FrancophonIA/ELRC3.0 huggingface dataset:
English: As a precautionary measure, ceftriaxone should only be used during pregnancy after benefit/risk assessment by the physician in charge, especially during the first trimester.
Danish: Som følge af, bør ceftriaxon kun bruge under graviditet efter at have foretaget en risiko/fordel vurdering foretaget af lægen, specielt under det første trimester.
English: • in infants < 2 years of age
Danish: • hos nyfødte <2 år
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CEFTRIAXONE TYROL PHARMA AND ASSOCIATED NAMES (see Annex I)
Danish: SAMLET RESUME AF DEN FAGLIGE VURDERING AF CEFTRIAXON TYROL PHARMA OG TILKNYTTEDE NAVNE (se bilag I)
English: Commonly susceptible species
Danish: Almindelig følsomme arter
English: The normal daily dose of ceftriaxone should be administered 30-90 minutes prior to surgery.
Danish: Den normale dosis af ceftriaxon bør administreres 30-90 minutter før operation.
English: Ceftriaxone cannot be expected to be active against the majority of bacteria with penicillin-binding proteins that have reduced affinity for beta-lactam medicinal products.
Danish: Ceftriaxon kan ikke forventes at være aktiv over for størstedelen af bakterier med penicillinbindende proteiner, som har nedsat affinitet over for medicinske beta-laktamer produkter.
English: Elimination
Danish: Eliminering
English: Ceftriaxone is active against organisms producing some types of beta-lactamase, for example TEM-1.
Danish: Ceftriaxon er aktiv over for organismer, der danner nogle typer af beta-laktamase, f.eks. TEM-1.
English: Ceftriaxone can be used to treat:
Danish: Ceftriaxon kan anvendes til behandling af:
English: In newborn infants of 3 days of age, the half-life of ceftriaxone in the serum amounts to approximately 16 hours, and approximately 9 hours in newborn infants aged from 9 to 30 days.
Danish: Hos nyfødte spædbørn på 3 dage er ceftriaxons halveringstid i serum niveauer op til ca. 16 timer og ca. 9 timer hos nyfødte spædbørn fra 9 til 30 dage.
English: The binding is 95 % at plasma concentrations less than 100 mg/l with the binding percentage decreasing as the concentration increases (to 85 % at ceftriaxone plasma concentrations of 300 µg/ml).
Danish: Bindingen er 95 % ved plasma koncentrationer under 100 mg/l med en bindingsprocent der falder i takt med at koncentrationen øges (til 85 % ved ceftriaxon plasma koncentrationer af 300 µg/ml).
English: This can be avoided by slow injection (2-4 minutes).
Danish: Dette kan undgås ved langsom injektion (2-4 minutter).
English: Animal studies indicate no reproductive toxicity (see section 5.3).
Danish: Dyreforsøg viser ingen reproduktionstoksicitet (se pkt.
English: Lyell syndrome/toxic epidermolysis, Stevens-Johnson syndrome or Erythema multiforme.
Danish: Lyell syndrom/toksisk epidermolyse, Steve-Johnson syndrom eller Erythema multiform.
English: If the patient is a child under 2 years old or a pregnant or breastfeeding woman, Ceftriaxone should only be given by slow injection into a vein.
Danish: Hvis patienten er et barn under 2 år eller en gravid- eller ammende kvinde, bør Ceftriaxon gives som en langsom injektion i en vene.
English: The breakpoints for sensitivity are 2 µg/ml for Haemophilus spp.
Danish: Break-points for følsomhed er 2 µg/ml for Heamophilus spp.
English: Special dose information:
Danish: Speciel doserings information:
English: vancomycin (antibiotic) and fluconazole (fungicide).
Danish: vancomycin (antibiotikum) og fluconazol (svampedræbende).
English: An intravenous injection should be administered over at least 2 - 4 minutes directly into the vein or via the tubing of an intravenous infusion.
Danish: En intravenøs injektion bør administreres over mindst 2-4 minutter direkte ind i åren eller via indtubering af en intravenøs infusion.
English: The solution (resulting volume 4.2 ml, concentration 238 mg/ml) should be administered by deep intramuscular injection.
Danish: Denne opløsning (som giver en volumen på 4,2 ml, koncentration 238 mg/ml) bør administreres som dyb intramuskulær injektion.
English: Discontinuation of therapy with ceftriaxone depending on the indication should be considered and appropriate treatment measures should be initiated: e.g. intake of specific antibiotics/chemotherapeutics with clinically proven efficacy.
Danish: Afbrydelse af behandlingen med ceftriaxon afhængig af indikationen bør overvejes og passende behandlingsforanstaltninger initieres: f.eks. indtagelse af specifik antibiotika/kemoterapeutika med klinisk bevist effekt.
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Dette medicinske produkt må ikke blandes med andre medicinske produkter end dem nævnt i pkt.
English: Ceftriaxone is reversibly bound to albumin.
Danish: Ceftriaxon er reversibelt bundet til albumin.
English: The infusion is given as a slow infusion into a vein.
Danish: infusionen kan gives som en langsom infusion i en vene.
English: Oral contraceptives:
Danish: Oral præventionsmiddel:
English: - A chemical intolerance of ceftriaxone has also been reported with amsacrine (antitumour agent),
Danish: - Kemisk intolerance af ceftriaxon er også blevet rapporteret ved amsacrin (antitumor præparat),
English: The plasma elimination half-life of ceftriaxone is almost not increased in these patient groups.
Danish: Plasma eliminerings halveringstid af ceftriaxon er næsten ikke øget hos denne patientgruppe.
English: Special dosage recommendations
Danish: Specielle dosis anbefalinger
English: This solution should then be diluted with 9 ml more of diluent giving a final volume of 20.5 ml and a concentration of 49 mg/ml.
Danish: Denne opløsning skal så fortyndes med 9 ml mere af fortyndingsvæsken og ende med at give en volumen på 20,5 ml og en koncentration på 49 mg/ml.
English: The WHO recommends even 80 mg/kg/day respectively 2 x 50mg/kg/every 12 hours (max single dose 4g) in meningitis for young infants aged between 7 days and 2 months.
Danish: WHO anbefaler endda 80 mg/kg/dag henholdsvis 2 x 50 mg/kg/hver 12. time (maksimal enkeltdosis på 4 g) mod meningitis hos unge spædbørn på mellem 7 dage og 2 måneder.
English: SPECIAL STORAGE CONDITIONS Keep the container in the outer carton.
Danish: SÆRLIGE OPBEVARINGSBETINGELSER Opbevar beholderen i pakningen.
English: Discontinuation of treatment should be considered too (see section 4.4).
Danish: Afbrydelse af behandlingen bør også overvejes (se pkt.
English: If you feel uncertain, ask your doctor or pharmacist.
Danish: Hvis du føler dig usikker, så kontakt din læge eller apoteket.
English: This applies to both haemodialysis and peritoneal dialysis.
Danish: Dette gælder både hæmodialyse og peritoneal dialyse.
English: In pregnancy the intramuscular administration is contraindicated when used together with lidocain.
Danish: Ved graviditet er intramuskulær administration kontraindiceret ved anvendelse sammen med lidocain.
English: When given before an operation, the normal daily dose is given 30-90 minutes before the operation.
Danish: Ved anvendelse før en operation, skal injektionen gives 30-90 minutter før operationen.
English: the CHMP has recommended by majority the granting of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Ceftriaxone Tyrol Pharma and associated names (see Annex I).
Danish: har CHMP efter en flertalsbeslutning anbefalet at udstede markedsføringstilladelserne, hvortil produktresumeet, etiketteringen og indlægssedlen fremgår af bilag III, for Ceftriaxon Tyrol Pharma og tilknyttede navne (se bilag I).
English: Synergistic effects of ceftriaxone and aminoglycosides on certain Gram-negative bacteria have been noted in vitro.
Danish: Synergieffekt af ceftriaxon og aminoglykosider på visse gram-negative bakterier er noteret in vitro.
English: , these medicinal products must be administered separately to avoid physicochemical incompatibility between ceftriaxone and the aminoglycoside..
Danish: Ydermere, skal disse medicinske produkter administreres separat for at undgå fysisk-kemisk uforenelighed mellem ceftriaxon og aminoglykosider.
English: The applicant has presented a number of publications from the literature in order to discuss the rational for deviation from the ICH Guideline on Clinical Investigation of Medicinal Products in the Paediatric Population (CPMP/ICH/2711/99) and the basis of differentiation of 0-14 and 15-28 days instead of the more general definition of neonates as ‘up to 28 days after birth', as well as the different dosing regimens used.
Danish: Ansøgeren har præsenteret en række publikationer fra litteraturen med henblik på at drøfte rationalet for afvigelse fra ICH-retningslinjerne for klinisk undersøgelse af lægemidler til børn (CPMP/ICH/2711/99) og baggrunden for differentieringen mellem 0-14 og 15-28 dage frem for den mere generelle definition af nyfødte som "op til 28 dage efter fødslen" samt de forskellige anvendte dosisregimina.
English: In adult patients with meningitis, therapeutic concentrations are achieved within 2-24 hours with the dose of 50 mg/kg.
Danish: Hos voksne patienter med meningitis, er terapeutiske koncentrationer opnået indenfor 2-24 timer med en dosis på 50 mg/kg.
English: Repeat dosing of 0.5 to 2 g results in 15 % -36 % accumulation above single dose values
Danish: gentagne doser på 0,5 til 2 g resulterer i 15 % -36 % akkumulation over enkelt dosis niveauer.
English: The dose your doctor gives depends on the type of infection and how bad the infection is.
Danish: Den dosis som din læge giver afhænger af den type infektion du har, samt hvor alvorlig infektionen er.
English: Pain and induration of tissue at the site of injection occur after intramuscular injection.
Danish: Smerte og induration af vævet på injektionsstedet kan forekomme efter intramuskulær injektion.
English: ANNEX II SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARIES OF PRODUCT CHARACTERISTICS, LABELLING AND PACKAGE LEAFLET PRESENTED BY THE EMEA
Danish: BILAG II FAGLIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF PRODUKTRESUMEET, ETIKETTERINGEN OG INDLÆGSSEDLEN FREMLAGT AF EMEA
English: Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole, aminoglycosides and labetalol.
Danish: På baggrund af litteraturreferencer er ceftriaxon ikke forligelig med amsacrin, vancomycin, fluconazol, aminoglykosider og labetalol.
English: Keep the container in the outer carton in order to protect from light.
Danish: Opbevar beholderen i yderpakningen, for at beskytte mod lyset.
English: • pneumonia
Danish: • Pneumonier.
English: Urinary excretion is via glomerular filtration.
Danish: Urinudskillelse sker via glomerulær filtration.
English: Some of them had received ceftriaxone and calcium at different times and on different intravenous lines.
Danish: Nogle af disse havde fået ceftriaxon og calcium på forskellige tidspunkter og på forskellige intravenøse linier.
English: Secondary infections are to be treated accordingly (see section 5.1).
Danish: Sekundære infektioner bør behandles i konsekvens heraf (se pkt.
English: Ceftriaxone concentrates in the urine.
Danish: Ceftriaxon koncentreres i urinen.
English: If you have any further questions on the use of this product, ask your doctor or pharmacist as well.
Danish: Hvis du har yderligere spørgsmål til, hvordan du skal anvende dette produkt, så spørg din læge eller apoteket.
English: In case of simultaneous impairment of renal and liver function, serum-level of ceftriaxone should be monitored in regular intervals.
Danish: I tilfælde af samtidig nedsættelse af nyre- og leverfunktionen, bør serum niveauerne af ceftriaxon monitoreres med regelmæssige intervaller.
English: Instructions for use and handling
Danish: Instruktion til brug og håndtering
English: Ceftriaxone has no effect on fertility or reproduction.
Danish: Ceftriaxon har ingen effekt på fertiliteten og reproduktionsevnen.
English: In case of concomitant administration of cephalosporins and aminoglycosides there has been reported an increased risk of oto- and nephrotoxicity.
Danish: I tilfælde af samtidig administration af cefalosporiner og aminoglykosider er der bleven reporteret en øget risiko for oto- og nefrotoksitet.
English: If you do not feel well at the end of the prescribed treatment course or even feel worse during treatment you should talk to your doctor.
Danish: Hvis du stadig føler dig syg efter endt behandling, eller får det værre under behandlingen, kontakt din læge.
English: In rapid intravenous injection intolerability reactions in the form of sensation of heat or nausea may occur.
Danish: Ved hurtig intravenøs injektion kan bivirkninger i form af varmefølelse eller kvalme optræde.
English: The time of infusion is at least 30 minutes.
Danish: Infusionstiden er minimum 30 minutter.
English: As ceftriaxone is dialysable only to a very minor extent there is no need for an additional dose of ceftriaxone after the dialysis.
Danish: Da ceftriaxon kan dialyseres i en mindre udstrækning er der ikke behov for en yderligere dosis ceftriaxon efter dialysen.
English: In CSF the peak concentrations of 18 mg/l are achieved, after a 50-100 mg/kg intravenous dose, in about four hours.
Danish: I CSF er peak koncentrationen på 18 mg/l opnået, efter en intravenøs dosis på 50-100 mg/kg, på omkring 4 timer.
English: Ceftriaxone has no or negligible influence on the ability to drive and use machines.
Danish: Ceftriaxon har ingen eller kun ringe indflydelse på evnen til at føre motorkøretøj eller betjene maskiner.
English: Eosinophilia, leucopenia, granulocytopenia.
Danish: Eosinofili, leukocytopeni, granulocytopeni
English: Limited data has been presented that shows use of doses in excess of 50mg /kg/din neonates in situation other than meningitis.
Danish: Der foreligger begrænsede data, som viser brugen af doser over 50 mg /kg/dag til nyfødte i andre situationer end ved meningitis.
English: In suspected or proven infections with Pseudomonas aeruginosa, high resistance rates (> 60 %) for ceftriaxone in at least some European countries should be taken into consideration (see section 5.1).
Danish: Hvis der er mistanke om eller påvist infektioner med psudominas aeruginosa, bør høj modstandsdygtig rate (> 60 %) for ceftriaxon i nogle europæiske lande tages op til overvejelse (se pkt.
English: Bacteriostatic antibiotics, such as chloramphenicol and tetracycline, may antagonise the activity of ceftriaxone, especially in acute infections accompanied by rapid proliferation of micro-organisms.
Danish: Bakterieostatisk antibiotika, så som chloramphenicol og tetracyclin, kan hæmme ceftriaxons aktivitet specielt ved akutte infektioner ledsaget af hastigt vækst af mikroorganismerne.
English: Severe acute hypersensitivity reactions and anaphylactic shock require immediate discontinuation of the administration of ceftriaxon and the initiation of appropriate emergency measures.
Danish: Alvorlig akut overfølsomhedsreaktion og anafylaktisk shock, kræver øjeblikkelig ophør med administrationen af ceftriaxon og indledning akut behandling.
English: Consideration should be given to official local guidance on the appropriate use of antibacterial agents.
Danish: Hensyn bør tages til lokale instrukser om anvendelse af det antibakterielle præparater.
English: As a matter of principle, ceftriaxone solutions must always be administered separately from other solutions for infusion.
Danish: Rent principielt, bør ceftriaxon opløsninger altid administreres separat fra andre infusionsopløsninger.
English: Any unused injection or infusion solutions should be disposed of.
Danish: Enhver tilberedt ubrugt injektion eller infusion skal destrueres.
English: After a dose of 1-2 g, concentrations have been shown to remain above the MIC values for most infection-causing pathogens for over 24 hours in over 60 different tissues (including lungs, heart, bile ducts, liver, tonsils, middle ear, nasal mucosa, bones) and in many tissue fluids (including cerebrospinal fluid, pleural fluid as well as prostatic and synovial fluid).
Danish: Efter en dosis på 1-2 g, er koncentrationerne påvist at ligge over MIC værdier for de fleste infektions forårsagende patogener i over 24 timer i over 60 forskellige væv (inklusiv lunger, hjerte, galdegang, lever, mandler, mellemøret, næsen, knogler) og i mange vævs væsker (inklusiv rygmarvsvæsken, lungehindevæske så vel som prostatisk og synovial væske).
English: Ceftriaxone distributes primarily into extracellular water, shows concentration dependant binding to albumin and in normal adults, has a relatively long biologic half-life (t 1/2) is eliminated equally by glomerular filtration and biliary secretion
Danish: Ceftriaxon distribueres primært til ekstracellulærvæske, viser koncentrationsafhængig binding til albumin, har hos normale voksne en relativt lang biologisk halveringstid (t 1/2) og elimineres i lige stor grad ved glomerulusfiltration og galdesekretion.
English: In cases of serious infections or infections caused by moderately sensitive micro-organisms the dose can be raised up to 4 g, administered once a day intravenously.
Danish: I tilfælde med alvorlige infektioner eller infektioner på grund af moderat følsomme mikroorganismer kan dosen øges til 4 g, indgivet intravenøst én gang daglig.
English: 1 - 2 g maximum: 4 g once daily
Danish: 1 - 2 g Maksimum: 4 g
English: Headache, dizziness, vertigo.
Danish: Hovedpine, svimmelhed, vertigo.
English: This can be minimised by slow injection (over 2-4 minutes).
Danish: Dette kan minimeres ved langsom injektion (over en periode på 2-4 minutter).
English: Unopened:
Danish: Uåbnet:
English: The minimum inhibitory concentration (MIC, according to the German Institute for Standardization DIN 58940) are 4 mg/l, - (sensitive) and 32 mg/l (resistant).
Danish: Den mindste hæmmende koncentration (MIC, i følge ”German Institute for Standardization DIN 58940”) er 4 mg/l, - (følsom) og 32 mg/l (resistent).
English: Inherently resistant species
Danish: Naturlig resistente arter
English: Resistance may also be mediated by bacterial impermeability or by bacterial drug efflux pumps.
Danish: Resistens kan også medieres ved bakteriel uigennemtrængelighed eller ved bakterielle udstrømningspumper i stoffer.
English: Cephalosporins as a class tend to be absorbed onto the surface of the red cell membranes and react with antibodies directed against the medicinal product to produce a positive Coombs' test and occasionally a rather mild haemolytic anaemia.
Danish: Cefalosporiner, som en klasse, har tendens til at absorbere til overfladen af røde blodlegemers membraner og reagerer med immunlegemer rettet mod det medicinske produkt og giver en positiv Coomb test og til tider en meget mild hæmolytisk anæmi.
English: In patients on continuous ambulatory peritoneal dialysis (CAPD), ceftriaxone may be administered either intravenously or in case of CAPD associated infections may be added directly to the dialysis solution (e.g. 1-2 g ceftriaxone in the first dialysis fluid of the respective day of treatment) (see section
Danish: Hos patienter på samtidig ambulant peritonal dialyse (CAPD) kan ceftriaxon administreres enten intravenøs eller i tilfælde af CAPD associerede infektioner kan tilsættes direkte til dialyse opløsningen (f.eks. 1-2 g ceftriaxon i den første dialyse væske på den pågældende behandlingsdag) (se pkt.
English: Hypersensitivity reactions against ceftriaxone are more likely in patients with any other type of hypersensitivity reaction or asthma bronchiale.
Danish: Overfølsomhedsreaktioner overfor ceftriaxon er mere sandsynlig hos patienter med andre typer af overfølsomhedsreaktioner eller astmatisk bronchitis.
English: The adverse reactions (e.g. gastrointestinal disturbances and nephrotoxicity) associated with high parenteral doses of cephalosporins have been shown to be reversible in animals during repeat dosing.
Danish: Bivirkninger (f.eks. gastrointestinale forstyrrelser og nefrotoksitet) forbundet med høje parentale doser af ceftriaxon har vist sig at være reversible hos dyr ved gentagne dosering.
English: No more than 1 g ceftriaxone should be injected on one side.
Danish: Ikke mere end 1 g ceftriaxon bør injiceres på en side.
English: However, it is inactivated by beta-lactamases that can efficiently hydrolyse cephalosporins, such as many of the extended-spectrum beta-lactamases and chromosomal cephalosporinases, such as AmpC type enzymes.
Danish: Det bliver dog inaktiveret af beta-laktamaser, som effektivt kan hydrolysere cefalosporiner, således mange af beta-laktamaserne med udvidet spektrum og kromosomale cefalosporinaser, som enzymer af AmpC-typen.
English: It belongs to a group of antibiotics that are called cephalosporins.
Danish: Det tilhører en gruppe af lægemidler som kaldes cefalosporiner.
English: The contents of the infusion bottles, once opened, should be used immediately.
Danish: Indholdet i infusionsflasken skal straks anvendes efter åbning.
English: Ceftriaxone is not absorbed after oral application.
Danish: Ceftriaxon er ikke absorberet efter oral indtagelse.
English: Ceftriaxone has a high degree of stability in the presence of β-lactamases produced by Gram-negative and Gram-positive bacteria.
Danish: Ceftriaxon har en høj grad af stabilitet ved tilstedeværelsen af beta-laktamase produceret af gramnegative og gram-positive bakterier.
English: The respective values for Streptococcus pneumoniae are 0.5 µg/ml (sensitive), 1 µg/ml (intermediate) and 2 µg/ml (resistant).
Danish: De respektive værdier for Streptococcus pneumonia er 0,5 µg/ml (følsom), 1 µg/ml (intermediat) og 2 µg/ml (resistent).
English: The dose does not need to be altered in patients with a liver disease provided that the renal function is normal (see section 4.8).
Danish: Der er ikke behov for at ændre dosis hos patienter med en leversygdom, forudsat at nyrefunktionen er normal (se pkt.
English: However, this symptomatology is reversible after discontinuation of ceftriaxone.
Danish: Dog er denne symptomatologi reversibel efter endt behandling med ceftriaxon.
English: Newborn infants (age 0 - 14 days):
Danish: Nyfødte spædbørn (alder 0-14 dage):
English: (sodium content of the powder: 83 mg, equivalent to 3.6 mmol).
Danish: (Natrium indhold i pulveret: 83 mg, svarende til 3,6 mmol).
English: In addition further to some reports of fatal evolution, it was agreed to contraindicate ceftriaxone in newborn requiring concomitant calcium treatment because of rarely severe adverse reactions reported in preterm and full-term newborns, some of them being fatal.
Danish: Desuden blev man i forbindelse med rapporteringer om dødelig udgang enige om at kontraindicere ceftriaxon til nyfødte, der kræver samtidig calciumbehandling, på grund af rapporteringer om sjældne komplikationer hos præmature og fuldbårne nyfødte, hvoraf nogle havde dødelig udgang.
English: Following parenteral administration the substance penetrates into almost all body-tissues, including the cerebro spinal fluid.
Danish: Efter parenteral indgift breder stoffet sig til næsten alt blødt kropsvæv, herunder cerebrospinalvæsken.
English: The infusion should be administered over at least 30 minutes.
Danish: Infusionen bør gives over mindst 30 minutter.
English: Dosage and mode of administration should be determined by the severity and site of infection, susceptibility of the causative micro-organism and the patient's age and condition.
Danish: Dosis og administrationsmetode bør bestemmes ud fra graden af infektionen og infektionsstedet, den årsagsgivende mikroorganismes modtagelighed og patientens alder og tilstand.
English: This medicine can alter the results of some blood tests (such as the Coombs' test, or measuring galactose in your blood).
Danish: Denne medicin kan påvirke resultatet af visse blodtest (f.eks. ”Coombs test” eller galactosemåling i blodet).
English: The reconstitution of the ready to use solution for infusion has to take place in two steps in order to allow the reconstitution of the necessary volume of solution for infusion: 1.
Danish: Blandingen af den færdige infusionsopløsning skal foretages over to trin for at muliggøre blanding af den nødvendige volumen af infusionsopløsning.
English: Not more than 1 g of ceftriaxone should be injected on either side of the body.
Danish: Ikke mere end 1 g ceftriaxon bør injiceres på begge sider af kroppen.