natgillin/translations-raw huggingface dataset:
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.
Of the total 28 % had one or more episodes of CDI within the six months prior to the episode under treatment (18 % of the patients had one, 7 % had two and a few patients had 3 or more prior episodes).
Među svim ispitanicima, 28% ih je imalo jednu ili više epizoda CDI-a unutar šest mjeseci prije epizode zbog koje su trenutno primali liječenje (18% bolesnika imalo je jednu epizodu, 7% dvije epizode, a manji broj bolesnika 3 ili više prethodnih epizoda).
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.
U kliničkim su ispitivanjima ozbiljne nuspojave koje su se javile unutar 12 tjedana nakon infuzije prijavljene u 29% bolesnika liječenih lijekom ZINPLAVA i 33% bolesnika koji su primali placebo.
The effects of various covariates on the pharmacokinetics of bezlotoxumab were assessed in a population pharmacokinetic analysis.
Učinci različitih kovarijanti na farmakokinetiku bezlotoksumaba ocjenjivali su se u populacijskoj farmakokinetičkoj analizi.
Hypervirulent strain included the following: 027, 078, or 244 ribotypes
Hipervirulentni soj uključivao je sljedeće ribotipove: 027, 078 ili 244
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.
Budući da se monoklonska protutijela mogu izlučivati u majčino mlijeko, treba donijeti odluku o tome hoće li se prekinuti dojenje ili se neće primijeniti ZINPLAVA, uzimajući u obzir važnost lijeka ZINPLAVA za majku.
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.
Među bolesnicima koji su doživjeli nuspojavu specifičnu za infuziju, većina je prijavila reakciju najviše blagog (78%) ili umjerenog (20%) intenziteta, a većina se tih reakcija povukla unutar 24 sata nakon nastupa.
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.
Terapijska monoklonska protutijela obično nemaju značajan potencijal za interakcije s drugim lijekovima jer ne djeluju izravno na enzime citokroma P450 i nisu supstrati za jetrene ili bubrežne prijenosnike.
History of one or more episodes of CDI in past 6 months Immunocompromised Severe CDI
Dob ≥ 65 godina Jedna ili više epizoda CDI-a u proteklih 6 mjeseci Imunokompromitirani Teški CDI
No anti-bezlotoxumab antibodies were detected after the second dose.
Nisu pronađena protutijela na bezlotoksumab nakon primjene druge doze.
The following side effects have been reported in clinical trials:
U kliničkim su ispitivanjima prijavljene sljedeće nuspojave:
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.
U Tablici 3 prikazani su rezultati prospektivno planirane objedinjene analize stopa recidiva CDI-a u unaprijed specificiranim podskupinama bolesnika s visokim rizikom od recidiva CDI-a u dva ispitivanja faze 3.
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.
Sljedeći faktori nisu klinički značajno utjecali na izloženost bezlotoksumabu, stoga nije potrebno prilagođavati dozu: dob (raspon: 18 - 100 godina), spol, rasa, etničko podrijetlo, oštećenje funkcije bubrega, oštećenje funkcije jetre i komorbiditeti.
Patients on oral vancomycin or oral fidaxomicin could have also received IV metronidazole.
Bolesnici koji su uzimali oralni vankomicin ili oralni fidaksomicin mogli su također primiti i intravenski metronidazol.
• The bacteria responsible for CDI produce a toxin that can inflame and damage your colon, causing stomach pain and severe diarrhoea.
• Bakterija odgovorna za tu infekciju (Clostridium difficile) proizvodi toksin koji može uzrokovati upalu i oštećenje debelog crijeva, izazivajući bol u trbuhu i jak proljev.
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.
Najčešće nuspojave nakon liječenja lijekom ZINPLAVA (prijavljene u ≥ 4% bolesnika unutar prva 4 tjedna nakon infuzije) bile su mučnina, dijareja, pireksija i glavobolja.
In clinical trials, healthy subjects received up to 20 mg/kg, which was generally well tolerated.
U kliničkim ispitivanjima zdravi ispitanici primili su dozu do 20 mg/kg, koju su u pravilu dobro podnosili.
These time limits include storage of the infusion solution in the IV bag through the duration of infusion.
Ta vremenska ograničenja uključuju čuvanje otopine za infuziju u vrećici za intravensku primjenu tijekom trajanja infuzije.
Bezlotoxumab is eliminated from the body primarily by protein degradation.
Bezlotoksumab se iz tijela eliminira prvenstveno razgradnjom proteina.
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.
Ukupno je 10% ispitanika u skupini liječenoj lijekom ZINPLAVA doživjelo jednu ili više nuspojava specifičnih za infuziju na dan njezine primjene ili dan nakon nje, u usporedbi s 8% onih koji su primali placebo.
The baseline characteristics of the 781 patients receiving ZINPLAVA and 773 receiving placebo were generally similar across treatment groups.
Početne karakteristike 781 bolesnika koji su primali lijek ZINPLAVA i 773 bolesnika koji su primali placebo općenito su bile slične u svim liječenim skupinama.
The effect of age on the pharmacokinetics of bezlotoxumab was evaluated in patients ranging from 18 to 100 years of age.
Učinak dobi na farmakokinetiku bezlotoksumaba ocjenjivao se u bolesnika u dobi od 18 do 100 godina.
There are limited data from the use of bezlotoxumab in pregnant women.
Postoje ograničeni podaci o primjeni bezlotoksumaba u trudnica.
No clinically meaningful differences in the exposure of bezlotoxumab were found between elderly patients 65 years and older and patients under 65 years of age.
Nisu utvrđene klinički važne razlike u izloženosti bezlotoksumabu između bolesnika u dobi od 65 godina ili starijih i onih mlađih od 65 godina.
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).
Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka ZINPLAVA u jednoj ili više podskupina pedijatrijske populacije u prevenciji recidiva CDI-a (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
† See Description of selected adverse reactions below.
† Vidjeti „Opis odabranih nuspojava” u nastavku.
Bezlotoxumab is a human monoclonal antibody produced in Chinese hamster ovary cells by recombinant DNA technology.
Bezlotoksumab je humano monoklonsko protutijelo proizvedeno u stanicama jajnika kineskog hrčka tehnologijom rekombinantne DNK.
In the studies, the clinical cure rates of the presenting CDI episode were comparable between the treatment arms.
U ispitivanjima, kliničke stope izlječenja trenutne epizode CDI-a su bile usporedive između liječenih skupina.
The mean clearance of bezlotoxumab was 0.317 L/day (CV: 41 %) and the terminal half-life (t½) was approximately 19 days
Srednja vrijednost klirensa bezlotoksumaba iznosila je 0,317 l/dan (CV: 41%), a terminalni poluvijek (t½) iznosio je približno 19 dana (28%).
How ZINPLAVA works
Kako ZINPLAVA djeluje
The CDI recurrence rates are shown in Table 2.
Stope recidiva CDI-a prikazane su u Tablici 2.
Randomisation was stratified by the antibacterial agent and hospitalisation status (inpatient vs. outpatient) at the time of study entry.
Randomizacija je bila stratificirana prema antibiotiku i statusu hospitalizacije (bolničko naspram ambulantnog liječenja) u trenutku uključivanja u ispitivanje.
Each mL of concentrate contains 0.2 mmol sodium, which is 4.57 mg sodium.
Jedan ml koncentrata sadrži 0,2 mmol natrija, što odgovara 4,57 mg natrija.
≥ 90 mL/min/1.73 m2) renal function.
(eGFR ≥ 90 ml/min/1,73 m2).
The clearance of bezlotoxumab increased with increasing body weight; the resulting exposure differences are adequately addressed by the administration of a weight-based dose.
Klirens bezlotoksumaba povećavao se s povećanjem tjelesne težine; posljedične razlike u izloženosti adekvatno se rješavaju doziranjem prema tjelesnoj težini.
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 %).
Nuspojave specifične za infuziju prijavljene u ≥ 0,5% ispitanika koji su primali lijek ZINPLAVA i s učestalošću većom nego kod primjene placeba bile su mučnina (3%), umor (1%), pireksija (1%), omaglica (1%), glavobolja (2%), dispneja (1%) i hipertenzija (1%).
What you need to know before you are given ZINPLAVA
Što morate znati prije nego primite lijek ZINPLAVA
• We don't know if ZINPLAVA gets in your breast milk and is passed to your baby.
• Nije poznato izlučuje li se ZINPLAVA u majčino mlijeko i prenosi li se na dijete.
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).
Otopina za infuziju: Dokazana je kemijska i fizikalna stabilnost tijekom 24 sata na temperaturi od 2°C - 8°C ili tijekom 16 sati na sobnoj temperaturi (25°C ili nižoj).
If you miss an appointment to get ZINPLAVA
Ako propustite termin za primjenu lijeka ZINPLAVA
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 antitoksinsko protutijelo koje se s visokim afinitetom vezuje za toksin B bakterije C. difficile i neutralizira njegovo djelovanje.
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.
Jednokratna infuzija lijeka ZINPLAVA ili placeba primijenjena je prije završetka antibiotske terapije, a zatim su bolesnici praćeni tijekom 12 tjedana nakon infuzije.
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.
Iako je lijek ZINPLAVA namijenjen za jednokratnu primjenu, imunogenost bezlotoksumaba ocijenjena je u 29 zdravih ispitanika nakon primjene druge doze od 10 mg/kg, 12 tjedana nakon primjene prve doze.
Excipients: Citric acid monohydrate, diethylenetriaminepentaacetic acid, polysorbate 80, sodium chloride, sodium citrate dihydrate, water for injections, sodium hydroxide.
Pomoćne tvari: citratna kiselina hidrat, dietilentriaminpentaacetatna kiselina, polisorbat 80, natrijev klorid, natrijev citrat dihidrat, voda za injekcije, natrijev hidroksid.
• You will get ZINPLAVA as an infusion (drip) into a vein.
• Lijek ZINPLAVA primit ćete infuzijom (ukapavanjem) u venu.
Efficacy results did not point towards a benefit of ZINPLAVA in patients with no known risk factors for CDI.
Rezultati djelotvornosti nisu ukazivali na korist primjene lijeka ZINPLAVA u bolesnika koji nisu imali poznate faktore rizika za CDI.
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.
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.
• 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.
• 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.
Patients received a 10- to 14-day course of oral antibacterial therapy for CDI (metronidazole, vancomycin or fidaxomicin, chosen by the investigator).
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).
• 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.
• 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.
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.
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.
• you are allergic to bezlotoxumab or any of the other ingredients of this medicine (listed in section 6).
Ne smijete primiti lijek ZINPLAVA: • ako ste alergični na bezlotoksumab ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
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.
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.
Infected with 027 ribotype n = Number of patients within subgroup that met the criteria for endpoint m = Number of patients within subgroup
n = broj bolesnika unutar podskupine koji su zadovoljavali kriterije za mjeru ishoda m = broj bolesnika unutar podskupine
In a Phase 1 clinical trial, healthy subjects received two consecutive doses of 10 mg/kg of bezlotoxumab separated by 12 weeks.
U kliničkom ispitivanju faze 1, zdravi ispitanici primili su dvije uzastopne doze bezlotoksumaba od 10 mg/kg u razmaku od 12 tjedana.
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.
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.
Fertility studies have not been conducted in animals.
Nisu provedena ispitivanja učinaka na plodnost u životinja.
The experience with ZINPLAVA in patients is limited to a single CDI episode and single administration (see section 4.4).
Iskustvo liječenja s lijekom ZINPLAVA u bolesnika je ograničeno na jednu epizodu CDI-a i jednokratnu primjenu (vidjeti dio 4.4).
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.
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.
Driving and using machines ZINPLAVA has no or very little effect on the ability to drive and use machines.
Upravljanje vozilima i strojevima ZINPLAVA ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
There is no clinical experience with overdosage of ZINPLAVA.
Nema kliničkog iskustva s predoziranjem lijekom ZINPLAVA.
Bezlotoxumab prevents CDI recurrence by providing passive immunity against toxin produced by the outgrowth of persistent or newly-acquired C. difficile spores.
Bezlotoksumab sprječava recidiv CDI-a tako što omogućuje pasivnu imunost protiv toksina koji nastaje uslijed rasta perzistentnih ili novostečenih spora bakterije C. difficile.
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).
Clostridium difficile infection, CDI) u odraslih osoba s visokim rizikom za recidiv CDI-a (vidjeti dijelove 4.2, 4.4 i 5.1).
Table 1 presents the adverse reactions reported within 4 weeks of infusion in ZINPLAVA-treated patients and listed by System Organ Class.
Tablica 1 prikazuje nuspojave prijavljene unutar 4 tjedna nakon infuzije u bolesnika liječenih lijekom ZINPLAVA, a navedene su prema organskim sustavima.
Type I glass vial containing 40 mL solution, with a chlorobutyl stopper, and a flip-off cap seal.
Staklena bočica (staklo tipa I) koja sadrži 40 ml otopine, s klorbutilnim čepom i zaštitnim zatvaračem s flip-off kapicom.
ZINPLAVA 25 mg/mL concentrate for solution for infusion
ZINPLAVA 25 mg/ml koncentrat za otopinu za infuziju
Within each frequency grouping, adverse reactions are presented in order of decreasing frequency.
Unutar svake skupine učestalosti, nuspojave su prikazane u padajućem nizu prema učestalosti.
Table 1: Adverse Reactions with ZINPLAVA MedDRA System Organ Class
Tablica 1: Nuspojave kod primjene lijeka ZINPLAVA Klasifikacija organskih sustava prema MedDRA-i