natgillin/translations-raw huggingface dataset:
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. 
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.
I denne situation må du ikke tage medicin, der stopper eller hæmmer afføringen. 
In this situation, you should not take medicines that stop or slow bowel movement
Kontakt lægen eller apotekspersonalet, hvis du får diarré, mens du tager Zerbaxa. 
Talk to your doctor or pharmacist if you develop diarrhoea while taking Zerbaxa.
Tazobactam hæmmer ikke alle klasse A-enzymer. 
Tazobactam does not inhibit all Class A enzymes.
Dosisjustering anbefales ikke på baggrund af race. 
No dose adjustment is recommended based on race.
Virkning er påvist i kliniske studier mod de patogener anført under hver indikation, der var følsomme over for Zerbaxa in vitro: 
Efficacy has been demonstrated in clinical studies against the pathogens listed under each indication that were susceptible to Zerbaxa in vitro:
In vitro-data indikerer, at følgende arter ikke er følsomme over for ceftolozan/tazobactam: Staphylococcus aureus 
In vitro data indicate that the following species are not susceptible to ceftolozane/tazobactam: Staphylococcus aureus
Fremstilling af opløsninger 
Preparation of solutions
Følsom Resistent 
Susceptible Resistant
Til intravenøs anvendelse efter rekonstitution og fortynding. 
For intravenous use after reconstitution and dilution.
Metallo-beta-lactamaser (fx New Delhi metallo-beta-lactamase [NDM]) iv. Ambler klasse D beta-lactamaser (OXA-carbapenemaser). 
Metallo-beta-lactamases (e.g., New Delhi metallo-beta-lactamase [NDM]) iv. Ambler Class D beta-lactamases (OXA-carbapenemases)
Den gennemsnitlige terminale halveringstid for elimination for ceftolozan og tazobactam hos raske voksne med normal nyrefunktion er henholdsvis ca. 3 timer og 1 time. 
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.
I de kliniske studier var der ikke tegn på hæmolyse hos patienter, som udviklede en positiv DAGT under behandlingen. 
In clinical studies, there was no evidence of haemolysis in patients who developed a positive DAGT on treatment.
Der er ingen data fra anvendelse af ceftolozan/tazobactam til gravide kvinder. 
There are no data on the use of ceftolozane/tazobactam in pregnant women.
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. 
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.
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. 
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.
For at bevare den samme systemiske eksponering som ved normal nyrefunktion er dosisjustering påkrævet (se pkt. 
To maintain similar systemic exposures to those with normal renal function, dosage adjustment is required (see section 4.2).
- 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). 
- 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).
Studier med ceftolozan hos mus og rotter har ikke vist tegn på reproduktionstoksicitet eller teratogenicitet. 
Studies with ceftolozane in mice and rats have not shown evidence of reproductive toxicity or teratogenicity.
Zerbaxa indeholder natrium 
Zerbaxa contains sodium
Det er uvist, om ceftolozan krydser placentabarrieren. 
It is not known if ceftolozane crosses the placenta.
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. 
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.
Resistensmekanismer 
Mechanisms of resistance
Følgende bivirkninger blev identificeret under kliniske studier med Zerbaxa. 
The following adverse reactions have been identified during clinical trials with Zerbaxa.
Svimmelhed kan forekomme efter administration af Zerbaxa (se pkt. 
Dizziness may occur following administration of Zerbaxa (see section 4.8).
I kliniske studier var der ingen tegn på hæmolyse hos patienter, der udviklede en positiv direkte Coombs test i nogen af behandlingsgrupperne. 
In clinical studies, there was no evidence of haemolysis in patients who developed a positive direct Coombs test in any treatment group.
Pakningsstørrelse med 10 hætteglas. 
Pack size of 10 vials.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ 
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
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). 
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).
Det er en hæmmer af mange molekylære klasse A beta-lactamaser, herunder CTX-M-, SHV- og TEM-enzymer. 
It is an inhibitor of many molecular Class A beta-lactamases, including CTX-M, SHV, and TEM enzymes.
Miljørisikovurderingsstudier har vist, at et af de aktive stoffer, ceftolozan, kan udgøre en risiko for organismer i overfladevand (se pkt. 
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).
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. 
If you are pregnant or breast-feeding, or think you may be pregnant, ask your doctor or pharmacist for advice before taking this medicine.
Fertilitetsstudier med rotter viste ingen påvirkning af fertilitet og parring efter intraperitoneal administration af tazobactam eller intravenøs administration af ceftolozan (se pkt 5.3). 
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).
Immunkompromitterede patienter, patienter med svær neutropeni og patienter i hæmodialyse med nyresygdom i slutstadiet blev udelukket fra kliniske studier. 
Patients who were immunocompromised, patients with severe neutropenia, and patients with end stage renal disease on haemodialysis were excluded from clinical trials.
Pædiatriske patienter 
Paediatric patients
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. 
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.
3, obstipation opkastning 3, abdominalsmerter 
3, constipation vomiting 3, abdominal pain
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. 
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.
Det er ukendt, om ceftolozan og tazobactam udskilles i human mælk. 
It is unknown whether ceftolozane and tazobactam are excreted in human milk.
Patienter med nedsat nyrefunktion ved baseline skal monitoreres hyppigt for ændringer i nyrefunktionen under behandlingen, og ceftolozan/tazobactam-dosis skal justeres efter behov. 
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.
Grampositive bakterier Streptococcus anginosus Streptococcus constellatus Streptococcus salivarius 
Gram-positive bacteria Streptococcus anginosus Streptococcus constellatus Streptococcus salivarius
Fremstilling af dosis 
Preparation of doses
Virkning på nyrefunktionen 
Effect on renal function
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. 
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.
Tabel 3: Bivirkninger identificeret under kliniske studier med ceftolozan/tazobactam Systemorganklasse 
Table 3: Adverse reactions identified during clinical trials with ceftolozane/tazobactam System organ class
Hyppighed Infusionstid Behandlingsvarighed 
Frequency Infusion time
Ceftolozan udviser baktericid aktivitet gennem binding til vigtige penicillin-bindende proteiner (PBPer), hvilket fører til, at den bakterielle cellevægsyntese hæmmes, og cellerne derefter dør. 
Ceftolozane exerts bactericidal activity through binding to important penicillin-binding proteins (PBPs), resulting in inhibition of bacterial cell-wall synthesis and subsequent cell death.
Kompliceret intraabdominal infektion* 
Complicated intra-abdominal infection*
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 
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
Tazobactam hæmmede de humane transportører OAT1 og OAT3 med IC50-værdier på henholdsvis 118 og 147 mikrog/ml in vitro. 
In vitro, tazobactam inhibited human OAT1 and OAT3 transporters with IC50 values of 118 and 147 mcg/mL, respectively.
Denne indlægsseddel blev senest ændret {MM/ÅÅÅÅ}. 
This leaflet was last revised in {month YYYY}.
Den højeste enkeltdosis Zerbaxa anvendt i kliniske studier var 3 g / 1,5 g ceftolozan/tazobactam administreret til raske frivillige. 
The highest single dose of Zerbaxa used in clinical trials was 3 g / 1.5 g of ceftolozane/tazobactam administered to healthy volunteers.
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) 
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)
Etnicitet 
Ethnicity
Cmax og AUC for ceftolozan/tazobactam stiger proportionalt med dosis. 
The Cmax and AUC of ceftolozane/tazobactam increase in proportion to dose.
Natriumchlorid Arginin 
Sodium chloride Arginine
Zerbaxa infusionsvæske, opløsning, er klar og farveløs til svagt gul. 
Zerbaxa solution for infusion is clear and colourless to slightly yellow.
Zerbaxa anvendes hos voksne til at behandle komplicerede infektioner i maven, nyrerne og urinvejene samt en infektion i lungerne kaldet ”pneumoni” (lungebetændelse). 
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”.
Tazobactams beta-lactam-ring hydrolyseres, så den danner den farmakologisk inaktive tazobactammetabolit M1. 
The beta-lactam ring of tazobactam is hydrolyzed to form the pharmacologically inactive, tazobactam metabolite M1.
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). 
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).
Candidiasis, inklusive orofaryngeal og vulvovaginal Clostridioides difficile-colitis urinvejsinfektion (svampe) Clostridioides difficile-infektion 
Candidiasis including oropharyngeal and vulvovaginal Clostridioides difficile colitis fungal urinary tract infection Clostridioides difficile infection
Et af de aktive stoffer, ceftolozan, kan have skadelig effekt, hvis det udledes i vandmiljøet. 
One of the active ingredients, ceftolozane, may have harmful effects if it reaches the aquatic environment.
Dette svarer til 11,5% af den anbefalede maksimale daglige indtagelse af natrium for en voksen. 
This is equivalent to 11.5% of the recommended maximum daily dietary intake of sodium for an adult.
Dette svarer til 13,3% af den anbefalede maksimale daglige indtagelse af natrium for en voksen. 
This is equivalent to 13.3% of the recommended maximum daily dietary intake of sodium for an adult.
Der kan udvikles en positiv direkte antiglobulin test (DAGT) under behandling med ceftolozan/tazobactam (se pkt. 
The development of a positive direct antiglobulin test (DAGT) may occur during treatment with ceftolozane/tazobactam (see section 4.8).
Ved hæmodialyse skal dosen administreres umiddelbart efter, at dialysen er afsluttet (se pkt. 
With haemodialysis, the dose should be administered immediately following completion of dialysis (see section 4.2).
Ikke almindelig (≥ 1/1.000 til < 1/100) 
Uncommon (≥ 1/1,000 to < 1/100)
Ceftolozan og tazobactam var ikke substrater for P-gp eller BCRP, og tazobactam var ikke substrat for OCT2 in vitro ved terapeutiske plasmakoncentrationer. 
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.
1, venetrombose 
1, venous thrombosis
Patienter i behandling for komplicerede infektioner i maven, nyrerne og urinvejene Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 personer): 
Patients treated for complicated infections within the abdomen, and kidney and urinary system Common side effects (may affect up to 1 in 10 people):
Det skal du vide, før du begynder at tage Zerbaxa 
What you need to know before you take Zerbaxa
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. 
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.
4.2 for oplysninger om anbefalede dosisregimer for Zerbaxa baseret på indikation og nyrefunktion. 
See section 4.2 for recommended dose regimens for Zerbaxa based on indication and renal function.
Serin-baserede carbapenemaser (fx Klebsiella pneumoniae carbapenemaser [KPCer]) iii. 
Serine-based carbapenemases (e.g., Klebsiella pneumoniae carbapenemases [KPCs]) iii.
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. 
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).
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 
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
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. 
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.
2 g ceftolozan/ 1 g tazobactam 
2 g ceftolozane / 1 g tazobactam
Ceftolozan/tazobactam er ikke aktivt mod bakterier, der producerer beta-lactamase-enzymer, som ikke hæmmes af tazobactam. 
Ceftolozane/tazobactam is not active against bacteria that produce beta-lactamase enzymes which are not inhibited by tazobactam.
Alvorlige og i nogle tilfælde dødelige overfølsomhedsreaktioner (anafylaksi) er mulige (se pkt. 
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions are possible (see sections 4.3 and 4.8).
Fortæl det altid til lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig. 
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Patienter, der tidligere har haft overfølsomhedsreaktioner over for cefalosporiner, penicilliner eller andre beta-lactamantibiotika, kan også være overfølsomme over for ceftolozan/tazobactam. 
Patients who have a history of hypersensitivity to cephalosporins, penicillins or other beta-lactam antibacterial agents may also be hypersensitive to ceftolozane/tazobactam.
3, forhøjet gamma-glutamyl-transpeptidase (GGT) i serum 
3, increased serum gamma-glutamyl transpeptidase (GGT)
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. 
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.
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. 
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.
Zerbaxa kan fjernes ved hæmodialyse. 
Zerbaxa can be removed by haemodialysis.
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. 
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.
Hud og subkutane væv Udslæt 
Skin and subcutaneous tissue disorders
Karcinogenicitetsstudier er ikke udført med ceftolozan/tazobactam. 
Carcinogenicity studies with ceftolozane/tazobactam have not been conducted.
Tabel 2: Anbefalede intravenøse doseringsregimer for Zerbaxa hos patienter med kreatininclearance ≤ 50 ml/min 
Table 2: Recommended intravenous dose regimens for Zerbaxa in patients with creatinine clearance ≤ 50 mL/min
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. 
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.
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. 
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.