FrancophonIA/ELRC3.0 huggingface dataset:
English: Before beginning treatment, it should be established whether the patient has a history of severe hypersensitivity reactions to ceftriaxone, to other cephalosporins or to any other type of beta-lactam agent.
Danish: Inden behandling påbegyndes, bør det fastslås, om patienten tidligere har oplevet svære overfølsomhedsreaktioner i forhold til ceftriaxon, andre cefalosporiner eller andre betalactamantibiotika.
English: Likewise, non-enzymatic methods for glucose determination in urine may yield false-positive results.
Danish: Tilsvarende kan ikke-enzymatiske metoder til glucosebestemmelse i urin give falsk-positive resultater.
English: As with other beta-lactams, the pharmacokinetic-pharmacodynamic index demonstrating the best correlation with in vivo efficacy is the percentage of the dosing interval that the unbound concentration remains above the minimum inhibitory concentration (MIC) of ceftriaxone for individual target species (i.e. %T > MIC).
Danish: Som med andet beta-laktam antibiotika er den procentdel af doseringsintervallet, hvor den ubundne koncentration forbliver over MIC for individuelle mål-stammer (dvs. %T >MIC), det farmakokinetiske/farmakodynamiske indeks, der bedst viser korrelationen med in vivo-effekten af ceftriaxon,.
English: Rocephin can also lead to false-positive test results for galactosaemia (see section 4.8).
Danish: Rocephin kan også give falsk-positive resultater ved test for galaktosæmi (se pkt.
English: Data to determine the frequency of ceftriaxone ADRs was derived from clinical trials.
Danish: Data til bestemmelse af hyppigheden af bivirkninger ved ceftriaxon stammer fra kliniske forsøg.
English: Rare (may affect up to 1 in 1,000 people)
Danish: Sjældne (kan påvirke op til 1 ud af 1000 patienter)
English: After intravenous bolus administration of ceftriaxone 500 mg and 1 g, mean peak plasma ceftriaxone levels are approximately 120 and 200 mg/l respectively.
Danish: Efter intravenøs bolus af ceftriaxon 500 mg og 1 g er ceftriaxons gennemsnitlige peak-plasmaniveau henholdsvis ca. 120 og 200 mg/l.
English: • 20 - 50 mg Rocephin for each kg of the child's body weight once a day depending on the severity and type of infection.
Danish: • 20-50 mg Rocephin for hvert kilo, barnet vejer, én gang dagligt, afhængigt af infektionens sværhedsgrad og type.
English: • reduced affinity of penicillin-binding proteins for ceftriaxone.
Danish: • penicillinbindende proteiner med mindsket affinitet for ceftriaxon
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
English: Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same intravenous administration line.
Danish: Udfældning af ceftriaxoncalcium kan også ske, når ceftriaxon blandes med calciumholdige infusionsvæsker i samme infusionsslange.
English: Discontinuation of therapy with ceftriaxone and the administration of specific treatment for Clostridium difficile should be considered.
Danish: Det bør overvejes at seponere ceftriaxon og initiere specifik behandling mod Clostridium difficile.
English: Available data do not indicate the need for dose adjustment in mild or moderate liver function impairment provided renal function is not impaired.
Danish: Foreliggende data indikerer ikke, at dosisjustering er nødvendig ved let til moderat nedsat leverfunktion, forudsat at nyrefunktionen er normal.
English: Interaction with calcium containing products
Danish: Interaktion med calciumholdige præparater
English: Talk to your doctor or pharmacist or nurse before you are given Rocephin if:
Danish: Kontakt lægen, apoteketspersonalet eller sundhedspersonalet, før du bruger Rocephin, hvis du:
English: Talk to your doctor if you experience these symptoms.
Danish: Kontakt lægen, hvis du føler dig svimmel.
English: • Form of anaemia where red blood cells are destroyed (haemolytic anaemia).
Danish: • En slags anæmi (blodmangel), hvor de røde blodlegemer ødelægges (hæmolytisk anæmi).
English: Ceftriaxone must not be administered simultaneously with calcium-containing intravenous solutions, including continuous calcium-containing infusions such as parenteral nutrition via a Y-site.
Danish: Ceftriaxon må ikke administreres samtidigt med calciumholdige infusionsvæsker, inklusive kontinuerlige calciumholdige infusionsvæsker som parenteral ernæring via Y-stykke.
English: The generally recommended doses are 500 mg-1 g once daily increased to 2 g once daily for neurosyphilis for 10-14 days.
Danish: Den generelt anbefalede dosis er 500 mg-1 g én gang dagligt, ved neurosyfilis øget til 2 g én gang dagligt, i 10-14 dage.
English: MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally]
Danish: INDEHAVER AF MARKEDSFØRINGSTILLADELSEN [Se bilag 1 - udfyldes nationalt]
English: • Difficulty in breathing (bronchospasm).
Danish: • Vejrtrækningsbesvær (bronkospasme).
English: However, in patients older than 28 days of age ceftriaxone and calcium-containing solutions may be administered sequentially one after another if infusion lines at different sites are used or if the infusion lines are replaced or thoroughly flushed between infusions with physiological salt-solution to avoid precipitation.
Danish: Til patienter, der er mere end 28 dage gamle, kan ceftriaxon og calciumholdige infusionsvæsker dog gives efter hinanden, hvis der anvendes forskellige infusionsslanger og forskellige infusionssteder, eller hvis infusionsslangen udskiftes eller skylles meget grundigt med fysiologisk natriunchloridinfusionsvæske mellem infusionerne for at undgå udfældning.
English: METHOD OF ADMINISTRATION Do not mix with calcium-containing solutions.
Danish: ADMINISTRATIONSMETODE Må ikke blandes med calciumholdige infusionsvæsker
English: In case a lidocaine solution is used as a solvent, ceftriaxone solutions must only be used for intramuscular injection.
Danish: Hvis der anvendes lidocain i opløsningsmidlet, må ceftriaxonopløsningen kun administreres ved intramuskulær injektion.
English: Precipitation is usually reversible upon discontinuation of ceftriaxone (see section 4.4).
Danish: Udfældning er sædvanligvis reversibel ved seponering af ceftriaxon (se pkt.
English: Use in patients with history of renal lithiasis or with hypercalciuria should be considered by the physician based on specific benefit risk assessment.
Danish: Lægen skal overveje anvendelse til patienter med nyresten eller hyperkalciuri i anamnesen ud fra en specifik vurdering af benefit/risk-forholdet.
English: 2 g powder for solution for infusion Intravenous use
Danish: 2 g pulver for infusionsvæske, opløsning Intravenøs anvendelse
English: Haematuria Glycosuria
Danish: Hæmaturi Glykosuri
English: In patients of any age ceftriaxone must not be mixed or administered simultaneously with any calciumcontaining intravenous solutions, even via different infusion lines or at different infusion sites.
Danish: Ceftriaxon må ikke, til nogen aldersgrupper, blandes eller administreres samtidig med nogen former for calciumholdige infusionsvæsker, heller ikke selvom det gives i forskellige infusionsslanger eller på forskellige infusionssteder.
English: your doctor will give you a higher dose (up to 4 g once a day).
Danish: Hvis du har en svær infektion, vil lægen give dig en højere dosis (op til 4 g én gang dagligt).
English: Other medicines and Rocephin
Danish: Brug af anden medicin sammen med Rocephin
English: • Sudden swelling of the face, throat, lips or mouth.
Danish: • at ansigt, svælg, læber eller mund pludseligt hæver op.
English: Eosinophilia Leucopenia Thrombocytopenia
Danish: Eosinofili Leukopeni Trombocytopeni
English: PHARMACEUTICAL FORM AND CONTENTS [To be completed nationally]
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) [Udfyldes nationalt]
English: Ceftriaxone concentrations cannot be reduced by haemodialysis or peritoneal dialysis.
Danish: Ceftriaxonkoncentrationen kan ikke reduceres ved hæmodialyse eller peritonealdialyse.
English: History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems).
Danish: Svær overfølsomhed (f.eks. anafylaktisk reaktion) over for ethvert andet beta-laktam-antibiotikum (penicillin, monobactam eller carbapenem) i anamnesen.
English: a. Susceptibility inferred from cefoxitin susceptibility.
Danish: ≤1d a. Følsomhed udledt af cefoxitinfølsomhed.
English: What Rocephin is and what it is used for What you need to know before you are given Rocephin How Rocephin is given
Danish: Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du får Rocephin Sådan får du Rocephin Bivirkninger
English: • A decrease in the number of white blood cells (granulocytopenia).
Danish: • Nedsat antal hvide blodlegemer (granulocytopeni).
English: Colitis/Overgrowth of non-susceptible microorganisms Antibacterial agent-associated colitis and pseudo-membranous colitis have been reported with nearly all antibacterial agents, including ceftriaxone, and may range in severity from mild to life-threatening.
Danish: Der er rapporteret antibiotika-associeret colitis og pseudomembranøs colitis, der kan variere i sværhedsgrad fra let til livstruende, med næsten alle antibiotika, også ceftriaxon.
English: An immune mediated haemolytic anaemia has been observed in patients receiving cephalosporin class antibacterials including Rocephin (see section 4.8).
Danish: Der er observeret immunmedieret hæmolytisk anæmi hos patienter behandlet med cefalosporiner, inklusive Rocephin (se pkt.
English: Newborn babies, infants and children aged 15 days to 12 years with a body weight of less than 50 kg:
Danish: Nyfødte, spædbørn og børn i aldersgruppen 15 dage til 12 år med en kropsvægt under 50 kilo:
English: Ceftriaxone crosses the placental barrier.
Danish: Ceftriaxon passerer placentabarrieren.
English: Injection site pain Pyrexia
Danish: Smerter ved injektionssstedet Pyreksi
English: • Reduction in number of red blood cells (anaemia).
Danish: • Nedsat antal røde blodlegemer (”blodmangel” - anæmi).
English: • A neurological condition that may occur in neonates with severe jaundice (kernicterus).
Danish: • Kernikterus (en neurologisk tilstand, der kan opstå hos nyfødte med svær gulsot).
English: Ceftriaxone is not removed by peritoneal- or haemodialysis.
Danish: Ceftriaxon fjernes ikke ved peritoneal- eller hæmodialyse.
English: The generally recommended doses are 75-100 mg/kg (max 4 g) once daily for 10-14 days.
Danish: Den generelt anbefalede dosis er 75-100 mg/kg (maks 4 g) én gang dagligt i 10-14 dage.
English: ** Twice daily (12 hourly) administration may be considered where doses greater than 2 g daily are administered.
Danish: *Ved dokumenteret bakteriæmi skal de anbefalede doser i den høje ende af skalaen overvejes ** Administration to gange dagligt (hver 12. time) kan overvejes, når der administreres doser over 2 g dagligt.
English: However, in patients other than neonates, ceftriaxone and calcium-containing solutions may be administered sequentially of one another if the infusion lines are thoroughly flushed between infusions with a compatible fluid.
Danish: Hos patienter med undtagelse af nyfødte kan ceftriaxon og calciumholdige infusionsvæsker dog administreres efter hinanden, såfremt infusionsslangerne skylles grundigt med kompatibel infusionsvæske mellem infusionerne.
English: • You have liver or kidney problems.
Danish: • har lever- eller nyreproblemer
English: Rocephin 250 mg Powder and Solvent for Solution for Injection Hungary, Portugal: Rocephin
Danish: Rocephin 250 mg pulver og solvens til injektionsvæske, opløsning Ungarn, Portugal: Rocephin
English: 250 mg, 500 mg, 1 g powder and solvent for solution for injection 250 mg powder for solution for injection 1 g powder for solution for injection or infusion 2 g powder for solution for injection or infusion Intravenous or intramuscular use
Danish: 250 mg, 500 mg, 1 g pulver og solvens for injektionsvæske, opløsning 250 mg pulver for injektionsvæske, opløsning 1 g pulver til injektions-/infusionsvæske, opløsning 2 g pulver til injektions-/infusionsvæske, opløsning Intravenøs eller intramuskulær anvendelse
English: In symptomatic cases, conservative nonsurgical management is recommended and discontinuation of ceftriaxone treatment should be considered by the physician based on specific benefit risk assessment (see section 4.8).
Danish: Konservativ, ikke-kirurgisk behandling anbefales i symptomatiske tilfælde, og lægen skal ud fra en specifik vurdering af benefit/risk-forholdet overveje, om ceftriaxon bør seponeres (se pkt.
English: In severe renal and hepatic insufficiency, close clinical monitoring for safety and efficacy is advised (see section 4.2).
Danish: Ved svært nedsat nyre- og leverfunktion tilrådes omhyggelig klinisk monitorering for sikkerhed og effekt (se pkt.
English: Caution should be used if ceftriaxone is given to patients with a history of non-severe hypersensitivity to other beta-lactam agents.
Danish: Der skal udvises forsigtighed, hvis ceftriaxon administreres til patienter, der tidligere har haft ikke-alvorlige overfølsomhedsreaktioner over for andre betalactamantibiotika.
English: Complicated urinary tract infections (including pyelonephritis) Infections of bones and joints
Danish: Kompliceret urinvejsinfektion (inklusive pyelonefritis) Infektion i knogler og led
English: Limited data suggest that in cases where the patient is severely ill or previous therapy has failed, Rocephin may be effective when given as an intramuscular dose of 1-2 g daily for 3 days.
Danish: En intramuskulær enkeltdosis af Rocephin på 1-2 g. Begrænsede data tyder på, at hvis patienten er svært syg, eller tidligere behandling har svigtet, kan Rocephin være effektivt, hvis det gives intramuskulært i doser på 1-2 g dagligt i 3 dage.
English: Safety and effectiveness of Rocephin in neonates, infants and children have been established for the dosages described under Posology and Method of Administration (see section 4.2).
Danish: Rocephins sikkerhed og effekt hos nyfødte, spædbørn og børn er fastlagt ved de doser, der omtales under pkt.
English: Hypersensitivity to ceftriaxone, to any other cephalosporin or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for ceftriaxon, ethvert andet cefalosporin eller et eller flere af hjælpestofferne anført i pkt.
English: Intravenous doses of 50 mg/kg or more in infants and children up to 12 years of age should be given by infusion.
Danish: Til spædbørn og børn op til 12 år skal intravenøse doser på 50 mg/kg og derover gives som infusion.
English: For this reason, glucose level determination in urine during therapy with ceftriaxone should be carried out enzymatically.
Danish: Urin-glucose bør derfor bestemmes enzymatisk under behandling med ceftriaxon.
English: When shadows are observed on sonograms, consideration should be given to the possibility of precipitates of calcium ceftriaxone.
Danish: Hvis der ses skygger ved ultralydsscanning, bør udfældning af ceftriaxoncalcium overvejes.
English: 1 g Powder for Solution for Injection or Infusion Ireland, Latvia, Malta, United Kingdom: Rocephin
Danish: 1 g pulver til injektions-/infusionsvæske, opløsning Irland, Letland, Malta, Storbritannien: Rocephin
English: Rarely precipitates of calcium ceftriaxone have been associated with symptoms.
Danish: Udfældning af ceftriaxoncalcium har i sjældne tilfælde været forbundet med symptomer.
English: Pre-operative prophylaxis of surgical site infections 2 g as a single pre-operative dose.
Danish: Profylaktisk inden operation mod infektioner på operationsstedet Enkeltdosis på 2 g præoperativt.
English: Caution should be particularly considered in the paediatric population.
Danish: Der bør udvises forsigtighed, særligt hos børn.
English: Complicated skin and soft tissue infections Infections of bones and joints Management of neutropenic patients with fever that is suspected to be due to a bacterial infection
Danish: Kompliceret hud- og bløddelsinfektion Infektion i knogler og led Neutropene patienter med feber, hvor der er mistanke om bakteriel infektion
English: Concentrations for the intravenous injection: 100 mg/ml, Concentrations for the intravenous infusion: 50 mg/ml (Please refer to section 4.2 for further information).
Danish: 6.6 Regler for destruktion og anden håndtering Koncentration ved intravenøs injektion: 100 mg/ml, Koncentration ved intravenøs infusion: 50 mg/ml (Se pkt.
English: Ceftriaxone (as Ceftriaxone Sodium)
Danish: Ceftriaxon (som ceftriaxonnatrium)
English: Not known (Frequency cannot be estimated from the available data)
Danish: Hyppighed kendes ikke (kan ikke vurderes ud fra de foreliggende data)
English: * In vitro studies have shown that ceftriaxone can displace bilirubin from its serum albumin binding sites leading to a possible risk of bilirubin encephalopathy in these patients.
Danish: 4.4, 4.8 og 6.2) *In vitro-studier har vist, at ceftriaxon kan displacere bilirubin fra dets bindingssteder på serumalbumin med en mulig risiko for bilirubin-encefalopati hos disse patienter.
English: 250 mg, 500 mg, 1 g powder and solvent for solution for injection Powder and solvent for solution for injection [To be completed nationally]
Danish: 250 mg, 500 mg, 1 g pulver og solvens til injektionsvæske, opløsning Pulver og solvens til injektionsvæske, opløsning [Udfyldes nationalt]
English: Bacterial meningitis Bacterial endocarditis * In documented bacteraemia, the higher end of the recommended dose range should be considered.
Danish: Bakteriel endokarditis *Ved dokumenteret bakteriæmi skal de anbefalede doser i den høje ende af skalaen overvejes Den maksimale daglige dosis på 50 mg/kg må ikke overskrides.
English: Fusobacterium spp.
Danish: Bacteroides spp Fusobacterium spp.
English: Summary of product characteristics, labelling and package leaflet
Danish: PRODUKTRESUMÈ, ETIKETTERING OG INDLÆGSSEDDEL
English: During treatment with ceftriaxone, undesirable effects may occur (e.g. dizziness), which may influence the ability to drive and use machines (see section 4.8).
Danish: 4.7 Virkninger på evnen til at føre motorkøretøj og betjene maskiner Der kan under behandling med ceftriaxon forekomme bivirkninger (f.eks. svimmelhed), der kan påvirke evnen til at føre motorkøretøj og betjene maskiner (se pkt.
English: Urine glucose determination during therapy with Rocephin should be done enzymatically (see section 4.8).
Danish: Under behandling med Rocephin bør urin-glucose bestemmes enzymatisk (se pkt.
English: • A false positive result for galactosaemia (an abnormal build up of the sugar galactose).
Danish: • Falsk-positivt resultat af blodprøve for galaktosæmi (unormal ophobning af galactose i blodet).
English: Indications for neonates 0-14 days that require specific dosage schedules:
Danish: Indikationer, hvor særlige dosisskemaer for nyfødte (0-14 dage), er påkrævet: Akut otitis media
English: 2 g Powder for Solution for Injection or Infusion United Kingdom: Rocephin
Danish: 2 g pulver til injektions-/infusionsvæske, opløsning Storbritannien: Rocephin
English: Ceftriaxone is contraindicated in: Premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age)* Full-term neonates (up to 28 days of age): with hyperbilirubinaemia, jaundice, or who are hypoalbuminaemic or acidotic because these are conditions in which bilirubin binding is likely to be impaired* if they require (or are expected to require) intravenous calcium treatment, or calcium-containing infusions due to the risk of precipitation of a ceftriaxone-calcium salt (see sections 4.4, 4.8 and 6.2).
Danish: Præmature nyfødte op til en postmenstruel alder på 41 uger (gestationsalder + postnatalalder)* Fuldbårne nyfødte (op til en alder på 28 dage): - med hyperbilirubinæmi, gulsot, hypoalbuminæmi eller acidose, da dette er tilstande hvor bilirubinbindingen sandsynligvis er reduceret*
English: • Shivering.
Danish: • Kramper.
English: In patients treated with ceftriaxone, the Coombs' test may lead to false-positive test results.
Danish: Behandling med ceftriaxon kan medføre falsk positivt resultat for Coombs test.
English: Cases of renal lithiasis have been reported, which is reversible upon discontinuation of ceftriaxone (see section 4.8).
Danish: Der er rapporteret tilfælde af nyresten, som er reversibel ved ophør med ceftriaxon (se pkt.
English: • Tell the person taking the sample that you have been given Rocephin.
Danish: Hvis du skal have foretaget sådanne prøver, skal du fortælle den person, der tager prøven, at du får Rocephin.
English: Therefore, ceftriaxone and calcium-containing solutions must not be mixed or administered simultaneously (see sections 4.3, 4.4 and 6.2).
Danish: Ceftriaxon og calciumholdige infusionsvæsker må derfor ikke blandes eller administreres samtidigt (se pkt.
English: The signs may include bruising easily and pain and swelling of your joints.
Danish: Tegn på dette kan være, at du nemt får blå mærker, og du har smertende og hævede led.
English: In particular, tell your doctor or pharmacist if you are taking any of the following medicines:
Danish: Det er særligt vigtigt at kontakte lægen eller apotekspersonalet, hvis du tager:
English: The information in the Summary of Product Characteristics of lidocaine should be considered.
Danish: Produktresuméet for lidocain bør følges.
English: Neonates, infants and children 15 days to 12 years of age (< 50 kg) For children with bodyweight of 50 kg or more, the usual adult dosage should be given.
Danish: Nyfødte, spædbørn og børn i aldersgruppen 15 dage til 12 år (<50 kg) Der anvendes voksendosering til børn med en kropsvægt på 50 kg og derover.
English: Pre-operative prophylaxis of surgical site infections 50-80 mg/kg as a single pre-operative dose.
Danish: Profylaktisk inden operation mod infektioner på operationsstedet Enkeltdosis på 50-80 mg/kg præoperativt.
English: 2 g Powder for Solution for injection or infusion 1 g powder for solution for injection or infusion Powder for solution for injection or infusion [To be completed nationally]
Danish: 2 g pulver til injektions-/infusionsvæske, opløsning 1 g pulver til injektions-/infusionsvæske, opløsning Pulver til injektions-/infusionsvæske, opløsning [Udfyldes nationalt]
English: 1 g Powder and Solvent for Solution for Injection Belgium, France, Luxembourg: Rocephine Denmark, Finland, Iceland, Sweden: Rocephalin
Danish: 1 g pulver og solvens til injektionsvæske, opløsning Belgien, Frankrig, Luxembourg: Rocephine Danmark, Finland, Island, Sverige: Rocephalin Tyskland, Grækenland, Ungarn, Irland, Holland, Portugal: Rocephin Italien: Rocefin
English: Erythema multiforme Acute generalised exanthematous pustulosis
Danish: Akut generaliseret eksantematøs pustulose
English: • Inflammation of the pancreas (pancreatitis).
Danish: • Betændelse i bugspytkirtlen (pankreatitis).
English: Contraindications to lidocaine must be excluded before intramuscular injection of ceftriaxone when lidocaine solution is used as a solvent (see section 4.4).
Danish: Hvis der anvendes lidocain i opløsningsmidlet, skal kontraindikationer i forhold til lidocain udelukkes inden intramuskulær injektion af ceftriaxon (se pkt.
English: In vitro studies using adult and neonatal plasma from umbilical cord blood demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium (see sections 4.2, 4.3, 4.4, 4.8 and 6.2).
Danish: Det er i in vitro-studier, hvor der er anvendt adult og neonatalt plasma fra navlestrengsblod, vist, at nyfødte har en øget risiko for udfældning af ceftriaxoncalcium (se pkt.
English: In patients with impaired renal function, there is no need to reduce the dosage of ceftriaxone provided hepatic function is not impaired.
Danish: Det er ikke nødvendigt at reducere dosis af ceftriaxon til patienter med nedsat nyrefunktion, forudsat at leverfunktionen er normal.
English: • Fungal infections (for example, thrush).
Danish: • Svampeinfektion (fx trøske).
English: 500 mg Powder and Solvent for Solution for Injection Denmark, Finland: Rocephalin
Danish: 500 mg pulver og solvens til injektionsvæske, opløsning Danmark, Finland: Rocephalin Frankrig: Rocephine
English: Patients with severe hepatic and renal impairment
Danish: Patienter med svært nedsat lever- og nyrefunktion