FrancophonIA/ELRC3.0 huggingface dataset:
English: The benefit of moxifloxacin treatment especially in infections with a low degree of severity should be balanced with the information contained in the warnings and precautions section.
Danish: Fordelen ved moxifloxacin-behandling, specielt ved mindre alvorlige infektioner, bør vejes op imod informationen i afsnittet om advarsler og forsigtighedsregler.
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 for tiden indtager orale antikoagulantia (indtaget via munden) (f.eks. warfarin), kan det være nødvendigt, at lægen følger blodets størkningsevne.
English: Pharmacokinetics are linear in the range of 50 - 800 mg single dose and up to 600 mg once daily dosing over 10 days.
Danish: Farmakokinetikken er linær i intervallet 50-800 mg givet som enkelt dosis og op til 600 mg ved en daglig dosering i 10 dage.
English: - [Invented name] may occasionally cause pain and inflammation of your tendons, particularly if you are elderly or if you are currently being treated with corticosteroids.
Danish: - [Lægemidlets navn] kan lejlighedsvis give smerter eller betændelse i Deres sener, især hvis De er ældre eller hvis De for tiden er i behandling med kortikosteroider.
English: ANNEX III AMENDMENTS TO SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET (RELEVANT SECTIONS ONLY)
Danish: BILAG III RETTELSER TIL PRODUKTRESUME OG INDLÆGSSEDDEL (KUN RELEVANTE AFSNIT)
English: Higher plasma concentrations are observed in healthy volunteers with low body weight (such as women) and in elderly volunteers.
Danish: Der blev observeret højere plasmakoncentrationer i raske forsøgspersoner med lav kropsvægt (eksempelvis kvinder) og i ældre forsøgspersoner.
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-studier og i in vitro-studier observeredes ingen metaboliske farmakokinetiske interaktioner med andre lægemidler, som gennemgår fase I biotransformation med cytokrom P450 enzymer.
English: Resistance mechanisms that inactivate penicillins, cephalosporins, aminoglycosides, macrolides and tetracyclines do not interfere with the antibacterial activity of moxifloxacin.
Danish: Resistensmekanismer, som inaktiverer penicilliner, cephalosporiner, aminoglykosider, makrolider og tetracykliner, påvirker ikke moxifloxacins antibakterielle aktivitet.
English: In addition, the risk of QTprolongation is already sufficiently addressed in the Product Information and will be adequately followed up by the MAH in the post-marketing setting.
Danish: Desuden er risikoen for QT-forlængelse allerede tilstrækkeligt behandlet i produktoplysningerne, og indehaveren af markedsføringstilladelsen vil sørge for passende opfølgning på dette efter markedsføringen.
English: In this referral procedure, the CHMP focused on the risk of more frequent QT-prolongation in women in the light of the prolonged treatment regimen in PID (14 days vs. 5-10 days), on the risk of coadministration with other QT-affecting substances and on the possible adverse effects on cartilage in the treatment population.
Danish: I forbindelse med denne indbringelsesprocedure lagde CHMP vægt på risikoen for hyppigere forekomst af QT-forlængelse hos kvinder set i lyset af den forlængede behandling i forbindelse med PID (14 dage kontra 5-10 dage), risikoen for samtidig administration af andre QT-påvirkende stoffer samt mulige uønskede bruskpåvirkninger i behandlingsgruppen.
English: - Quinolones have been shown to cause photosensitivity reactions in patients.
Danish: - Quinoloner har vist sig at kunne forårsage fotosensitivitetsreaktioner hos visse patienter.
English: There is insufficient experience in the clinical use of moxifloxacin in patients with impaired liver function.
Danish: Der er utilstrækkelig erfaring med den kliniske brug af moxifloxacin til patienter med nedsat leverfunktion.
English: Although it is well known that monotherapy increases compliance, this example of combination therapy would not decrease compliance since the proposed cephalosporin would only have to be given once during the physician's visit and only moxifloxacin would have to be continued orally.
Danish: Selv om det er velkendt, at kompliansen er større ved monoterapi, ville dette eksempel på kombinationsterapi ikke medføre forringet komplians, idet det foreslåede cephalosporin kun skal gives én gang ved lægebesøg, mens moxifloxacinet stadig skal indgives oralt.
English: - If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
Danish: - Hvis synet bliver nedsat, eller der opleves anden påvirkning af øjet, skal en øjenspecialist konsulteres med det samme.
English: Drugs inhibiting peristalsis are contraindicated in this situation.
Danish: er kontraindiceret i denne situation.
English: Concerning overall cardiac adverse events, no differences between short (up to 5 days) and longer duration (up to 15 days) of moxifloxacin therapy were observed.
Danish: Overordnet blev der, for så vidt angår uønskede hjertehændelser, ikke observeret nogen forskel på kort (op til 5 dage) og længerevarende (op til 15 dage) behandling med moxifloxacin.
English: Impaired liver function was associated with higher exposure to M1 in plasma, whereas exposure to parent drug was comparable to exposure in healthy volunteers.
Danish: Nedsat leverfunktion var forbundet med højere plasmakoncentrationer af M1, medens eksponeringen for moderstoffet var sammenlignelig med eksponeringen hos raske forsøgspersoner.
English: Medication that can reduce potassium levels should be used with caution in patients receiving moxifloxacin.
Danish: Lægemidler, der kan nedsætte kaliumniveauet, bør anvendes med forsigtighed til patienter, der får moxifloxacin.
English: - Moxifloxacin has been shown to prolong the QTc interval on the electrocardiogram in some patients.
Danish: - Moxifloxacin har vist sig at kunne forlænge QTc-intervallet på elektrokardiogrammet hos nogle patienter.
English: Moxifloxacin is mainly bound to serum albumin.
Danish: Moxifloxacin er hovedsageligt bundet til serumalbumin.
English: Moxifloxacin is eliminated from plasma with a mean terminal half life of approximately 12 hours.
Danish: Moxifloxacin elimineres fra plasma med en gennemsnitlig halveringstid på ca. 12 timer.
English: The pharmacokinetic properties of moxifloxacin are not significantly different in patients with renal impairment (including creatinine clearance > 20 ml/min/1.73 m2).
Danish: Moxifloxacins farmakokinetik er ikke signifikant forskellig hos patienter med nedsat nyrefunktion (inklusiv kreatinin clearance > 20 ml/min/1,73 m2).
English: Liver function tests/investigations should be performed in cases where indications of liver dysfunction occur.
Danish: Test/undersøgelse af leverfunktionen bør udføres ved tegn på nedsat leverfunktion.
English: In terms of safety the longer treatment duration, the risk of effects on cartilage in young patients and the risk of QT-prolongation were of concern.
Danish: Med hensyn til sikkerhed var årsagerne til betænkelighederne den længere behandlingsperiode, risikoen for bruskpåvirkninger hos yngre patienter samt risikoen for QT-forlængelse.
English: Concomitant administration of moxifloxacin with ranitidine or probenecid did not alter renal clearance of the parent drug.
Danish: Samtidig indgift af moxifloxacin med ranitidin eller probenecid ændrede ikke renal clearance af moderstoffet.
English: This is because [Invented name] can cause a certain change on the ECG, that is a prolongation of the QT-interval i.e delayed conduction of electrical signals.
Danish: Det skyldes, at [Lægemidlets navn] kan medføre visse EKG-ændringer, som forlænger QTintervallet, dvs. en forsinkelse i de elektriske signaler i hjertet.
English: It appears that the C8-methoxy moiety contributes to enhanced activity and lower selection of resistant mutants of Gram-positive bacteria compared to the C8-H moiety.
Danish: C8-methoxy-gruppen synes at bidrage til en øget aktivitet og lav selektion af resistente mutanter af grampositive bakterier sammenlignet med C8-H-gruppen.
English: There is insufficient data in patients with impaired liver function (see section 4.3).
Danish: Der er utilstrækkelige data vedrørende patienter med nedsat leverfunktion (se pkt.
English: Clinical and Laboratory Standards Institute™ (CLSI), formerly NCCLS breakpoints are presented in the below table for MIC testing (mg/l) or disc diffusion testing (zone diameter [mm]) using a 5-µg moxifloxacin disc.
Danish: Clinical and Laboratory Standards Institute™ (CLSI), tidligere NCCLS-brydningspunkter vises i tabellen nedenfor for test af MIC (mg/l), eller disk diffusionstest (zone-diameter [mm]) ved brug af en 5 mikrogram moxifloxacin-disk.
English: Clinical and Laboratory Standards Institute™ (CLSI) MIC and disc diffusion breakpoints for Staphylococcus spp.
Danish: Clinical and Laboratory Standards Institute™ (CLSI) MIC- og disk-diffusions brydningspunkt for Staphylococcus spp.
English: In clinical trials the tablets have been studied for up to 14 days treatment.
Danish: Der er gennemført kliniske undersøgelser af behandling i op til 14 dage med tabletterne.
English: As necessary, expert advice should be sought where the local prevalence of resistance is such that utility of the agent in at least some types of infections is questionable.
Danish: Ved lokal forekomst af resistens bør ekspertrådgivning søges, hvis der stilles spørgsmålstegn ved anvendeligheden af lægemidlet for mindst nogle af infektionstyperne.
English: Staphylococcus aureus* (methicillin-susceptible) Streptococcus agalactiae (Group B)
Danish: Staphylococcus aureus* (methicillin-følsom) Streptococcus agalactiae (Gruppe B)
English: - [Invented name] may cause a rapid and severe inflammation of the liver which could lead to life-threatening liver failure (see section 4.
Danish: - [Lægemidlets navn] kan give hurtig og alvorlig betændelse i leveren, som kan udvikle sig til livstruende leversvigt (se pkt, 4.
English: Before taking [Invented name] 400 mg film-coated tablets - [Invented name] can change your heart's ECG.
Danish: Før De tager [Lægemidlets navn] 400 mg filmovertrukne tabletter - [Lægemidlets navn] kan ændre hjertets EKG.
English: Available data demonstrated no evidence for increased cardiac morbidity related to oral moxifloxacin therapy when compared to comparator antibiotic therapy, especially in a younger female population, although in other trials QT interval prolongation and torsades de pointes were more common in women than in men.
Danish: De tilgængelige data indeholdt ingen dokumentation for øget hjertesygelighed i forbindelse med oral behandling med moxifloxacin i forhold til den antibiotikabehandling, der sammenlignes med, især hos den yngre kvindelige population, selv om QT-intervalforlængelse og torsades de pointes i andre undersøgelser var mere almindelige hos kvinder end hos mænd.
English: - Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Danish: - Patienter med sjælden arvelig galactoseintoleransforstyrrelse, Lapp laktasemangel eller med glucose-galactosemalabsorption bør ikke indtage dette lægemiddel.
English: - Tendon inflammation and rupture may occur with quinolone therapy including moxifloxacin, particularly in elderly patients and in those treated concurrently with corticosteroids.
Danish: - Tendinitis og seneruptur kan forekomme ved behandling med quinoloner, herunder moxifloxacin, specielt hos ældre patienter og patienter i samtidig behandling med kortikosteroider.
English: - Quinolones are known to trigger seizures.
Danish: - Quinoloner er kendt for at kunne udløse krampeanfald.
English: Moxifloxacin undergoes Phase II biotransformation and is excreted via renal and biliary/faecal pathways as unchanged drug as well as in the form of a sulpho-compound (M1) and a glucuronide (M2).
Danish: Moxifloxacin gennemgår fase II-biotransformation og udskilles dels via renale og galde/fækale udskillelsesveje som uforandret lægemiddel, dels i form af en sulfoforbindelse (M1) og et glukuronid (M2).
English: Following a 400 mg oral dose peak concentrations of 3.1 mg/l are reached within 0.5 - 4 h post administration.
Danish: Efter indgift af 400 mg oralt ses en maksimal serumkoncentration på 3,1 mg/l inden for 0,5-4 timer efter administration.
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 moxifloxacin også kontraindiceret til patienter med nedsat leverfunktion (Child-Pugh C) og til patienter med en stigning i transaminasen til mere end 5 gange øvre normalværdi (ULN).
English: - Patients with a history of tendon disease/disorder related to quinolone treatment.
Danish: - Patienter med tidligere tendo-sygdom/-lidelse relateret til quinolonbehandling.
English: Other special populations No adjustment of dosage is required in the elderly and in patients with low bodyweight.
Danish: Specielle patientpopulationer Det er ikke nødvendigt at justere dosis til ældre og patienter med lav kropsvægt.
English: Moxifloxacin has in vitro activity against a wide range of Gram-positive and Gram-negative pathogens.
Danish: Moxifloxacin er in vitro-aktiv mod et bredt spektrum af grampositive og gramnegative patogene organismer.
English: The MRP variation application DE/H/155/01/II/38 concerned an extension of the indication to include the treatment of mild to moderate pelvic inflammatory disease (PID), i.e. infections of upper genital tract, including salpingitis and endometritis.
Danish: Ansøgningen om ændring under proceduren for gensidig anerkendelse DE/H/155/01/II/38 vedrørte en udvidelse af indikationen til at omfatte let til moderat PID (pelvic inflammatory disease), dvs. infektioner i de øvre genitaler, herunder salpingitis og endometritis.
English: EE - Estonia
Danish: EE - Estland
English: - You may develop diarrhoea whilst taking, or after taking, antibiotics including [Invented name].
Danish: - De kan få diaré under behandlingen eller efter behandlingen med antibiotika, herunder [Lægemidlets navn].
English: The presence of the bulky bicycloamine substituent at the C-7 position prevents active efflux, associated with the norA or pmrA genes seen in certain Gram-positive bacteria.
Danish: Tilstedeværelsen af den rumlige bicycloaminsubstituent i position C-7 forhindrer aktiv udstrømning forbundet med nor-A- eller pmr-Agenerne set i visse grampositive bakterier.
English: Moxifloxacin should be used with caution in patients with ongoing proarrhythmic conditions, such as acute myocardial ischaemia or QT prolongation as this may lead to an increased risk for ventricular arrhythmias (incl.
Danish: Moxifloxacin bør anvendes med forsigtighed hos patienter med igangværende proarytmiske tilstande såsom akut myokardieiskæmi eller QT-forlængelse, da dette kan medføre en øget risiko for ventrikulære arytmier (inkl.
English: The MAH committed to monitor this adverse event in the next PSURS and committed to provide an updated Risk Management Plan taking into account the new indication mild to moderate PID.
Danish: Indehaveren af markedsføringstilladelsen har påtaget sig at overvåge denne bivirkning i fremtidige PSUR'er og fremsende en opdateret risikostyringsplan, hvori den nye indikation let til moderat PID indgår.
English: If signs of cardiac arrhythmia occur during treatment with moxifloxacin, treatment should be stopped and an ECG should be performed.
Danish: Hvis der opstår tegn på hjertearytmier under behandlingen med [Lægemidlets navn], skal behandlingen stoppes, og der bør tages et EKG.
English: However, as moxifloxacin inhibits both topoisomerase II and IV with similar activity in some Gram-positive bacteria, such bacteria may be resistant to other quinolones, but susceptible to moxifloxacin.
Danish: Eftersom moxifloxacin hos nogle grampositive bakterier hæmmer både topoisomerase II og IV med ens aktivitet, så kan disse bakterier dog kan være resistente mod andre quinoloner, men følsomme overfor moxifloxacin.
English: Dosage (adults) One 400 mg film-coated tablet once daily.
Danish: Dosering (voksne) En 400 mg filmovertrukken tablet én gang dagligt.
English: concentrations of the M2 metabolite (glucuronide) increase by up to a factor of 2.5 (with a creatinine clearance of < 30 ml/min/1.73 m2).
Danish: I takt med at nyrefunktionens clearance nedsættes, øges koncentrationen af M2-metabolitten (glucuronid) med op til en faktor 2,5 (ved kreatin clearance på < 30 ml/min/1,73 m2).
English: The bactericidal action of moxifloxacin results from the inhibition of both type II topoisomerases (DNA gyrase and topoisomerase IV) required for bacterial DNA replication, transcription and repair.
Danish: Den baktericide effekt af moxifloxacin fremkommer ved hæmning afbegge type II- topoisomeraser (DNA-gyrase og topoisomerase IV), som er nødvendig for bakteriel DNA- replikation, -transskription og -reparation.
English: Swallow the tablet as a whole (to mask the bitter taste) and with plenty of liquid.
Danish: Tabletten synkes hel (for at forhindre en bitter smag) sammen med rigelig væske.
English: To cover all etiologic agents of PID a combination with another antibiotic class such as the cephalosporins (e.g. ceftriaxone 250 mg intramuscular (IM) in a single dose) should be given empirically, which would be similar to other recommended treatment regimens given in combination.
Danish: For at dække alle stoffer med ætiologisk betydning for udvikling af PID skal en kombination med en anden gruppe af antibiotika såsom cephalosporiner (f.eks. ceftriaxon 250 mg intramuskulært (IM) i enkeltdosis) gives empirisk, hvilket svarer til fremgangsmåden ved andre anbefalede kombinationsbehandlinger.
English: - Pelvic inflammatory disease may be caused by fluoroquinolone resistant Neisseria gonorrhoeae.
Danish: - Bækkenbetændelse kan skyldes fluoroquinolon-resistent Neisseria gonorrhoeae.
English: Interference with culture test
Danish: Interferens med dyrkningsdiagnostik
English: The CHMP considered that in general women treated for PID for up to 14 days are not at an increased risk of cardiac adverse events compared to the shorter treatment duration in the other indications.
Danish: CHMP var af den opfattelse, at der generelt ikke er risiko for øget forekomst af uønskede hjertehændelser hos kvinder, der behandles for PID i op til 14 dage, sammenlignet med den kortere behandlingsperiode i forbindelse med de andre indikationer.
English: - Elderly patients with renal disorders should use moxifloxacin with caution if they are unable to maintain adequate fluid intake, because dehydration may increase the risk of renal failure.
Danish: - Ældre patienter med nyresygdomme bør anvende moxifloxacin med forsigtighed, hvis de ikke kan opretholde et tilstrækkeligt væskeindtag, da dehydrering kan øge risikoen for nyresvigt.
English: [Invented name] works by killing bacteria that cause infections, if they are caused by bacteria that are susceptible to the active ingredient moxifloxacin.
Danish: [Lægemidlets navn] virker ved at dræbe bakterier, der forårsager infektioner, hvis de er forårsaget af bakterier, der er følsomme over for det aktive indholdsstof moxifloxacin.
English: If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.
Danish: Hvis Deres symptomer ikke bedres efter tre dages behandling, skal De kontakte Deres læge.
English: - Any medicine containing magnesium or aluminium such as antacids for indigestion, or any medicine containing iron or zinc, medicine containing didanosine or medicine containing sucralfate to treat gastrointestinal disorders can reduce the action of [Invented name] tablets.
Danish: - Andre lægemidler, som indeholder magnesium eller aluminium, som f.eks. syreneutralisrende midler for dårlig mave, eller anden medicin, der indeholder jern eller zink, lægemidler, der indeholder didanosin eller lægemidler, der indeholder sucralfat til behandling af mave-tarmforstyrrelser kan nedsætte virkningen af [Lægemidlets navn]-tabletter.
English: In vitro resistance to moxifloxacin is acquired through a stepwise process by target site mutations in both type II topoisomerases, DNA gyrase and topoisomerase IV. Moxifloxacin is a poor substrate for active efflux mechanisms in Gram-positive organisms.
Danish: In vitro-resistens mod moxifloxacin udvikles langsomt via trinvise processer medieret af target-sitemutationer i begge type II topoisomeraser, DNA gyrase og topoisomerase IV. Moxifloxacin er et dårligt substrat for aktiv effluks-mekanismer i Grampositive organismer.
English: If this becomes severe or persistent or you notice that your stool contains blood or mucus you should stop taking [Invented name] immediately and consult your doctor.
Danish: Hvis det bliver alvorligere eller er vedvarende, eller hvis De opdager blod eller slim i afførringen, skal De straks stoppe med at tage [Lægemidlets navn] og kontakte lægen.
English: “Other” micro-organisms
Danish: “Andre” mikroorganismer
English: Patients should be advised to contact their doctor prior to continuing treatment if signs and symptoms of fulminant hepatic disease develop such as rapidly developing asthenia associated with jaundice, dark urine, bleeding tendency or hepatic encephalopathy.
Danish: Patienten skal rådes til at kontakte sin læge inden behandlingen fortsættes, hvis tegn og symptomer på fulminant hepatitis udvikler sig, som f.eks. hurtigt udviklende asteni forbundet med gulsot, mørk urin, tendens til blødning eller leverencefalopati.
English: [Invented name] contains moxifloxacin as the active ingredient which belongs to a group of antibiotics called fluoroquinolones.
Danish: Det aktive indholdsstof i [Lægemidlets navn] er moxifloxacin, der tilhører en gruppe antibiotika kaldet fluoroquinoloner.
English: Female genital tract*
Danish: Kvindelige genitialier*
English: Tissue
Danish: Væv
English: Inherently resistant organisms
Danish: Organismer med nedarvet resistens
English: - Taking oral medicinal charcoal at the same time as [Invented name] tablets reduces the action of [Invented name].
Danish: - Samtidig indtagelse af oralt medicinsk kul (indtaget via munden) og [Lægemidlets navn]tabletter nedsætter virkningen af [Lægemidlets navn].
English: - Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with quinolones.
Danish: - Patienter med kendt familiær disposition for eller erkendt glucose-6-fosfat dehydrogenasemangel, har tendens til hæmolytiske reaktioner, når de behandles med quinoloner.
English: Before you take [Invented name] …, Take special care …, Before taking [Invented name] 400 mg film-coated tablets).
Danish: 2: Det skal De vide, før De begynder at tage [Lægemidlets navn]….Vær ekstra forsigtig….Før De tager [Lægemidlets navn] 400 mg filmovertrukne tabletter).
English: - Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients.
Danish: - Overfølsomhed over for moxifloxacin, andre quinoloner eller over for et eller flere af hjælpestofferne.
English: [Invented name] tablets are for oral use.
Danish: [Lægemidlets navn]-tabletter er til anvendelse gennem munden.
English: Taking [Invented name] 400 mg film-coated tablets with food and drink The effect of [Invented name] is not influenced by food including dairy products.
Danish: Brug af [Lægemidlets navn] sammen med mad og drikke Virkningen af [Lægemidlets navn] påvirkes ikke af mad, herunder mejeriprodukter.
English: Both in preclinical investigations and in humans, changes in cardiac electrophysiology have been observed following exposure to moxifloxacin, in the form of QT prolongation.
Danish: Både i prækliniske undersøgelser og i humane undersøgelser med moxifloxacin, er der observeret ændringer i hjertets elektrofysiologi i form af QT-forlængelse.
English: Bayer HealthCare AG 51368 Leverkusen Germany
Danish: Bayer HealthCare AG 51368 Leverkusen Tyskland