundlag af den samlede sikkerhedsgennemgang, der blev fremlagt af indehaveren af markedsføringstilladelsen under denne henvisningsprocedure.
English: Since uUTI is defined as a presence of episodes of acute cystitis and acute pyelonephritism, the MAH proposed to harmonise this indication for “uncomplicated cystitis” to better reflect the patients population included in the study.
Danish: Da ukomplicerede urinvejsinfektioner er defineret som tilstedeværelse af episoder af akut cystitis og akut pyelonefritis, foreslog indehaveren af markedsføringstilladelsen at harmonisere denne indikation til “ukompliceret cystitis” for bedre at afspejle patientpopulationen i undersøgelsen.
English: Hence, Tavanic was included in the list of products for PI harmonisation, drawn up by the CMD(h), in accordance with Article 30(2) of Directive 2001/83/EC, as amended.
Danish: Tavanic blev derfor optaget på den liste over produkter med behov for harmonisering af produktinformationen, som blev opstillet af Koordinationsgruppen Vedrørende Gensidig Anerkendelse og Decentraliserede Godkendelsesprocedurer - human i overensstemmelse med artikel 30, stk. 2, i direktiv 2001/82/EF, som ændret.
English: In addition, this section of the SmpC was updated to reflect the core safety profile agreed in April 2011 as an outcome of the PSUR worksharing procedure.
Danish: Desuden blev dette afsnit af produktresuméet opdateret, så det afspejler de centrale sikkerhedsoplysninger, der blev godkendt i april 2011 under arbejdsdelingsproceduren vedrørende PSUR.
English: The Cmax/MIC ration of 10 and an AUC/MIC ratio of 100 are recommended in the literature to represent a rapid bactericidal activity.
Danish: I litteraturen anbefales et forhold Cmax/MIC på 10 og AUC/MIC på 100 for at opnå hurtig baktericid virkning.
English: Patients with CAP who are moderately to severely ill, are usually hospitalized.
Danish: Patienter med samfundserhvervet pneumoni af moderat til svær grad bliver sædvanligvis indlagt.
English: Tavanic, film-coated tablets, 250 mg and 500mg
Danish: Tavanic, filmovertrukne tabletter, 250 mg og 500 mg
English: This strength and presentation was linked with the indication for HAP which the MAH did not claim for in this harmonisation procedure.
Danish: Denne styrke og pakningsstørrelse var knyttet til indikationen nosokomiel pneumoni, som ikke blev påberåbt af indehaveren af markedsføringstilladelsen ved denne harmoniseringsprocedure.
English: This proposal for a restricted indication is in line with the current EU treatment guidelines to not overall recommend fluoroquinolones as first line treatment option.
Danish: I lighed med de gældende EU-behandlingsretningslinjer indeholder dette forslag til en begrænset indikation ingen generel anbefaling af fluorquinoloner som førstevalgsbehandling.
English: Due to the high spontaneous cure rates in this kind of infection, data showing superiority over placebo or comparators in more severe ABS are considered as a prerequisite to outweigh the extensive risks and to keep the benefits and risks balanced only in situations where beta-lactams, doxycycline or macrolides cannot be used for any reason or failed.
Danish: På grund af den høje spontane helbredelsesrate for denne type infektion kan data, der viser superioritet over placebo eller sammenligningspræparater, kun opveje de omfattende risici i tilfælde af sværere akut bakteriel sinuitis, hvor ß-lactamer, doxycyclin og makrolider uanset årsagen ikke kan anvendes eller har svigtet.
English: In addition the warning section of the SmPC now refers to the co-resistance of the fluroquinolones including levofloxacin to MRSA.
Danish: Desuden omtaler advarselsafsnittet i produktresuméet nu koresistens af MRSA over for fluorquinoloner, herunder levofloxacin.
English: This amendment is based on a newly submitted analysis showing that elderly are more vulnerable for tendon injury if received daily 1000 mg compared to 750 mg, epidemiologic studies, additional risk in renal impaired patients without dose adjustment and taking into account the biological plausibility of dose dependent cytotoxicity of fluoroquinolones these findings suggests that dosages of 1000 mg per day are an additional risk factor for tendon injuries.
Danish: Denne ændring bygger på en nylig forelagt analyse, der viser, at ældre personer er mere følsomme for seneskader, hvis de får 1 000 mg end hvis de får 750 mg, epidemiologiske undersøgelser, den ekstra risiko hos patienter med nedsat nyrefunktion uden dosisjustering og den biologiske plausibilitet af dosisafhængigheden af den cytotoksiske virkning af fluorquinoloner.
English: Current treatment guidelines usually recommend antipneumococcal fluoroquinolones for severe ABS, or where previous treatment has failed, or for infections involving resistant pneumococci.
Danish: De gældende behandlingsretningslinjer anbefaler sædvanligvis fluorquinoloner mod pneumokokker ved svære tilfælde af akut bakteriel sinuitis, hvor tidligere behandling har slået fejl, eller hvor infektionen omfatter resistente pneumokokker.
English: The CHMP noted the MAH proposal for this section and further agreed on a number of revisions.
Danish: CHMP noterede sig forslaget fra indehaveren af markedsføringstilladelsen vedrørende dette afsnit og fastlagde en række revisioner.
English: The warning on hepatobiliary disorders was updated to reflect the current evidence suggesting a causal relationship between levofloxacin and hepatotoxicity which may result in a fatal outcome.
Danish: Advarslen om sygdomme i lever og galdeveje blev opdateret, så den afspejler den nuværende dokumentation, der tyder på årsagssammenhæng mellem levofloxacin og hepatotoksicitet med muligt fatalt udfald.
English: The MAH voluntarily withdrew the marketing authorisation (MA) for the 750 mg film coated tablets and varied the terms of the MAs for the solution for infusion to remove the 150 ml presentation during this referral procedure.
Danish: Indehaveren af markedsføringstilladelsen trak frivilligt markedsføringsgodkendelsen for 750 mg filmovertrukne tabletter tilbage og ændrede betingelserne for markedsføringstilladelserne for infusionsvæske, opløsning, så pakningsstørrelsen 150 ml udgik ved denne henvisningsprocedure.
English: Complicated urinary tract infections (cUTIs) including pyelonephritis (PN)
Danish: Komplicerede urinvejsinfektioner, herunder pyelonefritis.
English: Complicated UTIs (cUTIs) including pyelonephritis (PN), has been submitted and approved in all except one EU MS, where only the indication for acute pyelonephritis (APN) was approved.
Danish: Indikationen komplicerede urinvejsinfektioner, herunder pyelonefritis, er ansøgt og godkendt i alle medlemsstater undtagen en enkelt, hvor kun indikationen akut pyelonefritis er godkendt.
English: • Pyelonephritis and complicated urinary tract infections (see section 4.4)
Danish: • Pyelonefritis og komplicerede urinvejsinfektioner (se afsnit 4.4)
English: This indication was not approved in one MS, due to the fact that the pivotal studies (five studies) did not use a conventional comparator also considering that, for uncomplicated SSTI the use of fluoroquinolones is not considered appropriate and for complicated SSTI the results were not clearly favouring levofloxacin.
Danish: En enkelt medlemsstat godkendte ikke indikationen, dels fordi hovedundersøgelserne (fem undersøgelser) var uden et sædvanligt sammenligningspræparat, dels fordi fluorquinoloner ikke anses for egnede til ukomplicerede infektioner i hud og underliggende væv, og endelig fordi resultaterne ved komplicerede infektioner i hud og underliggende væv ikke klart taler til fordel for levofloxacin.