FrancophonIA/ELRC3.0 huggingface dataset:
English: If you touch the sides or the thread, germs from your fingers can be transferred.
Estonian: Kui puudutate selle külgi või keermestikku, võivad mikroobid teie sõrmedelt üle kanduda.
English: Overweight N=9
Estonian: Ülekaal N=9
English: Do not touch the rubber stopper with your fingers as this can transfer germs.
Estonian: • Ärge puudutage kummikorki sõrmedega pärast selle puhastamist , sest mikroobid võivad teie sõrmedelt sinna üle kanduda.
English: L) Unscrew the vial adapter with the vial.
Estonian: L) Keerake viaali adapter viaali küljest lahti.
English: During storage, the product may be kept at:
Estonian: Kõlblikkusaja jooksul võib ravimit hoida
English: The table presented below is according to the MedDRA system organ classification (SOC and Preferred Term Level).
Estonian: Kõrvaltoimete tabel Alltoodud tabel on kooskõlas MeDRA organsüsteemi klassifikatsiooniga.
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))
Estonian: NovoEight 500 RÜ süstelahuse pulber ja lahusti NovoEight 1000 RÜ süstelahuse pulber ja lahusti NovoEight 1500 RÜ süstelahuse pulber ja lahusti NovoEight 2000 RÜ süstelahuse pulber ja lahusti NovoEight 3000 RÜ süstelahuse pulber ja lahusti alfaturoktokog (rekombinantne VIII hüübimisfaktor (rDNA))
English: More extensive haemarthrosis, muscle bleeding or haematoma
Estonian: Ulatuslikum hemartroos, veritsus lihases või hematoom
English: Do not use any other way to heat the vial and pre-filled syringe.
Estonian: Ärge soojendage viaali ja eeltäidetud süstalt ühelgi teisel viisil.
English: NovoEight 1500 IU
Estonian: NovoEight 1500 RÜ
English: Turn the syringe with the vial upside down.
Estonian: Keerake süstal koos viaaliga tagurpidi.
English: Prepare the vial and the syringe Take out the number of NovoEight packages you need.
Estonian: • Võtke välja nii mitu NovoEight pakendit kui vajate.
English: While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top.
Estonian: Viaali tagurpidi hoides koputage õrnalt süstalt, et õhumullid tõuseksid ülespoole.
English: NovoEight contains sodium
Estonian: NovoEight sisaldab naatriumi
English: Intravenous use
Estonian: Intravenoosne.
English: Please record the beginning of storage and the storage temperature on the product carton.
Estonian: Märkige säilitamise algus ja säilitamistemperatuur ravimi välispakendile.
English: Bring the vial and the pre-filled syringe to room temperature.
Estonian: Soojendage viaal ja eeltäidetud süstal toatemperatuurini.
English: Check the reconstituted solution.
Estonian: • Kontrollige saadud lahust.
English: This medicine contains 30.5 mg sodium (main component of cooking/table salt) per reconstituted vial.
Estonian: Ravim sisaldab pärast lahustamist 30,5 mg naatriumi (söögisoola peamine koostisosa) ühes viaalis.
English: NovoEight is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe.
Estonian: NovoEight manustatakse intravenoosselt pärast pulbri kokkusegamist süstlas oleva lahustiga.
English: How to use NovoEight
Estonian: Kuidas NovoEight'i kasutada
English: 1 vial with NovoEight powder 1 vial adapter
Estonian: • 1 viaal NovoEight pulbriga
English: Push the plunger rod slowly until all air bubbles are gone.
Estonian: Vajutage aeglaselt kolvivart, kuni kõik mullid on väljunud.
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).
Estonian: Eelnevalt VIII hübimisfaktoriga ravimata lastel võivad sageli (rohkem kui ühel patsiendil kümnest) tekkida hüübimisvastased antikehad (vt lõik 2).
English: Headache, dizziness, burning sensation
Estonian: Peavalu, pearinglus, põletustunne
English: swelling of lips and tongue, difficulty in breathing, wheezing, tightness of the chest, general feeling of being unwell, and dizziness.
Estonian: Allergilise reaktsiooni varased tunnused on lööve, nõgestõbi, kublad, üldine sügelemine, huulte ja keele paistetus, hingamisraskused, hingeldamine, pitsitustunne rinnus, üldine halb enesetunne ja peapööritus.
English: The higher CL and the shorter t½ seen in paediatric patients compared to adult patients with haemophilia A may be due in part to the known higher plasma volume per kilogram body weight in younger patients.
Estonian: See võib olla tingitud nooremate patsientide teadaolevalt suuremast plasma ruumalast ühe kehakaalu kilogrammi kohta.
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).
Estonian: • 4 tundi temperatuuril kuni 40 ºC ravimitele, mida on hoitud üheainsa maksimaalselt kolmekuulise perioodi jooksul toatemperatuurist kõrgemal temperatuuril (30 °C kuni 40 °C).
English: Fatigue, feeling hot, oedema peripheral, pyrexia
Estonian: Kurnatus, kuumatunne, perifeersed tursed, palavik
English: NovoEight 3000 IU
Estonian: NovoEight 3000 RÜ
English: • swelling of legs and feet
Estonian: • jalgade ja jalalabade paistetus
English: DK-2880 Bagsværd, Denmark
Estonian: Novo Nordisk A/S Novo Allé DK-2880 Bagsvaerd Taani
English: Remove the protective paper from the vial adapter.
Estonian: Eemaldage viaali adapterilt kaitsepaber.
English: Incremental recovery (IU/dl)/(IU/kg)
Estonian: Täiendav taastumine (RÜ/dl)/(RÜ/kg)
English: Keep reconstituted NovoEight solution out of direct light.
Estonian: Hoidke kokkusegatud NovoEight lahus valguse eest kaitstult.
English: This leaflet was last revised in Other sources of information
Estonian: Infoleht on viimati uuendatud.
English: Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
Estonian: Hoidke eeltäidetud süstalt kergelt kaldu, nii et viaal oleks suunaga allapoole.
English: Injecting NovoEight via needleless connectors for intravenous (IV) catheters
Estonian: NovoEight'i süstimine intravenoosse kateetri nõelavaba ühendusseadme abil
English: Leave the plunger rod untouched in the carton.
Estonian: Jätke kolvivars puutumatult karpi.
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)
Estonian: • 4 tundi temperatuuril 30 ºC ravimitele, mida on hoitud üheainsa maksimaalselt üheksakuulise perioodi jooksul toatemperatuuril (≤30 ºC);
English: L-methionine
Estonian: L-metioniin
English: Syringe tip (under syringe cap)
Estonian: Süstla ots (süstla katte all)
English: EXPIRY DATE
Estonian: Aeg-ajaltb
English: Administration of the reconstituted solution
Estonian: Valmistatud lahuse manustamine
English: • joint disease
Estonian: • liigesehaigus
English: Intravenous use Read the package leaflet before use
Estonian: Enne ravimi kasutamist lugege pakendi infolehte.
English: NovoEight 1000 IU
Estonian: NovoEight 1000 RÜ
English: SN: NN:
Estonian: SN:
English: Do not increase the total dose of NovoEight to control your bleed without talking to your doctor.
Estonian: Ärge suurendage NovoEight'i annust ilma oma arstiga sellest rääkimata.
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.
Estonian: Kõlblikkusaeg on trükitud välispakendile, viaalile, viaali adapterile ja eeltäidetud süstlale „Kõlblik kuni:“ järele.
English: 4 hours when stored at room temperature or up to 40°C and within 24 hours when stored at 2°C8°C.
Estonian: Kui seda lahust on hoitud temperatuuril 2 ºC…8 ºC, siis võib seda kasutada 24 tunni jooksul.
English: NovoEight is now ready to be injected into your vein.
Estonian: NovoEight on nüüd valmis süstimiseks veeni.
English: Store the reconstituted product in the vial.
Estonian: Kokkusegatud ravimit tuleb säilitada viaalis.
English: Flushing, Thrombophlebitis superficial
Estonian: Õhetus, pindmine tromboflebiit
English: NovoEight contains turoctocog alfa, a human coagulation factor VIII (rDNA), with a truncated Bdomain.
Estonian: NovoEight sisaldab alfaturoktokogi, inimese VIII hüübimisfaktorit (rDNA), mille B-domeeni on lühendatud.
English: NovoEight 2000 IU EU/1/13/888/005
Estonian: NovoEight 2000 RÜ EU/1/13/888/005
English: Side effects in children and adolescents
Estonian: Lastel ja noorukitel esinevad kõrvaltoimed
English: Sinus tachycardia, acute myocardial infarction
Estonian: Siinustahhükardia, äge müokardi infarkt
English: Non-clinical data reveal no special concern for humans based on conventional studies of safety pharmacology and repeated dose toxicity.
Estonian: Farmakoloogilise ohutuse ja korduvtoksilisuse mittekliinilised uuringud ei ole näidanud kahjulikku toimet inimesele.
English: NovoEight 2000 IU powder and solvent for solution for injection.
Estonian: NovoEight 2000 RÜ süstelahuse pulber ja lahusti.
English: Pyrexia, catheter site erythema
Estonian: • punetus kateetri sisestuskoha ümbruses
English: Contents of the pack and other information
Estonian: Kuidas NovoEight'i säilitada Pakendi sisu ja muu teave
English: FVIII level required (%) (IU/dl)
Estonian: Hemorraagia raskus/Operatsiooni tüüp VIII faktori vajalik tase (%) (RÜ/dl)
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).
Estonian: 32 kõrvaltoimet teatati 21-l täiskasvanud (vanus ≥18 aastat) patsiendil 155-st.
English: Table 1 Guide for dosing in bleeding episodes and surgery
Estonian: Annustamisjuhend hemorraagiate ja operatsioonide korral
English: AUC ((IU*h)/dl) 1510 (360) 1920 (610) CL (ml/h/kg) t½ (h)
Estonian: AUC ((RÜ*h)/dl) CL (ml/h/kg) t½ (h)
English: NovoEight 500 IU
Estonian: NovoEight 500 RÜ
English: - The ingredients in the solvent are sodium chloride and water for injections.
Estonian: - Lahusti koostisosaks on naatriumkloriid ja süstevesi.
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)
Estonian: Veritsuse raviks kasutatud annus (RÜ/kg kk) Keskmine (SD) Min. ; Maks.
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with NovoEight.
Estonian: A-hemofiiliaga patsientidel, keda ravitakse VIII hüübimisfaktoriga, sealhulgas NovoEight'iga võivad tekkida neutraliseerivad antikehad (inhibiitorid).
English: Excipient with known effect The medicinal product contains 30.5 mg sodium per reconstituted vial.
Estonian: Ravim sisaldab pärast lahustamist 30,5 mg naatriumi ühes viaalis.
English: NovoEight 3000 IU EU/1/13/888/006
Estonian: NovoEight 3000 RÜ EU/1/13/888/006
English: - The active substance is turoctocog alfa (human coagulation factor VIII (rDNA)).
Estonian: - Toimeaine on alfaturoktokog (inimese VIII hüübimisfaktor (rDNA)).
English: NovoEight in previously treated patients with severe haemophilia A (FVIII ≤1%).
Estonian: Kõik NovoEight farmakokineetika (PK) uuringud viidi läbi pärast 50 RÜ/kg NovoEight'i IVmanustamist eelnevalt ravitud tõsise A-hemofiiliaga patsientidel (FVIII aktiivsus ≤1%).
English: NovoEight 1500 IU powder and solvent for solution for injection.
Estonian: NovoEight 1500 RÜ süstelahuse pulber ja lahusti.
English: Keep the plunger rod pushed completely in.
Estonian: Hoidke kolvivars lõpuni sees.
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.
Estonian: Selleks keerake kolvivars kellaosuti suunas eeltäidetud süstla sees oleva kolvi sisse, kuni tunnete takistust.
English: Once you have reconstituted NovoEight it should be used right away.
Estonian: Kokkusegatud NovoEight lahus tuleb kohe ära kasutada.
English: Rash, lichenoid keratosis, skin burning sensation
Estonian: Lööve, lihhenoidne keratoos, naha põletustunne
English: NovoEight 250 IU EU/1/13/888/001
Estonian: NovoEight 250 RÜ EU/1/13/888/001
English: Sucrose
Estonian: Unetus
English: b Frequency is based on studies with all FVIII products which included patients with severe haemophilia A. c Injection site reactions include injection site erythema, injection site extravasation and injection site pruritus.
Estonian: b Esinemissagedus põhineb kõigi VIII faktori ravimitega tehtud uuringutel, mis hõlmasid raske Ahemofiiliaga patsiente.
English: Haemorrhage
Estonian: • väsimustunne
English: NovoEight 1500 IU EU/1/13/888/004
Estonian: NovoEight 1500 RÜ EU/1/13/888/004
English: If the syringe cap is loose or missing, do not use the pre-filled syringe.
Estonian: Ärge kasutage eeltäidetud süstalt, kui selle kate on lahti või puudub.
English: Psychiatric disorders Uncommon
Estonian: Psühhiaatrilised häired Aeg-ajalt
English: On-demand treatment
Estonian: Retseptiravim
English: NovoEight 500 IU EU/1/13/888/002
Estonian: NovoEight 500 RÜ EU/1/13/888/002
English: NovoEight 250 IU powder and solvent for solution for injection
Estonian: NovoEight 250 RÜ süstelahuse pulber ja lahusti
English: Powder:
Estonian: Pulber
English: Pre-filled syringe with solvent
Estonian: Eeltäidetud süstal lahusega
English: Turn over the protective cap and snap the vial adapter onto the vial.
Estonian: Tõstke kaitsepakend üles ja kinnitage adapter viaali külge.
English: Attach the vial adapter Remove the protective paper from the vial adapter.
Estonian: • Eemaldage viaali adapterilt kaitsepaber.
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.
Estonian: VIII hüübimisfaktori vastaste neutraliseerivate antikehade (inhibiitorid) teke on A-hemofiiliaga isikute ravimisel teadaolev tüsistus.
English: Incorrect dose administered
Estonian: Väära annuse manustamine
English: NovoEight 2000 IU powder for solution for injection turoctocog alfa
Estonian: NovoEight 2000 RÜ süstelahuse pulber Turoctocogum alfa i.v.
English: NovoEight 1000 IU EU/1/13/888/003
Estonian: NovoEight 1000 RÜ EU/1/13/888/003
English: NovoEight 1000 IU powder and solvent for solution for injection.
Estonian: NovoEight 1000 RÜ süstelahuse pulber ja lahusti.
English: Remove the protective cap from the vial adapter.
Estonian: Eemaldage viaali adapterilt kaitsepakend.
English: During all clinical studies with NovoEight in previously treated patients, a total of 35 adverse reactions were reported in 23 of 242 patients exposed to NovoEight.
Estonian: Eelnevalt ravitud patsientidel teatati NovoEight'iga läbi viidud kliinilistes uuringutes 35-st kõrvaltoimest 23-l patsiendil 242-st. Kõige sagedamini teatatud kõrvaltoimed olid süstekoha reaktsioonid, väära annuse manustamine ja maksaensüümide aktiivsuse suurenemine.
English: NovoEight 250 IU powder for solution for injection turoctocog alfa
Estonian: NovoEight 250 RÜ süstelahuse pulber Turoctocogum alfa i.v.
English: NovoEight is a powder and solvent for solution for injection.
Estonian: NovoEight on süstelahuse pulber ja lahusti.
English: NovoEight 250 IU powder and solvent for solution for injection.
Estonian: NovoEight 250 RÜ süstelahuse pulber ja lahusti.
English: Table 5 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by age - chromogenic assay - Mean (SD)
Estonian: NovoEight (50 RÜ/kg) üksikannuse farmakokineetilised parameetrid vanuse järgi, kromogeenne test, keskmine (SD)
English: After reconstitution NovoEight contains approximately 62.5 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Estonian: NovoEight sisaldab pärast lahustamist ligikaudu 62,5 RÜ/ml inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: After reconstitution NovoEight contains approximately 375 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Estonian: NovoEight sisaldab pärast lahustamist ligikaudu 375 RÜ/ml inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: NovoEight 3000 IU powder and solvent for solution for injection.
Estonian: NovoEight 3000 RÜ süstelahuse pulber ja lahusti.
English: • bruising
Estonian: • lööve
English: NovoEight 3000 IU powder for solution for injection turoctocog alfa
Estonian: NovoEight 3000 RÜ süstelahuse pulber Turoctocogum alfa i.v.
English: • feeling hot
Estonian: • naha õhetus
English: NovoEight 1500 IU powder for solution for injection turoctocog alfa
Estonian: NovoEight 1500 RÜ süstelahuse pulber Turoctocogum alfa i.v.
English: Treatment of bleeding
Estonian: • liigesesisesd verejooksud
English: Contents
Estonian: Ülitundlikkus
English: NovoEight contains the active substance turoctocog alfa, human coagulation factor VIII.
Estonian: NovoEight'i toimeaine on alfaturoktokog - inimese VIII hüübimisfaktor.
English: Haemarthrosis, Muscle haemorrhage
Estonian: Hemartroos, lihase hemorraagia
English: Syringe cap
Estonian: Süstla kate
English: Each powder vial contains nominally 250 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Estonian: Üks pulbriviaal sisaldab nominaalselt 250 RÜ inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: NovoEight 250 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Estonian: NovoEight 250 RÜ süstelahuse pulber ja lahusti Turoctocogum alfa (inimese VIII hüübimisfaktor (rDNA))
English: NovoEight 2000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Estonian: NovoEight 2000 RÜ süstelahuse pulber ja lahusti Turoctocogum alfa (inimese VIII hüübimisfaktor (rDNA))
English: Each powder vial contains nominally 2000 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Estonian: Üks pulbriviaal sisaldab nominaalselt 2000 RÜ inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: Each powder vial contains nominally 1500 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Estonian: Üks pulbriviaal sisaldab nominaalselt 1500 RÜ inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: Each powder vial contains nominally 3000 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Estonian: Üks pulbriviaal sisaldab nominaalselt 3000 RÜ inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: After reconstitution NovoEight contains approximately 125 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Estonian: NovoEight sisaldab pärast lahustamist ligikaudu 125 RÜ/ml inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi
English: One ml of NovoEight contains approximately 62.5 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Estonian: Üks ml NovoEight'i sisaldab pärast lahustamist ligikaudu 62,5 RÜ inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: NovoEight 500 IU powder for solution for injection turoctocog alfa
Estonian: NovoEight 500 RÜ süstelahuse pulber Turoctocogum alfa i.v.
English: NovoEight 500 IU powder and solvent for solution for injection.
Estonian: NovoEight 500 RÜ süstelahuse pulber ja lahusti.
English: One ml of NovoEight contains approximately 375 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Estonian: Üks ml NovoEight'i sisaldab pärast lahustamist ligikaudu 375 RÜ inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: 1 pre-filled syringe with solvent 1 plunger rod (placed under the syringe)
Estonian: • 1 kolvivars (asub süstla all)
English: Each powder vial contains nominally 500 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Estonian: Üks pulbriviaal sisaldab nominaalselt 500 RÜ inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: After reconstitution NovoEight contains approximately 750 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Estonian: NovoEight sisaldab pärast lahustamist ligikaudu 750 RÜ/ml inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: NovoEight 3000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Estonian: NovoEight 3000 RÜ süstelahuse pulber ja lahusti Turoctocogum alfa (inimese VIII hüübimisfaktor (rDNA))
English: NovoEight 500 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Estonian: NovoEight 500 RÜ süstelahuse pulber ja lahusti Turoctocogum alfa (inimese VIII hüübimisfaktor (rDNA))
English: One ml of NovoEight contains approximately 125 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Estonian: Üks ml NovoEight'i sisaldab pärast lahustamist ligikaudu 125 RÜ inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: NovoEight 1000 IU powder for solution for injection turoctocog alfa
Estonian: NovoEight 1000 RÜ süstelahuse pulber Turoctocogum alfa i.v.
English: After reconstitution NovoEight contains approximately 250 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Estonian: NovoEight sisaldab pärast lahustamist ligikaudu 250 RÜ/ml inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: Early haemarthrosis, muscle bleeding or oral bleeding
Estonian: Algav hemartroos, veritsus lihases või suuõõnes
English: NovoEight 1500 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Estonian: NovoEight 1500 RÜ süstelahuse pulber ja lahusti Turoctocogum alfa (inimese VIII hüübimisfaktor (rDNA))
English: Each powder vial contains nominally 1000 IU human coagulation factor VIII (rDNA), turoctocog alfa.
Estonian: Üks pulbriviaal sisaldab nominaalselt 1000 RÜ inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
Estonian: Tõmmake kolvivart kergelt tagasi, et lahus täidaks süstla.
English: NovoEight 1000 IU powder and solvent for solution for injection turoctocog alfa (human coagulation factor VIII (rDNA))
Estonian: NovoEight 1000 RÜ süstelahuse pulber ja lahusti Turoctocogum alfa (inimese VIII hüübimisfaktor (rDNA))
English: After reconstitution NovoEight contains approximately 500 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Estonian: NovoEight sisaldab pärast lahustamist ligikaudu 500 RÜ/ml inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: One ml of NovoEight contains approximately 750 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Estonian: Üks ml NovoEight'i sisaldab pärast lahustamist ligikaudu 750 RÜ inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: One ml of NovoEight contains approximately 250 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Estonian: Üks ml NovoEight'i sisaldab pärast lahustamist ligikaudu 250 RÜ inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: Once attached do not remove the vial adapter from the vial.
Estonian: Ärge tõstke viaali adapterit viaalilt,
English: Table 6 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by BMI classesaOne-stage clotting assay - Mean (SD)
Estonian: NovoEight (50 RÜ/kg) üksikannuse farmakokineetilised parameetrid KMI kategooriatea järgi, ühefaasiline hüübimistest, keskmine (SD)
English: Table 4 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by age - one stage clotting assay - Mean (SD)
Estonian: NovoEight (50 RÜ/kg) üksikannuse farmakokineetilised parameetrid vanuse järgi, ühefaasiline hüübimistest, keskmine (SD)
English: One ml of NovoEight contains approximately 500 IU of human coagulation factor VIII (rDNA), turoctocog alfa after reconstitution
Estonian: Üks ml NovoEight'i sisaldab pärast lahustamist ligikaudu 500 RÜ inimese VIII hüübimisfaktorit (rDNA), alfaturoktokogi.
English: Uncommonb
Estonian: • lihasvalu
English: Obese class I N=7
Estonian: Rasvumise I aste N=7