FrancophonIA/ELRC3.0 huggingface dataset:
English: • Check the name, strength and colour of the package to make sure it contains the correct product.
Croatian: • Provjerite naziv, jačinu i boju na pakiranju kako biste bili sigurni da sadrži odgovarajući lijek.
English: Check with your doctor if you are not sure about how to use Esperoct.
Croatian: Provjerite s liječnikom ako niste sigurni kako primijeniti lijek Esperoct.
English: • headache, nausea or vomiting.
Croatian: • glavobolja, mučnina ili povraćanje.
English: The safety and efficacy of Esperoct in previously untreated patients have not yet been established.
Croatian: Sigurnost i djelotvornost lijeka Esperoct u prethodno neliječenih bolesnika još nisu ustanovljene.
English: This corresponds to a higher volume of distribution per kilo body weight in children compared to adults (table 4).
Croatian: To odgovara većem volumenu distribucije po kilogramu tjelesne težine u djece u usporedbi s odraslima (tablica 4).
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Croatian: To je osobito važno kada se mijenja laboratorij i/ili testni reagens.
English: Nine of these patients reverted back to prophylaxis every 4 days during the randomised study phase.
Croatian: Devet od tih bolesnika vratilo se na profilaksu svaka 4 dana tijekom randomizirane faze ispitivanja.
English: Do not use Esperoct if either of the above applies to you.
Croatian: Nemojte primijeniti Esperoct ako se nešto od gore navedenog odnosi na Vas.
English: Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connections.
Croatian: Oprez: Napunjena štrcaljka izrađena je od stakla i oblikovana da bude kompatibilna sa standardnim luer-lock nastavcima.
English: * PTPs: Previously-treated patients.
Croatian: * PTP: Prethodno liječeni bolesnici.
English: If you are not sure, talk to your doctor before using this medicine.
Croatian: Ako niste sigurni, obratite se svom liječniku prije nego primijenite ovaj lijek.
English: • redness and/or swelling of the lips, tongue, face or hands
Croatian: • crvenilo i/ili oticanje usana, jezika, lica ili šaka
English: Do not reuse the equipment.
Croatian: Pribor nemojte ponovno koristiti.
English: • pale and cold skin, fast heartbeat, or dizziness (low blood pressure)
Croatian: • blijeda i hladna koža, ubrzani otkucaji srca ili omaglica (niski krvni tlak).
English: Do not throw it out with the ordinary household waste.
Croatian: Nemojte to baciti u običan kućni otpad.
English: Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
Croatian: Stoga se faktor VIII u trudnoći i tijekom dojenja smije primjenjivati samo ako za to postoje jasne indikacije.
English: From a microbiological point of view, the product should be used immediately.
Croatian: S mikrobiološkog stajališta, lijek se treba odmah primijeniti.
English: (pre- and post-operative)
Croatian: (prije i nakon zahvata)
English: Esperoct was effective in maintaining haemostasis during major surgery with a success rate of 95.6% in all major surgeries performed (43 out of 45 had the effect rated as ‘excellent‘ or ‘good‘).
Croatian: Esperoct je bio djelotvoran u održavanju hemostaze tijekom većih kirurških zahvata sa stopom uspješnosti od 95,6% u svim velikim kirurškim zahvatima (43 od 45 imala su učinak ocijenjen kao „odličan“ ili „dobar“).
English: Non-clinical data reveal no special concern for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije i toksičnosti ponovljenih doza.
English: Do not inject a double dose to make up for a forgotten dose.
Croatian: Nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
English: Heart disease
Croatian: Bolest srca
English: Repeat every 8 to 24 hours to maintain factor VIII activity within the target range
Croatian: Ponoviti svakih 8 do 24 sata za održavanje aktivnosti faktora VIII unutar ciljnog raspona
English: Factor VIII is a protein found in the blood that helps to prevent and stop bleeding.
Croatian: Faktor VIII je protein koji se nalazi u krvi, a pomaže spriječiti i zaustaviti krvarenje.
English: If you forget a dose, inject the missed dose as soon as you remember.
Croatian: Ako ste zaboravili primijeniti dozu, injicirajte propuštenu dozu čim se sjetite.
English: Animal reproduction studies have not been conducted with factor VIII.
Croatian: Nisu provedena ispitivanja reprodukcije na životinjama s faktorom VIII.
English: Spike (under protective paper)
Croatian: Šiljak (ispod zaštitnog papira)
English: Pharmacokinetic parameters
Croatian: Farmakokinetički parametri
English: Anti-PEG antibodies
Croatian: Anti-PEG protutijela
English: Consider to continue therapy for another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL)
Croatian: Razmotrite nastavak terapije idućih 7 dana za održavanje aktivnosti faktora VIII od 30% do 60% (IU/dl)
English: Repeat injection every 8 to 24 hours as necessary until adequate wound healing is achieved
Croatian: Ponoviti injekciju svakih 8 do 24 sata, po potrebi, dok se ne postigne prikladno zacjeljivanje rane
English: Follow the instructions for proper use for your connector and CVAD in consultation with your doctor or nurse.
Croatian: Slijedite upute o pravilnoj uporabi Vašeg konektora i CVAD-a u suradnji s liječnikom ili medicinskom sestrom.
English: 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: Učestalosti su procijenjene na sljedeći način: 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: Before reconstitution (before the powder is mixed with the solvent):
Croatian: Prije pripreme za primjenu (prije nego se prašak pomiješa s otapalom):
English: The product contains traces of hamster proteins, which in some patients may cause allergic reactions.
Croatian: Ovaj lijek sadrži proteine hrčka u tragovima, što u nekih bolesnika može izazvati alergijske reakcije.
English: What Esperoct looks like and contents of the pack
Croatian: Kako Esperoct izgleda i sadržaj pakiranja
English: Single dose or repeat injection every 24 hours for at least 1 day until healing is achieved
Croatian: Jednokratna doza ili ponoviti injekciju svakih 24 sata najmanje 1 dan do zacjeljenja.
English: The dose level and dosing intervals for surgery depend on the procedure and local practice.
Croatian: Razina doze i intervali doziranja za kirurški zahvat ovise o postupku i lokalnoj praksi.
English: If you stop using Esperoct, you may no longer be protected against bleeding or a current bleed may not stop.
Croatian: Ako prestanete primjenjivati lijek Esperoct, možda više nećete biti zaštićeni od krvarenja ili trenutno krvarenje možda neće prestati.
English: Other medicines and Esperoct
Croatian: Drugi lijekovi i Esperoct
English: When you prepare and inject medicine directly into a vein, it is important to use a clean and germ- free (aseptic) technique.
Croatian: Kada pripremate i injicirate lijek izravno u venu, važno je koristiti čistu tehniku bez mikroorganizama (aseptička tehnika).
English: If you have previously received more than 150 days of treatment with factor VIII, inhibitors (antibodies) may develop (may affect up to 1 in 100 people).
Croatian: Ako ste ranije, više od 150 dana liječenja, primali lijekove koji sadrže faktor VIII, mogu se razviti inhibitori (antitijela) (mogu se javiti do 1 na 100 osoba).
English: This will depend on your body weight and whether it is used to prevent or to treat a bleeding.
Croatian: Ona će ovisiti o Vašoj tjelesnoj težini i o tome koristi li se lijek za sprječavanje ili liječenje krvarenja.
English: Patients received a single dose of 50 IU/kg, and blood samples were collected prior to dosing and at multiple time points up to 96 hours after dosing.
Croatian: Bolesnici su primili jednu dozu od 50 IU/kg, a uzorci krvi prikupljeni su prije doziranja i u više navrata do 96 sati nakon doziranja.
English: Your doctor may choose another dose or how often the injections should be given, based on your need.
Croatian: Vaš liječnik može odabrati drugu dozu ili učestalost primjene injekcije, ovisno o Vašoj potrebi.
English: In children below 12 years long-term safety has not been established.
Croatian: U djece mlađe od 12 godina sigurnost dugotrajne primjene nije ustanovljena.
English: Of the 175 adults/adolescents on prophylaxis, 70 (40%) did not have any bleeds.
Croatian: Od 175 odraslih/adolescenata na profilaksi, 70 (40%) nije imalo nikakvih krvarenja.
English: Pharmacotherapeutic group: antihemorrhagics, blood coagulation factor VIII, ATC code: B02BD02.
Croatian: Farmakoterapijska skupina: antihemoragici, krvni koagulacijski faktor VIII, ATK oznaka: B02BD02.
English: Esperoct is available in packs containing 500 IU, 1000 IU, 1500 IU, 2000 IU, or 3000 IU.
Croatian: Esperoct je dostupan u pakiranjima koja sadrže 500 IU, 1000 IU, 1500 IU, 2000 IU ili 3000 IU.
English: Of the 68 children below 12 years on prophylaxis, 29 (42.6%) did not have any bleeds.
Croatian: Od 68 djece mlađe od 12 godina na profilaksi, 29 (42,6%) nije imalo nikakvih krvarenja.
English: Prophylaxis in children (below 12 years)
Croatian: Profilaksa u djece (mlađe od 12 godina)
English: Wide top end
Croatian: Široki gornji dio
English: Plastic cap
Croatian: Plastična kapica
English: The overall success rate for the treatment of bleeds was 87.7% and 94.4% of all bleeds treated with 1-2 injections.
Croatian: Ukupna stopa uspjeha za liječenje krvarenja bila je 87,7% i 94,4% svih krvarenja liječenih s 1-2 injekcije.
English: • Injecting into a CVAD may require using a sterile 10 mL plastic syringe for withdrawal of the reconstituted solution.
Croatian: • Injiciranje u CVAD možda će zahtijevati uporabu sterilne plastične štrcaljke od 10 ml za uvlačenje pripremljene otopine.
English: Stop the injection immediately if you develop severe and sudden allergic reactions (anaphylactic reactions).
Croatian: Odmah prekinite injiciranje ako razvijete teške i iznenadne alergijske reakcije (anafilaktičke reakcije).
English: You must contact your doctor or an emergency unit immediately if you have signs of an allergic reaction such as:
Croatian: Odmah se obratite liječniku ili hitnoj medicinskoj službi ako imate znakove alergijske reakcije kao što su:
English: This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.
Croatian: To odgovara 1,5 % preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
English: If, at any point, there is air in the syringe, inject the air back into the vial.
Croatian: Ako se u bilo kojem trenutku u štrcaljki pojavi zrak, ubrizgajte ga natrag u bočicu.
English: Including tooth extraction
Croatian: Uključujući vađenje zuba
English: Once the product has been taken out of the refrigerator, the product must not be returned to the refrigerator.
Croatian: Kada se lijek jednom izvadi iz hladnjaka, lijek se ne smije ponovno vraćati u hladnjak.
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Croatian: Kompleks faktora VIII/von Willebrandova faktora sastoji se od dviju molekula (faktora VIII i von Willebrandova faktora) različitih fizioloških funkcija.
English: Thrombin then converts fibrinogen into fibrin and a clot can be formed.
Croatian: Trombin zatim pretvara fibrinogen u fibrin i tako omogućuje stvaranje krvnog ugruška.
English: Each reconstituted vial contains 30.5 mg of sodium (see section 4.4).
Croatian: Jedna rekonstituirana bočica sadrži 30,5 mg natrija (vidjeti dio 4.4).
English: Of note, annualized bleeding rate (ABR) is not comparable between different factor concentrates and between different clinical studies.
Croatian: Treba napomenuti kako anualizirana stopa krvarenja (ASK) nije usporediva između različitih koncentrata faktora niti između različitih kliničkih ispitivanja.
English: Overall, including all extensions parts, 31 of 61 patients on every 7 days prophylaxis switched back to every 4 days treatment.
Croatian: Sveukupno, uključujući sve nastavke ispitivanja, 31 od 61 bolesnika na profilaksi svakih 7 dana ponovno se vratilo na liječenje svaka 4 dana.
English: The single dose pharmacokinetic parameters determined after 28 weeks of prophylactic treatment with Esperoct were consistent with the initial pharmacokinetic parameters.
Croatian: Farmakokinetički parametri jednokratne doze određeni nakon 28 tjedana profilaktičkog liječenja lijekom Esperoct bili su u skladu s inicijalnim farmakokinetičkim parametrima.
English: • gauze pads and plasters.
Croatian: • gaze i flastere.
English: In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Croatian: Kako bi se poboljšala sljedivost bioloških lijekova, naziv i broj serije primijenjenog lijeka potrebno je jasno evidentirati.
English: If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.
Croatian: Ako za dozu trebate više od jedne bočice, ponovite korake A do J s dodatnim bočicama, nastavcima za bočicu i napunjenim štrcaljkama dok ne dobijete potrebnu dozu.
English: The single dose pharmacokinetic parameters are comparable between young children (0 to below 6 years) and older children (6 to below 12 years), and between adolescents (12 to17 years) and adults (18 years and above).
Croatian: Farmakokinetički parametri jednokratne doze usporedivi su među mlađom djecom (0 do manje od 6 godina) i starijom djecom (6 do manje od 12 godina) te među adolescentima (12 do 17 godina) i odraslima (18 godina i više).
English: Known allergic reaction to hamster protein.
Croatian: Poznata alergijska reakcija na proteine hrčka.
English: The frequency of doses and duration of therapy should always be individually adjusted based on individual clinical response.
Croatian: Učestalost doziranja i trajanje terapije uvijek treba individualno prilagoditi na temelju individualnog kliničkog odgovora.
English: This incompatibility may prevent administration of the medicine and result in damage to the needleless connector.
Croatian: Ova inkompatibilnost može onemogućiti primjenu lijeka i dovesti do oštećenja konektora za primjenu bez igle.
English: The vast majority of bleeds treated with Esperoct were of mild/moderate severity.
Croatian: Velika većina krvarenja liječenih lijekom Esperoct bila je blage/umjerene težine.
English: Esperoct can not be used in children below 12 years of age.
Croatian: Djeca Esperoct se ne smije primjenjivati u djece mlađe od 12 godina.
English: The rate of administration should be determined by the patient's comfort level over approximately 2 minutes.
Croatian: Brzina primjene treba se odrediti prema razini ugodnosti za bolesnika tijekom otprilike 2 minute.
English: Do not use the equipment without proper training from your doctor or nurse.
Croatian: Nemojte koristiti pribor ako niste s liječnikom ili medicinskom sestrom prošli odgovarajuću edukaciju.
English: (IU*hour/dL) CL (mL/hour/kg) Vss (mL/kg) MRT (hours)
Croatian: AUCinf (IU*sat/dl) CL (ml/sat/kg) Vss (ml/kg) MRT (sati)
English: If symptoms of hypersensitivity occur, patients should be advised to immediately discontinue the use of the medicinal product and contact their physician.
Croatian: Ako se pojave simptomi preosjetljivosti, bolesnicima se treba savjetovati da odmah prekinu primjenu lijeka i obrate se svom liječniku.
English: The equipment in this package is designed to reconstitute and inject Esperoct.
Croatian: Pribor u ovome pakiranju namijenjen je za pripremu i injiciranje lijeka Esperoct.
English: If you use more Esperoct than you should
Croatian: Ako primijenite više lijeka Esperoct nego što ste trebali
English: • Lightly squeeze the protective cap with your thumb and index finger as shown.
Croatian: • Lagano stisnite zaštitni omot palcem i kažiprstom kako je prikazano.
English: If this happens, you should contact your doctor immediately.
Croatian: U tom se slučaju morate odmah obratiti svom liječniku.
English: Treatment monitoring
Croatian: Nadziranje liječenja
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.
Croatian: Ako se ne postignu očekivane razine aktivnosti faktora VIII u plazmi ili ako se krvarenje ne može kontrolirati primjenom odgovarajuće doze, potrebno je provesti testiranje na prisutnost inhibitora faktora VIII.
English: Eleven patients developed transient low titre anti-PEG antibodies.
Croatian: Jedanaest bolesnika razvilo je prolazne niske titre anti-PEG protutijela.
English: In such cases, it is recommended that a specialised haemophilia centre is contacted.
Croatian: U takvim se slučajevima preporučuje kontaktirati specijalizirani centar za liječenje hemofilije.
English: Esperoct is now ready to be injected into your vein.
Croatian: Esperoct je sada spreman za injiciranje u venu.
English: • itching (pruritus)
Croatian: • svrbež (pruritus)
English: No difference in the safety profile was observed between previously treated adolescents (12-18 years) and adult patients.
Croatian: Nije primijećena razlika u sigurnosnom profilu između prethodno liječenih adolescenata (1218 godina) i odraslih bolesnika.
English: The listed warnings and precautions apply both to adults and adolescents (12-18 years).
Croatian: Navedena upozorenja i mjere opreza vrijede kako za odrasle tako i za adolescente (12-18 godina).
English: Three patients had transiently positive test results for anti-drug antibodies after administration of Esperoct but no correlation with adverse events could be established.
Croatian: Tri bolesnika su imala prolazno pozitivne rezultate ispitivanja protutijela na lijek nakon primjene lijeka Esperoct, ali nije ustanovljena korelacija sa štetnim događajima.
English: How much to use
Croatian: Koliko lijeka treba primijeniti
English: Of the total 1,126 bleeds, 86.9% were effectively treated with 1 injection and 96.8% were effectively treated with 1-2 injections of Esperoct.
Croatian: Od ukupno 1126 krvarenja, 86,9% bilo je učinkovito liječeno 1 injekcijom, a 96,8% bilo je učinkovito liječeno 1-2 injekcije lijeka Esperoct.
English: Esperoct is given as an injection into a vein (intravenously), see “Instructions on how to use Esperoct” for more information.
Croatian: Esperoct se daje u obliku injekcije u venu (intravenski), za više informacija pogledajte „Upute za uporabu lijeka Esperoct“.
English: In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Croatian: U bolesnika s prisutnim kardiovaskularnim faktorima rizika, nadomjesna terapija faktorom VIII može povećati kardiovaskularni rizik.
English: For storage at room temperature and storage conditions after reconstitution of the medicinal product, see section 6.3.
Croatian: Za čuvanje na sobnoj temperaturi i uvjete čuvanja nakon rekonstitucije lijeka vidjeti dio 6.3.
English: The reconstituted product should not be administered in the same tubing or container with other medicinal products.
Croatian: Rekonstituirani lijek se ne smije primjenjivati u istim cjevčicama ili spremnicima zajedno s drugim lijekovima.
English: Do not use any other way to warm the vial and pre-filled syringe.
Croatian: Ne koristite nikakav drugi način za zagrijavanje bočice i napunjene štrcaljke.
English: Store in the original package to protect from light
Croatian: Čuvati u originalnom pakiranju radi zaštite od svjetlosti
English: As expected incremental recovery appeared to be lower while body weight adjusted clearance appeared to be higher in children compared to adults and adolescents.
Croatian: Kako je i očekivano, prirast po jedinici doze bio je manji dok je klirens prilagođen prema tjelesnoj težini bio viši u djece u usporedbi s odraslima i adolescentima.
English: • Remove the plastic cap from the vial.
Croatian: • Uklonite plastičnu kapicu s bočice.
English: The use of Esperoct in children below 12 years is not indicated (see section 4.2 for information on paediatric use).
Croatian: Primjena lijeka Esperoct u djece mlađe od 12 godina nije indicirana (za informacije o primjeni u pedijatrijskoj populaciji vidjeti dio 4.2).
English: Clinical efficacy of Esperoct during major surgery
Croatian: Klinička djelotvornost lijeka Esperoct tijekom većih kirurških zahvata
English: The risk of developing inhibitors is correlated to the severity of the disease as well as the 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 razvoja inhibitora u korelaciji je s težinom bolesti, kao i s izloženošću faktoru VIII, i najveći je unutar prvih 50 dana izloženosti, ali je prisutan cijelog života, premda je manje čest.
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products or reconstituted with injection solutions other than the provided sodium chloride solvent.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima niti rekonstituirati otopinama za injekcije koje nisu priložena otopina natrijevog klorida.
English: • if you are allergic to hamster proteins.
Croatian: • ako ste alergični na proteine hrčka.
English: When including imputations, (replacing missing data for withdrawn patients with a substituted value) the estimated mean ABR for all bleeds was 3.70 (95% CI: 2.94;4.66).
Croatian: Kada su uključene imputacije (zamjena podataka koji nedostaju sa supstituiranom vrijednošću za bolesnike koji su prekinuli primjenu lijeka), procijenjena srednja vrijednost ASK-a za sva krvarenja iznosila je 3,70 (95% CI: 2,94; 4,66).
English: Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed.
Croatian: Vrlo je rijetko opažen razvoj protutijela na proteine hrčka i s time povezane reakcije preosjetljivosti.
English: The prophylactic effect of Esperoct was demonstrated with a dosing at 50 IU per kg body weight every 4 days or every 3-4 days (twice weekly) in 175 patients.
Croatian: Profilaktički učinak lijeka Esperoct dokazan je doziranjem od 50 IU po kg tjelesne težine svaka 4 dana ili svaka 3-4 dana (dva puta tjedno) u 175 bolesnika.
English: Do not mix Esperoct with any other intravenous injections or medicines.
Croatian: Esperoct se ne smije miješati s drugim intravenskim injekcijskim otopinama ili lijekovima.
English: If you have a catheter where medicines can be injected into your blood (central venous access device), you may develop infections or blood clots at the site of the catheter.
Croatian: Ako imate kateter preko kojega se lijekovi mogu injicirati u Vašu krv (centralni venski kateter), na mjestu postavljenog katetera mogu se razviti infekcije ili krvni ugrušci.
English: Abbreviations: AUC = area under the factor VIII activity time profile; t1/2 = terminal half-life; MRT = mean residence time; CL = clearance; Vss = volume of distribution at steady-state; IR = Incremental recovery.
Croatian: Kratice: AUC=površina pod vremenskim profilom aktivnosti faktora VIII; t1/2=terminalni poluvijek; MRT=srednja vrijednost vremena zadržavanja (engl. mean residence time); CL=klirens; Vss=volumen distribucije u stanju dinamičke ravnoteže (engl. volume of distribution at steady-state); IR=prirast po jedinici doze (engl. incremental recovery).
English: The reconstituted product must be injected into your vein (intravenous (IV) injection).
Croatian: Pripremljeni lijek mora biti injiciran u venu (intravenska (i.v.) injekcija).
English: • allergic reactions (hypersensitivity).
Croatian: • alergijske reakcije (preosjetljivost).