FrancophonIA/ELRC3.0 huggingface dataset:
English: Excipients: Citric acid monohydrate, diethylenetriaminepentaacetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, water for injections, sodium hydroxide.
Croatian: Pomoćne tvari: citratna kiselina hidrat, dietilentriaminpentaacetatna kiselina, polisorbat 80, natrijev klorid, natrijev citrat dihidrat, voda za injekcije, natrijev hidroksid.
English: • You will get ZINPLAVA as an infusion (drip) into a vein.
Croatian: • Lijek ZINPLAVA primit ćete infuzijom (ukapavanjem) u venu.
English: Efficacy results did not point towards a benefit of ZINPLAVA in patients with no known risk factors for CDI.
Croatian: Rezultati djelotvornosti nisu ukazivali na korist primjene lijeka ZINPLAVA u bolesnika koji nisu imali poznate faktore rizika za CDI.
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.
Croatian: Dan infuzije lijeka ZINPLAVA ili placeba kretao se u periodu od prije početka antibiotske terapije do 14. dana liječenja, a medijan je bio 3. dan.
English: • 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.
Croatian: • Razrijeđenu otopinu treba pripremiti odmah nakon vađenja bočice(a) iz hladnjaka; bočica(e) se mogu čuvati i na sobnoj temperaturi, zaštićene od svjetlosti, tijekom najviše 24 sata prije pripreme razrijeđene otopine.
English: Patients received a 10- to 14-day course of oral antibacterial therapy for CDI (metronidazole, vancomycin or fidaxomicin, chosen by the investigator).
Croatian: Bolesnici su primili ciklus peroralne antibiotske terapije za liječenje CDI-a u trajanju od 10 do 14 dana (metronidazol, vankomicin ili fidaksomicin, prema izboru ispitivača).
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.
Croatian: • Iz bočice(a) izvucite željeni volumen utvrđen na temelju bolesnikove tjelesne težine (u kg) i prebacite ga u vrećicu za intravensku primjenu koja sadrži ili 0,9%-tnu otopinu natrijeva klorida za injekcije ili 5%-tnu otopinu glukoze za injekcije kako biste pripremili razrijeđenu otopinu čija se konačna koncentracija kreće u rasponu od 1 do 10 mg/ml.
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.
Croatian: Odrasli bolesnici imali su potvrđenu dijagnozu CDI-a, koja se definirala kao dijareja (3 ili više mekanih stolica definiranih kao tip 5 - 7 prema Bristolskoj ljestvici stolice u 24 ili manje sati) i pozitivan nalaz pretrage stolice na toksogeni C. difficile, provedene na uzorku stolice prikupljenom najviše 7 dana prije uključivanja u ispitivanje.
English: • you are allergic to bezlotoxumab or any of the other ingredients of this medicine (listed in section 6).
Croatian: Ne smijete primiti lijek ZINPLAVA: • ako ste alergični na bezlotoksumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: 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.
Croatian: Nije bilo primjetnih učinaka na reproduktivne organe mužjaka i ženki miševa u ispitivanjima toksičnosti ponovljenih doza, a nije opaženo ni vezivanje za tkiva reproduktivnog sustava u ispitivanjima tkivne križne reaktivnosti.
English: Infected with 027 ribotype n = Number of patients within subgroup that met the criteria for endpoint m = Number of patients within subgroup
Croatian: n = broj bolesnika unutar podskupine koji su zadovoljavali kriterije za mjeru ishoda m = broj bolesnika unutar podskupine
English: In a Phase 1 clinical trial, healthy subjects received two consecutive doses of 10 mg/kg of bezlotoxumab separated by 12 weeks.
Croatian: U kliničkom ispitivanju faze 1, zdravi ispitanici primili su dvije uzastopne doze bezlotoksumaba od 10 mg/kg u razmaku od 12 tjedana.
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.
Croatian: Broj bolesnika koji su završili ispitivanja i bili uključeni u populaciju svih randomiziranih bolesnika (engl. full analysis set, FAS) iznosio je 781 u skupini liječenoj lijekom ZINPLAVA naspram 773 u skupini koja je primala placebo.
English: Fertility studies have not been conducted in animals.
Croatian: Nisu provedena ispitivanja učinaka na plodnost u životinja.
English: The experience with ZINPLAVA in patients is limited to a single CDI episode and single administration (see section 4.4).
Croatian: Iskustvo liječenja s lijekom ZINPLAVA u bolesnika je ograničeno na jednu epizodu CDI-a i jednokratnu primjenu (vidjeti dio 4.4).
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.
Croatian: Nakon jednokratne intravenske doze bezlotoksumaba od 10 mg/kg, srednja vrijednost AUC(0-∞) i Cmax iznosila je 53 000 µg.h/ml odnosno 185 µg/ml u bolesnika s CDI-om.
English: Driving and using machines ZINPLAVA has no or very little effect on the ability to drive and use machines.
Croatian: Upravljanje vozilima i strojevima ZINPLAVA ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: There is no clinical experience with overdosage of ZINPLAVA.
Croatian: Nema kliničkog iskustva s predoziranjem lijekom ZINPLAVA.
English: Bezlotoxumab prevents CDI recurrence by providing passive immunity against toxin produced by the outgrowth of persistent or newly-acquired C. difficile spores.
Croatian: Bezlotoksumab sprječava recidiv CDI-a tako što omogućuje pasivnu imunost protiv toksina koji nastaje uslijed rasta perzistentnih ili novostečenih spora bakterije C. difficile.
English: 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).
Croatian: Clostridium difficile infection, CDI) u odraslih osoba s visokim rizikom za recidiv CDI-a (vidjeti dijelove 4.2, 4.4 i 5.1).
English: Table 1 presents the adverse reactions reported within 4 weeks of infusion in ZINPLAVA-treated patients and listed by System Organ Class.
Croatian: Tablica 1 prikazuje nuspojave prijavljene unutar 4 tjedna nakon infuzije u bolesnika liječenih lijekom ZINPLAVA, a navedene su prema organskim sustavima.
English: Type I glass vial containing 40 mL solution, with a chlorobutyl stopper, and a flip-off cap seal.
Croatian: Staklena bočica (staklo tipa I) koja sadrži 40 ml otopine, s klorbutilnim čepom i zaštitnim zatvaračem s flip-off kapicom.
English: ZINPLAVA 25 mg/mL concentrate for solution for infusion
Croatian: ZINPLAVA 25 mg/ml koncentrat za otopinu za infuziju
English: Within each frequency grouping, adverse reactions are presented in order of decreasing frequency.
Croatian: Unutar svake skupine učestalosti, nuspojave su prikazane u padajućem nizu prema učestalosti.
English: Table 1: Adverse Reactions with ZINPLAVA MedDRA System Organ Class
Croatian: Tablica 1: Nuspojave kod primjene lijeka ZINPLAVA Klasifikacija organskih sustava prema MedDRA-i
English: 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.
Croatian: Kako ZINPLAVA izgleda i sadržaj pakiranja Koncentrat za otopinu za infuziju je bistra do umjereno opalescentna, bezbojna do blijedožuta tekućina.
English: Immunogenicity of ZINPLAVA was evaluated using an electrochemiluminescence (ECL) assay in MODIFY I and MODIFY II.
Croatian: Imunogenost lijeka ZINPLAVA ocjenjivala se uz pomoć elektrokemiluminiscencije (engl. electrochemiluminescence, ECL) u ispitivanjima MODIFY
English: Serious adverse reactions
Croatian: Ozbiljne nuspojave
English: Elderly No dose adjustment is necessary in patients ≥ 65 years of age (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika u dobi od ≥ 65 godina (vidjeti dio 5.2).
English: ZINPLAVA should be administered during the course of antibacterial therapy for CDI (see sections 4.4 and 5.1).
Croatian: Lijek ZINPLAVA treba primijeniti tijekom ciklusa antibiotske terapije za liječenje CDI-a (vidjeti dijelove 4.4 i 5.1).
English: Your dose will be calculated using your body weight.
Croatian: Doza će se izračunati na temelju
English: No clinical data are available on the possible effects of bezlotoxumab on fertility.
Croatian: Nisu dostupni klinički podaci o mogućim učincima bezlotoksumaba na plodnost.
English: Bezlotoxumab is dosed via the IV route and therefore is immediately and completely bioavailable.
Croatian: Bezlotoksumab se primjenjuje intravenskim putem te je stoga njegova bioraspoloživost trenutačna i potpuna.
English: All patients received concomitant standard of care antibacterial therapy for CDI.
Croatian: Svi su bolesnici istodobno primali standardnu antibiotsku terapiju za liječenje CDI-a.
English: Table 2: CDI Recurrence Rate Through 12 Weeks After Infusion (MODIFY I and MODIFY II, Full Analysis Set
Croatian: Tablica 2: Stopa recidiva CDI-a tijekom 12 tjedana nakon infuzije (MODIFY
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.
Croatian: Učinak oštećenja funkcije jetre na farmakokinetiku bezlotoksumaba ocjenjivao se u bolesnika s oštećenjem funkcije jetre (koje se definiralo kao prisutnost dvaju ili više sljedećih elemenata: [1] albumin ≤ 3,1 g/dl; [2] ALT ≥ 2X GGN; [3] ukupni bilirubin ≥ 1,3X GGN; ili [4] blaga, umjerena ili teška bolest jetre prema Charlsonovu indeksu komorbiditeta) u odnosu na bolesnike s normalnom funkcijom jetre.
English: Bezlotoxumab-mediated drug-drug interactions are unlikely as the target of bezlotoxumab is an exogenous toxin.
Croatian: Interakcije između lijekova posredovane bezlotoksumabom nisu vjerojatne jer je cilj djelovanja bezlotoksumaba egzogeni toksin.
English: 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).
Croatian: Bezlotoksumab se nije vezivao za tkivo reproduktivnih organa u ispitivanjima tkivne križne reaktivnosti, a u ispitivanjima toksičnosti ponovljenih doza u miševa nije bilo zamjetnih učinaka na reproduktivne organe mužjaka i ženki (vidjeti dio 5.3).
English: Table 3: CDI Recurrence Rate by Risk Factor Subgroup (MODIFY I and MODIFY II, Full Analysis Set
Croatian: Tablica 3: Stopa recidiva CDI-a prema podskupinama faktora rizika (MODIFY
English: Intravenous use after dilution Single dose vial
Croatian: Primjena u venu nakon razrjeđivanja Jednodozna bočica
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.
Croatian: • Razrijeđenu otopinu za infuziju treba primijeniti intravenski tijekom 60 minuta koristeći sterilan, nepirogen, ugrađeni (in-line) ili pričvrsni (add-on) filtar od 0,2 do 5 µm, s malom sposobnošću vezanja proteina.
English: 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.
Croatian: ZINPLAVA je lijek koji se daje zajedno s antibiotikom za sprječavanje povratka infekcije uzrokovane bakterijom Clostridium difficile u bolesnika u dobi od 18 godina ili starijih u kojih postoji visok rizik od povratka infekcije uzrokovane tom bakterijom (engl.
English: Name and address of the manufacturer of the biological active substance
Croatian: Naziv i adresa proizvođača biološke djelatne tvari Lonza Biologics Inc.
English: Animal reproduction or developmental toxicity studies have not been conducted with bezlotoxumab.
Croatian: Nisu provedena ispitivanja reproduktivne ili razvojne toksičnosti bezlotoksumaba u životinja.
English: Bezlotoxumab has no or negligible influence on the ability to drive and use machines.
Croatian: Bezlotoksumab ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
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.
Croatian: Razrijeđena otopina lijeka ZINPLAVA može se čuvati na sobnoj temperaturi do 16 sati ili u hladnjaku (na temperaturi od 2°C do 8°C) do 24 sata.
English: 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
Croatian: Učinak oštećenja funkcije bubrega na farmakokinetiku bezlotoksumaba ocjenjivao se u bolesnika s blagim (eGFR od 60 do < 90 ml/min/1,73 m 2), umjerenim (eGFR od 30 do < 60 ml/min/1,73 m 2) ili teškim (eGFR od 15 do < 30 ml/min/1,73 m 2) oštećenjem funkcije bubrega ili u terminalnoj fazi bolesti bubrega (eGFR < 15 ml/min/1,73 m 2) u odnosu na bolesnike s normalnom funkcijom bubrega
English: Injury, poisoning and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije često reakcije na infuziju†
English: These adverse reactions were reported at a similar frequency in placebo treated patients compared with ZINPLAVA treated patients.
Croatian: Te su nuspojave prijavljene sa sličnom učestalošću u bolesnika koji su primali placebo kao i u bolesnika liječenih lijekom ZINPLAVA.
English: Following treatment with ZINPLAVA in MODIFY I and MODIFY II, none of the 710 evaluable patients tested positive for treatment-emergent anti-bezlotoxumab antibodies.
Croatian: I i MODIFY II, nijedan od 710 bolesnika u kojih se mogla provesti ocjena nije imao pozitivan nalaz na protutijela na bezlotoksumab nastala tijekom liječenja.
English: Bezlotoxumab is catabolized through protein degradation processes; metabolism does not contribute to its clearance.
Croatian: Bezlotoksumab se katabolizira procesima razgradnje proteina; metabolizam ne pridonosi njegovu klirensu.
English: There are no data on repeated administration of bezlotoxumab in patients with CDI.
Croatian: Nema podataka o ponovljenoj primjeni bezlotoksumaba u bolesnika s CDI-om.
English: In clinical trials, patients with CDI were only administered a single dose of ZINPLAVA (see section 5.1).
Croatian: U kliničkim ispitivanjima, u bolesnika s CDI-om primijenjena je samo jedna doza lijeka ZINPLAVA (vidjeti dio
English: 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.
Croatian: Nuspojave nakon primjene druge doze nisu se značajno razlikovale od onih opaženih nakon primjene prve doze te su odgovarale nuspojavama opaženima u dva ispitivanja faze 3 (MODIFY
English: • You should keep taking your antibiotic for CDI as directed by your doctor.
Croatian: • Nastavite uzimati antibiotik za liječenje infekcije bakterijom Clostridium difficile prema uputama Vašeg liječnika.
English: ZINPLAVA should not be administered as an intravenous push or bolus.
Croatian: ZINPLAVA se ne smije primijeniti intravenskom brzom ili bolusnom injekcijom.
English: What ZINPLAVA contains - The active substance is bezlotoxumab.
Croatian: Što ZINPLAVA sadrži - Djelatna tvar je bezlotoksumab.
English: Characteristic at study entry
Croatian: Značajka pri uključivanju u ispitivanje
English: There is no experience with repeat administration of ZINPLAVA in patients with CDI.
Croatian: Nema iskustva s ponovljenom primjenom lijeka ZINPLAVA u bolesnika s CDI-om.
English: ZINPLAVA 25 mg/mL concentrate for solution for infusion bezlotoxumab
Croatian: ZINPLAVA 25 mg/ml koncentrat za otopinu za infuziju bezlotoksumab
English: • If you are breast-feeding or are planning to breast-feed, check with your doctor first.
Croatian: • Ako dojite ili planirate dojiti, najprije o tome razgovarajte sa svojim liječnikom.
English: ZINPLAVA should be administered during the course of antibacterial therapy for CDI.
Croatian: Lijek ZINPLAVA treba primijeniti tijekom ciklusa antibiotske terapije CDI-a.
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.
Croatian: Djelotvornost lijeka ZINPLAVA (bezlotoksumab) ispitivala se u dva randomizirana, dvostruko slijepa, placebom kontrolirana, multicentrična ispitivanja faze 3 (MODIFY
English: ZINPLAVA acts by attaching to the toxin and blocking it, thereby preventing the symptoms of CDI from coming back.
Croatian: ZINPLAVA djeluje tako da se pričvrsti za taj toksin i blokira njegovo djelovanje te na taj način sprječava povratak simptoma infekcije bakterijom Clostridium difficile.
English: Clear to moderately opalescent, colourless to pale yellow liquid.
Croatian: Bistra do umjereno opalescentna, bezbojna do blijedožuta tekućina.
English: How to store ZINPLAVA
Croatian: Kako čuvati lijek ZINPLAVA
English: • If the diluted solution is refrigerated, allow the IV bag to come to room temperature prior to use.
Croatian: • Ako se razrijeđena otopina čuva u hladnjaku, prije primjene pričekajte da se vrećica za intravensku primjenu ugrije na sobnu temperaturu.
English: ZINPLAVA has no effect on the CDI you have now.
Croatian: ZINPLAVA nema učinka na infekciju bakterijom Clostridium difficile koju trenutno imate.
English: Lonza Biologics Inc. 101 International Drive Portsmouth
Croatian: 101 International Drive
English: No clinically meaningful differences in the exposure of bezlotoxumab were found between patients with hepatic impairment and patients with normal hepatic function.
Croatian: Nisu utvrđene klinički važne razlike u izloženosti bezlotoksumabu između bolesnika s oštećenjem funkcije bubrega i onih s normalnom funkcijom bubrega.
English: Preparation of diluted solution
Croatian: Priprema razrijeđene otopine
English: Concomitant oral standard of care (SoC) antibacterial therapy for CDI was given together with ZINPLAVA.
Croatian: Standardna peroralna antibiotska terapija za liječenje CDI-a primjenjivala se istodobno s lijekom ZINPLAVA.
English: Full Analysis Set = a subset of all randomised patients with exclusions for: (i) did not receive infusion of study medication, (ii) did not have a positive local stool test for toxigenic C. difficile; (iii) did not receive protocol defined standard of care therapy within a 1 day window of the infusion SoC = Standard of Care antibacterial (metronidazole or vancomycin or fidaxomicin) Based on the Miettinen and Nurminen method without stratification Based on medical conditions or medications received that may result in immunosuppression Zar score ≥ 2
Croatian: Svi randomizirani ispitanici = podskupina svih randomiziranih bolesnika, isključujući: (i) ispitanike koji nisu primili infuziju ispitivanog lijeka, (ii) ispitanike koji nisu imali pozitivan nalaz pretrage stolice na toksogeni C. difficile; (iii) ispitanike koji nisu primili protokolom definiranu standardnu terapiju unutar 1 dana od infuzije Standardna terapija = standardna antibiotska terapija (metronidazol ili vankomicin ili fidaksomicin)
English: Sodium citrate dihydrate (E331) Water for injections
Croatian: 80 (E433), natrijev klorid, natrijev citrat dihidrat (E331), voda za injekcije i natrijev hidroksid
English: If refrigerated, allow the IV bag to come to room temperature prior to use.
Croatian: Ako se vrećica za intravensku primjenu čuva u hladnjaku, prije primjene pričekajte da se ugrije na sobnu temperaturu.
English: Age ≥ 65 years
Croatian: 6.3 Rok valjanosti
English: Bezlotoxumab has limited extravascular distribution.
Croatian: Ekstravaskularna distribucija bezlotoksumaba je ograničena.
English: ZINPLAVA is a clear to moderately opalescent, colourless to pale yellow liquid.
Croatian: ZINPLAVA je bistra do umjereno opalescentna, bezbojna do blijedožuta tekućina.
English: - 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).
Croatian: 6.1 Popis pomoćnih tvari citratna kiselina hidrat (E330) dietilentriaminpentaacetatna kiselina polisorbat 80 (E433) natrijev klorid natrijev citrat dihidrat (E331) voda za injekcije natrijev hidroksid (E524) (za prilagodbu pH)
English: Placebo with SoC Percent (n/N)
Croatian: Placebo sa standardnom terapijom Postotak (n/N)
English: It is unknown whether bezlotoxumab is secreted in human milk.
Croatian: Nije poznato izlučuje li se bezlotoksumab u majčino mlijeko.
English: • Inspect vial contents for discoloration and particulate matter prior to dilution.
Croatian: • Sadržaj bočice treba prije razrjeđivanje pregledati zbog moguće promjene boje i prisutnosti vidljivih čestica.
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).
Croatian: Pripremljeni lijek ne smije se čuvati dulje od ukupno 24 sata na temperaturi od 2°C - 8°C ili 16 sati na sobnoj temperaturi (25°C ili nižoj).
English: Each mL contains 25 mg bezlotoxumab.
Croatian: Jedan ml sadrži 25 mg bezlotoksumaba.
English: One 40 mL vial contains 1,000 mg of bezlotoxumab.
Croatian: Jedna bočica od 40 ml sadrži 1000 mg bezlotoksumaba.
English: ZINPLAVA is given with the antibiotic therapy you are taking for CDI.
Croatian: ZINPLAVA se daje uz antibiotsku terapiju koju uzimate za liječenje infekcije bakterijom Clostridium difficile.
English: Each mL of concentrate contains 25 mg bezlotoxumab.
Croatian: Jedan ml koncentrata sadrži 25 mg bezlotoksumaba.
English: ZINPLAVA contains the active substance bezlotoxumab.
Croatian: ZINPLAVA sadrži djelatnu tvar bezlotoksumab.
English: Infected with a hypervirulent strain
Croatian: Infekcija hipervirulentnim sojem Infekcija ribotipom 027
English: Name and address of the manufacturer responsible for batch release
Croatian: Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet SP Labo N.V.
English: Renal impairment No dose adjustment is necessary for patients with renal impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem funkcije bubrega (vidjeti dio 5.2).
English: Hepatic impairment No dose adjustment is necessary for patients with hepatic impairment (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s oštećenjem funkcije jetre (vidjeti dio 5.2).
English: You can also report side effects directly the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava za prijavu nuspojava: navedenog u Dodatku V.
English: How you are given ZINPLAVA 4.
Croatian: Kako ćete primiti lijek ZINPLAVA
English: Each vial contains 1,000 mg bezlotoxumab.
Croatian: Jedna bočica sadrži 1000 mg bezlotoksumaba.
English: ZINPLAVA with SoC Percent (n/m)
Croatian: ZINPLAVA sa standardnom terapijom Postotak (n/m)