FrancophonIA/ELRC3.0 huggingface dataset:
English: Plivensia was expected to be used in adults with moderate to severe rheumatoid arthritis, a disease that causes inflammation of the joints.
Danish: Plivensia forventedes anvendt til behandling af voksne med moderat til svær leddegigt (reumatoid arthritis), der er en sygdom, som forårsager betændelse i leddene.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that, because of lack of proven long-term safety, the benefits of Plivensia did not outweigh its risks, and that further studies were needed.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Plivensia ikke opvejede risiciene, da der ingen langtidsvirkning var blevet påvist, og at yderligere undersøgelser var nødvendige.
English: Interleukin-6 is involved in causing inflammation and is found at high levels in the joints of patients with rheumatoid arthritis.
Danish: Interleukin-6 medvirker til betændelse (inflammation) og findes i høje koncentrationer i leddene hos patienter med leddegigt.
English: Two studies compared Plivensia with placebo (a dummy treatment) in patients with moderate to severe rheumatoid arthritis for whom treatment with a DMARD or with an anti-TNF agent (another type of medicine for rheumatoid arthritis) had not worked well enough or had led to troublesome side effects.
Danish: I to undersøgelser blev Plivensia sammenlignet med placebo (et uvirksomt stof) hos patienter med moderat til svær leddegigt, hvor behandling med et DMARD eller et anti-TNF-middel (en anden type lægemiddel mod leddegigt) ikke har virket tilstrækkeligt eller har medført problematiske bivirkninger.
English: The medicine was to be used in patients when treatment with one or more medicines known as disease-modifying anti-rheumatic drugs (DMARDs) had not worked well enough or had led to troublesome side effects.
Danish: Lægemidlet skulle anvendes, når et eller flere sygdomsmodificerende gigtmidler (DMARD'er) ikke har virket tilstrækkeligt eller har medført problematiske bivirkninger for patienterne.
English: The third study compared Plivensia with adalimumab (a monoclonal antibody targeting a chemical messenger called tumour necrosis factor - TNF) in patients who could not take methotrexate or whose condition had not responded adequately to methotrexate; the study looked at the improvement in how patients' joints worked (based on a standard rating score called DAS28-ESR) after 24 weeks of treatment.
Danish: I den tredje undersøgelse blev Plivensia sammenlignet med adalimumab (et monoklonalt antistof, der er rettet mod det kemiske signalstof TNF) hos patienter, der ikke kunne tage metotrexat, eller hvis sygdom ikke havde reageret tilstrækkeligt på metotrexat.
English: These changes returned to normal within two weeks.
Danish: Disse ændringer blev normale igen i løbet af 2 uger.
English: Avalox was initially approved in June 1999.
Danish: Avalox blev godkendt første gang i juni 1999.
English: The absolute bioavailability amounts to approximately 91%.
Danish: Den absolutte biotilgængelighed er på cirka 91 %.
English: It is important that you complete the course of treatment, even if you begin to feel better after a few days.
Danish: Det er vigtigt, at De færdiggøre forløbet af behandlingen, selv om De begynder at føle Dem bedre efter et par dage.
English: This Mutual Recognition variation procedure was started on 7 December 2006.
Danish: Den gensidige anerkendelsesprocedure vedrørende ændringen blev indledt den 7. december 2006.
English: - If you are under 18 years of age.
Danish: - hvis De er under 18 år.
English: In this situation adequate therapeutic measures should be initiated immediately.
Danish: I denne situation skal passende terapeutiske tiltag iværksættes omgående.
English: However it was questioned that this might not be compatible with clinical practice.
Danish: Der var dog tvivl om, hvorvidt dette kunne være inkompatibelt med klinisk praksis.
English: You can take [Invented name] with or without food.
Danish: De kan tage [Lægemidlets navn] med eller uden føde.
English: by suppression of mycobacterial growth.
Danish: ved undertrykkelse af mycobacteriel vækst.
English: - Patients below 18 years of age.
Danish: - Patienter under 18 år.
English: Therefore it is recommended that these medicines are not used together.
Danish: Det anbefales derfor, at denne medicin ikke anvendes samtidigt.
English: There is no indication of oxidative metabolism.
Danish: Der er ingen tegn på oxidativ metabolisme.
English: If you are affected in this way do not drive or operate machinery.
Danish: Hvis De bliver påvirket på denne måde, må De ikke køre bil eller betjene maskiner.
English: M1 and M2 are the only metabolites relevant in humans, both are microbiologically inactive.
Danish: M1 og M2 er de eneste relevante metabolitter hos mennesker, og begge er mikrobiologisk inaktive.
English: If you do not take your tablet on one day, take your normal dose (one tablet) on the next day.
Danish: Hvis De ikke tager Deres tablet én dag, skal De tage den normale dosis (én tablet) den efterfølgende dag.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Der skal tages hensyn til officielle retningslinier vedrørende hensigtsmæssig brug af antibiotika.
English: 3 from 3 h up to 36 h post dose 4 at the end of infusion
Danish: 3 fra 3 timer op til 36 timer efter dosis 4 ved slutningen af infusionen
English: Absorption and Bioavailability
Danish: Absorption og biotilgængelighed:
English: Therefore, the recommended dose should not be exceeded.
Danish: Den anbefalede dosis bør derfor ikke overskrides.
English: Bravničarjeva 13 1000 Ljubljana Slovenija
Danish: Bravničarjeva 13 1000 Ljubljana Slovenien
English: At steady-state the exposure within the dosing interval is approximately 30% higher than after the first dose.
Danish: Ved steady-state er eksponeringen i dosisintervallet ca. 30 % højere end efter den første dosis.
English: B-1050 Bruxelles
Danish: B-1050 Bryssel
English: Women with PID are generally young women with few underlying diseases and concomitant medications.
Danish: Kvinder med PID er i reglen unge kvinder med kun få grundliggende sygdomme og ringe grad af samtidig medicinering.
English: In vitro Susceptibility Data
Danish: In vitro-følsomhedsdata
English: Site: Plasma ratio
Danish: Sted: Plasma ratio
English: The steady-state volume of distribution (Vss) is approximately 2 l/kg.
Danish: Steady-state distributionsvolumenet (Vss) er ca. 2 l/kg.
English: The magnitude of QT prolongation may increase with increasing concentrations of the drug.
Danish: Størrelsen af QT-forlængelsen kan øges med stigende koncentrationer af lægemidlet.
English: It is recommended that you take the tablet at approximately the same time each day.
Danish: Det anbefales, at tabletten tages ca. på samme tidspunkt hver dag.
English: - The Committee considered that no additional safety concerns were expected with the claimed indication in comparison to the previously approved indications.
Danish: - Udvalget var af den opfattelse, at der ikke forventes at fremkomme yderligere betænkeligheder vedrørende den ansøgte indikations sikkerhed i forhold til tidligere godkendte indikationer.
English: - The Committee considered the Referral made under Article 6(12) of Commission Regulation (EC) No 1084/2003, for Avalox and associated names (See Annex 1).
Danish: - Udvalget behandlede sagen, der var indbragt i henhold til artikel 6, stk. 12, i Kommissionens forordning (EF) nr. 1084/2003, for Avalox og tilknyttede navne (se bilag I).
English: The duration of treatment depends upon the type of infection.
Danish: Behandlingensvarigheden afhænger af infektionstypen.
English: 30588 Murcia
Danish: 30588 Murcia Spanien
English: - Quinolone antibiotics may make your skin become more sensitive to sunlight or UV light.
Danish: - Quinolon-antibiotika kan gøre huden mere følsom over for sollys eller UV-lys.
English: In this situation, you should not take medicines that stop or slow down bowel movement.
Danish: I denne situation skal De ikke tage medicin, der stopper eller nedsætter tarmens bevægelighed.
English: UK - United Kingdom Bayer plc Bayer Schering Pharma Bayer House
Danish: UK - Storbritannien Bayer plc Bayer Schering Pharma Bayer House
English: - If you are pregnant or breast-feeding.
Danish: - hvis De er gravid eller ammer.
English: EUCAST clinical MIC breakpoints for moxifloxacin (31.01.2006): Organism
Danish: EUCAST clinical MIC breakpoints for moxifloxacin (31.01.2006): Organisme
English: Following oral administration moxifloxacin is rapidly and almost completely absorbed.
Danish: Efter oral administration absorberes moxifloxacin hurtigt og næsten fuldstændigt.
English: This procedure is a referral following a Mutual Recognition Procedure concerning the above variation application which was submitted for Avalox film-coated tablets to Germany as Reference Member State (RMS) and the Concerned Member States (CMS) AT, BE, CY, CZ, DK, EE, EL, ES, FI, FR, HU, IE, IT, LT, LU, LV, MT, NL, PL, PT, SE, SI, SK and UK on 5 December 2006.
Danish: Denne procedure er en indbringelsesprocedure efter en gensidig anerkendelsesprocedure vedrørende ovennævnte ansøgning om ændring, som blev indgivet for Avalox filmovertrukne tabletter den 5. december 2006 til Tyskland som referencemedlemsstat og de berørte medlemsstater AT, BE, CY, CZ, DK, EE, EL, ES, FI, FR, HU, IE, IT, LT, LU, LV, MT, NL, PL, PT, SE, SI, SK og UK.
English: Anaphylactic reactions can progress to a life-threatening shock, even after the first administration.
Danish: Anafylaktiske reaktioner kan udvikle sig til livstruende shock, selv efter første administration.
English: 151 25 Marousi Athens
Danish: 151 25 Marousi Aten Grækenland
English: In vitro and ex vivo experiments showed a protein binding of approximately 40 - 42% independent of the concentration of the drug.
Danish: In vitro- og ex vivostudier har påvist en proteinbinding på ca. 40-42 % uafhængigt af koncentrationen af lægemidlet.
English: Berkshire RG14 1JA UK
Danish: Berkshire RG14 1JA Storbritannien
English: The prevalence of acquired resistance may vary geographically and with time for selected species and local information of resistance is desirable, particularly when treating severe infections.
Danish: Forekomsten af resistens kan variere geografisk og over tid for udvalgte arter, og lokal information om resistensudviklingen er ønskelig, specielt ved behandling af alvorlige infektioner.
English: They are for use only for species that have not been given a species-specific breakpoint and are not for use with species where interpretative criteria remain to be determined (Gram-negative anaerobes).
Danish: De skal kun anvendes for arter, som ikke har fået et artsspecifikt brydningspunkt, og skal ikke anvendes for arter, hvor fortolkningskriterier endnu ikke er bestemt (Gram-negative anaerobe).
English: As these concerns were not resolved during the course of the variation procedure, a notification of an official referral for Arbitration, under Article 6(12) of Commission Regulation EC No 1084/2003, to the CHMP was made by Belgium on 19 October 2007.
Danish: Da disse betænkeligheder ikke blev løst i løbet af ændringsproceduren, sendte Belgien den 19. oktober 2007 en meddelelse til CHMP om, at sagen officielt var blevet henvist til voldgift i overensstemmelse med artikel 6, stk. 12, i Kommissionens forordning EF nr. 1084/2003.
English: QT-prolongation is a known undesirable effect of moxifloxacin.
Danish: QT-forlængelse er en kendt uønsket virkning af moxifloxacin.
English: Minimum bactericidal concentrations (MBC) were found to be in the range of the minimum inhibitory concentrations (MIC).
Danish: De minimale baktericide koncentrationer (MBC) blev anslået til at være inden for området for de minimale inhibitoriske koncentrationer (MIC).
English: If you are unsure about what to do, consult your doctor or pharmacist.
Danish: Hvis De er usikker på, hvad De skal gøre så kontakt lægen eller apoteket.
English: [Invented name] is an antibiotic belonging to the quinolone family.
Danish: [Lægemidlets navn] er et antibiotikum tilhørende quinolonfamilien.
English: The recommended dose (400 mg once daily) and duration of therapy for the indication being treated should not be exceeded.
Danish: Den anbefalede dosering (400 mg dagligt) samt behandlingsvarighed for den givne indikationen, bør ikke overskrides.
English: In view of these concerns, during the Mutual Recognition Procedure, Belgium considered that a positive benefit / risk balance had not been demonstrated and more robust evidence should be submitted in order to grant the indication applied for.
Danish: I løbet af proceduren for gensidig anerkendelse var Belgien med udgangspunkt i disse betænkeligheder af den opfattelse, at et positivt benefit/risk-forhold ikke var blevet påvist, og at der skulle fremlægges mere fyldestgørende beviser, før den ansøgte indikation kunne godkendes.
English: The Referral procedure was initiated on 15 November 2007 with the adoption of a CHMP List of Questions to be addressed by the MAHs.
Danish: Proceduren for indbragte sager blev indledt den 15. november 2007 med vedtagelse af CHMP's liste med spørgsmål til indehaverne af markedsføringstilladelsen.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg Deres læge eller apotek til råds, før De tager nogen form for medicin.
English: and fastidious organisms (M100-S17, 2007) and MIC breakpoints for anaerobes (M11-A7, 2007):
Danish: og følsomme organismer (M100-S17, 2007) og MIC brydningspunkt for anaerobe (M11-A7,2007):
English: BAYER SANTE 13, rue Jean Jaurès 92807 PUTEAUX CEDEX France
Danish: BAYER SANTE 13, rue Jean Jaurès 92807 PUTEAUX CEDEX Frankrig
English: Therefore, moxifloxacin should be used with caution in these patients.
Danish: Derfor bør moxifloxacin bruges med forsigtighed til disse patienter.
English: Nevertheless patients should be advised to avoid exposure to either UV irradiation or extensive and/or strong sunlight during treatment with moxifloxacin.
Danish: Ikke desto mindre bør patienter anbefales ikke at udsætte sig for UV-bestråling eller omfattende og/eller stærkt sollys under behandling med moxifloxacin.
English: Streptococcus pyogenes* (Group A)
Danish: Streptococcus pyogenes* (Gruppe A)
English: Moxifloxacin is contraindicated in children and adolescents (< 18 years).
Danish: Moxifloxacin er kontraindiceret til børn samt unge (< 18 år).
English: Pseudomonas aeruginosa *Activity has been satisfactorily demonstrated in susceptible strains in clinical studies in the approved clinical indications.
Danish: Pseudomonas aeruginosa *Aktivitet er tilfredstillende demonstreret i modtagelige bakteriestammer i kliniske studier ved de godkendte kliniske indikationer.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S) MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Danish: FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE SAMT NORGE OG ISLAND
English: However, studies have shown that moxifloxacin has a lower risk to induce photosensitivity.
Danish: Studier har dog vist, at moxifloxacin har lav risiko for at inducere fotosensitivitet.
English: The recommended dose and duration of treatment should not be exceeded (see section 2.
Danish: De anbefalede doser og behandlingsvarigheden bør ikke overskrides (se pkt.
English: Due to the potential risk of adverse effects on the cartilage in patients under the age of 18 years, and the fact that PID mostly affects young women, the existing wording of the contraindication in children and adolescents was further specified namely that it is contraindicated in patients below 18 years of age.
Danish: På grund af risikoen for uønskede bruskpåvirkninger hos patienter under 18 år samt det faktum, at PID mest rammer unge kvinder, blev den eksisterende ordlyd af kontraindikationen for børn og unge præciseret, således at der nu står, at der er kontraindikation for patienter under 18 år.
English: On the basis of the pharmacokinetic studies carried out so far in patients with liver failure (Child Pugh A, B), it is not possible to determine whether there are any differences compared with healthy volunteers.
Danish: På basis af farmakokinetiske studier som indtil nu er udført på patienter med nedsat leverfunktion (Child-Pugh A, B), er det ikke muligt at afgøre, hvorvidt der er forskelle sammenlignet med raske forsøgspersoner.
English: The mean apparent total body clearance following a 400 mg dose ranges from 179 to 246 ml/min.
Danish: Den gennemsnitlige tilsyneladende totale clearance efter en 400 mg dosis varierer fra 179 til 246 ml/min.
English: Although it is acknowledged that approximately 95% of the women with a PID might be ‘overtreated' by this combination therapy this fact outweighs the potential risk of not treating approximately 5% of a mainly very young population which could develop serious long-term sequelae.
Danish: Uagtet det anerkendes, at ca. 95 % af kvinderne med PID kan blive "overbehandlet" med denne kombinationsbehandling, vejer dette forhold tungere end den mulige risiko for manglende behandling af ca. 5 % hovedsageligt fra en yngre population, som på langt sigt risikerer at opleve alvorlige følgevirkninger.
English: Susceptible Intermediate Resistant
Danish: Følsomhed Intermediate Resistens
English: Effect on the intestinal flora in humans
Danish: Effekt på tarmfloraen hos mennesker
English: - If you have a severe liver disease or increased liver enzymes (transaminases) higher than 5 times the upper normal limit.
Danish: - hvis De har en alvorlig leversygdom eller en stigning i leverenzymerne (transaminaserne), der er mere end 5 gange højere end den normale øvre grænse).
English: Streptococcus milleri group* (S. anginosus, S. constellatus and S. intermedius) Streptococcus pneumoniae*
Danish: Streptococcus milleri gruppe (S. Anginosus, S. Constellatus and S. Intermedius)* Streptococcus pneumoniae*
English: Cross-resistance is observed with other fluoroquinolones.
Danish: Krydsresistens er observeret med andre fluoroquinoloner.
English: Peak and trough plasma concentrations at steady-state (400 mg once daily) were 3.2 and 0.6 mg/l, respectively.
Danish: Højeste og laveste plasmakoncentrationer ved steady state (400 mg én gang dagligt) var henholdsvis 3,2 og 0,6 mg/l.
English: The film-coated tablet should be swallowed whole with sufficient liquid and may be taken independent of meals.
Danish: Administration Tabletten skal synkes hel med tilstrækkelig mængde væske og kan indtages uafhængigt af måltider.
English: You should avoid prolonged exposure to sunlight or strong sunlight and should not use a sunbed or any other UV lamp while taking [Invented name].
Danish: De bør undgå langvarigt ophold i sollys eller stærkt sollys, og bør ikke anvende solarium eller andre UVlamper, mens De anvender [Lægemidlets navn].
English: * Non-species related breakpoints have been determined mainly on the basis of pharmacokinetic/pharmacodynamic data and are independent of MIC distributions of specific species.
Danish: > 1 mg/l *Ikke-artsrelaterede brydningspunkter er blevet bestemt hovedsageligt på baggrund af farmakokinetiske/farmakodynamiske data, og er uafhængige af MIC-fordelingen for specifikke arter.
English: Renal clearance amounted to about 24 - 53 ml/min suggesting partial tubular reabsorption of the drug from the kidneys.
Danish: Renal clearance er ca. 24-53 ml/min, hvilket tyder på delvis tubulær reabsorption af lægemidlet fra nyrerne.
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: Hvis De stopper behandlingen for tidligt, vil betændelsestilstanden måske ikke blive helt helbredt, betændelsen kan vende tilbage eller Deres tilstand kan forværres, og De kan danne bakterier, der er resistente mod antibiotikummet.
English: Overall, the CHMP agreed that the benefit/risk balance of moxifloxacin in the PID indication over 14 days is positive.
Danish: Overordnet var CHMP enig i, at der foreligger et positivt benefit/risk-forhold for moxifloxacin til indikationen for PID over en periode på 14 dage.
English: Commonly susceptible species
Danish: Almindelige følsomme arter:
English: In these cases moxifloxacin should be discontinued and suitable treatment (e.g. treatment for shock) initiated.
Danish: I disse tilfælde bør moxifloxacin seponeres og egnet behandling iværksættes (f.eks. behandling af shock).
English: Klebsiella oxytoca
Danish: Klebsilla oxytoca
English: If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.
Danish: Hvis der ikke opnås klinisk bedring efter tre dages behandling, skal behandlingen tages op til overvejelse.
English: After a 400 mg dose, recovery from urine (approximately 19% for unchanged drug, approximately 2.5% for M1, and approximately 14% for M2) and faeces (approximately 25% of unchanged drug, approximately 36% for M1, and no recovery for M2) totalled to approximately 96%.
Danish: Efter en 400 mg dosis genfindes i urin (ca. 19 % som uforandret lægemiddel, ca. 2,5 % som M1 og ca. 14 % som M2), og i fæces (ca. 25 % som uforandret lægemiddel, ca. 36 % som M1 og ingenting som M2) totalt ca. 96 %.
English: - Hypersensitivity and allergic reactions have been reported for fluoroquinolones including moxifloxacin after first administration.
Danish: - Overfølsomhedsreaktioner og allergiske reaktioner er blevet indberettet for fluoroquinoloner herunder moxifloxacin efter første administration.
English: Moxifloxacin is distributed to extravascular spaces rapidly; after a dose of 400 mg an AUC of 35 m·gh/l is observed.
Danish: Moxifloxacin distribueres hurtigt til det ekstravaskulære rum; Efter en dosis på 400 mg blev et AUC på 35 mg h/l observeret.
English: The following changes in the intestinal flora were seen in volunteers following oral administration of moxifloxacin: Escherichia coli, Bacillus spp., Enterococcus spp., and Klebsiella spp.
Danish: Følgende forandringer blev observeret i tarmfloraen hos frivillige forsøgspersoner efter oral administration af moxifloxacin: Escherichia coli, Bacillus spp., Enterococcus spp., og Klebsiella spp.
English: Other resistance mechanisms such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may also effect susceptibility to moxifloxacin.
Danish: Andre resistensmekanismer som permeationsbarrierer (almindelig hos Pseudomonas aeruginosa) og effluksmekanismer kan også påvirke følsomheden over for moxifloxacin.
English: * intravenous administration of a single 400 mg dose 1 10 h after administration
Danish: * Intravenøs indgift af en enkelt dosis på 400 mg 1 10 timer efter administration 2 frit lægemiddel
English: torsade de pointes) and cardiac arrest (see also section 4.3).
Danish: torsade de pointes) og hjertestop (se også pkt.
English: Aerobic Gram-negative micro-organisms Enterobacter cloacae* Escherichia coli*
Danish: Aerobe gramnegative mikroorganismer Enterobacter cloacae* Escherichia coli*
English: Avalox film-coated tablets contain 400 mg moxifloxacin as hydrochloride.
Danish: Avalox filmovertrukne tabletter indeholder 400 mg moxifloxacin som hydrochlorid.
English: The CHMP considered that QT-prolongation in PID should however be carefully addressed by the MAH in future PSURs.
Danish: CHMP var dog af den opfattelse, at QT-forlængelse i forbindelse med PID skal behandles omhyggeligt af indehaveren af markedsføringstilladelsen i fremtidige PSUR'er.
English: Avenue Louise 143 B-1050 Bruxelles
Danish: Avenue Louise 143 B-1050 Bryssel Belgien
English: Moxifloxacin therapy may give false negative culture results for Mycobacterium spp.
Danish: Behandling med moxifloxacin kan give falsk negativt dyrkningsresultat for Mycobacterium spp.