FrancophonIA/ELRC3.0 huggingface dataset:
English: Apart from nausea and diarrhoea all adverse reactions were observed at frequencies below 3%.
Danish: Bortset fra kvalme og diaré blev alle bivirkninger observeret med en hyppighed på under 3 %.
English: administration is only slightly higher than that observed after oral administration (35 mg·h/l) in accordance with the absolute bioavailability of approximately 91%.
Danish: administration er kun en smule højere end den der er observeret efter oral administration (35 mg⋅h/l) i overensstemmelse med, at den absolutte biotilgængelighed er på cirka 91 %.
English: The steady-state volume of distribution (Vss) is approximately 2 l/kg.
Danish: Steady-state fordelingsrumfanget (Vss) er ca. 2 l/kg.
English: Absorption and Bioavailability
Danish: Absorption og biotilgængelighed
English: Contact your doctor if you are not sure if you belong to a patient group described below.
Danish: Kontakt din læge, hvis du er i tvivl om du tilhører en af patientgrupperne nedenfor.
English: The following symptoms have been observed more frequently in patients treated intravenously: Common:
Danish: Følgende symptomer er set hyppigere hos patienter behandlet intravenøst: Almindelige:
English: Elpen Pharmaceutical Co, Inc
Danish: Grækenland Elpen Pharmaceutical Co, Inc
English: In this situation, you should not take medicines that stop or slow down bowel movement.
Danish: I denne situation skal De ikke tage lægemidler, der stopper eller nedsætter tarmbevægelser.
English: In addition, the comparisons made are not considered robust enough and the pooling of the data is inappropriate due to the very varied comparative regimens and patient populations treated.
Danish: Desuden anses de foretagne sammenligninger ikke for at være tilstrækkeligt udførlige, og samlingen af data er uhensigtsmæssig på grund af de meget forskellige sammenligningsregimer og behandlede patientpopulationer.
English: - Quinolone antibiotics may make your skin become more sensitive to sunlight or UV light.
Danish: - Quinolonantibiotika kan gøre huden mere følsom over for sollys og UV-lys.
English: The CHMP did not agree with the Applicant's conclusions, although the boxed warning was considered appropriate.
Danish: CHMP var ikke enigt i ansøgerens konklusioner, selv om advarselsboksen blev anset for at være hensigtsmæssig.
English: The recommended total duration of intravenous and oral treatment is 7 - 14 days for CAP and 7 - 21 days for cSSSI.
Danish: Den anbefalede samlede behandlingsvarighed for intravenøs og oral behandling er 7-14 dage for CAP og 7-21 dag for cSSSI.
English: It is therefore recommended not to store the infusion solution in a refrigerator.
Danish: Det anbefales derfor ikke at opbevare infusionsopløsningen i køleskab.
English: Streptococcus Groups A, B, C, G
Danish: Streptococcus gruppe A,B,C,G
English: The safety of moxifloxacin in human pregnancy has not been evaluated.
Danish: Sikkerheden ved moxifloxacin ved human graviditet er ikke blevet evalueret.
English: Using Octegra with food and drink The effect of Octegra is not influenced by food including dairy products.
Danish: Brug af Octegra sammen med mad og drikke Virkningen af Octegra påvirkes ikke af mad inklusive mejeriprodukter.
English: With regard to pathogens associated with atypical pneumonia, the data must be interpreted with extreme caution.
Danish: Når det gælder patogener i forbindelse med atypisk pneumoni, skal dataene fortolkes med meget stor forsigtighed.
English: Treatment of cSSI
Danish: Behandling af cSSSI
English: METHOD AND ROUTE(S) OF ADMINISTRATION Intravenous use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs anvendelse.
English: The AUC value of approximately 39 mg·h/l after i.v.
Danish: AUC-værdien på ca. 39 mg⋅h/l efter i.v.
English: Streptococcus milleri group* (S. anginosus, S. constellatus and S. intermedius) Streptococcus pneumoniae*
Danish: Streptococcus milleri gruppe * (S. anginosus, S. constellatus and S. intermedius) Streptococcus pneumoniae*
English: In vitro and ex vivo experiments showed a protein binding of approximately 40 - 42% independent of the concentration of the drug.
Danish: In vitro og ex vivo studier viste en proteinbinding på ca. 40-42 % uafhængig af lægemidlets koncentration.
English: Infections Common:
Danish: Infektioner Almindelige:
English: Do not take Octegra if you are pregnant or breast-feeding.
Danish: Tag ikke Octegra, hvis De er gravid eller ammer.
English: Like all medicines, Octegra can cause side effects, although not everybody gets them.
Danish: Octegra kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: If you are on a controlled-salt diet, please inform your doctor immediately.
Danish: Hvis De er på saltkontrolleret diæt, skal De straks oplyse Deres læge om det.
English: The corresponding peak concentration in alveolar macrophages amounted to 56.7 mg/kg.
Danish: Den tilsvarende maksimale koncentration i alveolære makrofager udgjorde 56,7 mg/kg.
English: In clinical studies most patients switched to oral therapy within 4 days (CAP) or 6 days (cSSSI).
Danish: I kliniske studier skiftede de fleste patienter til oral behandling inden for 4 dage (CAP) eller 6 dage (cSSSI).
English: The wording to be implemented was agreed by the CHMP and communicated to the Applicant.
Danish: Den ordlyd, der skulle anvendes, blev vedtaget af CHMP og meddelt til ansøgeren.
English: - If you have a severe liver disease or liver enzymes (transaminases) that are higher than 5 times the upper normal limit.
Danish: hvis De har alvorlig leversygdom eller leverenzymer (transaminaser), der er mere end 5 gange højere end den normale øvre grænse.
English: General symptomatic therapy should be initiated.
Danish: Almindelig symptomatisk terapi bør iværksættes.
English: On the basis of the pharmacokinetic studies carried out so far in patients with liver failure (Child Pugh A, B), it is not possible to determine whether there are any differences compared with healthy volunteers.
Danish: På basis af de farmakokinetiske studier som indtil nu er udført på patienter med leversvigt (ChildPugh A, B), er det ikke muligt at afgøre, hvorvidt der er forskelle sammenlignet med raske forsøgspersoner.
English: No prolongation of the QT interval was seen when a dose of 30 mg/kg was infused over 60 minutes.
Danish: Ingen forlængelse af QTintervallet blev set, hvis 30 mg/kg blev infunderet over 60 minutter.
English: - If you are pregnant or breast-feeding.
Danish: hvis De er gravid eller ammer.
English: The Applicant also discussed the feasibility of European surveillance, proposing to undertake an annual surveillance plan to collect moxifloxacin MIC data in European countries.
Danish: Ansøgeren gjorde ligeledes rede for gennemførligheden af europæisk overvågning og foreslog at iværksætte en årlig overvågningsplan med det formål at indsamle MIC-data for moxifloxacin i de europæiske lande.
English: For patients with complicated skin and skin structure infections the mean duration of intravenous treatment was approximately 6 days and the average overall duration of treatment (infusion followed by tablets) was 13 days.
Danish: For patienter med komplicerede hud- og hudstrukturinfektioner er den gennemsnitlige behandlingvarighed med infusionsvæske ca. 6 dage, og den gennemsnitlige totale behandlingsvarighed (infusion efterfulgt af tabletter) ca. 13 dage.
English: Possible side effects) contact your doctor immediately before you continue the treatment.
Danish: 4 Bivirkninger), skal De omgående kontakte Deres læge, inden De fortsætter behandlingen.
English: The prevalence of acquired resistance may vary geographically and with time for selected species and local information of resistance is desirable, particularly when treating severe infections.
Danish: Forekomsten af erhvervet resistens kan variere både geografisk og over tid for udvalgte arter, og lokal information om resistensudviklingen er ønskelig, specielt ved behandling af alvorlige infektioner.
English: You should avoid prolonged exposure to sunlight or strong sunlight and should not use a sunbed or any other UV lamp while taking Octegra.
Danish: De skal undgå langvarig ophold i sollys eller stærkt sollys og bør ikke bruge solarium eller andre UV-lamper, mens Octegra anvendes.
English: EUCAST clinical MIC breakpoints for moxifloxacin (31.01.2006): Organism
Danish: EUCAST kliniske MIC grænseværdier for moxifloxacin (31.01.2006): Organisme
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Der skal tages hensyn til officielle retningslinjer vedrørende hensigtsmæssig brug af antibiotika.
English: Sodium bicarbonate 4.2% and 8.4% solutions
Danish: Natriumhydrogencarbonat 4,2 % og 8,4 %
English: The trends described require years of observations before a clear association between use of either fluoroquinolone and resistance patterns, including mutation patterns can be established.
Danish: De beskrevne tendenser kræver flere års observationer, før der kan påvises en klar forbindelse mellem brugen af begge fluoroquinoloner og resistensmønstre, herunder mutationsmønstre.
English: If the treatment with this medicine is stopped too soon your infection may not be completely cured.
Danish: Hvis behandlingen med dette lægemiddel stoppes for tidligt kan det være, at infektionen ikke helbredes helt.
English: The data revealed no new decrease in moxifloxacin susceptibility and the Applicant concluded that the susceptibilities for relevant species were correctly reflected in section 5.1 of the SPC with no significant trends or changes.
Danish: Dataene viste ikke nogen ny reduktion i moxifloxacinfølsomheden, og ansøgeren konkluderede, at de relevante arters følsomhed var korrekt afspejlet i punkt 5.1 i produktresuméet uden nogen væsentlige tendenser eller ændringer.
English: Refer to sections 4.3, 4.4 and 4.5.
Danish: Se punkt 4.3, 4.4 og 4.5.
English: Therefore it is important to consider this diagnosis in patients who develop serious diarrhoea during or after the use of moxifloxacin.
Danish: Det er derfor vigtigt at overveje denne diagnose, hos patienter, som udvikler alvorlig diaré under eller efter moxifloxacinbehandling.
English: In these cases moxifloxacin should be discontinued and suitable treatment (e.g. treatment for shock) initiated.
Danish: I disse tilfælde bør moxifloxacin seponeres og passende behandling iværksættes (f.eks. behandling af shock).
English: This might lead to an increased risk of ventricular arrhythmias, including torsade de pointes.
Danish: Dette kan medføre en øget risiko for ventrikulære arytmier, herunder torsade de pointes.
English: The Applicant proposed the insertion of a section on QTc interval in section 4.4, as well as the following box-warning at the beginning of section 4.4:
Danish: Ansøgeren foreslog medtagelsen af et afsnit om QTc-intervallet i punkt 4.4 samt følgende advarselsboks i starten af punkt 4.4:
English: À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado
Danish: 4745-457 S. Mamede do Coronado Portugal
English: The proposed restricted indication does not preclude the use of moxifloxacin for the initial treatment of CAP if in accordance with the local/regional/national guidance.
Danish: Den foreslåede begrænsede indikation udelukker ikke anvendelsen af moxifloxacin til indledende behandling af samfundserhvervet pneumoni, når blot det sker i overensstemmelse med de lokale/regionale/nationale retningslinjer.
English: The Applicant accepted the restriction of cSSSI to a secondline treatment together with a warning towards MRSA in section 4.4.
Danish: Ansøgeren accepterede begrænsningen af cSSSI til andetvalgsbehandling sammen med en advarsel vedrørende MRSA i punkt 4.4.
English: The following side effects have been observed during treatment with Octegra.
Danish: De følgende bivirkninger er set under behandling med Octegra.
English: These effects occurred after the administration of high doses of moxifloxacin or after prolonged treatment.
Danish: Disse effekter forekom efter indgift af høje doser af moxifloxacin eller efter lang tids behandling.
English: However, the observed pharmacokinetic changes for glibenclamide did not result in changes of the pharmacodynamic parameters (blood glucose, insulin).
Danish: Imidlertid resulterede de observerede farmakokinetiske ændringer for glibenclamid ikke i ændringer af de farmakodynamiske parametre (blodsukker, insulin).
English: However, studies have shown that moxifloxacin has a lower risk to induce photosensitivity.
Danish: Studier har dog vist, at moxifloxacin har en lav risiko for at inducere fotosensitivitet.
English: CARTON FOR UNIT PACK AND LABEL - GLASS BOTTLE
Danish: ÆSKE TIL ENHEDSPAKKER OG ETIKET - GLASFLASKE
English: Interaction with food Moxifloxacin has no clinically relevant interaction with food including dairy products.
Danish: Interaktioner med fødevarer Moxifloxacin har ingen klinisk relevante interaktioner med fødevarer inklusive mejeriprodukter.
English: Nevertheless patients should be advised to avoid exposure to either UV irradiation or extensive and/or strong sunlight during treatment with moxifloxacin.
Danish: Ikke desto mindre bør patienter informeres om at undgå UV-bestråling eller meget og/eller stærkt sollys under behandling med moxifloxacin.
English: - If you are currently taking oral anti-coagulants (e.g. warfarin), it may be necessary for your doctor to monitor your blood clotting times.
Danish: - Hvis De tager orale antikoagulantia (f.eks. warfarin), kan det være nødvendigt, at lægen følger blodets størkningsevne.
English: No precaution is required for use with digoxin.
Danish: Ingen forholdsregler er nødvendige ved samtidig behandling med digoxin.
English: * Non-species related breakpoints have been determined mainly on the basis of pharmacokinetic/pharmacodynamic data and are independent of MIC distributions of specific species.
Danish: > 1 mg/l *Ikke-artsrelateret brydningspunkter er blevet bestemt hovedsageligt på baggrund af farmakokinetiske/farmakodynamiske data og er uafhængige af MIC-fordelingen for specifikke arter.
English: Microbiological Susceptibility
Danish: Mikrobiologisk følsomhed
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) / MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORMER, STYRKER, INDGIVELSESVEJE, INDEHAVER AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE
English: - Octegra should be given intravenously (in the vein) only, and should not be administered into an artery.
Danish: - Octegra må kun gives intravenøst (i venen) og må ikke gives i arterier.
English: All AEs that might potentially reflect arrhythmias need to be taken into account and therefore the concerns regarding hepatotoxicity were reiterated.
Danish: Det er nødvendigt at tage højde for alle utilsigtede hændelser, der potentielt kan være et udtryk for arytmi, og derfor blev betænkelighederne med hensyn til hepatotoksicitet gentaget.
English: Most importantly, response rates in staphylococcal infections were comparable between treatments as were responses for the relatively small number of Group A streptococcal infections.
Danish: Det vigtigste var, at responsraterne ved stafylokokinfektioner var sammenlignelige mellem behandlingerne, og det samme gjaldt for responsen for det relativt lille antal gruppe A-streptokokinfektioner.
English: Pharmacodynamic studies of fluoroquinolones in animal infection models and in human trials indicate that the primary determinant of efficacy is the AUC24/MIC ratio.
Danish: Farmakodynamiske studier af fluorquinoloner i infektionsmodeller hos dyr og i kliniske studier hos mennesker indikerer, at den primære determinant for virkningen er forholdet mellem AUC24/MIC.
English: - Hypersensitivity and allergic reactions have been reported for fluoroquinolones including moxifloxacin after first administration.
Danish: - Overfølsomhedsreaktioner og allergiske reaktioner er blevet rapporteret for fluorquinoloner inklusive moxifloxacin efter første administration.
English: After intravenous administration of moxifloxacin to dogs (30 mg/kg infused over 15, 30 or 60 minutes) the degree of QT prolongation was clearly depending on the infusion rate, i.e. the shorter the infusion time the more pronounced the prolongation of the QT interval.
Danish: Efter intravenøs administration af moxifloxacin til hunde (30 mg/kg infunderet over 15, 30 eller 60 minutter) var graden af QT-forlængelse klart afhængig af infusionshastigheden, dvs. jo kortere infusionstid desto mere udtalt var forlængelsen af QT-intervallet.
English: They are for use only for species that have not been given a species-specific breakpoint and are not for use with species where interpretative criteria remain to be determined (Gram-negative anaerobes).
Danish: De skal kun anvendes for arter, som ikke har fået et artsspecifikt grænseværdier, og skal ikke anvendes for arter, hvor fortolkningskriterier endnu ikke er bestemt (gramnegative anaerobe mikroorganismer).
English: Do not use Octegra after the expiry date which is stated on the label on the bottle bag and carton.
Danish: Brug ikke Octegra efter den udløbsdato, der står på pakningen.
English: The Applicant presented a summary of the monitoring of the susceptibility of relevant bacterial species to moxifloxacin through a systematic literature review.
Danish: Ansøgeren fremlagde et sammendrag af overvågningen af relevante bakteriearters følsomhed over for moxifloxacin ved hjælp af en systematisk litteraturgennemgang.
English: 6.3 Shelf life Polyolefine bag: 3 years Glass bottle:
Danish: Polyolefinpose: 3 år Glasflaske:
English: Your doctor should ensure that the infusion is given at a constant flow over 60 minutes.
Danish: Lægen skal sikre, at infusionen gives med en konstant hastighed i løbet af 60 minutter.
English: The prevalence of resistance among pneumococci is very variable across the EU and this is reflected in different treatment guidelines, including the need to use high doses of beta-lactam agents, combination therapy or to use fluoroquinolones in some regions.
Danish: Forekomsten af resistens blandt pneumokokker varierer meget i hele EU, og dette kommer til udtryk i de forskellige behandlingsretningslinjer, herunder nødvendigheden af at bruge høje doser af beta-lactam-midler, kombinationsbehandling eller fluoroquinoloner i nogle områder.
English: Octegra works by killing bacteria that cause infections if they are caused by bacteria that are susceptible to moxifloxacin.
Danish: Octegra virker ved at dræbe bakterier, der forårsager infektioner, hvis de er forårsaget af bakterier, der er følsomme over for moxifloxacin.
English: Common ≥ 1/100 to < 1/10
Danish: Almindelig ≥1/100 til <1/10
English: Female patients and elderly patients may be more sensitive to the effects of QTc-prolonging medications such as moxifloxacin and therefore special caution is required.
Danish: Kvindelige patienter og ældre patienter kan være mere følsomme over for virkningen af QTcforlængende lægemidler som f.eks. moxifloxacin, og derfor er særlig forsigtighed påkrævet.
English: Recovery of the dose (unchanged drug and metabolites) totalled to approximately 98% after intravenous administration of the drug.
Danish: Genfinding af dosen (uomdannede lægemiddelstof og metabolittter) var totalt cirka 98 % efter intravenøs indgift af lægemidlet.
English: The CHMP and requested the Applicant to further discuss this issue.
Danish: CHMP anmodede ansøgeren om en yderligere redegørelse for dette spørgsmål.
English: Note: This SPC, labelling and package leaflet is the version valid at the time of Commission Decision.
Danish: Bemærk: Dette produktresume, denne etikettering og denne indlægsseddel er den version, der er gældende ved kommissionsbeslutningen.
English: Therefore, the duration of infusion should not be less than the recommended 60 minutes and the intravenous dose of 400 mg once a day should not be exceeded.
Danish: Derfor må infusionstiden ikke være mindre end de anbefalede 60 minutter, og den intravenøs dosis på 400 mg én gang dagligt må ikke overskrides.
English: Vomiting Gastrointestinal and abdominal pains
Danish: Gastrointestinale og abdominale smerter
English: In clinical Phase I and in vitro studies no metabolic pharmacokinetic interactions with other drugs undergoing Phase I biotransformation involving cytochrome P450 enzymes were observed.
Danish: I kliniske fase I og i in vitro studier observeredes ingen metaboliske farmakokinetiske interaktioner med andre lægemidler, som gennemgår fase I biotransformation med cytokrom P450 enzymer.
English: The fact that moxifloxacin undergoes considerable metabolism led to concerns regarding its hepatotoxic potential.
Danish: Den kendsgerning, at moxifloxacin er genstand for en betydelig metabolisme, gav anledning til betænkeligheder med hensyn til dets hepatotoksiske potentiale.
English: While there were no clear reasons to reject an indication for CAP, the CHMP considered that the less than impressive data has to be weighed against the safety concerns.
Danish: Mens der ikke var nogen klare grunde til at afvise en indikation for samfundserhvervet pneumoni, var CHMP af den opfattelse, at de ikke alt for imponerende data skulle holdes op imod sikkerhedsbetænkelighederne.
English: Streptococcus agalactiae (Group B)
Danish: Streptococcus agalactiae (Gruppe B)
English: No TdPs were reported in over 15,000 patients in clinical studies and in over 90,000 patients in Post Marketing Studies and the frequency of treatment-emergent serious cardiac events was similar to that of the comparator.
Danish: Ingen tilfælde af TdP blev indberettet hos over 15.000 patienter i de kliniske undersøgelser og hos over 90.000 patienter i undersøgelserne efter markedsføringen, og hyppigheden af behandlingsrelaterede alvorlige kardiale hændelser var næsten den samme som for sammenligningslægemidlet.
English: Method of administration For intravenous use; constant infusion over 60 minutes (see also section 4.4).
Danish: Til intravenøs brug: konstant infusion over 60 minutter (se også pkt.
English: A slightly increased incidence of vertebral and rib malformations was observed in foetuses of rabbits but only at a dose (20 mg/kg i.v.)
Danish: En mindre øgning i forekomsten af vertebra- og ribbensmisdannelser blev set i kaninfostre, men kun ved en dosis (20 mg/kg i.v.
English: Considering these results a metabolic interaction via cytochrome P450 enzymes is unlikely.
Danish: Disse resultater taget i betragtning er metabolisk interaktion via cytokrom P-450 enzymer usandsynlig.
English: gait disturbances, esp. due to dizziness or vertigo)
Danish: Døsighed især pga. svimmelhed eller vertigo)
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt {MM/YYYY} [Udfyldes nationalt]
English: Anaerobic micro-organisms
Danish: Anaerobe mikroorganismer
English: As a number of issues remained to be clarified, the CHMP adopted a List of Outstanding Issues to be addressed by the Applicant.
Danish: Eftersom der stadig var en række spørgsmål, der skulle afklares, vedtog CHMP en liste over uafklarede spørgsmål, som ansøgeren skulle besvare.
English: The Applicant concluded that there are no differences between moxifloxacin and the comparator when comparing the total numbers and frequencies of reports on possible drug-related hepatic disorders.
Danish: Ansøgeren konkluderede, at der ikke er nogen forskel på moxifloxacin og sammenligningslægemidlet, når man sammenligner det totale antal og hyppigheden af indberetninger af mulige lægemiddelrelaterede leversygdomme.
English: Changes in INR
Danish: INR forandringer
English: However, such data may indicate a true excess risk of hepatotoxicity for the IV formulation.
Danish: Sådanne data kan dog indikere en egentlig øget risiko for hepatotoksicitet for den intravenøse formulerings vedkommende.
English: Jaundice Hepatitis (predominantly cholestatic)
Danish: Gulsot Hepatitis (overvejende kolestatisk)