natgillin/translations-raw huggingface dataset:
In a second double-blind study, 262 patients without VTE disease and undergoing hip replacement surgery initially treated, while hospitalized, with enoxaparin sodium 4,000 IU (40 mg) subcutaneously were randomized to a post-discharge regimen of either enoxaparin sodium 4,000 IU (40 mg) (n = 131) once a day subcutaneously or to placebo (n = 131) for 3 weeks. 
U drugom dvostruko slijepom ispitivanju, 262 bolesnika bez VTE-a podvrgnuta kirurškom zahvatu zamjene kuka, koja su prvotno (tijekom hospitalizacije) bila liječena enoksaparinnatrijem u supkutanoj dozi od 4000 IU (40 mg), randomizirana su da nakon otpuštanja iz bolnice primaju enoksaparinnatrij u dozi od 4000 IU (40 mg) (n = 131) supkutano jedanput na dan ili placebo (n = 131) tijekom 3 tjedna.
In a second double-blind study, 262 patients without VTE disease and undergoing hip replacement surgery initially treated, while hospitalized, with enoxaparin sodium 4,000 IU (40 mg) subcutaneously were randomized to a post-discharge regimen of either enoxaparin sodium 4,000 IU (40 mg) (n=131) once a day subcutaneously or to placebo (n=131) for 3 weeks. 
U drugom dvostruko slijepom ispitivanju, 262 bolesnika bez VTE-a podvrgnuta kirurškom zahvatu zamjene kuka, koja su prvotno (tijekom hospitalizacije) bila liječena enoksaparinnatrijem u supkutanoj dozi od 4000 IU (40 mg), randomizirana su da nakon otpuštanja iz bolnice primaju enoksaparinnatrij u dozi od 4000 IU (40 mg) (n=131) supkutano jedanput na dan ili placebo (n=131) tijekom 3 tjedna.
There is a lower weightadjusted clearance in obese subjects with subcutaneous dosing. 
Klirens prilagođen prema tjelesnoj težini u pretilih ispitanika manji je kod supkutane primjene.
What Inhixa looks like and contents of the pack Inhixa 12,000 IU (120 mg)/0.8 mL is 0.8 mL of solution in: - a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a purple polypropylene plunger rod. 
Inhixa 12 000 IU (120 mg)/0,8 ml jest 0,8 ml otopine u: štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil gume i ljubičastim klipom od polipropilena s pričvršćenom iglom i pokrovom za iglu.
2 pre-filled syringes with needle guard 6 pre-filled syringes with needle guard 10 pre-filled syringes with needle guard 12 pre-filled syringes with needle guard 24 pre-filled syringes with needle guard 30 pre-filled syringes with needle guard 2 pre-filled syringes with UltraSafe Passive needle guard 10 pre-filled syringes with UltraSafe Passive needle guard 
2 napunjene štrcaljke sa štitnikom za iglu 6 napunjenih štrcaljki sa štitnikom za iglu 10 napunjenih štrcaljki sa štitnikom za iglu 12 napunjenih štrcaljki sa štitnikom za iglu 24 napunjenih štrcaljki sa štitnikom za iglu 30 napunjenih štrcaljki sa štitnikom za iglu 2 napunjene štrcaljke sa UltraSafe Passive štitnikom za iglu 10 napunjenih štrcaljki sa UltraSafe Passive štitnikom za iglu
0.8 mL of solution in: - a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a red polypropylene plunger rod. 
0,8 ml otopine u: graduiranoj štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i crvenim klipom od polipropilena s pričvršćenom iglom i pokrovom za iglu.
Packs of: - 2, 5, 6, 10, 30 and 50 pre-filled syringes - 2, 5, 6, 10, 20, 30, 50 and 90 pre-filled syringes with needle guard - 2 and 6 pre-filled syringes with UltraSafe Passive needle guard 
Pakiranja od: - 2, 5, 6, 10, 30 i 50 napunjenih štrcaljki - 2, 5, 6, 10, 20, 30, 50 i 90 napunjenih štrcaljki sa štitnika za iglu - 2 i 6 napunjenih štrcaljki sa UltraSafe Passive štitnika za iglu
0.2 mL of solution in: - a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a blue polypropylene plunger rod. 
0,2 ml otopine u: štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i plavim klipom od polipropilena s pričvršćenom iglom i pokrovom za iglu.
What Inhixa contains 
Kako Inhixa izgleda i sadržaj pakiranja
2 pre-filled syringes with needle guard 6 pre-filled syringes with needle guard 10 pre-filled syringes with needle guard 12 pre-filled syringes with needle guard 20 pre-filled syringes with needle guard 24 pre-filled syringes with needle guard 30 pre-filled syringes with needle guard 2 pre-filled syringes with UltraSafe Passive needle guard 10 pre-filled syringes with UltraSafe Passive needle guard 
2 napunjene štrcaljke sa štitnikom za iglu 6 napunjenih štrcaljki sa štitnikom za iglu 10 napunjenih štrcaljki sa štitnikom za iglu 12 napunjenih štrcaljki sa štitnikom za iglu 20 napunjenih štrcaljki sa štitnikom za iglu 24 napunjenih štrcaljki sa štitnikom za iglu 30 napunjenih štrcaljki sa štitnikom za iglu 2 napunjene štrcaljke sa UltraSafe Passive štitnikom za iglu 10 napunjenih štrcaljki sa UltraSafe Passive štitnikom za iglu
5 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and grey aluminium-plastic cap in a cardboard box. 
5 ml otopine u bočici od prozirnog, bezbojnog stakla tipa I, s gumenim čepom i sivim zatvaračem od aluminija i plastike u kartonskoj kutiji.
Supplied in packs of: - 2, 5, 6, 10, 30 and 50 pre-filled syringes - 2, 5, 6, 10, 20, 30, 50 and 90 pre-filled syringes with needle guard - 2 and 6 pre-filled syringes with UltraSafe Passive needle guard 
Dostupno u pakiranjima od: - 2, 5, 6, 10, 30 i 50 napunjenih štrcaljki - 2, 5, 6, 10, 20, 30, 50 i 90 napunjenih štrcaljki sa štitnikom za iglu - 2 i 6 napunjenih štrcaljki s UltraSafe Passive štitnikom za iglu
Prevention of venous thromboembolic disease associated with surgery Extended prophylaxis of VTE following orthopaedic surgery In a double blind study of extended prophylaxis for patients undergoing hip replacement surgery, 179 patients with no venous thromboembolic disease initially treated, while hospitalized, with enoxaparin sodium 4,000 IU (40 mg) subcutaneously, were randomized to a post-discharge regimen of either enoxaparin sodium 4,000 IU (40 mg) (n=90) once a day subcutaneously or to placebo (n=89) for 3 weeks. 
U dvostruko slijepom ispitivanju produljene profilakse u bolesnika podvrgnutih kirurškom zahvatu zamjene kuka, 179 bolesnika bez venske tromboembolijske bolesti, koji su prvotno (tijekom hospitalizacije) bili liječeni enoksaparinnatrijem u supkutanoj dozi od 4000 IU (40 mg), randomizirano je da nakon otpusta iz bolnice prima enoksaparinnatrij u dozi od 4000 IU (40 mg) (n=90) supkutano jedanput na dan ili placebo (n=89) tijekom 3 tjedna.
2 pre-filled syringes with needle guard 6 pre-filled syringes with needle guard 10 pre-filled syringes with needle guard 20 pre-filled syringes with needle guard 50 pre-filled syringes with needle guard 90 pre-filled syringes with needle guard 2 pre-filled syringes with UltraSafe Passive needle guard 6 pre-filled syringes with UltraSafe Passive needle guard 
2 napunjene štrcaljke sa štitnikom za iglu 6 napunjenih štrcaljki sa štitnikom za iglu 10 napunjenih štrcaljki sa štitnikom za iglu 20 napunjenih štrcaljki sa štitnikom za iglu 50 napunjenih štrcaljki sa štitnikom za iglu 90 napunjenih štrcaljki sa štitnikom za iglu 2 napunjene štrcaljke sa UltraSafe Passive štitnikom za iglu 6 napunjenih štrcaljki sa UltraSafe Passive štitnikom za iglu
0.4 mL of solution in: - a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a yellow polypropylene plunger rod. 
0,4 ml otopine u: štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i žutim klipom od polipropilena s pričvršćenom iglom i pokrovom za iglu.
1 mL of solution in: - a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a black polypropylene plunger rod. 
1 ml otopine u: graduiranoj štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i crnim klipom od polipropilena s pričvršćenom iglom i pokrovom za iglu.
VTE = venous thromboembolic event (DVT and/or PE) *The 95% Confidence Intervals for the treatment differences for total VTE were: enoxaparin sodium once a day versus heparin (-3.0 to 3.5) enoxaparin sodium every 12 hours versus heparin (-4.2 to 1.7). 
• PE (%) VTE = venski tromboembolijski događaj (DVT i/ili PE) *Intervali pouzdanosti od 95% za razlike između liječenja za ukupni VTE bili su: enoksaparinnatrij jedanput na dan naspram heparina (-3,0 do 3,5) enoksaparinnatrij svakih 12 sati naspram heparina (-4,2 do 1,7)
0.6 mL of solution in: - a clear, colourless type I neutral glass graduated syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and an orange polypropylene plunger rod. 
0,6 ml otopine u: graduiranoj štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i narančastim klipom od polipropilena s pričvršćenom iglom i pokrovom za iglu.
10 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and white aluminium-plastic cap in a cardboard box. 
10 ml ml otopine u bočici od prozirnog, bezbojnog stakla tipa I, s gumenim čepom i bijelim zatvaračem od aluminija i plastike, u kartonskoj kutiji.
3 mL of solution in clear, colourless type I glass vial sealed with rubber injection stopper and white aluminium-plastic cap in a cardboard box. 
3 ml otopine u bočici od prozirnog, bezbojnog stakla tipa I, s gumenim čepom i bijelim zatvaračem od aluminija i plastike u kartonskoj kutiji.
0.8 mL of solution in a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a purple polypropylene plunger rod. 
0,8 ml otopine u: štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i ljubičastim klipom od polipropilena, s pričvršćenom iglom i pokrovom za iglu.
Monitoring of platelet counts 
Praćenje broja trombocita
4,000 IU (40 mg) of Inhixa each day. 
(40 mg) lijeka Inhixa.
Packs of: - 2, 6, 10, 30, 50 and 90 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard 
Pakiranja od: - 2, 6, 10, 30, 50 i 90 napunjenih štrcaljki - 2, 6, 10, 12, 24 i 30 napunjenih štrcaljki sa štitnika za iglu - 2 i 10 napunjenih štrcaljki sa UltraSafe Passive štitnika za iglu
Treatment of acute ST-segment elevation myocardial infarction In a large multicentre study, 20,479 patients with STEMI eligible to receive fibrinolytic therapy were randomized to receive either enoxaparin sodium in a single 3,000 IU (30 mg) intravenous bolus plus a 100 IU/kg (1 mg/kg) subcutaneous dose followed by an subcutaneous injection of 100 IU/kg (1 mg/kg) every 12 hours or intravenous unfractionated heparin adjusted based on aPTT for 48 hours. 
Bolesnici su bili randomizirani za primanje enoksaparinnatrija u jednokratnoj bolusnoj dozi od 3000 IU (30 mg) intravenski plus 100 IU/kg (1 mg/kg) supkutano, nakon kojih su slijedile supkutane injekcije enoksaparinnatrija u dozi od 100 IU/kg (1 mg/kg) svakih 12 sati, ili za primanje nefrakcioniranog heparina u intravenskoj dozi prilagođenoj prema aPTV-u tijekom 48 sati.
Supplied in packs of: - 2, 6, 10, 30, 50 and 90 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard 
Dostupno u pakiranjima od: - 2, 6, 10, 30, 50 i 90 napunjenih štrcaljki - 2, 6, 10, 12, 24 i 30 napunjenih štrcaljki sa štitnikom za iglu - 2 i 10 napunjenih štrcaljki s UltraSafe Passive štitnikom za iglu
Immunoallergic thrombocytope nia 
Vrlo rijetko: imunoalergijsk a trombocitopeni ja
Packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 20, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard 
Pakiranja od: - 2, 6, 10, 30 i 50 napunjenih štrcaljki - 2, 6, 10, 12, 20, 24 i 30napunjenih štrcaljki sa štitnika za iglu - 2 i 10 napunjenih štrcaljki sa UltraSafe Passive štitnika za iglu
- Changing from blood thinners called vitamin-K antagonists (e.g. warfarin) to Inhixa Stop taking the vitamin-K antagonist. 
- Prelazak s lijekova za razrjeđivanje krvi koji se zovu antagonisti vitamina K (npr. varfarin) na Inhixu
Supplied in packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 20, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard 
Dostupno u pakiranjima od: - 2, 6, 10, 30 i 50 napunjenih štrcaljki - 2, 6, 10, 12, 20, 24 i 30 napunjenih štrcaljki sa štitnikom za iglu - 2 i 10 napunjenih štrcaljki s UltraSafe Passive štitnikom za iglu
Supplied in packs of: - 1, 2, 6, 10 and 50 pre-filled syringe(s) - 2, 6, 10, 20, 50 and 90 pre-filled syringes with needle guard - 2 and 6 pre-filled syringes with UltraSafe Passive needle guard 
Dostupno u pakiranjima od: - 1 napunjena štrcaljka i 2, 6, 10, 50 napunjenih štrcaljki - 2, 6, 10, 20, 50 i 90 napunjenih štrcaljki sa štitnikom za iglu - 2 i 6 napunjenih štrcaljki s UltraSafe Passive štitnikom za iglu
Packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard 
Pakiranja od: - 2, 6, 10, 30 i 50 napunjenih štrcaljki - 2, 6, 10, 12, 24 i 30 napunjenih štrcaljki sa štitnika za iglu - 2 i 10 napunjenih štrcaljki sa UltraSafe Passive štitnika za iglu
- Changing from Inhixa to treatment with direct oral anticoagulant Stop taking Inhixa. 
- Prelazak s lijeka Inhixa na liječenje direktnim oralnim antikoagulansima
Packs of: - 1, 2, 6, 10 and 50 pre-filled syringe(s) - 2, 6, 10, 20, 50 and 90 pre-filled syringes with needle guard - 2 and 6 pre-filled syringes with UltraSafe Passive needle guard 
Pakiranja od: - 1 napunjena štrcaljka i 2, 6, 10, 50 napunjenih štrcaljki - 2, 6, 10, 20, 50 i 90 napunjenih štrcaljki sa štitnika za iglu - 2 i 6 napunjenih štrcaljki sa UltraSafe Passive štitnika za iglu
Supplied in packs of: - 2, 6, 10, 30 and 50 pre-filled syringes - 2, 6, 10, 12, 24 and 30 pre-filled syringes with needle guard - 2 and 10 pre-filled syringes with UltraSafe Passive needle guard 
Dostupno u pakiranjima od: - 2, 6, 10, 30 i 50 napunjenih štrcaljki - 2, 6, 10, 12, 24 i 30 napunjenih štrcaljki sa štitnikom za iglu - 2 i 10 napunjenih štrcaljki s UltraSafe Passive štitnikom za iglu
1 mL of solution in a clear, colourless type I neutral glass syringe barrel with fixed needle and needle shield closed by chlorobutyl rubber stopper and a dark blue polypropylene plunger rod. 
1 ml otopine u: - štrcaljki s tijelom od prozirnog, bezbojnog neutralnog stakla tipa I, zatvorenoj čepom od klorbutil-gume i tamnoplavim klipom od polipropilena, s pričvršćenom iglom i pokrovom za iglu.
Enoxaparin sodium may be safely administered with sodium chloride 9 mg/ml (0.9%) solution for injection or 5% dextrose in water. 
Enoksaparinnatrij se može sigurno primjenjivati zajedno s otopinom natrijeva klorida 9 mg/ml (0,9%) za injekciju ili vodenom otopinom glukoze (5%).
Changing from Inhixa to treatment with direct oral anticoagulant Stop using Inhixa. 
Prelazak s lijeka Inhixa na liječenje direktnim oralnim antikoagulansima
• you have kidney problems 
• ako imate bubrežnih tegoba
Unopened vial: 3 years. 
Neotvorena bočica: 3 godine.
Date of first authorisation: 18 January 2017 
Datum prvog odobrenja: 18 siječnja 2017.
• It is very important that you do not miss the dose of this medicine. 
• Vrlo je važno je da ne propustite primiti dozu ovog lijeka.
Activity in vitro and in vivo 
Aktivnost in vitro i in vivo
Genotoxicity and carcinogenic potential have not been evaluated. 
Genotoksičnost i kancerogeni potencijal nisu ocijenjeni.
From a microbiological point of view, the product must be used immediately. 
S mikrobiološkog stanovišta, lijek se mora odmah primijeniti.
• We don't know if ZINPLAVA will harm your baby while you are pregnant. 
• Nije poznato hoće li ZINPLAVA naškoditi Vašem djetetu dok ste trudni.
Adjusted Difference (95% CI) 
Prilagođena razlika (95% CI)
• The diluted solution can be infused via a central line or peripheral catheter. 
• Razrijeđena otopina može se dati infuzijom putem centralne linije ili perifernog katetera.
No formal interactions studies with other medicinal products were conducted. 
Nisu provedena formalna ispitivanja interakcija s drugim lijekovima.
• If you are pregnant or trying to get pregnant, tell your doctor. 
• Ako ste trudni ili pokušavate zatrudnjeti, obavijestite svog liječnika.
• You will get ZINPLAVA in one dose and it will take about 1 hour. 
• Lijek ZINPLAVA primit ćete u jednoj dozi, a primjena će trajati približno 1 sat.
• You and your doctor should decide together if you will use ZINPLAVA. 
• Vi i Vaš liječnik trebate zajedno odlučiti hoćete li primiti lijek ZINPLAVA.
• ZINPLAVA must not be co-administered with other medicinal products simultaneously through the same infusion line. 
• ZINPLAVA se ne smije primijeniti istodobno s drugim lijekovima u istoj infuzijskoj liniji.
ATC code: J06BB21 
ATK oznaka: J06BB21
What ZINPLAVA is and what it is used for 
Što je ZINPLAVA i za što se koristi
Children and adolescents ZINPLAVA should not be used in children and adolescents below 18 years of age. 
Djeca i adolescenti ZINPLAVA se ne smije davati djeci i adolescentima mlađim od 18 godina.
Tell your doctor or health care professional if you notice any of the side effects above. 
Obratite se svom liječniku ili zdravstvenom radniku ako primijetite bilo koju od gore navedenih nuspojava.
• Call your doctor or health care professional right away to reschedule your appointment. 
• Odmah nazovite svog liječnika ili zdravstvenog radnika i dogovorite novi termin.
Store in a refrigerator 2 °C to 8 °C. 
Čuvati u hladnjaku na temperaturi od 2°C do 8°C.
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose toxicity. 
Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja toksičnosti ponovljenih doza.
These patients presented with risk factors primarily but not exclusively associated with higher risk of CDI recurrence. 
Ti su bolesnici imali faktore rizika koji su prvenstveno, ali ne i isključivo povezani s višim rizikom od recidiva CDI-a.
The mean volume of distribution of bezlotoxumab was 7.33 L (CV: 16 %). 
Srednja vrijednost volumena distribucije bezlotoksumaba iznosila je 7,33 l (CV: 16%).
In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment should be instituted. 
U slučaju predoziranja, bolesnike treba pažljivo nadzirati zbog moguće pojave znakova ili simptoma nuspojava te treba uvesti odgovarajuće simptomatsko liječenje.
Talk to your doctor before you are given ZINPLAVA. 
Obratite se svom liječniku prije nego primite lijek ZINPLAVA.
ZINPLAVA should be administered as a single intravenous infusion of 10 mg/kg (see below and section 6.6). 
Lijek ZINPLAVA treba primjenjivati kao jednokratnu intravensku infuziju u dozi od 10 mg/kg (vidjeti niže i u dijelu 6.6).
A similar proportion of patients were receiving oral metronidazole (48 %) or oral vancomycin (48 %) and only 4 % were receiving fidaxomicin as antibacterial treatment for CDI. 
Sličan udio bolesnika primao je oralni metronidazol (48%) ili oralni vankomicin (48%), dok ih je samo 4% primalo fidaksomicin kao antibiotsku terapiju za liječenje CDI-a.
Twenty one (21) percent of the patients were immunocompromised and 16 % presented with clinically severe CDI. 
Dvadeset i jedan (21) posto bolesnika bilo je imunokompromitirano, a 16% ih je imalo klinički težak CDI.
• Do not freeze the diluted solution. 
• Nemojte zamrzavati razrijeđenu otopinu.
The safety and efficacy of ZINPLAVA in patients below 18 years of age have not been established. 
Sigurnost i djelotvornost lijeka ZINPLAVA u bolesnika mlađih od 18 godina nisu ustanovljene.
The safety profile of ZINPLAVA was assessed in two Phase 3 clinical studies. 
Sigurnosni profil lijeka ZINPLAVA ocjenjivao se u dva klinička ispitivanja faze 3.
There is no data regarding the efficacy of ZINPLAVA if given after the initial 10- to 14-days of antibacterial therapy for CDI. 
Nema podataka o djelotvornosti lijeka ZINPLAVA ako se primijeni nakon prvih 10 do 14 dana antibiotske terapije CDI-a.
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. 
Među 976/1554 (62%) bolesnika koji su imali pozitivan nalaz kulture stolice na C. difficile na početku ispitivanja, hipervirulentan soj (ribotipovi 027, 078 ili 244) izoliran je u njih 22% (217 od 976 bolesnika), od kojih je većina (87%, 189 od 217 sojeva) bila ribotipa 027.
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). 
Učestalost nuspojava definirana je kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
ZINPLAVA should not be used during pregnancy unless the clinical condition of the woman requires treatment with bezlotoxumab. 
ZINPLAVA se ne smije primjenjivati tijekom trudnoće, osim ako kliničko stanje žene ne zahtijeva liječenje bezlotoksumabom.
Sodium hydroxide (E524) (for pH adjustment). 
(E524) (za prilagodbu pH).
Bezlotoxumab exposures in healthy subjects increased in an approximately dose proportional manner across the 0.3 to 20 mg/kg dose range. 
Izloženost bezlotoksumabu u zdravih ispitanika povećavala se na način približno proporcionalan primijenjenoj dozi u rasponu doza od 0,3 do 20 mg/kg.
• Discard vial(s) and all unused contents. 
• Bacite bočicu(e) i sav neupotrijebljen sadržaj.
It binds to C. difficile toxin B. 
Vezuje se za toksin B bakterije C. difficile.
ZINPLAVA is not a treatment for CDI and has no effect on the current CDI episode. 
ZINPLAVA nije terapija za liječenje CDI-a i nema učinka na trenutnu epizodu CDI-a.
The toxin B epitope to which bezlotoxumab binds is conserved, though not identical, across all known toxin sequences. 
Epitop toksina B za koji se bezlotoksumab vezuje očuvan je, iako ne i identičan, kod svih poznatih toksinskih sljedova.
• When people get CDI, they are usually given an antibiotic to get rid of the infection, but CDI can often come back within weeks or months. 
• Kada ljudi dobiju infekciju uzrokovanu bakterijom Clostridium difficile, obično dobiju antibiotik da bi se izliječili od te infekcije, ali se ona često može vratiti unutar nekoliko tjedana ili mjeseci.
The median age was 65 years, 85 % were white, 57 % were female, and 68 % were inpatients. 
Medijan dobi iznosio je 65 godina, 85% ispitanika bili su bijelci, 57% žene, a 68% njih liječilo se u bolnici.
Overall, 51 % were ≥ 65 years, 29% were ≥ 75 years and 39 % received one or more systemic antibacterial agents during the 12 week follow-up period. 
Sveukupno je 51% ispitanika bilo u dobi od ≥ 65 godina, 29% ih je bilo u dobi od ≥ 75 godina, a 39% njih primilo je jedan ili više sistemskih antibiotika tijekom 12-tjednog razdoblja praćenja.
Other medicines and ZINPLAVA Tell your doctor if you are taking, have recently taken or might take any other medicines. 
Obavijestite svog liječnika ako uzimate, nedavno ste uzeli ili biste mogli uzeti bilo koje druge lijekove.
Pharmacotherapeutic group: Antiinfectives for systemic use, specific immunoglobulins. 
Farmakoterapijska skupina: lijekovi za liječenje sustavnih infekcija, specifični imunoglobulini.