FrancophonIA/ELRC3.0 huggingface dataset:
English: If you experience that the effect of Esperoct is insufficient, talk to your doctor.
Croatian: Ako osjetite da učinak lijeka Esperoct nije dostatan, obratite se svom liječniku.
English: It must be clear and colourless and no particles should be visible.
Croatian: Mora biti bistra i bezbojna i ne smije sadržavati vidljive čestice.
English: What Esperoct is and what it is used for What you need to know before you use Esperoct How to use Esperoct
Croatian: Što je Esperoct i za što se koristi Što morate znati prije nego počnete primjenjivati Esperoct
English: • difficulty in swallowing or breathing
Croatian: • poteškoće pri gutanju ili otežano disanje
English: One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml of human plasma.
Croatian: Jedna internacionalna jedinica (IU) aktivnosti faktora VIII jednaka je količini faktora VIII u jednome ml ljudske plazme.
English: Post-authorisation safety study (PASS): In order to investigate the potential effects of PEG accumulation in the choroid plexus of the brain and other tissues/organs, the MAH should conduct and submit the results of a post-authorisation safety study according to an agreed protocol.
Croatian: Ispitivanje sigurnosti primjene lijeka nakon davanja odobrenja za stavljanje lijeka u promet (PASS): kako bi se ispitali mogući učinci nakupljanja PEG-a u koroidnom spletu mozga i drugim tkivima/organima, nositelj odobrenja treba provesti i predati rezultate ispitivanja sigurnosti primjene u skladu s dogovorenim planom ispitivanja.
English: After reconstitution (after the powder has been mixed with the solvent): Once you have reconstituted Esperoct, it should be used immediately.
Croatian: Nakon pripreme za primjenu (nakon što se prašak pomiješao s otapalom): Esperoct treba primijeniti odmah nakon što ste ga pripremili za primjenu.
English: • if you are allergic to the active substance or to any of the other ingredients of this medicine
Croatian: • ako ste alergični na djelatnu tvar ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: The patient had a factor VIII gene intron 22 inversion and was at a high risk of developing factor VIII inhibitors.
Croatian: Bolesnik je na genu za faktor VIII imao inverziju introna 22 te je imao visoki rizik za razvoj inhibitora faktora VIII.
English: In general, there was a trend of increasing incremental recovery and decreasing clearance (mL/h/kg) with age.
Croatian: Općenito je postojao trend povećanja prirasta po jedinici doze i smanjenja klirensa (ml/h/kg) s godinama.
English: A total of 55 of the 120 eligible patients chose to be randomised (17 to the every 4 days dosing and 38 to the 75 IU every 7 days).
Croatian: Ukupno 55 bolesnika od 120 podobnih bolesnika odabralo je randomizaciju (17 za doziranje svaka 4 dana, a 38 za 75 IU svakih 7 dana).
English: Rubber stopper (under plastic cap)
Croatian: Gumeni čep (ispod plastične kapice)
English: In total, 129 single-dose pharmacokinetic (PK) profiles of Esperoct were evaluated in 86 patients (including 24 paediatric patients of 0 to below 12 years).
Croatian: Procijenjeno je ukupno 129 farmakokinetičkih profila (PK) s jednokratnom dozom lijeka Esperoct u 86 bolesnika (uključujući 24 pedijatrijska bolesnika od 0 do manje od 12 godina).
English: After reconstitution with the supplied solvent (sodium chloride 9 mg/mL (0.9%) solution for injection), the prepared solution for injection contains 125, 250, 375, 500 or 750 IU turoctocog alfa pegol per mL, respectively (based on the strength of turoctocog alfa pegol, i.e. 500, 1000, 1500, 2000 or 3000 IU).
Croatian: Nakon pripreme s priloženim otapalom (0,9%-tna (9 mg/ml) otopina natrijeva klorida za injekciju), pripremljena otopina za injekciju sadrži 125, 250, 375, 500 ili 750 IU turoktokog alfa pegola po ml (u skladu s jačinom turoktokog alfa pegola, tj. jačinom od 500, 1000, 1500, 2000 ili 3000 IU).
English: After reconstitution the solution appears as a clear and colourless liquid free of visible particles.
Croatian: Nakon rekonstitucije otopina je bistra i bezbojna tekućina bez vidljivih čestica.
English: Frequency of doses (hours) Duration of therapy
Croatian: Učestalost doziranja (sati) Trajanje liječenja
English: The specific activity of turoctocog alfa pegol is approximately 9500 IU/mg protein.
Croatian: Specifična aktivnost turoktokog alfa pegola približno je 9500 IU/mg proteina.
English: • Check the expiry date.
Croatian: • Provjerite rok valjanosti.
English: The maximum single dose is 75 IU/kg.
Croatian: Maksimalna jednokratna doza je 75 IU/kg.
English: Consideration should be given to maintain a factor VIII activity at or above the target range.
Croatian: Potrebno je paziti da se aktivnost faktora VIII održava na ili iznad ciljnog raspona.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Croatian: Dozu određenu prema tjelesnoj težini možda će trebati prilagoditi u bolesnika premale ili prekomjerne tjelesne težine.
English: The ABR for randomised patients was 1.77 (0.59; 5.32) for treatment every 4 days and 3.57 (2.13; 6.00) for once weekly prophylaxis.
Croatian: ASK za randomizirane bolesnike iznosio je 1,77 (0,59; 5,32) za liječenje svaka 4 dana i 3,57 (2,13; 6,00) za profilaksu jednom tjedno.
English: There was one case of persistent anti-drug antibodies concomitant with the confirmed case of factor VIII inhibitors (see Factor VIII inhibitors).
Croatian: Pojavio se jedan slučaj perzistirajućih protutijela na lijek istodobno s potvrđenim slučajem razvoja inhibitora faktora VIII (vidjeti Inhibitori faktora VIII).
English: The activity of factor VIII in plasma is expressed either as percentage (relative to normal human plasma level) or in International Units per dL (relative to the current International Standard for factor VIII in plasma).
Croatian: Aktivnost faktora VIII u plazmi izražava se ili kao postotak (u odnosu na normalnu razinu u ljudskoj plazmi) ili u internacionalnim jedinicama po dl (u odnosu na važeći međunarodni standard za faktor VIII u plazmi).
English: Within one hour before surgery to achieve factor VIII activity within the target range
Croatian: Unutar jednog sata prije kirurškog zahvata kako bi se postigla aktivnost faktora VIII unutar ciljnog raspona
English: Some needleless connectors with an internal spike are incompatible with the pre-filled syringe.
Croatian: Neki konektori za primjenu bez igle s unutarnjim šiljkom nisu kompatibilni s napunjenom štrcaljkom.
English: All pharmacokinetic studies with Esperoct were conducted in previously treated patients with severe haemophilia A (factor VIII <1%).
Croatian: Sva farmakokinetička ispitivanja s lijekom Esperoct provedena su u prethodno liječenih bolesnika s teškom hemofilijom A (faktor VIII <1%).
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as results of accidental or surgical trauma.
Croatian: Hemofilija A je spolno vezan nasljedni poremećaj koagulacije krvi uslijed smanjenih razina faktora VIII:C, a uzrokuje obilno krvarenje u zglobove, mišiće ili unutarnje organe, koje može nastati spontano ili kao posljedica slučajne ili kirurške traume.
English: The dose, dosing interval and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding, on the targeted factor VIII activity level and the patient's clinical condition.
Croatian: Doza, interval doziranja i trajanje nadomjesne terapije ovise o težini nedostatka faktora VIII, mjestu i opsegu krvarenja, o ciljnoj razini aktivnosti faktora VIII te o kliničkom statusu bolesnika.
English: The powder is white to off-white.
Croatian: Prašak je bijele do bjelkaste boje.
English: An incorrect technique can introduce germs that can infect your blood.
Croatian: Nepravilnom tehnikom u krvotok se mogu unijeti mikroorganizmi, koji mogu uzrokovati infekciju krvi.
English: There is a risk that you may experience a severe and sudden allergic reaction (e.g. anaphylactic reaction) to Esperoct.
Croatian: Postoji rizik od pojave teške i iznenadne alergijske reakcije (npr. anafilaktičke reakcije) na lijek Esperoct.
English: The potency (IU) is determined using the European Pharmacopoeia chromogenic assay.
Croatian: Potentnost (IU) je određena pomoću kromogenog testa prema Europskoj farmakopeji.
English: Do not touch the rubber stopper with your fingers as this can transfer germs.
Croatian: Ne dirajte gumeni čep prstima jer na taj način možete prenijeti mikroorganizme.
English: Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port:
Croatian: Injiciranje otopine putem pomagala za centralni venski pristup (CVAD, engl. central venous access device) kao što su centralni venski kateter ili potkožni port:
English: • Do not increase the total dose of Esperoct to control your bleed without talking to your doctor.
Croatian: • Nemojte povećavati ukupnu dozu lijeka Esperoct kako biste kontrolirali krvarenje ako o tome niste razgovarali sa svojim liječnikom.
English: Table 4 Single-dose pharmacokinetic parameters of Esperoct 50 IU/kg in children, adolescents and adults by age using the chromogenic assay (geometric mean [CV%])
Croatian: Tablica 4 Farmakokinetički parametri jednokratne doze lijeka Esperoct od 50 IU/kg u djece, adolescenata i odraslih po dobi dobiveni pomoću kromogenog testa (geometrijska srednja vrijednost [CV %]) Farmakokinetički parametar
English: Development of ‘FVIII inhibitors' (antibodies)
Croatian: Razvoj „inhibitora FVIII“ (antitijela)
English: For further information, see “Development of ‘FVIII inhibitors' (antibodies)” in section
Croatian: Za daljnje informacije pogledajte “Razvoj „inhibitora FVIII“ (antitijela)” u dijelu
English: • skin reactions where the injection is given
Croatian: • reakcije na koži na mjestu injiciranja
English: Adults/adolescents who had a low bleeding rate of 0-2 bleeding episodes during the last 6 months and had obtained at least 50 doses of Esperoct had the option of being randomised to prophylaxis treatment every 7 days (75 IU/kg every 7 days) or every 4 days (50 IU/kg every 4 days).
Croatian: Odrasli/adolescenti koji su imali nisku stopu krvarenja od 0-2 epizode krvarenja tijekom proteklih 6 mjeseci i koji su primili najmanje 50 doza lijeka Esperoct imali su mogućnost randomizacije za liječenje profilaksom svakih 7 dana (75 IU/kg svakih 7 dana) ili svaka 4 dana (50 IU/kg svaka 4 dana).
English: In people with haemophilia A, factor VIII is missing or does not work properly.
Croatian: U osoba s hemofilijom A faktor VIII nedostaje ili nema ispravnu funkciju.
English: To prevent bleeding
Croatian: Za sprječavanje krvarenja
English: In 12 patients above 18 years of age, 1,126 bleedings were treated among patients receiving on-demand treatment with an average treatment dose of 38.1 IU/kg with a mean annual consumption of 1457 IU/kg.
Croatian: U 12 bolesnika starijih od 18 godina, 1126 krvarenja liječeno je među bolesnicima koji su primali liječenje po potrebi s prosječnom dozom od 38,1 IU/kg sa srednjom vrijednosti godišnje potrošnje od 1457 IU/kg.
English: No interactions of human coagulation factor VIII (rDNA) with other medicinal products have been reported.
Croatian: Nisu prijavljene interakcije lijekova koji sadrže ljudski koagulacijski faktor VIII (rDNK) s drugim lijekovima.
English: Do not disassemble the equipment before disposal.
Croatian: Nemojte razdvajati pribor prije bacanja u otpad.
English: Adults and adolescents (12 years of age and above): The recommended starting dose is 50 IU of Esperoct per kg body weight every 4 days.
Croatian: Odrasli i adolescenti (u dobi od 12 i više godina): Preporučena početna doza je 50 IU lijeka Esperoct po kg tjelesne težine svaka 4 dana.
English: If this happens, your medicine may stop working properly and you may experience persistent bleeding.
Croatian: Ako se to dogodi Vama, lijekovi koje primjenjujete mogu prestati pravilno djelovati, pa se kod Vas može javiti krvarenje koje ne prestaje.
English: 30 months at 2°C - 8°C, during which the product may be stored for up to 30°C for a single period not exceeding 12 months, but not beyond the expiry date written on the package.
Croatian: 30 mjeseci na temperaturi 2°C-8°C, tijekom kojih je lijek moguće čuvati na temperaturi do 30°C tijekom jednokratnog razdoblja ne dužeg od 12 mjeseci, ali ne nakon isteka roka valjanosti navedenog na pakiranju.
English: Do not put Esperoct in the refrigerator again after it has been stored at room temperature.
Croatian: Nemojte odlagati Esperoct u hladnjak nakon što ste ga čuvali na sobnoj temperaturi.
English: The target factor VIII levels will depend on the severity and location of the bleeding.
Croatian: Ciljne razine faktora VIII ovisit će o težini i mjestu krvarenja.
English: A total of 108 single dose pharmacokinetic profiles at 50 IU/kg Esperoct were evaluated in 69 patients.
Croatian: Ukupno 108 farmakokinetičkih profila s jednokratnom dozom od 50 IU/kg lijeka Esperoct bilo je procijenjeno u 69 bolesnika.
English: These early signs may include rash, hives, weals, itching on large areas of skin, redness and/or swelling of lips, tongue, face or hands, difficulty in swallowing or breathing, wheezing, tightness of the chest, pale and cold skin, fast heartbeat, or dizziness, headache, nausea and vomiting.
Croatian: Ti rani znakovi mogu uključivati osip, koprivnjaču, svrbež na velikim površinama kože, crvenilo i/ili oticanje usana, jezika, lica ili šaka, poteškoće pri gutanju ili disanju, piskanje pri disanju, stezanje u prsnom košu, blijedu i hladnu kožu, ubrzane otkucaje srca ili omaglicu, glavobolju, mučninu i povraćanje.
English: An infusion set (butterfly needle with tubing), sterile alcohol swabs, gauze pads and plasters will also be needed.
Croatian: Potrebni su i infuzijski set (leptirasta igla s cjevčicom), sterilni alkoholni tupferi, gaze i flasteri.
English: During the course of treatment, appropriate determination of factor VIII activity levels is advised to guide adjustments of the dosing regimen of Esperoct, if needed.
Croatian: Tijekom liječenja preporučuje se odgovarajuće određivanje razina aktivnosti faktora VIII kako bi se, po potrebi, mogao prilagoditi režim doziranja lijeka Esperoct.
English: Keep the reconstituted solution out of direct light.
Croatian: Pripremljenu otopinu držite podalje od izravne svjetlosti.
English: Table 2 includes general recommendation for dosing of Esperoct for perioperative management.
Croatian: Tablica 2 uključuje opće preporuke za doziranje lijeka Esperoct za perioperativno zbrinjavanje.
English: • Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ-free as possible.
Croatian: • Obrišite gumeni čep sterilnim alkoholnim tupferom i pričekajte nekoliko sekundi da se osuši na zraku prije uporabe kako biste bili sigurni da je broj mikroorganizama sveden na najmanju moguću mjeru.
English: Do not stop using Esperoct without talking to your doctor.
Croatian: Nemojte prestati primjenjivati Esperoct bez savjetovanja s liječnikom.
English: Esperoct is for intravenous use.
Croatian: Esperoct je namijenjen za intravensku primjenu.
English: The efficacy of Esperoct in the treatment of bleeding episodes was demonstrated in all age groups.
Croatian: Djelotvornost lijeka Esperoct u liječenju epizoda krvarenja dokazana je u svim dobnim skupinama.
English: These devices are not included in the Esperoct package.
Croatian: Ovaj pribor nije uključen u pakiranje lijeka Esperoct.
English: Inhibitors (antibodies) can develop during the treatment with all factor VIII medicines
Croatian: Inhibitori (antitijela) se mogu razviti tijekom liječenja svim lijekovima koji sadrže faktor VIII
English: • If your bleeding is not being controlled with Esperoct, tell your doctor immediately
Croatian: • Ako se Vaše krvarenje ne može kontrolirati pomoću lijeka Esperoct, odmah se obratite liječniku
English: The mean annual consumption for prophylaxis was 4641 IU/kg.
Croatian: Srednja vrijednost godišnje potrošnje za profilaksu bila je 4641 IU/kg.
English: There is no indication of an increased risk of factor VIII inhibitor development with treatment of Esperoct as compared to other factor VIII products.
Croatian: Ne postoje indicije o povećanom riziku razvoja inhibitora faktora VIII tijekom liječenja lijekom Esperoct u usporedbi s drugim lijekovima koji sadrže faktor VIII.
English: Tell your doctor if you have used factor VIII medicines before, especially if you developed inhibitors (antibodies) against the medicine, since there might be a risk that it happens again.
Croatian: Ranija upotreba lijekova koji sadrže faktor VIII Obavijestite liječnika ako ste prethodno liječeni lijekovima koji sadrže faktor VIII, osobito ako su se kod Vas razvili inhibitori (antitijela) lijeka, jer može postojati povećan rizik da se to ponovno dogodi.
English: The dose of Esperoct is calculated depending on your body weight and the factor VIII levels to be achieved.
Croatian: Doza lijeka Esperoct izračunava se na temelju tjelesne težine i razina faktora VIII koje se žele postići.
English: By factor VIII replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Croatian: Nadomjesnom terapijom faktorom VIII povećavaju se razine faktora VIII u plazmi, čime se omogućuje privremena korekcija nedostatka faktora te korekcija sklonosti krvarenju.
English: Esperoct replaces this faulty or missing factor VIII and helps blood to form clots at the site of bleeding.
Croatian: Esperoct zamjenjuje taj „faktor VIII“ koji nedostaje ili ne djeluje pravilno te pomaže u stvaranju krvnih ugrušaka na mjestu krvarenja.
English: If you are in doubt, contact your doctor.
Croatian: Ako imate nedoumica, obratite se svom liječniku.
English: No symptoms of overdose with recombinant coagulation factor VIII have been reported.
Croatian: Nisu prijavljeni simptomi predoziranja rekombinantnim koagulacijskim faktorom VIII.
English: (bromobutyl) and a rubber tip cap (bromobutyl) - 1 plunger rod (polypropylene).
Croatian: (bromobutil) i gumenim poklopcem vrha (bromobutil) - 1 potisnik klipa (polipropilen).
English: The calculation of the required dose of factor VIII is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dL.
Croatian: Izračun potrebne doze faktora VIII temelji se na empirijskim nalazima da 1 internacionalna jedinica (IU) faktora VIII po kg tjelesne težine povećava aktivnost faktora VIII u plazmi za 2 IU/dl.
English: If a central venous access device (CVAD) is required, the risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Croatian: Ako je potreban centralni venski kateter, treba uzeti u obzir rizik od komplikacija povezanih s centralnim venskim kateterom, kao što su lokalne infekcije, bakterijemija i tromboza na mjestu postavljenog katetera.
English: 18 years and above N=42
Croatian: 18 godina i stariji N=42
English: Adjustments of doses and administration intervals may be considered based on achieved factor VIII levels and individual bleeding tendency.
Croatian: Prilagodbe doza i intervala primjene mogu se razmotriti na temelju postignutih razina faktora VIII i individualne sklonosti krvarenju.
English: This medicine contains 30.5 mg sodium (main component of cooking/table salt) per reconstituted vial.
Croatian: Ovaj lijek sadrži 30,5 mg natrija (glavni sastojak kuhinjske soli) u jednoj bočici pripremljenoj za primjenu.
English: a Incremental recovery and factor VIII were assessed 30 min post-dosing for patients 12 years and above and 60 min post-dosing (first sample) for children below12 years.
Croatian: a Prirast po jedinici doze i faktor VIII ocjenjivani su 30 min. nakon doziranja za bolesnike od 12 godina i starije te 60 min. nakon doziranja (prvi uzorak) za djecu mlađu od 12 godina.
English: • redness of skin (erythema)
Croatian: • crvenilo kože (eritem)
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available.
Croatian: Zbog rijetke pojave hemofilije A u žena, nema iskustava s primjenom faktora VIII tijekom trudnoće i dojenja.
English: The half-life of Esperoct was 1.6 fold longer compared to unmodified factor VIII products in adults.
Croatian: U odraslih bolesnika poluvijek lijeka Esperoct bio je 1,6 puta duži u usporedbi s neizmijenjenim faktorom VIII.
English: • sterile alcohol swabs
Croatian: • sterilne alkoholne tupfere
English: Calcium chloride dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Croatian: L-metionin kalcijev klorid dihidrat natrijev hidroksid (za podešavanje pH) kloridna kiselina (za podešavanje pH)
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the users and would normally not be recommended for longer than 4 hours stored at room temperature (up to 30°C) or 24 hours in a refrigerator (2°C - 8°C), unless reconstitution has taken place in controlled and validated aseptic conditions.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja prije primjene lijeka odgovornost su korisnika te se normalno ne preporučuje čuvanje dulje od 4 sata na sobnoj temperaturi (do 30°C) ili dulje od 24 sata u hladnjaku (2°C-8°C), osim ako rekonstitucija nije provedena u kontroliranim i validiranim aseptičkim uvjetima.
English: • Grasp the plunger rod by the wide top end and take it out of the carton.
Croatian: • Uhvatite potisnik klipa za široki gornji dio i izvadite ga iz kutije.
English: If you use more Esperoct than you should, contact your doctor straight away.
Croatian: Ako primijenite više lijeka Esperoct nego što ste trebali, odmah se obratite svom liječniku.
English: Esperoct should be administered by intravenous injection (over approximately 2 minutes) after reconstitution of the powder with 4 mL supplied solvent (sodium chloride 9 mg/mL (0.9%) solution for injection).
Croatian: Esperoct se treba primjenjivati intravenskom injekcijom (tijekom otprilike 2 minute) nakon rekonstitucije praška sa 4 ml priloženog otapala (0,9%-tna (9 mg/ml) otopina natrijevog klorida za injekciju).
English: In the case of major surgical interventions in particular, monitoring of the factor VIII substitution therapy by measurement of plasma factor VIII activity is necessary.
Croatian: U slučaju većih kirurških zahvata posebno je neophodno praćenje nadomjesne terapije faktora VIII pomoću mjerenja aktivnosti faktora VIII u plazmi.
English: Esperoct has no influence on the ability to drive and use machines.
Croatian: Esperoct ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The amount to be administered and the frequency of administration should always be oriented to the clinical effectiveness in the individual case.
Croatian: Količinu koju treba primijeniti i učestalost primjene uvijek treba prilagoditi postizanju kliničke učinkovitosti potrebne u pojedinom slučaju.
English: The clinical efficacy of Esperoct for prophylaxis and treatment of bleeds was investigated in five prospective, multi-centre clinical studies in 270 previously treated patients (PTPs) with severe haemophilia A.
Croatian: Klinička djelotvornost lijeka Esperoct za profilaksu i liječenje krvarenja ispitivana je u pet prospektivnih, multicentričnih kliničkih ispitivanja u 270 prethodno liječenih bolesnika (PTP) s teškom hemofilijom A.
English: The medicinal product contains 30.5 mg sodium per reconstituted vial, equivalent to 1.5% of the WHO recommended maximum daily intake of 2.0 g sodium for an adult.
Croatian: Ovaj lijek sadrži 30,5 mg natrija po rekonstituiranoj bočici, što odgovara 1,5% maksimalnog dnevnog unosa od 2 g natrija prema preporukama Svjetske zdravstvene organizacije za odraslu osobu.