FrancophonIA/ELRC3.0 huggingface dataset:
English: The most common adverse drug reactions reported in ABSSSI Phase 2 and 3 studies involving 868 patients exposed to delafloxacin, intravenous or oral formulation, were diarrhoea and nausea (6.91% and 7.83%, respectively) which were mild to moderate in intensity.
Danish: De mest almindelige bivirkninger indberettet i ABSSSI fase 2- og 3-studier, som omfatter 868 patienter, der blev eksponeret for delafloxacin, intravenøst eller oralt, var diarré og kvalme (henholdsvis 6,91 % og 7,83 %) i let til moderat grad.
English: Beige to mottled beige, oblong biconvex tablets of approximately 10 mm width x 21 mm length, with RX3341 debossed on one side.
Danish: Beige til beigemarmorerede, aflange bikonvekse tabletter ca. 10 mm brede og 21 mm lange med RX3341 præget på den ene side.
English: Intravenous use after reconstitution and dilution.
Danish: Til intravenøs brug efter rekonstitution og fortynding.
English: Before initiating therapy with Quofenix, careful inquiry should be made about previous hypersensitivity reactions to other quinolone or fluoroquinolone antibacterial medicinal products.
Danish: Før behandling med Quofenix indledes, skal der omhyggeligt spørges ind til tidligere overfølsomhedsreaktioner ved andre lægemidler indeholdende quinoloner eller fluoroquinoloner.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNIT VIAL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLASETIKET
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, tell your doctor before you are taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du tager dette lægemiddel.
English: In patients with moderate to severe renal impairment, accumulation of cyclodextrins occurs.
Danish: Hos patienter med moderat til svært nedsat nyrefunktion vil cyclodextriner akkumuleres.
English: Talk to your doctor or pharmacist or nurse before taking Quofenix if:
Danish: Tal med din læge, apotekspersonalet eller sygeplejersken, før du tager Quofenix, hvis:
English: Therefore, fluoroquinolones should only be used after careful benefit-risk assessment and after consideration of other therapeutic options in patients with positive family history of aneurysm disease, or in patients diagnosed with pre-existing aortic aneurysm and/or aortic dissection, or in presence of other risk factors or conditions predisposing for aortic aneurysm and dissection (e.g. Marfan syndrome, vascular Ehlers-Danlos syndrome, Takayasu arteritis, giant cell arteritis, Behcet's disease, hypertension, known atherosclerosis).
Danish: Derfor bør fluoroquinoloner kun anvendes efter en grundig vurdering af benefit/risk-forholdet og efter overvejelse af andre terapeutiske muligheder hos patienter med en familieanamnese med aneurismesygdomme og hos patienter diagnosticeret med allerede eksisterende aortaaneurisme og/eller aortadissektion eller ved tilstedeværelse af andre risikofaktorer eller tilstande, der prædisponerer for aortaaneurisme og - dissektion (f.eks. Marfans syndrom, vaskulær Ehlers-Danlos syndrom, Takayasus arteritis, kæmpecelle arteritis, Behcets sygdom, hypertension eller kendt aterosklerose).
English: Aortic dissection and aneurysm
Danish: Aortadissektion og aneurisme
English: The safety and efficacy of the dose adjustment guidance in patients with severe renal impairment has not been clinically evaluated and is based on pharmacokinetic modelling data.
Danish: Sikkerhed og virkning af retningslinjerne for dosisjustering hos patienter med svært nedsat nyrefunktion er ikke vurderet klinisk og bygger på data fra farmakokinetiske modeller.
English: • Abnormal hair loss
Danish: • Unormalt hårtab
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, tell your doctor before you are given this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: Streptococcus oralis, Streptococcus mitis, and Streptococcus sanguinis)
Danish: Streptococcus oralis, Streptococcus mitis og Streptococcus sanguinis)
English: Central Nervous System Effects
Danish: Indvirkning på centralnervesystemet
English: Importantly, gastrointestinal effects and slightly elevated liver enzymes in dogs were not associated with histopathological changes of gastrointestinal and annexed tissues (pancreas, liver).
Danish: Vigtigst af alt blev der ikke fundet nogen forbindelse mellem de gastrointestinale virkninger eller de let forhøjede leverenzymer hos hunde og de histopatologiske ændringer i de gastrointestinale væv og tilknyttet væv (pankreas, lever).
English: Likewise at clinically relevant concentrations delafloxacin does not inhibit the transporters MDR1, BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, MATE2K and BSEP.
Danish: Tilsvarende hæmmer delafloxacin ved klinisk relevante koncentrationer ikke transportørerne MDR1, BCRP, OAT1, OAT3, OCT1, OCT2, OATP1B1, OATP1B3, MATE1, MATE2K og BSEP.
English: Sodium hydroxide (for pH-adjustment) Hydrochloric acid, concentrated (for pH-adjustment)
Danish: Natriumhydroxid (til pH-justering) Saltsyre, koncentreret (til pH-justering)
English: • Change in taste
Danish: • Smagsforandringer
English: Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken eller blisteren efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The effects of delafloxacin on fertility in humans have not been studied.
Danish: Der foreligger ingen studier af delafloxacins indvirkning på fertiliteten hos mennesker.
English: If this happens, stop taking Quofenix and inform your doctor immediately in order to prevent the development of potentially irreversible condition.
Danish: Skulle det ske, må du ikke få Quofenix, og du skal straks fortælle det til lægen, så det ikke udvikler sig til noget, der eventuelt kan blive en permanent tilstand.
English: Light yellow to tan cake, which may exhibit cracking and shrinkage and slight variation in texture and colour.
Danish: Lysegult til lysebrunt kompakt pulver, som kan revne og krympe og udvise små variationer i konsistens og farve.
English: Delafloxacin should be discontinued immediately at the first signs or symptoms of any serious adverse reaction and patients should be advised to contact their prescriber for advice.
Danish: Brug af delafloxacin bør straks seponeres ved første tegn eller symptomer på alvorlige bivirkninger, og patienterne bør rådes til at kontakte den læge, der har ordineret lægemidlet, for nærmere råd og vejledning.
English: Dose adjustment is needed in patients with severe renal impairment (see section 4.2).
Danish: Der er behov for dosisjustering hos patienter med svært nedsat nyrefunktion (se pkt 4.2).
English: Paediatric population Quofenix is contraindicated in children and adolescents (see section 4.3).
Danish: Pædiatrisk population Quofenix er kontraindiceret til børn og unge (se pkt.
English: • You have had tendon problems during previous treatment with a fluoroquinolone or quinolone antibiotic.
Danish: • Du har haft problemer med senerne i forbindelse med tidligere behandling med antibiotika indeholdende fluoroquinoloner eller quinoloner.
English: • The reconstituted solution must be then diluted in 250mL IV bag (either 0.9% Sodium Chloride Injection or D5W) prior to administration.
Danish: • Den rekonstituerede opløsning skal derefter fortyndes i en 250 ml i.v.-pose (enten 0,9 % natriumchlorid injektionsvæske eller D5W) før administration.
English: Pregnancy, women of childbearing potential not using contraception and breast-feeding (see section
Danish: Graviditet, behandling af fertile kvinder, der ikke anvender prævention, og amning (se pkt.
English: The safety and efficacy of the dose recommendation in patients with severe renal impairment has not been clinically evaluated and is based on pharmacokinetic modelling data.
Danish: Sikkerhed og virkning af den anbefalede dosis til patienter med svært nedsat nyrefunktion er ikke vurderet klinisk og bygger på data fra farmakokinetiske modeller.
English: Hypertension Hypotension Flushing Phlebitis
Danish: Hypertension Hypotension Rødmen Flebitis
English: The half-life of IV delafloxacin is approximately 10 hours.
Danish: Halveringstiden for intravenøs delafloxacin er ca. 10 timer.
English: After single intravenous dose of 14C-labeled delafloxacin, 65% of the radioactivity is excreted in the urine and 28% is excreted in the faeces.
Danish: C-mærket delafloxacin udskilles 65 % af radioaktiviteten i urinen og 28 % i fæces.
English: This medicine contains 175 mg of sodium (main component of cooking salt) in each vial.
Danish: Dette lægemiddel indeholder 175 mg natrium (hovedkomponent i madlavnings-/bordsalt) pr. hætteglas.
English: If you experience any of these side effects after taking Quofenix, contact your doctor immediately prior to continuing treatment.
Danish: Hvis du får nogen af disse bivirkninger efter at have taget Quofenix, skal du straks kontakte lægen, før du fortsætter behandlingen.
English: Following a single oral (400 mg) administration to patients with mild, moderate or severe renal impairment, mean total exposure (AUCt) was about 1.5-fold higher for subjects with moderate and severe renal impairment compared with healthy subjects, whereas total systemic exposures were comparable to subjects with mild renal impairment.
Danish: Efter en enkelt oral (400 mg) administration til patienter med let, moderat eller svært nedsat nyrefunktion var den samlede middeleksponering (AUC) ca. 1,5 gange højere for forsøgspersoner med moderat og svært nedsat nyrefunktion sammenlignet med raske forsøgspersoner, hvorimod den samlede systemiske eksponering var sammenlignelig med forsøgspersoner med let nedsat nyrefunktion.
English: It is available in perforated unit dose blister pack which contains blisters of 10x1 tablets into pack size of 10,20,30,50, 60 or 100 tablets per carton.
Danish: Tabletterne fås i perforerede enkeltdosisblisterpakninger indeholdende blistre med 10x1 tabletter i pakningsstørrelser med 10, 20, 30, 50, 60 eller 100 tabletter pr. æske.
English: Gastrooesophageal reflux disease Paraesthesia oral Hypoaesthesia oral Glossodynia
Danish: Gastroøsofageal reflukssygdom Oral paræstesi
English: - The other ingredients are cellulose microcrystalline, povidone, crospovidone, sodium hydrogen carbonate, sodium dihydrogen phosphate monohydrate, citric acid, magnesium stearate.
Danish: øvrige indholdsstoffer: mikrokrystallinsk cellulose, povidon, crospovidon, natriumhydrogencarbonat, natriumdihydrogenphosphat monohydrat, citronsyre, magnesiumstearat.
English: Clinically significant gender-related differences in delafloxacin pharmacokinetics have not been observed in healthy subjects or in patients with ABSSSI.
Danish: Der er ikke observeret klinisk relevante, kønsrelaterede forskelle i delafloxacins farmakokinetik hos raske forsøgspersoner eller hos patienter med ABSSSI.
English: Delafloxacin does not induce CYP1A2, CYP2B6, CYP2C9, CYP2C8, CYP2C19 or CYP3A4/5.
Danish: Delafloxacin inducerer ikke CYP1A2, CYP2B6, CYP2C9, CYP2C8, CYP2C19 eller CYP3A4/5.
English: You should not be given fluoroquinolone/quinolone antibacterial medicines, including Quofenix, if you have experienced any serious adverse reaction in the past when taking a quinolone or fluoroquinolone.
Danish: Du må ikke få antibakteriel medicin indholdende fluoroquinoloner/quinoloner, herunder Quofenix, hvis du tidligere har fået alvorlige bivirkninger, når du har taget fluoroquinoloner eller quinoloner.
English: Women of childbearing potential have to use effective contraception during treatment with delafloxacin.
Danish: Fertile kvinder skal anvende effektiv prævention under behandling med delafloxacin.
English: Each vial contains 175 mg of sodium.
Danish: Hvert hætteglas indeholder 175 mg natrium.
English: • The required dose of Quofenix reconstituted solution should be aseptically transferred from the vial to a 250 mL intravenous bag.
Danish: • Den ønskede dosis Quofenix rekonstitueret opløsning skal aseptisk overføres fra hætteglasset til en 250 ml i.v.-pose.
English: Talk to your doctor or pharmacist or nurse before you are given Quofenix if:
Danish: Tal med din læge, apotekspersonalet eller sygeplejersken, før du får Quofenix, hvis:
English: As per fluoroquinolone class patients aged over 60 years are at increased risk for developing severe tendon disorders including tendon rupture (see sections 4.4 and
Danish: I lyset af fluoroquinoloners karakter har patienter over 60 år en øget risiko for at udvikle alvorlige senelidelser, herunder seneruptur (se pkt.
English: No clinically meaningful changes in delafloxacin Cmax and AUC∞ were observed, following administration of a single 300 mg intravenous dose of delafloxacin into patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B and C) compared to matched healthy control subjects.
Danish: Der blev ikke observeret klinisk meningsfulde ændringer i delafloxacin Cmax og AUC∞ efter administration af en enkelt intravenøs dosis delafloxacin på 300 mg hos patienter med let, moderat eller svært nedsat leverfunktion (Child-Pugh klasse A, B og C) sammenlignet med en tilsvarende gruppe raske kontrolpersoner.
English: Following single intravenous (300 mg) administration to patients with mild, moderate, or severe renal impairment or ESRD on haemodialysis with and without haemodialysis after dosing, mean total exposure (AUCt) were 1.3, 1.7, 2.1, 3.5 and 4.1-fold higher than values for matched control subjects.
Danish: Efter intravenøs administration af en enkelt dosis (300 mg) til patienter med let, moderat eller svært nedsat nyrefunktion eller ESRD i hæmodialyse med eller uden hæmodialyse efter dosering var den samlede middeleksponering (AUCt) 1,3; 1,7; 2,1; 3,5 og 4,1 gange højere end værdierne for de tilsvarende kontrolpersoner.
English: No clinically meaningful changes in delafloxacin pharmacokinetics when administered delafloxacin in patients with mild, moderate or severe hepatic impairment (Child-Pugh Class A, B and C) compared to matched healthy control subjects.
Danish: Der blev ikke observeret klinisk meningsfulde ændringer i farmakokinetikken for delafloxacin ved administration af delafloxacin til patienter med let, moderat eller svært nedsat leverfunktion (ChildPugh klasse A, B og C) sammenlignet med en tilsvarende gruppe raske kontrolpersoner.
English: Thrombocytopenia Haematocrit decreased White blood cell count decreased Haemoglobin decreased Red blood cell count decreased
Danish: Trombocytopeni Nedsat hæmatokrit Nedsat antal hvide blodlegemer Nedsat hæmoglobin Nedsat antal røde blodlegemer
English: • You have a family history of aortic aneurysm or aortic dissection or other risk factors or predisposing conditions (e. g. connective tissue disorders such as Marfan syndrome, or vascular Ehlers-Danlos syndrome, or vascular disorders such as Takayasu arteritis, giant cell arteritis, Behcet's disease, high blood pressure, or known atherosclerosis).
Danish: • der i din familie tidligere har været et tilfælde af aortaaneurisme eller aortadissektion eller andre risikofaktorer eller prædisponerende sygdomme (f.eks. bindevævssygdom som Marfans syndrom eller vaskulær Ehlers-Danlos syndrom eller karsygdomme som f.eks. Takayasu arteritis (blodårebetændelse), kæmpecelle arteritis, Behcets sygdom, for højt blodtryk eller kendt aterosklerose (åreforkalkning)).
English: Delafloxacin should be used when the benefits of treatment exceed the risks in patients with known or suspected CNS disorders (e.g., severe cerebral arteriosclerosis, epilepsy) or in the presence of other risk factors that may predispose to seizures or lower the seizure threshold.
Danish: Delafloxacin bør anvendes, når fordelene ved behandlingen overstiger risiciene for patienter med kendte eller formodede lidelser i centralnervesystemet (dvs. svær cerebral arteriosklerose, epilepsi) eller ved forekomst af andre risikofaktorer, der kan gøre patienten prædisponeret for anfald eller sænke tærsklen for anfald.
English: In diabetic patients, careful monitoring of blood glucose is recommended.
Danish: Det anbefales at monitorere blodsukkeret nøje hos diabetespatienter.
English: Accumulation of the intravenous vehicle sulfobutylbetadex sodiumoccurs in patients with moderate to severe renal impairment; therefore serum creatinine levels should be closely monitored in these patients, and, if increases occur, consideration should be given to switch to Quofenix 450 mg tablet every 12 hours.
Danish: Serumkreatinin-niveauerne bør derfor monitoreres nøje hos disse patienter, og i tilfælde af en forøgelse skal det overvejes at skifte til Quofenix 450 mg tablet hver 12. time.
English: • Flushing (e.g. redness of the face or neck)
Danish: • Rødmen (f.eks. rødme i ansigtet eller på halsen)
English: The following adverse reactions have been identified in four comparative ABSSSI Phase 2 and 3 studies classified by preferred term and System Organ Class, and by frequency.
Danish: Bivirkningerne er klassificeret efter foretrukken term og systemorganklasse samt hyppighed.
English: The use of delafloxacin is not recommended in patients with known history of myasthenia gravis.
Danish: Delafloxacin bør ikke anvendes til patienter med myasthenia gravis i anamnesen.
English: Sinus tachycardia Palpitations Bradycardia
Danish: Sinustakykardi Palpitationer Bradykardi
English: Medical device complication
Danish: Komplikation med det medicinske udstyr
English: No effects were detected on rat male and female fertility at a level of exposure about 5-fold higher than that observed in humans.
Danish: Der blev ikke observeret virkninger på fertiliteten hos han- og hunrotter ved et eksponeringsniveau, der var ca. 5 gange højere end det, der er observeret for mennesker.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (TABLETS)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE ÆSKE (TABLETTER)
English: Hypertransaminasaemia Blood alkaline phosphatase increased Blood albumin decreased
Danish: Hypertransaminasæmi Forhøjet alkalisk fosfatase i blodet Nedsat albumin i blodet
English: The use of delafloxacin should be avoided in patients who have experienced serious adverse reactions in the past when using quinolone or fluoroquinolone containing products (see section 4.8).
Danish: Brug af delafloxacin skal undgås til patienter, der har oplevet alvorlige bivirkninger i forbindelse med anvendelse af midler indeholdende quinolon eller fluoroquinolon (se pkt.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du ønsker yderligere oplysninger om Quofenix, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: Hypersensitivity to any fluoroquinolone or quinolone antibacterial medicinal product.
Danish: Overfølsomhed over for et antibakterielt fluoroquinolon- eller quinolon-lægemiddel.
English: In case of sudden abdominal, chest or back pain, patients should be advised to immediately consult a physician in an emergency department.
Danish: I tilfælde af pludselige smerter i maven, brystet eller ryggen skal patienterne rådes til at tage på skadestuen øjeblikkeligt.
English: In patients with moderate, or severe renal impairment or ESRD on haemodialysis, accumulation of the intravenous vehicle sulfobutylbetadex sodium occurs.
Danish: Hos patienter med moderat eller svært nedsat nyrefunktion eller ESRD i hæmodialyse forekom der akkumulering af det intravenøse hjælpestof sulfobutylether-beta-cyclodextrinnatrium.
English: Dysglycaemia
Danish: Dysglykæmi
English: This medicinal product does not require any special storage conditions.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende opbevaring.
English: The steady state volume of distribution of delafloxacin is about 40 L which approximates total body water.
Danish: Delafloxacins fordelingsvolumen ved steady state er omtrent 40 l, hvilket svarer nogenlunde til væskemængden i kroppen.
English: At the first sign of pain or inflammation of a tendon (for example in your ankle, wrist, elbow, shoulder or knee), stop taking Quofenix, contact your doctor and rest the painful area.
Danish: Så snart du mærker de første tegn på smerte eller inflammation i en sene (for eksempel i ankel, håndled, albue, skulder eller knæ), må du ikke længere få Quofenix.
English: Switch to delafloxacin 450 mg tablet orally every 12 hours is possible at the discretion of the physician.
Danish: Skift til delafloxacin 450 mg tablet oralt hver 12. time, hvis det efter lægens vurdering er muligt.
English: Quofenix must not be used in women of childbearing potential not using contraception.
Danish: Quofenix må ikke bruges til kvinder, der kan blive gravide, og som ikke bruge prævention.
English: • Inflammation of the lining of the stomach, inflammation of the internal tissues of the mouth,
Danish: • Inflammation i maveslimhinden, inflammation i vævet i munden, mavesmerter,
English: After reconstitution each ml contains 25 mg of delafloxacin.
Danish: Efter rekonstitution indeholder hver ml 25 mg delafloxacin.
English: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving fluoroquinolone antibacterial medicinal products.
Danish: Der er indberettet tilfælde af alvorlige, herunder letale, overfølsomhedsreaktioner (anafylaktiske reaktioner) hos patienter, der fik antibakterielle lægemidler indeholdende fluoroquinoloner.
English: Psychiatric disorders*
Danish: Psykiske forstyrrelser*
English: EU/1/19/1393/002-007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/19/1393/002-007
English: Patients with known hypersensitivity to delafloxacin or other fluoroquinolones should not take Quofenix (see section 4.3).
Danish: Patienter med kendt overfølsomhed over for delafloxacin eller andre fluoroquinoloner bør ikke tage Quofenix (se pkt.
English: If you experience any of these side effects after receiving Quofenix, contact your doctor immediately prior to continuing treatment.
Danish: Hvis du får nogen af disse bivirkninger efter at have fået Quofenix, skal du straks fortælle det til lægen, før du fortsætter behandlingen.
English: Clostridioides difficile infection (see section 4.4)
Danish: Infektion med Clostridioides difficile (se pkt.
English: Other medicines and Quofenix
Danish: Brug af anden medicin sammen med Quofenix
English: This medicinal product contains sulfobutylbetadex sodium.
Danish: Dette lægemiddel indeholder sulfobutylether-beta-cyclodextrinnatrium.
English: The radioactivity recovered from faeces is unchanged delafloxacin.
Danish: Den radioaktivitet, der genfindes i fæces, er uomdannet delafloxacin.
English: If a common intravenous line is being used to administer other medicinal products in addition to Quofenix the line should be flushed before and after each Quofenix infusion with sodium chloride 9 mg/ml (0.9%) solution for injection or D5W.
Danish: Ved anvendelse af en fælles i.v.-slange til administration af andre lægemidler ud over Quofenix skal slangen skylles med natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning eller med D5W, før og efter hver infusion af Quofenix.
English: Patients with known hypersensitivity to delafloxacin or other fluoroquinolones must not take Quofenix (see section 4.3).
Danish: Patienter med kendt overfølsomhed over for delafloxacin eller andre fluoroquinoloner må ikke tage Quofenix (se pkt.
English: If women of a sexually mature age are treated, effective contraception must be used during treatment (see section 4.6).
Danish: Fertile kvinder skal anvende effektiv prævention under behandlingen (se pkt.
English: This medicinal product does not require any special temperature storage conditions.
Danish: Dette lægemiddel kræver ingen særlige forholdsregler vedrørende temperatur under opbevaringen.