FrancophonIA/ELRC3.0 huggingface dataset:
English: When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients' blood samples, plasma factor VIII activity results can be significantly affected by both the type of the aPTT reagent and the reference standard used in the assay.
Croatian: Kad se za određivanje aktivnosti faktora VIII u uzorcima krvi bolesnika koristi jednostupanjski test zgrušavanja krvi in vitro temeljen na tromboplastinskom vremenu (aPTV), na rezultate za aktivnost faktora VIII u plazmi mogu značajno utjecati i vrsta aPTV reagensa i referentni standard koji se koristi u testu.
English: The prepared product should be injected intravenously over several minutes.
Croatian: Pripremljeni lijek treba ubrizgavati u venu tijekom nekoliko minuta.
English: Of note, ABR is not comparable between different factor concentrates and between different clinical studies.
Croatian: Važno je napomenuti da godišnja stopa krvarenja nije usporediva u slučaju različitih koncentrata faktora kao ni u slučaju različitih kliničkih ispitivanja.
English: 1 Pharmacokinetic parameters are presented in Geometric Mean (95% CI) Abbreviations: CI = confidence interval; AUC = area under the FVIII activity time curve; t½ = terminal half-life;
Croatian: 1 Farmakokinetički parametri prikazani su kao geometrijska srednja vrijednost (95% CI) Skraćenice: CI = interval pouzdanosti; AUC = površina ispod krivulje aktivnosti faktora VIII u vremenu;
English: If your or your child's bleeding is not being controlled with ELOCTA, tell your doctor immediately.
Croatian: Vašeg djeteta ne može kontrolirati pomoću lijeka ELOCTA, odmah se obratite liječniku.
English: ELOCTA (efmoroctocog alfa) is a fully recombinant fusion protein with extended half-life.
Croatian: ELOCTA (efmoroktokog alfa) je potpuno rekombinantni fuzijski protein s produljenim poluvijekom eliminacije.
English: Subjects on on-demand therapy prior to entry either entered the individualised prophylaxis arm or were randomised to the weekly prophylaxis or on-demand arms.
Croatian: Ispitanici koji su se liječili prema potrebi prije ulaska u ispitivanje bili su raspoređeni u skupinu koja je primala individualiziranu profilaksu ili su bili randomizirani u skupine koje su primale tjednu profilaksu ili liječenje prema potrebi.
English: If you forget to use ELOCTA
Croatian: Ako ste zaboravili primijeniti lijek ELOCTA
English: Prophylaxis, age 6 up to 12 years: Median dose interval was 3.49 days in Study II and 3.50 days in Study III.
Croatian: Profilaksa, dob 6 do 12 godina: Medijan intervala doziranja bio je 3,49 dana u Ispitivanju II i 3,50 dana u Ispitivanju III.
English: The final solution must be inspected visually before administration.
Croatian: Pripremljena otopina mora se vizualno pregledati prije primjene.
English: It is strongly recommended that every time that ELOCTA is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the medicinal product.
Croatian: Izrazito se preporučuje zabilježiti ime bolesnika i broj serije lijeka ELOCTA prilikom svake primjene kako bi se održala poveznica između bolesnika i serije ovog lijeka.
English: Note: If the solution is not to be used immediately, the syringe cap should be carefully put back on the syringe tip.
Croatian: Ako se otopina ne primijeni odmah, zatvarač štrcaljke treba pažljivo vratiti na vrh štrcaljke.
English: Do not use if the medicine has expired.
Croatian: Nemojte primijeniti lijek ako je istekao rok valjanosti.
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 povećavaju se razine faktora VIII u plazmi, što privremeno ispravlja manjak faktora i korigira sklonost krvarenju.
English: If you stop using ELOCTA
Croatian: Ako prestanete primjenjivati lijek ELOCTA
English: The number of units of recombinant factor VIII Fc administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products.
Croatian: Broj primijenjenih jedinica rekombinantnog faktora VIII Fc izražava se u međunarodnim jedinicama (IU), koje su u skladu s važećim standardom SZO za lijekove s faktorom VIII.
English: Do not touch the top of the vial or allow it to touch anything else once wiped.
Croatian: Nemojte dodirivati vrh bočice nakon što ste ga obrisali i pazite da ni sa čim ne dođe u dodir.
English: Prophylaxis, age <6 years: Median dose interval was 3.50 days in Study II and Study III.
Croatian: Profilaksa, dob < 6 godina: Medijan intervala doziranja bio je 3,50 dana u Ispitivanju II i Ispitivanju III.
English: You must contact your doctor immediately if you experience any of the following symptoms of allergic reactions: swelling of the face, rash, generalised itching, hives, tightness of the chest, difficulty breathing, burning and stinging at the injection site, chills, flushing, headache, low blood pressure, general feeling of being unwell, nausea, restlessness and fast heartbeat, feeling dizzy or loss of consciousness.
Croatian: Morate se odmah obratiti liječniku ako osjetite bilo koji od sljedećih simptoma alergijske reakcije: oticanje lica, osip, generalizirani svrbež, koprivnjaču, stezanje u prsima, otežano disanje, žarenje i probadanje na mjestu primjene injekcije, zimice, navale crvenila, glavobolja, nizak krvni tlak, opće loše osjećanje, mučnina, nemir i ubrzan rad srca, vrtoglavica i gubitak svijesti.
English: Table 1: Guide to ELOCTA dosing for treatment of bleeding episodes and surgery Degree of haemorrhage /
Croatian: Tablica 1: Smjernica za doziranje lijeka ELOCTA za liječenje epizoda krvarenja i u kirurgiji
English: Turn the leaflet over for section 7.
Croatian: Pogledajte na drugoj strani upute o lijeku dio 7.
English: Recording of batch number
Croatian: Bilježenje broja serije
English: Open the infusion set package and remove the cap at the end of the tubing.
Croatian: Otvorite pakiranje kompleta za infuziju i uklonite zatvarač na kraju cijevi.
English: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Sweden
Croatian: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm, Švedska
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.
Croatian: Ako je potreban centralni venski kateter, potrebno je uzeti u obzir rizik od komplikacija povezanih s centralnim venskim kateterom uključujući lokalne infekcije, bakterijemiju i trombozu na mjestu postavljanja katetera.
English: Study II enrolled a total of 71 previously treated male paediatric patients <12 years of age with severe haemophilia A. Of the 71 enrolled subjects, 69 received at least 1 dose of ELOCTA and were evaluable for efficacy (35 were <6 years of age and 34 were 6 to <12 years of age).
Croatian: Od 71 uključenog ispitanika, 69 je primilo najmanje 1 dozu lijeka ELOCTA i u njih se mogla procijeniti djelotvornost (35 bolesnika bilo je u dobi < 6 godina, a 34 je bilo u dobi od 6 do < 12 godina).
English: With the syringe still connected to the adapter and the plunger rod pressed down, gently swirl the vial until the powder is dissolved.
Croatian: Uz štrcaljku i dalje spojenu s nastavkom i klipom potisnutim prema dolje, vrtite laganim kružnim pokretima sve dok se prašak ne otopi.
English: Can be stored at room temperature (up to 30°C) for a single period up to 6 months.
Croatian: Može se čuvati na sobnoj temperaturi (do 30 °C) tijekom jednog razdoblja do 6 mjeseci.
English: In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
Croatian: U nekim slučajevima, osobito u mlađih bolesnika, mogu biti potrebni kraći vremenski razmaci između doza ili više doze.
English: Repeat injection every 12 to 24 hours for at least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
Croatian: Ponovite injekciju svakih 12 do 24 sata tijekom najmanje 1 dana, sve dok se ne riješi bolna epizoda krvarenja ili ne postigne zacjeljivanje.
English: ELOCTA is given as an injection into a vein.
Croatian: ELOCTA se daje injekcijom u venu.
English: Place the vial on a clean flat surface.
Croatian: Postavite bočicu na čistu, ravnu površinu.
English: Keep this medicine out of the sight and reach of children.
Croatian: Kako čuvati lijek ELOCTA Lijek čuvajte izvan pogleda i dohvata djece.
English: Pharmacokinetic properties were evaluated in 28 subjects (≥15 years) receiving ELOCTA (rFVIIIFc).
Croatian: Farmakokinetička svojstva bila su procijenjena u 28 ispitanika (u dobi od ≥15 godina) koji su primali lijek
English: After storage at room temperature, the product may not be returned to the refrigerator.
Croatian: Nakon čuvanja na sobnoj temperaturi lijek se ne može vratiti u hladnjak.
English: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm Sweden
Croatian: Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm Švedska
English: Powder: sucrose, sodium chloride, L-Histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, hydrochloric acid.
Croatian: Prašak: saharoza, natrijev klorid, L-histidin, kalcijev klorid dihidrat, polisorbat 20, natrijev hidroksid, kloridna kiselina
English: Hold the vial adapter in its protective cap and place it squarely over the top of the vial.
Croatian: Držeći nastavak za bočicu u njegovom zaštitnom zatvaraču, postavite ga točno iznad vrha bočice.
English: Protect from direct sunlight.
Croatian: Zaštitite ga od izravnog sunčevog svjetla.
English: Patients should be informed of the signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Croatian: Bolesnike treba upoznati sa znakovima reakcija preosjetljivosti koji uključuju koprivnjaču, generaliziranu urtikariju, stezanje u prsima, piskanje, hipotenziju i anafilaksiju.
English: Discard any unused solution appropriately.
Croatian: Odbacite neprimijenjenu otopinu na odgovarajući način.
English: After storage at room temperature, the product must not be put back in the refrigerator.
Croatian: Nakon čuvanja na sobnoj temperaturi lijek se ne smije vratiti u hladnjak.
English: B) 3 mL solvent in pre-filled syringe C) 1 Plunger rod
Croatian: A) 1 bočicu praška B) 3 ml otapala u napunjenoj štrcaljki C) 1 klip
English: If any of these symptoms occur, stop the injection immediately and contact your doctor.
Croatian: odmah prestanite s primjenom injekcije i obratite se svom liječniku.
English: Do not touch the inside of the cap or the syringe tip.
Croatian: Nemojte dodirivati unutrašnjost zatvarača ili vrh štrcaljke.
English: Protect the prepared solution from direct sunlight.
Croatian: Zaštitite pripremljenu otopinu od izravnog sunčevog svjetla.
English: Slowly depress the plunger rod to inject all the solvent into the ELOCTA vial.
Croatian: Polako potiskujte klip kako biste ubrizgali cjelokupno otapalo u bočicu lijeka ELOCTA.
English: • The other ingredients are sucrose, sodium chloride, L-Histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, hydrochloric acid and water for injections.
Croatian: - Drugi sastojci su saharoza, natrijev klorid, L-histidin, kalcijev klorid dihidrat, polisorbat 20, natrijev hidroksid, kloridna kiselina i voda za injekcije.
English: ELOCTA is administered by intravenous (IV) injection after dissolving the powder for injection with the solvent supplied in the pre-filled syringe.
Croatian: ELOCTA se primjenjuje injekcijom u venu (i.v.) nakon otapanja praška za injekciju otapalom iz priložene napunjene štrcaljke.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Croatian: bolesnicima treba savjetovati da odmah prekinu primjenu lijeka i obrate se svom liječniku.
English: Attach the plunger rod (C) to the solvent syringe by inserting the tip of the plunger rod into the opening in the syringe plunger.
Croatian: Spojite klip (C) sa štrcaljkom s otapalom tako što ćete uvesti vrh klipa u otvor za klip na štrcaljki.
English: In the case of major surgical interventions in particular, precise monitoring of the substitution therapy by means of coagulation analysis (plasma factor VIII activity) is indispensable.
Croatian: Osobito u slučaju većih kirurških zahvata neophodno je precizno praćenje nadomjesne terapije analizom zgrušavanja krvi
English: Tables 5 and 6 present the pharmacokinetic parameters calculated from the paediatric data of subjects less than 18 years of age.
Croatian: 6 prikazuju farmakokinetičke parametre izračunate iz podataka pedijatrijskih ispitanika mlađih od
English: ELOCTA contains the active substance efmoroctocog alfa, a recombinant coagulation factor VIII, Fc fusion protein.
Croatian: ELOCTA sadrži djelatnu tvar efmoroktokog alfa, rekombinantni faktor zgrušavanja krvi VIII, Fc fuzijski protein.
English: Lift the protective cap away from the adapter and discard.
Croatian: Podignite zaštitni zatvarač s nastavka i odbacite ga.
English: The vial of lyophilised product powder for injection must be reconstituted with the supplied solvent (water for injections) from the pre-filled syringe using the sterile vial adapter for reconstitution.
Croatian: Liofilizirani prašak za injekciju u bočici mora se rekonstituirati otapalom (voda za injekcije) iz priložene napunjene štrcaljke koristeći sterilni nastavak za bočicu za rekonstituciju.
English: Paediatric population No age-specific differences in adverse reactions were observed between paediatric and adult subjects.
Croatian: Nisu opažene razlike u nuspojavama između pedijatrijskih i odraslih ispitanika koje bi bile specifične za dob.
English: Alternatively, ELOCTA may be stored at room temperature (up to 30°C) for a single period not exceeding 6 months.
Croatian: Drugi je način da se ELOCTA čuva na sobnoj temperaturi (do 30 °C) tijekom jednog razdoblja ne duljeg od 6 mjeseci.
English: All pharmacokinetic studies with ELOCTA were conducted in previously treated patients with severe haemophilia A. Data presented in this section were obtained by chromogenic and one-stage clotting assays.
Croatian: 5.2 Farmakokinetička svojstva Sva farmakokinetička ispitivanja lijeka ELOCTA provedena su u prethodno liječenih bolesnika s teškom hemofilijom A. Podaci prikazani u ovom dijelu dobiveni su kromogenim testom i jednostupanjskim testom zgrušavanja krvi.
English: This medicine contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Croatian: Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
English: Powder: 250 IU efmoroctocog alfa (approx. 83 IU/mL after reconstitution) Powder: 500 IU efmoroctocog alfa (approx. 167 IU/mL after reconstitution) Powder: 750 IU efmoroctocog alfa (approx. 250 IU/mL after reconstitution) Powder: 1000 IU efmoroctocog alfa (approx. 333 IU/mL after reconstitution) Powder: 1500 IU efmoroctocog alfa (approx. 500 IU/mL after reconstitution) Powder: 2000 IU efmoroctocog alfa (approx. 667 IU/mL after reconstitution) Powder: 3000 IU efmoroctocog alfa (approx. 1000 IU/mL after reconstitution) Powder: 4000 IU efmoroctocog alfa (approx. 1333 IU/mL after reconstitution) Powder: 5000 IU efmoroctocog alfa (approx. 1667 IU/mL after reconstitution) Powder: 6000 IU efmoroctocog alfa (approx. 2000 IU/mL after reconstitution)
Croatian: Prašak: 250 IU efmoroctocog alfa (oko 83 IU/ml nakon rekonstitucije), Prašak: 500 IU efmoroctocog alfa(oko 167 IU/ml nakon rekonstitucije), Prašak: 750 IU efmoroctocog alfa (oko 250 IU/ml nakon rekonstitucije), Prašak: 1000 IU efmoroctocog alfa (oko 333 IU/ml nakon rekonstitucije), Prašak: 1500 IU efmoroctocog alfa (oko 500 IU/ml nakon rekonstitucije), Prašak: 2000 IU efmoroctocog alfa (oko 667 IU/ml nakon rekonstitucije), Prašak: 3000 IU efmoroctocog alfa (oko 1000 IU/ml nakon rekonstitucije), Prašak: 4000 IU efmoroctocog alfa (oko 1333 IU/ml nakon rekonstitucije), Prašak: 5000 IU efmoroctocog alfa (oko 1667 IU/ml nakon rekonstitucije),
English: In some cases, especially in younger patients, shorter dosing intervals or higher doses may be necessary.
Croatian: osobito u mlađih bolesnika, mogu biti potrebni kraći intervali ili više doze.
English: ELOCTA 250 IU powder and solvent for solution for injection
Croatian: ELOCTA 250 IU prašak i otapalo za otopinu za injekciju
English: Do not touch the syringe tip or the inside of the cap.
Croatian: Nemojte dodirivati vrh štrcaljke ili unutrašnjost zatvarača.
English: Peel back the protective paper lid from the clear plastic vial adapter (D).
Croatian: Odvojite zaštitni papirni pokrov s prozirne plastike nastavka za bočicu (D).
English: Each vial of ELOCTA contains nominally 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 5000 or 6000 IU efmoroctocog alfa.
Croatian: Jedna bočica lijeka ELOCTA nominalno sadrži 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 5000
English: Median dose to maintain haemostasis during surgery was 60.6 IU/kg (min 38, max 158).
Croatian: Medijan doze za održavanje hemostaze tijekom operacije bio je 60,6 IU/kg (min.
English: MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per mL of plasma using the modified assay.
Croatian: Ti su inhibitori obično IgG imunoglobulini usmjereni protiv prokoagulantne aktivnosti faktora VIII, a njihova količina se određuje u Bethesda jedinicama (BU) po ml plazme pomoću modificiranog testa.
English: ELOCTA 500 IU powder and solvent for solution for injection
Croatian: ELOCTA 500 IU prašak i otapalo za otopinu za injekciju
English: Remove the plastic flip-top cap from the ELOCTA vial.
Croatian: Uklonite plastični zatvarač s bočice lijeka ELOCTA.
English: If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter site thrombosis should be considered.
Croatian: Komplikacije povezane s kateterom Ako Vam je potreban centralni venski kateter, potrebno je uzeti u obzir rizik od komplikacija povezanih s centralnim venskim kateterom koje uključuju lokalne infekcije, prisutnost bakterija u krvi i trombozu na mjestu postavljenog katetera.
English: Table 2: Adverse reactions reported for ELOCTA in clinical trials MedDRA System Organ Class
Croatian: Tablica 2: Nuspojave zabilježene za lijek ELOCTA u kliničkim ispitivanjima
English: Animal reproduction studies have not been conducted with ELOCTA.
Croatian: Nisu provedena ispitivanja utjecaja lijeka ELOCTA na reprodukciju u životinja.
English: ELOCTA is provided as a powder and solvent for solution for injection.
Croatian: ELOCTA se isporučuje kao prašak i otapalo za otopinu za injekciju.
English: No fertility studies have been conducted in animals with ELOCTA.
Croatian: Nisu provedena ispitivanja utjecaja lijeka ELOCTA na plodnost u životinja.
English: Each pack of ELOCTA contains 1 powder vial, 3 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 alcohol swabs, 2 plasters and 1 gauze pad.
Croatian: Jedno pakiranje lijeka ELOCTA sadrži 1 bočicu praška, 3 ml otapala u napunjenoj štrcaljki, 1 klip, 1 nastavak za bočicu, 1 komplet za infuziju, 2 alkoholom natopljene vatice, 2 flastera i 1 kompresu od gaze.
English: Talk to your doctor if you think that your bleeding is not being controlled with the dose you receive.
Croatian: Ako mislite da se Vaše krvarenje ne kontrolira dozom koju primate, obratite se svom liječniku.
English: Median total time on Study I+III was 4.2 years and median no of exposure days was 309.
Croatian: I i III bio je 4,2 godine, a medijan broja dana izloženosti bio je 309.
English: Headache, dizziness, taste alteration, slow heartbeat, high blood pressure, hot flushes, vascular pain after injection, cough, abdominal pain, rash, joint swelling, muscle pain, back pain, joint pain, general discomfort, chest pain, feeling cold, feeling hot and low blood pressure.
Croatian: Manje česte nuspojave (mogu se javiti u najviše 1 na 100 osoba) Glavobolja, omaglica, promjena osjeta okusa, usporeni otkucaji srca, visok krvni tlak, navale vrućine, bol u krvnoj žili nakon injekcije, kašalj, bol u trbuhu, oticanje zglobova, križobolja, opća nelagoda, bol u prsima, osjećaj hladnoće, osjećaj vrućine i nizak krvni tlak.
English: Break off the white, tamper-resistant, plastic cap from the solvent syringe by bending at the perforation cap until it snaps off. Set the cap aside by placing it with the top down on a flat surface.
Croatian: Odlomite bijeli, plastični zatvarač za zaštitu od otvaranja sa štrcaljke s otapalom tako što ćete ga savijati na perforiranom mjestu dok se ne odvoji.
English: Turn the plunger rod firmly clockwise until it is securely seated in the syringe plunger.
Croatian: Zakrenite čvrsto klip u smjeru kazaljke na satu sve dok ne bude čvrsto postavljen u štrcaljki.
English: Ensuring that the syringe plunger rod is still fully pressed down, invert the vial.
Croatian: Pazeći da je klip štrcaljke i dalje potisnut do kraja, okrenite bočicu naopako.
English: Wipe the top of the vial with one of the alcohol swabs (F) provided in the pack, and allow to air dry.
Croatian: Obrišite vrh bočice jednom od alkoholom natopljenih vatica (F)
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava inhibicija faktora VIII
English: Firmly push and turn the syringe clockwise until it is securely connected.
Croatian: Čvrsto pritisnite i zakrenite štrcaljku u smjeru kazaljke na satu dok se ne uspostavi čvrsti spoj.
English: Hypertension Hot flush Angiopathy2
Croatian: Krvožilni poremećaji hipertenzija navala vrućine angiopatija2
English: Treatment of bleeding: 447 bleeding events were treated during Study II and III with a median dose of 63 IU/kg (min 28, max 186) to control each bleed.
Croatian: Liječenje krvarenja: Tijekom Ispitivanja II i III liječeno je 447 slučajeva krvarenja s medijanom doze od
English: Cases of recurrent inhibitor (low titre) have been observed after switching from one factor VIII product to another in previously treated patients with more than 100 exposure days who have a previous history of inhibitor development.
Croatian: drugim u prethodno liječenih bolesnika s više od 100 dana izloženosti, u kojih je prethodno bio zabilježen razvoj inhibitora.
English: Content: 1 powder vial, 3 mL solvent in pre-filled syringe, 1 plunger rod, 1 vial adapter, 1 infusion set, 2 alcohol swabs, 2 plasters, 1 gauze.
Croatian: Sadržaj: 1 bočica s praškom, 3 ml otapala u napunjenoj štrcaljki, 1 klip, 1 nastavak za bočicu, 1 komplet za infuziju, 2 alkoholom natopljene vatice, 2 flastera, 1 kompresa od gaze
English: Method of administration ELOCTA is for intravenous use.
Croatian: ELOCTA se primjenjuje intravenski.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Croatian: Pomoćne tvari koje treba uzeti u obzir Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
English: During the shelf-life, the product may be stored at room temperature (up to 30°C) for a single period not exceeding 6 months.
Croatian: Unutar roka valjanosti lijek se može čuvati na sobnoj temperaturi (do 30 °C) tijekom jednog razdoblja ne duljeg od 6 mjeseci.
English: F) 2 Alcohol swabs G) 2 Plasters
Croatian: D) 1 nastavak za bočicu E) 1 komplet za infuziju F) 2 alkoholom natopljene vatice G) 2 flastera
English: Early haemarthrosis, muscle bleeding or oral bleeding
Croatian: Rana hemartroza, krvarenje u mišiće ili u usnoj šupljini
English: Abdominal pain, lower Uncommon
Croatian: Poremećaji probavnog sustava bol u donjem dijelu abdomena manje često
English: How to store ELOCTA
Croatian: Kako primjenjivati lijek ELOCTA