natgillin/translations-raw huggingface dataset:
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.
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.
Table 2: Adverse reactions reported for ELOCTA in clinical trials MedDRA System Organ Class
Tablica 2: Nuspojave zabilježene za lijek ELOCTA u kliničkim ispitivanjima
Animal reproduction studies have not been conducted with ELOCTA.
Nisu provedena ispitivanja utjecaja lijeka ELOCTA na reprodukciju u životinja.
ELOCTA is provided as a powder and solvent for solution for injection.
ELOCTA se isporučuje kao prašak i otapalo za otopinu za injekciju.
No fertility studies have been conducted in animals with ELOCTA.
Nisu provedena ispitivanja utjecaja lijeka ELOCTA na plodnost u životinja.
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.
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.
Talk to your doctor if you think that your bleeding is not being controlled with the dose you receive.
Ako mislite da se Vaše krvarenje ne kontrolira dozom koju primate, obratite se svom liječniku.
Median total time on Study I+III was 4.2 years and median no of exposure days was 309.
I i III bio je 4,2 godine, a medijan broja dana izloženosti bio je 309.
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.
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.
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.
Odlomite bijeli, plastični zatvarač za zaštitu od otvaranja sa štrcaljke s otapalom tako što ćete ga savijati na perforiranom mjestu dok se ne odvoji.
Turn the plunger rod firmly clockwise until it is securely seated in the syringe plunger.
Zakrenite čvrsto klip u smjeru kazaljke na satu sve dok ne bude čvrsto postavljen u štrcaljki.
Ensuring that the syringe plunger rod is still fully pressed down, invert the vial.
Pazeći da je klip štrcaljke i dalje potisnut do kraja, okrenite bočicu naopako.
Wipe the top of the vial with one of the alcohol swabs (F) provided in the pack, and allow to air dry.
Obrišite vrh bočice jednom od alkoholom natopljenih vatica (F)
Blood and lymphatic system disorders
Poremećaji krvi i limfnog sustava inhibicija faktora VIII
Firmly push and turn the syringe clockwise until it is securely connected.
Čvrsto pritisnite i zakrenite štrcaljku u smjeru kazaljke na satu dok se ne uspostavi čvrsti spoj.
Hypertension Hot flush Angiopathy2
Krvožilni poremećaji hipertenzija navala vrućine angiopatija2
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.
Liječenje krvarenja: Tijekom Ispitivanja II i III liječeno je 447 slučajeva krvarenja s medijanom doze od
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.
drugim u prethodno liječenih bolesnika s više od 100 dana izloženosti, u kojih je prethodno bio zabilježen razvoj inhibitora.
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.
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
Method of administration ELOCTA is for intravenous use.
ELOCTA se primjenjuje intravenski.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially ‘sodium-free'.
Pomoćne tvari koje treba uzeti u obzir Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
During the shelf-life, the product may be stored at room temperature (up to 30°C) for a single period not exceeding 6 months.
Unutar roka valjanosti lijek se može čuvati na sobnoj temperaturi (do 30 °C) tijekom jednog razdoblja ne duljeg od 6 mjeseci.
F) 2 Alcohol swabs G) 2 Plasters
D) 1 nastavak za bočicu E) 1 komplet za infuziju F) 2 alkoholom natopljene vatice G) 2 flastera
Early haemarthrosis, muscle bleeding or oral bleeding
Rana hemartroza, krvarenje u mišiće ili u usnoj šupljini
Abdominal pain, lower Uncommon
Poremećaji probavnog sustava bol u donjem dijelu abdomena manje često
How to store ELOCTA
Kako primjenjivati lijek ELOCTA
Slowly pull on the plunger rod to draw back all the solution through the vial adapter into the syringe.
Polako povlačite klip kako biste izvukli otopinu kroz nastavak za bočicu natrag u štrcaljku.
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).
generaliziranu urtikariju, glavobolju, hipotenziju, letargiju, mučninu, nemir, tahikardiju) rijetko su opažene i mogu, u nekim slučajevima, napredovati do teške anafilaksije (uključujući šok).
The calculation of the required dose of recombinant factor VIII Fc is based on the empirical finding that 1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 2 IU/dL.
1 međunarodna jedinica (IU) faktora VIII po kg tjelesne težine povećava aktivnost faktora VIII u plazmi za 2 IU/dl.
Dose based on bodyweight may require adjustment in underweight and overweight patients.
U pothranjenih bolesnika i bolesnika s prekomjernom tjelesnom težinom može biti potrebna prilagodba doze obzirom na tjelesnu težinu.
The solvent provided for preparation of the solution to inject, is a clear, colourless solution.
Otapalo priloženo za pripremu otopine koja će se ubrizgati je bistra, bezbojna tekućina.
• The active substance is efmoroctocog alfa (recombinant coagulation factor VIII, Fc fusion protein).
- Djelatna tvar je efmoroktokog alfa (rekombinantni faktor zgrušavanja krvi VIII, Fc fuzijski protein).
Type of surgical procedure
Stupanj krvarenja / vrsta kirurškog postupka
Protect product from direct sunlight.
Zaštitite lijek od izravne sunčeve svjetlosti.
Following a washout period of at least 96 hours (4 days), the subjects received a single dose of 50 IU/kg of ELOCTA.
(4 dana) ispitanici su primili jednu dozu od 50 IU/kg lijeka ELOCTA.
On-demand treatment
Liječenje prema potrebi
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia.
4.2 Doziranje i način primjene Liječenje treba započeti pod nadzorom liječnika s iskustvom u liječenju hemofilije.
AUC/Dose (IU*h/dL per IU/kg)
Postupni oporavak (IU/dl po IU/kg) AUC/doza (IU*h/dl po IU/kg) t½ (h)
H) 1 Gauze pad
H) 1 kompresu od gaze
Median annual factor consumption was 4700 IU/kg (min 3819, max 8230 IU/kg) in Study II and 4990 IU/kg (min 3856, max 9527) in Study III.
3819, maks. 8230 IU/kg) u Ispitivanju II i 4990 IU/kg (min.
Table 4: Pharmacokinetic parameters of ELOCTA using the chromogenic assay Pharmacokinetic parameters1
Tablica 4: Farmakokinetički parametri lijeka ELOCTA određeni pomoću kromogenog testa Farmakokinetički parametri1
Pharmacokinetic parameters of ELOCTA were determined for adolescents in study I (pharmacokinetic sampling was conducted pre-dose followed by assessment at multiple time points up to 120 hours (5 days) post-dose) and for children in study II (pharmacokinetic sampling was conducted pre-dose followed by assessment at multiple time points up to 72 hours (3 days) post-dose).
(5 dana) poslije doziranja) i za djecu u ispitivanju II (farmakokinetički uzorci bili su prikupljeni prije doziranja, a potom u više vremenskih točaka u razdoblju od 72 sata (3 dana) poslije doziranja).
The reconstituted solution should be clear to slightly opalescent and colourless.
Rekonstituirana otopina mora biti bistra do blago zamućena i bezbojna.
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.
t½= poluvijek eliminacije; CL = klirens; MRT = srednja vrijednost vremena zadržavanja; Vss = volumen distribucije u stanju dinamičke ravnoteže.
Once you have prepared ELOCTA it should be used right away.
Lijek ELOCTA mora se primijeniti odmah nakon pripreme.
The prepared solution will be clear to slightly opalescent and colourless.
Pripremljena otopina bit će bistra do blago zamućena i bezbojna.
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.
Medijan godišnje potrošnje faktora bio je 5572 IU/kg (min. 3849, maks. 7035) u Ispitivanju
More extensive haemarthrosis, muscle bleeding or haematoma
krvarenje u mišiće ili hematom
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Prašak saharoza natrijev klorid L-histidin kalcijev klorid dihidrat polisorbat 20 natrijev hidroksid (za podešavanje pH) kloridna kiselina (za podešavanje pH)
Signs of allergic reactions may include generalised itching, hives, tightness of the chest, difficulty breathing and low blood pressure.
stezanje u prsima, otežano disanje ili nizak krvni tlak.
After preparation, the solution to inject is clear to slightly opalescent and colourless.
Nakon pripreme otopina koja će se ubrizgati je bistra do blago zamućena i bezbojna.
Nervous system disorders
Poremećaji živčanog sustava glavobolja omaglica disgeuzija manje često
Reconstituted medicinal product should be inspected visually for particulate matter and discoloration prior to administration.
Prije primjene potrebno je vizualno pregledati rekonstituirani lijek na prisutnost čestica i promjenu boje.
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
ELOCTA 250 IU prašak za injekciju ELOCTA 500 IU prašak za injekciju ELOCTA 750 IU prašak za injekciju ELOCTA 1000 IU prašak za injekciju ELOCTA 1500 IU prašak za injekciju ELOCTA 2000 IU prašak za injekciju ELOCTA 3000 IU prašak za injekciju ELOCTA 4000 IU prašak za injekciju ELOCTA 5000 IU prašak za injekciju ELOCTA 6000 IU prašak za injekciju efmoroctocog alfa rekombinantni faktor zgrušavanja krvi VIII i.v.
Posology
Ispitivanje
Respective median ABR was 3.59 (min 0, max 58.0) and 2.24 (min 0, max 17.2).
58,0) i 2,24 (min. 0; maks.
After reconstitution, each mL of solution for injection contains approximately 83 IU efmoroctocog alfa.
Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 83 IU efmoroktokoga alfa.
ELOCTA 750 IU powder and solvent for solution for injection Each vial contains nominally 750 IU efmoroctocog alfa.
ELOCTA 750 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 750 IU efmoroktokoga alfa (efmoroctocog alfa).
Sodium chloride
Izraženija hemartroza,
Detach the syringe from the vial adapter by gently pulling and turning the vial counterclockwise.
15. Odvojite štrcaljku od nastavka za bočicu nježnim povlačenjem i zakretanjem bočice u suprotnom smjeru od kazaljke na satu.
Connect the solvent syringe to the vial adapter by inserting the tip of the syringe into the adapter opening.
Štrcaljku s otapalom spojite s nastavkom za bočicu tako što ćete vrh štrcaljke uvesti u otvor nastavka.
Press down firmly until the adapter snaps into place on top of the vial, with the adapter spike penetrating the vial stopper.
Čvrsto ga pritisnite prema dolje dok ne sjedne na mjesto na vrhu bočice, tako da šiljak nastavka probije čep bočice.
Do not remove the adapter from its protective cap. Do not touch the inside of the vial adapter package.
Nemojte odvajati nastavak od njegovog zaštitnog zatvarača.
Respective median ABR was 2.01 (min 0, max 27.2) and 1.59 (min 0, max 8.0).
27,2) i 1,59 (min. 0; maks.
After reconstitution, each mL of solution for injection contains approximately 1333 IU efmoroctocog alfa.
Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 1333 IU efmoroktokoga alfa.
ELOCTA 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU efmoroctocog alfa.
ELOCTA 2000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 2000 IU efmoroktokoga alfa (efmoroctocog alfa).
Median annual factor consumption was 5146 IU/kg (min 3695, max 8474) in Study II and 5418 IU/kg (min 3435, max 9564) in Study III.
3695, maks. 8474) u Ispitivanju II i 5418 IU/kg
ELOCTA 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU efmoroctocog alfa.
ELOCTA 250 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 250 IU efmoroktokoga alfa (efmoroctocog alfa).
After reconstitution, each mL of solution for injection contains approximately 333 IU efmoroctocog alfa.
Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 333 IU efmoroktokoga alfa.
ELOCTA 6000 IU powder and solvent for solution for injection Each vial contains nominally 6000 IU efmoroctocog alfa.
ELOCTA 6000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 6000 IU efmoroktokoga alfa (efmoroctocog alfa).
Table 6: Pharmacokinetic parameters of ELOCTA for paediatrics using the chromogenic assay Pharmacokinetic parameters1
Tablica 6: Farmakokinetički parametri lijeka ELOCTA u pedijatrijskih ispitanika određeni pomoću kromogenog testa
The solution should appear clear to slightly opalescent and colourless.
Otopina izgledom mora biti bistra do blago zamućena i bezbojna.
After reconstitution, each mL of solution for injection contains approximately 2000 IU efmoroctocog alfa.
Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 2000 IU efmoroktokoga alfa.
ELOCTA 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU efmoroctocog alfa.
ELOCTA 1500 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 1500 IU efmoroktokoga alfa (efmoroctocog alfa).
After reconstitution, each mL of solution for injection contains approximately 250 IU efmoroctocog alfa.
Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 250 IU efmoroktokoga alfa.
ELOCTA 4000 IU powder and solvent for solution for injection Each vial contains nominally 4000 IU efmoroctocog alfa.
ELOCTA 4000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 4000 IU efmoroktokoga alfa (efmoroctocog alfa).
After reconstitution, each mL of solution for injection contains approximately 667 IU efmoroctocog alfa.
Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 667 IU efmoroktokoga alfa.
ELOCTA 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU efmoroctocog alfa.
ELOCTA 3000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 3000 IU efmoroktokoga alfa (efmoroctocog alfa).
Do not refrigerate the prepared solution.
Pripremljenu otopinu ne držite u hladnjaku.
After reconstitution, each mL of solution for injection contains approximately 1667 IU efmoroctocog alfa.
Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 1667 IU efmoroktokoga alfa.
Respective median ABR was 1.92 (min 0, max 7.1) and 1.25 (min 0, max 9.5).
7,1) i 1,25 (min. 0; maks.
After reconstitution, each mL of solution for injection contains approximately 500 IU efmoroctocog alfa.
Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 500 IU efmoroktokoga alfa.
ELOCTA 5000 IU powder and solvent for solution for injection Each vial contains nominally 5000 IU efmoroctocog alfa.
ELOCTA 5000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 5000 IU efmoroktokoga alfa (efmoroctocog alfa).
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.
Tjedna profilaksa: Medijan godišnje potrošnje faktora bio je 3805 IU/kg (min.
After reconstitution, each mL of solution for injection contains approximately 167 IU efmoroctocog alfa.
Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 167 IU efmoroktokoga alfa.
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.
I i III liječeno je 2490 slučajeva krvarenja medijanom doze od
ELOCTA 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU efmoroctocog alfa.
ELOCTA 500 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 500 IU efmoroktokoga alfa (efmoroctocog alfa).
After reconstitution, each mL of solution for injection contains approximately 1000 IU efmoroctocog alfa.
Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 1000 IU efmoroktokoga alfa.
ELOCTA 250 IU powder and solvent for solution for injection ELOCTA 500 IU powder and solvent for solution for injection ELOCTA 750 IU powder and solvent for solution for injection ELOCTA 1000 IU powder and solvent for solution for injection ELOCTA 1500 IU powder and solvent for solution for injection ELOCTA 2000 IU powder and solvent for solution for injection ELOCTA 3000 IU powder and solvent for solution for injection ELOCTA 4000 IU powder and solvent for solution for injection ELOCTA 5000 IU powder and solvent for solution for injection ELOCTA 6000 IU powder and solvent for solution for injection efmoroctocog alfa recombinant coagulation factor VIII, Fc fusion protein
ELOCTA 250 IU prašak i otapalo za otopinu za injekciju ELOCTA 500 IU prašak i otapalo za otopinu za injekciju ELOCTA 750 IU prašak i otapalo za otopinu za injekciju ELOCTA 1000 IU prašak i otapalo za otopinu za injekciju ELOCTA 1500 IU prašak i otapalo za otopinu za injekciju ELOCTA 2000 IU prašak i otapalo za otopinu za injekciju ELOCTA 3000 IU prašak i otapalo za otopinu za injekciju ELOCTA 4000 IU prašak i otapalo za otopinu za injekciju ELOCTA 5000 IU prašak i otapalo za otopinu za injekciju ELOCTA 6000 IU prašak i otapalo za otopinu za injekciju efmoroctocog alfa rekombinantni faktor zgrušavanja krvi VIII, Fc fuzijski protein
ELOCTA 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU efmoroctocog alfa.
ELOCTA 1000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 1000 IU efmoroktokoga alfa (efmoroctocog alfa).
Table 3: Pharmacokinetic parameters of ELOCTA using the one-stage clotting assay Pharmacokinetic parameters1
Tablica 3: Farmakokinetički parametri lijeka ELOCTA određeni pomoću jednostupanjskog testa zgrušavanja krvi Farmakokinetički parametri
ELOCTA 750 IU powder and solvent for solution for injection ELOCTA 1000 IU powder and solvent for solution for injection ELOCTA 1500 IU powder and solvent for solution for injection ELOCTA 2000 IU powder and solvent for solution for injection ELOCTA 3000 IU powder and solvent for solution for injection ELOCTA 4000 IU powder and solvent for solution for injection ELOCTA 5000 IU powder and solvent for solution for injection ELOCTA 6000 IU powder and solvent for solution for injection efmoroctocog alfa (recombinant coagulation factor VIII)
ELOCTA 750 IU prašak i otapalo za otopinu za injekciju ELOCTA 1000 IU prašak i otapalo za otopinu za injekciju ELOCTA 1500 IU prašak i otapalo za otopinu za injekciju ELOCTA 2000 IU prašak i otapalo za otopinu za injekciju ELOCTA 3000 IU prašak i otapalo za otopinu za injekciju ELOCTA 4000 IU prašak i otapalo za otopinu za injekciju ELOCTA 5000 IU prašak i otapalo za otopinu za injekciju ELOCTA 6000 IU prašak i otapalo za otopinu za injekciju efmoroktokog alfa (efmoroctocog alfa) (rekombinantni faktor zgrušavanja krvi VIII)
Respective median Annualized Bleed Rate (ABR) was 0.00 (min 0, max 10.5) and 1.18 (min 0, max 9.2).
Odgovarajući medijani godišnje stope krvarenja bili su 2,01 (min. 0; maks.
Respective median Annualized Bleed Rate (ABR) was 1.60 (min 0, max 18.2) and 0.74 (min 0, max 15.6).
Odgovarajući medijani godišnje stope krvarenja bili su 1,60 (min. 0; maks.
Respiratory, thoracic, and mediastinal disorders
Poremećaji dišnog sustava, prsišta i sredoprsja kašalj manje često
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.
Individualizirana profilaksa: Medijan godišnje potrošnje faktora bio je 4212 IU/kg (min.
ELOCTA 250 IU powder and solvent for solution for injection ELOCTA 500 IU powder and solvent for solution for injection ELOCTA 750 IU powder and solvent for solution for injection ELOCTA 1000 IU powder and solvent for solution for injection ELOCTA 1500 IU powder and solvent for solution for injection ELOCTA 2000 IU powder and solvent for solution for injection ELOCTA 3000 IU powder and solvent for solution for injection ELOCTA 4000 IU powder and solvent for solution for injection ELOCTA 5000 IU powder and solvent for solution for injection ELOCTA 6000 IU powder and solvent for solution for injection
ELOCTA 250 IU prašak i otapalo za otopinu za injekciju ELOCTA 500 IU prašak i otapalo za otopinu za injekciju ELOCTA 750 IU prašak i otapalo za otopinu za injekciju ELOCTA 1000 IU prašak i otapalo za otopinu za injekciju ELOCTA 1500 IU prašak i otapalo za otopinu za injekciju ELOCTA 2000 IU prašak i otapalo za otopinu za injekciju ELOCTA 3000 IU prašak i otapalo za otopinu za injekciju ELOCTA 4000 IU prašak i otapalo za otopinu za injekciju ELOCTA 5000 IU prašak i otapalo za otopinu za injekciju ELOCTA 6000 IU prašak i otapalo za otopinu za injekciju
Haemorrhage
ROK VALJANOSTI
On-demand treatment: Median annual factor consumption was 1039 IU/kg (min 280, max 3571) for 23 patients randomised to the on-demand treatment arm in Study I and 671 IU/kg (min 286, max 913) for 6 patients remaining on on-demand treatment for at least one year in Study III.
Liječenje prema potrebi: Medijan godišnje potrošnje faktora bio je 1039 IU/kg (min.
Table 5: Pharmacokinetic parameters of ELOCTA for paediatrics using the one-stage clotting assay Pharmacokinetic parameters1
Tablica 5: Farmakokinetički parametri lijeka ELOCTA u pedijatrijskih ispitanika određeni pomoću jednostupanjskog testa zgrušavanja krvi
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.
- 3 ml otapala u napunjenoj štrcaljki od stakla tipa 1 s čepom klipa od brombutilne gume - klip