FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on the review of the data, at the time of the withdrawal, the CHMP had had some concerns and was of the provisional opinion that Faldaprevir Boehringer Ingelheim could not have been approved for the treatment of hepatitis C. The Committee had concerns regarding the starting materials used for the manufacture of the active substance.
Croatian: Na temelju pregleda podataka, u trenutku povlačenja CHMP je izrazio svoju zabrinutost oko određenih pitanja te je njegovo privremeno mišljenje bilo da nije moguće dati odobrenje za lijek Faldaprevir Boehringer Ingelheim za liječenje hepatitisa C.
English: How is Faldaprevir Boehringer Ingelheim expected to work?
Croatian: Kako je Faldaprevir Boehringer Ingelheim trebao djelovati?
English: EMA/354906/2014
Croatian: Boehringer Ingelheim (faldaprevir) EMA/445616/2014
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: Oral Contraceptives*
Croatian: Oralni kontraceptivi*
English: Date of latest renewal: 8th February 2018
Croatian: Datum posljednje obnove odobrenja: 8. veljače 2018
English: [Mechanism of interaction]
Croatian: [Mehanizam interakcije]
English: • Existing symptomatic arrhythmias.
Croatian: • postojeće simptomatske aritmije.
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: Currently available data are described in sections 4.8 and 5.1 but no recommendation on a posology can be made.
Croatian: Do sada dostupni podaci opisani su u dijelovima 4.8 i 5.1, međutim nije moguće dati preporuke za doziranje.
English: • Sinus bradycardia.
Croatian: • sinusna bradikardija.
English: Dosage adjustment (Adults)
Croatian: Prilagodba doze (Odrasli)
English: This leaflet was last approved in {MM/YYYY}.
Croatian: Ova uputa je zadnji puta revidirana u {MM/GGGG}
English: Clinical experience Successful outcome in this section is defined as complete or partial response.
Croatian: Pozitivan ishod u ovom je odjeljku definiran kao potpun ili djelomičan odgovor.
English: • Cardiomyopathy, in particular when heart failure is present.
Croatian: • kardiomiopatija, posebice ako je prisutno i zatajivanje srca.
English: Of these 7 patients, 3 had eye, 1 had sinus, and 3 had disseminated infection.
Croatian: Od 7 navedenih bolesnika, 3 su imala infekciju oka, 1 sinusa, a u 3 je bolesnika infekcija bila diseminirana.
English: Women of child-bearing potential must always use effective contraception during treatment.
Croatian: Žene reproduktivne dobi uvijek moraju koristiti učinkovitu kontracepciju tijekom liječenja.
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: Reminds patients when and how to report relevant signs and symptoms of phototoxicity and skin cancer.
Croatian: - Podsjeća bolesnika kada i kako prijaviti značajne znakove i simptome fototoksičnosti i raka kože.
English: Children and adolescents Voriconazole Accord should not be given to children younger than 2 years of age.
Croatian: Djeca i adolescenti Voriconazole Accord se ne smije davati djeci mlađoj od 2 godine.
English: Contraindicated (see section 4.3)
Croatian: Kontraindicirana (vidjeti dio 4.3)
English: >R (Resistant)
Croatian: S (Osjetljivi) > R (Rezistentni)
English: Success was defined as the ability to continue study drug prophylaxis for 100 days after HSCT (without stopping for >14 days) and survival with no proven or probable IFI for 180days after HSCT.
Croatian: Uspjeh je definiran kao sposobnost nastavljanja profilakse ispitivanim lijekom 100 dana nakon HSCT-a (bez prekida >14 dana) i preživljenje bez dokazane ili vjerojatne invazivne gljivične infekcije 180 dana nakon HSCT-a.
English: Voriconazole Accord film-coated tablets are to be taken at least one hour before, or one hour following, a meal.
Croatian: Voriconazole Accord filmom obložene tablete moraju se uzimati najmanje jedan sat prije ili jedan sat nakon obroka.
English: Conventional studies of safety pharmacology, genotoxicity or carcinogenic potential did not reveal a special hazard for humans.
Croatian: Standardna ispitivanja sigurnosne farnakologije, genotoksičnosti odnosno kancerogenosti nisu otkrila poseban rizik za ljude.
English: How to take Voriconazole Accord Always take this medicine exactly as your doctor has told you.
Croatian: Kako uzimati Voriconazole Accord Uvijek uzmite ovaj lijek točno onako kako Vam je rekao Vaš liječnik.
English: For prophylaxis use, dose adjustments are not recommended in the case of lack of efficacy or treatment-related adverse events.
Croatian: Pri upotrebi u profilaksi, prilagodba doze se ne preporučuje u slučaju izostanka djelotvornosti ili štetnih događaja povezanih s liječenjem.
English: Prophylaxis in adults and children
Croatian: Profilaksa u odraslih i djece
English: Do not take Voriconazole Accord If you are allergic to voriconazole or any of the other ingredients of this medicine (listed in section 6).
Croatian: Nemojte uzimati Voriconazole Accord Ako ste alergični na vorikonazol ili neki drugi sastojak ovog lijeka (naveden u dijelu 6).
English: Voriconazole was shown to be effective against the following rare fungal pathogens:
Croatian: Vorikonazol se pokazao djelotvornim protiv sljedećih rijetkih patogenih gljivca:
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Voriconazole Accord if:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego uzmete Voriconazole Accord:
English: It is important to cover sun exposed areas of skin and use sunscreen with high sun protection factor (SPF),, as an increased sensitivity of skin to the sun's UV rays can occur.
Croatian: Važno je da pokrijete područja kože izložena suncu i koristite sredstvo za zaštitu od sunca s visokim zaštitnim faktorom (SPF) jer može doći do pojačane osjetljivosti kože na sunčeve UV zrake.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 16 May 2013
Croatian: Datum prvog odobrenja:16. svibnja 2013.
English: Voriconazole Accord may cause blurring of vision or uncomfortable sensitivity to light.
Croatian: Voriconazole Accord može uzrokovati zamagljen vid ili neugodnu preosjetljivost na svjetlost.
English: Continue taking Voriconazole Accord until your doctor tells you to stop.
Croatian: Nastavite uzimati Voriconazole Accord sve dok Vam liječnik ne kaže da prestanete.
English: The following instructions apply to both treatment and prophylaxis
Croatian: Sljedeće informacije odnose se i na liječenje i na profilaksu
English: Clinical studies examining QTc interval
Croatian: Klinička ispitivanja u kojima je ispitivan QTc-interval
English: 4.7 Effects on ability to drive and use machines Voriconazole Accord has moderate influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Voriconazole Accord umjereno utječe na sposobnost upravljanja vozilima i rada na strojevima.
English: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacioalnim propisima.
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: Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom
Croatian: Accord Healthcare Limited, Sage House, 319 Pinner road, North Harrow, Middlesex, HA1 4HF, Ujedinjeno Kraljevstvo
English: Please 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, nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove, uključujući i one koje ste nabavili bez recepta.
English: It is important to take your Voriconazole Accord tablets regularly at the same time each day.
Croatian: Važno je da Voriconazole Accord tablete uzimate redovito, svakog dana u isto vrijeme.
English: Ritonavir (protease inhibitor)
Croatian: Ritonavir (inhibitor proteaze)
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 dobijete poremećaje kože opisane u prethodnom tekstu, Vaš liječnik Vas može uputiti dermatologu, koji nakon konzultacija može odlučiti da je važno da redovito dolazite na kontrole.
English: If you or your child are taking Voriconazole Accord for prevention of fungal infections, your doctor may stop giving Voriconazole Accord if you or your child develop treatment related side effects.
Croatian: Ako Vi ili Vaše dijete uzimate Voriconazole Accord za prevenciju gljivičnih infekcija, liječnik Vam može prestati davati Voriconazole Accord ako Vi ili Vaše dijete razvijete nuspojave povezane s liječenjem.
English: Your doctor should monitor the function of your liver and kidney by doing blood tests.
Croatian: Vaš liječnik Vam mora pratiti funkciju Vaše jetre i bubrega putem krvnih pretraga.
English: The recommended dose for adults (including elderly patients) is as follows: Tablets Patients 40 kg and above Patients less than 40 kg
Croatian: Preporučena doza za odrasle (uključujući starije bolesnike) je kako slijedi: Tablete Bolesnici tjelesne težine 40 kg i više
English: Successful response to voriconazole therapy was seen in 16 (6 complete, 10 partial responses) of 28 patients with S. apiospermum and in 2 (both partial responses) of 7 patients with S. prolificans infection.
Croatian: Pozitivan odgovor na liječenje vorikonazolom postignut je u 16 (6 potpunih, 10 djelomičnih odgovora) od 28 bolesnika s infekcijom uzročnika S. apiospermum te u 2 (oba djelomična odgovora) od 7 bolesnika s infekcijom uzročnika S. prolificans.
English: • inflammation)
Croatian: • upale)
English: Astemizole, cisapride, pimozide, quinidine and terfenadine
Croatian: Astemizol, cisaprid, pimozid, kinidin i terfenadin
English: Neoplasms benign, malignant and unspecified (including cysts and polyps)
Croatian: Dobroćudne, zloćudne i nespecificiran e novotvorine (uključujući ciste i polipe)
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
English: The major metabolite of voriconazole is the N-oxide, which accounts for 72% of the circulating radiolabeled metabolites in plasma.
Croatian: Glavni metabolit vorikonazola je N-oksid, koji čini 72% radioaktivno obilježenih metabolita koji cirkuliraju u plazmi.
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: Therefore unless your doctor instructs you to stop treatment, it is important to keep taking Voriconazole Accord correctly, as described above.
Croatian: Stoga je, ako Vam liječnik nije rekao da prekinete liječenje, važno da Voriconazole Accord uzimate na pravilan način, kako je prethodno opisano.
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 may also be available as powder for solution for infusion, powder and solvent for solution for infusion and powder for oral suspension, however not under this tradename.
Croatian: Vorikonazol može biti dostupan i kao prašak za otopinu za infuziju, prašak i otapalo za otopinu za infuziju te prašak za oralnu suspenziju, ali ne pod ovim zaštićenim nazivom.
English: Serious side effects - Stop taking Voriconazole Accord and see a doctor immediately - Rash - Jaundice; Changes in blood tests of liver function - Pancreatitis
Croatian: Ozbiljne nuspojave - prestanite uzimati Voriconazole Accord i odmah se javite liječniku - osip - žutica; promjene jetrenih funkcija u krvnim pretragama - pankreatitis (upala gušterače).
English: Voriconazole Accord should be discontinued if premalignant skin lesions or squamous cell carcinoma are identified (see below the section under Long-term treatment).
Croatian: Voriconazole Accord treba ukinuti ako se identificiraju premaligne lezije kože ili karcinom skvamoznih stanica (vidjeti u nastavku pod Dugotrajno liječenje).
English: Omeprazole (40 mg QD)*
Croatian: Omeprazol (40 mg QD)*
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, nepravilane otkucaje srca, usporene otkucaje srca ili nepravilnost u elektrokardiogramu (EKG) koja se naziva „sindrom produljenog QTc-intervala“.
English: Clinical management should include laboratory evaluation of hepatic function (specifically AST and ALT) at the initiation of treatment with Voriconazole Accord and at least weekly for the first month of treatment.
Croatian: Kliničko zbrinjavanje treba uključivati laboratorijsku procjenu funkcije jetre (osobito AST-a i ALT-a) na samom početku uzimanja lijeka Voriconazole Accord i zatim barem svaki tjedan tijekom prvog mjeseca uzimanja.
English: Contact your doctor immediately if you become pregnant while taking Voriconazole Accord.
Croatian: Odmah se javite svom liječniku ako zatrudnite za vrijeme uzimanja lijeka Voriconazole Accord.
English: • serious fungal infections caused by Scedosporium sp.or Fusarium sp. (two different species of fungi).
Croatian: • teške gljivične infekcije uzrokovane vrstama iz rodova Scedosporium ili Fusarium (dva različita tipa gljivica).
English: In addition Voriconazole Accord has been associated with phototoxicity including reactions such as ephelides, lentigo, actinic keratosis and pseudoporphyria.
Croatian: Uz to, Voriconazole Accord se povezuje s fototoksičnošću, uključujući reakcije kao što su pjege, lentigo, aktinička keratoza i pseudoporfirija.
English: The safety of voriconazole was investigated in 288 paediatric patients aged 2 to <12 years (169) and 12 to<18 years (119) who received voriconazole for prophylaxis (183) and therapeutic use (105) in clinical trials.
Croatian: Sigurnost vorikonazola ispitana je u 288 pedijatrijskih bolesnika u dobi od 2 do < 12 godina (169) i 12 do <18 godina (119) koji su primili vorikonazol kao profilaksu (183) ili terapiju (105) u kliničkim ispitivanjima.
English: If you have liver disease, your doctor may prescribe a lower dose of Voriconazole Accord.
Croatian: Ako imate bolest jetre, liječnik će Vam možda propisati nižu dozu lijeka Voriconazole Accord.
English: [UDP-glucuronyl transferase substrate]
Croatian: [supstrat UDP-glukuronil transferaze]
English: 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: Dose reduction of NSAIDs may be needed.
Croatian: Možda će biti potrebno smanjiti dozu NSAR-a.
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 Accord 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 lijekom Voriconazole Accord.
English: What Voriconazole Accord is and what it is used for
Croatian: Što je Voriconazole Accord i za što se koristi
English: Hypromellose Titanium dioxide (E171) Lactose monohydrate Triacetin
Croatian: Film ovojnica hipromeloza titanijev dioksid (E171) laktoza hidrat triacetin
English: • candidaemia (another type of fungal infection due to Candida sp) in non-neutropenic patients (patients without abnormally low white blood cells count),
Croatian: • kandidemiju (drugu vrstu gljivične infekcije uzrokovanu vrstama iz roda Candida) u bolesnika bez neutropenije (bolesnika bez abnormalno sniženog broja bijelih krvih stanica),
English: Serious refractory Candida infections
Croatian: Teške refraktorne infekcije gljivicom Candida
English: Extended and frequent monitoring for respiratory depression and other opiate associated adverse reactions is recommended.
Croatian: Preporučuju se opsežne i česte kontrole zbog moguće depresije disanja i drugih nuspojava povezanih s opijatima.
English: Based on the population pharmacokinetic analysis, 12 to 14 year old adolescents weighing less than 50 kg should receive children's doses (sees ection4.2).
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: In the 22 patients less than 2 years old who received voriconazole in a compassionate use programme, the following adverse reactions (for which a relationship to voriconazole could not be excluded) were reported: photosensitivity reaction (1), arrhythmia (1), pancreatitis(1), blood bilirubin increased (1), hepatic enzymes increased (1), rash (1) and papilloedema (1).
Croatian: U 22 bolesnika mlađa od 2 godine koja su dobivala vorikonazol u okviru programa milosrdne primjene lijeka zabilježene su sljedeće nuspojave (za koje se nije mogla isključiti povezanost s vorikonazolom): reakcija fotoosjetljivosti (1), aritmija (1), pankreatitis (1), povišenje vrijednosti bilirubina u krvi (1), povišenje vrijednosti jetrenih enzima (1), osip (1), papiloedem (1).
English: Voriconazole Accord must not be taken during pregnancy, unless indicated by your doctor.
Croatian: Voriconazole Accord se ne smije uzimati tijekom trudnoće osim ako Vaš liječnik nije tako odlučio.
English: The visual impairments were generally mild, rarely resulted in discontinuation and were not associated with long-term sequelae.
Croatian: Poremećaji vida su uglavnom bili blagi, rijetko su doveli do prekida primjene lijeka i nisu bili povezani s dugoročnim posljedicama.
English: The recommended doses in children and adolescent patients are based on a population pharmacokinetic analysis of data obtained from 112 immunocompromised paediatric patients aged 2 to <12 years and 26 immunocompromised adolescent patients aged 12to <17 years.
Croatian: Preporučene doze u djece i adolescenata temelje se na populacijskoj farmakokinetičkoj analizi podataka prikupljenih u 112 imunokompromitiranih pedijatrijskih bolesnika u dobi od 2 do < 12 godina i 26 imunokompromitiranih adolescentnih bolesnika u dobi 12 do < 17 godina.
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-a 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: What Voriconazole Accord is and what it is used for What you need to know before you take Voriconazole Accord How to take Voriconazole Accord Possible side effects
Croatian: Što je Voriconazole Accord i za što se koristi Što morate znati prije nego počnete uzimati Voriconazole Accord Kako uzimati Voriconazole Accord Moguće nuspojave
English: Scedosporium and Fusarium infections
Croatian: Infekcije uzročnicima Scedosporium i Fusarium
English: • Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, delavirdine, nevirapine) (used for treating HIV) (some doses of efavirenz can NOT be taken at the same time as Voriconazole
Croatian: • nenukleozidne inhibitore reverzne transkriptaze (npr. efavirenz, delavirdin, nevirapin) (koriste se za liječenje HIV-a) (neke doze efavizina se NE SMIJU uzimati istovremeno s lijekom
English: In 10 therapeutic studies, the median for the average and maximum plasma concentrations in individual subjects across the studies was 2425 ng/ml (inter-quartile range 1193 to 4380 ng/ml) and 3742 ng/ml (inter-quartile range 2027 to 6302 ng/ml), respectively.
Croatian: U 10 ispitivanja s terapijskom primjenom lijeka medijan prosječnih plazmatskih koncentracija u pojedinačnih ispitanika u svim ispitivanjima bio je 2425 ng/ml (interkvartilni raspon od 1193 do 4380 ng/ml), dok je medijan maksimalnih plazmatskih koncentracija iznosio 3742 ng/ml (interkvartilni raspon od 2027 do 6302 ng/ml).
English: The safety profile of voriconazole in adults is based on an integrated safety database of more than 2,000 subjects (including 1,603 adult patients in therapeutic trials) and an additional 270 adults in prophylaxis trials.
Croatian: Sigurnosni profil vorikonazola u odraslih temelji se na objedinjoj bazi podataka o sigurnosti primjene u više od 2000 ispitanika (uključujući 1603 odrasla bolesnika u terapijskim kliničkim ispitivanjima) i dodatnih 270 odraslih ispitanika u ispitivanjima profilakse.
English: In children experiencing photoaging injuries such as lentigines or ephelides, sun avoidance and dermatologic follow-up are recommended even after treatment discontinuation.
Croatian: U djece s lezijama uzrokovanim fotostarenjem, kao što su lentigo ili pjege, preporučuje se izbjegavanje sunca i dermatološki kontrolni pregledi čak i nakon prekida liječenja.
English: There is limited data on the safety of voriconazole in patients with abnormal liver function tests (aspartate transaminase [AST], alanine transaminase [ALT], alkaline phosphatase [ALP], or total bilirubin >5 times the upper limit of normal).
Croatian: Podaci o sigurnosti vorikonazola u bolesnika s abnormalnim testovima funkcije jetre (aspartat transaminaza [AST], alanin transaminaza [ALT], alkalna fosfataza [AP] ili ukupan bilirubin > 5 puta od gornje granice normalne vrijednosti) su ograničeni.
English: The 84-day survival rate for voriconazole was statistically significantly higher than that for the comparator and a clinically and statistically significant benefit was shown in favour of voriconazole for both time to death and time to discontinuation due to toxicity.
Croatian: Udio 84-dnevnog preživljenja je kod primjene vorikonazola bio statistički značajno veći od onog kod primjene usporednog lijeka, a pokazala se i klinički i statistički značajna prednost vorikonazola s obzirom na vrijeme do nastupa smrti i vrijeme do prekida terapije zbog toksičnih učinaka lijeka.