natgillin/translations-raw huggingface dataset:
It is strongly recommended that every time ALPROLIX is given, the name and batch number of the product are recorded.
Izrazito se preporučuje da se, kod svakog davanja lijeka ALPROLIX, zapišu naziv i broj serije lijeka.
ALPROLIX 250 IU powder and solvent for solution for injection
ALPROLIX 250 IU prašak i otapalo za otopinu za injekciju
By replacement therapy the plasma level of factor IX is increased thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Nadomjesnom terapijom povećava se razina faktora IX u plazmi, što privremeno ispravlja manjak faktora i korigira sklonost krvarenju.
ALPROLIX contains sodium
ALPROLIX sadrži natrij
The median average dose per injection to treat a bleeding episode was 63.51 (interquartile range, 48.9299.44) IU/kg.
Medijan prosječne doze po injekciji za liječenje epizode krvarenja iznosio je 63,51 (interkvartilni raspon, 48,92-99,44) IU/kg.
This medicinal product contains less than 1 mmol sodium (23 mg) per vial, that is to say essentially “sodiumfree”.
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici, tj. zanemarive količine natrija.
ALPROLIX is given as an injection into a vein.
ALPROLIX se daje injekcijom u venu.
Do not refrigerate the solution after preparation.
Otopinu nakon pripreme ne držite u hladnjaku.
This medicine contains less than 1 mmol sodium (23 mg) per vial after preparation, that is to say essentially “sodium free”..
Ovaj lijek sadrži manje od 1 mmol (23 mg) natrija po bočici nakon pripreme, tj. zanemarive količine natrija.
After this time, the prepared ALPROLIX should be discarded.
Nakon tog vremena pripremljeni lijek ALPROLIX treba zbrinuti.
Dosing intervals and factor consumption remained similar in Study III compared to Study II.
Intervali doziranja i potrošnja faktora koagulacije u ispitivanju III ostali su slični u usporedbi s onima u ispitivanju II.
Table 4: The Observed Mean (SD) FIX activity [IU/dL] following a single dose of ALPROLIX1 for patients
Opažena srednja vrijednost (SD) aktivnosti FIX [IU/dl] nakon jedne doze lijeka
If you forget to use ALPROLIX
Ako ste zaboravili primijeniti ALPROLIX
Elderly population There is limited experience in patients ≥ 65 years.
≥65 godina je ograničeno.
Solvent: the solution is clear to colourless.
Otapalo: otopina je bistra do bezbojna.
The Fc fusion protein in ALPROLIX increases the length of time that the medicine works.
Fc fragment u lijeku ALPROLIX produljuje djelovanje lijeka.
Median annualised bleeding rates in subjects <12 years of age evaluable for efficacy were 1.97 (interquartile range 0.00-3.13) in Study II and remained similar throughout Study III (extension study).
<12 godina u kojih se mogla procijeniti djelotvornost iznosio je 1,97 (interkvartilni raspon 0,00-3,13) u ispitivanju II i zadržao se na sličnoj vrijednosti tijekom cijelog ispitivanja III (produžetak ispitivanja).
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 blood clots should be considered.
Ako Vam je potreban centralni venski kateter, potrebno je uzeti u obzir rizik od komplikacija povezanih s centralnim venskim kateterom koji uključuje lokalne infekcije, prisutnost bakterija u krvi i krvne ugruške na mjestu postavljenog katetera.
Discard any unused solution appropriately.
Neprimijenjenu otopinu zbrinite na odgovarajući način.
ALPROLIX is administered by intravenous (IV) injection after dissolving the powder for injection with the solvent supplied in the pre-filled syringe.
ALPROLIX se primjenjuje injekcijom u venu (i.v.) nakon otapanja praška za injekciju otapalom iz priložene napunjene štrcaljke.
There is a potential risk of thromboembolic episodes following the administration of factor IX products, with a higher risk for low purity preparations.
Nakon primjene lijekova s faktorom IX postoji mogući rizik od tromboembolijskih epizoda, s time da je taj rizik viši kod lijekova niske čistoće.
Table 1: Guide to ALPROLIX dosing for treatment of bleeding episodes and surgery
Tablica 1 može služiti kao smjernica za doziranje u slučajevima krvarenja i kirurških zahvata: Tablica 1: Smjernica za doziranje lijeka ALPROLIX za liječenje epizoda krvarenja i u kirurgiji
B) 5 mL Solvent in pre-filled syringe C) 1 Plunger rod
A) 1 bočicu s praškom B) 5 ml otapala u napunjenoj štrcaljki C) 1 klip
Table 5: Comparison of PK Parameters of ALPROLIX (rFIXFc) by Age Category PK Parameters1
Tablica 5: Usporedba farmakokinetičkih parametara lijeka ALPROLIX (rFIXFc) po dobnoj kategoriji
Factor IX 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 IX in plasma).
koje su u skladu s važećim standardom SZO za lijekove s faktorom IX. Aktivnost faktora IX u plazmi izražava se kao postotak (u odnosu na normalnu ljudsku plazmu) ili u IU (u odnosu na međunarodni standard za faktor IX u plazmi).
Solvent: 5 mL sodium chloride and water for injections.
Otapalo: 5 ml natrijevog klorida i vode za injekcije
You must contact your doctor immediately if you experience any of the following symptoms of allergic reactions: swelling of the face, rash, generalised itching, hives, tightness of the chest, difficulty breathing, burning and stinging at the injection site, chills, flushing, headache, general feeling of being unwell, nausea, restlessness, fast heartbeat, and low blood pressure.
Morate se odmah obratiti liječniku ako osjetite bilo koji od sljedećih simptoma alergijske reakcije: oticanje lica, osip, generalizirani svrbež, koprivnjaču, stezanje u prsnom košu, otežano disanje,
The median overall dose to treat a bleeding episode was 51.47 IU/kg (IQR: 35.21-61.73) in the weekly prophylaxis arm, 49.62 IU/kg (IQR: 35.71-94.82) in the individualised interval prophylaxis arm and 46.58 IU/kg (IQR: 33.
Medijan ukupne doze za liječenje epizode krvarenja iznosio je 51,47 IU/kg (IQR: 35,21-61,73) u skupini koja je primala profilaksu u tjednim intervalima, 49,62 IU/kg (IQR: 35,71-94,82) u skupini koja je primala profilaksu u individualiziranim intervalima te 46,58 IU/kg (IQR: 33,33-59,41) u skupini liječenoj po potrebi.
Content: 1 powder vial, 5 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, 5 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
1 Pharmacokinetic parameters are presented in Geometric Mean (95% CI) 2 These pharmacokinetic parameters obtained from the compartmental analysis Abbreviations: CI = confidence interval; Cmax= maximum activity; AUC = area under the FIX activity time curve; t1/2 = terminal half-life; t½α = distribution half-life; t½β = elimination half-life; CL = clearance; Vss = volume of distribution at steady-state; MRT = mean residence time.
Skraćenice: CI = interval pouzdanosti; Cmax= vršna aktivnost; AUC = površina ispod krivulje aktivnosti faktora IX u vremenu; t½=terminalni poluvijek, t½α = poluvijek distribucije; t½β = poluvijek eliminacije; CL = klirens; Vss = volumen distribucije u stanju dinamičke ravnoteže; MRT = srednja vrijednost vremena zadržavanja.
The dose or interval may be adjusted by your doctor.
Liječnik može prilagoditi tu dozu ili vremenski razmak između doza.
An instructional video on how to prepare and administer ALPROLIX is available by scanning the QR code with a smartphone or via the website
Skeniranjem QR koda pomoću pametnog telefona ili putem internetske stranice možete pristupiti videu s uputama o tome kako pripremiti i primijeniti lijek ALPROLIX Uključiti QR kod + http://www.alprolix-instructions.com
Because of the risk of allergic reactions with factor IX products, the initial administrations of factor IX should, according to the treating physician's judgement, be performed under medical observation where proper medical care for allergic reactions could be provided.
Potrebno je naglasiti da u bolesnika s inhibitorima faktora IX može postojati povećan rizik od anafilaksije kod sljedeće primjene faktora IX. Zbog rizika od alergijskih reakcija na lijekove s faktorom IX, početne primjene faktora IX treba, sukladno prosudbi nadležnog liječnika, provesti pod medicinskim nadzorom, gdje se može pružiti odgovarajuće medicinsko liječenje alergijskih reakcija.
How to store ALPROLIX
Kako primjenjivati ALPROLIX
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ(I) ODGOVORAN(NI)
The median average weekly dose of ALPROLIX was 59.40 IU/kg (interquartile range, 52.95 to 64.78 IU/kg) for subjects <6 years of age and 57.78 IU/kg (interquartile range, 51.67 to 65.01 IU/kg) for subjects 6 to <12 years of age.
64,78 IU/kg) u ispitanika < 6 godina te 57,78 IU/kg (interkvartilni raspon od 51,67 do 65,01 IU/kg) u ispitanika u dobi od 6 do <12 godina.
Treatment should be under the supervision of a physician experienced in the treatment of haemophilia.
4.2 Doziranje i način primjene Liječenje treba biti pod nadzorom liječnika s iskustvom u liječenju hemofilije.
Pharmacokinetic parameters of ALPROLIX were determined for adolescents in study I (pharmacokinetic sampling was conducted pre-dose followed by assessment at multiple time points up to 336 hours (14 days) post-dose) and for children in study II (pharmacokinetic sampling was conducted pre-dose followed by assessment at 7 time points up to 168 hours (7 days) post-dose).
(14 dana) poslije doziranja) i za djecu u ispitivanju II (farmakokinetički uzorci bili su prikupljeni prije doziranja, a potom u 7 vremenskih točaka u razdoblju od 168 sati (7 dana) poslije doziranja).
Dosing intervals and factor consumption remained similar in Study III (extension study) compared to Study I for both prophylactic regimens.
Intervali doziranja i potrošnja faktora koagulacije u ispitivanju III (produžetak ispitivanja) ostali su slični u usporedbi s onima u ispitivanju
Remove the plastic flip-top cap from the ALPROLIX vial
Uklonite plastični zatvarač s bočice lijeka ALPROLIX.
ALPROLIX contains the active substance eftrenonacog alfa, recombinant coagulation factor IX, Fc fusion protein.
ALPROLIX sadrži djelatnu tvar eftrenonakog alfa, fuzijski protein rekombinantnog faktora zgrušavanja krvi IX i Fc fragmenta.
In case of self-administration or administration by a caregiver appropriate training is needed.
U slučaju da bolesnik sam sebi daje lijek ili da mu ga daje njegovatelj, potrebna im je odgovarajuća obuka.
ALPROLIX is provided as a powder and solvent for solution for injection.
ALPROLIX se isporučuje kao prašak i otapalo za otopinu za injekciju.
Lift the protective cap away from the adapter and discard.
Podignite zaštitni zatvarač s nastavka i zbrinite ga.
Dose based on bodyweight may require adjustment in underweight or overweight patients.
U pothranjenih bolesnika ili bolesnika s prekomjernom tjelesnom težinom može biti potrebna prilagodba doze s obzirom na tjelesnu težinu.
The median overall dose to treat a bleeding episode was 68.22 IU/kg (interquartile range,
Medijan ukupne doze za liječenje epizode krvarenja iznosio je 68,22 IU/kg
Slowly depress the plunger rod to inject all the solvent into the ALPROLIX vial.
Polako potiskujte klip kako biste ubrizgali cjelokupno otapalo u bočicu lijeka ALPROLIX.
Solvent for ALPROLIX sodium chloride water for injections
Otapalo za ALPROLIX natrijev klorid voda za injekcije
Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
L-histidin manitol polisorbat 20 natrijev hidroksid (za podešavanje pH) kloridna kiselina (za podešavanje pH)
Alternatively, ALPROLIX may be stored at room temperature (up to 30°C) for a single period not exceeding 6 months.
Drugi je način da se ALPROLIX čuva na sobnoj temperaturi (do 30 °C) tijekom jednog razdoblja ne duljeg od 6 mjeseci.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ(I) BIOLOŠKE DJELATNE TVARI I PROIZVOĐAČ
Incremental Recovery (IU/dL per IU/kg) AUC/Dose (IU*h/dL per IU/kg)
Prirast po jedinici doze (IU/dl po IU/kg) AUC/doza (IU*h/dl po IU/kg) Cmax (IU/dl) CL (ml/h/kg) t½ (h)
≥ 12 years of Age
< 12 godina) u ispitivanju
Each pack of ALPROLIX contains 1 powder vial, 5 mL solvent in pre-filled syringe, 1plunger rod, 1vial adapter, 1 infusion set, 2 alcohol swabs, 2 plasters and 1 gauze pad
Jedno pakiranje lijeka ALPROLIX sadrži 1 bočicu praška, 5 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.
The study enrolled a total of 123 previously treated male patients (12 to 71 years of age) with severe haemophilia B (≤2% endogenous FIX activity).
(u dobi od 12 do 71 godine) s teškom hemofilijom B (≤2% aktivnosti endogenog FIX).
Nephrotic syndrome has been reported following attempted immune tolerance induction in haemophilia B patients with factor IX inhibitors and a history of allergic reaction.
Nakon pokušaja indukcije imunološke tolerancije u bolesnika s hemofilijom B i inhibitorima faktora IX te alergijskom reakcijom u povijesti bolesti, zabilježen je nefrotski sindrom.
No fertility studies have been conducted in animals with ALPROLIX.
Nisu provedena ispitivanja utjecaja lijeka ALPROLIX na plodnost u životinja.
powder and solvent for solution for injection
Prašak i otapalo za otopinu za injekciju
All patients received treatment with ALPROLIX and were followed for up to 52 weeks.
Svi su bolesnici bili liječeni lijekom ALPROLIX i praćeni do
Ensuring that the syringe plunger rod is still fully pressed down, invert the vial.
14. Pazeći da je klip štrcaljke i dalje potisnut do kraja, okrenite bočicu naopako.
Animal reproduction studies have not been conducted with ALPROLIX.
Nisu provedena ispitivanja utjecaja lijeka ALPROLIX na reprodukciju u životinja.
For example, the formation of antibodies (also known as inhibitors) to factor IX is a known complication that can occur during the treatment of haemophilia B.
na faktor IX poznata je komplikacija koja može nastati tijekom liječenja hemofilije B.
Protect the solution from direct sunlight.
Zaštitite lijek od izravne sunčeve svjetlosti.
Signs of allergic reactions may include, generalised itching, hives, tightness of the chest, difficulty breathing and low blood pressure.
stezanje u prsnom košu, otežano disanje ili nizak krvni tlak.
The number of units of recombinant factor IX Fc administered is expressed in International Units (IU), which are related to the current WHO standard for factor IX products.
Broj primijenjenih jedinica rekombinantnog faktora IX Fc izražava se u međunarodnim jedinicama (IU),
1PK parameters derived from noncompartmental analysis are presented in Geometric Mean (95% CI) Abbreviations: CI = confidence interval; IR = incremental recovery; AUC = area under the FIX activity time curve; t1/2 = terminal half-life; MRT = mean residence time; CL = clearance; Vss = volume of distribution at steady-state
Skraćenice: CI = interval pouzdanosti; IR = prirast po jedinici doze (engl. incremental recovery); AUC = površina ispod krivulje aktivnosti faktora IX u vremenu; t½= terminalni poluvijek; MRT =
ALPROLIX increases factor IX level in the blood and temporarily corrects the bleeding tendency.
ALPROLIX se primjenjuje da nadomjesti nedostatak ili manjkavost faktora IX. ALPROLIX povećava razinu faktora IX u krvi i privremeno ispravlja sklonost krvarenju.
ALPROLIX 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU eftrenonacog alfa.
ALPROLIX 250 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 250 IU eftrenonakoga alfa (eftrenonacog alfa).
Protect product from direct sunlight.
Zaštitite otopinu od izravnog sunčevog svjetla.
Once you have prepared ALPROLIX it should be used right away.
ALPROLIX se mora primijeniti odmah nakon pripreme.
More extensive haemarthrosis, muscle bleeding or haematoma
Rana hemartroza, krvarenje u mišiće ili u usnoj šupljini
ALPROLIX 250 IU powder for injection ALPROLIX 500 IU powder for injection ALPROLIX 1000 IU powder for injection ALPROLIX 2000 IU powder for injection ALPROLIX 3000 IU powder for injection eftrenonacog alfa recombinant coagulation factor IX IV
ALPROLIX 250 IU prašak za injekciju ALPROLIX 500 IU prašak za injekciju ALPROLIX 1000 IU prašak za injekciju ALPROLIX 2000 IU prašak za injekciju ALPROLIX 3000 IU prašak za injekciju eftrenonacog alfa rekombinantni faktor zgrušavanja krvi IX i.v.
ALPROLIX 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU eftrenonacog alfa.
ALPROLIX 2000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 2000 IU eftrenonakoga alfa (eftrenonacog alfa).
Median weekly dose for subjects in the fixed weekly arm was 45.17 IU/kg (interquartile range (IQR) 38.153.7) in Study I. The corresponding median Annualised Bleeding Rates (ABR) in subjects evaluable for efficacy were 2.95 (IQR: 1.01-4.35) and remained similar throughout Study III (1.85 (IQR: 0.76-4.0)).
Pripadajući medijan anualizirane stope krvarenja (engl. annualised bleeding rates, ABR) u ispitanika u kojih se mogla procijeniti djelotvornost iznosio je 2,95 (IQR: 1,01-4,35) i zadržao se na sličnoj vrijednosti tijekom cijelog trajanja ispitivanja III (1.85 (IQR: 0,76-4,0)).
All pharmacokinetic studies with ALPROLIX were conducted in previously treated patients with severe haemophilia B. Data presented in this section were obtained by one-stage clotting assay with a silica-based aPTT reagent calibrated against factor IX plasma standards.
Podaci prikazani u ovom dijelu dobiveni su jednostupanjskim testom zgrušavanja krvi s reagensom za određivanje aPTV-a na bazi silicijevog dioksida baždarenim prema standardima za faktor IX u plazmi.
Do not use if the product has expired.
Nemojte primijeniti lijek ako je istekao rok valjanosti.
ALPROLIX 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU eftrenonacog alfa.
ALPROLIX 500 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 500 IU eftrenonakoga alfa (eftrenonacog alfa).
For subjects in the individualised interval arm, the median dosing interval was 12.53 days (IQR: 10.4-13.4) in Study I. The corresponding median ABR was 1.38 (IQR: 0.00-3.43) and remained similar throughout Study III (1.85 (IQR: 0.76-4.0)).
Pripadajući medijan anualizirane stope krvarenja iznosio je 1,38 (IQR: 0,00-3,43) i zadržao se na sličnoj vrijednosti tijekom cijelog trajanja ispitivanja III (1,85 (IQR: 0,76-4,0)).
Following a washout period of at least 120 hours (5 days), the subjects received a single dose of 50 IU/kg of ALPROLIX.
(5 dana) ispitanici su primili jednu dozu od 50 IU/kg lijeka ALPROLIX.
ALPROLIX 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU eftrenonacog alfa.
ALPROLIX 3000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 3000 IU eftrenonakoga alfa (eftrenonacog alfa).
ALPROLIX 250 IU powder and solvent for solution for injection ALPROLIX 500 IU powder and solvent for solution for injection ALPROLIX 1000 IU powder and solvent for solution for injection ALPROLIX 2000 IU powder and solvent for solution for injection ALPROLIX 3000 IU powder and solvent for solution for injection
ALPROLIX 250 IU prašak i otapalo za otopinu za injekciju ALPROLIX 500 IU prašak i otapalo za otopinu za injekciju ALPROLIX 1000 IU prašak i otapalo za otopinu za injekciju ALPROLIX 2000 IU prašak i otapalo za otopinu za injekciju ALPROLIX 3000 IU prašak i otapalo za otopinu za injekciju
Powder
Nuspojave
A) 1 Powder vial
D) 1 nastavak za bočicu
Pharmacokinetic parameters of the non-compartmental analysis after 50 IU/kg dose of ALPROLIX are presented in Table 3.
Farmakokinetički parametri analize bez uključivanja odjeljaka nakon doze lijeka ALPROLIX od
The safety, efficacy, and pharmacokinetics of ALPROLIX were evaluated in 2 multinational, open-label, pivotal studies; a phase 3 study in adults and adolescents, referred to as study I and a phase 3 paediatric study, referred to as study II (see Paediatric population).
Sigurnost, djelotvornost i farmakokinetika lijeka ALPROLIX bile su procijenjene u 2 multinacionalna,
Patients with a factor IX inhibitor may be at an increased risk of anaphylaxis during future treatment with factor IX.
Bolesnici s inhibitorom faktora IX mogu imati povećani rizik od anafilaksije tijekom budućeg liječenja faktorom IX. Stoga, ako razvijete alergijske reakcije kao što su one opisane gore, trebate se testirati na prisutnost inhibitora.
ALPROLIX 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU eftrenonacog alfa.
ALPROLIX 1000 IU prašak i otapalo za otopinu za injekciju Jedna bočica nominalno sadrži 1000 IU eftrenonakoga alfa (eftrenonacog alfa).
Patients with haemophilia B may develop neutralising antibodies (inhibitors) to factor IX.
Bolesnici s hemofilijom B mogu razviti neutralizirajuća protutijela (inhibitore) na faktor IX. Ako se pojave takvi inhibitori, to će se stanje manifestirati kao nedostatan klinički odgovor.
Powder:
Napomena:
• The active substance is eftrenonacog alfa (recombinant coagulation factor IX, Fc fusion protein).
Prašak: • Djelatna tvar je eftrenonakog alfa (fuzijski protein rekombinantnog faktora zgrušavanja krvi IX i
Metabolism and nutrition disorders
Poremećaji metabolizma i prehrane smanjeni apetit manje često
ALPROLIX 250 IU powder and solvent for solution for injection ALPROLIX 500 IU powder and solvent for solution for injection ALPROLIX 1000 IU powder and solvent for solution for injection ALPROLIX 2000 IU powder and solvent for solution for injection ALPROLIX 3000 IU powder and solvent for solution for injection eftrenonacog alfa recombinant coagulation factor IX, Fc fusion protein
ALPROLIX 250 IU prašak i otapalo za otopinu za injekciju ALPROLIX 500 IU prašak i otapalo za otopinu za injekciju ALPROLIX 1000 IU prašak i otapalo za otopinu za injekciju ALPROLIX 2000 IU prašak i otapalo za otopinu za injekciju ALPROLIX 3000 IU prašak i otapalo za otopinu za injekciju eftrenonacog alfa fuzijski protein rekombinantnog faktora zgrušavanja krvi IX i Fc fragmenta rekombinantni faktor zgrušavanja krvi IX <(side of outer carton, only)>
ALPROLIX 500 IU powder and solvent for solution for injection ALPROLIX 1000 IU powder and solvent for solution for injection ALPROLIX 2000 IU powder and solvent for solution for injection ALPROLIX 3000 IU powder and solvent for solution for injection eftrenonacog alfa recombinant coagulation factor IX, Fc fusion protein This medicine is subject to additional monitoring.
ALPROLIX 500 IU prašak i otapalo za otopinu za injekciju ALPROLIX 1000 IU prašak i otapalo za otopinu za injekciju ALPROLIX 2000 IU prašak i otapalo za otopinu za injekciju ALPROLIX 3000 IU prašak i otapalo za otopinu za injekciju eftrenonakog alfa (eftrenonacog alfa) (fuzijski protein rekombinantnog faktora zgrušavanja krvi IX i Fc fragmenta)
After reconstitution, each mL of solution for injection contains approximately 50 IU eftrenonacog alfa.
Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 50 IU eftrenonakoga alfa.
Solvent: sodium chloride, water for injections
Otapalo: natrijev klorid voda za injekcije
After reconstitution, each mL of solution for injection contains approximately 600 IU eftrenonacog alfa.
Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 600 IU eftrenonakoga alfa.
After reconstitution, each mL of solution for injection contains approximately 400 IU eftrenonacog alfa.
Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 400 IU eftrenonakoga alfa.
After reconstitution, each mL of solution for injection contains approximately 100 IU eftrenonacog alfa.
Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 100 IU eftrenonakoga alfa.
After reconstitution, each mL of solution for injection contains approximately 200 IU eftrenonacog alfa.
Nakon rekonstitucije, svaki ml otopine za injekciju sadrži približno 200 IU eftrenonakoga alfa.