FrancophonIA/ELRC3.0 huggingface dataset:
English: Clinical response to treatment and renal function should be closely monitored in these patients.
Danish: Den kliniske reaktion på behandlingen og nyrefunktionen bør monitoreres omhyggeligt for disse patienter.
English: Cellulose, microcrystalline Povidone
Danish: Cellulose, mikrokrystallinsk Povidon
English: Other types of skin infections have not been studied.
Danish: Andre former for hudinfektioner er ikke undersøgt.
English: Treatment of these patients with delafloxacin should only be initiated in the absence of alternative treatment options and after careful benefit/risk assessment (see also section 4.3).
Danish: Behandling med delafloxacin af disse patienter bør kun indledes i fravær af alternative behandlingsmuligheder og efter en nøje vurdering af benefit/risk-forholdet (se også pkt.
English: Your risk is increased if you are elderly (above 60 years of age), have received an organ transplant, have kidney problems or if you are being treated with corticosteroids.
Danish: Du har en øget risiko, hvis du er ældre (over 60 år), har fået foretaget en organtransplantation, har problemer med nyrerne, eller hvis du er under behandling med kortikosteroider.
English: Glucuronidation of delafloxacin is the primary metabolic pathway with oxidative metabolism representing <1% of an administered dose.
Danish: Glukuronidering af delafloxacin er den primære metaboliseringsvej, hvor oksidativ metabolisering udgør < 1 % af en administreret dosis.
English: For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6.
Danish: For instruktioner vedrørende rekonstitution og fortynding af lægemidlet før administration, se pkt.
English: If you accidentally take more tablets than you should, tell a doctor or get other medical advice.
Danish: Hvis du ved et uheld har taget flere tabletter, end du skulle, skal du sige det til en læge eller søge anden lægelig rådgivning.
English: There are no or limited amount of data from the use of delafloxacin in pregnant women.
Danish: Der er ingen eller utilstrækkelige data om anvendelse af delafloxacin til gravide kvinder.
English: MIC breakpoints (mg/L) Susceptible (S ≤)
Danish: MIC-grænser (mg/l) Følsomme (S ≤)
English: A tendon is the cord that joins your muscle to your skeleton.
Danish: En sene er den ”snor”, der forbinder dine muskler til skelettet.
English: • Worsening of a wound
Danish: • Forværring af sår
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for delafloxacin are as follows:
Danish: Grænserne for den mindste hæmmende koncentration (minimum inhibitory concentration - MIC) for delafloxacin fastlagt af EUCAST (European Committee on Antimicrobial Susceptibility Testing) er som følger:
English: It is unknown whether delafloxacin/metabolites are excreted in human milk.
Danish: Det er ukendt, om delafloxacin/metabolitter udskilles i human mælk.
English: From a microbiological point of view, the product should be used immediately after reconstitution and dilution.
Danish: Fra et mikrobiologisk synspunkt skal produktet anvendes straks efter rekonstitution og fortynding.
English: Quofenix can make you feel dizzy and lightheaded.
Danish: Quofenix kan få dig til at føle dig svimmel og ør.
English: The tablets are swallowed whole with a sufficient amount of water, and can be taken with or without food.
Danish: Tabletterne sluges hele med en tilstrækkelig mængde vand, og kan indtages sammen med eller uden mad.
English: 10 single-dose vials
Danish: 10 enkeltdosishætteglas
English: Delafloxacin pharmacokinetic is comparable in patients with ABSSSI and healthy volunteers.
Danish: Delafloxacins farmakokinetik er sammenlignelig hos patienter med ABSSSI og raske frivillige.
English: • Feeling lightheaded or faint, usually because of a drop in blood pressure
Danish: • Ørhed eller svaghed, i reglen på grund af et fald i blodtrykket
English: Talk to your doctor or pharmacist before you stop taking your medicine.
Danish: Tal med din læge eller apotekspersonalet, før du holder op med at tage din medicin.
English: Delafloxacin is a probable substrate of BCRP.
Danish: Delafloxacin er formentlig et substrat for BCRP.
English: Do not drive, operate machinery, or do other activities that require mental alertness or coordination until you know how Quofenix affects you.
Danish: Undlad at føre motorkøretøj, betjene maskiner eller gøre andet, der kræverårvågenhed og koordination, indtil du ved, hvordan Quofenix påvirker dig.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 20 to 25ºC or at 2 to 8°C.
Danish: Den kemiske og fysiske stabilitet i brug er blevet påvist for 24 timer ved 20 til 25 °C eller ved 2 til 8 °C.
English: Delafloxacin may be administered with or without food as total systemic exposure (AUC∞) is unchanged between fasted and fed (high-fat, high-calorie) conditions.
Danish: Delafloxacin kan administreres sammen med eller uden mad, da den samlede systemiske eksponering (AUC∞) ikke ændres mellem fastende og ikke-fastende (måltid med højt fedt- og kalorieindhold) forhold.
English: Administration of oral delafloxacin in patients with severe renal impairment and low body weight may lead to increased systemic exposures.
Danish: Administration af delafloxacin oralt til patienter med svært nedsat nyrefunktion og lav kropsvægt kan føre til øget systemisk eksponering.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution and dilution has taken place in controlled and validated aseptic conditions.
Danish: Hvis produktet ikke anvendes med det samme, er opbevaringstid og -forhold inden anvendelse brugeres ansvar og vil normalt ikke være længere end 24 timer ved 2 til 8 °C, medmindre rekonstitution og fortynding har fundet sted under kontrollerede og validerede aseptiske forhold.
English: Quofenix has moderate influence on the ability to drive and use machines.
Danish: Quofenix påvirker i moderat grad evnen til at føre motorkøretøj og betjene maskiner.
English: It is used to treat adults with serious short-term infections of the skin and tissues under the skin caused by certain bacteria when usual antibiotics cannot be used or have not worked.
Danish: Det anvendes til at behandle voksne med alvorlige, kortvarige infektioner forårsaget af visse bakterier, i huden og de underliggende væv, når de sædvanlige antibiotika ikke kan anvendes eller ikke har virket.
English: • High blood pressure
Danish: • Højt blodtryk
English: Менарини България ЕООД
Danish: Менарини България ЕООД тел.
English: Please, inform your doctor or nurse immediately if you get any of these symptoms, as the medicine should be stopped and you may need urgent medical attention:
Danish: Fortæl det straks til lægen eller sygeplejersken, hvis du får nogen af disse symptomer, da du i så fald ikke længere bør få medicinen og kan have brug for øjeblikkelig lægehjælp:
English: • You or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase.
Danish: • Du eller en i din familie har fået konstateret mangel på glukose-6-fosfat dehydrogenase.
English: Oral use.
Danish: Oral indtagelse.
English: Epidemiologic studies report an increased risk of aortic aneurysm and dissection after intake of fluoroquinolones, particularly in the older population.
Danish: Der er i epidemiologiske studier rapporteret en øget risiko for aortaaneurisme og -dissektion efter indtagelse af fluoroquinoloner, især hos den ældre population.
English: Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur.
Danish: Patienterne bør rådes til straks at kontakte deres læge, før behandlingen fortsættes, hvis der forekommer hud- og/eller slimhindereaktioner.
English: In the two major trials in ABSSSI the types of infections treated were confined to cellulitis/erysipelas, abscesses and wound infections only.
Danish: I de to største studier med ABSSSI blev de behandlede infektionstyper begrænset til udelukkende cellulitis/erypsipelas, abscesser og sårinfektioner.
English: Quofenix is an antibiotic that contains the active substance delafloxacin.
Danish: Quofenix er et antibiotikum, der indeholder det aktive stof delafloxacin.
English: Delafloxacin tablets can be taken with or without food.
Danish: Delafloxacin tabletter kan tages sammen med eller uden mad.
English: • Burning sensation in the mouth
Danish: • Brændende fornemmelse i munden
English: Arthritis reactive
Danish: Reaktiv artritis
English: Corticosteroids should not be used if signs of tendinopathy occur (see section 4.8).
Danish: Kortikosteroider bør ikke anvendes ved tegn på tendinopati (se pkt 4.8).
English: If superinfection occurs during therapy, appropriate measures should be taken.
Danish: Skulle der forekomme en superinfektion under behandlingen, bør der tages passende forholdsregler.
English: Abnormal dreams
Danish: Abnorme drømme
English: Patheon Italia S.p.A. 2° Trav.
Danish: Patheon Italia S.p.A.
English: • Ringing or buzzing in the ears (tinnitus)
Danish: • Ringen eller summen for ørerne (tinnitus)
English: At the first sign of tendinitis (e.g. painful swelling, inflammation) the treatment with delafloxacin should be discontinued and alternative treatment should be considered.
Danish: Ved første tegn på tendinitis (f.eks. smertende hævelse, inflammation) bør behandling med delafloxacin ophøre, og der bør overvejes anden behandling.
English: If these reactions occur in patients receiving delafloxacin, delafloxacin should be discontinued immediately and appropriate measures should be instituted.
Danish: Hvis disse reaktioner optræder hos patienter, der får delafloxacin, bør brug af delafloxacin straks ophøre, og der skal iværksættes passende foranstaltninger.
English: Delafloxacin is excreted both unchanged and as glucuronide metabolites in urine.
Danish: Delafloxacin udskilles både uændret og som glukuronidmetabolitter i urinen.
English: Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.
Danish: Fortæl det til din læge, hvis du har problemer med nyrerne, fordi din dosis i så tilfælde måske skal justeres.
English: Inflammation and ruptures of tendons may occur within the first 48 hours of treatment and even up to several months after stopping Quofenix therapy.
Danish: Inflammation i sener eller bristede sener kan forekomme i løbet af de første 48 timer af behandlingen eller endda op til flere måneder efter ophør af behandling med Quofenix.
English: Pharmacotherapeutic group: Antibacterials for systemic use, fluoroquinolones, ATC code: J01MA23 Mechanism of action
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, fluoroquinoloner, ATCkode: J01MA23
English: • If you are pregnant, might become pregnant, or think you might be pregnant.
Danish: • Hvis du er gravid, planlægger graviditet, eller har mistanke om at du er gravid.
English: Tablets should be swallowed and can be taken with or without food.
Danish: Tabletterne skal sluges og kan indtages sammen med eller uden mad.
English: There are no data available on severe cases of hypoglycaemia resulting in coma or death after delafloxacin use.
Danish: Der foreligger ingen data om alvorlige tilfælde af hypoglykæmi, der har medført koma eller dødsfald efter brug af delafloxacin.
English: • You have experienced a previous episode of aortic dissection (a tear in the aorta wall).
Danish: • Du tidligere har haft et tilfælde af aortadissektion (en rift i aortavæggen).
English: Efficacy has been demonstrated in clinical studies against the following pathogens that were susceptible to delafloxacin in vitro.
Danish: Virkningen er påvist i kliniske studier over for følgende patogener, der var følsomme over for delafloxacin in vitro.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Sundhedspersoner anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V
English: Delafloxacin should only be used in such patients when it is considered that the expected clinical benefit outweighs the potential risk.
Danish: Delafloxacin bør kun anvendes til denne type patienter i de tilfælde, hvor den kliniske fordel forventes at opveje de potentielle risici.
English: There are no available data concerning specific effects of other medicinal products on delafloxacin.
Danish: Der foreligger ingen data om andre lægemidlers specifikke virkninger på delafloxacin.
English: The patient should drink a sufficient amount of fluids while taking Quofenix.
Danish: Patienten bør drikke tilstrækkeligt med væske ved indtagelse af Quofenix.
English: Injection/infusion site reaction
Danish: Reaktioner på injektions/infusionsstedet
English: After reconstitution: Chemical and physical in-use stability has been demonstrated for 24 hours at 20 to 25ºC or at 2 to 8°C.
Danish: Efter rekonstitution: Den kemiske og fysiske stabilitet under brug er blevet påvist til 24 timer ved 20 til 25 °C eller ved 2 til 8 °C.
English: Tendinitis and tendon rupture (especially but not limited to Achilles tendon), sometimes bilateral, may occur as early as within 48 hours of starting treatment with quinolones and fluoroquinolones and have been reported to occur even up to several months after discontinuation of treatment.
Danish: Tendinitis og seneruptur (især, men ikke begrænset til akillessenen), nogle gange bilateralt, kan optræde allerede inden for 48 timer efter start af behandling med quinoloner og fluoroquinoloner, og der er indberettet tilfælde indtil flere måneder efter ophør med behandlingen.
English: Gastritis erosive
Danish: Erosiv gastritis
English: This medicinal product does not require any special storage conditions if kept unopened in the original container.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaring, hvis det opbevares uåbnet i den oprindelige beholder.
English: Staphylococcus aureus Streptococcus pyogenes Streptococcus dysgalactiae Streptococcus agalactiae Streptococcus anginosus group Escherichia coli
Danish: Staphylococcus aureus Streptococcus pyogenes Streptococcus dysgalactiae Streptococcus agalactiae Streptococcus anginosus gruppen Escherichia coli
English: The European Medicines Agency has waived the obligation to submit the results of studies with Quofenix in all subsets of the paediatric population in the treatment of local infections of skin and subcutaneous tissues (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Quofenix i alle undergrupper af den pædiatriske population ved behandling af lokale infektioner i hud og subkutant væv (se pkt.
English: Talk to your doctor if you have any concerns or questions about this and using Quofenix.
Danish: Tal med lægen, hvis du er bekymret eller har spørgsmål om dette og det at tage Quofenix.
English: Effect of delafloxacin on other medicinal products
Danish: Delafloxacins indvirkning på andre lægemidler
English: Cross-resistance between delafloxacin and other fluoroquinolones may be observed, although some isolates resistant to other fluoroquinolone may retain susceptibility to delafloxacin.
Danish: Der kan observeres krydsresistens mellem delafloxacin og andre fluoroquinoloner, selvom nogle isolater, der er resistente over for andre fluoroquinoloner, kan vedblive at være følsomme over for delafloxacin.
English: Long-term carcinogenicity studies have not been conducted with delafloxacin.
Danish: Der har ikke været foretaget længerevarende karcinogenicitetsstudier med delafloxacin.
English: Quofenix must not be co-infused with other medications.
Danish: Quofenix må ikke infunderes sammen med andre lægemidler.
English: • Allergic reaction
Danish: • Allergisk reaktion
English: Patients with glucose-6-phosphate dehydrogenase deficiency
Danish: Patienter med mangel på glucose-6-fosfat-dehydrogenase
English: Patients with toxic shock, neutropenia (neutrophil counts <500 cells/mm3) or severely immunocompromised patients were not included in the studies.
Danish: Patienter med toksisk shock, neutropeni (neutrofiltal < 500 celler/mm3) eller svært immunkompromitterede patienter blev ikke medtaget i studierne.
English: Dermatitis allergic Urticaria
Danish: Allergisk dermatitis Urticaria
English: Therefore, no dosage adjustment is necessary.
Danish: Der er således ikke behov for dosisjustering.
English: Some adverse drug reactions (e.g. dizziness, headache, visual disorders) may impair the patient's ability to concentrate and react, and therefore may constitute a risk in situations where the patient operates an automobile or machinery or engages in other activities requiring mental alertness and coordination.
Danish: Visse bivirkninger (f.eks. svimmelhed, hovedpine, synsforstyrrelser) kan hæmme patientens koncentrationsog reaktionsevne og kan således udgøre en risiko i situationer, hvor patienten skal føre motorkøretøj eller betjene maskiner eller deltage i andre aktiviteter, der kræver årvågenhed og koordination.
English: No dose adjustment is recommended based on gender.
Danish: Der anbefales ikke dosisjusteringer ud fra køn.
English: Resistance to fluoroquinolones, including delafloxacin, can occur due to mutations in defined regions of the target bacterial enzymes topoisomerase IV and DNA gyrase referred to as Quinolone-Resistance Determining Regions (QRDRs), or through other resistance mechanisms such as efflux mechanisms.
Danish: Resistens over for fluoroquinoloner, herunder delafloxacin, kan forekomme som følge af mutationer i definerede områder af de bakterielle målenzymer topoisomerase IV og DNA-gyrase (betegnet QRDR'er (Quinolone-Resistance Determining Regions)) eller gennem andre resistensmekanismer som f.eks. effluxmekanismer.
English: Pack-size: 10 vials.
Danish: Pakningsstørrelse: 10 hætteglas.
English: Oral administration of delafloxacin with antacids containing aluminium or magnesium, with sucralfate, with metal cations such as iron, or with multivitamins containing iron or zinc, or with formulations containing divalent and trivalent cations such as didanosine buffered tablets for oral suspension or the paediatric powder for oral solution, may substantially interfere with the absorption of delafloxacin, resulting in systemic concentrations considerably lower than desired.
Danish: Oral administration af delafloxacin med antacida indeholdende aluminium eller magnesium, med sukralfat, med metalkationer som f.eks. jern eller med multivitaminer indeholdende jern eller zink eller med formuleringer indeholdende divalente og trivalente kationer som f.eks. didanosin buffertabletter til oral suspension eller pædiatrisk pulver til oral opløsning, kan i væsentlig grad interferere med absorptionen af delafloxacin og således medføre systemiske koncentrationer, der er væsentligt lavere end ønsket.
English: Peak plasma delafloxacin concentrations are achieved at the end of the 1 hour intravenous infusion.
Danish: Maksimale plasmakoncentrationer af delafloxacin opnås ved slutningen af 1 times intravenøs infusion.
English: MillMount Healthcare Block-7, City North Business Campus, Stamullen, Co. Meath Ireland or
Danish: Millmount Healthcare Block-7, City North Business Campus, Stamullen, Co. Meath Irland eller
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ENHEDER 300 mg
English: Fluoroquinolones have neuromuscular blocking activity and may exacerbate muscle weakness in persons with myasthenia gravis.
Danish: Fluoroquinoloner virker neuromuskulært blokkerende og kan forværre muskelsvaghed hos personer med myasthenia gravis.
English: These may be signs of an infection of the bowel, which should not be treated with diarrhoea medicines that stop your bowels from moving.
Danish: Dette kan være tegn på en tarminfektion, som ikke bør behandles med medicin mod diarré, der får din mave til at gå i stå.
English: Pharmacokinetic/pharmacodynamic relationship
Danish: Farmokokinetiske/farmakodynamiske forhold
English: This medicine contains 39 mg of sodium (main component of cooking salt) in each tablet.
Danish: Dette lægemiddel indeholder 39 mg natrium (hovedkomponent i madlavnings-/bordsalt) i hver tablet.
English: If Clostridioides difficile-associated disease is suspected or confirmed treatment with delafloxacin should be discontinued and appropriate supportive measures together with the specific antibacterial treatment of C. difficile should be considered.
Danish: Ved mistænkt eller bekræftet sygdom forbundet med Clostridioides difficile bør behandling med delafloxacin ophøre, og der bør overvejes passende understøttende foranstaltninger sammen med specifik antibakteriel behandling af Clostridioides difficile.
English: • You have or may have problems with the central nervous system (e.g. severe cerebral arteriosclerosis, epilepsy) or have other risk factors that may put you at more risk of having seizures (fits).
Danish: • Du har eller har mistanke om at du har problemer med centralnervesystemet (for eksempel svær cerebral arteriosklerose, epilepsi), eller du har andre risikofaktorer, som kan give dig en større risiko for at få krampeanfald.
English: Fluoroquinolones have been associated with an increased risk of central nervous system (CNS) reactions, including: convulsions and increased intracranial pressure (including pseudotumor cerebri) and toxic psychosis.
Danish: Fluoroquinoloner har været forbundet med en øget risiko for reaktioner i centralnervesystemet, herunder kramper og øget intrakranielt tryk (herunder idiopatisk intrakraniel hypertension) og toksisk psykose.
English: Delafloxacin inhibits bacterial topoisomerase IV and DNA gyrase (topoisomerase II), enzymes required for bacterial DNA replication, transcription, repair, and recombination.
Danish: Delafloxacin hæmmer bakteriel topoisomerase IV og DNA-gyrase (topoisomerase II), enzymer, der er nødvendige til bakteriel DNA-replikation, transkription, reparation og rekombination.
English: Known fluoroquinolones-associated possible interactions shall be considered.
Danish: Der skal tages højde for kendte mulige interaktioner forbundet med fluoroquinoloner.
English: Clostridioides difficile-associated disease
Danish: Sygdom forbundet med Clostridioides difficile
English: Peak plasma delafloxacin concentrations are achieved within about 1 hour after oral administration under fasting conditions.
Danish: Maksimale plasmakoncentrationer af delafloxacin opnås inden for ca. 1 time efter oral administration under faste.
English: The risk of tendinitis and tendon rupture is increased in older patients, patients with renal impairment, patients with solid organ transplants, and those treated concurrently with corticosteroids.
Danish: Risikoen for tendinitis og seneruptur er øget hos ældre patienter, patienter med nedsat nyrefunktion, patienter, der har gennemgået organtransplantation, samt patienter, der samtidigt behandles med kortikosteroider.
English: Medicinal products inhibiting the peristalsis are contraindicated if Clostridioides difficile-associated disease is suspected.
Danish: Lægemidler, der hæmmer peristaltikken, er kontraindicerede, hvis der er mistanke om sygdom forbundet med Clostridioides difficile.
English: Infection of the bowel (Clostridioides difficile infection) is an uncommon side effect that may affect up to 1 in 100 people.
Danish: Tarminfektion (en infektion med Clostridioides difficile) er en ikke almindelig bivirkning og kan forekomme hos op til 1 ud af 100 personer.
English: Clostridioides difficileassociated disease must be considered in all patients who present with diarrhoea.
Danish: Sygdom forbundet med Clostridioides difficile skal overvejes hos alle patienter ramt af diarré.
English: The half-life of oral delafloxacin is approximately 14 hours.
Danish: Halveringstiden for oral delafloxacin er ca. 14 timer.