FrancophonIA/ELRC3.0 huggingface dataset:
English: The time above a threshold concentration has been determined to be the parameter that best predicts the efficacy of tazobactam in in vitro and in vivo non-clinical models.
Danish: Tiden over en grænsekoncentration har vist sig at være den parameter, der bedst forudsiger tazobactams virkning i non-kliniske in vitro- og in vivo-modeller.
English: Mechanisms of resistance
Danish: Resistensmekanismer
English: The following adverse reactions have been identified during clinical trials with Zerbaxa.
Danish: Følgende bivirkninger blev identificeret under kliniske studier med Zerbaxa.
English: Dizziness may occur following administration of Zerbaxa (see section 4.8).
Danish: Svimmelhed kan forekomme efter administration af Zerbaxa (se pkt.
English: In clinical studies, there was no evidence of haemolysis in patients who developed a positive direct Coombs test in any treatment group.
Danish: I kliniske studier var der ingen tegn på hæmolyse hos patienter, der udviklede en positiv direkte Coombs test i nogen af behandlingsgrupperne.
English: Pack size of 10 vials.
Danish: Pakningsstørrelse med 10 hætteglas.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ
English: For tazobactam the PD index associated with efficacy was determined to be the percentage of the dose interval during which the plasma concentration of tazobactam exceeds a threshold value (%T > threshold).
Danish: For tazobactam var det farmakodynamiske indeks associeret med virkning fastslået til at være den procentdel af dosisintervallet, hvor tazobactams plasmakoncentration overstiger en grænseværdi (%T > grænseværdi).
English: It is an inhibitor of many molecular Class A beta-lactamases, including CTX-M, SHV, and TEM enzymes.
Danish: Det er en hæmmer af mange molekylære klasse A beta-lactamaser, herunder CTX-M-, SHV- og TEM-enzymer.
English: Environmental risk assessment studies have shown that one of the active ingredients, ceftolozane, may pose a risk to surface water organisms (see section 6.6).
Danish: Miljørisikovurderingsstudier har vist, at et af de aktive stoffer, ceftolozan, kan udgøre en risiko for organismer i overfladevand (se pkt.
English: If you are pregnant or breast-feeding, or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, eller har mistanke om, at du er gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager Zerbaxa.
English: Fertility studies in rats showed no effect on fertility and mating after intraperitoneal administration of tazobactam or intravenous administration of ceftolozane (see section 5.3).
Danish: Fertilitetsstudier med rotter viste ingen påvirkning af fertilitet og parring efter intraperitoneal administration af tazobactam eller intravenøs administration af ceftolozan (se pkt 5.3).
English: Patients who were immunocompromised, patients with severe neutropenia, and patients with end stage renal disease on haemodialysis were excluded from clinical trials.
Danish: Immunkompromitterede patienter, patienter med svær neutropeni og patienter i hæmodialyse med nyresygdom i slutstadiet blev udelukket fra kliniske studier.
English: Paediatric patients
Danish: Pædiatriske patienter
English: If you are breast-feeding, your doctor will advise you on whether you should stop breast-feeding or stop or avoid Zerbaxa therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for you.
Danish: Hvis du ammer, vil din læge rådgive dig om, hvorvidt du skal stoppe med at amme eller stoppe med eller undgå behandling med Zerbaxa under hensyntagen til fordelen ved amning for barnet og fordelen ved behandlingen for dig.
English: 3, constipation vomiting 3, abdominal pain
Danish: 3, obstipation opkastning 3, abdominalsmerter
English: Peri/postnatal development was impaired (reduced pup weights, increase in stillbirths, increase in pup mortality) concurrent with maternal toxicity after intraperitoneal administration of tazobactam in the rat.
Danish: Peri-/postnatal udvikling var nedsat (nedsat vægt hos ungerne, stigning i dødfødsler, stigning i ungernes dødelighed) svarende til maternel toksicitet efter intraperitoneal administration af tazobactam i rotter.
English: It is unknown whether ceftolozane and tazobactam are excreted in human milk.
Danish: Det er ukendt, om ceftolozan og tazobactam udskilles i human mælk.
English: Patients with renal impairment at baseline should be monitored frequently for any changes in renal function during treatment and the dose of ceftolozane/tazobactam should be adjusted as necessary.
Danish: Patienter med nedsat nyrefunktion ved baseline skal monitoreres hyppigt for ændringer i nyrefunktionen under behandlingen, og ceftolozan/tazobactam-dosis skal justeres efter behov.
English: Gram-positive bacteria Streptococcus anginosus Streptococcus constellatus Streptococcus salivarius
Danish: Grampositive bakterier Streptococcus anginosus Streptococcus constellatus Streptococcus salivarius
English: Preparation of doses
Danish: Fremstilling af dosis
English: Effect on renal function
Danish: Virkning på nyrefunktionen
English: A dose of 300 mg/kg/day to rats was associated with a ceftolozane plasma exposure (AUC) value lower than the ceftolozane plasma AUC value at the highest recommended human dose of 2 grams every 8 hours.
Danish: En dosis på 300 mg/kg/dag i rotter var associeret med en eksponering for ceftolozan i plasma (AUC) med en værdi, der var lavere end ceftolozans AUC-værdi i plasma ved den højeste anbefalede dosis hos mennesker på 2 gram hver 8. time.
English: Table 3: Adverse reactions identified during clinical trials with ceftolozane/tazobactam System organ class
Danish: Tabel 3: Bivirkninger identificeret under kliniske studier med ceftolozan/tazobactam Systemorganklasse
English: Frequency Infusion time
Danish: Hyppighed Infusionstid Behandlingsvarighed
English: Ceftolozane exerts bactericidal activity through binding to important penicillin-binding proteins (PBPs), resulting in inhibition of bacterial cell-wall synthesis and subsequent cell death.
Danish: Ceftolozan udviser baktericid aktivitet gennem binding til vigtige penicillin-bindende proteiner (PBPer), hvilket fører til, at den bakterielle cellevægsyntese hæmmes, og cellerne derefter dør.
English: Complicated intra-abdominal infection*
Danish: Kompliceret intraabdominal infektion*
English: Inflammation of the large intestine due to C. difficile bacteria, inflammation of the stomach, abdominal distension, indigestion, excessive gas in stomach or bowel, obstruction of the intestine, yeast infection in the mouth (thrush), yeast infection of female genitalia, fungal urinary tract infection, increase in sugar (glucose) levels (from blood tests), decrease in magnesium levels (from blood tests), decrease in phosphate levels (from blood tests), ischemic stroke (stroke caused by reduced blood flow in brain), irritation or inflammation of a vein at injection site, venous thrombosis (blood clot in a vein), low red blood cell counts, atrial fibrillation (rapid or irregular heartbeat), fast heart beat, angina pectoris (chest pain or feeling of tightness, pressure or heaviness in chest), itchy rash or swellings on the skin, hives, Coombs test positive (a blood test that looks for antibodies that may fight against your red blood cells), kidney problems, kidney disease, shortness of breath
Danish: Inflammation (en betændelseslignende reaktion) i tyktarmen på grund af bakterien C. difficile, inflammation i maven, oppustet og udspilet mave, fordøjelsesbesvær, for meget luft i maven eller tarmen, tilstopning af tarmen, gærsvampeinfektion i munden (oral candidiasis), infektion med gærsvampe i kønsdelene hos kvinder, urinvejsinfektion (svampe), forhøjet blodsukker (fra blodprøver), nedsat indhold af magnesium (fra blodprøver), nedsat indhold af fosfat (fra blodprøver), iskæmisk slagtilfælde (slagtilfælde forårsaget af nedsat blodgennemstrømning til hjernen), irritation eller inflammation i en vene, ved injektionsstedet, venetrombose (blodprop i en vene), lavt antal røde blodlegemer, atrieflimren (hurtige eller uregelmæssige hjerteslag), hurtig hjerterytme (puls), hjertekrampe (angina pectoris - brystsmerter eller en knugende, trykkende smerte eller en sammensnørende fornemmelse i brystet), kløende udslæt eller hævelse i huden, nældefeber, positiv Coombs test (en blodprøve, der tester for antistoffer, som bekæmper dine røde blodlegemer), nyreproblemer, nyresygdom, kortåndethed
English: In vitro, tazobactam inhibited human OAT1 and OAT3 transporters with IC50 values of 118 and 147 mcg/mL, respectively.
Danish: Tazobactam hæmmede de humane transportører OAT1 og OAT3 med IC50-værdier på henholdsvis 118 og 147 mikrog/ml in vitro.
English: This leaflet was last revised in {month YYYY}.
Danish: Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}.
English: The highest single dose of Zerbaxa used in clinical trials was 3 g / 1.5 g of ceftolozane/tazobactam administered to healthy volunteers.
Danish: Den højeste enkeltdosis Zerbaxa anvendt i kliniske studier var 3 g / 1,5 g ceftolozan/tazobactam administreret til raske frivillige.
English: Patients treated for an infection of the lungs called “pneumonia” Common side effects (may affect up to 1 in 10 people): Inflammation of the large intestine due to C. difficile bacteria, diarrhoea, vomiting, increase in liver enzymes (from blood tests)
Danish: Patienter i behandling for en infektion i lungerne kaldet “pneumoni” (lungebetændelse) Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer): Inflammation (en betændelseslignende reaktion) i tyktarmen på grund af bakterien C. difficile, diarré, opkastning, stigning i leverenzymer (fra blodprøver)
English: Ethnicity
Danish: Etnicitet
English: The Cmax and AUC of ceftolozane/tazobactam increase in proportion to dose.
Danish: Cmax og AUC for ceftolozan/tazobactam stiger proportionalt med dosis.
English: Sodium chloride Arginine
Danish: Natriumchlorid Arginin
English: Zerbaxa solution for infusion is clear and colourless to slightly yellow.
Danish: Zerbaxa infusionsvæske, opløsning, er klar og farveløs til svagt gul.
English: Zerbaxa is used in adults to treat complicated infections within the abdomen, kidney and urinary system infections, and an infection of the lungs called “pneumonia”.
Danish: Zerbaxa anvendes hos voksne til at behandle komplicerede infektioner i maven, nyrerne og urinvejene samt en infektion i lungerne kaldet ”pneumoni” (lungebetændelse).
English: The beta-lactam ring of tazobactam is hydrolyzed to form the pharmacologically inactive, tazobactam metabolite M1.
Danish: Tazobactams beta-lactam-ring hydrolyseres, så den danner den farmakologisk inaktive tazobactammetabolit M1.
English: Co-administration of ceftolozane/tazobactam with OAT1 and OAT3 substrate furosemide in a clinical study did not significantly increase furosemide plasma exposures (geometric mean ratios of 0.83 and 0.87 for Cmax and AUC, respectively).
Danish: Samtidig administration af ceftolozan/tazobactam og OAT1- og OAT3-substratet furosemid i et klinisk studie øgede ikke eksponeringen af furosemid i plasma signifikant (geometriske middelværdier på 0,83 og 0,87 for henholdsvis Cmax og AUC).
English: Candidiasis including oropharyngeal and vulvovaginal Clostridioides difficile colitis fungal urinary tract infection Clostridioides difficile infection
Danish: Candidiasis, inklusive orofaryngeal og vulvovaginal Clostridioides difficile-colitis urinvejsinfektion (svampe) Clostridioides difficile-infektion
English: One of the active ingredients, ceftolozane, may have harmful effects if it reaches the aquatic environment.
Danish: Et af de aktive stoffer, ceftolozan, kan have skadelig effekt, hvis det udledes i vandmiljøet.
English: This is equivalent to 11.5% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 11,5% af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: This is equivalent to 13.3% of the recommended maximum daily dietary intake of sodium for an adult.
Danish: Dette svarer til 13,3% af den anbefalede maksimale daglige indtagelse af natrium for en voksen.
English: The development of a positive direct antiglobulin test (DAGT) may occur during treatment with ceftolozane/tazobactam (see section 4.8).
Danish: Der kan udvikles en positiv direkte antiglobulin test (DAGT) under behandling med ceftolozan/tazobactam (se pkt.
English: With haemodialysis, the dose should be administered immediately following completion of dialysis (see section 4.2).
Danish: Ved hæmodialyse skal dosen administreres umiddelbart efter, at dialysen er afsluttet (se pkt.
English: Uncommon (≥ 1/1,000 to < 1/100)
Danish: Ikke almindelig (≥ 1/1.000 til < 1/100)
English: Ceftolozane and tazobactam were not substrates for P-gp or BCRP, and tazobactam was not a substrate for OCT2, in vitro at therapeutic plasma concentrations.
Danish: Ceftolozan og tazobactam var ikke substrater for P-gp eller BCRP, og tazobactam var ikke substrat for OCT2 in vitro ved terapeutiske plasmakoncentrationer.
English: 1, venous thrombosis
Danish: 1, venetrombose
English: Patients treated for complicated infections within the abdomen, and kidney and urinary system Common side effects (may affect up to 1 in 10 people):
Danish: Patienter i behandling for komplicerede infektioner i maven, nyrerne og urinvejene Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer):
English: What you need to know before you take Zerbaxa
Danish: Det skal du vide, før du begynder at tage Zerbaxa
English: The incidence of seroconversion to a positive direct Coombs test was 0.2% in patients receiving Zerbaxa and 0% in patients receiving the comparator in the complicated intra-abdominal infections and complicated urinary tract infections clinical trials.
Danish: Incidensen af serokonversion til en positiv direkte Coombs test var 0,2% hos patienter, der fik Zerbaxa, og 0% hos patienter, der fik komparator, i kliniske studier af komplicerede intraabdominale infektioner og komplicerede urinvejsinfektioner.
English: See section 4.2 for recommended dose regimens for Zerbaxa based on indication and renal function.
Danish: 4.2 for oplysninger om anbefalede dosisregimer for Zerbaxa baseret på indikation og nyrefunktion.
English: Serine-based carbapenemases (e.g., Klebsiella pneumoniae carbapenemases [KPCs]) iii.
Danish: Serin-baserede carbapenemaser (fx Klebsiella pneumoniae carbapenemaser [KPCer]) iii.
English: In patients with moderate or severe renal impairment, and in patients with end stage renal disease on haemodialysis, the dose should be adjusted as listed in Table 2 (see sections 5.1 and 6.6).
Danish: Hos patienter med moderat eller svært nedsat nyrefunktion og hos patienter i hæmodialyse med nyresygdom i slutstadiet bør dosis justeres som anført i tabel 2 (se pkt.
English: Headache, stomach ache, constipation, diarrhoea, nausea, vomiting, increase in liver enzymes (from blood tests), rash, fever (high temperature), decrease in blood pressure, decrease in potassium (from blood tests), increase in the number of certain types of blood cells known as platelets, dizziness, anxiety, difficulty sleeping, infusion site reactions
Danish: Hovedpine, mavesmerter (mavepine), forstoppelse, diarré, kvalme, opkastning, stigning i leverenzymer (fra blodprøver), udslæt, feber (forhøjet temperatur), fald i blodtrykket, fald i kalium (fra blodprøver), stigning i antallet af visse typer blodceller kendt som blodplader, svimmelhed, angst, søvnbesvær, reaktioner på infusionsstedet
English: Free plasma ceftolozane concentrations were greater than 8 mcg/mL over 70% of an 8-hour period; free tazobactam concentrations were greater than 1 mcg/mL over 60% of an 8-hour period.
Danish: Koncentrationen af frit ceftolozan i plasma var højere end 8 mikrog/ml over 70% i en periode på 8 timer; koncentrationen af frit tazobactam var højere end 1 mikrog/ml over 60% i en periode på 8 timer.
English: 2 g ceftolozane / 1 g tazobactam
Danish: 2 g ceftolozan/ 1 g tazobactam
English: Ceftolozane/tazobactam is not active against bacteria that produce beta-lactamase enzymes which are not inhibited by tazobactam.
Danish: Ceftolozan/tazobactam er ikke aktivt mod bakterier, der producerer beta-lactamase-enzymer, som ikke hæmmes af tazobactam.
English: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions are possible (see sections 4.3 and 4.8).
Danish: Alvorlige og i nogle tilfælde dødelige overfølsomhedsreaktioner (anafylaksi) er mulige (se pkt.
English: Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterial agents may also be hypersensitive to ceftolozane/tazobactam.
Danish: Patienter, der tidligere har haft overfølsomhedsreaktioner over for cefalosporiner, penicilliner eller andre beta-lactamantibiotika, kan også være overfølsomme over for ceftolozan/tazobactam.
English: 3, increased serum gamma-glutamyl transpeptidase (GGT)
Danish: 3, forhøjet gamma-glutamyl-transpeptidase (GGT) i serum
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Zerbaxa therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Danish: Det skal besluttes, om amning skal ophøre eller behandling med Zerbaxa seponeres, idet der tages højde for fordelene ved amning for barnet i forhold til de terapeutiske fordele for moderen.
English: No significant medicinal product interactions are anticipated between ceftolozane/tazobactam and substrates, inhibitors, and inducers of cytochrome P450 enzymes (CYPs) based on in vitro and in vivo studies.
Danish: Der forventes ingen signifikante lægemiddelinteraktioner mellem ceftolozan/tazobactam og substrater for, inhibitorer og induktorer af CYP-isoenzymer (CYPer) baseret på in vitro- og in vivo-studier.
English: Zerbaxa can be removed by haemodialysis.
Danish: Zerbaxa kan fjernes ved hæmodialyse.
English: In clinical trials of complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis, the efficacy of ceftolozane/tazobactam was lower in patients with moderate renal impairment compared with those with normal or mildly impaired renal function at baseline.
Danish: I kliniske studier af komplicerede intraabdominale infektioner og komplicerede urinvejsinfektioner, herunder pyelonefritis, var virkningen af ceftolozan/tazobactam mindre hos patienter med moderat nedsat nyrefunktion sammenlignet med patienter med normal eller let nedsat nyrefunktion ved baseline.
English: Skin and subcutaneous tissue disorders
Danish: Hud og subkutane væv Udslæt
English: Carcinogenicity studies with ceftolozane/tazobactam have not been conducted.
Danish: Karcinogenicitetsstudier er ikke udført med ceftolozan/tazobactam.
English: Table 2: Recommended intravenous dose regimens for Zerbaxa in patients with creatinine clearance ≤ 50 mL/min
Danish: Tabel 2: Anbefalede intravenøse doseringsregimer for Zerbaxa hos patienter med kreatininclearance ≤ 50 ml/min
English: The incidence of seroconversion to a positive direct Coombs test was 31.2% in patients receiving Zerbaxa and 3.6% in patients receiving meropenem in the hospital-acquired pneumonia, including ventilator-associated pneumonia clinical trial.
Danish: Incidensen af serokonversion til en positiv direkte Coombs test var 31,2% hos patienter, der fik Zerbaxa, og 3,6% hos patienter, der fik meropenem, i kliniske studier af hospitalserhvervet pneumoni, herunder respiratorassocieret pneumoni.
English: Adverse reactions not observed in clinical studies, but seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows: ceftolozane administered to rats during pregnancy and lactation was associated with a decrease in auditory startle response in postnatal day (PND) 60 male pups at maternal doses of 300 and 1,000 mg/kg/day.
Danish: Bivirkninger, som ikke er observeret i kliniske studier, men er set hos dyr ved eksponering for plasmakoncentrationer svarende til human-terapeutiske doser, kan muligvis være relevante ved klinisk anvendelse som følger: Ceftolozan administreret i rotter under drægtighed og diegivning var associeret med et fald i respons på pludselige høje lyde hos hanunger postnatalt på dag (postnatal day, PND) 60 ved doser på 300 og 1.000 mg/kg/dag administreret i moderdyrene.
English: See section 4.2 of the Summary of Product Characteristics for recommended dose regimens for Zerbaxa based on indication and renal function.
Danish: 4.2 i produktresuméet for oplysninger om anbefalede dosisregimer for Zerbaxa baseret på indikation og nyrefunktion.
English: The recommended dose of Zerbaxa is 1 g of ceftolozane and 0.5 g of tazobactam or 2 g of ceftolozane and 1 g of tazobactam every 8 hours, which is given into one of your veins (directly into the bloodstream).
Danish: Den anbefalede dosis Zerbaxa er 1 g ceftolozan og 0,5 g tazobactam eller 2 g ceftolozan og 1 g tazobactam hver 8. time, som gives i en af dine blodårer (direkte ind i blodet).
English: The respective tazobactam dose normalized geometric mean AUC increased approximately up to 1.3-fold, 2-fold, and 4-fold.
Danish: Det normaliserede geometriske gennemsnit for tazobactamdosens AUC steg op til henholdsvis ca. 1,3 gange, 2 gange og 4 gange.
English: Plasma levels of ceftolozane/tazobactam do not increase appreciably following multiple IV infusions of up to 2.0 g / 1.0 g administered every 8 hours for up to 10 days in healthy adults with normal renal function.
Danish: Ceftolozan/tazobactams plasmaniveau stiger ikke mærkbart efter flere intravenøse infusioner med op til 2,0 g / 1,0 g administreret hver 8. time i op til 10 dage hos raske voksne med normal nyrefunktion.
English: Metabolism and nutrition disorders
Danish: Metabolisme og ernæring Hypokalæmi
English: Ceftolozane/tazobactam contains 230 mg sodium per vial, equivalent to 11.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Danish: Ceftolozan/tazobactam indeholder 230 mg natrium pr. hætteglas, svarende til 11,5% af den WHO anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
English: Complicated intra-abdominal infections
Danish: Komplicerede intraabdominale infektioner
English: The elimination half-life (t½) of ceftolozane is independent of dose.
Danish: Halveringstiden for elimination (t½) af ceftolozan er uafhængig af dosis.
English: Unopened vials: Store in a refrigerator (2°C - 8°C).
Danish: Hætteglas inden åbning: Opbevares i køleskab (2 °C - 8 °C).
English: No dose adjustment of ceftolozane/tazobactam is recommended for hospital-acquired pneumonia, including ventilatorassociated pneumonia patients with augmented renal clearance.
Danish: Dosisjustering af ceftolozan/tazobactam anbefales ikke for patienter med hospitalserhvervet pneumoni, herunder respiratorassocieret pneumoni og forøget renal clearance.
English: Other medicines and Zerbaxa
Danish: Brug af anden medicin sammen med Zerbaxa
English: Tazobactam is a beta-lactam structurally related to penicillins.
Danish: Tazobactam er et beta-lactam, hvis struktur minder om penicillins.
English: After a single dose of ceftolozane/tazobactam, renal clearance of ceftolozane (3.41 - 6.69 L/h) was similar to plasma clearance (4.10 - 6.73 L/h) and similar to the glomerular filtration rate for the unbound fraction, suggesting that ceftolozane is eliminated by the kidney via glomerular filtration.
Danish: Efter en enkelt dosis ceftolozan/tazobactam svarede ceftolozans renale clearance (3,41 - 6,69 l/t) til plasmaclearance (4,106,73 l/t) og til den glomerulære filtrationsrate for den ubundne fraktion, hvilket tyder på, at ceftolozan udskilles af nyren via glomerulær filtration.
English: What Zerbaxa contains - The active substances are ceftolozane and tazobactam.
Danish: Zerbaxa indeholder: - Aktive stoffer: ceftolozan og tazobactam.