FrancophonIA/ELRC3.0 huggingface dataset:
English: The frequencies of cardiac adverse events and adverse events were similar and the postmarketing observational studies and post-marketing surveillance of spontaneous adverse events do not show any evidence that IV/oral moxifloxacin is associated with a significantly higher risk of developing liver or cardiac adverse events than standard therapy.
Danish: Hyppigheden af kardiale utilsigtede hændelser og bivirkninger var næsten ens, og observationsundersøgelserne og overvågningen af spontane utilsigtede hændelser efter markedsføringen viser ikke nogen evidens for, at intravenøs/oral moxifloxacin er forbundet med en signifikant højere risiko for hepatiske eller kardiale utilsigtede hændelser end standardbehandlingen.
English: Uncommon: Tingling sensation (pins and needles) and/or numbness, changes in taste (in very rare cases loss of taste), confusion and disorientation, sleep problems (predominately sleeplessness), shaking, sensation of dizziness (spinning or falling over), sleepiness
Danish: prikkende fornemmelse (som at sidde på nåle) og/eller følelsesløshed, smagsforstyrrelser (i meget sjældne tilfælde tab af smagsans), konfusion og desorientering, søvnproblemer (især søvnløshed), rysten, fornemmelse af svimmelhed (snurre rundt eller falde omkuld), træthed.
English: Increased blood sugar, increased blood uric acid Psychiatric Effects
Danish: forhøjet blodsukker, forhøjet urinsyre i blodet.
English: Intra-arterial administration should be avoided since preclinical studies demonstrated peri-arterial tissue inflammation following infusion by this route.
Danish: Intra-arteriel indgift skal undgås, da prækliniske studier viser, at denne indgivelsemåde kan forårsage betændelse i det periarterielle væv.
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: Såvel i prækliniske undersøgelser som i undersøgelser på mennesker er der efter udsættelse for moxifloxacin observeret ændringer i hjertets elektrofysiologi i form af forlænget QT-interval.
English: There are no clinical data to demonstrate that moxifloxacin is active against pneumococci that are insusceptible to other fluoroquinolones as a result of acquired resistance.
Danish: Der er ingen kliniske data, som dokumenterer, at moxifloxacin er virksomt mod pneumokokker, der på grund af erhvervet resistens ikke er følsomme over for andre fluoroquinoloner.
English: The following solutions are incompatible with moxifloxacin solution for infusion: Sodium chloride 10% and 20% solutions
Danish: Følgende infusionsvæsker er inkompatible med moxifloxacin-infusionsvæske, opløsning: Natriumchlorid 10 % og 20 %
English: In the absence of human data and due to the experimental risk of damage by fluoroquinolones to the weight-bearing cartilage of immature animals, breast-feeding is contraindicated during moxifloxacin therapy (see section 4.3).
Danish: Da der savnes data fra mennesker, og på grund af den empiriske risiko for skader fra fluorquinologer på den vægtbærende brusk hos ikke fuldt udviklede dyr, er amning kontraindiceret under behandling med moxifloxacin (se pkt.
English: The submitted ECG data and the analysis of outlying QTc values demonstrated a consistent excess risk of moxifloxacin in the studies with ECG data.
Danish: De fremsendte EKG-data og analysen af de perifere QTc-værdier viste en konsekvent øget risiko ved moxifloxacin i undersøgelserne med EKG-data.
English: - The other ingredients are sodium chloride, hydrochloric acid (for pH-adjustment), sodium hydroxide (for pH-adjustment) and water for injections
Danish: - Øvrige indholdsstoffer: natriumchlorid, saltsyre (til justering af pH), natriumhydroxid (til justering af pH) og vand til injektionsvæsker.
English: diplopia and blurred vision (especially in the course of CNS reactions, see section 4.4)
Danish: diplopi og sløret syn (især pga. CNSreaktioner, se pkt.
English: - the efficacy of IV (followed by PO) moxifloxacin in the treatment of CAP and cSSTI is established, however the safety profile of intravenous moxifloxacin when used to treat CAP or cSSTI raises some concerns, particularly with regard to hepatotoxicity and cardiac conduction effects,
Danish: - Virkningen af intravenøs (efterfulgt af oral) moxifloxacin til behandling af samfundserhvervet pneumoni og cSSSI er dokumenteret, men sikkerhedsprofilen for intravenøs moxifloxacin til behandling af samfundserhvervet pneumoni eller cSSTI giver anledning til visse betænkeligheder, navnlig hvad angår hepatotoksicitet og virkninger på hjertets ledningssystem.
English: QT prolongation (see section 4.4) Palpitations Tachycardia Atrial fibrillation Angina pectoris Vasodilatation
Danish: Palpitationer Takykardi Atrieflimren Angina pectoris Vasodilatation
English: In Phase III-IV clinical studies, the rates of cardiac adverse events, drug-related cardiac adverse events and serious cardiac adverse events were similar between moxifloxacin and the comparator.
Danish: I de kliniske fase III-IV-undersøgelser lignede raterne for kardiale utilsigtede hændelser, lægemiddelrelaterede kardiale utilsigtede hændelser og alvorlige kardiale utilsigtede hændelser hinanden for moxifloxacin og sammenligningslægemidlet.
English: Moxifloxacin should be used with caution in patients with any condition pre-disposing to cardiac arrhythmias (e.g. acute myocardial ischaemia) because they may have an increased risk of developing ventricular arrhythmias (incl.
Danish: Moxifloxacin skal anvendes med forsigtighed hos patienter, der er disponeret for hjertearytmier (f.eks. akut myokardieiskæmi), fordi de kan have en øget risiko for at udvikle ventrikulære arytmier (herunder torsades de pointes) og hjertestop.
English: - If you develop a skin reaction or blistering and/or peeling of the skin and/or mucosal reactions (see section 4.
Danish: - Hvis De får hududslæt eller blistrer og/eller afskalning af hud og/eller slimhindebetændelse (se pkt.
English: - If you experience palpitations or irregular heart beat during the period of treatment, you should stop taking Octegra and inform your doctor immediately.
Danish: - Hvis De får hjertebanken eller uregelmæssig puls under behandlingen, skal De holde op med at tage Octegra og straks kontakte lægen.
English: Pain and swelling of the tendons (tendonitis), muscle cramp, muscle twitching
Danish: smerter og hævelser af sener (tendonitis), muskelkramper, muskeltrækninger.
English: If you stop taking this medicine too soon your infection may not be completely cured, the infection may return or your condition may get worse, and you may also create a bacterial resistance to the antibiotic.
Danish: Infektionen kan vende tilbage eller Deres tilstand kan forværres, og Deres bakterier kan blive resistente over for antibiotikummet.
English: - Cases of fulminant hepatitis potentially leading to liver failure (including fatal cases) have been reported with moxifloxacin (see section 4.8).
Danish: - Tilfælde af fulminant hepatitis, som potentielt kan føre til leversvigt (herunder dødsfald), er set ved brug af moxifloxacin (se pkt.
English: “Complicated skin and skin structure infections only when it is considered inappropriate to use antibacterial agents that are commonly recommended for the initial treatment of this infection (see section
Danish: “Anvendes udelukkende til komplicerede infektioner i hud og blødt væv, når det anses for uhensigtsmæssigt at anvende de antibakterielle midler, der almindeligvis anbefales til den indledende behandling af denne infektion (se punkt 4.4)”
English: Bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis (potentially lifethreatening, see section 4.4)
Danish: Bulløse hudreaktioner som Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse (potentielt livstruende, se pkt.
English: If you miss a dose of Octegra If you are concerned that you may have missed a dose of Octegra, contact your doctor immediately.
Danish: Hvis De har glemt at få Octegra Hvis De er bekymret for, at De mangler at få en dosis, skal De straks kontakte lægen.
English: The Applicant discussed in depth the advantages of moxifloxacin for the treatment of CAP requiring initial IV therapy, providing data from clinical studies on the efficacy of moxifloxacin IV/oral, hepatic safety in sequential IV/oral and from studies on the cardiac safety in IV/oral.
Danish: Ansøgeren gjorde omhyggeligt rede for fordelene ved moxifloxacin til behandling af samfundserhvervet pneumoni, som kræver indledende intravenøs behandling, og fremlagde data fra kliniske undersøgelser af virkningen af intravenøs/oral moxifloxacin, leversikkerhed ved sekventiel intravenøs/oral anvendelse samt data fra undersøgelser af hjertesikkerheden ved intravenøs/oral anvendelse.
English: culture test by suppression of mycobacterial growth causing false negative results.
Danish: - Moxifloxacin-behandling kan påvirke dyrkningsprøver med Mycobacterium spp, ved suppression af mykobakteriel vækst, hvilket kan medføre falsk negative resultater.
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg på apoteket hvordan De skal aflevere medicinrester.
English: Ringing/noise in the ears Cardiovascular System Common:
Danish: ringen/støj for ørene.
English: The CHMP was of the opinion that the use of IV moxifloxacin for treatment of CAP should be qualified by the same wording as the cSSSI indication.
Danish: CHMP var af den opfattelse, at der for brugen af intravenøs moxifloxacin til behandlingen af samfundserhvervet pneumoni burde gælde samme ordlyd som for cSSSI-indikationen.
English: However, fluoroquinolones including moxifloxacin may result in an impairment of the patient's ability to drive or operate machinery due to CNS reactions (e.g. dizziness, see section 4.8) or acute and short lasting loss of consciousness (syncope, see section 4.8).
Danish: Fluorquinoloner, herunder moxifloxacin kan dog resultere i en forringelse af patientens evne til at køre eller betjene maskiner pga. CNS-reaktioner (f.eks. svimmelhed, se pkt.
English: Nausea, vomiting, stomach and abdominal ache, diarrhoea Uncommon: Loss of appetite, wind and constipation, stomach upset (indigestion/heartburn), inflammation of the stomach, increase of a special digestive enzyme in the blood (amylase)
Danish: appetitløshed, luft i maven og forstoppelse, maveforstyrrelser (dårlig fordøjelse/halsbrand), mavekatar, forhøjet indhold af et specielt fordøjelsesenzym i blodet (amylase).
English: Hypoaesthesia Smell disorders (incl.
Danish: Hypæstesi Lugteforstyrrelser (inkl.
English: Moxifloxacin IV for cSSSI was approved in 2005 in all countries that had already approved the intravenous formulation for use in CAP. No consensus was reached on Day 60 of the CMD(h) referral and the procedure was therefore referred to the CHMP.
Danish: Intravenøs moxifloxacin til cSSSI blev godkendt i 2005 i alle de lande, der allerede havde godkendt den intravenøse formulering til brug ved samfundserhvervet pneumoni.
English: The CHMP considers that the benefit-risk relationship for IV/PO moxifloxacin in the management of cSSSI is only favourable with qualification of the indication for use.
Danish: CHMP mener, at risk/benefit-forholdet for intravenøs/oral moxifloxacin til behandling af cSSSI udelukkende er positivt, hvis indikationerne for anvendelse begrænses.
English: Hyperlipidemia Hyperglycemia Hyperuricemia
Danish: Hyperglykæmi Hyperurikæmi
English: Take special care with Octegra
Danish: Vær ekstra forsigtig med at tage Octegra
English: The Applicant discussed the safety overview of sequential IV/oral moxifloxacin, overall and specifically in cSSSIs and analysed data on the incidence of liver events from sequential IV/oral clinical studies (overall and cSSSIs), stating that there was no difference in overall incidences of hepatic adverse events and adverse drug reactions between moxifloxacin and comparators.
Danish: Ansøgeren gjorde rede for sikkerheden for sekventiel intravenøs/oral moxifloxacin, både samlet set og specifikt for cSSSI'er, og analyserede data for incidensen af leverbivirkninger fra kliniske undersøgelser af sekventiel intravenøs/oral anvendelse (samlet set og for cSSSI'er), og ansøgeren anførte, at der ikke var nogen forskel på den samlede incidens af hepatiske utilsigtede hændelser og lægemiddelbivirkninger, når man sammenlignede moxifloxacin og sammenligningslægemidlerne.
English: Furthermore, there have been very rare cases of the following side effects reported following treatment with other quinolone antibiotics, which might possibly also occur during treatment with Octegra: transient loss of vision, increased blood sodium levels, increased blood calcium levels, increased breakdown of red blood cells, muscle reactions with muscle cell damage, increased sensitivity of the skin to sunlight or UV light.
Danish: Disse må også formodes at kunne forekomme under behandlingen med Octegra: Forbigående synstab, forhøjet natriumindhold i blodet, forhøjet calciumindhold i blodet, øger nedbrydning af røde blodlegemer, muskelreaktioner med beskadigelse af muskelceller, øget følsomhed af huden over for sollys og UV-lys.
English: Uncommon: Distinct alteration of the electrical activity of the heart (ECG), palpitations, irregular and fast heart beat, severe cardiac rhythm abnormalities, angina pectoris, flushing
Danish: tydelig ændring i den elektriske hjerteaktivitet (EKG), hjertebanken, uregelmæssig og hurtig hjerteslag (puls), alvorlige hjerterytmeforstyrrelser, hjertekramper, rødmen.
English: The analysis of outlying QTc values demonstrated a consistent excess risk for moxifloxacin for the data from the CAP studies with ECG data.
Danish: Analysen af perifere QTcværdier viste en konsekvent øget risiko ved moxifloxacin, hvad angår dataene fra CAPundersøgelserne med EKG-data.
English: Increase of a special liver enzyme in the blood (gamma-glutamyl-transferase) Uncommon: Abnormal fast heart rate, low blood pressure, swelling (of the hands, feet, ankles, lips, mouth, throat), severe diarrhoea containing blood and/or mucus (antibiotic associated colitis) which in very rare circumstances, may develop into complications that are lifethreatening, convulsions, hallucination, kidney impairment (incl.
Danish: unormal hurtig hjerterytme, lavt blodtryk, hævelser (af hænder, fødder, ankler, læber, mund og hals), alvorlig diaré med blod og/eller slim (antibiotikaassocieret tyktarms betændelse), hvor der i meget sjældne tilfælde kan opstå livstruende komplikationer, krampetrækninger, hallucination, nedsat nyrefunktion (inkl.
English: - If you are currently taking any medicine that decreases your blood potassium levels, consult your doctor before taking Octegra because this can increase the risk of heart rhythm disturbances.
Danish: - Hvis De tager andre lægemidler, der nedsætter blodets kaliumniveau, skal De kontakte lægen, inden De begynder at tage Octegra, da dette kan øge risikoen for forstyrrelser i hjerterytmen.
English: INFORMATION IN BRAILLE Justification for not including Braille accepted
Danish: INFORMATION I BRAILLE-SKRIFT Fritaget for krav om blindeskrift.
English: The frequency of possible side effects listed below is defined using the following convention:
Danish: Hyppigheden af de mulige bivirkninger nedenfor er opgjort i henhold til følgende hyppighedstabel: Meget almindelige: forekommer hos flere end 1 ud af 10 behandlede Almindelige:
English: - If your eyesight becomes impaired or if you have any other eye disturbances whilst taking Octegra, consult an eye specialist immediately.
Danish: - Hvis Deres syn bliver forringet, eller hvis De oplever andre øjenforstyrrelser under behandlingen med Octegra, skal De straks kontakte en øjenlægen.
English: The Applicant reiterated that the QTc changes observed did not translate into a higher risk to develop a clinical cardiac event.
Danish: Sikkerhed ved behandling af samfundserhvervet pneumoni Ansøgeren gentog, at de observerede QTc-ændringer ikke medførte en højere risiko for at udvikle en klinisk kardial hændelse.
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: Lægemidler, som hæmmer peristaltikken, er kontraindiceret hos patienter, - Ældre patienter med nyresygdom bør anvende moxifloxacin med forsigtighed, hvis de ikke kan opretholde et tilstrækkeligt væskeindtag, da dehydrering kan øge risikoen for nyresvigt.
English: MARKETING AUTHORISATION NUMBER(S) [To be completed nationally.]
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) [Udfyldes nationalt.]
English: Do not use if you notice any visible particulate matter or if the solution is cloudy.
Danish: Brug ikke Octegra, hvis De opdager synlige partikler i opløsningen eller hvis opløsningen er uklar.
English: Staphylococcus aureus*+
Danish: Almindelige følsomme arter Aerobe grampositive mikroorganismer Staphylococcus aureus*+
English: Infections caused by resistant bacteria or fungi e.g. oral and vaginal infections caused by Candida
Danish: infektioner forårsaget af resistente bakterier eller svampe, f.eks. svamp i mund eller skede forårsaget af Candida
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Af hensyn til miljøet må De må ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: - Special care is need if you are taking other medicines that can lower your blood potassium levels or cause a slow heart rate because these can also increase the risk of serious heart rhythm disturbances while taking Octegra.
Danish: - Du skal være særlig opmærksom, hvis du samtidig med Avelox tager anden medicin, der kan sænke indholdet af kalium i blodet eller medføre langsom hjerterytme, da dette også kan øge risikoen for alvorlige forstyrrelser i hjerterytmen.
English: See also sections 4.3 and 4.5.
Danish: 4.3 og 4.5.
English: Moxifloxacin resistance rate of > 50% have been reported for methicillin resistant S. aureus.
Danish: Der er set en moxifloxacin-resistensfrekvens på >50 % for methicillinresistent S. aureus #ESBL-producerende stammer er normalt også resistente over for fluorquinoloner.
English: After a single 400 mg intravenous 1 hour infusion peak plasma concentrations of approximately 4.1 mg/l were observed at the end of the infusion corresponding to a mean increase of approximately 26% relative to those seen after oral administration (3.1 mg/l).
Danish: Efter en enkelt 400 mg intravenøs infusion over 1 time blev der i slutningen af infusionen observeret en maksimal plasmakoncentration på ca. 4,1 mg/l.
English: - Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with moxifloxacin (see section 4.8).
Danish: - Der er set tilfælde med bulløse hudreaktioner som f.eks. Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse ved anvendelsen af moxifloxacin (se pkt.
English: Enterobacter cloacae*
Danish: Aerobe gramnegative mikroorganismer Enterobacter cloacae* Escherichia coli* #
English: Octegra is a clear, yellow solution for infusion.
Danish: Octegra-infusionsvæske, opløsning, er en klar, gullig opløsning til infusion.
English: Increased gamma-glutamyl-transferase
Danish: Øget gammaglutamyl-transferase
English: The Applicant then discussed the cumulative review of spontaneous ADR reports on “QT/QTc prolongation” and “Torsade de Pointes” for IV only or IV/PO sequential treatment.
Danish: Herefter redegjorde ansøgeren for den samlede gennemgang af spontane bivirkningsindberetninger af QT/QTcforlængelse og torsade de pointes ved intravenøs anvendelse alene og ved sekventiel intravenøs/oral anvendelse.
English: grand mal convulsions (see section 4.4), hallucination, renal impairment (incl.
Danish: 4.4), hallucinationer, nedsat nyrefunktion (inkl.
English: Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
Danish: Patienten skal informeres om at seponere behandlingen og straks kontakte læge, hvis der kommer hud- eller slimhindereaktioner.
English: Anaphylaxis incl.
Danish: Anafylaksi inkl.
English: Therefore co-administration of moxifloxacin with any of the following medicinal products is contraindicated (see also section 4.3): - antiarrhythmics class IA (e.g. quinidine, hydroquinidine, disopyramide) - antiarrhythmics class III (e.g. amiodarone, sotalol, dofetilide, ibutilide) - neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride) - tricyclic antidepressive agents - certain antimicrobial agents (sparfloxacin, erythromycin IV, pentamidine, antimalarials particularly halofantrine) - certain antihistaminics (terfenadine, astemizole, mizolastine) - others (cisapride, vincamine IV, bepridil, diphemanil).
Danish: 4.3): - klasse 1a-antiarytmika (f.eks. quiinidin, hydroquinidin, disopyramid) - klasse 3-antiarytmika (f.eks. amiodaron, sotalol, dofetilid, ibutilid) - neuroleptika (f.eks. phenthiaziner, pimozid, sertindol, haloperidol, sultoprid) - tricykliske antidepressiva - visse antibiotika (sparfloxacin, erythromycin IV, pentamidin)
English: - Moxifloxacin solution for infusion is for intravenous administration only.
Danish: - Moxifloxacin-infusionsvæske er kun beregnet til intravenøs indgift.
English: Each bottle bag contains 400mg moxifloxacin (as hydrochloride).
Danish: Hver flaske pose indeholder 400 mg moxifloxacin (som hydrochlorid).
English: NAME OF THE MEDICINAL PRODUCT Octegra and associated names (see Annex I) 400 mg/250 ml solution for infusion [See Annex I - To be completed nationally]
Danish: Octegra og tilhørende navne (se bilag I) 400 mg/250 ml infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
English: It was considered that the same restrictions should apply to the indications for both CAP and cSSTI as already adopted by CHMP for oral moxifloxacin to treat CAP. Intravenous moxifloxacin is almost always followed by oral treatment and as such the restriction for use of oral moxifloxacin should be reflected in the SPC of the intravenous product.
Danish: Man var af den opfattelse, at de samme begrænsninger burde gælde for indikationerne for både samfundserhvervet pneumoni og cSSSI, sådan som CHMP allerede havde vedtaget, når det gælder oral moxifloxacin til behandling af samfundserhvervet pneumoni.
English: Muscular and Joint System Uncommon: Joint pain, muscle pain Rare:
Danish: Muskler og led Ikke almindelige:
English: The Applicant also claimed growing evidence that moxifloxacin has the best PK/PD profile to avoid the selection of resistance amongst the respiratory fluoroquinolones currently available in Europe.
Danish: Ansøgeren anførte også, at der er voksende evidens for, at ud af de fluoroquinoloner til luftvejsinfektioner, der i øjeblikket er tilgængelige i Europa, er moxifloxacin den, som har den bedste farmakokinetiske/farmakodynamiske profil til at forhindre resistens.
English: Sodium content: 34 mmol/250 ml
Danish: Natrium 34 mmol/250 ml.
English: - The efficacy of Octegra in the treatment of severe burns, infections of deep tissue, major purulent ulcers (abscesses) and diabetic foot infections with osteomyelitis (infections of the bone marrow) has not been established.
Danish: - Effekten af Octegra kendes ikke ved alvorlige forbrændinger, infektioner dybt nede i vævet, meget materiefyldte sår (bylder) og ved fodinfektioner med knoglemarvsbetændelse hos sukkersygepatienter.
English: pain in back, chest, pelvic and extremities) Sweating
Danish: smerter i ryg, bryst, bækken og ekstremiteter) Sved (trombo)phlebitis på infusionssted
English: Single use only.
Danish: Til engangsbrug.
English: The following co-infusions were found to be compatible with moxifloxacin 400 mg solution for infusion: 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: Octegra kan administreres via et T-rør sammen med følgende opløsninger: Vand til injektioner, natriumchlorid 0,9 %, natriumchlorid 1 molær, glucose 5 % / 10 % / 40 %, xylitol 20 %, Ringers opløsning, kombinerede natrium-lactatopløsninger (Hartmanns opløsning, Ringerlactatopløsning).