FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Zavicefta in one or more subsets of the paediatric population in the treatment of intra-abdominal infections, urinary tract infections, pneumonia and Gram-negative bacterial infections (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med Zavicefta i en eller flere undergrupper af den pædiatriske population ved behandling af intra-abdominale infektioner, urinvejsinfektioner, pneumoni og infektioner forårsaget af Gram-negative bakterier (se pkt.
English: Direct antiglobulin test (DAGT or Coombs test) seroconversion and potential risk of haemolytic anaemia
Danish: Direkte antiglobulintest (DAT eller Coombs test) serokonversion og potentiel risiko for hæmolytisk anæmi
English: Zavicefta is an antibiotic medicine that contains two active substances ceftazidime and avibactam.
Danish: Zavicefta er et antibiotikum, der indeholder de to aktive stoffer ceftazidim og avibactam.
English: In two studies in patients with cUTI, 381/1091 (34.9%) patients were enrolled with cUTI without pyelonephritis while 710 (65.1%) were enrolled with acute pyelonephritis (mMITT population).
Danish: I to studier med patienter med cUTI deltog 381/1091 (34,9 %) patienter med cUTI uden pyelonefritis, mens 710 (65,1 %) havde akut pyelonefritis (mMITT-population).
English: Dry powder
Danish: Tørt pulver
English: As ceftazidime and avibactam do not appear to undergo significant hepatic metabolism, the systemic clearance of either active substance is not expected to be significantly altered by hepatic impairment.
Danish: Da ceftazidim og avibactam ikke synes at undergå signifikant hepatisk metabolisme, forventes nedsat leverfunktion ikke at ændre den systemiske clearance af nogen af stofferne i betydelig grad.
English: Gammaglutamyltransferase increased
Danish: Forhøjet gammaglutamyltransferase
English: No synergy or antagonism was demonstrated in in vitro drug combination studies with ceftazidime/avibactam and metronidazole, tobramycin, levofloxacin, vancomycin, linezolid, colistin and tigecycline.
Danish: Der blev ikke påvist synergisme eller antagonisme i kombinationsstudier in vitro med ceftazidim/avibactam og metronidazol, tobramycin, levofloxacin, vancomycin, linezolid, colistin og tigecyclin.
English: However, if you have side effects or think you have been given too much Zavicefta, tell your doctor or nurse straight away.
Danish: Hvis du har bivirkninger eller tror, at du har fået for meget Zavicefta, skal du dog straks fortælle det til lægen eller sundhedspersonalet.
English: Controlled sodium diet
Danish: Diæt med kontrolleret natriumindhold
English: • infections of the stomach and gut (abdomen)
Danish: • infektioner i mave og tarm (abdomen)
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER ANSVARLIG FOR BATCHFRIGIVELSE
English: Insert a gas relief needle through the vial closure to relieve the internal pressure.
Danish: Indsæt en gasudligningskanyle gennem hætteglassets prop for at lette det indre tryk.
English: Other side effects Tell your doctor or nurse if you notice any of the following side effects:
Danish: Andre bivirkninger Fortæl det til lægen eller sundhedspersonalet, hvis du får nogen af følgende bivirkninger:
English: Patients experiencing anaemia during or after treatment with Zavicefta should be investigated for this possibility.
Danish: Patienter, der får anæmi under eller efter behandling med Zavicefta, skal derfor undersøges for dette.
English: It is available in packs containing 10 vials.
Danish: Det fås i pakninger indeholdende 10 hætteglas.
English: Avibactam is a non β-lactam, βlactamase inhibitor that acts by forming a covalent adduct with the enzyme that is stable to hydrolysis.
Danish: Avibactam er en non-β-laktam-βlaktamasehæmmer, der virker ved at danne et covalent addukt med enzymet, som er stabilt over for hydrolyse.
English: Aseptic technique must be followed in preparing the infusion solution.
Danish: Aseptisk teknik skal følges ved fremstilling af infusionsvæsken.
English: Toxic epidermal necrolysis
Danish: Toksisk epidermal nekrolyse
English: Prolonged use may result in the overgrowth of non-susceptible organisms (e.g. enterococci, fungi), which may require interruption of treatment or other appropriate measures.
Danish: Langvarig brug kan resultere i overvækst af ikke-følsomme mikroorganismer (fx enterococci, svampe), der kan gøre det nødvendigt at afbryde behandlingen eller tage andre passende foranstaltninger.
English: >8 mg/L
Danish: >8 mg/l >8 mg/l
English: Tubulointerstitial nephritis
Danish: Tubulointerstitiel nefritis
English: Gram-negative micro-organisms
Danish: Gram-negative mikroorganismer
English: Clostridium difficile-associated diarrhoea has been reported with ceftazidime/avibactam, and can range in severity from mild to life-threatening.
Danish: Clostridium difficile-associeret diarré er indberettet for ceftazidim/avibactam og kan variere i sværhedsgrad fra let til livstruende.
English: Before beginning treatment, it should be established whether the patient has a history of hypersensitivity reactions to ceftazidime, to other cephalosporins or to any other type of β-lactam antibacterial agent.
Danish: Inden behandlingen påbegyndes, skal det fastslås, hvorvidt patienten tidligere har haft overfølsomhedsreaktioner over for ceftazidim, over for andre cefalosporiner eller over for andre β-lactam-antibiotika.
English: Carcinogenicity studies have not been conducted with avibactam.
Danish: Der er ikke udført karcinogenicitetsstudier med avibactam.
English: No data are available on animal studies with ceftazidime.
Danish: Der foreligger ingen data fra dyrestudier med ceftazidim.
English: ≤8 mg/L
Danish: ≤8 mg/l ≤8 mg/l
English: For avibactam the PK-PD index is the percent time of the free drug concentration above a threshold concentration over the dose interval (% fT >CT).
Danish: For avibactam er PK-PD-indekset den procent af tiden i dosisintervallet, hvor den frie lægemiddelkoncentration er over en tærskelkoncentration (% fT >CT).
English: Standard aseptic techniques should be used for solution preparation and administration.
Danish: Aseptiske standardteknikker skal anvendes til fremstilling og administration af infusionsvæsken.
English: Serum levels of ceftazidime can be reduced by haemodialysis or peritoneal dialysis.
Danish: Serumniveauet af ceftazidim kan reduceres ved hæmodialyse eller peritonealdialyse.
English: ceftazidime 2 g/avibactam 0.5 g
Danish: ceftazidim 2 g/avibactam 0,5 g
English: Hospital-acquired pneumonia, including VAP
Danish: Nosokomiel pneumoni, herunder VAP
English: Dysgeusia
Danish: Dysgeusi
English: Infections due to aerobic Gram-negative organisms in patients with limited treatment options
Danish: Infektioner forårsaget af aerobe Gramnegative mikroorganismer hos patienter med begrænsede behandlingsmuligheder
English: Gender and race The pharmacokinetics of ceftazidime/avibactam is not significantly affected by gender or race.
Danish: Køn og race Ceftazidim/avibactams farmakokinetik påvirkes ikke signifikant af køn eller race.
English: Currently available data are described in section 4.8 but no recommendation on a posology can be made.
Danish: 4.8, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: Reduced doses may be achieved by transfer of an appropriate volume of the resultant solution to an infusion bag, based upon ceftazidime and avibactam content of 167.3 mg/mL and 41.8 mg/mL, respectively.
Danish: Reducerede doser kan opnås ved at overføre et passende volumen af den resulterende opløsning til en infusionspose baseret på ceftazidim- og avibactamindhold på henholdsvis 167,3 mg/ml og 41,8 mg/ml.
English: If this happens do not take medicines that stop or slow bowel movement.
Danish: Hvis dette sker, må du ikke tage medicin, der virker stoppende på tarmbevægelser.
English: • Ceftazidime belongs to the group of antibiotics called “cephalosporins”.
Danish: • Ceftazidim tilhører en gruppe antibiotika, som kaldes cefalosporiner.
English: Among a subgroup with baseline CrCL 30 to 50 mL/min death occurred in 16.7% (9/54) of patients who received Zavicefta and metronidazole and 6.8% (4/59) of patients who received meropenem.
Danish: I en undergruppe med baseline-CrCL 30-50 ml/min døde 16,7 % (9/54) af de patienter, som fik Zavicefta og metronidazol, og 6,8 % (4/59) af de patienter, som fik meropenem.
English: • Complicated urinary tract infection (cUTI), including pyelonephritis
Danish: • Kompliceret urinvejsinfektion (cUTI), herunder pyelonefritis
English: The pharmacokinetics of both ceftazidime and avibactam are approximately linear across the dose range studied (50 mg to 2000 mg) for a single intravenous administration.
Danish: Farmakokinetikken for både ceftazidim og avibactam er omtrent lineær over det undersøgte dosisinterval (50 mg til 2000 mg) efter en enkelt intravenøs administration.
English: Other medicines and Zavicefta Tell your doctor or nurse if you are using, have recently used or might use any other medicines.
Danish: Brug af anden medicin sammen med Zavicefta Fortæl altid lægen eller sundhedspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: • yellowing of the whites of the eyes or skin sudden onset of a severe rash or blistering or peeling skin, possibly accompanied by a high fever or joint pain (these may be signs of more serious medical conditions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme or a condition known as DRESS,
Danish: • pludselig forekomst af et kraftigt udslæt eller blærer eller afskalning af huden, muligvis ledsaget af høj feber eller ledsmerter (dette kan være tegn på en mere alvorlig lidelse såsom toksisk epidermal nekrolyse, Stevens-Johnsons syndrom, erythema multiforme eller en sygdom, der kaldes DRESS, lægemiddelfremkaldt reaktion med eosinofili og systemiske symptomer)
English: Ceftazidime inhibits bacterial peptidoglycan cell wall synthesis following binding to penicillin binding proteins (PBPs), which leads to bacterial cell lysis and death.
Danish: Ceftazidim hæmmer bakteriel peptidoglycan-cellevægssyntese efter binding til penicillinbindende proteiner (PBP'er), hvilket medfører bakteriolyse og celledød.
English: • you have ever had a severe allergic reaction to other antibiotics belonging to the penicillin or carbapenem groups
Danish: • du nogensinde har haft en alvorlig allergisk reaktion på andre antibiotika, der hører til gruppen af penicilliner eller carbapenemer
English: Clinical efficacy has not been established against the following pathogens that are relevant to the approved indications although in vitro studies suggest that they would be susceptible to ceftazidime/avibactam in the absence of acquired mechanisms of resistance.
Danish: Klinisk virkning er ikke fastlagt for følgende patogener, der er relevante ved de godkendte indikationer, selvom in vitro-studier antyder, at de ville være følsomme for ceftazidim/avibactam i fravær af erhvervet resistensmekanisme.
English: In the rat, no adverse effects were observed on embryofetal development or fertility.
Danish: Der blev ikke observeret nogen negative virkninger på embryoføtal udvikling eller fertilitet hos rotter.
English: Complicated intra-abdominal infections
Danish: Komplicerede intra-abdominale infektioner
English: Clinical data have demonstrated that there is no interaction between ceftazidime and avibactam, and between ceftazidime/avibactam and metronidazole.
Danish: Kliniske data har vist, at der ikke er interaktion mellem ceftazidim og avibactam, og mellem ceftazidim/avibactam og metronidazol.
English: Elimination of ceftazidime and avibactam is decreased in patients with moderate or severe renal impairment.
Danish: Eliminationen af ceftazidim og avibactam er nedsat hos patienter med moderat eller svært nedsat nyrefunktion.
English: The mean elimination half-life of ceftazidime ranged from 3.5 to 4 hours following intravenous bolus dosing with 2 g every 12 hours in elderly patients aged 80 years or older.
Danish: Den gennemsnitlige eliminationshalveringstid for ceftazidim varierede fra 3,5 til 4 timer efter intravenøs bolus af 2 g hver 12. time til ældre patienter i alderen 80 år eller ældre.
English: Hypersensitivity reactions
Danish: Overfølsomhedsreaktioner
English: How much to use The recommended dose is one vial (2 g of ceftazidime and 0.5 g of avibactam), every 8 hours.
Danish: Så meget skal der bruges Den anbefalede dosis er et hætteglas (2 g ceftazidim og 0,5 g avibactam) hver 8. time.
English: • you have ever had any allergic reaction (even if only a skin rash) to other antibiotics belonging to the penicillin or carbapenem groups
Danish: • du nogensinde har haft en allergisk reaktion (selv hvis det kun var udslæt på huden) over for andre antibiotika, der tilhører gruppen af penicilliner eller carbapenemer
English: To be used in combination with metronidazole when anaerobic pathogens are known or suspected to be contributing to the infectious process To be used in combination with an antibacterial agent active against Gram-positive pathogens when these are known or suspected to be contributing to the infectious process The total duration shown may include intravenous Zavicefta followed by appropriate oral therapy There is very limited experience with the use of Zavicefta for more than 14 days
Danish: Skal anvendes i kombination med et antibiotikum, der er aktivt mod Gram-positive patogener, når det er verificeret, eller der er mistanke om, at de bidrager til infektionsprocessen Den viste samlede behandlingsvarighed kan omfatte intravenøs Zavicefta efterfulgt af passende oral behandling Der er meget begrænset erfaring med anvendelse af Zavicefta i mere end 14 dage
English: If you get any side effects, talk to your doctor or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteket.
English: Since a clinical interaction study of avibactam and probenecid has not been conducted, co-administration of avibactam with probenecid is not recommended.
Danish: Da der ikke er udført et klinisk interaktionsstudie med avibactam og probenecid, frarådes samtidig administration af avibactam og probenecid.
English: The average increases in avibactam AUC are 3.8-fold and 7-fold in subjects with moderate and severe renal impairment, see section 4.2.
Danish: Den gennemsnitlige stigning i avibactam-AUC er 3,8 gange og 7 gange hos forsøgspersoner med henholdsvis moderat og svært nedsat nyrefunktion, se pkt.
English: Death occurred in 2.1% (18/857) of patients who received Zavicefta and metronidazole and in 1.4% (12/863) of patients who received meropenem.
Danish: 2,1 % (18/857) af de patienter, som fik Zavicefta og metronidazol, og 1,4 % (12/863) af de patienter, der fik meropenem, døde.
English: Ceftazidime crosses the placenta readily, and is excreted in the breast milk.
Danish: Ceftazidim krydser nemt placenta og udskilles i mælk.
English: Overdose with ceftazidime/avibactam can lead to neurological sequelae including encephalopathy, convulsions and coma, due to the ceftazidime component.
Danish: Overdosering af ceftazidim/avibactam kan medføre neurologiske sequelae, herunder encefalopati, kramper og koma, som skyldes ceftazidim-komponenten.
English: Caution should be used if ceftazidime/avibactam is given to patients with a history of non-severe hypersensitivity to penicillins, monobactams or carbapenems.
Danish: Der skal udvises forsigtighed, hvis ceftazidim/avibactam gives til patienter med tidligere tilfælde af ikke-alvorlig overfølsomhed over for pencilliner, monobactamer eller carbapenemer.
English: Intravenous use
Danish: Intravenøs anvendelse.
English: Ceftazidime and avibactam are eliminated via the kidneys, therefore, the dose should be reduced according to the degree of renal impairment (see section 4.2).
Danish: Ceftazidim og avibactam udskilles via nyrerne, og dosis bør derfor reduceres i forhold til graden af nyrefunktionsnedsættelse (se pkt.
English: The inhibitory spectrum of avibactam includes many of the enzymes that inactivate ceftazidime, including Ambler class A β-lactamases and class C β-lactamases.
Danish: Det hæmmende spektrum for avibactam omfatter mange af de enzymer, der inaktiverer ceftazidim, herunder Ambler klasse A-β-laktamaser og klasse C-β-laktamaser.
English: No appreciable accumulation of ceftazidime or avibactam was observed following multiple intravenous infusions of 2000 mg/500 mg of ceftazidime/avibactam administered every 8 hours for up to 11 days in healthy adults with normal renal function.
Danish: Der blev ikke observeret nogen væsentlig akkumulering af ceftazidim eller avibactam efter multiple intravenøse infusioner af 2000 mg/500 mg ceftazidim/avibactam administreret hver 8. time i op til 11 dage hos raske voksne med normal nyrefunktion.
English: The use of ceftazidime/avibactam to treat patients with infections due to Gram-negative aerobic pathogens who have limited treatment options is based on experience with ceftazidime alone and on analyses of the pharmacokinetic-pharmacodynamic relationship for ceftazidime/avibactam (see section
Danish: Anvendelsen af ceftazidim/avibactam til behandling af infektioner, forårsaget af Gram-negative aerobe patogener hos patienter med begrænsede behandlingsmuligheder, er baseret på erfaring med ceftazidim alene og på analyser af de farmakokinetiske-farmakodynamiske relationer mellem ceftazidim/avibactam (se pkt.
English: Ceftazidime has little or no activity against the majority of Gram-positive organisms and anaerobes (see sections 4.2 and 5.1).
Danish: Ceftazidim har ringe eller ingen aktivitet mod de fleste Gram-positive mikroorganismer og anaerober (se pkt.
English: The steady-state volumes of distribution of ceftazidime and avibactam were about 22 L and 18 L, respectively in healthy adults following multiple doses of 2000 mg/500 mg ceftazidime/avibactam infused over 2 hours every 8 hours.
Danish: Fordelingsvolumen ved steady state for ceftazidim og avibactam var henholdsvis ca. 22 l og 18 l hos raske voksne efter multiple doser på 2000 mg/500 mg ceftazidim/avibactam infunderet over 2 timer hver 8. time.
English: Mild to moderate hepatic impairment had no effect on the pharmacokinetics of ceftazidime in individuals administered 2 g intravenously every 8 hours for 5 days, provided renal function was not impaired.
Danish: Let til moderat nedsat leverfunktion havde ingen indvirkning på ceftazidims farmakokinetik hos patienter, som fik 2 g intravenøst hver 8. time i 5 dage, forudsat at nyrefunktionen ikke var nedsat.
English: After reconstitution, 1 mL of solution contains 167.3 mg of ceftazidime and 41.8 mg of avibactam (see section 6.6).
Danish: Efter rekonstitution indeholder 1 ml koncentrat 167,3 mg ceftazidim og 41,8 mg avibactam (se pkt.
English: • fungal infections, including those of the mouth and vagina
Danish: • svampeinfektioner, herunder i mund og skede
English: Dosing of Zavicefta on haemodialysis days should occur after completion of haemodialysis.
Danish: Dosering af Zavicefta på hæmodialysedage skal ske efter afsluttet hæmodialyse.
English: In-vitro data indicate that the following species are not susceptible to ceftazidime/avibactam.
Danish: In vitro-data indikerer, at følgende arter ikke er følsomme for ceftazidim/avibactam.
English: Bacterial resistance mechanisms that could potentially affect ceftazidime/avibactam include mutant or acquired PBPs, decreased outer membrane permeability to either compound, active efflux of either compound, and β-lactamase enzymes refractory to inhibition by avibactam and able to hydrolyse ceftazidime.
Danish: Bakterielle resistensmekanismer, der potentielt kunne påvirke ceftazidim/avibactam, omfatter muterede eller erhvervede PBP'er, nedsat permeabilitet af den ydre membran for et af stofferne, aktiv effluks af et af stofferne samt β-lactamaseenzymer, der er refraktære over for avibactams hæmning, og som kan hydrolysere ceftazidim.
English: Powder for concentrate for solution for infusion (powder for concentrate).
Danish: Pulver til koncentrat til infusionsvæske, opløsning (pulver til koncentrat).
English: • a medicine for gout called probenecid
Danish: • medicin mod urinsyregigt kaldet probenecid
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity or genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser eller genotoksicitet.
English: Animal studies with avibactam do not indicate harmful effects with respect to fertility (see section 5.3).
Danish: Dyrestudier med avibactam indikerer ikke skadelige virkninger på fertiliteten (se pkt.
English: Zavicefta contains sodium
Danish: Zavicefta indeholder natrium
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, reproduction toxicity or genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser, reproduktionstoksicitet eller genotoksicitet.
English: These include thrush (fungal infections of the mouth or genital area).
Danish: Dette omfatter trøske (svampeinfektion i munden eller omkring kønsorganerne).
English: Drug Reaction with Eosinophilia and Systemic Symptoms)
Danish: Lægemiddelfremka ldt reaktion med eosinofili og systemiske symptomer (DRESS)
English: Ceftazidime/avibactam use may cause development of a positive direct antiglobulin test (DAGT, or Coombs test), which may interfere with the cross-matching of blood and/or may cause drug induced immune haemolytic anaemia (see section 4.8).
Danish: Anvendelse af ceftazidim/avibactam kan medføre udvikling af en positiv direkte antiglobulintest (DAT eller Coombs test), der kan interferere med krydsmatching af blod og/eller kan forårsage lægemiddelinduceret immun hæmolytisk anæmi (se pkt.
English: Talk to your doctor before using Zavicefta if you are taking any of the following medicines:
Danish: Tal med lægen, før du bruger Zavicefta, hvis du tager noget af følgende medicin:
English: Alanine aminotransferase increased
Danish: Forhøjet alaninaminotransferase
English: Blood alkaline phosphatase increased
Danish: Forhøjet alkalisk fosfatase i blodet
English: A decision must be made whether to discontinue breast feeding or to discontinue/abstain from ceftazidime/avibactam therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Danish: Der skal besluttes, om amning eller behandling med ceftazidim/avibactam skal ophøre, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: Ceftazidime does not interfere with enzymebased tests for glycosuria.
Danish: Ceftazidim interfererer ikke med enzymbaserede analyser for glukosuri.
English: Animal studies with avibactam have shown reproductive toxicity without evidence of teratogenic effects (see section 5.3).
Danish: Dyrestudier med avibactam har vist reproduktionstoksicitet uden evidens for teratogene virkninger (se pkt.
English: ESRD including on haemodialysis
Danish: ESRD 3 inklusive i hæmodialyse
English: Ceftazidime
Danish: Ceftazidim
English: Vials of ceftazidime/avibactam powder should be reconstituted with 10 mL of sterile water for injections, followed by shaking until the content dissolves.
Danish: Hætteglas med ceftazidim/avibactam-pulver skal rekonstitueres med 10 ml sterilt vand til injektionsvæsker og skal efterfølgende rystes, indtil indholdet opløses.