FrancophonIA/ELRC3.0 huggingface dataset:
English: In the subgroup of patients who had received up to one line of treatment for metastatic/advanced disease, the hazard ratio was of 0.565 (95% CI: 0.428, 0.744), with a median PFS of 14.6 months (95% CI: 12.5, 18.5) and 9.1 months (95% CI: 6.1, 11.1) in the Kisqali and placebo arms, respectively.
Danish: I subgruppen med patienter, der havde fået op til én linje med behandling mod metastatisk/fremskreden sygdom, var hazard ratio 0,565 (95 % CI: 0,428; 0,744), med en median-PFS på 14,6 måneder (95 % CI: 12,5; 18,5) og 9,1 måneder (95 % CI: 6,1; 11,1) i henholdsvis Kisqali- og placebo-armen.
English: C] ribociclib, 91.7% of the total administered radioactive dose was recovered within 22 days; faeces was the major route of excretion (69.1%), with 22.6% of the dose recovered in urine.
Danish: Fæces var den primære udskillelsesvej (69,1 %) med 22,6 % af dosis genfundet i urin.
English: Abdominal pain: abdominal pain, abdominal pain upper.
Danish: Mavesmerter: mavesmerter, smerter i øvre del af abdomen.
English: If treatment with a strong CYP3A4 inhibitor cannot be avoided, the dose should be reduced to 400 mg once daily (see sections 4.2 and 4.5).
Danish: Hvis behandling med en potent CYP3A-hæmmer ikke kan undgås, bør dosis af Kisqali reduceres til 400 mg én gang daglig (se pkt.
English: Based on the severity of the neutropenia, treatment with Kisqali may have to be interrupted, reduced or discontinued as described in Table 2 (see sections 4.2 and 4.8).
Danish: Alt efter sværhedsgraden af neutropeni kan det være nødvendigt at afbryde, reducere eller seponere behandling med Kisqali, som beskrevet i tabel 2 (se pkt.
English: Dry mouth, oropharyngeal pain
Danish: Mundtørhed, orofaryngeale smerter
English: Kisqali was evaluated in a randomised, double-blind, placebo-controlled, multicentre phase III clinical study in the treatment of postmenopausal women with hormone receptor-positive, HER2-negative, advanced breast cancer who received no prior therapy for advanced disease in combination with letrozole versus letrozole alone.
Danish: Kisqali blev evalueret i et randomiseret, dobbeltblindet, placebokontrolleret, klinisk multicenterfase III-studie med behandling af postmenopausale kvinder med hormonreceptor-positiv, HER2negativ fremskreden brystkræft, der ikke tidligere havde fået behandling mod fremskreden sygdom, i kombination med letrozol versus letrozol alene.
English: Based on the severity of the transaminase elevations, treatment with Kisqali may have to be interrupted, reduced or discontinued as described in Table 3 (see sections 4.2 and 4.8).
Danish: Alt efter sværhedsgraden af forhøjede transaminaser, kan det være nødvendigt at afbryde, reducere eller seponere behandling med Kisqali som beskrevet i tabel 3 (se pkt.
English: Within this subgroup, the hazard ratio for the second line patients who had received prior endocrine therapy in the advanced breast cancer setting was 0.539 (95% CI: 0.333, 0.873), with a median PFS of 18.8 months (95% CI: 12.5, NE) and 11.4 months (95% CI: 3.7, 16.3) in the Kisqali and placebo arms, respectively.
Danish: I denne undergruppe var hazard ratio for anden linje patienter, som tidligere havde fået endokrin behandling for fremskreden brystkræft 0,539 (95 % CI: 0,333; 0,873) med en median PFS på 18,8 måneder (95 % CI: 12,5; NE) og 11,4 måneder (95 % CI: 3,7; 16,3) i henholdsvis Kisqali- og placebo-armen.
English: In the subgroup of patients who were treatment-naive in the metastatic/advanced disease setting, the hazard ratio was of 0.577 (95% CI: 0.415, 0.802), with a median PFS not reached in the Kisqali arm and 18.3 months (95% CI: 14.8, 23.1) in the placebo arm.
Danish: I subgruppen med patienter, der ikke tidligere havde fået behandling mod metastatisk/fremskreden sygdom, var hazard ratio 0,577 (95 % CI: 0,415; 0,802), med en median-PFS ikke nået i Kisqaliarmen og på 18,3 måneder (95 % CI: 14,8; 23,1) i placebo-armen.
English: Placebo + letrozole (%, 95% CI)
Danish: Placebo + letrozol (%, 95 % CI)
English: Dose interruption of Kisqali until recovery to ≤ baseline grade, then resume at next lower dose level.
Danish: Afbryd doseringen af Kisqali indtil bedring til ≤ graden ved baseline.
English: The primary efficacy results demonstrated a statistically significant improvement in PFS in patients receiving Kisqali plus fulvestrant compared to patients receiving placebo plus fulvestrant in the full analysis set (hazard ratio of 0.593, 95% CI: 0.480, 0.732, one-sided stratified log-rank test p-value 4.1x10
Danish: De primære effektresultater viste en statistisk signifikant forbedring i PFS hos patienter, der fik Kisqali plus fulvestrant, sammenlignet med patienter, der fik placebo plus fulvestrant, i det fulde analysesæt (hazard ratio på 0,593; 95 % CI: 0,480; 0,732; p-værdi ved ensidet stratificeret log ranktest på 4,1 x 10
English: Kisqali + letrozole (%, 95% CI)
Danish: Kisqali + letrozol (%, 95 % CI)
English: Complete blood counts (CBC) should be performed before initiating treatment with Kisqali.
Danish: Der skal foretages komplet blodtælling (CBC), før behandling indledes.
English: Drug-drug interaction between ribociclib and letrozole
Danish: Lægemiddelinteraktion mellem ribociclib og letrozol
English: Discontinue Kisqali.
Danish: Seponér Kisqali.
English: Kaplan-Meier median Ribociclib: NE Placebo: 40.7 months
Danish: Kaplan-Meier median Ribociclib: NE Placebo: 40,7 måneder
English: Kaplan-Meier median Ribociclib: 23.8 months Placebo: 13.0 months
Danish: Kaplan-Meier-median Ribociclib: 23,8 måneder Placebo: 13,0 måneder
English: Kisqali was evaluated in a randomised double-blind, placebo-controlled, multicentre phase III clinical study in the treatment of men and postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer who had received no or only one line of prior endocrine treatment, in combination with fulvestrant versus fulvestrant alone.
Danish: Kisqali blev evalueret i et randomiseret, dobbeltblindet, placebokontrolleret, klinisk multicenterfase III-studie med behandling af mænd og postmenopausale kvinder med hormonreceptor-positiv, HER2-negativ fremskreden brystkræft, der ikke tidligere havde fået eller kun havde fået én tidligere linje med endokrin behandling, i kombination med fulvestrant versus fulvestrant alene.
English: Very common (may affect more than 1 in 10 people).
Danish: Meget almindelige (kan forekomme hos flere end 1 ud af 10 personer).
English: Kaplan-Meier median Ribociclib: NE Placebo: 40.9 months
Danish: Kaplan-Meier median Ribociclib: NE Placebo: 40,9 måneder
English: Kaplan-Meier median Ribociclib: 20.5 months Placebo: 12.8 months
Danish: Kaplan-Meier-median Ribociclib: 20,5 måneder Placebo: 12,8 måneder
English: • Medicines used for the treatment of gastrointestinal disorders such as cisapride.
Danish: • Lægemidler til behandling af sygdomme i mave-tarmkanalen, fx cisaprid.
English: If toxicity recurs at grade 3: dose interruption until recovery to grade ≤2, then resume Kisqali and reduce by 1 dose level.
Danish: Hvis toksiciteten vender tilbage og er af grad 3, skal doseringen afbrydes indtil bedring til grad ≤2.
English: • Weakness (asthenia)
Danish: • Svaghed (asteni)
English: • Loss of skin colour in patches (vitiligo)
Danish: • Hvide striber og pletter i huden (vitiligo)
English: Your heart activity will also be monitored before and during treatment with Kisqali with a test called an electrocardiogram (ECG).
Danish: Hjerteaktiviteten vil også blive målt før og under behandling med Kisqali.
English: Drug-drug interaction between ribociclib and anastrozole
Danish: Lægemiddelinteraktion mellem ribociclib og anastrozol
English: • Medicines used to treat angina such as bepridil.
Danish: • Lægemidler til behandling af angina pectoris (hjertekrampe), fx bepridil.
English: If necessary, your doctor may reduce your dose of Kisqali or temporarily stop it to allow your liver, blood cells, electrolyte levels or heart activity to recover.
Danish: Det gøres for at få en bedring af din lever, niveauet af blodlegemer, niveauet af elektrolytter eller hjerteaktiviteten.
English: Kaplan-Meier median Ribociclib: 27.5 months Placebo: 13.8 months
Danish: Kaplan-Meier-median Ribociclib: 27,5 måneder Placebo: 13,8 måneder
English: Uncommon (may affect up to 1 in 100 people).
Danish: Ikke almindelige (kan forekomme hos op til 1 ud af 100 personer).
English: Effect of ribociclib on cytochrome P450 enzymes
Danish: Effekt af ribociclib på CYP-enzymer
English: Liver function tests (LFTs) should be performed before initiating treatment with Kisqali.
Danish: Der skal foretages leverfunktionsundersøgelser (LFT), før behandling med Kisqali indledes.
English: Censoring times Ribociclib (N=334) Placebo (N=334)
Danish: Censoreringstidspunkter Ribociclib (N=334) Placebo (N=334)
English: How long to take Kisqali
Danish: Så længe skal du tage Kisqali
English: • Some medicines used for sedation or anaesthesia such as midazolam.
Danish: • Nogle lægemidler, der anvendes til at berolige eller bedøve med, fx midazolam.
English: If you have any questions about how Kisqali works or why this medicine has been prescribed for you, ask your doctor, pharmacist or nurse.
Danish: Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis du har spørgsmål til, hvordan Kisqali virker, eller hvorfor dette lægemiddel er blevet ordineret til dig.
English: ECG should be assessed before initiating treatment with Kisqali.
Danish: Der skal foretages EKG-vurdering før behandling med Kisqali indledes.
English: 189 (3 x 63) film-coated tablets (in PCTFE/PVC blisters)
Danish: 189 (3 x 63) filmovertrukne tabletter (i PCTFE/PVCblistere)
English: Baseline grade = 2: No dose interruption.
Danish: Sværhedsgrad ved baseline = 2:
English: Censoring times Ribociclib (N=248) Placebo (N=247)
Danish: Censoreringstidspunkter Ribociclib (N=248) Placebo (N=247)
English: Censoring times Ribociclib (N=335) Placebo (N=337)
Danish: Censoreringstidspunkter Ribociclib (N=335) Placebo (N=337)
English: 189 (3 x 63) film-coated tablets (in PA/alu/PVC blisters)
Danish: 189 (3 x 63) filmovertrukne tabletter (i PA/alu/PVC-blistere)
English: Thus, ribociclib may interact with medicinal products which are metabolised via CYP3A4, which may lead to increased serum concentrations of CYP3A4 substrates (see section 4.5).
Danish: Dette kan medføre forhøjede serumkoncentrationer af CYP3A4-substrater (se pkt.
English: Common (may affect up to 1 in 10 people).
Danish: Almindelige (kan forekomme hos op til 1 ud af 10 personer).
English: 42 film-coated tablets (in PCTFE/PVC blisters)
Danish: 42 filmovertrukne tabletter (i PCTFE/PVC-blistere)
English: 126 (3 x 42) film-coated tablets (in PA/alu/PVC blisters)
Danish: 126 (3 x 42) filmovertrukne tabletter (i PA/alu/PVC-blistere)
English: What Kisqali is and what it is used for What you need to know before you take Kisqali How to take Kisqali
Danish: Det skal du vide, før du begynder at tage Kisqali Sådan skal du tage Kisqali Bivirkninger
English: 63 film-coated tablets (in PA/alu/PVC blisters)
Danish: 63 filmovertrukne tabletter (i PA/alu/PVC-blistere)
English: 63 film-coated tablets (in PCTFE/PVC blisters)
Danish: 63 filmovertrukne tabletter (i PCTFE/PVC-blistere)
English: 21 film-coated tablets (in PCTFE/PVC blisters)
Danish: 21 filmovertrukne tabletter (i PCTFE/PVC-blistere)
English: Liver function tests should be performed before initiating treatment with Kisqali.
Danish: Der skal foretages leverfunktionsundersøgelser, før behandling med Kisqali indledes.
English: 63 (3 x 21) film-coated tablets (in PCTFE/PVC blisters)
Danish: 63 (3 x 21) filmovertrukne tabletter (i PCTFE/PVC-blistere)
English: 42 film-coated tablets (in PA/alu/PVC blisters)
Danish: 42 filmovertrukne tabletter (i PA/alu/PVC-blistere)
English: 21 film-coated tablets (in PA/alu/PVC blisters)
Danish: 21 filmovertrukne tabletter (i PA/alu/PVC-blistere)
English: 126 (3 x 42) film-coated tablets (in PCTFE/PVC blisters)
Danish: 126 (3 x 42) filmovertrukne tabletter (i PCTFE/PVCblistere)
English: 63 (3 x 21) film-coated tablets (in PA/alu/PVC blisters)
Danish: 63 (3 x 21) filmovertrukne tabletter (i PA/alu/PVC-blistere)
English: • Some medicines used to treat heart rhythm problems or high blood pressure such as amiodarone, disopyramide, procainamide, quinidine, sotalol and verapamil.
Danish: disopyramid, procainamid, quinidin, sotalol og verapamil.
English: Kisqali is also not recommended to be used in combination with tamoxifen (see sections 4.1, 4.4 and 5.1).
Danish: Det anbefales desuden ikke at anvende Kisqali i kombination med tamoxifen (se pkt.
English: Hepatobiliary disorders Hepatotoxicity
Danish: Lever og galdeveje Hepatotoksicitet
English: Hepatic impairment
Danish: Hjerte Synkope
English: Censoring Times Ribociclib (N=248) Placebo (N=247)
Danish: Censoreringstidspunkter Ribociclib (N=248) Placebo (N=245)
English: How to take Kisqali
Danish: Sådan skal du tage Kisqali
English: If QTcF ≥481 msec recurs, interrupt dose until QTcF resolves to
Danish: Hvis QTcF ≥481 ms vender tilbage, afbrydes doseringen, indtil QTcF bedres til <481 ms, og herefter genoptages behandlingen med Kisqali ved næste lavere dosis.
English: (listed in section 6).
Danish: Kisqali (angivet i punkt 6).
English: At the time of the primary PFS analysis overall survival data were not mature with 89 (13%) of deaths (HR 0.
Danish: Data vedrørende den samlede overlevelse var ikke modne på tidspunktet for den primære PFS-analyse med 89 (13 %) dødsfald (HR 0,916 [95 % CI: 0,601; 1,396]).
English: 2/ End of 2016
Danish: 2/ Udgangen af 2016
English: Within 1 week from CMDh adopted position
Danish: Senest 1 uge efter vedtagelse af CMDh's standpunkt
English: The primary composite endpoint is 90-day mortality and 90-days renal failure.
Danish: Det primære sammensatte endepunkt er 90-dages dødelighed og 90-dages nyresvigt.
English: Within 24 months after protocol agreement
Danish: Senest 24 måneder efter vedtagelse af protokollen
English: The MAH(s) should conduct a drug utilisation study in several Member States to evaluate the effectiveness of the risk minimisation measures taken.
Danish: Indehaverne af markedsføringstilladelse udfører en undersøgelse af lægemiddelanvendelse i en række medlemsstater til vurdering af effektiviteten af de gennemførte risikominimeringstiltag.
English: DHPC Communication circulation according to the PRAC agreed communication plan and conditions.
Danish: Udsendelse af direkte henvendelse til sundhedspersoner i henhold til den kommunikationsplan og de betingelser, der er godkendt af PRAC.
English: The MAH(s) should perform two phase IV randomised clinical trials (RCTs) with an appropriate control and clinically meaningful endpoints to demonstrate the efficacy and safety in the perioperative setting and trauma.
Danish: Indehaverne af markedsføringstilladelse udfører to randomiserede kliniske fase IV-undersøgelser med passende kontrol og klinisk meningsfulde endepunkter til påvisning af virkningen og sikkerheden hos perioperative patienter og traumepatienter.
English: Final study report by:
Danish: Endelig undersøgelsesrapport senest:
English: The secondary endpoints are: - major peri-operative complications (e.g. infections, bleedings, anastomosis insufficiency, reoperation rate, diagnosis of pulmonary oedema).
Danish: - større perioperative komplikationer (f.eks. infektioner, blødninger, anastomoseinsufficiens, reoperationsrate, diagnosen lungeødem),
English: - Haemodynamic stabilisation in relation to dose (e.g. Heart rate, mean arterial pressure, central venous pressure, central venous oxygen saturation, serum lactate level, base excess and urine output) - length of stay, morbidity, coagulation, inflammation, hospital mortality - measurement of creatinine (GFR) 1/ The protocol of the studies should be submitted to the NCAs 2/ Final study reports by:
Danish: - hæmodynamisk stabilisering i forhold til dosis (f.eks. hjertefrekvens, arterielt middelblodtryk, centralt venetryk, central venøs oxygenmætning, serumlaktat, baseoverskud og urinmængde),
English: The MAH(s) should submit the core elements (including protocol of DUS, protocol of the RCTs) of a risk management plan in EU format.
Danish: Indehaverne af markedsføringstilladelse forelægger kerneelementerne i en risikostyringsplan i EU-format (herunder protokol for undersøgelse af lægemiddelanvendelse, protokol for de randomiserede kliniske undersøgelser).
English: Study protocol by:
Danish: Forsøgsprotokol senest:
English: Zinnat was first approved in Europe in the late 1980's and is available as oral formulations.
Danish: Zinnat blev første gang godkendt i EU i slutningen af 1980'erne og dispenseres som orale formuleringer.
English: Lyme disease
Danish: Lymes sygdom
English: Overall summary of the scientific evaluation of Zinnat and associated names (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Zinnat og relaterede navne (se bilag I)
English: A referral under Article 30(2) of Directive 2001/83/EC was therefore triggered to resolve these divergences and thus harmonise the Product Information (PI) across the EU.
Danish: Der blev derfor indledt en henvisning i henhold til artikel 30, stk. 2, i direktiv 2001/83/EF med henblik på at fjerne disse divergenser og harmonisere produktoplysningerne i EU.
English: In conclusion, the CHMP adopted harmonised posology recommendations for adults and children.
Danish: Som konklusion vedtog CHMP harmoniserede doseringsanbefalinger for voksne og børn.
English: In conclusion, the CHMP adopted a harmonised wording for Section 4.2.
Danish: Som konklusion vedtog CHMP en harmoniseret ordlyd til afsnit 4.2.
English: Treatment of early Lyme disease.
Danish: • Behandling af Lymes sygdom i tidligt stadium.
English: The CHMP reviewed the data from five randomised controlled studies, two of which included patients aged >12 years (Nadelman 1995; Lugar 1995), one which included patients aged >15 years (Cerar 2010), one study including children aged < 15 years (Arnez 1995) and one study including children aged between 6 months - 12 years.
Danish: CHMP gennemgik data fra fem randomiserede, kontrollerede undersøgelser, hvoraf to omfatter patienter >12 år (Nadelman 1995; Lugar 1995), én omfatter patienter >15 år (Cerar 2010), én omfatter patienter < 15 år (Arnez 1995) og én omfatter patienter fra seks måneder til 12 år.
English: The CHMP also agreed on a cut-off age, stating that there is no experience of using Zinnat in children under the age of 3 months.
Danish: CHMP fastlagde desuden en alderstærskel og en tilføjelse om, at der ikke er erfaring med anvendelse af Zinnat til børn under tre måneder.
English: Pyelonephritis.
Danish: • Pyelonefritis.
English: The CHMP removed the option of parenteral-to-oral sequential therapy for all patients,, due to the significant reduction in exposure to the active drug when switching to the oral formulation.
Danish: CHMP slettede muligheden for parenteral-til-oral sekvensterapi for alle patienter på grund af den betydeligt ringere eksponering for aktivt stof efter overgang til den orale formulering.
English: For Lyme disease, the CHMP considered that the existing clinical data supported treatment for 14 days, with a range of 10 to 21 days (European Union Concerted Action on Lyme Borreliosis, 2010), in adults and in paediatric patients.
Danish: Vedrørende Lymes sygdom fandt CHMP, at der er klinisk dokumentation for en behandlingslængde på 14 dage, område 10-21 dage (European Union Concerted Action on Lyme Borreliosis, 2010) for voksne og pædiatriske patienter.
English: Based on the available data, including one double blind study and several supporting studies, the CHMP concluded that there is sufficient data in support of the indication “uncomplicated skin and soft tissue infections”.
Danish: På grundlag af de foreliggende data bestående af en dobbeltblindundersøgelse og flere støttende undersøgelser konkluderede CHMP, at der er tilstrækkelig dokumentation for indikationen “ukomplicerede infektioner i hud og underliggende væv”.
English: The CHMP also noted that the 2009 European Guideline on the Diagnosis and Treatment of Gonorrhoea in Adults does not include cefuroxime on the list of antibiotics recommended in this indication, due to its suboptimal pharmacokinetic and pharmacodynamic (PK/PD) characteristics which may lead to worse effectiveness and to the selection of the resistant bacteria strains (Aison et al, 2004).
Danish: CHMP bemærkede desuden, at European Guideline on the Diagnosis and Treatment of Gonorrhoea in Adults fra 2009 ikke medtager cefuroxim på listen over anbefalede antibiotika til denne indikation på grund af dets suboptimale farmakokinetiske og farmakodynamiske egenskaber, som kan medføre forringet effektivitet og selektion af resistente stammer (Aison et al, 2004).
English: The CHMP noted that no studies were provided to support the indication “urethritis” and therefore recommends the removal of this indication.
Danish: CHMP bemærkede, at der ikke er forelagt undersøgelser til støtte for indikationen “urethritis”, og anbefalede derfor, at denne indikation udgår.
English: The CHMP noted that acute bacterial sinusitis is difficult to differentiate from the much more common viral sinusitis and that antibacterial treatment is often not warranted.
Danish: CHMP bemærkede, at akut bakteriel sinuitis er vanskelig at skelne fra den langt mere almindelige virale sinuitis og ofte ikke kræver antibiotisk behandling.
English: The section on paediatric patients was revised extensively, including a revision of the table of dosing recommendations for children below 40 kg to describe dosage and duration per indication as well as the dosing calculations depending on the patient's body mass.
Danish: Afsnittet om pædiatriske patienter blev gennemrevideret, herunder tabellen med dosisanbefalinger for børn under 40 kg, med beskrivelse af dosering og varighed for hver indikation og doseringsberegning efter patientvægt.
English: Having reviewed the minimum inhibitory concentrations (MIC) distributions for common respiratory pathogens such as penicillin-intermediate S. pneumoniae, H. influenzae and M.catarrhalis (Bulitta et al, 2009), the CHMP considered that the changes in MIC distributions over the last decades have impacted the suitability of cefuroxime axetil in this indication.
Danish: Efter gennemgang af fordelingen af mindste hæmmende koncentrationer (MIC) for almindelige luftvejspatogener såsom intermediære penicillinresistente S. pneumoniae, H. influenzae og M.catarrhalis (Bulitta et al., 2009) konstaterede CHMP, at ændringerne i MIC-fordelingen gennem de seneste tiår har medført ændret følsomhed for cefuroximaxetil ved denne indikation.
English: the CHMP has recommended the variation to the terms of the marketing authorisations for which the summary of product characteristics, labelling and package leaflet are set out in Annex III for Zinnat and associated names (see Annex I).
Danish: der er foreslået af indehaveren af markedsføringstilladelsenanbefalede CHMP ændring af betingelserne for de markedsføringstilladelser, for hvilke produktresumé, etikettering og indlægsseddel fremgår af bilag III for Zinnat og relaterede navne (se bilag I).
English: Having reviewed the available data, the CHMP agreed that cefuroxime can be a valuable treatment option in the indications “pyelonephritis” and “cystitis”, including in children and pregnant women and therefore considered these indications acceptable.
Danish: Efter gennemgang af de foreliggende data fandt CHMP, at cefuroxim kan være en værdifuld behandlingsmulighed ved indikationerne “pyelonefritis” og “cystitis”, herunder for børn og gravide kvinder, og godkendte derfor disse indikationer.
English: The CHMP considered that no suitable dosing regimen could be identified to provide adequate coverage for less susceptible pathogens which have MIC up to 1 mg/L.
Danish: CHMP fastslog, at der ikke kan udpeges et passende dosisregime, der tilstrækkeligt dækker mindre følsomme patogener med MIC op til 1 mg/l.
English: Cefuroxime exerts a bactericidal action by inhibiting bacterial enzymes necessary for cell-wall synthesis (peptidoglycan synthesis), thereby causing cell death.
Danish: Cefuroxim virker baktericidt ved at hæmme de enzymer, der er nødvendige til syntese af bakteriernes cellevæg (peptidoglycan-syntese), og medfører derved celledød.