FrancophonIA/ELRC3.0 huggingface dataset:
English: The interactions in the table are presented in the following order: contraindications, those requiring dose adjustment and careful clinical and/or biological monitoring, and finally those that have no significant pharmacokinetic interaction but may be of clinical interest in this therapeutic field.
Croatian: Interakcije su u tablici prikazane sljedećim redoslijedom: kontraindikacije, one koje zahtijevaju prilagodbu doze i pažljivo kliničko i/ili biološko praćenje te na kraju one kod kojih nema značajnije farmakokinetičke interakcije, ali mogu biti od kliničkog interesa za ovo terapijsko područje.
English: The survival rate at Day 180 was 80.0% (32/40) and at 1 year was 70.0% (28/40).
Croatian: Dan bila je 80,0% (32/40), a u 1. godini bila je 70,0% (28/40).
English: • Treatment of invasive aspergillosis.
Croatian: • liječenje invazivne aspergiloze,
English: Non-infectious periostitis with elevated fluoride and alkaline phosphatase levels has been reported in transplant patients.
Croatian: Neinfektivni periostitis s povišenim vrijednostima fluorida i alkalne fosfataze prijavljen je u transplantiranih bolesnika.
English: The safety and efficacy of voriconazole use for longer than 180 days has not been adequately studied in clinical trials.
Croatian: Sigurnost i djelotvornost primjene vorikonazola duže od 180 dana nisu prikladno ispitivane u kliničkim ispitivanjima.
English: The following instructions apply to both Treatment and Prophylaxis.
Croatian: Sljedeće informacije odnose se i na liječenje i na profilaksu.
English: In clinical trials there were 3 cases of accidental overdose.
Croatian: Tijekom kliničkih ispitivanja zabilježena su 3 slučajna predoziranja.
English: Overall, the safety profile of voriconazole in paediatric population was similar to that in adults.
Croatian: Općenito, sigurnosni profil vorikonazola u pedijatrijskoj populaciji bio je sličan onom u odraslih.
English: Success rates and other secondary endpoints are presented in the table below:
Croatian: Stope uspjeha i drugi sekundarni ishodi prikazani su u tablici u nastavku:
English: This should include laboratory evaluation, particularly serum creatinine.
Croatian: To uključuje laboratorijske pretrage, a naročito određivanje vrijednosti kreatinina u serumu.
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 bolesnika s faktorima rizika za lošu prognozu, uključujući reakciju presatka protiv primatelja, te posebice infekcije mozga (obično povezane s gotovo 100%-tnom smrtnošću).
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: These visual impairmentswere 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: If you develop skin disorders as described above, your doctor may refer you to a dermatologist, who after consultation may decide that it is important for you to be seen on a regular basis.
Croatian: Ako razvijete poremećaje kože opisane u prethodnom tekstu, Vaš liječnik može Vas uputiti dermatologu, koji nakon konzultacija može odlučiti da je važno da redovito dolazite na kontrole.
English: One study enrolled 31 patients with possible, proven or probable invasive aspergillosis (IA), of whom 14 patients had proven or probable IA and were included in the MITT efficacy analyses.
Croatian: Jedno je ispitivanje uključivalo 31 bolesnika s mogućom, dokazanom ili vjerojatnom invazivnom aspergilozom (IA), od čega je 14 bolesnika imalo dokazanu ili vjerojatnu IA i bilo je uključeno u analize djelotvornosti MITT.
English: - Provides HCPs with the current recommendations to monitor and manage these risks.
Croatian: - Pruža zdravstvenim radnicima trenutne preporuke za praćenje i upravljanje tim rizicima.
English: Oral dosage forms of voriconazole are available from other manufacturers.
Croatian: Oralni dozirni oblici vorikonazola su dostupni od drugih proizvođača.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V
Croatian: Od zdravstvenih radnika se traži da prijave svaku sumnju na nuspojavu lijeka putem nacionalnog sustava prijave nuspojava navedenog u Dodatku V*.
English: Compatible Infusion Solutions: The reconstituted solution can be diluted with:
Croatian: Kompatibilne infuzijske otopine: Pripremljena otopina može se razrijediti sa:
English: In addition, a successful response was seen in 1 of 3 patients with infections caused by more than one organism including Scedosporium spp.
Croatian: Uz to, uspješan odgovor je zabilježen i u 1 od 3 bolesnika s infekcijama izazvanima više nego jednim uzročnikom, uključujući i nekim iz roda Scedosporium.
English: It is likely that these subjects may metabolize voriconazole more similarly to children than to adolescents/adults.
Croatian: Ti ispitanici vjerojatno mogu metabolizirati vorikonazol sličnije djeci nego adolescentima/odraslima.
English: 6 See “Visual impairments” paragraph in section 4.8.
Croatian: 6 Vidjeti “Oštećenja vida” u dijelu 4.8.
English: The median duration of study drug prophylaxis was 96 days for voriconazole and 68 days for itraconazole in the MITT group.
Croatian: Medijan trajanja profilakse ispitivanim lijekom bio je 96 dana za vorikonazol i 68 dana za itrakonazol u skupini MITT.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those that are obtained without a prescription.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: In the light of these data the duration of treatment of the intravenous formulation should be no longer than 6 months.
Croatian: U svjetlu tih podataka, liječenje intravenskim oblikom ne smije trajati dulje od 6 mjeseci.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C (in a refrigerator), unless reconstitution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme čuvanja i uvjeti čuvanja prije primjene odgovornost su korisnika i obično ne bi smjeli premašiti 24 sata na temperaturi od 2°C do 8°C (u hladnjaku), osim ako priprema za primjenu nije provedena u kontroliranim i validiranim aseptičkim uvjetima.
English: Squamous cell carcinoma of the skin has been reported in patients, some of whom have reported prior phototoxic reactions.
Croatian: Karcinom skvamoznih stanica kože prijavljen je u bolesnika od kojih su neki prethodno prijavili fototoksične reakcije.
English: *Oral dosage forms of voriconazole are available from other manufacturers **This also applies to patients aged 15 years and older.
Croatian: * oralni dozirni oblici vorikonazola su dostupni od drugih proizvođača **odnosi se također na bolesnike u dobi od 15 godina ili više godina
English: However, lower voriconazole exposure was observed in some young adolescents with low body weight compared to adults.
Croatian: Međutim, opažena je niža izloženost vorikonazolu u nekih mlađih adolescenata male tjelesne težine u odnosu na odrasle.
English: Your doctor may stop the infusion if this occurs.
Croatian: Ako se to dogodi, liječnik može prekinuti infuziju.
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Voriconazole Hikma if:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primite Vorikonazol Hikma:
English: The reconstituted solution can be diluted with:
Croatian: Pripremljena otopina može se razrijediti sa:
English: • Cardiomyopathy, in particular when heart failure is present
Croatian: • kardiomiopatija, posebice ako je prisutno i zatajenje srca
English: • Small dry scaly skin patches, sometimes thick with spikes or ‘horns'
Croatian: - male suhe ljuskaste mrlje na koži, katkad debele sa šiljcima ili "rogovima"
English: This should be taken into consideration if you are on a strictly controlled sodium diet.
Croatian: O tome treba voditi računa ako ste na režimu prehrane sa strogo ograničenim unosom natrija.
English: The safety and efficacy of voriconazole in children below 2 years has not been established.
Croatian: Sigurnost i djelotvornost vorikonazola u djece mlađe od 2 godine nisu ustanovljene.
English: Packs of 1 or 5 vials.
Croatian: Pakiranja s 1 do 5 bočica.
English: Prophylaxis with study drug was started immediately after HSCT: 224 received voriconazole and 241 received itraconazole.
Croatian: Profilaksa ispitivanim lijekom započeta je neposredno nakon HSCT-a: 224 primilo je vorikonazol, a 241 primilo je itrakonazol.
English: In rats, mice and dogs, voriconazole also induced minimal adrenal changes.
Croatian: U štakora, miševa i pasa vorikonazol je također izazvao minimalne promjene nadbubrežne žlijezde.
English: It is very important that you inform your doctor or pharmacist if you are taking or have taken any other medicines, even those that are obtained without a prescription, or herbal medicines.
Croatian: Vrlo je važno da obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzimali neke druge lijekove, uključujući i one koje ste nabavili bez recepta ili biljne lijekove.
English: Norethisterone/ethinylestradiol (1 mg/0.035 mg QD)
Croatian: Noretisteron/etinilestradiol (1 mg/0,035 mg QD)
English: Pregnancy There are no adequate data on the use of voriconazole in pregnant women available.
Croatian: Trudnoća Nema dostupnih odgovarajućih podataka o primjeni vorikonazola u trudnica.
English: Do not use this medicine after the expiry date which is stated on the label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na oznaci iza „Rok valjanosti“/EXP.
English: Prophylaxis should be as short as possible depending on the risk for developing invasive fungal infection (IFI) as defined by neutropenia or immunosuppression.
Croatian: Profilaksa treba trajati što kraće ovisno o riziku od nastanka invazivne gljivične infekcije definirane neutropenijom ili imunosupresijom.
English: Serious refractory Candida infections
Croatian: Ozbiljne refraktorne infekcije gljivicom Candida
English: 10 Includes drug-induced liver injury, hepatitis toxic, hepatocellular injury and hepatotoxicity.
Croatian: 10 Uključuje oštećenja jetre uzrokovana lijekovima, toksični hepatitis, hepatocelularne ozljede i hepatotoksičnost.
English: Contraindicated (see section 4.3)
Croatian: Kontraindikacije (vidjeti dio 4.3)
English: Conventional studies of safety pharmacology, genotoxicity or carcinogenic potential did not reveal a special hazard for humans.
Croatian: Standardna ispitivanja sigurnosne farmakologije, genotoksičnosti odnosno kancerogenosti nisu otkrila poseban rizik za ljude.
English: Therefore, no dosage adjustment based on gender is necessary.
Croatian: Stoga nije potrebno prilagođavati dozu na temelju spola.
English: Interactions between voriconazole and other medicinal products are listed in the table below (once daily as “QD”, twice daily as “BID”, three times daily as “TID” and not determined as “ND”).
Croatian: Interakcije između vorikonazola i drugih lijekova navedene su u sljedećoj tablici (oznaka "QD" znači jedanput na dan, "BID" dvaput na dan, "TID" triput na dan, a "ND" znači da nije određeno).
English: Dose reduction of NSAIDs may be needed.
Croatian: Možda će biti potrebno smanjiti dozu NSAIL-a.
English: If you or your child are taking Voriconazole Hikma for prevention of fungal infections, your doctor may stop giving Voriconazole Hikma if you or your child develop treatment related side effects.
Croatian: Ako Vi ili Vaše dijete uzimate Vorikonazol Hikma za prevenciju gljivičnih infekcija, liječnik Vam može prestati davati Vorikonazol Hikma ako Vi ili Vaše dijete razvijete povezane nuspojave.
English: Amphotericin B → fluconazole (N=122)
Croatian: Amfotericin B→ flukonazol (N=122)
English: Scedosporium and Fusarium infections Voriconazole was shown to be effective against the following rare fungal pathogens:
Croatian: Infekcije uzročnicima Scedosporium i Fusarium Vorikonazol se pokazao djelotvornim protiv sljedećih rijetkih patogenih gljiva:
English: Please refer to the treatment tables above.
Croatian: Pogledajte tablice liječenja u gornjem tekstu.
English: Careful monitoring of blood glucose is recommended.
Croatian: Preporučuje se pažljivo praćenje razine glukoze u krvi.
English: Therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, anti-infective therapy should be adjusted accordingly.
Croatian: S liječenjem se može započeti prije nego budu poznati rezultati kulture i drugih laboratorijskih pretraga; međutim, kad ti rezultati budu poznati, antimikrobnu terapiju treba uskladiti s dobivenim nalazima.
English: The primary endpoint was the rate of occurrence of proven and probable IFI during the first year after HSCT.
Croatian: Primarni ishod bila je stopa pojave dokazane i vjerojatne invazivne gljivične infekcije tijekom prve godine nakon HSCT-a.
English: Teenagers aged 12 to 14 years weighing 50 kg or more; and all teenagers older than 14
Croatian: Adolescenti od 12 do 14 godina koji imaju 50 kg i više; i svi adolescenti stariji od 14 godina
English: 1 Strains with MIC values above the Susceptible (S) breakpoint are rare, or not yet reported.
Croatian: Nedovoljno podataka 1 Sojevi s MIK vrijednostima iznad granične vrijednosti osjetljivosti (S) su rijetki ili do sada nisu zabilježeni.
English: The frequency of phototoxicity reactions is higher in the paediatric population.
Croatian: Učestalost fototoksičnih reakcija veća je u pedijatrijskoj populaciji.
English: The overall rate of response (ICC and EC combined) was 88.9% (8/9) for 2 to <12 years old and 62.5% (5/8) for 12 to <18 years old.
Croatian: Ukupna stopa reakcije (ICC i EC zajedno) bila je 88,9% (8/9) za bolesnike u dobi od 2 do <12 godina i 62,5% (5/8) za bolesnike u dobi od 12 do <18 godina.
English: A positive association between mean, maximum or minimum plasma voriconazole concentration and efficacy in therapeutic studies was not found and this relationship has not been explored in prophylaxis studies.
Croatian: Nije utvrđena pozitivna povezanost između prosječne, maksimalne ili minimalne koncentracije vorikonazola u plazmi i djelotvornosti lijeka u terapijskim ispitivanjima, niti je ta povezanost istražena u ispitivanjima profilakse.
English: The majority of abnormal liver function tests either resolved during treatment without dose adjustment or following dose adjustment, including discontinuation of therapy.
Croatian: Većina odstupanja vrijednosti parametara funkcije jetre se tijekom primjene lijeka normalizirala bez prilagodbe doze, ili nakon prilagodbe doze, uključujući i prekid primjene lijeka.
English: • Oral contraceptives (if you take Voriconazole Hikma whilst using oral contraceptives, you may get side effects such as nausea and menstrual disorders)
Croatian: • oralne kontraceptive (ako uzimate Vorikonazol Hikma istodobno s oralnim kontraceptivima, možete imati nuspojave poput mučnine i poremećaja menstruacije)
English: Close monitoring of prothrombin time or other suitable anticoagulation tests is recommended, and the dose of anticoagulants should be adjusted accordingly.
Croatian: Preporučuje se pažljivo pratiti protrombinsko vrijeme ili druge primjerene testove antikoagulacije te prema tome prilagođavati dozu antikoagulansa.
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 kidneys by doing blood tests.
Croatian: Vaš liječnik Vam mora nadzirati funkciju Vaše jetre i bubrega putem krvnih pretraga
English: The direction of the arrow for each pharmacokinetic parameter is based on the 90% confidence interval of the geometric mean ratio being within (↔), below (↓) or above (↑) the 80-125% range.
Croatian: Smjer strelice kod svakog farmakokinetičkog parametra određen je ovisno o tome nalazi li se vrijednost koja predstavlja 90%-tni interval pouzdanosti omjera geometrijske sredine unutar (↔), ispod (↓) ili iznad (↑) granica raspona od 80-125%.
English: • Elevated liver enzymes
Croatian: - povišeni jetreni enzimi
English: Specifically, for C. glabrata, the MICs of voriconazole for fluconazole-resistant isolates are proportionally higher than are those of fluconazole-susceptible isolates.
Croatian: Konkretno, kod C. glabrata, vrijednosti MIK-a vorikonazola za izolate rezistentne na flukonazol proporcionalno su veće od onih za izolate osjetljive na flukonazol.
English: 4 Includes hypoxic-ischaemic encephalopathy and metabolic encephalopathy.
Croatian: 4 Uključuje hipoksičnu-ishemičnu encefalopatiju i metaboličku encefalopatiju.
English: From a microbiological point of view, once reconstituted, the product must be used immediately.
Croatian: Stoga se, s mikrobiološkog stajališta, jednom pripremljena otopina mora odmah primijeniti.
English: Serious side effects - Stop taking Voriconazole Hikma and see a doctor immediately
Croatian: Ozbiljne nuspojave - Prestanite uzimati Vorikonazol Hikma i odmah se javite liječniku:
English: Pharmacokinetics in special patient groups
Croatian: Farmakokinetika u posebnim skupinama bolesnika Spol
English: 7 Prolonged optic neuritis has been reported post-marketing.
Croatian: 7 Produženi optički neuritis prijavljen je nakon stavljanja lijeka u promet.
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 QTc-intervala“.
English: • candidaemia (another type of fungal infection due to Candida sp.) in non-neutropenic patients (patients without abnormally low white blood cell count),
Croatian: • kandidemiju (drugu vrstu gljivične infekcije uzrokovanu vrstama iz roda Candida) u bolesnika bez neutropenije (bolesnika s neuobičajeno malim brojem bijelih krvnih stanica),
English: The major metabolite of voriconazole is the N-oxide, which accounts for 72 % of the circulating radiolabelled metabolites in plasma.
Croatian: Glavni metabolit vorikonazola je N-oksid, koji čini 72% radioaktivno obilježenih metabolita koji cirkuliraju u plazmi.
English: - Reminds patients to take steps to minimize the risk of skin reactions and skin SCC (by avoiding exposure to direct sunlight, use of a sunscreen and protective clothing) and inform HCPs if they experience relevant skin abnormalities.
Croatian: - Podsjeća bolesnike na poduzimanje koraka radi umanjivanja rizika od kožnih reakcija i SCC kože (izbjegavanje izravnog izlaganja suncu, upotreba sredstava za sunčanje i zaštitne odjeće) te da informiraju zdravstvene radnike ako se pojave znatne promjene na koži.
English: Not studied clinically.
Croatian: Interakcija nije klinički ispitana.
English: Elderly No dose adjustment is necessary for elderly patients (see section 5.2).
Croatian: Nije potrebno prilagođavati dozu u starijih bolesnika (vidjeti dio 5.2).
English: • Serious dermatological adverse reactions (including SCC)
Croatian: • Ozbiljne kožne nuspojave (uključujući SCC)
English: On the basis of the high oral bioavailability (96 %; see section 5.2), switching between intravenous and oral administration is appropriate when clinically indicated.
Croatian: S obzirom na visoku bioraspoloživost lijeka nakon peroralne primjene (96%; vidjeti dio 5.2.), moguće je prelaziti s intravenske na peroralnu primjenu i obrnuto kada je to klinički indicirano.
English: VORICONAZOLE HIKMA should be discontinued if premalignant skin lesions or squamous cell carcinoma are identified (see below the section under Long-term treatment).
Croatian: VORIKONAZOL HIKMA treba ukinuti ako se identificiraju premaligne lezije kože ili karcinom skvamoznih stanica (vidjeti odjeljak u nastavku Dugotrajno liječenje).
English: Voriconazole Hikma may cause blurring of vision or uncomfortable sensitivity to light.
Croatian: Hikma može uzrokovati zamagljen vid ili neugodnu preosjetljivost na svjetlost.
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 uobičajeni izgled stolice.
English: Symptoms appeared immediately upon initiating the infusion (see section
Croatian: Simptomi su se pojavili odmah po započinjanju infuzije (vidjeti dio 4.4).
English: It is estimated that, on average, increasing the oral dose from 200 mg twice daily to 300 mg twice daily leads to a 2.5-fold increase in exposure (AUCτ).
Croatian: Procjenjuje se da, u prosjeku, povećanje peroralne doze s 200 na 300 mg dvaput na dan dovodi do povećanja izloženosti lijeku (AUCτ) za 2,5 puta.
English: Patients, especially children, with risk factors for acute pancreatitis (e.g., recent chemotherapy, haematopoietic stem cell transplantation (HSCT)), should be monitored closely during voriconazole treatment.
Croatian: Bolesnike, pogotovo djecu, u kojih postoje faktori rizika za razvoj akutnog pankreatitisa (npr. nedavna kemoterapija, transplantacija hematopoetskih matičnih stanica) treba pomno nadzirati tijekom liječenja vorikonazolom.
English: Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows:
Croatian: Vorikonazol je antimikotik širokog spektra iz skupine triazola i namjenjen je za primjenu u odraslih i djece u dobi od 2 ili više godina u sljedećim indikacijama:
English: • serious fungal infections caused by Scedosporium sp. or Fusarium sp. (two different species of fungi).
Croatian: • ozbiljne gljivične infekcije uzrokovane vrstama iz rodova Scedosporium ili Fusarium (dva različita tipa gljivica).
English: The Investigator's assessment of successful outcome at each of these time points is shown in the following table.
Croatian: Procjena ispitivača o uspješnosti liječenja u svakoj od navedenih vremenskih točaka prikazana je u sljedećoj tablici:
English: Proven or probable IFIs developed in 7.5% (3/40) of patients during the first year after HSCT, including one candidemia, one scedosporiosis (both relapses of prior IFI), and one zygomycosis.
Croatian: Dokazane ili vjerojatne invazivne gljivične infekcije nastale su u 7,5% (3/40) bolesnika tijekom prve godine nakon HSCT-a, uključujući jedan slučaj kandidemije, jedan slučaj scedosporioze (oba relapse prethodne invazivne gljivične infekcije) te jedan slučaj zigomikoze.