FrancophonIA/ELRC3.0 huggingface dataset:
English: The duration of treatment should follow the recommendations in Table 1.
Danish: Behandlingsvarighed bør følge anbefalingerne i tabel 1.
English: This medicine should not be given to children under 18 years old because there is not enough information on use in this age group.
Danish: Dette lægemiddel må ikke gives til børn under 18 år, da der ikke er nok information om anvendelse hos denne aldersgruppe.
English: Variations in colour within this range do not affect the potency of the product.
Danish: Farvevariationer inden for disse grænser påvirker ikke produktets styrke.
English: One of these 60 patients had bacteraemia at baseline.
Danish: En af disse 60 patienter havde bakteriæmi ved baseline.
English: Tell your doctor if you think you may have another infection.
Danish: Kontakt lægen, hvis du tror, du kan have en anden infektion.
English: Your doctor may also want to test your blood to make sure you receive an appropriate dose, especially if you have to take this medicine for a long time.
Danish: Din læge vil måske også gerne tage en blodprøve for at være sikker på, at du får den rigtige dosis, især hvis du skal tage denne medicin i lang tid.
English: Modification of PBPs
Danish: Ændring af PBPerne
English: From a microbiological point of view, the medicinal product should be used immediately upon reconstitution.
Danish: Ud fra et mikrobiologisk synspunkt skal lægemidlet anvendes umiddelbart efter rekonstitution.
English: CAUTION: THE RECONSTITUTED SOLUTION IS NOT FOR DIRECT INJECTION.
Danish: FORSIGTIG: DEN REKONSTITUEREDE OPLØSNING ER IKKE TIL DIREKTE INJEKTION.
English: **All doses of Zerbaxa are administered intravenously over 1 hour and are recommended for all indications.
Danish: **Alle Zerbaxadoser administreres intravenøst over 1 time og anbefales til alle indikationer.
English: This can increase the time it takes for tazobactam to leave your body.
Danish: Dette kan øge den tid, det tager for tazobactam at komme ud af kroppen.
English: Your doctor will decide on the dose that you need.
Danish: Lægen vil beslutte, hvilken dosis, du skal have.
English: 15 to 29
Danish: 15 til 29
English: CrCL (mL/min)*
Danish: Estimeret CrCl (ml/min)*
English: Coombs test positive
Danish: Positiv Coombs test
English: As this product is given by a doctor or other healthcare professional, it is very unlikely that you will be given too much Zerbaxa.
Danish: Da præparatet gives af en læge eller andet sundhedspersonale, er det meget usandsynligt, at du vil få for meget Zerbaxa.
English: The dose depends on the type of infection that you have, where the infection is in your body and how serious the infection is.
Danish: Dosis afhænger af den type infektion, du har, og hvor i kroppen infektionen befinder sig samt af hvor alvorlig infektionen er.
English: Do not use this medicine after the expiry date which is stated on the carton and vial after “EXP.” The expiry date refers to the last day of that month.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Your doctor or other healthcare professional will give you this medicine into one of your veins through an infusion (a drip) lasting one hour.
Danish: Din læge eller andet sundhedspersonale vil give dig dette lægemiddel ind i en blodåre som infusion (et drop), der varer en time.
English: Safety and efficacy in paediatric patients have not been established.
Danish: Sikkerhed og virkning hos pædiatriske patienter er ikke klarlagt.
English: Non-susceptible micro-organisms
Danish: Ikke-følsomme mikroorganismer
English: Tazobactam is a substrate for OAT1 and OAT3.
Danish: Tazobactram er et substrat for OAT1 og OAT3.
English: 1 hour
Danish: 1 time
English: The preparation for each dose is shown below.
Danish: Fremstillingsmetoden for hver dosis er vist nedenfor.
English: If super infection occurs during or following treatment, appropriate measures should be taken.
Danish: Hvis superinfektioner opstår under eller efter behandling, skal passende forholdsregler tages.
English: 7 days
Danish: 7 dage
English: Minimum inhibitory concentration breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Danish: Grænseværdierne for den mindste hæmmende koncentration, fastlagt af European Committee on Antimicrobial Susceptibility Testing (EUCAST), er som følger:
English: 63963, Clermont Ferrand Cedex 9 France
Danish: 63963, Clermont Ferrand Cedex 9 Frankrig
English: Zerbaxa should only be used during pregnancy if the expected benefit outweighs the possible risks to the pregnant woman and foetus.
Danish: Zerbaxa bør kun anvendes under graviditet, hvis den forventede gavnlige virkning opvejer de mulige risici for den gravide kvinde og fostret.
English: Adverse reactions are classified according to MedDRA system organ class and frequency.
Danish: Bivirkningerne er angivet i henhold til MedDRA-systemorganklasse og hyppighed.
English: The infusion time is 1 hour for all doses of Zerbaxa.
Danish: Infusionstiden er 1 time for alle Zerbaxadoser.
English: 30 to 50
Danish: 30 til 50
English: *To be used in combination with metronidazole when anaerobic pathogens are suspected.
Danish: *Skal anvendes i kombination med metronidazol, når der er mistanke om anaerobe patogener.
English: Aseptic technique must be followed in preparing the infusion solution.
Danish: Aseptisk teknik skal følges ved fremstilling af infusionsopløsningen.
English: Augmented renal clearance
Danish: Forøget renal clearance (Augmented renal clearance)
English: There is no experience with overdose of Zerbaxa.
Danish: Der er ingen erfaring med overdosering af Zerbaxa.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions and would normally not be longer than 24 hours at 2 to 8°C.
Danish: Hvis det ikke anvendes med det samme, er opbevaringstid og -forhold før anvendelse brugerens ansvar, medmindre rekonstitution/fortynding har fundet sted under kontrollerede og validerede aseptiske forhold og vil normalt ikke være længere end 24 timer ved 2 til 8 °C.
English: If you are told that you have an abnormal blood test (called Coombs test) tell your doctor that you are having or have recently had Zerbaxa.
Danish: Hvis du har fået at vide, at du har en unormal blodprøve (en såkaldt Coombs test), skal du fortælle lægen, at du får eller for nylig har fået Zerbaxa.
English: Minimum Inhibitory Concentrations (mg/L)
Danish: Mindste hæmmende koncentration (mg/l)
English: Your doctor will advise if you should receive Zerbaxa during pregnancy.
Danish: Din læge vil rådgive dig om, hvorvidt du skal have Zerbaxa under graviditeten.
English: See section 6.6 for instructions on reconstitution and dilution of the medicinal product before administration.
Danish: 6.6 for instruktioner om rekonstitution og fortynding af lægemidlet før administration.
English: Zerbaxa is for intravenous infusion.
Danish: Zerbaxa er til intravenøs infusion.
English: Tazobactam crosses the placenta.
Danish: Tazobactam krydser placentabarrieren.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Behandlingen skal ske under iagttagelse af officielle retningslinjer for korrekt anvendelse af antibakterielle midler.
English: Treatment with Zerbaxa sometimes causes production of antibodies that react with your red blood cells.
Danish: Behandling med Zerbaxa kan nogle gange medføre dannelse af antistoffer, som reagerer med de røde blodlegemer.
English: Treatment with Zerbaxa normally lasts between 4 and 14 days, depending on the severity and location of the infection and on how your body responds to the treatment.
Danish: Behandling med Zerbaxa varer normalt mellem 4 og 14 dage, afhængigt af infektionens sværhedsgrad, hvor infektionen er, og hvordan din krop reagerer på behandlingen.
English: Limitations of the clinical data
Danish: Begrænsninger i kliniske data
English: In the event of overdose, Zerbaxa should be discontinued and general supportive treatment given.
Danish: I tilfælde af overdosering skal Zerbaxa seponeres, og der skal gives generelt understøttende behandling.
English: Clinical efficacy against specific pathogens
Danish: Klinisk virkning på specifikke patogener
English: Zerbaxa is a medicine used to treat a range of bacterial infections.
Danish: Zerbaxa er et lægemiddel til behandling af en række bakterieinfektioner.
English: After reconstitution, chemical and physical in-use stability has been demonstrated for 4 days at 2 to 8°C.
Danish: Efter rekonstitution er dokumenteret kemisk og fysisk stabilitet i brug 4 dage ved 2 til 8 °C.
English: 8-14 days
Danish: 8-14 dage
English: Environmental Risk Assessment (ERA)
Danish: Miljørisikovurdering
English: *CrCL estimated using Cockcroft-Gault formula.
Danish: *CrCl er estimeret ud fra Cockcrofts og Gaults formel.
English: The safety and efficacy of ceftolozane/tazobactam in children and adolescents below 18 years of age have not yet been established.
Danish: Ceftolozan/tazobactams sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: Direct antiglobulin test (Coombs test) seroconversion and potential risk of haemolytic anaemia
Danish: Direkte antiglobulin test (Coombs test) serokonversion og potentiel risiko for hæmolytisk anæmi
English: However, active substances that inhibit OAT1 or OAT3 (e.g., probenecid) may increase tazobactam plasma concentrations.
Danish: Aktive stoffer, der hæmmer OAT1 eller OAT3 (f.eks. probenecid), kan dog øge koncentrationen af tazobactam i plasma.
English: **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.
Danish: **Skal anvendes i kombination med et antibiotikum, der er aktivt mod grampositive patogener, når det er verificeret, eller der er mistanke om, at de bidrager til infektionsprocessen.
English: The medicinal product is photosensitive and should be protected from light when not stored in the original carton.
Danish: Lægemidlet er lysfølsomt og skal beskyttes mod lys, hvis det ikke opbevares i den originale æske.
English: These types of infection may range in severity from mild to life-threatening.
Danish: Sværhedsgraden af disse infektionstyper kan strække sig fra let til livstruende.
English: The binding of ceftolozane and tazobactam to human plasma proteins is low (approximately 16% to 21% and 30%, respectively).
Danish: Bindingen af ceftolozan og tazobactam til humane plasmaproteiner er lav (henholdsvis ca. 16% til 21% og 30%).
English: - if you are allergic to medicines known as “cephalosporins”.
Danish: - hvis du er allergisk over for medicin der kaldes "cefalosporiner".
English: Approximately 82% of all patients in the trial had APACHE II (Acute Physiology and Chronic Health Evaluation II) scores of < 10 and 2.3% had bacteraemia at baseline.
Danish: Ca. 82% af alle patienter i studiet havde en APACHE II (Acute Physiology and Chronic Health Evaluation II) score på <10 og 2,3% havde bakteriæmi ved baseline.
English: 1, diarrhoea
Danish: 1, diarré
English: Tell your doctor straight away if you get these symptoms as you may need urgent medical treatment: - Sudden swelling of your lips, face, throat or tongue; a severe rash; and, swallowing or breathing problems.
Danish: Kontakt straks lægen, hvis du får disse symptomer, da du kan have brug for akut lægehjælp: - Pludselig hævelse af læber, ansigt, svælg eller tunge; alvorligt udslæt; og problemer med at synke eller trække vejret.
English: Pharmacotherapeutic group: Antibacterials for systemic use, other cephalosporins and penems, ATC code: J01DI54.
Danish: Farmakoterapeutisk klassifikation: Antibakterielle midler til systemisk brug, andre cephalosporiner og penemer, ATC-kode: J01DI54.
English: 4-14 days
Danish: 4-14 dage
English: Your doctor may need to reduce the dose of Zerbaxa or decide how often Zerbaxa is given to you.
Danish: Din læge kan være nødt til at nedsætte Zerbaxadosen eller beslutte, hvor ofte du skal have Zerbaxa.
English: 1, infusion site reactions
Danish: 1, reaktioner på infusionsstedet
English: Elderly (≥ 65 years of age) No dose adjustment is necessary for the elderly based on age alone (see section 5.2).
Danish: Ældre (≥ 65 år) Dosisjustering er ikke nødvendig hos ældre på baggrund af alder alene (se pkt.
English: The development of a positive direct Coombs test may occur during treatment with Zerbaxa.
Danish: Udvikling af en positiv direkte Coombs test kan forekomme under behandling med Zerbaxa.
English: The dose of medicine given to you depends on whether or not you have kidney problems.
Danish: Hvor stor en dosis, du får af lægemidlet, afhænger af, om du har nyreproblemer eller ej.
English: This medicine contains 230 mg sodium (main component of cooking/table salt) in each vial.
Danish: Denne medicin indeholder 230 mg natrium (hovedbestanddelen i køkkensalt/bordsalt) i hvert hætteglas.
English: Clinical efficacy data in patients with complicated lower urinary tract infection are limited.
Danish: Kliniske effektdata hos patienter med kompliceret infektion i nedre urinveje er begrænsede.
English: No dose adjustment is recommended based on gender.
Danish: Dosisjustering anbefales ikke på baggrund af køn.
English: Approximately 66% of ceftolozane, 56% of tazobactam, and 51% of the M1 metabolite of tazobactam were removed by dialysis.
Danish: Ca. 66% af ceftolozan, 56% af tazobactam og 51% af M1-metabolitterne fra tazobactam blev fjernet med dialyse.
English: Alanine aminotransferase increased aspartate aminotransferase increased transaminases increased
Danish: Forhøjet alaninaminotransferase forhøjet aspartataminotransferase forhøjede transaminaser
English: Pharmacokinetic/pharmacodynamic relationships
Danish: Farmakokinetiske/farmakodynamiske forhold
English: Talk to your doctor or pharmacist before taking Zerbaxa if you know you are, or have previously been allergic to cephalosporins, penicillins or other antibiotics.
Danish: Kontakt lægen eller apotekspersonalet, før du tager Zerbaxa, hvis du ved, du er, eller tidligere har været, allergisk over for cefalosporiner, penicillin eller andre antibiotika.
English: Therefore, it is important to consider this diagnosis in patients who present with diarrhoea during or subsequent to the administration of ceftolozane/tazobactam.
Danish: Derfor er det vigtigt at overveje denne diagnose hos patienter, der får diarré under eller efter administration af ceftolozan/tazobactam.
English: Infection due to C. difficile bacteria, C. difficile test positive (from stool test), Coombs test positive (a blood test that looks for antibodies that may fight against your red blood cells)
Danish: Infektion på grund af bakterien C. difficile, positiv C. difficile-test (fra afføringsprøve), positiv Coombs test (en blodprøve, der tester for antistoffer, som bekæmper dine røde blodlegemer)
English: If you think you have not been given a dose of Zerbaxa, tell your doctor or other healthcare professional immediately.
Danish: Hvis du tror, at du mangler af få en dosis Zerbaxa, skal du straks sige det til din læge eller andet sundhedspersonale.
English: In such circumstances, the discontinuation of therapy with ceftolozane/tazobactam and the use of supportive measures together with the administration of specific treatment for Clostridioides difficile should be considered.
Danish: I sådanne tilfælde skal seponering af behandlingen med ceftolozan/tazobactam og anvendelse af understøttende behandling samt administration af specifik behandling mod Clostridioides difficile overvejes.
English: Zerbaxa may have a minor influence on the ability to drive and use machines.
Danish: Zerbaxa kan i mindre grad påvirke evnen til at føre motorkøretøj og betjene maskiner.
English: White to yellowish powder.
Danish: Hvidt til gulligt pulver.
English: More than 80% of tazobactam was excreted as the parent compound with the remaining amount excreted as the tazobactam M1 metabolite.
Danish: Over 80% af tazobactam blev udskilt uændret, mens den resterende mængde blev udskilt som tazobactam M1-metabolit.
English: However, if you have any concerns you should let your doctor, nurse or pharmacist know immediately.
Danish: Men hvis du er bekymret, skal du straks lade lægen, sygeplejersken eller apotekspersonalet vide det.
English: Infections caused by bacteria that are not sensitive to Zerbaxa or caused by a fungus can occur during or following treatment with Zerbaxa.
Danish: Infektioner forårsaget af bakterier, som ikke er følsomme over for Zerbaxa, eller som er forårsaget af en svamp, kan forekomme under eller efter behandling med Zerbaxa.
English: Zerbaxa is indicated for the treatment of the following infections in adults (see section 5.1):
Danish: Zerbaxa er indiceret til behandling af følgende infektioner hos voksne (se pkt.
English: Frequency categories are derived according to the following conventions: common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) (see Table 3).
Danish: Hyppighed defineres i henhold til følgende konvention: almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100) (se tabel 3).
English: In the clinically evaluable (CE) patients, the clinical cure rates for ceftolozane/tazobactam were 95.9% in 293 patients aged less than 65 years and 87.8% in 82 patients aged 65 years or more.
Danish: Hos de klinisk evaluerbare (CE) patienter var den kliniske helbredelsesprocent for ceftolozan/tazobactam 95,9% hos 293 patienter under 65 år og 87,8% hos 82 patienter i alderen 65 år eller derover.
English: Ceftolozane is eliminated in the urine as unchanged parent substance and thus does not appear to be metabolised to any appreciable extent.
Danish: Ceftolozan udskilles uændret i urinen og synes således ikke at blive metaboliseret i nogen mærkbar udstrækning.
English: If you stop taking Zerbaxa
Danish: Hvis du holder op med at tage Zerbaxa
English: The use of ceftolozane/tazobactam may promote the overgrowth of non-susceptible micro-organisms.
Danish: Anvendelse af ceftolozan/tazobactam kan fremme overvæksten af ikke-følsomme mikroorganismer.
English: If a severe allergic reaction occurs during treatment with ceftolozane/tazobactam, the medicinal product should be discontinued and appropriate measures taken.
Danish: Hvis der opstår svære allergiske reaktioner under behandlingen med ceftolozan/tazobactam, skal behandlingen seponeres, og hensigtsmæssige forholdsregler skal tages.
English: Do not take Zerbaxa - if you are allergic to ceftolozane, tazobactam or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Zerbaxa - hvis du er allergisk over for ceftolozan, tazobactam eller et af de øvrige indholdsstoffer i Zerbaxa (angivet i punkt 6).
English: Clostridioides difficile-associated diarrhoea
Danish: Clostridioides difficile-associeret diarré
English: For ceftolozane the time that the plasma concentration exceeds the minimum inhibitory concentration of ceftolozane for the infecting organism has been shown to be the best predictor of efficacy in animal models of infection.
Danish: For ceftolozan har den tid, som ceftolozans plasmakoncentration overstiger mindste hæmmende koncentration for den inficerende organisme, vist sig at være den bedste indikator for virkningen i infektionsmodeller hos dyr.
English: In this situation, you should not take medicines that stop or slow bowel movement
Danish: I denne situation må du ikke tage medicin, der stopper eller hæmmer afføringen.
English: Talk to your doctor or pharmacist if you develop diarrhoea while taking Zerbaxa.
Danish: Kontakt lægen eller apotekspersonalet, hvis du får diarré, mens du tager Zerbaxa.
English: Tazobactam does not inhibit all Class A enzymes.
Danish: Tazobactam hæmmer ikke alle klasse A-enzymer.
English: No dose adjustment is recommended based on race.
Danish: Dosisjustering anbefales ikke på baggrund af race.
English: Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication that were susceptible to Zerbaxa in vitro:
Danish: Virkning er påvist i kliniske studier mod de patogener anført under hver indikation, der var følsomme over for Zerbaxa in vitro:
English: In vitro data indicate that the following species are not susceptible to ceftolozane/tazobactam: Staphylococcus aureus
Danish: In vitro-data indikerer, at følgende arter ikke er følsomme over for ceftolozan/tazobactam: Staphylococcus aureus
English: Preparation of solutions
Danish: Fremstilling af opløsninger
English: Susceptible Resistant
Danish: Følsom Resistent
English: For intravenous use after reconstitution and dilution.
Danish: Til intravenøs anvendelse efter rekonstitution og fortynding.
English: Metallo-beta-lactamases (e.g., New Delhi metallo-beta-lactamase [NDM]) iv. Ambler Class D beta-lactamases (OXA-carbapenemases)
Danish: Metallo-beta-lactamaser (fx New Delhi metallo-beta-lactamase [NDM]) iv. Ambler klasse D beta-lactamaser (OXA-carbapenemaser).
English: The mean terminal elimination half-life of ceftolozane and tazobactam in healthy adults with normal renal function is approximately 3 hours and 1 hour, respectively.
Danish: Den gennemsnitlige terminale halveringstid for elimination for ceftolozan og tazobactam hos raske voksne med normal nyrefunktion er henholdsvis ca. 3 timer og 1 time.
English: In clinical studies, there was no evidence of haemolysis in patients who developed a positive DAGT on treatment.
Danish: I de kliniske studier var der ikke tegn på hæmolyse hos patienter, som udviklede en positiv DAGT under behandlingen.
English: There are no data on the use of ceftolozane/tazobactam in pregnant women.
Danish: Der er ingen data fra anvendelse af ceftolozan/tazobactam til gravide kvinder.
English: In a randomised active-controlled trial 18.2% (126/693) of microbiologically evaluable (ME) patients had complicated lower urinary tract infection, including 60/126 patients who were treated with ceftolozane/tazobactam.
Danish: I et randomiseret aktivt-kontrolleret studie havde 18,2% (126/693) af de mikrobiologisk evaluerbare (ME) patienter kompliceret infektion i nedre urinveje, herunder 60/126 patienter, som blev behandlet med ceftolozan/tazobactam.
English: In a trial in patients with complicated intra-abdominal infections, the most common diagnosis was appendiceal perforation or peri-appendiceal abscess (420/970 [43.3%] patients), of which 137/420 (32.6%) had diffuse peritonitis at baseline.
Danish: I et studie med patienter med komplicerede intraabdominale infektioner var den hyppigste diagnose perforeret appendicit eller periappendikulær absces (420/970 [43,3%] patienter), hvoraf 137/420 (32,6%) havde diffus peritonitis ved baseline.
English: To maintain similar systemic exposures to those with normal renal function, dosage adjustment is required (see section 4.2).
Danish: For at bevare den samme systemiske eksponering som ved normal nyrefunktion er dosisjustering påkrævet (se pkt.
English: - if you have had a severe allergic reaction (e.g., severe skin peeling; swelling of the face, hands, feet, lips, tongue or throat; or difficulty swallowing or breathing) to certain other antibiotics (e.g., penicillins or carbapenems).
Danish: - hvis du har haft en alvorlig allergisk reaktion (fx alvorlig hudafskalning, hævelse af ansigt, hænder, fødder, læber, tunge eller svælg, eller besvær med at synke eller trække vejret) over for visse andre antibiotika (fx penicilliner eller carbapenemer).
English: Studies with ceftolozane in mice and rats have not shown evidence of reproductive toxicity or teratogenicity.
Danish: Studier med ceftolozan hos mus og rotter har ikke vist tegn på reproduktionstoksicitet eller teratogenicitet.
English: Zerbaxa contains sodium
Danish: Zerbaxa indeholder natrium
English: It is not known if ceftolozane crosses the placenta.
Danish: Det er uvist, om ceftolozan krydser placentabarrieren.