FrancophonIA/ELRC3.0 huggingface dataset:
English: 20 mL glass vial (Type 1) closed with a rubber (halobutyl) stopper and aluminium seal with flip-off cap.
Danish: 20-ml hætteglas (type 1) lukket med gummiprop (halobutyl) og aluminiumsforsegling med flip-offhætte.
English: The plasma protein binding of ceftaroline is low (approximately 20%) and ceftaroline is not distributed into erythrocytes.
Danish: Plasmaproteinbindingen for ceftarolin er lav (ca. 20 %), og ceftarolin trænger ikke ind i erytrocytter.
English: Agranulocytosis, eosinophilia
Danish: Agranulocytose, eosinofili
English: However, the possibility that haemolytic anaemia may occur in association with cephalosporins including Zinforo treatment cannot be ruled out.
Danish: Muligheden for, at der opstår hæmolytisk anæmi i forbindelse med cefalosporiner, herunder Zinforo behandlingen, kan imidlertid ikke udelukkes.
English: The active moiety after Zinforo administration is ceftaroline.
Danish: Den aktive substans efter administration af Zinforo er ceftarolin.
English: In vitro data indicate that the following species are not susceptible to ceftaroline:
Danish: In vitro-data tyder på, at de følgende arter ikke er følsomme over for ceftarolin:
English: Haemophilus influenzae Enterobacterales
Danish: Haemophilus influenzae Enterobakterier
English: A course of treatment usually lasts for 5 to 14 days for skin infections and 5 to 7 days for pneumonia.
Danish: Et behandlingsforløb varer som regel 5 til 14 dage ved hudinfektioner og 5 til 7 dage ved lungebetændelse.
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om dette lægemiddel findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Calculated using the Schwartz formula for paediatric patients (in mL/min/1.73 m
Danish: Beregnet under anvendelse af Schwartz-formlen for pædiatriske patienter (ml/min/1,73 m
English: Standard dose
Danish: Standarddosis
English: Posology (mg/infusion)
Danish: Dosering (mg/infusion)
English: Clinical efficacy has not been established against the following pathogens although in vitro studies suggest that they would be susceptible to ceftaroline in the absence of acquired mechanisms of resistance:
Danish: Klinisk effekt er ikke blevet fastslået over for følgende patogener, selvom in vitro-studier tyder på, at de ville være følsomme over for ceftarolin i fravær af erhvervede resistensmekanismer:
English: Neonates from birth to < 2 months
Danish: Nyfødte fra fødsel til < 2 måneder
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftaroline fosamil (see section 4.8).
Danish: Det er derfor vigtigt at tage hensyn til denne diagnose hos patienter, som får diarré under eller efter administration af ceftarolinfosamil (se pkt.
English: As ceftaroline does not appear to undergo significant hepatic metabolism, the systemic clearance of ceftaroline is not expected to be significantly affected by hepatic impairment.
Danish: Da ceftarolin tilsyneladende ikke undergår signifikant hepatisk metabolisering, forventes den systemiske clearance af ceftarolin ikke at blive væsentligt påvirket af nedsat leverfunktion.
English: Renal cortical cysts were oberved in all groups, including controls, on PND50.
Danish: Der blev observeret kortikale cyster i nyrerne i alle grupper, herunder kontroller, på postnatal dag 50.
English: 120/every 8 hours
Danish: 120/hver 8. time
English: Undesirable effects e.g. dizziness may occur and this may have an effect on the ability to drive and use of machines (see section 4.8).
Danish: Der kan forekomme bivirkninger som f.eks. svimmelhed, hvilket kan have indvirkning på evnen til at føre motorkøretøj og betjene maskiner (se pkt.
English: Ceftaroline fosamil (prodrug) is converted into the active ceftaroline in plasma by phosphatase enzymes and concentrations of the prodrug are measurable in plasma primarily during intravenous infusion.
Danish: Ceftarolinfosamil (pro-drug) omdannes til det aktive ceftarolin i plasma ved fosfatase-enzymer, og koncentrationer af pro-drug kan måles i plasma primært under intravenøs infusion.
English: Other important toxicologic findings noted in the rat and monkey included histopathologic changes in the bladder and spleen.
Danish: Blandt de øvrige vigtige toksikologiske fund hos rotter og aber var histopatologiske forandringer i blære og milt.
English: In such circumstance, the discontinuation of therapy with ceftaroline fosamil and the use of supportive measures together with the administration of specific treatment for Clostridium difficile should be considered.
Danish: I sådanne tilfælde bør seponering af behandling med ceftarolinfosamil, understøttende foranstaltninger og samtidig påbegyndelse med specifik behandling mod Clostridium difficile overvejes.
English: Renal clearance of ceftaroline is approximately equal, or slightly lower than the glomerular filtration rate in the kidney, and in vitro transporter studies indicate that active secretion does not contribute to the renal elimination of ceftaroline.
Danish: Den renale clearance af ceftarolin er omtrent lig med eller lidt lavere end den glomerulære filtration i nyrerne, og in vitro-studier af transportstoffer tyder på, at aktiv sekretion ikke bidrager til den renale elimination af ceftarolin.
English: MIC breakpoints (mg/L) Susceptible (≤ S)
Danish: Grænseværdier for MIC'er (mg/l) Følsom (≤ S)
English: The bactericidal action of ceftaroline is mediated through binding to essential penicillinbinding proteins (PBPs).
Danish: Ceftarolins baktericide virkning medieres ved binding til penicillin-bindende proteiner (PBPer).
English: Approximate ceftaroline concentration (mg/mL)
Danish: Omtrentlig koncentration af ceftarolin (mg/ml)
English: The kidney was the primary target organ of toxicity in both the monkey and rat.
Danish: Nyren var det primære målorgan for toksicitet hos både aber og rotter.
English: Therefore, no dosage adjustment is recommended for patients with hepatic impairment.
Danish: Der anbefales således ingen dosisjustering til patienter med nedsat leverfunktion.
English: Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterials may also be hypersensitive to ceftaroline fosamil.
Danish: Patienter, der tidligere har vist overfølsomhed over for cefalosporiner, penicilliner eller andre betalaktamantibiotika, kan også være overfølsomme over for ceftarolinfosamil.
English: Resistance may also be mediated by bacterial impermeability or drug efflux pump mechanisms.
Danish: Resistens kan også medieres af bakterieimpermeabilitet eller bakteriernes effluxpumpemekanismer over for lægemidler.
English: • If you have had previous severe allergic reactions to other antibiotics like penicillin or carbapenem.
Danish: • hvis du tidligere har oplevet en alvorlig allergisk reaktion over for andre antibiotika, såsom penicillin eller carbapenem.
English: The recommended dosage of Zinforo shown in Table 2 for paediatric patients < 2 months of age are based on pharmacokinetic-pharmacodynamic modelling and simulation.
Danish: Den anbefalede dosis af Zinforo, der er vist i tabel 2 for pædiatriske patienter < 2 måneder, er baseret på farmakokinetisk/farmakodynamisk modellering og simulering.
English: The effects of ceftaroline fosamil on fertility on humans have not been studied.
Danish: Virkningerne af ceftarolinfosamil på fertiliteten hos mennesker er ikke blevet undersøgt.
English: Dosage strength (mg)
Danish: Doseringsstyrke (mg)
English: The infusion solution concentration during preparation and administration should not exceed 12 mg/mL ceftaroline fosamil.
Danish: Koncentrationen af infusionsopløsningen under fremstilling og administration må ikke overskride 12 mg/ml ceftarolinfosamil.
English: Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication that were susceptible to ceftaroline in vitro.
Danish: Effekten er blevet påvist i kliniske studier mod de under hver indikation anførte patogener, som var følsomme over for ceftarolin in vitro.
English: The following adverse reactions have been identified during clinical trials and post-marketing experience with Zinforo.
Danish: De følgende bivirkninger er rapporteret under kliniske forsøg med Zinforo og efter markedsføringen.
English: In this situation, you should not take medicines that stop or slow bowel movement.
Danish: I denne situation bør du ikke tage medicin, der stopper tarmaktivitet helt eller delvist.
English: • Staphylococcus aureus (including methicillin-resistant strains)
Danish: • Staphylococcus aureus (inklusive methicillin-resistente stammer)
English: Direct antiglobulin test (Coombs test) seroconversion and potential risk of haemolytic anaemia The development of a positive direct antiglobulin test (DAGT) may occur during treatment with cephalosporins.
Danish: Serokonversion ved direkte antiglobulintest (Coombs test) og potentiel risiko for hæmolytisk anæmi Under behandling med cefalosporiner kan der forekomme en positiv direkte antiglobulintest (DAT).
English: • Complicated skin and soft tissue infections (cSSTI) • Community-acquired pneumonia (CAP)
Danish: • Komplicerede hud- og bløddelsinfektioner (cSSTI; complicated skin and soft tissue infections) • Samfundserhvervet pneumoni (CAP; community acquired pneumonia)
English: For treatment of S. aureus for which the ceftaroline MIC is ≤ 1 mg/L, the standard dose is recommended.
Danish: Til behandling af S. aureus, for hvilken ceftarolin MIC er ≤ 1 mg/l, anbefales standarddosen.
English: Zinforo is an antibiotic medicine that contains the active substance ceftaroline fosamil.
Danish: Zinforo er et antibiotisk lægemiddel, der indeholder det aktive stof ceftarolinfosamil.
English: The reconstituted solution must be further diluted to produce Zinforo solution for infusion.
Danish: Den rekonstituerede opløsning skal fortyndes yderligere for at fremstille Zinforo-opløsningen til infusion.
English: Creatinine clearance (mL/min)
Danish: Kreatininclearance (ml/min)
English: What Zinforo contains
Danish: Zinforo indeholder
English: Important: Please refer to the Summary of Product Characteristics before prescribing.
Danish: Vigtigt: Se produktresuméet, før lægemidlet ordineres.
English: S. aureus with ceftaroline MICs ≥ 4 mg/L are rare.
Danish: S. aureus med ceftarolin MIC'er ≥ 4 mg/l er sjælden.
English: Pyrexia, infusion site reactions (erythema, phlebitis, pain)
Danish: Feber, reaktioner på infusionsstedet (erytem, flebitis, smerte)
English: Indications
Danish: Indikation
English: Zinforo is indicated for the treatment of the following infections in neonates, infants, children, adolescents and adults(see sections 4.4 and 5.1):
Danish: Zinforo er indiceret til behandling af følgende infektioner hos nyfødte, spædbørn, børn, unge og voksne (se pkt.
English: Intravenous bolus dosing of ceftaroline fosamil to suckling rats from post-natal day 7 to 20 was well tolerated at plasma exposures approximately 2-fold higher than those for paediatric patients.
Danish: Intravenøs bolusdosering af ceftarolinfosamil til diende rotter fra postnatal dag 7 til 20 var veltolereret ved plasmaeksponeringer, der var ca. 2 gange højere end dem, der gives til pædiatriske patienter.
English: Infants ≥ 2 months to < 2 years
Danish: Spædbørn ≥ 2 måneder til < 2 år
English: • An increase in the number of certain white blood cells in your blood (eosinophilia).
Danish: • En stigning i antallet af visse typer hvide blodlegemer i dit blod (eosinofili).
English: Volume of diluent to be added (mL)
Danish: Mængde af fortyndingsmiddel, der skal tilsættes (ml)
English: Animal studies with ceftaroline fosamil do not indicate harmful effects with respect to fertility (see section 5.3).
Danish: Dyreforsøg med ceftarolinfosamil viser ingen skadelige virkninger med hensyn til fertilitet (se pkt.
English: Diarrhoea, nausea, vomiting, abdominal pain
Danish: Diarré, kvalme, opkastning, mavesmerter
English: As a result, minimum inhibitory concentrations (MICs) of ceftaroline against a proportion of these organisms tested fall into the susceptible range (see Resistance section below).
Danish: Som følge heraf ligger de mindste hæmmende koncentrationer af ceftarolin (MIC'er) på en del af disse testede mikroorganismer i det følsomme område (se punktet Resistens nedenfor).
English: Gram-negative micro-organisms • Fusobacterium spp.
Danish: Gramnegative mikroorganismer • Fusobacterium arter
English: Investigations Coombs Direct Test
Danish: Undersøgelser Coombs direkte test positiv (se pkt.
English: Seizures have occurred in toxicology studies at 7-25 times human ceftaroline Cmax levels (see section 5.3).
Danish: I toksikologistudier har der været tilfælde af krampeanfald ved 7-25 gange de humane Cmaxkoncentrationer af ceftarolin (se pkt.
English: Organisms
Danish: Mikroorganismer
English: Ceftaroline is not active against strains of Enterobacterales producing extended-spectrum betalactamases (ESBLs) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC), class B metallo-beta-lactamases or class C (AmpC) cephalosporinases.
Danish: Ceftarolin er ikke virksomt mod stammer af Enterobakterier, som producerer betalaktamaser med udvidet spektrum (ESBL) af familierne TEM, SHV eller CTX-M, serin-carbapenemaser (såsom KPC), metallo-betalaktamaser i klasse B eller klasse C (AmpC)-cefalosporinaser.
English: • An increase in the level of creatinine in your blood.
Danish: • En forøget koncentration i dit blod af kreatinin.
English: Following the administration of a single 600 mg intravenous dose of radiolabelled ceftaroline fosamil to healthy male adults, approximately 88% of radioactivity was recovered in urine and 6% in faeces.
Danish: Efter indgift af en enkelt intravenøs dosis af radioaktivt mærket ceftarolinfosamil på 600 mg til raske voksne mænd blev ca. 88 % af radioaktiviteten genfundet i urinen og 6 % i fæces.
English: • Changes in a blood test called a ‘Coombs test' commonly seen in patients receiving this type of antibiotic.
Danish: • Hos patienter, som får behandling med denne type antibiotikum, ses der ofte forandringer i en blodtest kaldet "Coombs test".
English: Following administration of a single 600 mg intravenous dose of ceftaroline fosamil, the pharmacokinetics of ceftaroline were similar between healthy elderly subjects (≥ 65 years of age), and healthy young adult subjects (18-45 years of age).
Danish: Efter indgift af en enkelt intravenøs dosis af ceftarolinfosamil på 600 mg var farmakokinetikken for ceftarolin ens for raske ældre forsøgspersoner (≥ 65 år) og raske unge forsøgspersoner (18-45 år).
English: Do not use this medicine after the expiry date which is stated on the container.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter Exp. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Non-susceptible organisms Superinfections may occur during or following treatment with Zinforo.
Danish: Ikke-følsomme mikroorganismer Der kan opstå superinfektioner under eller efter behandling med Zinforo.
English: The Cmax and AUC of ceftaroline increase approximately in proportion to dose within the single dose range of 50 to 1000 mg. No appreciable accumulation of ceftaroline is observed following multiple intravenous infusions of 600 mg every 8 or 12 hours in healthy adults with CrCL > 50 mL/min.
Danish: Cmax og AUC for ceftarolin stiger omtrent proportionalt med dosen inden for enkeltdosisområdet på 50 til 1000 mg. Der er ikke observeret nogen nævneværdig akkumulering af ceftarolin efter multiple intravenøse infusioner på 600 mg hver 8. eller 12. time hos raske voksne med CrCL > 50 ml/min.
English: Following administration throughout pregnancy and lactation in the rat, there was no effect on pup birth weight or growth, although minor changes in foetal weight and delayed ossification of the interparietal bone were observed when ceftaroline fosamil was administered during organogenesis (see section 5.3).
Danish: Efter administration under hele graviditeten og dieperioden hos rotter blev der ikke observeret nogen virkning på afkommets fødselsvægt eller vækst, selvom der blev observeret mindre ændringer i fødselsvægt og forsinket ossifikation af den interparietale knogle, når ceftarolinfosamil blev administreret under organogenesen (se pkt.
English: • Diarrhoea, stomach pain
Danish: • Diarré, mavesmerter
English: The reconstituted solution is a pale yellow solution that is free of any particles.
Danish: Den rekonstituerede opløsning er en svagt gullig opløsning uden partikler.
English: There is no experience with ceftaroline in the treatment of cSSTI in the following patient groups: the immunocompromised, patients with severe sepsis/septic shock, necrotizing fasciitis, perirectal abscess and patients with third degree and extensive burns.
Danish: Der er ingen erfaring med ceftarolin til behandling af cSSTI i de i følgende patientgrupper: patienter med nedsat immunforsvar, patienter med svær sepsis/septisk shock, nekrotiserende fasciitis, perianal absces og patienter med tredjegrads- og udbredte forbrændinger.
English: The available clinical data cannot substantiate efficacy against penicillin non-susceptible strains of S. pneumoniae.
Danish: De tilgængelige kliniske data dokumenterer ikke en virkning på stammer af S. pneumoniae, der ikke er følsomme over for penicillin.
English: Zinforo dose adjustment is not required in elderly patients with creatinine clearance above 50 mL/min.
Danish: Der er ikke behov for dosisjustering af Zinforo til ældre patienter med en kreatininclearance over 50 ml/min.
English: ESRD, including haemodialysis
Danish: ESRD, inklusive hæmodialyse
English: Zinforo powder should be reconstituted with 20 mL of sterile water for injections.
Danish: Zinforo pulver skal rekonstitueres med 20 ml sterilt vand til injektion.
English: Ceftaroline fosamil and ceftaroline were clastogenic in an in vitro chromosomal aberration assay, however there was no evidence of mutagenic activity in an Ames test, mouse lymphoma and unscheduled DNA synthesis assay.
Danish: Ceftarolinfosamil og ceftarolin var klastogene i en in vitro-analyse af kromosomafvigelser, men der var ingen tegn på mutagen aktivitet ved Ames-test, muselymfomtest og ikke-planmæssig DNAsyntesetest (unscheduled DNA synthesis assay).
English: The dose should be adjusted when creatinine clearance (CrCL) is ≤ 50 mL/min, as shown in Tables 3 and 4 (see section 5.2).
Danish: Dosis skal justeres, hvis kreatininclearance (CrCl) er ≤ 50 ml/min, som vist i tabel 3 og 4 (se pkt.
English: Hypersensitivity reactions Serious and occasionally fatal hypersensitivity reactions are possible (see sections 4.3 and 4.8).
Danish: Overfølsomhedsreaktioner Der kan opstå alvorlige og til tider fatale overfølsomhedsreaktioner (se pkt.
English: There is no experience with ceftaroline in the treatment of CAP in the following patient groups: the immunocompromised, patients with severe sepsis/septic shock, severe underlying lung disease, those with PORT Risk Class V, and/or CAP requiring ventilation at presentation, CAP due to methicillinresistant S. aureus or patients requiring intensive care.
Danish: Der er ingen erfaring med ceftarolin i behandlingen af CAP i de følgende patientgrupper: patienter med nedsat immunforsvar, patienter med svær sepsis/septisk shock, alvorlig underliggende lungesygdom, patienter med PORT Risikoklasse V og/eller CAP, der har behov for respiratorbehandling ved indlæggelsen, CAP på grund af methicillin-resistent Staphylococcus aureus eller patienter, der kræver intensiv pleje.
English: > 50 mL/min*
Danish: (CrCL) > 50 ml/min*
English: Zinforo should not be used to treat cSSTI due to S. aureus for which the ceftaroline MIC is > 4 mg/L.
Danish: Zinforo bør ikke anvendes til behandling af cSSTI, der skyldes S. aureus, for hvilket ceftarolin MIC er > 4 mg/l.
English: Juvenile toxicity
Danish: Toksicitet hos børn og unge
English: Genetic toxicology
Danish: Genetisk toksikologi
English: • If you are allergic to other cephalosporin antibiotics
Danish: • hvis du er allergisk over for andre cefalosporin-antibiotika.
English: The recommended durations of treatment are 5-14 days for cSSTI and 5-7 days for CAP.
Danish: Den anbefalede behandlingsvarighed er 5-14 dage for cSSTI og 5-7 dage for CAP.
English: Histopathologic findings included pigment deposition and inflammation of the tubular epithelium.
Danish: Histopatologiske fund omfattede pigmentaflejring og inflammation af tubulusepitel.
English: Dose adjustments are required for neonates, infants, children and adolescents with bodyweight < 33 kg (see section 4.2).
Danish: Det er nødvendigt med dosisjusteringer til nyfødte, spædbørn, børn og unge med en legemsvægt på < 33 kg (se pkt.
English: Ceftaroline administration to pregnant rabbits resulted in an increased foetal incidence of angulated hyoid alae, a common skeletal variation in rabbit fetuses, at exposures similar to those observed clinically.
Danish: Efter administration af ceftarolin til drægtige kaniner sås en øget incidens af angulated hyoid alae hos fostrene, hvilket er en almindelig skeletvariation hos kaninfostre ved niveauer svarende til den observerede kliniske eksponering.
English: Patients with pre-existing seizure disorder
Danish: Patienter med tidligere krampeanfald
English: 600 mg b/every 12 hours
Danish: 600 mg b/hver 12. time
English: Clostridium difficile colitis (see section 4.4)
Danish: Clostridium difficile-relateret colitis (se pkt.
English: Convulsions have been observed at relatively high exposures during single and multi-dose studies in both the rat and monkey (≥ 7 times to the estimated ceftaroline Cmax level of a 600 mg twice a day).
Danish: I enkelt- og flerdosisstudier er der i både rotter og aber observeret kramper ved relativt høje eksponeringer (≥ 7 gange det anslåede Cmax-niveau for ceftarolin for en 600 mg-dosis to gange daglig).
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere oplysninger om Zinforo på Det Europæiske Lægemiddelagenturs hjemmeside:http://www.ema.europa.eu/
English: Interaction with other antibacterial agents
Danish: Interaktion med andre antibakterielle stoffer
English: The median steady-state volume of distribution of ceftaroline in healthy adult males following a single 600 mg intravenous dose of radiolabelled ceftaroline fosamil was 20.3 l, similar to the volume of extracellular fluid.
Danish: Ceftarolins gennemsnitlige distributionsvolumen ved steady-state hos raske voksne mænd efter en enkelt intravenøs dosis af radioaktivt mærket ceftarolinfosamil på 600 mg var 20,3 l, svarende til mængden af ekstracellulærvæsken.
English: The resulting solution should be administered according to the dose selected over 5 to 60 minutes for standard dose or 120 minutes for high dose in infusion volumes of 50 mL, 100 mL or 250 mL.
Danish: Afhængigt af den valgte dosis skal den fremstillede opløsning indgives over 5 til 60 minutter (standarddosis) eller 120 minutter (høj dosis) ved et infusionsvolumen på 50 ml, 100 ml eller 250 ml.
English: Antibacterial-associated colitis and pseudomembranous colitis have been reported with ceftaroline fosamil and may range in severity from mild to life threatening.
Danish: Der er rapporteret om antibiotika-relateret colitis og pseudomembranøs colitis ved behandling med ceftarolinfosamil, og sværhedsgraden kan variere fra let til livstruende.
English: Hydrolysis of the beta-lactam ring of ceftaroline occurs to form the microbiologically inactive, open-ring metabolite, ceftaroline M-1.
Danish: Ceftarolins betalaktamring hydrolyseres og danner den mikrobiologisk inaktive metabolit med åben ring, ceftarolin M-1.
English: 10 mg/kg 120/every 8 hours
Danish: 10 mg/kg 120/hver 8. time
English: What you need to know before you use Zinforo
Danish: Det skal du vide, før du begynder at bruge Zinforo
English: Other medicines and Zinforo Tell your doctor or nurse if you are using, have recently used or might use any other medicines.
Danish: Fortæl det altid til lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.