FrancophonIA/ELRC3.0 huggingface dataset:
English: In 10 children with severe sepsis Cmax was 6.1 mg/L (range 4.6-8.3 mg/L) after a 1-hour intravenous infusion of 10 mg/kg in children aged less than 1 year compared to 7.2 mg/L (range 4.7-11.8 mg/L) for children between 1 and 5 years of age.
Danish: Hos 10 børn med svær sepsis var Cmax 6,1 mg/l (område 4,6-8,3 mg/L) efter en 1-times intravenøs infusion i en dosis på 10 mg/kg hos børn under 1 år sammenlignet med 7,2 mg/l (område 4,7-11,8 mg/l) hos børn mellem 1 og 5 år.
English: As a precautionary measure, it is preferable to avoid the use of ciprofloxacin during pregnancy.
Danish: Som en sikkerhedsforanstaltnng bør anvendelse af ciprofloxacin under graviditet derfor undgås.
English: Ciprofloxacin should be used in combination with other antimicrobial agents depending on the results of the microbiological documentation.
Danish: Ciprofloxacin bør anvendes i kombination med andre antibakterielle lægemidler, afhængigt af resultaterne af de mikrobiologiske undersøgelser.
English: Taking Ciprofloxacin Bayer with food and drink
Danish: Brug af Ciprofloxacin Bayer sammen med mad og drikke
English: Data on photomutagenicity/photocarcinogenicity show a weak photomutagenic or phototumorigenic effect of ciprofloxacin in-vitro and in animal experiments.
Danish: Data om fotomutagenicitet/fotocarcinogenicitet viser en svag fotomutagen eller fototumorigen virkning af ciprofloxacin in vitro og i dyreforsøg.
English: Daily dose in mg
Danish: Daglig dosis i mg
English: Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin)
Danish: Behandlingsvarighed (inklusiv evt. initial parenteral behandling med ciprofloxacin)
English: Rare ≥ 1/10 000 to <
Danish: Sjælden ≥ 1/10.000 til <
English: 2 to 4 weeks (acute)
Danish: 2-4 uger (akut)
English: Mycotic superinfections
Danish: Mykotiske superinfektioner
English: Therefore, the CHMP and the Applicant/MAH were in agreement that a duration up to 3 months with ciprofloxacin was justified for the treatment of malignant external otitis.
Danish: CHMP og ansøgeren/indehaveren af markedsføringstilladelsen var derfor enige om, at der forelå tilstrækkelig begrundelse for en varighed på op til 3 måneder med ciprofloxacin til behandling af malign ekstern otitis.
English: Ciprofloxacin works by killing bacteria that cause infections.
Danish: Ciprofloxacin virker ved at dræbe de bakterier, som forårsager infektionerne.
English: The infection typically occurs in elderly diabetic patient and is thought to arise at the osseous-cartilaginous junction.
Danish: Infektionen sker typisk hos ældre diabetespatienter og menes at opstå i leddet mellem knoglerne og brusken.
English: • You may experience symptoms of neuropathy such as pain, burning, tingling, numbness and/or weakness.
Danish: • Du kan opleve symptomer på neuropati, som f.eks. smerte, brændende fornemmelse, prikken og stikken, følelsesløshed og/eller slaphed.
English: • Your skin becomes more sensitive to sunlight or ultraviolet (UV) light when taking Ciprofloxacin Bayer.
Danish: • Huden bliver mere følsom over for sollys eller ultraviolet lys (UV-lys), når du tager Ciprofloxacin Bayer.
English: Ciprofloxacin is present in plasma largely in a nonionised form and has a large steady state distribution volume of 2-3 L/kg body weight.
Danish: Ciprofloxacin findes overvejende uioniseret i plasma og har i steadystate et stort distributionsvolumen på 2-3 l/kg legemsvægt.
English: Oral Dose [mg] See Usual Dosage.
Danish: Oral dosis [mg] Se normaldosering.
English: Tell your doctor if you:
Danish: Fortæl det til din læge, hvis du tager:
English: After evaluating the data presented by the Applicant/MAH, the CHMP considered that the therapeutic indication related to the empiric ciprofloxacin treatment of Shigellosis or the traveller's diarrhoea was acceptable with the wording “infections of the gastro-intestinal tract (e.g. travellers' diarrhoea)” and restricted its use in “severe” cases in section 4.2, with the following schedule regimens:
Danish: Efter at have evalueret de af ansøgeren/indehaveren af markedsføringstilladelsen fremlagte data vurderede CHMP, at den terapeutiske indikation til empirisk behandling med ciprofloxacin af shigellose eller turistdiaré var acceptabel med anvendelse af ordlyden "infektioner i mave-tarm-kanalen (f.eks. turistdiaré)" og begrænsede stoffets anvendelse til "svære" tilfælde i afsnit 4.2 i følgende behandlingsregimer:
English: In these cases, ciprofloxacin should be discontinued.
Danish: I disse tilfælde skal ciprofloxacin seponeres.
English: Apart from routine emergency measures, it is recommended to monitor renal function, including urinary pH and acidify, if required, to prevent crystalluria.
Danish: Bortset fra rutinemæssige nødforanstaltninger bør nyrefunktionen overvåges om nødvendigt for at undgå krystalluri, herunder urinens pH og surhedsgrad.
English: • Diarrhoea may develop while you are taking antibiotics, including Ciprofloxacin Bayer, or even several weeks after you have stopped taking them.
Danish: • Der kan komme diaré, mens du tager antibiotika, herunder Ciprofloxacin Bayer, selv flere uger efter, at du er stoppet med at tage dem.
English: The infusion solution can be infused either directly or after mixing with other compatible infusion solutions (see section 6.2).
Danish: Infusionsopløsningen kan infunderes enten direkte eller efter blanding med andre kompatible infusionsopløsninger (se pkt.
English: Allergic reaction Allergic oedema / angiooedema
Danish: Allergisk reaktion Allergisk ødem / angioødem
English: If it becomes severe or persistent or you notice that your stool contains blood or mucus, stop taking Ciprofloxacin Bayer immediately, as this can be life-threatening.
Danish: Hvis diaréen bliver svær eller fortsætter, eller hvis du opdager, at der er blod eller slim i afføringen, skal du omgående stoppe med at tage Ciprofloxacin Bayer, da det kan være livsfarligt.
English: Therefore, make sure you know how you react to Ciprofloxacin Bayer before driving a vehicle or operating machinery.
Danish: Vær derfor sikker på, hvordan du reagerer på Ciprofloxacin Bayer, før du kører bil, motorcykel, cykel eller betjener maskiner.
English: Daily dose in mg and in mL
Danish: Daglig dosis i mg og ml
English: Even with the first dose, there is a small chance that you may experience a severe allergic reaction with the following symptoms: tightness in the chest, feeling dizzy, sick or faint, or experiencing dizziness when standing up.
Danish: Selv efter den første dosis er der en lille risiko for, at du kan udvikle en svær allergisk reaktion med følgende symptomer: strammen om brystet, svimmelhed, almen utilpashed eller besvimelse, eller svimmelhed, når du rejser dig op.
English: Long-term safety profile of ciprofloxacin to treat bone and joint infections Since a treatment duration of up to 3 months may be required in clinical practice to treat bone and joints infections, the CHMP requested that the applicant/MAH provide long term safety data to substantiate the safety profile of the drug in such a prolonged use.
Danish: Sikkerhedsprofilen over lang tid for ciprofloxacin til behandling af knogle- og ledinfektioner Eftersom en behandlingsvarighed på op til 3 måneder kan være nødvendig i klinisk praksis for at behandle knogle- og ledinfektioner, anmodede CHMP ansøgeren/indehaveren af markedsføringstilladelsen om at fremlægge langtidsdata vedrørende sikkerhed til begrundelse af lægemidlets sikkerhedsprofil, når det anvendes over så lang tid.
English: The Applicant/MAH proposed to take the Ciprofloxacin Modified Release Tablets out of this Referral procedure to significantly simplify the exercise of harmonisation.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen foreslog at trække ciprofloxacin-tabletterne med modificeret udløsning ud af denne henvisningsprocedure med henblik på en betydelig forenkling af harmoniseringsprocessen.
English: • Gonococcal urethritis and cervicitis (only for oral formulations)
Danish: • Urethritis gonorrhoica og cervicitis (gælder kun for perorale formuleringer)
English: Indications approved for children and adolescents in most European countries include acute pulmonary exacerbations of patients with cystic fibrosis caused by Pseudomonas aeruginosa, complicated urinary tract infections, pyelonephritis, and post-exposure prophylaxis of inhalational anthrax.
Danish: Blandt de godkendte indikationer til børn og unge i de fleste europæiske lande er akutte pulmonale eksacerbationer hos patienter med cystisk fibrose fremkaldt af Pseudomonas aeruginosa, komplicerede urinvejsinfektioner, pyelonefritis og profylakse af lungemiltbrand efter udsættelse for smitte.
English: Ciprofloxacin has been shown to cause photosensitivity reactions.
Danish: Det er vist, at ciprofloxacin kan forårsage fotosensitivitetsreaktioner.
English: Injection and infusion site reactions (only intravenous administration)
Danish: Reaktioner på injektions- og infusionsstedet (kun efter intravenøs indgift)
English: • tizanidine (for muscle spasticity in multiple sclerosis)
Danish: • tizanidin (mod muskelspasticitet ved dissemineret sklerose)
English: Overall, the CHMP considered that the therapeutic indication “acute sinusitis” could not be accepted, as the most commonly involved pathogen in this infection, Streptococcus pneumoniae, is only intermediately susceptible to ciprofloxacin and its efficacy in this indication is poorly substantiated by the submitted data.
Danish: CHMP vurderede samlet set, at den terapeutiske indikation "akut sinuitis" ikke kunne accepteres, idet det mest almindelige patogen, der forårsager denne infektion, Streptococcus pneumoniae, kun er midlertidigt følsom over for ciprofloxacin, og stoffets virkning i denne indikation kun understøttes i ringe grad af de indsendte data.
English: System Organ Class
Danish: Organklasse Almindelig
English: Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose, and determination of serum concentrations (e.g. of theophylline) may be necessary (see section 4.5).
Danish: Patienter, som tager disse stoffer sammen med ciprofloxacin, skal derfor kontrolleres omhyggeligt for kliniske tegn på overdosering, og der skal om nødvendigt foretages serumkoncentrationsbestemmelser (f.eks. for teofyllin) (se pkt.
English: • Diarrhoea may develop while you are on antibiotics, including Ciprofloxacin Bayer, or even several weeks after you have stopped using them.
Danish: • Der kan komme diaré, mens du behandles med antibiotika, herunder Ciprofloxacin Bayer, selv flere uger efter, at du er stoppet med at anvende dem.
English: The graduated measuring spoon must be used for measuring the required prescribed amount of Ciprofloxacin oral suspension 50 mg/mL.
Danish: Måleskeen skal bruges til afmåling af den foreskrevne mængde ciprofloxacinsuspension 50 mg/ml.
English: Plasmidmediated resistance encoded by qnr-genes has been reported.
Danish: Der er set plasmidmedieret resistens kodet via qnr-gener.
English: Press down the child-proof cap and turn it to the left.
Danish: Åbn begge flasker.Tryk det børnesikrede låg ned og drej det til venstre.
English: Ciprofloxacin should be discontinued in patients experiencing symptoms of neuropathy, including pain, burning, tingling, numbness, and/or weakness in order to prevent the development of an irreversible condition (see section 4.8).
Danish: Ciprofloxacin bør seponeres hos patienter, som får symptomer på neuropati, herunder smerter, brænden, prikken og stikken, følelsesløshed og/eller slaphed for at hindre udvikling af en irreversibel tilstand (se pkt.
English: Ciprofloxacin should be used in combination with other antimicrobial agents, such as rifampicin in infections due to Staphylococci, and beta-lactams or aminoglycosides in infections due to Pseudomonas aeruginosa.
Danish: Ciprofloxacin bør anvendes i kombination med andre antimikrobielle stoffer såsom rifampicin ved infektioner forårsaget af Staphylococci og betalaktamer eller aminoglycosider ved infektioner forårsaget af Pseudomonas aeruginosa.
English: The frequency analysis takes into account data from both oral and intravenous administration of ciprofloxacin.
Danish: Hyppighedsanalysen er baseret på oplysninger fra både oral og intravenøs indgift af ciprofloxacin.
English: ($): Natural intermediate susceptibility in the absence of acquired mechanism of resistance (1): Studies have been conducted in experimental animal infections due to inhalations of Bacillus anthracis spores; these studies reveal that antibiotics starting early after exposition avoid the occurrence of the disease if the treatment is made up to the decrease of the number of spores in the organism under the infective dose.
Danish: ($): Naturlig intermediær følsomhed i fravær af erhvervet resistensmekanisme (1): Der er foretaget studier ved eksperimentelle infektioner hos dyr efter inhalation af Bacillus anthracis sporer; disse studier viser, at tidlig antibiotikabehandling efter eksponering, kan forhindre sygdommen, hvis behandlingen tilpasses til at mindske antallet af sporer i organismen med den infektive dosis.
English: This medicinal product is authorised in the Member States of the EEA under the following names:
Danish: Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: Belgien:
English: At any sign of tendinitis (e.g. painful swelling, inflammation), ciprofloxacin treatment should be discontinued.
Danish: Ved tegn på tendinitis (f.eks. smertefuld hævelse eller inflammation), skal behandlingen med ciprofloxacin seponeres.
English: Probenecid interferes with renal secretion of ciprofloxacin.
Danish: Probenecid interfererer med den renale udskillelse af ciprofloxacin.
English: As a fluoroquinolone antibacterial agent, the bactericidal action of ciprofloxacin results from the inhibition of both type II topoisomerase (DNA-gyrase) and topoisomerase IV, required for bacterial DNA replication, transcription, repair and recombination.
Danish: Som et fluorquinolon-antibiotikum udøver Ciprofloxacin sin baktericide virkning ved at hæmme både type II topo-isomerase (DNA-gyrase) og top-isomerase IV, som er nødvendig for bakteriel DNAreplikation, transskription, genopretning og rekombination.
English: Your doctor will decide whether treatment with Ciprofloxacin Bayer needs to be stopped.
Danish: Lægen vil tage stilling til, om behandlingen med Ciprofloxacin Bayer skal stoppes.
English: Oedema Sweating (hyperhidrosis)
Danish: Ødemer Svedtendens (hyperhidrosis)
English: - exacerbations of chronic obstructive pulmonary disease
Danish: - exacerbationer af kronisk, obstruktiv lungesygdom
English: In patients for whom sodium intake is of medical concern (patients with congestive heart failure, renal failure, nephrotic syndrome, etc.), the additional sodium load should be taken into account (for sodium chloride content, see section 2).
Danish: Hos patienter for hvem indtagelse af natrium er af medicinsk betydning (patienter med kongestiv hjertesygdom, nyreinsufficiens, nefrotisk syndrome etc.), skal den ekstra natriumbelastning tages i betragtning (se pkt.
English: The visual signs of incompatibility are e.g. precipitation, clouding, and discolouration.
Danish: De visuelle tegn på inkompatibilitet er udfældning, uklarheder og misfarvning.
English: The dosage is determined by the indication, the severity and the site of the infection, the susceptibility to ciprofloxacin of the causative organism(s), the renal function of the patient and, in children and adolescents the body weight.
Danish: Doseringen afhænger af indikationen, infektionens sværhedsgrad og infektionsstedet, de sygdomsfremkaldende bakteriers følsomhed for ciprofloxacin, patientens nyrefunktion, og hos børn og unge, patientens vægt.
English: - breakpoints for ciprofloxacin relate to high dose therapy.
Danish: - breakpoints for ciprofloxacin refererer til højdosisbehandling.
English: Psychiatric reactions may occur even after the first administration of ciprofloxacin.
Danish: Der kan forekomme psykiske reaktioner selv efter første indgift af ciprofloxacin.
English: 4.7 Effects on ability to drive and use machines Due to its neurological effects, ciprofloxacin may affect reaction time.
Danish: 4.7 Virkning på evnen til at føre motorkøretøj eller betjene maskiner Ciprofloxacin kan påvirke reaktionstiden på grund af dets neurologiske virkninger.
English: Care should be taken to keep the affected limb at rest.
Danish: Den berørte legemsdel skal holdes i ro.
English: Any calcium you take as part of a meal will not seriously affect uptake.
Danish: Hvis du tager calcium som en del af et måltid, vil det ikke påvirke optagelsen væsentligt.
English: Ciprofloxacin treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents.
Danish: Ciprofloxacin-behandling må kun påbegyndes af en læge, der har erfaring i behandling af cystisk fibrose og/eller svære infektioner hos børn og unge.
English: 6.6 Special precautions for disposal and other handling For ease of use the infusion vial stopper should be penetrated in the central ring.
Danish: 6.6 Regler for destruktion og anden håndtering For at lette brugen, skal gummiproppen på infusionshætteglasset penetreres i den centrale ring.
English: In rare cases, depression or psychosis can progress to selfendangering behaviour.
Danish: I sjældne tilfælde kan en depression eller psykose udvikle sig således, at patienten bliver til fare for sig selv.
English: Posology for the treatment of uncomplicated cystitis The CHMP asked the applicant/MAH to provide reassurance that a 100 mg BID dose for 3 days (currently validated in some EU countries) is adequate for treating uncomplicated cystitis in young women with regards to the epidemiological figure pertaining to the bacteria potentially involved and with regards to the treatment response as compared to the proposed higher dose of 250 mg- 500 mg BID.
Danish: CHMP bad ansøgeren/indehaveren af markedsføringstilladelsen om at fremlægge sikkerhed for, at en dosis på 100 mg 2 gange dagligt i 3 dage (hvilket på nuværende tidspunkt er godkendt i nogle EUlande) er hensigtsmæssig til behandling af ukompliceret cystitis hos unge kvinder, for så vidt angår det epidemiologiske mønster, der gælder for de bakterier, der kan indgå, og med hensyn til behandlingsrespons sammenlignet med den foreslåede højere dosis på 250 mg - 500 mg 2 gange dagligt.
English: • Your skin becomes more sensitive to sunlight or ultraviolet (UV) light under treatment with Ciprofloxacin Bayer.
Danish: • Huden bliver mere følsom over for sollys eller ultraviolet lys (UV-lys) under behandling med Ciprofloxacin Bayer.
English: Injection Site Reaction
Danish: Reaktioner på injektionstedet
English: Tablets are to be swallowed unchewed with fluid.
Danish: Tabletterne skal sluges hele med væske.
English: Belgium BAYER SA-NV Avenue Louise 143
Danish: BAYER SA-NV Avenue Louise 143
English: In most cases, ciprofloxacin should be administered in combination with another appropriate (beta-lactam) antibiotic.
Danish: I de fleste tilfælde bør ciprofloxacin administreres i kombination med et andet passende (betalaktam) antibiotikum.
English: Treatment of some infections (e.g. pelvic inflammatory disease, intra-abdominal infections, infections in neutropenic patients and infections of bones and joints) may require co-administration with other appropriate antibacterial agents depending on the pathogens involved.
Danish: Behandling af nogle infektioner (f.eks. underlivsbetændelse, intraabdominale infektioner, infektioner hos neutropeniske patienter og infektioner i knogler og led) kan kræve samtidig indgift af andre passende antibakterielle midler, afhængigt af de involverede patogener.
English: Like all medicines, Ciprofloxacin Bayer can cause side effects, although not everybody gets them.
Danish: Ciprofloxacin Bayer kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: • a polymeric phosphate binder (e.g. sevelamer)
Danish: • en polymerisk fosfatbinder (f.eks. sevelamer)
English: Ciprofloxacin is largely excreted unchanged both renally and, to a smaller extent, faecally.
Danish: Ciprofloxacin udskilles overvejende uændret, både renalt og i mindre grad fækalt.
English: Co-administration of ciprofloxacin and tizanidine is contra-indicated.
Danish: Samtidig indtagelse af ciprofloxacin og tizanidin er kontraindiceret.
English: • Chronic suppurative otitis media
Danish: • Kronisk suppurativ otitis media
English: DATE OF REVISION OF THE TEXT {MM/YYYY} [To be completed nationally]
Danish: DATO FOR ÆNDRING AF TEKSTEN [MM/ÅÅÅÅ] [Udfyldes nationalt]
English: The following undesirable effects have a higher frequency category in the subgroups of patients receiving intravenous or sequential (intravenous to oral) treatment:
Danish: Følgende bivirkninger forekommer hyppigere hos de patienter, som får intravenøs eller sekventiel behandling (intravenøs og oral):
English: Ciprofloxacin is excreted in breast milk.
Danish: Ciprofloxacin udskilles i modermælk.
English: • pentoxifylline (for circulatory disorders) • caffeine
Danish: • pentoxifyllin (forstyrrelser i blodomløbet) • koffein
English: The proposed wording of the therapeutic indications was as follows: “Inhalation anthrax (post exposure prophylaxis and curative treatment)” for oral and IV pharmaceutical presentations.
Danish: Den foreslåede ordlyd for de terapeutiske indikationer var som følger: "Lungemiltbrand (profylakse efter udsættelse for smitte og kurativ behandling)" for perorale og intravenøse farmaceutiske formuleringer.
English: From the data presented, ciprofloxacin prescriptions in “bone and joint infections” were supported by several clinical studies and an extensive use in clinical practice.
Danish: Det fremgik af de fremlagte data, at udskrivning af ciprofloxacin ved knogle- og ledinfektioner var understøttet af adskillige kliniske undersøgelser og en omfattende anvendelse i klinisk praksis.
English: It is an often intractable bacterial infection of the ear, mastoid and skull base caused by Pseudomonas aeruginosa.
Danish: Det er en ofte umedgørlig bakterieinfektion i øret, processus mastoideus og kraniet forårsaget af Pseudomonas aeruginosa.
English: Staphylococci or Pseudomonas aeruginosa are the main bacteria involved in these infections and ciprofloxacin bacterial activity had to be taken into account regarding these targeted species.
Danish: De væsentligste bakterier, der fremkalder disse infektioner, er Staphylococci eller Pseudomonas aeruginosa, og det var nødvendigt at tage højde for ciprofloxacins bakterielle aktivitet, for så vidt angår disse målarter.
English: Only after reconstitution Shake well before use.
Danish: Rystes godt før brugen.
English: From the data submitted the CHMP considered that 500 mg bid could be used in the oral treatment of upper respiratory tract infections such as acute exacerbations of chronic sinusitis and chronic suppurative otitis media.
Danish: På grundlag af de indsendte data vurderede CHMP, at 500 mg 2 gange dagligt kunne anvendes til peroral behandling af infektioner i de øvre luftveje såsom akutte eksacerbationer hos patienter med kronisk sinuitis og kronisk suppurativ otitis media.
English: Studies have been conducted in experimental animal infections due to inhalations of Bacillus anthracis spores; these studies reveal that antibiotics starting early after exposition, avoid the occurrence of the disease if the treatment is made up to the decrease of the number of spores in the organism under the infective dose.
Danish: Der er gennemført undersøgelser af infektioner forårsaget af inhalerede Bacillus anthracis-sporer i dyreforsøg; det blev i disse undersøgelser påvist, at indgift af antibiotika tidligt efter udsættelse for smitte forebygger sygdommen, hvis behandlingen fortsættes, indtil antallet af sporer i organismen er faldet til under den infektiøse dosis.
English: 2 - Strictly follow the prescription.
Danish: 2- Følge doseringen nøje