FrancophonIA/ELRC3.0 huggingface dataset:
English: Waylivra, along with a low fat diet, is used to reduce triglyceride blood levels in patients with FCS that has been confirmed by genetic testing.
Croatian: Zajedno s dijetom siromašnom mastima, lijek Waylivra primjenjuje se za smanjenje razina triglicerida u krvi u bolesnika s FCS-om koji je potvrđen genetskim testiranjem.
English: What benefits of Waylivra have been shown in studies?
Croatian: Koje su koristi od lijeka Waylivra utvrđene u ispitivanjima?
English: For the full list of side effects and restrictions with Waylivra, see the package leaflet.
Croatian: Potpuni popis nuspojava i ograničenja pri primjeni lijeka Waylivra potražite u uputi o lijeku.
English: How is Waylivra used?
Croatian: Kako se Waylivra primjenjuje?
English: All patients in the study were on a low fat diet in addition to receiving Waylivra or placebo.
Croatian: Uz lijek Waylivra ili placebo koji su primali, svi bolesnici u ispitivanju bili su na dijeti s niskom količinom masti.
English: Waylivra was effective in reducing triglycerides in the blood in a study of 67 patients with FCS.
Croatian: U ispitivanju provedenom na 67 bolesnika s FCS-om lijek Waylivra bio je učinkovit u smanjivanju razina triglicerida u krvi.
English: The expiry date refers to the last date of that month.
Croatian: Rok valjanosti odnosi se na zadnji dan navedenog mjeseca.
English: What ATryn is and what it is used for
Croatian: Što je ATryn i za što se koristi
English: Antithrombin contains two functionally important domains.
Croatian: Antitrombin sadrži dvije funkcionalno važne domene.
English: The safety and efficacy of ATryn in children and adolescents (<18 years) have not been established.
Croatian: Sigurnost i djelotvornost lijeka ATryn u djece i adolescenata (<18 godina) nisu ustanovljene.
English: The experience from repeated treatment with this medicine is very limited.
Croatian: Iskustvo ponovljenog liječenja ovim lijekom je vrlo ograničeno.
English: It is one of the most important natural inhibitors of blood coagulation.
Croatian: To je jedan od najvažnijih prirodnih inhibitora koagulacije krvi.
English: This medicine should therefore not be used if you are less than18 years.
Croatian: Ovaj lijek se zato ne smije koristiti ako ste mlađi od 18 godina.
English: Mississauga, Ontario, Canada L5N 8H9
Croatian: Mississauga, Ontario, Kanada L5N 8H9
English: • bleeding (at site of infusion or after surgery)
Croatian: • krvarenje (na mjestu infuzije ili nakon operacije)
English: After reconstitution, from a microbiological pointy of view, this medicinal product should be used immediately.
Croatian: Nakon rekonstitucije, s mikrobiološkog gledišta, ovaj lijek treba odmah primijeniti.
English: • Information about the currently registered indications and population, including that the product is not indicated in the paediatric population.
Croatian: • Informacije o trenutno registriranim indikacijama i populaciji, uključujući informaciju da lijek nije indiciran u pedijatrijskoj populaciji.
English: However, chemical and physical stability has been demonstrated for 3 hours after reconstitution and 8 hours after dilution at a temperature not above 25°C.
Croatian: Međutim, kemijska i fizikalna stabilnost dokazana je tijekom 3 sata nakon rekonstitucije i 8 sati nakon razrjeđivanja na temperaturi koja nije prelazila 25°C.
English: The Physician educational material shall contain the following key elements:
Croatian: Edukacijski materijal za liječnike sadržavat će sljedeće ključne elemente:
English: Injury and poisoning and procedural complications Common
Croatian: Ozljede, trovanja i proceduralne komplikacije Često
English: Available data do not suggest harmful effects to the mother or infant.
Croatian: Raspoloživi podaci ne upućuju na štetne učinke za majku ili dijete.
English: It is unknown whether it is present in breast milk.
Croatian: Nije poznato je li prisutan u majčinom mlijeku.
English: In case of shock, standard medical treatment should be administered.
Croatian: U slučaju šoka treba primijeniti standardno medicinsko liječenje.
English: Other medicines and ATryn
Croatian: Ostali lijekovi i ATryn
English: Read all of this leaflet carefully before you start using this medicine because it contains important
Croatian: Pažljivo pročitajte cijelu uputu prije nego počnete primjenjivati ovaj lijek jer sadrži Vama važne podatke.
English: Frequencies are defined as: common (≥ 1/100 to < 1/10) and uncommon (≥1/1,000 to <1/100).
Croatian: Učestalosti su definirane kao: često (≥ 1/100 do < 1/10) i manje često (≥1/1000 do <1/100).
English: Patients treated with this medicine should be monitored for possible clinical immunological reactions.
Croatian: Bolesnike liječene ovim lijekom treba motriti zbog mogućih kliničkih imunoloških reakcija.
English: What you need to know before you use ATryn
Croatian: Što morate znati prije nego počnete primjenjivati ATryn
English: Antibody status should be monitored and reported.
Croatian: Treba pratiti i bilježiti status antitijela.
English: Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Croatian: Bolesnike se mora pomno motriti i pažljivo promatrati za bilo kakve simptome kroz cijelo razdoblje davanja infuzije.
English: To test whether you developed an allergic reaction, blood may be collected and tested before and some time after you have been treated with ATryn.
Croatian: Za provjeru jeste li razvili alergijsku reakciju možda će se izvaditi i testirati krv prije i neko vrijeme nakon liječenja lijekom ATryn.
English: The specific activity of ATryn is approximately 7 IU/mg protein.
Croatian: Specifična aktivnost lijeka ATryn je približno 7 IU/mg proteina.
English: Date of first authorisation: 28 July 2006 Date of latest renewal: 15 July 2016
Croatian: Datum posljednje obnove odobrenja: 15. srpnja 2016.
English: Therefore, it is important that your antithrombin blood level be maintained at sufficient levels in these situations.
Croatian: Zato je bitno da se razina antitrombina u krvi u tim situacijama održava na dostatnoj razini.
English: As with any intravenous protein product, allergic type hypersensitivity reactions are possible.
Croatian: Kao i sa svakim intravenskim proteinskim lijekom, moguće su reakcije preosjetljivosti alergijskog tipa.
English: • Clearance: 0.665 ± 0.0493 l/h (Mean ± SE)
Croatian: • Klirens: 0,665 ± 0,0493 l/h (srednja vrijednost ± SE)
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and toxicity to reproduction.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti i reproduktivne toksičnosti.
English: To protect you from developing blood clots the medicine will continue to be administered to you until your doctor determines it safe to stop treatment.
Croatian: Kako bi se spriječilo stvaranje krvnih ugrušaka, lijek će Vam se i dalje davati dok Vaš liječnik ne odredi da je sigurno prekinuti liječenje.
English: Pharmacotherapeutic Group: Antithrombotic agents: heparin group; ATC code: B01AB02.
Croatian: Farmakoterapijska skupina: Antitrombotici; heparinska grupa; ATK oznaka: B01AB02.
English: Therefore your doctor will carefully monitor the use of this medicine when administered together with these anti-clotting medicines.
Croatian: Zato će Vaš liječnik pomno motriti primjenu ovog lijeka kada se primjenjuje zajedno s tim lijekovima protiv zgrušavanja.
English: Population pharmacokinetic parameters for ATryn derived from the same study revealed (mean ± SD):
Croatian: Populacijski farmakokinetički parametri za lijek ATryn izvedeni iz istog ispitivanja pokazali su (srednja vrijednost ± SD):
English: A marketing authorization variation will be submitted to seek to expand the indication and dosing of pregnant women.
Croatian: Podnijet će se i izmjena odobrenja za stavljanje lijeka u promet u svrhu proširenja indikacija i doziranja za trudnice.
English: This post-marketing surveillance will run up until such time as 40 patients are enrolled.
Croatian: To praćenje nakon stavljanja lijeka u promet će se vršiti sve dok se ne uključi 40 bolesnika.
English: Check AT activity level 30 minutes after any change in infusion rate, or four hours after a value within the target range.
Croatian: Potrebno je provjeriti razinu aktivnosti AT-a 30 minuta nakon bilo kakve promjene brzine infuzije ili četiri sata nakon postizanja vrijednosti unutar ciljnog raspona.
English: This may be in the vessels of your legs (deep vein thrombosis) or in other vessels of your body (thromboembolism).
Croatian: To može biti u žilama nogu (tromboza dubokih vena) ili u drugim žilama tijela (tromboembolija).
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from ATryn therapy taking into account the benefit of breastfeeding for the child and the
Croatian: Nužno je odlučiti da li prekinuti dojenje ili prekinuti liječenje/suzdržati se od liječenja lijekom ATryn uzimajući u obzir korist dojenja za dijete i korist liječenja za ženu.
English: It is used when the patients are having surgery, to prevent problems due to the formation of blood clots in the vessels.
Croatian: Koristi se kad bolesnici imaju operaciju kako bi se spriječili problemi uzrokovani stvaranjem krvnih ugrušaka u žilama.
English: The factors most strongly inhibited are thrombin and Factor Xa, but also factors of contact activation, intrinsic system and the Factor VIIa/tissue factor complex.
Croatian: Faktori koji su najsnažnije inhibirani su trombin i faktor Xa, ali i faktori kontaktne aktivacije, intrinzičnog sustava i kompleks faktora VIIa/ tkivnog faktora.
English: Subsequently, antithrombin activity should be checked 1-2 times a day and dose adjustments made accordingly.
Croatian: Nakon toga treba provjeravati aktivnost antitrombina 1-2 puta dnevno i sukladno tome prilagođavati dozu.
English: If diluted, the solution prepared in infusion bags should be administered immediately and no longer than 8 hours after dilution.
Croatian: Ako je razrijeđena, otopina pripremljena u infuzijskim vrećicama treba se primijeniti odmah i ne više od 8 sati nakon razrjeđivanja.
English: If you have an inborn deficiency of antithrombin, your blood level of antithrombin is lower than normal.
Croatian: Ako imate urođeni nedostatak antitrombina, razina antitrombina u vašoj krvi je niža od normale.
English: • Area under the curve: 587.88 ± 1.63 (% x h)
Croatian: • Površina ispod krivulje: 587,88 ± 1,63 (% x h)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (1, 10 OR 25 VIALS)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU VANJSKA KUTIJA (1, 10 ILI 25 BOČICA)
English: • Distribution half-life: 1.74 ± 1.28 h, elimination half-life: 10.16 ± 1.28 h.
Croatian: • Poluvijek distribucije: 1,74 ± 1,28 h, poluvijek eliminacije: 10,16 ± 1,28 h.
English: Paediatric antithrombin levels may be different from adult levels, particularly in neonates.
Croatian: Pedijatrijske razine antitrombina mogu se razlikovati od razina u odraslih, pogotovo za novorođenčad.
English: The antithrombin activity level should be maintained above 80% for the duration of the treatment, unless clinical particulars would indicate a different effective level.
Croatian: Razina aktivnosti antitrombina treba se održavati iznad 80% tijekom cijelog liječenja, osim ako klinički podaci upućuju na drukčiju učinkovitu razinu.
English: ATryn is not indicated for use in pregnant women.
Croatian: ATryn nije indiciran za primjenu kod trudnica.
English: Feeling hot
Croatian: • osjećaj vrućine
English: It is unknown whether antithrombin alfa or its metabolites are excreted in human milk.
Croatian: Nije poznato izlučuje li se antitrombin alfa ili njegovi metaboliti u ljudsko mlijeko.
English: Reconstitution/dilution
Croatian: Rekonstitucija/razrjeđivanje
English: This medicine has been authorised under ‘exceptional circumstances'.
Croatian: Ovaj lijek je odobren u ”iznimnim okolnostima”.
English: No case of overdose has been reported.
Croatian: Nema prijavljenih slučajeva predoziranja.
English: The inhibitor-coagulation enzyme complexes are removed by the reticulo-endothelial system.
Croatian: Kompleksi inhibitora i enzima koagulacije se eliminiraju pomoću retikuloendotelnog sustava.
English: No information on the use of ATryn in patients less than 18 years is available.
Croatian: Nisu dostupne informacije o primjeni lijeka ATryn kod bolesnika mlađih od 18 godina.
English: The educational material for healthcare professionals is aimed at increasing the awareness about the potential efficacy issues resulting from off-label use of Atryn.
Croatian: Edukacijski materijal za zdravstvene radnike ima za cilj povećanje svijesti o potencijalnim problemima s djelotvornošću koji su posljedica primjene lijeka ATryn izvan uvjeta odobrenja.
English: Compatibility with PVC infusion lines with in-line filters has been established.
Croatian: Utvrđena je kompatibilnost s PVC infuzijskim cijevima s ugrađenim filtrima.
English: The results of completed study GTC AT HD 012-04 and in particular the results of investigations in pregnant women treated during the peri-partum period have been submitted.
Croatian: Podneseni su rezultati završenog ispitivanja GTC AT HD 012-04 i posebno rezultati ispitivanja kod trudnica liječenih u peripartalnom razdoblju.
English: Therapeutic Monitoring and Dose Adjustment
Croatian: Terapijsko praćenje i prilagodba doze
English: During consumptive states (e.g. major surgery, concomitant use of heparin) the actual dose may be higher.
Croatian: U potrošnim stanjima (npr. opsežna operacija, istodobno primanje heparina), stvarna doza može biti viša.
English: The first contains the reactive centre and provides a cleavage site for proteinases such as thrombin, a prerequisite for forming a stable proteinaseinhibitor complex.
Croatian: Prva sadrži reaktivni centar i osigurava mjesto cijepanja proteinaza poput trombina, što je preduvjet za stvaranje stabilnog kompleksa inhibitora i proteinaze.
English: Antithrombin alfa should therefore not be used in pregnant women.
Croatian: Stoga se antitrombin alfa ne smije primjenjivati u trudnica.
English: This medicine is used in patients who have ‘congenital antithrombin deficiency' (inherited low levels of the protein antithrombin).
Croatian: Ovaj lijek se koristi kod bolesnika koji imaju „urođeni nedostatak antitrombina” (naslijeđene niske razine proteina antitrombina).
English: However due to the difference in pharmacokinetic characteristics of this medicine in pregnant versus non-pregnant patients no recommendation for dosing in pregnancy can be given at this time (see section 4.4).
Croatian: Međutim, zbog razlike u farmakokinetičkim svojstvima ovog lijeka kod trudnih bolesnica naspram onih koje nisu trudne, u ovom trenutku nije moguće dati preporuke za doziranje u trudnoći (vidjeti dio 4.4).
English: No antibodies to antithrombin alfa have been detected up to 90 days following treatment with ATryn.
Croatian: Nisu otkrivena antitijela na antitrombin alfa do 90 dana nakon liječenja lijekom ATryn.
English: Antithrombin, a 58 kD, 432 amino-acid glycoprotein, belongs to the serpin (serine protease inhibitor) superfamily.
Croatian: Antitrombin, glikoprotein od 58 kD, 432 aminokiseline, spada u superobitelj serpina (inhibitora serin proteaze).
English: Response may vary in individual patients, achieving different levels of in vivo recovery and different half-lives.
Croatian: Odgovor se može razlikovati od bolesnika do bolesnika uz postizanje različitih razina in vivo povrata i različitih poluvijekova.
English: One International Unit (IU) of antithrombin activity is equivalent to that quantity of antithrombin in one ml of normal human plasma.
Croatian: Jedna međunarodna jedinica (IU) aktivnosti antitrombina je ekvivalentna količini antitrombina u jednom ml normalne ljudske plazme.
English: In the treatment of congenital antithrombin deficiency, the dose and duration of treatment should be individualised for each patient taking into account the family history with regard to thromboembolic events, the actual clinical risk factors, and the laboratory assessment.
Croatian: U liječenju urođenog nedostatka antitrombina, dozu i trajanje liječenja treba individualizirati za svakog bolesnika uzimajući u obzir obiteljsku anamnezu s obzirom na tromboembolijske događaje, stvarne čimbenike kliničkog rizika i laboratorijsku procjenu.
English: - In order to properly adjust the dose of the anticoagulant and to avoid excessive hypocoagulability, controls of the extent of anticoagulation (APTT, and where appropriate anti-Factor Xa activity) should be performed regularly, at close intervals and in particular in the first minutes/hours following the start
Croatian: Kako bi se prilagodba doze antikoagulansa obavila na adekvatan način i kako bi se izbjegla prekomjerna hipokoagulabilnost, treba redovito provoditi kontrole razmjera antikoagulacije (APTT i gdje je potrebno anti-faktor Xa aktivnost), u kratkim vremenskim razmacima i pogotovo u prvim minutama/satima nakon početka primjene antitrombina.
English: Hypersensitivity to goat proteins or goat milk components.
Croatian: Preosjetljivost na proteine koze ili sastojke kozjeg mlijeka.
English: Dizziness headache
Croatian: Omaglica Glavobolja
English: In the body, antithrombin blocks thrombin, a substance that plays a central role in the process of blood clotting.
Croatian: Antitrombin u tijelu blokira trombin, tvar koja igra središnju ulogu u procesu zgrušavanja krvi.
English: The dose should be adjusted on the basis of laboratory measurements of antithrombin activity.
Croatian: Dozu treba prilagoditi na osnovi laboratorijskih mjerenja aktivnosti antitrombina.
English: ATryn contains antithrombin alfa which is similar to the naturally occurring human antithrombin.
Croatian: ATryn sadrži antitrombin alfa koji je sličan prirodnom ljudskom antitrombinu.
English: This medicine is intended for single use only.
Croatian: Ovaj lijek namijenjen je isključivo za jednokratnu primjenu.
English: Please discuss possibility of stopping the treatment with your doctor.
Croatian: Mogućnost prekida liječenja razmotrite sa svojim liječnikom.
English: - Antithrombin levels should be measured daily, in order to adjust the individual dose.
Croatian: - Razine antitrombina treba mjeriti svakodnevno kako bi se podesila pojedinačna doza.
English: This may result in a higher tendency to form clots in your blood vessels.
Croatian: To može rezultirati većom sklonošću za stvaranje ugrušaka u krvnim žilama.
English: Animal studies performed in rats did not indicate harmful effects on parturition, embryonal/foetal and post-natal development.
Croatian: Ispitivanja provedena na štakorima nisu upućivala na štetne učinke na porod, ni na razvoj embrija/fetusa ni postnatalni razvoj.
English: The reconstituted product should be administered by intravenous infusion using a sterile disposable syringe or an infusion bag with a 0.22 micron pore size in-line filter.
Croatian: Rekonstituirani lijek treba primijeniti intravenskom infuzijom pomoću sterilne jednokratne štrcaljke ili infuzijske vrećice s ugrađenim filtrom veličine pora od 0,22 mikrona.
English: The second is a glycosaminoglycan binding domain responsible for the interaction with heparin and related substances, which accelerates the inhibition of thrombin.
Croatian: Druga je domena vezanja glikozaminoglikana koja je odgovorna za interakciju s heparinom i srodnim tvarima, što ubrzava inhibiciju trombina.
English: Laboratoire Français du Fractionnement et des Biotechnologies, Les Ulis, France
Croatian: Laboratoire Français du Fractionnement et des Biotechnologies, Les Ulis, Francuska
English: The MAH shall ensure that in each Member State where Atryn is marketed, all healthcare professionals who are expected to prescribe and use Atryn have access to/are provided with the following educational package:
Croatian: Nositelj odobrenja za stavljanje lijeka u promet pobrinut će se da u svakoj državi članici gdje se ATryn nalazi na tržištu, svi zdravstveni radnici od kojih se očekuje propisivanje i primjena lijeka ATryn imaju pristup / dobiju sljedeći edukacijski paket:
English: Close surveillance with regard to immunological reactions is especially important in such situations.
Croatian: Od posebne je važnosti u tim situacijama provesti pomni nadzor u smislu imunoloških reakcija.
English: This medicinal product contains 1.65 mmol (or 37.9 mg) sodium per vial.
Croatian: Ovaj lijek sadrži 1,65 mmol (ili 37,9 mg) natrija po bočici.
English: Initial treatment starts with a loading dose targeting an antithrombin activity level of 100%.
Croatian: Početno liječenje počinje udarnom dozom koja cilja razinu aktivnosti antitrombina od 100%.
English: Protocol GTC AT HD 012-04: A Multicenter, Multinational Study to Assess the Safety and Efficacy of Antithrombin alfa in Hereditary Antithrombin (AT) Deficient Patients in High-Risk Situations for Thrombosis.
Croatian: Plan ispitivanja GTC AT HD 012-04: Multicentrično, multinacionalno ispitivanje za ocjenu sigurnosti i djelotvornosti antitrombina alfa kod bolesnika s nasljednim nedostatkom antitrombina (AT) u visokorizičnim situacijama za trombozu.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Croatian: Bolesnike treba informirati o ranim znakovima reakcija preosjetljivosti uključujući koprivnjaču, generaliziranu urtikariju, stezanje u prsištu, piskanje pri disanju, hipotenziju i anafilaksiju.
English: This medicine contains 38 mg (1.65 mmol) sodium per 10 ml vial.
Croatian: Ovaj lijek sadrži 38 mg (1,65 mmol) natrija u bočici od 10 ml.
English: The powder should be reconstituted with 10 ml of water for injections (WFI) injected along the side wall of the vial and gently swirled (not shaken) to prevent foaming.
Croatian: Prašak treba rekonstituirati s 10 ml vode za injekcije koja se ubrizga niz stijenku bočice te blago zavrtjeti (ne tresti) kako bi se spriječilo stvaranje pjene.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: Prior to launch of Atryn in each Member State the MAH must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja lijeka ATryn u promet, nositelj odobrenja za stavljanje lijeka u promet mora u svakoj državi članici s nadležnim nacionalnim tijelom dogovoriti sadržaj i format edukacijskog programa, uključujući medije komunikacije, modalitete distribucije i sve druge aspekte programa.
English: If these symptoms occur after administration, they should contact their physician.
Croatian: Ako se ti simptomi pojave nakon primjene, trebali bi se obratiti svojem liječniku.
English: Antithrombin activity is greatly enhanced by heparin and the anticoagulant effects of heparin depend on the presence of antithrombin.
Croatian: Aktivnost antitrombina uvelike se pojačava heparinom, a antikoagulantni učinci heparina ovise o prisutnosti antitrombina.
English: • Mean residence time (MRT): 8.57 ± 1.24 h
Croatian: • Srednje vrijeme zadržavanja: 8,57 ± 1,24 h
English: After the start of the maintenance dose infusion, blood for AT activity levels should be drawn at 45 minutes after the start of the loading dose infusion.
Croatian: Nakon početka infuzije doze održavanja, treba izvaditi krv za određivanje razine aktivnosti AT-a 45 minuta nakon početka davanja infuzije udarne doze.