FrancophonIA/ELRC3.0 huggingface dataset:
English: • If the CVAD line needs to be flushed before or after NovoSeven injection, use sodium chloride 9 mg/ml solution for injection.
Croatian: • Ako CVAD liniju treba isprati prije ili nakon injekcije lijeka NovoSeven, upotrijebite otopinu za injekciju natrijeva klorida 9 mg/ml.
English: Patients/carers should inform the physician/supervising hospital at the earliest possible opportunity about all usages of NovoSeven.
Croatian: Bolesnici/skrbnici moraju najranijom mogućom prilikom obavijestiti liječnika/nadležnu bolnicu o svim primjenama lijeka NovoSeven.
English: • If you have a serious blood infection
Croatian: • Ako imate tešku infekciju krvi
English: When you prepare and inject medication directly into the vein, it is important to use a clean and germ free (aseptic) technique.
Croatian: Kada pripremate i injicirate lijek izravno u venu, važno je koristiti tehniku koja osigurava čistu primjenu bez mikroorganizama (aseptička tehnika).
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders.
Croatian: Liječenje treba započeti pod nadzorom liječnika koji ima iskustva u liječenju hemofilije i/ili poremećaja krvarenja.
English: Clearance appears related with age, therefore in younger patients clearance may be increased by more than 50%.
Croatian: Čini se da je klirens povezan s dobi, tako da u mlađih bolesnika klirens može biti povećan za više od 50%.
English: Follow the instructions for use for the needleless connector.
Croatian: Slijedite upute za uporabu konektora za primjenu bez igle.
English: NovoSeven should be given as early as possible after the start of a bleeding episode.
Croatian: NovoSeven treba primijeniti što je moguće ranije nakon početka epizode krvarenja.
English: The excretion of rFVIIa in milk has not been studied in animals.
Croatian: Izlučivanje rFVIIa u mlijeko nije ispitivano na životinjama.
English: If continued therapy is indicated, the dose interval can then be increased to 3 hours for 1 - 2 days.
Croatian: Ukoliko je indicirana kontinuirana terapija, interval doziranja potom se može povećati na 3 sata tijekom 1 - 2 dana.
English: Dosing frequency should initially be every second hour until clinical improvement is observed.
Croatian: Učestalost doziranja u početku treba biti svaka dva sata dok se ne uoči kliničko poboljšanje.
English: Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock connections.
Croatian: Oprez: Napunjena štrcaljka izrađena je od stakla i dizajnirana kako bi bila kompatibilna sa standardnim luerlock nastavcima.
English: Initially 2 - 3 hours to obtain haemostasis.
Croatian: U početku svaka 2 - 3 sata da se postigne hemostaza.
English: NovoSeven must not be mixed with infusion solutions or be given in a drip.
Croatian: NovoSeven se ne smije miješati s infuzijskim otopinama ni davati u dripu.
English: As the total number of treatment episodes in clinical trials is below 10,000, the lowest possible frequency of adverse drug reactions that can be assigned is rare (> 1/10,000 to < 1/1,000).
Croatian: Budući da je ukupan broj liječenih slučajeva u kliničkim ispitivanjima manji od 10 000, najniža moguća učestalost nuspojava koja se može pripisati je rijetko (≥ 1/10 000 do < 1/1000).
English: - Rash (including allergic dermatitis and rash erythematous)
Croatian: - Osip (uključujući alergijski dermatitis i eritematozni osip)
English: • Do not use this medicine after the expiry date that is stated on the carton.
Croatian: • Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji.
English: You will also need an administration set (tubing and butterfly needle, sterile alcohol swabs, gauze pads and plasters).
Croatian: Trebat će Vam i set za primjenu (cjevčica i leptirasta igla, sterilni alkoholni tupferi, gaze i flasteri).
English: • Allergic, hypersensitivity or anaphylactic reactions.
Croatian: • Alergijske reakcije, reakcije preosjetljivosti ili anafilaktičke reakcije.
English: It is important that the dosage regimen of NovoSevenis compliant with the recommended dosage as stated in section 4.2.
Croatian: Važno je dozirati NovoSeven u skladu s preporučenim doziranjem kao što je navedeno u dijelu 4.2.
English: An observational registry (F7HAEM-3521) covered 133 subjects with Glanzmann's thrombasthenia treated with NovoSeven.
Croatian: Opservacijski registar (F7HAEM-3521) uključivao je 133 ispitanika s Glanzmannovom trombastenijom liječenih lijekom NovoSeven.
English: If allergic or anaphylactic-type reactions occur, the administration should be discontinued immediately.
Croatian: Ukoliko se pojave alergijske ili anafilaktičke reakcije, odmah treba prestati s liječenjem.
English: The equipment in this package is designed to reconstitute and inject NovoSeven.
Croatian: Pribor u ovom pakiranju namijenjen je za pripremu i injiciranje lijeka NovoSeven.
English: Limited clinical experience in long term prophylaxis has been gathered in the paediatric population below 12 years of age, with a severe clinical phenotype (see section 5.1).
Croatian: Ograničeno kliničko iskustvo u dugotrajnoj profilaksi prikupljeno je u pedijatrijskoj populaciji mlađoj od 12 godina s teškim kliničkim fenotipom (vidjeti dio 5.1).
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with NovoSeven should be made taking into account the benefit of breast-feeding to the child and the benefit of NovoSeven therapy to the woman.
Croatian: Potrebno je donijeti odluku o tome da li nastaviti/prekinuti dojenje, odnosno da li nastaviti/prekinuti terapiju lijekom NovoSeven uzimajući u obzir korist dojenja za dijete i korist terapije s lijekom NovoSeven za ženu.
English: Four cases of overdose have been reported in patients with haemophilia in 16 years.
Croatian: Tijekom 16 godina prijavljena su četiri slučaja predoziranja u bolesnika s hemofilijom.
English: It works in all types of bleeds, including joint bleeds.
Croatian: Djeluje kod svih vrsta krvarenja, uključujući krvarenja u zglobove.
English: Handling procedures for both presentations are described below.
Croatian: Upute za rukovanje za oba oblika opisane su u nastavku.
English: In case the factor VIIa activity fails to reach the expected level or bleeding is not controlled after treatment with the recommended doses, antibody formation may be suspected and analysis for antibodies should be performed.
Croatian: U slučaju da faktor VIIa ne uspije postići očekivanu razinu aktivnosti ili se krvarenje ne smanjuje nakon liječenja preporučenom dozom, može se posumnjati na stvaranje protutijela te je potrebna analiza na prisutnost protutijela.
English: Follow the injection procedure as instructed by your healthcare professional.
Croatian: Slijedite postupak za injiciranje u skladu s uputama zdravstvenog radnika.
English: • If you are prone to disseminated intravascular coagulation (DIC, a condition where blood clots develop throughout the blood stream) you must be carefully monitored.
Croatian: • Ako ste skloni diseminiranoj intravaskularnoj koagulaciji (DIK, stanje kad se u krvotoku stvaraju krvni ugrušci) morate biti pomno praćeni.
English: Invasive procedure/surgery
Croatian: Invazivni postupak/operativni zahvat
English: • If, at any point, there is too much air in the syringe, inject the air back into the vial.
Croatian: • Ako se u bilo kojem trenutku u štrcaljki pojavi previše zraka, ubrizgajte ga nazad u bočicu.
English: • Draw approximately 5 ml of sterile air into the 50 ml syringe (polypropylene).
Croatian: • Uvucite približno 5 ml sterilnog zraka u štrcaljku od 50 ml (polipropilen).
English: There is no requirement for monitoring of NovoSeven therapy.
Croatian: Nema zahtjeva za praćenje terapije lijekom NovoSeven.
English: • If you were born with haemophilia and do not respond normally to factors VIII or IX treatment
Croatian: • ako ste rođeni s hemofilijom i nemate normalan odgovor na liječenje faktorom VIII ili IX
English: Following the initial dose of NovoSeven further injections may be given if required.
Croatian: Nakon početne doze lijeka NovoSeven, mogu se dati dodatne injekcije ukoliko je potrebno.
English: The mechanism of action includes the binding of factor VIIa to exposed tissue factor.
Croatian: Mehanizam djelovanja uključuje vezanje faktora VIIa na izloženi tkivni faktor.
English: • If you have an increased risk of blood clots (thrombosis)
Croatian: • Ako imate povećan rizik stvaranja krvnih ugrušaka (tromboza)
English: Take care not to touch the end of the transfer needle.
Croatian: Pazite da pritom ne dotaknete kraj igle za prijenos.
English: Locate a suitable site, and slowly inject NovoSeven into a vein over a period of 2 - 5 minutes without removing the needle from the injection site.
Croatian: Nađite primjereno mjesto i polako injicirajte NovoSeven u venu tijekom perioda od 2 - 5 minuta bez micanja igle s mjesta injiciranja.
English: Safely dispose of the used materials.
Croatian: Zbrinite iskorištene materijale na siguran način.
English: A higher risk of arterial thromboembolic adverse events (see table: Vascular disorders) (5.6% in patients treated with NovoSeven versus 3.0% in placebo-treated patients) has been shown in a meta-analysis of pooled data from placebo-controlled trials conducted outside current approved indications in various clinical settings, each of these having distinct patient characteristics and hence different underlying risk profiles.
Croatian: Veći rizik od štetnih događaja povezanih s arterijskom tromboembolijom (vidjeti tablicu: Krvožilni poremećaji) (5,6% u bolesnika liječenih lijekom NovoSeven naspram 3,0% u bolesnika liječenih placebom) uočen je u metaanalizi podataka dobivenih iz placebom kontroliranih ispitivanja provedenih izvan trenutno odobrenih indikacija u različitim kliničkim uvjetima gdje svaki bolesnik ima različite karakteristike te su stoga i profili postojećeg rizika različiti.
English: Do not touch the rubber stopper after wiping it.
Croatian: Ne dirajte gumeni čep nakon što ste ga obrisali.
English: • in patients with congenital FVII deficiency
Croatian: • u bolesnika s prirođenim nedostatkom FVII
English: NovoSeven is used to treat bleeding, and to prevent excessive bleeding after surgery or other important treatments.
Croatian: NovoSeven se koristi za liječenje krvarenja i u prevenciji prekomjernog krvarenja nakon operativnih zahvata ili drugih važnih postupaka.
English: Glanzmann's thrombasthenia
Croatian: Glanzmannova trombastenija
English: • Do not use any other way to warm the vial and pre-filled syringe.
Croatian: • Ne koristite nikakav drugi način da ugrijete bočicu i napunjenu štrcaljku.
English: • Reconstitute the product as described above under Reconstitution for relevant product presentation.
Croatian: • Rekonstituirajte lijek kako je opisano gore pod Rekonstitucija za relevantnu vrstu spremnika.
English: It is recommended to use NovoSeven immediately after reconstitution.
Croatian: Preporučuje se NovoSeven primijeniti odmah nakon rekonstitucije.
English: The first dose should be given as early as possible after bleeding has started.
Croatian: Doza Prvu dozu potrebno je dati što je moguće prije nakon pojave krvarenja.
English: Eptacog alfa (activated) is recombinant coagulation factor VIIa (rFVIIa) with a molecular mass of approximately 50,000 Daltons produced in baby hamster kidney cells (BHK Cells) by recombinant DNA technology.
Croatian: Eptakog alfa (aktivirani) je rekombinantni koagulacijski faktor VIIa (rFVIIa) s molekulskom masom od približno 50 000 Daltona proizveden tehnologijom rekombinantne DNK u stanicama bubrega novorođenoga hrčka (BHK stanicama).
English: What NovoSeven is and what it is used for What you need to know before you use NovoSeven How to use NovoSeven
Croatian: Što je NovoSeven i za što se koristi Što morate znati prije nego počnete primjenjivati NovoSeven Kako primjenjivati NovoSeven
English: Subjects were stratified according to sex and ethnic group and dosed with 40, 80 and 160 µg rFVIIa per kg body weight (3 doses each) and/or placebo.
Croatian: Ispitanici su bili podijeljeni uzimajući u obzir spol i etničku skupinu i dana im je doza od 40, 80 i 160 µg rFVIIa po kg tjelesne težine (3 doze svaki) i/ili placebo.
English: - Increased fibrin degradation products
Croatian: - Povećana razina produkata nastalih razgradnjom fibrina
English: Mean volume of distribution at steady state was 196 ml/kg in paediatric patients versus 159 ml/kg in adults.
Croatian: Srednji volumen distribucije u stanju dinamičke ravnoteže bio je 196 ml/kg u pedijatrijskih bolesnika naspram 159 ml/kg u odraslih.
English: - Anaphylactic reaction
Croatian: - Anafilaktička reakcija
English: Pharmacokinetics of NovoSeven in patients with Glanzmann's thrombasthenia have not been investigated, but are expected to be similar to the pharmacokinetics in haemophilia A and B patients.
Croatian: Farmakokinetika lijeka NovoSeven u bolesnika s Glanzmannovom trombastenijom nije ispitivana, no smatra se da je slična farmakokinetici u bolesnika s hemofilijom A i B.
English: Use a disposable syringe of an appropriate size and a vial adapter, transfer needle (20 - 26G) or other suitable device.
Croatian: Upotrijebite štrcaljku za jednokratnu uporabu odgovarajuće veličine i nastavak za bočicu, iglu za prijenos (20 - 26G) ili drugo prikladno pomagalo.
English: The pharmacodynamic effect of factor VIIa gives rise to an increased local formation of factor Xa, thrombin and fibrin.
Croatian: Farmakodinamički učinci Farmakodinamički učinak faktora VIIa pojačava lokalno stvaranje faktora Xa, trombina i fibrina.
English: • If you recently had a crush injury
Croatian: • Ako ste nedavno imali ozljedu tipa nagnječenja
English: • Injecting into a CVAD may require using a sterile 10 ml plastic syringe for withdrawal of the reconstituted solution.
Croatian: • Injiciranje u CVAD može zahtijevati upotrebu sterilne plastične štrcaljke od 10 ml za uvlačenje pripremljene otopine.
English: Uncommon (≥1/1,000 to
Croatian: Rijetko (≥1/10 000 do
English: Dose and frequency of injections for prophylaxis should be based on clinical response and adapted to each individual.
Croatian: Doziranje i učestalost injekcija za profilaksu treba temeljiti na kliničkom odgovoru i prilagoditi individualno svakoj osobi.
English: NovoSeven was used in 157 surgical procedures, at a median dose of 92 µg/kg (up to 270 µg/kg).
Croatian: NovoSeven je primijenjen u 157 operativnih zahvata, a medijan doze bio je 92 µg/kg (do 270 µg/kg).
English: If devices other than those supplied by Novo Nordisk are used, ensure the use of an adequate filter with a pore size of 25 micrometer.
Croatian: Ako se koriste pomagala koja ne isporučuje Novo Nordisk, osigurajte primjenu odgovarajućeg filtera, veličine pora od 25 mikrometara.
English: Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a subcutaneous port:
Croatian: Injiciranje otopine putem pomagala za centralni venski pristup (CVAD) kao što je centralni venski kateter ili potkožni port:
English: - Coagulopathy
Croatian: - Koagulopatija
English: NovoSeven contains activated recombinant coagulation factor VII.
Croatian: NovoSeven sadrži aktivirani rekombinantni koagulacijski faktor VII.
English: A theoretical risk for the development of systemic activation of the coagulation system in patients suffering from underlying diseases predisposing them to DIC cannot be totally excluded.
Croatian: Ne može se posve isključiti teoretski rizik razvoja sistemske aktivacije koagulacijskog sustava u bolesnika koji imaju bolesti koje predisponiraju razvoj DIK-a.
English: Data from non-clinical studies as well as post-marketing data show no indication that rFVIIa has a harmful effect on male or female fertility.
Croatian: Podaci iz nekliničkih ispitivanja, kao i oni dobiveni nakon stavljanja lijeka na tržište, ne ukazuju da rFVIIa ima štetan učinak na plodnost muškaraca ili žena.
English: When NovoSeven is administered to patients outside approved indications, arterial thromboembolic events are common (≥ 1/100 to < 1/10).
Croatian: Kada se NovoSeven primjenjuje u bolesnika izvan odobrenih indikacija, arterijske tromboembolije su česte (≥ 1/100 i < 1/10).
English: For single dose injection
Croatian: Za jednokratnu injekciju.
English: Haemophilia A and B with inhibitors
Croatian: Hemofilija A i B s inhibitorima
English: NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures in the following patient groups:
Croatian: NovoSeven je indiciran za liječenje epizoda krvarenja i prevenciju krvarenja u osoba koje se podvrgavaju operativnom zahvatu ili invazivnim postupcima u sljedećim skupinama bolesnika:
English: The most frequent adverse drug reactions are pyrexia and rash (uncommon: > 1/1,000 to < 1/100), and the most serious adverse drug reactions are thromboembolic events.
Croatian: Najčešće nuspojave su pireksija i osip (manje često: ≥1/1000 do < 1/100), a najozbiljnije nuspojave su tromboembolijski događaji.
English: • All steps should be completed under controlled and validated aseptic conditions by adequately trained staff.
Croatian: • Sve korake trebaju provesti educirani zdravstveni radnici u kontroliranim i validiranim aseptičkim uvjetima.
English: Clinical trials conducted in 484 patients (including 4297 treatment episodes) with haemophilia A and B, acquired haemophilia, factor VII deficiency or Glanzmann's thrombasthenia have shown that adverse drug reactions are common (≥ 1/100 to < 1/10).
Croatian: Klinička ispitivanja provedena u 484 bolesnika (uključujući 4297 liječenih slučajeva) s hemofilijom A i B, stečenom hemofilijom, nedostatkom faktora VII ili Glanzmannovom trombastenijom, pokazala su da su nuspojave česte (≥ 1/100 do < 1/10).
English: If you forget an injection, or if you want to stop the treatment, get your doctor's advice.
Croatian: Ako ste zaboravili injicirati NovoSeven Ako ste zaboravili injekciju ili ako želite prestati s liječenjem, zatražite savjet liječnika.
English: • If you have severe liver disease
Croatian: • Ako imate tešku bolest jetre
English: • If you have Glanzmann's thrombasthenia (a bleeding disorder) and your condition cannot be treated effectively with platelet transfusion, or if platelets are not readily available.
Croatian: • ako imate Glanzmannovu trombasteniju (poremećaj krvarenja) i Vaše stanje se ne može učinkovito liječiti transfuzijom trombocita, ili ako trombociti nisu odmah dostupni.
English: If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled syringes until you have reached your required dose.
Croatian: Ako za doziranje trebate više od jedne bočice, ponovite korake A do J s dodatnim bočicama, nastavcima za bočicu i napunjenim štrcaljkama dok ne dođete do potrebne doze.
English: Make sure not to aim the stream of solvent directly at the NovoSeven powder as this will cause foaming.
Croatian: Nemojte usmjeriti mlaz otapala izravno u NovoSeven prašak jer će to izazvati pjenjenje.
English: Dose proportionality was established in children for the investigated doses of 90 and 180 µg per kg body weight, which is in accordance with previous findings at lower doses (17.5 - 70 µg/kg rFVIIa).
Croatian: Utvrđena je proporcionalnost s obzirom na dozu u djece za ispitivane doze od 90 i 180 µg po kg tjelesne težine, što odgovara ranijim nalazima pri nižim dozama (17,5 - 70 µg/kg rFVIIa).
English: Thromboembolic events may lead to cardiac arrest.
Croatian: Tromboembolije mogu dovesti do zastoja rada srca.
English: The recommended initial dose, administered by intravenous bolus injection, is 90 µg per kg body weight.
Croatian: Preporučena početna doza, primijenjena intravenski bolus injekcijom, je 90 µg po kg tjelesne težine.
English: - Increase of alanine aminotransferase, alkaline phosphatase, lactate dehydrogenase and prothrombin
Croatian: - Porast alanin aminotransferaze, alkalne fosfataze, laktat dehidrogenaze i protrombina
English: In case of severe bleeds the product should be administered in hospitals preferably specialised in treatment of haemophilia patients with coagulation factor VIII or IX inhibitors, or if not possible, in close collaboration with a physician specialised in haemophilia treatment.
Croatian: U slučaju jakih krvarenja lijek treba primijeniti po mogućosti u bolnici specijaliziranoj za liječenje bolesnika s hemofilijom s inhibitorima na koagulacijske faktore VIII ili IX, a ukoliko to nije moguće, u bliskoj suradnji s liječnikom specijaliziranim za liječenje hemofilije.
English: 2) One single injection of 270 µg per kg body weight.
Croatian: 2) Jedna pojedinačna injekcija od 270 µg po kg tjelesne težine.
English: There is no clinical experience with administration of a single dose of 270 µg per kg body weight in elderly patients.
Croatian: Nema kliničkog iskustva s primjenom pojedinačne doze od 270 µg po kg tjelesne težine u starijih bolesnika.
English: • The active substance is recombinant coagulation factor VIIa (activated eptacog alfa).
Croatian: • Djelatna tvar je rekombinantni koagulacijski faktor VIIa (eptakog alfa, aktivirani).
English: The reconstituted NovoSeven must be injected into your vein (intravenous injection).
Croatian: Pripremljeni NovoSeven mora biti injiciran u venu (intravenska injekcija).
English: The following dose varies according to the type and severity of the haemorrhage.
Croatian: Sljedeća doza varira ovisno o tipu i težini krvarenja.
English: After reconstitution, chemical and physical stability has been demonstrated for 6 hours at 25°C and 24 hours at 5°C.
Croatian: Nakon rekonstitucije, dokazana kemijska i fizikalna stabilnost iznosi 6 sati na temperaturi od 25°C i 24 sata na temperaturi od 5°C.
English: 1) Two to three injections of 90 µg per kg body weight administered at three-hour intervals.
Croatian: 1) Dvije do tri injekcije od 90 µg po kg tjelesne težine primijenjene u trosatnim intervalima.
English: It is unknown whether rFVIIa is excreted in human breast milk.
Croatian: Nije poznato izlučuje li se rFVIIa u majčino mlijeko u ljudi.
English: The initial dose interval should be 2 - 3 hours.
Croatian: Početni interval doziranja treba biti svaka 2 - 3 sata.
English: • Repeat the above procedure with the remaining vials with reconstituted product, to obtain the desired volume in the syringe.
Croatian: • Ponovite postupak s preostalim bočicama s rekonstituiranim lijekom kako biste dobili željeni volumen u štrcaljki.
English: Store protected from light
Croatian: Čuvati zaštićeno od svjetlosti.
English: • Blood clots in the veins in lungs, legs, liver, kidneys or at site of injection.
Croatian: • Krvni ugrušci u venama pluća, nogu, jetre, bubrega ili na mjestu injiciranja.
English: All findings in the preclinical safety programme were related to the pharmacological effect of rFVIIa.
Croatian: Svi neklinički podaci o sigurnosti primjene povezani su s farmakološkim učinkom rFVIIa.
English: Risk factors that may have contributed to antibody development including previous treatment with human plasma and/or plasma-derived factor VII, severe mutation of FVII gene, and overdose of NovoSeven, were present.
Croatian: Bili su prisutni faktori rizika koji su možda pridonijeli razvoju protutijela uključujući prethodno liječenje ljudskom plazmom i/ili s faktorom VII dobivenim iz plazme, značajna mutacija gena za FVII i predoziranje lijekom NovoSeven.
English: Factor VII deficient patients should be monitored for prothrombin time and factor VII coagulant activity before and after administration of NovoSeven.
Croatian: U bolesnika s nedostatkom faktora VII treba pratiti protrombinsko vrijeme i aktivnost koagulacije faktora VII prije i nakon primjene lijeka NovoSeven.
English: Dose and frequency of injections should be adapted to each individual.
Croatian: Doziranje i učestalost injekcija treba prilagoditi individualno svakoj osobi.
English: - Hypersensitivity (see sections 4.3 and 4.4)
Croatian: (vidjeti dijelove 4.3 i 4.4)
English: What you need to know before you use NovoSeven Do not use NovoSeven
Croatian: Što morate znati prije nego počnete primjenjivati NovoSeven Nemojte primjenjivati NovoSeven