FrancophonIA/ELRC3.0 huggingface dataset:
English: Studies with mature animals (rat, dog) revealed no evidence of cartilage lesions.
Danish: Studier med fuldt udvoksede dyr (rotter, hunde) viste ikke tegn på brusklæsioner.
English: The use of ciprofloxacin in children and adolescents should follow available official guidance.
Danish: Anvendelsen af ciprofloxacin til børn og unge skal ske i henhold til tilgængelig officiel vejledning.
English: Other specific severe infections
Danish: Andre specifikke svære infektioner
English: Subsequent intravenous administration is not contraindicated unless the reactions recur or worsen.
Danish: Det er ikke kontraindiceret at fortsætte med infusionerne medmindre reaktionerne kommer igen eller forværres.
English: Renal clearance is between 180-300 mL/kg/h and the total body clearance is between 480-600 mL/kg/h.
Danish: Den renale clearance er på 180 og 300 ml/kg/time og den totale bodyclearance er mellem 480 og 600 ml/kg/time.
English: Total duration of treatment (including switch to oral therapy as soon as possible)
Danish: Behandlingsvarighed (inklusiv skift til oral behandling så hurtigt som muligt)
English: Dietary calcium as part of a meal does not significantly affect absorption.
Danish: Calciumindholdet i kosten som en del af et måltid påvirker ikke absorptionen væsentligt.
English: Dosing in children with impaired renal and/or hepatic function has not been studied.
Danish: Doseringen til børn med nedsat nyre- og/eller leverfunktion er ikke undersøgt.
English: Common side effects (between 1 and 10 in every 100 people are likely to get these): - nausea, diarrhoea - joint pains in children
Danish: Almindelige bivirkninger (forekommer hos mellem 1 og 10 af hver 100 personer): - kvalme, diaré - ledsmerter hos børn
English: Vasodilatation Hypotension Syncope
Danish: Vasodilatation Hypotension Synkope
English: The mean treatment duration of ciprofloxacin for MEO as reported in the meta-analysis on 13 publications, published by Gehanno (1993) was 3 months (6 months in 3 studies, 2 months in one study).
Danish: Den gennemsnitlige behandlingsvarighed af ciprofloxacin for malign ekstern otitis indberettet i en metaanalyse af 13 publikationer, der er foretaget af Gehanno (1993) var 3 måneder (6 måneder i 3 undersøgelser, 2 måneder i 1 undersøgelse).
English: Impermeability and/or active substance efflux pump mechanisms of resistance may have a variable effect on susceptibility to fluoroquinolones, which depends on the physiochemical properties of the various active substances within the class and the affinity of transport systems for each active substance.
Danish: Impermeabilitet og/eller resistens, som påvirker mekanismen af efflukspumpen for den aktive substans, kan have forskellig virkning på følsomheden over for fluoroquinoloner, hvilket afhænger af de fysiokemiske egenskaber hos forskellige aktive substanser inden for klassen og affiniteten af transportsystemerne for hver aktiv substans.
English: As the oral suspension contains sucrose, it should not be used in patients with fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency.
Danish: Da den orale suspension indeholder sukrose, må den ikke bruges til patienter med fruktoseintolerans, glukose-galaktose malabsorption eller sukrose-isomaltase-insufficiens.
English: However, this indication was not considered acceptable for the IV ciprofloxacin formulation.
Danish: Denne indikation blev imidlertid ikke fundet acceptabel for den intravenøse formulering af ciprofloxacin.
English: Therefore, the CHMP asked the applicant/MAH to discuss (PK/PD rational) and make a proposal in this field.
Danish: CHMP bad derfor ansøgeren/indehaveren af markedsføringstilladelsen om at drøfte dette (PK/PD-rationalet) og fremsætte et forslag til løsning heraf.
English: Thus, the ability to drive or to operate machinery may be impaired.
Danish: Derfor kan evnen til at føre motorkøretøj eller betjene maskiner påvirkes.
English: - pneumonia
Danish: - pneumoni
English: Increased amylase * These events were reported during the postmarketing period and were observed predominantly among patients with further risk factors for QT prolongation (see section 4.4).
Danish: Øget amylase * Disse hændelser blev indberettet i perioden efter markedsføringen og blev fortrinsvis set hos patienter med yderligere risikofaktorer for QT-forlængelse (se pkt.
English: Occasionally the suspension may contain yellow-orange droplets and globular particles.
Danish: Suspensionen kan af og til indeholde små gulligorange dråber og kugleformede partikler.
English: After treatment has been completed, it should not be reused.
Danish: Når behandlingen er afsluttet, må suspensionen ikke bruges mere.
English: The reconstituted suspension is stable for no more than about 14 days even when stored in a refrigerator.
Danish: Den færdigblandede opløsning holder sig i højst 14 dage, også selvom den opbevares i køleskab.
English: Ciprofloxacin is known to be a moderate inhibitor of the CYP 450 1A2 iso-enzymes.
Danish: Ciprofloxacin er kendt for at være en moderat hæmmer af CYP 450 1A2-iso-enzymer.
English: Consequently ciprofloxacin should be used only after microbiological documentation and empirical treatment was not recommended.
Danish: Som følge deraf bør ciprofloxacin kun anvendes efter mikrobiologisk dokumentation, og empirisk behandling blev ikke anbefalet.
English: oral use
Danish: Oral anvendelse
English: • ropinirole (for Parkinson's disease)
Danish: • ropinirol (mod Parkinson's sygdom)
English: Ciprofloxacin Bayer treatment will have to be stopped immediately, as this can be life-threatening.
Danish: Behandlingen med Ciprofloxacin Bayer skal stoppes omgående, da det kan være livsfarligt.
English: It only works with specific strains of bacteria.
Danish: Det virker kun på visse bakterier.
English: To date, ciprofloxacin has been the fluoroquinolone that has been used most extensively in adolescents.
Danish: Hidtil har ciprofloxacin været det fluoroquinolon, der har været mest anvendt til unge.
English: Even if a 3-day treatment has some advantages in efficacy, the 500 mg single-dose therapy still has a place in the strategy provided its use is adequately guided by the clinical status of the patients and diagnostic tools.
Danish: Selvom 3-dages-behandlingen har visse fordele for så vidt angår virkning, vil enkeltdosisbehandlingen på 500 mg stadig være én af behandlingsmulighederne, så længe stoffets anvendelse i tilstrækkelig grad er baseret på patienternes kliniske tilstand og de diagnostiske værktøjer.
English: The degree of cross-resistance between ciprofloxacin and other fluoroquinolones that results is variable.
Danish: Graden af krydsresistens mellem ciprofloxacin og andre fluoroquinoloner, der hidrører herfra, er variabel.
English: The infusion solution can be infused either directly or after mixing with other compatible infusion solutions.
Danish: Infusionsopløsningen kan infunderes enten direkte eller efter blanding med andre kompatible infusionsopløsninger.
English: The CHMP had concerns with regards to the therapeutic indication “single dose treatment of uncomplicated UTI”.
Danish: CHMP var betænkelig ved den terapeutiske indikation "enkeltdosisbehandling af ukompliceret urinvejsinfektion".
English: The AUC values were 17.4 mg*h/L (range 11.8-32.0 mg*h/L) and 16.5 mg*h/L (range 11.0-23.8 mg*h/L) in the respective age groups.
Danish: AUC-værdierne var hhv. 17,4 mg*h/l (område 11,8-32,0 mg*h/l) og 16,5 mg*h/l (område 11,0-23,8 mg*h/l) i de respektive aldersgrupper.
English: Cystic fibrosis
Danish: Cystisk fibrose
English: With regards to the prophylaxis in neutropenic patients, the studies submitted by the Applicant/MAH showed comparable results between treatment groups.
Danish: For så vidt angår profylakse hos neutropeniske patienter, fremgik det af de undersøgelser, som ansøgeren/indehaveren af markedsføringstilladelsen indsendte, at resultaterne fra behandlingsgrupperne var sammenlignelige.
English: However, the CHMP considered that the particular context of anthrax (i.e.bioterrorism) required deviation from the usual requirement of clinical data and the benefit assessment.
Danish: CHMP var imidlertid af den holdning, at den særlige kontekst, som miltbrand optræder i (dvs. bioterrorisme), krævede en afvigelse fra det sædvanlige krav om kliniske data og en benefit/riskvurdering.
English: The use of ciprofloxacin for specific severe infections other than those mentioned above has not been evaluated in clinical trials and the clinical experience is limited.
Danish: Brugen af ciprofloxacin til specifikke svære infektioner, bortset fra behandling af infektionerne nævnt ovenfor, er ikke undersøgt i kliniske studier, og de kliniske erfaringer er begrænsede.
English: The recommended dosage can be higher (750 mg bid) depending on the severity and the microorganism.
Danish: Den anbefalede dosering kan være højere (750 mg 2 gange dagligt) afhængigt af sværhedsgraden og mikroorganismen.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of single dose toxicity, repeated dose toxicity, carcinogenic potential, or toxicity to reproduction.
Danish: De prækliniske data viser ingen særlig risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter enkeltdoser, toksicitet efter gentagne doser, karcinogenicitet eller reproduktionstoksicitet.
English: Ciproxin oral suspension oral use
Danish: Ciproxin suspension oral anvendelse
English: With regards to inhalation, intestinal and cutaneous anthrax, EMEA proposed guidelines in 2002 including the recommended use of ciprofloxacin in a first line treatment.
Danish: For så vidt angår lunge-, tarm- og hudmiltbrand foreslog EMEA i 2002 retningslinjer for bl.a. den anbefalede anvendelse af ciprofloxacin som førstevalgsbehandling.
English: Food and drink does not affect your treatment with Ciprofloxacin Bayer.
Danish: Mad og drikke påvirker ikke din behandling med Ciprofloxacin Bayer.
English: Read all of this leaflet carefully before you are given this medicine.
Danish: Læs denne indlægsseddel grundigt inden du får denne denne medicin.
English: Treatment usually lasts between 5 and 21 days, but may be longer for severe infections.
Danish: Behandlingen varer normalt mellem 5 og 21 dage, men kan vare længere i tilfælde af svære infektioner.
English: The treatment usually lasts from 5 to 21 days, but may take longer for severe infections.
Danish: Behandlingen varer normalt fra 5 til 21 dage, men kan vare længere i tilfælde af svære infektioner.
English: The adequacy of the therapeutic strategy between monotherapy and combination therapy should be re-considered as soon as microbiological results become available and local guidelines should allow to adequately adapt the ciprofloxacin use.
Danish: Valget af terapeutisk behandlingsstrategi mellem monoterapi og kombinationsbehandling bør overvejes på ny, så snart de mikrobiologiske resultater foreligger, og de lokale retningslinjer bør tillade en tilpasning af anvendelsen af ciprofloxacin.
English: Treatment or prophylaxis in patients with severe neutropenia:
Danish: Behandling eller profylakse hos patienter med svær neutropeni:
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CIPROFLOXACIN BAYER AND ASSOCIATED NAMES (SEE ANNEX I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF CIPROFLOXACIN BAYER OG TILKNYTTEDE NAVNE (SE BILAG I)
English: Chelation Complex Formation
Danish: Dannelse af chelatkompleks
English: However, for infections such as malignant external otitis (MEO), the scenario is different.
Danish: Scenariet for infektioner såsom malign ekstern otitis er dog anderledes.
English: Tinnitus Hearing loss / Hearing impaired
Danish: Tinnitus Tab af hørelse / nedsat hørelse
English: Do not chew the tablets because they do not taste nice.
Danish: De smager ikke godt.
English: Diarrhoea caused by bacterial pathogens including Shigella spp.
Danish: Diaré forårsaget af bakterielle patogener, herunder Shigella spp.
English: (2): Methicillin-resistant S. aureus very commonly express co-resistance to fluoroquinolones.
Danish: (2): Methicillinresistente S .aureus viser meget hyppigt samme resistens over for fluoroquinoloner.
English: Patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided.
Danish: Patienter, som får ciprofloxacin, skal være godt hydrerede og stærk alkalisering af urinen bør undgås.
English: Additionally, the use of ciprofloxacin in prophylaxis of neutropenia was further supported by a recent trial with other fluoroquinolones (levofloxacin).
Danish: Desuden blev anvendelsen af ciprofloxacin som profylakse af neutropeni yderligere understøttet af en nylig undersøgelse med andre fluoroquinoloner (levofloxacin).
English: • medicines or supplements containing calcium, magnesium, aluminium or iron If these preparations are essential, take Ciprofloxacin Bayer about two hours before or no sooner than four hours after them.
Danish: • medicin eller kosttilskud, som indeholder calcium, magnesium, aluminium eller jern Hvis det er vigtigt, at du tager disse præparater, skal du tage dem omkring to timer før eller tidligst fire timer efter, at du har taget Ciprofloxacin Bayer.
English: An acute overdose of 16 g has been reported to cause acute renal failure.
Danish: Det er indberettet, at en akut overdosis på 16 g har medført akut nyresvigt.
English: Avoid exposure to strong sunlight or artificial UV light such as sunbeds.
Danish: Undgå udsættelse for stærkt sollys eller kunstigt UV-lys som f.eks. solarier.
English: Ciprofloxacin should be used only when the resort to rifampcicin is not possible.
Danish: Ciprofloxacin bør kun anvendes, når det ikke er muligt at anvende rifampicin.
English: at least 10 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses)
Danish: Mindst 10 dage, i nogle tilfælde kan behandlingen fortsætte i længere end 21 dage (f.eks. ved abscesser)
English: The risk of tendinopathy may be increased in elderly patients or in patients concomitantly treated with corticosteroids (see section 4.8).
Danish: Risikoen for tendinopati kan øges hos ældre patienter eller hos patienter, som samtidigt behandles med kortikosteroider (se pkt.
English: After a long discussion, an agreement was achieved to using precautionary statements for downgrading the recommendation of the single dose regimen as compared to the 3-day regimen and by restricting this possible option to uncomplicated cystitis in pre-menopausal women.
Danish: Efter en længerevarende drøftelse blev det aftalt at anvende forsigtige vendinger for at nedtone anbefalingen af enkeltdosisbehandlingen i forhold til 3dages-behandlingen og at begrænse denne mulighed til ukompliceret cystitis hos præmenopausale kvinder.
English: Ciprofloxacin should be avoided in these patients unless the potential benefit is considered to outweigh the possible risk.
Danish: Derfor bør ciprofloxacin undgås hos disse patienter, med mindre de potentielle fordele opvejer de potentielle risici.
English: Acute exacerbation of chronic sinusitis
Danish: Akut exacerbation af kronisk sinusitis
English: However, after careful deliberations, an agreement was reach to include a statement in section 4.1 to cover the possible resort of ciprofloxacin in severe infections with a cross reference in section 4.4 that details such situations.
Danish: Efter omhyggelig drøftelse blev det imidlertid aftalt at indsætte en vending i afsnit 4.1 for at dække muligheden for at anvende ciprofloxacin til svære infektioner med en krydsreference til afsnit 4.4, hvor sådanne situationer beskrives nærmere.
English: During or following a course of treatment with ciprofloxacin bacteria that demonstrate resistance to ciprofloxacin may be isolated, with or without a clinically apparent superinfection.
Danish: Under og efter behandling med ciprofloxacin kan bakterier, der viser resistens over for ciprofloxacin, isoleres, med eller uden klinisk tydelig superinfektion.
English: The metabolites display in-vitro antimicrobial activity but to a lower degree than the parent compound.
Danish: Metabolitterne har antibakteriel aktivitet in vitro, men svagere end moderstoffet.
English: As it is not compulsory to specify the recommended antibiotic strategy in the wording of the therapeutic indication in the Marketing Authorisation, the CHMP recommended that the proposed 4.1 SPC wording “prophylaxis of invasive infections due to Neisseria meningitidis” remain, and accepted the adult posology: PO: 1 x 500 mg/d (single dose).
Danish: Eftersom det ikke er obligatorisk at specificere den anbefalede antibiotiske behandlingsstrategi i vendingen for den terapeutiske indikation i markedsføringstilladelsen, anbefalede CHMP at beholde den foreslåede ordlyd i afsnit 4.1 i produktresuméet "profylakse af invasive infektioner forårsaget af Neisseria meningitidis" og accepterede doseringen til voksne: Peroralt: 1 x 500 mg dagligt (enkeltdosis).
English: • Ciprofloxacin Bayer may cause a reduction in the number of white blood cells and your resistance to infection may be decreased.
Danish: • Ciprofloxacin kan forårsage en nedsættelse af antallet af hvide blodlegemer og din modstandskraft over for infektioner kan være nedsat.
English: Reclose the bottle properly after use according to the instructions on the cap.
Danish: Luk flasken godt til igen efter brugen iht.
English: Other Indications
Danish: Andre indikationer
English: Use of Ciprofloxacin in Children and Adolescents
Danish: Anvendelse af ciprofloxacin hos børn og unge
English: Microorganisms
Danish: Mikroorganisme
English: The occurrence of severe and persistent diarrhoea during or after treatment (including several weeks after treatment) may indicate an antibiotic-associated colitis (life-threatening with possible fatal outcome), requiring immediate treatment (see section 4.8).
Danish: Hvis der forekommer svær og vedvarende diaré under eller efter behandlingen (selv efter flere ugers behandling), kan det være tegn på en antibiotika-associeret colitis (livstruende med evt. fatalt udfald), som kræver omgående behandling (se pkt.
English: The following sections of the SPC were also subject to extensive harmonisation during this referral procedure, namely sections 4.4 Special warnings and precautions, 4.5 Interactions, 4.6 Pregnancy and lactation, 4.8 Undesirable effects, 4.9 Overdose, 5.1 Pharmacodynamic properties, and 5.2 Pharmacokinetic properties.
Danish: Følgende afsnit i produktresuméet var også genstand for omfattende harmonisering i forbindelse med denne henvisningsprocedure: afsnit 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen, 4.5 Interaktion med andre lægemidler og andre former for interaktion, 4.6 Graviditet og amning, 4.8 Bivirkninger, 4.9 Overdosering, 5.1 Farmakodynamiske egenskaber og 5.2 Farmakokinetiske egenskaber.
English: Nevertheless the CHMP noted that consideration should be given to the precautions of use in ciprofloxacin treatment of such infections.
Danish: Ikke desto mindre bemærkede CHMP, at det var nødvendigt at være opmærksom på forsigtighedsreglerne ved anvendelse af ciprofloxacin til behandling af sådanne infektioner.
English: {Name and address} <{tel}> <{fax}> <{e-mail}>
Danish: <{Tlf}> <{Fax}> <{Email}>
English: However, after extensive discussions, the CHMP considered that ciprofloxacin still remains a useful therapeutic option in uncomplicated cystitis.
Danish: Efter en grundig drøftelse vurderede CHMP dog, at ciprofloxacin stadig er en nyttig terapeutisk mulighed til behandling af ukompliceret cystitis.
English: Ciprofloxacin Bayer may make you feel less alert.
Danish: Ciprofloxacin Bayer kan få dig til at føle dig mindre vågen.
English: The active substance is ciprofloxacin.
Danish: Det aktive stof er ciprofloxacin.
English: Oral suspension in single-dose sachets can be taken independent of mealtimes.
Danish: Oral suspension i enkeltdosisposer kan tages uafhængigt af måltiderne.
English: Resistance mechanisms that inactivate other antibiotics such as permeation barriers (common in Pseudomonas aeruginosa) and efflux mechanisms may affect susceptibility to ciprofloxacin.
Danish: Resistensmekanismer, som inaktiverer andre antibiotika, som f.eks. permeationsbarrierer (almindelig hos Pseudomonas aeruginosa) og effluksmekanismer, kan påvirke følsomheden over for ciprofloxacin.
English: They can be taken independent of mealtimes.
Danish: De kan tages uafhængigt af måltiderne.
English: 60 days from the confirmation of Bacillus anthracis exposure
Danish: 60 dage efter bekræftelse af eksponering for Bacillus anthracis
English: Like a number of other quinolones, ciprofloxacin is phototoxic in animals at clinically relevant exposure levels.
Danish: Som mange andre quinoloner er ciprofloxacin fototoksisk hos dyr efter en klinisk relevant eksponering.
English: If you have a severe infection or one that is caused by more than one type of bacterium, you may be given additional antibiotic treatment in addition to Ciprofloxacin Bayer.
Danish: Hvis du har en svær infektion eller en infektion, som skyldes mere end én bakterie, skal du måske have anden antibiotisk behandling i tillæg til Ciprofloxacin Bayer.
English: Interaction with tests
Danish: Interaktioner med laboratorietests
English: 1 day (single dose)
Danish: 1 dag (éngangsdosis)
English: Diarrhoea caused by Shigella dysenteriae type 1
Danish: Diaré forårsaget af Shigella dysenteriae type 1
English: The CHMP agreed with this last Applicant/MAH proposal which is in line with the bioequivalence data.
Danish: CHMP var enig i ansøgerens/indehaveren af markedsføringstilladelsens sidste forslag, som er i overensstemmelse med bioækvivalensdataene.
English: Ciprofloxacin is approved for the treatment of uncomplicated and complicated infections caused by ciprofloxacinsusceptible bacteria and thus a broad variety of infections in adults.
Danish: Ciprofloxacin er godkendt til behandling af ukomplicerede og komplicerede infektioner forårsaget af ciprofloxacin-følsomme bakterier og dermed en lang række infektioner hos voksne.
English: The CHMP raised concerns on the potential uncontrolled use of ciprofloxacin in the empirical treatment of shigellosis or traveller's diarrhoea and questioned its effectiveness, especially in the mild form, pointing out the high risk of resistance induction.
Danish: CHMP var betænkelig ved den potentielle ukontrollerede anvendelse af ciprofloxacin til empirisk behandling af shigellose eller turistdiaré og satte spørgsmålstegn ved dets virkning, især i den milde form, idet udvalget fremhævede den store risiko for udvikling af resistens.
English: Press down according to instructions on the cap while turning to the left.
Danish: vejledningen samtidig med, at det drejes til venstre.
English: The choice of ciprofloxacin should take into account information on resistance to ciprofloxacin in relevant pathogens in the countries visited.
Danish: Ved valget af ciprofloxacin skal der tages hensyn til resistensen over for ciprofloxacin hos relevante patogener i de lande, der besøges.
English: No additions should be made to the mixed final ciprofloxacin suspension.
Danish: Der må ikke tilsættes noget til den færdigblandede ciprofloxacin-suspension.
English: Patients taking ciprofloxacin should be advised to avoid direct exposure to either extensive sunlight or UV irradiation during treatment (see section 4.8).
Danish: Patienter, som tager ciprofloxacin, skal rådes til at undgå direkte udsættelse for stærkt sollys eller UV-stråling under behandlingen (se pkt.
English: Your doctor will explain to you exactly how much Ciprofloxacin Bayer you will have to take as well as how often and for how long.
Danish: Din læge vil forklare dig nøjagtigt, hvor meget Ciprofloxacin Bayer, du skal tage, samt hvor tit og i hvor lang tid.
English: Your doctor will explain to you exactly how much Ciprofloxacin Bayer you will be given as well as how often and for how long.
Danish: Din læge vil forklare dig nøjagtigt, hvor meget Ciprofloxacin Bayer, du vil få, samt hvor tit og i hvor lang tid.