FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-Interchangeability between Noxafil Tablets and Noxafil Oral Suspension
Croatian: Međusobna nezamjenjivost Noxafil tableta i Noxafil oralne suspenzije
English: Based on Kaplan-Meier estimates, the probability of survival up to day 100 after randomisation, was significantly higher for posaconazole recipients; this survival benefit was demonstrated when the analysis considered all causes of death (P= 0.0354) as well as IFI-related deaths (P = 0.0209).
Croatian: Na temelju KaplanMeierovih procjena, vjerojatnost preživljenja do 100. dana nakon randomizacije bila je značajno veća u bolesnika koji su primali posakonazol; taj se koristan utjecaj na preživljenje pokazao kada je analiza obuhvatila sve uzroke smrti (p=0,0354) kao i smrti povezane s IGI (p=0,0209).
English: Noxafil contains a medicine called posaconazole.
Croatian: Noxafil sadrži lijek koji se zove posakonazol.
English: Posaconazole was shown to be non-inferior to fluconazole for clinical success rates at Day 14 as well as 4 weeks after the end of treatment.
Croatian: Pokazalo se da posakonazol nije bio inferioran flukonazolu s obzirom na uspjeh kliničkog odgovora 14. dana terapije kao i 4 tjedna nakon završetka liječenja.
English: Noxafil works by killing or stopping the growth of some types of fungi that can cause infections.
Croatian: Noxafil djeluje tako što ubija ili zaustavlja rast nekih vrsta gljivica koje mogu uzrokovati infekcije.
English: • tacrolimus and sirolimus (used during or after transplant surgery)
Croatian: • takrolimus i sirolimus (primjenjuju se tijekom ili nakon transplantacije),
English: Noxafil 40 mg/mL oral suspension
Croatian: Noxafil 40 mg/ml oralna suspenzija
English: • swelling, redness, and tenderness along the vein in which Noxafil was given
Croatian: • oticanje, crvenilo i osjetljivost duž vene u koju je primijenjen Noxafil,
English: Limited data on the effect of hepatic impairment (including Child-Pugh C classification of chronic liver disease) on the pharmacokinetics of posaconazole demonstrate an increase in plasma exposure compared to subjects with normal hepatic function, but do not suggest that dose adjustment is necessary (see sections 4.4 and 5.2).
Croatian: Ograničeni podaci o utjecaju oštećenja funkcije jetre (uključujući kroničnu bolest jetre stadija C prema Child-Pugh klasifikaciji) na farmakokinetiku posakonazola pokazuju povećanu izloženost u plazmi u usporedbi s ispitanicima s normalnom funkcijom jetre, ali ne ukazuju na potrebu prilagodbe doze (vidjeti dijelove 4.4 i 5.2).
English: • rifabutin and rifampicin (used to treat certain infections).
Croatian: • rifabutin i rifampicin (primjenjuju se za liječenje nekih infekcija).
English: Gastro-resistant tablet (tablet) Yellow-coated, capsule-shaped tablet of 17.5 mm length debossed with “100” on one side.
Croatian: Želučanootporna tableta (tableta) Žuto obložena tableta u obliku kapsule, duljine 17,5 mm, s utisnutim "100" na jednoj strani.
English: • medicines used to decrease stomach acid such as cimetidine and ranitidine or omeprazole and similar medicines that are called proton pump inhibitors.
Croatian: • lijekovi koji smanjuju lučenje želučane kiseline, kao što su cimetidin i ranitidin ili omeprazol i slični lijekovi koji se zovu inhibitori protonske pumpe.
English: Posaconazole, after administration of the tablet, has a mean apparent volume of distribution of 394 L (42 %), ranging between 294-583 L among the studies in healthy volunteers.
Croatian: Nakon primjene tablete, posakonazol ima srednju vrijednost prividnog volumena distribucije od 394 l (42%), koji se kreće u rasponu od 294-583 l u ispitivanjima u zdravih dobrovoljaca.
English: • ciclosporin (used during or after transplant surgery)
Croatian: • ciklosporin (primjenjuje se tijekom ili nakon transplantacije),
English: • heart failure or heart attack which could lead to the heart stopping beating and death, heart rhythm problems, with sudden death
Croatian: • zatajenje srca ili srčani udar, koji mogu dovesti do prestanka kucanja srca i smrti, tegobe sa srčanim ritmom uz iznenadnu smrt
English: liver function tests raised (ALT increased, AST increased, bilirubin increased, alkaline phosphatase increased, GGT increased)
Croatian: povišene vrijednosti testova jetrene funkcije (povišen ALT, povišen AST, povišen bilirubin, povišena alkalna fosfataza, povišen GGT)
English: In a nonclinical study using intravenous administration of posaconazole in very young dogs (dosed from 2-8 weeks of age) an increase in the incidence of brain ventricle enlargement was observed in treated animals as compared with concurrent control animals.
Croatian: U pretkliničkom ispitivanju uz intravensku primjenu posakonazola u vrlo mladih pasa (kojima je lijek primjenjivan od 2. do 8. tjedna života), primijećen je porast incidencije povećanja moždane klijetke u tretiranih životinja u usporedbi s kontrolnim životinjama.
English: • any medicines that contain “ergot alkaloids” such as ergotamine or dihydroergotamine used to treat migraines.
Croatian: • svi lijekovi koji sadrže ergot alkaloide, kao što su ergotamin ili dihidroergotamin koji se primjenjuju za liječenje migrena.
English: Patients were immunocompromised with underlying conditions including haematological malignancy, neutropenia post-chemotherapy, GVHD, and post HSCT.
Croatian: Bolesnici su bili imunokompromitirani, s osnovnim stanjima kao što su hematološka zloćudna bolest, neutropenija nakon kemopterapije, GVHD i stanje nakon HSCT.
English: Steady-state is attained following 7 to 10 days of multiple-dose administration.
Croatian: Stanje dinamičke ravnoteže postiže se nakon 7 do 10 dana primjene višekratnih doza.
English: Contains sodium.
Croatian: Sadrži natrij.
English: Noxafil is used to prevent and treat many different fungal infections.
Croatian: Noxafil se primjenjuje za sprječavanje i liječenje velikog broja različitih gljivičnih infekcija.
English: • severe allergic reactions, including widespread blistering rash and skin peeling
Croatian: • teške alergijske reakcije, uključujući rasprostranjeni osip u obliku mjehurića i ljuštenje kože
English: Type I glass vial closed with bromobutyl rubber stopper and aluminium seal containing 16.7 mL of solution.
Croatian: Staklena bočica (staklo tip I) zatvorena bromobutilnim gumenim čepom i aluminijskim zaštitnim zatvaračem koja sadrži 16,7 ml otopine.
English: Posaconazole is slowly absorbed and slowly eliminated with a large apparent volume of distribution (1,774 litres) and is highly protein bound (> 98 %), predominantly to serum albumin.
Croatian: Posakonazol se polako apsorbira i sporo eliminira uz velik prividan volumen distribucije (1774 litre) te se u visokom postotku veže za proteine (> 98%), uglavnom za serumski albumin.
English: This medicine is available in a single use glass vial closed with bromobutyl rubber stopper and aluminium seal.
Croatian: Lijek je dostupan u staklenoj bočici za jednokratnu uporabu, zatvorenoj bromobutilnim gumenim čepom i aluminijskim zaštitnim zatvaračem.
English: Alternatively, patients who can tolerate food or a nutritional supplement may take 400 mg (10 mL) twice a day during or immediately following a meal or nutritional supplement.
Croatian: Alternativa za bolesnike koji podnose hranu ili nadomjeske prehrani je uzimati dozu od 400 mg (10 ml) dvaput na dan tijekom ili neposredno nakon obroka ili nadomjeska prehrani.
English: Posaconazole must not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Croatian: Posakonazol se ne smije uzimati tijekom trudnoće osim ako korist liječenja za majku jasno nadilazi mogući rizik za plod.
English: Noxafil should be administered with caution to patients with pro-arrhythmic conditions such as:
Croatian: Noxafil se mora primjenjivati uz oprez u bolesnika s proaritmijskim stanjima, kao što su:
English: Similarly, in the prophylaxis studies, the mean steady-state posaconazole average concentration (Cav) was comparable among ten adolescents (13-17 years of age) to Cav achieved in adults (≥ 18 years of age).
Croatian: Slično tomu, u ispitivanjima profilaktičke primjene srednja vrijednost prosječne koncentracije posakonazola u stanju dinamičke ravnoteže (Cav) u 10 adolescenata (u dobi od 13-17 godina) bila je usporediva s Cav u odraslih (≥18 godina).
English: Talk to your doctor, pharmacist or nurse before taking Noxafil if you:
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Noxafil:
English: Noxafil gastro-resistant tablets are packaged in a blister in cartons of 24 (2x12) or 96 (8x12) tablets.
Croatian: Noxafil želučanootporne tablete pakirane su u blisteru u kutijama s 24 (2x12) ili 96 (8x12) tableta.
English: • “pancytopenia” low level of all blood cells (red and white blood cells and platelets) shown in blood tests
Croatian: • pancitopenija, nizak broj svih krvnih stanica (crvenih i bijelih krvnih stanica i krvnih pločica)
English: Do not take Noxafil if you are pregnant unless you are told to by your doctor.
Croatian: Nemojte uzeti Noxafil ako ste trudni, osim ako Vam to nije preporučio Vaš liječnik.
English: • pimozide (used to treat symptoms of Tourette's and mental illness)
Croatian: • pimozid (primjenjuje se za liječenje simptoma Touretteovog sindroma i duševne bolesti),
English: Noxafil gastro-resistant tablets are yellow-coated and capsule-shaped, debossed “100” on one side packaged in a blister in cartons of 24 (2x12) or 96 (8x12) tablets.
Croatian: Noxafil želučanootporne tablete imaju žutu ovojnicu i oblika su kapsule, s utisnutim "100" na jednoj strani, pakirane u blisteru u kutijama s 24 (2x12) ili 96 (8x12) tableta.
English: Multiple doses of posaconazole administered via a peripheral venous catheter were associated with thrombophlebitis (60 % incidence).
Croatian: Primjena višekratnih doza posakonazola kroz periferni venski kateter bila je povezana s tromboflebitisom (incidencija 60%).
English: In patients with moderate or severe renal impairment (creatinine clearance <50 mL/min), accumulation of the intravenous vehicle, Betadex Sulfobutyl Ether Sodium (SBECD), is expected to occur.
Croatian: U bolesnika s umjerenim ili teškim oštećenjem funkcije bubrega (klirens kreatinina <50 ml/min) očekuje se nakupljanje intravenskog vehikuluma, natrijeva sulfobutileter β-ciklodekstrina (SBECD).
English: • pituitary gland not working properly - this may cause low blood levels of some hormones that affect the function of the male or female sex organs
Croatian: • neispravan rad hipofize - to može uzrokovati niske razine nekih hormona koji utječu na funkciju muških odnosno ženskih spolnih organa
English: Cohort 0 was designed to evaluate the tolerability of a single dose of posaconazole concentrate for solution for infusion when administered via a central line.
Croatian: Kohorta 0 dizajnirana je kako bi se ocijenila podnošljivost jednokratne doze posakonazol koncentrata za otopinu za infuziju primijenjene kroz centralnu liniju.
English: • Equilibrate the refrigerated vial of Noxafil to room temperature.
Croatian: • Pustite da se rashlađena bočica lijeka Noxafil ugrije na sobnu temperaturu.
English: All drug interactions with posaconazole oral suspension, except for those that affect the absorption of posaconazole (via gastric pH and motility) are considered relevant to posaconazole concentrate for solution for infusion as well.
Croatian: Sve interakcije lijekova s posakonazol oralnom suspenzijom, osim onih koje utječu na apsorpciju posakonazola (putem želučanog pH i motiliteta), smatraju se relevantnima i za posakonazol koncentrat za otopinu za infuziju.
English: abnormal dreams, confusional state, sleep disorder psychotic disorder, depression
Croatian: neuobičajeni snovi, stanje smetenosti, poremećaj spavanja psihotični poremećaj, depresija
English: 5 % dextrose in water 0.9 % sodium chloride 0.45 % sodium chloride 5 % dextrose and 0.45 % sodium chloride 5 % dextrose and 0.9 % sodium chloride 5 % dextrose and 20 mEq KCl
Croatian: 5%-tnom vodenom otopinom glukoze 0,9%-tnom otopinom natrijeva klorida 0,45%-tnom otopinom natrijeva klorida otopinom s 5% glukoze i 0,45% natrijeva klorida otopinom s 5% glukoze,9% natrijeva klorida otopinom s 5% glukoze i 20 mEq kalijeva klorida
English: The tablet and oral suspension are not to be used interchangeably due to the differences between these two formulations in frequency of dosing, administration with food and plasma drug concentration achieved.
Croatian: Tablete i oralna suspenzija ne smiju se međusobno zamjenjivati zbog razlika u učestalosti doziranja, primjeni uz hranu i postignutim koncentracijama u plazmi između ovih dviju formulacija.
English: Overall efficacy of posaconazole oral suspension at the end of treatment for invasive aspergillosis in comparison to an external control group Posaconazole oral suspension
Croatian: Ukupna djelotvornost posakonazol oralne suspenzije na završetku liječenja invazivne aspergiloze u usporedbi s vanjskom kontrolnom skupinom Posakonazol oralna suspenzija
English: Food The absorption of posaconazole is significantly increased by food (see sections 4.2 and 5.2).
Croatian: Hrana Hrana značajno povećava apsorpciju posakonazola (vidjeti dijelove 4.2 i 5.2).
English: Oral formulations of Noxafil should be used in these patients unless an assessment of the benefit/risk to the patient justifies the use of Noxafil concentrate for solution for infusion.
Croatian: U tih bolesnika treba primjenjivati peroralne oblike lijeka Noxafil, osim ako procjena koristi i rizika za bolesnika ne opravdava primjenu Noxafil koncentrata za otopinu za infuziju.
English: • “haemolytic uraemic syndrome” when red blood cells breakup (hemolysis) which may happen with or without kidney failure
Croatian: • hemolitičko-uremijski sindrom, kada dolazi do razaranja crvenih krvnih stanica (hemoliza), koji može nastati sa ili bez zatajenja bubrega
English: When administered through a peripheral venous catheter, the infusion should be administered over approximately 30 minutes.
Croatian: Kada se primjenjuje kroz periferni venski kateter, infuziju treba davati tijekom približno 30 minuta.
English: After the first day, take 100 mg (2.5 mL) once a day.
Croatian: Nakon prvog dana uzimajte 100 mg (2,5 ml) jedanput na dan.
English: This medicine can also be used to prevent fungal infections in adults who are at high risk of getting a fungal infection, such as:
Croatian: Ovaj se lijek također može primjenjivati za sprječavanje gljivičnih infekcija u bolesnika s visokim rizikom od dobivanja gljivične infekcije, kao što su:
English: • have had an allergic reaction to another antifungal medicine such as ketoconazole, fluconazole,
Croatian: • ako ste ikada imali alergijsku reakciju na druge antimikotike, kao što su ketokonazol,
English: If a central venous catheter was not readily available, patients could receive a single infusion over 30 minutes via a peripheral venous catheter.
Croatian: Ako centralni venski kateter nije odmah bio na raspolaganju, bolesnici su mogli primiti jednokratnu infuziju u trajanju od 30 minuta kroz periferni venski kateter.
English: Based on the pharmacokinetics and safety results of Cohorts 1 and 2, all subjects in Cohort 3 received 300 mg twice daily on Day 1, followed by 300 mg once daily thereafter.
Croatian: Na temelju farmakokinetičkih rezultata i rezultata koji se tiču sigurnosti primjene u Kohortama 1 i 2, svi su ispitanici u Kohorti 3 primali dozu od 300 mg dvaput na dan 1. dana, a zatim 300 mg jedanput na dan.
English: Eleven patients received a single dose of 200 mg posaconazole concentrate for solution for infusion, 21 patients received 200 mg daily dose for a median of 14 days, and 237 patients received 300 mg daily dose for a median of 9 days.
Croatian: Jedanaest bolesnika primilo je jednokratnu dozu od 200 mg posakonazol koncentrata za otopinu za infuziju, 21 bolesnik primao je dnevnu dozu od 200 mg tijekom medijana od 14 dana, a 237 bolesnika primalo je dozu od 300 mg na dan tijekom medijana od 9 dana.
English: The safety of posaconazole tablet has been assessed in 336 patients and healthy volunteers enrolled in clinical trials.
Croatian: Sigurnost primjene posakonazol tableta ocijenjena je u 336 bolesnika i zdravih dobrovoljaca uključenih u klinička ispitivanja.
English: Posaconazole is absorbed with a median tmax of 3 hours (fed patients).
Croatian: Posakonazol se apsorbira uz medijan tmax od 3 sata (u bolesnika koji su jeli).
English: • Glipizide or other “sulfonylureas” (used to treat high blood sugar).
Croatian: • glipizid ili druge sulfonilureje (primjenjuju se za liječenje povišenog šećera u krvi).
English: Noxafil is a white, cherry flavoured, 105 mL oral suspension packaged in amber glass bottles.
Croatian: Noxafil je bijela oralna suspenzija od 105 ml, okusa trešnje, pakirana u smeđoj staklenoj boci.
English: Noxafil contains glucose
Croatian: Noxafil sadrži glukozu
English: A key secondary endpoint was the incidence of proven/probable IFIs at 100 days post-randomisation.
Croatian: Ključna sekundarna mjera ishoda bila je incidencija dokazane/vjerojatne IGI 100 dana nakon randomizacije.
English: Patients who have severe diarrhoea or vomiting should be monitored closely for breakthrough fungal infections.
Croatian: Bolesnike koji imaju jaki proljev ili povraćaju treba pozorno nadzirati zbog mogućih probojnih gljivičnih infekcija.
English: • halofantrine (used to treat malaria)
Croatian: • halofantrin (primjenjuje se za liječenje malarije),
English: If you are a woman who could become pregnant you should use effective contraception while you are using Noxafil.
Croatian: Ako postoji mogućnost da zatrudnite, morate koristiti učinkovitu kontracepciju dok primjenjujete Noxafil.
English: Cav = the average concentration when measured at steady state *20 patients received 200 mg once daily (Day 1 200 mg twice daily)
Croatian: Cav = prosječna koncentracija kad se mjeri u stanju dinamičke ravnoteže *20 bolesnika primalo je 200 mg jedanput na dan (1. dana 200 mg dvaput na dan)
English: Noxafil must not be administered with medicinal products that are substrates for CYP3A4 and are known to prolong the QTc interval (see sections 4.3 and 4.5).
Croatian: Noxafil se ne smije primjenjivati s lijekovima koji su supstrati enzima CYP3A4 i za koje je poznato da produljuju QTc-interval (vidjeti dijelove 4.3 i 4.5).
English: The effect of co-administration with posaconazole on plasma levels of CYP3A4 substrates may also be variable within a patient, unless posaconazole is administered in a strictly standardised way with food, given the large food effect on posaconazole exposure (see section 5.2).
Croatian: Učinak istodobne primjene posakonazola na koncentraciju supstrata CYP3A4 u plazmi može biti promjenjiv i u istog bolesnika, osim ako se posakonazol ne primjenjuje na strogo standardiziran način s hranom, s obzirom na velik učinak hrane na izloženost posakonazolu (vidjeti dio 5.2).
English: Patients who develop abnormal liver function tests during Noxafil therapy must be routinely monitored for the development of more severe hepatic injury.
Croatian: Bolesnike u kojih tijekom liječenja lijekom Noxafil dođe do odstupanja od normalnih vrijednosti pretraga jetrene funkcije mora se rutinski nadzirati zbog mogućeg razvoja težeg oštećenja jetre.
English: adrenal insufficiency, blood gonadotropin decreased pseudoaldosteronism
Croatian: insuficijencija nadbubrežne žlijezde, snižene vrijednosti gonadotropina u krvi pseudoaldosteronizam
English: When administered through a peripheral venous catheter, the infusion should be administered over approximately 30 minutes (see section 4.8 and 6.6).
Croatian: Kada se primjenjuje kroz periferni venski kateter, infuziju treba davati tijekom približno 30 minuta (vidjeti dijelove 4.8 i 6.6).
English: Posaconazole tablets are absorbed with a median Tmax of 4 to 5 hours and exhibits dose proportional pharmacokinetics after single and multiple dosing up to 300 mg.
Croatian: Posakonazol tablete apsorbiraju se uz medijan tmax od 4 do 5 sati i pokazuju farmakokinetiku proporcionalnu dozi nakon jednokratnog i višekratnog doziranja do 300 mg.
English: • Do not use this medicine after the expiry date which is stated on the blister after EXP.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici iza oznake „EXP“.
English: During clinical trials, patients who received posaconazole oral suspension doses up to 1,600 mg/day experienced no different adverse reactions from those reported with patients at the lower doses.
Croatian: U kliničkim ispitivanjima, bolesnici koji su primali posakonazol oralnu suspenziju u dozama do 1600 mg na dan nisu imali drugačije nuspojave od onih prijavljenih u bolesnika koji su primali niže doze lijeka.
English: Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects:
Croatian: Druge nuspojave Obavijestite liječnika, ljekarnika ili medicinsku sestru ako primijetite neku od sljedećih nuspojava:
English: Rifabutin (300 mg once a day) decreased the Cmax (maximum plasma concentration) and AUC (area under the plasma concentration time curve) of posaconazole to 57 % and 51 %, respectively.
Croatian: Rifabutin (300 mg jedanput na dan) je snizio Cmax (maksimalna koncentracija u plazmi) posakonazola na 57%, a AUC (površina ispod krivulje koncentracija-vrijeme) na 51%.
English: Pharmacotherapeutic group: Antimycotics for systemic use, triazole derivatives, ATC code: J02A C04.
Croatian: Farmakoterapijska skupina: antimikotici za sistemsku primjenu, derivati triazola, ATK oznaka: J02A C04.
English: • Congenital or acquired QTc prolongation
Croatian: • urođeno ili stečeno produljenje QTc-intervala
English: Ear and labyrinth disorder Rare:
Croatian: Poremećaji uha i labirinta Rijetko:
English: Noxafil contains approximately 1.75 g of glucose per 5 mL of suspension.
Croatian: Noxafil sadrži približno 1,75 g glukoze u 5 ml suspenzije.
English: • hair loss (alopecia)
Croatian: • ispadanje kose (alopecija),
English: Noxafil can also be used to prevent fungal infections in adults who are at high risk of getting a fungal infection, such as:
Croatian: Noxafil se također može primjenjivati za sprječavanje gljivičnih infekcija u odraslih s visokim rizikom od dobivanja gljivične infekcije, kao što su:
English: Discontinuation of Noxafil should be considered if clinical signs and symptoms are consistent with development of liver disease.
Croatian: Potrebno je razmotriti mogućnost prekida primjene lijeka Noxafil u slučaju nastupa kliničkih znakova i simptoma koji ukazuju na razvoj jetrene bolesti.
English: Combining fosamprenavir with posaconazole may lead to decreased posaconazole plasma concentrations.
Croatian: Kombinacija fosamprenavira i posakonazola može dovesti do sniženja koncentracije posakonazola u plazmi.
English: • large purple discolourations on the skin (thrombotic thrombocytopenic purpura)
Croatian: • velike ljubičaste mrlje na koži (trombotička trombocitopenijska purpura)
English: itraconazole or voriconazole.
Croatian: flukonazol, itrakonazol ili vorikonazol;
English: H2 receptor antagonists and proton pump inhibitors No clinically relevant effects were observed when posaconazole tablets are concomitantly used with antacids, H2-receptor antagonists and proton pump inhibitors.
Croatian: Antagonisti H2-receptora i inhibitori protonske pumpe Nisu opaženi klinički važni učinci kad su se posakonazol tablete istodobno primjenjivale s antacidima, antagonistima H2-receptora i inhibitorima protonske pumpe.
English: EUCAST MIC breakpoints for posaconazole [susceptible (S); resistant (R)]:
Croatian: Granične vrijednosti MIK-a za posakonazol određene od strane EUCAST-a [osjetljiv (S); rezistentan (R)], su:
English: When administered through a peripheral venous catheter, the infusion should be administered over approximately 30 minutes to reduce the likelihood of infusion site reactions (see section 4.8).
Croatian: Kada se primjenjuje kroz periferni venski kateter, infuziju treba davati tijekom približno 30 minuta kako bi se smanjila vjerojatnost reakcija na mjestu infuzije (vidjeti dio 4.8).