FrancophonIA/ELRC3.0 huggingface dataset:
English: With regards to the treatment of febrile patients with neutropenia, the CHMP considered that, despite the lack of robustness of the available data (limited number of patients included in these studies), the use of ciprofloxacin remained well admitted in the scientific community and had become part of the clinical practice.
Danish: For så vidt angår behandling af febrile patienter med neutropeni, vurderede CHMP, at anvendelsen af ciprofloxacin på trods af den manglende robusthed af de tilgængelige data (begrænset antal patienter i disse undersøgelser) stadig var almindeligt anerkendt i de faglige kredse og var blevet en del af den kliniske praksis.
English: Only a small quantity of ciprofloxacin (<10%) is eliminated by haemodialysis or peritoneal dialysis.
Danish: Det er kun en mindre mængde ciprofloxacin (<10%), der elimineres ved hæmodialyse eller peritonealdialyse.
English: The small bottle contains granules which you add to the solvent in the larger bottle.
Danish: Den lille flaske indeholder granulat, som du sætter til opløsningsmidlet i den store flaske.
English: 4.5 Interaction with other medicinal products and other forms of interaction Effects of other medicinal products on ciprofloxacin:
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion Virkninger af andre lægemidler på ciprofloxacin:
English: If you stop using this medicine too soon your infection may not be completely cured and the symptoms of the infection may return or get worse.
Danish: Hvis du stopper med at bruge medicinen for hurtigt, er infektionen måske ikke forsvundet helt, og symptomerne kan vende tilbage eller forværres.
English: Quinolones are known to trigger seizures or lower the seizure threshold.
Danish: Quinoloner er kendt for at kunne udløse krampeanfald eller sænke krampetærsklen.
English: Severely impaired renal function leads to increased half lives of ciprofloxacin of up to 12 h.
Danish: Svært nedsat nyrefunktion medfører en stigning i ciprofloxacins halveringstid på op til 12 timer.
English: In addition, taking into account the large use of ciprofloxacin in post-marketing, no safety signal was identified with long-term use of ciprofloxacin in PSURs.
Danish: Desuden blev der under hensyntagen til den udbredte anvendelse af ciprofloxacin i postmarketingperioden ikke konstateret sikkerhedsmæssige betænkeligheder ved langtidsanvendelse af ciprofloxacin i PSUR'erne.
English: Remember to drink plenty of fluids while you are taking Ciprofloxacin Bayer.
Danish: Husk at drikke masser af væske, mens du tager Ciprofloxacin Bayer.
English: Following an intravenous infusion of ciprofloxacin the mean maximum serum concentrations were achieved at the end of infusion.
Danish: Efter en intravenøs infusion af ciprofloxacin opnås den gennemsnitlige maksimumserumkoncentration ved slutningen af infusionen.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMÉER, ETIKETTERING OG INDLÆGSSEDDEL FREMLAGT AF EMEA
English: Non-renal clearance of ciprofloxacin is mainly due to active trans-intestinal secretion and metabolism.
Danish: Ciprofloxacins non-renale clearance sker primært ved aktiv transintestinal sekretion og ved metabolisering.
English: If clinical improvement is not achieved after 3 days of treatment, the therapy should be reconsidered.
Danish: Hvis der ikke opnås effekt i løbet af 3 dage, skal behandlingen tages op til revision.
English: Based on population pharmacokinetic analysis of paediatric patients with various infections, the predicted mean half-life in children is approx. 4-5 hours and the bioavailability of the oral suspension ranges from 50 to 80%.
Danish: Baseret på populationsfarmakokinetiske analyser er den forventede gennemsnitlige halveringstid hos børn med forskellige infektioner ca. 4-5 timer, og biotilgængeligheden af den orale suspension er mellem 50 og
English: Additionally, the following statement was recommended in section 4.4: Caution is advised when treating traveller's diarrhea especially if the travel concerns countries a high rate of ciprofloxacin resistant Shigella is observed.
Danish: Derudover anbefalede udvalget anvendelsen af følgende vending i afsnit 4.4: Ved behandling af turistdiaré tilrådes det at udvise forsigtighed, især hvis rejsen er til lande, hvor der er observeret mange tilfælde af ciprofloxacin-resistent Shigella.
English: In summary, the CHMP was of the opinion that anthrax should remain part of the indications to avoid any confusion for prescribers and to be consistent with EU and international guidelines including a recommendation on ciprofloxacin as a first line treatment.
Danish: Samlet set var CHMP af den opfattelse, at miltbrand fortsat skulle være blandt indikationerne for at undgå forvirring for de ordinerende læger og for at være konsistent med såvel EU's egne som internationale retningslinjer for ciprofloxacin som førstevalgsbehandling.
English: • If you suffer from epilepsy or other neurological conditions such as cerebral ischemia or stroke, you may experience side effects associated with the central nervous system.
Danish: • Hvis du har epilepsi eller andre neurologiske sygdomme som f.eks. nedsat ilttilførsel til hjernen (cerebral iskæmi) eller slagtilfælde, kan du få bivirkninger fra centralnervesystemet.
English: Comparison of the pharmacokinetic parameters for a twice a day and three times a day intravenous dose regimen indicated no evidence of drug accumulation for ciprofloxacin and its metabolites.
Danish: En sammenligning af de farmakokinetiske parametre efter intravenøs administration hhv. to gange dagligt og tre gange dagligt viste ingen tegn på akkumulering af ciprofloxacin og dets metabolitter.
English: In a study in young beagle dogs, ciprofloxacin caused severe articular changes at therapeutic doses after two weeks of treatment, which were still observed after 5 months.
Danish: I et studie med unge beagle hunde forårsagede ciprofloxacin alvorlige forandringer i leddene ved terapeutiske doser efter 2ugers behandling, som stadig blev observeret efter 5 måneder.
English: Avoid any unnecessary exercise, as this might increase the risk of a tendon rupture.
Danish: Undgå unødvendige bevægelser, da det kan øge risikoen for senebrud (seneruptur).
English: If you suffer from depression or psychosis, your symptoms may become worse under treatment with Ciprofloxacin Bayer.
Danish: Hvis du har en depression eller psykose, kan symptomerne forværres under behandlingen med Ciprofloxacin Bayer.
English: The CHMP therefore recommended the following wording to distinguish, by specific indications, the prophylactic and curative uses of ciprofloxacin in neutropenic patients with the following wording: -treatment of infections in neutropenic patients, -prophylaxis of infections in neutropenic patients.
Danish: CHMP anbefalede derfor den følgende ordlyd for at skelne mellem de specifikke indikationer til profylaktisk og kurativ anvendelse af ciprofloxacin hos neutropeniske patienter: - behandling af infektioner hos neutropeniske patienter, - profylakse af infektioner hos neutropeniske patienter.
English: Therefore, the CHMP and the Applicant/MAH were in agreement with the proposal to adapt the national SPCs of Ciprofloxacin MR tablets in those European Member States where the product is approved, to the outcome of the referral procedure for the other Ciprofloxacin Bayer formulations by submitting adequate national variations.
Danish: CHMP og ansøgeren/indehaveren af markedsføringstilladelsen var derfor enige i forslaget om at tilpasse de nationale produktresuméer for ciprofloxacin-tabletterne med modificeret udløsning i de EU-medlemslande, hvor produktet er godkendt, til resultatet af henvisningsproceduren for de øvrige Ciprofloxacin Bayer-formuleringer og indsende de fyldestgørende nationale ændringer.
English: Do not take medicines that stop or slow down bowel movements and contact your doctor.
Danish: Tag ikke medicin, som stopper maven eller nedsætter tarmbevægelserne og kontakt lægen.
English: Children and adolescents Indications
Danish: Børn og unge Indikationer
English: Oral suspension can be taken independent of mealtimes.
Danish: Oral suspension kan tages uafhængigt af måltiderne.
English: There are limited data on the efficacy of ciprofloxacin in the treatment of post-surgical intra-abdominal infections.
Danish: Der er begrænsede data om virkningen af ciprofloxacin til behandling af postoperative intraabdominale infektioner.
English: There have been many reports of increases in oral anti-coagulant activity in patients receiving antibacterial agents, including fluoroquinolones.
Danish: Der er set et stort antal tilfælde med stigninger i oral antikoagulant-aktivitet hos patienter, som har fået antibakterielle midler, herunder fluoroquinoloner.
English: Always use the measuring spoon provided.
Danish: Brug altid den medfølgende måleske.
English: other than Shigella dysenteriae type 1 and empirical treatment of severe travellers' diarrhoea
Danish: bortset fra Shigella dysenteriae type 1 og empirisk behandling af svær turistdiaré
English: If you stop taking this medicine too soon, your infection may not be completely cured and the symptoms of the infection may return or get worse.
Danish: Hvis du stopper med at tage medicinen for hurtigt, er infektionen måske ikke forsvundet helt, og symptomerne kan vende tilbage eller forværres.
English: Ciprofloxacin undergoes both glomerular filtration and tubular secretion.
Danish: Ciprofloxacin udskilles både ved glomerulær filtration og tubulær sekretion.
English: 6.6 Special precautions for disposal and other handling Since the infusion solution is photosensitive, the infusion bags should be removed from the box only immediately before use.
Danish: 6.6 Regler for destruktion og anden håndtering Da infusionsopløsningen er lysfølsom, skal infusionsposerne tages ud af pakningen umiddelbart før brugen.
English: - the CHMP concluded that the Marketing Authorisation could be harmonised on the following indications for oral and intravenous formulations in adults:
Danish: - CHMP konkluderede, at markedsføringstilladelsen kunne harmoniseres for de følgende indikationer for perorale og intravenøse formuleringer hos voksne:
English: Treatment should be initiated only by physicians who are experienced in the treatment of cystic fibrosis and/or severe infections in children and adolescents (see sections 4.4 and 5.1).
Danish: Behandlingen bør kun iværksættes af læger, der har erfaring med behandling af cystisk fibrose og/eller svære infektioner hos børn og unge (se afsnit 4.4 og 5.1).
English: - the CHMP concluded that the Marketing Authorisation could be harmonised on the following indications for oral and intravenous formulations in children and adolescents:
Danish: - CHMP konkluderede, at markedsføringstilladelsen kunne harmoniseres for de følgende indikationer for perorale og intravenøse formuleringer hos børn og unge:
English: Single doses of 100-750 mg produced dose-dependent maximum serum concentrations (Cmax) between 0.56 and 3.7 mg/L.
Danish: Efter enkeltdoser på 100-750 mg blev der nået dosisafhængige maksimale serumkoncentrationer (Cmax) mellem 0,56 og 3,7 mg/l.
English: Referring to the lack of clinical data to support the use of ciprofloxacin in anthrax, the applicant/MAH proposed a statement in section 5.1.
Danish: Under henvisning til manglen på kliniske data til understøttelse af anvendelsen af ciprofloxacin mod miltbrand foreslog ansøgeren/indehaveren af markedsføringstilladelsen indsættelsen af en vending i afsnit 5.1.
English: In studies supporting the use of oral ciprofloxacin in acute exacerbation of chronic sinusitis and exacerbation of chronic otitis media, the treatment duration was 10 days and efficacy results have shown that this duration was sufficient.
Danish: I de undersøgelser, der understøtter anvendelsen af peroral ciprofloxacin til akutte eksacerbationer af kronisk sinuitis og eksacerbationer af kronisk otitis media, varede behandlingen 10 dage, og resultater af virkningen har vist, at dette var en tilstrækkelig varighed.
English: SPECIES FOR WHICH ACQUIRED RESISTANCE MAY BE A PROBLEM Aerobic Gram-positive micro-organisms
Danish: ARTER, HVOR ERHVERVET RESISTENS KAN VÆRE ET PROBLEM Aerobe grampositive mikroorganismer
English: • phenytoin (for epilepsy)
Danish: • phenytoin (mod epilepsi)
English: Treatment of infections caused by Bacillus Anthracis The CHMP asked the Applicant/MAH to provide an updated review of the non clinical data (including animal data) and on the clinical experience gained up to now in the use of ciprofloxacin in inhalation anthrax.
Danish: Behandling af infektioner forårsaget af Bacillus anthracis CHMP bad ansøgeren/indehaveren af markedsføringstilladelsen om at fremlægge en opdateret gennemgang af de ikke-kliniske data (herunder for dyr) og af den hidtidige kliniske erfaring med anvendelse af ciprofloxacin mod lungemiltbrand.
English: In particular, the Applicant/MAH did not discuss its benefit-risk ratio in comparison to the other longer treatment duration (3 day treatment).
Danish: Navnlig redegjorde ansøgeren/indehaveren af markedsføringstilladelsen ikke for stoffets benefit/risk-forhold i forhold til den anden og længerevarende behandling (3-dages-behandling).
English: After intravenous initiation of treatment, the treatment can be switched to oral treatment with tablet or suspension if clinically indicated at the discretion of the physician.
Danish: Efter intravenøs påbegyndelse af behandlingen, kan behandlingen, hvis det er klinisk indiceret, ændres til oral behandling med tabletter eller suspension efter lægens skøn.
English: Reversible renal toxicity has been reported.
Danish: Der er beskrevet reversibel nyretoksicitet.
English: • infections of the testicles
Danish: • infektioner i testiklerne
English: Therefore, the following wording was proposed for section 4.1: Ciprofloxacin may also be used to treat severe infections in children and adolescents when this is considered to be necessary.
Danish: Følgende ordlyd blev derfor foreslået for afsnit 4.1: Ciprofloxacin kan også anvendes til behandling af svære infektioner hos børn og unge, når det anses for nødvendigt.
English: This effect was comparable to that of other gyrase inhibitors.
Danish: Virkningerne var sammenlignelige med virkningen af andre gyrasehæmmere.
English: • Ciprofloxacin Bayer may cause liver damage.
Danish: • Ciprofloxacin Bayer kan give leverskader.
English: Geriatric patients should receive a dose selected according to the severity of the infection and the patient's creatinine clearance.
Danish: Ældre patienter skal have en dosis, der fastsættes ud fra infektionens alvorlighed og patientens kreatininclearance.
English: Protein binding of ciprofloxacin is low (20-30%).
Danish: Ciprofloxacin har en lav proteinbinding (20-30%).
English: Restriction of the indication “Infections of the lower respiratory tract” The CHMP noted that ciprofloxacin was not suited for therapy of pneumococci and its efficacy against chlamydia was worse compared to other fluoroquinolones such as levofloxacin or moxifloxacin.
Danish: Begrænsning i indikationen "Infektioner i de nedre luftveje" CHMP bemærkede, at ciprofloxacin ikke var egnet til behandling af Streptococcus pneumoniae, og dets virkning mod klamydia var ringere end andre fluoroquinoloner såsom levofloxacin og moxifloxacin.
English: It was shown in a clinical study that concomitant use of ropinirole with ciprofloxacin, a moderate inhibitor of the CYP450 1A2 isozyme, results in an increase of Cmax and AUC of ropinirole by 60% and 84%, respectively.
Danish: I et klinisk studie er det vist, at samtidig indgift af ropinirol og ciprofloxacin, en moderat hæmmer af isoenzym CYP450 1A2, medfører en stigning i Cmax og AUC for ropinirol på hhv. 60% og 84%.
English: Therefore, the following statement was recommended in Section 4.2 of the SPC: “ciprofloxacin should be co-administered with appropriate antibacterial agents in accordance to official guidance”.
Danish: Derfor blev den følgende vending anbefalet i afsnit 4.2 i produktresuméet: "Ciprofloxacin bør administreres samtidigt med passende antibakterielle stoffer i overensstemmelse med de officielle retningslinjer".
English: The pharmacokinetic data in paediatric patients are limited.
Danish: De foreliggende data om farmakokinetikken hos børn er begrænsede.
English: Epididymo-orchitis and pelvic inflammatory diseases may be caused by fluoroquinolone-resistant Neisseria gonorrhoeae.
Danish: Epidymoorchitis og underlivsbetændelse kan være forårsaget af fluoroquinolonresistente Neisseria gonorhoeae.
English: • Severe, sudden allergic reaction (an anaphylactic reaction/shock, angio-oedema).
Danish: • Svær, pludselig allergisk reaktion (en anafylaktisk reaktion/chok, angioødem).
English: The ready-to-use suspension is now finished.
Danish: Suspensionen er nu klar til brug.
English: Cases of polyneuropathy (based on neurological symptoms such as pain, burning, sensory disturbances or muscle weakness, alone or in combination) have been reported in patients receiving ciprofloxacin.
Danish: Der er indberetninger om polyneuropati (baseret på neurologiske symptomer som f.eks. smerter, brænden, sensoriske forstyrrelser eller muskelsvaghed, alene eller i kombination) hos patienter, som får ciprofloxacin.
English: Do not take Ciprofloxacin Bayer during breast feeding because ciprofloxacin is excreted in breast milk and can be harmful for your child.
Danish: Du må ikke tage Ciprofloxacin Bayer, hvis du ammer, fordi ciprofloxacin udskilles i modermælken og kan være skadeligt for dit barn.
English: Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, ropinirole, tizanidine).
Danish: Ciprofloxacin hæmmer CYP1A2 og kan derfor medføre øgede serumkoncentrationer af lægemidler, som gives samtidigt, og som metaboliseres af dette enzym (f.eks. teofyllin, clozapin, ropinirol og tizanidin).
English: However, the recommendation of the administration of 750 mg tid and 1g bid by oral route in severe infections (respiratory tract infections, bone and joint infections) was not supported by the data submitted and the CHMP considered that none of the proposed posologies could be included in the Marketing Authorisation.
Danish: Anbefalingen af peroral indgift af 750 mg 3 gange dagligt og 1 000 mg 2 gange dagligt ved svære infektioner (infektioner i luftveje, knogler og led) var imidlertid ikke understøttet af de indsendte data, og CHMP vurderede, at ingen af de foreslåede doseringer kunne inkluderes i markedsføringstilladelsen.
English: Haemophilus influenzae*
Danish: Haemophilius influenzae*
English: Following concomitant administration of 250 mg ciprofloxacin with clozapine for 7 days, serum concentrations of clozapine and N-desmethylclozapine were increased by 29% and 31%, respectively.
Danish: Efter samtidig indgift af 250 mg ciprofloxacin og clozapin i 7 dage steg serumkoncentrationerne af clozapin og N-desmetylclozapin med hhv. 29% og 31%.
English: Other severe infections
Danish: Andre svære infektioner
English: Typically, the infection spreads to the basis of the skull and mastoid, resulting in cranial neuropathies, and rarely, brain abscess, sphenoidal sinusitis.
Danish: Typisk spreder infektionen sig til kraniekassens bund og processus mastoideus, hvilket resulterer i kraniel neuropati og i sjældne tilfælde til hjerneabsces og sinuitis sphenoidalis.
English: Peripheral neuropathy (see section
Danish: Perifer neuropati (se pkt.
English: After careful evaluation, the CHMP agreed with the Applicant/MAH to delete the dose regimen “100 mg bid for 3 days” allocated to the treatment of uncomplicated cystitis.
Danish: Efter grundig evaluering var CHMP enig med ansøgeren/indehaveren af markedsføringstilladelsen i at slette dosisregimet "100 mg 2 gange dagligt i 3 dage", som var rettet mod behandling af ukompliceret cystitis.
English: It can also increase the probability of experiencing side effects.
Danish: Samtidig indtag kan også øge risikoen for bivirkninger.
English: The in-vitro activity of ciprofloxacin against Mycobacterium tuberculosis might give false negative bacteriological test results in specimens from patients currently taking ciprofloxacin.
Danish: Ciprofloxacins in vitro-aktivitet over for Mycobacterium tuberculosis kan resultere i falsk negative bakteriologiske testresultater i prøver fra patienter, som tager ciprofloxacin.
English: Some medicines reduce the effect of Ciprofloxacin Bayer.
Danish: Nogen slags medicin nedsætter virkningen af Ciprofloxacin Bayer.
English: Subsequently, the CHMP reached an agreement with the Applicant/MAH concerning the new proposals for dose adjustments in case of renal impairment.
Danish: CHMP nåede derefter til enighed med ansøgeren/indehaveren af markedsføringstilladelsen vedrørende de nye forslag til dosisjusteringer i tilfælde af nedsat nyrefunktion.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNESNAVNE,LÆGEMIDDELFORMER,STYRKER, INDGIVELSESVEJER, INDEHAVER AF MARKEDSFØRINGSTILLADELSER I MEDLEMSSTATERNE OG NORGE OG ISLAND
English: Modified Release Tablets Formulation
Danish: Tabletformulering med modificeret udløsning
English: The following oral and intravenous formulations are currently approved and marketed in different EU countries: - Immediate release film-coated tablets: 100 mg, 250 mg, 500 mg, 750 mg - Granules and solvent for oral suspension: 250 mg/5 ml, 500 mg/5 ml - Solution for infusion (glass bottles and flexibags): 100 mg/50 ml, 200 mg/100 ml and 400 mg/200 ml - Modified release film-coated tablets: 500 mg, 1000 mg. - Sachets: 250mg, 500mg
Danish: Følgende perorale og intravenøse formuleringer er i øjeblikket godkendt og markedsføres i forskellige EU-lande: - Filmovertrukne tabletter med umiddelbar udløsning: 100 mg, 250 mg, 500 mg, 750 mg - Granulater og solvens til peroral suspension: 250 mg/5 ml, 500 mg/5 ml - Infusionsvæske, opløsning (glasflasker og flexibags): 100 mg/50 ml, 200 mg/100 ml og
English: Ventricular arrhythmia, QT prolongation, torsades de pointes *
Danish: Ventrikulær arytmi QTforlængelse Torsades de pointes *
English: There may be a particular risk of selecting for ciprofloxacin-resistant bacteria during extended durations of treatment and when treating nosocomial infections and/or infections caused by Staphylococcus and Pseudomonas species.
Danish: Der kan være en særlig risiko ved ciprofloxacin-resistente bakterier ved længere behandlingsforløb og ved behandling af nosokomielle infektioner og/eller infektioner, der skyldes Staphylococcus- og Pseudomonas-arter.
English: Other micro-organisms
Danish: Andre mikroorganismer
English: • clozapine (an antipsychotic)
Danish: • clozapin (mod psykoser)
English: In-vitro resistance to ciprofloxacin can be acquired through a stepwise process by target site mutations in both DNA gyrase and topoisomerase IV.
Danish: In vitro-resistens over for ciprofloxacin kan erhverves gennem en trinvis proces af mutationer på målstedet af både topoisomerase II, DNA gyrase og topoisomerase IV.
English: Prophylaxis of invasive infections of adults due to Neisseria meningitides Ciprofloxacin is used in clinical practice in prophylaxis of invasive infections of adults due to Neisseria meningitidis when rifampicin is contra-indicated or after microbiologically documentation when Neisseria meningitidis is resistant to rifampicin, in line with some therapeutic guidelines.
Danish: Profylakse af invasive infektioner hos voksne forårsaget af Neisseria meningitidis Ciprofloxacin anvendes i klinisk praksis til profylakse af invasive infektioner hos voksne forårsaget af Neisseria meningitidis, når rifampicin er kontraindiceret, eller efter mikrobiologisk påvisning, når Neisseria meningitidis er resistent over for rifampicin, i overensstemmelse med en række terapeutiske retningslinjer.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER
Danish: MINDSTEKRAV TIL MÆRKNING DER SKAL ANFØRES PÅ BLISTERKORT ELLER BLISTERSTRIPS