FrancophonIA/ELRC3.0 huggingface dataset:
English: Among the 976/1554 (62 %) patients who had a positive baseline stool culture for C. difficile a hypervirulent strain (ribotypes 027, 078 or 244) was isolated in 22 % (217 of 976 patients), of which the majority (87 %, 189 of 217 strains) were ribotype 027.
Danish: Hos 976/1.554 (62 %) af de patienter, der ved baseline havde en positiv fæcesprøve for C. difficile, blev der isoleret en hypervirulent stamme (ribotype 027, 078 eller 244) hos 22 % (217 ud af 976 patienter), hvor størstedelen (87 %, 189 ud af 217 stammer) var ribotype 027.
English: Table 3 shows the results of a prospectively planned combined analysis of the CDI recurrence rates in pre-specified subgroups of patients at high risk for CDI recurrence across the two Phase 3 Trials.
Danish: Tabel 3 viser resultaterne af en prospektivt planlagt kombineret analyse af CDI-recidivraterne hos forudspecificerede subgrupper af patienter med høj risiko for recidiv af CDI i de to fase 3-studier.
English: The number of patients completing the studies and included in the full analysis set (FAS) was 781 in the ZINPLAVA group versus 773 in the placebo group.
Danish: Antallet af patienter, som gennemførte studierne og var inkluderet i det fulde analysesæt (FAS), var 781 i ZINPLAVA-gruppen versus 773 i placebogruppen.
English: Tell your doctor or health care professional if you notice any of the side effects above.
Danish: Fortæl det til lægen eller sundhedspersonalet, hvis du får en eller flere af ovennævnte bivirkninger.
English: In clinical trials, healthy subjects received up to 20 mg/kg, which was generally well tolerated.
Danish: I kliniske studier fik raske forsøgspersoner op til 20 mg/kg, hvilket generelt blev tålt godt.
English: Overall, 10 % of subjects in the ZINPLAVA group experienced one or more infusion specific adverse reactions on the day of, or the day after, the infusion compared to 8 % in the placebo group.
Danish: Samlet set oplevede 10 % af forsøgspersonerne i ZINPLAVA-gruppen en eller flere infusionsreaktioner på infusionsdagen eller dagen efter infusion sammenlignet med 8 % i placebogruppen.
English: The CDI recurrence rates are shown in Table 2.
Danish: CDI-recidivraten er vist i tabel 2.
English: • The diluted solution can be infused via a central line or peripheral catheter.
Danish: • Den fortyndede infusionsvæske kan infunderes via et centralt venekateter eller et perifert kateter.
English: The median age was 65 years, 85 % were white, 57 % were female, and 68 % were inpatients.
Danish: Medianalderen var 65 år, 85 % var kaukasere, 57 % var kvinder, og 68 % var hospitalsindlagte.
English: A single infusion of ZINPLAVA or placebo was administered prior to completion of antibacterial therapy and patients were followed for 12 weeks following the infusion.
Danish: En enkelt infusion af ZINPLAVA eller placebo blev administreret før den antibakterielle behandling var fuldført, og patienterne blev fulgt i 12 uger efter infusionen.
English: The following factors had no clinically meaningful effect on the exposure of bezlotoxumab and no dose adjustment is required: age (range 18 to 100 years), gender, race, ethnicity, renal impairment, hepatic impairment, and presence of co-morbid conditions.
Danish: Følgende faktorer havde ingen klinisk relevant indvirkning på eksponeringen for bezlotoxumab, og det er ikke nødvendigt at justere dosis: alder (18-100 år), køn, race, etnisk oprindelse, nedsat nyrefunktion, nedsat leverfunktion og tilstedeværelse af komorbiditet.
English: History of one or more episodes of CDI in past 6 months Immunocompromised Severe CDI
Danish: En eller flere episoder med CDI inden for de forudgående 6 måneder
English: The frequency of adverse reactions is defined as follows: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000), not known (cannot be estimated from the available data).
Danish: Bivirkningerne er anført efter systemorganklasse og hyppighed, som er defineret på følgende måde: Meget almindelig (≥ 1/10), Almindelig (≥ 1/100 til < 1/10), Ikke almindelig (≥ 1/1.000 til < 1/100), Sjælden (≥ 1/10.000 til < 1/1.000), Meget sjælden (< 1/10.000), Ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: The clearance of bezlotoxumab increased with increasing body weight; the resulting exposure differences are adequately addressed by the administration of a weight-based dose.
Danish: Bezlotoxumabs clearance øgedes i takt med stigende legemsvægt; der tages på passende vis højde for de resulterende forskelle i eksponering ved at administrere en vægtbaseret dosis.
English: ZINPLAVA has no effect on the CDI you have now.
Danish: Zinplava har ingen virkning på den CDI, du har nu.
English: The most common adverse reactions following treatment with ZINPLAVA (reported in ≥ 4 % of patients within the first 4 weeks of infusion) were nausea, diarrhoea, pyrexia and headache.
Danish: De hyppigste bivirkninger efter behandling med ZINPLAVA (rapporteret hos ≥ 4 % af patienterne inden for de første 4 uger efter infusion) var kvalme, diarré, pyreksi og hovedpine.
English: Within each frequency grouping, adverse reactions are presented in order of decreasing frequency.
Danish: Inden for hver frekvensgruppe er bivirkningerne opstillet efter, hvor hyppige de er.
English: Patients received a 10- to 14-day course of oral antibacterial therapy for CDI (metronidazole, vancomycin or fidaxomicin, chosen by the investigator).
Danish: Patienterne fik et 10 til 14 dages forløb med oral antibakteriel behandling mod CDI (metronidazol, vancomycin eller fidaxomicin, valgt af investigator).
English: The toxin B epitope to which bezlotoxumab binds is conserved, though not identical, across all known toxin sequences.
Danish: Toksin B-epitopen, som bezlotoxumab bindes til, bevares, dog ikke i identisk form, på tværs af alle kendte toksin-sekvenser.
English: It is unknown whether bezlotoxumab is secreted in human milk.
Danish: Det er ukendt, om bezlotoxumab udskilles i human mælk.
English: Therapeutic monoclonal antibodies do not typically have significant drug-drug interaction potential, as they do not directly affect cytochrome P450 enzymes and are not substrates of hepatic or renal transporters.
Danish: Terapeutiske monoklonale antistoffer har typisk ikke et signifikant lægemiddelinteraktionspotentiale, da de ikke har direkte indvirkning på CYP-enzymer og ikke er substrater for hepatiske eller renale transportører.
English: How you are given ZINPLAVA 4.
Danish: Sådan får du Zinplava 4.
English: These time limits include storage of the infusion solution in the IV bag through the duration of infusion.
Danish: Disse tidsgrænser omfatter også opbevaring af infusionsvæsken i i.v.-infusionsposen under hele infusionen.
English: Other medicines and ZINPLAVA Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Zinplava Fortæl lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: There is no clinical experience with overdosage of ZINPLAVA.
Danish: Der er ingen klinisk erfaring med overdosering af ZINPLAVA.
English: You should not be given ZINPLAVA if:
Danish: Du må ikke få Zinplava:
English: ZINPLAVA is not a treatment for CDI and has no effect on the current CDI episode.
Danish: ZINPLAVA er ikke en behandling mod CDI og har ingen virkning på den aktuelle CDI-episode.
English: The baseline characteristics of the 781 patients receiving ZINPLAVA and 773 receiving placebo were generally similar across treatment groups.
Danish: Baseline-karakteristika for de 781 patienter, der fik ZINPLAVA, og de 773 patienter, der fik placebo, var generelt sammenlignelige på tværs af behandlingsgrupperne.
English: The efficacy of ZINPLAVA (bezlotoxumab) was investigated in two randomised, double-blind, placebo-controlled, multicentre, Phase 3 studies (MODIFY I and MODIFY II) where 810 patients were randomised to bezlotoxumab and 803 to placebo.
Danish: ZINPLAVAs (bezlotoxumabs) virkning blev undersøgt i to randomiserede, dobbeltblinde, placebokontrollerede fase 3-multicenterstudier (MODIFY I og MODIFY II), hvor 810 patienter blev randomiseret til bezlotoxumab og 803 patienter til placebo.
English: Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på kartonen og etiketten på hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: ZINPLAVA should not be administered as an intravenous push or bolus.
Danish: ZINPLAVA må ikke administreres som intravenøs push- eller bolus-injektion.
English: The effects of various covariates on the pharmacokinetics of bezlotoxumab were assessed in a population pharmacokinetic analysis.
Danish: Indvirkningen af forskellige kovariater på bezlotoxumabs farmakokinetik blev vurderet i en farmakokinetisk populationsanalyse.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af toksicitet efter gentagne doser.
English: The mean volume of distribution of bezlotoxumab was 7.33 L (CV: 16 %).
Danish: Det gennemsnitlige fordelingsvolumen for bezlotoxumab var 7,33 l (variationskoefficient (CV): 16 %).
English: ZINPLAVA should be administered as a single intravenous infusion of 10 mg/kg (see below and section 6.6).
Danish: ZINPLAVA skal administreres som en enkelt intravenøs infusion på 10 mg/kg (se nedenfor og pkt.
English: Store in a refrigerator 2 °C to 8 °C.
Danish: Opbevares i køleskab (2 °C-8 °C).
English: Pharmacotherapeutic group: Antiinfectives for systemic use, specific immunoglobulins.
Danish: Farmakoterapeutisk klassifikation: Systemiske midler mod infektioner, specifikke immunglobuliner.
English: In clinical studies, serious adverse reactions occurring within 12 weeks following infusion were reported in 29 % of ZINPLAVA-treated patients and 33 % in patients receiving placebo.
Danish: I kliniske studier blev der rapporteret alvorlige bivirkninger inden for 12 uger efter infusion hos 29 % af patienterne i ZINPLAVA-gruppen og hos 33 % i placebogruppen.
English: Bezlotoxumab-mediated drug-drug interactions are unlikely as the target of bezlotoxumab is an exogenous toxin.
Danish: Bezlotoxumab-medierede lægemiddelinteraktioner er ikke sandsynlige, da target for bezlotoxumab er et eksogent toksin.
English: Randomisation was stratified by the antibacterial agent and hospitalisation status (inpatient vs. outpatient) at the time of study entry.
Danish: Randomiseringen blev stratificeret efter antibakterielt middel og indlæggelsesstatus (indlagt patient versus ambulant patient) på tidspunktet for indtræden i studiet.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ZINPLAVA in one or more subsets of the paediatric populations for the prevention of recurrence of Clostridium difficile infection (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med ZINPLAVA i en eller flere undergrupper af den pædiatriske population ved forebyggelse af recidiv af Clostridium difficile-infektion (se pkt.
English: Of the patients who experienced an infusion specific adverse reaction, the majority reported a reaction with a maximum intensity of mild (78 %) or moderate (20 %), and the majority of reactions resolved within 24 hours following onset.
Danish: Størstedelen af de patienter, der oplevede en infusionsreaktion, rapporterede, at reaktionen havde en maksimal intensitet, der var let (78 %) eller moderat (20 %), og størstedelen af infusionsreaktionerne gik over inden for 24 timer efter indtræden.
English: Bezlotoxumab is eliminated from the body primarily by protein degradation.
Danish: Bezlotoxumab elimineres primært fra kroppen via proteinnedbrydning.
English: Although ZINPLAVA is intended for single dose administration, the immunogenicity of bezlotoxumab following a second administration of 10 mg/kg, 12 weeks after the first dose, was assessed in 29 healthy subjects.
Danish: Selvom ZINPLAVA er beregnet til at blive administreret som en enkelt dosis, blev immunogeniciteten af bezlotoxumab vurderet hos 29 raske personer efter en ny administration på 10 mg/kg 12 uger efter den første dosis.
English: Intravenous use after dilution Single dose vial
Danish: Intravenøs anvendelse efter fortynding Enkeltdosis-hætteglas
English: • Inspect vial contents for discoloration and particulate matter prior to dilution.
Danish: • Kontroller hætteglassets/hætteglassenes indhold for misfarvning og partikler før fortynding.
English: Bezlotoxumab prevents CDI recurrence by providing passive immunity against toxin produced by the outgrowth of persistent or newly-acquired C. difficile spores.
Danish: Bezlotoxumab forebygger recidiv af CDI ved at give passiv immunitet over for toksin dannet som følge af udvækst af persisterende eller nyerhvervede C. difficile-sporer.
English: • The bacteria responsible for CDI produce a toxin that can inflame and damage your colon, causing stomach pain and severe diarrhoea.
Danish: • Bakterien, som forårsager CDI, producerer et særligt giftstof, et toksin, som kan irritere og beskadige tyktarmen samt give mavesmerter og voldsom diarré.
English: Patients on oral vancomycin or oral fidaxomicin could have also received IV metronidazole.
Danish: Patienterne i behandling med oralt vancomycin eller oralt fidaxomicin kunne også have fået intravenøst metronidazol.
English: Bezlotoxumab is a human monoclonal antitoxin antibody that binds with high affinity to C. difficile toxin B and neutralizes its activity.
Danish: Bezlotoxumab er et humant monoklonalt antitoksin-antistof, der binder med høj affinitet til C. difficile-toksin B og neutraliserer dets aktivitet.
English: Excipients: Citric acid monohydrate, diethylenetriaminepentaacetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, water for injections, sodium hydroxide.
Danish: Hjælpestoffer: citronsyremonohydrat, diethylentriaminpentaeddikesyre, polysorbat 80, natriumchlorid, natriumcitratdihydrat, vand til injektionsvæsker, natriumhydroxid.
English: Bezlotoxumab has limited extravascular distribution.
Danish: Bezlotoxumab har begrænset ekstravaskulær fordeling.
English: • Withdraw the required volume from the vial(s) based on the patient's weight (in kg) and transfer into an IV bag containing either 0.9 % Sodium Chloride Injection, or 5 % Dextrose Injection, to prepare a diluted solution with a final concentration ranging from 1 to 10 mg/mL.
Danish: • Udtag det nødvendige volumen fra hætteglasset/hætteglassene på basis af patientens vægt (i kg), og overfør koncentratet til en i.v.-infusionspose, der indeholder enten 0,9 % natriumchloridinjektionsvæske eller 5 % glucoseinjektionsvæske, for at fremstille den færdige infusionsvæske med en endelig koncentration på 1-10 mg/ml.
English: In a Phase 1 clinical trial, healthy subjects received two consecutive doses of 10 mg/kg of bezlotoxumab separated by 12 weeks.
Danish: I et klinisk fase 1-studie fik raske forsøgspersoner to doser på 10 mg/kg bezlotoxumab med 12 ugers mellemrum.
English: The mean clearance of bezlotoxumab was 0.317 L/day (CV: 41 %) and the terminal half-life (t½) was approximately 19 days
Danish: Den gennemsnitlige clearance for bezlotoxumab var 0,317 l/dag (CV: 41 %), og den terminale halveringstid (t½) var ca. 19 dage (CV: 28 %).
English: The day of the infusion of ZINPLAVA or placebo ranged from prior to the start of antibacterial therapy up to day 14 of treatment, with a median on day 3.
Danish: Infusionsdagen for ZINPLAVA eller placebo lå fra før initiering af den antibakterielle behandling til op til dag 14 i behandlingen; medianen var på dag 3.
English: The effect of age on the pharmacokinetics of bezlotoxumab was evaluated in patients ranging from 18 to 100 years of age.
Danish: Indvirkningen af alder på bezlotoxumabs farmakokinetik blev undersøgt hos patienter i alderen 18-100 år.
English: Infusion related reactions†
Danish: Infusionsreaktioner†
English: The experience with ZINPLAVA in patients is limited to a single CDI episode and single administration (see section 4.4).
Danish: Erfaringen med ZINPLAVA hos patienter er begrænset til en enkelt CDI-episode og engangsadministration (se pkt.
English: • Administer the diluted solution for infusion intravenously over 60 minutes using a sterile, non-pyrogenic, low-protein binding 0.2 micron to 5 micron in-line or add-on filter.
Danish: • Administrer den fortyndede infusionsvæske intravenøst over 60 minutter med et infusionssæt med et in-line eller add-on sterilt, ikke-pyrogent, minimalt proteinbindende filter (porestørrelse 0,2-5 µm).
English: Citric acid monohydrate (E330) Diethylenetriaminepentaacetic acid Polysorbate 80 (E433)
Danish: Citronsyremonohydrat (E330) Diethylentriaminpentaeddikesyre Polysorbat 80 (E433)
English: All patients received concomitant standard of care antibacterial therapy for CDI.
Danish: Alle patienter fik samtidig antibakteriel standardbehandling mod CDI.
English: No anti-bezlotoxumab antibodies were detected after the second dose.
Danish: Der blev ikke påvist antistoffer mod bezlotoxumab efter den anden dosis.
English: • We don't know if ZINPLAVA gets in your breast milk and is passed to your baby.
Danish: • Det vides ikke, om Zinplava udskilles i din mælk, og dit barn dermed får det.
English: Manufacturer SP Labo NV
Danish: SP Labo NV
English: After a single IV dose of 10 mg/kg bezlotoxumab, mean AUC(0-∞) and Cmax were 53,000 mcg.h/mL and 185 mcg/mL, respectively, in patients with CDI.
Danish: Efter en enkelt intravenøs dosis på 10 mg/kg bezlotoxumab var gennemsnitligt AUC(0-∞) og Cmax henholdsvis 53.000 µg•time/ml og 185 µg/ml hos patienter med CDI.
English: The safety and efficacy of ZINPLAVA in patients below 18 years of age have not been established.
Danish: ZINPLAVAs sikkerhed og virkning hos patienter under 18 år er ikke klarlagt.
English: Bezlotoxumab is a human monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
Danish: Bezlotoxumab er et humant monoklonalt antistof, der fremstilles ved rekombinant dna-teknologi i ovarieceller fra kinesiske hamstre.
English: Concomitant oral standard of care (SoC) antibacterial therapy for CDI was given together with ZINPLAVA.
Danish: Oral standardbehandling (SoC) med antibakterielle midler mod CDI blev givet sammen med ZINPLAVA.
English: Bezlotoxumab exposures in healthy subjects increased in an approximately dose proportional manner across the 0.3 to 20 mg/kg dose range.
Danish: Eksponeringen for bezlotoxumab hos raske forsøgspersoner steg nogenlunde dosisproportionalt i dosisintervallet 0,3-20 mg/kg.
English: Warnings and precautions ZINPLAVA is not a treatment for CDI.
Danish: Advarsler og forsigtighedsregler Zinplava kan ikke anvendes til at behandle CDI.
English: ZINPLAVA acts by attaching to the toxin and blocking it, thereby preventing the symptoms of CDI from coming back.
Danish: Zinplava virker ved at blive bundet til toksinet og blokere det, og Zinplava forhindrer derved, at symptomerne på CDI kommer igen.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and must not be longer than a total of 24 hours at 2°C - 8°C or 16 hours at room temperature (at or below 25°C).
Danish: Hvis infusionsvæsken ikke anvendes straks, er i-brugopbevaringstider og -forhold forud for anvendelse brugerens ansvar og må ikke overstige 24 timer ved 2 °C-8 °C eller 16 timer ved stuetemperatur (ved eller under 25 °C).
English: Table 2: CDI Recurrence Rate Through 12 Weeks After Infusion (MODIFY I and MODIFY II, Full Analysis Set
Danish: Tabel 2: CDI-recidivrate inden for 12 uger efter infusion (MODIFY I og MODIFY II, FAS
English: Bezlotoxumab is dosed via the IV route and therefore is immediately and completely bioavailable.
Danish: Bezlotoxumab administreres intravenøst, og biotilgængeligheden er derfor øjeblikkelig og fuldstændig.
English: In clinical trials, patients with CDI were only administered a single dose of ZINPLAVA (see section 5.1).
Danish: I kliniske studier fik patienter med CDI kun administreret en enkelt dosis ZINPLAVA (se pkt.
English: Solution for infusion: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C - 8°C or 16 hours at room temperature (at or below 25°C).
Danish: Infusionsvæske: Kemisk og fysisk i-brug-stabilitet er dokumenteret i 24 timer ved 2 °C-8 °C og i 16 timer ved stuetemperatur (ved eller under 25 °C).
English: Adult patients had a confirmed diagnosis of CDI, which was defined as diarrhoea (passage of 3 or more loose bowel movements as defined in the Bristol stool chart as types 5 through 7 in 24 or fewer hours) and a positive stool test for toxigenic C. difficile from a stool sample collected no more than 7 days before study entry.
Danish: Voksne patienter havde en bekræftet diagnose på CDI, defineret som diarré (i løbet af højst 24 timer passage af 3 eller flere løse afføringer defineret som type 5 til 7 på Bristolskalaen for afføringstyper) og en positiv test for toksindannende C. difficile i en fæcesprøve, der var opsamlet inden for maksimalt 7 dage før indtræden i studiet.
English: The diluted solution of ZINPLAVA may be stored either at room temperature for up to 16 hours or under refrigeration at 2 °C to 8 °C for up to 24 hours.
Danish: Den fortyndede Zinplava-infusionsvæske kan enten opbevares ved stuetemperatur i op til 16 timer eller i køleskab ved 2 °C-8 °C i op til 24 timer.
English: Each mL of concentrate contains 0.2 mmol sodium, which is 4.57 mg sodium.
Danish: Hver ml koncentrat indeholder 0,2 mmol natrium, svarende til 4,57 mg natrium.
English: No clinical data are available on the possible effects of bezlotoxumab on fertility.
Danish: Der foreligger ingen kliniske data om bezlotoxumabs mulige indvirkning på fertilitet.
English: Table 3: CDI Recurrence Rate by Risk Factor Subgroup (MODIFY I and MODIFY II, Full Analysis Set
Danish: Tabel 3: CDI-recidivrate efter risikofaktor-subgruppe (MODIFY I og MODIFY II, FAS
English: What you need to know before you are given ZINPLAVA 3.
Danish: Det skal du vide, før du får Zinplava 3.
English: Bezlotoxumab has no or negligible influence on the ability to drive and use machines.
Danish: Bezlotoxumab påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: The effect of hepatic impairment on the pharmacokinetics of bezlotoxumab was evaluated in patients with hepatic impairment (defined as having two or more of the following: [1] albumin ≤ 3.1 g/dL; [2] ALT ≥ 2X ULN; [3] total bilirubin ≥ 1.3X ULN; or [4] mild, moderate or severe liver disease as reported by the Charlson Co-morbidity Index), as compared to patients with normal hepatic function.
Danish: Indvirkningen af nedsat leverfunktion på bezlotoxumabs farmakokinetik blev vurderet hos patienter med nedsat leverfunktion (defineret som havende to eller flere af følgende: [1] albumin ≤ 3,1 g/dl, [2] ALAT ≥ 2 x ULN, [3] total-bilirubin ≥ 1,3 x ULN eller [4] let, moderat eller svær leversygdom i henhold til Charlson Comorbidity Index) i forhold til patienter med normal leverfunktion.
English: There are no data on repeated administration of bezlotoxumab in patients with CDI.
Danish: Der er ingen data om gentagen administration af bezlotoxumab hos patienter med CDI.
English: Efficacy results did not point towards a benefit of ZINPLAVA in patients with no known risk factors for CDI.
Danish: Virkningsresultaterne pegede ikke i retning af, at patienter uden kendte risikofaktorer for CDI havde fordel af ZINPLAVA.
English: Elderly No dose adjustment is necessary in patients ≥ 65 years of age (see section 5.2).
Danish: Ældre Det er ikke nødvendigt at justere dosis hos patienter ≥ 65 år (se pkt.
English: Bezlotoxumab is catabolized through protein degradation processes; metabolism does not contribute to its clearance.
Danish: Bezlotoxumab nedbrydes via proteinnedbrydningsprocesser; metabolisering bidrager ikke til bezlotoxumabs clearance.