FrancophonIA/ELRC3.0 huggingface dataset:
English: • If the CVAD line needs to be flushed before or after the injection of Esperoct, use sodium chloride 9 mg/mL (0.9%) solution for injection.
Croatian: • Ako CVAD liniju treba isprati prije ili nakon injekcije lijeka Esperoct, upotrijebite 0,9 %-tnu (9 mg/ml) otopinu natrijeva klorida za injekciju.
English: Factor VIII inhibitors
Croatian: Inhibitori faktora VIII
English: • Inject the reconstituted solution as instructed by your doctor or nurse.
Croatian: • Injicirajte pripremljenu otopinu u skladu s uputama koje ste dobili od liječnika ili medicinske sestre.
English: Chemical and physical in-use stability have been demonstrated for 24 hours when stored in a refrigerator (2°C - 8°C) and 4 hours when stored at room temperature (up to 30°C).
Croatian: Dokazana je kemijska i fizikalna stabilnost pripremljene otopine tijekom 24 sata kad se čuva u hladnjaku (2°C-8°C) te tijekom 4 sata na sobnoj temperaturi (do 30°C).
English: Esperoct is recommended to be used immediately after it has been reconstituted.
Croatian: Preporučuje se primijeniti Esperoct odmah nakon pripreme za primjenu.
English: The efficacy and safety of Esperoct for prophylaxis treatment of bleeds were evaluated in an open-label, single-arm, non-controlled trial in 68 children below 12 years with severe haemophilia A. The prophylactic effect of Esperoct was demonstrated with a dosing at 60 IU per kg body weight (50-75 IU/kg) twice weekly.
Croatian: Djelotvornost i sigurnost lijeka Esperoct za profilaktičko liječenje krvarenja ispitane su u otvorenom, nekontroliranom ispitivanju s jednom skupinom u 68 djece mlađe od 12 godina s teškom hemofilijom A. Profilaktički učinak lijeka Esperoct dokazan je doziranjem od 60 IU po kg tjelesne težine (50-75 IU/kg) dvaput tjedno.
English: The median and estimated mean annualised bleeding rate in children below 12 years receiving Esperoct twice weekly was 1.95 and 2.13 (95% CI: 1.48;3.06), whereas the spontaneous ABR was 0.00 and 0.58 (95% CI: 0.24;1.40), traumatic ABR was 0.00 and 1.52 (95% CI: 1.07;2.17) and joint ABR was 0.00 and 1.03 (95% CI: 0.59;1.81), respectively.
Croatian: Medijan i procijenjena srednja vrijednost anualizirane stope krvarenja u djece mlađe od 12 godina koja su primala lijek Esperoct dvaput tjedno iznosili su 1,95 i 2,13 (95% CI: 1,48; 3,06), dok je spontana anualizirana stopa krvarenja iznosila 0,00 i 0,58 (95% CI: 0,24; 1,40), traumatski ASK iznosio je 0,00 i 1,52 (95% CI: 1,07; 2,17), a ASK za zglobove iznosio je 0,00 i 1,03 (95% CI: 0,59; 1,81).
English: • Place the vial on a flat and solid surface.
Croatian: • Stavite bočicu na ravnu i čvrstu podlogu.
English: Do not use this medicine after the expiry date which is stated after ‘EXP' on the carton, on the vial, and on the pre-filled syringe labels.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji te na naljepnicama na bočici i napunjenoj štrcaljki iza oznake „EXP“.
English: Activated factor VIII acts as a cofactor for activated factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts prothrombin into thrombin.
Croatian: Aktivirani faktor VIII djeluje kao kofaktor za aktivirani faktor IX te tako ubrzava pretvorbu faktora X u aktivirani faktor X.
English: Thirty-two patients had pre-existing anti-PEG antibodies before administration of Esperoct.
Croatian: Trideset i dva bolesnika imala su već postojeća anti-PEG protutijela prije primjene lijeka Esperoct.
English: • factor VIII inhibitors (antibodies) in patients previously treated with factor VIII.
Croatian: • inhibitori faktora VIII (antitijela) u bolesnika ranije liječenih lijekovima koji sadrže faktor VIII.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis.
Croatian: Bolesnici trebaju biti informirani o ranim znakovima reakcija preosjetljivosti, uključujući koprivnjaču, generaliziranu urtikariju, stezanje u prsima, piskanje pri disanju, hipotenziju i anafilaksiju.
English: Esperoct contains sodium
Croatian: Esperoct sadrži natrij
English: • The other ingredients are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine, calcium chloride dihydrate, sodium hydroxide and hydrochloric acid.
Croatian: • Drugi sastojci su L-histidin, saharoza, polisorbat 80, natrijev klorid, L-metionin, kalcijev klorid dihidrat, natrijev hidroksid i kloridna kiselina.
English: One confirmed case of factor VIII inhibitor occurred in an 18 year-old previously treated patient on prophylactic treatment with Esperoct.
Croatian: Jedan potvrđeni slučaj razvoja inhibitora faktora VIII javio se u prethodno liječenog bolesnika u dobi od 18 godina koji je liječen lijekom Esperoct u profilaksi.
English: *Human factor VIII, produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cells line, and no additives of human or animal origin are used in the cell culture, purification, conjugation or formulation of Esperoct.
Croatian: Chinese Hamster Ovary, CHO), bez bilo kakvih dodataka ljudskog ili životinjskog porijekla tijekom postupaka dobivanja u staničnoj kulturi, pročišćavanja, konjugacije ili formulacije lijeka Esperoct.
English: • The active substance is turoctocog alfa pegol (pegylated human coagulation factor VIII (rDNA)).
Croatian: • Djelatna tvar je turoktokog alfa pegol (pegilirani ljudski koagulacijski faktor VIII (rDNK)).
English: The mean annual consumption for prophylaxis was 6475 IU/kg.
Croatian: Srednja vrijednost godišnje potrošnje za profilaksu bila je 6475 IU/kg.
English: Solvent: sodium chloride, water for injections
Croatian: Otapalo: natrijev klorid, voda za injekcije
English: Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.
Croatian: Liječenje se treba provoditi pod nadzorom liječnika s iskustvom u liječenju hemofilije.
English: Clinical efficacy during prophylaxis and treatment of bleeding episodes
Croatian: Klinička djelotvornost tijekom profilakse i liječenja epizoda krvarenja
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Croatian: Opaženi su rijetki slučajevi preosjetljivosti ili alergijskih reakcija (koje mogu uključivati angioedem, pečenje i bockanje na mjestu primjene injekcije, zimicu, navale crvenila, generaliziranu urtikariju, glavobolju, koprivnjaču, hipotenziju, letargiju, mučninu, nemir, tahikardiju, stezanje u prsnom košu, trnce, povraćanje, piskanje pri disanju) koje u nekim slučajevima mogu napredovati do teške anafilaksije (uključujući šok).
English: • 1 plunger rod (placed under the syringe)
Croatian: • 1 potisnik klipa (smješten je ispod štrcaljke)
English: Allergic reactions (hypersensitivity)
Croatian: Alergijske reakcije (preosjetljivost)
English: • Use a clean and germ-free (aseptic) technique.
Croatian: • Koristite tehniku koja osigurava čistu primjenu bez mikroorganizama (aseptička tehnika).
English: ** Frequency is based on studies with all factor VIII products which included patients with severe haemophilia A. *** Preferred terms included in injection site reactions: Injection site reaction, Vessel puncture site haematoma, Infusion site reaction, Injection site erythema, Injection site rash, Vessel puncture site pain, and Injection site swelling.
Croatian: ** Učestalost se temelji na ispitivanjima sa svim lijekovima s faktorom VIII koja su uključivala bolesnike s teškom hemofilijom A. *** Preporučeni pojmovi uključeni u reakcije na mjestu primjene injekcije: Reakcija na mjestu primjene injekcije, hematom na mjestu uboda u krvnu žilu, reakcija na mjestu primjene infuzije, eritem na mjestu primjene injekcije, osip na mjestu primjene injekcije, bol na mjestu uboda u krvnu žilu i oticanje na mjestu primjene injekcije.
English: Do not touch the syringe tip under the syringe cap.
Croatian: Ne dodirujte vrh štrcaljke ispod zatvarača štrcaljke.
English: Do not touch the syringe tip.
Croatian: Nemojte dodirivati vrh štrcaljke.
English: The factor VIII activity of Esperoct can be measured using the conventional factor VIII assays, the chromogenic assay and the one-stage assay.
Croatian: Aktivnost faktora VIII lijeka Esperoct se može mjeriti pomoću konvencionalnog testa faktora VIII, kromogenog testa i jednostupanjskog testa.
English: The efficacy of Esperoct for prophylaxis and treatment of bleeds was evaluated in an open-label, non-controlled trial in adolescents and adult patients with severe haemophilia A ages 12 years and above.
Croatian: Djelotvornost lijeka Esperoct za profilaksu i liječenje krvarenja ispitivana je u otvorenom, nekontroliranom ispitivanju u adolescenata i odraslih bolesnika s teškom hemofilijom A dobi od 12 godina i starijih.
English: Sodium chloride
Croatian: Prašak natrijev klorid
English: Adolescents (12 years of age and above) can use the same dose as adults.
Croatian: Primjena u djece i adolescenata Adolescenti (u dobi od 12 i više godina) mogu koristiti istu dozu kao i odrasli.
English: the dose you need, as instructed by your doctor or nurse.
Croatian: potrebne doze, kako Vas je uputio liječnik ili medicinska sestra.
English: If you forget to use Esperoct
Croatian: Ako ste zaboravili primijeniti Esperoct
English: Also there can be significant discrepancies between assay results obtained by aPTTbased one stage clotting assay and the chromogenic assay according to Ph. Eur.
Croatian: Osim toga, mogu postojati značajne nepodudarnosti između rezultata dobivenih jednostupanjskim testom koagulacije koji se temelji na aPTV-u i onih dobivenih kromogenim testom prema Europskoj farmakopeji.
English: Instructions on how to use Esperoct Read these instructions carefully before using Esperoct.
Croatian: Prije primjene lijeka Esperoct pažljivo pročitajte ove upute.
English: Esperoct can be kept at room temperature (up to 30°C) for up to 12 months within the shelf life of the product.
Croatian: Esperoct možete čuvati na sobnoj temperaturi (do 30°C) do 12 mjeseci unutar roka trajanja lijeka.
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and incremental recoveries.
Croatian: Pojedini bolesnici mogu imati različite odgovore na faktor VIII, te pokazivati različite poluvijekove i prirast po jedinici doze.
English: Do not dispose of any of the items until after you have injected the reconstituted solution.
Croatian: Nemojte bacati u otpad niti jedan predmet dok ne injicirate pripremljenu otopinu.
English: Can be stored at room temperature (up to 30°C) for a single period up to 12 months.
Croatian: Može se čuvati na sobnoj temperaturi (do 30°C) tijekom jednokratnog razdoblja od najviše 12 mjeseci.
English: The dose in adolescents (12 years and above) is the same as for adults.
Croatian: Doza u adolescenata (12 godina i više) jednaka je onima za odrasle bolesnike.
English: 4.4 Special warnings and precautions for use
Croatian: 4.4 Posebna upozorenja i mjere opreza pri uporabi Sljedivost
English: Each pack of Esperoct contains: - 1 glass vial (type I) with powder closed with a chlorobutyl rubber stopper, an aluminium seal with a plastic snap-off cap - 1 sterile vial adapter for reconstitution - 1 pre-filled syringe of 4 mL solvent with backstop (polypropylene), a rubber plunger
Croatian: Jedno pakiranje lijeka Esperoct sadrži: - 1 staklenu bočicu (staklo tipa I) s praškom zatvorenu čepom od klorobutilne gume, i zatvaračem od aluminija s plastičnom snap-off kapicom - 1 sterilni nastavak za bočicu za rekonstituciju - 1 napunjenu štrcaljku s 4 ml otapala s graničnikom (polipropilen), gumenim klipom
English: The PEG is attached to the O-linked glycan in the truncated B-domain of rFVIII (turoctocog alfa).
Croatian: PEG se veže na O-vezani glikan u skraćenoj B-domeni rFVIII (turoktokog alfa).
English: Twenty of the 32 patients were negative for anti-PEG antibodies post administration of Esperoct.
Croatian: Dvadeset od tih 32 bolesnika bilo je negativno na anti-PEG protutijela nakon primjene lijeka Esperoct.
English: Table 2 Guidance for dosing of Esperoct for perioperative management Type of surgical procedure
Croatian: Tablica 2 Smjernice za doziranje lijeka Esperoct za perioperativno zbrinjavanje Vrsta kirurškog zahvata
English: Prophylaxis The recommended starting dose is 50 IU of Esperoct per kg body weight every 4 days.
Croatian: Preporučena početna doza je 50 IU lijeka Esperoct po kg tjelesne težine svaka 4 dana.
English: Powder: sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid
Croatian: natrijev klorid, L-histidin, saharoza, polisorbat 80, L-metionin, kalcijev klorid dihidrat, natrijev hidroksid, kloridna kiselina
English: If you stop using Esperoct
Croatian: Ako prestanete primjenjivati Esperoct
English: Injection site reactions*** Common
Croatian: Reakcije na mjestu primjene injekcije***
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with Esperoct.
Croatian: Do razvoja neutralizirajućih protutijela (inhibitora) može doći u bolesnika s hemofilijom A koji su liječeni faktorom VIII, uključujući lijekom Esperoct.
English: • Push the plunger rod slowly until all air bubbles are gone.
Croatian: • Polako pritišćite potisnik klipa dok svi mjehurići zraka ne izađu.
English: Sodium chloride Water for injections
Croatian: Otapalo natrijev klorid voda za injekcije
English: • Bring the vial and the pre-filled syringe to room temperature.
Croatian: • Bočica i napunjena štrcaljka trebaju postići sobnu temperaturu.
English: • rash.
Croatian: • osip.
English: Prepare the vial and the syringe
Croatian: Pripremite bočicu i štrcaljku
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 aPTT reagent and the reference standard used in the assay.
Croatian: Kada se za određivanje aktivnosti faktora VIII u krvnim uzorcima bolesnika koristi in vitro jednostupanjski test koagulacije koji se temelji na tromboplastinskom vremenu (aPTV), na rezultate za aktivnost faktora VIII u plazmi mogu značajno utjecati i tip reagensa koji se koristi za određivanje aPTV-a i referentni standard upotrijebljen u testu.
English: When injected into a haemophiliac patient, factor VIII binds to von Willebrand factor in the patient's circulation.
Croatian: Kada se lijek primijeni u bolesnika s hemofilijom, faktor VIII se veže za von Willebrandov faktor u bolesnikovu krvotoku.
English: Each vial of Esperoct contains nominally 500, 1000, 1500, 2000 or 3000 IU turoctocog alfa pegol.
Croatian: Jedna bočica lijeka Esperoct nominalno sadrži 500, 1000, 1500, 2000 ili 3000 IU turoktokog alfa pegola.
English: Perioperative management
Croatian: Perioperativno zbrinjavanje
English: • an infusion set (butterfly needle with tubing)
Croatian: • infuzijski set (leptirasta igla s cjevčicom)
English: When using a one-stage clotting assay some silica based reagents should be avoided as they cause underestimation.
Croatian: Kod upotrebe jednostupanjskog testa koagulacije treba izbjegavati neke reagense na bazi silicijevog dioksida jer uzrokuju niži rezultat za razinu aktivnosti od stvarne.
English: 6 to below 12 years N=11
Croatian: 6 do mlađi od 12 godina N=11
English: Injecting Esperoct via needleless connectors for intravenous (IV) catheters
Croatian: Injiciranje lijeka Esperoct putem konektora za primjenu bez igle za intravenske (i.v.) katetere:
English: More extensive haemarthrosis, muscle bleeding, haematoma
Croatian: Umjereno Jača hemartroza, krvarenje u mišiću, hematom
English: On demand treatment and treatment of bleeding episodes
Croatian: Liječenje po potrebi i liječenje epizoda krvarenja
English: Esperoct is supplied as a powder.
Croatian: Esperoct dolazi u obliku praška.
English: What Esperoct is used for
Croatian: Za što se Esperoct koristi
English: If the protective paper is not fully sealed or if it is broken, do not use the vial adapter.
Croatian: Ako zaštitni papir nije u potpunosti pričvršćen ili je oštećen, nemojte koristiti nastavak za bočicu.
English: Do not use the equipment if you suspect it is contaminated.
Croatian: Nemojte koristiti pribor ako mislite da je onečišćen.
English: 0 to below 6 years N=13
Croatian: 0 do mlađi od 6 godina N=13
English: The powder in the vial appears as a white to off-white powder.
Croatian: Prašak u bočici je bijele do bjelkaste boje.
English: The number of units of factor VIII administered is expressed in International Units (IU), which is related to the current WHO concentrate standard for factor VIII products.
Croatian: Broj primijenjenih jedinica faktora VIII izražava se u internacionalnim jedinicama (IU), koje su u skladu s važećim standardom Svjetske zdravstvene organizacije za koncentrat za lijekove koji sadrže faktor VIII.
English: Anti-drug antibodies
Croatian: Protutijela na lijek
English: IR (IU/dL) per (IU/kg)a
Croatian: (%) (IU/dl)a
English: • Check the reconstituted solution.
Croatian: • Pregledajte pripremljenu otopinu.
English: Disposal • After injection, safely dispose of all unused Esperoct solution, the syringe with the infusion set, the vial with the vial adapter and other waste materials as instructed by your pharmacist.
Croatian: • Nakon injiciranja, bacite neiskorištenu otopinu lijeka Esperoct, štrcaljku s infuzijskim setom, bočicu s nastavkom za bočicu i drugi otpadni materijal na siguran način, u skladu s uputama koje ste dobili od ljekarnika.
English: • 1 vial with Esperoct powder
Croatian: • 1 bočicu s praškom Esperoct
English: • 1 pre-filled syringe with solvent
Croatian: • 1 napunjenu štrcaljku s otapalom
English: • The ingredients in the solvent are sodium chloride 9 mg/mL (0.9%) solution for injection and water for injections.
Croatian: • Sastojci u otapalu su 0,9 %-tna (9 mg/ml) otopina natrijeva klorida za injekciju i voda za injekcije.
English: Turoctocog alfa pegol is a purified recombinant human factor VIII (rFVIII) product with a 40 kDa polyethylene-glycol (PEG) conjugated to the protein.
Croatian: Turoktokog alfa pegol je pročišćeni rekombinantni ljudski faktor VIII (rFVIII) s polietilenglikolom (PEG) od 40 kDa konjugiranim na protein.
English: Inject the reconstituted solution
Croatian: Injicirajte pripremljenu otopinu
English: Solvent for Esperoct Sodium chloride 9 mg/mL
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za Esperoct natrijev klorid 9 mg/ml
English: The median annualised bleeding rate (ABR) in adults and adolescents receiving Esperoct was 1.18 (Interquartile range IQR: 0.00;4.25), whereas the spontaneous ABR was 0.00 (IQR: 0.00;1.82), traumatic ABR was 0.00 (IQR: 0.00;1.74) and joint ABR was 0.85 (IQR: 0.00;2.84).
Croatian: Medijan anualizirane stope krvarenja (ASK) u odraslih i adolescenata koji su primali lijek Esperoct iznosio je 1,18 (interkvartilni raspon: 0,00; 4,25), dok je spontana anualizirana stopa krvarenja iznosila 0,00 (interkvartilni raspon: 0,00; 1,82), traumatski ASK iznosio je 0,00 (interkvartilni raspon: 0,00; 1,74), a ASK za zglobove iznosio je 0,85 (interkvartilni raspon; 0,00; 2,84).
English: For treatment of bleeds a maximum single dose of Esperoct at 75 IU/kg and a maximum total dose of 200 IU/kg/24 hours may be administered.
Croatian: Za liječenje krvarenja može se primijeniti maksimalna jednokratna doza lijeka Esperoct od 75 IU/kg i maksimalna ukupna doza od 200 IU/kg/24 sata.
English: Esperoct 500 IU powder and solvent for solution for injection Esperoct 1000 IU powder and solvent for solution for injection Esperoct 1500 IU powder and solvent for solution for injection Esperoct 2000 IU powder and solvent for solution for injection Esperoct 3000 IU powder and solvent for solution for injection.
Croatian: Esperoct 500 IU prašak i otapalo za otopinu za injekciju Esperoct 1000 IU prašak i otapalo za otopinu za injekciju Esperoct 1500 IU prašak i otapalo za otopinu za injekciju Esperoct 2000 IU prašak i otapalo za otopinu za injekciju Esperoct 3000 IU prašak i otapalo za otopinu za injekciju
English: • Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe.
Croatian: • Prestanite pritiskati potisnik klipa i pustite ga da se samostalno pomiče unatrag dok pripremljena otopina ne ispuni štrcaljku.
English: Do not use the reconstituted solution if you notice any particles or discolouration.
Croatian: Nemojte upotrijebiti pripremljenu otopinu za primjenu ako primijetite bilo kakve čestice ili ako je došlo do promjene boje.
English: Duration of therapy
Croatian: Trajanje liječenja
English: The mechanism of action of turoctocog alfa pegol is based on the replacement of the deficient or absent factor VIII in patients with haemophilia A. When turoctocog alfa pegol is activated by thrombin at the site of injury, the B-domain containing the PEG moiety and the a3-region are cleaved off, thus generating activated recombinant factor VIII (rFVIIIa) which is similar in structure to native factor VIIIa.
Croatian: Kad se turoktokog alfa pegol aktivira trombinom na mjestu ozljede, B domena koja sadrži PEG skupinu i a3 regiju se cijepa, time stvarajući aktivirani rekombinantni faktor VIII (rFVIIIa) koji je strukturom sličan nativnom faktoru VIIIa.
English: Do not lift the vial adapter from the vial when removing the protective cap.
Croatian: Nemojte podići nastavak za bočicu s bočice kad skidate zaštitni omot.
English: What you need to know before you use Esperoct Do not use Esperoct:
Croatian: Što morate znati prije nego počnete primjenjivati Esperoct
English: Frequency of doses (hours)
Croatian: Učestalost doziranja (sati)
English: Factor VIII inhibition Uncommon (PTPs)**
Croatian: Manje često (PTP)**
English: The mean trough plasma factor VIII activity levels at steady-state during prophylactic treatment with Esperoct dosed with 50 IU/kg every 4 days is 3.0 IU/dL (95% CI: 2.6;3.4) in patients 12 years and above.
Croatian: U bolesnika u dobi od 12 godina i starijih srednja vrijednost najniže razine aktivnosti faktora VIII u plazmi u stanju dinamičke ravnoteže tijekom profilaktičkog liječenja lijekom Esperoct u dozi od 50 IU/kg svaka 4 dana je 3,0 IU/dl (95% CI: 2,6; 3,4).
English: Must not be returned to the refrigerator after storage at room temperature Date removed from refrigerator: ____________
Croatian: Ne smije se vraćati u hladnjak nakon čuvanja na sobnoj temperaturi
English: Clinical efficacy of Esperoct in treatment of bleeding episodes and during on-demand treatment
Croatian: Klinička djelotvornost lijeka Esperoct u liječenju epizoda krvarenja i tijekom liječenja po potrebi
English: Do not freeze the reconstituted solution or store it in syringes.
Croatian: Pripremljenu otopinu ne smijete zamrzavati niti čuvati u štrcaljkama.
English: • Remove the syringe cap from the pre-filled syringe by bending it down until the perforation breaks.
Croatian: • Uklonite zatvarač štrcaljke s napunjene štrcaljke savijajući ga prema dolje dok se perforirani dio ne odvoji.
English: Esperoct is used to treat and prevent bleeding in people 12 years and above with haemophilia A (inborn factor VIII deficiency).
Croatian: Esperoct se koristi za liječenje i sprječavanje krvarenja u osoba s hemofilijom A (urođeni nedostatak faktora VIII) u dobi od 12 i više godina.
English: Before injection, it must be reconstituted with the solvent supplied in the syringe.
Croatian: Prije injiciranja lijek mora biti pripremljen s otapalom koje dolazi u štrcaljki.
English: For instructions on reconstitution of the medicinal product before administration, see the package leaflet.
Croatian: Za upute o rekonstituciji lijeka prije primjene, vidjeti u uputi o lijeku.
English: Once attached, do not remove the vial adapter from the vial.
Croatian: Kad ste ga pričvrstili, nemojte odvajati nastavak za bočicu s bočice.