FrancophonIA/ELRC3.0 huggingface dataset:
English: Uncommon: Low red blood cell count, low white blood cells count, low numbers of special white blood cells (neutrophils), decrease or increase of special blood cells necessary for blood clotting, increased specialised white blood cells (eosinophils), decreased blood clotting
Danish: nedsat antal røde og hvide blodlegemer, nedsat antal af specielle hvide blodlegemer (neutrofiler), nedsat eller øget antal af specielle blodlegemer, der er nødvendige for blodets størksningsevne (blodplader), øget antal af specielle hvide blodlegemer (eosinofiler), nedsat størkningsevne
English: Quinolones, including moxifloxacin, are known to cause lesions in the cartilage of the major diarthrodial joints in immature animals.
Danish: Quinoloner, herunder moxifloxacin, er kendt for at forårsage bruskskader i de store frit bevægelige led hos ikke fuldt udviklede dyr.
English: - If you or any member of your family have glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), inform your doctor, who will advise whether Octegra is suitable for you.
Danish: Kontakt straks Deres læge, hvis De tror, at dette gælder for Dem. - Hvis De eller nogen i Deres familie har glucose-6-phosphat dehydrogenase mangel (en sjælden arvelig sygdom), skal De informere lægen, der vil fortælle Dem, om Octegra er velegnet til Dem.
English: Moxifloxacinwas genotoxic in in vitro tests using bacteria or mammalian cells.
Danish: Moxifloxacin var genotoksisk i in vitro-tests med bakterier eller pattedyrceller.
English: While the efficacy data are sufficient to support an indication for use in CAP they suggest that moxifloxacin may not be as good as some alternative regimens.
Danish: Selv om virkningsdataene er tilstrækkelige til at støtte en indikation for brugen ved samfundserhvervet pneumoni, tyder de på, at moxifloxacin måske ikke er lige så godt som alternative regimener.
English: Species for which acquired resistance may be a problem Aerobic Gram-positive micro-organisms
Danish: Arter, hvor erhvervet resistens kan være et problem Aerobe grampositive mikroorganismer Enterococcus faecalis*
English: In conventional repeated dose studies moxifloxacin revealed haematological and hepatic toxicity in rodents and non-rodents.
Danish: Konventionelle studier med gentagne doser viste at moxifloxacin er hæmatologisk og hepatisk toksisk hos gnavere og ikke-gnavere.
English: Excipient: 250 ml of solution for infusion contains 34 mmol sodium.
Danish: Hjælpestoffer: 250 ml opløsningen infusionsvæske indeholder 34 mmol natrium.
English: [Moxifloxacin] 400 mg solution for infusion is indicated for the treatment of: - Community acquired pneumonia - Complicated skin and structure infections
Danish: [Moxifloxacin] 400 mg infusionsvæske, opløsning, er indiceret til behandling af: - Samfundserhvervet pneumoni - Komplicerede infektioner i hud og blødt væv
English: The CHMP acknowledges that a drug prolonging the QTc does not necessarily translate into a higher risk of cardiac ADRs, including arrhythmias.
Danish: CHMP erkender, at et lægemiddel, der forlænger QTc, ikke nødvendigvis medfører en højere risiko for hjertebivirkninger, herunder arytmi.
English: Anorexia Constipation Dyspepsia Flatulence Gastritis
Danish: Anoreksi Forstoppelse Dyspepsi Flatulens Gastritis Øget amylase
English: There was an increase in the incidence of abortions in monkeys and rabbits at human therapeutic plasma concentrations.
Danish: En øget abortincidens sås hos aber og kaniner ved en plasmakoncentration modsvarende terapeutisk niveau hos mennesker.
English: Do not use Octegra - If you are allergic (hypersensitive) to the active ingredient moxifloxacin, any other quinolone antibiotics or any of the other ingredients (see section 6.
Danish: Tag ikke Octegra hvis De er overfølsom (allergisk) over for moxifloxacin, andre quinolonantibiotika eller et af de øvrige indholdsstoffer.
English: - Moxifloxacin should be used with caution in patients with myasthenia gravis because the symptoms can be exacerbated.
Danish: - Moxifloxacin skal anvendes med forsigtighed hos patienter med myasthenia gravis, da symtomerne kan forværres.
English: Moxifloxacin is distributed to extravascular spaces rapidly.
Danish: Moxifloxacin distribueres hurtigt til det ekstravaskulære rum.
English: Muscle rigidity Exacerbation of symptoms of myasthenia gravis (see section 4.4)
Danish: Muskelstivhed Forværring af symptomer på myasthenia gravis (se pkt.
English: Pruritus Rash Urticaria Dry skin
Danish: Pruritus Udslæt Urticaria Tør hud
English: - Clinical efficacy of moxifloxacin in the treatment of severe burn infections, fasciitis, major abscesses and diabetic foot infections with osteomyelitis has not been established.
Danish: - Klinisk effekt af moxifloxacin ved behandling af alvorlige brandsårsinfektioner, fasciitis, større abscesser samt infektioner i fødder hos diabetikere med osteomyelitis er ikke fastslået.
English: Active ingredient: Moxifloxacin
Danish: Moxifloxacin
English: In conclusion, the CHMP considered that the use of IV moxifloxacin for treatment of community-acquired pneumonia (CAP) or complicated skin and soft tissue infections (cSSTI) should be qualified as follows:
Danish: CHMP var således af den opfattelse, at der for brugen af intravenøs moxifloxacin til behandling af samfundserhvervet pneumoni (CAP) eller komplicerede infektioner i hud og blødt væv (cSSSI) burde gælde følgende ordlyd:
English: The 250 ml bottle is available in packs of 1 and 5 bottles.
Danish: 250 ml flasken fås i pakker med 1 og 5 flasker.
English: - The active substance is moxifloxacin.
Danish: - Aktivt stof: moxifloxacin.
English: A feeling of self-detachment (not being yourself), insanity (potentially leading to self-harm) Nervous System
Danish: forandret personlighed (ikke være sig selv), sindssyge (kan måske føre til, at man gør skade på sig selv).
English: Octegra contains moxifloxacin as the active ingredient which belongs to a group of antibiotics called fluoroquinolones.
Danish: Det aktive indholdsstof i Octegra er moxifloxacin, der tilhører en gruppe antibiotika kaldet fluoroquinoloner.
English: Finally, the Applicant claimed that the superior potency and pharmacokinetics of moxifloxacin avoids the selection of quinolone resistant isolates of
Danish: Endelig hævdede ansøgeren, at moxifloxacins bedre styrke og farmakokinetiske egenskaber hindrer selektionen af quinolon-resistente isolater af S. pneumoniae.
English: Moxifloxacin hydrochloride is a synthetic antibacterial agent of the fluoroquinolone class.
Danish: Moxifloxacinhydrochlorid er et syntetisk antibakterielt middel i fluoroquinolongruppen.
English: An early evaluation of the effects of moxifloxacin on QTc showed a correlation between plasma concentration and QTc in healthy subjects and increases in QTc were significantly higher in healthy elderly subjects post-moxifloxacin versus placebo.
Danish: En tidlig vurdering af moxifloxacins virkning på QTc viste en sammenhæng mellem plasmakoncentration og QTc hos raske forsøgspersoner, og stigningerne i QTc var betydeligt højere hos raske ældre forsøgspersoner efter indgivelse af moxifloxacin i forhold til placebo.
English: There have been very rare cases of the following side effects reported following treatment with other fluoroquinolones, which might possibly also occur during treatment with moxifloxacin: transient loss of vision, hypernatraemia, hypercalcaemia, haemolysis, rhabdomyolysis, photosensitivity reactions (see section
Danish: Der har været meget sjældne tilfælde af følgende bivirkninger efter behandling med andre fluorquinoloner, som måske også vil kunne forekomme under behandling med moxifloxacin: Forbigående synstab, hypernatriæmi, hypercalcæmi, hæmolyse, rabdomyolyse, fotosensitivitetsreaktioner (se pkt.
English: As renal function decreases, 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 nyrefunktionen nyrefunktion (indbefatter creatininclearance > 20 ml/min/1,73 m forringes, øges koncentrationen af M2 metabolitten (glukuronid) med op til en faktor 2,5 (ved creatininclearance < 30 ml/min/1,73 m2).
English: Leucopenia(s) Neutropenia Thrombocytopenia Thrombocythemia Blood eosinophilia Prothrombin time prolonged / INR increased
Danish: Leukopeni Neutropeni Trombocytopeni Trombocytæmi Eosinofili Forlænget protrombintid/øget INR
English: Consult your doctor if you wish to stop the treatment with Octegra solution for infusion or Octegra tablets before the end of the course of treatment.
Danish: Kontakt lægen, hvis De ønsker at stoppe behandlingen med Octegra-infusionsvæske eller Octegra-tabletter før tid.
English: Depersonalization Psychotic reactions (potentially culminating in selfendangering behaviour)
Danish: Personlighedsforandringer Psykotiske reaktioner (potentielt kulminerende i selvdestruktiv adfærd)
English: The Applicant discussed the efficacy and safety of sequential IV/oral moxifloxacin in the treatment of cSSSI and concluded that non-inferiority was demonstrated, and that the clinical studies and post-marketing safety data show no evidence that moxifloxacin-treated patients are at greater risk for morbidity, including cardiac and hepatic morbidity, than patients receiving comparator antibiotics.
Danish: Ansøgeren gjorde rede for virkning og sikkerhed af sekventiel intravenøs/oral moxifloxacin til behandling af cSSSI og konkluderede, at der blev påvist non-inferioritet, og at de kliniske undersøgelser og sikkerhedsdata efter markedsføringen ikke viser nogen evidens for, at moxifloxacinbehandlede patienter har større risiko for morbiditet, herunder kardial og hepatisk morbiditet, end patienter, som får sammenligningsantibiotika.
English: - If you suffer from epilepsy or a condition which makes you likely to have convulsions, tell your doctor before taking Octegra.
Danish: - Hvis De lider af epilepsi eller en sygdom, hvor De ofte får kramper, skal De fortælle det til lægen, inden De begynder at tage Octegra.
English: Jaundice (yellowing of the whites of the eyes or skin), inflammation of the liver
Danish: gulsot (gulfarvning af det hvide i øjnene eller af huden), leverbetændelse.
English: Emotional lability Depression (in very rare cases potentially culminating in self-endangering behaviour) Hallucination
Danish: Emotionel labilitet Depression (i meget sjældne tilfælde potentielt kulminerende i selvdestruktiv Hallucinationer
English: Visual disturbances incl.
Danish: synsforstyrrelser inkl.
English: - Quinolones are known to trigger seizures.
Danish: - Quinoloner vides at kunne udløse krampeanfald.
English: A large number of cases showing an increase in oral anticoagulant activity have been reported in patients receiving antibacterial agents, especially fluoroquinolones, macrolides, tetracyclines, cotrimoxazole and some cephalosporins.
Danish: Der er blevet indberettet mange tilfælde af øget virkning af orale antikoagulantia hos patienter i behandling med antibiotika, især fluorquinoloner, makrolider, tetracycliner, sulfamethoxazol/trimethoprim og visse cefalosporiner.
English: - Antibiotic associated diarrhoea (AAD) and antibiotic-associated colitis (AAC), including pseudomembranous colitis and Clostridium difficile-associated diarrhoea, has been reported in association with the use of broad spectrum antibiotics including moxifloxacin and may range in severity from mild diarrhoea to fatal colitis.
Danish: - Antibiotikarelateret diaré (AAD) og antibiotikarelateret colitis (AAC), herunder pseudomembranøs colitis og Clostridium difficile-relateret diaré, er set i forbindelse med brugen af bredspektrede antibiotika, herunder moxifloxacin.
English: In conclusion, the efficacy data for IV/PO moxifloxacin in treatment of CAP and cSSSI are considered to be sufficient but not overwhelmingly convincing and suggest that IV/PO moxifloxacin is not among the optimal treatments for either of these indications.
Danish: Virkningsdataene for intravenøs/oral moxifloxacin til behandling af samfundserhvervet pneumoni og cSSSI anses således for at være tilstrækkelige, men ikke alt for overbevisende, og de tyder på, at intravenøs/oral moxifloxacin ikke er en af de optimale behandlinger til nogen af disse indikationer.
English: Potential co-morbidities do not change the fact that IV administration carried an excess risk over comparators, including in the study in elderly.
Danish: Potientelle komorbiditeter ændrer ikke den kendsgerning, at intravenøs indgivelse gav en øget risiko i forhold til sammenligningslægemidler, herunder i undersøgelsen hos ældre.
English: Due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of immature animals and reversible joint injuries described in children receiving some fluoroquinolones, moxifloxacin must not be used in pregnant women (see section 4.3).
Danish: På grund af den empiriske risko for skader fra fluorquinoloner på den vægtbærende brusk hos ikke fuldt udviklede dyr og reversible ledskader, der er beskrevet hos børn behandlet med visse fluorquinoloner, må moxifloxacin ikke anvendes til gravide kvinder (se pkt.
English: The Applicant concluded that the QTc prolongation seen for moxifloxacin has not translated into a higher risk of developing clinical cardiac events, including arrhythmias, compared to other agents.
Danish: Ansøgeren konkluderede, at den observerede QTc-forlængelse for moxifloxacin ikke medførte en højere risiko for udvikling af kliniske kardiale hændelser, herunder arytmi, sammenlignet med andre midler.
English: Water for injections, sodium chloride 0.9%, sodium chloride 1 molar, glucose 5%/10%/40%, Xylitol 20%, Ringer's solution, compound sodium lactate solution (Hartmann's solution, Ringer-lactate solution).
Danish: Vand til injektionsvæsker, natriumchlorid 0,9 %, natriumchlorid 1 molær, glucose 5 %/10 %/40 %, xylitol 20 %, Ringers opløsning, kombinerede natrium-lactat opløsninger (Hartmanns opløsning, Ringer-lactatopløsning).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER PACKAGING FOR MULTIPACK - GLASS BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE TIL FLERSTYKSPAKNING - GLASFLASKE
English: A total of 6 IV/PO studies in CAP were presented, however, the pooling of data across studies was considered inappropriate and overall, the data suggested that moxifloxacin may not be quite as good as a very good comparative regimen.
Danish: Der blev fremlagt i alt 6 undersøgelser af intravenøs/oral anvendelse ved samfundserhvervet pneumoni, men samlingen af data på tværs af undersøgelserne blev betragtet som uhensigtsmæssig, og overordnet set tydede dataene på, at moxifloxacin måske ikke er helt lige så godt som et udmærket sammenligningsregime.
English: In patients, there is no need for age or gender related dose adjustment on intravenous moxifloxacin.
Danish: Dosisjustering i henhold til patienters alder eller køn er ikke nødvendig ved intravenøs behandling med moxifloxacin.
English: If the blood supply to your heart muscle is impaired, consult your doctor before you are given Octegra because this can increase the risk of heart rhythm disturbances.
Danish: Hvis blodtilførslen til Deres hjertemuskel er nedsat, skal De kontakte Deres læge, før De får Avelox, da dette kan øge risikoen for forstyrrelser i hjerterytmen.
English: Octegra is packaged in cartons containing 250ml polyolefine bags with polypropylene port sealed in aluminium foil overwrap.
Danish: Octegra er pakket i æsker indeholdende 250 ml polyolefiner poser med polypropylenåbning forseglet med aluminiumsfoliedække.
English: 250 ml pack available in cartons of 5 and 12 bags.
Danish: 250 ml posen fås i pakker med 5 og 12 poser.
English: Adverse reactions observed in clinical trials with moxifloxacin 400 mg daily administered by the intravenous or oral route sorted by frequencies are listed below:
Danish: Nedenfor er en oversigt over bivirkninger set i kliniske studier med moxifloxacin 400 mg givet dagligt intravenøst eller oralt, og ordnet efter hyppighed:
English: - Octegra may cause a rapid and severe inflammation of the liver which could lead to life-threatening liver failure (including fatal cases, see section 4.
Danish: - Octegra kan give en hurtigt udviklet og alvorlig betændelse i leveren, som kan medføre livstruende leversvigt (herunder tilfælde af dødsfald, se pkt.
English: Moxifloxacin solution for infusion should not be co-infused with other drugs.
Danish: Moxifloxacin-infusionsvæske, opløsning bør ikke infunderes sammen med andre lægemidler.
English: At the first sign of any pain or inflammation you should stop taking Octegra, rest the affected limb and consult your doctor immediately.
Danish: Ved det første tegn på smerte eller betændelse, skal De stoppe med at tage Octegra, hvile det angrebne ben og straks kontakte lægen.
English: The relationship between moxifloxacin concentrations and change in QTc interval was investigated in CAP and cSSSI studies and the Phase III trials suggested similar results for moxifloxacin and the comparators.
Danish: Forholdet mellem moxifloxacinkoncentrationer og ændringer i QTc-intervallet blev undersøgt i CAP- og cSSSI-undersøgelser, og fase IIIundersøgelserne tydede på, at resultaterne for moxifloxacin og sammenligningslægemidlerne lignede hinanden.
English: - If you were born with or have had any condition with certain abnormal electrocardiogram (ECG,
Danish: hvis De er født med eller har haft sygdomme med unormalt hjertediagram (EKG, elektrisk måling af hjertet).
English: Octegra is indicated for the treatment of: - Community acquired pneumonia (CAP) - Complicated skin and skin structure infections (cSSSI) Moxifloxacin should be used only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of these infections.
Danish: Octegra 400 mg anvendes til behandling af: - Pneumoni erhvervet uden for hospital (CAP) - Komplicerede infektioner i huden og hudens struktur (cSSSI) Moxifloxacin må kun anvendes, hvis det ikke anses for hensigtsmæssigt at anvende det antibiotikum, der sædvanligvis anbefales som førstevalg til behandling af disse infektioner.
English: - If you have a history of tendon disease or disorder which was related to treatment with quinolone antibiotics (see sections Take special care ... and 4.
Danish: hvis De tidligere har haft senesygdomme eller forstyrrelser, der var relateret til behandling med quinolonantibiotika (se afsnittet 2.
English: - If you have a history of abnormal heart rhythms (arrhythmias).
Danish: hvis De tidligere har haft uregelmæssig hjerterytme (arytmi).
English: In the interstitial fluid unbound concentration time profiles similar to those in plasma were found with unbound peak concentrations of 1.0 mg/l (geometric mean) reached approximately 1.8 h after an intravenous dose.
Danish: I interstitielvæsken svarede koncentrationsprofilen for frit lægemiddel til profilen i plasma med maksimal koncentration af frit lægemiddel på 1,0 mg/l (geometrisk middelværdi) ca. 1,8 timer efter en intravenøs dosis.
English: Octegra is packaged in cartons containing a 250ml glass bottle with a chlorobutyl rubber stopper.
Danish: Octegra er pakket i æsker indeholdende 250 ml flasker med en gummiprop.
English: Moxifloxacin has been shown to prolong the QTc interval on the electrocardiogram in some patients.
Danish: Det har vist sig, at moxifloxacin forlænger QTc-intervallet i elektrokardiogrammet hos nogle patienter.
English: The cumulative review of spontaneous ADR reports of serious “possible drug related hepatic disorders” on IV only or IV/oral sequential treatment, suggested that serious moxifloxacin-induced hepatic events were very rare, unpredictable and idiosyncratic and that the benefit-risk has not changed for IV moxifloxacin.
Danish: Den samlede gennemgang af spontane bivirkningsindberetninger af alvorlige "mulige lægemiddelrelaterede leversygdomme" ved intravenøs anvendelse alene og ved sekventiel intravenøs/oral anvendelse tydede på, at alvorlige moxifloxacinrelaterede leverbivirkninger var meget sjældne, uforudsigelige og idiosynkratiske, og at risk/benefit-forholdet for intravenøs moxifloxacin er uændret.
English: Chlamydophila (Chlamydia) pneumoniae*
Danish: Chlamydophila (Chlamydia) pneumoniae* Coxiella burnetii
English: double and blurred vision
Danish: dobbelsyn og sløret syn.
English: Hydrochloric acid (for pH-adjustment) Sodium hydroxide (for pH-adjustment) Water for injections
Danish: Saltsyre (til justering af pH) Natriumhydroxid (til justering af pH) Vand til injektionsvæsker
English: Increased blood clotting Allergic Reactions Uncommon: Allergic reaction Rare:
Danish: Allergiske reaktioner Ikke almindelige:
English: LDH increase) Increased bilirubin Increased gammaglutamyltransferase Increase in blood alkaline phosphatase
Danish: øgning af LDH) Øget bilirubin Øget gammaglutamylØgning af alkaliske fosfataser i blodet
English: Moraxella (Branhamella) catarrhalis
Danish: Moraxella (Branhamella) catarrhalis Anaerobe mikroorganismer
English: Impairment of skin sensation, changes in smell (incl.
Danish: nedsat hudfølsomheden, lugtforstyrrelser (inkl.
English: Use immediately after first opening and/or dilution.
Danish: Anvendes straks efter åbning og/eller fortynding
English: An analysis of cardiac safety in sequential IV/oral clinical studies (overall and cSSSIs) was presented, along with an overview of the incidence of treatmentemergent adverse events relevant as surrogates for arrhythmia.
Danish: Der blev fremlagt en analyse af hjertesikkerheden i kliniske undersøgelser af sekventiel intravenøs/oral moxifloxacin (samlet set og for cSSSI'er) samt en oversigt over incidensen af behandlingsrelaterede utilsigtede hændelser, der er relevante som surrogat for arytmi.
English: If this happens treatment with Octegra solution for infusion has to be discontinued immediately.
Danish: Hvis De oplever ovenstående, skal infusionen med Octegra stoppes øjeblikkeligt.
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: Patienter skal rådes til at kontakte deres læge, inden behandlingen fortsættes, hvis tegn og symptomer af fulminant hepatitis udvikler sig såsom hurtigt udviklende asteni forbundet med gulsot, mørk urin, blødningstendens eller hepatisk encefalopati.. Test/undersøgelse af leverfunktionen bør udføres ved tegn på nedsat leverfunktion.
English: increase in special kidney laboratory test results like urea and creatinine), kidney failure
Danish: forøgelse i specielle laboratorieprøver for nyrefunktion såsom urinstof og creatinin), nyresvigt.
English: If this becomes severe or persistent or you notice that your stool contains blood or mucus you should stop taking Octegra immediately and consult your doctor.
Danish: Hvis det bliver alvorligere eller er vedvarende, eller hvis De opdager blod eller slim i afførringen, skal De strak stoppe med at tage Octegra og kontakte lægen.
English: The following solutions were incompatible with Octegra: Sodium chloride 10% and 20% solutions, Sodium bicarbonate 4.2% and 8.4% solutions
Danish: Følgende opløsninger er inkompatible med Octegra-infusionsvæske: natriumchloridopløsninger 10 % og 20 %, natriumhydrogencarbonatopløsninger 4,2 % og 8,4 %.
English: No adjustment of dosage is required in patients with mild to severely impaired renal function or in patients on chronic dialysis i.e. haemodialysis and continuous ambulatory peritoneal dialysis (see section 5.2 for more details).
Danish: Det er ikke nødvendigt at justere dosis til patienter med let til svært nedsat nyrefunktion eller til patienter i kronisk dialyse, dvs. hæmodialyse og kontinuerlig ambulant peritonealdialyse (se pkt.