FrancophonIA/ELRC3.0 huggingface dataset:
English: When VFEND treatment is stopped by your doctor you should not experience any effects.
Croatian: Kada liječnik odredi prekid liječenja lijekom VFEND, ne biste trebali imati nikakvih nuspojava.
English: Take your box of VFEND tablets with you.
Croatian: Ponesite sa sobom kutiju lijeka VFEND.
English: Please advise your doctor if you have any stomach pains or if your stools have a different consistency.
Croatian: Obavijestite svog liječnika ako imate bolove u trbuhu ili ako se promijeni uobičajena konzistencija stolice.
English: Success at day 180*
Croatian: Uspjeh na 180. dan*
English: Tell your doctor if you are taking any of the following medicines, as a dose adjustment or monitoring may be required to check that the medicines and/ or VFEND are still having the desired effect:
Croatian: Obavijestite svog liječnika ako uzimate neki od sljedećih lijekova, jer će možda trebati prilagoditi dozu lijeka ili provjeravati imaju li oni i/ili VFEND i dalje željeni učinak:
English: An impurity present in SBECD has been shown to be an alkylating mutagenic agent with evidence for carcinogenicity in rodents.
Croatian: Pokazalo se da je onečišćenje prisutno u SBECD-u alkilirajuća mutagena tvar, dokazano kancerogena u glodavaca.
English: The modified intent-to-treat (MITT) group included 465 allogeneic HSCT recipients with 45% of patients having AML.
Croatian: Skupina modiﬁcirane ITT populacije (engl. modified intent-to-treat, MITT) uključivala je 465 primatelja alogene HSCT, a 45% bolesnika imalo je akutnu mijeloičnu leukemiju (AML).
English: Standard genotoxicity and reproduction studies with the excipient SBECD reveal no special hazard for humans.
Croatian: Standardna ispitivanja genotoksičnosti i reproduktivne toksičnosti pomoćne tvari SBECD-a nisu otkrila poseban rizik za ljude.
English: • Warfarin and other anticoagulants (e.g., phenprocoumon, acenocoumarol; used to slow down clotting of the blood)
Croatian: • varfarin i ostale antikoagulanse (npr. fenprokumon, acenokumarol; primjenjuju se za usporavanje zgrušavanja krvi)
English: The combination of voriconazole with rifabutin should, if possible be avoided.
Croatian: Ako je moguće, treba izbjegavati kombinaciju vorikonazola s rifabutinom.
English: Altered taste perception
Croatian: Promjena osjeta okusa
English: A comparison of the paediatric and adult population pharmacokinetic data indicated that the predicted total exposure (AUC) in children following administration of a 9 mg/kg IV loading dose was comparable to that in adults following a 6 mg/kg IV loading dose.
Croatian: Usporedba farmakokinetičkih podataka u pedijatrijskoj i odrasloj populaciji pokazala je da je predviđena ukupna izloženost (AUC) u djece nakon intravenske primjene udarne doze od 9 mg/kg bila usporediva s onom u odraslih nakon intravenske primjene udarne doze od 6 mg/kg.
English: • Oxycodone and other long-acting opiates such as hydrocodone (used for moderate to severe pain)
Croatian: • oksikodon i ostale opijate dugog djelovanja, kao što je hidrokodon (koriste se za ublažavanje umjerene do jake boli)
English: Squamous cell carcinoma of the skin (SCC) has been reported in relation with long-term VFEND treatment.
Croatian: Karcinom skvamoznih stanica kože (SCC) prijavljen je u vezi s dugotrajnim liječenjem lijekom VFEND.
English: In the primary analysis, successful response as assessed by a Data Review Committee (DRC) blinded to study medicinal product was defined as resolution/improvement in all clinical signs and symptoms of infection with eradication of Candida from blood and infected deep tissue sites 12 weeks after the end of therapy (EOT).
Croatian: Data Review Committee - DRC) koje nije znalo koji su lijek ispitanici uzimali, pozitivan odgovor definiran kao povlačenje/poboljšanje svih kliničkih znakova i simptoma infekcije uz eradikaciju kandide iz krvi i inficiranih dubokih tkiva 12 tjedana po završetku liječenja.
English: The efficacy and survival benefit of voriconazole versus conventional amphotericin B in the primary treatment of acute invasive aspergillosis was demonstrated in an open, randomised, multicentre study in 277 immunocompromised patients treated for 12 weeks.
Croatian: Djelotvornost i korist vorikonazola s obzirom na preživljenje, u odnosu na konvencionalni amfotericin B, u primarnom liječenju akutne invazivne aspergiloze dokazana je u otvorenom, randomiziranom, multicentričnom ispitivanju s 277 imunokompromitiranih bolesnika liječenih tijekom 12 tjedana.
English: Fluconazole (CYP2C9, CYP2C19 and CYP3A4 inhibitor) Coadministration of oral voriconazole and oral fluconazole resulted in a significant increase in Cmax and AUCτ of voriconazole in healthy subjects.
Croatian: Flukonazol (inhibitor CYP2C9, CYP2C19 i CYP3A4) Istodobna primjena peroralnog vorikonazola i peroralnog flukonazola dovela je do značajnog povećanja vrijednosti Cmax i AUCτ vorikonazola u zdravih ispitanika.
English: Tap the bottle to release the powder.
Croatian: Kucnite bocu da rastresete prašak.
English: Nine subjects in the voriconazole group and 5 in the amphotericin B followed by fluconazole group also had mycologically proven infection in deep tissue.
Croatian: Devet ispitanika iz skupine liječene vorikonazolom i 5 iz skupine liječene amfotericinom B pa potom flukonazolom, imali su i mikološki dokazanu infekciju dubokih tkiva.
English: Each vial contains 200 mg voriconazole, equivalent to a 10 mg/ml solution when reconstituted as directed by your hospital pharmacist or nurse (see the information at the end of this leaflet).
Croatian: Jedna bočica sadrži 200 mg vorikonazola, što odgovara koncentraciji otopine od 10 mg/ml nakon što je bolnički ljekarnik ili medicinska sestra pripreme prema uputama (vidjeti informacije na kraju ove upute).
English: VFEND is supplied as a white to off-white powder for oral suspension providing a white to off-white, orange flavoured suspension when constituted with water.
Croatian: VFEND je bijeli do gotovo bijeli prašak za oralnu suspenziju, koji nakon pripreme s vodom daje bijelu do gotovo bijelu suspenziju s okusom naranče.
English: Write the date of expiry of the constituted suspension on the bottle label (the shelf-life of the constituted suspension is 14 days).
Croatian: Na naljepnicu boce napišite datum isteka roka valjanosti pripremljene suspenzije (rok valjanosti pripremljene suspenzije je 14 dana).
English: Psychiatric disorders depression, hallucination, anxiety, insomnia, agitation, confusional state
Croatian: Psihijatrijski poremećaji depresija, halucinacije, anksioznost, nesanica, agitacija, smetenost
English: The connected syringe and vial are then gently swirled to ensure that the VFEND powder has completely dissolved and no particulates are visible (do not shake).
Croatian: Zatim se priključena štrcaljka i bočica nježno okreću kružnim pokretima kako bi se osiguralo da se VFEND prašak potpuno otopi i da nisu vidljive čestice (ne tresti).
English: Based on the population pharmacokinetic analysis, 12- to 14year-old adolescents weighing less than 50 kg should receive children's doses (see section 4.2).
Croatian: Na osnovu populacijske farmakokinetičke analize, adolescenti u dobi od 12-14 godina koji teže manje od 50 kg trebaju primati doze za djecu (vidjeti dio 4.2).
English: Your doctor should monitor the function of your liver and kidney by doing blood tests.
Croatian: Vaš liječnik Vam mora nadzirati funkciju jetre i bubrega putem krvnih pretraga.
English: Studies conducted in Caucasian and Japanese healthy subjects have shown that poor metabolisers have, on average, 4-fold higher voriconazole exposure (AUCτ) than their homozygous extensive metaboliser counterparts.
Croatian: Ispitivanja provedena u zdravih bijelaca i Japanaca pokazala su da spori metabolizatori imaju prosječno 4 puta veću izloženost vorikonazolu (AUCτ) nego odgovarajući im homozigotni brzi metabolizatori.
English: See “Visual impairments” paragraph in section 4.8.
Croatian: “Oštećenja vida” u dijelu 4.8.
English: Instances of hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly haematological malignancy).
Croatian: Primijećeno je da se jetrene reakcije pojavljuju prvenstveno u bolesnika s ozbiljnim popratnim bolestima (pretežno s malignim hematološkim bolestima).
English: The intravenous vehicle, SBECD, is haemodialysed with a clearance of 55 ml/min.
Croatian: Intravenski vehikulum SBECD odstranjuje se hemodijalizom, a klirens mu iznosi 55 ml/min.
English: Digoxin Cmax ↔ Digoxin AUC ↔
Croatian: Digoksin Cmax ↔ Digoksin AUC ↔
English: The overall incidence of transaminase increases >3 xULN (not necessarily comprising an adverse event) in the voriconazole clinical programme was 18.0% (319/1,768) in adults and 25.8% (73/283) in paediatric subjects who received voriconazole for pooled therapeutic and prophylaxis use.
Croatian: Ukupna incidencija povećanja vrijednosti transaminaza >3 x ULN (ne nužno uključujući i nuspojavu) u ispitanika koji su u kliničkim ispitivanjima primali vorikonazol iznosila je 18,0% (319/1768) u odraslih i 25,8% (73/283) kod pedijatrijskih ispitanika koji su primili vorikonazol u kombiniranu terapeutsko-profilaktičku svrhu.
English: VFEND powder and solvent for solution for infusion will be reconstituted and diluted to the correct concentration by your hospital pharmacist or nurse.
Croatian: VFEND prašak i otapalo za otopinu za infuziju će pripremiti i razrijediti do točne koncentracije bolnički ljekarnik ili medicinska sestra.
English: • Everolimus (used for treating advanced kidney cancer and in transplant patients)
Croatian: • everolimus (koristi se za liječenje uznapredovalog raka bubrega i u bolesnika s presatkom organa)
English: If a patient develops skeletal pain and radiologic findings compatible with periostitis VFEND discontinuation should be considered after multidisciplinary advice.
Croatian: Ako se u bolesnika razvije bol u skeletu, a radiološki nalazi upućuju na periostitis, nakon multidisciplinarnog savjetovanja treba razmotriti prekid primjene lijeka VFEND.
English: In the same study, no significant differences in Cmax and AUCτ were observed between healthy elderly males and healthy elderly females (≥65 years).
Croatian: U istom ispitivanju nisu zabilježene značajne razlike u Cmax i AUCτ između zdravih starijih muškaraca i žena (≥ 65 godina).
English: As VFEND has been known to affect the liver and the kidney, your doctor should monitor the function of your liver and kidney by doing blood tests.
Croatian: S obzirom da je poznato da VFEND utječe na jetru i bubrege, liječnik Vam mora pratiti funkciju jetre i bubrega putem krvnih pretraga.
English: Fill the measuring cup to the top of the marked line then pour the water into the bottle.
Croatian: Napunite odmjernu čašicu do gornjeg ruba oznake te izlijte vodu u bocu.
English: No subject experienced an interval exceeding the potentially clinically-relevant threshold of 500 msec.
Croatian: Niti u jednog ispitanika nije primijećeno produljenje intervala preko potencijalno klinički značajnog praga od 500 ms.
English: A 4-hour haemodialysis session does not remove a sufficient amount of voriconazole to warrant dose adjustment.
Croatian: Tijekom četverosatne hemodijalize ne odstrani se dovoljna količina vorikonazola koja bi opravdavala prilagodbu doze.
English: Take your suspension at least one hour before, or two hours after a meal.
Croatian: Suspenziju uzimajte najmanje jedan sat prije ili dva sata nakon jela.
English: How to take VFEND
Croatian: Kako uzimati VFEND
English: • you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome'.
Croatian: • ako se zna da imate kardiomiopatiju, nepravilne otkucaje srca, usporen puls ili nepravilnost u elektrokardiogramu (EKG) koja se naziva „sindrom produljenog QTcintervala“.
English: There have been reports of skin cancer in patients treated with VFEND for long periods of time.
Croatian: Prijavljen je rak kože u bolesnika koji su liječeni lijekom VFEND kroz duži vremenski period.
English: The visual impairments were generally mild, rarely resulted in discontinuation and were not associated with long-term sequelae.
Croatian: Oštećenja vida su uglavnom bila blaga, rijetko su dovela do prekida primjene lijeka i nisu bila povezana s dugoročnim posljedicama.
English: (Please refer to the end of this leaflet for further information).
Croatian: (Dodatne informacije navedene su na kraju ove upute o lijeku).
English: Once constituted, VFEND oral suspension should only be administered using the oral syringe supplied with each pack.
Croatian: Nakon pripreme VFEND oralna suspenzija se mora primjenjivati isključivo pomoću štrcaljke za usta priložene u svakom pakovanju lijeka.
English: Further information is provided for medical or healthcare professionals at the end of the Package Leaflet.
Croatian: Dodatne informacije za zdravstvene radnike nalaze se na kraju Uputa o lijeku.
English: - Reminds HCPs of use of the HCP Checklist and the Patient Alert Card and how to obtain additional copies.
Croatian: - Podsjeća zdravstvene radnike na korištenje kontrolnog popisa i kartice s upozorenjima za bolesnika te kako dobiti dodatne primjerke.
English: It is recommended that all patients, including children, avoid exposure to direct sunlight during VFEND treatment and use measures such as protective clothing and sunscreen with high sun protection factor (SPF).
Croatian: Preporučuje se da svi bolesnici tijekom primjene lijeka VFEND, uključujući djecu, izbjegavaju izlaganje izravnoj sunčevoj svjetlosti te koriste zaštitnu odjeću i sredstva za zaštitu od sunca s visokim zaštitnim faktorom (SPF).
English: If you are already being treated with phenytoin your blood concentration of phenytoin will need to be monitored during your treatment with VFEND and your dose may be adjusted.
Croatian: Ako već primate fenitoin, za vrijeme liječenja lijekom VFEND morat će se pratiti koncentracija fenitoina u krvi i možda prilagoditi doza lijeka.
English: Four additional patients with fusariosis had an infection caused by several organisms; 2 of them had a successful outcome.
Croatian: Još su 4 bolesnika s fuzariozom imala infekciju izazvanu više nego jednim uzročnikom, a u 2 od njih je ishod liječenja bio pozitivan.
English: Instructions for use: Shake the closed bottle of constituted suspension for approximately 10 seconds before each use.
Croatian: Upute za primjenu: Prije svake primjene zatvorenu bocu s oralnom suspenzijom protresite približno 10 sekundi.
English: VFEND must not be diluted with 4.2% Sodium Bicarbonate Infusion.
Croatian: VFEND se ne smije razrjeđivati s otopinom natrijevog bikarbonata za infuziju od 4,2%.
English: Patients receiving VFEND must be carefully monitored for hepatic toxicity.
Croatian: U bolesnika koji uzimaju VFEND mora se pažljivo pratiti hepatotoksičnost.
English: A satisfactory global response (complete or partial resolution of all attributable symptoms, signs, radiographic/bronchoscopic abnormalities present at baseline) was seen in 53% of voriconazole-treated patients compared to 31% of patients treated with comparator.
Croatian: Zadovoljavajući opći odgovor (potpuno ili djelomično povlačenje svih simptoma bolesti kao i rendgenskih/bronhoskopskih promjena prisutnih na početku liječenja) uočen je u 53% bolesnika liječenih vorikonazolom u usporedbi s 31% bolesnika liječenih usporednim lijekom.
English: Carbamazepine and long-acting barbiturates (e.g., phenobarbital, mephobarbital) [potent CYP450 inducers]
Croatian: Karbamazepin i barbiturati dugog djelovanja (npr. fenobarbital, mefobarbital) [snažni induktori CYP450]
English: You may experience abnormal intolerance to light as a result of taking more VFEND than you should.
Croatian: Možete osjetiti neuobičajeno nepodnošenje svjetlosti kao posljedicu uzimanja prevelike količine lijeka VFEND.
English: Remove the cap. Press the bottle adaptor into the neck of the bottle (as shown on figure below).
Croatian: Utisnite nastavak za bocu u grlo boce (kako je prikazano na slici).
English: • Patient Alert Card for Phototoxicity and SCC: - Reminds patients of the risk of phototoxicity and skin SCC.
Croatian: • Kartica s upozorenjima za bolesnika o fototoksičnosti i SCC-u: - Podsjeća bolesnike na rizik od fototoksičnosti i SCC-a kože.
English: In the pre- and post-natal development study in rats at exposures lower than those obtained in humans with therapeutic doses, voriconazole prolonged the duration of gestation and labour and produced dystocia with consequent maternal mortality and reduced perinatal survival of pups.
Croatian: U istraživanjima prenatalnog i postnatalnog razvoja na štakorima, pri nižim razinama izloženosti od onih koje se postižu primjenom terapijskih doza u ljudi, vorikonazol je produljio gestacijski period i trajanje okota, uz otežan okot koji je za posljedicu imao veći mortalitet majki i manje perinatalno preživljenje mladunčadi.
English: Fertility In an animal study, no impairment of fertility was demonstrated in male and female rats (see section 5.3).
Croatian: U istraživanjima na životinjama nisu zabilježeni štetni učinci na plodnost mužjaka i ženki štakora (vidjeti dio 5.3).
English: There have been reports of prolonged visual adverse reactions, including blurred vision, optic neuritis and papilloedema (see section 4.8).
Croatian: Prijavljeni su slučajevi produljenih nuspojava vezanih uz vid koje uključuju zamagljen vid, optički neuritis i papiloedem (vidjeti dio 4.8).
English: • This will provide an extractable volume of 20 ml of clear concentrate containing 10 mg/ml of voriconazole.
Croatian: • Tako se dobiva iskoristivi volumen od 20 ml bistrog koncentrata koji sadrži 10 mg/ml vorikonazola.
English: If phototoxic reactions occur multidisciplinary advice should be sought, VFEND discontinuation and use of alternative antifungal agents should be considered and the patient should be referred to a dermatologist.
Croatian: Ako se pojavi fototoksična reakcija, treba zatražiti savjet multidisciplinarnog tima, razmotriti prekid primjene lijeka VFEND i primjenu zamjenskih antimikotika te bolesnika uputiti dermatologu.
English: • Benzodiazepines (e.g midazolam, triazolam) (used for severe insomnia and stress)
Croatian: • benzodiazepine (npr. midazolam, triazolam) (koriste se kod teške nesanice i stresa)
English: Undesirable effects reported in subjects receiving voriconazole:
Croatian: Nuspojave prijavljene u ispitanika koji su primali vorikonazol:
English: • The other ingredients are lactose monohydrate, pregelatinised starch, croscarmellose sodium, povidone and magnesium stearate which make up the tablet core and hypromellose, titanium dioxide (E171), lactose monohydrate and glycerol triacetate which make up the film-coat.
Croatian: • Drugi sastojci su: laktoza hidrat, prethodno geliran škrob, umrežena karmelozanatrij, povidon i magnezijev stearat koji čine jezgru tablete te hipromeloza, titanijev dioksid (E171), laktoza hidrat i gliceroltriacetat koji čine film ovojnicu.
English: For the constituted suspension:
Croatian: Pripremljena suspenzija:
English: Dosage adjustment (Children [2 to <12 years] and young adolescents with low body weight [12 to 14 years and <50 kg])
Croatian: Prilagodba doze (djeca [2 do <12 godina] i mlađi adolescenti male tjelesne težine [12 do 14 godina i <50 kg])
English: Caution should be used in prescribing VFEND to patients with hypersensitivity to other azoles (see also section 4.8).
Croatian: Potreban je oprez kod propisivanja lijeka VFEND bolesnicima preosjetljivima na ostale azole (vidjeti i dio 4.8).
English: For administration, the twist-off port at the bottom of the infusion bag should be opened and the infusion line connected and primed.
Croatian: Za primjenu, potrebno je odviti zatvarač s ulaznog otvora na dnu infuzijske vrećice te priključiti i pripremiti infuzijsku liniju.
English: Voriconazole has not been studied in patients with severe chronic hepatic cirrhosis (Child-Pugh C).
Croatian: Vorikonazol nije ispitivan u bolesnika s teškom kroničnom cirozom jetre (Child-Pughov stadij C).
English: Remove the syringe.
Croatian: Izvadite štrcaljku.
English: Prolonged optic neuritis has been reported post-marketing.
Croatian: Produženi optički neuritis prijavljen je nakon stavljanja lijeka u promet.
English: A study has been conducted in healthy volunteers which examined the effect on QTc interval of single doses of voriconazole up to 4 times the usual daily dose.
Croatian: U ispitivanju provedenom u zdravih dobrovoljaca ispitivao se učinak vorikonazola na QTc-interval uz primjenu pojedinačnih doza i do 4 puta većih od uobičajene dnevne doze.
English: In clinical studies, response to voriconazole in patients with C. glabrata infections was 21% lower compared to C. albicans, C. parapsilosis and C. tropicalis.
Croatian: U kliničkim ispitivanjima je odgovor na vorikonazol u bolesnika s infekcijama uzročnika C. glabrata bio 21% niži u odnosu na one infekcije čiji su uzročnici bili C. albicans, C. parapsilosis i C. tropicalis.
English: Voriconazole Cmax and AUC ↔
Croatian: Vorikonazol Cmax i AUC
English: • For dilution, gently invert the vial, vial adapter and syringe assembly and withdraw the required volume of the reconstituted concentrate into the syringe (see table below).
Croatian: • Za razrjeđivanje, nježno preokrenite sklop bočice, nastavka za bočicu i štrcaljke te izvucite potreban volumen rekonstituiranog koncentrata u štrcaljku (vidjeti sljedeću tablicu).
English: The predicted total exposure in children following an oral maintenance dose of 9 mg/kg (maximum of 350 mg) twice daily was comparable to that in adults following 200 mg oral twice daily.
Croatian: Predviđena ukupna izloženost u djece nakon primjene peroralne doze održavanja od 9 mg/kg (najviše 350 mg) dvaput na dan bila je usporediva s onom u odraslih nakon peroralne primjene doze od 200 mg dvaput na dan.
English: Coadministration of standard doses of voriconazole with efavirenz doses of 400 mg once daily or higher is contraindicated, because efavirenz significantly decreases plasma voriconazole concentrations in healthy subjects at these doses.
Croatian: Istodobna primjena standardne doze vorikonazola s dozama efavirenza od 400 mg jedanput na dan ili više je kontraindicirana, jer efavirenz u toj dozi značajno smanjuje koncentraciju vorikonazola u plazmi zdravih ispitanika.
English: - Reminds HCPs to discuss with the patient/care giver the risks of phototoxicity/skin SCC and hepatotoxicity, what to look for, how and when to seek immediate attention.
Croatian: - Podsjeća zdravstvene radnike da razgovaraju s bolesnikom/skrbnikom o riziku od fototoksičnosti/SCC-a i toksičnosti za jetru, što tražiti, kako i kada potražiti hitnu pomoć.
English: Careful monitoring for any occurrence of drug toxicity and/or lack of efficacy, and dose adjustment may be needed.
Croatian: Možda će biti potrebno pomno pratiti bolesnika zbog moguće toksičnosti i/ili nedostatka djelotvornosti lijeka te eventualno prilagoditi dozu.
English: Each bottle contains 3 g of voriconazole.
Croatian: Jedna bočica sadrži 3 g vorikonazola.
English: VFEND 200 mg film-coated tablets Each tablet contains 253.675 mg lactose monohydrate.
Croatian: VFEND 200 mg filmom obložene tablete Jedna tableta sadrži 253,675 mg laktoze hidrata.
English: • Once the syringe is reconnected to the blue port of the infusion bag, the contents are then emptied into the infusion bag from the syringe to provide a final voriconazole solution containing 0.5-5 mg/ml.
Croatian: • Nakon je štrcaljka ponovno priključena na plavi ulazni otvor infuzijske vrećice, sadržaj se zatim prazni u infuzijsku vrećicu iz štrcaljke kako bi se dobila konačna otopina vorikonazola koja sadrži 0,5 - 5 mg/ml.
English: All occurred in paediatric patients, who received up to five times the recommended intravenous dose of voriconazole.
Croatian: Sva 3 slučaja zabilježena su u pedijatrijskih bolesnika koji su dobili do 5 puta veću intravensku dozu vorikonazola od preporučene.