FrancophonIA/ELRC3.0 huggingface dataset:
English: You and your doctor will decide on continuing the treatment considering also an antibiotic from another class.
Danish: Du og din læge vil derefter afgøre, om du skal fortsætte med behandlingen eller eventuelt skal have en anden form for antibiotikum.
English: • Decrease of special blood cells necessary for blood clotting
Danish: • Reduktion i antallet af særlige blodceller, der er nødvendige for, at blodet kan størkne
English: Cases of hypoglycaemic coma have been reported.
Danish: Der er indberettet tilfælde af hypoglykæmisk koma.
English: • an antacid, multivitamin, or other product that has magnesium, aluminium, iron, or zinc
Danish: • et syreneutraliserende lægemiddel, et multivitaminpræparat eller andre produkter indeholdende magnesium, aluminium, jern eller zink
English: In rats foetal effects occurred at a level of exposure exceeding about 2fold that observed in humans based on the AUC, but in rabbits, a species known to be extremely sensitive to maternal toxicity of antibacterial drugs, the effects on foetuses were recorded at levels of exposure well below that observed in humans.
Danish: Hos rotter forekom der fostervirkninger ved et eksponeringsniveau, der var omkring 2 gange større end det, der blev observeret for mennesker, ud fra AUC; men hos kaniner, en dyreart, der er kendt for at være ekstremt sensitiv over for maternal toksicitet ved antibakterielle stoffer, blev fostervirkninger registreret ved eksponeringsniveauer, der lå et godt stykke under de eksponeringsniveauer, der blev observeret hos mennesker.
English: Patients with a family history of, or actual glucose-6-phosphate dehydrogenase deficiency are prone to haemolytic reactions when treated with other quinolones.
Danish: Patienter med familiær baggrund for eller med aktuel mangel på glucose-6-fosfat dehydrogenase har tendens til hæmolytiske reaktioner ved behandling med andre quinoloner.
English: Quofenix is not recommended in patients with ESRD.
Danish: Quofenix anbefales ikke til patienter med ESRD.
English: This medicinal product contains 39 mg sodium per tablet, equivalent to 2% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 39 mg natrium pr. tablet, svarende til 2 % af den WHO anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: България Берлин-Хеми/А.
Danish: Берлин-Хеми/А.
English: Based on in vitro data on metabolising enzymes and transporters delafloxacin possesses a low potential to alter the disposition of other medicinal products (see section 5.2).
Danish: Ud fra in vitro-data om metaboliserende enzymer og transportører har delafloxacin kun ringe potentiale for at ændre andre lægemidlers fordeling (se pkt.
English: This is equivalent to 8.8% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 8,8 % af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: • Dry eye
Danish: • Tørre øjne
English: • You have kidney problems.
Danish: • Du har problemer med nyrerne.
English: - Difficulty in swallowing or difficulty in breathing and cough; swelling of your lips, face, throat or tongue; dry throat or throat tightening and severe rash.
Danish: De omfatter smerter i sener, muskler og led i arme og ben,
English: You will be given one infusion of Quofenix, containing 300 mg of the medicine, twice a day between 5 and 14 days at the discretion of your doctor.
Danish: Du vil få en infusion med Quofenix indeholdende 300 mg af medicinen 2 gange dagligt i 5-14 dage alt efter lægens vurdering.
English: • After reconstitution and dilution, Quofenix is to be administered via intravenous infusion, using a total infusion time of 60 minutes.
Danish: • Efter rekonstitution og opløsning skal Quofenix administreres ved intravenøs infusion i løbet af en samlet infusionstid på 60 minutter.
English: The fAUC24/MIC ratio, as for other quinolone antibiotics, resulted in the pharmacokinetic/ pharmacodynamic parameter most closely associated with the efficacy of delafloxacin.
Danish: Forholdet mellem fAUC24 og MIC resulterede som for andre quinoloner i den farmakokinetiske/farmakodynamiske parameter, der er tættest forbundet med virkningen af delafloxacin.
English: Sodium hydrogen carbonate Sodium dihydrogen phosphate monohydrate Citric acid
Danish: Natriumhydrogencarbonat Natriumdihydrogenphosphat monohydrat Citronsyre
English: As delafloxacin is excreted in milk, severe toxicity was observed in newborn rats during lactation when mothers were treated during pregnancy and lactation with delafloxacin at a dose producing a systemic exposure about 5-fold higher than observed in humans.
Danish: Eftersom delafloxacin udskilles i mælk, blev der observeret svær toksicitet hos nyfødte rotter, der diede, når mødrene under drægtighed og laktation blev behandlet med delafloxacin i en dosis, der medførte en systemisk eksponering, der var ca. 5 gange højere end den, der er observeret for mennesker.
English: Quofenix is not recommended in patients with End Stage Renal Disease (ESRD).
Danish: Quofenix anbefales ikke til patienter med terminalt nyresvigt (End Stage Renal Disease - ESRD).
English: Millmount Healthcare Block-7, City North Business Campus, Stamullen, Co. Meath Ireland or
Danish: MillMount Helathcare Block-7, City North Business Campus, Stamullen, Co. Meath Irland eller
English: 10x1 tablets 20x1 tablets 30x1 tablets 50x1 tablets 60x1 tablets 100x1 tablets
Danish: 10x1 tabletter 20x1 tabletter 30x1 tabletter 50x1 tabletter 60x1 tabletter 100x1 tabletter
English: Available pharmacodynamic/toxicological data in animals have shown excretion of delafloxacin/metabolites in milk (see section 5.3).
Danish: Foreliggende farmakokinetiske/toksikologiske data for dyr har vist, at delafloxacin/metabolitter udskilles i mælken (se pkt.
English: Quofenix is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults when it is considered inappropriate to use other antibacterial agents that are commonly recommended for the initial treatment of these infections (see sections 4.4 and 5.1).
Danish: Quofenix er indiceret til behandling af akutte bakterieinfektioner i huden og hudstrukturen (acute bacterial skin and skin structure infections - ABSSSI) hos voksne, hvis det anses for uhensigtsmæssigt at anvende andre antibakterielle midler, der almindeligvis anbefales til den indledende behandling af disse infektioner (se pkt.
English: However, no such effects and no other developmental abnormalities occurred in the progeny of mothers exposed up to a level about 2-fold higher than observed in humans.
Danish: Der forekom dog ikke tilsvarende virkninger og ingen andre udviklingsmæssige anomalier hos afkommet af mødre, der blev eksponeret for et niveau på op til ca. 2 gange højere end det, der er observeret for mennesker.
English: Ask your pharmacist how to throw away medicines you no longer use.
Danish: Spørg apotekespersonalet, hvordan du skal bortskaffe medicinrester.
English: Cases of bullous skin reactions like Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with other fluoroquinolones.
Danish: Der er indberettet tilfælde af bulløse hudreaktioner som f.eks. Stevens-Johnsons syndrom eller toksisk epidermal nekrolyse med andre fluoroquinoloner.
English: Nonclinical studies conducted with delafloxacin in rats do not indicate harmful effects with respect to fertility or reproductive performance (see section 5.3).
Danish: Non-kliniske studier af delafloxacin hos rotter giver ingen indikation på skadelige virkninger, hvad angår fertilitet eller reproduktionsevne (se pkt.
English: No adverse effects were seen in rats at exposures about 2-fold higher than humans, or in dogs at exposures approximately equal to humans.
Danish: Der blev ikke set bivirkninger hos rotter ved eksponeringer, der var ca. 2 gange højere end for mennesker, eller hos hunde ved eksponeringer, der omtrent svarede til dem for mennesker.
English: Patients under treatment with delafloxacin should be advised to inform their doctor prior to continuing treatment if symptoms of neuropathy such as pain, burning, tingling, numbness, or weakness develop in order to prevent the development of potentially irreversible condition (see section 4.8).
Danish: Patienter, der behandles med delafloxacin, bør rådes til at informere deres læge om det, før behandlingen fortsættes, hvis der udvikler sig symptomer på neuropati såsom smerter, en brændende eller snurrende fornemmelse, følelsesløshed eller svaghed for at forebygge udvikling af en potentielt irreversibel tilstand (se pkt.
English: It works by blocking bacteria enzymes needed to copy and to repair their DNA.
Danish: Det virker ved at blokere enzymer, der er nødvendige for at kunne kopiere og reparere bakteriernes DNA.
English: • You may have a severe skin reaction such as blistering or lesion.
Danish: • Du måske har en kraftig hudreaktion, som for eksempel blærer eller sår.
English: • Muscle inflammation/pain
Danish: • Muskelinflammation/-smerter
English: • Abnormal dreams
Danish: • Abnorme drømme
English: Tell your doctor or nurse immediately if you are concerned that you may have been given too much Quofenix.
Danish: Sig det straks til lægen eller sygeplejersken, hvis du er bekymret for, om du kan have fået for meget Quofenix.
English: Serious bullous skin reactions
Danish: Alvorlige bulløse hudreaktioner
English: Effect of other medicinal products on delafloxacin
Danish: Andre lægemidlers indvirkning på delafloxacin
English: • Blood test alteration related to kidney or liver function (blood alkaline phosphatase increased,
Danish: • Ændring i blodprøve forbundet med nyre- eller leverfunktionen (forhøjet alkalisk fosfatase i blodet, nedsat albumin i blodet)
English: In embryo-fetal development studies carried out in rats and rabbits, delafloxacin was devoid of teratogenic effects but induced foetal growth retardation and ossification delays at levels of dose producing maternal toxicity.
Danish: I embryoføtale udviklingsstudier med rotter og kaniner sås der ingen teratogene virkninger af delafloxacin, men delafloxacin inducerede nedsat fostervækst og forsinket ossifikation ved doser, der medførte maternal toksicitet.
English: No dose adjustment is necessary in patients with mild to moderate renal impairment (CrCl of ≥30 mL/min).
Danish: Det er ikke nødvendigt at justere dosis til patienter med let til moderat nedsat nyrefunktion (CrCl ≥30 ml/min).
English: There are no data concerning an interaction of intravenous delafloxacin with multivitamins, other supplements or didanosine.
Danish: Der foreligger ingen data om en påvirkning af intravenøst indgivet delafloxacin på multivitaminer, andre kosttilskud eller didanosin.
English: 20 ml clear type I glass vials outfitted with 20 mm type I rubber stoppers and 20 mm flip-off caps.
Danish: Type I hætteglas (glas) på 20 ml forsynet med 20 mm type I gummipropper og 20 mm flip-off hætter.
English: Do not take any medicine to treat your diarrhoea without first checking with your doctor.
Danish: Du må ikke tage medicin mod diarréen, før du har talt med lægen.
English: Cases of sensory or sensorimotor polyneuropathy resulting in paraesthesia, hypaesthesia, dysesthesia, or weakness have been reported in patients receiving quinolones and fluoroquinolones.
Danish: Der er indberettet tilfælde af sensorisk eller sensomotorisk polyneuropati resulterende i paræstesi, hypæstesi, dysæstesi eller svaghed hos patienter, der modtager quinoloner og fluoroquinoloner.
English: • If you have ever had a problem with your tendons such as tendonitis that was related to treatment with a ‘quinolone antibiotic'.
Danish: • Hvis du nogen sinde har haft problemer med dine sener (som senebetændelse) i forbindelse med behandling med et ”quinolon-antibiotikum”.
English: However, delafloxacin should not be co-administered with any solution containing multivalent cations, e.g. magnesium, through the same intravenous line (see section 4.2 and
Danish: Delafloxacin bør dog ikke administreres samtidigt med opløsninger indeholdende multivalente kationer, som f.eks. magnesium, gennem samme intravenøse slange (se pkt.
English: Clostridioides difficile-associated disease has been reported in users of nearly all systemic antibacterial medicinal products, with severity ranging from mild diarrhoea to fatal colitis.
Danish: Der er indberettet tilfælde af sygdom forbundet med Clostridioides difficile hos brugere af næsten alle former for systemiske, antibakterielle lægemidler i sværhedsgrader, der går fra let diarré til kolitis med dødelig udgang.
English: This is equivalent to 2% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Det svarer til 2 % af den anbefalede maximale daglige indtagelse af natrium for en voksen.
English: Pack sizes of 10 x1, 20 x1, 30 x1, 50 x1, 60 x1 or 100 x1 tablets.
Danish: Pakningsstørrelser med 10 x 1, 20 x 1, 30 x 1, 50 x 1, 60 x 1 eller 100 x 1 tabletter.
English: Tell your doctor or nurse immediately if you are concerned that you may have missed a dose.
Danish: Sig det straks til lægen eller sygeplejersken, hvis du er bekymret for, om du kan have sprunget en dosis over.
English: If you feel sudden, severe pain in your abdomen, chest or back, go immediately to an emergency room.
Danish: Hvis du pludseligt får kraftige smerter i maven, brystet eller ryggen, skal du straks tage på skadestuen.
English: By blocking these enzymes, Quofenix kills bacteria that cause the infection.
Danish: Ved at blokere disse enzymer, dræber Quofenix de bakterier, der har forårsaget infektionen.
English: Plasma protein binding of delafloxacin is not significantly affected by the degree of renal impairment.
Danish: Delafloxacins plasmaproteinbinding påvirkes ikke signifikant af graden af nyrefunktionsnedsættelsen.
English: However, Quofenix should not be given together with any solution containing substances such as calcium and magnesium, through the same intravenous line.
Danish: Quofenix bør dog ikke gives i samme dropslange som opløsninger, der indeholder stoffer som kalcium og magnesium.
English: If you might become pregnant you have to use effective contraception during treatment with Quofenix.
Danish: Hvis der er risiko for, at du kan blive gravid, skal du bruge effektiv prævention, mens du behandles med Quofenix.
English: This medicinal product contains 175 mg sodium per vial, equivalent to 8.8% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Dette lægemiddel indeholder 175 mg natrium pr. hætteglas, svarende til 8,8 % af den WHO anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: Quofenix will be given to you by a nurse or doctor via an infusion (drip) into a vein.
Danish: Du vil få Quofenix af en sygeplejerske eller en læge som et drop i en vene.
English: In addition increases in serum ALT and ALP, and reduced total protein and globulin values were recorded at the end of the treatment period in the pivotal 4-week IV dog study at the high dose (75 mg/kg) in individual dogs.
Danish: Derudover blev der registreret en forøgelse af serum ALAT og ALP samt reduktion af de samlede protein- og globulinværdier i slutningen af behandlingsperioden i det pivotale 4-ugers i.v.
English: - The active substance is delafloxacin.
Danish: Aktivt stof: delafloxacin.
English: Quofenix contains sodium
Danish: Quofenix indeholder natrium
English: • You have been diagnosed with an enlargement or “bulge” of a large blood vessel (aortic aneurysm or large vessel peripheral aneurysm).
Danish: • Du er diagnosticeret med en udposning på en stor blodåre (aortaaneurisme eller perifer aneurisme i en stor blodåre).
English: Fluoroquinolone antibiotics, including Quofenix, may cause levels of glucose in the blood to rise too high or fall too low.
Danish: Fluoroquinoloner, herunder Quofenix, kan medføre, at blodsukkeret bliver for højt eller for lavt.
English: No clinical trials have been conducted with delafloxacin in paediatric patients.
Danish: Der er ikke udført kliniske studier med delafloxacin hos pædiatriske patienter.
English: Hallucination auditory Anxiety
Danish: Auditive hallucinationer Angst
English: • Prepare the required dose for intravenous infusion by withdrawing the volume of 12 ml for Quofenix 300 mg or 8 ml for Quofenix 200 mg from the reconstituted vial.
Danish: • Forbered den ønskede dosis til intravenøs infusion ved at trække et volumen på 12 ml til Quofenix 300 mg eller et volumen på 8 ml til Quofenix 200 mg op fra det rekonstituerede hætteglas.
English: - Drop in blood pressure; blurred vision; dizziness.
Danish: - Fald i blodtryk, sløret syn, svimmelhed.
English: Following oral administration of 450 mg of delafloxacin every 12 hours, steady state concentrations are achieved after approximately 5 days with about 36% accumulation after multiple administrations.
Danish: Efter oral administration af 450 mg delafloxacin hver 12. time opnås der steady state-koncentrationer efter ca. 5 dage med omtrent 36 % akkumulering efter flere administrationer.
English: Following intravenous use of 300 mg delafloxacin every 12 hours, steady state concentrations are achieved after approximately 3-5 days with about 10% accumulation after multiple administrations.
Danish: Efter intravenøs administration af 300 mg delafloxacin hver 12. time opnås der steady statekoncentrationer efter ca. 3-5 dage med omtrent 10 % akkumulering efter flere administrationer.
English: In repeat dose toxicity studies in rats and dogs, gastrointestinal effects were the main findings: these included dilated cecum (oral only), abnormal stool, and decreased food intake and / or body weight in rats, and emesis, salivation and abnormal stool / diarrhoea in dogs.
Danish: De primære fund i toksicitetsstudier af gentagne doser til rotter og hunde var gastrointestinale virkninger, som omfattede dilateret cøkum (kun oralt), abnorm afføring og nedsat fødeindtag og/eller kropsvægt hos rotter og emese, spytsekretion og abnorm afføring/diarré hos hunde.
English: If an anaphylactic reaction to Quofenix occurs, the medicinal product should be discontinued immediately and appropriate therapy should be instituted.
Danish: I tilfælde af en anafylaktisk reaktion over for Quofenix bør brug af lægemidlet straks ophøre og passende behandling iværksættes.
English: Berlin-Chemie AG Tel: +49 (0) 30 67070
Danish: Deutschland Berlin-Chemie AG Tel: +49 (0) 30 67070
English: Post-marketing serious adverse reactions, including deaths and requirement for ventilator support, have been associated with fluoroquinolone use in persons with myasthenia gravis.
Danish: Alvorlige bivirkninger efter markedsføringen, herunder dødsfald og behov for respirationshjælp, er blevet sat i forbindelse med brug af fluoroquinoloner hos patienter med myasthenia gravis.
English: Following a single oral dose of 14C-labeled delafloxacin, 50% of the radioactivity is excreted in the urine as unchanged delafloxacin and glucuronide metabolites and 48% is excreted unchanged in the faeces.
Danish: C-mærket delafloxacin udskilles 50 % af radioaktiviteten i urinen i form af uomdannet delafloxacin og glukuronidmetabolitter, og 48 % udskilles uændret i fæces.
English: The glucuronidation of delafloxacin is mediated mainly by UGT1A1, UGT1A3 and UGT2B15.
Danish: Delafloxacins glukoronidering medieres hovedsageligt af UGT1A1, UGT1A3 og UGT2B15.
English: • Irregular or rapid heart beats, feeling your heart beat (palpitation), decrease of heart beat
Danish: • Uregelmæssig eller hurtig hjerterytme, hjertebanken (palpitation), nedsat hjerterytme
English: • You had sometimes long treatment with antibiotics; it can mean that you get another infection caused by other bacteria (superinfection) which cannot be treated by the antibiotic.
Danish: Det kan betyde, at du kan få en anden infektion, der skyldes andre bakterier (en superinfektion), som ikke kan behandles med antibiotika.
English: • Inflammation of joints, pain in hands or feet, back pain, muscle spasm
Danish: • Inflammation i led, smerter i hænder eller fødder, rygsmerter, muskelkramper
English: Breast-feeding is contraindicated during treatment with delafloxacin.
Danish: Amning er kontraindiceret under behandling med delafloxacin.
English: - Abdominal (belly) pain with possible severe diarrhoea; fever and nausea.
Danish: - Mavesmerter eventuelt med kraftig diarré, feber og kvalme.
English: The 450-mg tablet and 300-mg IV formulations are bioequivalent with regard to total exposure (AUC).
Danish: 450 mg tabletten og 300 mg i.v.-formuleringen er bioækvivalente, hvad angår den samlede eksponering (AUC).
English: • Increase in the amount of enzymes produced by your liver called transaminases - shown in blood tests
Danish: • Øget antal leverenzymer, kaldet transaminaser - ses i blodprøver
English: Fluoroquinolones may also cause CNS reactions of nervousness, agitation, insomnia, anxiety, nightmares, paranoia, dizziness, confusion, tremors, hallucinations, depression, and suicidal thoughts or acts.
Danish: Fluoroquinoloner kan også medføre en række øvrige reaktioner i centralnervesystemet som nervøsitet, agitation, søvnløshed, angst, mareridt, paranoia, svimmelhed, konfusion, tremor, hallucinationer, depression samt suicidaltanker eller -adfærd.
English: Peak exposure (Cmax) was not statistically significantly different between renal impaired and healthy subjects.
Danish: Det maksimale eksponering (Cmax) var ikke statistisk signifikant forskellig mellem forsøgspersoner med nedsat nyrefunktion og raske forsøgspersoner.
English: Quofenix must be reconstituted under aseptic conditions, using 10.5 mL of dextrose 50 mg/ml (5%) solution for injection (D5W) or sodium chloride 9 mg/ml (0.9%) solution for injection for each 300 mg vial.
Danish: Quofenix skal rekonstitueres under aseptiske forhold ved brug af 10,5 ml dextrose 50 mg/ml (5 %) injektionsvæske, opløsning (D5W) eller natriumchlorid 9 mg/ml (0,9 %) injektionsvæske, opløsning for hvert 300 mg hætteglas.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS ALUMINIUM/ALUMINIUM BLISTER (TABLETS)
Danish: MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS ALUMINIUM/ALUMINIUM-BLISTER (TABLETTER) 1.
English: In the absence of human data and findings in non-clinical studies at human therapeutic exposures, delafloxacin is contraindicated during pregnancy and in women of childbearing potential not using contraception (see sections 4.3 and 4.4).
Danish: I fravær af humane data og fund i non-kliniske studier med eksponeringer svarende til humane terapeutiske doser, er delafloxacin kontraindiceret under graviditet og til fertile kvinder, der ikke anvender prævention (se pkt.
English: By blocking these enzymes Quofenix kills bacteria that cause the infection.
Danish: Ved at blokere disse enzymer dræber Quofenix de bakterier, der har forårsaget infektionen.
English: Chelation active substance: antacids, sucralfate, metal cations, multivitamins There are no data concerning an interaction of intravenous delafloxacin with multivitamins, didanosine, or metal cations.
Danish: Kelerende stoffer: antacida, sukralfat, metalkationer, multivitaminer Der foreligger ingen data om interaktioner mellem intravenøst indgivet delafloxacin og multivitaminer, didanosin eller metalkationer.
English: The following information is intended for healthcare professionals only: For single use only.
Danish: Nedenstående oplysninger er til læger og sundhedspersonale:
English: It is available in packs containing 10 vials.
Danish: Det fås i pakninger med 10 hætteglas.
English: Pharmacokinetic parameters are not altered in obese patients (BMI ≥ 30 kg/m2).
Danish: De farmakokinetiske parametre ændres ikke hos adipøse patienter (BMI ≥ 30 kg/m2).
English: The recommended dose is 300 mg delafloxacin every 12 hours administered over 60 minutes by intravenous infusion.
Danish: Den anbefalede dosis er 300 mg delafloxacin hver 12. time indgivet som en intravenøs infusion i løbet af 60 minutter.
English: The 300-mg IV formulation and 450 mg tablet are bioequivalent with regard to total exposure (AUC).
Danish: Den intravenøse formulering på 300 mg og en 450 mg tablet er bioækvivalente, hvad angår den samlede eksponering (AUC).