FrancophonIA/ELRC3.0 huggingface dataset:
English: Do not use Avalox - 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 Avelox - hvis De er overfølsom (allergisk) over for moxifloxacin, andre quinolonantibiotika eller et af de øvrige indholdsstoffer.
English: 7 - 14 days Most patients with pneumonia were switched to oral treatment with Avalox tablets within 4 days.
Danish: De fleste patienter med lungebetændelse bliver skiftet over til Avelox-tabletter inden for 4 dage.
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 (indbefattar creatininclearance > 20 ml/min/1,73 m forringes, øges koncentrationen af M2 metabolitten (glukuronid) med op til en faktor 2,5 (ved creatininclearance på < 30 ml/min/1,73 m2).
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-lactatopløsninger (Hartmanns opløsning, Ringer-lactatopløsning).
English: Blackthorn Road Dublin 18
Danish: Bayer Limited The Atrium Blackthorn Road, Dublin 18
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 postmarketing 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 Avalox.
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 Avelox.
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 the blood supply to your heart muscle is impaired, consult your doctor before you are given Avalox 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: 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: Use immediately after first opening and/or dilution.
Danish: Anvendes umiddelbart efter åbning og/eller fortynding.
English: If this happens treatment with Avalox solution for infusion has to be discontinued immediately.
Danish: Hvis De oplever ovenstående, skal infusionen med Avelox stoppes øjeblikkeligt,.
English: Consult your doctor if you wish to stop the treatment with Avalox solution for infusion or Avalox tablets before the end of the course of treatment.
Danish: Kontakt lægen, hvis De ønsker at stoppe behandlingen med Avelox-infusionsvæske eller Avelox-tabletter, før tid.
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: Pain and swelling of the tendons (tendonitis), muscle cramp, muscle twitching
Danish: smerter og hævelser af sener (tendonitis), muskelkramper, muskeltrækninger
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 4.4).
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: - 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: If this becomes severe or persistent or you notice that your stool contains blood or mucus you should stop taking Avalox 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 Avelox og kontakte lægen.
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 Avalox 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-phosphatdehydrogenasemangel (en sjælden arvelig sygdom), skal De informere lægen, der vil fortælle Dem, om Avelox er velegnet til Dem.
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 indgivelsesmåde kan forårsage betændelse i det periarterielle væv.
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: Avalox is for intravenous use.
Danish: Avelox-infusionsvæske er til intravenøst brug.
English: Avalox contains moxifloxacin as the active ingredient which belongs to a group of antibiotics called fluoroquinolones.
Danish: Det aktive indholdsstof i Avelox er moxifloxacin, der tilhører en gruppe antibiotika kaldet fluoroquinoloner.
English: The frequencies of cardiac adverse events and adverse events were similar and the post-marketing 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: An analysis of cardiac safety in sequential IV/oral clinical studies (overall and cSSSIs) was presented, along with an overview of the incidence of treatment-emergent 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: At the first sign of any pain or inflammation you should stop taking Avalox, rest the affected limb and consult your doctor immediately.
Danish: Ved det første tegn på smerte eller betændelse, skal De stoppe med at tage Avelox, hvile det angrebne ben og straks kontakte lægen.
English: Headache, dizziness
Danish: hovedpine, svimmelhed
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: - If you have a history of abnormal heart rhythms (arrhythmias).
Danish: - hvis De tidligere har haft uregelmæssig hjerterytme (arytmi)
English: Emotional instability, depression (in very rare cases leading to self-harm),
Danish: følelsesmæssig ustabilitet, depression (kan i meget sjældne tilfælde føre til, at man gør skade på sig selv), hallucinationer
English: - Avalox may cause a rapid and severe inflammation of the liver which could lead to lifethreatening liver failure (including fatal cases, see section 4.
Danish: - Avelox kan give en hurtigt udviklet og alvorlig betændelse i leveren, som kan medføre livstruende leversvigt (herunder tilfælde af dødsfald, se pkt.
English: Avalox can be administered via a T-tube together with the following solutions: 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: Avelox 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).
English: - Quinolones are known to trigger seizures.
Danish: Quinoloner vides at kunne udløse krampeanfald.
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: 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 dem 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: Avalox is packaged in cartons containing 250ml polyolefine bags with polypropylene port sealed in aluminium foil overwrap.
Danish: Avelox er pakket i æsker indeholdende 250 ml polyolefiner poser med polypropylen åbning forseglet med aluminiumsfoliedække.
English: Moxifloxacin solution for infusion should not be co-infused with other drugs.
Danish: Moxifloxacininfusionsvæske, opløsning bør ikke infunderes sammen med andre lægemidler.
English: The following solutions were incompatible with Avalox: Sodium chloride 10% and 20% solutions, Sodium bicarbonate 4.2% and 8.4% solutions
Danish: Følgende opløsninger er inkompatible med Avelox-infusionsvæske: natriumchloridopløsninger 10 % og 20 %, natriumhydrogencarbonatopløsninger 4,2 % og 8,4 %.
English: At cool storage temperatures precipitation may occur, which will re-dissolve at room temperature.
Danish: Ved kølige stuetemperaturer kan der forekomme bundfald, som vil genopløses ved stuetemperatur.
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 Moxifloxacin should not be used concurrently with other drugs that prolong the QT interval (see also section 4.5).
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: For Avalox be aware of the following: - If you are taking other medicines that affect your heart during treatment with Avalox there is an increased risk for altering your heart rhythm.
Danish: Vær opmærksom på følgende med Avelox: - Hvis De anvender Avelox samtidig med andre lægemidler, som påvirker hjertet, er der en øget risiko for ændringer i hjerterytmen (pulsen).
English: - If you experience palpitations or irregular heart beat during the period of treatment, you should stop taking Avalox and inform your doctor immediately.
Danish: - Hvis De får hjertebanken eller uregelmæssig puls under behandlingen, skal De holde op med at tage Avelox og straks kontakte lægen.
English: Cross resistance should be expected between moxifloxacin andother fluoroquinolones.
Danish: Der må forventes krydsresistens mellem moxifloxacin og andre fluoroquinoloner.
English: LDH increase) Increased bilirubin Increased gammaglutamyltransferase Increase in blood alkaline phosphatase
Danish: øgning af LDH) Øget bilirubin Øget gammaglutamyltransferase
English: Avalox is packaged in cartons containing a 250ml glass bottle with a chlorobutyl rubber stopper.
Danish: Avelox er pakket i æsker indeholdende 250 ml flasker med en gummiprop.
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: 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: 6.3 Shelf life Polyolefine bag: 3 years Glass bottle:
Danish: Polyolefinpose: 3 år
English: Avalox 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: Avelox 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 miss a dose of Avalox If you are concerned that you may have missed a dose of Avalox, contact your doctor immediately.
Danish: Hvis De har glemt at få Avelox Hvis De er bekymret for, at De mangler at få en dosis skal De straks kontakte lægen.
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 life-threatening, 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 tyktarmsbetændelse), hvor der i meget sjældne tilfælde kan opstå livstruende komplikationer, krampetrækninger, hallucination, nedsat nyrefunktion (inkl.
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, Deres tilstand kan forværres, og Deres bakterier kan blive resistente over for antibiotikummet.
English: The following co-infusions were found to be compatible with moxifloxacin 400 mg solution for infusion:
Danish: Følgende infusionsvæsker har vist sig at være kompatible med Avelox 400 mg infusionsvæske, opløsning:
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 Avalox.
Danish: - De skal være særlig opmærksom, hvis De 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: Ringing/noise in the ears Cardiovascular System Common:
Danish: ringen/støj for ørene
English: - If your eyesight becomes impaired or if you have any other eye disturbances whilst taking Avalox, consult an eye specialist immediately.
Danish: - Hvis Deres syn bliver forringet, eller hvis De oplever andre øjenforstyrrelser under behandlingen med Avelox, skal De straks kontakte en øjenlægen.
English: Do not use if you notice any visible particulate matter or if the solution is cloudy.
Danish: Brug ikke Avelox, hvis De opdager synlige partikler i opløsningen, eller hvis opløsningen er uklar.
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 Avalox: 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 behandling med Avelox: 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: - If you have salt imbalance in the blood, especially low concentrations of potassium in the blood
Danish: - hvis De har ubalance i blodets salte, specielt lavt kaliumindhold (hypokaliæmi), der ikke korrigeres for med behandling på nuværende tidspunkt.
English: - If you are currently taking any medicine that decreases your blood potassium levels, consult your doctor before taking Avalox 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 Avelox, da dette kan øge risikoen for forstyrrelser i hjerterytmen.
English: Lithuania:
Danish: Litauen:
English: What Avalox contains
Danish: Avelox indeholder
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. quinidin, hydroqiinidin, 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) - malariamidler (især halofantrin) - visse antihistaminer (terfenadin, astemizol, mizolastin) - andre (cisaprid, vincamin IV, bepridil, diphemanil).
English: Uncommon: affects 1 to 10 users in 1,000 Rare:
Danish: Meget almindelige: forekommer hos flere end 1 ud af 10 behandlede Almindelige:
English: Seizures incl.
Danish: Anafylaksi inkl.
English: Increased blood sugar, increased blood uric acid Psychiatric Effects
Danish: forhøjet blodsukker, forhøjet urinsyre i blodet Psykiske bivirkninger Ikke almindelige:
English: The 250 ml bottle is available in packs of 1 and 5 bottles.
Danish: Glas flaskerne kan fås i pakker med 1 eller 5 flasker.
English: potentially life-threatening swelling of the airway)
Danish: potentielt livstruende hævelser i luftvejene) Ændringer i laboratorieprøver
English: Látvia
Danish: Øjne
English: NAME OF THE MEDICINAL PRODUCT Avalox and associated names (see Annex I) 400 mg/250 ml solution for infusion [See Annex I - To be completed nationally]
Danish: Avelox og tilhørende navne (se bilag I) 400mg/250 ml infusionsvæske, opløsning [Se bilag I - Udfyldes nationalt]
English: Therefore, do not take the following medicines during treatment with Avalox: Medicines that belong to the group of anti-arrhythmics (e.g. quinidine, hydroquinidine, disopyramide, amiodarone, sotalol, dofetilide, ibutilide), neuroleptics (e.g. phenothiazines, pimozide, sertindole, haloperidol, sultopride), tricyclic antidepressants, some antimicrobials (e.g. sparfloxacin, intravenous erythromycin, pentamidine, antimalarials particularly halofantrine), some antihistamines (e.g. terfenadine, astemizole, mizolastine), and other medicines (e.g. cisapride, intravenous vincamine, bepridil and diphemanil).
Danish: amiodaron, sotalol, dofetilid, ibutilid) neuroleptika (f.eks phenthiaziner, pimozid, sertindol, haloperidol, sultoprid) tricykliske antidepressiva visse antibiotika (f.eks. sparfloxacin, intravenøs erythromycin, pentamidin) malariamidler (især halofantrin) visse antihistaminer (f.eks. terfenadin, astemizol, mizolastin) visse andre lægemidler (f.eks. cisaprid, intravenøs vincamin, bepridil og difemanil).
English: - If you were born with or have had any condition with certain abnormal electrocardiogram
Danish: - hvis De er født med eller har haft sygdomme med unormalt hjertediagram (EKG, elektrisk måling af hjertet).