FrancophonIA/ELRC3.0 huggingface dataset:
English: What are the risks associated with Cerdelga?
Croatian: Koji su rizici povezani s lijekom Cerdelga?
English: Cerdelga can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in the management of Gaucher disease.
Croatian: Lijek Cerdelga izdaje se samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju Gaucherove bolesti.
English: Gaucher disease is rare, and Cerdelga was designated an ‘orphan medicine' (a medicine used in rare diseases) on 4 December 2007.
Croatian: Gaucherova bolest je rijetka bolest, a lijek Cerdelga dobio je status lijeka za rijetku bolest 4. prosinca 2007.
English: What benefits of Cerdelga have been shown in studies?
Croatian: Koje su koristi od lijeka Cerdelga utvrđene u ispitivanjima?
English: How does Cerdelga work?
Croatian: Kako djeluje Cerdelga?
English: How is Cerdelga used?
Croatian: Kako se Cerdelga primjenjuje?
English: All patients who are prescribed Cerdelga will be provided with a patient alert card. All healthcare professionals who are expected to prescribe Cerdelga will be provided with a prescriber guide.
Croatian: Svim zdravstvenim radnicima za koje se očekuje da će propisivati lijek Cerdelga bit će dostavljen vodič za zdravstvene radnike.
English: For the full list of side effects reported for Cerdelga, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Cerdelga potražite u uputi o lijeku.
English: • Do not take a double dose to make up for a forgotten dose.
Croatian: • Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: 6-12 years
Croatian: 6-12 godina
English: DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
Croatian: DATUM PRVOG ODOBRENJA/DATUM OBNOVE ODOBRENJA
English: The required dose is determined using the following formula:
Croatian: Potrebna doza određuje se prema sljedećoj formuli:
English: Not known***
Croatian: Nepoznato***
English: This can be done either by leaving the vials at room temperature for about an hour, or by holding them in your hands for a few minutes.
Croatian: To možete postići tako da bočice ostavite na sobnoj temperaturi otprilike jedan sat ili držeći ih u ruci nekoliko minuta.
English: Currently available data are described in Sections 4.8and 5.2.
Croatian: Trenutno dostupni podaci opisani su u dijelovima 4.8 i 5.2. Starije osobe
English: Reconstitution and withdrawal must be carried out under aseptic conditions.
Croatian: Rekonstitucija i izvlačenje mora se provesti u aseptičkim uvjetima.
English: • Proceed with your next dose immediately and continue at regular intervals as advised by your doctor.
Croatian: • Odmah nastavite s primjenom sljedeće doze i nastavite u redovnim intervalima kako Vam je to savjetovao Vaš liječnik.
English: The injection/infusion rate should not exceed 6 ml per minute.
Croatian: Brzina injiciranja/infuzije ne smije premašiti 6 ml po minuti.
English: • you notice that the medicine stops working properly (bleeding is not stopped).
Croatian: • primijetite da je lijek prestao djelovati (krvarenje nije prestalo)
English: • your body weight (see also section “The following information is intended for healthcare professionals only”).
Croatian: • Vašoj tjelesnoj težini (pogledajte također dio “Sljedeće informacije namijenjene su samo zdravstvenim radnicima”).
English: -not applicable
Croatian: -nije primjenjivo
English: • the site and intensity of the bleeding
Croatian: • mjestu i intenzitetu krvarenja
English: - VWF produces delayed correction of the associated FVIII deficiency.
Croatian: - VWF uzrokuje odgođenu korekciju pridruženog manjka FVIII.
English: After reconstitution the chemical and physical in-use stability has been demonstrated for 8 hours at room temperature (below 25 °C).
Croatian: Nakon rekonstitucije kemijska i fizikalna stabilnost u uporabi dokazana je tijekom 8 sati na sobnoj temperaturi (ispod 25 °C).
English: This effect occurs immediately and is known to depend to a large extent on the level of polymerisation of the protein.
Croatian: Taj se učinak javlja odmah te se zna da je uvelike ovisan o razini polimerizacije proteina.
English: As Voncento contains both FVIII and VWF, it is important to know which factor you most need.
Croatian: S obzirom da Voncento sadrži FVIII i VWF važno je zapamtiti koji faktor vam je najviše potreban.
English: Not all pack sizes may be marketed.
Croatian: Na tržištu ne moraju biti dostupne sve veličine pakiranja.
English: Date of first authorisation: 12 August 2013 Date of latest renewal: 26 April 2018
Croatian: Datum posljednje obnove odobrenja: 26. travnja 2018.
English: What Voncento is and what it is used for
Croatian: Što je Voncento i za što se koristi
English: Of note, annualized bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Croatian: Napominjemo, godišnja stopa krvarenja (ABR) nije usporediva između različitih koncentrata faktora i između različitih kliničkih studija.
English: • If you are allergic to VWF or FVIII or any of the other ingredients of this medicine (listed in section 6).
Croatian: • Ako ste alergični na VWF ili FVIII na bilo koji sastojak ovog lijeka (naveden u dijelu 6.).
English: • your clinical condition
Croatian: • Vašem kliničkom statusu
English: parameter
Croatian: parametar
English: Draw air into an empty, sterile syringe.
Croatian: Uvucite zrak u praznu, sterilnu štrcaljku.
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Croatian: Trombin potom pretvara fibrinogen u fibrin i omogućuje stvaranje ugruška.
English: The vials must not be heated above body temperature (37 ºC).
Croatian: Bočice se ne smiju zagrijati iznad tjelesne temperature (37 °C).
English: The amount of VWF and FVIII you need to take and the duration of treatment depend on:
Croatian: Količina VWF-a i FVIII koju trebate uzeti i trajanje liječenja ovise o:
English: This also applies to any unknown or emerging viruses or other types of infections.
Croatian: To se također odnosi na bilo koje nepoznate ili novootkrivene viruse ili druge vrste infekcija.
English: An appropriate dose should be re-administered every 12 - 24 hours.
Croatian: Odgovarajuću dozu treba ponovno primijeniti svakih 12 do 24 sata.
English: Factor VIII level required (% or IU/dl)
Croatian: Potrebna razina faktora VIII (% ili IU/dl)
English: What Voncento looks like and contents of the pack
Croatian: Kako Voncento izgleda i sadržaj pakiranja
English: • Voncento must not be mixed with other medicines, diluents or solvents except those mentioned in section 6.
Croatian: • Voncento se ne smije miješati s drugim lijekovima, otopinama ili otapalima osim onih navedenih u odjeljku 6.
English: Talk to your doctor, nurse or pharmacist before taking Voncento.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Voncento.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta lijek treba odmah upotrijebiti.
English: Elderly No dose adjustment is necessary for the older people.
Croatian: Nije potrebna prilagodba doze za starije osobe.
English: Hypersensitivity (allergic reactions)
Croatian: Preosjetljivost (alergijske reakcije)
English: Without opening the vials, warm the Voncento powder and the liquid to room or body temperature.
Croatian: Bez otvaranja bočica zagrijte prašak Voncento i tekućinu na sobnu ili tjelesnu temperaturu.
English: The FVIII/VWF complex consists of two molecules (FVIII and VWF) with different physiological functions.
Croatian: Kompleks FVIII/VWF sastoji se od dvije molekule (FVIII i VWF) s različitim fiziološkim funkcijama.
English: Like all medicines, Voncento can cause side effects, although not everybody gets them.
Croatian: Kao i svi lijekovi, Voncento može uzrokovati nuspojave iako se neće javiti kod svakoga.
English: Take care not to get any blood in the syringe containing the product.
Croatian: Pazite da ne uvučete krv u štrcaljku koja sadrži lijek.
English: See leaflet for further information.
Croatian: Vidjeti uputu za daljnje informacije.
English: Experience in the treatment of pregnant or breast-feeding women is not available.
Croatian: Iskustva u liječenju trudnica ili dojilja nisu dostupna.
English: <6 years
Croatian: <6 godina
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Croatian: Sljedeća tablica može poslužiti kao smjernica za doziranje u epizodama krvarenja i kirurgiji:
English: Five cases of overdose have been reported from clinical trials.
Croatian: Pet slučajeva predoziranja uočeno je u kliničkim ispitivanjima.
English: PC: SN: NN:
Croatian: PC: SN:
English: Voncento contains approximately 128.2 mmol/l (2.95 mg/ml) of sodium.
Croatian: Voncento sadrži približno 128,2 mmol/l (2,95 mg/ml) natrija.
English: For safety with respect to transmissible agents, see section 4.4.
Croatian: Za sigurnosne podatke s obzirom na prijenosne agense vidjeti dio 4.4.
English: These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors.
Croatian: Ti inhibitori, posebno kada su u visokim razinama, zaustavljaju ispravno djelovanje liječenja, te ćete Vi ili Vaše dijete biti pod pažljivim praćenjem zbog mogućeg razvoja tih inhibitora.
English: Follow the directions given to you by your doctor.
Croatian: Pridržavajte se uputa koje Vam je dao liječnik.
English: No interaction of VWF and FVIII with other medicinal products have been studied.
Croatian: Nisu ispitivane interakcije VWF i FVIII s drugim lijekovima.
English: Your doctor should inform you of the early signs of hypersensitivity reactions.
Croatian: Vaš doktor Vas treba upoznati s prvim znakovima reakcija preosjetljivosti.
English: This is equivalent to 1.48% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 1,48 % preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
English: Minor surgery including tooth extraction
Croatian: Manja operacija uključujući vađenje zuba
English: See section 2 “Voncento contains sodium”.
Croatian: Vidjeti odlomak 2. „Voncento sadrži natrij“
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Croatian: Pojedini bolesnici mogu se razlikovati u svojim odgovorima na faktor VIII i iskazivati različite vrijednosti poluvijeka i oporavaka.
English: • The reconstituted product should preferably be used immediately.
Croatian: • Pripremljeni lijek treba po mogućnosti odmah upotrijebiti.
English: Furthermore patients may develop inhibitors to FVIII and VWF.
Croatian: Osim toga, bolesnici mogu razviti inhibitore na FVIII i VWF.
English: The marketing authorisation holder shall submit the first periodic safety update report for this product within six months following authorisation.
Croatian: Nositelj odobrenja za stavljanje lijeka u promet će prvo periodičko izvješće o neškodljivosti za ovaj lijek dostaviti unutar šest mjeseci nakon dobivanja odobrenja.
English: Catheter-related complications
Croatian: Komplikacije povezane s kateterom
English: The risk of developing inhibitors is correlated to the severity of the disease as well as exposure to factor VIII, this risk being highest within the first 50 exposure days but continues throughout life although the risk is uncommon.
Croatian: Rizik od razvijanja inhibitora u korelaciji je s težinom bolesti, kao i s izloženošću faktoru VIII, a najveći je unutar prvih 50 dana izloženosti no nastavlja se tijekom cijelog života iako je rizik rijetkost.
English: Lack of either factor means that blood does not clot as quickly as it should so there is an increased tendency to bleed.
Croatian: Manjak bilo kojeg faktora znači da se krv ne zgrušava dovoljno brzo pa postoji povećana sklonost krvarenju.
English: Let blood flow back to the end of the tube.
Croatian: Krv treba poteći prema kraju cjevčice.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Croatian: Doze bazirane na tjelesnoj težini mogu zahtijevati prilagodbu kod pothranjenih ili pretilih bolesnika.
English: You may develop an inhibitor (neutralising antibody) to VWF, in which case VWF will not work properly any more.
Croatian: Mogu nastati i inhibitorna (neutralizirajuća) antitijela na VWF; u tom slučaju VWF više neće djelovati kako treba.
English: • the severity of your disease
Croatian: • težini Vaše bolesti
English: Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Croatian: U svakoj grupi učestalosti, nuspojave su prikazane redoslijedom smanjenja ozbiljnosti.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Croatian: Slijedom navedenog, nositelj odobrenja će ta izvješća podnositi u skladu s referentnim popisom datuma EU (EURD popis) predviđenim člankom 107.c stavkom 7. Direktive 2001/83/EZ i objavljenim na europskom internetskom portalu za lijekove.
English: Inject/infuse the reconstituted solution slowly (at a rate not more than 6 ml per minute) into the vein following the instructions given to you by your doctor.
Croatian: Polako injicirajte/infundirajte rekonstituiranu otopinu (pri brzini ne većoj od 6 ml po minuti) u venu pridržavajući se uputa koje ste dobili od liječnika.
English: • Do not use this medicine after the expiry date, which is stated on the label and carton.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na naljepnici i kutiji.
English: If you have been prescribed Voncento to use at home, your doctor will make sure that you are shown how to inject it and how much to use.
Croatian: Ako Vam je Voncento propisan za primjenu kod kuće, Vaš liječnik će se pobrinuti da Vam se objasni kako ćete si davati injekciju i u kojoj količini.
English: Preclinical studies with repeated dose applications (chronic toxicity, carcinogenicity and mutagenicity) cannot be reasonably performed in conventional animal models due to the development of antibodies following the application of heterologous human proteins.
Croatian: Pretklinička ispitivanja s primjenama ponovljenih doza (kronične toksičnosti, kancerogenosti, mutagenosti) ne mogu se prikladno provesti na standardnim životinjskim modelima zbog razvoja protutijela nakon primjene heterolognih ljudskih proteina.
English: Check yourself for any side effects that might happen straight away.
Croatian: Provjerite imate li nuspojave koje bi se mogle pojaviti odmah.
English: Treatment of bleeding
Croatian: Liječenje krvarenja
English: Allow the vials to dry before opening the Mix2Vial package (which contains the filter transfer device), then follow the instructions given below.
Croatian: Pustite da se bočice osuše prije nego što otvorite pakiranje Mix2Vial (koji sadrži prijenosni uređaj s filtrom), a potom se pridržavajte uputa u nastavku.
English: Based on the rare occurrence of haemophilia A in women, experience regarding the treatment during pregnancy and breastfeeding is not available.
Croatian: Na temelju rijetke pojavnosti hemofilije A u žena nisu dostupna iskustva u vezi s liječenjem tijekom trudnoće i dojenja.
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Croatian: Općenito, sve bolesnike liječene lijekovima koji sadrže koagulacijski faktor VIII potrebno je pažljivo pratiti na razvoj inhibitora pomoću odgovarajućih kliničkih pregleda i laboratorijskih testova.
English: In case of shock, the current medical standards for shock treatment should be observed.
Croatian: U slučaju šoka treba primijeniti važeće medicinske mjere za liječenje šoka.
English: • Do not store above 25 °C.
Croatian: • Ne čuvati na temperaturi iznad 25 °C.
English: • Any unused product or waste material should be disposed of in accordance with local requirements and as instructed by your doctor.
Croatian: • Bilo koji neiskorišteni lijek ili otpadni materijal treba zbrinuti u skladu s lokalnim zahtjevima te prema uputama liječnika.
English: Voncento should be administered to pregnant or breast-feeding VWF deficient women only if clearly indicated, taking into consideration that delivery confers an increased risk of haemorrhagic events in these patients.
Croatian: Voncento treba davati trudnicama ili dojiljama s manjkom VWF samo ako je to jasno indicirano, uzimajući u obzir da porođaj predstavlja povećani rizik od hemoragijskih događaja u tih bolesnica.
English: If this happens your or your child's medicines may stop working properly and you or your child may experience persistent bleeding.
Croatian: U tom slučaju Vaš lijek ili lijek Vašeg dijeteta može prestati ispravno djelovati, a kod Vas ili Vašeg djeteta može se javiti krvarenje koje ne prestaje.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Croatian: Standardne mjere za sprječavanje infekcija koje su posljedica uporabe lijekova dobivenih iz ljudske krvi ili plazme uključuju odabir davatelja, testiranja pojedinačnih donacija i pulova plazme na markere infekcije i uključivanje djelotvornih koraka proizvodnje za deaktivaciju/uklanjanje virusa.
English: MedDRA Standard System Organ Class
Croatian: MedDRA standardna klasifikacija organskih sustava
English: The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre posing less of a risk of insufficient clinical response than high titre inhibitors.
Croatian: Klinički značaj razvoja inhibitora ovisit će o titru inhibitora, pri čemu inhibitori s niskim titrom predstavljaju manji rizik za pojavu nedovoljnog kliničkog odgovora u odnosu na inhibitore s visokim titrom.
English: There are no data on fertility available.
Croatian: Plodnost Nema podataka o utjecaju na plodnost.
English: General instructions
Croatian: Opće upute
English: The pharmacokinetic data in patients with von Willebrand disease are very similar to those observed in the adult population.
Croatian: Farmakokinetički podaci za bolesnike s von Willebrandovom bolesti vrlo su slični podacima za odraslu populaciju.
English: Frequency of doses (hours) / Duration of therapy (days)
Croatian: Učestalost doziranja (sati) / trajanje liječenja (dani)
English: Your doctor should give you treatment to prevent thrombosis.
Croatian: Liječnik Vam treba dati lijekove za sprječavanje tromboze.
English: In some cases it may progress to a serious allergic reaction (anaphylaxis) that causes severe difficulty in breathing, dizziness or shock.
Croatian: U nekim slučajevima moguć je napredak do ozbiljne alergijske reakcije (anafilaksije) koja uzrokuje jako otežano disanje, omaglicu ili šok.
English: Your treatment should be monitored by a doctor who is experienced in the treatment of blood clotting disorders.
Croatian: Liječenje treba nadgledati liječnik s iskustvom u liječenju poremećaja zgrušavanja krvi.
English: Therefore, patients experiencing an anaphylactic reaction should be evaluated for the presence of an inhibitor.
Croatian: Stoga bolesnike koje imaju anafilaktične reakcije treba pregledati na prisutnost inhibitora.
English: Frequencies have been evaluated according to the following convention: 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
Croatian: Učestalost je razvrstana u skladu sa sljedećim kategorijama učestalosti: 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: By replacement therapy the plasma level of FVIII is increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendency.
Croatian: Zamjenskom terapijom povećava se plazmatska razina FVIII što omogućava privremenu korekciju manjka faktora i korekciju sklonosti krvarenju.
English: The patient should be observed for any immediate reaction.
Croatian: Bolesnika treba nadzirati zbog moguće pojave neposredne reakcije.
English: If you use more Voncento than you should
Croatian: Ako primijenite više lijeka Voncento nego što ste trebali
English: For prevention of excessive bleeding during or after surgery the application should start 1 - 2 hours before the surgical procedure.
Croatian: Za prevenciju prekomjernog krvarenja tijekom ili nakon kirurškog zahvata primjenu treba započeti 1 - 2 sata prije samog zahvata.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Croatian: Ako se pojave simptomi preosjetljivosti bolesnicima treba savjetovati da odmah prekinu uporabu lijeka i obrate se svom liječniku.
English: Haemophilia A
Croatian: Hemofilija A
English: The frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Croatian: Učestalost primjene treba uvijek određivati prema kliničkoj učinkovitosti u pojedinom slučaju.
English: • The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medicines.
Croatian: • Stvaranje inhibitora (antitijela) poznata je komplikacija koja se može pojaviti tijekom liječenja bilo kojim lijekom koji sadrži faktor VIII.
English: Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia).
Croatian: Infekcije parvovirusom B19 mogu biti ozbiljne za trudnice (fetalna infekcija) i za osobe s imunodeficijencijom ili povećanom eritropoezom (primjerice, hemolitička anemija).
English: • The powder must be mixed with the solvent (liquid) and withdrawn from the vial under aseptic conditions.
Croatian: • Prašak treba promiješati s otapalom (tekućinom) te izvući iz bočice u aseptičkim uvjetima.
English: If your doctor thinks you could administer Voncento yourself, appropriate instructions will be provided to you by your doctor.
Croatian: Voncento sebi mogli davati sami, dobit ćete odgovarajuće upute od svog liječnika.
English: • for individuals with a weakened immune system or with an increased production of red blood cells due to certain types of anaemia (e.g. sickle cell anaemia or haemolytic anaemia).
Croatian: • za osobe s oslabljenim imunološkim sustavom ili povećanim stvaranjem eritrocita zbog određenih tipova anemije (primjerice anemija srpastih stanica ili hemolitička anemija).
English: The reconstituted preparation should be injected/infused slowly intravenously at a rate comfortable for the patient.
Croatian: Rekonstituirani lijek treba injicirati/infundirati polako intravenski pri brzini koja odgovara bolesniku.
English: The listed warnings and precautions apply to children and adolescents.
Croatian: Navedena upozorenja i mjere opreza odnose se na djecu i adolescente.
English: Pharmacotherapeutic group: antihaemorrhagics,blood coagulation factors, von Willebrand factor and coagulation factor VIII in combination, ATC code: B02BD06
Croatian: Farmakoterapijska skupina: Antihemoragici: Faktori zgrušavanja krvi, kombinacija von Willebrandova faktora i koagulacijskog faktora VIII, ATK oznaka: B02BD06
English: It is important to calculate the dose using the number of IU of FVIII:C specified.
Croatian: Važno je izračunati dozu uporabom broja IU navedenog FVIII:C.