FrancophonIA/ELRC3.0 huggingface dataset:
English: Resistance to fluoroquinolones can arise through mutations in DNA gyrase and topoisomerase IV. Other mechanisms may include over-expression of efflux pumps, impermeability, and protein-mediated protection of DNA gyrase.
Danish: Resistens over for fluorquinoloner kan opstå via mutationer i DNA-gyrase og topoisomerase IV. Andre mekanismer kan omfatte overekspression af efflukspumper, impermeabilitet og proteinmedieret beskyttelse af DNA-gyrase.
English: Ventricular tachyarrhythmias Syncope (i.e., acute and short lasting loss of consciousness) Hypertension Hypotension
Danish: Ventrikulære takyarytmier Synkope (dvs. akut og kortvarigt tab af bevidsthed) Hypertension Hypotension
English: The CHMP does not concur with the argument that the benefit-risk is different for patients in need of initial IV treatment as it can be argued that these patients are actually at greater risk of experiencing ADRs.
Danish: CHMP er ikke enigt i argumentet om, at risk/benefit-forholdet er anderledes for patienter, der har behov for indledende intravenøs behandling, eftersom det kan fremføres, at disse patienter faktisk har større risiko for at få bivirkninger.
English: The clinical development plan for cSSSI consisted of two controlled studies which were the basis for the approval.
Danish: Den kliniske udviklingsplan for komplicerede infektioner i hud og blødt væv (cSSSI) bestod af to kontrollerede undersøgelser, der udgjorde grundlaget for godkendelsen.
English: In vitro studies with human cytochrome P450 enzymes support these findings.
Danish: In vitro-studier med humane cytokrom P-450-enzymer underbygger disse oplysninger.
English: The first submission of moxifloxacin IV for CAP in 2002 included data from 550 moxifloxacin-treated subjects from two controlled clinical trials, which were later supplemented with an additional 942 subjects from five additional CAP studies.
Danish: Den første ansøgning om godkendelse af intravenøs moxifloxacin til samfundserhvervet pneumoni (CAP) i 2002 omfattede data fra 550 moxifloxacinbehandlede forsøgspersoner i to kontrollerede kliniske undersøgelser, som senere blev suppleret med yderligere 942 forsøgspersoner i fem yderligere CAPundersøgelser.
English: The combination of glibenclamide and moxifloxacin could theoretically result in a mild and transient hyperglycaemia.
Danish: Kombinationen af glibenclamid og moxifloxacin kan teoretisk resultere i en mild og forbigående hyperglykæmi.
English: In addition, the post-marketing data show that significant and serious ADRs associated with QTc prolongation do occur.
Danish: Desuden viser dataene efter markedsføringen, at der forekommer signifikante og alvorlige bivirkninger i forbindelse med QTc-forlængelse.
English: - Quinolones have been shown to cause photosensitivity reactions in patients.
Danish: - Quinoloner er vist at kunne forårsage fotosensitivitetsreaktioner hos patienter.
English: Under these circumstances, it is difficult to evaluate whether the infection or the treatment caused the INR (international normalised ratio) disorder.
Danish: Under disse omstændigheder kan det være svært at bedømme om INR (international normaliseret ratio)-forstyrrelserne skyldtes infektionen eller behandlingen.
English: Initial intravenous treatment may be followed by oral treatment with moxifloxacin 400 mg tablets, when clinically indicated.
Danish: Indledende intravenøs behandling kan efterfølges af oral behandling med 400 mg moxifloxacintabletter, når det er klinisk indiceret.
English: Swelling (of the hands, feet, ankles, lips, mouth, throat)
Danish: hævelser (af hænder, fødder, ankler, læber, mund og hals).
English: Injection and infusion site reactions
Danish: Reaktioner på injektions- og infusionssted
English: Prothrombin level increased / INR decreased
Danish: Forhøjet protrombinniveau/ INR sænkning
English: In in vivo tests, no evidence of genotoxicity was found despite the fact that very high moxifloxacin doses were used.
Danish: I in vivo-tests blev der ikke fundet tegn på genotoksicitet, fundet på trods af anvendelse af meget høje doser af moxifloxacin.
English: Severe, sudden generalised allergic reaction incl.
Danish: alvorlig, pludseligt opstået allergisk reaktion inkl.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR POSITIVE OPINION AND AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR POSITIV UDTALELSE OG ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
English: 5 years Use immediately after first opening and/or dilution.
Danish: 5 år Anvendes umiddelbart efter åbning og/eller fortynding.
English: Concomitant administration of charcoal with a dose of 400 mg oral or intravenous moxifloxacin will reduce systemic availability of the drug by more than 80% or 20% respectively.
Danish: Samtidig indgift af aktivt kul og en dosis på 400 mg oral eller intravenøs moxifloxacin vil formindske den systemiske biotilgængelighed af lægemidlet med mere end 80 % respektive 20 %.
English: 400 mg moxifloxacin, infused once daily.
Danish: 400 mg moxifloxacin, indgivet som infusion én gang dagligt.
English: In studies conducted in diabetic volunteers, concomitant administration of oral moxifloxacin with glibenclamide resulted in a decrease of approximately 21% in the peak plasma concentrations of glibenclamide.
Danish: I studier udført på frivillige diabetikere resulterede samtidig administration af oral moxifloxacin og glibenclamid i et fald på ca. 21 % i den maksimale plasmakoncentration af glibenclamid.
English: Octegra will always be given to you by a doctor or healthcare professional.
Danish: Octegra-infusionsvæske vil altid blive givet af en læge eller sygeplejerske.
English: Octegra may make you feel dizzy or light-headed or you might faint for a short period.
Danish: Octegra kan medføre svimmelhed eller uklarhed, eller De kan besvime i en kortere periode.
English: Renal clearance amounted to about 24 - 53 ml/min suggesting partial tubular reabsorption of the drug from the kidneys.
Danish: Renal clearance er ca. 24-53 ml/min, hvilket tyder på delvis tubulær reabsorption af lægemidlet.
English: The activity of moxifloxacin is not affected by mechanisms of resistance that are specific to antibacterial agents of other classes.
Danish: Aktiviteten af moxifloxacin påvirkes ikke af resistensmekanismer, der er specifikke for antibakterielle midler i andre klasser.
English: Octegra should not be co-infused with other drugs.
Danish: Octegra må ikke infunderes sammen med andre lægemidler.
English: The Applicant presented the results from the two studies, concluding that the bacteriological responses to moxifloxacin were supportive of the clinical responses and that the bacteriological eradication rates for moxifloxacin indicated good consistency between the two studies.
Danish: Ansøgeren fremlagde resultaterne af de to undersøgelser og konkluderede, at moxifloxacins bakteriologiske respons støttede den kliniske respons, og at moxifloxacins bakteriologiske eradikationsrater indikerede en god overensstemmelse mellem de to undersøgelser.
English: Pharmacokinetics are linear in the range of 50 - 1200 mg single oral dose, up to 600 mg single intravenous dose and up to 600 mg once daily dosing over 10 days.
Danish: Farmakokinetikken er lineær i intervallet 50-1 200 mg givet som enkelt dosis, op til 600 mg som enkelt intravenøs dosis og op til 600 mg ved én daglig dosering i 10 dage.
English: - If you are a child or an adolescent still growing.
Danish: hvis De er barn eller ung i voksealderen.
English: The data indicates that moxifloxacin carries a risk of severe hepatotoxicity at least 2-fold greater than comparators and the CHMP considers that the consistency of these risk estimates is a strong signal of an increased risk of hepatotoxicity, supporting non-first line use in the proposed indications.
Danish: Dataene viser, at moxifloxacin medfører en risiko for alvorlig hepatotoksicitet, der er mindst to gange større end sammenligningslægemidlernes, og CHMP mener, at disse risikoestimaters konsekvens er et stærkt tegn på en øget risiko for hepatotoksicitet, der støtter en ikkeførstevalgsbrug i de foreslåede indikationer.
English: Patients should be advised to see how they react to moxifloxacin before driving or operating machinery.
Danish: Patienter skal rådes til at være opmærksomme på deres reaktion på moxifloxacin før bilkørsel eller betjening af maskiner.
English: Rare ≥ 1/10,000 to
Danish: Sjælden ≥1/10.000 til
English: Simple comparisons between moxifloxacin and pooled comparators are misleading due to the variety of comparative regimens used.
Danish: Simple sammenligninger mellem moxifloxacin og de samlede sammenligningslægemidler er misvisende, fordi der blev anvendt forskellige sammenligningsregimer.
English: The magnitude of QT prolongation may increase with increasing plasma concentrations due to rapid intravenous infusion.
Danish: Størrelsen på QT-forlængelsen kan øges med øgede plasmakoncentrationer som følge af en hurtig intravenøs infusion.
English: Toxic effects on the CNS were observed in monkeys.
Danish: Der blev observeret toksisk virkning på CNS hos aber.
English: After intravenous administration findings indicative of systemic toxicity were most pronounced when moxifloxacin was given by bolus injection (45 mg/kg) but they were not observed when moxifloxacin (40 mg/kg) was given as slow infusion over 50 minutes.
Danish: Efter intravenøs indgift var observationer, der indikerede systemisk toksicitet, mest udtalte, når moxifloxacin blev givet som bolusinjektion (45 mg/kg), men de blev ikke observeret, når moxifloxacin (40 mg/kg) blev givet som langsom infusion over 50 minutter.
English: The toxicological experiments did not indicate that the liver was a prominent target organ for moxifloxacin and no specific risk factors for severe hepatic events were identified.
Danish: De toksikologiske undersøgelser viste ikke, at leveren var et vigtigt målorgan for moxifloxacin, og der blev ikke identificeret nogen specifikke risikofaktorer for alvorlige hepatiske hændelser.
English: Neither the CAPNETZ data nor the meta-analysis support the conclusion that moxifloxacin is better than alternatives.
Danish: Hverken CAPNETZ-dataene eller metaanalysen underbygger den konklusion, at moxifloxacin er bedre end alternativerne.
English: +Methicillin resistant S. aureus have a high probability of resistance to fluoroquinolones.
Danish: +Methicillinresistent S. aureus har en høj sandsynlighed for at være resistent over for fluorquinoloner.
English: Infusion site Common:
Danish: Infusionsstedet Almindelige:
English: The Applicant discussed the many factors that affect the QT interval and stated that while prolongation of the QTc interval is commonly used as a surrogate marker for the risk of developing ventricular arrhythmias such as Torsade de Pointes (TdP), there is no consensus on the degree of QT prolongation that is considered clinically significant.
Danish: Ansøgeren gjorde rede for de mange faktorer, der påvirker QT-intervallet, og anførte, at mens en forlængelse af QTc-intervallet almindeligvis anvendes som surrogatmarkør for risikoen for at udvikle ventrikulær arytmi såsom torsade de pointes (TdP), er der ikke enighed om den grad af QTforlængelse, der betragtes som klinisk signifikant.
English: - If you suffer from myasthenia gravis using Octegra may worsen the symptoms of your disease.
Danish: - Hvis De lider af myasthenia gravis, kan behandling med Octegra forværre symptomerne på sygdommen.
English: Preclinical data indicate that small amounts of moxifloxacin are secreted in milk.
Danish: Prækliniske data viser, at små mængder moxifloxacin udskilles i mælken.
English: Moxifloxacin is contraindicated in children and growing adolescents.
Danish: Moxifloxacin er kontraindiceret til børn og unge i voksealderen.
English: Therefore no clinically relevant interaction was observed between moxifloxacin and glibenclamide.
Danish: Der er således ikke observeret nogen klinisk betydende interaktion mellem moxifloxacin og glibenclamid.
English: Moxifloxacin undergoes Phase II biotransformation and is excreted via renal (approximately 40%) and biliary/faecal (approximately 60%) pathways as unchanged drug as well as in the form of a sulphocompound (M1) and a glucuronide (M2).
Danish: Moxifloxacin gennemgår fase II biotransformation og udskilles via renale (ca. 40 %) og galde/fækale (ca. 60 %) udskillelsesveje som uomdannet lægemiddel såvel som i form af en sulfoforbindelse (M1) og et glukuronid (M2).
English: - This medicinal product contains 787 mg (approximately 34 mmol) sodium per dose.
Danish: - Dette lægemiddel indeholder 787 mg (ca. 34 mmol) natrium pr. dosis.
English: EXP Use immediately after first opening and/or dilution.
Danish: EXP Anvendes umiddelbart efter åbning og/eller fortynding.
English: Overall, the CHMP considers that the data regarding the efficacy of IV/PO moxifloxacin are not overly impressive and this fact needs to be weighed against the safety profile as discussed further below.
Danish: Overordnet set er CHMP af den opfattelse, at dataene vedrørende intravenøs/oral moxifloxacins virkning ikke er alt for imponerende, og denne kendsgerning skal opvejes mod sikkerhedsprofilen som behandlet nedenfor.
English: Packs of 5 and 12 bags.
Danish: Pakninger med 5 og 12 poser.
English: If medically indicated the solution for infusion can be administered via a T-tube, together with compatible infusion solutions (see section 6.6).
Danish: Hvis det er medicinsk indiceret, kan infusionsopløsningen administreres via en 3-vejshane sammen med en kompatibel infusionsopløsning (se pkt.
English: Moxifloxacin inhibits bacterial type II topoisomerases (DNA gyrase and topoisomerase IV) that are required for bacterial DNA replication, transcription and repair.
Danish: Moxifloxacin hæmmer bakterielle type II topoisomeraser (DNA-gyrase og topoisomerase IV), som er nødvendige for bakteriel DNA-replikation, -transskription og -reparation.
English: Post-marketing data show that patients have been given moxifloxacin despite the contraindications and warnings in the SPC, therefore strengthening these precautions in the SPC is unlikely to achieve a major shift in behaviour.
Danish: Dataene efter markedsføringen viser, at patienter har fået moxifloxacin på trods af kontraindikationerne og advarslerne i produktresuméet, og derfor er det usandsynligt, at en styrkelse af disse forholdsregler i produktresuméet vil føre til en større adfærdsændring.
English: potentially lifethreatening swelling of the airway)
Danish: potentielt livstruende hævelser i luftvejene).
English: Regarding section 5.2 of the SPC, the Applicant agreed to remove the CLSI disk diffusion and MIC breakpoint criteria for aerobic bacteria but retained the CLSI recommendations for anaerobes in the SPC, as there are no MIC breakpoints established by EUCAST making the CLSI standard the only reference available to guide physicians.
Danish: Hvad angår punkt 5.2 i produktresuméet, gik ansøgeren med til at fjerne CLSI-diskdiffusionskriteriet og MIC-breakpointkriteriet for aerobe bakterier, men fastholdt CLSIanbefalingerne for anaerobe bakterier i produktresuméet, eftersom EUCAST ikke har opstillet nogen MIC-breakpoints, hvilket gør CLSI-standarden til den eneste reference, der er tilgængelig til at vejlede lægerne.
English: Moxifloxacin demonstrated efficacy against S. pneumoniae and pathogens associated with atypical pneumonia and the Applicant also discussed data obtained by the competence network CAPNETZ.
Danish: Moxifloxacin viste en virkning mod S. pneumoniae og patogener i forbindelse med atypisk pneumoni, og ansøgeren fremlagde ligeledes data fra kompetencenetværket CAPNETZ.
English: This applied to the overall incidence rates during IV/oral therapy and during initial IV therapy.
Danish: Dette gjaldt for de samlede incidensrater under intravenøs/oral behandling og under indledende intravenøs behandling.
English: Anxiety reactions Psychomotor hyperactivity / agitation
Danish: Angstanfald Psykomotorisk hyperaktivitet/agita tion
English: anosmia) Abnormal dreams Disturbed coordination (incl.
Danish: anosmi) Unormale drømme Svigtende koordination (inkl.
English: QT prolongation in patients with hypokalaemia (see section 4.4)
Danish: QT-forlængelse hos patienter med hypokaliæmi (se pkt.
English: Therefore, this SPC, labelling and package leaflet may not necessarily represent the current text.
Danish: Derfor er dette produktresume, denne etikettering og denne indlægsseddel ikke nødvendigvis den endelige version.
English: - Moxifloxacin is not recommended for the treatment of MRSA infections.
Danish: - Moxifloxacin kan ikke anbefales til behandling af MRSA-infektioner.
English: Animal studies have shown reproductive toxicity (see section 5.3).
Danish: Dyrestudier har vist toksicitet (se pkt.
English: What Octegra contains
Danish: Octegra indeholder
English: Moxifloxacin was non-carcinogenic in an initiation-promotion study in rats.
Danish: Moxifloxacin var ikke karcinogent i et initation-promotion studie med rotter.
English: Intravenous moxifloxacin was not associated with an increased incidence of events that would be considered surrogates for a QTc-related arrhythmia.
Danish: Intravenøs moxifloxacin var ikke forbundet med en øget incidens af hændelser, der kunne betragtes som surrogater for en QTcrelateret arytmi.
English: The CHMP adopted a List of Questions, to be addressed by the Applicant.
Danish: CHMP vedtog en liste med spørgsmål, som ansøgeren skulle besvare.
English: - There is limited experience on use of sequential intravenous/oral Octegra for the treatment of infection of the lungs (pneumonia) acquired outside the hospital.
Danish: - Der er begrænset erfaring med anvendelsen af skiftende intravenøst/oral Octegra-behandling til lungeinfektion (lungebetændelse) erhvervet uden for hospitalet.
English: Cross resistance should be expected between moxifloxacin and other fluoroquinolones.
Danish: Der må forventes krydsresistens mellem moxifloxacin og andre fluorquinoloner.
English: If AAD or AAC is suspected or confirmed, ongoing treatment with antibacterial agents, including moxifloxacin, should be discontinued and adequate therapeutic measures should be initiated immediately.
Danish: Ved mistænkt eller bekræftet AAD eller AAC skal igangværende behandling med moxifloxacin seponeres, og passende terapeutiske tiltag omgående initieres.
English: Due to limited clinical data, moxifloxacin is also contraindicated in patients with impaired liver function (Child Pugh C) and in patients with transaminases increase > 5fold ULN.
Danish: Grundet begrænsede kliniske data er Octegra også kontraindiceret til patienter med nedsat leverfunktion (Child-Pugh C) og til patienter med stigning i transaminaser > 5 gange øvre normalværdi (ULN).
English: Non-species related breakpoints*
Danish: Ikke-artsrelaterede grænseværdier *
English: Reproductive studies performed in rats, rabbits and monkeys indicate that placental transfer of moxifloxacin occurs.
Danish: Reproduktive studier udført på rotter, kaniner og aber tyder på, at moxifloxacin passerer placenta.
English: The Applicant considers that the proposed SPC now contains adequate warning regarding the patient groups at risk and potential precautionary measures to be noted before administering IV moxifloxacin.
Danish: Ansøgeren mener, at det foreslåede produktresumé nu indeholder en tilstrækkelig advarsel med hensyn til de udsatte patientgrupper og de potentielle forholdsregler, der skal træffes inden indgivelsen af intravenøs moxifloxacin.
English: Efficacy and safety of moxifloxacin in children and adolescents have not been established (see section 4.3).
Danish: Effekt og sikkerhed ved brug af moxifloxacin til børn og unge er ikke fastlagt (se pkt.
English: However, there was a suggestion that moxifloxacin may not be as effective against anaerobes, which might correlate with erratic in-vitro activity against anaerobic species.
Danish: Noget tydede dog på, at moxifloxacin muligvis ikke er så effektivt mod anaerobe bakterier, hvilket måske hænger sammen med uregelmæssig in-vitro aktivitet mod anaerobe arter.
English: Maximum concentrations of 5.4 mg/kg and 20.7 mg/l (geometric mean) were reached in bronchial mucosa and epithelial lining fluid, respectively, 2.2 h after an oral dose.
Danish: Maksimumkoncentrationer på 5,4 mg/kg og 20,7 mg/l (geometrisk middelværdi) blev opnået i henholdsvis bronkialslimhinden og epitelial væskefilm (epithelial lining fluid) 2,2 timer efter en oral dosis.
English: The CHMP considered that the effects of moxifloxacin on QTc indicate a correlation between plasma concentration and QTc.
Danish: CHMP mente, at moxifloxacins virkninger på QTc indikerer en sammenhæng mellem plasmakoncentration og QTc.
English: In addition, the lower 95% CI in the primary analyses exceeded or bordered on -10%, which adds to the opinion that IV/PO moxifloxacin is not an optimal overall treatment for cSSSI.
Danish: Hertil kommer, at det lavere 95 % CI i de primære analyser oversteg eller lå på grænsen til -10 %, hvilket bestyrker den opfattelse, at intravenøs/oral moxifloxacin ikke er en optimal samlet behandling af cSSSI.
English: Patients were more likely to have a notable increase in QTc on intravenous moxifloxacin than on oral moxifloxacin.
Danish: Der var større sandsynlighed for, at patienterne fik en betydelig stigning i QTc, hvis de fik intravenøs moxifloxacin, end hvis de fik oral moxifloxacin.
English: The risks may be even greater with intravenous use due to the differences in pharmacokinetics and the likely higher predisposition of patients with more severe CAP and with cSSSI to develop certain adverse reactions.
Danish: Risiciene kan være endnu større ved intravenøs brug som følge af de farmakokinetiske forskelle og den sandsynligvis højere prædisposition, som patienter med alvorlig samfundserhvervet pneumoni og med cSSSI har for at udvikle visse utilsigtede hændelser.
English: In conclusion, the CHMP is of the opinion that the efficacy of moxifloxacin in the two indications claimed is not over-impressive.
Danish: CHMP er således af den opfattelse, at moxifloxacins virkning i de to indikationer, der ansøges om, ikke er alt for imponerende.
English: Please contact your doctor before you continue the treatment if you suddenly start to feel unwell or notice yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed or disturbances of thought or wakefulness.
Danish: Kontakt Deres læge, før De fortsætter behandlingen, hvis De pludseligt bliver utilpas eller bemærker en gulfarvning af det hvide i øjnene, mørk urin, hudkløe, tendens til at bløde eller tankeforstyrrelser eller søvnløshed.
English: In case of a suspected or confirmed infection due to MRSA, treatment with an appropriate antibacterial agent should be started (see section 5.1).
Danish: I tilfælde af mistænkt eller bekræftet infektion på grund af MRSA skal behandling med et passende antibiotikum påbegyndes (se pkt.
English: - You may develop diarrhoea whilst taking, or after taking, antibiotics including Octegra.
Danish: - De kan få diaré under eller efter behandling med antibiotika inklusive Octegra.
English: Distinct alteration of the electrical activity of the heart (ECG) in patients with decreased blood potassium
Danish: tydelig ændring i den elektriske hjerteaktivitet (EKG) hos patienter med nedsat kaliumindhold i blodet.
English: In several cases, the lower 95% CI around the treatment differences in individual studies were borderline with instances of notable numerical inferiority for moxifloxacin versus comparators.
Danish: I adskillige tilfælde lå det lavere 95 % CI for behandlingsforskellene i individuelle undersøgelser på grænsen, og der var tilfælde med en væsentlig numerisk inferioritet for moxifloxacin i forhold til sammenligningslægemidler.
English: Octegra is for intravenous use.
Danish: Octegra-infusionsvæske er til intravenøst brug.
English: Other special populations No adjustment of dosage is required in the elderly and in patients with low bodyweight.
Danish: Andre specielle patientgrupper Det er ikke nødvendigt at justere dosis til ældre og til patienter med lav kropsvægt.