FrancophonIA/ELRC3.0 huggingface dataset:
English: Following oral administration of single doses of 250 mg, 500 mg, and 750 mg of ciprofloxacin tablets, ciprofloxacin is absorbed rapidly and extensively, mainly from the small intestine, reaching maximum serum concentrations 1-2 hours later.
Danish: Efter oral indgift af enkeltdoser på henholdsvis 250 mg, 500 mg og 750 mg ciprofloxacintabletter har ciprofloxacin en hurtig og god absorption, der primært sker fra tyndtarmen.
English: Immune System Disorders
Danish: Forstyrrelser i immunsystemet
English: 250-500 mg every 24 h (after dialysis)
Danish: 250-500 mg hver 24. time (efter dialyse)
English: Ciprofloxacin should generally not be used in patients with a history of tendon disease/disorder related to quinolone treatment.
Danish: Ciprofloxacin bør generelt ikke bruges til patienter, som har haft senesygdomme relateret til behandling med quinoloner.
English: Toxic epidermal necrolysis (potentially lifethreatening)
Danish: epidermal nekrolyse (potentielt livstruende)
English: Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate.
Danish: Inhalationsanthrax, profylakse efter eksponering og kurativ behandling til patienter, som kan behandles oralt, når det er klinisk passende.
English: Photosensitivity reactions (see section 4.4)
Danish: Fotosensitivitetsreaktioner (se pkt.
English: • Treatment of infections in neutropenic patients
Danish: • Behandling af infektioner hos neutropeniske patienter
English: The applicant/MAH provided documentation to support the use of ciprofloxacin as a valuable therapeutic option both prophylaxis and treatment of febrile neutropenic patients.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen fremlagde dokumentation til støtte for anvendelsen af ciprofloxacin som en nyttig terapeutisk behandlingsmulighed til såvel profylakse som behandling hos febrile neutropeniske patienter.
English: Ciprofloxacin Bayer is used in adults to treat the following bacterial infections:
Danish: Ciprofloxacin Bayer bruges til voksne til behandling af følgende infektioner, som skyldes bakterier:
English: Ciprofloxacin is a broad spectrum antibacterial agent that belongs to the fluoroquinolone family.
Danish: Ciprofloxacin er et bredspektret antibakterielt stof i fluoroquinolon-gruppen.
English: Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solution (e.g. penicillin, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of the ciprofloxacin infusion solutions: 3.9-4.5).
Danish: Der er inkompatibilitet med alle infusionsopløsninger/lægemidler, som er fysisk eller kemisk ustabile ved opløsningens pH (fx penicilliner, heparinopløsninger), specielt i kombination med opløsninger, som er justeret til en basisk pH (ciprofloxacin-infusionopløsningernes pH: 3,9-4,5).
English: • to prevent infections due to the bacterium Neisseria meningitidis
Danish: • forebyggelse af infektioner, som skyldes bakterien Neisseria meningitidis
English: If possible, take your tablets or the box with you to show the doctor.
Danish: Tag om muligt tabletterne eller pakningen med til lægen.
English: 100 mg/mL ORAL SUSPENSION (containing the bottle(s) for the granules and the bottle(s) for the solvent)
Danish: 100 mg/ml ORAL SUSPENSION (som indeholder flasken/flaskerne med granulat og flasken/flaskerne med solvens)
English: You may even help bacteria become resistant and therefore delay your cure or decrease antibiotic efficacy if you do not respect appropriate: dosages schedules duration of treatment
Danish: Hvis du ikke tager hensyn til følgende, kan du til og med hjælpe bakterierne med at blive resistente og dermed forsinke helbredelsen: - dosis - hvor ofte dosis skal tages - behandlingens varighed
English: A 500 mg oral dose given every 12 hours has been shown to produce an area under the serum concentration-time curve (AUC) equivalent to that produced by an intravenous infusion of 400 mg ciprofloxacin given over 60 minutes every 12 hours.
Danish: En oral dosis på 500 mg hver 12. time har et areal under serumkoncentrationskurven (AUC), som er ækvivalent med AUC efter en intravenøs infusion af 400 mg ciprofloxacin givet over 60 minutter hver 12. time.
English: Simultaneous administration of ciprofloxacin with warfarin may augment its anti-coagulant effects.
Danish: Samtidig indgift af ciprofloxacin og warfarin kan forstærke den antikoagulante virkning.
English: It is recommended that the INR should be monitored frequently during and shortly after co-administration of ciprofloxacin with an oral anticoagulant agent.
Danish: INR skal derfor overvåges hyppigt under og kort efter samtidig indgift af ciprofloxacin og et oralt antikoagulant middel.
English: • long lasting or recurring ear or sinus infections
Danish: • kroniske eller tilbagevendende infektioner i ører og bihuler
English: PHARMACEUTICAL FORM Granules and solvent for oral suspension [To be completed nationally]
Danish: Granulat og solvens til oral suspension [Udfyldes nationalt]
English: Long-term safety profile of ciprofloxacin to treat upper-respiratory tract infections The CHMP requested that applicant/MAH provide the rationale for a 3-month treatment duration of upper respiratory tract infections and substantiate the long-term safety of the drug in such a prolonged use.
Danish: Sikkerhedsprofilen over lang tid for ciprofloxacin til behandling af infektioner i de øvre luftveje CHMP anmodede ansøgeren/indehaveren af markedsføringstilladelsen om at redegøre for rationalet ved en behandlingsvarighed på 3 måneder for infektioner i de øvre luftveje og begrunde sikkerheden ved anvendelse af lægemidlet over så lang tid.
English: Swallow the tablets with plenty of fluid.
Danish: g. Slug tabletterne med masser af væske.
English: - the scope of the referral was the harmonisation of the Summaries of Products Characteristics, labelling and package leaflet.
Danish: Ud fra følgende betragtninger: - Indbringelsen skulle afdække harmoniseringen af produktresuméer, etikettering og indlægsseddel.
English: In such cases, ciprofloxacin should immediately be discontinued, and an appropriate therapy initiated.
Danish: I det tilfælde skal ciprofloxacin omgående seponeres, og passende behandling skal påbegyndes.
English: Ciprofloxacin Bayer should be checked visually prior to use.
Danish: Ciprofloxacin infusionsvæske, opløsning skal kontrolleres visuelt før brugen.
English: In the event of any signs and symptoms of hepatic disease (such as anorexia, jaundice, dark urine, pruritus, or tender abdomen), treatment should be discontinued.
Danish: Hvis der optræder symptomer på leversygdom (f.eks. anoreksi, gulsot, mørkfarvet urin, kløe eller abdominal ømhed), skal behandlingen seponeres.
English: Do try to take the tablets at around the same time every day.
Danish: b. Prøv at tage tabletterne på samme tid hver dag.
English: Complicated cystitis, Uncomplicated pyelonephritis
Danish: Kompliceret cystitis, Ukompliceret pyelonephritis
English: A 60-minute intravenous infusion of 200 mg ciprofloxacin or the oral administration of 250 mg ciprofloxacin, both given every 12 hours, produced an equivalent area under the serum concentration time curve (AUC).
Danish: En 60 minutters intravenøs infusion af 200 mg ciprofloxacin og en oral administration af 250 mg ciprofloxacin, begge givet hver 12. time, havde samme areal under serumkoncentrations/tid-kurven (AUC).
English: Posology in the treatment of upper respiratory tract infections The CHMP asked the applicant/MAH to further substantiate the efficacy/risk of the lower dosage proposed (500 mg BID) in the treatment of upper respiratory tract infection, especially with regard to malignant external otitis.
Danish: Dosering ved behandling af infektioner i de øvre luftveje CHMP bad ansøgeren/indehaveren af markedsføringstilladelsen om yderligere begrundelse for virkning/risici ved den foreslåede lave dosering (500 mg 2 gange dagligt) til behandling af infektioner i de øvre luftveje, især med hensyn til malign ekstern otitis.
English: Common ≥ 1/100 to <
Danish: Almindelig ≥ 1/100 til <
English: Ciprofloxacin reaches high concentrations in a variety of tissues such as lung (epithelial fluid, alveolar macrophages, biopsy tissue), sinuses, inflamed lesions (cantharides blister fluid), and the urogenital tract (urine, prostate, endometrium) where total concentrations exceeding those of plasma concentrations are reached.
Danish: Ciprofloxacin når høje koncentrationer i mange væv som f.eks. lungevæv (epitelvæske, alveolære makrofager, biopsivæv), bihuler og inflammerede læsioner (cantharides blistervæske) og urogenitalsystemet (urin, prostata, endometrium), hvor totalkoncentrationerne kan overstige plasmakoncentrationerne.
English: Effects of ciprofloxacin on other medicinal products:
Danish: Virkningen af ciprofloxacin på andre lægemidler:
English: 50 mg/mL ORAL SUSPENSION (containing the bottle(s) for the granules and the bottle(s) for the solvent)
Danish: 50 mg/ml ORAL SUSPENSION (som indeholder flasken/flaskerne med granulat og flasken/flaskerne med solvens
English: The CHMP asked the applicant/MAH to discuss the extent to which ciprofloxacin could be viewed as an acceptable option for treating bone and joints infections due to Gram-positive bacteria (in particular Staphyloccocus species).
Danish: CHMP bad ansøgeren/indehaveren af markedsføringstilladelsen om at redegøre for, hvorvidt ciprofloxacin kunne anses for at være en acceptabel mulighed til behandling af knogle- og ledinfektioner forårsaget af grampositive bakterier (især Staphylococcus-arterne).
English: In pre-menopausal women, 500 mg single dose may be used
Danish: Hos præ-menopausale kvinder kan der gives 500 mg som éngangsdosis
English: Gastrointestinal System
Danish: Gastrointestinale sygdomme
English: This leaflet was last approved in {MM/YYYY} [To be completed nationally]
Danish: Denne indlægsseddel blev senest godkendt { MM/ÅÅÅÅ } [Udfyldes nationalt]
English: Most reported adverse events were not unexpected, mainly gastro-intestinal disorders or cutaneous disorders.
Danish: De fleste indberettede uønskede hændelser var forventede, især lidelser relateret til mave-tarm-kanalen eller huden.
English: If seizures occur ciprofloxacin should be discontinued (see section 4.8).
Danish: Hvis der forekommer krampeanfald, skal ciprofloxacin seponeres (se pkt 4.8).
English: Tell your doctor immediately, if any of the following occurs during treatment with Ciprofloxacin Bayer.
Danish: Fortæl det omgående til din læge, hvis noget af følgende hænder, under behandlingen med Ciprofloxacin Bayer.
English: • Prophylaxis of invasive infections due to Neisseria meningitides (only for oral formulations)
Danish: • Profylakse af invasive infektioner forårsaget af Neisseria meningitidis (gælder kun for perorale formuleringer)
English: The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the fluoroquinolone to the increase in INR (international normalised ratio) is difficult to assess.
Danish: Det er derfor svært at vurdere fluoroquinolons bidrag til stigningen i INR (international normaliseret ratio).
English: The most commonly reported adverse drug reactions (ADRs) are nausea, diarrhoea, vomiting, transient increase in transaminases, rash, and injection and infusion site reactions.
Danish: De almindeligst indberettede bivirkninger er kvalme, diaré, opkastning, forbigående stigning i tranaminaser, udslæt og reaktioner på infusionssstedet.
English: Monitoring of ropinirole-related side effects and dose adjustment as appropriate is recommended during and shortly after co-administration with ciprofloxacin (see section
Danish: Der tilrådes overvågning af ropinirole-relaterede bivirkninger og passende justering af dosis under og kort efter samtidig indgift med ciprofloxacin (se pkt.
English: In this case, potential occurrence of haemolysis should be monitored.
Danish: I dette tilfælde skal patienterne overvåges for evt. optræden af hæmolyse.
English: If possible, take the oral suspension or the box with you to show the doctor.
Danish: Tag om muligt suspensionen eller pakningen med til lægen.
English: Very rare side effects (less than 1 in every 10,000 people are likely to get these):
Danish: Meget sjældne bivirkninger (forekommer hos mindre end 1 af hver 10.000 personer):
English: - inflammation of the bowel (colitis) linked to antibiotic use (can be fatal in rare cases) (see
Danish: - tarmbetændelse (colitis) relateret til brug af antibiotika (kan i sjældne tilfælde være dødelig)
English: Bulgaria:
Danish: Bulgarien:
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Ciprofloxacin Bayer and associated names (see Annex I).
Danish: anbefaler CHMP ændring af markedsføringstilladelserne for Ciprofloxacin Bayer og tilknyttede navne (se bilag I).
English: Romania:
Danish: Rumænien:
English: Shake vigorously each time before use for approximately 15 seconds.
Danish: Ryst altid flasken kraftigt i ca. 15 sekunder før den bruges.
English: Intra-abdominal infections due to Gram-negative bacteria
Danish: Intraabdominale infektioner, som skyldes gramnegative bakterier
English: If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, stop taking Ciprofloxacin Bayer and contact your doctor immediately.
Danish: Hvis du får symptomer som f.eks. appetitløshed, gulfarvning af huden (gulsot), mørkfarvet urin, kløen eller spændinger i maven, skal du stoppe med at tage Ciprofloxacin Bayer og omgående kontakte lægen.
English: Section 2: Take special care with Ciprofloxacin Bayer) - increased blood sugar (hyperglycemia) - anxiety reaction, strange dreams, depression, mental disturbances (psychotic reactions) (see
Danish: 2 Vær ekstra forsigtig med Ciprofloxacin Bayer) - øget blodsukker (hyperglykæmi) - angst, mærkelige drømme, depression, psykiske forstyrrelser (psykotiske reaktioner) (se pkt.
English: Ciprofloxacin Bayer solution for infusion contains 10 g glucose in 200 mL solution for infusion.
Danish: Ciprofloxacin infusionsopløsning indeholder 10 g glucose i 200 ml opløsning til infusion.
English: Single-dose treatment of uncomplicated UTI:
Danish: Enkeltdosisbehandling af ukompliceret urinvejsinfektion:
English: PHARMACEUTICAL FORM Film-coated tablet [To be completed nationally]
Danish: LÆGEMIDDELFORM Filmovertrukne tabletter [Udfyldes nationalt]
English: Do not chew the granules present in the suspension, simply swallow them.
Danish: Lad være med at tygge på granulatet i suspensionen.
English: - pins and needles, unusual sensitivity to stimuli of the senses, decreased skin sensitivity, tremors,
Danish: - stikken og prikken, usædvanlig følsomhed over for sanseindtryk, nedsat hudfølsomhed, rysten,
English: Renal tubular transport of methotrexate may be inhibited by concomitant administration of ciprofloxacin, potentially leading to increased plasma levels of methotrexate and increased risk of methotrexate-associated toxic reactions.
Danish: Det kan medføre forhøjede plasmakoncentrationer af methotrexat og øge risikoen for methotrexatbetingede toksiske reaktioner.
English: Anaphylactic reaction Anaphylactic shock (lifethreatening) (see section
Danish: Anafylaktisk reaktion Anafylaktisk shock (livstruende) (se pkt.
English: When a switch down to oral therapy is possible, a 750 mg bid ciprofloxacin regimen is recommended.
Danish: Når et skift til peroral behandling er muligt, anbefales en dosering på 750 mg ciprofloxacin 2 gange dagligt.
English: Excretion of ciprofloxacin (% of dose) Oral Administration Urine
Danish: Udskillelse af ciprofloxacin (% af dosis) Oral indgift Urin
English: However, 500 mg bid PO was considered inadequate for the treatment of malignant external otitis, and a dose of 750 mg bid PO was recommended for oral administration.
Danish: En peroral dosis på 500 mg 2 gange dagligt ansås imidlertid for at være utilstrækkelig til behandling af malign ekstern otitis, og i stedet anbefaledes en peroral dosis på 750 mg 2 gange dagligt.
English: If such reaction occurs, ciprofloxacin should be discontinued and an adequate medical treatment is required.
Danish: Hvis det sker, skal behandlingen med ciprofloxacin seponeres, og der skal påbegyndes passende medicinsk behandling.
English: Excretion of ciprofloxacin (% of dose) Intravenous Administration Urine
Danish: Udskillelse af ciprofloxacin (% af dosis) Intravenøs indgift Urin
English: • theophylline (for breathing problems)
Danish: • teofyllin (mod åndedrætsbesvær)
English: Complicated and uncomplicated pyelonephritis
Danish: Kompliceret og ukompliceret pyelonephritis
English: The increase of suspected drug-related arthropathy cases over time was not statistically significant between groups.
Danish: Der var ingen statistisk signifikant forskel mellem grupperne i stigningen over tid af lægemiddelrelateret artropati.
English: However, the concurrent administration of dairy products or mineral-fortified drinks alone (e.g. milk, yoghurt, calcium-fortified orange juice) with ciprofloxacin should be avoided because absorption of ciprofloxacin may be reduced.
Danish: Derimod bør samtidig indtagelse af mælkeprodukter (f.eks. mælk eller yoghurt) eller indtagelse af drikke tilsat mineraler (f.eks. orangejuice tilsat calcium) undgås samtidig med indtagelse af ciprofloxacin, fordi absorptionen af ciprofloxacin kan nedsættes.
English: Ciprofloxacin Bayer is used in children and adolescents, under specialist medical supervision, to treat the following bacterial infections:
Danish: Ciprofloxacin Bayer bruges til børn og unge til behandling af følgende bakterieinfektioner under nøje overvågning af en lægelig specialist:
English: Tell your doctor immediately, if any of the following occurs while taking Ciprofloxacin Bayer.
Danish: Fortæl det omgående til din læge, hvis noget af følgende hænder, mens du tager Ciprofloxacin Bayer.
English: Groupings of relevant species according to ciprofloxacin susceptibility (for Streptococcus species see section 4.4)
Danish: Inddeling af relevante arter efter ciprofloxacinfølsomhed (se pkt.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING COLOURLESS TYPE-2 GLASS BOTTLE WITH GREY SILICONISED BROMOBUTYL STOPPER OR CHLOROBUTYL STOPPER
Danish: FARVELØS TYPE-2 GLASFLASKE MED GRÅ, SILIKONISERET BROMBUTYLGUMMIPROP ELLER KLORBUTYLGUMMIPROP
English: • Inhalation anthrax (post-exposure prophylaxis and curative treatment)
Danish: • Inhalationsanthrax (profylakse efter eksponering og kurativ behandling)
English: Effects of other medicinal products on Ciprofloxacin:
Danish: Virkninger af andre lægemidler på ciprofloxacin:
English: Symptoms in overdose consist of dizziness, tremor, headache, tiredness, seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria and haematuria.
Danish: Symptomerne på overdosering omfatter: svimmelhed, tremor, hovedpine, træthed, krampeanfald, hallucinationer, konfusion, maveubehag, nedsat nyre- og leverfunktion samt krystalluri og hæmaturi.
English: Complicated urinary tract infections and pyelonephritis Ciprofloxacin treatment of urinary tract infections should be considered when other treatments cannot be used, and should be based on the results of the microbiological documentation.
Danish: Komplicerede urinvejsinfektioner og pyelonephritis Det bør overvejes at behandle urinvejsinfektioner med ciprofloxacin, når andre behandlinger ikke kan bruges.
English: Dose adjustments for patients with impaired renal function The CHMP reviewed the Applicant/MAH's initial proposal for dose adjustment in case of renal impairment and considered it incomplete and poorly substantiated.
Danish: CHMP gennemgik ansøgerens/indehaveren af markedsføringstilladelsens oprindelige forslag om dosisjustering i tilfælde af nedsat nyrefunktion og var af den opfattelse, at det var ufuldstændigt og dårligt understøttet.
English: The recommended use in human subjects is based primarily on in vitro susceptibility and on animal experimental data together with limited human data.
Danish: Den anbefalede dosis til mennesker er primært baseret på in vitro-følsomhed og på dyreeksperimentelle data sammen med begrænsede humane data.
English: max. of 3 months
Danish: Højst i 3 måneder
English: Ciprofloxacin Bayer solution for infusion contains 5 g glucose in 100 mL solution for infusion.
Danish: Ciprofloxacin infusionsopløsning indeholder 5 g glucose i 100 ml opløsning til infusion.
English: During the combination, serum theophylline concentrations should be checked and the theophylline dose reduced as necessary (see section 4.4).
Danish: Ved samtidig indgift, skal teofyllinkoncentrationerne kontrolleres, og teofyllindosis skal om nødvendigt nedsættes (se pkt.
English: 200-400 mg every 24 h
Danish: 200-400 mg hver 24. time
English: The full spoon will give you a dose of 500 mg Ciprofloxacin Bayer.
Danish: En fuld måleske giver dig en dosis på 500 mg Ciprofloxacin Bayer.
English: • Pelvic inflammatory disease including cases due to Neisseria gonorrhoeae In the above genital tract infections when thought or known to be due to Neisseria gonorrhoeae it is particularly important to obtain local information on the prevalence of resistance to ciprofloxacin and to confirm susceptibility based on laboratory testing.
Danish: Ved ovennævnte infektioner i genitalkanalen, som er mistænkt for eller kendt for at skyldes Neisseria gonorrhoeae, er det særligt vigtigt at indhente oplysninger lokalt om, hvor udbredt resistensen over for ciprofloxacin er, og at bekræfte følsomheden på basis af laboratorieundersøgelser.
English: 5 to 14 days
Danish: 5-14 dage
English: Infections of the skin and soft tissue
Danish: Infektioner i hud og bløddele
English: A 60-minute intravenous infusion of 400 mg ciprofloxacin every 12 hours was bioequivalent to a 500 mg oral dose every 12 hours with regard to AUC.
Danish: En 60 minutters intravenøs infusion af 400 mg ciprofloxacin hver 12. time var bioækvivalent med en oral dosis på 500 mg hver 12. time med hensyn til AUC.
English: If you notice any symptoms such as loss of appetite, jaundice (yellowing of the skin), dark urine, itching, or tenderness of the stomach, Ciprofloxacin Bayer must be stopped immediately.
Danish: Hvis du får symptomer som f.eks. appetitløshed, gulfarvning af huden (gulsot), mørkfarvet urin, kløen eller spændinger i maven, skal behandlingen med Ciprofloxacin Bayer stoppes omgående.
English: Creatinine Clearance [mL/min/1.73 m²]
Danish: Kreatininclearance [ml/min/ 1,73 m²]
English: Drug administration should begin as soon as possible after suspected or confirmed exposure.
Danish: Behandlingen skal påbegyndes så hurtigt som muligt efter suspekt eller bekræftet eksponering.
English: Increase in blood alkaline phosphatase
Danish: Stigning i basisk fosfatase i blodet
English: System Organ
Danish: systemet
English: 250-500 mg every 24 h
Danish: 250-500 mg hver 24. time
English: Czech Republic: Ciprobay Uro Germany:
Danish: Ciprobay Uro Storbritannien:
English: Therefore the following wording was recommended: “Lower respiratory tract infections due to Gram negative bacteria: - exacerbations of chronic obstructive pulmonary disease - broncho-pulmonary infections in cystic fibrosis or in bronchiectasis - pneumonia”
Danish: Derfor blev den følgende ordlyd anbefalet: "Infektioner i de nedre luftveje forårsaget af gramnegative bakterier: - eksacerbationer hos patienter med kronisk obstruktiv lungesygdom - bronkopulmonale infektioner hos patienter med cystisk fibrose eller bronchiectasi - pneumoni"
English: Pancytopenia, Bone marrow depression, Anaphylactic shock, Psychotic reactions, Migraine, Olfactory nerve disorders, Hearing impaired, Vasculitis, Pancreatitis, Liver necrosis, Petechiae, Tendon rupture
Danish: Pancytopeni, knoglemarvsdepression, anafylaktisk shock, psykotiske reaktioner, migræne, lugteforstyrrelser, nedsat hørelse, vasculitis, pancreatitis, levernekrose, petekkier, seneruptur
English: • Prophylaxis of infections in neutropenic patients
Danish: • Profylakse af infektioner hos neutropeniske patienter