FrancophonIA/ELRC3.0 huggingface dataset:
English: In addition, other amendments to the Summary of Product Characteristics, labelling and package leaflet not in relation with the outcome of the referral procedure were included in accordance with the Guideline on SPC, excipient guideline and the latest Quality Review of Documents templates.
Danish: Endvidere blev der i produktresuméet, etiketteringen og indlægssedlen foretaget andre ændringer, som ikke har forbindelse med resultatet af henvisningsproceduren, og som er medtaget i overensstemmelse med retningslinjen for produktresuméer, retningslinjen for hjælpestoffer og de seneste skabeloner for kvalitetsvurdering af dokumenter.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton box
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske
English: Rare: tachycardia.
Danish: Sjælden: takykardi.
English: Rare: anxiety, nightmares, depression, hallucinations.
Danish: Sjælden: angst, mareridt, depression, hallucinationer.
English: Ciprofloxacin inhibits CYP1A2 and thus may cause increased serum concentration of concomitantly administered substances metabolised by this enzyme (e.g. theophylline, clozapine, tacrine, ropinirol, tizanidine).
Danish: Ciprofloxacin hæmmer CYP1A2 og kan derfor forårsage øget serumkoncentration af samtidigt administrerede stoffer, der metaboliseres af dette enzym (f.eks. theophyllin, clozapin, tacrin, ropinirol, tizanidin).
English: The total body clearance of ciprofloxacin is independent of the dose and remains unchanged in case of multiple administrations.
Danish: Den totale clearance of ciprofloxacin i kroppen er afhængig af dosen og er uændret i tilfælde af flere administrationer.
English: ESBL: Extended Spectrum Beta-lactamases MRSA: Methicillin-resistant Staphylococcus aureus
Danish: ESBL: Extended Spectrum Beta-lactamases MRSA: Methicillin-resistent Staphylococcus aureus
English: Especially patients undergoing long-term treatment (e.g. in cystic fibrosis, osteomyelitis), or patients who are extremely susceptible to infections (e.g. in selective prophylaxis in certain groups of neutropenic patients, artificial ventilation) show the highest risk.
Danish: Særligt patienter, der gennemgår langtidsbehandling (f.eks. ved cystisk fibrose, osteomyelitis), eller patienter, som er ekstremt modtagelige for infektioner (f.eks. ved selektiv profylakse hos visse grupper af neutropene patienter, kunstig vejtrækning) viser den højeste risiko.
English: Generally, acute and chronic infections (e.g. osteomyelitis and prostatitis, etc), where the causative organism is known to be sensitive to ciprofloxacin, should be treated for at least three days after the signs and symptoms of the infection have disappeared.
Danish: Generelt bør akutte og kroniske infektioner (f.eks. osteomyelitis og prostatitis, osv.), hvor den kausative organisme vides at være følsom over for ciprofloxacin, behandles i mindst tre dage, efter tegn og symptomer på infektionen er forsvundet.
English: As a result of its mechanism of action, ciprofloxacin does not show cross-resistance with other important, chemically different groups of substances such as beta-lactam antibiotics, aminoglycosides, tetracyclines, macrolides and polypeptides, sulphonamides, trimethoprim and nitrofurantoine.
Danish: Som et resultat af denne handlingsmekanisme udviser ciprofloxacin ikke krydsresistens med andre vigtige, kemisk forskellige grupper af stoffer, som f.eks. beta-laktam antibiotika, aminoglycosider, tetracycliner, makrolider og polypeptider, sulfonamider, trimethoprim og nitrofurantoin.
English: A larger number of metabolites after oral administration indicates some degree of first-pass metabolism, mainly forming sulphociprofloxacin.
Danish: Efter oral administration angiver et større antal metabolitter nogen grad af first-pass-metabolisme, hvilket hovedsageligt danner sulfociprofloxacin.
English: Common: nausea, diarrhoea.
Danish: Almindelig: kvalme, diarré.
English: As with other fluoroquinolones, specific undesirable effects with regard to the central nervous system must be taken into account when using Ciprofloxacin Hikma.
Danish: Som ved andre fluorquinoloner skal man være opmærksom på muligheden for specifikke uønskede virkninger på centralnervesystemet ved anvendelse af Ciprofloxacin Hikma.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label
Danish: MINDSTEKRAV TIL OPLYSNINGER, DER SKAL ANFØRES PÅ SMÅ INDRE EMBALLAGER
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: Tolv timer efter intravenøs administration af 200 mg er plasmakoncentrationen stadig højere end MIC-værdierne for størstedelen af de klinisk relevante patogener (ca. 0,1 µg/ml).
English: Ciprofloxacin can reduce your attention.
Danish: Ciprofloxacin kan nedsætte din opmærksomhed.
English: Pharmacotherapeutic group: Antibacterial quinolones, ATC code: J01MA02
Danish: Farmakoterapeutisk klassifikation: Antibakterielle quinoloner, ATC-kode: J01MA02 Virkning:
English: Transferable plasmid-mediated quinolone resistance associated with qnr has been detected in quinolone-resistant clinical strains of E.coli and Klebsiella spp.
Danish: Overførbar plasmid-medieret quinolonresistens associeret med qnr er blevet påvist i quinolonresistente kliniske stammer af E.coli og Klebsiella spp.
English: The reconstituted solution is clear.
Danish: Den rekonstituerede opløsning er klar.
English: The pharmacokinetics of ciprofloxacin in children with cystic fibrosis differs from that in children without cystic fibrosis, and dosing recommendations are only applicable for children with cystic fibrosis.
Danish: De farmakokinetiske egenskaber for ciprofloxacin hos børn med cystisk fibrose er forskellig fra egenskaberne hos børn uden cystisk fibrose, og doseringsanbefalingerne gælder kun for børn med cystisk fibrose.
English: Infections and infestations: Uncommon: moniliasis
Danish: Infektioner og parasitære sygdomme: Ikke almindelig: moniliasis
English: Anaphylactic/anaphylactoid reactions can in very rare cases develop into life-threatening shock, sometimes even after the first administration of ciprofloxacin.
Danish: Anafylaktiske/anafylaktoide reaktioner kan i meget sjældne tilfælde udvikle sig til livstruende shock, nogle gange selv efter den første administration af ciprofloxacin.
English: Compatibility with these solutions has been proven in ciprofloxacin concentrations of 1 mg/ml.
Danish: Kompatibilitet med disse opløsninger er blevet bevist i ciprofloxacinkoncentrationer på 1 mg/ml.
English: Other specific situations such as osteomyelitis and paediatric patients are stated under Posology.
Danish: Andre specifikke situationer som f.eks. osteomyelitis og behandling af pædiatriske patienter er anført i dette punkt.
English: He/she may find it necessary to adjust your dose due to a reduced kidney function.
Danish: Lægen kan finde det nødvendigt at justere din dosis pga. En nedsat nyrefunktion.
English: Dosage adjustment
Danish: Justering af dosis
English: Ciprofloxacin and other fluoroquinolones may cause photosensibility.
Danish: Ciprofloxacin og andre fluorquinoloner kan forårsage fotosensitivitet.
English: • feeling depressed or confused after administration of Ciprofloxacin Hikma.
Danish: • en følelse af depression eller forvirring efter indgivelse af Ciprofloxacin Hikma.
English: The elimination half-life of ciprofloxacin does not change with age.
Danish: Eliminationshalveringstiden for ciprofloxacin ændres ikke med alder.
English: Concentrations in pulmonary tissue, gynaecological tissue and prostate tissue and fluid were also significantly higher than the serum concentration.
Danish: Koncentrationerne i lungevæv, gynækologisk væv og prostatavæv og væske var også signifikant højere end serumkoncentrationen.
English: Very rare: erythema nodosum, erythema multiforme (minor), Stevens-Johnson syndrome, epidermal necrolysis (Lyell Syndrome), petechia.
Danish: Meget sjælden: erythema nodosum, erythema multiforme (mindre), Stevens-Johnson syndrom, epidermal nekrolyse (Lyell Syndrom), petechia.
English: Resistance to ciprofloxacin develops in stages through genomic mutations (multiple-step type).
Danish: Resistens mod ciprofloxacin udvikles i stadier gennem genome mutationer (multiple-trin typen).
English: • liver impairment in the past.
Danish: • tidligere leversvigt.
English: Development of resistance to ciprofloxacin and other fluoroquinolones has been observed in staphylococci, especially methicillinresistant S. aureus, P. aeruginosa, E.coli and E. faecalis (see the sensitivity table).
Danish: Udvikling af resistens mod ciprofloxacin og andre fluorquinoloner er blevet observeret ved staphylokokker, især methicillinresistent S. aureus, P. aeruginosa, E.coli og E. faecalis (se følsomhedstabellen).
English: The bioavailability is lower if antacids that contain aluminium and/or magnesium hydroxide, and calcium and iron salts are used concomitantly.
Danish: Biotilgængeligheden er lavere, hvis antacider, som indeholder aluminium og/eller magnesiumhydroxid og calcium og jernsalte, anvendes konkomitant.
English: • glibenclamide (used to treat diabetes).
Danish: • glibenclamid (bruges til behandling af diabetes).
English: Ciprofloxacin Hikma should be administered via a short-term intravenous infusion (infusion into a vein) over 30 to 60 minutes.
Danish: Ciprofloxacin Hikma bør indgives gennem en kortvarig intravenøs infusion (infusion i en vene) i løbet af 30 til 60 minutter.
English: For any information about this medicine, please contact the the Marketing Authorisation Holder.
Danish: Yderligere oplysninger om denne medicin fås ved indehaveren af markedsføringstilladelsen.
English: If there is any indication of tendinitis (e.g. painful swelling) the administration of ciprofloxacin or other fluoroquinolones must immediately be discontinued, the affected extremity should not be strained and a physician must be consulted.
Danish: Hvis der er tegn på tendinitis (f.eks. smertefuld hævelse) skal administration af ciprofloxacin eller andre fluorquinoloner straks indstilles, og den berørte ekstremitet bør aflastes og en læge konsulteres.
English: - complicated skin and soft tissue infections - osteomyelitis
Danish: - komplicerede hud- og bløddelsinfektioner - osteomyelitis
English: This product being a solution intended for intravenous infusion, should be restricted to the treatment of complicated UTI's.
Danish: Da produktet er en opløsning til intravenøs infusion, bør indikationen indskrænkes til behandling af komplicerede urinvejsinfektioner.
English: Management of patients with complicated urinary tract infections (UTIs) currently includes empirical treatment with a broad-spectrum antibiotic (fluoroquinolone), and potential subsequent treatment for 1014 days based on urine culture and sensitivity.
Danish: Behandlingen af komplicerede urinvejsinfektioner består i dag i empirisk behandling med et bredspektret antibiotikum (fluorquinolon) og mulig efterfølgende behandling i 10-14 dage på grundlag af urindyrkning og følsomhed.
English: Metabolism and nutrition disorders: Rare: hyperglycaemia.
Danish: Metabolisme og ernæring: Sjælden: hyperglykæmi.
English: • certain anti-inflammatory agents (e.g. ibuprofen, naproxen, but not acetylsalicylic acid), if ciprofloxacin is given in very high doses.
Danish: • visse antiinflammatoriske midler (f.eks ibuprofen, naproxen, men ikke acetylsalicylsyre), hvis ciprofloxacin gives i meget høje doser.
English: When used simultaneously, ciprofloxacin may, in certain cases, increase the effect of glibenclamide (hypoglycaemia).
Danish: Ved samtidig anvendelse kan ciprofloxacin i nogle tilfælde øge virkningen af glibenclamid (hypoglykæmi).
English: The applicant/MAH did not submit any clinical data to address the CHMP questions related to the risk/benefit of the proposed dose in UTIs and the maximum adult daily dose, as this application is a so called ″generic″ application (reference product/originator Ciproxin from Bayer).
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen forelagde ikke kliniske data til besvarelse af CHMP's spørgsmål om benefit/risk-forholdet for den ansøgte dosering ved urinvejsinfektioner og den maksimale daglige dosis til voksne, idet der er tale om en generisk ansøgning (referencelægemidlet/det oprindelige lægemiddel er Ciproxin (Bayer)).
English: - The literature provided by the applicant support a dose of 200 - 400 mg twice daily in the treatment of complicated urinary tract infections and a maximum adult daily dose of 400 mg three times daily.
Danish: - den af ansøgeren forelagte litteratur understøtter en dosis på 200-400 mg to gange dagligt til behandling af komplicerede urinvejsinfektioner og en maksimal daglig dosis til voksne på 400 mg tre gange dagligt
English: Simultaneous administration of ciprofloxacin and phenytoin may result in increased or reduced serum levels of phenytoin such that monitoring of drug levels is recommended.
Danish: Samtidig administration af ciprofloxacin og phenytoin kan resultere i forhøjede eller reducerede serumniveauer af phenytoin, således at overvågning af medicinniveauer tilrådes.
English: Important information about some of the ingredients of Ciprofloxacin Hikma If you are on a low-sodium diet, take into account that 100 ml of Ciprofloxacin Hikma contains 15.4 mmol (equivalent to 354 mg) sodium.
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Ciprofloxacin Hikma Hvis du er på en natrium- eller saltfattig diæt, skal du tage højde for, at 100 ml Ciprofloxacin Hikma indeholder 15,4 mmol (svarer til 354 mg) natrium.
English: From the published data, which have demonstrated for the proposed maximum dose 400 mg intravenous 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: De publicerede data viser, at den ansøgte maksimale dosis på 400 mg intravenøst tre gange dagligt resulterer i bedre forebyggelse af resistensudvikling uden væsentlig forøgelse af bivirkningerne ved behandling af alvorlige og livstruende infektioner i andre organsystemer, og disse data giver ikke anledning til at slutte, at denne gunstige benefit/risk-profil vil være væsentligt anderledes ved behandling af komplicerede urinvejsinfektioner
English: Oral anticoagulants (e.g. warfarin)
Danish: Orale antikoagulanter (f.eks. warfarin)
English: Because ciprofloxacin has some activity against Mycobacterium tuberculosis, false-negative cultures may occur when the specimens are obtained during ciprofloxacin treatment.
Danish: Da ciprofloxacin har nogen aktivitet mod Mycobacterium tuberculosis, kan der forekomme falsknegative kulturer, når prøverne tages under behandling med ciprofloxacin.
English: • oral anticoagulants (used to prevent blood from clotting, e.g. warfarin).
Danish: • orale antikoagulantia (bruges til at forhindre blodet i at koagulere, f.eks. warfarin).
English: Very rare: moniliasis (gastro-intestinal), pancreatitis.
Danish: Meget sjælden: moniliasis (gastro-intestinal), pankreatitis.
English: Following concomitant administration of ciprofloxacin and cyclosporine a transient increase of the serum creatinine concentration has been observed in separate cases.
Danish: Efter konkomitant administration af ciprofloxacin og cyclosporin er en forbigående stigning af serumkreatininkoncentrationen blevet observeret i enkeltstående tilfælde.
English: The reconstituted solution should be inspected visually for particulate matter and discoloration prior to administration.
Danish: Den rekonstituerede opløsning bør inspiceres visuelt for partikler og misfarvning inden administration.
English: Side effects have been reported in 5-14% of patients receiving ciprofloxacin.
Danish: Der er rapporteret bivirkninger hos 5-14 % af de patienter, som får ciprofloxacin.
English: Patients receiving ciprofloxacin should be well hydrated and excessive alkalinity of the urine should be avoided.
Danish: Patienter, som får ciprofloxacin, skal hydreres tilstrækkeligt, og udtalt alkalinitet af urinen bør undgås.
English: Animal experiments have shown that ciprofloxacin passes the placenta and is excreted in breast milk.
Danish: Dyreforsøg har vist, at ciprofloxacin passerer placenta og udskilles i modermælk.
English: • significant renal impairment.
Danish: • betydelig nyresvigt.
English: • Concurrent administration of ciprofloxacin and tizanidine
Danish: • samtidig administration af ciprofloxacin og tizanidin
English: • theophylline (used to treat asthma), clozapine (used to treat schizophrenia), tacrine (used to treat symptoms of Alzheimer´s disease), ropinirol (used to treat Parkinson disease) and tizanidine (used to treat muscle spasms).
Danish: • theophyllin (bruges til behandling af astma), clozapin (bruges til behandling af schizofreni), tacrine (bruges til behandling af symptomer på Alzheimers sygdom), ropinirol (bruges til behandling af Parkinsons sygdom) og tizanidin (bruges til behandling af muskelkramper).
English: Ear and labyrinth disorders: Rare: tinnitus, transient hearing loss (particularly high frequencies).
Danish: Øre og labyrint: Sjælden: tinnitus, forbigående høretab (især høje frekvenser).
English: • crystalluria (presence of crystals in the urine with discomfort when passing urine).
Danish: • krystaluri (krystaller i urinen med ubehag ved vandladning).
English: • convulsions (seizures), epilepsy or another brain disease, for example decreased blood circulation in the brain, stroke or increased sensitivity to convulsions, since possible side effects of ciprofloxacin may cause damage to the brain.
Danish: • konvulsioner (krampeanfald), epilepsi eller anden hjernesygdom, f.eks. nedsat blodomløb i hjernen, slagtilfælde eller øget følsomhed over for krampeanfald, da nogle af ciprofloxacins mulige bivirkninger kan skade hjernen.
English: Uncommon: (thrombo) phlebitis.
Danish: Ikke almindelig: (thrombo) flebitis.
English: Since the risks for humans are unknown Ciprofloxacin Hikma must not be administered during pregnancy (see section 4.3).
Danish: Da risikoen for mennesker er ukendt, må Ciprofloxacin Hikma ikke administreres under graviditet (se pkt.
English: In very rare cases ventricular arrhythmia, QT interval prolongation and torsades de pointes have been reported.
Danish: I meget sjælde tilfælde er ventrikulære arytmier, forlænget QT-interval og torsades de pointes blevet rapporteret.
English: In juvenile and prenatal animals exposed to quinolones effects on immature cartilage have been observed (see section 5.3).
Danish: Hos unge dyr og prænatale dyr, der er blevet eksponeret for quinoloner, er der observeret virkninger på ikke-udvokset brusk (se pkt.
English: Therefore, patients taking these substances concomitantly with ciprofloxacin should be monitored closely for clinical signs of overdose.
Danish: Patienter, som tager disse stoffer samtidigt med ciproflaxacin, bør derfor overvåges nøje for kliniske tegn på overdosis.
English: • phenytoin (used to treat epilepsy).
Danish: • phenytoin (bruges til behandling af epilepsi).
English: Very rare: hepatitis, liver cell necrosis (very rarely resulting in life-threatening liver function failure).
Danish: Meget sjælden: hepatitis, levercelle nekrose (meget sjældent resulterende i livstruende leversvigt).
English: The phototoxic, photomutagenic and photocarcinogenic potential of ciprofloxacin is comparable to that of other gyrase inhibitors.
Danish: Ciprofloxacins fototoksiske, fotomutagene og fotocarcinogene potentiale kan sammenlignes med andre gyrase-inhibitorer.
English: Ciprofloxacin is mainly excreted unchanged.
Danish: Ciprofloxacin udskilles hovedsageligt i uændret form.
English: The undesirable effects sometimes occur already after the first administration of ciprofloxacin.
Danish: De uønskede virkninger opstår allerede efter første administration af ciprofloxacin.
English: However, since decreased clearance of diazepam, with a prolonged half-life have been reported during co-administration of ciprofloxacin and diazepam, and in very rare cases with midazolam, careful monitoring of benzodiazepine therapy is recommended.
Danish: Da nedsat udskillelse (clearance) af diazepam med en forlænget halveringstid er blevet rapporteret under samtidig indgivelse af ciprofloxacin og diazepam, og i meget sjældne tilfælde med midazolam, tilrådes det at overvåge behandling med benzodiazepin meget nøje.
English: In case of very severe infections the dose can be increased up to a maximum daily dose of 1200 mg (400 mg thrice daily).
Danish: I tilfælde med meget alvorlige infektioner kan dosis øges til en maksimal daglig dosis på 1200 mg (400 mg tre gange dagligt).
English: The following indications can be considered for treatment with Ciprofloxacin Hikma when oral therapy is not possible or not reliable: - complicated urinary tract infections - infections of the lower respiratory tract including pneumonia caused by aerobic gram-negative bacteria, in case of Streptococcus pneumoniae infections ciprofloxacin is not the substance of first choice.
Danish: Følgende indikationer kan overvejes til behandling med Ciprofloxacin Hikma, når oral behandling ikke er mulig eller er upålidelig: - komplicerede urinvejsinfektioner - infektioner af nedre luftveje, herunder lungebetændelse forårsaget af aerobe gram-negative bakterier.
English: Prior to initiation of therapy, bacteriological sensitivity tests should be conducted.
Danish: Der skal foretages bakteriologiske sensitivitetstest inden indledning af behandling.
English: Hypersensitivity reactions and allergic reactions occurred in some cases after the first administration of ciprofloxacin.
Danish: Hypersensitivitetsreaktioner og allergiske reaktioner forekom i nogle tilfælde efter den første administration af ciprofloxacin.
English: Ciprofloxacin Hikma is an antibiotic.
Danish: Ciprofloxacin Hikma er et antibiotikum.
English: Most frequent side effects affect the stomach and intestine, the nervous system and the skin and connective tissue.
Danish: Bivirkningerne påvirker oftest maven og tarmene, nervesystemet og huden og bindevævet.
English: Ciprofloxacin inhibits DNA-gyrase, resulting in inhibition of DNA synthesis.
Danish: Ciprofloxacin hæmmer DNA-gyrase, hvilket resulterer i inhibition af DNA-syntese.
English: In that case, the ciprofloxacin treatment must be discontinued, and medical treatment for shock should be given.
Danish: I dette tilfælde skal behandling med ciprofloxacin indstilles, og der skal gives medicinsk behandling mod shock.
English: Ciprofloxacin is effective in vitro against a large number of Gram-negative aerobic bacteria including P. aeruginosa.
Danish: Ciprofloxacin er effektivt in vitro mod en lang række Gram-negative aerobe bakterier, inklusiv P. aeruginosa.
English: Simultaneous administration of ciprofloxacin and mexiletine can lead to increased plasma concentrations of mexiletine.
Danish: Samtidig administration af ciprofloxacin og mexiletin kan føre til forhøjede plasmakoncentrationer af mexiletin.
English: This medicinal product is authorised in the Member States of EEA under the following names: Austria - Ciprofloxacin Hikma 200mg/100ml Infusionslösung Germany - Ciprofloxacin Hikma 200mg/100ml Lösung zur Intravenösen Anwendung Ireland - Ciprofloxacin Hikma 200mg/100ml Solution for Infusion Italy - Ciprofloxacin Hikma 200mg/100ml Soluzione per Infusione Endovenosa United Kingdom - Ciprofloxacin Hikma 200mg/100ml Solution for Infusion The Netherlands - Ciprofloxacine Hikma 200mg/100ml Oplossing voor Intraveneuze Infusie
Danish: Østrig - Ciprofloxacin Hikma 200 mg/100 ml Infusionslösung Tyskland - Ciprofloxacin Hikma 200 mg/100 ml Lösung zur Intravenösen Anwendung Irland - Ciprofloxacin Hikma 200 mg/100 ml Solution for Infusion Italien - Ciprofloxacin Hikma 200 mg/100 ml Soluzione per Infusione Endovenosa Storbritannien - Ciprofloxacin Hikma 200 mg/100 ml Solution for Infusion Nederlandene - Ciprofloxacine Hikma 200 mg/100 ml Oplossing voor Intraveneuze Infusie