natgillin/translations-raw huggingface dataset:
Because monoclonal antibodies may be excreted in human milk, a decision should be made whether to discontinue breast-feeding or to not administer ZINPLAVA, taking into account the importance of ZINPLAVA to the mother. 
Monoklonska protitelesa se lahko pri človeku izločajo v materino mleko, zato se je treba odločiti med prenehanjem dojenja ali neuporabo zdravila ZINPLAVA, pri čemer je treba upoštevati pomen zdravila ZINPLAVA za mater.
ZINPLAVA acts by attaching to the toxin and blocking it, thereby preventing the symptoms of CDI from coming back. 
Zdravilo ZINPLAVA deluje tako, da se veže na toksin in ga blokira in tako prepreči ponovitev simptomov CDI.
Each mL of concentrate contains 0.2 mmol sodium, which is 4.57 mg sodium. 
En mililiter koncentrata vsebuje 0,2 mmol natrija, kar je 4,57 mg natrija.
Intravenous use after dilution Single dose vial 
intravenska uporaba po razredčitvi viala za enkratni odmerek
• We don't know if ZINPLAVA gets in your breast milk and is passed to your baby. 
• Ni znano, ali zdravilo ZINPLAVA prehaja v materino mleko in se tako prenaša na dojenčka.
Within each frequency grouping, adverse reactions are presented in order of decreasing frequency. 
V razvrstitvah pogostnosti so neželeni učinki navedeni po padajoči pogostnosti.
In a Phase 1 clinical trial, healthy subjects received two consecutive doses of 10 mg/kg of bezlotoxumab separated by 12 weeks. 
V kliničnem preskušanju 1. faze so zdravi preiskovanci prejeli dva zaporedna odmerka 10 mg/kg bezlotoksumaba v presledku 12 tednov.
All patients received concomitant standard of care antibacterial therapy for CDI. 
Vsi bolniki so sočasno prejeli standardno protibakterijsko zdravljenje za CDI.
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). 
Če ni uporabljeno takoj, so čas shranjevanja med uporabo in pogoji pred uporabo odgovornost uporabnika; skupni čas ne sme preseči 24 ur pri temperaturi od 2 °C do 8 °C oziroma 16 ur pri sobni temperaturi (25 °C ali manj).
The mean clearance of bezlotoxumab was 0.317 L/day (CV: 41 %) and the terminal half-life (t½) was approximately 19 days 
Povprečni očistek bezlotoksumaba je bil 0,317 l/dan (CV: 41 %) in njegov terminalni razpolovni čas (t½) približno 19 dni (28 %).
The effect of age on the pharmacokinetics of bezlotoxumab was evaluated in patients ranging from 18 to 100 years of age. 
Vpliv starosti na farmakokinetiko bezlotoksumaba so ocenili pri bolnikih v starosti od 18 do 100 let.
The adverse reactions after the second dose were not markedly different from those observed after the first dose, and are consistent with adverse reactions observed in the two Phase 3 trials (MODIFY I and MODIFY II; see section 5.1) in which all patients received a single dose. 
Neželeni učinki po drugem odmerku niso bili bistveno drugačni od tistih, ki so jih opazili po prvem odmerku, in so skladni z neželenimi učinki, opaženimi v dveh preskušanjih 3. faze (MODIFY I in MODIFY II; glejte poglavje 5.1), v katerih so vsi bolniki prejeli enkraten odmerek.
There is no data regarding the efficacy of ZINPLAVA if given after the initial 10- to 14-days of antibacterial therapy for CDI. 
Podatkov o učinkovitosti zdravila ZINPLAVA, ki bi bilo uporabljeno kasneje kot v prvih 10- do 14-dneh protibakterijskega zdravljenja CDI, ni na voljo.
Efficacy results did not point towards a benefit of ZINPLAVA in patients with no known risk factors for CDI. 
Rezultati glede učinkovitosti niso pokazali koristi zdravila ZINPLAVA pri bolnikih brez znanih dejavnikov tveganja za CDI.
Table 3: CDI Recurrence Rate by Risk Factor Subgroup (MODIFY I and MODIFY II, Full Analysis Set 
Preglednica 3: Delež ponovitev CDI po podskupinah glede na dejavnik tveganja (MODIFY I in MODIFY II, celotni nabor za analizo
• Prepare the diluted solution immediately after removal of the vial(s) from refrigerated storage, or the vial(s) may be stored at room temperature protected from light for up to 24 hours prior to preparation of the diluted solution. 
• Razredčeno raztopino pripravite takoj, ko vialo/viale vzamete iz hladilnika; viala/viale so lahko shranjene tudi pri sobni temperaturi (zaščitene pred svetlobo) do 24 ur pred pripravo razredčene raztopine.
ZINPLAVA is a medicine that is given together with an antibiotic to prevent Clostridium difficile infection (CDI) from coming back in patients 18 years of age or older who have a high risk of CDI coming back. 
Zdravilo ZINPLAVA je zdravilo, ki se skupaj z antibiotikom uporablja za preprečitev ponovne okužbe z bakterijo Clostridium difficile (CDI - Clostridium difficile infection) pri bolnikih, starih 18 let ali več, z visokim tveganjem za ponovitev CDI.
How you are given ZINPLAVA 4. 
Kako boste prejeli zdravilo ZINPLAVA 4.
The clearance of bezlotoxumab increased with increasing body weight; the resulting exposure differences are adequately addressed by the administration of a weight-based dose. 
Očistek bezlotoksumaba se je povečeval z naraščanjem telesne mase, a nastale razlike v izpostavljenosti ustrezno odtehta uporaba odmerka, določenega na podlagi telesne mase.
The toxin B epitope to which bezlotoxumab binds is conserved, though not identical, across all known toxin sequences. 
Epitop toksina B, na katerega se veže bezlotoksumab, je ohranjen pri vseh znanih zaporedjih toksina, čeprav ne identičen.
Patients on oral vancomycin or oral fidaxomicin could have also received IV metronidazole. 
Bolniki, ki so prejemali peroralni vankomicin ali peroralni fidaksomicin, so lahko prejeli tudi intravenski metronidazol.
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. 
Med bolniki, pri katerih so se pojavili za infuzijo specifični neželeni učinki, je večina navedla največjo intenzivnost učinka kot blago (78 %) ali zmerno (20 %); večina učinkov je minila v 24 urah po pojavu.
• You will get ZINPLAVA as an infusion (drip) into a vein. 
• Zdravilo ZINPLAVA boste prejeli v infuziji ("kapalni") v veno.
Table 2: CDI Recurrence Rate Through 12 Weeks After Infusion (MODIFY I and MODIFY II, Full Analysis Set 
Preglednica 2: Deleži ponovitev CDI v 12 tednih po infundiranju (MODIFY I in MODIFY II, celotni nabor za analizo
Bezlotoxumab is a human monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology. 
Bezlotoksumab je humano monoklonsko protitelo, pridobljeno s tehnologijo rekombinantne DNA na ovarijskih celicah kitajskega hrčka.
Other medicines and ZINPLAVA Tell your doctor if you are taking, have recently taken or might take any other medicines. 
Obvestite zdravnika, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
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. 
Najpogostejši neželeni učinki po zdravljenju z zdravilom ZINPLAVA (poročani pri ≥ 4 % bolnikov v prvih 4 tednih po infundiranju) so bili navzea, diareja, zvišana telesna temperatura in glavobol.
What you need to know before you are given ZINPLAVA 3. 
Kaj morate vedeti, preden boste prejeli zdravilo ZINPLAVA 3.
Excipients: Citric acid monohydrate, diethylenetriaminepentaacetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, water for injections, sodium hydroxide. 
Pomožne snovi: citronska kislina monohidrat, dietilentriaminpentaocetna kislina, polisorbat 80, natrijev klorid, natrijev citrat dihidrat, voda za injekcije, natrijev hidroksid.
The effect of renal impairment on the pharmacokinetics of bezlotoxumab was evaluated in patients with mild (eGFR 60 to < 90 mL/min/1.73 m 2), moderate (eGFR 30 to < 60 mL/min/1.73 m 2), or severe 
Vpliv okvare ledvic na farmakokinetiko bezlotoksumaba so ocenili pri bolnikih z blago (eGFR 60 do < 90 ml/min/1,73 m 2), zmerno (eGFR 30 do < 60 ml/min/1,73 m 2) ali hudo
ZINPLAVA is not a treatment for CDI and has no effect on the current CDI episode. 
Zdravilo ZINPLAVA ni zdravilo za CDI in nima vpliva na trenutno epizodo CDI.
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). 
Raztopina za infundiranje: Kemična in fizikalna stabilnost med uporabo sta dokazani za 24 ur pri temperaturi od 2 °C do 8 °C ali 16 ur pri sobni temperaturi (25 °C ali manj).
ZINPLAVA is indicated for the prevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDI (see sections 4.2, 4.4 and 5.1). 
Zdravilo ZINPLAVA je indicirano za preprečevanje ponovitve okužbe z bakterijo Clostridium difficile (CDI - Clostridium difficile infection) pri odraslih z visokim tveganjem za ponovitev CDI (glejte poglavja 4.2, 4.4 in 5.1).
The following side effects have been reported in clinical trials: 
V kliničnih preskušanjih so poročali o naslednjih neželenih učinkih:
Bezlotoxumab-mediated drug-drug interactions are unlikely as the target of bezlotoxumab is an exogenous toxin. 
Medsebojno delovanje z zdravili, povzročeno zaradi bezlotoksumaba, je malo verjetno, saj je tarča bezlotoksumaba eksogeni toksin.
What ZINPLAVA is and what it is used for 
Kaj je zdravilo ZINPLAVA in za kaj ga uporabljamo
There are limited data from the use of bezlotoxumab in pregnant women. 
Podatkov o uporabi bezlotoksumaba pri nosečnicah je malo.
In clinical trials, patients with CDI were only administered a single dose of ZINPLAVA (see section 5.1). 
V kliničnih preskušanjih so bolniki s CDI prejeli samo enkraten odmerek zdravila ZINPLAVA (glejte poglavje 5.1).
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. 
Bolniki so zdravilo ZINPLAVA oziroma placebo prejeli v obdobju od dneva pred začetkom protibakterijskega zdravljenja do 14. dneva zdravljenja, z mediano na 3. dan zdravljenja.
Bezlotoxumab is eliminated from the body primarily by protein degradation. 
Bezlotoksumab se iz telesa izloči predvsem z beljakovinsko razgradnjo.
Bezlotoxumab prevents CDI recurrence by providing passive immunity against toxin produced by the outgrowth of persistent or newly-acquired C. difficile spores. 
Bezlotoksumab prepreči ponovitev CDI tako, da zagotovi pasivno imunost proti toksinu, ki nastaja zaradi razrasta perzistentnih ali novopridobljenih spor bakterije C. difficile.
Bezlotoxumab is catabolized through protein degradation processes; metabolism does not contribute to its clearance. 
Katabolizem bezlotoksumaba poteka s procesi razgradnje beljakovin; presnova ne pripomore k njegovemu očistku.
Infusion specific adverse reactions reported in ≥ 0.5 % of subjects receiving ZINPLAVA and at a frequency greater than placebo were nausea (3 %), fatigue (1 %), pyrexia (1 %), dizziness (1 %), headache (2 %), dyspnoea (1 %) and hypertension (1 %). 
Neželeni učinki, specifični za infuzijo in poročani pri ≥ 0,5 % preiskovancev, zdravljenih z zdravilom ZINPLAVA, in s pogostnostjo, ki je bila večja kot pri placebu, so bili navzea (3 %), utrujenost (1 %), zvišana telesna temperatura (1 %), omotica (1 %), glavobol (2 %), dispneja (1 %) in hipertenzija (1 %).
Table 1 presents the adverse reactions reported within 4 weeks of infusion in ZINPLAVA-treated patients and listed by System Organ Class. 
V preglednici 1 so navedeni neželeni učinki, o katerih so poročali v 4 tednih po infundiranju pri bolnikih, zdravljenih z zdravilom ZINPLAVA; navedeni so po organskih sistemih.
ZINPLAVA should be administered during the course of antibacterial therapy for CDI (see sections 4.4 and 5.1). 
Zdravilo ZINPLAVA je treba uporabiti tekom protibakterijskega zdravljenja CDI (glejte poglavji 4.4 in 5.1).
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. 
Razredčeno raztopino zdravila ZINPLAVA je mogoče shranjevati bodisi pri sobni temperaturi do 16 ur ali v hladilniku (od 2 °C do 8 °C) do 24 ur.
(eGFR < 15 mL/min/1.73 m 2), as compared to patients demonstrating normal (eGFR 
(eGFR < 15 ml/min/1,73 m 2) v primerjavi z bolniki z normalnim delovanjem ledvic
The experience with ZINPLAVA in patients is limited to a single CDI episode and single administration (see section 4.4). 
Izkušnje z uporabo zdravila ZINPLAVA pri bolnikih so omejene na enkratno epizodo CDI in enkratno uporabo zdravila (glejte poglavje 4.4).
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. 
Vpliv okvare jeter na farmakokinetiko bezlotoksumaba so ocenili pri bolnikih z okvaro jeter (opredeljeni kot tisti, ki so imeli dvoje ali več od naslednjega: [1] albumin ≤ 3,1 g/dl, [2] ALT ≥ 2x ZMN, [3] celokupni bilirubin ≥ 1,3x ZMN ali [4] blago, zmerno ali hudo bolezen jeter po Charlsonovem indeksu sočasnih bolezni) v primerjavi z bolniki z normalnim delovanjem jeter.
You should not be given ZINPLAVA if: 
Zdravila ZINPLAVA ne smete prejeti:
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. 
Bolniki so pred zaključkom protibakterijskega zdravljenja prejeli eno infuzijo zdravila ZINPLAVA ali placeba; bolnike so spremljali 12 tednov po infuziji.
Bezlotoxumab is a human monoclonal antitoxin antibody that binds with high affinity to C. difficile toxin B and neutralizes its activity. 
Bezlotoksumab je humano monoklonsko protitelo proti toksinom, ki se z veliko afiniteto veže na toksin B bakterije C. difficile in nevtralizira njegovo delovanje.
• 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. 
• Razredčeno raztopino za infundiranje aplicirajte intravensko v 60 minutah; uporabite sterilen, nepirogen 0,2 do 5 µm linijski ali dodatni filter, ki minimalno veže beljakovine.
These adverse reactions were reported at a similar frequency in placebo treated patients compared with ZINPLAVA treated patients. 
O teh neželenih učinkih so s podobno pogostnostjo poročali pri bolnikih, ki so prejemali placebo, in pri tistih, ki so bili zdravljeni z zdravilom ZINPLAVA.
What you need to know before you are given ZINPLAVA 
Kaj morate vedeti, preden boste prejeli zdravilo ZINPLAVA
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. 
781 bolnikov, ki so zaključili študijo in bili vključeni v celotni nabor za analizo, je bilo v skupini z zdravilom ZINPLAVA in 773 v skupini s placebom.
Bezlotoxumab has no or negligible influence on the ability to drive and use machines. 
Bezlotoksumab nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Bezlotoxumab exposures in healthy subjects increased in an approximately dose proportional manner across the 0.3 to 20 mg/kg dose range. 
Pri zdravih preiskovancih se je izpostavljenost bezlotoksumabu v razponu odmerkov od 0,3 do 20 mg/kg povečevala približno sorazmerno odmerku.
Immunogenicity of ZINPLAVA was evaluated using an electrochemiluminescence (ECL) assay in MODIFY I and MODIFY II. 
Imunogenost zdravila ZINPLAVA so v študijah MODIFY I in MODIFY II ocenili z elektrokemiluminiscenčno (ECL) metodo.
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. 
Čeprav je zdravilo ZINPLAVA namenjeno za uporabo v enkratnem odmerku, so pri 29 zdravih preiskovancih ocenili imunogenost bezlotoksumaba po drugem odmerku 10 mg/kg, uporabljenem 12 tednov po prvem odmerku.
(eGFR 15 to < 30 mL/min/1.73 m 2) renal impairment, or with end stage renal disease 
(eGFR 15 do < 30 ml/min/1,73 m 2) okvaro ledvic ali s končno odpovedjo ledvic
• Do not freeze the diluted solution. 
• Razredčene raztopine ne smete zamrzniti.
Infected with 027 ribotype n = Number of patients within subgroup that met the criteria for endpoint m = Number of patients within subgroup 
Vrednost p n = Število bolnikov v analizni populaciji, ki je izpolnjevala merila za opazovani dogodek N = Število bolnikov, vključenih v analizno populacijo
Driving and using machines ZINPLAVA has no or very little effect on the ability to drive and use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Zdravilo ZINPLAVA nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
- The other ingredients are citric acid monohydrate (E330), diethylenetriaminepentaacetic acid, polysorbate 80 (E433), sodium chloride, sodium citrate dihydrate (E331), water for injections, and sodium hydroxide (E524) (for pH adjustment). 
- Druge sestavine zdravila so citronska kislina monohidrat (E330), dietilentriaminpentaocetna kislina, polisorbat 80 (E433), natrijev klorid, natrijev citrat dihidrat (E331), voda za injekcije in natrijev hidroksid (E524) (za prilagoditev pH).
ZINPLAVA 25 mg/mL concentrate for solution for infusion 
ZINPLAVA 25 mg/ml koncentrat za raztopino za infundiranje
There is no clinical experience with overdosage of ZINPLAVA. 
Kliničnih izkušenj s prevelikim odmerjanjem zdravila ZINPLAVA ni.
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. 
Po enkratnem intravenskem odmerku 10 mg/kg bezlotoksumaba je bila pri bolnikih s CDI povprečna AUC(0-∞) 53.000 µg.h/ml in povprečna Cmax 185 µg/ml.
ZINPLAVA is given with the antibiotic therapy you are taking for CDI. 
Zdravilo ZINPLAVA se daje skupaj z antibiotičnim zdravljenjem, ki ga jemljete za CDI.
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. 
Diagnoza CDI je bila opredeljena kot diareja (3 ali več iztrebljanj mehkega blata tipa 5 do 7 po Bristolski lestvici blata v 24 urah ali manj) skupaj s pozitivnim fekalnim testom za toksigeno bakterijo C. difficile v vzorcu blata, odvzetem ne več kot 7 dni pred vključitvijo v študijo.
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. 
Skupno je imelo na dan infundiranja zdravila ali dan pozneje enega ali več za infuzijo specifičnih neželenih učinkov 10 % preiskovancev v skupini z zdravilom ZINPLAVA in 8 % preiskovancev v skupini s placebom.
There was no binding of bezlotoxumab to reproductive tissue in tissue cross reactivity studies, and no notable effects in the male and female reproductive organs in repeat dose toxicity studies in mice (see section 5.3). 
Študije tkivne navzkrižne reaktivnosti niso pokazale vezave bezlotoksumaba na reproduktivna tkiva, v študijah toksičnosti ponavljajočih odmerkov pri miših pa niso zaznali opaznih učinkov na reproduktivne organe samcev in samic (glejte poglavje 5.3).
Type I glass vial containing 40 mL solution, with a chlorobutyl stopper, and a flip-off cap seal. 
Viala iz stekla tipa I, s 40 ml raztopine, s klorbutilnim zamaškom in zaporko s snemljivim pokrovčkom.
What ZINPLAVA looks like and contents of the pack The concentrate for solution for infusion is a clear to moderately opalescent, colourless to pale yellow liquid. 
Izgled zdravila ZINPLAVA in vsebina pakiranja Koncentrat za raztopino za infundiranje je bistra do zmerno opalescentna, brezbarvna do bledorumena raztopina.
Bezlotoxumab is dosed via the IV route and therefore is immediately and completely bioavailable. 
Bezlotoksumab se uporablja intravensko, zato je njegova biološka uporabnost takojšnja in popolna.
How ZINPLAVA works 
Kako deluje zdravilo ZINPLAVA
ZINPLAVA should be administered during the course of antibacterial therapy for CDI. 
Zdravilo ZINPLAVA je treba uporabiti tekom protibakterijskega zdravljenja CDI.
Nausea, diarrhoea 
Bolezni prebavil pogosti navzea, diareja
There were no notable effects in the male and female reproductive organs in mice based on repeat dose toxicity studies and no binding to reproductive tissues was observed in tissue cross-reactivity studies. 
V študijah toksičnosti ponavljajočih se odmerkov niso ugotovili opaznih učinkov na reproduktivne organe samcev in samic, v študijah tkivne navzkrižne reaktivnosti pa niso ugotovili vezave na reproduktivna tkiva.
If refrigerated, allow the IV bag to come to room temperature prior to use. 
Če je zdravilo shranjeno v hladilniku, pred uporabo pustite, da se intravenska vrečka ogreje na sobno temperaturo.
It binds to C. difficile toxin B. 
Bezlotoksumab se veže na toksin B bakterije C. difficile.
No clinical data are available on the possible effects of bezlotoxumab on fertility. 
Kliničnih podatkov o možnih učinkih bezlotoksumaba na plodnost ni na voljo.
There are no data on repeated administration of bezlotoxumab in patients with CDI. 
Podatkov o ponavljajoči se uporabi bezlotoksumaba pri bolnikih s CDI ni.
United States 
ZDA
• If the diluted solution is refrigerated, allow the IV bag to come to room temperature prior to use. 
• Če je razredčena raztopina shranjena v hladilniku, pred uporabo pustite, da se intravenska vrečka ogreje na sobno temperaturo.
Animal reproduction or developmental toxicity studies have not been conducted with bezlotoxumab. 
Z bezlotoksumabom niso izvedli študij reproduktivne ali razvojne toksičnosti na živalih.
There is no experience with repeat administration of ZINPLAVA in patients with CDI. 
Izkušenj s ponavljajočo uporabo zdravila ZINPLAVA pri bolnikih s CDI ni.
ZINPLAVA 25 mg/mL concentrate for solution for infusion bezlotoxumab 
ZINPLAVA 25 mg/ml koncentrat za raztopino za infundiranje bezlotoksumab
Elderly No dose adjustment is necessary in patients ≥ 65 years of age (see section 5.2). 
Starejši Pri bolnikih, starih ≥ 65 let, prilagoditev odmerka ni potrebna (glejte poglavje 5.2).
Serious adverse reactions 
Resni neželeni učinki
Table 1: Adverse Reactions with ZINPLAVA MedDRA System Organ Class 
Preglednica 1: Neželeni učinki zdravila ZINPLAVA
Do not use the vial if the solution is discoloured or contains visible particles. 
Če je raztopina spremenjene barve ali vsebuje vidne delce, viale ne uporabite.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity. 
Predklinični podatki na osnovi običajnih študij toksičnosti pri ponavljajočih odmerkih ne kažejo posebnega tveganja za človeka.
Placebo with SoC Percent (n/N) 
Placebo s SoC Odstotek (n/N)
• If you are breast-feeding or are planning to breast-feed, check with your doctor first. 
• Če dojite ali nameravate dojiti, se prej posvetujte z zdravnikom.
Infected with a hypervirulent strain 
Okužba s hipervirulentnim sevom Okužba z ribotipom 027
ZINPLAVA has no effect on the CDI you have now. 
Zdravilo ZINPLAVA nima vpliva na epizodo CDI, ki je trenutno prisotna.