FrancophonIA/ELRC3.0 huggingface dataset:
English: • Keep the vial in the outer carton in order to protect from light.
Croatian: • Čuvati bočicu u vanjskoj kutiji radi zaštite od svjetlosti.
English: • Bring the dropper bottle tip close to the eye. Use the mirror if it helps.
Croatian: • Prinesite vrh bočice s kapaljkom blizu oka.
English: • 1 dropper applicator.
Croatian: • 1 aplikator za kapaljku
English: 1 bottle + 1 syringe + 1 bottle adapter
Croatian: 1 boca+ 1 štrcaljka + 1 nastavak za grlo bočice
English: Oral solution Oral use
Croatian: Oralna otopina
English: Then rinse with water.
Croatian: NAVOĐENJE DJELATNE(IH) TVARI
English: Continue taking VFEND until your doctor tells you to stop.
Croatian: Nastavite uzimati VFEND sve dok Vam liječnik ne kaže da prestanete.
English: What VFEND is and what it is used for
Croatian: Što je VFEND i za što se koristi
English: Insufficient evidence
Croatian: Nedovoljno dokaza
English: * This also applies to patients aged 15 years and older
Croatian: *Odnosi se također na bolesnike u dobi od 15 ili više godina
English: For example, 15-20% of Asian populations may be expected to be poor metabolisers.
Croatian: Primjerice, može se očekivati da će 15-20% azijske populacije biti spori metabolizatori.
English: • you have had an allergic reaction to other azoles.
Croatian: • ako ste imali alergijsku reakciju na druge azole.
English: You should always add a total of 46 ml of water irrespective of the dose you are taking.
Croatian: Uvijek morate dodati ukupno 46 ml vode, bez obzira na dozu koju uzimate.
English: Clinical experience Successful outcome in this section is defined as complete or partial response.
Croatian: Kliničko iskustvo Pozitivan ishod u ovom je odjeljku definiran kao potpun ili djelomičan odgovor.
English: Macrolide antibiotics
Croatian: Makrolidni antibiotici
English: Località Marino del Tronto 63100 Ascoli Piceno (AP) Italy
Croatian: Località Marino del Tronto 63100 Ascoli Piceno (AP) Italija
English: Do not stop treatment early because your infection may not be cured.
Croatian: Nemojte prerano prestati s liječenjem jer infekcija možda neće biti izliječena.
English: Swallow the tablet whole with some water.
Croatian: Progutajte cijelu tabletu s malo vode.
English: Do not squirt the medicine out quickly.
Croatian: Nemojte naglo uštrcati lijek.
English: VFEND suspension is constituted if it is in a liquid form.
Croatian: VFEND suspenzija je pripremljena ako je u tekućem obliku.
English: • you are suffering from, or have ever suffered from liver disease.
Croatian: • ako sada bolujete ili ste ikada imali bolest jetre.
English: It is important to take your VFEND suspension regularly at the same time each day.
Croatian: Važno je da VFEND suspenziju uzimate redovito, svakog dana u isto vrijeme.
English: The recommended dosing regimen is as follows:
Croatian: Preporučeni režim doziranja je kako slijedi:
English: • Tablets must only be given if the child is able to swallow tablets.
Croatian: • Tablete se smiju davati samo ako ih dijete može progutati.
English: Other medicines and VFEND
Croatian: Drugi lijekovi i VFEND
English: The contents of the infusion bag are now ready for infusion to the patient.
Croatian: Sadržaj infuzijske vrećice sada je spreman za infuziju bolesniku.
English: No clinically significant differences were seen when the safety data were analysed by age, race, or gender.
Croatian: Nisu uočene klinički značajne razlike kad su se podaci o sigurnosti primjene analizirali s obzirom na dob, rasu ili spol.
English: • Existing symptomatic arrhythmias.
Croatian: • postojeće simptomatske aritmije
English: However, as there were only 9 cases available for EUCAST analysis, there is currently insufficient evidence to set clinical breakpoints for C. krusei.
Croatian: Međutim, s obzirom da je bilo samo 9 slučajeva dostupnih za EUCAST analizu, za sada nema dovoljno dokaza za utvrđivanje graničnih vrijednosti za C. krusei.
English: Patients with a weakened immune system or those with difficult infections may require long-term treatment to prevent the infection from returning.
Croatian: Bolesnicima s oslabljenim imunološkim sustavom ili onima s teškim infekcijama možda će biti potrebno dulje liječenje kako bi se spriječio povratak infekcije.
English: It is important to take your VFEND tablets regularly at the same time each day.
Croatian: Važno je da VFEND tablete uzimate redovito, svakog dana u isto vrijeme.
English: When cleared, proceed as directed.
Croatian: Kada se pročisti, nastavite prema uputama.
English: Frequency categories are expressed as: 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).
Croatian: Kategorije učestalosti izražene su 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); nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Take your bottle of VFEND suspension with you.
Croatian: Ponesite sa sobom bocu VFEND suspenzije.
English: Instructions for Use - please be guided by the pictograms to understand how to use this product.
Croatian: Upute za uporabu - slijedite piktograme kako biste razumjeli kako koristiti ovaj lijek.
English: Allergic reaction or exaggerated immune response
Croatian: - alergijska reakcija ili pretjerani imunološki odgovor
English: Maximum increase in prothrombin time was approximately 2-fold.
Croatian: Maksimalno produljenje protrombinskog vremena bilo je približno dvostruko.
English: Medicinal product [Mechanism of interaction]
Croatian: Lijek [Mehanizam interakcije]
English: The suspension should not be further diluted with water or any other liquids.
Croatian: Suspenzija se ne smije dodatno razrjeđivati s vodom ili drugim tekućinama.
English: Date of first authorisation: 19 March 2002 Date of latest renewal: 21 February 2012
Croatian: Datum posljednje obnove odobrenja: 21. veljače 2012.
English: The majority (>94%) of the total radioactivity is excreted in the first 96 hours after both oral and intravenous dosing.
Croatian: Većina (> 94%) ukupne radioaktivnosti izluči se tijekom prvih 96 sati i nakon peroralne i nakon intravenske primjene.
English: Constituted suspension: Do not store above 30°C; do not refrigerate or freeze.
Croatian: Pripremljena suspenzija: Ne čuvati na temperaturi iznad 30°C; ne odlagati u hladnjak i ne zamrzavati.
English: Your doctor may change your dose depending on your condition.
Croatian: Liječnik može promijeniti dozu ovisno o Vašem stanju.
English: Please see instructions below before using VFEND suspension.
Croatian: Pročitajte sljedeće upute prije uzimanja VFEND suspenzije.
English: What you need to know before you take VFEND
Croatian: Što morate znati prije nego počnete uzimati VFEND
English: Add 46 ml of water and shake vigorously for about 1 minute.
Croatian: Dodajte 46 ml vode i snažno tresite približno 1 minutu.
English: • Sinus bradycardia.
Croatian: • sinusna bradikardija
English: VFEND may cause blurring of vision or uncomfortable sensitivity to light.
Croatian: VFEND može uzrokovati zamagljen vid ili neugodnu preosjetljivost na svjetlost.
English: Manufacturer Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, France.
Croatian: Proizvođač Fareva Amboise, Zone Industrielle, 29 route des Industries, 37530 Pocé-sur-Cisse, Francuska.
English: The survival rate at Day 180 was 80.0% (32/40) and at 1 year was 70.0% (28/40).
Croatian: Stopa preživljenja na 180. dan bila je 80,0% (32/40), a u 1. godini bila je 70,0% (28/40).
English: As you will be given this medicine under close medical supervision, it is unlikely that a dose would be missed.
Croatian: Budući da ćete ovaj lijek primati pod strogim nadzorom liječnika, nije vjerojatno da ćete propustiti dozu.
English: What VFEND looks like and contents of the pack
Croatian: Kako VFEND izgleda i sadržaj pakiranja
English: Therefore unless your doctor instructs you to stop treatment, it is important to keep taking VFEND correctly, as described above.
Croatian: Stoga je, ako Vam liječnik nije rekao da prekinete liječenje, važno da VFEND uzimate na pravilan način, kako je prethodno opisano.
English: VFEND suspension should not be mixed with any other medicine.
Croatian: VFEND suspenzija se ne smije miješati s drugim lijekovima.
English: Includes febrile neutropenia and neutropenia.
Croatian: Uključuje febrilnu neutropeniju i neutropeniju.
English: The asterisk (*) indicates a twoway interaction.
Croatian: Zvjezdicom (*) je označena dvosmjerna interakcija.
English: Sunburn or severe skin reaction following exposure to light or sun was experienced more frequently in children.
Croatian: Opekline od sunca ili teška kožna reakcija uslijed izlaganja svjetlosti ili suncu nastale su češće u djece.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Croatian: • prilikomi svake izmjene sustava za upravljanje rizikom, a naročito kada je ta izmjena rezultat primitka novih informacija koje mogu voditi ka značajnim izmjenama omjera korist/rizik, odnosno kada je izmjena rezultat ostvarenja nekog važnog cilja (u smislu farmakovigilancije ili minimizacije rizika).
English: This product should only be taken under the supervision of a doctor.
Croatian: Ovaj se lijek smije uzimati samo pod nadzorom liječnika.
English: Ask your pharmacist how to throw away medicines you no longer required.
Croatian: Pitajte svog ljekarnika kako baciti lijekove koje više ne trebate.
English: What VFEND is and what it is used for What you need to know before you take VFEND How to take VFEND
Croatian: Što je VFEND i za što se koristi Što morate znati prije nego počnete uzimati VFEND Kako uzimati VFEND
English: Pregnancy There are no adequate data on the use of VFEND in pregnant women available.
Croatian: Trudnoća Nema dostupnih odgovarajućih podataka o primjeni lijeka VFEND u trudnica.
English: VFEND must not be administered simultaneously with any blood product or any short-term infusion of concentrated solutions of electrolytes, even if the two infusions are running in separate lines.
Croatian: VFEND se ne smije primjenjivati istodobno s bilo kojim krvnim pripravkom ili kratkotrajnom infuzijom koncentriranih otopina elektrolita, čak ni ako se koriste dvije odvojene infuzijske linije.
English: Use in children and adolescents The recommended dose for children and teenagers is as follows:
Croatian: Primjena u djece i adolescenata Preporučena doza za djecu i adolescente je kako slijedi:
English: If you stop taking VFEND
Croatian: Ako prestanete uzimati VFEND
English: Children and adolescents VFEND should not be given to children younger than 2 years of age.
Croatian: Djeca i adolescenti VFEND se ne smije davati djeci mlađoj od 2 godine.
English: (Maintenance Dose)
Croatian: (doza održavanja)
English: Your treatment will be started as an infusion
Croatian: Liječenje će započeti infuzijom
English: The infusion bag should be checked to ensure that the entire contents of the bag have been infused, especially if the same intravenous line is to be used for sequential infusion of other drugs.
Croatian: Potrebno je provjeriti vrećicu kako bi se osigurali da se cijeli sadržaj vrećice infundirao, naročito ako se ista intravenska linija koristi redom za infuziju drugih lijekova.
English: It is recommended that your pharmacist constitutes VFEND suspension before giving it to you.
Croatian: Preporučuje se da ljekarnik pripremi VFEND suspenziju prije nego što Vam izda lijek.
English: Following constitution, the total volume of the suspension must be 75 ml.
Croatian: Nakon pripreme, ukupni volumen suspenzije mora biti 75 ml.
English: For Caucasians and Blacks the prevalence of poor metabolisers is 3-5%.
Croatian: Među pripadnicima bijele i crne rase prevalencija sporih metabolizatora iznosi 3-5%.
English: • Oral contraceptives (if you take VFEND whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)
Croatian: • oralne kontraceptive (ako uzimate VFEND istodobno s oralnim kontraceptivima, možete imati nuspojave poput mučnine i poremećaja menstruacije)
English: For prophylaxis use, dose adjustments are not recommended in the case of lack of efficacy or treatmentrelated adverse events.
Croatian: Pri upotrebi u profilaksi, prilagodba doze se ne preporučuje u slučaju izostanka djelotvornosti ili štetnih događaja povezanih s liječenjem.
English: Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C to 8°C.
Croatian: Dokazana kemijska i fizička stabilnost lijeka u primjeni je 24 sata na temperaturi od 2°C do 8°C.
English: The bag should be checked to ensure that the infusion is complete.
Croatian: Potrebno je provjeriti vrećicu kako bi se bilo sigurno da je infuzija dovršena.
English: Success at day 100
Croatian: Uspjeh na 100. dan
English: Treatment duration should be as short as possible; however, if based on the benefit-risk assessment the treatment is continued (see section 4.2), monitoring frequency can be reduced to monthly if there are no changes in the liver function tests.
Croatian: Liječenje bi trebalo trajati što je kraće moguće, međutim ako se ono temelji na procjeni koristi i rizika, liječenje se nastavlja (vidjeti dio 4.2), a učestalost praćenja se može smanjiti na mjesečne provjere ako nema promjena u testovima funkcije jetre.
English: If you or your child are taking VFEND for prevention of fungal infections, your doctor may stop giving VFEND if you or your child develop treatment related side effects.
Croatian: Ako Vi ili Vaše dijete uzimate VFEND za prevenciju gljivičnih infekcija, liječnik Vam može prestati davati VFEND ako Vi ili Vaše dijete razvijete povezane nuspojave.
English: In this analysis a successful response was seen in 41% of patients in both treatment arms.
Croatian: U toj je analizi pozitivan odgovor na liječenje utvrđen u 41% bolesnika u obje skupine.
English: If you have liver disease, your doctor may prescribe a lower dose of VFEND.
Croatian: Ako imate bolest jetre, liječnik će Vam možda propisati nižu dozu lijeka VFEND.
English: Elevated liver enzymes
Croatian: - povišeni jetreni enzimi
English: The reconstituted solution can be diluted with:
Croatian: Rekonstituirana otopina može se razrijediti sa:
English: Powder for oral suspension 45 g
Croatian: Prašak za oralnu suspenziju 45 g
English: Therefore, from a microbiological point of view, once solvent has been removed from the bag to reconstitute the VFEND powder for solution for infusion and then reintroduced into the bag, the product must be used immediately.
Croatian: Stoga se, s mikrobiološkog stanovišta, jednom izvađeno otapalo iz vrećice kako bi se rekonstituirao VFEND prašak za otopinu za infuziju i zatim vraćen u vrećicu, lijek se mora odmah primijeniti.
English: If you forget to take one dose, take your next dose when it is due.
Croatian: Ako zaboravite uzeti jednu dozu, uzmite sljedeću dozu u predviđeno vrijeme.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking VFEND if:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete VFEND:
English: Powder for solution for infusion and powder for oral suspension: Fareva Amboise
Croatian: Prašak za otopinu za infuziju i prašak za oralnu suspenziju: Fareva Amboise
English: If you forget to take VFEND
Croatian: Ako ste zaboravili uzeti VFEND
English: Contact your doctor immediately if you become pregnant while taking VFEND.
Croatian: Odmah se javite svom liječniku ako zatrudnite za vrijeme uzimanja lijeka VFEND.
English: This study confirmed findings from an earlier, prospectively designed study where there was a positive outcome in subjects with risk factors for a poor prognosis, including graft versus host disease, and, in particular, cerebral infections (normally associated with almost 100% mortality).
Croatian: Ovo je ispitivanje potvrdilo rezultate ranijeg prospektivnog ispitivanja, u kojem je zabilježen pozitivan ishod u ispitanika s faktorima rizika za lošu prognozu, uključujući reakciju presatka protiv primatelja, te posebice infekcije mozga (obično povezane s gotovo 100%-tnom smrtnošću).
English: If particles are seen, swirl again and re-inspect.
Croatian: Ako su vidljive čestice, još je okrećite i ponovno pregledajte.
English: Serious side effects - Stop taking VFEND and see a doctor immediately
Croatian: Ozbiljne nuspojave - prestanite uzimati VFEND i odmah se javite liječniku
English: The safety and efficacy of VFEND in children below 2 years has not been established.
Croatian: Sigurnost i djelotvornost lijeka VFEND u djece mlađe od 2 godine nisu ustanovljene.
English: These visual impairments were transient and fully reversible, with the majority spontaneously resolving within 60 minutes and no clinically significant long-term visual effects were observed.
Croatian: Ta su oštećenja vida bila prolazna i potpuno reverzibilna, a većina ih se spontano povukla u roku od 60 minuta te nisu primijećeni klinički značajni dugoročni poremećaji vida.
English: 5b Empty the contents of the syringe into the bag.
Croatian: 5b Ispraznite sadržaj štrcaljke u vrećicu.
English: Treatment of invasive aspergillosis.
Croatian: liječenje invazivne aspergiloze.
English: Plasma protein binding is estimated to be 58%.
Croatian: Procjenjuje se da se na proteine plazme vezuje u omjeru od 58%.
English: • The syringe may then be removed and the contents of the infusion bag mixed gently by inverting the bag several times.
Croatian: • Štrcaljka se zatim smije ukloniti i sadržaj infuzijske vrećice nježno promiješati preokretanjem vrećice nekoliko puta.
English: Completed at least 100 days of study drug prophylaxis
Croatian: Dovršeno najmanje 100 dana profilakse ispitivanim lijekom
English: The medicines in the following list must not be taken during your VFEND treatment:
Croatian: Lijekovi navedeni u sljedećem popisu ne smiju se uzimati za vrijeme liječenja lijekom VFEND:
English: Compatible Infusion Solutions: The reconstituted solution can be diluted with:
Croatian: Kompatibilne infuzijske otopine: Rekonstituirana otopina može se razrijediti sa:
English: Total parenteral nutrition: Total parenteral nutrition (TPN) need not be discontinued when prescribed with VFEND, but does need to be infused through a separate line.
Croatian: Potpuna parenteralna prehrana: Infuzija pripravka potpune parenteralne prehrane (TPN - total parenteral nutrition) ne mora se prekidati ako se istodobno primjenjuje VFEND, ali je treba davati u zasebnoj infuzijskoj liniji.
English: • Cardiomyopathy, in particular when heart failure is present.
Croatian: • kardiomiopatija, posebice ako je prisutno i zatajenje srca
English: VFEND must not be infused into the same line or cannula concomitantly with other drug infusions, including parenteral nutrition (e.g., Aminofusin 10% Plus).
Croatian: VFEND se ne smije primijeniti u istoj infuzijskoj liniji ili kanili istodobno s drugim lijekovima, uključujući i pripravke za parenteralnu prehranu (npr. Aminofusin 10% Plus).
English: There is a small chance that skin cancer could develop with long-term use of VFEND.
Croatian: Postoji mala šansa od razvoja raka kože uz dugoročnu primjenu lijeka VFEND.
English: Infusion of total parenteral nutrition can occur simultaneously with VFEND but not in the same line or cannula.
Croatian: Infuzija pripravka potpune parenteralne prehrane može se odvijati istodobno s primjenom lijeka VFEND, ali ne u istoj infuzijskoj liniji ili kanili.
English: What VFEND contains
Croatian: Što VFEND sadrži
English: If you take more VFEND than you should
Croatian: Ako uzmete više lijeka VFEND nego što ste trebali
English: In the combined data from three bioequivalence studies using the powder for oral suspension formulation, treatment-related taste perversion was recorded in 12 (14%) of subjects.
Croatian: U kombiniranim podacima iz tri ispitivanja bioekvivalencije u kojima je korišten prašak za oralnu suspenziju, promjena osjeta okusa povezana s liječenjem zabilježena je u 12 ispitanika (14%).
English: Any unused suspension should be discarded after this date.
Croatian: Nakon tog datuma treba baciti neiskorištenu suspenziju.
English: To measure the dose accurately, the top edge of the black ring should be lined up with the graduated mark on the oral syringe.
Croatian: Da biste dozu točno odmjerili, vrh crnog prstena mora biti poravnat s oznakom na štrcaljki za usta.
English: A single adverse reaction of photophobia of 10 minutes duration was reported.
Croatian: Prijavljena je samo jedna nuspojava, i to fotofobija u trajanju od 10 minuta.
English: VFEND must not be used during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
Croatian: VFEND se ne smije primjenjivati u trudnoći, osim ako korist liječenja za majku jasno ne nadilazi mogući rizik za plod.
English: Add 2 measuring cups of water, providing a total volume of 46 ml.
Croatian: Dodajte 2 odmjerne čašice vode, što daje ukupan volumen od 46 ml.
English: Following constitution, the volume of the suspension is 75 ml, providing a usable volume of 70 ml.
Croatian: Nakon pripreme volumen suspenzije iznosi 75 ml, što daje iskoristivi volumen od 70 ml.
English: Bioequivalence between the powder for oral suspension and tablets has not been investigated in a paediatric population.
Croatian: Nije ispitana bioekvivalencija između praška za oralnu suspenziju i tableta u pedijatrijskoj populaciji.
English: Amphotericin B → fluconazole (N=122)
Croatian: Amfotericin B → flukonazol (N=122)
English: If the liver function tests become markedly elevated, VFEND should be discontinued, unless the medical judgment of the risk-benefit of the treatment for the patient justifies continued use.
Croatian: Ako testovi funkcije jetre postanu značajno povišeni, mora se prekinuti uzimanje lijeka VFEND, osim ako medicinska procjena rizika i koristi liječenja za bolesnika opravdava nastavak korištenja.
English: The following instructions apply to both Treatment and Prophylaxis
Croatian: Sljedeće informacije odnose se i na liječenje i na profilaksu
English: Pharmacokinetic/pharmacodynamic Relationship
Croatian: Farmakokinetički/farmakodinamički odnos
English: VFEND should be discontinued if premalignant skin lesions or squamous cell carcinoma are identified (see below the section under Long-term treatment).
Croatian: VFEND treba ukinuti ako se identificiraju premaligne lezije kože ili karcinom skvamoznih stanica (vidjeti odjeljak u nastavku Dugotrajno liječenje).
English: VFEND requires reconstitution and dilution (see section 6.6) prior to administration as an intravenous infusion.
Croatian: VFEND se mora pripremiti i razrijediti (vidjeti dio 6.6) prije primjene intravenskom infuzijom.
English: Set the infusion rate accurately.
Croatian: Precizno namjestite brzinu infuzije.
English: The bag should be carefully inspected to ensure that there are no particulates.
Croatian: Vrećicu treba pažljivo pregledati kako bi se osiguralo da nisu vidljive čestice.
English: The instructions should be followed for reconstitution, dilution and administration of each kit.
Croatian: Potrebno je pridržavati se uputa za rekonstituciju, razrjeđivanje i primjenu svakog kompleta.
English: Depending on your response to treatment, your doctor may increase or decrease the daily dose.
Croatian: Ovisno o Vašem odgovoru na liječenje, liječnik može povećati ili smanjiti dnevnu dozu.
English: Pull the plunger out of the syringe and wash both parts in warm soapy water.
Croatian: Izvucite klip iz štrcaljke i oba dijela operite u toploj vodi s deterdžentom.
English: In addition VFEND has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Croatian: Uz to, VFEND se povezuje s fototoksičnošću, uključujući reakcije kao što su pjege, lentigo, aktinička keratoza i pseudoporfirija.
English: Shake the closed bottle vigorously for about 1 minute.
Croatian: Snažno tresite zatvorenu bocu otprilike 1 minutu.