FrancophonIA/ELRC3.0 huggingface dataset:
English: If necessary, the oral anticoagulant dose should be adjusted as appropriate.
Danish: Hvis det er nødvendigt, bør den orale dosis af antikoagulanten justeres efter behov.
English: In very rare cases these allergic reactions may lead to life-threatening shock.
Danish: Disse allergiske reaktioner kan i meget sjældne tilfælde føre til livstruende schock.
English: In this case you should immediately consult your doctor.
Danish: I dette tilfælde bør du straks tale med din læge.
English: Determination of serum concentrations, especially of theophylline, and dose adjustments may be necessary.
Danish: Bestemmelse af serumkoncentrationer, især af theophyllin, og dosisjusteringer kan være nødvendigt.
English: The dosage in children with impaired renal and/or hepatic function has not been investigated.
Danish: Doseringen hos børn med nedsat nyre- og/eller leverfunktion er ikke blevet undersøgt.
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 samlede clearance i kroppen og er ca. 3 gange højere end kreatininclearance.
English: • myastenia gravis (a particular type of muscle weakness).
Danish: • myastenia gravis (en særlig type muskelsvaghed).
English: These may be manifested as local skin reactions, which rapidly disappear after the infusion has been completed.
Danish: De kan manifestere sig som lokale hudreaktioner, der hurtigt forsvinder efter infusionen er afsluttet.
English: This may increase the effect of glibenclamide (too low blood sugar level).
Danish: Dette middel kan øge virkningen af glibenclamid (for lavt blodsukkerniveau).
English: Ciprofloxacin is rapidly and effectively absorbed after oral administration.
Danish: Ciprofloxacin absorberes hurtigt og effektivt efter oral administration.
English: No accumulation occurs on repeated administration (twice daily).
Danish: Der sker ingen akkumulering ved gentagen administration (to gange dagligt).
English: This relatively high distribution volume indicates an effective tissue and fluid penetration.
Danish: Dette relativt høje fordelingsvolumen indikerer en effektiv vævs- og væskepenetration.
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 den øgede risiko for lokalreaktioner bør særligt højere intravenøse doser kun administreres gennem en stor vene eller en centralslange.
English: • Do not refrigerate or freeze.
Danish: • Må ikke opbevares i køleskab eller nedfryses.
English: • severe and continuous diarrhoea during treatment, possibly with blood and mucus.
Danish: • svær og vedblivende diarré under behandlingen, muligvis med blod og slim.
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: Ciprofloxacins plasmaprotein-binding ligger mellem 16 % og 28 % og er ikke afhængig af koncentrationen og pH (bestemmes ved hjælp af ultrafiltration).
English: These events were observed predominantly among patients with further risk factors for QTc prolongation.
Danish: Disse hændelser blev hovedsageligt observeret hos patienter med yderligere risiko for forlænget QTc.
English: In this case the kidney function must be frequently (twice per week) monitored.
Danish: I dette tilfælde skal nyrefunktionen overvåges hyppigt (to gange ugentlig).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs brug.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest godkendt den {MM/YYYY}.
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 konkomitant administration af disse produkter, bør protrombintiden (PT) eller andre passende koagulationstest kontrolleres nøje.
English: These are set out in Annex III for Ciprofloxacin and associated names (see Annex I).
Danish: Disse fremgår af bilag III for Ciprofloxacin og tilknyttede navne (se bilag I).
English: This has to be taken into consideration for patients on a controlled sodium diet.
Danish: Man skal være opmærksom på dette hos patienter, der er på kontrolleret natriumdiæt.
English: When undesirable effects on the central nervous system, like dizziness, occur, it is prohibited to drive a vehicle or to operate machines.
Danish: Når der opstår uønskede virkninger på centralnervesystemet, f.eks. svimmelhed, er det forbudt at føre motorkøretøj eller betjene maskiner.
English: • glucose-6-phosphate dehydrogenase defect (hereditary disease of the red blood cells based on a defect in an enzyme).
Danish: • glucose-6-phosphat-dehydrogenase-defekt (arvelig sygdom i de røde blodlegemer på grundlag af en defekt i et enzym).
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 Hikma or the other medicine.
Danish: Hvis en af overnævnte situationer gælder for dig, kan din læge beslutte at ordinere et andet lægemiddel eller at justere dosis af Ciprofloxacin Hikma eller den anden medicin.
English: These side effects occur predominantly in patients at risk for certain heart disorders.
Danish: Disse bivirkninger forekommer hovedsageligt hos patienter med risiko for visse hjertelidelser.
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: Hvis du er over 65 år, kan din læge ordinere en dosis baseret på din nyrefunktion og sygdommens sværhedsgrad.
English: Other xanthine derivatives
Danish: Andre derivater af xanthin
English: Species for which acquired resistance may be a problem Gram-positive aerobes
Danish: Arter, hvor erhvervet resistens kan være et problem Gram-positive aerober
English: Hypersensitivity:
Danish: Hypersensitivitet:
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Danish: Der kan søges ekspertrådgivning efter behov, når den lokale resistensprævalens er således, at nyttigheden af midlet i mindst nogle typer infektioner er tvivlsom.
English: The solution for infusion should be administered over an infusion period of 60 minutes.
Danish: Infusionsvæsken bør administreres i løbet af en infusionsperiode på 60 minutter.
English: • increased skin sensitivity to sunlight or UV light.
Danish: • øget hudfølsomhed over for sollys eller ultraviolet lys.
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 tale med din læge, da du kan have en alvorlig betændelse af tyktarmen (pseudo membranøs colitis).
English: Commonly susceptible species Gram-negative aerobe species Citrobacter spp.
Danish: Almindeligt følsomme arter Gram-negative aerobe arter Citrobacter spp.
English: Tel.: +351 219 608 410
Danish: Tlf.: +351 219 608 410
English: In this case consult your doctor as your urine needs to be tested.
Danish: I dette tilfælde skal du søge læge, da din urin skal testes.
English: In order to avoid treatment failure and emergence of resistance it is a prerequisite that patient's compliance and dosing be adequate.
Danish: For at undgå behandlingssvigt og resistensdannelse må patientens compliance og doseringen være tilstrækkelig.
English: Your doctor will monitor you for signs of methotrexate overdose.
Danish: Din læge vil holde øje med eventuelle tegn på methotrexat overdosis.
English: Average duration of treatment can be 4-6 weeks.
Danish: Behandlingens gennemsnitlige varighed er 4-6 uger.
English: You should consult your doctor if you are pregnant or wish to become pregnant.
Danish: Du bør tale med lægen, hvis du er gravid eller ønsker at blive gravid.
English: Therefore the amount of these other medicines may rise in the blood.
Danish: Mængden af disse andre lægemidler kan derfor stige i blodet.
English: Characteristics in patients:
Danish: Karakteristika hos patienter:
English: The bioavailability of ciprofloxacin after oral administration is between 70 % and 85 %.
Danish: Biotilgængeligheden for ciprofloxacin efter oral administration er mellem 70 % og 85 %.
English: Breakpoints:
Danish: Break points:
English: Mechanism of resistance:
Danish: Resistensmekanisme:
English: To be used immediately after the vial is opened.
Danish: Skal bruges straks efter åbning af hætteglasset.
English: The following infections may be treated intravenously (via the blood) with Ciprofloxacin Hikma:
Danish: Følgende infektioner kan behandles intravenøst (gennem blodet) med Ciprofloxacin Hikma:
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: Prævalensen af erhvervet resistens kan variere geografisk og tidsmæssigt for visse arter og indhentning af lokale oplysninger om resistens er derfor vigtigt, især ved behandling af alvorlige infektioner.
English: Very rare (<1/10,000), not known (cannot be estimated from the available data)
Danish: Sjælden (≥ 1/10,000 til, < 1/1,000) Meget sjælden (< 1/10,000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data)
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANT, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM, STYRKE, INDGIVELSESVEJ, ANSØGER, INDEHAVER AF MARKEDSFØRINGSTILLADELSE I MEDLEMSSTATERNE
English: Patients with pre-existent significant renal disorders should be carefully monitored to detect any deterioration in function.
Danish: Patienter med præeksisterende, signifikante nyresygdomme bør monitoreres nøje med henblik på at påvise en eventuel forringet funktion.
English: This may cause epileptic seizures.
Danish: Det kan forårsage epileptiske krampeanfald.
English: Unless compatibility is proven, the solution for infusion should always be administered separately.
Danish: Medmindre kompatibilitet bevises, bør infusionsvæsken altid administreres separat.
English: Rare: photosensibility, erythema multiforme and erythema nodusum.
Danish: Sjælden: fotosensitivitet, erythema multiforme og erythema nodusum.
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-forhold er ciprofloxacins tilsyneladende fordelingsvolume mellem 1,7 og 2,7 l/kg.
English: The ciprofloxacin concentration in the sputum consists of 50-70% of the serum concentration.
Danish: Koncentrationen af ciprofloxacin i sputum består af 50-70 % af serumkoncentrationen.
English: Do not use Ciprofloxacin Hikma after the expiry date which is stated on the packaging after “Exp”.
Danish: Brug ikke Ciprofloxacin Hikma efter den udløbsdato, der står på pakningen efter “Exp”.
English: Gram-negative aerobes
Danish: Gram-negative aerober
English: During the growth phase of bacteria, a partial rolling up and unfolding of chromosomes takes place.
Danish: Under bakteriens vækstfase finder der en delvis oprulning og udfoldning af kromosomer sted.
English: Very rare: increment of amylase/lipase levels.
Danish: Meget sjælden: forøgelse af amylase/lipaseniveauer.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CIPROFLOXACIN HIKMA AND ASSOCIATED NAMES (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF CIPROFLOXACIN HIKMA OG TILKNYTTEDE NAVNE (se bilag I)
English: Up to now, no evidence has been found of an increased risk of congenital abnormalities or other undesirable effects following use of ciprofloxacin or other quinolones during the first trimester.
Danish: Der er ikke fundet evidens til dags dato om en øget risiko for medfødte anomalier eller andre uønskede bivirkninger efter brug af ciprofloxacin eller andre quinoloner i løbet af det første trimester.
English: Chemical and physical in-use stability has been demonstrated immediately after dilution, after 24 hours at 2-8°C and after 24 hours at room temperature.
Danish: Kemisk og fysisk anvendelsesstabilitet er blevet påvist umiddelbart efter fortynding, efter 24 timer ved 2-8 °C og efter 24 timer ved stuetemperatur.
English: The transaminase or alkaline phosphatase concentrations may temporarily increase or cholestatic icterus might occur, especially in patients with previous liver damage.
Danish: Transaminase- eller alkalinefosfatasekoncentrationerne kan midlertidigt stige, eller der kan forekomme cholestatisk icterus især hos patienter med tidligere leverskade.
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: Maksimal plasmakoncentration nås 0,5 - 2 timer efter indtagelse af 50 - 1000 mg p.o. og varierer fra 0,3 - 5,9 mg/l.
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 højst sandsynlig resistent over for ciprofloxacin, og ciprofloxacin bør ikke anvendes til at behandle formodede eller kendte MRSA infektioner, medmindre organismen vides at være følsom.
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 sås kun ved eksponeringer, som på tilstrækkelig vis overstiger den maksimale eksponering hos mennesker, således at der på baggrund af dyredata kan ses bort fra bekymringer vedr.
English: According to EUCAST the following breakpoints for aerobic bacteria have been defined for ciprofloxacin:
Danish: I henhold til EUCAST er følgende break points for aerobe bakterier blevet defineret for ciprofloxacin:
English: The diluted solution should be clear.
Danish: Den fortyndede opløsning skal være klar.
English: Very rare: psychotic reactions (which may progress to self-endangering behaviour).
Danish: Meget sjælden: psykotiske reaktioner (der kan udvikle sig til selvbeskadigelse).
English: • methotrexate (used to treat cancer or suppress the immune system).
Danish: • methotrexat (bruges til at behandle cancer eller undertrykke immunsystemet).
English: In case of mixed infections with anaerobes ciprofloxacin must be combined with other antibiotics effective against anaerobes.
Danish: I tilfælde med blandede infektioner med anaerober skal ciprofloxacin kombineres med andre antibiotika, der er effektive mod anaerober.
English: You should avoid long exposure to strong sunlight, sunlamps or other sources of UV radiation.
Danish: Du bør undgå langvarig udsættelse for stærkt sollys, sollamper eller andre ultraviolette strålingskilder.
English: The CHMP has therefore recommended the granting of the Marketing Authorisation(s) and the amendment of the Summary of Product Characteristics, labelling and package leaflet of the Reference Member State.
Danish: CHMP anbefalede derfor udstedelse af markedsføringstilladelse(r) og ændring af referencemedlemsstatens produktresumé, etikettering og indlægsseddel.
English: The ciprofloxacin level in the blood can be increased.
Danish: Niveauet af ciprofloxacin i blodet kan øges.
English: It is also effective against Gram-positive organisms, such as staphylococci and streptococci.
Danish: Det er også effektivt mod Gram-positive organismer, som f.eks. staphylokokker og streptokokker.
English: • In children aged below 5 years
Danish: • til børn under 5 år
English: • If Ciprofloxacin Hikma and tizanidine (used to treat muscle spasms) are given at the same time.
Danish: • hvis Ciprofloxacin Hikma og tizanidin (bruges til at behandle muskelkramper) gives samtidigt.
English: • allergic reactions after the first administration of this medicine.
Danish: • allergiske reaktioner efter den første indgivelse af medicinen.
English: • cyclosporine (used to prevent rejection reactions after organ transplantations).
Danish: • cyclosporin (bruges til at forebygge udstødelsesreaktioner efter organtransplantater).
English: As with all other antibiotics, the patient should be monitored during therapy for the development of resistant strains of initially sensitive bacteria, especially P. aeruginosa and S. aureus (see the relevant statements in section
Danish: Som ved alle andre antibiotika skal patienten monitoreres under behandlingen for udvikling af resistente stammer af indledningsvist følsomme bakterier, især P. aeruginosa og S. aureus (se de relevante oplysninger i pkt.
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: • local reactions after administration of this medicine.
Danish: • lokalreaktioner efter indgivelse af medicinen.
English: At haemodialysis or peritoneal dialysis only a modest amount of ciprofloxacin (less than 10%) is eliminated.
Danish: Ved hæmodialyse eller peritoneal dialyse elimineres kun en beskeden mængde ciprofloxacin (mindre end 10 %).
English: The blood level of this medicine can be increased or reduced.
Danish: Denne medicins niveau i blodet kan øges eller reduceres.
English: Ciprofloxacin has a rapid bactericidal effect, both in the growth phase and in the rest phase.
Danish: Ciprofloxacin har en hurtig bakteriedræbende virkning, både i vækstfasen og i hvilefasen.
English: Part of it is converted into desethylene-, sulpho-, oxoand formylciprofloxacin.
Danish: En del af det omdannes til desethylen-, sulfo-, oxo- og formylciprofloxacin.
English: • certain lower respiratory tract infections including pneumonia
Danish: • visse infektioner i de nedre luftveje, herunder lungebetændelse
English: • life-threatening increase heart rate (torsade de pointes).
Danish: • livstruende øget hjertefrekvens (torsade de pointes).
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 med meget alvorlige, livstruende eller recidive infektioner kan doseringen øges til 400 mg tre gange dagligt.
English: Photosensibility:
Danish: Fotosensitivitet:
English: The treatment of acute pulmonary infections in children and adolescents with cystic fibrosis will take 10-14 days.
Danish: Behandlingen af akutte lungebetændelser hos børn og unge med cystisk fibrose vil vare 10-14 dage.
English: They may take the form of local skin reactions, such as reddening of the skin, irritation or pain, which usually disappear quickly after termination of the infusion.
Danish: Det kan være i form af lokale hudreaktioner, f.eks. rødmen af huden, irritation eller smerter, der sædvanligvis forsvinder hurtigt efter ophør af infusionen.
English: These reactions may occcur particularly when the infusion time is 30 minutes or less.
Danish: Disse reaktioner kan især forekomme, når infusionstiden er 30 minutter eller derunder.
English: The elimination half-life of ciprofloxacin after single or multiple oral dosage is between 3.4 and 6.9 hours.
Danish: Eliminationshalveringstiden for ciprofloxacin efter enkelt eller multipel oral dosering er mellem 3,4 og 6,9 timer.
English: Ciprofloxacin is potentially neurotoxic and causes reversible defects of the testes in case of higher dosage.
Danish: Ciprofloxacin er potentielt neurotoksisk og forårsager reversible defekter i testis i tilfælde af højere dosering.
English: Ciprofloxacin Hikma cannot be mixed with solutions that are not stable at a pH of approximately 4.
Danish: Ciprofloxacin Hikma kan ikke blandes med opløsninger, der ikke er stabile ved en pH på ca. 4.
English: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings.
Danish: Behandlingens varighed afhænger af infektionens sværhedsgrad, den kliniske respons og de bakteriologiske fund.
English: An extensive destruction of red blood cells (haemolytic reactions) may occur, causing anaemia.
Danish: Der kan forekomme en omfattende ødelæggelse af de røde blodlegemer (hæmolytiske reaktioner), hvilket forårsager blodmangel.
English: There are insufficient data available with regard to the use of ciprofloxacin in children and adolescents.
Danish: Der er ikke tilstrækkelige data tilgængelige med hensyn til anvendelse af ciprofloxacin hos børn og unge.
English: • temporary pain and inflammation of the tendons, in particular of the Achilles tendon.
Danish: • midlertidige smerter og hævelse af senerne, især af achilles-senen.
English: The interaction between theophylline and ciprofloxacin is potentially life-threatening.
Danish: Interaktionen mellem theophyllin og ciprofloxacin er potentielt livstruende.
English: However, like a number of other quinolones ciprofloxacin is phototoxic in animals in exposure values relevant to humans.
Danish: Som en række quinoloner er ciprofloxacin imidlertid fototoksisk hos dyr ved eksponeringsværdier, der er relevante for mennesker.
English: For more details regarding some of the side effects please see Section 2, ‘Take special care with Ciprofloxacin Hikma- During or after treatment'.
Danish: Du finder nærmere oplysninger om nogle af disse bivirkninger i afsnit 2: ‘Vær ekstra forsigtig med at bruge Ciprofloxacin Hikma- Under eller efter behandling'.
English: Therefore, it is recommended to avoid prolonged exposure to sunlight or UV light during treatment with ciprofloxacin.
Danish: Det tilrådes derfor at undgå langvarig eksponering for sollys eller ultraviolet lys under behandling med ciprofloxacin.
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 svært nedsat nyrefunktion (kreatininclearance < 30 ml/min) kan eliminationshalveringstiden forlænges med en faktor på 2.
English: Due to the higher plasma levels in the elderly it is advisable to administer a doses based on creatinine clearance and severity of disease.
Danish: På grund af højere plasmaniveauer hos ældre tilrådes det at administrere en dosis, som er baseret på kreatininclearance og sygdommens sværhedsgrad.
English: Inherently resistant organisms Gram-positive aerobes
Danish: Inherente resistente organismer Gram-positive aerober
English: It is contained in a type I, clear, colourless glass vial containing 100 ml solution.
Danish: Opløsningen er i en type I, klar, farveløs hætteglas, der indeholder 100 ml opløsning.
English: Within the class of quinolones cross-resistance has been observed.
Danish: Krydsresistens er blevet observeret inden for klassen af quinoloner.
English: Animal trials have shown that the concurrent administration of very high doses of fluoroquinolones and certain NSAIDs (but not acetylsalicylic acid) may provoke convulsions.
Danish: Dyreforsøg har vist, at samtidig administration af meget høje doser af fluorquinoloner og visse NSAID'er (men ikke acetylsalicylsyre) kan fremkalde krampeanfald.
English: Oral administration of 20 mg/kg twice daily to children with cystic fibrosis gives an exposure that is comparable to that in adults following an oral dose of 750 mg twice daily.
Danish: Oral administration af 20 mg/kg to gange dagligt til børn med cystisk fibrose giver en eksponering, der kan sammenlignes med eksponeringen hos voksne efter en oral dosis på 750 mg to gange dagligt.
English: You must not breast-feed your child during treatment with ciprofloxacin, due to the risk of malformation of joint cartilage and other harmful effects in the breast-fed infant.
Danish: Du må ikke amme dit barn under behandling med ciprofloxacin, pga. risikoen for misdannelse af ledbrusken og andre skadelige virkninger på det ammende spædbarn.
English: Rare: pseudomembranous colitis, moniliasis (oral).
Danish: Sjælden: pseudomembranøs colitis, moniliasis (oral).