FrancophonIA/ELRC3.0 huggingface dataset:
English: Management of patients with complicated urinary tract infections (UTIs) currently includes empirical treatment with a broad-spectrum antibiotic (fluoroquinolone), and potential subsequent treatment for 10-14 days based on urine culture and sensitivity.
Danish: Behandlingen af komplicerede urinvejsinfektioner består i dag i empirisk behandling med et bredspektret antibiotikum (fluorquinolon) og mulig efterfølgende behandling i 10-14 dage på grundlag af urindyrkning og følsomhed.
English: Rare: tachycardia.
Danish: Sjælden: Takykardi.
English: Patients with a family history of or actual defects in glucose-6-phosphate dehydrogenase activity are prone to haemolytic reactions with quinolones, and so ciprofloxacin should be used with caution in these patients.
Danish: Patienter med familiær baggrund for eller med aktuelle defekter i glucose-6-phosphat dehydrogenaseaktiviten er disponeret for hæmolytiske reaktioner med quinoloner og derfor bør ciprofloxacin anvendes med forsigtighed til disse patienter.
English: No clinical study using 100 mg i.v.
Danish: Der blev ikke fundet nogen kliniske undersøgelser, hvor 100 mg i.v.
English: Animal trials have shown that the concurrent administration of very high doses of fluoroquinolones and certain NSAIDs (but not acetylsalicylic acid) may provoke convulsions.
Danish: Forsøg med dyr har vist at samtidig indgift af meget høje doser af fluoroquinoloner og visse NSAID'er (men ikke acetylsalicylsyre) kan provokere kramper.
English: Glibenclamide
Danish: Glibenclamid
English: The ciprofloxacin concentration in the sputum consists of 50-70% of the serum concentration.
Danish: Ciprofloxacin koncentrationen i spyt er tæt på 50- 70 % af serumkoncentrationen.
English: Up to now, no evidence has been found of an increased risk of congenital abnormalities or other undesirable effects following use of ciprofloxacin or other quinolones during the first trimester.
Danish: Indtil nu er der ingen evidens for en øget risiko for medfødte abnormiteter eller andre bivirkninger, som følge af brugen af ciprofloxacin eller andre quinoloner, under 1. trimester.
English: • complicated urinary tract infections
Danish: • komplicerede urinvejsinfektioner
English: Ciprofloxacin is rapidly and effectively absorbed after oral administration.
Danish: Ciprofloxcin absorberes hurtigt og effektivt efter oral indgift.
English: Commonly susceptible species Gram-positive species Bacillus anthracis Gram-negative aerobe species Citrobacter spp.
Danish: Normalt følsomme Gram-positive arter Bacillus anthracis Gram-negative aerobe arter Citrobacter spp.
English: Within the class of quinolones cross-resistance has been observed.
Danish: Der er observeret krydsresistens indenfor quinolonklassen.
English: Ciprofloxacin Kabi cannot be mixed with solutions that are not stable at a pH of approximately 4.
Danish: Ciprofloxacin Kabi må ikke blandes med opløsninger, der ikke er stabile ved pH ca. 4.
English: - complicated skin and soft tissue infections - osteomyelitis
Danish: - komplicerede hud og blødvævsinfektioner - osteomyelitis
English: Rare: anxiety, nightmares, depression, hallucinations.
Danish: Sjælden: Angst, mareridt, depression, hallucinationer.
English: Local reaction:
Danish: Lokale reaktioner
English: Anaphylactic/anaphylactoid reactions can in very rare cases develop into life-threatening shock, sometimes even after the first administration of ciprofloxacin.
Danish: Anafylaktiske/anafylaktoide reaktioner kan i meget sjældne tilfælde udvikle sig til livstruende chok, nogle gange selv efter første indgift af ciprofloxacin.
English: In very rare cases ventricular arrhythmia, QT interval prolongation and torsades de pointes have been reported.
Danish: I meget sjældne tilfælde har der været rapporteret ventrikulær arrytmi, QT intervalforlængelse og torsades de pointes.
English: The interaction between theophylline and ciprofloxacin is potentially life-threatening.
Danish: Interaktion mellem theophyllin og ciprofloxacin kan være livstruende.
English: - pregnancy and lactation - patients with a history of tendon disorder related to fluoroquinolone administration
Danish: - graviditet og amning - patienter med forhistorie af seneskader relateret til indgift af fluoroquinolon
English: The bioavailability is lower if antacids that contain aluminium and/or magnesium hydroxide, and calcium and iron salts are used concomitantly.
Danish: Biotilgængeligheden bliver lavere ved samtidig indgift af antacida med indhold af aluminium og/eller magnesiumhydroxid samt calcium- og jernsalte.
English: Amp-C producing Escherichia coli
Danish: Amp-C producerende Escherichia coli
English: Transferable plasmid-mediated quinolone resistance associated with qnr has been detected in quinolone-resistant clinical strains of E.coli and Klebsiella spp.
Danish: Overførbar plasmid medieret quinolonresistens forbundet med qnr er blevet påvist i quinolon resistente kliniske stammer af E.coli og Klebsiella spp.
English: Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, tacrine, ropinirol, tizanidine).
Danish: Ciprofloxacin hæmmer CYP1A2 og det kan forårsage øget plasmakoncentration af samtidigt indgivne stoffer, der metaboliseres af dette enzym (f.eks. theophyllin, clozapin, tacrin, ropinirol, tizanidin).
English: Development of resistance to ciprofloxacin and other fluoroquinolones has been observed in staphylococci, especially methicillinresistant S. aureus, P. aeruginosa, E.coli and E. faecalis (see the sensitivity table).
Danish: Udvikling af resistens mod ciprofloxacin og andre fluoroquinoloner er observeret ved stafylokokker, især methicillin-resistente S. aureus, P. aeruginosa, E.coli og E. faecalis (se følsomhedstabellen).
English: • certain anti-inflammatory agents (e.g. ibuprofen, naproxen, but not acetylsalicylic acid), if ciprofloxacin is given in very high doses.
Danish: visse anti-inflammatoriske stoffer (f. eks. ibuprofen, naproxen, men ikke acetylsalicylsyre), hvis ciprofloxacin gives i høje doser.
English: Due to the higher plasma levels in the elderly it is advisable to administer a doses based on creatinine clearance and severity of disease.
Danish: Begrundet i højere plasmaniveauer hos ældre anbefales en dosis baseret på kreatininclearance og infektionens sværhedsgrad.
English: The ciprofloxacin level in the blood can be increased.
Danish: Ciprofloxacinniveauet i blodet kan øges.
English: Ciprofloxacin is potentially neurotoxic and causes reversible defects of the testes in case of higher dosage.
Danish: Ciprofloxacin er neurotoksisk og kan forårsage reversible skader på testis i tilfælde af højere doser.
English: They may take the form of local skin reactions, such as reddening of the skin, irritation or pain, which usually disappear quickly after termination of the infusion.
Danish: Reaktionerne kan være lokale hudreaktioner, som rødmen, irritation eller smerte, der sædvanligvis hurtigt forsvinder efter infusionen.
English: If exposure to sunlight or UV light is inevitable you should use sun cream to protect yourself.
Danish: Er det uundgåeligt at du udsætter dig for sollys eller UV lys, bør du anvende en beskyttende solcreme.
English: Read the package leaflet before use.
Danish: Læs indlægesedlen før brug.
English: Pharmacotherapeutic group: Quinolone antibacterials (ATC code: J01MA02) Mode of action:
Danish: Farmakoterapeutisk klassifikation: Antibakterielt quinolonderivat ( ATC kode: J 01 MA 02)
English: The reconstituted solution should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Den blandede opløsning bør inspiceres visuelt for indhold af partikler og misfarvning før anvendelsen.
English: Species for which acquired resistance may be a problem Gram-positive aerobes
Danish: Arter, hvor resistens kan være et problem
English: Ciprofloxacin Kabi has minor or moderate influence on the ability to drive and use machines.
Danish: CiprofloxacinKabi har en lille eller moderat påvirkning på evnen til at køre bil eller betjene maskiner.
English: • Do not refrigerate or freeze.
Danish: • Må ikke opbevares i køleskal eller fryses.
English: Photosensibility:
Danish: Fotosensibilitet
English: The phototoxic, photomutagenic and photocarcinogenic potential of ciprofloxacin is comparable to that of other gyrase inhibitors.
Danish: Det fototoksiske, fotomutagenene og fotocarcinogene potentiale af ciprofloxacin er sammenlignelig med det, der gælder for andre gyrase inhibitorer.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til intravenous anvendelse.
English: Very rare: erythema nodosum, erythema multiforme (minor), Stevens-Johnson syndrome, epidermal necrolysis (Lyell Syndrome).
Danish: Meget sjælden: Erythema nodosum, erythema multiforme (mindre), Stevens-Johnson syndrom, epidermal nekrolyse (Lyells syndrom).
English: Oral administration of 20 mg/kg twice daily to children with cystic fibrosis gives an exposure that is comparable to that in adults following an oral dose of 750 mg twice daily.
Danish: Oral indgift af 20 mg/kg to gange dagligt til børn med cystisk fibrose giver en eksponering, der er sammenlignelig med oral indgift af 750 mg to gange dagligt til voksne.
English: • glucose-6-phosphate dehydrogenase defect (hereditary disease of the red blood cells based on a defect in an enzyme).
Danish: glukose-6-fosfatasedehydrogenase-defekt (arvelig sygdom i de røde blodlegemer på grund af en enzymdefekt).
English: As a result of its mechanism of action, ciprofloxacin does not show cross-resistance with other important, chemically different groups of substances such as beta-lactam antibiotics, aminoglycosides, tetracyclines, macrolides and polypeptides, sulphonamides, trimethoprim and nitrofurantoine.
Danish: Som resultat af virkningemekanismen viser ciprofloxacin ikke krydsresistens med andre vigtige kemisk forskellige grupper af stoffer, som betalaktamantibiotika, aminoglykosider, tetracykliner, makrolider, og polypeptider, sulfonamider, trimetoprim og nitrofurantoin.
English: If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Danish: Hvis en bivirkning bliver alvorlig eller du bemærker nogen form for bivirkninger, som ikke er nævnt i denne indlægsseddel, bør du fortælle det til din læge eller apotek.
English: The elimination half-life of ciprofloxacin does not change with age.
Danish: Ciprofloxacins eliminationshalveringstid ændrer sig ikke med alderen.
English: Ciprofloxacin, like other quinolones, may enhance the effect of coumarin derivates including warfarin.
Danish: Ciprofloxacin kan, som andre quinoloner, påvirke virkningen af coumarinderivater inklusiv warfarin.
English: increased heart rate (tachycardia)
Danish: øget hjerteslag (takykardi)
English: In case of mixed infections with anaerobes ciprofloxacin must be combined with other antibiotics effective against anaerobes.
Danish: I tilfælde af blandede infektioner med anaerobe bakterier skal ciprofloxacin kombineres med andre antibiotika med virkning mod disse.
English: The percentage of resistant strains can be subject to great local variation.
Danish: Den procentvise andel resistente stammer kan være genstand for stor lokal variation, hvorfor regelmæssig resistensbestemmelse anbefales.
English: When used simultaneously, ciprofloxacin may, in certain cases, increase the effect of glibenclamide (hypoglycaemia).
Danish: Ved sideløbende indgift kan ciprofloxacin i visse tilfælde øge virkningen af glibenclamid (hypoglykæmi).
English: Since under-dosing is one of the 3 major factors in the development if antibiotic resistance to fluoroquinolones (4), this may be a case for using the higher dose of ciprofloxacin proposed by the applicant in the treatment of complicated UTIs.
Danish: Da underdosering er den ene af de tre hovedfaktorer i udvikling af mikrobiel resistens over fluorquinolonerne (4), kan der her være grund til at vælge den højeste dosis ciprofloxacin, der af ansøgeren søges godkendt til behandling af komplicerede urinvejsinfektioner.
English: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings.
Danish: Behandlingsvarigheden afhænger af infektionsgraden, det kliniske respons og de bakteriologiske fund.
English: Determination of serum concentrations, especially of theophylline, and dose adjustments may be necessary.
Danish: Måling af plasmakoncentrationer og dosisjustering, specielt af theopyllin, kan være nødvendig.
English: If you experience these symptoms you should immediately consult your doctor and rest the respective leg.
Danish: Oplever du disse symptomer, bør du kontakte din læge med det samme og undgå at belaste den berørte sene.
English: Concentrations in pulmonary tissue, gynaecological tissue and prostate tissue and fluid were also significantly higher than the serum concentration.
Danish: Koncentrationen i lungevæv, gynækologisk væv og prostatavæv og væske var ligeledes væsentlig højere end serumkoncentrationen.
English: The applicant/MAH did not submit any clinical data to address the questions related to the risk/benefit of the proposed dose in UTIs and the maximum adult daily dose, as this application is a so called ″generic″ application (reference product/originator Ciproxin from Bayer).
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen forelagde ikke kliniske data som led i besvarelsen af spørgsmålene om benefit/risk-forholdet for den ansøgte dosering ved urinvejsinfektioner og den maksimale daglige dosis til voksne, idet der er tale om en generisk ansøgning (referencelægemidlet/det oprindelige lægemiddel er Ciproxin (Bayer)).
English: Evidence is mounting that suggests a link between inappropriate fluoroquinolone use, development of antimicrobial resistance against the entire fluoroquinolone class, and clinical failure.
Danish: Stadig flere vidnesbyrd tyder på en sammenhæng mellem uhensigtsmæssig brug af fluorquinoloner, resistensudvikling over for hele klassen af fluorquinoloner og behandlingssvigt.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: To maintain the activity of the fluoroquinolone class, clinicians need to implement an evidence-based approach to antimicrobial selection, particularly a strategy in which the most pharmacodynamically potent fluoroquinolone is matched, on an empiric basis when required, to anticipated bacterial pathogens.
Danish: For at bevare virkningen af fluorquinolonerne bør klinikernes valg af antimikrobielle midler ske på evidensbaseret grundlag, dvs. en strategi, hvor man, om nødvendigt på empirisk grundlag, vælger det farmakodynamisk mest potente fluorquinolon svarende til de forventede patogene bakterier.
English: - From the published data, which have demonstrated for the proposed maximum dose 400 mg i.v.
Danish: De publicerede data, der viser, at den ansøgte maksimale dosering på 400 mg i.v.
English: Signs of anaemia are a feeling of weakness and in more severe cases breathlessness and pale skin.
Danish: Tegn på blodtab er svaghedsfølelse og i alvorligere tilfælde åndenød og bleghed.
English: In patients on haemodialysis or CAPD, the maximum daily intravenous dose is also 400 mg. On the dialysis days, the dose is given after the haemodialysis session.
Danish: Hos patienter i hæmodialyse eller CAPD er maksimal daglig intravenøs dosis ligeledes 400 mg. På dialysedage indgives dosis efter hæmodialysebehandingen.
English: Very rare:
Danish: Meget sjældne:
English: Ciprofloxacin (as hydrogen sulphate)
Danish: Ciprofloxacin (som hydrogensulphat)
English: Renal and urinary system:
Danish: Nyrer og urinvejssystemet:
English: clinical data and discuss the risk/benefit of the maximum adult daily dose, i.e. whether it should be 400 mg bid or 400 mg three times daily.
Danish: Kliniske data og redegørelse for benefit/risk-forholdet for den maksimale daglige dosis, dvs. hvorvidt denne burde være 400 mg to gange dagligt eller 400 mg tre gange dagligt.
English: Average duration of treatment can be 4-6 weeks.
Danish: Den gennemsnitlige behandlingstid er 46 uger.
English: Ciprofloxacin has a rapid bactericidal effect, both in the growth phase and in the rest phase.
Danish: Ciprofloxacin har en hurtig baktericid virkning både i vækstog hvilefasen.
English: nausea, diarrhoea
Danish: kvalme, diaré.
English: Ciprofloxacin Kabi can reduce your attention.
Danish: Ciprofloxacin Kabi kan nedsætte din opmærksomhed.
English: anxieties, nightmares, severe depression, seeing things or hearing voices that do not exist (hallucinations)
Danish: angst, mareridt, alvorlig depression, syns- og lydoplevelser som ikke eksisterer (hallucinationer)
English: Fresenius Kabi España S.A.c./ Marina 16-18, planta 17,E-08005
Danish: Fresenius Kabi España S.A.c./ Marina 16-18, planta 17,E-08005 Barcelona, Spanien
English: If you have kidney problems you should inform your doctor.
Danish: Har du nyreproblemer, bør du informere din læge.
English: Very rare: moniliasis (gastro-intestinal), pancreatitis.
Danish: Meget sjælden: Moniliasis (gastro-intestinal), pancreatitis.
English: Fresenius Kabi Pharma Portugal Lda., Avenida do Forte 3, Edifício Suécia IV, Piso 3, 2794-039
Danish: Fresenius Kabi Pharma Portugal Lda., Avenida do Forte 3, Edifício Suécia IV, Piso 3, 2794-039 Carnaxide, Portugal
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Danish: I hver hyppighedsgruppe er bivirkningerne vist i en rækkefølge svarende til faldende alvorlighed.
English: In this case consult your doctor as your urine needs to be tested.
Danish: I dette tilfælde bør du tale med lægen, da din urin måske skal undersøges.
English: These side effects occur predominantly in patients at risk for certain heart disorders.
Danish: Disse bivirkninger rammer først og fremmest patienter med andre risikofaktorer for hjerteproblemer.
English: • The active substance is ciprofloxacin (as hydrogen sulphate).
Danish: • Det aktive stof er ciprofloxacin (som ciprofloxacin hydrogensulphat).
English: ESBL: Extended Spectrum Beta-lactamases MRSA: Methicillin-resistant Staphylococcus aureus
Danish: ESBL: Extended Spectrum Beta-lactamases (bredspektrede Beta-laktamase antibiotika) MRSA: Methicillin-resistent Staphylococcus aureus
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKING Bag
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Pose
English: Animal experiments have shown that ciprofloxacin passes the placenta and is excreted in breast milk.
Danish: Forsøg på dyr har vist at ciprofloxacin paserer placentabarieren og udskilles med brystmælk.
English: clinical data and discuss the risk/benefit of the proposed dose in urinary tract infections (UTI).
Danish: Kliniske data og en gennemgang af benefit/risk-forholdet for den ansøgte dosering til urinvejsinfektioner.
English: WHAT CIPROFLOXACIN KABI IS AND WHAT IT IS USED FOR
Danish: HVAD CIPROFLOXACIN KABI ER, OG HVAD DET ANVENDES TIL
English: If there is any indication of tendinitis (e.g. painful swelling) the administration of ciprofloxacin or other fluoroquinolones must immediately be discontinued, the affected extremity should not be strained and a physician must be consulted.
Danish: Er der nogen tegn på tendinitis (f.eks. smertefuld hævelse) ved indgift af ciprofloxacin eller andre fluoroquinoloner skal behandlingen straks afbrydes, den berørte ekstremitet bør ikke belastes og lægen kontaktes.
English: The undesirable effects sometimes occur already after the first administration of ciprofloxacin.
Danish: Bivirkningerne forekommer i visse tilfælde allerede efter første administrationen af ciprofloxacin.
English: After oral administration 45% is excreted unchanged in the urine and 25% is excreted in the faeces.
Danish: Efter oral indgift udskilles 45 % uomdannet i urinen og 25 % i fæces.
English: The bioavailability of ciprofloxacin after oral administration is between 70 % and 85 %.
Danish: Biotilgælgeligheden efter oral indgift af ciprofloxacin er mellem 70 og 85 %.
English: Musculoskeletal system:
Danish: Muskoloskeletale system
English: In juvenile and prenatal animals exposed to quinolones effects on immature cartilage have been observed.
Danish: I unge og prenatale dyr er der ved eksponering til quinoloner observeret virkning på immatur brusk.
English: Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose.
Danish: Derfor skal patienter, der tager disse stoffer samtidig med ciprofloxacin, monitoreres omhyggeligt for kliniske tegn på overdosering.
English: • complicated skin and soft tissue infections
Danish: • komplicerede hud og blødvævsinfektioner
English: demonstrated clinical efficacy of 93% and bacterial eradication of 89%, but this was for the treatment of uncomplicated UTI (3) and efficacy of 91% (n=23) without development of resistance (2).
Danish: I to undersøgelser, hvor der anvendtes en oral dosis på 100 mg to gange dagligt, påvistes en klinisk virkning på 93 % og en bakteriel udryddelse på 89 %, dog i forbindelse med behandling af ukomplicerede urinvejsinfektioner (3), og en virkning på 91 % (n=23) uden resistensudvikling (2).
English: The total body clearance of ciprofloxacin is independent of the dose and remains unchanged in case of multiple administration.
Danish: Den totale ciprofloxacinclearance er uafhængig af dosis og forbliver uændret ved flerdosis indgift.
English: The blood level of this medicine can be increased or reduced.
Danish: Niveauet af dette lægemiddel i blodet kan falde eller stige.
English: This may lead to a prolongation of the bleeding time.
Danish: Dette kan føre til forlænget blødningstid og derfor bør denne kontrolleres.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Danish: Om nødvendigt bør der søges specialistbistand, når den lokale resistensprevalens gør at brugen af ciproflocxacin ved nogle infektionstyper kan være af tvivlsom karakter.
English: The frequencies of probably and/or possibly drug-related adverse events did not differ significantly between ciprofloxacin-treated patients and the comparator groups.
Danish: Der var ikke signifikant forskel i hyppigheden af formodentlig eller muligvis lægemiddelforårsagede uønskede hændelser hos ciprofloxacin-behandlede patienter og i sammenligningsgrupperne.
English: As with all other antibiotics, the patient should be monitored during therapy for the development of resistant strains of initially sensitive bacteria, especially P. aeruginosa and S. aureus (see the relevant statements in section 5.1).
Danish: Forud for behandling bør der foretages bakteriologisk test. Som ved alle andre antibiotika, bør patienten følges under behandlingen for resistensudvikling af de initialt følsomme bakterier, især P. aeruginosa og S. aureus (se relevante erklæringer i pkt.
English: Very rare in less than 1 in 10,000 patients, including isolated reports
Danish: Meget sjældne hos flere end 1 af 10.000 patienter, inklusive enkeltstående rapporter.
English: • known allergic reaction to ciprofloxacin or any of the other ingredients of Ciprofloxacin Kabi or other medicines of the quinolone type
Danish: • kendt overfølsom over for ciprofloxacin eller andre af indholdsstofferne i Ciprofloxacin Kabi eller andre lægemidler af kinolontypen
English: Ciprofloxacin Kabi is contraindicated in: - patients with a hypersensitivity to ciprofloxacin, chinolin carboxylic acid derivatives or to any of the excipients - children under 5 years of age.
Danish: Ciprofloxacin Kabi er kontraindiceret til: - patienter med overfølsomhed over for ciprofloxacin, chinolincarboxylsyrederivater eller nogle af hjælpestofferne - børn under 5 år.