FrancophonIA/ELRC3.0 huggingface dataset:
English: The powder is a white to off-white powder or cake.
Croatian: Prašak je bijeli do gotovo bijeli prašak ili kolačić.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with ELOCTA in one or more subsets of the paediatric population in the treatment of hereditary Factor VIII deficiency (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka ELOCTA u jednoj ili više podskupina pedijatrijske populacije u liječenju nasljednog nedostatka faktora VIII (vidjeti dio 4.2
English: If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with an appropriate dose, testing for factor VIII inhibitor presence should be performed.
Croatian: Ako se ne postignu očekivane razine aktivnosti faktora VIII u plazmi ili se krvarenje ne kontrolira odgovarajućom dozom, potrebno je provesti testiranje kako bi se ustanovilo je li prisutan inhibitor faktora VIII.
English: The immunogenicity of ELOCTA was evaluated in the clinical trial programme in 276 previously treated patients with severe haemophilia A (207 adolescents and adult and 69 paediatric patients).
Croatian: Imunogenost lijeka ELOCTA procijenjena je u programu kliničkog ispitivanja u 276 prethodno liječenih bolesnika s teškom hemofilijom A (207 adolescenata i odraslih te 69 pedijatrijskih bolesnika).
English: This receptor is expressed throughout life and is part of a naturally occurring pathway that protects immunoglobulins from lysosomal degradation by cycling these proteins back into circulation, resulting in their long plasma half-life.
Croatian: Ekspresija ovog receptora traje cijeli život i dio je prirodnog puta koji štiti imunoglobuline od lizosomske razgradnje tako što ciklički vraća te proteine u krvotok, što rezultira njihovim dugim poluvijekom eliminacije iz plazme.
English: Do not use this medicine if you notice that it is cloudy or contains visible particles.
Croatian: Ovaj lijek se ne smije upotrijebiti ako primijetite da je mutan ili sadrži vidljive čestice.
English: Documentation
Croatian: Dokumentacija
English: Do not use this medicine after the expiry date which is stated on the carton and the 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: Study II
Croatian: Ispitivanje II
English: A single large luer lock syringe may be used to draw back the prepared contents of each of the individual vials.
Croatian: Može se uporabiti jedna velika štrcaljka s luer-lock spojem za izvlačenje pripremljenog sadržaja iz svake pojedine bočice.
English: ELOCTA can be used for all age groups.
Croatian: ELOCTA se može primjenjivati u svim dobnim skupinama.
English: In the case of the following haemorrhagic events, the factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dL) in the corresponding period.
Croatian: U slučaju sljedećih hemoragijskih događaja aktivnost faktora VIII ne smije se spustiti ispod navedene razine plazmatske aktivnosti (izraženo kao % u odnosu na normalnu ili u IU/dl) unutar odgovarajućeg razdoblja.
English: The date that the product is removed from refrigeration should be recorded on the carton.
Croatian: Datum uklanjanja lijeka iz hladnjaka treba zabilježiti na kutiji.
English: Must not be returned to refrigerator after storage at room temperature.
Croatian: Ne smije se vratiti u hladnjak nakon čuvanja na sobnoj temperaturi.
English: Solvent: water for injections, a clear, colourless solution.
Croatian: Otapalo: voda za injekcije, bistra, bezbojna otopina.
English: In patients with haemophilia A, factor VIII is missing or not working properly.
Croatian: U bolesnika s hemofilijom A, faktor VIII nedostaje ili ne djeluje na pravi način.
English: Efmoroctocog alfa binds to neonatal Fc receptor thereby utilising this same naturally occurring pathway to delay lysosomal degradation and allow for longer plasma half-life than endogenous factor VIII.
Croatian: Efmoroktokog alfa veže se za neonatalni Fc receptor i tako iskorištava isti prirodni put kako bi usporio lizosomsku razgradnju i postigao dulji poluvijek eliminacije iz plazme nego endogeni faktor VIII.
English: Intravenous use, after reconstitution.
Croatian: Intravenski, nakon rekonstitucije.
English: Note: If you use more than one vial of ELOCTA per injection, each vial should be prepared separately as per the previous instructions (steps 1 to 13) and the solvent syringe should be removed, leaving the vial adapter in place.
Croatian: Napomena: Ako primjenjujete više od jedne bočice lijeka ELOCTA po injekciji, svaka se bočica mora pripremiti zasebno prema prethodnim uputama (koraci 1 do 13) i štrcaljka s otapalom mora se ukloniti,
English: 1500 IU 2000 IU 3000 IU 4000 IU 5000 IU 6000 IU
Croatian: 250 IU 500 IU 750 IU 1000 IU 1500 IU 2000 IU 3000 IU 4000 IU 5000 IU 6000 IU
English: ELOCTA increases factor VIII level in the blood and temporarily corrects the bleeding tendency.
Croatian: ELOCTA povećava razinu faktora VIII u krvi i privremeno ispravlja sklonost krvarenju.
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available.
Croatian: Na temelju rijetke pojavnosti hemofilije A u žena nema dostupnog iskustva s primjenom faktora VIII tijekom trudnoće i dojenja.
English: Do not push the solution through the needle.
Croatian: Nemojte potisnuti otopinu kroz iglu.
English: Repeat injection every 8 to 24 hours as necessary until adequate wound healing, then therapy at least for another 7 days to maintain a factor VIII activity of 30% to 60% (IU/dL).
Croatian: 24 sata do odgovarajućeg cijeljenja rane, a potom nastavite s terapijom tijekom najmanje 7 dodatnih dana kako biste održali aktivnost faktora VIII od 30% do 60% (IU/dl).
English: Excipient with known effect 0.6 mmol (or 14 mg) sodium per vial.
Croatian: Pomoćna tvar s poznatim učinkom 0,6 mmol (ili 14 mg) natrija po bočici.
English: If this happens you or your child´s medicines may stop working properly and you or your child may experience persistent bleeding.
Croatian: tom slučaju Vaš lijek ili lijek Vašeg dijeteta može prestati ispravno djelovati, a kod Vas ili Vašeg djeteta može se javiti krvarenje koje ne prestaje.
English: Factor VIII activity in plasma is expressed either as a percentage (relative to normal human plasma) or in International Units (relative to an International Standard for factor VIII in plasma).
Croatian: Aktivnost faktora VIII u plazmi izražava se kao postotak (u odnosu na normalnu ljudsku plazmu) ili u IU (u odnosu na međunarodni standard za faktor VIII u plazmi).
English: ELOCTA pack contains:
Croatian: Pakiranje lijeka ELOCTA sadrži:
English: One IU of recombinant factor VIII Fc activity is equivalent to that quantity of factor VIII in one mL of normal human plasma.
Croatian: Jedna IU aktivnosti rekombinantnog faktora VIII Fc odgovara količini faktora VIII u jednom ml normalne ljudske plazme.
English: ELOCTA has no influence on the ability to drive and use machines.
Croatian: ELOCTA ne utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Upon activation of the clotting cascade, factor VIII is converted to activated factor VIII and released from von Willebrand factor.
Croatian: Nakon pokretanja koagulacijske kaskade, faktor VIII pretvara se u aktivirani faktor VIII i oslobađa od von Willebrandovog faktora.
English: Record on the carton the date that ELOCTA is removed from the refrigerator and set at room temperature.
Croatian: Zabilježite na kutiju datum kad ste izvadili lijek ELOCTA iz hladnjaka i ostavili ga na sobnoj temperaturi.
English: Therefore, it is recommended to monitor all patients carefully for inhibitor occurrence following any product switch.
Croatian: Stoga se preporučuje pažljivo pratiti sve bolesnike zbog pojave inhibitora nakon svake zamjene jednog pripravka drugim.
English: 1 Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. PTPs= previously treated patients, PUPs= previously untreated patients.
Croatian: 1 Učestalost se temelji na ispitivanjima sa svim lijekovima s FVIII koja su uključivala bolesnike s teškom hemofilijom A. PTPs = prethodno liječeni bolesnici (engl. previously-treated patients), PUPs = prethodno neliječeni bolesnici (engl. previously-untreated patients)
English: USA
Croatian: Sjedinjene Američke Države
English: The pharmacokinetic parameters from the chromogenic assay data were similar to those derived for the one-stage assay.
Croatian: Farmakokinetički parametri iz podataka dobivenih kromogenim testom bili su slični onima dobivenima jednostupanjskim testom.
English: Individualised prophylaxis: 25 to 65 IU/kg every 3 to 5 days.
Croatian: Individualizirana profilaksa: 25 do 65 IU/kg svakih 3 do 5 dana.
English: The PK data demonstrate that ELOCTA has a prolonged circulating half-life.
Croatian: Farmakokinetički podaci pokazuju da ELOCTA ima produljeni poluvijek eliminacije iz cirkulacije.
English: Check the expiry date on the ELOCTA carton.
Croatian: Provjerite rok valjanosti na kutiji lijeka ELOCTA.
English: 2 Investigator term: vascular pain after injection of ELOCTA
Croatian: 2 Izraz ispitivača: bol u krvnoj žili nakon injekcije lijeka ELOCTA
English: In children below the age of 12, higher doses or more frequent injections may be needed.
Croatian: U djece mlađe od 12 godina mogu biti potrebne više doze ili češće davanje injekcija.
English: Efmoroctocog alfa (recombinant human coagulation factor VIII, Fc fusion protein (rFVIIIFc)) has 1,890 amino acids.
Croatian: Efmoroktokog alfa (rekombinantni ljudski koagulacijski faktor VIII, Fc fuzijski protein (rFVIIIFc)) ima 1890 aminokiselina.
English: Hypersensitivity to the active substance (recombinant human coagulation factor VIII, and/or Fc domain) or to any of the excipients listed in section 6.1.
Croatian: Preosjetljivost na djelatnu tvar (rekombinantni ljudski faktor zgrušavanja krvi VIII i/ili Fc domena) ili neku od pomoćnih tvari navedenih u dijelu 6.1.
English: The starting prophylactic regimen consisted of 25 IU/kg on the first day followed by 50 IU/kg on the fourth day.
Croatian: Početni profilaktički režim sastojao se od doze od 25 IU/kg prvog dana i doze od 50 IU/kg četvrtog dana.
English: ELOCTA contains sodium
Croatian: ELOCTA sadrži natrij
English: Elderly There is limited experience in patients ≥65 years.
Croatian: ≥65 godina je ograničeno.
English: For children not previously treated with factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however, patients who have received previous treatment with factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Croatian: 10 bolesnika) mogu nastati inhibitorna antitijela (vidjeti dio 2); međutim, u bolesnika koji su ranije primali terapiju s faktorom VIII (više od 150 dana liječenja) rizik je manje čest (manje od 1 na 100 bolesnika).
English: No effects on ability to drive or use of machines have been observed.
Croatian: Nisu opaženi učinci na sposobnost upravljanja vozilima ili rukovanja strojevima.
English: ELOCTA should be administered using the infusion set (E) provided in this pack.
Croatian: Lijek ELOCTA treba primijeniti pomoću kompleta za infuziju (E) priloženog u ovom pakiranju.
English: Repeat injection every 8 to 24 hours until threat is resolved.
Croatian: Ponovite injekciju svakih 8 do 24 sata dok se ne ukloni opasnost po život.
English: The dose may be adjusted by your doctor in the range of 25 to 65 IU per kg of body weight.
Croatian: Liječnik može prilagoditi tu dozu u rasponu od 25 do 65 IU po kg tjelesne težine.
English: Remove any air in the infusion set tubing by slowly depressing on the plunger rod until liquid has reached the infusion set needle.
Croatian: Uklonite sav zrak iz cijevi kompleta za infuziju sporim potiskivanjem klipa sve dok tekućina ne dosegne iglu kompleta za infuziju.
English: Subjects that switched from on-demand treatment to weekly prophylaxis during Study III had a median ABR of 1.67.
Croatian: U ispitanika koji su se prebacili s liječenja prema potrebi na tjednu profilaksu tijekom Ispitivanja III medijan godišnje stope krvarenja bio je 1,67.
English: The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Croatian: Doziranje Doza i trajanje nadomjesne terapije ovise o težini nedostatka faktora VIII, mjestu i opsegu krvarenja te bolesnikovom kliničkom stanju.
English: Powder: lyophilised, white to off-white powder or cake.
Croatian: Prašak: liofilizirani, bijeli do gotovo bijeli prašak ili kolačić.
English: Injury, poisoning, and procedural complications
Croatian: Ozljede, trovanja i proceduralne komplikacije proceduralna hipotenzija manje često
English: ELOCTA 250 ELOCTA 500 ELOCTA 750 ELOCTA 1000 ELOCTA 1500 ELOCTA 2000 ELOCTA 3000 ELOCTA 4000
Croatian: ELOCTA 250 ELOCTA 500 ELOCTA 750 ELOCTA 1000 ELOCTA 1500 ELOCTA 2000 ELOCTA 3000 ELOCTA 4000 ELOCTA 5000 ELOCTA 6000
English: Out of 67 subjects having completed Study II, 61 enrolled onto Study III (extension study).
Croatian: Od 67 ispitanika koji su završili Ispitivanje II, 61 bolesnik uključen je u Ispitivanje III (nastavak ispitivanja).
English: Fertility There are no fertility data available.
Croatian: Nema dostupnih podataka o utjecaju na plodnost.
English: Do not use the solution if cloudy or contains visible particles.
Croatian: Nemojte primijeniti otopinu ako je mutna ili sadrži vidljive čestice.
English: After preparation, ELOCTA can be stored at room temperature for up to 6 hours before administration.
Croatian: Nakon pripreme lijek ELOCTA može se čuvati na sobnoj temperaturi najviše 6 sati prije primjene.
English: The vial should be gently swirled until all of the powder is dissolved.
Croatian: Bočicu treba nježno vrtjeti dok se sav prašak ne otopi.
English: The target factor VIII levels will depend on the severity and location of the bleeding.
Croatian: Ciljne razine faktora VIII ovisit će o jačini i mjestu krvarenja.
English: Individual patients may vary in their response to factor VIII, demonstrating different half-lives and recoveries.
Croatian: U pojedinog bolesnika odgovor na faktor VIII može biti različit, uz različite vrijednosti poluvijeka eliminacije i oporavka.
English: Pharmacokinetic samples were collected pre-dose and then subsequently at 7 time points up to 120 hours (5 days) post-dose.
Croatian: Farmakokinetički uzorci bili su prikupljeni prije doziranja, a potom u 7 vremenskih točaka u razdoblju od 120 sati (5 dana) nakon doziranja.
English: ELOCTA should be injected intravenously over several minutes.
Croatian: Lijek ELOCTA treba ubrizgavati intravenski tijekom nekoliko minuta.
English: Insert the infusion set needle into a vein as instructed by your doctor or nurse and remove the tourniquet.
Croatian: Uvedite iglu kompleta za infuziju u venu prema uputama liječnika ili medicinske sestre i uklonite povesku.
English: Repeat injection every 12 to 24 hours for 3-4 days or more until pain and acute disability are resolved.
Croatian: Ponovite injekciju svakih 12 do 24 sata tijekom 3-4 dana ili više dok se ne izliječe bol ili akutna onesposobljenost.
English: The following side effects may occur with this medicine.
Croatian: Uz ovaj lijek mogu nastati sljedeće nuspojave.
English: During the course of treatment, appropriate determination of factor VIII levels (by one-stage clotting or chromogenic assays) is advised to guide the dose to be administered and the frequency of repeated injections.
Croatian: Tijekom liječenja savjetuje se odgovarajuće određivanje razine faktora VIII (jednostupanjskim testom zgrušavanja krvi ili kromogenim testom) kao smjernica za dozu koju treba primijeniti i učestalost ponavljanja injekcija.
English: It is strongly recommended that every time ELOCTA is given, the name and batch number of the product are recorded.
Croatian: Posebno se preporučuje kod svakog davanja lijeka ELOCTA zapisati naziv i broj serije lijeka.
English: Study I*
Croatian: Ispitivanje I*
English: The usual dose of ELOCTA is 50 IU per kg of body weight, given every 3 to 5 days.
Croatian: Uobičajena doza lijeka ELOCTA je 50 IU po kg tjelesne težine koja se daje svakih 3 do 5 dana.
English: Allergic type hypersensitivity reactions are possible with ELOCTA.
Croatian: Preosjetljivost Moguće su alergijske reakcije preosjetljivosti na lijek ELOCTA.
English: The frequencies in Table 2 below were observed in a total of 276 patients with severe haemophilia A in phase III clinical studies and an extension study with a duration of up to four years.
Croatian: Tablični popis nuspojava Učestalosti u tablici 2 niže bile su opažene u ukupno 276 bolesnika s teškom hemofilijom A u kliničkim ispitivanjima faze III i jednom nastavku ispitivanja koje je trajalo do 4 godine.
English: Remove the clear plastic protective cover from the needle.
Croatian: Uklonite prozirni plastični štitnik s igle.
English: ELOCTA is comprised of recombinant B-domain deleted human coagulation factor VIII covalently linked to the Fc domain of human immunoglobulin G1.
Croatian: ELOCTA se sastoji od rekombinantne B-domene delecijom promijenjenog ljudskog koagulacijskog faktora VIII koja je kovalentno vezana na Fc domenu ljudskog imunoglobulina G1.
English: • The formation of inhibitors (antibodies) is a known complication that can occur during treatment with all factor VIII medicines.
Croatian: - Stvaranje inhibitora (antitijela) poznata je komplikacija koja se može pojaviti tijekom liječenja bilo kojim lijekom koji sadrži faktor VIII.
English: If needed apply a tourniquet and prepare the injection site by wiping the skin well with the other alcohol swab provided in the pack.
Croatian: Po potrebi stavite povesku i pripremite mjesto za injekciju tako što ćete dobro obrisati kožu drugom alkoholom natopljenom vaticom priloženom u pakiranju.
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ELOCTA.
Croatian: Do razvoja neutralizirajućih antitijela (inhibitora) može doći u bolesnika s hemofilijom A koji su liječeni faktorom VIII, uključujući lijek ELOCTA.
English: What you need to know before you use ELOCTA Do not use ELOCTA:
Croatian: Što morate znati prije nego počnete primjenjivati lijek ELOCTA
English: Only the provided infusion set should be used because treatment failure can occur as a consequence of coagulation factor VIII adsorption to the internal surfaces of some injection equipment.
Croatian: Smije se koristiti samo priloženi komplet za infuziju zato što liječenje može biti neuspješno zbog adsorpcije faktora zgrušavanja krvi VIII na unutrašnju površinu nekih pribora za injiciranje.
English: Median total time on study II+III was 3.4 years and median no of exposure days was 332.
Croatian: Medijan ukupnog vremena u Ispitivanju II i III bio je 3,4 godine, a medijan broja dana izloženosti bio je 332.
English: ELOCTA is a medicine used for the treatment and prevention of bleeding in all age groups of patients with haemophilia A (inherited bleeding disorder caused by factor VIII deficiency).
Croatian: ELOCTA je lijek koji se primjenjuje za liječenje i sprječavanje krvarenja u svih dobnih skupina bolesnika s hemofilijom A (nasljednim poremećajem krvi prouzročenim manjkom faktora VIII).
English: Incremental Recovery (IU/dL per IU/kg) AUC/Dose (IU*h/dL per IU/kg) Cmax (IU/dL) CL (mL/h/kg) t½ (h) MRT (h) Vss (mL/kg) 1 Pharmacokinetic parameters are presented in Geometric Mean (95% CI) Abbreviations: CI = confidence interval; Cmax= maximum activity; AUC = area under the FVIII activity time curve; t½= terminal half-life; CL = clearance; Vss = volume of distribution at steady-state; MRT = mean residence time.
Croatian: Postupni oporavak (IU/dl po IU/kg) AUC/doza (IU*h/dl po IU/kg) Cmax (IU/dl) CL (ml/h/kg) t½ (h) MRT (h) Vss (ml/kg) 1 Farmakokinetički parametri prikazani su kao geometrijska srednja vrijednost (95% CI) Skraćenice: CI = interval pouzdanosti; Cmax= vršna aktivnost; AUC = površina ispod krivulje aktivnosti faktora VIII u vremenu; t½= poluvijek eliminacije; CL = klirens; Vss = volumen distribucije u stanju dinamičke ravnoteže; MRT = srednja vrijednost vremena zadržavanja.
English: Perioperative management (surgical prophylaxis): A total of 48 major surgical procedures were performed and assessed in 34 subjects in Study I and Study III.
Croatian: Perioperativno liječenje (kirurška profilaksa): Ukupno je izvedeno i ocijenjeno 48 većih kirurških zahvata u 34 ispitanika u Ispitivanju
English: Study I enrolled 165 previously treated male patients (12 to 65 years of age) with severe haemophilia A. Subjects on prophylaxis regimens prior to entering the study were assigned to the individualised prophylaxis arm.
Croatian: I uključilo je ukupno 165 prethodno liječenih muškaraca (u dobi od 12 do 65 godina) s teškom hemofilijom A. Ispitanici koji su se profilaktički liječili prije ulaska u ispitivanje bili su raspoređeni u skupinu koja je primala individualiziranu profilaksu.
English: Haemophilia A is an X-linked hereditary disorder of blood coagulation due to decreased levels of functional factor VIII and results in bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Croatian: Hemofilija A je nasljedni poremećaj zgrušavanja krvi povezan s X kromosomom i nastaje zbog smanjenih razina funkcionalnog faktora VIII te rezultira krvarenjem u zglobove, mišiće ili unutarnje organe, spontano ili nakon ozljede ili kirurškog zahvata.
English: See package leaflet for additional information on reconstitution and administration.
Croatian: Vidjeti uputu o lijeku za dodatne informacije o rekonstituciji i primjeni.
English: These inhibitors, especially at high levels, stop the treatment working properly and you or your child will be monitored carefully for the development of these inhibitors.
Croatian: zaustavljaju ispravno djelovanje liječenja, te ćete Vi ili Vaše dijete biti pod pažljivim praćenjem zbog mogućeg razvoja tih inhibitora.
English: The safety, efficacy, and pharmacokinetics of ELOCTA were evaluated in 2 multinational, open-label, pivotal studies; a phase 3 study, referred to as Study I and a phase 3 paediatric study, referred to as Study II (see Paediatric population).
Croatian: Sigurnost, djelotvornost i farmakokinetika lijeka ELOCTA bile su procijenjene u 2 multinacionalna, ključna ispitivanja otvorenog tipa: jednom ispitivanju faze 3 koje se naziva Ispitivanje
English: For long term prophylaxis, the recommended dose is 50 IU/kg every 3 to 5 days.
Croatian: Za dugotrajnu profilaksu preporučena doza je 50 IU/kg svakih 3 do 5 dana.
English: Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Croatian: Liječenje takvih bolesnika trebaju voditi liječnici s iskustvom u skrbi za bolesnike s hemofilijom i inhibitorima faktora VIII.
English: Repeat injection every 24 hours, for at least 1 day, until healing is achieved.
Croatian: Ponovite injekciju svaka 24 sata tijekom najmanje 1 dana sve dok se ne postigne zacjeljivanje.
English: Treatment with ELOCTA will be started by a doctor who is experienced in the care of patients with haemophilia.
Croatian: Liječenje lijekom ELOCTA započet će liječnik koji ima iskustva u liječenju bolesnika s hemofilijom.
English: The potency (International Units) is determined using the European Pharmacopoeia chromogenic assay against an in-house standard that is referenced to the WHO factor VIII standard.
Croatian: Potentnost (međunarodne jedinice) se određuje kromogenim testom prema Europskoj farmakopeji u odnosu na standard ustanove usklađen s preporučenim standardom za faktor VIII Svjetske zdravstvene organizacije (SZO).
English: Solvent for ELOCTA water for injections
Croatian: Otapalo za ELOCTA voda za injekcije