FrancophonIA/ELRC3.0 huggingface dataset:
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 koji nastaje zbog snižene razine faktora VIII:C i rezultira profuznim krvarenjem u zglobove, mišiće i unutarnje organe, bilo spontano ili kao posljedica slučajnih ili kirurških trauma.
English: Dose based on bodyweight may require adjustment in underweight or overweight patients.
Croatian: Doza koja se temelji na tjelesnoj težini može zahtijevati prilagodbu kod pothranjenih bolesnika ili bolesnika prekomjerne tjelesne težine.
English: In patients with existing cardiovascular risk factors, substitution therapy with factor VIII may increase the cardiovascular risk.
Croatian: Kod bolesnika s postojećim kardiovaskularnim čimbenicima rizika, nadomjesna terapija faktorom VIII može povećati kardiovaskularni rizik.
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of bleeding, and on 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: Anaphylaxis is a severe allergic reaction that can cause difficulty in swallowing and/or breathing, red or swollen face and/or hands.
Croatian: Anafilaksija je teška alergijska reakcija koja može prouzročiti poteškoće pri gutanju i/ili disanju, crvenilo i oticanje lica i/ili šaka.
English: ReFacto AF has no influence on the ability to drive and use machines.
Croatian: ReFacto AF ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Note: To prevent the escape of fluid from the tip of the syringe, do not push the plunger rod with excessive force.
Croatian: Napomena: Da biste spriječili izlazak tekućine s vrha štrcaljke, nemojte prejako potiskivati klip.
English: Because of 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 dostupnog iskustva s primjenom faktora VIII tijekom trudnoće i dojenja.
English: For children not previously treated with factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Croatian: U djece koja ranije nisu bila liječena lijekovima koji sadrže faktor VIII, vrlo često (u više od 1 na 10 bolesnika) mogu nastati inhibitorna antitijela (vidjeti dio 2.); međutim, u bolesnika koji su ranije primali terapiju s faktorom VIII (više od 150 dana liječenja) rizik je manje čest (manje od 1 na 100 bolesnika).
English: Wipe the top of the vial with the alcohol swab provided, or use another antiseptic solution and allow to dry.
Croatian: Obrišite vrh bočice priloženom vaticom natopljenom alkoholom ili uporabite drugu antiseptičku otopinu i ostavite da se osuši.
English: What you need to know before you use ReFacto AF
Croatian: Što morate znati prije nego počnete primjenjivati ReFacto AF
English: In patients with haemophilia A (inborn factor VIII deficiency), it is missing or not working properly.
Croatian: U bolesnika s hemofilijom A (urođenim nedostatkom faktora VIII) taj faktor ili nedostaje ili ne funkcionira ispravno.
English: The calculation of the required dose of factor VIII is based upon the empirical finding that 1 IU of 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 nalazu da 1 IU faktora VIII po kg tjelesne težine povećava aktivnost faktora VIII u plazmi za 2 IU/dl.
English: Required units (IU) = body weight (kg) x desired factor VIII rise (% or IU/dl) x 0.5 (IU/kg per IU/dl), where 0.5 IU/kg per IU/dl represents the reciprocal of the recovery generally observed following infusions of factor VIII.
Croatian: Potreban broj jedinica (IU) = tjelesna težina (kg) x željeno povećanje faktora VIII (% ili IU/dl) x 0,5 (IU/kg po IU/dl), gdje 0,5 IU/kg po IU/dl predstavlja recipročnu vrijednost povrata po jedinici doze koji se općenito opaža nakon infuzije faktora VIII.
English: Patients should follow the specific reconstitution and administration procedures provided by their doctors.
Croatian: Bolesnici trebaju slijediti posebne postupke pripreme i primjene prema uputama njihovog liječnika.
English: Once you learn how to self-infuse, you can follow the instructions in this Package Leaflet.
Croatian: Nakon što naučite sami sebi primijeniti lijek infuzijom, možete slijediti niže opisane upute.
English: All components used in the reconstitution and administration of this product should be used as soon as possible after opening their sterile containers, to minimise unnecessary exposure to the air.
Croatian: 3. Sav pribor koji se koristi za pripremu i primjenu ovog lijeka treba uporabiti što prije nakon otvaranja sterilnih pakiranja u kojima se nalaze, kako bi se nepotrebno izlaganje zraku svelo na najmanju moguću mjeru.
English: The manufacturing process for ReFacto was modified to eliminate any exogenous human- or animal-derived protein in the cell culture process, purification, or final formulation; and at the same time the invented name was changed to ReFacto AF.
Croatian: Proces proizvodnje lijeka ReFacto izmijenjen je kako bi se tijekom postupka kultivacije stanica, pročišćavanja i konačne formulacije uklonili svi egzogeni proteini ljudskog ili životinjskog porijekla; te je istovremeno zaštićeni naziv promijenjen u ReFacto AF.
English: • certain blood tests may show an increase in antibodies to factor VIII
Croatian: • određene krvne pretrage mogu pokazati porast protutijela na faktor VIII
English: For long-term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses are 20 to 40 IU of factor VIII per kg body weight at intervals of 2 to 3 days.
Croatian: Za dugotrajnu profilaksu krvarenja u bolesnika s teškom hemofilijom A, uobičajene doze su 20 do 40 IU faktora VIII po kg tjelesne težine u vremenskim razmacima od 2 do 3 dana.
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in IU (relative to an International Standard for factor VIII in plasma).
Croatian: Aktivnost faktora VIII u plazmi izražava se kao postotak (u odnosu na normalnu ljudsku plazmu) ili u IU (u odnosu na Međunarodni standard za faktor VIII u plazmi).
English: Degree of haemorrhage/ Type of surgical procedure
Croatian: Stupanj krvarenja/ vrsta kirurškog postupka
English: When prescribing ReFacto AF it is important to individually titrate and monitor each patient's factor level in order to ensure an adequate therapeutic response (see section 4.8).
Croatian: Kad se propisuje ReFacto AF, važno je pojedinačno titrirati i pratiti razinu faktora kod svakog bolesnika da bi se osigurao odgovarajući terapijski odgovor (vidjeti dio
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered (see section 4.8).
Croatian: Ako je neophodan centralni venski kateter (CVK), treba uzeti u obzir komplikacije vezane uz centralni venski kateter koje uključuju lokalnu infekciju, bakterijemiju i trombozu na mjestu katetera (vidjeti dio 4.8).
English: Also there can be significant discrepancies between assay results obtained by aPTT-based one-stage clotting assay and the chromogenic assay.
Croatian: Također može biti značajnih razlika između rezultata testa dobivenih jednofaznim testom zgrušavanja na temelju aPTT-a i kromogenog testa.
English: Any unused product or waste material is to be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek ili otpadni materijal potrebno je zbrinuti sukladno nacionalnim propisima.
English: Angina pectoris; tachycardia; palpitations
Croatian: Srčani poremećaji angina pektoris; tahikardija; palpitacije
English: b Patients aged 6 to <12 years only.
Croatian: Samo bolesnici u dobi od 6 do < 12 godina.
English: The ratios of geometric least-square means of month 6-to-baseline pharmacokinetic were 107%, 100% and 104% for recovery, AUCt and AUC∞, respectively.
Croatian: Omjeri geometrijskih srednjih vrijednosti najmanjih kvadrata farmakokinetičkih parametara u 6. mjesecu naspram početnih iznosili su 107%, 100% za AUCt i 104% za povrat, AUCt i AUC.
English: Avoid touching the open end of the syringe or the protective blue vented cap.
Croatian: Izbjegavajte dodirivati otvoreni kraj štrcaljke ili zaštitni plavi propusni zatvarač.
English: 5 How to store ReFacto AF Contents of the pack and other information
Croatian: Kako čuvati ReFacto AF Sadržaj pakiranja i druge informacije
English: - if your bleeding does not stop as expected and contact your doctor or seek immediate emergency care.
Croatian: - ako Vam krvarenje ne prestane prema očekivanju, obratite se liječniku ili odmah potražite medicinsku pomoć.
English: Administration (Intravenous Infusion)
Croatian: Primjena (intravenska infuzija)
English: Due to the difference in methods used to assign product potency of XYNTHA and ReFacto AF, 1 IU of the XYNTHA product (one-stage assay calibrated) is approximately equivalent to 1.38 IU of the ReFacto AF product (chromogenic assay calibrated).
Croatian: Zbog razlike u metodama koje su se rabile za dodjeljivanje jačine lijekovima XYNTHA i ReFacto AF, 1 IU lijeka XYNTHA (kalibrirano jednofaznim testom) približno odgovara 1,38 IU lijeka ReFacto AF (kalibrirano kromogenim testom).
English: The cap may need to be replaced (if not administering reconstituted ReFacto AF immediately), so set it aside by placing it on its top.
Croatian: Možda ćete morati vratiti zatvarač (ako pripremljeni ReFacto AF ne primijenite odmah) na štrcaljku pa ga odložite sa strane tako što ćete ga postaviti vrhom dolje.
English: The ratios of geometric least-square means of ReFacto AF-to-ReFacto were 100.6%, 99.5% and 98.1% for recovery, AUCt and AUC∞ (area under the plasma concentration curve from time zero to infinity), respectively.
Croatian: Omjeri geometrijskih srednjih vrijednosti najmanjih kvadrata za ReFacto AF i ReFacto iznosili su 100,6%, 99,5% za AUCt i 98,1% za povrat, AUCt i AUC∞ (površina ispod krivulje koncentracije u plazmi od vremena nula do beskonačno).
English: Some of the signs of allergic reactions are difficulty in breathing, shortness of breath, swelling, hives, itching, tightness of the chest, wheezing, and low blood pressure.
Croatian: Neki znakovi alergijskih reakcija su otežano disanje, nedostatak zraka, oticanje, koprivnjača, svrbež, stezanje u prsnom košu, piskanje pri disanju i nizak krvni tlak.
English: If a patient normally treated with XYNTHA is prescribed ReFacto AF, the treating physician may consider adjustment of dosing recommendations based on factor VIII recovery values.
Croatian: Ako se bolesniku koji se obično liječi lijekom XYNTHA propiše ReFacto AF, nadležni liječnik može razmotriti prilagodbu preporučenih doza na temelju vrijednosti povrata faktora VIII.
English: ReFacto AF should be administered using the infusion set included in the kit, unless otherwise advised by your doctor or other healthcare professional.
Croatian: ReFacto AF treba primijeniti pomoću pribora za infuziju uključenog u komplet, osim ako liječnik ili drugi zdravstveni radnik ne savjetuju drugačije.
English: By 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 u plazmi se povisuju razine faktora VIII, što omogućuje privremenu korekciju nedostatka tog faktora i korekciju sklonosti krvarenju.
English: Other sterile disposable syringes may be used for administration.
Croatian: Druge sterilne štrcaljke za jednokratnu uporabu mogu se uporabiti za primjenu.
English: Allow the pre-filled syringe to reach room temperature.
Croatian: Dopustite da napunjena štrcaljka dosegne sobnu temperaturu.
English: The medicinal product contains traces of hamster proteins.
Croatian: Lijek sadrži proteine hrčka u tragovima.
English: Only the provided infusion set is to be used, because treatment failure can occur as a consequence of human-coagulation factor VIII adsorption to the internal surfaces of some infusion equipment.
Croatian: Smije se upotrijebiti samo priloženi set za infuziju, zato što liječenje može biti neuspješno ako dođe do adsorpcije ljudskog koagulacijskog faktora VIII na unutarnju površinu nekog infuzijskog pribora.
English: • inhibitor development for patients who have been previously treated with factor VIII products (less than 1 in 100 patients)
Croatian: • razvoj inhibitora u bolesnika koji su prethodno bili liječeni lijekovima s faktorom VIII (manje od 1 na 100 bolesnika)
English: The product, when reconstituted, contains polysorbate-80, which is known to increase the rate of di-(2-ethylhexyl) phthalate (DEHP) extraction from polyvinyl chloride (PVC).
Croatian: Lijek nakon rekonstitucije sadrži polisorbat 80, za koji je poznato da povećava brzinu ekstrakcije di(2-etilheksil)ftalata (DEHP) iz polivinil klorida (PVC).
English: One IU of factor VIII activity is equivalent to the quantity of factor VIII in one mL of normal human plasma.
Croatian: Djelovanje jednog IU faktora VIII odgovara količini faktora VIII u jednom ml normalne ljudske plazme.
English: Allergic reactions If severe, sudden allergic reactions (anaphylactic) occur, the infusion must be stopped immediately.
Croatian: Ako nastanu teške, iznenadne alergijske reakcije (anafilaktičke), odmah morate prekinuti primjenu infuzije.
English: Remove the tourniquet.
Croatian: Uklonite podvezu.
English: After infusing ReFacto AF, remove the infusion set and discard.
Croatian: Nakon davanja infuzije ReFacto AF, uklonite pribor za infuziju i bacite ga.
English: - if you are allergic to hamster proteins.
Croatian: - ako ste alergični na proteine hrčka.
English: • decreased appetite, diarrhoea, vomiting, stomach pain, nausea
Croatian: • smanjen apetit, proljev, povraćanje, bol u trbuhu, mučnina
English: If you are not going to use the ReFacto AF solution immediately, you should store the syringe in an upright position, with the protective blue vented cap on the pre-filled syringe until you are ready to infuse.
Croatian: Ako nećete odmah primijeniti ReFacto AF otopinu, štrcaljku trebate čuvati u uspravnom položaju, s plavim zaštitnim propusnim zatvaračem na napunjenoj štrcaljki sve dok niste spremni primijeniti infuziju.
English: When infused into a haemophiliac patient, factor VIII binds to the von Willebrand factor present in the patient's circulation.
Croatian: Kad se primijeni infuzijom bolesniku s hemofilijom, faktor VIII veže se za von Willebrandov faktor prisutan u krvotoku bolesnika.
English: Note: If you need to use more than one pre-filled syringe of ReFacto AF per infusion, each syringe should be reconstituted according to the specific directions.
Croatian: Napomena: Ako trebate primijeniti više od jedne napunjene štrcaljke lijeka ReFacto AF po infuziji, svaku je štrcaljku potrebno pripremiti prema posebnim uputama.
English: ReFacto AF should not be mixed with other infusion solutions.
Croatian: ReFacto AF ne smije se miješati s drugim otopinama za infuziju.
English: Additional safety experience in children has been accrued through studies that encompassed both previously treated (n=18 aged <6 years and n=19 aged 6 to <12 years) and previously untreated (n=23 aged <6 years) patients and which supports a safety profile similar with that observed in adult patients.
Croatian: Dodatno iskustvo o sigurnosti primjene u djece prikupljeno je tijekom ispitivanja koja su obuhvatila prethodno liječene (n = 18 u dobi < 6 godina i n = 19 u dobi od 6 do < 12 godina) i prethodno neliječene (n = 23 u dobi < 6 godina) bolesnike te ono podržava sigurnosni profil sličan onome koji je zabilježen u odraslih bolesnika.
English: Antibody test positive; Anti-factor VIII antibody test positive
Croatian: Pretrage pozitivan test na protutijela; pozitivan test na protutijela na faktor VIII
English: For the purposes of these instructions, this device will be referred to as a pre-filled syringe.
Croatian: U ovim ćemo uputama tu napravu nazivati napunjena štrcaljka.
English: One event of cyst in an 11-year old patient and one event described as confusion in a 13-year old patient have been reported as possibly related to ReFacto AF treatment
Croatian: Za jedan slučaj ciste u 11-godišnjeg bolesnika i jedan slučaj opisan kao smetenost u 13-godišnjeg bolesnika zabilježeno je da postoji mogućnost povezanosti s liječenjem lijekom ReFacto AF.
English: The frequencies are based on all causality treatment emergent adverse events in pooled clinical trials with 765 subjects.
Croatian: Učestalosti se temelje na štetnim događajima nastalim tijekom liječenja zbog bilo kojeg uzroka u udruženim kliničkim ispitivanjima na 765 bolesnika.
English: A separate 10 cc or larger luer lock syringe (not included in this kit) may be used to draw back the reconstituted contents of each syringe (see
Croatian: Zasebna štrcaljka od 10 cc ili veća štrcaljka s luer lock-om (nije uključena u ovaj komplet) može se uporabiti za izvlačenje pripremljenog sadržaja svake štrcaljke (pogledajte Dodatne upute)
English: Inhibitor development
Croatian: Razvoj inhibitora
English: ReFacto AF is administered by intravenous (IV) infusion after reconstitution.
Croatian: ReFacto AF primjenjuje se intravenskom (i.v.) infuzijom nakon pripreme.
English: Reports of lack of effect, mainly in prophylaxis patients, have been received in the clinical trials and in the post-marketing setting for ReFacto.
Croatian: Prijave izostanka učinka, uglavnom u bolesnika koji su primali profilaksu, zaprimljene su u kliničkim ispitivanjima i nakon stavljanja lijeka ReFacto u promet.
English: For reconstitution instructions prior to administration, see section 6.6.
Croatian: Za upute o rekonstituciji lijeka prije primjene vidjeti dio 6.6.
English: - the formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medicines.
Croatian: - stvaranje inhibitora (antitijela) poznata je komplikacija koja se može pojaviti tijekom liječenja bilo kojim lijekom koji sadrži faktor VIII.
English: Please see package leaflet, section 3, for additional information on reconstitution and administration.
Croatian: Molimo pogledajte dio 3. upute o lijeku za dodatne informacije o rekonstituciji i primjeni.
English: Several began with OD infusions but switched to prophylaxis treatment during their participation, and some had only sporadic prophylaxis infusions.
Croatian: Nekoliko njih započelo je s infuzijama primljenim prema potrebi, ali su prešli na profilaktičko liječenje tijekom sudjelovanja u ispitivanju, dok su neki od njih samo povremeno primali profilaktičke infuzije.
English: Another moroctocog alfa product approved for use outside Europe has a different manufacturing potency assigned that has been calibrated to the WHO International Standard using a one-stage clotting assay; this product is identified by the tradename XYNTHA.
Croatian: Drugi lijek s moroktokogom alfa odobren za primjenu izvan Europe ima različitu jačinu dodijeljenu prema proizvodnom standardu jačine kalibriranom prema Međunarodnom standardu SZO-a pomoću jednofaznog testa zgrušavanja krvi; taj se lijek prepoznaje po zaštićenom nazivu XYNTHA.
English: Data on immune tolerance induction (ITI) have been collected in patients with haemophilia A who had developed inhibitors to factor VIII.
Croatian: Podaci o izazivanju imunološke tolerancije (ITI) prikupljeni su u bolesnika s hemofilijom A koji su razvili inhibitore na faktor VIII.
English: Based on their current regimen, individuals with haemophilia A should be advised to bring an adequate supply of factor VIII product for anticipated treatment when travelling.
Croatian: Ovisno o režimu koji trenutno primaju, pojedinim osobama s hemofilijom A treba savjetovati da na putovanje ponesu odgovarajuću zalihu lijeka s faktorom VIII za predviđeno liječenje.
English: * The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay.
Croatian: * Jačina (internacionalne jedinice) je određena pomoću kromogenog testa prema Europskoj farmakopeji.
English: These patients (n=59; median age 10 ± 8.3 months) had a mean recovery at Week 0 of 1.5 ± 0.6 IU/dl per IU/kg (range 0.2 to 2.8 IU/dl per IU/kg) which was lower than that obtained in PTPs treated with ReFacto at Week 0 with a mean recovery of 2.4 ± 0.4 IU/dl per IU/kg (range 1.1 to 3.8 IU/dl per IU/kg).
Croatian: Ti su bolesnici (n=59; medijan dobi 10 ± 8,3 mjeseci) imali srednju vrijednost prirasta po jedinici doze u 0. tjednu od 1,5 ± 0,6 IU/dl po IU/kg (u rasponu od 0,2 do 2,8 IU/dl po IU/kg) koji je bio niži od onog dobivenog u 0. tjednu u prethodno liječenih bolesnika koji su primali ReFacto sa srednjim povratom od 2,4 ± 0,4 IU/dl po IU/kg (u rasponu od 1,1 do 3,8 IU/dl po IU/kg).
English: At the end of this room temperature storage period, the product must not be put back in the refrigerator, but must be used or discarded.
Croatian: Na kraju tog razdoblja čuvanja na sobnoj temperaturi, lijek se ne smije vratiti natrag u hladnjak, nego se mora primijeniti ili baciti.
English: Note: Please dispose of all unused solution, the empty pre-filled syringe, and the used medical supplies in an appropriate container for throwing away medical waste, as these materials may hurt others if not disposed of properly.
Croatian: Napomena: Molimo bacite svu neiskorištenu otopinu, praznu napunjenu štrcaljku i potrošeni medicinski pribor u odgovarajući spremnik za odlaganje medicinskog otpada, da se druge osobe ne bi ozlijedile u slučaju neispravnog odlaganja ovog otpada.
English: Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Croatian: Unutar svake skupine po učestalosti nuspojave su prikazane u padajućem nizu prema ozbiljnosti.
English: Intravenous use, single use administration only.
Croatian: Intravenska primjena, samo za jednokratnu primjenu.
English: Dose by weight (IU/kg) per bleeding episode for bleed treatment median (min, max)
Croatian: Doza prema težini (IU/kg) po epizodi krvarenja za liječenje krvarenja medijan (minimum, maksimum)
English: Reconstitute all ReFacto AF pre-filled syringes according to instructions shown above in the reconstitution directions (see Reconstitution and Administration).
Croatian: 1. Pripremite sve ReFacto AF napunjene štrcaljke prema uputama prikazanima gore u uputama za pripremu (pogledajte Priprema i primjena).
English: No interactions of recombinant coagulation factor VIII products with other medicinal products have been reported.
Croatian: Nisu zabilježene interakcije rekombinantnog koagulacijskog faktora VIII s drugim lijekovima.
English: Pharmacokinetic properties of ReFacto, derived from a cross-over study of ReFacto and a plasmaderived FVIII concentrate, using the chromogenic substrate assay (see section 4.2), in 18 previously treated patients are listed in the table below.
Croatian: Farmakokinetička svojstva lijeka ReFacto, izvedena iz ukriženog ispitivanja lijeka ReFacto i koncentrata FVIII dobivenog iz plazme, pomoću testa kromogenim supstratom (vidjeti dio 4.2), u 18 prethodno liječenih bolesnika navedena su u tablici niže.
English: In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma levels (in % of normal or in IU/dl) in the corresponding period.
Croatian: U slučaju krvarenja, aktivnost faktora VIII ne smije pasti ispod zadanih razina u plazmi (u % normalne vrijednosti ili u IU/dl) u odgovarajućem razdoblju.