FrancophonIA/ELRC3.0 huggingface dataset:
English: Cefuroxime crosses the placenta.
Danish: Cefuroxim krydser placenta.
English: According to the NCCLS (National Committee on Clinical Laboratory Standards) in 2001 the following breakpoints have been defined for cefuroxime axetil:
Danish: Ifølge NCCLS (National Committee on Clinical Laboratory Standards) i 2001, er der defineret følgende resistensbestemmelser for cefuroximaxetil:
English: If you think you are having any of these types of reaction, stop taking this medicine and contact your doctor or your nearest hospital accident and emergency department.
Danish: Hvis du mener, du har en af disse typer reaktioner, skal du holde op med at tage lægemidlet og kontakte din læge eller nærmeste skadestue.
English: Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100)) Rare (≥1/10,000 to <1/1,000)) Very rare (<1/10,000))
Danish: 4.8 Bivirkninger Almindelig (> 1/100, < 1/10) Ikke almindelig (> 1/1000, < 1/100) Sjælden (> 1/10 000, < 1/1000) Meget sjælden (< 1/10 000)
English: However, you should not take this medicine if you have ever had a severe allergic reaction to any penicillin.
Danish: Du bør dog ikke tage dette lægemiddel, hvis du før har haft en alvor overfølsomhedsreaktion over for nogen form for penicillin.
English: Metabolism: Cefuroxime is not metabolised.
Danish: Metabolisme: Cefuroxim metaboliseres ikke.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Officielle retningslinjer vedrørende hensigtsmæssig brug af antibakterielle midler bør tages i betragtning.
English: The tablets should be taken after meals because this improves the absorption of Cefuroxime axetil into the body.
Danish: Tabletterne bør tages efter et måltid, da det forbedrer Cefuroximaxetils optagelse i kroppen.
English: Patients undergoing haemodialysis will require a supplementary dose of cefuroxime at the end of each dialysis treatment.
Danish: Patienter i hæmodialyse behøver en ekstra dosis af cefuroxim ved slutningen af hver dialysebehandling.
English: Streptococcal isolates susceptible to penicillin (MIC90 ≤ 0.12 µg/ml) may be considered susceptible to cefuroxime.
Danish: Streptococcal-isolater, der er følsomme over for penicilin (MIC90 ≤ 0.12 µg/ml) kan betragtes som følsomme over for cefuroxim.
English: Cefuroxime axetil should not be used during pregnancy unless considered essential by the physician.
Danish: Cefuroximaxetil bør ikke anvendes under graviditet med mindre det af lægen skønnes absolut nødvendigt.
English: The dosage depends on the severity of the infection.
Danish: Doseringen afhænger af infektionens sværhedsgrad.
English: Kidneys and urinary tract: blood in the urine, fever and pain in the side (acute interstitial nephritis)
Danish: Nyrer og urinveje: blod i urinen, feber og smerter i siden (akut interstitiel nefritis).
English: Preclinical effects were observed in dosages far above the maximal human dosage which are therefore hardly relevant for the clinical use of cefuroxime axetil.
Danish: Prækliniske effekter blev observeret ved doser langt over den maksimale menneskelige dosis og er derfor næppe relevante for klinisk brug af cefuroximaxetil.
English: Like all antibiotics Cefuroxime axetil is only effective against some types of bacteria.
Danish: Som alt antibiotika er Cefuroximaxetil kun effektiv imod nogle typer af bakterier.
English: About 50% of cefuroxime in the circulation is bound to plasma proteins.
Danish: Omkring 50% af cirkulerende cefuroxim er bundet til plasmaproteiner.
English: Enterobacter species
Danish: Enterobacter arter
English: Al/Al blister packaging
Danish: Alu/alu blisterpakning
English: Coated tablets oral use
Danish: Overtrukne tabletter oral brug
English: 6.4 Special precautions for storage Al/Al strip: Store in the original packaging Al/Al blister:
Danish: 6.4 Særlige opbevaringsforhold Alu/alu strip: opbevares i original emballage Alu/alu blister: opbevares i original emballage
English: Citrobacter species
Danish: Citrobacter arter
English: • infections in the skin and the layers just under the skin (such as furuncles, impetigo-an infection on the surface of the skin)
Danish: • Infektioner i huden og lagene lige under huden (såsom furunculus og børnesår -en infektion i hudoverfladen)
English: In order to comply with the NfG on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections (CPMP/EWP/558/95 rev.1), the applicant accepted that proposed SPC should be updated in due time to include EUCAST breakpoints.
Danish: For at efterkomme retningslinjen "Note for Guidance on Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections" (CPMP/EWP/558/95 rev.1) accepterede ansøgeren, at det ansøgte produktresumé bliver opdateret i rette tid til, at tærskelværdier fra EUCAST kan indgå.
English: Severe allergic reactions to this medicine are very rare (affecting less than 1 in 10,000 people) or rare (affecting less than 1 in 1,000 people).
Danish: Alvorlige overfølsomhedsreaktioner over for dette lægemiddel er meget sjældne (forekommer hos færre end 1 ud af 10.000 behandlede) eller sjældne (forekommer hos mellem 1 og 10 ud af 10.000 behandlede).
English: In patients who develop severe diarrhoea during or after use of cefuroxime axetil, the risk of life threatening pseudomembranous colitis should be taken into account.
Danish: Hos patienter, som udvikler kraftig diarré under eller efter brug af cefuroximaxetil, bør risikoen for livstruende pseudomembranøs colitis tages i betragtning.
English: Therefore, the inclusion of uncomplicated gonococcal disease is a matter of major concern from a public health perspective, both at individual and community level.
Danish: Medtagelsen af ukompliceret infektion med gonokokker giver derfor anledning til betænkelighed, både set i forhold til den enkelte og til samfundet.
English: Erythema multiforme, Stevens-Johnson syndrome and toxic epidermal necrolysis
Danish: Meget sjælden Erythema multiforme, Stevens-Johnson syndrom og toksisk epidermal nekrolyse
English: It is recommended to avoid this combination (see section 4.4).
Danish: Det anbefales at undgå denne kombination (se pkt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON / BOX
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE PAKNING/ÆSKE
English: The use of cefuroxime axetil is not recommended in patients with severe intestinal tract disorders accompanied by vomiting and diarrhoea, since in these situations a sufficient absorption can not be guaranteed.
Danish: Det anbefales ikke at anvende cefuroximaxetil til patienter med alvorlige tarmkanalslidelser ledsaget af opkastning og diarré, da tilstrækkelig absorption ikke kan garanteres i sådanne situationer.
English: Cefuroxime axetil kills bacteria and it can be used against various sorts of infections.
Danish: Cefuroximaxetil dræber bakterier, og det kan bruges imod forskelliger typer af infektioner.
English: • reduced affinity of penicillin-binding proteins for cefuroxime
Danish: • Nedsat affinitet af penicillinbindende proteiner over for cefuroxim
English: If the person being treated still feels unwell at the end of the prescribed course of treatment, or feels worse during treatment, tell your doctor.
Danish: Hvis du stadig føler dig dårlig, når den ordinerede kur er endt, eller hvis du har fået det værre under behandlingen, skal du fortælle din læge det.
English: Pseudomonas species
Danish: Pseudomonas arter
English: This is because small amounts of it enter the milk.
Danish: Små mængder trænger ind i modermælken.
English: Talk to your doctor or pharmacist if any of the above apply to you.
Danish: Fortæl lægen eller apoteket hvis noget af ovenstående passer på dig.
English: • chest infections such as bronchitis
Danish: • Infektioner i nedre luftveje, såsom bronchitis
English: Probenecid competes with cefuroxime for renal tubular secretion resulting in higher and more prolonged plasma concentrations of cefuroxime.
Danish: Probenecid konkurrerer med cefuroxim om renal tubulær sekretion, hvilket resulterer i højere og mere langvarige plasmakoncentrationer af cefuroxim.
English: Penicillin-resistant Streptococcus pneumoniae are cross-resistant to cephalosporins such as cefuroxime through alteration of penicillin binding proteins.
Danish: Penicillin-resistente Streptococcus pneumoniae er krydsresistente over for cefalosporiner såsom cefuroxim via ændring af penicillinbindende proteiner.
English: Commonly susceptible species
Danish: Sædvanlige følsomme arter
English: - Loss of consciousness (fainting) - severe diarrhoea or if you see blood in your diarrhoea.
Danish: - Bevidsthedstab (besvimelse) - Alvorlig diarré eller blod i afføringen
English: Cefuroxime does not interfere in the alkaline picrate assay for creatinine (see section 4.5 ).
Danish: Cefuroxim påvirker ikke i den alkaliske pikratprøve for creatinin (se afsnit 4.5).
English: The use of preparations inhibiting the intestinal peristaltism is contra-indicated (see section 4.8 ).
Danish: Brug af præparater, der hæmmer den intestinale peristaltik er kontraindiceret (se afsnit 4.8).
English: • early Lyme disease (from a tick bite) and to prevent late complications in adults and children above the age of 12.
Danish: • Tidligt stadie af Lyme sygdom (efter flåtbid) og til at forebygge senere komplikationer hos voksne og børn over 12 år.
English: Transient increases of hepatic enzyme levels (AST, ALT and LDH) and serum bilirubin.
Danish: Forbigående stigning af leverenzymer (AST, ALT og LDH) og serum-bilirubin.
English: After a β-lactam antibiotic has bound to these receptors, the transpeptidation reaction is inhibited and peptidoglycan synthesis is blocked.
Danish: Efter et β-laktam antibiotikum er blevet bundet til disse receptorer, er transpeptidationsreaktionen hæmmet og peptidglykansyntesen blokeret.
English: The dose you are prescribed will depend on the type and severity of the infection.
Danish: Den dosis, der udskrives til dig, afhænger af infektionens art og alvorlighedsgrad.
English: The initial step in drug action consists of binding of the drug to cell receptors, called Penicillin-Binding Proteins.
Danish: Det initiale trin i stofvirkningen består i binding af stoffet til cellereceptorer, kaldet penicillinbindende proteiner.
English: There is no experience in children under 3 months of age.
Danish: Der findes ingen erfaring med anvendelse til børn under 3 måneder.
English: Skin rashes, urticaria, pruritus.
Danish: Hududslæt, urticaria, pruritus
English: Staphylococcus aureus (methicillin-susceptible) Coagulase-negative staphylococci (methicillinsusceptible)
Danish: Staphylococcus aureus (methicillin-følsomme) Coagulase-negative stafylokokker (methicillin-følsomme) Streptococcus agalactiae
English: Drug fever
Danish: Sjælden Drug fever
English: If you have been told by your doctor that you have a metabolic disorder called phenylketonuria or if you are on a low-phenylalanine diet, contact your doctor before taking this medicinal product.
Danish: Hvis din læge har fortalt dig, at du lider af en stofskiftesygdom kaldet Føllings sygdom, eller hvis du følger en phenylalaninfattig diæt, skal du kontakte din læge, inden du begynder at tage dette lægemiddel.
English: The efficacy of cefuroxime axetil on other anatomical locations, (which often remain asymptomatic), is highly questionable and consequently treatment with cefuroxime axetil might not curtail further transmission of the infection.
Danish: Cefuroximaxetils virkning på andre anatomiske lokalisationer (hvor sygdommen ofte er asymptomatisk) er stærkt tvivlsom, hvorfor behandling med cefuroximaxetil muligvis ikke begrænser videre transmission af sygdommen.
English: SPECIAL STORAGE CONDITIONS Store in the original package.
Danish: UDLØBSDATO Udløbsdato: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i original emballage 10.
English: The experience with cefuroxime axetil in limited numbers of patients with uncomplicated anorectal gonorrhoea or pharyngeal gonorrhoea is not sufficient and the efficacy is not established and therefore not acceptable and should not be included in the product information.
Danish: Erfaringerne med cefuroximaxetil omfatter et begrænset antal patienter med ukompliceret anorektal gonorré og faryngeal gonorré og er utilstrækkelige; virkningen er ikke dokumenteret og kan derfor ikke godtages, hvorfor dette ikke bør medtages i produktresuméet.
English: Serratia species
Danish: Serratia arter
English: The use of cefuroxime axetil may be accompanied by a false positive Coombstest.
Danish: Brugen af cefuroxim kan ledsages af en falsk positiv Coombstest.
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER / APPLICANTS IN THE MEMBER STATES
Danish: BILAG I FORTEGNELSE OVER LÆGEMIDLERNES NAVNE, LÆGEMIDDELFORM(ER), STYRKE(R), INDGIVELSESVEJ(E), ANSØGER(E), INDEHAVER(E) AF MARKEDSFØRINGSTILLADELSE(R) I MEDLEMSSTATERNE
English: Simultaneous use of medicines enhancing the pH of the stomach decreases the bioavailability of cefuroxime axetil.
Danish: Samtidig brug af lægemidler, der øger mavens pH-værdi, nedsætter cefuroximaxetils biotilgængelighed.
English: Taking into account the originator SPCs of cefuroxime axetil and recommendations from the literature on the use of cefuroxime in the treatment of uncomplicated gonorrhoea, it was argued that the inclusion of this indication is fully justified from a clinical and pharmacological point of view.
Danish: På baggrund af de oprindelige produktresuméer for cefuroximaxetil og anbefalingerne i litteraturen om anvendelse af cefuroxim til behandling af ukompliceret gonorré blev det hævdet, at medtagelsen af denne indikation er klinisk og farmakologisk velbegrundet.
English: This may be the case when Cefuroximaxetil is used together with: - medicines that decrease stomach acidity (medicines for heartburn); - certain other medicines for the prevention or control of infections (antibiotics), such as tetracyclines, macrolides, chloramphenicol, aminoglycosids; - probenecid (a medicine for gout and other ailments).
Danish: Dette kan være tilfældet, hvis Cefuroximaxetil bruges sammen med: lægemidler der sænker mavesyren (lægemidler mod halsbrand); visse andre lægemidler til forebyggelse eller kontrol af infektioner (antibiotika), såsom tetracycliner, macrolider og aminoglykosider, probenecid (et lægemiddel mod podagra og andre lidelser).
English: Simultaneous use of medicines enhancing the pH of the stomach is not recommended (see section 4.5).
Danish: Samtidig brug af lægemidler, der øger mavens pH-værdi anbefales ikke (se pkt 4.5).
English: Like all medicines, this medicine can cause side effects, although not everybody gets them.
Danish: Cefuroximaxetil kan, som al anden medicin, give bivirkninger, selvom ikke alle får bivirkninger.
English: Cefuroximaxetil tablets are coated.
Danish: Cefuroximaxetil tabletter er overtrukne.
English: Distribution: Cefuroxime is widely distributed in the body including pleural fluid, sputum, bone, synovial fluid, and aqueous humour, but only achieves therapeutic concentrations in the CSF when the meninges are inflamed.
Danish: Distribution: Cefuroxim er bredt distribueret i kroppen inklusiv i pleural væske, spyt, knogler, synovialvæske og kammervæsken, men når kun terapeutiske koncentrationer i cerebrospinalvæsken (CSF) ved inflammation af meninges.
English: Cefuroxime may be efficiently hydrolysed by certain of the extended-spectrum beta-lactamases (ESBLs) and by the chromosomally-encoded (AmpC) enzyme that may be induced or stably derepressed in certain aerobic gram-negative bacterial species
Danish: Cefuroxim kan hydrolyseres effektivt af visse af de bredspektrede β-laktamaser (ESBLs) og af kromosomalt medierede (AmpC) enzymer, der kan være fremkaldt eller stabiliseret hos visse aerobe gram-negative bakterielle typer.
English: Blood and the lymphatic system disorders
Danish: Blod- og lymfesystem:
English: The use of cefuroxime axetil should be discontinued and the appropriate treatment established.
Danish: Behandling med cefuroximaxetil bør seponeres, og fornøden behandling bør iværksættes.
English: Dialysis causes the decrease of cefuroxime serum levels.
Danish: Dialyse forårsager et fald i cefuroxim serumkoncentrationen.
English: Cephalosporin antibiotics at high dosage should be given with caution to patients receiving potent diuretics, aminoglycosides, or amphotericin as these combinations increases the risk of nephrotoxicity.
Danish: Cefalosporinantibiotika i høj dosis bør gives med forsigtighed til patienter, som er i samtidig behandling med potente diuretika, aminoglykosid eller amfoteracin, da samtidig brug øger risikoen for nefrotoksicitet.
English: The reaction results directly from the bactericidal activity of cefuroxime axetil on the spirochaete Borrelia burgdorferi.
Danish: Denne reaktion er et direkte resultat af cefuroximaxetils baktericide virkning på spirochaeten Borrelia burgdorferi.
English: If you are not sure about anything, ask your doctor or pharmacist.
Danish: Hvis du er i tvivl om noget, så spørg lægen eller på apoteket.
English: • ear, sinus and throat infections
Danish: • Øre-, bihule- og halsbetændelser
English: BEFORE YOU TAKE CEFUROXIME AXETIL Do not take this medicine if: - You are allergic (hypersensitive) to Cefuroxime axetil or to any of the other ingredients of this medicine (See “Further Information”).
Danish: Tag ikke tage Cefuroximaxetil: - hvis du er overfølsom (allergisk) over for cefuroximaxetil eller et af de øvrige indholdsstoffer i dette lægemiddel (Se ”Yderligere oplysninger”)
English: Since bacteriostatic drugs may interfere with the bactericidal action of cephalosporins, it is advisable to avoid giving tetracyclines, macrolides, or chloramphenicol in conjunction with cefuroxime axetil.
Danish: Da bakteriostatiske midler kan påvirke cefalosporiners baktericide virkning, anbefales det at undgå administration af tetracyclin, makrolider eller chloramphenicol sammen med cefuroximaxetil.
English: Special care should be taken with phenylketonuric patients because of the aspartame containing coating.
Danish: Der bør udvises særlig forsigtighed hos patienter med Føllings sygdom pga. det aspartamholdige tabletovertræk.
English: Taking this medicine with cefuroxime axetil can cause higher and more persistent levels of cefuroxime in the blood and bile; - Water tablets or injections (diuretics) - Certain medicines against fungal infections (Amphotericin) - certain tests, such as tests for determining the amount of glucose (sugar) in the blood or urine - certain tests, such as tests for determining some substances in your blood (Coombs test)
Danish: Hvis man tager dette lægemiddel sammen med cefuroximaxetil kan det forårsage højere og mere vedvarende koncentrationer af cefuroxim i blodet og galden vandtabletter eller -injektioner (diuretika) visse lægemidler mod svampeinfektioner (Amphotericin) visse prøver, såsom prøver til at fastslå mængden af glucose (sukker) i blodet eller urinen visse prøver, såsom prøver til at fastslå visse stoffer i dit blod (Coombs prøve)
English: Previous immediate and /or severe hypersensitivity reaction to a penicillin or to any other type of betalactammedicinal products.
Danish: Tidligere akut og/eller alvorlig overfølsomhedsreaktion over for penicillin eller andre β-laktam antibiotika.
English: • outer membrane impermeability, which restricts access of cefuroxime to penicillin binding proteins in gram-negative organisms
Danish: • Cellevægsuigennemtrængelighed, hvilket begrænser adgangen af cefuroxim til penicillinbindende proteiner i de gram-negative organismer.
English: Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.
Danish: Der skal udvises særlig forsigtighed hos patienter, som har haft en allergisk reaktion over for penicillin eller andre β-laktam antibiotika.
English: To address the concerns of the CHMP, the Applicant submitted an extensive review of the literature supporting the efficacy of cefuroxime axetil in the treatment of uncomplicated gonorrhoea and specifically in cervicitis and urethritis.
Danish: For at imødekomme CHMP's betænkeligheder fremlagde ansøgeren en omfattende gennemgang af litteratur, der støtter virkningen af cefuroximaxetil til behandling af ukompliceret gonorré, specielt ved cervicitis og uretritis.
English: - (high) fever - joint pain - Swelling of eyelids, face or lips - Severe skin rashes that can blister and may involve the eyes, mouth and throat and genitals.
Danish: - (høj) feber - ledsmerter - hævelser af øjenlågene, ansigtet eller læberne - alvorlige hududslæt, der kan danne blærer og omfatte øjnene, munden, halsen og kønsdelene.
English: The applicant had to address the safety and efficacy of cefuroximaxetil in uncomplicated gonorrhoea and to conclude on the risk-benefit balance for this sought indication.
Danish: Ansøgeren skulle gennemgå sikkerheden og virkningen af cefuroximaxetil ved ukompliceret gonorré og drage konklusioner om benefit/risk-forholdet for denne ansøgte indikation.
English: Cefuroxime may interfere with the determination of glucose in urine with copper containing reagentia (Benedict- or Fehling-solution, Clinitest).
Danish: Cefuroxim kan påvirke målingen af urinsukker med kobber-indeholdende reagenser (Benedicts eller Fehlings opløsning, Clinitest).
English: During CHMP arbitration, the applicant was asked to further justify the indication “uncomplicated gonorrhoea: urethritis and cervicitis”.
Danish: Under voldgiften i CHMP blev ansøgeren anmodet om at give en nærmere begrundelse for indikationen ”ukompliceret gonorré: uretritis og cervicitis”.
English: Diarrhoea, nausea and vomiting.
Danish: Diarré, kvalme og opkastning.
English: Cefuroxime is excreted to a small degree in human milk; breast feeding should be avoided in women using cefuroxime axetil.
Danish: Cefuroxim udskilles i små mængder i modermælken; amning bør derfor undgås hos mødre i behandling med cefuroximaxetil.
English: Absorption: After oral administration cefuroxime axetil is absorbed from the gastrointestinal tract and rapidly hydrolysed in the intestinal mucosa and blood causing the release of the active compound cefuroxime into the circulation.
Danish: Absorption: Efter peroral indgift absorberes cefuroximaxetil fra mave-tarmkanalen og hydrolyseres hurtigt i tarmslimhinderne og blodet, hvilket forårsager frigivelsen af den aktive substans cefuroxim i kredsløbet.
English: General: drug fever
Danish: Alment: lægemiddelfeber (drug fever).
English: As with other broad spectrum antibiotics, prolonged use of cefuroxime axetil may result in the overgrowth of non-susceptible organisms (e.g., candida, enterococci and clostridium diffficile, which may require interruption of treatment.
Danish: Som med andre typer bredspektrede antibiotika kan langvarig brug af cefuroximaxetil føre til overvækst af ikke-følsomme organismer (f.eks. candida, enterokokker, clostridium difficile), hvilket kan nødvendiggøre afbrydelse af behandlingen.
English: : ≤ 4 µg/ml susceptible; ≥ 16 µg/ml resistant Streptococcus pneumoniae: ≤ 1 µg/ml susceptible, ≥ 4 µg/ml resistant Streptococcus spp.
Danish: : ≤ 4 µg/ml følsom; ≥ 16 µg/ml resistent Streptococcus pneumoniae: ≤ 1 µg/ml følsom, ≥ 4 µg/ml resistent Streptococcus spp.
English: Either the glucose oxidase or the hexokinase methods are recommended to determine the blood and plasma glucose levels in patients receiving cefuroxime axetil.
Danish: Det anbefales, at enten glukoseoxidase eller hexokinase metoder anvendes til at bestemme blod/plasma glukoseværdier hos patienter, der får cefuroximaxetil.
English: • Are you breast-feeding?
Danish: • Ammer du?