FrancophonIA/ELRC3.0 huggingface dataset:
English: This is of importance particularly when changing the laboratory and/or reagents used in the assay.
Croatian: To je osobito važno pri promjeni laboratorija i/ili reagensa koji se koristi u testu.
English: For long term prophylaxis against bleeding, the recommended starting regimens are either:
Croatian: Za dugotrajnu profilaksu krvarenja, preporučeni početni režimi su:
English: Thrombin then converts fibrinogen into fibrin and a clot is formed.
Croatian: Trombin potom pretvara fibrinogen u fibrin i stvara se ugrušak.
English: Date removed from refrigerator:
Croatian: Datum vađenja iz hladnjaka:
English: The haemostatic response was rated as excellent or good in 100% of major surgeries.
Croatian: Hemostatski odgovor ocijenjen je kao odličan ili dobar u 100% većih kirurških zahvata.
English: How often you need an injection will depend on how well ALPROLIX is working for you.
Croatian: Koliko često ćete trebati primati injekciju ovisit će o tome koliko dobro ALPROLIX kod Vas djeluje.
English: Patients were less than 12 years of age (15 were <6 years of age and 15 were 6 to <12 years of age).
Croatian: Bolesnici su bili mlađi od 12 godina (15 je bilo mlađe od 6, a 15 je bilo u dobi od 6 do <12 godina).
English: Your doctor will perform appropriate laboratory tests to make sure that you have adequate factor IX levels in your blood.
Croatian: Vaš će liječnik provesti odgovarajuće laboratorijske testove kako bi se osiguralo da imate odgovarajuću razinu faktora IX u krvi.
English: • if you are allergic to eftrenonacog alfa or any other ingredients of this medicine (listed in section 6).
Croatian: • ako ste alergični na eftrenonakog alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: If you stop using ALPROLIX you may no longer be protected against bleeding or a current bleed may not stop.
Croatian: Ako prestanete primjenjivati ALPROLIX, možda više nećete biti zaštićeni od krvarenja ili trenutno krvarenje možda neće prestati.
English: Therefore, factor IX should be used during pregnancy and breast-feeding only if clearly indicated.
Croatian: Stoga se faktor IX smije primjenjivati tijekom trudnoće i dojenja samo ako za to postoji jasna indikacija.
English: Contents of the pack and other information What ALPROLIX contains
Croatian: Sadržaj pakiranja i druge informacije Što ALPROLIX sadrži
English: In case of anaphylactic shock, standard medical treatment for shock should be implemented.
Croatian: U slučaju anafilaktičkog šoka potrebno je provesti standardno medicinsko liječenje šoka.
English: Chemical and physical stability has been demonstrated for 6 hours when stored at room temperature (up to 30°C).
Croatian: Dokazana je kemijska i fizikalna stabilnost u trajanju od 6 sati kad se čuva na sobnoj temperaturi (do 30 °C).
English: Other medicines and ALPROLIX
Croatian: Drugi lijekovi i ALPROLIX
English: NA 4.81
Croatian: ND 4,81
English: What ALPROLIX is and what it is used for
Croatian: Što je ALPROLIX i za što se koristi
English: 6.5 Nature and contents of container and special equipment for use, administration
Croatian: 6.5 Vrsta i sadržaj spremnika i posebna oprema za uporabu, primjenu
English: • Talk to your doctor if you think that your bleeding is not being controlled with the dose you receive, as there can be several reasons for this.
Croatian: • Obratite se svom liječniku ako mislite da Vam se krvarenje ne kontrolira dozom koju primate, jer za to može postojati nekoliko razloga.
English: The median time on Study II+III was 2.88 years and median number of exposure days was 166.
Croatian: Medijan vremena provedenog u ispitivanju II+III iznosio je 2,88 godina, a medijan broja dana izloženosti bio je 166.
English: NA 2.86
Croatian: ND 2,86
English: Your doctor will decide the dose of ALPROLIX (in International Units or “IU”) you will receive.
Croatian: Vaš će liječnik odlučiti koju ćete dozu lijeka ALPROLIX (u međunarodnim jedinicama ili “IU”) primati.
English: Talk to your doctor, pharmacist or nurse before using ALPROLIX.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite ALPROLIX.
English: Pharmacokinetic parameters1
Croatian: Farmakokinetički parametri1
English: (pre- and post-operative)
Croatian: (prije i poslije kirurškog zahvata)
English: NA 77.1
Croatian: ND 77,1
English: The antibodies prevent the treatment from working properly.
Croatian: Protutijela sprječavaju ispravno djelovanje liječenja.
English: In some cases, especially in younger patients, shorter dosing intervals or higher doses may be necessary.
Croatian: U nekim slučajevima, osobito u mlađih bolesnika, mogu biti potrebni kraći vremenski razmaci između doza ili više doze.
English: Adverse events were monitored for a total of 561 subject years.
Croatian: Štetni događaji su praćeni za ukupno 561 ispitanikgodinu.
English: The elimination half-life of ALPROLIX (82 hours) is influenced by the Fc region, which in animal models was shown to be mediated by neonatal Fc receptor cycling pathways.
Croatian: Na poluvijek eliminacije lijeka ALPROLIX (82 sata) utječe Fc regija, za koju se na životinjskim modelima pokazalo da je posredovana putevima kruženja neonatalnog Fc receptora.
English: ALPROLIX can be used in children and adolescents of all ages.
Croatian: ALPROLIX se može primjenjivati u djece i adolescenata svih uzrasta.
English: • There is a small chance that you may experience an anaphylactic reaction (a severe, sudden allergic reaction) to ALPROLIX.
Croatian: • Postoji mala vjerojatnost da razvijete anafilaktičku reakciju (jaka, iznenadna alergijska reakcija) na
English: NA 36.7
Croatian: ND 36,7
English: Studies to investigate genotoxicity, carcinogenicity, toxicity to reproduction or embryo-foetal development have not been conducted.
Croatian: Ispitivanja kojima bi se istražila genotoksičnost, kancerogenost, reproduktivna i embriofetalna razvojna toksičnost nisu provedena.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user.
Croatian: Ako se ne primijeni odmah, vrijeme i uvjeti čuvanja lijeka u primjeni do uporabe odgovornost su korisnika.
English: Do not stop using ALPROLIX without consulting your doctor.
Croatian: Nemojte prestati primjenjivati ALPROLIX bez savjetovanja s liječnikom.
English: The Fc region of human immunoglobulin G1 binds with the neonatal Fc receptor.
Croatian: Fc regija ljudskog imunoglobulina G1 veže se s neonatalnim Fc receptorom.
English: If you are on a controlled sodium diet, see section 2.
Croatian: Ako ste na dijeti s ograničenim unosom natrija, pogledajte dio 2.
English: The specific activity of ALPROLIX is 55-84 IU/mg protein.
Croatian: Specifična aktivnost lijeka ALPROLIX je 55-84 IU/mg proteina.
English: If any of these symptoms occur, stop the injection immediately and contact your doctor.
Croatian: Ako se pojavi bilo koji od ovih simptoma, odmah prestanite s primjenom injekcije i obratite se svom liječniku.
English: Prophylaxis fixed weekly and individualised intervals:
Croatian: Profilaksa u fiksnim tjednim i individualiziranim intervalima:
English: If you are using ALPROLIX to prevent bleeding, your doctor will calculate the dose for you.
Croatian: Ako primjenjujete ALPROLIX radi sprječavanja krvarenja, liječnik će Vam izračunati dozu.
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 koja će se primijeniti i učestalost primjene uvijek treba određivati ovisno o kliničkoj učinkovitosti u pojedinom slučaju.
English: Please safely dispose of the used needle, any unused solution, the syringe and the empty vial in an appropriate medical waste container as these materials may hurt others if not disposed of properly.
Croatian: Molimo da na siguran način zbrinete uporabljenu iglu, svu neprimijenjenu otopinu, štrcaljku i praznu bočicu u odgovarajući spremnik za medicinski otpad, jer se drugi mogu ozlijediti ovim priborom ako ga se ne zbrine na odgovarajući način.
English: Some patients who are well-controlled on a once every 10 days regimen might be treated on an interval of 14 days or longer.
Croatian: Neki bolesnici koji su dobro kontrolirani režimom primjene jedanput svakih 10 dana mogu primati terapiju u vremenskom razmaku od 14 dana ili duljem.
English: 1 In some patients and circumstances the dosing interval can be prolonged up to 48 hours (see section 5.2 for pharmacokinetic data).
Croatian: 1 U nekih bolesnika i u nekim okolnostima, vremenski razmak između doziranja može se produljiti na 48 sati (vidjeti dio 5.2 za farmakokinetičke podatke).
English: Paediatric population The listed warnings and precautions apply both to adults and children.
Croatian: Pedijatrijska populacija Navedena upozorenja i mjere opreza odnose se kako na odrasle tako i na djecu.
English: In a placental transfer study, ALPROLIX has been shown to cross the placenta in small amounts in mice.
Croatian: U ispitivanju placentarnog prijenosa pokazalo se da ALPROLIX prelazi placentu u malim količinama u miševa.
English: Of the 35 major surgeries, 28 surgeries (80.0%) required a single pre-operative dose to maintain haemostasis during surgery.
Croatian: Od 35 većih kirurških zahvata, u 28 kirurških zahvata (80,0%) bila je potrebna jedna doza prije operacije za održavanje hemostaze tijekom kirurškog zahvata.
English: This receptor is expressed throughout life as part of a naturally occurring pathway that protects immunoglobulins from lysosomal degradation by cycling these proteins back into circulation, resulting in their long plasma half-life.
Croatian: Ekspresija ovog receptora traje cijeli život kao dio prirodnog puta koji štiti imunoglobuline od lizosomske razgradnje tako što ciklički vraća te proteine u krvotok, što rezultira njihovim dugim poluvijekom eliminacije iz plazme.
English: Administration (Intravenous Injection):
Croatian: Primjena (injekcija u venu):
English: Factor IX level required (%) (IU/dL)
Croatian: Potrebna razina faktora IX (%) (IU/dl)
English: The use of high purity factor IX is rarely associated with thromboembolic complications.
Croatian: Primjena faktora IX visoke čistoće rijetko je povezana s tromboembolijskim komplikacijama.
English: The benefit of treatment with ALPROLIX in these situations should be weighed against the risk of these complications.
Croatian: U takvim je situacijama potrebno procijeniti korist od liječenja lijekom ALPROLIX u odnosu na rizik od ovih komplikacija.
English: If you use more ALPROLIX than you should
Croatian: Ako primijenite više lijeka ALPROLIX nego što ste trebali
English: In patients with existing cardiovascular risk factors, substitution therapy with FIX may increase the cardiovascular risk.
Croatian: U bolesnika s postojećim kardiovaskularnim čimbenicima rizika, zamjenska terapija FIX-om može povećati kardiovaskularni rizik.
English: ALPROLIX is prepared by recombinant technology without addition of any human- or animal-derived components in the manufacturing process.
Croatian: ALPROLIX je proizveden rekombinantnom tehnologijom bez dodavanja ikakvih sastojaka ljudskog ili životinjskog podrijetla u procesu proizvodnje.
English: Excipient with known effect: 0.3 mmol (6.4 mg) sodium per vial.
Croatian: Pomoćna tvar s poznatim učinkom: 0,3 mmol (6,4 mg) natrija po bočici.
English: The safety and efficacy of ALPROLIX in previously untreated patients have not yet been established.
Croatian: Prethodno neliječeni bolesnici Sigurnost i djelotvornost lijeka ALPROLIX u bolesnika koji prethodno nisu bili liječeni nisu još ustanovljene.
English: Note: If you use more than one vial of ALPROLIX per injection, each vial should be prepared separately as per the previous instructions (steps 1 to 13) and the solvent syringe should be removed, leaving the vial adapter in place.
Croatian: Napomena: Ako primjenjujete više od jedne bočice lijeka ALPROLIX po injekciji, svaka se bočica mora pripremiti zasebno prema prethodnim uputama (koraci 1 do 13) i štrcaljka s otapalom mora se ukloniti, a nastavak za bočicu ostaviti na mjestu.
English: Based on the rare occurrence of haemophilia B in women, experience regarding the use of factor IX during pregnancy and breast-feeding is not available.
Croatian: Na temelju rijetke pojavnosti hemofilije B u žena, nema dostupnog iskustva s primjenom faktora IX tijekom trudnoće i dojenja.
English: In patients with haemophilia B, factor IX is missing or not working properly.
Croatian: U bolesnika s hemofilijom B, faktor IX nedostaje ili ne djeluje na pravi način.
English: Factor IX products may increase the risk of unwanted blood clots in your body, especially if you have risk factors for developing blood clots.
Croatian: Lijekovi s faktorom IX mogu povećati rizik od nepoželjnih krvnih ugrušaka u tijelu, osobito ako imate čimbenike rizika za nastanak krvnih ugrušaka.
English: Please record on the carton the date that ALPROLIX is removed from the refrigerator and set at room temperature.
Croatian: Molimo da zabilježite na kutiju datum kad ste izvadili ALPROLIX iz hladnjaka i ostavili ga na sobnoj temperaturi.
English: What ALPROLIX looks like and contents of the pack
Croatian: Kako ALPROLIX izgleda i sadržaj pakiranja
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 primjenu lijeka i obrate se svom liječniku.
English: • 50 IU/kg once weekly, adjust dose based on individual response or
Croatian: • 50 IU/kg jedanput tjedno, uz prilagodbu doze na temelju odgovora pojedinog bolesnika ili
English: Intravenous use, after reconstitution.
Croatian: Intravenska primjena, nakon rekonstitucije.
English: The effects of higher than recommended doses of ALPROLIX have not been characterised.
Croatian: Učinci doza lijeka APROLIX koje su više od preporučenih nisu opisani.
English: If ALPROLIX has been stored in a refrigerator, allow the vial of ALPROLIX (A) and the syringe with solvent (B) to reach room temperature before use.
Croatian: Ako se ALPROLIX čuvao u hladnjaku, dopustite da bočica lijeka ALPROLIX (A) i štrcaljka s otapalom (B) postignu sobnu temperaturu prije primjene.
English: Table 2: Adverse reactions reported for ALPROLIX in clinical trials
Croatian: Tablica 2: Nuspojave zabilježene za ALPROLIX u kliničkim ispitivanjima
English: Factor IX is a protein produced naturally in the body necessary for the blood to form clots and stop bleeding.
Croatian: Faktor IX je protein koji se prirodno stvara u tijelu i neophodan je za stvaranje krvnih ugrušaka i zaustavljanje krvarenja.
English: The total number of exposure days was 26,106 with a median of 165 (range 1-528) exposure days persubject.
Croatian: Ukupni broj dana izloženosti iznosio je 26 106, uz medijan od 165 (raspon: 1-528) dana izloženosti po ispitaniku.
English: Table 2 presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Croatian: Tablica 2 u nastavku u skladu je s klasifikacijom organskih sustava prema MedDRA (SOC i razina preporučenog pojma).
English: MRT (h) Vss (mL/kg) Time to 1% (days)2
Croatian: MRT (h) Vss (ml/kg) Vrijeme do 1% (dani)2
English: Frequency, type and severity of adverse reactions in children are expected to be similar as in adults.
Croatian: Očekuje se da će učestalost, vrsta i težina nuspojava u djece biti slične onima u odraslih.
English: If the product is not used within 6 hours, it must be discarded.
Croatian: Ako se ne primijeni u roku od 6 sati, lijek se mora baciti.
English: ALPROLIX should not be mixed with other solutions for injection or infusion.
Croatian: ALPROLIX se ne smije miješati s drugim otopinama za injekciju ili infuziju.
English: If you cannot use the prepared ALPROLIX solution immediately, it should be used within 6 hours when stored at room temperature.
Croatian: Ako ne možete odmah primijeniti pripremljenu otopinu lijeka ALPROLIX, treba je primijeniti u roku od 6 sati kad se čuva na sobnoj temperaturi.
English: The dose of ALPROLIX is calculated depending on your body weight and the factor IX levels to be achieved.
Croatian: Doza lijeka ALPROLIX izračunava se ovisno o Vašoj tjelesnoj težini i razinama faktora IX koje treba postići.
English: Please see package leaflet, for additional information on reconstitution and administration.
Croatian: Molimo vidjeti uputu o lijeku za dodatne informacije o rekonstituciji i primjeni.
English: All patients received treatment with ALPROLIX and were followed for up to 77 weeks.
Croatian: Svi su bolesnici bili liječeni lijekom ALPROLIX i praćeni do 77 tjedana.
English: ALPROLIX has no influence on the ability to drive and use machines.
Croatian: ALPROLIX ne utječe na sposobnost upravljanja vozilima i rukovanja strojevima.
English: Out of 123 subjects who completed Study I, 93 were enrolled in Study III (extension study) with median total follow-up time of 6.5 years.
Croatian: Od 123 ispitanika koji su završili ispitivanje I, 93 ih je bilo uključeno u ispitivanje III (produžetak ispitivanja) s medijanom ukupnog trajanja praćenja od 6,5 godina.
English: For extent and age characterisation of the safety database in children see section 5.1.
Croatian: Za opseg i dobnu karakterizaciju baze podataka o sigurnosti primjene u djece vidjeti dio 5.1 Prijavljivanje sumnji na nuspojavu
English: Required units = body weight (kg) x desired factor IX rise (%) (IU/dL) x {reciprocal of observed recovery (IU/kg per IU/dL)}
Croatian: Potrebne jedinice = tjelesna težina (kg) x željeni porast faktora IX (%) (IU/dl) x {recipročna vrijednost opaženog povrata (IU/kg po IU/dl)}
English: Out of 30 patients having completed Study II, 27 enrolled to Study III (extension study).
Croatian: Od 30 bolesnika koji su završili ispitivanje II, 27 ih je bilo uključeno u ispitivanje III (produžetak ispitivanja).
English: Repeat injection every 8 to 24 hours until threat is resolved.
Croatian: Ponovite injekciju svakih 8 do 24 sata dok se ne ukloni opasnost.
English: There have been reports in the literature showing a correlation between the occurrence of a factor IX inhibitor and allergic reactions.
Croatian: U literaturi je opisana korelacija između pojave inhibitora faktora IX i alergijskih reakcija.
English: Check with your doctor, pharmacist or nurse if you are not sure.
Croatian: Provjerite s Vašim liječnikom, ljekarnikom ili medicinskom sestrom ako niste sigurni.
English: Please turn the leaflet over for section 7.
Croatian: Molimo pogledajte na drugoj strani upute o lijeku dio 7.
English: The product should not be used beyond the expiry date printed on the vial or six months after removing the carton from refrigeration, whichever is earlier.
Croatian: Lijek se ne smije primjenjivati nakon isteka roka valjanosti otisnutog na bočici ili šest mjeseci nakon vađenja kutije iz hladnjaka, štogod bude ranije.
English: In some cases, these reactions have progressed to severe anaphylaxis, and they have occurred in close temporal association with development of factor IX inhibitors (see also 4.4).
Croatian: U nekim su slučajevima te reakcije napredovale do teške anafilaksije i njihov je nastanak bio vremenski usko povezan s razvojem inhibitora faktora IX (vidjeti dio 4.4).
English: The dose will depend on your individual needs for replacement factor IX therapy and on whether it is used for prevention or treatment of bleeding.
Croatian: Doza će ovisiti o Vašim osobnim potrebama za nadomjesnom terapijom faktorom IX i o tome primjenjuje li se za sprječavanje ili za liječenje krvarenja.
English: The powder is a white to offwhite powder or cake.
Croatian: Prašak je bijeli do gotovo bijeli prašak ili kolačić.
English: Factor IX is a single chain glycoprotein with a molecular mass of about 68,000 Dalton.
Croatian: Faktor IX je jednolančani glikoprotein molekularne mase približno 68 000 Daltona.
English: Symptoms of a possible unwanted blood clot may include: pain and/or tenderness along a vein, unexpected swelling of an arm or leg or sudden shortness of breath or difficulty breathing.
Croatian: Simptomi mogućeg nepoželjnog krvnog ugruška mogu biti sljedeći: bol i/ili osjetljivost duž vene, neočekivano oticanje ruke ili noge ili iznenadni nedostatak zraka ili otežano disanje.
English: No interactions of ALPROLIX with other medicinal products have been reported.
Croatian: Nisu zabilježene interakcije lijeka ALPROLIX s drugim lijekovima.
English: If a repeat dose is required to control the bleed, the prolonged half-life of ALPROLIX should be taken into account (see section 5.2).
Croatian: Ako je za kontrolu krvarenja potrebno ponoviti dozu, treba voditi računa o produljenom poluvijeku lijeka APROLIX (vidjeti dio 5.2).
English: Degree of haemorrhage / Type of surgical procedure
Croatian: Stupanj krvarenja / vrsta kirurškog postupka
English: The procedure below describes the preparation and administration of ALPROLIX.
Croatian: Sljedeći postupak opisuje pripremu i primjenu lijeka ALPROLIX.
English: ALPROLIX should be administered using the infusion set (E) provided in this pack.
Croatian: ALPROLIX treba primijeniti pomoću kompleta za infuziju (E) priloženog u ovom pakiranju.
English: After repeated treatment with human coagulation factor IX products, patients should be monitored for the development of neutralising antibodies (inhibitors) that should be quantified in Bethesda Units (BU) using appropriate biological testing.
Croatian: Nakon ponovljenog liječenja lijekovima s ljudskim faktorom zgrušavanja krvi IX, bolesnike treba nadzirati zbog mogućeg razvoja neutralizirajućih protutijela (inhibitora) koje treba kvantificirati u Bethesda jedinicama (BU) pomoću odgovarajućeg biološkog testiranja.
English: ALPROLIX should be injected intravenously over several minutes.
Croatian: ALPROLIX treba ubrizgavati intravenski tijekom nekoliko minuta.
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor IX, ATC code: B02BD04
Croatian: Farmakoterapijska skupina: antihemoragici, faktor zgrušavanja krvi IX, ATK oznaka: B02BD04 Mehanizam djelovanja
English: Therefore, patients experiencing allergic reactions should be evaluated for the presence of an inhibitor.
Croatian: Stoga, u bolesnika koji razviju alergijske reakcije treba provjeriti je li prisutan inhibitor.
English: Pharmacokinetic samples were collected pre-dose and then subsequently at 11 time points up to 240 hours (10 days) post-dose.
Croatian: Farmakokinetički uzorci bili su prikupljeni prije doziranja, a potom u 11 vremenskih točaka u razdoblju od 240 sati (10 dana) nakon doziranja.
English: The highest recommended dose for prophylaxis is 100 IU/kg
Croatian: Najviša preporučena doza za profilaksu je 100 IU/kg.
English: With the exception of one patient whose last prescribed dose was 100 IU/kg every 5 days, the other 29 patients last prescribed doses were up to 70 IU/kg every 7 days.
Croatian: Uz iznimku jednog bolesnika kojem je zadnja propisana doza iznosila 100 IU/kg svakih 5 dana, zadnje propisane doze u ostalih 29 bolesnika bile su do 70 IU/kg svakih 7 dana.
English: The date that the product is removed from refrigeration should be recorded on the carton.
Croatian: Datum vađenja lijeka iz hladnjaka treba zabilježiti na kutiji.
English: Treatment with ALPROLIX will be started by a doctor who is experienced in the care of patients with haemophilia.
Croatian: Liječenje lijekom ALPROLIX započet će liječnik koji ima iskustva u liječenju bolesnika s hemofilijom.
English: Treatment of bleeding: Of the 636 bleeding events observed during study I, 90.4 % were controlled with 1 injection and overall 97.3% with 2 or fewer injections.
Croatian: Liječenje krvarenja: Od 636 događaja krvarenja opaženih tijekom ispitivanja I, 90,4% dovelo se pod kontrolu s 1 injekcijom, a ukupno 97,3% s 2 ili manje injekcija.
English: Repeat injection after 24 hours, as needed until healing is achieved1.
Croatian: Ponovite injekciju nakon 24 sata po potrebi, sve dok se ne postigne zacjeljivanje 1.
English: <6 years
Croatian: 4 godine