FrancophonIA/ELRC3.0 huggingface dataset:
English: Animal studies do not indicate direct or indirect harmful effects with respect to embryonal/foetal, perinatal and postnatal development (see section 5.3).
Danish: Dyrestudier indikerer hverken direkte eller indirekte skadelige virkninger hvad angår embryo/føtal, perinatal eller postnatal udvikling (se pkt.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: However, if it is almost time for your next injection, skip the missed injection.
Danish: Hvis det næsten er tid til næste indsprøjtning, skal den glemte indsprøjtning dog springes over.
English: The recommended treatment durations vary and national or local guidelines should be taken into consideration.
Danish: Den anbefalede behandlingsvarighed varierer, og nationale eller lokale retningslinjer bør inkluderes i overvejelsen.
English: It can be given as a drip (intravenous infusion) or as an injection directly into a vein or into a muscle.
Danish: Det kan gives i et drop (intravenøs infusion) eller som en indsprøjtning direkte i en åre eller muskel.
English: Rocephin is usually given by a doctor or nurse.
Danish: Du får normalt Rocephin af en læge eller sygeplejerske.
English: stomach pain and fever.
Danish: mavesmerter og feber.
English: Italy: Rocefin
Danish: Italien: Rocefin
English: • You are on a low sodium diet.
Danish: • er på saltfattig diæt
English: Long term treatment
Danish: Længerevarende behandling
English: c. Isolates with a ceftriaxone MIC above the susceptible breakpoint are rare and, if found, should be re tested and, if confirmed, should be sent to a reference laboratory.
Danish: c. Isolater med ceftriaxon-MIC over grænseværdierne for følsomheden er sjældne og bør, hvis identificeret, testes igen og, hvis bekræftet, sendes til et referencelaboratorium.
English: Rocephin can cause dizziness.
Danish: Rocephin kan forårsage svimmelhed.
English: Rocephin must not be given to babies if:
Danish: Rocephin må ikke gives til spædbørn, hvis:
English: It works by killing bacteria that cause infections.
Danish: Det virker ved at slå de bakterier, der forårsager infektionen, ihjel.
English: Simultaneous administration of probenecid does not reduce the elimination of ceftriaxone.
Danish: Samtidig administration af probenecid reducerer ikke eliminationen af ceftriaxon.
English: In polymicrobial infections, where suspected pathogens include organisms resistant to ceftriaxone, administration of an additional antibiotic should be considered.
Danish: Ved polymikrobielle infektioner, hvor mistænkte patogener inkluderer organismer, der er resistente over for ceftriaxon, skal administration af yderligere et antibiotikum overvejes.
English: the heart.
Danish: • hjertet.
English: It belongs to a group of medicines called cephalosporins.
Danish: Det tilhører en gruppe af lægemidler, der kaldes cefalosporiner.
English: Use of lidocaine
Danish: Brug af lidocain
English: During childhood, the half-life is lower than in neonates or adults.
Danish: Hos børn er halveringstiden lavere end hos nyfødte og voksne.
English: Adults and children over 12 years of age (≥ 50 kg)
Danish: Voksne og børn over 12 år (≥50 kg)
English: As with antibiotic therapy in general, administration of ceftriaxone should be continued for 48 - 72 hours after the patient has become afebrile or evidence of bacterial eradication has been achieved.
Danish: Som det generelt gælder for antibiotisk behandling, bør administration af ceftriaxon fortsætte 48-72 timer efter, patienten er blevet afebril, eller der er tegn på, at bakteriel eradikation er opnået.
English: • Pain or a burning feeling along the vein where Rocephin has been given.
Danish: • Smerter eller brændende fornemmelse langs den vene, hvor Rocephin er indsprøjtet.
English: This should be taken into consideration in patients on a controlled sodium diet.
Danish: Dette bør tages i betragtning hos patienter på natriumfattig diæt.
English: • outer membrane impermeability in Gram-negative organisms.
Danish: • manglende permeabilitet af den ydre membran i gram-negative organismer.
English: Ceftriaxone should only be administered during pregnancy and in particular in the first trimester of pregnancy if the benefit outweighs the risk.
Danish: Ceftriaxon bør kun anvendes under graviditet, og specielt i første trimester, hvis fordele opvejer risici.
English: Rocephin can affect the results of urine tests for sugar and a blood test known as the Coombs test.
Danish: Rocephin kan påvirke resultatet af urinprøver for sukker og en type blodprøve, der kaldes Coombs test.
English: Close clinical monitoring for safety and efficacy is advised.
Danish: Omhyggelig klinisk monitorering for sikkerhed og effekt anbefales.
English: In particularly severe cases, doses at the higher end of the recommended range should be considered.
Danish: I meget svære tilfælde bør de anbefalede doser i den høje ende af skalaen overvejes.
English: There are limited amounts of data from the use of ceftriaxone in pregnant women.
Danish: Der er begrænsede data fra anvendelse af ceftriaxon til gravide kvinder.
English: • A type of antibiotic called an aminoglycoside.
Danish: • en type antibiotika, der kaldes aminoglykosider
English: Stevens Johnson Syndromeb
Danish: Stevens-Johnson syndromb
English: An 8 - 15 % increase in mean peak plasma concentration (Cmax) is seen on repeated administration; steady state is reached in most cases within 48 - 72 hours depending on the route of administration.
Danish: Der ses en 815% stigning i gennemsnitlig peak-plasmakoncentration (Cmax) ved gentagen administration; steadystate nås i de fleste tilfælde inden for 48-72 timer afhængigt af administrationsvejen.
English: Ceftriaxone is reversibly bound to albumin.
Danish: Ceftriaxon bindes reversibelt til albumin.
English: Rocephin is an antibiotic given to adults and children (including newborn babies).
Danish: Rocephin er et antibiotikum, der gives til voksne og børn (også nyfødte spædbørn).
English: Only in cases of preterminal renal failure (creatinine clearance < 10 ml/min) should the ceftriaxone dosage not exceed 2 g daily.
Danish: Kun i tilfælde af præterminalt nyresvigt (kreatininclearance <10 ml/min) bør ceftriaxon-dosis ikke overstige 2 g dagligt.
English: • The baby is newborn (up to 28 days of age) and has certain blood problems or jaundice (yellowing of the skin or the whites of the eyes) or is to be given a product that contains calcium into their vein.
Danish: • barnet er nyfødt (op til 28 dage gammel) og har visse blodproblemer eller gulsot (gulfarvning af huden eller det hvide i øjnene) eller skal have en infusionsvæske, der indeholder calcium.
English: The signs include severe pain in the stomach which spreads to your back.
Danish: Tegn på dette kan være svære smerter i maven med udstråling til ryggen.
English: The plasma clearance and volume of distribution of total ceftriaxone are greater in neonates, infants and children than in adults.
Danish: Plasma-clearance og fordelingsvolumen af total-ceftriaxon er større hos nyfødte, spædbørn og børn end hos voksne.
English: This effect is usually asymptomatic, but the precipitations have been accompanied by clinical symptoms such as pain, nausea and vomiting in rare cases.
Danish: Denne bivirkning er som regel asymptomatisk, men udfældning har i sjældne tilfælde været ledsaget af kliniske symptomer som smerter, kvalme og opkastning.
English: • You have recently received or are about to receive products that contain calcium.
Danish: • for nylig har fået eller skal have præparater, der indeholder calcium
English: This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.
Danish: Dette medfører, at cellevæggens (peptidoglycan) biosyntese afbrydes, hvilket igen medfører bakteriecellelyse og -død.
English: • Loose stools or diarrhoea.
Danish: • Løs afføring eller diarré.
English: Intravenous intermittent injection should be given over 5 minutes preferably in larger veins.
Danish: Intravenøs intermitterende injektion skal gives over 5 minutter fortrinsvist i større vener.
English: Binding is saturable and the bound portion decreases with rising concentration (up to 85 % at a plasma concentration of 300 mg/l).
Danish: Bindingen kan mættes, og den bundne fraktion falder ved stigende koncentrationer (op til 85% ved en plasmakoncentration på 300 mg/l).
English: You are allergic to lidocaine and you are to be given Rocephin as an injection into a muscle.
Danish: • du er allergisk over for lidocain, og Rocephin skal indsprøjtes i en muskel.
English: 50 - 60 % of ceftriaxone is excreted unchanged in the urine, primarily by glomerular filtration, while 40 - 50 % is excreted unchanged in the bile.
Danish: 50-60% af ceftriaxon udskilles uomdannet i urinen, primært ved glomerulær filtration, mens 40-50% udskilles uomdannet via galden.
English: Severe cases of haemolytic anaemia, including fatalities, have been reported during Rocephin treatment in both adults and children.
Danish: Der er rapporteret svære tilfælde af hæmolytisk anæmi, inklusive dødelige tilfælde, under Rocephin-behandling hos såvel voksne som børn.
English: d. Breakpoints apply to a daily intravenous dose of 1 g x 1 and a high dose of at least 2 g x 1.
Danish: d. Grænseværdierne gælder for daglige intravenøse doser på 1 g x 1 og høje doser på mindst 2 g x 1.
English: • to treat specific sexually transmitted infections (gonorrhoea and syphilis).
Danish: • behandle visse kønssygdomme (gonoré og syfilis).
English: The signs include sudden swelling of the throat or face which might make it difficult to breath or swallow, sudden swelling of the hands, feet and ankles, and a severe rash that develops quickly.
Danish: Tegn på dette kan være pludselig hævelse i svælg eller ansigt, som kan gøre det svært at trække vejret eller synke, pludselig hævelse af hænder, fødder og ankler eller svært udslæt, der udvikler sig hurtigt.
English: Rocephin can be administered by intravenous infusion over at least 30 minutes (preferred route) or by slow intravenous injection over 5 minutes, or by deep intramuscular injection.
Danish: Rocephin kan administreres som intravenøs infusion over mindst 30 minutter (den foretrukne administrationsvej), som langsom intravenøs injektion over 5 minutter eller som dyb intramuskulær injektion.
English: The maximum plasma concentration after a single intramuscular dose of 1 g is about 81 mg/l and is reached in 2 - 3 hours after administration.
Danish: Den maksimale plasmakoncentration efter en enkelt intramuskulær dosis på 1 g er ca. 81 mg/l og nås 2-3 timer efter administration.
English: Dilution Test (MIC, mg/L)
Danish: Fortyndingstest (MIC, mg/l) Følsom Resistent
English: • The maximum daily dose is not to be more than 50 mg for each kg of the baby's weight.
Danish: • Den daglige dosis må ikke overstige 50 mg for hvert kilo, barnet vejer.
English: Plasma clearance of total ceftriaxone (bound and unbound) is 10 - 22 ml/min.
Danish: Plasma-clearance af total-ceftriaxon (bundet og ubundet) er 10-22 ml/min.
English: Intra-abdominal infections
Danish: Intra-abdominal infektion
English: b. Susceptibility inferred from penicillin susceptibility.
Danish: b. Følsomhed udledt af penicillinfølsomhed.
English: Plasma protein binding is about 95 % at plasma concentrations below 100 mg/l.
Danish: Plasmaproteinbindingen er ca. 95% ved plasmakoncentrationer under 100 mg/l.
English: • 1 to 2 g once a day depending on the severity and type of infection.
Danish: • 1-2 g én gang dagligt, afhængigt af infektionens sværhedsgrad og type.
English: However, a risk of diarrhoea and fungal infection of the mucous membranes cannot be excluded.
Danish: Risiko for diarré og svampeinfektion i slimhinderne kan dog ikke udelukkes.
English: At least one of them had received ceftriaxone and calcium at different times and through different intravenous lines.
Danish: Mindst et af børnene havde fået ceftriaxon og calcium på forskellige tidspunkter og gennem forskellige intravenøse slanger.
English: Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 1 g should be injected at one site.
Danish: Intramuskulære injektioner skal gives i en forholdsvis stor muskel, og der må ikke gives mere end 1 g per injektionssted.
English: This is also due to an increase in plasma free fraction of ceftriaxone contributing to the observed paradoxical increase in total drug clearance, with an increase in volume of distribution paralleling that of total clearance.
Danish: Dette skyldes også den øgede frie fraktion af ceftriaxon i plasma, der bidrager til den observerede paradoksale stigning i clearance af totallægemiddel med en parallel stigning i fordelingsvolumen.
English: Based on literature reports, ceftriaxone is not compatible with amsacrine, vancomycin, fluconazole and aminoglycosides.
Danish: Baseret på litteraturrapporter er ceftriaxon ikke forligeligt med amsacrin, vancomycin, fluconazol og aminoglykosider.
English: Concomitant use with oral anticoagulants may increase the anti-vitamin K effect and the risk of bleeding.
Danish: Anvendelse sammen med orale antikoagulantia kan potensere hæmningen af vitamin K og øge risikoen for blødning.
English: In overdose, the symptoms of nausea, vomiting and diarrhoea can occur.
Danish: Ved overdosis kan symptomer som kvalme, opkastning og diarré forekomme.
English: Non-linearity is due to saturation of plasma protein binding and is therefore observed for total plasma ceftriaxone but not for free (unbound) ceftriaxone.
Danish: Non-lineariteten skyldes mætning af plasma-proteinbindingen og ses derfor for total-plasmaceftriaxon, men ikke for frit (ubundet) ceftriaxon.
English: • to treat patients with low white blood cell counts (neutropenia) who have fever due to bacterial infection.
Danish: • behandle patienter med et lavt indhold af hvide blodlegemer (neutropeni), som har feber på grund af en bakterieinfektion.
English: Rocephin is contraindicated in premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age).
Danish: Rocephin er kontraindiceret til præmature nyfødte op til en postmenstruel alder på 41 uger (gestationsalder + postnatalalder)
English: Ceftriaxone has a limited spectrum of antibacterial activity and may not be suitable for use as a single agent for the treatment of some types of infections unless the pathogen has already been confirmed (see section 4.2).
Danish: Ceftriaxon har et begrænset antibakterielt spektrum og vil ofte ikke være velegnet til enkeltstofbehandling af visse typer infektioner, medmindre patogenet allerede er bekræftet (se pkt.
English: Rocephin is made up by the doctor, pharmacist or nurse and will not be mixed with or given to you at the same time as calcium-containing injections.
Danish: Rocephin gøres klar til brug af lægen, apotekspersonalet eller sygeplejersken, og det vil ikke blive blandet med eller givet til dig samtidig med injektioner, der indeholder calcium.
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftriaxone (see section 4.8).
Danish: Det er derfor vigtigt at overveje denne diagnose hos patienter med diarré under eller umiddelbart efter administration af ceftriaxon (se pkt.
English: Cases of renal precipitation have been reported, primarily in children older than 3 years of age and who have been treated with either high daily doses (e.g. ≥ 80 mg/kg/day) or total doses exceeding 10 grams and who presented with other risk factors (e.g. fluid restrictions or confinement to bed).
Danish: Tilfælde af udfældning i nyrerne er rapporteret, primært hos børn over 3 år, som enten er behandlet med høje, daglige doser (f.eks. ≥80 mg/kg/dag) eller totaldoser på mere end 10 gram, og som havde andre risikofaktorer (f.eks. væskerestriktion eller var sengeliggende).
English: If you have any further questions on the use of this medicine, ask your doctor or nurse.
Danish: Hvis du har yderligere spørgsmål vedrørende brugen af medicinen, skal du spørge lægen eller sundhedspersonalet.
English: Severe cutaneous adverse reactions (Stevens Johnson syndrome or Lyell's syndrome/toxic epidermal necrolysis) have been reported; however, the frequency of these events is not known (see section 4.8).
Danish: Der har været rapporter om svære kutane bivirkninger (Stevens-Johnsons syndrom og Lyells syndrom/toksisk epidermal nekrolyse); hyppigheden af disse bivirkninger er dog ukendt (se pkt.
English: The dose will depend on the severity and type of infection; whether you are on any other antibiotics; your weight and age; how well your kidneys and liver are working.
Danish: Dosis vil afhænge af sværhedsgraden og typen af infektion, om du får andre antibiotika, din vægt og alder, samt hvor godt dine nyrer og lever fungerer.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of ceftriaxone in at least some types of infections is questionable.
Danish: Ekspertråd skal søges i det omfang, det er nødvendigt, hvis den lokale prævalens af resistens gør, at brug af ceftriaxon ved i hvert fald nogle former for infektioner er problematisk.
English: Newborn babies (0-14 days)
Danish: Nyfødte børn (0-14 dage gamle)
English: From birth to 14 days of age, the levels of free ceftriaxone may be further increased by factors such as reduced glomerular filtration and altered protein binding.
Danish: Fra fødslen og indtil børnene er 14 dage gamle, kan niveauet af frit ceftriaxon yderligere øges af faktorer som nedsat glomerulær filtration og ændret proteinbinding.
English: Your doctor will decide how much Rocephin you will need and will check you closely depending on the severity of the liver and kidney disease.
Danish: Lægen beslutter, hvor meget Rocephin du har behov for, og vil følge dig tæt, afhængigt af lever- eller nyresygdommens sværhedsgrad.
English: As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported (see section 4.8).
Danish: Som med alle betalaktam-antibiotika har der været tilfælde af alvorlige og indimellem dødelige overfølsomhedsreaktioner (se pkt.
English: Streptococcus pyogenes (Group A) Streptococcus agalactiae (Group B) Streptococcus pneumoniae Viridans Group Streptococci
Danish: Streptococcus pyogenes (gruppe A) Streptococcus agalactiae (gruppe B) Streptococcus pneumoniae Viridans-gruppe Streptococci
English: Commonly susceptible species
Danish: Almindeligvis følsomme arter
English: Ceftriaxone penetrates the meninges.
Danish: Ceftriaxon penetrerer meninges.
English: Penetration is greatest when the meninges are inflamed.
Danish: Penetrationen er størst ved inflammeret meninges.
English: In vitro studies demonstrated that neonates have an increased risk of precipitation of ceftriaxone-calcium compared to other age groups.
Danish: In vitro-studier har vist, at nyfødte har en øget risiko for udfældning af ceftriaxoncalcium sammenlignet med andre aldersgrupper.
English: Shadows, which have been mistaken for gallstones, have been detected on sonograms of the gallbladder and have been observed more frequently at ceftriaxone doses of 1 g per day and above.
Danish: Skygger, der fejlagtigt er vurderet at være galdesten, har været påvist ved skanning af galdeblæren og har været set hyppigere ved ceftriaxondoser på 1 g dagligt og derover.
English: • Rocephin may interfere with some types of blood glucose tests - please check with your doctor.
Danish: • Rocephin kan påvirke visse typer målinger af blod-glucose - tal med lægen.
English: Rocephin may be used:
Danish: Rocephin kan anvendes til:
English: Reports of diarrhoea following the use of ceftriaxone may be associated with Clostridium difficile.
Danish: Indberetninger om diarré efter brug af ceftriaxon kan være forbundet med Clostridium difficile.
English: The pharmacokinetics of ceftriaxone are non-linear and all basic pharmacokinetic parameters, except the elimination half-life, are dose dependent if based on total drug concentrations, increasing less than proportionally with dose.
Danish: Ceftriaxons farmakokinetik er non-lineær, og alle grundliggende farmakokinetiske parametre, bortset fra halveringstid, er dosisafhængige hvis baseret på totallægemiddelkoncentrationen, der øges mindre end proportionalt med dosis.
English: Superinfectionb
Danish: Superinfektionb
English: Rocephin is indicated for the treatment of the following infections in adults and children including term neonates (from birth):
Danish: Rocephin er indiceret til behandling af følgende infektioner hos voksne og børn, inklusive spædbørn født til termin (fra fødslen):
English: Studies have shown that ceftriaxone, like some other cephalosporins, can displace bilirubin from serum albumin.
Danish: Studier har vist, at ceftriaxon, ligesom andre cefalosporiner, kan displacere bilirubin fra serum-albumin.
English: • Children with a body weight of 50 kg or more should be given the usual adult dose.
Danish: • Børn med en kropsvægt på 50 kilo eller derover skal have voksendosis.
English: Interference with Coombs tests may occur, as Rocephin may lead to false-positive test results.
Danish: Der kan forekomme interferens med Coombs-test, da Rocephin kan give falsk-positive resultater.
English: • You are allergic to ceftriaxone or any of the other ingredients of this medicine (listed in section 6).
Danish: • du er allergisk over for ceftriaxon eller et af de øvrige indholdsstoffer i Rocephin (angivet i punkt 6).
English: Non-species related
Danish: Ikke artsrelateret
English: Do not mix with solutions that contain calcium, including Hartmann's, Ringers and Total Parenteral Nutrition
Danish: Må ikke blandes med opløsnigner, som indeholder calcium, herunder Hartmanns opløsning, Ringers opløsning og total parenteral ernæring.
English: Gonorrhoea 500 mg as a single intramuscular dose.
Danish: Gonorré 500 mg som intramuskulær enkeltdosis.
English: Rarely, severe, and in some cases, fatal, adverse reactions have been reported in pre-term and full-term neonates (aged < 28 days) who had been treated with intravenous ceftriaxone and calcium.
Danish: Sjældne, alvorlige og i nogle tilfælde dødelige bivirkninger er rapporteret blandt præmature og fuldbårne nyfødte (alder <28 dage) behandlet intravenøst med ceftriaxon og calcium.
English: In patients requiring continuous infusion with calcium-containing total parenteral nutrition (TPN) solutions, healthcare professionals may wish to consider the use of alternative antibacterial treatments which do not carry a similar risk of precipitation.
Danish: Hos patienter med behov for kontinuerlig infusion af calciumholdig, total parenteral ernæring (TPN) kan sundhedspersonalet overveje at bruge anden antibiotisk behandling, hvor der ikke er tilsvarende risiko for udfældning.
English: Borrelia burgdorferi Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis Neisseria gonorrhoea Neisseria meningitidis Proteus mirabilis Providencia spp.
Danish: Borrelia burgdorferi Haemophilus influenzae Haemophilus parainfluenzae Moraxella catarrhalis Neisseria gonorrhoea Neisseria meningitides Proteus mirabilis Providentia spp Treponema pallidum
English: Uncommon (≥ 1/1000 - < 1/100) Rare (≥ 1/10000 - < 1/1000)
Danish: Ikke almindelig (≥1/1000 til <1/100) Sjælden (≥1/10000 til <1/1000)
English: carbapenemases and Amp C enzymes that may be induced or stably derepressed in certain aerobic
Danish: (ESBL), cabapenemaser og Amp C-enzymer, der kan induceres eller stabiliseres i visse aerobe gram-negative bakteriestammer
English: If your daily dose is higher than 2 g, you may receive it as a single dose once a day or as two separate doses.
Danish: Hvis din daglige dosis er større end 2 g, kan du få den som en enkelt dosis én gang dagligt eller som to doser.