FrancophonIA/ELRC3.0 huggingface dataset:
English: Bayer Pharma, d.o.o., Bravničarjeva 13 SI-1000 Ljubljana Slovenia
Danish: Bayer Pharma, d.o.o., Bravničarjeva 13
English: Posology for the treatment of infections due to Vibrio cholerae The CHMP asked the Applicant/MAH to justify the suggested dosage regimen for the treatment of infections caused by Vibrio cholerae (oral and iv formulations).
Danish: Dosering ved behandling af infektioner forårsaget af Vibrio cholerae CHMP bad ansøgeren/indehaveren af markedsføringstilladelsen om at begrunde det foreslåede dosisregime til behandling af infektioner forårsaget af Vibrio cholerae (perorale og intravenøse formuleringer).
English: 08970 Sant Joan Despí Barcelona
Danish: Av. Baix Llobregat, 3-508970 Sant Joan DespíBarcelona
English: The following information is intended for medical or healthcare professionals only Ciprofloxacin Bayer should be administered by intravenous infusion.
Danish: Følgende oplysninger er kun til læger og sundhedspersonale: Ciprofloxacin skal anvendes til intravenøs infusion.
English: Ciprofloxacin should be administered by intravenous infusion.
Danish: Ciprofloxacin skal anvendes til intravenøs infusion.
English: Intra-abdominal infections
Danish: Intra-abdominale infektioner
English: Prothrombin level abnormal
Danish: Abnormt protrombinniveau
English: • Hypersensitivity to the active substance, to other quinolones or to any of the excipients (see section 6.1).
Danish: • Overfølsomhed over for det aktive stof, over for andre quinoloner eller over for et eller flere af hjælpestofferne (se pkt.
English: At the first sign of any pain or inflammation stop taking Ciprofloxacin Bayer and rest the painful area.
Danish: Ved det første tegn på smerter eller betændelse skal du stoppe med at tage Ciprofloxacin Bayer og holde det smertefulde område i ro.
English: • warfarin or other oral anti-coagulants (to thin the blood)
Danish: • warfarin eller andre blodfortyndingsmidler (orale antikoagulantia)
English: Ciprofloxacin Bayer is an antibiotic belonging to the fluoroquinolone family.
Danish: Ciprofloxacin Bayer er et antibiotikum, som hører til quinolonfamilien.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til oral anvendelse
English: Streptococcal Infections (including Streptococcus pneumoniae) Ciprofloxacin is not recommended for the treatment of streptococcal infections due to inadequate efficacy.
Danish: Streptokokinfektioner (herunder Streptococcus pneumonia) Ciprofloxacin må ikke anvendes til behandling af streptokokinfektioner på grund af utilstrækkelig effekt.
English: Taking the suspension
Danish: Indtagelse af suspensionen
English: Pour the granules completely into the large bottle with the suspension fluid.
Danish: Hæld granulatet i den store flaske med suspensionsvæske.
English: 7 to 21 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses)
Danish: 7-21 dage, i nogle tilfælde kan behandlingen fortsætte i længere end 21 dage (fx ved abscesser)
English: Ask your doctor or pharmacist if you are not sure how to take Ciprofloxacin Bayer.
Danish: Spørg lægen eller apoteket til råds, hvis du ikke er sikker på, hvordan du skal tage Ciprofloxacin Bayer.
English: Malignant external otitis
Danish: Malign ekstern otitis
English: Pharmacotherapeutic group: Fluoroquinolones, ATC code: J01MA02
Danish: Farmakoterapeutisk klassifikation: Fluoroquinolon, ATC-kode: J01 MA 02.
English: Treatment of infections due to certain bacteria (e.g. Pseudomonas aeruginosa, Acinetobacter or Staphylococci) may require higher ciprofloxacin doses and co-administration with other appropriate antibacterial agents.
Danish: Behandling af infektioner, der skyldes visse bakterier (f.eks. Pseudomonas aeruginosa, Acinetobacter eller Stafylokokker), kan kræve højere ciprofloxacindoser og samtidig indgift af andre passende antibakterielle midler.
English: If you experience an infection with symptoms such as fever and serious deterioration of your general condition, or fever with local infection symptoms such as sore throat/pharynx/mouth or urinary problems you should see your doctor immediately.
Danish: Hvis du får en infektion med symptomer som f.eks. feber og alvorlig forværring af din almentilstand, eller feber med lokale symptomer på infektion som f.eks. ondt i halsen, svælget eller munden eller problemer med urinen, skal du omgående kontakte lægen.
English: The data that are available on administration of ciprofloxacin to pregnant women indicates no malformative or feto/neonatal toxicity of ciprofloxacin.
Danish: De oplysninger, der er tilgængelige vedrørende indgift af ciprofloxacin til gravide kvinder tyder ikke på misdannelser eller foetotoksicitet hhv. neonatal toksicitet efter ciprofloxacin.
English: Psychotic reactions (see section
Danish: Psykotiske reaktioner (se pkt.
English: Ciprofloxacin should be used with caution in patients with myasthenia gravis (see section 4.8).
Danish: Ciprofloxacin skal bruges med forsigtighed til patienter med myasthenia gravis (se pkt.
English: Always use the graduated measuring spoon to obtain the exact dose for administering the suspension.
Danish: Brug altid måleskeen, når du tager suspensionen for at få den rigtige dosis.
English: • to prevent infections in patients with a very low white blood cell count (neutropenia)
Danish: • forebyggelse af infektion hos patienter med et lavt antal hvide blodlegemer (neutropeni)
English: BAYER HELLAS ΑΒΕΕ 18-20 Sorou Street 15125 Marousi , Athens, Greece
Danish: BAYER HELLAS ΑΒΕΕ 18-20 Sorou Street Maoussi 15125
English: • Pain and swelling in the joints and tendinitis may occur occasionally, particularly if you are elderly and are also being treated with corticosteroids.
Danish: • Der kan af og til forekomme smerter og hævelse i leddene samt seneskedehindebetændelse (tendinitis), især hvis du er ældre og også behandles med binyrebarkhormon.
English: The graduated measuring spoon with the markings 1/2 is equivalent to 2.6 mL containing 2.5 mL of final suspension and 1/1 is equivalent to 5.2 mL containing 5.0 mL of final suspension.
Danish: Måleskeens mærke 1/2 svarer til 2,6 ml, som indeholder 2,5 ml suspension og 1/1 svarer til 5,2 ml, som indeholder 5,0 ml suspension.
English: Severe infections and mixed infections with Gram-positive and anaerobic pathogens Ciprofloxacin monotherapy is not suited for treatment of severe infections and infections that might be due to Gram-positive or anaerobic pathogens.
Danish: Svære infektioner og blandingsinfektioner med grampositive og anaerobe patogener Ciprofloxacin egner sig ikke til monoterapi af svære infektioner og infektioner, som kan skyldes grampositive eller anaerobe patogener.
English: Recommended starting and maintenance doses for patients with impaired renal function:
Danish: Anbefalede start- og vedligeholdelsesdoser til patienter med nedsat nyrefunktion:
English: Appearance of the reconstituted product:
Danish: Det rekonstituerede præparats udseende
English: Ciprofloxacin may also be used to treat severe infections in children and adolescents when this is considered to be necessary.
Danish: Ciprofloxacin kan også anvendes til at behandle alvorlige infektioner hos børn og unge, når det anses for nødvendigt.
English: Member State Marketing Authorisation Holder
Danish: Medlemsland Indehaver af markedsføringstilladelsen
English: Posology for severe respiratory tract infections, severe bone and joint infections In severe respiratory tract infections as well as in severe bone and joint infections, higher doses than that currently recommended (such as 750 mg x 3/day or 1000 mg x 2/day) for oral route are currently used in clinical practice given the known decreased susceptibility of the main pathogens involved (including Pseudomonas aeruginosa, Acinetobacter, Staphylococcus aureus) and the severity of the disease (as well as the difficulties in reaching optimal concentration at the bone level).
Danish: Dosering ved svære infektioner i luftveje, knogler og led Ved svære infektioner i luftveje såvel som ved svære infektioner i knogler og led anvendes der aktuelt i klinisk praksis højere perorale doser end, hvad der i øjeblikket anbefales (f.eks. 750 mg 3 gange dagligt eller 1 000 mg 2 gange dagligt) på grund af den kendte nedsatte følsomhed over for de væsentligste patogener, der forårsager sygdommen (herunder Pseudomonas aeruginosa, Acinetobacter, Staphylococcus aureus), og sygdommens sværhedsgrad (samt vanskelighederne med at opnå en optimal koncentration på knogleniveau).
English: Nausea Diarrhoea
Danish: Kvalme Diaré
English: For treatment of febrile neutropenic patients, when an intravenous antibiotic administration is necessary, ciprofloxacin should be administered at a 400 mg bid or tid regimen.
Danish: Ved behandling af de febrile neutropeniske patienter, hvor en intravenøs antibiotisk indgift er nødvendig, bør doseringen af ciprofloxacin være 400 mg 2 eller 3 gange dagligt.
English: The CHMP was of the opinion that the therapeutic indication “selective digestive decontamination in immuno-suppressed patients” could not be accepted, as there is an absence of specific data submitted by the Applicant/MAH to support such therapeutic use and there is no consensus in the scientific community on the use ciprofloxacin in such indication.
Danish: CHMP vurderede, at den terapeutiske indikation "selektiv rensning af fordøjelsessystemet hos immunosupprimerede patienter" ikke kunne accepteres, eftersom der blandt de af ansøgeren/indehaveren af markedsføringstilladelsen indsendte data ikke forefindes nogen specifik dokumentation til at understøtte en sådan terapeutisk anvendelse, og eftersom der ikke er enighed i de faglige kredse om anvendelsen af ciprofloxacin til denne indikation.
English: The pharmacokinetics of ciprofloxacin oral suspension 50 mg/mL and 100 mg/mL are similar to those of tablets.
Danish: Farmakokinetikken for ciprofloxacin oral suspension 50 mg/ml og 100 mg/ml ligner tabletternes farmakokinetik.
English: The simultaneous administration of ciprofloxacin (oral) and multivalent cation-containing drugs and mineral supplements (e.g. calcium, magnesium, aluminium, iron), polymeric phosphate binders (e.g. sevelamer), sucralfate or antacids, and highly buffered drugs (e.g. didanosine tablets) containing magnesium, aluminium, or calcium reduces the absorption of ciprofloxacin.
Danish: Samtidig indgift af ciprofloxacin (oral) og lægemidler, som indeholder multivalente kationer, og mineraltilskud (f.eks. calcium, magnesium, aluminium og jern), fosfatbundne polymerer (f.eks. sevelamer), sucralfat eller antacida og stærkt bufrede lægemidler (f.eks. didanosintabletter), som indeholder magnesium, aluminium eller calcium, nedsætter absorptionen af ciprofloxacin.
English: Empty the bottle containing the granules for oral suspension into the opening of the bottle of solvent.
Danish: Tøm flasken med granulat til oral suspension ned i flasken med opløsningsmiddel.
English: • have a history of abnormal heart rhythms (arrythmias)
Danish: • hvis du har haft unormal hjerterytme (arytmier)
English: Content (concentratio n)
Danish: Lægemiddelform Administrationsvej Indhold (koncentratio n)
English: The Applicant/MAH did not provide any data or scientific discussion to support the single dose oral ciprofloxacin treatment of uncomplicated cystitis.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen havde ikke indsendt nogen data eller faglig redegørelse til at understøtte peroral enkeltdosisbehandling med ciprofloxacin af ukompliceret cystitis.
English: Co-administration of probenecid and ciprofloxacin increases ciprofloxacin serum concentrations.
Danish: Samtidig indgift af probenecid og ciprofloxacin øger serumkoncentrationerne af ciprofloxacin.
English: • You may experience psychiatric reactions the first time you take Ciprofloxacin Bayer.
Danish: • Du kan få psykiske symptomer første gang, du tager Ciprofloxacin Bayer.
English: Pancytopeni a (lifethreatening) Bone marrow depression (lifethreatening)
Danish: Pancytopeni (livstruende) Knoglemarvsdepression (livstruende)
English: On concurrent administration of Ciprofloxacin and caffeine or pentoxifylline (oxpentifylline), raised serum concentrations of these xanthine derivatives were reported.
Danish: Ved samtidig indgift af ciprofloxacin og koffein eller pentoxifyllin (oxpentifyllin) er der beskrevet forhøjede serumkoncentrationer af disse xanthinderivativer.
English: The Applicant/MAH subsequently proposed to follow the same proposal for other diarrhoea indications, taking into account data supporting oral 500 mg bid daily dose and considering bioavailability purposes, the corresponding IV dosage should be 400 mg bid.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen foreslog efterfølgende at følge samme forslag som for andre indikationer ved diaré under hensyntagen til data, der understøtter en peroral daglig dosis på 500 mg 2 gange dagligt, samt biotilgængeligheden, hvormed den tilsvarende intravenøse dosis skulle være 400 mg 2 gange dagligt.
English: Daily dose in mg Daily dose in mL (Number of 5-mL measuring spoonfuls)
Danish: Daglig dosis i ml (antal 5 ml måleskeer)
English: If this happens, tell your doctor immediately since the administration of Ciprofloxacin Bayer will have to be stopped.
Danish: Hvis det sker, skal du omgående fortælle det til lægen, da indgivelsen af Ciprofloxacin Bayer skal stoppes.
English: In adult patients, infusion time is 60 minutes for 400 mg Ciprofloxacin Bayer and 30 minutes for 200 mg Ciprofloxacin Bayer.
Danish: Hos voksne patienter er infusionstiden 60 minutter for 400 mg Ciprofloxacin Bayer og 30 minutter for 200 mg Ciprofloxacin Bayer.
English: The most commonly reported adverse drug reactions (ADRs) are nausea and diarrhoea.
Danish: De almindeligst indberettede bivirkninger er kvalme og diaré.
English: 6.6 Special precautions for disposal and other handling Take the prescribed amount of sachets.
Danish: 6.6 Regler for destruktion og anden håndtering Tag det ordinerede antal poser.
English: The CHMP asked the applicant/MAH to provide a substantiated discussion on the use of ciprofloxacin in prophylaxis of invasive infections of adults, to harmonize the therapeutic management of patients.
Danish: CHMP bad ansøgeren/indehaveren af markedsføringstilladelsen om at fremlægge en begrundet redegørelse for anvendelsen af ciprofloxacin til profylakse af invasive infektioner hos voksne med henblik på at harmonisere den terapeutiske styring af patienterne.
English: If it becomes severe or persistent or you notice that your stool contains blood or mucus tell your doctor immediately.
Danish: Hvis diaréen bliver svær eller fortsætter, eller hvis du opdager, at der er blod eller slim i afføringen, skal du omgående fortælle det til lægen.
English: If this happens, stop taking Ciprofloxacin Bayer and contact your doctor immediately.
Danish: Hvis det sker, skal du stoppe med at tage Ciprofloxacin Bayer og omgående kontakte lægen.
English: Pharmacokinetics of ciprofloxacin were linear over the dose range up to 400 mg administered intravenously.
Danish: Ciprofloxacins farmakokinetik var lineær op til en intravenøs dosis på 400 mg.
English: At the first sign of any pain or inflammation Ciprofloxacin Bayer will have to be stopped, rest the painful area.
Danish: Ved det første tegn på smerter eller betændelse skal behandlingen med Ciprofloxacin Bayer stoppes, og det smertefulde område skal holdes i ro.
English: Do try to take the suspension at around the same time every day.
Danish: Tag opløsningen på ca. samme tid hver dag.
English: In patients with low-risk neutropenic fever, a 750 mg bid ciprofloxacin regimen can also be used.
Danish: Hos patienter med lav-risiko neutropenisk feber kan en dosering på 750 mg ciprofloxacin 2 gange dagligt også anvendes.
English: Cyprus:
Danish: Cypern:
English: Overall, the CHMP harmonised this section, providing particular attention to the available information on resistance to ciprofloxacin for each indication.
Danish: Produktresuméets afsnit 4.1 Terapeutiske indikationer CHMP harmoniserede dette afsnit samlet set under særlig hensyntagen til den tilgængelige information om resistens over for ciprofloxacin for hver enkelt indikation.
English: The CHMP raised concerns on the following wording in Section 4.1 of the SPC : “Other severe infections in accordance with Official guidance, after careful benefit-risk evaluation when other treatments cannot be used, or after failure to conventional therapy and when the microbiological documentation can justify a ciprofloxacin use.” It was deemed to describe clinical situations in which the use of ciprofloxacin may be considered in spite of a missing indication, in children and adolescents.
Danish: CHMP var betænkelig ved følgende ordlyd i afsnit 4.1 i produktresuméet: "Andre svære infektioner i overensstemmelse med de officielle retningslinjer, efter grundig evaluering af benefit/risk-forholdet, når andre behandlinger ikke kan anvendes eller efter behandlingssvigt ved konventionel terapi, og når anvendelsen af ciprofloxacin er baseret på mikrobiologisk påvisning.
English: Ciprofloxacin Bayer may increase the levels of the following medicines in your blood:
Danish: Ciprofloxacin Bayer kan øge koncentrationen i blodet af følgende stoffer:
English: Therefore, the CHMP considered that the data provided was sufficient to include the therapeutic indication “Infections of the bones and joints” in Ciprofloxacin Marketing Authorisations, and noted that the SPC should give a clear message on the need for co-administration with appropriate antibacterial agent(s).
Danish: Det var derfor CHMP's holdning, at de fremlagte data var tilstrækkelige til at omfatte den terapeutiske indikation "infektioner i knogler og led" i markedsføringstilladelserne for ciprofloxacin, og CHMP bemærkede, at produktresuméet bør give klar besked om behovet for samtidig administration af et eller flere passende antimikrobielle stoffer.
English: The CHMP also considers that the safety data do not show any evidence that the safety profile of ciprofloxacin is affected by a longer treatment duration up to 3 months.
Danish: CHMP er desuden af den overbevisning, at der i sikkerhedsdataene ikke er tegn på, at sikkerhedsprofilen for ciprofloxacin ved længere tids anvendelse i op til 3 måneder skulle være berørt.
English: Safety data from a randomised double-blind study on ciprofloxacin use in children (ciprofloxacin: n=335, mean age = 6.3 years; comparators: n=349, mean age = 6.2 years; age range = 1 to 17 years) revealed an incidence of suspected drug-related arthropathy (discerned from joint-related clinical signs and symptoms) by Day +42 of 7.2% and 4.6%.
Danish: Sikkerhedsdata fra et randomiseret, dobbeltblindt studie om brug af ciprofloxacin til børn (ciprofloxacin: n=335, gennemsnitsalder = 6,3 år; referencegruppe: n = 349, gennemsnitsalder = 6,2 år, aldersområde: 1 til 17 år) viste en hyppighed af formodet lægemiddelrelateret artropati (bedømt ud fra ledrelaterede kliniske symptomer) efter dag 42 på hhv. 7,2% og 4,6%.
English: The CHMP considered that the therapeutic indication “septicaemia due to Gram negative bacteria” could not be accepted as the Applicant/MAH did not provide reassurance on the fact that ciprofloxacin could be viewed as an adequate option in this severe situation with regards its level of activity and the available therapeutic alternatives.
Danish: CHMP var af den opfattelse, at den terapeutiske indikation "sepsis forårsaget af gramnegative bakterier" ikke kunne accepteres, eftersom ansøgeren/indehaveren af markedsføringstilladelsen ikke havde givet tilstrækkelig begrundelse for, at ciprofloxacin kunne betragtes som passende behandling af denne svære tilstand med udgangspunkt i stoffets aktivitetsniveau og tilgængelige terapeutiske alternativer.
English: Renal and hepatic impairment Recommended starting and maintenance doses for patients with impaired renal function:
Danish: Nedsat nyre- og leverfunktion Anbefalede start- og vedligeholdelsesdoser til patienter med nedsat nyrefunktion:
English: Therefore, the CHMP agreed that the safety data did not show any evidence that the safety profile of ciprofloxacin is affected by a longer treatment duration up to 3 months.
Danish: CHMP enedes derfor om, at der i sikkerhedsdataene ikke var tegn på, at sikkerhedsprofilen for ciprofloxacin ved længere tids anvendelse i op til 3 måneder skulle være berørt.
English: As reported for other gyrase inhibitors, ciprofloxacin causes damage to the large weight-bearing joints in immature animals.
Danish: Som indberettet for andre gyrasehæmmere, forårsager ciprofloxacin skade på de store vægtbærende led hos ikke fuldt udvoksede dyr.
English: Antibiotic associated colitis (very rarely with possible fatal outcome) (see section 4.4)
Danish: Antibiotika-relateret colitis (meget sjældent med evt. fatalt udfald) (se pkt.
English: Tizanidine
Danish: Tizanidin
English: Complicated pyelonephritis
Danish: Kompliceret pyelonephritis
English: - nausea, diarrhoea, vomiting - joint pains in children - local reaction at the injection site, rash - temporary increased amounts of substances in the blood (transaminases)
Danish: - kvalme, diaré, opkastning - ledsmerter hos børn - lokal reaktion på injektionsstedet, udslæt - forbigående stigning i nogle enzymer (transaminaser)
English: • to treat infections in patients with a very low white blood cell count (neutropenia)
Danish: • behandling af infektion hos patienter med et lavt antal hvide blodlegemer (neutropeni)
English: • lung and bronchial infections in children and adolescents suffering from cystic fibrosis
Danish: • lungeinfektioner og infektioner i bronkierne hos børn og unge, som har cystisk fibrose
English: In patients with impaired liver function no dose adjustment is required.
Danish: Dosisjustering er ikke nødvendig hos patienter med nedsat leverfunktion.
English: Increased muscle tone and cramping
Danish: Øget muskeltonus og muskelkramper
English: Despite antibiotics, some bacteria may survive or grow.
Danish: Visse bakterier kan overleve eller formere sig på trods af behandling med antibiotika.
English: • genital organ infections in women
Danish: • underlivsinfektioner hos kvinder
English: The pharmacokinetics of ciprofloxacin 250 mg and 500 mg oral suspension in single-dose sachets are similar to those of tablets.
Danish: Farmakokinetikken for ciprofloxacin 250 mg og 500 mg oral suspension i enkeltdosisposer ligner farmakokinetikken for tabletter.
English: Incompatibility appears with all infusion solutions/drugs that are physically or chemically unstable at the pH of the solution (e.g. penicillins, heparin solutions), especially in combination with solutions adjusted to an alkaline pH (pH of the ciprofloxacin infusion solutions: 3.5-4.6).
Danish: Der er inkompatibilitet med alle infusionsopløsninger/lægemidler, som er fysisk eller kemisk ustabile ved opløsningens pH (fx penicilliner, heparinopløsninger), specielt i kombination med opløsninger, som er justeret til en basisk pH (ciprofloxacin-infusionopløsningernes pH: 3,5-4,6).
English: 200-400 mg every 24 h (after dialysis)
Danish: 200-400 mg hver 24. time (efter dialyse)
English: Therefore, both strategies in the treatment of uncomplicated cystitis were considered noteworthy in the oral ciprofloxacin MAA.
Danish: Begge strategier for behandling af ukompliceret cystitis blev derfor anset for at være værd at lægge mærke til i ansøgningen om markedsføringstilladelse for peroral ciprofloxacin.
English: Genital tract infections
Danish: Genitale infektioner
English: The changes to the SPC have been taken into account in the amendments to the Package Leaflet and Labelling.
Danish: Indlægsseddel og etikettering Ændringerne til produktresuméet er medtaget i ændringerne til indlægssedlen og etiketteringen.
English: Excepted as listed above
Danish: Undtagen ovennævnte
English: Ciprofloxacin should be used with caution in patients with CNS disorders which may be predisposed to seizure.
Danish: Ciprofloxacin skal bruges med forsigtighed hos patienter med sygdomme i centralnervesystemet, som kan prædisponere for krampeanfald.
English: 10 to 21 days
Danish: 10-21 dage