FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor will explain to you how much you should use, when you should use it and for how long.
Croatian: Vaš će Vam liječnik objasniti koliko lijeka trebate primijeniti, kada ga trebate primijeniti i kako dugo.
English: In the absence of compatability studies, this medicinal product must not be mixed with other medicinal products.
Croatian: Zbog nedostatka ispitivanja kompatibilnosti ovaj lijek se ne smije miješati s drugim lijekovima.
English: In case of shock, the current medical standards for shock treatment should be observed.
Croatian: U slučaju šoka, treba primijeniti važeće medicinske standarde za liječenje šoka.
English: Side effects in children are expected to be the same as in adults.
Croatian: Očekuju se da će nuspojave kod djece biti iste kao i kod odraslih.
English: Allergic reactions (hypersensitivity reactions) have occurred rarely in the treatment of bleeding disorders with similar medicines (affecting up to 1 in 1,000 people), and sometimes progress to shock.
Croatian: Alergijske reakcije (reakcije preosjetljivosti) rijetko se pojavljuju u liječenju poremećaja krvarenja sličnim lijekovima (javljaju se u do 1 na 1000 osoba) i ponekad prerastu u šok.
English: Coagadex was considered to be good (7%) or excellent (91%) in treating 98% of bleeding episodes.
Croatian: Lijek Coagadex smatrao se dobrim (7%) ili izvrsnim (91%) u liječenju 98% epizoda krvarenja.
English: Four subjects were aged 0 to 5 years and five were aged 6 to 11 years inclusive.
Croatian: Četiri ispitanika bila su u dobi između 0 i 5 godina, a pet ih je bilo u dobi od 6 do uključivo 11 godina.
English: The careful control of dose and duration of treatment is especially important in cases of major surgery.
Croatian: Pažljiva kontrola doze i trajanja liječenja posebno je važna u slučajevima velikog operativnog zahvata.
English: After: During the first few days after the operation, your plasma factor X concentration will be checked regularly.
Croatian: Poslije: Tijekom prvih nekoliko dana nakon operativnog zahvata, redovito će se provjeravati koncentracija faktora X u Vašoj plazmi.
English: Generally the doses for children less than 12 years old are larger than doses for adolescents which should follow those in adults.
Croatian: Uobičajeno, doze za djecu mlađu od 12 godina veće su od doza za adolescente, koje trebaju pratiti dozu za odrasle.
English: If the solution is cloudy or has any particles, do not use it.
Croatian: Ako je otopina zamućena ili sadrži čestice, nemojte je upotrijebiti.
English: No adverse events were reported relating to this overdose.
Croatian: Nisu prijavljeni štetni događaji vezani uz to predoziranje.
English: Your doctor will usually tell you your dose in terms of the number of full vials that supply the dose most suited to you.
Croatian: Vam liječnik obično reći Vašu dozu koja se odnosi na broj punih bočica koje daju dozu koja Vam najviše odgovara.
English: Each pack contains:
Croatian: Jedno pakiranje sadrži:
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Croatian: Ako ste trudni ili dojite, mislite da biste mogli biti trudni ili planirate imati dijete, obratite se svom liječniku ili ljekarniku za savjet prije nego primijenite ovaj lijek.
English: Four bleeding episodes in two subjects were considered treatment failures.
Croatian: Četiri epizode krvarenja u dva ispitanika smatrane su neuspješnim liječenjem.
English: The dose you need will be calculated by your doctor.
Croatian: Dozu koja Vam je potrebna izračunat će Vaš liječnik.
English: During the dose-adjustment phase, two trough levels were <5 IU/dL but thereafter none were below this threshold.
Croatian: Tijekom faze prilagodbe doze, dvije najniže koncentracije bile su <5 IU/dl, ali poslije toga nijedna vrijednost nije bila ispod tog praga.
English: Although the dose can be estimated using the calculations above, whenever possible appropriate laboratory tests, such as serial factor X assays, should be performed to guide dose adjustments.
Croatian: Iako se doza može procijeniti korištenjem izračuna navedenih iznad, kad god je moguće treba provesti odgovarajuće laboratorijske testove, kao što su serijski testovi faktora X, kako bi vodili prilagodbu doze.
English: The mean age was 7.3 (range 2.6 to 11.9) years.
Croatian: Medijan dobio bio je 7,3 godine (raspon od 2,6 do 11,9 godina).
English: In general, all patients treated with Coagadex should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Croatian: Općenito, sve bolesnike liječene lijekom Coagadex treba pažljivo pratiti na razvoj inhibitora odgovarajućim kliničkim pregledima i laboratorijskim testovima.
English: Paediatric population (less than 12 years of age)
Croatian: Pedijatrijska populacija (djeca mlađa od 12 godina)
English: • The medicine should be injected when the first sign of bleeding occurs
Croatian: • Lijek treba injicirati kada se pojavi prvi znak krvarenja.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeat-dose toxicity, thrombogenicity and local tolerability.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti jednokratne i ponovljene doze, trombogenosti i lokalne ponošljivosti.
English: Both before and after treatment with this medicine, particularly for your first course of treatment, your doctor will probably carry out tests to check the level of factor X in your blood.
Croatian: I prije i nakon liječenja ovim lijekom, pogotovo kod prve kure liječenja, Vaš će liječnik vjerojatno provesti testove u svrhu provjere razine faktora X u Vašoj krvi.
English: - if the dissolved powder and solvent form a gel or a clot (if this happens please tell your healthcare provider, reporting the batch number printed on the vial).
Croatian: - ako otopljeni prašak i otapalo stvaraju gel ili grudicu (ako se ovo dogodi, molimo Vas obavijestite zdravstvenog djelatnika i prijavite broj serije otisnut na bočici).
English: How much is given regularly for long-term prevention of bleeds?
Croatian: Koliko se lijeka redovito primjenjuje za dugoročno sprječavanje krvarenja?
English: Follow the normal safety practices to administer the medicine.
Croatian: Slijedite normalne sigurnosne postupke za primjenu lijeka.
English: Note: If you have more than one vial to make up your dose, repeat steps 1 through 6 withdrawing the solution in the vial into the same syringe.
Croatian: Ako vam je potrebno više od jedne bočice kako biste napravili svoju dozu, ponovite korake od 1. do 6. povlačeći otopinu iz bočice u istu štrcaljku.
English: Ninety eight (53%) were major bleeding episodes, and 88 (47%) were minor bleeds (one bleed was not assessed).
Croatian: Devedeset osmero (53%) bile su epizode teškog krvarenja, a 88 (47%) su bila manja krvarenja (jedno krvarenje nije ocijenjeno).
English: A clear or slightly pearl-like solution should be obtained, usually in less than 1 minute (5 minutes maximum).
Croatian: Trebali biste dobiti prozirnu ili blago bisernu otopinu, obično u manje od 1 minute (najviše 5 minuta).
English: A total of 184 infusions of Coagadex were given as a preventative measure.
Croatian: Ukupno 184 infuzije lijeka Coagadex primijenjene su kao preventivna mjera.
English: Once made up, Coagadex must be used within one hour.
Croatian: Nakon pripreme, Coagadex se mora primijeniti unutar jednog sata.
English: -if you have a larger or longer bleed than usual and the bleeding does not stop after an injection of Coagadex.
Croatian: - ako imate obilnije ili dugotrajnije krvarenje nego što je uobičajeno i ono se ne zaustavi nakon injekcije lijeka Coagadex.
English: The vials should be brought to room temperature (not above 30oC) prior to the removal of the snap-off cap closure from the powder vial.
Croatian: Bočice treba zagrijati na sobnu temperaturu (ne iznad 30°C) prije skidanja „snap-off“ zatvarača s bočice praška.
English: The listed warnings and precautions for adults also apply to children (aged 2 to 11 years) and adolescents (aged 12 to 18 years).
Croatian: Navedena upozorenja i mjere opreza za odrasle primjenjive su i na djecu (u dobi od 2 do 11 godina) te adolescente (u dobi od 12 do 18 godina).
English: Check with your doctor if you think this applies to you.
Croatian: Provjerite s liječnikom ako mislite da se navedeno odnosi na Vas.
English: Immediate containers
Croatian: Neposredni spremnici
English: Do not use the water for injections if signs of particulate matter are visible.
Croatian: Nemojte koristiti vodu za injekcije ako ima vidljivih čestica.
English: After reconstitution, the product should be administered by the intravenous route at a suggested rate of 10 mL/min, but no more than 20 mL/min.
Croatian: Nakon rekonstitucije lijek treba primijeniti intravenskim putem preporučenom brzinom od 10 ml/min, ali ne više od 20 ml/min.
English: Make sure you use the product within an hour after it has been made up.
Croatian: Pazite da primijenite lijek unutar jednog sata nakon pripreme.
English: There are no known effects of this medicine on the ability to drive or operate machinery.
Croatian: Nema poznatih učinaka ovog lijeka na sposobnost upravljanja vozilima i strojevima.
English: Neither subject had any bleeds during these periods.
Croatian: Nijedan ispitanik u tom razdoblju nije imao krvarenja.
English: The median dosing interval for all of the nine children was 3 days (range 2 to 8 days).
Croatian: Medijan intervala doziranja u svih devetero ispitanika bio je 3 dana (raspon od 2 do 8 dana).
English: This also applies to any unknown or emerging viruses or other types of infections.
Croatian: To također vrijedi za sve nepoznate ili novootkrivene viruse ili za druge tipove infekcija.
English: Judge each individual bleed on its own severity.
Croatian: Procijenite svako pojedino krvarenje prema njegovoj težini.
English: Depending on individual clinical response, longer intervals, e.g. once weekly, might be adequate (see section 5.1).
Croatian: Ovisno o kliničkom odgovoru u svakog pojedinog bolesnika, mogu biti dovoljni dulji intervali, npr. jednom tjedno (vidjeti dio 5.1).
English: It is recommended that your blood factor X level is kept above 50 units/dL.
Croatian: Preporučuje se da se razina faktora X u Vašoj krvi održava iznad 50 jedinica/dl.
English: Contents of the pack and other information What Coagadex contains
Croatian: Sadržaj pakiranja i druge informacije Što Coagadex sadrži
English: Do not use this medicine after the expiry date which is stated on the containers after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na spremnicima nakon oznake „EXP“.
English: Frequencies have been evaluated according to the following convention: very common (≥1/10 subjects); common (≥1/100 to <1/10).
Croatian: Učestalosti su procijenjene u skladu sa sljedećom konvencijom: vrlo često (≥1/10 osoba); često (≥1/100 i <1/10).
English: If you administer more Coagadex than your doctor prescribed, it is possible you might develop a blood clot.
Croatian: Ako primijenite više lijeka Coagadex nego što Vam je propisao liječnik, može doći do stvaranja krvnog ugruška.
English: Of the 187 bleeding episodes in the efficacy analysis, 155 bleeds (83%) were treated with one infusion, 28 bleeds (15%) with two infusions, 3 bleeds (2%) with three infusions and 1 bleed (0.5%) with four infusions.
Croatian: Od 187 epizoda krvarenja u analizi djelotvornosti, 155 krvarenja (83%) liječeno je jednom infuzijom, 28 krvarenja (15%) s dvije infuzije, 3 krvarenja (2%) s tri infuzije i 1 krvarenje (0,5%) s četiri infuzije.
English: Pharmacokinetic studies have not been performed in children under the age of 12 years.
Croatian: Farmakokinetička ispitivanja nisu provedena u djece mlađe od 12 godina.
English: For safety information with respect to transmissible agents, see section 4.4.
Croatian: Za sigurnosne informacije o prenosivim uzročnicima vidjeti dio 4.4.
English: Citric acid
Croatian: Citratna kiselina
English: Thrombin then acts upon soluble fibrinogen and factor XIII to generate a cross-linked fibrin clot.
Croatian: Trombin zatim djeluje na topivi fibrinogen i faktor XIII kako bi stvorio unakrsno vezani fibrinski ugrušak.
English: The dose you need will depend on your normal blood level of factor X and will be calculated by your doctor.
Croatian: Doza koja Vam je potrebna ovisit će o Vašoj normalnoj razini faktora X u krvi te će je izračunati Vaš liječnik.
English: Coagadex is a white or off-white powder and is packed in quantities of 250 IU and 500 IU.
Croatian: Coagadex je bijeli ili bjelkasti prašak i pakiran je u količinama od 250 IU i 500 IU.
English: After being made up, the solution is colourless, clear or pearl-like (opalescent).
Croatian: Nakon pripreme, otopina je bezbojna, prozirna ili biserna (opalescentna).
English: The other subject, aged 22 years, used 24.6 IU/kg once weekly for 8.5 months.
Croatian: Drugi ispitanik, u dobi od 22 godine, primao je 24,6 IU/kg jednom tjedno tijekom 8,5 mjeseci.
English: Your treatment should be initiated by a doctor who is experienced in the treatment of bleeding disorders.
Croatian: Vaše liječenje treba započeti liječnik s iskustvom u liječenju poremećaja krvarenja.
English: Three children (33.3%), one in the 0-5 years age group and two in the 6-11 years age group had a total of 10 bleeds due to epistaxes, trauma or menorrhagia.
Croatian: Troje djece (33,3%), jedno dijete iz dobne skupine od 0 do 5 godina i dva djeteta iz dobne skupine od 6 do 11 godina, imalo je ukupno 10 krvarenja zbog epistakse, traume ili menoragije.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove: http:/www.ema.europa.eu
English: Frequencies of uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to
Croatian: Učestalosti manje često (≥1/1000 i <1/100); rijetko (≥1/10 000 i
English: Coagadex has no or negligible influence on the ability to drive and use machines.
Croatian: Coagadex ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: The measures taken are considered effective for the following viruses: human immunodeficiency virus (HIV), hepatitis B virus, hepatitis C virus, hepatitis A virus and parvovirus B19.
Croatian: Poduzete mjere smatraju se učinkovitima za sljedeće viruse: virus humane imunodeficijencije (HIV), virus hepatitisa B, virus hepatitisa C, virus hepatitisa A i parvovirus B19.
English: One subject, aged 58 years, used 28 IU/kg once weekly for 8 weeks and, later, 25 IU/kg every 2 weeks for more than 5 months.
Croatian: Jedan ispitanik, u dobi od 58 godina, primao je 28 IU/kg jednom tjedno tijekom 8 tjedana i kasnije 25 IU/kg svaka 2 tjedna tijekom više od 5 mjeseci.
English: If your blood factor X concentration is too low (this will be tested by your doctor), or if it decreases faster than expected, an inhibitor to factor X may be present which stops Coagadex from working properly.
Croatian: Ako je koncentracija faktora X u Vašoj krvi previše niska (to će ispitati Vaš liječnik) ili ako se smanjuje brže nego što je očekivano, možda je prisutan inhibitor faktora X koji zaustavlja pravilno djelovanje lijeka Coagadex.
English: Your treatment centre will provide a special container to dispose of any solution that remains, any used syringes, needles and empty containers.
Croatian: Centar za liječenje dat će Vam poseban spremnik za odlaganje ostataka otopine, svih iskorištenih štrcaljki, igala i praznih spremnika.
English: What Coagadex is and what it is used for
Croatian: Što je Coagadex i za što se koristi
English: Make up the medicine as follows:
Croatian: Pripremite lijek prema sljedećim uputama:
English: Factor X is converted from its inactive form to the active form (factor Xa) by the cleavage of a 52-residue peptide from the heavy chain.
Croatian: Faktor X prelazi iz svog neaktivnog oblika u aktivni oblik (faktor Xa) cijepanjem peptida od 52 ostatka s teškog lanca.
English: You can dissolve Coagadex using the needle-free Mix2Vial transfer device included within each pack.
Croatian: Možete otopiti Coagadex pomoću naprave za prijenos bez igle Mix2Vial koja se nalazi u svakom pakiranju.
English: Adult How much Coagadex is given to treat a bleed or prevent further bleeding?
Croatian: Koliko lijeka Coagadex treba primijeniti za liječenje krvarenja ili sprečavanje daljnjeg krvarenja?
English: If you use more Coagadex than you should
Croatian: Ako primijenite više lijeka Coagadex nego što ste trebali
English: Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes.
Croatian: Pažljiva kontrola nadomjesne terapije posebno je važna u slučajevima većeg operativnog zahvata ili epizode krvarenja opasnog po život.
English: The third study evaluated the use of Coagadex in routine prophylaxis of bleeding episodes in nine children aged less than 12 years of age.
Croatian: U trećem ispitivanju procijenjena je primjena lijeka Coagadex za rutinsku profilaksu epizoda krvarenja u devetero djece mlađe od 12 godina.
English: Do not use this medicine: - if the solvent is not pulled into the vial (this indicates loss of vacuum in the vial, so the powder must not be used).
Croatian: - ako se otapalo ne uvuče u bočicu (to pokazuje gubitak vakuuma u bočici, tako da se prašak ne smije koristiti).
English: Powder vial containing white or off-white powder.
Croatian: Bočica s praškom sadrži bijeli ili bjelkasti prašak.
English: Your doctor will tell you how much Coagadex to administer to treat a bleed and to prevent further bleeding; the dose required will depend on your normal blood level of factor X
Croatian: Vaš će Vam liječnik reći koju količinu lijeka Coagadex treba primijeniti za liječenje krvarenja i za sprečavanje daljnjeg krvarenja; potrebna doza ovisit će o Vašoj normalnoj razini faktora X u krvi
English: When the reconstitution process is complete, the used transfer device should be disposed of it in the ‘sharps box'.
Croatian: Kada je postupak rekonstitucije završen, iskorištenu napravu za prijenos treba odložiti u „spremnik za oštre predmete“.
English: Factor X is an inactive zymogen, which can be activated by factor IXa (via the intrinsic pathway) or by factor VIIa (via the extrinsic pathway).
Croatian: Faktor X neaktivni je zimogen, kojeg može aktivirati faktor IXa (unutrašnjim putem) ili faktor VIIa (vanjskim putem).
English: Coagadex should be injected directly into a vein.
Croatian: Coagadex treba injicirati izravno u venu.
English: This also applies to unknown or emerging viruses and other pathogens.
Croatian: To je primjenjivo i na nepoznate ili novootkrivene viruse i ostale patogene.
English: The powder should only be reconstituted with the water for injections provided in the pack.
Croatian: Prašak se smije rekonstituirati samo vodom za injekcije koja je priložena u pakiranju.
English: Eight subjects had severe FX deficiency, the other had moderate deficiency.
Croatian: Osam ispitanika imalo je teški nedostatak faktora X, u ostalih je nedostatak bio umjeren.
English: One case of accidental overdose was reported in the clinical trials, in which a subject received approximately 80 IU/kg Coagadex to treat a bleed.
Croatian: Prijavljen je jedan slučaj slučajnog predoziranja u kliničkim ispitivanjima, u kojem je ispitanik primio otprilike 80 IU/kg lijeka Coagadex za liječenje krvarenja.
English: Bring the containers of Coagadex to room temperature before mixing.
Croatian: Spremnici lijeka Coagadex trebaju doseći sobnu temperaturu prije miješanja.
English: Factor Xa associates with factor Va on a phospholipid surface to form the prothrombinase complex, which activates prothrombin to thrombin in the presence of calcium ions.
Croatian: Va na fosfolipidnoj površini kako bi formirao protrombinski kompleks koji aktivira protrombin u trombin u prisutnosti iona kalcija.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Croatian: Standardne mjere sprječavanja infekcija koje su posljedica primjene lijekova proizvedenih od ljudske krvi ili plazme uključuju odabir donora, probir pojedinačnih donacija i pulova plazme radi otkrivanja specifičnih markera infekcije i uključenje učinkovitih proizvodnih koraka za inaktivaciju/uklanjanje virusa.
English: Pharmacotherapeutic group: Anti-haemorrhagics, vitamin K and other haemostatics, coagulation factor X, ATC code: B02BD13.
Croatian: Farmakoterapijska skupina: Antihemoragijski lijekovi, vitamin K i drugi hemostatici, koagulacijski faktor X, ATK oznaka: B02BD13.
English: Patients may vary in their pharmacokinetic (e.g. half-life, in vivo recovery) and clinical responses to Coagadex.
Croatian: Bolesnici se mogu razlikovati prema farmakokinetici (npr. poluvijek, in vivo povrat) i kliničkom odgovoru na Coagadex.
English: Allergic type hypersensitivity reactions, including anaphylaxis, are possible.
Croatian: Moguće su reakcije preosjetljivosti alergijskog tipa, uključujući anafilaksiju.
English: The recommended dose of 25 IU/kg Coagadex to treat a bleed was maintained during the study for 14 of the 16 subjects.
Croatian: Preporučena doza od 25 IU/kg lijeka Coagadex za liječenje krvarenja održavala se tijekom ispitivanja kod 14 od 16 ispitanika.
English: Your doctor will advise if this use is suitable for you and, if so, of the appropriate dose.
Croatian: Vaš liječnik će Vas uputiti je li ovakva primjena odgovarajuća za Vas, te ako jest, u kojoj dozi.
English: For routine prophylaxis of bleeding episodes in children aged less than 12 years: 40 IU/kg twice weekly.
Croatian: Za rutinsku profilaksu epizoda krvarenja u djece mlađe od 12 godina: 40 IU/kg dva puta tjedno.
English: Frequency, type and severity of adverse reactions in children are expected to be the same as in adults (see section 5.1).
Croatian: Kod djece se očekuje jednaka učestalost, vrsta i težina nuspojava kao i kod odraslih (vidjeti dio 5.1).
English: Due to the rarity of hereditary factor X deficiency, experience regarding the use of Coagadex during pregnancy and breast-feeding is not available.
Croatian: Zbog rijetkosti nasljednog nedostatka faktora X, nije dostupno iskustvo u pogledu primjene lijeka Coagadex tijekom trudnoće i dojenja.
English: 1 Transfer Device (Mix2Vial)
Croatian: 1 naprava za prijenos (Mix2Vial)
English: The measures taken are considered effective for enveloped viruses such as HIV, HBV and HCV, and for the non-enveloped viruses HAV and parvovirus B19.
Croatian: Poduzete mjere smatraju se učinkovitima za viruse s ovojnicom poput HIV-a, HBV-a i HCV-a i za viruse bez ovojnice HAV i parvovirus B19.
English: Therefore, Coagadex should be used during pregnancy only if clearly indicated.
Croatian: Stoga se Coagadex smije primjenjivati tijekom trudnoće samo ako je jasno indicirano.
English: Coagadex is supplied with the amount of solvent as shown in the table.
Croatian: Coagadex se isporučuje s količinom otapala koja je prikazana u tabeli.
English: Solvent vial containing clear colourless liquid.
Croatian: Bočica s otapalom sadrži prozirnu bezbojnu tekućinu.
English: Coagadex contains approximately 100 IU/mL human coagulation factor X after reconstitution with 2.5 mL (250 IU) or 5 mL (500 IU) sterilised water for injections.
Croatian: Coagadex sadrži otprilike 100 IU/ml ljudskog koagulacijskog faktora X nakon rekonstitucije s 2,5 ml (250 IU) ili 5 ml (500 IU) sterilizirane vode za injekcije.
English: Do not use solutions that are cloudy or have deposits.
Croatian: Ne primjenjujte otopine koje su mutne ili imaju taloge.