FrancophonIA/ELRC3.0 huggingface dataset:
English: The daily dose of 1200 mg should not however be exceeded.
Danish: Den daglige dosis på 1 200 mg bør imidlertid ikke overskrides.
English: Medicines should not be disposed via wastewater or household waste.
Danish: Medicinen må ikke tilføres spildevand eller husholdningsaffald.
English: This medicine may cause these side effects, particularly if you are older or take a medicine of the socalled steroid group, such as hydrocortisone.
Danish: Dette lægemiddel kan forårsage disse bivirkningen, især hvis du er ældre og tager medicin af den såkaldte steroidgruppe, som hydrokortison.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Danish: Er dette ikke tilfældet er brugsopbevaringstiden og betingelserne før anvendelsen brugerens ansvar.
English: In very rare cases these allergic reactions may lead to life-threatening shock.
Danish: I meget sjældne tilfælde kan disse overfølsomhedsreaktioner føre til livstruende chok.
English: The patient should be monitored closely and treated symptomatically with supportive measures.
Danish: Patienten bør overvåges nøje og gives symptomatisk behandlling med understøttende målinger.
English: Maintaining fluoroquinolone class efficacy: review of influencing factors.
Danish: Scheld WM. Maintaining fluoroquinolone class efficacy: review of influencing factors.
English: Before starting treatment - if you suffer or have suffered from one of the following diseases:
Danish: Inden behandlingen starter-hvis du har eller har haft nogen af følgende sygdomme:
English: Teratogenic effects have not been observed in animal experimental research.
Danish: Der er ikke observeret teratogene virkninger ved forsøg på dyr.
English: An additional factor for consideration is the emergence of increasing ciprofloxacin resistance, particularly in the last 10-15 years.
Danish: Endnu en faktor, der bør tages i betragtning, er den stigende resistensudvikling over for ciprofloxacin, navnlig i de sidste 10-15 år.
English: This may increase the effect of glibenclamide (too low blood sugar level).
Danish: Kan forstærke virkningen af glibenclamid (for lavt blodsukkerniveau).
English: N-1753 Halden Norway
Danish: N-1753 Halden Norge
English: The renal clearance constitutes 60%-70% of the total body clearance and is approximately 3 times higher than the creatinine clearance.
Danish: Den renale clearance udgør 60- 70 % af den totale clearance og er ca. 3 gange højere end kreatininclearance.
English: Ask your doctor or pharmacist for advice before taking any medicine.
Danish: Spørg din læge eller apoteket om råd før du tager nogen form for medicin.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Officielle retningslinier for passende brug af antibiotika skal tages i betragtning.
English: Very rare: increment of amylase/lipase levels.
Danish: Meget sjælden: Forøgelse af amylase/lipase niveauer.
English: However, if this is not possible the patient is recommended to use a sun-protection cream.
Danish: Er dette ikke muligt at undgå anbefales det at patienten anvender solbeskyttelsescreme.
English: There is a linear correlation between dose on the one hand and plasma concentration and AUC on the other.
Danish: Der er lineær korrelation mellem dosis på den ene side og plasmakoncentration og AUC på den anden.
English: Monitoring the level of active substance in the blood provides the most reliable basis for dose adjustment.
Danish: Måling af niveauet af aktiv stof i blodet giver den bedste baggrund for dosisjusteringen.
English: Further intravenous administration is not contraindicated unless the reactions reoccur or worsen.
Danish: Yderligere intravenøs indgift er ikke kontraindiceret med mindre reaktionerne vender tilbage eller forværres.
English: If one of the above-mentioned situations is applicable to you, your doctor may decide to prescribe you another medicine or to adjust the dose of Ciprofloxacin Kabi or the other medicine.
Danish: Hvis en af ovennævnte situationer passer på dig, kan din læge beslutte at udskrive en anden medicin eller justere dosis af Ciprofloxacin Kabi eller det andet lægemiddel.
English: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Danish: Den normalt forekommende resistens kan variere geografisk og over tid for udvalgte arter og lokal information om resistens er at foretrække, især når alvorlige infektioner skal behandles.
English: The dosage in children with impaired renal and/or hepatic function has not been investigated.
Danish: Dosering til børn med nedsat nyre og/eller leverfunktion er ikke undersøgt.
English: If you suffer from dizziness, do not drive or operate machines, which require your full concentration.
Danish: Hvis du lider af svimmelhed må du ikke køre bil eller betjene maskiner, som kræver din fulde opmærksomhed.
English: If you or someone in your family suffers from this disease, you should consult your doctor.
Danish: Hvis du eller nogen i din familie lider af denne sygdom, bør du tale med lægen.
English: All metabolites are active, but in a lesser degree than ciprofloxacin.
Danish: Alle metabolitter er aktive, men i en mindre grad end ciprofloxacin.
English: In the case of concomitant administration of these products, prothrombin time (PT) or other suitable coagulation tests should be monitored.
Danish: I tilfælde af samtidig indgift af disse lægemidler bør prothrombin tiden (PT) eller andre passende koagulationstest udføres.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette lægemiddel må ikke blandes med andre lægemidler end nævnt i pkt.
English: An overdose of 12 g has been reported to lead to mild symptoms of toxicity.
Danish: En overdosis på 12 g har ført til lettere toksiske symptomer.
English: • Keep this leaflet.
Danish: • Gem denne information.
English: EXPIRY DATE EXP (MM/YYYY)
Danish: UDLØBSDATO EXP (MM/YYYY)
English: Due to the increased risk of local reactions, higher intravenous doses in particular should only be administered via a large vein or a central line.
Danish: På grund af øget risiko for lokale reaktioner bør især høje intravenøse doser kun indgives via en stor vene eller centralt venekateter.
English: These events were observed predominantly among patients with further risk factors for QTc prolongation.
Danish: Disse tilfælde blev overvejende observeret blandt patienter med yderligere risikofaktorer for QT intervalforlængelse.
English: The MIC of the Bacillus anthrax strain that was applied in this study was 0.08 µg/ml.
Danish: MIC90 af Bacillus anthrax stammen, der blev påført i denne undersøgelse, var 0,08 µg/ml.
English: In this section undesirable effects are defined as follows:
Danish: Følgende bivirkninger er forekommet: I dette afsnit er bivirkningerne defineret som følger:
English: Use only clear solutions and undamaged containers.
Danish: Anvend kun klare opløsninger og ubeskadigede beholdere.
English: Ask your pharmacist how to dispose of medicines no longer required.
Danish: Spørg ders apotek hvad De skal gøre ved medicin, der ikke længere er nødvendig.
English: Other studies comparing efficacy of low and higher dose ciprofloxacin showed superiority of the higher dose both in short term (1, 2) and long term efficacy (2).
Danish: I andre undersøgelser, der sammenlignede virkningen af den lave og høje dosis af ciprofloxacin, var den høje dosis overlegen både i korttidsvirkning (1, 2) og langtidsvirkning (2).
English: Antiperistaltics are contraindicated.
Danish: Anti- peristaltikmidler er kontraindicerede.
English: Other preclinical effects were observed only at exposures that were sufficiently in excess of the maximum human exposure so that concern for human safety is negligible.
Danish: Andre prækliniske virkninger blev kun observeret ved eksponeringer, der var væsentlig over den maksimalt tilladte for mennesker og det sikkerhedsmæssige aspekt for mennesker uden betydning.
English: To be used immediately after the bag is opened.
Danish: Skal anvendes umiddelbart efter åbning.
English: The following infections may be treated intravenously (via the blood) with Ciprofloxacin Kabi:
Danish: Følgende sygdomstilfælde kan behandles intravenøst (via blodet) med Ciprofloxacin Kabi:
English: The renal clearance occurs through glomerular filtration and active tubular secretion.
Danish: Den renale clearance sker gennem glomerulær filtration og aktiv tubulær sekretion.
English: The treatment was well tolerated, the most commonly occurring adverse event were gastrointestinal disorders.
Danish: Behandlingen tåltes godt; de hyppigst forekommende bivirkninger var gastrointestinale.
English: In this case you should immediately consult your doctor, since you may have a severe inflammation of the large intestine (pseudo membranous colitis).
Danish: I dette tilfælde bør du straks konsultere din læge, da du kan have en alvorlig betændelse i tyktarmen (pseudo membranøs colitis).
English: The blood level of these medicines can be increased.
Danish: Blodniveauet af disse lægemidler kan øges.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CIPROFLOXACIN KABI AND ASSOCIATED NAMES (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF CIPROFLOXACIN KABI OG TILKNYTTEDE NAVNE (se bilag I)
English: The reconstituted solution is clear and colourless.
Danish: Den blandede opløsning er klar og farveløs.
English: There is a linear correlation between dose and plasma concentration.
Danish: Der er lineær sammenhæng mellem dosis og plasmakoncentration.
English: altered vision such as double vision (diplopia) and seeing all objects in a certain colour (chromatopsia)
Danish: forstyrret syn som dobbeltsyn (diplopi) og at se al ting i bestemte farver (kromatopsi)
English: No accumulation occurs on repeated administration (twice daily).
Danish: Der sker ingen akkumulering ved gentaget indgift (to gange dagligt).
English: Fresenius Kabi AB SE-75174 Uppsala Sweden
Danish: Fresenius Kabi AB SE-75174 Uppsala Sverige
English: Rare: photosensibility.
Danish: Sjælden: Fotosensibilitet.
English: These reactions occur more frequently when the infusion time is 30 minutes or less.
Danish: Disse reaktioner forekommer hyppigere når infusionstiden er 30 minutter eller derunder.
English: Compatibility with these solutions has been proven in the dilution range of 1+1 and 1+4, corresponding to ciprofloxacin concentrations of 0.4 to 1 mg/ml.
Danish: Forligeligheden med disse opløsninger har været testet i et fortyndingsområde på 1+1 og 1+4, svarende til ciprofloxacin koncentrationer på fra 0,4 til 0,1 mg/ml.
English: • certain lower respiratory tract infections including pneumonia
Danish: • visse infektioner i de nedre luftveje, også lungebetændelse
English: three times daily as a maximum dose, a superior prevention of antibiotic resistance without a significant increase in adverse reactions in serious and life-threatening infections of other organ systems, there is no reason to conclude that this favourable risk/benefit profile would differ significantly in the treatment of complicated UTIs.
Danish: tre gange dagligt resulterer i bedre forebyggelse af resistensudvikling uden væsentlig forøgelse af bivirkningerne ved behandling af alvorlige og livstruende infektioner i andre organsystemer, giver ikke anledning til at slutte, at denne gunstige benefit/risk-profil ville være væsentligt anderledes ved behandling af komplicerede urinvejsinfektioner.
English: increased sensitivity to light (photosensitivity)
Danish: øget lysfølsomhed (fotosensibilitet)
English: The frequency of side effects is classified into the following categories: Very common in more than 1 in 10 patients
Danish: Bivirkningshyppigheden kan inddeles i følgende klasser: Meget almindelig hos flere end 1 ud af 10 patienter
English: The solution for infusion should be administered over an infusion period of 60 minutes.
Danish: Infusionsvæsken bør indgives over en infusionsperiode på 60 minutter.
English: The applicant has submitted evidence demonstrating the historical development of ciprofloxacin resistance and the decreasing margin between antibiotic resistance and the MIC.
Danish: Ansøgeren har forelagt dokumentation, der viser den historiske udvikling i forekomsten af resistens over for ciprofloxacin og den svindende margin mellem den antibiotiske resistens og MIC-værdien.
English: twice daily for the treatment of complicated urinary tract infections was identified.
Danish: to gange dagligt var anvendt til komplicerede urinvejsinfektioner.
English: With respect to the maximal dose, the applicant reviewed 6 clinical studies addressing the safety and efficacy of the proposed high dose ciprofloxacin treatment regimens in critically ill patients.
Danish: Vedrørende den maksimale dosis har ansøgeren refereret 6 kliniske undersøgelser af sikkerheden og virkningen af ciprofloxacin i de ansøgte høje doseringsregimer til kritisk syge patienter.
English: Part of it is converted into desethylene-, sulpho-, oxoand formylciprofloxacin.
Danish: En del er omdannet til desethylene-, sulpho-, oxo- and formylciprofloxacin.
English: When photosensibility occurs the treatment must be discontinued.
Danish: Forekommer fotosensibilisering skal behandlingen afbrydes.
English: There are however no sufficient clinical data available to draw conclusion about the effectiveness of ciprofloxacin in the treatment of anthrax in humans.
Danish: Der er imidlertid ikke tilstrækkelige kliniske data tilgængelige til at drage en konklusion om virkningen af ciprofloxacin til behandling af anthrax hos mennesker.
English: If you are older than 65 years your doctor may prescribe you a dose based on your kidney function and severity of disease.
Danish: Er du ældre end 65 år vil din læge eventuelt udskrive en lavere dosis afhængig af din nyrefunktion og infektionens alvorlighed.
English: In acute and extreme overdosage, reversible kidney damage is seen.
Danish: Ved akut og ekstrem overdosering er der set reversible nyreskader.
English: Do not prepare admixtures in glass bottles.
Danish: Fremstil ikke tilblandinger i glasflasker.
English: • cyclosporine (used to prevent rejection reactions after organ transplantations).
Danish: cyclosporin (en medicin til at undgå afstødelsesreaktioner efter organtransplantationer).
English: If necessary, the oral anticoagulant dose should be adjusted as appropriate.
Danish: Om nødvendigt skal der foretages passende justering af den antikoagulative dosis.
English: The maximum daily dose is 1200 mg.
Danish: Den maksimale daglige dosis er 1200 mg.
English: It is also effective against Gram-positive organisms, such as staphylococci and streptococci.
Danish: Stoffet er også effektivt mod grampositive organismer som staphylococci og streptococci.
English: • methotrexate (used to treat cancer or suppress the immune system).
Danish: metotrexat (anvendes til behandling af cancer eller for at undertrykke immunforsvaret).
English: • increased skin sensitivity to sunlight or UV light.
Danish: øget følsomhed for sollys eller UV lys.
English: administration of 200 mg the plasma concentration is still higher than the MIC values of the majority of clinically relevant pathogens (approximately 0.1 µg/ml).
Danish: indgift af 200 mg er plasmakoncentrationen stadig højere end MIC værdierne for størstedelen af de klinisk relevante bakterier (ca. 0,1 µg/ml).
English: The transaminase or alkaline phosphatase concentrations may temporarily increase or cholestatic icterus might occur, especially in patients with previous liver damage.
Danish: Koncentrationen af transaminase eller bassisk phosphatase kan midlertidigt øges eller cholestatisk gulsot kan forekomme, specielt hos patienter med tidligere leverskader.
English: In case of very serious, life-threatening or recurrent infections the dosage can be increased to 400 mg three times daily.
Danish: I tilfælde af meget alvorlige, livstruende eller tilbagevendende infektioner kan dosis øges til 400 mg 3 gange dagligt.
English: Because the MIC90 for ciprofloxacin of 70 other Bacillus anthrax strains varied between 0.03-0.06 µg/ml, it seems likely that ciprofloxacin would also be effective in other strains than the one that was applied in this study.
Danish: Da MIC90 for ciprofloxacin for 70 andre Bacillus anthraxstammer varierer mellem 0,03-0,06 µg/ml, er det sandsynligt at ciprofloxacin også vil være virksomt mod andre stammer end den der er anvendt i undersøgelsen.
English: In steady-state conditions the apparent distribution volume of ciprofloxacin is situated between 1,7 and 2,7 l/kg.
Danish: I steady state tilstand er det umiddelbare fordelingsvolumen af ciprofloxacin mellem 1,7 og 2,7 l/kg.
English: In order to avoid treatment failure and emergence of resistance it is a prerequisite that patient's compliance and dosing need to be adequate.
Danish: Hvis behandlingssvigt og resistensdannelse skal undgås, forudsætter dette, at såvel patientens compliance som doseringen er tilstrækkelig.
English: Other xanthine derivatives
Danish: Andre xanthinderivater
English: In doing so the applicant/ MAH should discuss the data in relation to complicated and uncomplicated, upper and lower urinary tract infections.
Danish: I denne forbindelse skulle ansøgeren/indehaveren af markedsføringstilladelsen redegøre for data vedrørende komplicerede og ukomplicerede øvre og nedre urinvejsinfektioner.
English: • severe and continuous diarrhoea during treatment, possibly with blood and mucus.
Danish: alvorlig og vedvarende diaré under behandlingen, muligvis med blod og slim.
English: • local reactions after administration of this medicine.
Danish: lokale reaktioner efter indgift af dette lægemiddel.
English: A study on Rhesus-monkeys that were exposed to anthrax by inhalation revealed that 8/9 animals survived the experiment when these animals were treated from 1 day after anthrax exposure with ciprofloxacin twice daily for a period of 30 days.
Danish: En undersøgelse med rhesusaber, der blev eksponeret for inhaleret anthrax, viste at 8/9 af dyrene overlevede forsøget, når disse var behandlet med ciprofloxacin 2 gange dagligt i en periode på 30 dage fra 1. dag efter exponeringen.
English: When undesirable effects on the central nervous system, like dizziness, occur, it is prohibited to drive a vehicle or to operate machines.
Danish: Hvis bivirkninger i centralnervesystemet, som svimmelhed, forekommer, er det ikke tilladt at køre bil eller betjene maskiner.
English: During the growth phase of bacteria, a partial rolling up and unfolding of chromosomes takes place.
Danish: Under bakteriernes vækstfase finder der en delvis oprulning og udfoldning sted af kromosomer.
English: A larger number of metabolites after oral administration indicates some degree of first-pass metabolism, mainly forming sulphociprofloxacin.
Danish: Et stort antal metabolitter efter oral indgift tyder på en vis grad af first-pass metabolisme, hovedsagelig under dannelse af sulphociprofloxacin.
English: In patients with severely impaired renal function (creatinine clearance <30 ml/min) the elimination half-life may be prolonged by a factor of 2.
Danish: Hos patienter med alvorlig nedsat nyrefunktion (kreatininclearance < 30 ml/min) kan eliminationshalveringtiden blive forlænget med en faktor 2.
English: Characteristics in patients:
Danish: Særlige forhold hos patienten:
English: The plasma protein binding of ciprofloxacin is situated between 16% and 28% and is not dependent on the concentration and pH (determined by means of ultrafiltration).
Danish: Ciprofloxacin har en proteinbinding mellen 16 og 28 % og er uafhængig af koncentration og pH (bestemt ved hjælp af ultrafiltration).
English: These may be manifested as local skin reactions, which rapidly disappear after the infusion has been completed.
Danish: Det kan være lokale hudreaktioner, som hurtigt forsvinder efter endt infusion.
English: These reactions may occcur particularly when the infusion time is 30 minutes or less.
Danish: Disse reaktioner viser sig især, når infusionstiden er 30 minutter eller derunder.
English: Like all medicines, Ciprofloxacin Kabi can cause side effects, although not everybody gets them.
Danish: Som alle andre lægemidler kan Ciprofloxacin Kabi give bivirkninger, selv om ikke alle får bivirkningerne.
English: Do not use Ciprofloxacin Kabi after the expiry date which is stated on the packaging after “Exp”.
Danish: Anvend Ciprofloxacin Kabi før udløbsdatoen anført på pakningen efter “Exp”.
English: The peak plasma concentration is reached 0.5 - 2 hours after taking 50 - 1000 mg p.o. and varies from 0.3 - 5.9 mg/l.
Danish: Den maksimale plasmakoncentration nås 0,5- 2 timer efter oral indtag af 50- 1000 mg og varierer fra 0,3 - 5,9 mg/l.
English: Medical practice in the treatment of complicated UTI's with ciprofloxacin has developed and changed since the time of first licensing in 1987 and the proposed dosing is in line with current medical practice (5) and supported by the published literature.
Danish: Praksis ved behandling af komplicerede urinvejsinfektioner med ciprofloxacin har udviklet sig og har undergået ændringer siden den første godkendelse i 1987, og den ansøgte dosering er både på linje med aktuel behandlingspraksis (5) og underbygget i den publicerede litteratur.
English: Other information:
Danish: Anden information:
English: You should avoid long exposure to strong sunlight, sunlamps or other sources of UV radiation.
Danish: Du bør undgå at udsætte dig for lang tids stærk sollys, solarier eller andre UV kilder.
English: The elimination half-life of ciprofloxacin after single or multiple oral dosage is between 3,4 and 6,9 hours.
Danish: Eliminationshalveringstiden af ciprofloxacin efter enkelt- eller flerdosis oral indgift er mellem 3,4 og 6,9 timer.
English: Adequate hydration must be ensured.
Danish: Passende væskebalance bør sikres.
English: At haemodialysis or peritoneal dialysis only a modest amount of ciprofloxacin (less than 10%) is eliminated.
Danish: Ved hæmo- eller peritonealdialyse elimineres kun en ringe del af ciprofloxacin (mindre end 10 %).
English: very common common uncommon rare very rare, including isolated reports
Danish: Meget sjælden, inklusive enkeltstående rapporter
English: There are limited data on the use of ciprofloxacin during pregnancy.
Danish: Der er begrænsede data om brugen af ciprofloxacin under graviditet.
English: increased blood level of amylase (enzyme that breaks down starch) and lipase (enzyme that breaks down fats).
Danish: øget niveau af amylase (enzym, der nedbryder stivelse) og lipase (enzym der nedbryder fedt)
English: • In this case the kidney function must be frequently (twice per week) monitored.
Danish: I dette tilfælde skal nyrefunktionen måles regelmæssigt (to gange ugentligt).
English: Any unused product or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt produkt eller spildt materiale bør bortskaffes i overensstemmelse med lokale retningslinier.
English: Do not refrigerate or freeze.
Danish: Må ikke opbevares koldt eller fryses.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉERNE, ETIKETTERINGEN OG INDLÆGSSEDLEN FREMLAGT AF EMEA
English: Rare: pseudomembranous colitis, moniliasis (oral).
Danish: Sjælden: Pseudomembranøs colitis, moniliasis (oral).
English: * MRSA are very likely to be resistant to ciprofloxacin and ciprofloxacin should not be used to treat presumed or known MRSA infections unless the organism is known to be susceptible.
Danish: * MRSA er ofte resistente over for ciprofloxacin og derfor bør ciprofloxacin ikke anvendes til behandling af formodede eller kendte MRSA infektioner med mindre organismen er kendt for at være følsom.
English: Ciprofloxacin Kabi is an antibiotic.
Danish: Ciprofloxacin Kabi er et antibiotikum.