FrancophonIA/ELRC3.0 huggingface dataset:
English: For pre-operative prophylaxis of surgical site infections, ceftriaxone should be administered 30-90 minutes prior to surgery.
Danish: Ved præoperativ profylakse mod infektioner på operationsstedet bør ceftriaxon gives 30-90 minutter før operation.
English: Protein binding
Danish: Proteinbinding
English: Carcinogenicity studies on ceftriaxone were not conducted.
Danish: Der er ikke udført karcinogenicitetsstudier med ceftriaxon.
English: In case of severe hypersensitivity reactions, treatment with ceftriaxone must be discontinued immediately and adequate emergency measures must be initiated.
Danish: I tilfælde af svære overfølsomhedsreaktioner skal ceftriaxon straks seponeres og relevant akutberedskab igangsættes.
English: The risk of precipitate formation is increased in immobilized or dehydrated patients.
Danish: Risiko for udfældning øges hos immobile og dehydrerede patienter.
English: The elimination half-life of total ceftriaxone in adults is about 8 hours.
Danish: Halveringstiden for total-ceftriaxon er ca. 8 timer hos voksne.
English: There are no study data in patients with severe hepatic impairment (see section 5.2).
Danish: Der er ingen data fra studier med patienter med svært nedsat leverfunktion (se pkt.
English: Gram-negative aerobes
Danish: Gram-negative aerobe
English: Ceftriaxone is excreted into human milk in low concentrations but at therapeutic doses of ceftriaxone no effects on the breastfed infants are anticipated.
Danish: Ceftriaxon udskilles i human mælk i lave koncentrationer, men ved terapeutiske doser forventes ingen påvirkning af det ammede barn.
English: The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient.
Danish: Dosis afhænger af sværhedsgrad, følsomhed, infektionssted og infektionstype samt af patientens alder og lever- og nyrefunktion.
English: Animal studies produced no evidence of toxicity to reproduction and genotoxicity.
Danish: Dyrestudier har ikke kunnet påvise reproduktionstoksicitet eller genotoksicitet.
English: Peak ceftriaxone concentrations in CSF are reached approximately 4-6 hours after intravenous injection.
Danish: Peak-koncentration af ceftriaxon i cerebrospinalvæsken nås ca. 4-6 timer efter intravenøs injektion.
English: the blood.
Danish: • blodet
English: • A false positive result in a Coombs' test (a test for some blood problems).
Danish: • Falsk-positivt resultat af Coombs test (en blodprøve).
English: The area under the plasma concentration-time curve after intramuscular administration is equivalent to that after intravenous administration of an equivalent dose.
Danish: Arealet under plasmakoncentrations-tidskurven efter intramuskulær administration svarer til det, der ses efter intravenøs administration af en ækvivalent dosis.
English: • Problems with your gallbladder, which may cause pain, feeling sick and being sick.
Danish: • Problemer med galdeblæren, som kan forårsage smerter, kvalme og opkastning.
English: Not known (cannot be estimated from the available data)
Danish: Ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: If you have a severe infection, your doctor will give you a higher dose up to 100 mg for each kg of body weight to a maximum of 4 g once a day.
Danish: Hvis barnet har en svær infektion, vil lægen give en højere dosis på op til 100 mg for hvert kilo, barnet vejer, op til højst 4 g én gang dagligt.
English: Precipitation of ceftriaxone calcium salt in the gallbladder has been observed, primarily in patients treated with doses higher than the recommended standard dose.
Danish: Der er set udfældning af ceftriaxoncalcium i galdeblæren, primært hos patienter behandlet med doser over den anbefalede standarddosis.
English: For doses greater than 2 g intravenous administration should be used.
Danish: Intravenøs administration skal anvendes ved doser over 2 g.
English: The signs include diarrhoea, usually with blood and mucus,
Danish: Tegn på dette kan være diarré, sædvanligvis ledsaget af blod og slim,
English: There is evidence from animal studies that high doses of ceftriaxone calcium salt led to formation of concrements and precipitates in the gallbladder of dogs and monkeys, which proved to be reversible.
Danish: Dyrestudier har vist, at høje doser ceftriaxoncalcium medfører dannelse af konkrementer og udfældning i galdeblæren hos hunde og aber, som er vist at være reversibel.
English: • hydrolysis by beta-lactamases, including extended-spectrum beta-lactamases (ESBLs),
Danish: • hydrolyse forårsaget af beta-laktamaser, inklusive beta-laktamaser med udvidet spektrum
English: Inherently resistant organisms
Danish: Generelt resistente organismer
English: This medicine has been prescribed for you only.
Danish: • Lægen har ordineret dette lægemiddel til dig personligt.
English: If you are given Rocephin for a long time, you may need to have regular blood tests.
Danish: Hvis du skal have taget en blod- eller urinprøve Hvis du får Rocephin i længere tid, skal der måske tages blodprøver jævnligt.
English: If a patient develops anaemia while on ceftriaxone, the diagnosis of a cephalosporin-associated anaemia should be considered and ceftriaxone discontinued until the aetiology is determined.
Danish: Hvis en patient udvikler anæmi under behandling med ceftriaxon, bør diagnosen cefalosporinassocieret anæmi overvejes og ceftriaxon seponeres, indtil ætiologien er bestemt.
English: • You have had a sudden or severe allergic reaction to penicillin or similar antibiotics (such as cephalosporins, carbapenems or monobactams).
Danish: • du tidligere har haft en pludselig eller svær allergisk reaktion over for penicillin eller et tilsvarende antibiotikum (fx cefalosporin, monobactam eller carbapenem).
English: In an in-vitro study antagonistic effects have been observed with the combination of chloramphenicol and ceftriaxone.
Danish: Der er i et in vitro-studie observeret antagonistisk effekt ved kombinationen chloramfenicol og ceftriaxon.
English: The doctor will consider the benefit of treating you with Rocephin against the risk to your baby.
Danish: Lægen vil vurdere, om dit behov for behandling med Rocephin opvejer risikoen for dit barn.
English: You must not be given Rocephin if:
Danish: Du får ikke Rocephin hvis:
English: Gram-positive aerobes
Danish: Gram-positive aerobe
English: Ceftriaxone, like other antibiotics, may result in false-positive tests for galactosaemia.
Danish: Ceftriaxon kan, som andre antibiotika, forårsage falsk-positiv test for galaktosæmi.
English: Common (≥ 1/100 - < 1/10)
Danish: Almindelig (≥1/100 til <1/10)
English: Syphilis
Danish: Syfilis
English: The volume of distribution of ceftriaxone is 7 - 12 l. Concentrations well above the minimal inhibitory concentrations of most relevant pathogens are detectable in tissue including lung, heart, biliary tract/liver, tonsil, middle ear and nasal mucosa, bone, and in cerebrospinal, pleural, prostatic and synovial fluids.
Danish: Ceftriaxons fordelingsvolumen er 7-12 l. Koncentrationer et godt stykke over MIC for de mest relevante patogener kan påvises i væv, inklusive lunger, hjerte, galdeveje/lever, tonciller, mellemøre og næseslimhinde, knogler samt i cerebrospinal-, pleura-, prostata- og synovialvæske.
English: Your doctor will decide the correct dose of Rocephin for you.
Danish: Lægen beslutter, hvilken dosis Rocephin du skal have.
English: Disseminated Lyme borreliosis (early [Stage II] and late [Stage III]) 2 g once daily for 14-21 days.
Danish: Dissemineret Lyme-borreliose (tidligt stadie (II) og sent stadie (III)) 2 g én gang dagligt i 14-21 dage.
English: Appropriate fluid and electrolyte management should be instituted (see section 4.4).
Danish: Relevant væske- og elektrolytbehandling bør institueres (se pkt.
English: The half-life of ceftriaxone is prolonged in neonates.
Danish: Ceftriaxons halveringstid er forlænget hos nyfødte.
English: • Abnormalities with your white blood cells (such as a decrease of leucocytes and an increase of eosinophils) and platelets (decrease of thrombocytes).
Danish: • Ændringer i antallet af hvide blodlegemer (såsom fald i leukocytter og stigning i eosinofilocytter) og blodplader (fald i trombocytter).
English: Ceftriaxone inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs).
Danish: Ceftriaxon hæmmer bakteriens cellevægssyntese efter binding til penicillinbindende proteiner (PBP).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ceftriaxone therapy, taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Det bør besluttes om amning skal ophøre, eller om behandling med ceftriaxon skal seponeres/undlades, idet fordelene ved amning for barnet og moderens gavn af behandlingen afvejes.
English: • Abnormal kidney function test (blood creatinine increased).
Danish: • Abnorme prøver for nyrefunktionen (stigning i blod-kreatinin).
English: Mean peak ceftriaxone concentrations in CSF in patients with bacterial meningitis are reported to be up to 25 % of plasma levels compared to 2 % of plasma levels in patients with uninflamed meninges.
Danish: Gennemsnitlig peak-koncentration af ceftriaxon i cerebrospinalvæsken er rapporteret at være op til 25% af plasmaniveauet hos patienter med bakteriel meningitis sammenlignet med 2% af plasmaniveauet hos patienter, hvor meninges ikke er inflammeret.
English: See information in the Summary of Product Characteristics of lidocaine, especially contraindications.
Danish: Se produktresumé for lidocain, særligt under kontraindikationer.
English: It is recommended that the International Normalised Ratio (INR) is monitored frequently and the posology of the anti-vitamin K drug adjusted accordingly, both during and after treatment with ceftriaxone (see section 4.8).
Danish: Der anbefales, at INR (International Normalised Ratio) måles ofte, og doseringen af vitamin K-antagonisten justeres under og efter behandling med ceftriaxon (se pkt.
English: This event may be symptomatic or asymptomatic, may lead to renal insufficiency and anuria, and is reversible upon discontinuation of ceftriaxone (see section 4.4).
Danish: Denne bivirkning kan være symptomatisk eller asymptomatisk og kan medføre nedsat nyrefunktion og anuri, men er reversibel ved seponering af ceftriaxon (se pkt.
English: In symptomatic cases, sonography should be performed.
Danish: I symptomatiske tilfælde bør der udføres skanning.
English: In patients undergoing dialysis no additional supplementary dosing is required following the dialysis.
Danish: Det er ikke nødvendigt at give en supplerende dosis til dialysepatienter efter dialyse.
English: Cases of fatal reactions with calcium-ceftriaxone precipitates in lungs and kidneys in premature and fullterm neonates aged less than 1 month have been described.
Danish: Der er beskrevet tilfælde af dødelige reaktioner med udfældning af ceftriaxoncalcium i lunger og nyrer hos præmature og fuldbårne nyfødte under 1 måned.
English: Ceftriaxone solutions containing lidocaine should never be administered intravenously.
Danish: Ceftriaxonopløsninger indeholdende lidocain må aldrig administreres intravenøst.
English: Reproductive studies have shown no evidence of adverse effects on male or female fertility.
Danish: Reproduktionsstudier har ikke vist tegn på negativ påvirkning af fertiliteten hos hanner og hunner.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER
English: Staphylococcus aureus (methicillin-susceptible)£ Staphylococci coagulase-negative (methicillin-susceptible)£
Danish: Staphylococcus aureus (methicillinfølsom)£ Staphylococci koagulase-negativ (methicillinfølsom)£
English: If lidocaine is used as a solvent, the resulting solution should never be administered intravenously (see section 4.3).
Danish: Hvis lidocain anvendes som solvens, må den færdige opløsning aldrig administreres intravenøst (se pkt.
English: Superinfections with non-susceptible micro-organisms may occur as with other antibacterial agents.
Danish: Som med andre antibiotika kan der forekomme superinfektioner med ikke-følsomme mikroorganismer.
English: • Problems with the way your blood clots.
Danish: • Problemer med blodets størkning.
English: • Sudden swelling of the hands, feet and ankles.
Danish: • at hænder, fødder og ankler pludselig hæver op.
English: • The signs may include a severe rash that develops quickly, with blisters or peeling of the skin and possibly blisters in the mouth.
Danish: • hurtigt udviklende svært udslæt med blærer eller afskalning af huden og eventuelt blister i munden.
English: Non enzymatic methods for glucose determination false positiveb a Based on post-marketing reports.
Danish: Falsk-positive resultater ved ikkeenzymatiske metoder til glucosebestemmelseb a Baseret på rapporter efter markedsføring.
English: There is conflicting evidence regarding a potential increase in renal toxicity of aminoglycosides when used with cephalosporins.
Danish: Der er modsatrettet dokumentation vedrørende potentielt øget nefrotoksisk effekt af aminoglykosider, hvis de anvendes sammen med cefalosporiner.
English: Rocephin should be co-administered with other antibacterial agents whenever the possible range of causative bacteria would not fall within its spectrum (see section 4.4).
Danish: Rocephin skal administreres sammen med andre antibiotika, hvis de formodede kausale bakterier ikke falder inden for dets spektrum (se pkt.
English: What you need to know before you are given Rocephin
Danish: Det skal du vide, før du får Rocephin
English: Such precipitates disappear after discontinuation of ceftriaxone therapy.
Danish: Sådan udfældning forsvinder efter ophør af ceftriaxonbehandling.
English: Contraindications to lidocaine, warnings and other relevant information as detailed in the Summary of Product Characteristics of lidocaine must be considered before use (see section 4.3).
Danish: Kontraindikationer for lidocain, advarsler og anden relevant information findes i produktresuméet for lidocain, som skal læses inden brug (se pkt.
English: No impairment of renal function has been observed after concurrent administration of large doses of ceftriaxone and potent diuretics (e.g. furosemide).
Danish: Der er ikke set påvirkning af nyrefunktionen efter samtidig administration af store doser ceftriaxon og potente diuretika (f. eks. furosemid).
English: • You have other illnesses, such as haemolytic anaemia (a reduction in your red blood cells that may make your skin pale yellow and cause weakness or breathlessness).
Danish: • lider af andre sygdomme, fx hæmolytisk anæmi (nedsat antal røde blodlegemer, som kan gøre din hud bleggul og forårsage svækkelse eller åndenød)
English: If you stop using Rocephin
Danish: Hvis du holder op med at få Rocephin
English: Coombs test false positiveb
Danish: Falsk-positiv Coombs testb
English: Solutions containing ceftriaxone should not be mixed with or added to other agents except those mentioned in section 6.6.
Danish: Ceftriaxonholdige opløsninger må ikke blandes med eller tilsættes til andre stoffer undtaget dem, som står i pkt.
English: After intravenous infusion of ceftriaxone 500 mg, 1 g and 2 g, the plasma ceftriaxone levels are approximately 80, 150 and 250 mg/l respectively.
Danish: Efter intravenøs infusion af ceftriaxon 500 mg, 1 g og 2 g er plasmaniveauet af ceftriaxon henholdsvis ca. 80, 150 og 250 mg/l.
English: Viridans group Streptococci Haemophilus influenzae
Danish: Viridans-gruppe Streptococci Haemophilus influenza
English: Most patients presented with risk factors for biliary stasis and biliary sludge e.g. preceding major therapy, severe illness and total parenteral nutrition.
Danish: De fleste patienter havde risikofaktorer for galdestase og galdeslam, f.eks. patienter som tidligere havde fået større behandling, haft svær sygdom og fået total parenteral ernæring.
English: Limited data suggest that in cases where the child is severely ill or initial therapy has failed, Rocephin may be effective when given as an intramuscular dose of 50 mg/kg daily for 3 days.
Danish: Begrænsede data tyder på, at hvis barnet er svært sygt eller initial behandling har svigtet, kan Rocephin være effektivt, hvis det gives intramuskulært i doser på 50 mg/kg dagligt i 3 dage.
English: Neonates 0-14 days
Danish: Nyfødte 0-14 dage
English: Staphylococcus epidermidis+ Staphylococcus haemolyticus+ Staphylococcus hominis+
Danish: Gram-positive aerobe Staphylococcus epidermidis+ Staphylococcus haemolyticus+ Staphylococcus hominis+
English: Disseminated Lyme borreliosis (early [Stage II] and late [Stage III]) 50-80 mg/kg once daily for 14-21 days.
Danish: Dissemineret Lyme-borreliose (tidligt stadie (II) og sent stadie (III)) 50-80 mg/kg én gang dagligt i 14-21 dage.
English: Non-enzymatic methods for the glucose determination in urine may give false-positive results.
Danish: Ikke-enzymatiske metoder til bestemmelse af glucose i urinen kan give falsk-positive resultater.
English: Toxic epidermal necrolysisb
Danish: Toksisk epidermal nekrolyseb
English: Pseudomembranous colitisb
Danish: Pseudomembranøs colitisb
English: Germany, Hungary, Netherlands, Portugal: Rocephin Italy: Rocefin
Danish: Tyskland, Ungarn, Holland, Portugal: Rocephin Italien: Rocefin
English: • to treat infections of the chest in adults with chronic bronchitis.
Danish: • behandle akut forværring af kronisk bronkitis hos voksne.
English: In patients with renal or hepatic dysfunction, the pharmacokinetics of ceftriaxone are only minimally altered with the half-life slightly increased (less than two fold), even in patients with severely impaired renal function.
Danish: Ceftriaxons farmakokinetik ændres kun minimalt hos patienter med nedsat nyre- eller leverfunktion, idet halveringstiden kun øges let (mindre end 2 fold), selv hos patienter med svært nedsat nyrefunktion.
English: Oliguria Renal precipitation (reversible)
Danish: Udfældning i nyrerne (reversibel)
English: In neonates, intravenous doses should be given over 60 minutes to reduce the potential risk of bilirubin encephalopathy (see section 4.3 and 4.4).
Danish: Til nyfødte skal intravenøse doser gives over 60 minutter for at formindske en mulig risiko for bilirubinencefalopati (se pkt.
English: In the available scientific data, there are no reports of confirmed intravascular precipitations in patients, other than neonates, treated with ceftriaxone and calcium-containing solutions or any other calcium-containing products.
Danish: Der er i foreliggende videnskabelige data ingen rapporter om bekræftede intravaskulære udfældninger hos patienter, bortset fra nyfødte, behandlet med ceftriaxon og calciumholdige infusionsvæsker eller andre calciumholdige præparater.
English: The dose recommendations in syphilis, including neurosyphilis, are based on very limited data.
Danish: Dosisanbefalingerne for syfilis og neurosyfilis er baseret på meget begrænsede data.
English: Genital fungal infection
Danish: Genital svampeinfektion
English: Immune mediated haemolytic anaemia
Danish: Immunmedieret hæmolytisk anæmi
English: The relatively modest increase in half-life in renal impairment is explained by a compensatory increase in non-renal clearance, resulting from a decrease in protein binding and corresponding increase in non-renal clearance of total ceftriaxone.
Danish: Den relativt beskedne stigning i halveringstiden ved nedsat nyrefunktion forklares ved en kompensatorisk stigning i den ikke-renale clearance af total-ceftriaxon pga. et fald i proteinbindingen.
English: • Kidney problems caused by deposits of calcium ceftriaxone.
Danish: • Nyreproblemer, der skyldes aflejringer af ceftriaxoncalcium.
English: Rocephin is contraindicated in premature and full-term neonates at risk of developing bilirubin encephalopathy (see section 4.3).
Danish: Rocephin er kontraindiceret til præmature børn og fuldbårne nyfødte, som har risiko for at udvikle bilirubin-encefalopati (se pkt.
English: The dosages recommended for adults require no modification in older people provided that renal and hepatic function is satisfactory.
Danish: Dosisanbefalinger til voksne gælder også for ældre patienter, forudsat at nyre- og leverfunktionen er tilfredsstillede.
English: The dose recommendations in syphilis, including neurosyphilis, are based on limited data.
Danish: Doseringsanbefalingerne ved syfilis og neurosyfilis er baseret på begrænsede data.
English: The generally recommended dose is 50 mg/kg once daily for 10-14 days.
Danish: Den generelt anbefalede dosis er 50 mg/kg én gang dagligt i 10-14 dage.
English: Ceftriaxone crosses the placental barrier and is excreted in the breast milk at low concentrations (see section 4.6).
Danish: Ceftriaxon passerer placentabarrieren og udskilles i mælk i lave koncentrationer (se pkt.
English: • to treat Lyme disease (caused by tick bites) in adults and children including newborn babies from
Danish: • behandle Lymes-sygdom (som skyldes skovflåtbid) hos voksne og børn, herunder nyfødte fra de er 15 dage gamle.
English: + Resistance rates >50% in at least one region % ESBL producing strains are always resistant
Danish: £ Alle methicillinresistente stafylokokker er resistente over for ceftriaxon + Resistensrate >50% i mindst en region % ESBL-producerende stammer er altid resistente
English: • Changes in the results of blood tests for liver functions.
Danish: • Blodprøver, der viser, ændringer i leverfunktionen.
English: The high risk of precipitation in neonates is a result of their low blood volume and the longer half-life of ceftriaxone compared with adults (see sections 4.3, 4.4, and 5.2).
Danish: Den høje risiko for udfældning hos nyfødte skyldes det lille blodvolumen og den længere halveringstid for ceftriaxon sammenlignet med voksne (se pkt.
English: Following intramuscular injection, mean peak plasma ceftriaxone levels are approximately half those observed after intravenous administration of an equivalent dose.
Danish: Efter intramuskulær injektion er det gennemsnitlige peak-plasmaniveau af ceftriaxon ca. det halve af det, der ses efter intravenøs administration af en ækvivalent dosis.
English: • Inflammation of the tongue (glossitis).
Danish: • Betændelseslignende tilstand i tungen (glossitis).
English: If the use of ceftriaxone is considered necessary in patients requiring continuous nutrition, TPN solutions and ceftriaxone can be administered simultaneously, albeit via different infusion lines at different sites.
Danish: Hvis brug af ceftriaxon vurderes at være nødvendig for patienter med vedvarende behov for TPN, kan disse og ceftriaxon administreres samtidig, dog via forskellige infusionslanger og -steder.
English: There have been no reports of an interaction between ceftriaxone and oral calcium-containing products or interaction between intramuscular ceftriaxone and calcium-containing products (intravenous or oral).
Danish: Der er ingen rapporter vedrørende interaktion mellem ceftriaxon og orale præparater, som indeholder calcium, eller mellem ceftriaxon, som er givet intramuskulært, og andre præparater (intravenøse eller orale), som indeholder calcium.
English: Route of administration: [To be completed nationally]
Danish: Administrationsvej: [Udfyldes nationalt]
English: Complicated skin and soft tissue infections Gonorrhoea
Danish: Kompliceret hud- og bløddelsinfektion Gonorré
English: • Severe decrease in white blood cells (agranulocytosis).
Danish: • Alvorligt nedsat antal hvide blodlegemer (agranulocytose).
English: • 50-80 mg Rocephin for each kg of the child's body weight once a day depending on the severity and type of infection.
Danish: • 50-80 mg Rocephin for hvert kilo, barnet vejer, én gang dagligt, afhængigt af infektionens sværhedsgrad og type.
English: The most frequently reported adverse reactions for ceftriaxone are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash, and hepatic enzymes increased.
Danish: De hyppigst indberettede bivirkninger for ceftriaxon er eosinofili, leukopeni, trombocytopeni, diarré, udslæt og forhøjede leverenzymer.
English: For initial treatment of acute otitis media, a single intramuscular dose of Rocephin 50 mg/kg can be given.
Danish: Til initial behandling af akut otitis media kan der gives en intramuskulær enkeltdosis af Rocephin på 50 mg/kg.