FrancophonIA/ELRC3.0 huggingface dataset:
English: This is because if left, the medicine may no longer be sterile and could cause infections.
Croatian: Naime, ako se ne primijeni odmah, lijek možda više neće biti sterilan pa bi mogao uzrokovati infekcije.
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with NovoEight.
Croatian: Do razvoja neutralizirajućih protutijela (inhibitora) može doći u bolesnika s hemofilijom A koji su liječeni faktorom VIII, uključujući lijekom NovoEight.
English: Wipe the rubber stopper with a sterile alcohol swab and allow it to air dry for a few seconds before use to ensure that it is as germ free as possible.
Croatian: Obrišite gumeni čep sterilnim alkoholnim tupferom i pričekajte nekoliko sekundi da se osuši na zraku prije uporabe kako biste bili sigurni da je broj mikroorganizama sveden na najmanju moguću mjeru.
English: Minor surgery including tooth extraction
Croatian: uključujući vađenje zuba
English: For storage at room temperature (≤30°C) or up to 40°C and storage conditions after reconstitution of the medicinal product, see section 6.3.
Croatian: Za čuvanje na sobnoj temperaturi (≤30°C) ili do 40°C i uvjete čuvanja nakon rekonstitucije lijeka,
English: NovoEight 250 IU powder and solvent for solution for injection NovoEight 500 IU powder and solvent for solution for injection NovoEight 1000 IU powder and solvent for solution for injection NovoEight 1500 IU powder and solvent for solution for injection NovoEight 2000 IU powder and solvent for solution for injection NovoEight 3000 IU powder and solvent for solution for injection
Croatian: NovoEight 250 IU prašak i otapalo za otopinu za injekciju NovoEight 500 IU prašak i otapalo za otopinu za injekciju NovoEight 1000 IU prašak i otapalo za otopinu za injekciju NovoEight 1500 IU prašak i otapalo za otopinu za injekciju NovoEight 2000 IU prašak i otapalo za otopinu za injekciju NovoEight 3000 IU prašak i otapalo za otopinu za injekciju
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Croatian: Kompleks faktora VIII/von Willebrandova faktora sastoji se od dviju molekula (faktora VIII
English: Grasp the plunger rod by the wide top and immediately connect the plunger rod to the syringe by turning it clockwise into the plunger inside the pre-filled syringe until resistance is felt.
Croatian: Uhvatite potisni klip za široki gornji dio i odmah ga spojite sa štrcaljkom tako da ga navijete u smjeru kazaljke na satu u klip koji se nalazi unutar napunjene štrcaljke, sve dok ne osjetite otpor.
English: After reconstitution the solution appears as a clear or slightly opalescent solution.
Croatian: Nakon rekonstitucije otopina mora biti bistra ili blago opalescentna.
English: See ‘Instructions on how to use NovoEight' for more information.
Croatian: Za više informacija pogledajte dio „Upute za uporabu lijeka NovoEight“.
English: It must be clear to slightly opalescent
Croatian: Mora biti bistra do blago opalescentna (blago zamućena).
English: Each pack of NovoEight 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU and 3000 IU powder and solvent for solution for injection contains:
Croatian: Jedno pakiranje NovoEight 250 IU, 500 IU, 1000 IU, 1500 IU, 2000 IU i 3000 IU praška i otapala za otopinu za injekciju sadrži:
English: The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO standard for factor VIII products.
Croatian: Broj primijenjenih jedinica faktora VIII izražava se u internacionalnim jedinicama (IU), koje su u skladu s važećim standardom Svjetske zdravstvene organizacije (SZO) za lijekove koji sadrže faktor VIII.
English: How to store NovoEight
Croatian: Kako primjenjivati NovoEight
English: • bleeding in muscle tissue
Croatian: • krvarenje u mišićno tkivo
English: Store in refrigerator (2°C - 8°C).
Croatian: Čuvati u hladnjaku (2°C-8°C).
English: Do not touch the syringe tip under the syringe cap.
Croatian: Nemojte dodirnuti vrh štrcaljke ispod zatvarača štrcaljke.
English: The reconstituted NovoEight must be injected into your vein (intravenous injection).
Croatian: Pripremljeni NovoEight mora biti injiciran u venu (intravenska injekcija).
English: • swelling of legs and feet
Croatian: • oticanje nogu i stopala
English: Injecting NovoEight via needleless connectors for intravenous (IV) catheters
Croatian: Injiciranje lijeka NovoEight putem konektora za primjenu bez igle za intravenske (i.v.) katetere:
English: When infused into a haemophilia patient, factor VIII binds to endogenous von Willebrand Factor in the patient's circulation.
Croatian: Kada se lijek primjeni u bolesnika s hemofilijom, faktor VIII veže se za endogeni von Willebrandov faktor u bolesnikovu krvotoku.
English: Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe.
Croatian: Prestanite pritiskati potisni klip i pustite ga da se samostalno pomiče unatrag dok rekonstituirana otopina ne ispuni štrcaljku.
English: Do not use this medicine after the expiry date, which is stated after ‘EXP' on the carton and on the vial and the pre-filled syringe labels.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji te na naljepnicama na bočici i napunjenoj štrcaljki iza oznake „Rok valjanosti“.
English: Powder: Sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid Solvent: Sodium chloride, water for injections
Croatian: Prašak: natrijev klorid, L-histidin, saharoza, polisorbat 80, L-metionin, kalcijev klorid dihidrat, natrijev hidroksid, kloridna kiselina
English: Check the reconstituted solution.
Croatian: Pregledajte pripremljenu otopinu.
English: • stiffness of muscles
Croatian: • ukočenost mišića
English: Do not freeze reconstituted NovoEight solution or store it in syringes.
Croatian: Pripremljenu otopinu lijeka NovoEight ne smijete zamrzavati niti čuvati u štrcaljkama.
English: What you need to know before you use NovoEight Do not use NovoEight:
Croatian: Što morate znati prije nego počnete primjenjivati NovoEight
English: While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top.
Croatian: Dok držite bočicu okrenutu naopako, lagano lupnite štrcaljku kako bi se mjehurići zraka podigli na vrh.
English: Table 2 Frequency of adverse drug reactions in clinical trials
Croatian: Tablica 2 Učestalost nuspojava na lijek u kliničkim ispitivanjima Klasifikacija organskih sustava
English: NovoEight is supplied as a powder.
Croatian: NovoEight dolazi u obliku praška.
English: The following side effects may occur with this medicine.
Croatian: Kod primjene ovog lijeka mogu se javiti sljedeće nuspojave.
English: Turn the syringe with the vial upside down.
Croatian: Okrenite štrcaljku s bočicom naopako.
English: After injection, safely dispose of all unused NovoEight solution, the syringe with the infusion set, the vial with the vial adapter and other waste materials as instructed by your pharmacist.
Croatian: Nakon injiciranja, oprezno bacite u otpad neiskorištenu otopinu lijeka NovoEight, štrcaljku s infuzijskim setom, bočicu s nastavkom za bočicu i drugi otpadni materijal, u skladu s uputama koje ste dobili od ljekarnika.
English: If you or your child´s bleeding is not being controlled with NovoEight, tell your doctor immediately.
Croatian: Vašeg djeteta ne može kontrolirati pomoću lijeka NovoEight, odmah se obratite liječniku.
English: The powder in the vial appears as a white or slightly yellow powder.
Croatian: U bočici je bijeli ili žućkasti prašak.
English: The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) per ml of plasma using the modified assay.
Croatian: Ti su inhibitori obično IgG imunoglobulini koji djeluju protiv prokoagulantne aktivnosti faktora VIII, a njihova količina određuje se u Bethesda jedinicama (BU) po ml plazme korištenjem modificiranog testa.
English: Of the 35 adverse reactions, 2 were reported in 1 out of 31 patients below 6 years of age, none in patients from 6 to ≤12 years of age, 1 event in 1 out of 24 patients (12 to <18 years of age) and 32 were reported in 21 out of 155 adults (≥18 years).
Croatian: Od 35 nuspojava, 2 su prijavljene u 1 od 31 bolesnika mlađeg od 6 godina, nijedna nuspojava nije prijavljena u bolesnika u dobi od 6 do ≤ 12 godina, 1 nuspojava prijavljena je u 1 od 24 bolesnika
English: • above room temperature (30°C up to 40°C) for a single period no longer than 3 months.
Croatian: • iznad sobne temperature (30°C do 40°C) tijekom jednokratnog razdoblja od najviše 3 mjeseca.
English: Instructions on how to use NovoEight
Croatian: Upute za uporabu lijeka NovoEight
English: If you touch the sides or the thread, germs from your fingers can be transferred.
Croatian: Ako dotaknete bočne stranice ili navoj, može doći do prijenosa mikroorganizama s Vaših prstiju.
English: Each pack of NovoEight contains a vial with white or slightly yellow powder, a 4 ml pre-filled syringe with a clear colourless solution, a plunger rod and a vial adapter.
Croatian: Jedno pakiranje lijeka NovoEight sadrži bočicu s bijelim ili žućkastim praškom, napunjenu štrcaljku s 4 ml bistre i bezbojne otopine, potisni klip i nastavak za bočicu.
English: • blushing of the skin
Croatian: • crvenilo kože
English: Please record the beginning of storage and the storage temperature on the product carton.
Croatian: Na kutiji lijeka zabilježite datum početka čuvanja lijeka i temperaturu čuvanja.
English: NovoEight 500 IU powder and solvent for solution for injection NovoEight 1000 IU powder and solvent for solution for injection NovoEight 1500 IU powder and solvent for solution for injection NovoEight 2000 IU powder and solvent for solution for injection NovoEight 3000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Croatian: NovoEight 500 IU prašak i otapalo za otopinu za injekciju NovoEight 1000 IU prašak i otapalo za otopinu za injekciju NovoEight 1500 IU prašak i otapalo za otopinu za injekciju NovoEight 2000 IU prašak i otapalo za otopinu za injekciju NovoEight 3000 IU prašak i otapalo za otopinu za injekciju turoktokog alfa (humani koagulacijski faktor VIII (rDNK))
English: Remove the syringe cap from the pre filled syringe by bending it down until the perforation breaks.
Croatian: Uklonite zatvarač štrcaljke s napunjene štrcaljke savijajući ga prema dolje dok se perforirani dio ne odvoji.
English: Unopened vial 30 months when stored in a refrigerator (2°C - 8°C).
Croatian: 30 mjeseci kada se čuva u hladnjaku (2°C-8°C).
English: <6 years) PUP
Croatian: Mlađa djeca (0 do <6 godina) PUP
English: NovoEight contains the active substance turoctocog alfa, human coagulation factor VIII.
Croatian: NovoEight sadrži djelatnu tvar turoktokog alfa, humani koagulacijski faktor VIII.
English: Overview Vial with NovoEight powder
Croatian: Pregled Bočica s NovoEight praškom
English: Taken out of refrigerator: _____________Stored at ≤30°C __ Stored at 30°C up to 40°C __
Croatian: Datum vađenja iz hladnjaka: ____________Čuvano na ≤30°C __ Čuvano na 30°C do 40°C __ Čuvati u originalnom pakiranju radi zaštite od svjetlosti.
English: Do not store the solution without your doctor's advice.
Croatian: Ne čuvajte otopinu bez savjetovanja s liječnikom.
English: Remove the protective paper from the vial adapter.
Croatian: Uklonite zaštitni papir s nastavka za bočicu.
English: NovoEight is now ready to be injected into your vein.
Croatian: NovoEight je sada spreman za injiciranje u venu.
English: NovoEight contains turoctocog alfa, a human coagulation factor VIII (rDNA), with a truncated Bdomain.
Croatian: NovoEight sadrži turoktokog alfa, humani koagulacijski faktor VIII (rDNK), sa skraćenom B-domenom.
English: If you notice visible particles or discolouration, do not use it. Use a new package instead.
Croatian: Ako primijetite vidljive čestice ili promjenu boje, nemojte koristiti otopinu.
English: • pain in muscles
Croatian: • bol u mišićima
English: Calcium chloride dihydrate Sodium hydroxide (for pH adjustment) Hydrochloric acid (for pH adjustment)
Croatian: L-histidin saharoza polisorbat 80 L-metionin kalcijev klorid dihidrat natrijev hidroksid (za podešavanje pH) kloridna kiselina (za podešavanje pH)
English: • room temperature (≤ 30°C) for a single period no longer than 9 months or
Croatian: • na sobnoj temperaturi (≤30°C) tijekom jednokratnog razdoblja od najviše 9 mjeseci ili
English: Talk to your doctor before using NovoEight.
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku prije nego primijenite NovoEight.
English: Keep the plunger rod pressed down and swirl the vial gently until all the powder is dissolved.
Croatian: Pritisnite potisni klip do kraja i nježno vrtite bočicu dok se sav prašak ne otopi.
English: Take the vial, the vial adapter and the pre-filled syringe out of the carton.
Croatian: Izvadite bočicu, nastavak za bočicu i napunjenu štrcaljku iz kutije.
English: 1 pre-filled syringe with solvent 1 plunger rod (placed under the syringe)
Croatian: • 1 potisni klip (smješten je ispod štrcaljke)
English: READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOEIGHT.
Croatian: PRIJE PRIMJENE LIJEKA NOVOEIGHT PAŽLJIVO PROČITAJTE OVE UPUTE.
English: • 4 hours stored up to 40°C, for product which has been kept for a single period no longer than 3 months at above room temperature (30°C up to 40°C).
Croatian: • 4 sata ako se čuva na temperaturi do 40°C, za lijek koji je tijekom jednokratnog razdoblja od najviše 3 mjeseca čuvan iznad sobne temperature (30°C do 40°C).
English: Obese class II/III N=7
Croatian: II./III.stupnja N=7
English: Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
Croatian: Držite napunjenu štrcaljku lagano nagnutu s bočicom prema dolje.
English: Pre-filled syringe with solvent
Croatian: Napunjena štrcaljka s otapalom
English: Allergic type hypersensitivity reactions are possible with NovoEight.
Croatian: Kod primjene lijeka NovoEight moguća je pojava reakcija preosjetljivosti alergijskog tipa.
English: • 4 hours stored at ≤ 30°C, for product which has been kept for a single period no longer than 9 months at room temperature (≤30°C)
Croatian: • 4 sata ako se čuva na temperaturi od 30°C, za lijek koji je tijekom jednokratnog razdoblja od najviše 9 mjeseci čuvan na sobnoj temperaturi (≤30°C)
English: 4 hours when stored at room temperature or up to 40°C and within 24 hours when stored at 2°C8°C.
Croatian: Ako ne možete odmah primijeniti pripremljenu otopinu lijeka NovoEight, morate je upotrijebiti unutar 4 sata ako je čuvate na sobnoj temperaturi ili do 40°C, odnosno unutar 24 sata ako je čuvate na temperaturi od 2°C-8°C.
English: If the plastic cap is loose or missing, do not use the vial.
Croatian: Ako plastični zatvarač nije dobro pričvršćen ili nedostaje, nemojte koristiti bočicu.
English: - The other ingredients are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine,
Croatian: - Drugi sastojci su L-histidin, saharoza, polisorbat 80, natrijev klorid, L-metionin, kalcijev klorid dihidrat, natrijev hidroksid i kloridna kiselina.
English: Number of patients Dose used for prevention per patient (IU/kg BW) Mean (SD) Min ; Max Dose used for treatment of bleed (IU/kg BW)
Croatian: Min; Maks Doza primijenjena za liječenje krvarenja (IU/kg TT)
English: Incremental recovery (IU/dl)/(IU/kg)
Croatian: Prirast po jedinici doze (IU/dl)/(IU/kg)
English: White or slightly yellow powder or friable mass. Clear and colourless solution for injection.
Croatian: Bijeli do žućkasti prašak ili drobljiva masa.
English: • feeling tired
Croatian: • osjećaj omaglice
English: Reconstitute the powder with the solvent
Croatian: Pripremite prašak s otapalom
English: NovoEight is recommended to be used immediately after it has been reconstituted.
Croatian: NovoEight treba primijeniti odmah nakon što ste ga pripremili za primjenu.
English: Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
Croatian: Lagano povucite potisni klip prema dolje kako biste uvukli rekonstituiranu otopinu u štrcaljku.
English: Musculoskeletal stiffness, arthropathy, pain in extremity, musculoskeletal pain
Croatian: artropatija, bol u ekstremitetima, bol u mišićima i kostima često hemartroza, krvarenje u mišićima
English: Do not shake the vial as this will cause foaming.
Croatian: Ne tresite bočicu jer će to izazvati pjenjenje.
English: The expiry date is printed after ‘EXP' on the outer carton, on the vial, on the vial adapter, and on the pre-filled syringe.
Croatian: Rok valjanosti otisnut je iza „Rok valjanosti“ na kutiji, bočici, nastavku za bočicu i napunjenoj štrcaljki.
English: Uncommon side effects (may affect up to 1 in 100 people)
Croatian: Manje česte nuspojave (mogu se javiti u do 1 na 100 osoba) • osjećaj umora
English: Turn over the protective cap, and snap the vial adapter onto the vial.
Croatian: Preokrenite zaštitni omot i pričvrstite nastavak za bočicu na bočicu.
English: Push the plunger rod to inject all the solvent into the vial.
Croatian: Pritisnite potisni klip kako biste cjelokupno otapalo ubrizgali u bočicu.
English: Powder and solvent for solution for injection Pack contains: 1 powder vial, 4 ml solvent in pre-filled syringe, plunger rod and vial adapter
Croatian: Pakiranje sadrži: 1 bočicu s praškom, 4 ml otapala u napunjenoj štrcaljki, potisni klip i nastavak za bočicu.
English: Haemorrhage
Croatian: Šiljak
English: Keep the plunger rod pushed completely in.
Croatian: Držite potisni klip pritisnutim do kraja.
English: NovoEight is a powder and solvent for solution for injection.
Croatian: NovoEight je prašak i otapalo za otopinu za injekciju.
English: - The active substance is turoctocog alfa (human coagulation factor VIII (rDNA)).
Croatian: Što NovoEight sadrži - Djelatna tvar je turoktokog alfa (humani koagulacijski faktor VIII (rDNK)).
English: NovoEight is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe.
Croatian: 6.6 Posebne mjere za zbrinjavanje i druga rukovanja lijekom NovoEight se primjenjuje intravenski nakon rekonstitucije praška s otapalom koje dolazi u štrcaljki.
English: Life threatening haemorrhages
Croatian: Krvarenja opasna po život
English: Do not use the equipment if it is expired.
Croatian: Nemojte koristiti pribor ako mu je istekao rok valjanosti.
English: Adolescents <18 years) PTP
Croatian: (12 do <18 godina) PTP
English: Administration of the reconstituted solution
Croatian: Primjena rekonstituirane otopine
English: NovoEight in previously treated patients with severe haemophilia A (FVIII ≤1%).
Croatian: Sva farmakokinetička (PK) ispitivanja s lijekom NovoEight provedena su nakon i.v. primjene 50 IU/kg lijeka NovoEight u prethodno liječenih bolesnika s teškom hemofilijom A (FVIII ≤1%).
English: Underweight N=5
Croatian: N=5
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica
English: Contusion
Croatian: Pretilost
English: NovoEight 2000 IU powder and solvent for solution for injection.
Croatian: NovoEight 2000 IU prašak i otapalo za otopinu za injekciju
English: The reconstituted solution will be clear to slightly opalescent.
Croatian: Otopina pripremljena za primjenu mora biti bistra do blago opalescentna.
English: Respiratory, thoracic and mediastinal disorders
Croatian: Poremećaji dišnog sustava, prsišta i sredoprsja često kašalj
English: Major surgery
Croatian: Veći kirurški zahvat
English: BioReliance Ltd
Croatian: Ltd
English: NovoEight 250 IU powder and solvent for solution for injection
Croatian: NovoEight 250 IU prašak i otapalo za otopinu za injekciju
English: Table 5 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by age - chromogenic assay - Mean (SD)
Croatian: Tablica 5 Farmakokinetički parametri jednokratne doze lijeka NovoEight (50 IU/kg) po dobikromogeni test - srednja vrijednost (SD)
English: 1 vial with NovoEight powder 1 vial adapter
Croatian: • 1 bočicu s NovoEight praškom
English: NovoEight 1500 IU powder and solvent for solution for injection.
Croatian: NovoEight 1500 IU prašak i otapalo za otopinu za injekciju
English: Early haemarthrosis, muscle bleeding or oral bleeding
Croatian: Rana hemartroza, krvarenje u mišiću ili krvarenje u usnoj šupljini
English: NovoEight 3000 IU powder and solvent for solution for injection.
Croatian: NovoEight 3000 IU prašak i otapalo za otopinu za injekciju
English: NovoEight 1000 IU powder and solvent for solution for injection.
Croatian: NovoEight 1000 IU prašak i otapalo za otopinu za injekciju
English: • bruising
Croatian: • osip
English: • rash, hives, weals or generalised itching
Croatian: • osip, koprivnjača, urtike ili svrbež po cijelom tijelu
English: AUC ((IU*h)/dl)
Croatian: Prirast po jedinici doze (IU/dl)/(IU/kg) AUC ((IU*h)/dl)
English: Remove the protective cap from the vial adapter.
Croatian: Uklonite zaštitni omot s nastavka za bočicu.
English: <12 years) PTP
Croatian: Odrasli godina) PTP
English: NovoEight 1500 IU powder for solution for injection turoctocog alfa
Croatian: NovoEight 1500 IU prašak za otopinu za injekciju turoktokog alfa Za intravensku primjenu.
English: NovoEight 250 IU powder for solution for injection turoctocog alfa
Croatian: NovoEight 250 IU prašak za otopinu za injekciju turoktokog alfa Za intravensku primjenu.
English: NovoEight 3000 IU powder for solution for injection turoctocog alfa
Croatian: NovoEight 3000 IU prašak za otopinu za injekciju turoktokog alfa Za intravensku primjenu.
English: NovoEight 500 IU powder and solvent for solution for injection.
Croatian: NovoEight 500 IU prašak i otapalo za otopinu za injekciju
English: Heart rate increased
Croatian: Prekomjerna tjelesna težina
English: After reconstitution NovoEight contains approximately 62.5 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Croatian: Nakon rekonstitucije, NovoEight sadrži približno 62,5 IU/ml humanog koagulacijskog faktora VIII (rDNK), turoktokoga alfa.
English: into the plunger inside the pre-filled syringe until resistance is felt.
Croatian: Čvrsto navijte napunjenu štrcaljku na nastavak za bočicu dok ne osjetite otpor.
English: After reconstitution NovoEight contains approximately 375 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Croatian: Nakon rekonstitucije, NovoEight sadrži približno 375 IU/ml humanog koagulacijskog faktora VIII (rDNK), turoktokoga alfa.
English: Each powder vial contains nominally 250 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Croatian: Jedna bočica s praškom nominalno sadrži 250 IU humanog koagulacijskog faktora VIII (rDNK), turoktokoga alfa.
English: Each powder vial contains nominally 2000 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Croatian: Jedna bočica s praškom nominalno sadrži 2000 IU humanog koagulacijskog faktora VIII (rDNK), turoktokoga alfa.
English: Blood and lymphatic system disorders
Croatian: Poremećaji krvi i limfnog sustava manje čestob vrlo čestob inhibicija faktora VIII
English: NovoEight 500 IU powder for solution for injection turoctocog alfa
Croatian: NovoEight 500 IU prašak za otopinu za injekciju turoktokog alfa Za intravensku primjenu.
English: Table 7 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by BMI classesaChromogenic assay - Mean (SD)
Croatian: Table 7 Farmakokinetički parametri jednokratne doze lijeka NovoEight (50 IU/kg) u skupinama prema ITM-ua - kromogeni test - srednja vrijednost (SD) PK parametar
English: After reconstitution NovoEight contains approximately 125 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Croatian: Nakon rekonstitucije, NovoEight sadrži približno 125 IU/ml humanog koagulacijskog faktora VIII (rDNK), turoktokoga alfa.