FrancophonIA/ELRC3.0 huggingface dataset:
English: This is equivalent to 1.5% of the recommended maximum dietary intake of sodium for an adult.
Croatian: To odgovara 1,5% preporučenog maksimalnog dnevnog unosa natrija za odraslu osobu.
English: Of the 3,293 reported bleeds observed in 298 of the patients, 2,902 (88.1%) of the bleeds were resolved with 1-2 infusions of NovoEight.
Croatian: Od 3293 prijavljena krvarenja primijećena u 298 bolesnika, 2902 (88,1%) slučaja krvarenja riješena su primjenom 1-2 infuzije lijeka NovoEight.
English: The study showed that comparable and consistent results were obtained for both products and that NovoEight can be reliably measured in plasma without the need of a separate NovoEight standard.
Croatian: Ispitivanje je pokazalo da su dobiveni rezultati usporedivi i konzistentni za oba lijeka te da se NovoEight može pouzdano izmjeriti u plazmi bez potrebe za zasebnim NovoEight standardom.
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 uskladiti s kliničkom djelotvornošću u svakom pojedinom slučaju.
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: The most frequently reported adverse reaction was Factor VIII inhibition, see section 4.4.
Croatian: Najčešće prijavljena nuspojava bila je inhibicija faktora VIII, vidjeti dio 4.4.
English: Therefore, factor VIII should be used during pregnancy and lactation only if clearly indicated.
Croatian: Stoga se tijekom trudnoće i dojenja faktor VIII smije primjenjivati samo ako je to jasno indicirano.
English: Of note, annualised 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: Treatment with NovoEight will be started by a doctor who is experienced in the care of patients with haemophilia A. Always use this medicine exactly as your doctor has told you.
Croatian: Liječenje lijekom NovoEight započet će liječnik s iskustvom u liječenju bolesnika s hemofilijom A. Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik.
English: • If the CVAD line needs to be flushed before or after NovoEight injection, use sodium chloride 9 mg/ml solution for injection.
Croatian: • Ako CVAD liniju treba isprati prije ili nakon injekcije lijeka NovoEight, upotrijebite otopinu za injekciju natrijeva klorida od 9 mg/ml.
English: Adolescents (above the age of 12) can use the same dose as adults.
Croatian: Adolescenti (stariji od 12 godina) mogu primjenjivati jednaku dozu kao i odrasli.
English: The recommended infusion rate for NovoEight is 1-2 ml/min.
Croatian: Preporučena brzina infuzije lijeka NovoEight je 1-2 ml/min.
English: Paediatric population The listed warnings and precautions apply both to adults and children.
Croatian: Pedijatrijska populacija Navedena upozorenja i mjere opreza odnose se i na odrasle i na djecu.
English: Repeat infusion every 8-24 hours until adequate wound healing, then therapy for at least another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dl)
Croatian: Ponavljati infuziju svakih 8-24 sata do odgovarajućeg zacijeljenja rane, a zatim nastaviti liječenje tijekom još najmanje 7 dana kako bi se aktivnost faktora VIII održala između 30% i 60% (IU/dl).
English: The pharmacokinetic parameters were comparable between paediatric patients below 6 years of age and the paediatric patients from 6 to below 12 years of age.
Croatian: Farmakokinetički parametri bili su usporedivi između pedijatrijskih bolesnika mlađih od 6 godina i pedijatrijskih bolesnika u dobi od 6 do manje od 12 godina.
English: (pre- and postoperative)
Croatian: (prije i nakon zahvata)
English: Known allergic reaction to hamster proteins.
Croatian: Poznata alergijska reakcija na proteine hrčka.
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Croatian: Reakcije preosjetljivosti ili alergijske reakcije (koje mogu uključivati angioedem, žarenje i peckanje na mjestu infuzije, zimicu, crvenilo praćeno osjećajem vrućine, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsištu, trnce, povraćanje, piskanje pri disanju) primijećene su rijetko, a u nekim slučajevima mogu napredovati do teške anafilaksije (uključujući šok).
English: If this happens to you or your child´s medicines may stop working properly and you or your child may experience persistent bleeding.
Croatian: Ako se to dogodi Vama ili Vašem djetetu, lijekovi koje primjenjujete mogu prestati pravilno djelovati, pa se kod Vas ili Vašeg djeteta može javiti krvarenje koje ne prestaje.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Croatian: Sljedeća se tablica može koristiti kao vodič za doziranje kod epizoda krvarenja i kirurških zahvata:
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: In patients with high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should be considered.
Croatian: U bolesnika s visokim razinama inhibitora liječenje faktorom VIII možda neće biti učinkovito pa treba razmotriti druge terapijske opcije.
English: A total of 30 surgeries were performed in 25 patients of which 26 were major surgeries and 4 were minor.
Croatian: Ukupno je izvedeno 30 kirurških zahvata u 25 bolesnika, od čega 26 većih i 4 manja zahvata.
English: Do not throw it out with the ordinary household waste.
Croatian: Ne bacajte u obični kućni otpad.
English: It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells, and prepared without the addition of any human or animal derived protein in the cell culture process, purification or final formulation.
Croatian: Chinese hamster ovary, CHO) i priprema se bez dodavanja bilo kojeg proteina ljudskog ili životinjskog podrijetla tijekom postupka kultiviranja stanica, pročišćavanja ili konačne formulacije.
English: Solvent for NovoEight Sodium chloride 9 mg/ml
Croatian: Otapalo za NovoEight natrijev klorid 9 mg/ml
English: Some variation was observed in the pharmacokinetic parameters of NovoEight between paediatric and adult patients.
Croatian: Primijećena je određena varijabilnost farmakokinetičkih parametara lijeka NovoEight između pedijatrijskih bolesnika i odraslih bolesnika.
English: Four multi-centre, open-labelled, non-controlled trials have been conducted to evaluate the safety and efficacy of NovoEight in the prevention and treatment of bleeds and during surgery in patients with severe haemophilia A (FVIII activity ≤1%).
Croatian: Provedena su četiri multicentrična, otvorena, nekontrolirana ispitivanja sigurnosti i djelotvornosti lijeka NovoEight u prevenciji i liječenju krvarenja te tijekom kirurških zahvata u bolesnika s teškom hemofilijom A (aktivnost FVIII ≤1%).
English: Other medicines and NovoEight
Croatian: Drugi lijekovi i NovoEight
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Croatian: • Periodička izvješća o neškodljivosti (PSUR) Zahtjevi za podnošenje periodičkih izvješća o neškodljivosti za ovaj lijek definirani su u referentnom popisu datuma EU (EURD popis) predviđenom člankom 107.c stavkom 7. Direktive 2001/83/EZ i svim sljedećim ažuriranim verzijama objavljenima na europskom internetskom portalu za lijekove.
English: There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to NovoEight.
Croatian: Iako se to rijetko događa, postoji mogućnost da dobijete anafilaktičku reakciju (tešku i iznenadnu alergijsku reakciju) na NovoEight.
English: d Hepatic enzymes increased include alanine aminotransferase, aspartate aminotransferase, gamma-glutamyltransferase and bilirubin.
Croatian: d Povišene vrijednosti jetrenih enzima uključuju alanin aminotransferazu, aspartat aminotransferazu, gama-glutamiltransferazu i bilirubin.
English: Do not increase the total dose of NovoEight to control your bleed without talking to your doctor.
Croatian: Nemojte povećavati ukupnu dozu lijeka NovoEight kako biste kontrolirali krvarenje ako o tome niste razgovarali sa svojim liječnikom.
English: Required units = body weight (kg) x desired factor VIII rise (%) (IU/dl) x 0.5 (IU/kg per IU/dl).
Croatian: Potreban broj jedinica = tjelesna težina (kg) x željeno povećanje faktora VIII (%) (IU/dl) x 0,5 (IU/kg po IU/dl).
English: In children (below the age of 12) higher doses or more frequent injections may be needed.
Croatian: U djece (mlađe od 12 godina) možda će biti potrebne veće doze ili češće injekcije.
English: If you use more NovoEight than you should, tell your doctor or go to a hospital straight away.
Croatian: Ako primijenite više lijeka NovoEight nego što ste trebali, odmah o tome obavijestite svog liječnika ili otiđite u bolnicu.
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 primjerenom dozom, treba provesti test radi utvrđivanja prisutnosti inhibitora faktora VIII.
English: If not used straight away the medicine may no longer be sterile and could cause infection.
Croatian: Ako se ne upotrijebi odmah, lijek možda neće više biti sterilan pa bi mogao izazvati infekciju.
English: After reconstitution with the supplied solvent (sodium chloride 9 mg/ml (0.9%) solution for injection), the prepared solution for injection contains 62.5, 125, 250, 375, 500 or 750 IU turoctocog alfa per ml, respectively, (based on the strength of turoctocog alfa, i.e. 250, 500, 1000, 1500, 2000 or 3000 IU).
Croatian: Nakon pripreme s priloženim otapalom (otopina za injekciju natrijeva klorida 9 mg/ml (0,9%)) pripremljena otopina za injekciju sadrži 62,5, 125, 250, 375, 500 ili 750 IU turoktokoga alfa po ml (u skladu s jačinom turoktokoga alfa, tj. jačinom od 250, 500, 1000, 1500, 2000 ili 3000 IU).
English: In general, all patients treated with coagulation factor VIII products should be carefully monitored for the development of inhibitors by appropriate clinical observation and laboratory test.
Croatian: Općenito, sve bolesnike liječene lijekovima koji sadrže koagulacijski faktor VIII treba pažljivo pratiti odgovarajućim kliničkim pregledima i laboratorijskim testovima zbog razvoja inhibitora.
English: What NovoEight is and what it is used for What you need to know before you use NovoEight How to use NovoEight
Croatian: Što je NovoEight i za što se koristi Što morate znati prije nego počnete primjenjivati NovoEight Kako primjenjivati NovoEight Moguće nuspojave
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and the patient's clinical condition.
Croatian: Doza i trajanje nadomjesne terapije ovise o težini nedostatka faktora VIII, mjestu i opsegu krvarenja te kliničkom stanju bolesnika.
English: Do not use any other way to heat the vial and pre-filled syringe.
Croatian: Ne koristite nikakav drugi način za zagrijavanje bočice i napunjene štrcaljke.
English: NovoEight contains nominally 250, 500, 1000, 1500, 2000 or 3000 IU turoctocog alfa.
Croatian: NovoEight nominalno sadrži 250, 500, 1000, 1500, 2000 ili 3000 IU turoktokoga alfa.
English: Frequency of doses (hours)/Duration of therapy (days)
Croatian: Učestalost doziranja (sati)/trajanje terapije
English: Very rarely development of antibodies to hamster protein with related hypersensitivity reactions has been observed.
Croatian: Vrlo je rijetko primijećen razvoj protutijela na proteine hrčka i s time povezane reakcije preosjetljivosti.
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 razvijanja 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: One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in one ml normal human plasma.
Croatian: Jedna internacionalna jedinica (IU) aktivnosti faktora VIII jednaka je količini faktora VIII u jednome ml normalne ljudske plazme.
English: Mean residence time (h)
Croatian: Srednja vrijednost vremena zadržavanja(h)
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Croatian: Osobito u slučaju većih kirurških zahvata, neizostavno je precizno praćenje nadomjesne terapije pomoću analize koagulacije (određivanja aktivnosti faktora VIII u plazmi).
English: Sodium chloride
Croatian: natrijev klorid
English: If, at any point, there is too much air in the syringe, inject the air back into the vial.
Croatian: Ako se u bilo kojem trenutku u štrcaljki pojavi previše zraka,
English: The most frequently reported adverse reactions were injection site reactions, incorrect dose administered and hepatic enzymes increased.
Croatian: Najčešće prijavljene nuspojave bile su reakcije na mjestu injiciranja, primjena netočne doze i povišene vrijednosti jetrenih enzima.
English: Total
Croatian: Ukupno
English: The usual dose of NovoEight is 20 to 50 international units (IU) per kg of body weight.
Croatian: Uobičajena doza lijeka NovoEight je 20 do 50 internacionalnih jedinica (IU) po kg tjelesne težine.
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 empirijskom saznanju da 1 internacionalna jedinica (IU) faktora VIII po kg tjelesne težine povećava aktivnost faktora VIII u plazmi za 2 IU/dl.
English: Do not mix NovoEight with any other intravenous infusions or medicines.
Croatian: NovoEight se ne smije miješati s drugim intravenskim infuzijskim otopinama ili lijekovima.
English: If you cannot use the reconstituted NovoEight solution immediately, it should be used within:
Croatian: Ako ne možete odmah primijeniti pripremljenu otopinu lijeka NovoEight, morate je upotrijebiti unutar:
English: It is strongly recommended that every time that NovoEight is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Croatian: Izrazito se preporučuje pri svakoj primjeni lijeka NovoEight u bolesnikov karton upisati naziv i broj serije lijeka kako bi se održala veza između bolesnika i serije lijeka.
English: Improper technique can introduce germs that can infect the blood.
Croatian: Nepravilnom tehnikom u krvotok se mogu unijeti mikroorganizmi, koji mogu uzrokovati infekciju krvi.
English: In clinical trials involving 63 previously treated paediatric patients between 0 and 12 years of age and 24 adolescents between 12 and 18 years of age with severe haemophilia A no difference in the safety profile of NovoEight was observed between paediatric patients and adults.
Croatian: U kliničkim ispitivanjima, u kojima su sudjelovala 63 prethodno liječena pedijatrijska bolesnika u dobi od 0 do 12 godina i 24 adolescenta u dobi od 12 do 18 godina s teškom hemofilijom A, nije primijećena razlika u sigurnosnom profilu lijeka NovoEight između pedijatrijskih i odraslih bolesnika.
English: Abbreviations: AUC = area under the factor VIII activity time profile; CL = clearance; t1/2 = terminal half-life; Vss = volume of distribution at steady-state; Cmax = maximum factor VIII activity.
Croatian: Kratice: AUC=područje ispod krivulje aktivnosti faktora VIII i vremenskog profila; CL=klirens; t1/2=terminalni poluvijek; Vss=volumen distribucije u stanju dinamičke ravnoteže (engl. volume of distribution at steady-state); Cmax=maksimalna aktivnost faktora VIII.
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 se mora savjetovati da odmah prestanu primjenjivati lijek i obrate se svom liječniku.
English: For paediatric patients above the age of 12 the dose recommendations are the same as for adults.
Croatian: Za pedijatrijske bolesnike starije od 12 godina preporučene doze jednake su onima za odrasle bolesnike.
English: The activity of factor VIII in plasma is expressed either as percentage (relative to normal level human plasma) or in International Units (relative to an International Standard for factor VIII in plasma).
Croatian: Aktivnost faktora VIII u plazmi izražava se ili postotkom (u odnosu na normalnu razinu u ljudskoj plazmi) ili u internacionalnim jedinicama (u odnosu na međunarodni standard za faktor VIII u plazmi).
English: The equipment in this package is designed to reconstitute and inject NovoEight.
Croatian: Pribor u ovome pakiranju namijenjen je za pripremu i injiciranje lijeka NovoEight.
English: If you stop using NovoEight
Croatian: Ako prestanete primjenjivati NovoEight
English: No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have been reported.
Croatian: Nisu prijavljene interakcije lijekova koji sadrže humani koagulacijski faktor VIII (rDNK) s drugim lijekovima.
English: In a single dose pharmacokinetic study in adult patients the maximum exposure (Cmax) and the total exposure (AUC) increased with increasing body mass index (BMI) indicating that dose adjustments may be required.
Croatian: U farmakokinetičkom ispitivanju primjene jednokratne doze u odraslih bolesnika maksimalna izloženost (Cmax) i ukupna izloženost (AUC) su se povećale s povećanjem indeksa tjelesne mase (ITM), što ukazuje na moguću potrebu za prilagodbom doze.
English: Rubber stopper (under plastic cap)
Croatian: Gumeni čep (ispod plastičnog zatvarača)
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/stolne soli) po pripremljenoj bočici.
English: Common side effects (may affect up to 1 in 10 people) in patients who have not previously treated with Factor VIII medicines
Croatian: Česte nuspojave (mogu se javiti u do 1 na 10 osoba) u bolesnika koji se prethodno nisu liječili lijekovima koji sadrže faktor VIII
English: Treatment should be under the supervision of a doctor experienced in the treatment of haemophilia.
Croatian: Liječenje treba provoditi pod nadzorom liječnika s iskustvom u liječenju hemofilije.
English: Animal reproduction studies have not been conducted with NovoEight.
Croatian: Nisu provedena ispitivanja reprodukcije na životinjama s lijekom NovoEight.
English: Prepare the vial and the syringe Take out the number of NovoEight packages you need.
Croatian: Uzmite onoliki broj NovoEight pakiranja koliko trebate.
English: (<1/10,000), and not known (cannot be estimated from the available data).
Croatian: (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000) i nepoznato (ne može se procijeniti iz dostupnih podataka).
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 a result 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: These devices are not included in the NovoEight package.
Croatian: Ovaj pribor nije uključen u pakiranje lijeka NovoEight.
English: The higher CL and the shorter t½ seen in paediatric patients compared to adult patients with haemophilia A may be due in part to the known higher plasma volume per kilogram body weight in younger patients.
Croatian: Viši klirens (CL) i kraći poluvijek (t½) primijećen u pedijatrijskih bolesnika u usporedbi s odraslim bolesnicima s hemofilijom A dijelom bi mogli biti posljedica poznate činjenice da je volumen u plazmi po kilogramu tjelesne težine veći u mlađih bolesnika.
English: This glycoprotein has the same structure as human factor VIII when activated, and posttranslational modifications that are similar to those of the plasma-derived molecule.
Croatian: Ovaj glikoprotein ima istu strukturu kao i aktivirani humani faktor VIII te posttranslacijske promjene slične onima kod molekule dobivene iz plazme.
English: High risk genetic mutations were identified in 92.3% of the overall and 93.8% of the high titre confirmed inhibitors.
Croatian: Visokorizične genske mutacije pronađene su kod 92,3% bolesnika s bilo kojim titrom inhibitora te 93,8% bolesnika s potvrđenim visokim titrom inhibitora.
English: Scale
Croatian: Skala
English: The potency (IU) is determined using the European Pharmacopoeia (Ph. Eur) chromogenic assay.
Croatian: Potentnost (IU) se određuje kromogenim testom prema Europskoj farmakopeji (Ph. Eur).
English: Older children
Croatian: Starije osobe
English: • difficulty in breathing, shortness of breath or wheezing
Croatian: • otežano disanje, nedostatak zraka ili piskanje pri disanju
English: Treatment with NovoEight was shown to be safe and had the intended haemostatic and preventive effect.
Croatian: Pokazalo se da je liječenje lijekom NovoEight sigurno te da se njime postiže željeni hemostatski i preventivni učinak.
English: AUC ((IU*h)/dl) 1510 (360) 1920 (610) CL (ml/h/kg) t½ (h)
Croatian: AUC ((IU*h)/dl) 1510 (360) 1920 (610) CL (ml/h/kg)
English: Some people using this medicine can develop antibodies to factor VIII (also known as factor VIII inhibitors).
Croatian: U nekih ljudi koji primjenjuju ovaj lijek mogu se razviti protutijela na faktor VIII (nazivaju se i inhibitorima faktora VIII).
English: The trials included 298 exposed patients; 175 adolescents or adult patients without inhibitors from the age of 12 years (≥150 exposure days), 63 previously treated paediatric patients without inhibitors below 12 years of age (≥50 exposure days) and 60 previously untreated patients below 6 years of age.
Croatian: U ispitivanja je bilo uključeno 298 bolesnika izloženih lijeku; 175 adolescenata ili odraslih bolesnika bez inhibitora u dobi od 12 i više godina (≥150 dana izloženosti), 63 prethodno liječena pedijatrijska bolesnika bez inhibitora mlađa od 12 godina (≥50 dana izloženosti) i 60 prethodno neliječenih bolesnika mlađih od 6 godina.