natgillin/translations-raw huggingface dataset:
Da ceftolozan/tazobactam ikke metaboliseres i leveren, forventes ceftolozan/tazobactams systemiske clearance ikke at blive påvirket af nedsat leverfunktion.
As ceftolozane/tazobactam does not undergo hepatic metabolism, the systemic clearance of ceftolozane/tazobactam is not expected to be affected by hepatic impairment.
Blod og lymfesystem Trombocytose
Blood and the lymphatic system disorders
Komplicerede urinvejsinfektioner, herunder pyelonefritis
Complicated urinary tract infections, including pyelonephritis
- Øvrige indholdsstoffer: natriumchlorid, arginin og citronsyre, vandfri.
- The other excipients are sodium chloride, arginine, and citric acid, anhydrous.
Til doser over 1 g ceftolozan og 0,5 g tazobactam skal der anvendes to hætteglas.
For doses above 1 g ceftolozane and 0.5 g tazobactam, two vials are used.
Ceftolozan er et antimikrobielt middel, der tilhører cefalosporingruppen.
Ceftolozane belongs to the cephalosporin class of antimicrobials.
In vitro-studier påviste, at ceftolozan, tazobactam og M1-metabolitten af tazobactam ikke hæmmede CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 eller CYP3A4 og ikke inducerede CYP1A2, CYP2B6 eller CYP3A4 ved terapeutiske plasmakoncentrationer.
In vitro studies demonstrated that ceftolozane, tazobactam and the M1 metabolite of tazobactam did not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, or CYP3A4 and did not induce CYP1A2, CYP2B6, or CYP3A4 at therapeutic plasma concentrations.
Det normaliserede geometriske gennemsnit for ceftolozandosens AUC steg op til 1,26 gange, 2,5 gange og 5 gange hos forsøgspersoner med henholdsvis let, moderat og svært nedsat nyrefunktion sammenlignet med raske forsøgspersoner med normal nyrefunktion.
The ceftolozane dose normalized geometric mean AUC increased up to 1.26-fold, 2.5-fold, and 5-fold in subjects with mild, moderate, and severe renal impairment, respectively, compared to healthy subjects with normal renal function.
Det anbefalede intravenøse dosisregime til patienter med kreatininclearance > 50 ml/min er vist for hver infektionstype i tabel 1.
The recommended intravenous dose regimen for patients with creatinine clearance > 50 mL/min is shown by infection type in Table 1.
De mest almindelige bivirkninger (≥ 5% i et fase 3-studie af hospitalserhvervet pneumoni, herunder respiratorassocieret pneumoni), der forekom hos de patienter, der fik Zerbaxa, var diarré, forhøjet alaninaminotransferase og forhøjet aspartataminotransferase, og sværhedsgraden var generelt let eller moderat.
The most common adverse reactions (≥ 5% in a Phase 3 trial of hospital-acquired pneumonia, including ventilator-associated pneumonia) occurring in patients receiving Zerbaxa were diarrhoea, alanine aminotransferase increased, and aspartate aminotransferase increased and were generally mild or moderate in severity.
Hyperglykæmi hypomagnesiæmi hypofosfatæmi
Hyperglycaemia hypomagnesaemia hypophosphataemia
Halveringstiden for elimination (t½) af ceftolozan eller tazobactam er uafhængig af dosis.
The elimination half-life (t½) of ceftolozane or tazobactam is independent of dose.
Hos forsøgspersoner i hæmodialyse med nyresygdom i slutstadiet fjernes ca. to tredjedele af ceftolozan/tazobactam-dosen ved hæmodialyse.
In subjects with end stage renal disease on haemodialysis, approximately two-thirds of the administered ceftolozane/tazobactam dose is removed by haemodialysis.
Ceftolozan/tazobactam skal anvendes med forsigtighed hos patienter med tidligere overfølsomhedsreaktioner af enhver anden type over for penicilliner eller andre beta-lactamantibiotika.
Ceftolozane/tazobactam should be used with caution in patients with a history of any other type of hypersensitivity reaction to penicillins or other beta-lactam antibacterial agents.
Gramnegative bakterier Escherichia coli Klebsiella pneumoniae Proteus mirabilis
Gram-negative bacteria Escherichia coli Klebsiella pneumoniae Proteus mirabilis
Det indeholder to aktive stoffer: - ceftolozan, et antibiotikum som tilhører gruppen "cefalosporiner", og som kan dræbe visse bakterier, der medfører infektion.
It contains two active substances: - ceftolozane, an antibiotic that belongs to the group of “cephalosporins” and which can kill certain bacteria that can cause infection; - tazobactam, which blocks the action of certain enzymes called beta-lactamases.
Infektionstype
Type of infection
**Baseret på 2 g ceftolozan / 1 g tazobactam intravenøst hver 8. time.
**Based on 2 g ceftolozane / 1 g tazobactam intravenously every 8 hours.
Når pulveret er rekonstitueret med 10 ml natriumchloridinjektionsvæske 9 mg/ml (0,9%), indeholder hætteglasset 11,5 mmol (265 mg) natrium.
When the powder is reconstituted with 10 mL of sodium chloride 9 mg/mL (0.9%) solution for injection, the vial contains 11.5 mmol (265 mg) of sodium.
Ceftolozan/tazobactams gennemsnitlige fordelingsvolumen ved steady-state (variationskoefficient CV%) hos raske voksne mænd (n=51) efter en enkelt intravenøs dosis på 1 g / 0,5 g var 13,5 l (21%) og 18,2 l (25%) for henholdsvis ceftolozan og tazobactam, hvilket svarer til den ekstracellulære væskevolumen.
The mean (coefficient of variation CV%) steady-state volume of distribution of ceftolozane/tazobactam in healthy adult males (n=51) following a single 1 g / 0.5 g IV dose was 13.5 L (21%) and 18.2 L (25%) for ceftolozane and tazobactam, respectively, similar to extracellular fluid volume.
Ceftolozan, tazobactam og tazobactammetabolitten M1 elimineres via nyrerne.
Ceftolozane, tazobactam and the tazobactam metabolite M1 are eliminated by the kidneys.
Zerbaxa kan forårsage svimmelhed, som kan påvirke evnen til at føre motorkøretøj og betjene maskiner.
Driving and using machines Zerbaxa may cause dizziness, which can affect your ability to drive and use machines.
Et af de aktive stoffer, ceftolozan, kan have skadelig effekt, hvis det udledes i vandmiljøet (se pkt.
One of the active ingredients, ceftolozane, may have harmful effects if it reaches the aquatic environment (see section 5.3).
Det rekonstituerede hætteglas med 10 ml 0,9% natriumchloridinjektionsvæske (normal saltvandsopløsning) indeholder 265 mg natrium pr. hætteglas, svarende til 13,3% af den WHO anbefalede maksimale daglige indtagelse af 2 g natrium for en voksen.
The reconstituted vial with 10 mL of 0.9% sodium chloride (normal saline) for injection contains 265 mg sodium per vial, equivalent to 13.3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
De mest almindelige bivirkninger (≥ 3% i puljede fase-3 studier af komplicerede intraabdominale infektioner og komplicerede urinvejsinfektioner, herunder pyelonefritis), der forekom hos de patienter, der fik Zerbaxa, var kvalme, hovedpine, obstipation, diarré og pyreksi, og sværhedsgraden var generelt let eller moderat.
The most common adverse reactions (≥ 3% in pooled Phase 3 trials of complicated intra-abdominal infections and complicated urinary tract infections, including pyelonephritis) occurring in patients receiving Zerbaxa were nausea, headache, constipation, diarrhoea, and pyrexia and were generally mild or moderate in severity.
Ceftolozan/tazobactam-dosis bør justeres på baggrund af nyrefunktionen (se pkt.
The ceftolozane/tazobactam dose should be adjusted based on renal function (see section 4.2, Table 2).
Tabel 1: Intravenøs Zerbaxadosis for hver infektionstype hos patienter med kreatininclearance > 50 ml/min
Table 1: Intravenous dose of Zerbaxa by type of infection in patients with creatinine clearance > 50 mL/min
Hjælpestof, som behandleren skal være opmærksom på Hvert hætteglas indeholder 10 mmol (230 mg) natrium.
Excipient with known effect Each vial contains 10 mmol (230 mg) of sodium.
1, udspilet abdomen dyspepsi
1, abdominal distension dyspepsia
Antibakteriel-associeret colitis og pseudomembranøs colitis er blevet rapporteret med ceftolozan/tazobactam (se pkt.
Antibacterial-associated colitis and pseudomembranous colitis have been reported with ceftolozane/tazobactam (see section 4.8).
20 ml hætteglas (type I, klart glas) med prop (brombutylgummi) og en flip off-hætte som forsegling.
20 mL vial (Type I clear glass) with stopper (bromobutyl rubber) and flip-off seal.
Hospitalserhvervet pneumoni, herunder respiratorassocieret pneumoni** *Baseret på 1 g ceftolozan / 0,5 g tazobactam intravenøst hver 8. time.
Hospital-acquired pneumonia, including ventilator-associated pneumonia** *Based on 1 g ceftolozane / 0.5 g tazobactam intravenously every 8 hours.
Cmax og AUC for ceftolozan/tazobactam forøges omtrent proportionalt med dosis inden for ceftolozans enkeltdosisinterval på 250 mg til 3 g og tazobactams enkeltdosisinterval på 500 mg til 1,5 g. Der sås ingen væsentlig akkumulering af ceftolozan/tazobactam efter flere intravenøse infusioner af 1 times varighed med 1 g / 0,5 g ceftolozan/tazobactam eller 2 g / 1 g ceftolozan/tazobactam administreret hver 8. time i op til 10 dage hos raske voksne med normal nyrefunktion.
The Cmax and AUC of ceftolozane/tazobactam increase approximately in proportion to dose within ceftolozane single-dose range of 250 mg to 3 g and tazobactam single-dose range of 500 mg to 1.5 g. No appreciable accumulation of ceftolozane/tazobactam is observed following multiple 1-hour IV infusions of 1 g / 0.5 g ceftolozane/tazobactam or 2 g / 1 g ceftolozane/tazobactam administered every 8 hours for up to 10 days in healthy adults with normal renal function.
Gramnegative bakterier Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens
Gram-negative bacteria Enterobacter cloacae Escherichia coli Haemophilus influenzae Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa Serratia marcescens
Efter en enkelt intravenøs infusion af 1 times varighed med 2 g / 1 g ceftolozan/tazobactam til kritisk syge patienter med kreatininclearance (CrCL) højere end eller lig med 180 ml/min (N=10) var den gennemsnitlige terminale halveringstid for ceftolozan og tazobactam henholdsvis 2,6 timer og 1,5 timer.
Following a single 1-hour intravenous infusion of 2 g / 1 g ceftolozane/tazobactam to critically ill patients with CrCL greater than or equal to 180 mL/min (N=10), mean terminal half-life values of ceftolozane and tazobactam were 2.6 hours and 1.5 hours, respectively.
Hvert hætteglas med pulver til koncentrat til infusionsvæske, opløsning, rekonstitueres med 10 ml vand til injektionsvæsker eller natriumchloridinjektionsvæske 9 mg/ml (0,9%) pr. hætteglas; efter rekonstitution omrystes hætteglasset forsigtigt for at opløse pulveret.
The powder for concentrate for solution for infusion for each vial is reconstituted with 10 mL of water for injections or sodium chloride 9 mg/mL (0.9%) solution for injection per vial; following reconstitution the vial should be shaken gently to dissolve the powder.
Natriumchlorid, arginin, citronsyre; vandfri
Sodium chloride, arginine, citric acid, anhydrous
1 g ceftolozan/ 0,5 g tazobactam
1 g ceftolozane / 0.5 g tazobactam
I en populationsfarmakokinetisk analyse af ceftolozan/tazobactam sås ingen klinisk relevante forskelle i AUC for ceftolozan og tazobactam.
In a population pharmacokinetic analysis of ceftolozane/tazobactam, no clinically relevant differences in AUC were observed for ceftolozane and tazobactam.
Gælder for alle indikationer: komplicerede intraabdominale infektioner, akut pyelonefritis, komplicerede urinvejsinfektioner og hospitalserhvervet pneumoni, herunder respiratorassocieret pneumoni.
Applies across all indications: complicated intra-abdominal infections, acute pyelonephritis, complicated urinary tract infections, and hospital-acquired pneumonia, including ventilator-associated pneumonia.
Pulver til koncentrat til infusionsvæske, opløsning 10 hætteglas
Powder for concentrate for solution for infusion 10 vials
1, svimmelhed
1, dizziness
In vitro-data indikerer, at ceftolozan ikke hæmmede P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, MRP, BSEP, OAT1, OAT3, MATE1 eller MATE2-K in vitro ved terapeutiske plasmakoncentrationer.
In vitro data indicate that ceftolozane did not inhibit P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, MRP, BSEP, OAT1, OAT3, MATE1, or MATE2-K in vitro at therapeutic plasma concentrations.
1, angina pectoris
Atrial fibrillation 1, tachycardia angina pectoris
I en populationsfarmakokinetisk analyse af ceftolozan/tazobactam sås ingen klinisk relevante forskelle i ceftolozan/tazobactams AUC hos kaukasere sammenlignet med andre etniske afstamninger.
In a population pharmacokinetic analysis of ceftolozane/tazobactam, no clinically relevant differences in ceftolozane/tazobactam AUC were observed in Caucasians compared to other ethnicities.
Dyrestudier med tazobactam har påvist reproduktionstoksicitet (se pkt.
Animal studies with tazobactam have shown reproductive toxicity (see section 5.3) without evidence of teratogenic effects.
Ceftolozan/tazobactam er også kontraindiceret hos patienter med svær overfølsomhed (f.eks. anafylaktisk reaktion, svær hudreaktion) over for alle andre typer beta-lactamantibiotika (f.eks. penicilliner eller carbapenemer) (se pkt.
Ceftolozane/tazobactam is also contraindicated in patients with severe hypersensitivity (e.g., anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins or carbapenems) (see section 4.3).
Nedsat leverfunktion Dosisjustering er ikke nødvendig hos patienter med nedsat leverfunktion (se pkt.
Hepatic impairment No dose adjustment is necessary in patients with hepatic impairment (see section 5.2).
Gramnegative bakterier Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
Gram-negative bacteria Enterobacter cloacae Escherichia coli Klebsiella oxytoca Klebsiella pneumoniae Proteus mirabilis Pseudomonas aeruginosa
Specifikt for indikationerne komplicerede intraabdominale infektioner, akut pyelonefritis og komplicerede urinvejsinfektioner behandlet med Zerbaxa (1 g / 0,5 g intravenøst hver 8. time) i op til 14 dage.
Specific for the complicated intra-abdominal infections, acute pyelonephritis, and complicated urinary tract infections indications treated with Zerbaxa (1 g / 0.5 g intravenously every 8 hours) for up to 14 days.
Zerbaxa er et hvidt til svagt gult pulver til koncentrat til infusionsvæske, opløsning (pulver til koncentrat), der leveres i et hætteglas.
What Zerbaxa looks like and contents of the pack Zerbaxa is a white to slightly yellow powder for concentrate for solution for infusion (powder for concentrate) supplied in a vial.
Dog tyder in vitro-studier på følsomhed over for Zerbaxa ved fravær af erhvervede resistensmekanismer:
Clinical efficacy has not been established against the following pathogens although in vitro studies suggest that they would be susceptible to Zerbaxa in the absence of acquired mechanisms of resistance:
Sådan skal du tage Zerbaxa
How to take Zerbaxa
Der foreligger ingen studier af ceftolozans og tazobactams påvirkning af fertiliteten hos mennesker.
The effects of ceftolozane and tazobactam on fertility in humans have not been studied.
Efter intravenøs infusion af 1 times varighed med 2 g / 1 g ceftolozan/tazobactam eller justeret i forhold til nyrefunktionen hver 8. time hos respirator-patienter med bekræftet eller mistænkt pneumoni (N=22) var koncentrationerne af ceftolozan og tazobactam i lungevæsken (epithelial lining fluidELF) højere end henholdsvis 8 mikrog/ml og 1 mikrog/ml, over 100% af doseringsintervallet.
Following 1 hour intravenous infusions of 2 g / 1 g ceftolozane/tazobactam or adjusted based on renal function every 8 hours in ventilated patients with confirmed or suspected pneumonia (N=22), ceftolozane and tazobactam concentrations in pulmonary epithelial lining fluid were greater than 8 mcg/mL and 1 mcg/mL, respectively, over 100% of the dosing interval.
2, unormal leverfunktionstest
2, liver function test abnormal
Zerbaxa blev evalueret i komparatorkontrollerede kliniske fase 3-studier af komplicerede intraabdominale infektioner og komplicerede urinvejsinfektioner (herunder pyelonefritis), som omfattede i alt 1.015 patienter, der blev behandlet med Zerbaxa (1 g / 0,5 g intravenøst hver 8. time, justeret i forhold til nyrefunktionen, hvor dette var relevant) i op til 14 dage.
Zerbaxa was evaluated in Phase 3 comparator-controlled clinical trials of complicated intra-abdominal infections and complicated urinary tract infections (including pyelonephritis), which included a total of 1,015 patients, treated with Zerbaxa (1 g / 0.5 g intravenously every 8 hours, adjusted to match renal function where appropriate) for up to 14 days.
Dosisjustering er ikke nødvendig hos patienter med let nedsat nyrefunktion (estimeret kreatininclearance [CrCl] > 50 ml/min) (se pkt.
In patients with mild renal impairment (estimated creatinine clearance [CrCL] > 50 mL/min), no dose adjustment is necessary, see section 5.2.
Zerbaxa blev evalueret i et komparatorkontrolleret klinisk fase 3-studie af hospitalserhvervet pneumoni, herunder respiratorassocieret pneumoni, som omfattede i alt 361 patienter, der blev behandlet med Zerbaxa (2 g / 1 g intravenøst hver 8. time, justeret i forhold til nyrefunktionen, hvor dette var relevant) i op til 14 dage.
Zerbaxa was evaluated in a Phase 3 comparator-controlled clinical trial of hospital-acquired pneumonia, including ventilator-associated pneumonia, which included a total of 361 patients, treated with Zerbaxa (2 g / 1 g intravenously every 8 hours, adjusted to match renal function where appropriate) for up to 14 days.
Koncentratet indeholder 88 mg/ml ceftolozan og 44 mg/ml tazobactam.
The resultant concentration is approximately 132 mg/mL (88 mg/mL of ceftolozane and 44 mg/mL of tazobactam) per vial.
- Hvert hætteglas indeholder ceftolozansulfat svarende til 1 g ceftolozan og tazobactamnatrium svarende til 0,5 g tazobactam.
- Each vial contains ceftolozane sulfate equivalent to 1 g ceftolozane and tazobactam sodium equivalent to 0.5 g tazobactam.
Ceftolozan/tazobactam og tazobactammetabolitten M1 udskilles via nyrerne.
Ceftolozane/tazobactam and the tazobactam metabolite M1 are eliminated by the kidneys.
Det rekonstituerede hætteglas med 10 ml 0,9% natriumchloridinjektionsvæske (normal saltvandsopløsning) indeholder 265 mg natrium i hvert hætteglas.
The reconstituted vial with 10 mL of 0.9% sodium chloride (normal saline) for injection contains 265 mg sodium in each vial.
Ceftolozan/tazobactam er kontraindiceret hos patienter med tidligere overfølsomhed over for ceftolozan, tazobactam eller cefalosporiner (se pkt.
Ceftolozane/tazobactam is contraindicated in patients with a history of hypersensitivity to ceftolozane, tazobactam, or cephalosporins (see section 4.3).
1, paralytisk ileus
1, flatulence 1, ileus paralytic
Komplicerede intraabdominale infektioner, komplicerede urinvejsinfektioner og akut pyelonefritis**
Complicated intra-abdominal infections, complicated urinary tract infections, and acute pyelonephritis**
500 mg ceftolozan/ 250 mg tazobactam intravenøst hver 8. time
500 mg ceftolozane / 250 mg tazobactam intravenously every 8 hours
250 mg ceftolozan/ 125 mg tazobactam intravenøst hver 8. time
250 mg ceftolozane / 125 mg tazobactam intravenously every 8 hours
Komplicerede intraabdominale infektioner* Komplicerede urinvejsinfektioner* Akut pyelonefritis*
Complicated intra-abdominal infections* Complicated urinary tract infections* Acute pyelonephritis*
Hospitalserhvervet pneumoni, herunder respiratorassocieret pneumoni**
Hospital-acquired pneumonia, including ventilator-associated pneumonia**
Hvert hætteglas indeholder ceftolozansulfat svarende til 1 g ceftolozan og tazobactamnatrium svarende til 0,5 g tazobactam.
Each vial contains ceftolozane sulfate equivalent to 1 g ceftolozane and tazobactam sodium equivalent to 0.5 g tazobactam.
1 g ceftolozan/ 0,5 g tazobactam intravenøst hver 8. time
1 g ceftolozane / 0.5 g tazobactam intravenously every 8 hours
Den anbefalede dosis hos patienter med komplicerede intraabdominale infektioner, komplicerede urinvejsinfektioner og akut pyelonefritis i hæmodialyse med nyresygdom i slutstadiet er en enkelt støddosis på 500 mg / 250 mg ceftolozan/tazobactam efterfulgt af en vedligeholdelsesdosis på 100 mg / 50 mg ceftolozan/tazobactam, administreret hver 8. time i den resterende behandlingsperiode.
The recommended dose in complicated intra-abdominal infections, complicated urinary tract infections, and acute pyelonephritis subjects with end stage renal disease on haemodialysis is a single loading dose of 500 mg / 250 mg ceftolozane/tazobactam followed by a 100 mg / 50 mg maintenance dose of ceftolozane/tazobactam administered every 8 hours for the remainder of the treatment period.
Disse enzymer kan gøre bakterier resistente over for ceftolozan ved at nedbryde det antibiotiske lægemiddel, før det kan virke.
These enzymes make bacteria resistant to ceftolozane by breaking down the antibiotic before it can act. By blocking their action, tazobactam makes ceftolozane more effective at killing bacteria.
In vitro-data indikerer, at hverken tazobactam eller tazobactammetabolitten M1 hæmmer transportørerne P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2 eller BSEP ved terapeutiske plasmakoncentrationer.
In vitro data indicate that neither tazobactam nor the tazobactam metabolite M1 inhibit P-gp, BCRP, OATP1B1, OATP1B3, OCT1, OCT2, or BSEP transporters at therapeutic plasma concentrations.
- Diarré som bliver alvorlig, eller som ikke går væk, eller blod eller slim i afføringen under eller efter behandling med Zerbaxa.
These may be signs of a severe allergic reaction (anaphylaxis) and may be lifethreatening - Diarrhoea that becomes severe or does not go away or stool that contains blood or mucus during or after treatment with Zerbaxa.
Specifikt for indikationen hospitalserhvervet pneumoni, herunder respiratorassocieret pneumoni, behandlet med Zerbaxa (2 g / 1 g intravenøst hver 8. time) i op til 14 dage.
Specific for the hospital-acquired pneumonia, including ventilator-associated pneumonia indication treated with Zerbaxa (2 g / 1 g intravenously every 8 hours) for up to 14 days.
Zerbaxa 1 g/0,5 g pulver til koncentrat ceftolozan/tazobactam
Zerbaxa 1 g / 0.5 g powder for concentrate ceftolozane / tazobactam
Den anbefalede dosis hos forsøgspersoner med hospitalserhvervet pneumoni, herunder respiratorassocieret pneumoni, i hæmodialyse med nyresygdom i slutstadiet er en enkelt støddosis på 1,5 g / 0,75 g ceftolozan/tazobactam efterfulgt af en vedligeholdelsesdosis på 300 mg / 150 mg ceftolozan/tazobactam, administreret hver 8. time i den resterende behandlingsperiode.
The recommended dose in hospital-acquired pneumonia, including ventilator-associated pneumonia subjects with end stage renal disease on haemodialysis is a single loading dose of 1.5 g / 0.75 g ceftolozane/tazobactam followed by a 300 mg / 150 mg maintenance dose of ceftolozane/tazobactam administered every 8 hours for the remainder of the treatment period.
En enkelt støddosis på 500 mg ceftolozan/ 250 mg tazobactam, som efter 8 timer efterfølges af en vedligeholdelsesdosis på 100 mg ceftolozan/ 50 mg tazobactam, der administreres hver 8. time i den resterende del af behandlingstiden (på hæmodialysedage skal dosis administreres så tidligt som muligt, efter at hæmodialysen er afsluttet)
A single loading dose of 500 mg ceftolozane / 250 mg tazobactam followed after 8 hours by a 100 mg ceftolozane / 50 mg tazobactam maintenance dose administered every 8 hours for the remainder of the treatment period (on haemodialysis days, the dose should be administered at the earliest possible time following completion of haemodialysis)
6.1 - Overfølsomhed over for alle cefalosporin-antibiotika - Svær overfølsomhed (f.eks. anafylaktisk reaktion, svær hudreaktion) over for alle andre typer beta-lactamantibiotika (f.eks. penicilliner eller carbapenemer).
- Hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - Hypersensitivity to any cephalosporin antibacterial agent; - Severe hypersensitivity (e.g., anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e.g., penicillins or carbapenems).