FrancophonIA/ELRC3.0 huggingface dataset:
English: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Danish: Prævalensen af erhvervet resistens kan variere geografisk og over tid for udvalgte arter, og der bør indhentes lokale oplysninger om resistens, især ved behandling af alvorlige infektioner.
English: 6.6 Special precautions for disposal and other handling Instructions for constitution
Danish: 6.6 Regler for destruktion og anden håndtering Vejledning til rekonstitution
English: It is not necessary to reduce the standard dose (750 mg to 1.5 g three times daily).
Danish: Det er ikke nødvendigt at reducere standarddosis (750 mg til 1,5 g 3 gange daglig).
English: Babies (over 3 weeks) and children
Danish: Spædbørn (over 3 uger) og børn
English: 10% Invert Sugar in Water for Injection
Danish: 10 % invertsukker i vand til injektionsvæsker
English: Zinacef strength
Danish: Zinacef styrke
English: Data from clinical trials were used to determine the frequency of very common to rare adverse reactions.
Danish: Data fra kliniske studier blev anvendt til at fastlægge hyppigheden af meget sjældne til sjældne bivirkninger.
English: Zinacef is usually be given by a doctor or nurse.
Danish: Du vil normalt få Zinacef af en læge eller en sygeplejerske.
English: These may affect up to 1 in 10 people:
Danish: Almindelige bivirkninger Disse kan forekomme hos op til 1 ud af 10 personer:
English: Like all medicines, Zinacef can cause side effects, although not everybody gets them.
Danish: Zinacef kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: 4 The beta-lactam susceptibility of beta-haemolytic streptococci groups A, B, C and G is inferred from the penicillin susceptibility.
Danish: 4 Beta-laktamfølsomhed af beta-hæmolytiske streptokokgrupper A, B, C og G er baseret på følsomhed over for penicillin.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction and development.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, genotoksicitet samt reproduktions- og udviklingstoksicitet.
English: This side effect is more likely if you take Zinacef for a long time.
Danish: Der er større risiko for denne bivirkning, hvis du får Zinacef i en længere periode.
English: Following IM or IV administration, the absorption, distribution and excretion of cefuroxime in elderly patients are similar to younger patients with equivalent renal function.
Danish: Efter i.m.- eller i.v.-administration er absorption, distribution og udskillelse af cefuroxim hos ældre patienter svarende til hos yngre patienter med samme nyrefunktion.
English: Your doctor or nurse will dispose of any medicine that is no longer required.
Danish: Lægen eller sundhedspersonalet vil bortskaffe medicin, der ikke længere skal anvendes.
English: Severe infections
Danish: Alvorlige infektioner
English: Do not use this medicine after the expiry date which is stated on the pack after EXP.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: $ All methicillin-resistant S. aureus are resistant to cefuroxime.
Danish: $ Alle methicilin-resistente S.aureus er resistente over for cefuroxim.
English: There is an almost complete recovery (85 to 90%) of unchanged cefuroxime in urine within 24 hours of administration.
Danish: Cefuroxim genfindes næsten fuldstændigt (85-90 %) uomdannet i urinen i løbet af 24 timer efter administration.
English: 1 The cephalosporin breakpoints for Enterobacteriaceae will detect all clinically important resistance mechanisms (including ESBL and plasmid mediated AmpC).
Danish: 1 Cefalosporin-grænseværdierne for Enterobacteriaceae vil detektere alle klinisk vigtige resistensmekanismer (herunder ESBL og plasmidmedieret AmpC).
English: Discontinuation of therapy with cefuroxime and the administration of specific treatment for Clostridium difficile should be considered.
Danish: Seponering af cefuroximbehandling og administration af specifik behandling mod Clostridium difficile skal overvejes.
English: Note: This SPC, labelling and package leaflet is the version valid at the time of Commission decision.
Danish: Dette produktresumé, denne etikettering og denne indlægsseddel er den udgave, som er gyldig på tidspunktet for Kommissionens afgørelse.
English: • water tablets (diuretics), such as furosemide
Danish: • vanddrivende tabletter (diuretika), såsom furosemid
English: In case of severe hypersensitivity reactions, treatment with cefuroxime must be discontinued immediately and adequate emergency measures must be initiated.
Danish: I tilfælde af alvorlige overfølsomhedsreaktioner skal behandling med cefuroxim straks afbrydes og passende procedurer påbegyndes.
English: Pharmacotherapeutic group: antibacterials for systemic use, Second-generation cephalosporins, ATC code: J01DC02
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, 2.generationscephalosporiner, ATC-kode: J01DC02
English: Commonly susceptible species
Danish: Arter, der normalt er følsomme
English: Zinacef should be administered by intravenous injection over a period of 3 to 5 minutes directly into a vein or via a drip tube or infusion over 30 to 60 minutes, or by deep intramuscular injection.
Danish: Zinacef skal administreres ved intravenøs injektion over 3-5 minutter direkte i en vene eller ved intravenøst drop eller infusion over 30-60 minutter, eller ved dyb intramuskulær injektion.
English: Intra-abdominal infections
Danish: Intraabdominale infektioner
English: There are limited amounts of data from the use of cefuroxime in pregnant women.
Danish: Der er utilstrækkelige data fra anvendelse af cefuroxim til gravide kvinder.
English: Cefuroxome sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.
Danish: Cefuroximnatrium er forligeligt med vandige opløsninger indeholdende op til 1 % lidocainhydrochlorid.
English: However, this should not lead to false-positive results, as may be experienced with some other cephalosporins.
Danish: Dette medfører dog normalt ikke falsk positive resultater, som det kan ses ved andre cefalosporiner.
English: Depending on the mechanism of resistance, organisms with acquired resistance to penicillins may demonstrate reduced susceptibility or resistance to cefuroxime.
Danish: Afhængigt af resistensmekanismen, kan organismer med erhvervet resistens over for penicilliner demonstrere reduceret følsomhed eller resistens over for cefuroxim.
English: Microorganisms for which acquired resistance may be a problem Gram-positive aerobes:
Danish: Mikroorganismer, hvor resistens kan være et problem Grampositive aerober:
English: A small number of people taking Zinacef get an allergic reaction or potentially serious skin reaction.
Danish: Et lille antal af de personer, som får Zinacef får en allergisk reaktion eller en hudreaktion, som kan blive alvorlig.
English: This leaflet was last approved in {MM/YYYY}.
Danish: Denne indlægsseddel blev senest revideret {MM/ÅÅÅÅ}
English: As with all beta-lactam antibacterial agents, serious and occasionally fatal hypersensitivity reactions have been reported.
Danish: Som med alle andre beta-laktamantibiotika er der observeret alvorlige og i nogle tilfælde letale overfølsomhedsreaktioner.
English: The serum half-life after either intramuscular or intravenous injection is approximately 70 minutes.
Danish: Halveringstiden i serum efter intramuskulær og intravenøs injektion er ca. 70 minutter.
English: ** The resulting volume of the solution of cefuroxime in reconstitution medium is increased due the displacement factor of the drug substance resulting in the listed concentrations in mg/ml.
Danish: ** Det endelige volumen af den rekonstituerede opløsning af cefuroxim øges på grund af fortrængningsfaktoren for lægemiddelstoffet, hvilket resulterer i de ovenfor listede koncentrationer i mg/ml.
English: This should be considered for patients who are on a controlled sodium diet.
Danish: Dette skal der tages højde for hos patienter, der er på en kost med kontrolleret natriumindhold.
English: Contact a doctor or nurse immediately if you get any of these symptoms.
Danish: Kontakt straks lægen eller sundhedspersonalet, hvis du får et eller flere af disse symptomer.
English: 2 Breakpoint relates to a dosage of 1.5 g × 3 and to E. coli, P. mirabilis and Klebsiella spp.
Danish: 2 Grænseværdier relaterer til en dosering på 1,5 g × 3 og kun for E. coli, P. mirabilis og Klebsiella spp.
English: Holding it upright, fill the vial to approximately two-thirds capacity by squeezing the bag several times.
Danish: Idet hætteglasset holdes i opret position, fyldes det ca. totredjedele ved at klemme posen adskillige gange.
English: 750 mg twice daily; for low-flux haemofiltration follow the dosage recommended under impaired renal function.
Danish: 750 mg 2 gange daglig; ved low-flux hæmofiltration skal den anbefalede dosering ved nedsat nyrefunktion følges.
English: In vitro the activities of cefuroxime sodium and aminoglycoside antibiotics in combination have been shown to be at least additive with occasional evidence of synergy.
Danish: In vitro er aktiviteten af cefuroximnatrium og aminoglykosid-antibiotika i kombination vist at være mindst additiv med lejlighedsvis evidens for synergi.
English: Infants and toddlers > 3 weeks and children < 40 kg
Danish: Spædbørn og småbørn > 3 uger og børn < 40 kg
English: Signs include raised and itchy rash, swelling, sometimes of the face or mouth causing difficulty in breathing.
Danish: Symptomer omfatter hævet og kløende udslæt, hævelser, undertiden i ansigtet eller munden, hvilket kan forårsage vejrtrækningsbesvær
English: Treatment related adverse reactions, all grades, are listed below by MedDRA body system organ class, frequency and grade of severity.
Danish: Alle grader af behandlingsrelaterede bivirkninger er listet nedenfor i henhold til MedDRAkonventionens systemorganklasse, hyppighed og alvorlighedsgrad.
English: No differences in the pharmacokinetics of cefuroxime were observed between males and females following a single IV bolus injection of 1000 mg of cefuroxime as the sodium salt.
Danish: Der blev ikke observeret forskelle i cefuroxims farmakokinetik mellem mænd og kvinder efter en enkelt i.v.-bolusinjektion af 1.000 mg cefuroxim som natriumsalt.
English: Tell the person taking the sample that you have been given Zinacef.
Danish: Fortæl den person, der tager prøven, at du har fået Zinacef.
English: These may affect up to 1 in 100 people:
Danish: Ikke almindelige bivirkninger Disse kan forekomme hos op til 1 ud af 100 personer:
English: • aminoglycoside-type antibiotics
Danish: • aminoglykosid-antibiotika
English: Slight interference with copper reduction methods (Benedict's, Fehling's, Clinitest) may be observed.
Danish: Der kan forekomme en let påvirkning af kobberreduktionsmetoder (Benedicts, Fehlings, Clinitest).
English: Staphylococcus aureus (methicillin-suscpetible) $ Streptococcus pyogenes
Danish: Staphylococcus aureus (methicillin-følsomme) $ Streptococcus pyogenes
English: • Acute exacerbations of chronic bronchitis.
Danish: • Akutte eksacerbationer af kronisk bronkitis.
English: Dispose of the empty Monovial safely.
Danish: Bortskaf det tomme Monovial-hætteglas på sikker vis.
English: Tell your doctor before you start on Zinacef if you think that this applies to you.
Danish: Tal med lægen, før du får Zinacef, hvis du mener, at dette gælder for dig.
English: This results in the interruption of cell wall (peptidoglycan) biosynthesis, which leads to bacterial cell lysis and death.
Danish: Dette blokerer biosyntesen af cellevæggen (peptidoglykan), hvilket fører til bakteriolyse og celledød.
English: Concurrent administration of probenecid prolongs the excretion of the antibiotic and produces an elevated peak serum level.
Danish: Samtidig administration af probenecid forlænger udskillelsen af antibiotika og medfører et øget maksimalt serumniveau.
English: Austria - Curocef
Danish: Østrig - Curocef
English: Talk to your doctor if this applies to you.
Danish: Tal med lægen, hvis dette gælder for dig.
English: Prolonged use may also result in the overgrowth of other non-susceptible microorganisms (e.g. enterococci and Clostridium difficile), which may require interruption of treatment (see section 4.8).
Danish: Langvarig anvendelse kan desuden resultere i overvækst af andre ikke-følsomme mikroorganismer (f.eks. enterokokker og Clostridium difficile), som kan nødvendiggøre afbrydelse af behandlingen (se pkt.
English: This diagnosis should be considered in patients with diarrhoea during or subsequent to the administration of cefuroxime (see section 4.8).
Danish: Denne diagnose skal tages i betragtning hos patienter, der får diarré under eller efter administration af cefuroxim (se pkt.
English: • increases in substances (enzymes) produced by the liver
Danish: • stigning i koncentrationen af stoffer (enzymer), der bliver dannet i leveren
English: For cephalosporins, the most important pharmacokinetic-pharmacodynamic index correlating with in vivo efficacy has been shown to be the percentage of the dosing interval (%T) that the unbound concentration remains above the minimum inhibitory concentration (MIC) of cefuroxime for individual target species (i.e. %T>MIC).
Danish: For cefalosporiner er det vist, at det vigtigste farmakokinetiske-farmakodynamiske indeks, der korrelerer med effekten in vivo, er den procent af tiden i doseringsintervallet (%T), hvor den ubundne koncentration ligger over den mindste hæmmende koncentration (MIC) af cefuroxim for de individuelle target-arter (dvs. %T> MIC).
English: • red blood cells destroyed too quickly (haemolytic anaemia).
Danish: • røde blodlegemer, der ødelægges for hurtigt (hæmolytisk anæmi)
English: Insert the needle of the Monovial into the additive port of the infusion bag.
Danish: Stik kanylen i Monovial-hætteglasset i den additive port på infusionsposen.
English: The frequency categories assigned to the adverse reactions below are estimates, as for most reactions suitable data for calculating incidence are not available.
Danish: Hyppigheder anført nedenfor er estimater, idet de tilgængelige data for de fleste reaktioner ikke er tilstrækkelige til at kunne beregne hyppigheden.
English: T1/2 (hrs)
Danish: T1/2 (timer)
English: • Intra-abdominal infections (see section 4.4).
Danish: • Intraabdominale infektioner (se pkt.
English: Surgical prophylaxis for cardiovascular and oesophageal operations
Danish: Profylakse i forbindelse med kardiovaskulære og øsofageale operationer
English: Peel off the removable top part of the label and remove the cap.
Danish: Træk den aftagelige øverste del af etiketten af og fjern hætten.
English: Organisms that have acquired resistance to other injectable cephalosporins are expected to be resistant to cefuroxime.
Danish: Organismer, der har erhvervet resistens over for andre injicerbare cefalosporiner, forventes at være resistente over for cefuroxim.
English: Concurrent treatment with potent diuretics or aminoglycosides
Danish: Samtidig behandling med potente diuretika eller aminoglykosider
English: As a false negative result may occur in the ferricyanide test, it is recommended that either the glucose oxidase or hexokinase methods are used to determine blood/plasma glucose levels in patients receiving cefuroxime sodium.
Danish: Da der kan forekomme falsk negative resultater for ferricyanid test, anbefales det at anvende enten glucoseoxidase metoder eller hexokinase metoder til bestemmelse af blod/plasma-glucose hos patienter, der får cefuroximnatrium.
English: Cefuroxime is excreted by glomerular filtration and tubular secretion.
Danish: Cefuroxim udskilles ved glomerulær filtration og tubulær sekretion.
English: Breakpoints (mg/L)
Danish: Grænseværdier (mg/l)
English: Cefuroxime may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.
Danish: Cefuroxim påvirker tarmfloraen, hvilket kan medføre lavere reabsorption af østrogen og nedsat effekt af orale kontraceptiva (kombinationspræparater).
English: Overdose can lead to neurological sequelae including encephalopathy, convulsions and coma.
Danish: Overdosering kan medføre neurologiske sequelae, herunder encefalopati, kramper og koma.
English: * Reconstituted solution to be added to 50 or 100 ml of compatible infusion fluid (see information on compatibility, below)
Danish: * Rekonstitueret opløsning skal tilsættes til 50 eller 100 ml forligelig infusionsvæske (se oplysninger om forligelighed nedenfor).
English: Zinacef is indicated for the treatment of the infections listed below in adults and children, including neonates (from birth) (see sections 4.4 and 5.1).
Danish: Zinacef er indiceret til behandling af nedenstående infektioner hos voksne og børn, herunder nyfødte (fra fødslen) (se pkt.
English: General disorders and administration site conditions injection site reactions which may include pain and thrombophlebitis Description of selected adverse reactions Cephalosporins as a class tend to be absorbed onto the surface of red cell membranes and react with antibodies directed against the drug to produce a positive Coomb's test (which can interfere with cross matching of blood) and very rarely haemolytic anaemia.
Danish: Almene symptomer og reaktioner på administrationsstedet reaktioner ved injektionsstedet, som kan inkludere smerte og tromboflebitis Beskrivelse af udvalgte bivirkninger Cefalosporiner som klasse har tendens til at blive adsorberet til overfladen af røde blodcellemembraner og reagere med antistoffer rettet mod lægemidlet og derved udvikle en positiv Coombs' test (hvilket kan interferere med blodtype-matching) og meget sjældent hæmolytisk anæmi.
English: M/6 Sodium Lactate Injection
Danish: M/6 natriumlactat-injektionsvæske
English: Patients in renal failure on continuous arteriovenous haemodialysis (CAVH) or high-flux haemofiltration (HF) in intensive therapy units
Danish: Patienter med nyresvigt i kontinuerlig arterio-venøs hæmodialyse (CAVH) eller highflux-hæmofiltration (HF) på intensivafdelinger
English: Due to its spectrum of activity, cefuroxime is not suitable for the treatment of infections caused by Gramnegative non-fermenting bacteria (see section 5.1).
Danish: På grund af cefuroxims bakterielle spektrum og aktivitet er det ikke egnet til behandling af infektioner forårsaget af gramnegative, ikke-fermenterende bakterier (se pkt.
English: As necessary, expert advice should be sought when the local prevalence of resistance is known and the utility of the agent in at least some types of infections is questionable.
Danish: Ekspertrådgivning bør indhentes, når den lokale forekomst af resistens er kendt, og nytteværdien af cefuroxim til i det mindste nogle typer af infektioner er tvivlsom.
English: Dose mg
Danish: Dosis i mg
English: Paediatric population The safety profile for cefuroxime sodium in children is consistent with the profile in adults.
Danish: Sikkerhedsprofilen for cefuroximnatrium hos børn stemmer overens med sikkerhedsprofilen hos voksne.
English: There was no evidence of accumulation of cefuroxime in the serum from normal volunteers following repeat intravenous administration of 1500 mg doses every 8 hours.
Danish: Der var ingen tegn på akkummulering af cefuroxim hos raske forsøgspersoner efter gentagen intravenøs administration af 1.500 mg hver 8. time.
English: The serum half-life of cefuroxime has been shown to be substantially prolonged in neonates according to gestational age.
Danish: Halveringstiden af cefuroxim i serum er vist at være væsentligt forlænget hos nyfødte afhængigt af gestationsalder.
English: In the treatment and prevention of infections in which it is very likely that anaerobic organisms will be encountered, cefuroxime should be administered with additional appropriate antibacterial agents.
Danish: Ved behandling og forebyggelse af infektioner, hvor der er stor sandsynlighed for anaerobe mikroorganismer, bør cefuroxim administreres i kombination med andre relevante antibiotika.
English: Italy - Curoxim
Danish: Italien - Curoxim
English: Some strains that produce beta-lactamases are susceptible or intermediate to 3rd or 4th generation cephalosporins with these breakpoints and should be reported as found, i.e. the presence or absence of an ESBL does not in itself influence the categorization of susceptibility.
Danish: Nogle arter, som producerer betalaktamaser er følsomme eller delvist følsomme over for 3. og 4. generations cefalosporiner med disse grænseværdier og skal rapporteres som værende til stede, dvs. at tilstedeværelse eller fravær af ESBL ikke i sig selv påvirker kategoriseringen af følsomhed.
English: Because elderly patients are more likely to have decreased renal function, care should be taken in cefuroxime dose selection, and it may be useful to monitor renal function (see section 4.2).
Danish: Idet der er større sandsynlighed for, at ældre patienter har nedsat nyrefunktion, skal dosis vælges med omhu, og det kan være hensigtsmæssigt at monitorere nyrefunktionen (se pkt.
English: Pain at the intramuscular injection site is more likely at higher doses.
Danish: Smerte ved administrationsstedet efter intramuskulær injektion er hyppigere ved høje doser.
English: • the skin and soft tissue
Danish: • huden og bløddele
English: AUC and Cmax appear to increase linearly with increase in dose over the single dose range of 250 to 1000 mg following IM and IV administration.
Danish: AUC og Cmax synes at øges lineært med stigning i dosis over enkeltdosis-intervallet 250-1.000 mg efter i.m.- og i.v.-administration.
English: Infants (birth to 3 weeks)
Danish: Spædbørn (fra fødsel til 3 uger)
English: Heparin (10 and 50 units/ml) in 0.9% Sodium Chloride Injection; Potassium Chloride (10 and 40
Danish: Heparin (10 og 50 enheder/ml) i 0,9 % natriumchlorid-injektionsvæske; kaliumchlorid (10 og
English: You must look out for certain symptoms such as allergic reactions and gastrointestinal disorders such as diarrhoea while you are being given Zinacef.
Danish: Du skal holde øje med visse symptomer, såsom overfølsomhedsreaktioner og gener fra mavetarmkanalen som f.eks. diarré, mens du får Zinacef.
English: Concomitant use of probenicid is not recommended.
Danish: Samtidig administration af probenecid frarådes.
English: Adverse reactions at therapeutic doses are not expected, although a risk of diarrhoea and fungus infection of the mucous membranes cannot be excluded.
Danish: Der forventes ikke bivirkninger ved terapeutiske doser, men risiko for diarré og svampeinfektion i slimhinder kan ikke udelukkes.
English: Tell your doctor if you are taking any other medicines, if you've started taking any recently or you start taking new ones.
Danish: Fortæl altid lægen, hvis du bruger anden medicin eller har gjort det for nylig.
English: The development of a positive Coomb's Test associated with the use of cefuroxime may interfere with cross matching of blood (see section 4.8).
Danish: Udvikling af positiv Coombs' test i forbindelse med anvendelse af cefuroxim kan interferere med blodtypematching (se pkt.
English: only 3 Susceptibility of staphylococci to cephalosporins is inferred from the methicillin susceptibility except for ceftazidme and cefixime and ceftibuten, which do not have breakpoints and should not be used for staphylococcal infections.
Danish: 3 Følsomhed af stafylokokker over for cefalosporiner er baseret på følsomhed over for methicillin med undtagelse af ceftazidim, cefixim og ceftibuten, som ikke har grænseværdier, og som ikke bør anvendes til stafylokokinfektioner.
English: (intravenously) given as 2 or 3 divided doses (see section 5.2)
Danish: fordelt på 2 eller 3 doser (se pkt.