FrancophonIA/ELRC3.0 huggingface dataset:
English: Treatment should be continued until the risk for venous thromboembolisms is reduced and/or when effective follow-on anticoagulation has been established.
Croatian: Liječenje treba nastaviti sve dok se rizik od venske tromboembolije ne smanji i/ili ne uspostavi učinkovita daljnja antikoagulacija.
English: Upon complete dissolution, the reconstituted product may be drawn up into a sterile disposable syringe.
Croatian: Nakon potpunog otapanja, rekonstituirani lijek može se uvući u sterilnu jednokratnu štrcaljku.
English: The half-life of recombinant antithrombin may be altered with concomitant treatment with these anticoagulants due to an altered antithrombin turnover.
Croatian: Poluvijek rekombinantnog antitrombina može se promijeniti kod istodobnog liječenja tim antikoagulansima zbog promijenjene metaboličke izmjene antitrombina.
English: Due to differences in pharmacokinetic characteristics of ATryn in pregnant versus non-pregnant patients, recommendations for dosing in pregnancy or in the peripartum period cannot be given.
Croatian: Zbog razlike u farmakokinetičkim svojstvima lijeka ATryn u bolesnica koje su trudne naspram onih koje nisu trudne, ne mogu se dati preporuke za doziranje u trudnoći ili u peripartalnom razdoblju.
English: Due to differences in pharmacokinetics of antithrombin alfa and plasma-derived antithrombin, treatment should follow the specific dose recommendations described below.
Croatian: Zbog razlika u farmakokinetici antitrombina alfa i antitrombina dobivenog iz plazme, liječenje treba pratiti specifične preporuke za doziranje navedene u nastavku.
English: The number of units of antithrombin alfa administered is expressed in International Units (IU), which is related to the current WHO standard for antithrombin concentrate.
Croatian: Broj jedinica danog antitrombina alfa izražava se u međunarodnim jedinicama (IU), što se odnosi na važeće standarde WHO za koncentrat antitrombina.
English: In other clinical trials with acquired antithrombin deficient cardiac surgery patients (n=118) and healthy volunteers (n=102), undesirable effects reported to be related to treatment with ATryn that were observed more than once are listed by System Organ Class in the table below.
Croatian: U drugim kliničkim ispitivanjima s bolesnicima koji su operirali srce, a imali su stečeni nedostatak antitrombina (n=118) i zdravim dobrovoljcima (n=102), prijavljene nuspojave povezane s liječenjem lijekom ATryn koje su opažene više od jedan puta navedene su u tablici niže prema klasifikaciji organskih sustava.
English: This antibody testing should be provided upon request of a physician and when the MAH receives a report suggestive of a possible immune
Croatian: To testiranje antitijela treba provesti na zahtjev liječnika i kada nositelj odobrenja za stavljanje lijeka u promet primi izvješće koje upućuje na moguću imunološku reakciju ili izostanak djelotvornosti.
English: Uncommon side effects (may affect up to 1 in 100 people) are:
Croatian: Manje česte nuspojave (mogu se javiti u manje od 1 na 100 osoba) su:
English: Limited clinical data are available on the use of antithrombin alfa in pregnant women.
Croatian: Dostupni su ograničeni klinički podaci o primjeni antitrombina alfa kod trudnica.
English: If you experience hives, itchy welts or wheals all over the skin, tightness of the chest, wheezing (difficulty breathing), you should immediately contact your physician since these might be symptoms of a severe allergic reaction.
Croatian: Ako imate koprivnjaču, područja s crvenilom i oticanjem koja svrbe po cijeloj koži, stezanje u prsištu, piskanje pri disanju (otežano disanje), odmah se obratite svojem liječniku jer to mogu biti simptomi teške alergijske reakcije.
English: Therefore, an additional check of the AT activity level should be done after the surgery.
Croatian: Zato nakon operacije treba obaviti dodatnu provjeru razine aktivnosti AT-a.
English: After intravenous administration of ATryn (intravenous bolus dose of 50 IU/kg or 100 IU/kg body weight) to congenital antithrombin deficient patients without clinical symptoms of thrombosis, and not using heparin, the incremental recovery was 2.07 ± 1.54 %/IU/kg body weight (mean ± SD).
Croatian: Nakon intravenske primjene lijeka ATryn (intravenska bolus doza od 50 IU/kg ili 100 IU/kg tjelesne težine) bolesnicima s urođenim nedostatkom antitrombina bez kliničkih simptoma tromboze i koji ne dobivaju heparin, prirast po jedinici doze bio je 2,07 ± 1,54 %/IU/kg tjelesne težine (srednja vrijednost ± SD).
English: If you have any further questions on the use of this medicine, ask your doctor.
Croatian: U slučaju bilo kakvih dodatnih pitanja u vezi s primjenom ovog lijeka, obratite se svom liječniku.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Croatian: Za upute o rekonstituciji razrjeđivanju lijeka prije primjene vidjeti dio 6.6.
English: Powder in glass vial (type I) with a stopper (siliconized bromobutyl rubber) and capped with a seal (aluminum) and flip-off cap (plastic).
Croatian: Prašak u bočici (staklo tip I) sa čepom (silikonizirana brombutil guma) i zaštitnim zatvaračem (aluminij) te kapicom na otkidanje (plastika).
English: Clinical and biological surveillance when antithrombin is used together with heparin, low molecular weight heparin or other anticoagulants which potentiate the anticoagulant activity of antithrombin:
Croatian: Klinički i biološki nadzor kada se antitrombin koristi zajedno s heparinom, heparinom niske molekulske težine ili drugim antikoagulansima koji potenciraju antikoagulantnu aktivnost antitrombina:
English: When ATryn is used together with heparin (an anti-clotting medicine), or some other anti-clotting medicines, this may increase the risk of bleeding.
Croatian: Kada se ATryn primjenjuje zajedno s heparinom (lijek protiv zgrušavanja krvi) ili nekim drugim lijekovima protiv zgrušavanja, to može povećati rizik od krvarenja.
English: In case the AT activity level is greater than 120% decrease the infusion rate by 30%.
Croatian: U slučaju da je razina aktivnosti AT-a viša od 120%, treba smanjiti brzinu infuzije za 30%.
English: In case the AT activity level is between 80% and 120% (0.8 - 1.2 IU/ml), no dose adjustment is needed.
Croatian: U slučaju da je razina aktivnosti AT-a između 80% i 120% (0,8 - 1,2 IU/ml) ne treba podešavati dozu.
English: In case the activity level is below 80% a 15 minutes bolus infusion of AT can be given to quickly restore the AT activity level.
Croatian: Ako je razina aktivnosti ispod 80%, može se dati 15-minutna bolus infuzija AT-a kako bi se brzo ponovno uspostavila razina aktivnosti AT-a.
English: In a formal clinical trial employing serial Duplex ultrasound examinations, antithrombin alfa was shown to be effective in the prevention of thromboembolic events in fourteen congenital antithrombin deficient patients in clinical high risk situations.
Croatian: U formalnom kliničkom ispitivanju u kojem su korišteni serijski pregledi duplex ultrazvukom, pokazalo se da je antitrombin alfa djelotvoran u sprječavanju tromboembolijskih događaja kod četrnaestoro bolesnika s urođenim nedostatkom antitrombina u klinički visokorizičnim situacijama.
English: The dose can be calculated utilizing the post-surgical AT activity in the loading dose formula above.
Croatian: Doza se može izračunati koristeći aktivnost AT-a nakon operacije u navedenoj formuli za udarnu dozu.
English: Antithrombin (AT) activity in plasma is expressed either as a percentage (relative to human plasma) or in International Units (relative to the International Standard for antithrombin in plasma).
Croatian: Aktivnost antitrombina (AT) u plazmi izražena je bilo kao postotak (u odnosu na ljudsku plazmu) ili u međunarodnim jedinicama (u odnosu na
English: In case the AT activity level is less than 80%, increase the maintenance infusion rate by 50%.
Croatian: U slučaju da je razina aktivnosti AT-a manja od 80%, treba povećati brzinu infuzije održavanja za 50%.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Croatian: POSEBNE MJERE ZA ZBRINJAVANJE NEISKORIšTENOG LIJEKA ILI OTPADNIH MATERIJALA KOJI POTJEČU
English: • feeling hot • infusion site reactions such as pain, bruising and redness
Croatian: • reakcije na mjestu davanja infuzije, poput boli, stvaranja modrica i crvenila
English: It is normally given in association with heparin or low molecular weight heparin (another medicine that helps to prevent blood clots).
Croatian: Obično se daje zajedno s heparinom ili heparinom niske molekulske težine (drugim lijekom koji pomaže spriječiti stvaranje krvnih ugrušaka).
English: It is possible that the surgical procedure will influence AT activity levels.
Croatian: Moguće je da kirurški zahvat utječe na razinu aktivnosti AT-a.
English: - if you are allergic to antithrombin alfa or any of the other ingredients of this medicine (listed in section - if you are allergic to goat products as antithrombin alfa is produced in the milk of transgenic goats by
Croatian: Nemojte primjenjivati ATryn: - ako ste alergični na antitrombin alfa ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ste alergični na kozje proizvode budući da se antitrombin alfa proizvodi u mlijeku transgenskih koza tehnologijom rekombinantne DNK (rDNK).
English: ATryn is indicated for the prophylaxis of venous thromboembolism in surgery of adult patients with congenital antithrombin deficiency.
Croatian: ATryn je indiciran za profilaksu venske tromboembolije u kirurgiji odraslih bolesnika s urođenim nedostatkom antitrombina.
English: Antithrombin replacement during administration of anticoagulants that potentiate the anticoagulant activity of antithrombin (e.g., heparin, low molecular weight heparin), may increase the risk of bleeding.
Croatian: Nadomjestak antitrombina tijekom primjene antikoagulansa koji potenciraju antikoagulantnu aktivnost antitrombina (npr. heparin, heparin niske molekulske težine), može povećati rizik od krvarenja.
English: The required loading dose is determined using the following formula:
Croatian: Potrebna udarna doza određuje se prema sljedećoj formuli:
English: In studies with ATryn the following side effects were reported: Common side effects (may affect up to 1 in 10 people) are:
Croatian: U ispitivanjima s lijekom ATryn prijavljene su sljedeće nuspojave: Česte nuspojave (mogu se javiti u manje od 1 na 10 osoba) su:
English: No information is available on the possible effects of antithrombin alfa on male and female fertility.
Croatian: Plodnost Nema dostupnih informacija o mogućim učincima antitrombina alfa na plodnost muškaraca i žena.
English: Do not use this medicine after the expiry date stated which is stated on the carton and vial label after EXP.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici bočice iza oznake EXP.
English: The required maintenance dose for surgical patients is given as a continuous infusion and is determined using the following formula:
Croatian: Potrebna održavanja za kirurške bolesnike daje se kao kontinuirana infuzija i određuje se sljedećom formulom:
English: The loading dose should be given as a 15 minute infusion immediately followed by initiation of the maintenance infusion.
Croatian: Udarnu dozu treba dati kao 15-minutnu infuziju neposredno nakon uvođenja infuzije održavanja.
English: Therefore it is not recommended to breastfeed whilst being treated with this medicine.
Croatian: Zato se tijekom liječenja ovim lijekom ne preporuča dojenje.
English: ATryn is supplied as a powder for solution for infusion (1750 IU powder in vial).
Croatian: ATryn se isporučuje kao prašak za otopinu za infuziju (1750 IU praška u bočici).
English: After reconstitution, 1 ml of solution contains 175 IU antithrombin alfa.
Croatian: Nakon rekonstitucije, 1 ml otopine sadrži 175 IU antitrombina alfa.
English: The most serious reported adverse reactions observed in clinical trials are haemorrhage and post procedural
Croatian: Najozbiljnije prijavljene nuspojave opažene u kliničkim ispitivanjima su krvarenje i krvarenje nakon zahvata.
English: The active substance is antithrombin alfa*: 1750 IU.
Croatian: Djelatna tvar je antitrombin alfa*: 1750 IU.
English: Vials should be brought at temperature not above 25°C prior to reconstitution.
Croatian: Prije rekonstitucije bočice treba dovesti na temperaturu koja ne prelazi 25°C.
English: Frequent antithrombin activity assessments and dosing adjustments may be necessary when starting treatment and just
Croatian: Česte procjene aktivnosti antitrombina i prilagodbe doze možda će biti potrebne na početku liječenja i neposredno nakon operacije.
English: Any unused medicinal product or waste material should be disposed of in accordance with local
Croatian: Neiskorišteni lijek ili otpadni materijali potrebno je zbrinuti sukladno nacionalnim propisima.
English: The MAH will ensure that material provided to physicians provides information on the post-marketing surveillance programme and the immunosurveillance programme.
Croatian: c) Nositelj odobrenja za stavljanje lijeka u promet će osigurati da materijali dani liječnicima pružaju informacije o programu praćenja nakon stavljanja lijeka u promet i o programu imunološkog praćenja.
English: Thus, concurrent administration of antithrombin with heparin, low molecular weight heparin, or other anticoagulants that potentiate the anticoagulant activity of antithrombin to a patient with increased risk of bleeding must be monitored clinically and biologically.
Croatian: Stoga, istodobna primjena antitrombina s heparinom, heparinom niske molekulske težine ili drugi antikoagulansima koji potenciraju antikoagulantnu aktivnost antitrombina kod bolesnika s povećanim rizikom od krvarenja, mora se motriti klinički i biološki.
English: It is normally given in association with heparin or low molecular weight
Croatian: Obično se daje zajedno s heparinom ili heparinom niske molekulske težine.
English: * potency (IU) determined using European Pharmacopoeial chromogenic assay.
Croatian: * jačina (IU) određena pomoću kromogenog testa Europske farmakopeje.
English: The usual loading dose in surgical patients (baseline AT activity 50%, bodyweight 75 kg) with congenital antithrombin deficiency in clinical risk situations is 20-25 IU/kg bodyweight.
Croatian: Uobičajena udarna doza kod kirurških bolesnika (početna aktivnost AT 50%, tjelesna težina 75 kg) s urođenim nedostatkom antitrombina u situacijama kliničkog rizika je 20-25 IU/kg tjelesne težine.
English: • Information regarding the resulting efficacy issues associated with off-label use of ATryn, especially
Croatian: • Informacije koje se odnose na nastale probleme s djelotvornošću povezane s primjenom lijeka ATryn izvan uvjeta odobrenja, posebice u pedijatrijskoj populaciji.
English: The usual maintenance dose in surgical patients with congenital antithrombin deficiency in clinical risk situations is 4-5 IU/kg/h.
Croatian: Uobičajena doza održavanja kod kirurških bolesnika s urođenim nedostatkom antitrombina u situacijama kliničkog rizika je 4-5 IU/kg/h.
English: Adverse drug reactions including lack of efficacy Physicians should be encouraged to enrol patients in the surveillance programme and results of the surveillance should be provided in the update to the EU-RMP or at the time of the annual reassessment, whichever comes first.
Croatian: Liječnike treba potaknuti da uključe bolesnike u program praćenja, a rezultate praćenja treba navesti u ažuriranom EU-RMP-u ili u vrijeme godišnje ponovljene procjene, što god od toga je prvo.
English: The other ingredients are: glycine, sodium chloride, sodium citrate
Croatian: Ostali sastojci su: glicin, natrijev klorid, natrijev citrat Kako ATryn izgleda i sadržaj pakiranja
English: The therapeutic goal of treatment with antithrombin alfa is to increase to, and maintain antithrombin activity between 80 - 120% of normal (0.8 - 1.2 IU/ml) for the duration of treatment.
Croatian: Terapijski cilj liječenja antitrombinom alfa je povećati i održati aktivnost antitrombina na 80-120% od normale (0,8 - 1,2 IU/ml) tijekom cijelog liječenja.
English: The most commonly reported adverse reactions observed in clinical trials are dizziness, headache, haemorrhage, nausea, venipuncture site haemorrhage, post procedural haemorrhage and wound secretion.
Croatian: Najčešće prijavljene nuspojave opažene u kliničkim ispitivanjima su omaglica, glavobolja, krvarenje, mučnina, krvarenje na mjestu uboda u venu, krvarenje nakon zahvata i iscjedak iz rane.
English: The calculation of the required dosage of antithrombin alfa is based on pre-treatment plasma antithrombin activity and body weight.
Croatian: Izračun potrebne doze antitrombina alfa temelji se na aktivnosti antitrombina u plazmi prije liječenja i tjelesnoj težini.
English: The solution should be slightly yellow, clear to slightly opalescent.
Croatian: Otopina treba biti blijedožuta, bistra do blago opalescentna.
English: To be taken into consideration by patients on a controlled sodium diet.
Croatian: To treba uzeti u obzir u bolesnika na dijeti s kontroliranim unosom natrija.
English: Due date
Croatian: Do datuma
English: The following information is intended for healthcare professionals only: This medicine is intended for single use only.
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima:
English: Laboratoire Français du Fractionnement et des Biotechnologies, 3 Avenue des Tropiques, ZA de
Croatian: Laboratoire Français du Fractionnement et des Biotechnologies 3 Avenue des Tropiques
English: Adverse reactions are presented below by system organ class and absolute frequency.
Croatian: Nuspojave su navedene u nastavku prema klasifikaciji organskih sustava i apsolutnoj učestalosti.
English: The reconstituted product should be inspected visually for particulate matter and/or discolouration prior to administration.
Croatian: Rekonstituirani lijek treba vizualno pregledati za prisutnost čestica i/ili promjenu boje prije primjene.
English: In clinical trials involving congenital antithrombin deficient patients (n=35) one mild undesirable effect of “application site pruritis” was reported as related to treatment with ATryn.
Croatian: U kliničkim ispitivanjima koja su uključivala bolesnike s urođenim nedostatkom antitrombina (n=35), prijavljena je jedna blaga nuspojava„svrbeža na mjestu primjene” vezano uz liječenje lijekom ATryn.
English: ** recombinant human antithrombin produced in the milk of transgenic goats by recombinant DNA
Croatian: ** rekombinantni ljudski antitrombin proizveden u mlijeku transgenskih koza tehnologijom rekombinantne DNK (rDNK).
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of patients with congenital antithrombin deficiency.
Croatian: Liječenje treba početi pod nadzorom liječnika koji ima iskustva u liječenju bolesnika s urođenim nedostatkom antitrombina.
English: Prior to launch in any EU Member State, the MAH will set up a post-marketing surveillance programme to collect the following information about congenital AT deficient patients treated with ATryn
Croatian: Praćenje nakon stavljanja lijeka u promet a) Prije stavljanja u promet u bilo kojoj zemlji članici EU, nositelj odobrenja za stavljanje lijeka u promet će uspostaviti program praćenja nakon stavljanja lijeka u promet u svrhu prikupljanja sljedećih podataka o bolesnicima s urođenim nedostatkom AT-a koji su liječeni lijekom ATryn
English: OTHER CONDITIONS AND REQUIREMENTS OF THE
Croatian: OSTALI UVJETI I ZAHTJEVI ODOBRENJA
English: * recombinant human antithrombin produced in the milk of transgenic goats by recombinant DNA
Croatian: *rekombinantni ljudski antitrombin proizveden u mlijeku transgenskih koza tehnologijom rekombinantne DNK (rDNK).
English: Some additional data have been obtained from a number of patients in
Croatian: Dobiveni su dodatni podaci od niza bolesnika u programu milosrdne primjene.
English: Any unused medicinal product should be disposed of in accordance with local requirements.
Croatian: Neiskorišteni lijek potrebno je zbrinuti sukladno nacionalnim propisima.
English: Do not use solutions that are cloudy or have deposits.
Croatian: Ne smiju se koristiti otopine koje su zamućene ili sadrže taloge.
English: Maintenance dose (IU/hour) = [(100 - patient's pre-treatment AT activity level in %) /10.22] x Body Weight in kg
Croatian: Doza održavanja (IU/sat) = [(100 - razina aktivnosti AT kod bolesnika prije liječenja u %) /10,22] x tjelesna težina u kg
English: See therapeutic monitoring and dose adjustment recommendations below.
Croatian: Preporuke za terapijsko praćenje i prilagodbu doze pogledati u nastavku.
English: POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCES
Croatian: POSEBNE OBVEZE ZA PROVEDBE MJERA NAKON DAVANJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET U IZNIMNIM OKOLNOSTIMA
English: Normal sodium chloride solution 9 mg/ml (0.9%) may be added to dilute to a concentration convenient for
Croatian: Za razrjeđenje na koncentraciju koja je odgovarajuća za primjenu, može se dodati otopina natrijevog klorida od 9 mg/ml (0,9%).
English: Loading dose (IU) = [(100 - patient's pre-treatment AT activity level in %) /2.28] x Body Weight in kg
Croatian: Udarna doza (IU) = [(100 - razina aktivnosti AT kod bolesnika prije liječenja u %) /2,28] x tjelesna težina u kg
English: ATryn 1750 IU powder for solution for infusion.
Croatian: NAZIV LIJEKA ATryn 1750 IU prašak za otopinu za infuziju.
English: This initial loading dose is based on body weight and on the pretreatment antithrombin activity level.
Croatian: Ova početna udarna doza temelji se na tjelesnoj težini i aktivnosti antitrombina prije liječenja.
English: Normal antithrombin activity in adults is 80 - 120% (0.8-1.2 IU/ml) and levels in neonates are about
Croatian: Normalna antitrombinska aktivnost kod odraslih je 80 - 120% (0,8-1,2 IU/ml) a razina kod novorođenčadi je 40 - 60% (0,4-0,6 IU/ml).
English: The contents of the syringes should be administered immediately and no longer than 3 hours after reconstitution.
Croatian: Sadržaj štrcaljki treba primijeniti odmah i ne više od 3 sata nakon rekonstitucije.
English: The risk of diminution of antithrombin levels by prolonged treatment with a non-fractionated heparin should be
Croatian: Treba uzeti u obzir rizik od pada razine antitrombina kod produljenog liječenja nefrakcioniranim heparinom.
English: The reconstituted solution should be used immediately and no longer than 3 hours after reconstitution.
Croatian: Rekonstituiranu otopinu treba upotrijebiti odmah i ne više od 3 sata nakon rekonstitucije.
English: The required maintenance dose for surgical patients is given as a continuous infusion and is determined
Croatian: Potrebna doza održavanja za kirurške bolesnike daje se kao kontinuirana infuzija i određuje se sljedećom formulom:
English: Around major surgical procedures this tendency to clot is even more increased.
Croatian: Ta se sklonost zgrušavanju dodatno povećava kod većih kirurških zahvata.
English: LFB-BIOTECHNOLOGIES, 3 Avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, France MedImmune Pharma BV Lagelandseweg 78 6545 CG Nijmegen, The Netherlands.
Croatian: LFB-BIOTECHNOLOGIES, 3 Avenue des Tropiques, ZA de Courtaboeuf, 91940 Les Ulis, Francuska.
English: Justification for not including Braille accepted.
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma.
English: One vial contains nominally 1750 IU antithrombin alfa*.
Croatian: Jedna bočica nominalno sadrži 1750 IU anitrombina alfa*.
English: Venipuncture site haemorrhage
Croatian: Therapure Biopharma
English: Powder for solution for infusion (1750 IU)
Croatian: Prašak za otopinu za infuziju (1750 IU) 1 bočica
English: If you use more ATryn than you should
Croatian: Ako prestanete primjenjivati ATryn
English: Frequency category
Croatian: BROJ SERIJE
English: The doctor will treat you, as appropriate, if you have any particular side effects.
Croatian: Ako primite više lijeka ATryn nego što ste trebali Liječnik će Vas prema potrebi liječiti ako imate bilo kakve posebne nuspojave.