FrancophonIA/ELRC3.0 huggingface dataset:
English: Mycamine should not be used during pregnancy unless clearly necessary.
Croatian: Mycamine se ne smije primjenjivati tijekom trudnoće osim kad je jasno da je to neophodno.
English: For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.
Croatian: Uvjete čuvanja nakon rekonstitucije i razrjeđivanja lijeka, vidjeti u dijelu 6.3.
English: Prolongation of infusion time reducing the plasma concentration peak appeared to reduce these effects.
Croatian: Čini se da produljenje trajanja infuzije, čime se smanjuje vršna koncentracija u plazmi, smanjuje ove učinke.
English: Consequently, the occurrence of these adverse responses may be expected in human clinical use of micafungin.
Croatian: Posljedično tome, nastanak ovakvih štetnih odgovora može se očekivati kod kliničke primjene mikafungina u ljudi.
English: The overall incidence of hepatic adverse reactions in the patients treated with micafungin in clinical studies was 8.6% (260/3028).
Croatian: Ukupna incidencija jetrenih nuspojava u bolesnika liječenih mikafunginom u kliničkim ispitivanjima iznosila je 8,6% (260/3028).
English: Please inform your doctor if you experience any effects that may cause you to have problems with driving or using other machinery.
Croatian: Obavijestite svog liječnika ako osjetite neke učinke zbog kojih biste mogli imati tegobe kod upravljanja vozilima i rada sa strojevima.
English: If you use Mycamine you should not breast-feed.
Croatian: Ako uzimate Mycamine, ne smijete dojiti.
English: This medicinal product must not be mixed or co-infused with other medicinal products except those mentioned in section 6.6.
Croatian: Lijek se ne smije miješati niti primjenjivati infuzijom zajedno s drugim lijekovima osim onih navedenih u dijelu 6.6.
English: Treatment success was defined as the absence of a proven, probable, or suspected systemic fungal infection through the end of therapy and absence of a proven or probable systemic fungal infection through the end of study.
Croatian: Uspjeh liječenja definirao se kao odsustvo dokaza, vjerojatnosti ili sumnje na sistemsku gljivičnu infekciju do kraja terapije i odsustvo dokaza ili vjerojatnosti za sistemsku gljivičnu infekciju do kraja ispitivanja.
English: No micafungin dose adjustments are necessary when these medicines are administered concomitantly.
Croatian: Nisu potrebne prilagodbe doza mikafungina kad se istodobno primjenjuju ovi lijekovi.
English: If central nervous system (CNS) infection is suspected, a higher dosage (e.g. 10 mg/kg) should be used due to the dose-dependent penetration of micafungin into the CNS (see section 5.2).
Croatian: Ako se sumnja na infekciju središnjeg živčanog sustava (SŽS), potrebno je upotrijebiti višu dozu (npr. 10 mg/kg) zbog penetracije mikafungina u SŽS ovisne o dozi (vidjeti dio 5.2).
English: Micafungin exhibits fungicidal activity against most Candida species and prominently inhibits actively growing hyphae of Aspergillus species.
Croatian: Mikafungin pokazuje fungicidno djelovanje protiv većine vrsta Candide i izrazito inhibira aktivni rast hifa kod vrsta Aspergillus.
English: In animal studies micafungin crossed the placental barrier and reproductive toxicity was seen (see section 5.3).
Croatian: U ispitivanjima na životinjama mikafungin je prolazio placentarnu barijeru i opažena je reproduktivna toksičnost (vidjeti dio 5.3).
English: • To treat adults, adolescents and children including neonates who have a serious fungal infection called invasive candidiasis (infection that has penetrated the body).
Croatian: • Za liječenje odraslih, adolescenata i djece, uključujući novorođenčad, koji imaju ozbiljnu gljivičnu infekciju zvanu invazivna kandidijaza (infekcija koja je prodrla u tijelo).
English: The assumed threshold for tumour development in rats is approximately in the range of clinical exposure.
Croatian: Predviđeni prag za razvoj tumora u štakora nalazi se otprilike unutar raspona kliničke izloženosti.
English: Micafungin and liposomal amphotericin B were received for a median duration of 15 days (range, 4 to 42 days in adults; 12 to 42 days in children).
Croatian: Medijan trajanja primanja mikafungina i liposomalnog amfotericina B je bio 15 dana (raspon, 4 do 42 dana u odraslih; 12 do 42 dana u djece).
English: Other breakthrough infections were caused by Fusarium (1 and 2 patients, respectively) and Zygomycetes (1 and 0 patients, respectively).
Croatian: Druge probojne infekcije bile su prouzročene gljivicama Fusarium (1 odnosno 2 bolesnika) i Zygomycetes (1 odnosno 0 bolesnika).
English: In one spontaneous case, it was reported a dosage of 16 mg/kg/day was administered in a newborn patient.
Croatian: U jednom spontanom slučaju prijavljena je doza od 16 mg/kg/dan primijenjena u novorođenčeta.
English: Elderly: When administered as a single 1-hour infusion of 50 mg the pharmacokinetics of micafungin in the elderly (aged 66-78 years) were similar to those in young (20-24 years) subjects.
Croatian: Stariji: Kad se primijenio u dozi od 50 mg kao jednokratna jednosatna infuzija, farmakokinetika mikafungina u starijih (u dobi od 66-78 godina) bila je slična onoj u mlađih (u dobi od 20 do 24 godine) ispitanika.
English: The decision to use Mycamine should take into account a potential risk for the development of liver tumours (see section 4.4).
Croatian: Kod odluke o primjeni Mycaminea treba uzeti u obzir mogući rizik od razvoja tumora jetre (vidjeti dio 4.4).
English: Total clearance was 0.15-0.3 ml/min/kg in healthy subjects and adult patients and is independent of dose after single and repeated administration.
Croatian: Ukupni klirens bio je 0,15-0,3 ml/min/kg u zdravih ispitanika i odraslih bolesnika i ne ovisi o dozi nakon jednokratne i ponovljene primjene.
English: Mycamine should therefore only be used if other antifungals are not appropriate.
Croatian: Stoga se Mycamine smije primjenjivati samo ako drugi antimikotici nisu pogodni.
English: Body weight > 40 kg Body weight ≤ 40 kg
Croatian: Tjelesna težina ≤ 40 kg
English: The unopened vial does not require any special storage conditions.
Croatian: Neotvorena bočica ne zahtijeva posebne uvjete čuvanja.
English: In the clinical study, successful outcome was numerically slightly lower for C. tropicalis than for C. albicans at both dosages (100 and 150 mg daily).
Croatian: Tijekom kliničkog ispitivanja uspješan ishod je numerički bio nešto niži za C. tropicalis nego za C. albicans kod oba doziranja (100 i 150 mg na dan).
English: The duration of micafungin dosing in these rat studies (6 months) exceeds the usual duration of micafungin dosing in patients (see section 5.1).
Croatian: Trajanje primjene mikafungina u ovim ispitivanjima na štakorima (6 mjeseci) bilo je dulje od uobičajenog trajanja primjene mikafungina u bolesnika (vidjeti dio 5.1).
English: Micafungin was not mutagenic or clastogenic when evaluated in a standard battery of in vitro and in vivo tests, including an in vitro study on unscheduled DNA synthesis using rat hepatocytes.
Croatian: Mikafungin nije bio mutagen ili klastogen kad se procjenjivao u standardnoj bateriji in vitro i in vivo testova, uključujući in vitro test neplanirane sinteze DNK na hepatocitima štakora.
English: In rats, signs of haemolytic anaemia were observed after repeated bolus injection of micafungin.
Croatian: U štakora su znakovi hemolitičke anemije bili opaženi nakon ponovljene bolus injekcije mikafungina.
English: These data indicate that elimination of micafungin is primarily non-renal.
Croatian: Ovi podaci pokazuju da se eliminacija mikafungina primarno odvija izvan bubrega.
English: It interferes with the production of a part of the fungal cell wall.
Croatian: Ometa proizvodnju dijelova stanične stijenke gljivice.
English: In plasma, metabolites M-1 and M-2 were detected only at trace concentrations and metabolite M-5, the more abundant metabolite, accounted for a total of 6.5% relative to parent compound.
Croatian: U plazmi, metaboliti M-1 i M-2 bili su otkriveni samo u tragovima, a metabolit M-5, obilnije prisutan, činio je ukupno 6,5% u odnosu na ishodišni spoj.
English: There are no data from the use of micafungin in pregnant women.
Croatian: Nema podataka o primjeni mikafungina u trudnica.
English: The mean terminal half-life is approximately 10-17 hours and stays consistent across doses up to 8 mg/kg and after single and repeated administration.
Croatian: Srednja vrijednost terminalnog poluvremena iznosi približno 10-17 sati i toliko iznosi za sve doze do 8 mg/kg nakon jednokratne kao i nakon ponovljene primjene.
English: • The decision to use Mycamine should take into account a potential risk for the development of liver tumours.
Croatian: • Kod odluke o primjeni Mycaminea treba uzeti u obzir mogući rizik od razvoja tumora jetre.
English: Prophylaxis of Candida infections: Micafungin should be administered for at least one week after neutrophil recovery.
Croatian: Profilaksa infekcija Candidom: Mikafungin treba primjenjivati još najmanje jedan tjedan nakon oporavka neutrofila.
English: Even though micafungin is a substrate for CYP3A in vitro, hydroxylation by CYP3A is not a major pathway for micafungin metabolism in vivo.
Croatian: Iako je mikafungin supstrat enzima CYP3A in vitro, hidroksilacija pomoću CYP3A nije glavni put metabolizma mikafungina in vivo.
English: Mycamine causes defects in the fungal cell wall, making the fungus unable to live and grow.
Croatian: Mycamine uzrokuje oštećenja u staničnoj stijenci gljivice, zbog čega ona ne može živjeti i rasti.
English: The reconstituted concentrate and the diluted infusion solution should be used immediately, because it does not contain any preservatives to prevent bacterial contamination.
Croatian: Koncentrat pripremljen za primjenu i razrijeđena otopina za infuziju trebaju se odmah primijeniti zato što ne sadrže konzervanse za sprječavanje kontaminacije bakterijama.
English: Most patients (97%, N=882) had neutropenia at baseline (< 200 neutrophils/µL).
Croatian: Većina bolesnika (97%, N = 882) imala je neutropeniju na početku ispitivanja (< 200 neutrofila/µl).
English: Clearance was influenced by weight, with mean values of weight-adjusted clearance 1.35 times higher in the younger children (4 months to 5 years) and 1.14 times higher in paediatric patients aged 6 to 11 years.
Croatian: Na klirens je utjecala tjelesna težina, uz srednje vrijednosti klirensa prilagođenog za tjelesnu težinu 1,35 puta veće u mlađe djece (4 mjeseca do 5 godina) i 1,14 puta veće u pedijatrijskih bolesnika u dobi od 6 do 11 godina.
English: • To treat adults and adolescents ≥ 16 years of age who have a fungal infection in the gullet (oesophagus) where treatment into a vein (intravenous) is appropriate.
Croatian: • Za liječenje odraslih i adolescenata u dobi od 16 ili više godina koji imaju gljivičnu infekciju jednjaka (ezofagusa) kad je prikladno provesti liječenje u venu (intravenski).
English: Mechanism(s) of resistance
Croatian: Mehanizam(mehanizmi) rezistencije
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti, nuspojave su prikazane slijedom prema sve manjoj ozbiljnosti.
English: In both studies increased incidences/numbers of hepatocellular tumours were observed after the 18 and 20 month treatment free period in the high dose group of 32 mg/kg/day as well as in a lower dose group (although not statistically significant).
Croatian: U oba je ispitivanja opažena povećana incidencija / broj hepatocelularnih tumora nakon 18 i 20 mjeseci razdoblja bez liječenja, kako u skupini koja je primala visoku dozu od 32 mg/kg na dan, tako i u skupini koja je primala nižu dozu (iako razlike nisu bile statistički značajne).
English: Testicular toxicity was observed in animal studies (see section 5.3).
Croatian: U ispitivanjima na životinjama opažena je testikularna toksičnost (vidjeti dio 5.3).
English: Reduced susceptibility to echinocandins has been associated with mutations in the Fks1 and Fks2 genes coding for a major subunit of glucan synthase.
Croatian: Smanjena osjetljivost na ehinokandine povezana je s mutacijama u genima Fks1 i Fks2 koji kodiraju glavnu podjedinicu glukan sintaze.
English: There is no experience with overdoses of micafungin.
Croatian: Nema iskustva s predoziranjem mikafunginom.
English: These data are insufficient to support a dosing recommendation in patients with severe hepatic impairment.
Croatian: Ovi podaci nisu dovoljni da bi poduprli preporuke za doziranje u bolesnika s teškim oštećenjem funkcije jetre.
English: In animals models of candidiasis, a correlation was observed between exposure of micafungin divided by MIC (AUC/MIC) and efficacy defined as the ratio required to prevent progressive fungal growth.
Croatian: Na životinjskim modelima kandidijaze primijećena je korelacija između izloženosti mikafunginu podijeljene s minimalnom inhibitornom koncentracijom (AUC/MIK) i djelotvornosti definirane kao omjer potreban za prevenciju progresivnog rasta gljivica.
English: The plastic cap must be removed from the vial and the stopper disinfected with alcohol.
Croatian: Plastični poklopac mora se ukloniti s bočice, a čep dezinficirati alkoholom.
English: Pharmacokinetics are linear over the daily dose range of 12.5 mg to 200 mg and 3 mg/kg to 8 mg/kg.
Croatian: Farmakokinetika je linearna u rasponu dnevnih doza od 12,5 mg do 200 mg te od 3 mg/kg do 8 mg/kg.
English: From a microbiological point of view, the reconstituted and diluted solutions should be used immediately.
Croatian: S mikrobiološkog stajališta, rekonstituiranu i razrijeđenu otopinu treba odmah primijeniti.
English: Exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported.
Croatian: Zabilježene su eksfolijativne kožne reakcije, kao što su Stevens-Johnsonov sindrom i toksična epidermalna nekroliza.
English: Endocrine disorders hyperhidrosis
Croatian: Endokrini poremećaji hiperhidroza
English: Paediatric patients: In paediatric patients AUC values were dose proportional over the dose range of 0.5-4 mg/kg.
Croatian: U pedijatrijskih bolesnika vrijednosti AUC-a bile su proporcionalne dozi u rasponu doze od 0,5-4 mg/kg.
English: Volume of sodium chloride (0.9%) or glucose (5%) to be added per vial
Croatian: Volumen natrijevog klorida (0,9%) ili glukoze
English: In dog, liver effects consisted of increased weight and centrilobular hypertrophy, no degenerative changes of hepatocytes were observed.
Croatian: U psa su se učinci na jetru sastojali od povećanja težine jetre i centrilobularne hipertrofije, no nisu opažene degenerativne promjene hepatocita.
English: Following intravenous administration concentrations of micafungin show a biexponential decline.
Croatian: Nakon intravenske primjene, koncentracije mikafungina pokazuju bieksponencijalni pad.
English: An endoscopic grade of 0 (endoscopic cure) at the end of treatment was observed for 87.7% (228/260) and 88.0% (227/258) of patients in the micafungin and fluconazole groups, respectively (95% CI for difference: [-5.9%, 5.3%]).
Croatian: (endoskopski utvrđeno izlječenje) na kraju liječenja opaženo je u 87,7% (228/260) bolesnika u skupini liječenoj mikafunginom i 88,0% (227/258) bolesnika u skupini liječenoj flukonazolom (95% CI za razliku: [-5,9%, 5,3%]).
English: Population PK modeling demonstrated that a dose of 10 mg/kg in children less than 4 month of age would be sufficient to achieve the target exposure for the treatment of CNS Candida infections.
Croatian: U populacijskom farmakokinetičkom modeliranju pokazano je da bi doza od 10 mg/kg u djece mlađe od 4 mjeseca bila dovoljna za postizanje ciljne izloženosti za liječenje infekcija SŽS-a Candidom.
English: Powder for solution for infusion White compact powder
Croatian: Prašak za otopinu za infuziju Bijeli kompaktni prašak
English: The incidence of some adverse reactions was higher in paediatric patients than in adult patients (see section 4.8).
Croatian: Incidencija nekih nuspojava bila je viša u pedijatrijskih bolesnika nego u odraslih bolesnika (vidjeti dio 4.8).
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Mycamine should be made taking into account the benefit of breast-feeding to the child and the benefit of Mycamine therapy to the mother.
Croatian: Odluku o nastavku ili prekidu dojenja odnosno nastavku ili prekidu terapije Mycamineom treba donijeti uzimajući u obzir korist od dojenja za dijete i koristi od terapije Mycamineom za majku.
English: Serious reactions (e.g. anaphylactoid reaction 0.2%, 6/3028) were uncommonly reported during therapy with micafungin and only in patients with serious underlying conditions (e.g. advanced AIDS, malignancies) requiring multiple co-medications.
Croatian: Ozbiljne reakcije (npr. anafilaktoidna reakcija 0,2%, 6/3028) nisu bile često zabilježene tijekom terapije mikafunginom i samo u bolesnika s ozbiljnim osnovnim bolestima (npr., uznapredovali AIDS, zloćudne bolesti) koje su zahtijevale istodobno liječenje većim brojem lijekova.
English: In repeated dose toxicity studies in rat signs of hepatotoxicity consisted of increased liver enzymes and degenerative changes of hepatocytes which were accompanied by signs of compensatory regeneration.
Croatian: U ispitivanjima toksičnosti ponovljenih doza u štakora, znakovi hepatotoksičnosti sastojali su se od povišenih vrijednosti jetrenih enzima i degenerativnih promjena hepatocita, koji su bili praćeni znakovima kompenzacijske regeneracije.
English: Prophylaxis of Candida infection
Croatian: Profilaksa infekcije Candidom
English: Since this may be of clinical significance this coadministration should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities (see section 4.4).
Croatian: Budući da to može biti klinički značajno, ovi se lijekovi smiju primjenjivati istodobno samo kad koristi jasno premašuju rizike, uz pažljiv nadzor toksičnosti amfotericin B dezoksikolata (vidjeti dio 4.4).
English: However, if you are concerned that you may have missed a dose, speak to your doctor or another healthcare professional immediately.
Croatian: Međutim, ako ste zabrinuti da ste možda propustili dozu, odmah se obratite svom liječniku ili drugom zdravstvenom radniku.
English: Mycamine must not be mixed or co-infused with other medicinal products except those mentioned below.
Croatian: Mycamine se ne smije miješati niti primjenjivati infuzijom zajedno s drugim lijekovima osim onih navedenih niže.
English: However, if you are concerned that you may have been given too much Mycamine, speak to your doctor or another healthcare professional immediately.
Croatian: Međutim, ako ste zabrinuti da ste možda dobili previše Mycaminea, odmah se obratite Vašem liječniku ili drugom zdravstvenom radniku.
English: Paediatric patients < 1 year of age might be more prone to liver injury (see section 4.8).
Croatian: Pedijatrijski bolesnici u dobi do 1 godine mogu biti skloniji oštećenju jetre (vidjeti dio 4.8).
English: The median treatment duration was 14 days and the median average daily dose was 150 mg for micafungin (N=260) and 200 mg for fluconazole (N=258).
Croatian: Medijan trajanja liječenja iznosio je 14 dana, a medijan prosječne dnevne doze iznosio je 150 mg za mikafungin (N = 260) i 200 mg za flukonazol (N = 258).
English: Candidaemia and Invasive Candidiasis: Micafungin (100 mg/day or 2 mg/kg/day) was as effective as and better tolerated than liposomal amphotericin B (3 mg/kg) as first-line treatment of candidaemia and invasive candidiasis in a randomised, double-blind, multinational non-inferiority study.
Croatian: Kandidemija i invazivna kandidijaza: Mikafungin (100 mg na dan ili 2 mg/kg na dan) je bio jednako učinkovit i bolje se podnosio od liposomalnog amfotericina B (3 mg/kg) kao prva linija liječenja kandidemije i invazivne kandidijaze u randomiziranom, dvostruko slijepom, multinacionalnom ispitivanju neinferiornosti.
English: During administration of micafungin, anaphylactic/anaphylactoid reactions, including shock, may occur.
Croatian: Tijekom primjene mikafungina mogu nastati anafilaktičke/anafilaktoidne reakcije, uključujući i šok.
English: Micafungin non-competitively inhibits the synthesis of 1,3-β-D-glucan, an essential component of the fungal cell wall.
Croatian: Mikafungin nekompetitivno inhibira sintezu 1,3-β-D-glukana, osnovne sastavnice stanične stijenke gljivice.
English: Prophylaxis: Micafungin was more effective than fluconazole in preventing invasive fungal infections in a population of patients at high risk of developing a systemic fungal infection (patients undergoing haematopoietic stem cell transplantation [HSCT] in a randomised, double-blind, multicentre study).
Croatian: Profilaksa: Mikafungin je bio učinkovitiji od flukonazola u sprječavanju invazivnih gljivičnih infekcija u populaciji bolesnika s visokim rizikom od razvoja sistemske gljivične infekcije (bolesnici na transplantaciji matičnih hematopoetskih stanica, u randomiziranom, dvostruko slijepom, multicentričnom ispitivanju).
English: Micafungin demonstrated a smaller mean peak decrease in estimated glomerular filtration rate during treatment (p<0.001) and a lower incidence of infusion-related reactions (p=0.001) than liposomal amphotericin B.
Croatian: Mikafungin je imao manju srednju vrijednost vršnog sniženja procijenjene brzine glomerularne filtracije tijekom liječenja (p < 0,001) i nižu incidenciju reakcija povezanih s infuzijom (p = 0,001) od liposomalnog amfotericina B.
English: Oesophageal Candidiasis: In a randomised, double-blind study of micafungin versus fluconazole in the first-line treatment of oesophageal candidiasis, 518 patients received at least a single dose of study drug.
Croatian: Ezofagealna kandidijaza: U randomiziranom, dvostruko slijepom ispitivanju mikafungina u usporedbi s flukonazolom, u prvoj liniji liječenja kandidijaze jednjaka, 518 bolesnika primilo je najmanje jednu dozu ispitivanog lijeka.
English: In repeat dose studies in dogs, haemolytic anaemia was not observed.
Croatian: U ispitivanjima ponovljene doze u pasa nije bila opažena hemolitička anemija.
English: Exposure (AUC) of itraconazole, sirolimus and nifedipine was slightly increased in the presence of micafungin (22%, 21% and 18% respectively).
Croatian: itrakonazolu, sirolimusu i nifedipinu bila je blago povećana u prisutnosti mikafungina (22%, 21%
English: Mycamine is called an antifungal medicine because it is used to treat infections caused by fungal cells.
Croatian: Mycamine se naziva antimikotikom zato što se primjenjuje za liječenje infekcija uzrokovanih stanicama gljivica.
English: If you miss a dose of Mycamine
Croatian: Ako ste propustili dozu Mycaminea
English: The toxicology of micafungin following repeated intravenous dosing in rats and/or dogs showed adverse responses in liver, urinary tract, red blood cells, and male reproductive organs.
Croatian: Toksikologija mikafungina nakon ponovljene intravenske primjene u štakora i/ili pasa pokazala je štetne učinke na jetru, mokraćni trakt, crvene krvne stanice i reproduktivne organe mužjaka.
English: C. krusei † Micafungin rate minus the liposomal amphotericin B rate, and 2-sided 95% confidence interval for the difference in overall success rate based on large sample normal approximation.
Croatian: C. krusei † Stopa za mikafungin umanjena za stopu za liposomalni amfotericin B i dvostrani 95% interval pouzdanosti za razliku stopa ukupnog uspjeha liječenja, na temelju normalne aproksimacije velikog uzorka.
English: The mean period of treatment was 19 days for micafungin and 18 days for fluconazole in the adult population (N=798) and 23 days for both treatment arms in the paediatric population (N=84).
Croatian: Prosječno razdoblje liječenja iznosilo je 19 dana za mikafungin i 18 dana za flukonazol u odrasloj populaciji (N = 798) te 23 dana u obje terapijske skupine u pedijatrijskoj populaciji (N = 84).
English: Most frequent reactions were increase in AP (2.7%), AST (2.3%), ALT (2.0%), blood bilirubin (1.6%) and liver function test abnormal (1.5%).
Croatian: Najčešće reakcije bile su povišenje AP (2,7%), AST (2,3%), ALT (2,0%), bilirubina u krvi (1,6%) i poremećaji nalaza jetrene funkcije (1,5%).