FrancophonIA/ELRC3.0 huggingface dataset:
English: Important information about some of the ingredients of Octegra This medicinal product contains 787mg (approximately 34mmol) sodium per dose.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Octegra Dette lægemiddel indeholder 787 mg (ca. 34 mmol) natrium pr. dosis.
English: Fluoroquinolones exhibit a concentration dependent killing of bacteria.
Danish: Fluorquinoloner udviser en koncentrationsafhængig ødelæggelse af bakterier.
English: - If you are taking other medicines that result in certain abnormal ECG changes (see section Taking other medicines).
Danish: hvis De tager andre lægemidler, der resulterer i unormale EKG-ændringer (se afsnittet 2.
English: In particular there is no clinical evidence to support an assertion that moxifloxacin might remain clinically active against organisms that have acquired reduced susceptibility to other fluoroquinolones.
Danish: Navnlig er der ingen klinisk evidens til støtte for påstanden om, at moxifloxacin kan forblive klinisk virksomt mod organismer, der har erhvervet nedsat følsomhed mod andre fluoroquinoloner.
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 familiær disposition eller erkendt glucose-6-fosfatdehydrogenasemangel har tendens til hæmolytiske reaktioner, når de behandles med quinoloner.
English: Octegra is used in adults for treating the following bacterial infections: - Infection of the lungs (pneumonia) acquired outside the hospital - Infections of the skin and soft tissue
Danish: Octegra anvendes til behandling af voksne med følgende bakterielle infektioner: - lungeinfektion (lungebetændelse) erhvervet uden for hospitalet - infektioner i hud og bløddele
English: Before using Octegra for the first time - Octegra can temporarily change your heart's ECG, which can very rarely lead to life-threatening disturbances of the heart rhythm.
Danish: Før de tager Octegra-infusionsvæske - Octegra kan midlertidigt ændre hjertediagrammet, hvilket meget sjældent kan medføre livstruende forstyrrelser i hjerterytmen.
English: Polyolefine bags with polypropylene port sealed in aluminium foil overwrap.
Danish: Polyolefinposer med polypropylenport forseglet med aluminiumfolie.
English: Clinical studies have shown no interactions following concomitant administration of moxifloxacin with: ranitidine, probenecid, oral contraceptives, calcium supplements, morphine administered parenterally, theophylline or itraconazole.
Danish: Kliniske studier har ikke vist nogen interaktioner efter samtidig administration af moxifloxacin med: Ranitidin, probenecid, orale kontraceptiva, calciumtilskud, parenteralt administreret morphin, theophyllin eller itraconazol.
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 inklusive moxifloxacin, specielt hos ældre patienter og patienter i samtidig behandling med kortikosteroider.
English: Abnormal fast heart rate, fainting, high blood pressure, low blood pressure
Danish: unormal, hurtig hjerteslag, besvimmelse, forhøjet blodtryk, for lavt blodtryk.
English: In some cases your doctor may start your treatment with Octegra solution for infusion and then continue your treatment with Octegra tablets.
Danish: I nogle tilfælde vil lægen starte behandlingen med Octegra-infusionsvæske og derpå fortsætte behandlingen med Octegratabletter.
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 den renale clearance af modersubstancen.
English: The data collected during the first two CAP studies shows that patients were more likely to have a notable increase in QTc on intravenous moxifloxacin.
Danish: De data, der blev indsamlet under de to første CAP-undersøgelser, viser, at der var større sandsynlighed for, at patienterne fik en betydelig stigning i QTc med intravenøs moxifloxacin.
English: - Treatment with moxifloxacin should be stopped if signs or symptoms that may be associated with cardiac arrhythmia occur during treatment, with or without ECG findings.
Danish: Behandling med moxifloxacin skal stoppes, hvis der under behandlingen opstår tegn eller symptomer, som kan være relateret til hjertearytmi med eller uden påvisning i EKG.
English: Following a 400 mg intravenous infusion recovery of unchanged drug from urine was approximately 22% and from faeces approximately 26%.
Danish: Efter intravenøs infusion af 400 mg genfandtes cirka 22 % af det uomdannede lægemiddel i urinen og cirka 26 % i fæces.
English: The Applicant concluded that moxifloxacin has enhanced activity against penicillin/macrolide-susceptible and -resistant strains of S. pneumoniae, is active against pathogens associated with atypical pneumonia and is consistently effective in hospitalised patients requiring initial IV therapy.
Danish: Ansøgeren konkluderede, at moxifloxacin har forbedret virkning mod penicillin-/makrolidfølsomme og -resistente stammer af S. pneumoniae, er virksom mod patogener i forbindelse med atypisk pneumoni og konsekvent er virksom hos hospitalsindlagte patienter, der kræver indledende intravenøs behandling.
English: The Applicant again presented data for the pooled CAP studies, stating that adverse events and drug reactions were slightly less common in patients treated with moxifloxacin.
Danish: Ansøgeren fremlagde igen data for de samlede CAP-undersøgelser og anførte, at utilsigtede hændelser og bivirkninger var lidt mindre almindelige hos patienter, der blev behandlet med moxifloxacin.
English: Unspecific abnormal heart rhythms, irregular heart beat (Torsade de Pointes), stopping of heart beat (see section 2.
Danish: uspecifik unormal hjerterytme, uregelmæssig hjerteslag (torsades de pointes), hjertestop (se afsnittet 2.
English: Allergic reaction (see section 4.4)
Danish: Allergisk reaktion (se pkt.
English: On the grounds of safety and benefit-risk, the CHMP maintains its position that both indications for use of IV moxifloxacin should be qualified with the same wording as for the cSSSI indication.
Danish: På baggrund af sikkerheden og risk/benefit-forholdet fastholder CHMP det synspunkt, at begge indikationer for brugen af intravenøs moxifloxacin bør have samme ordlyd som for cSSSI-indikationen.
English: In vitro, moxifloxacin revealed cardiac electrophysiological properties that can cause prolongation of the QT interval, even though at high concentrations.
Danish: In vitro udviste moxifloxacin kardielle elektrofysiologiske egenskaber, der kan medføre en forlængelse af QT-intervallet, selv om det er ved høje koncentrationer.
English: There is no data available in lactating or nursing women.
Danish: Der er ingen tilgængelige data om ammende kvinder.
English: No studies on the effects of moxifloxacin on the ability to drive and use machines have been performed.
Danish: Der er ikke foretaget undersøgelser af virkningen på evnen til at føre motorkøretøj eller betjene maskiner.
English: Do not use if there are any visible particulate matter or if the solution is cloudy.
Danish: Brug ikke opløsningen, hvis der er synlige partikler i opløsningen, eller hvis opløsningen er grumset.
English: very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse), swelling (incl.
Danish: meget sjælden livstruende shock (f.eks. åndedrætsbesvær, blodtryks sfald, , hurtig puls), hævelser (inkl.
English: - If vision becomes impaired or any effects on the eyes are experienced, an eye specialist should be consulted immediately.
Danish: - Ved synsnedsættelse eller anden påvirkning af øjet, skal en øjenlæge konsulteres omgående.
English: The Applicant considered that moxifloxacin IV had demonstrated non-inferiority or superiority in six controlled studies involving over 1,100 moxifloxacin-treated patients.
Danish: Virkning ved behandling af samfundserhvervet pneumoni Ansøgeren mente, at intravenøs moxifloxacin havde vist non-inferioritet eller superioritet i seks kontrollerede undersøgelser, der omfattede over 1.100 moxifloxacinbehandlede patienter.
English: Taking into account these considerations, the CHMP did not support the Applicant's assertion that the difference in benefit-risk relationship between oral and intravenous uses justifies an unqualified indication for the use of IV moxifloxacin to treat CAP.
Danish: Ud fra disse betragtninger støttede CHMP ikke ansøgerens påstand om, at forskellen i risk/benefitforholdet for oral og intravenøs brug berettiger en uændret indikation for brugen af intravenøs moxifloxacin til behandling af samfundserhvervet pneumoni.
English: In addition, the Applicant was requested to commit to amend the SPC for the moxifloxacin tablets, in order to bring it in line with the IV formulation, and make it clear that the tablets may be used for cSSSI and CAP of any severity only when IV therapy has already resulted in substantial improvement in the patient's condition, such that a switch to oral treatment is considered appropriate.
Danish: Desuden blev ansøgeren bedt om at ændre produktresuméet for moxifloxacin tabletter, så det bringes i overensstemmelse med den intravenøse formulering, og om at gøre det klart, at tabletterne udelukkende må anvendes til cSSSI og samfundserhvervet pneumoni af enhver sværhedsgrad, når intravenøs behandling allerede har resulteret i en væsentlig forbedring af patientens tilstand, således at en overgang til oral behandling anses for hensigtsmæssig.
English: Emotional instability, depression (in very rare cases leading to self-harm), hallucination
Danish: følelsesmæssig ustabilitet, depression (kan i meget sjældne tilfælde føre til, at man gør skade på sig selv), hallucinationer.
English: There is no advantage to be expected from moxifloxacin over approved fluoroquinolones in the indications claimed except over ciprofloxacin in CAP (due to the inherently low activity of ciprofloxacin against S. pneumoniae).
Danish: Der kan ikke forventes nogen fordele ved moxifloxacin i forhold til godkendte fluoroquinoloner i de indikationer, der ansøges om, undtagen i forhold til ciprofloxacin ved samfundserhvervet pneumoni (som følge af ciprofloxacins naturlige ringe virkning mod S. pneumoniae).
English: For reasons of drug safety, moxifloxacin is therefore contraindicated in patients with: - Congenital or documented acquired QT prolongation - Electrolyte disturbances, particularly in uncorrected hypokalaemia - Clinically relevant bradycardia - Clinically relevant heart failure with reduced left-ventricular ejection fraction - Previous history of symptomatic arrhythmias
Danish: Af hensyn til sikkerheden ved anvendelsen af lægemidlet er moxifloxacin derfor kontraindiceret ved: - medfødt eller dokumenteret erhvervet forlænget QT-interval - elektrolytforstyrrelser, specielt ukorrigeret hypokaliæmi - klinisk relevant bradykardi - klinisk relevant hjertesvigt med nedsat venstre ventrikel uddrivningsfraktion - anamnese med symptomatiske arytmier
English: 7 - 14 days Most patients with pneumonia were switched to oral treatment with Octegra tablets within 4 days.
Danish: De fleste patienter med lungebetændelse bliver skiftet over til Octegra-tabletter inden for 4 dage.
English: 6.4 Special precautions for storage Do not refrigerate or freeze.
Danish: 6.4 Særlige opbevaringsforhold Må ikke opbevares i køleskab eller nedfryses.
English: However, in light of the ADR and cardiac safety data submitted by the Applicant, there were differences between the two treatment groups with respect to the incidence of clinical AEs that could be considered surrogates for QTc prolongation, as higher incidences of ventricular tachycardia and cardiac arrest were seen in the moxifloxacin group.
Danish: I lyset af de bivirknings- og hjertesikkerhedsdata, som ansøgeren har indsendt, var der dog forskelle på de to behandlingsgrupper, hvad angår incidensen af kliniske utilsigtede hændelser, der kunne betragtes som surrogater for QTcforlængelse, eftersom der blev observeret en højere incidens af ventrikulær takykardi og hjertestop hos moxifloxacin-gruppen.
English: The Applicant provided further justifications supporting the indication in CAP.
Danish: Ansøgeren fremlagde yderligere begrundelser til støtte for indikationen ved samfundserhvervet pneumoni.
English: It was considered that the efficacy of moxifloxacin in the two indications claimed is adequate.
Danish: Moxifloxacins virkning i de to indikationer, der ansøges om, blev betragtet som tilstrækkelig.
English: Ear Rare:
Danish: Øre Sjældne:
English: Spontaneous reporting rates are higher for IV/sequential treatment than for oral treatment and the Applicant's argument that this is accounted for by the greater background morbidity in the population treated with IV/PO compared to those treated only with PO moxifloxacin can be partly accepted.
Danish: De spontane indberetningstal er højere for intravenøs/sekventiel behandling end for oral behandling, og ansøgerens argument om, at dette kan forklares med den større underliggende morbiditet hos den population, der behandles med intravenøs/oral moxifloxacin, sammenlignet med den population, der udelukkende behandles med oral moxifloxacin, kan delvist accepteres.
English: The safety profile of oral moxifloxacin also applies to intravenous moxifloxacin and there are particular concerns regarding hepatotoxicity and adverse reactions resulting from the effects of moxifloxacin on cardiac conduction.
Danish: Sikkerhedsprofilen for oral moxifloxacin gælder også for intravenøs moxifloxacin, og der er særlige betænkeligheder med hensyn til hepatotoksicitet og utilsigtede hændelser som følge af moxifloxacins virkninger på hjertets ledningssystem.
English: Feeling unwell (predominantly asthenia or fatigue) Painful conditions (incl.
Danish: Utilpashed (overvejende asteni eller træthed) Smertefulde tilstande (inkl.
English: However, the CHMP maintained its position, stating that the clinical and microbiological responses point to a conclusion that moxifloxacin IV/PO is not among the optimal treatments for cSSSI.
Danish: CHMP fastholdt dog sit synspunkt og bemærkede, at den kliniske og mikrobiologiske respons peger på den konklusion, at intravenøs/oral moxifloxacin ikke er en af de optimale behandlinger af cSSSI.
English: Alterations of the skin and mucous membranes (painful blisters in the mouth/nose or at the penis/vagina), potentially life-threatening (Stevens-Johnson-Syndrome, toxic epidermal necrolysis)
Danish: ændringer i huden og slimhinder (smertefulde blærer i munden/næsen eller ved penis/skeden), kan være livstruende (Stevens-Johnsons syndrom, toksisk epidermal nekrolyse).
English: GROUNDS FOR POSITIVE OPINION AND AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET
Danish: BEGRUNDELSER FOR POSITIV UDTALELSE OG ÆNDRING AF PRODUKTRESUMÉ, ETIKETTERING OG INDLÆGSSEDDEL
English: Superinfections due to resistant bacteria or fungi e.g. oral and vaginal candidiasis
Danish: Superinfektioner forårsaget af resistente bakterier eller svampe f.eks. oral eller vaginal candidiasis
English: At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature.
Danish: Ved kølige temperaturer kan der forekomme bundfald, som vil genopløses ved stuetemperatur.
English: Increase of skin sensitivity
Danish: øget hudfølsomheden.
English: An additive effect on QT interval between moxifloxacin and other medicinal products that may prolong the QTc interval cannot be excluded.
Danish: En additiv effekt på forlængelsen af QT-intervallet kan ikke udelukkes ved anvendelsen af moxifloxacin og andre lægemidler, der kan forlænge QTc-intervallet.
English: and monkeys (p.o.) did not show evidence of teratogenicity or impairment of fertility following administration of moxifloxacin.
Danish: og aber (p.o.) viste ingen tegn på teratogenicitet eller nedsat fertilitet efter indgift af moxifloxacin.
English: Regarding the risk of hepatic ADRs associated with IV/PO moxifloxacin, the greater background morbidity/clinical monitoring may partly explain the increased rates but it remains plausible that it is linked to the greater bioavailability of the IV formulation.
Danish: Hvad angår risikoen for leverbivirkninger i forbindelse med intravenøs/oral moxifloxacin, kan den større underliggende morbiditet og kliniske overvågning måske delvist forklare de højere tal, men det er stadig plausibelt, at den er forbundet med den intravenøse formulerings større biotilgængelighed.
English: Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval (see also section 4.5).
Danish: Moxifloxacin bør ikke bruges samtidig med andre lægemidler, som forlænger QT-intervallet (se også pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
Danish: DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OG PÅ DEN DIREKTE EMBALLAGE
English: The duration of treatment depends upon the type of infection, and how well you respond to treatment but the recommended durations of use are:
Danish: Behandlingsvarigheden vil afhænge af infektionstypen og af, hvor godt De reagerar på behandlingen.
English: In dogs, high oral doses (≥ 60 mg/kg) leading to plasma concentrations ≥ 20 mg/l caused changes in the electroretinogram and in isolated cases an atrophy of the retina.
Danish: Hos hunde medførte høje orale doser (>60 mg/kg), med deraf følgende plasmakoncentrationer på >20 mg/l, ændringer i elektroretinogrammet og i isolerede tilfælde atrofi af retina.
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 resulterede i højere plasmakoncentrationer af M1, medens eksponeringen for moderstoffet var sammenlignelig med eksponeringen hos raske forsøgspersoner.
English: Infused at a constant flow rate over 60 minutes.
Danish: Infusionen gives med en konstant hastighed i løbet af 60 minutter.
English: The use of charcoal early during absorption may be useful to prevent excessive increase in the systemic exposure to moxifloxacin in cases of oral overdose.
Danish: Ved oral overdosering kan anvendelse af aktivt kul tidligt i absorptionsforløbet kan være nyttig for at undgå en voldsom stigning i systemisk eksponering for moxifloxacin.
English: At the first sign of pain or inflammation, patients should discontinue treatment with moxifloxacin and rest the affected limb(s).
Danish: Ved de første tegn på smerte eller inflammation skal patienten afbryde behandlingen med moxifloxacin og aflaste den afficerede ekstremitet.
English: Rupture of tendon, inflammation of joints, muscle rigidity, worsening of the symptoms of myasthenia gravis
Danish: sprængning af sene, betændelse i led, muskelstivhed, forværring af symptomer for myasthenia gravis.
English: If you stop using Octegra
Danish: Hvis De holder op med at få Octegra
English: loss of smell), abnormal dreams, balance disorder and poor co-ordination (due to dizziness), convulsions, disturbed concentration, impaired speech, partial or total loss of memory
Danish: tab af lugtesansen), unormale drømme, balance- og koordineringsforstyrrelser (som følge af svimmelhed), krampetrækninger, koncentrationsforstyrrelser, taleforstyrrelser, delvis eller hel tab af hukommelsestab.
English: Colourless glass bottles (type 2) with a chlorobutyl rubber stopper as closure.
Danish: Farveløse glasflasker (type 2) med chlorbutylgummiprop.
English: Moxifloxacin IV for CAP was approved through MRP in two subsequent waves, in 2002 and 2004.
Danish: Intravenøs moxifloxacin til samfundserhvervet pneumoni blev godkendt via den gensidige anerkendelsesprocedure ad to på hinanden følgende omgange, nemlig i 2002 og 2004.
English: After repeated dosing in healthy volunteers moxifloxacin increased Cmax of digoxin approximately 30% without affecting AUC or trough levels.
Danish: Efter gentagen dosering til raske forsøgspersoner forøgede moxifloxacin Cmax for digoxin med ca.30 % uden påvirkning af AUC eller dalkoncentrationer.
English: PK/PD predictions of the relative likelihood of levofloxacin and moxifloxacin selecting for resistance are scientifically plausible but not fully validated clinically.
Danish: Farmakokinetiske/farmakodynamiske beregninger af den relative sandsynlighed for levofloxacins og moxifloxacins selektion for resistens er plausible set ud fra et videnskabeligt synspunkt, men er ikke fuldstændigt klinisk validerede.
English: 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: Moxifloxacin bør udelukkende anvendes, når det anses som uhensigtsmæssigt at anvende de antibakterielle midler, der almindeligvis anbefales til indledende behandling af disse infektioner.
English: increase of a special liver enzyme in the blood (LDH)), increase of bilirubin in the blood, increase of a special liver enzyme in the blood (gammaglutamyl-transferase and/or alkaline phosphatase)
Danish: forhøjet indhold af specielle leverenzymer i blodet (LDH)), forhøjet bilirubin i blodet, forhøjet indhold af specielle leverenzymer i blodet (gamma-glytamyltransferase og/eller alkalisk fosfatase).
English: The CHMP noted that while the pre-defined non-inferiority margins had been met, the data indicates that IV moxifloxacin was not quite as good as the best available regimens.
Danish: CHMP bemærkede, at selv om de forudfastsatte noninferioritetsmarginer var nået, viser dataene, at intravenøs moxifloxacin ikke var helt lige så godt som de bedste tilgængelige regimer.
English: The CHMP noted the Applicant response but considered that the data indicated that moxifloxacin is probably not quite as good as comparative therapy.
Danish: CHMP noterede sig ansøgerens svar, men var af den opfattelse, at dataene indikerede, at moxifloxacin sandsynligvis ikke er lige så godt som sammenlignende behandling.
English: The CHMP considers that the totality of the safety data relating to use of moxifloxacin (IV and oral and IV/PO) should be taken into account together when assessing the overall benefit-risk and therefore, the safety profile described for oral administration applies to intravenous administration, with the additional expectation that the difference in PK and in patient and infection characteristics for those in need of initial IV treatment is likely to increase any risks associated with systemic administration.
Danish: CHMP er af den opfattelse, at der bør tages højde for de samlede sikkerhedsdata for brugen af moxifloxacin (intravenøs og oral samt intravenøs/oral) ved vurderingen af det overordnede risk/benefit-forhold, og derfor gælder den sikkerhedsprofil, der er beskrevet for oral indgivelse, også for intravenøs indgivelse, med den yderligere forventning, at forskellen på de farmakokinetiske egenskaber og på patient- og infektionsegenskaberne for dem, der har behov for indledende intravenøs behandling, sandsynligvis vil øge enhver risiko i forbindelse med systemisk indgivelse.
English: When using Octegra - The risk of cardiac abnormalities may increase with the dose and the speed of the infusion into your vein.
Danish: Når de tager Octegra-infusionsvæske - Risikoen for hjerteforstyrrelser kan øges ved højere dosis og højere hastighed for indsprøjtningen i Deres blodåre.
English: In skin blister fluid concentrations of 1.75 mg/l were observed 10 h after intravenous administration.
Danish: I væsken i blærer på huden blev der fundet koncentrationer på 1,75 mg/l 10 timer efter intravenøs indgift.