FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Pri prehodu z zdravila, ki vsebuje en faktor VIII, na zdravilo, ki vsebuje drugega, so pri predhodno zdravljenih bolnikih, ki so bili izpostavljeni več kot 100 dni in so imeli razvoj inhibitorjev v anamnezi,
English: Discard the vial and the adapter.
Slovenian: Vialo in nastavek zavrzite.
English: Each pack contains: - powder in a type 1 glass vial with a chlorobutyl rubber stopper - 3 mL solvent in a type 1 glass pre-filled syringe with a bromobutyl rubber plunger stopper - a plunger rod - a sterile vial adapter for reconstitution - a sterile infusion set - two alcohol swabs - two plasters - one gauze pad.
Slovenian: Eno pakiranje vsebuje: - prašek v viali iz stekla tipa 1 s klorobutilnim gumijastim zamaškom - 3 ml vehikla v napolnjeni injekcijski brizgi iz stekla tipa 1 z zamaškom z batom iz brombutilne gume - bat - sterilni nastavek viale za rekonstitucijo - sterilni infuzijski komplet - dva alkoholna zloženca
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.
Slovenian: Zdravljenje krvavitve: Med študijo II in III je bilo zdravljenih 447 dogodkov krvavitve z mediano odmerka 63 i.e./kg (najmanj 28, največ 186) za nadzor posamezne krvavitve.
English: After storage at room temperature, the product may not be returned to the refrigerator.
Slovenian: Po shranjevanju pri sobni temperaturi zdravila ne vračajte v hladilnik.
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).
Slovenian: Pri bolnikih, ki so se predhodno že zdravili s faktorjem VIII (zdravljenje je trajalo več kot 150 dni), pa je tveganje občasno (pri manj kot 1 od 100 bolnikov).
English: ELOCTA contains the active substance efmoroctocog alfa, a recombinant coagulation factor VIII, Fc fusion protein.
Slovenian: Zdravilo ELOCTA vsebuje učinkovino efmoroktokog alfa, rekombinantni koagulacijski faktor VIII, fuzijsko beljakovino Fc.
English: Table 2: Adverse reactions reported for ELOCTA in clinical trials MedDRA System Organ Class
Slovenian: Preglednica 2: Neželeni učinki, o katerih so poročali za zdravilo ELOCTA v kliničnih preskušanjih
English: Rarely, inhibitors may develop after the first 100 exposure days.
Slovenian: Po prvih 100 dnevih izpostavljenosti pa se zaviralci pojavijo le redko.
English: Lift the protective cap away from the adapter and discard.
Slovenian: Dvignite zaščitni ovoj z nastavka in ga zavrzite.
English: See package leaflet for additional information on reconstitution and administration.
Slovenian: Za dodatne informacije o rekonstituciji in dajanju glejte navodilo za uporabo.
English: Slowly depress the plunger rod to inject all the solvent into the ELOCTA vial.
Slovenian: Bat počasi potiskajte, da injicirate celotno količino vehikla v vialo z zdravilom ELOCTA.
English: If ELOCTA has been stored in a refrigerator, allow the vial of ELOCTA (A) and the syringe with solvent (B) to reach room temperature before use.
Slovenian: ELOCTA (A) in injekcijska brizga z vehiklom (B) pred uporabo ogrejeta na sobno temperaturo.
English: H) 1 Gauze pad
Slovenian: H) 1 gazo
English: Treatment of bleeding: 2490 bleeding events were treated during Study I and III with a median dose of 43.8 IU/kg (min 13.0, max 172.8) to control each bleed.
Slovenian: Zdravljenje krvavitve: Med študijo I in III so zdravili 2.490 dogodkov krvavitve z mediano odmerka 43,8 i.e./kg (najmanj 13,0, največ 172,8) za nadzor posamezne krvavitve.
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.
Slovenian: Eno pakiranje zdravila ELOCTA vsebuje 1 vialo s praškom, 3 ml vehikla v napolnjeni injekcijski brizgi, 1 bat, 1 nastavek za vialo, 1 infuzijski komplet, 2 alkoholna zloženca, 2 obliža, 1 gazo.
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.
Slovenian: Vsebina: 1 viala s praškom, 3 ml vehikla v napolnjeni injekcijski brizgi, 1 bat, 1 nastavek za vialo, 1 infuzijski komplet, 2 alkoholna zloženca, 2 obliža, 1 gaza.
English: Protect the prepared solution from direct sunlight.
Slovenian: Pripravljeno raztopino zaščitite pred neposredno sončno svetlobo.
English: Animal reproduction studies have not been conducted with ELOCTA.
Slovenian: Študij o vplivu zdravila ELOCTA na sposobnost razmnoževanja pri živalih niso izvedli.
English: Peel back the protective paper lid from the clear plastic vial adapter (D).
Slovenian: Odluščite zaščitni papirnati ovoj z brezbarvnega plastičnega nastavka za vialo (D).
English: ELOCTA 250 IU powder and solvent for solution for injection
Slovenian: ELOCTA 250 i.e. prašek in vehikel za raztopino za injiciranje
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.
Slovenian: 1 Pogostnost temelji na študijah z vsemi zdravili s FVIII, ki so vključevale bolnike s hudo hemofilijo A.
English: Injury, poisoning, and procedural complications
Slovenian: Poškodbe, zastrupitve in zapleti pri posegih hipotenzija pri posegu občasni
English: Alternatively, ELOCTA may be stored at room temperature (up to 30°C) for a single period not exceeding 6 months.
Slovenian: Zdravilo ELOCTA lahko shranite tudi pri sobni temperaturi (do 30 °C), in sicer za enkratno obdobje največ 6 mesecev.
English: Respiratory, thoracic, and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora kašelj občasni
English: CL (mL/h/kg)
Slovenian: Očistek (ml/h/kg)
English: With the syringe still connected to the adapter and the plunger rod pressed down, gently swirl the vial until the powder is dissolved.
Slovenian: Z injekcijsko brizgo, pritrjeno na nastavek, in batom, stisnjenim navzdol, vialo nežno obračajte, da se prašek raztopi.
English: ELOCTA 500 IU powder and solvent for solution for injection
Slovenian: ELOCTA 500 i.e. prašek in vehikel za raztopino za injiciranje
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.
Slovenian: Bat (C) nataknite na injekcijsko brizgo z vehiklom tako, da vstavite konico bata v odprtino v batu injekcijske brizge.
English: Attach the syringe with the prepared ELOCTA solution to the end of the infusion set tubing by turning clockwise.
Slovenian: Z obračanjem v smeri urnega kazalca pritrdite injekcijsko brizgo s pripravljeno raztopino zdravila ELOCTA na konec cevke infuzijskega kompleta.
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.
Slovenian: Občasni neželeni učinki (pojavijo se lahko pri največ 1 od 100 bolnikov) glavobol, omotica, sprememba okusa, počasno utripanje srca, visok krvni tlak, vročinski oblivi, vaskularna bolečina po injiciranju, kašelj, bolečina v trebuhu, izpuščaj, otekli sklepi, bolečina v mišicah, bolečina v hrbtu, bolečina v sklepih, splošno nelagodje, bolečina v prsnem košu, mrazenje, občutek vročine in nizek krvni tlak.
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).
Slovenian: osrednjih študijah; v študiji faze 3, imenovani študija I, in pediatrični študiji faze 3, imenovani študija II
English: Table 1 can be used to guide dosing in bleeding episodes and surgery:
Slovenian: Za vodilo pri odmerjanju pri krvavitvah in kirurških posegih lahko uporabimo preglednico 1:
English: F) 2 Alcohol swabs G) 2 Plasters
Slovenian: D) 1 nastavek za vialo E) 1 infuzijski komplet F) 2 alkoholna zloženca G) 2 obliža
English: • The other ingredients are sucrose, sodium chloride, L-Histidine, calcium chloride dihydrate, polysorbate 20, sodium hydroxide, hydrochloric acid and water for injections.
Slovenian: • Druge sestavine zdravila so saharoza, natrijev klorid, L-histidin, kalcijev klorid dihidrat,
English: Do not use if the medicine has expired.
Slovenian: Zdravila, ki mu je potekel rok uporabnosti, ne uporabite.
English: A single large luer lock syringe may be used to draw back the prepared contents of each of the individual vials.
Slovenian: Vsebino vsake posamične viale lahko izvlečete z eno samo veliko injekcijsko brizgo z nastavkom luer.
English: 1500 IU 2000 IU 3000 IU 4000 IU 5000 IU 6000 IU
Slovenian: 250 i.e. 500 i.e. 750 i.e. 1000 i.e. 1500 i.e. 2000 i.e. 3000 i.e. 4000 i.e. 5000 i.e. 6000 i.e.
English: Individualised prophylaxis: Median annual factor consumption was 4212 IU/kg (min 2877, max 7943) in Study I and 4223 IU/kg (min 2668, max 8317) in Study III.
Slovenian: Individualizirana profilaksa: Mediana letna poraba faktorja je bila 4.212 i.e./kg (najmanj 2.877, največ 7.943) v študiji I in 4.223 i.e./kg (najmanj 2.668, največ 8.317) v študiji III.
English: The reconstituted solution should be clear to slightly opalescent and colourless.
Slovenian: Rekonstituirana raztopina mora biti bistra do rahlo motna in brezbarvna.
English: Connect the solvent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening.
Slovenian: Injekcijsko brizgo z vehiklom povežite z nastavkom viale tako, da konico injekcijske brizge vtaknete v odprtino nastavka.
English: Respective median ABR was 3.59 (min 0, max 58.0) and 2.24 (min 0, max 17.2).
Slovenian: Ustrezna mediana letna stopnje krvavitev je bila 3,59 (najmanj 0, največ 58,0) oziroma 2,24 (najmanj 0, največ 17,2).
English: Hypersensitivity or allergic reactions (which may include swelling of the face, rash, hives, tightness of the chest and difficulty breathing, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hypotension, lethargy, nausea, restlessness, tachycardia) have been observed rarely and may in some cases progress to severe anaphylaxis (including shock).
Slovenian: V redkih primerih so opazili preobčutljivostne ali alergijske reakcije (ki lahko vključujejo oteklost obraza, izpuščaj, koprivnico, stiskanje v prsnem košu in težave z dihanjem, pekoč občutek in zbadanje na mestu infundiranja, mrzlico, zardevanje, generalizirano urtikarijo, glavobol, hipotenzijo, letargijo, navzeo,
English: ELOCTA is provided as a powder and solvent for solution for injection.
Slovenian: Zdravilo ELOCTA je na voljo v obliki praška in vehikla za raztopino za injiciranje.
English: How ELOCTA works
Slovenian: Delovanje zdravila ELOCTA
English: The solvent provided for preparation of the solution to inject, is a clear, colourless solution.
Slovenian: Vehikel za pripravo raztopine za injiciranje je bistra, brezbarvna raztopina.
English: The powder is a white to off-white powder or cake.
Slovenian: Prašek je bel do belkast prašek ali pogača.
English: Remove the plastic flip-top cap from the ELOCTA vial.
Slovenian: Z viale z zdravilom ELOCTA snemite plastično zaporko.
English: Press down firmly until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper.
Slovenian: Čvrsto pritiskajte navzdol, dokler se nastavek ne zaskoči na vrhu viale, konica nastavka pa prebije zamašek viale.
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
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)
Slovenian: Postopno okrevanje (i.e./dl na i.e./kg) AUC/odmerek (i.e.*h/dl na i.e./kg) t½ (h)
English: Life threatening haemorrhages
Slovenian: Življenjsko nevarne krvavitve
English: Weekly prophylaxis: Median annual factor consumption was 3805 IU/kg (min 3353, max 6196) in Study I and 3510 IU/kg (min 2758, max 3984) in Study III.
Slovenian: Tedenska profilaksa: Mediana letna poraba faktorja je bila 3.805 i.e./kg (najmanj 3.353, največ 6.196) v študiji I in 3.510 i.e./kg (najmanj 2.758, največ 3.984) v študiji III.
English: The final solution must be inspected visually before administration.
Slovenian: Pred uporabo morate končno raztopino pregledati s prostim očesom.
English: Protect product from direct sunlight.
Slovenian: Zagotovite zaščito zdravila pred neposredno sončno svetlobo.
English: Powder: lyophilised, white to off-white powder or cake.
Slovenian: Prašek: liofiliziran, bel do belkast prašek ali pogača.
English: Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Slovenian: L-histidin kalcijev klorid dihidrat polisorbat 20 natrijev hidroksid (za uravnavanje pH) klorovodikova kislina (za uravnavanje pH)
English: 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.
Slovenian: FVIII v odvisnosti od časa (area under time curve); t½ = končni razpolovni čas; Vss = volumen porazdelitve v stanju dinamičnega ravnovesja (volume of distribution at steady-state); MRT = povprečni čas zadrževanja (mean residence time).
English: Once you have prepared ELOCTA it should be used right away.
Slovenian: Pripravljeno zdravilo ELOCTA takoj uporabite.
English: Talk to your doctor, pharmacist or nurse before using ELOCTA.
Slovenian: Pred začetkom uporabe zdravila ELOCTA se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: ELOCTA is given as an injection into a vein.
Slovenian: Zdravilo ELOCTA se daje v veno s pomočjo injekcije.
English: Dosing of up to 80 IU/kg and a dosing interval as short as 2 days was allowed and used in a limited number of patients.
Slovenian: Pri omejenem številu bolnikov je bilo dovoljeno in uporabljeno odmerjanje do
English: Respective median Annualized Bleed Rate (ABR) was 1.60 (min 0, max 18.2) and 0.74 (min 0, max 15.6).
Slovenian: Ustrezna mediana letne stopnje krvavitev (Annualized Bleed Rate, ABR) je bila 1,60 (najmanj 0, največ 18,2) oziroma 0,74 (najmanj 0,
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.
Slovenian: Odlomite bel plastični varnostni pokrovček s konice injekcijske brizge z vehiklom tako, da ga pregibate na perforaciji pokrovčka, dokler se ne prelomi.
English: L-Histidine
Slovenian: (rFVIIIFc).
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with ELOCTA.
Slovenian: Pri bolnikih s hemofilijo A, zdravljenih s faktorjem VIII, vključno z zdravilom ELOCTA, lahko pride do nastanka nevtralizirajočih protiteles (zaviralcev).
English: After preparation, the solution to inject is clear to slightly opalescent and colourless.
Slovenian: Po pripravi je raztopina, ki se injicira, bistra do blago motna in brezbarvna.
English: Median annual factor consumption was 5572 IU/kg (min 3849, max 7035) in Study I and 4456 IU/kg (min 3563, max 8011) in Study III.
Slovenian: Mediana letna poraba faktorja je bila 5.572 i.e./kg (najmanj 3.849, največ 7.035) v študiji I in 4.456 i.e./kg (najmanj 3.563, največ 8.011) v študiji III.
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.
Slovenian: (voda za injekcije) iz napolnjene injekcijske brizge s pomočjo sterilnega nastavka viale za rekonstitucijo.
English: Table 4: Pharmacokinetic parameters of ELOCTA using the chromogenic assay Pharmacokinetic parameters1
Slovenian: Preglednica 4: Farmakokinetični parametri zdravila ELOCTA pridobljeni s kromogenim preskusom
English: Slowly pull on the plunger rod to draw back all the solution through the vial adapter into the syringe.
Slovenian: Počasi vlecite za bat, da izvlečete vso raztopino skozi nastavek viale v injekcijsko brizgo.
English: ELOCTA 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU efmoroctocog alfa.
Slovenian: ELOCTA 2000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 2000 i.e. efmoroktokoga alfa (efmoroctocogum alfa).
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.
Slovenian: Zdravilo lahko v roku uporabnosti za eno samo obdobje, ki ne sme biti daljše od 6 mesecev, shranjujete pri sobni temperature (do 30 °C).
English: After reconstitution, each mL of solution for injection contains approximately 83 IU efmoroctocog alfa.
Slovenian: Po rekonstituciji vsebuje en mililiter raztopine za injiciranje približno 83 i.e. efmoroktokoga alfa.
English: ELOCTA 750 IU powder and solvent for solution for injection Each vial contains nominally 750 IU efmoroctocog alfa.
Slovenian: ELOCTA 750 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 750 i.e. efmoroktokoga alfa (efmoroctocogum alfa).
English: AUC/Dose (IU*h/dL per IU/kg)
Slovenian: Postopno okrevanje (i.e./dl na i.e./kg) AUC/odmerek (i.e.*h/dl na i.e./kg)
English: Respective median ABR was 2.01 (min 0, max 27.2) and 1.59 (min 0, max 8.0).
Slovenian: Ustrezna mediana letne stopnje krvavitev je bila 2,01 (najmanj 0, največ 27,2) oziroma 1,59 (najmanj 0, največ 8,0).
English: Respective median Annualized Bleed Rate (ABR) was 0.00 (min 0, max 10.5) and 1.18 (min 0, max 9.2).
Slovenian: Ustrezna mediana letne stopnje krvavitev je bila 0,00 (najmanj 0, največ 10,5) oziroma 1,18 (najmanj 0, največ 9,2).
English: The solution should appear clear to slightly opalescent and colourless.
Slovenian: Videz raztopine mora biti bister do rahlo moten in brezbarven.
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;
Slovenian: 1 Farmakokinetični parametri so predstavljeni kot geometrična sredina (95-odstotni IZ) Okrajšave: IZ = interval zaupanja; AUC = površina pod krivuljo aktivnosti FVIII v odvisnosti od časa (area under time curve); t½ = končni razpolovni čas; MRT = povprečni čas zadrževanja (mean residence time); Vss = volumen porazdelitve v stanju dinamičnega ravnovesja (volume of distribution at steadystate) *Farmakokinetični parametri za 12 do < 18 let so vključevali osebe iz vseh krakov v študiji I z različnimi shemami vzorčenja
English: STATEMENT OF ACTIVE SUBSTANCE(S)
Slovenian: Podatki glede pomožnih snovi
English: Early haemarthrosis, muscle bleeding or oral bleeding
Slovenian: krvavitev v mišico ali krvavitev v ustni votlini
English: ELOCTA is administered by intravenous (IV) injection after dissolving the powder for injection with the solvent supplied in the pre-filled syringe.
Slovenian: injekcije potem, ko se prašek za injekcijo raztopi z vehiklom v napolnjeni injekcijski brizgi.
English: Respective median ABR was 1.92 (min 0, max 7.1) and 1.25 (min 0, max 9.5).
Slovenian: Ustrezna mediana letne stopnje krvavitev je bila 1,92 (najmanj 0, največ 7,1) oziroma 1,25 (najmanj 0, največ 9,5).
English: Turn the plunger rod firmly clockwise until it is securely seated in the syringe plunger.
Slovenian: Bat čvrsto obračajte v smeri urnega kazalca, da se varno usede v bat injekcijske brizge.
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.
Slovenian: 24 ur, dokler krvavitev, sodeč po bolečini, ne preneha ali dokler se ne zaceli.
English: After reconstitution, each mL of solution for injection contains approximately 1333 IU efmoroctocog alfa.
Slovenian: Po rekonstituciji vsebuje en mililiter raztopine za injiciranje približno 1333 i.e. efmoroktokoga alfa.
English: Type of surgical procedure
Slovenian: Večji kirurški poseg
English: ELOCTA 250 IU powder for injection ELOCTA 500 IU powder for injection ELOCTA 750 IU powder for injection ELOCTA 1000 IU powder for injection ELOCTA 1500 IU powder for injection ELOCTA 2000 IU powder for injection ELOCTA 3000 IU powder for injection ELOCTA 4000 IU powder for injection ELOCTA 5000 IU powder for injection ELOCTA 6000 IU powder for injection efmoroctocog alfa recombinant coagulation factor VIII IV
Slovenian: ELOCTA 250 i.e. prašek za injekcijo ELOCTA 500 i.e. prašek za injekcijo ELOCTA 750 i.e. prašek za injekcijo ELOCTA 1000 i.e. prašek za injekcijo ELOCTA 1500 i.e. prašek za injekcijo ELOCTA 2000 i.e. prašek za injekcijo ELOCTA 3000 i.e. prašek za injekcijo ELOCTA 4000 i.e. prašek za injekcijo ELOCTA 5000 i.e. prašek za injekcijo ELOCTA 6000 i.e. prašek za injekcijo efmoroctocogum alfa rekombinantni koagulacijski faktor VIII i.v.
English: ELOCTA 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU efmoroctocog alfa.
Slovenian: ELOCTA 250 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 250 i.e. efmoroktokoga alfa (efmoroctocogum alfa).
English: Gastrointestinal disorders
Slovenian: pridobljeni s kromogenim preskusom
English: After reconstitution, each mL of solution for injection contains approximately 333 IU efmoroctocog alfa.
Slovenian: Po rekonstituciji vsebuje en mililiter raztopine za injiciranje približno 333 i.e. efmoroktokoga alfa.
English: How to store ELOCTA
Slovenian: Shranjevanje zdravila ELOCTA
English: After reconstitution, each mL of solution for injection contains approximately 2000 IU efmoroctocog alfa.
Slovenian: Po rekonstituciji vsebuje en mililiter raztopine za injiciranje približno 2000 i.e. efmoroktokoga alfa.
English: ELOCTA 6000 IU powder and solvent for solution for injection Each vial contains nominally 6000 IU efmoroctocog alfa.
Slovenian: ELOCTA 6000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 6000 i.e. efmoroktokoga alfa (efmoroctocogum alfa).
English: After reconstitution, each mL of solution for injection contains approximately 250 IU efmoroctocog alfa.
Slovenian: Po rekonstituciji vsebuje en mililiter raztopine za injiciranje približno 250 i.e. efmoroktokoga alfa.
English: After reconstitution, each mL of solution for injection contains approximately 1667 IU efmoroctocog alfa.
Slovenian: Po rekonstituciji vsebuje en mililiter raztopine za injiciranje približno 1667 i.e. efmoroktokoga alfa.
English: Detach the syringe from the vial adapter by gently pulling and turning the vial counterclockwise.
Slovenian: Injekcijsko brizgo z nežnim vlečenjem in obračanjem viale v nasprotno smer urnega kazalca ločite od nastavka viale.
English: ELOCTA 4000 IU powder and solvent for solution for injection Each vial contains nominally 4000 IU efmoroctocog alfa.
Slovenian: ELOCTA 4000 i.e. prašek in vehikel za raztopino za injiciranje Ena viala vsebuje nominalno 4000 i.e. efmoroktokoga alfa (efmoroctocogum alfa).
English: Do not refrigerate the prepared solution.
Slovenian: Pripravljene raztopine ne shranjujte v hladilniku.
English: After reconstitution, each mL of solution for injection contains approximately 667 IU efmoroctocog alfa.
Slovenian: Po rekonstituciji vsebuje en mililiter raztopine za injiciranje približno 667 i.e. efmoroktokoga alfa.