FrancophonIA/ELRC3.0 huggingface dataset:
English: • blood tests showing changes in the way the liver functions • reactions (redness and itching) around the site where you injected the medicine.
Slovenian: • reakcije (rdečica in srbečica) okoli mesta, kjer ste injicirali zdravilo
English: The factor VIII/von Willebrand factor complex consists of two molecules (factor VIII and von Willebrand factor) with different physiological functions.
Slovenian: (faktorja VIII in von Willebrandovega faktorja), ki imata različni fiziološki funkciji.
English: The solvent is a sodium chloride 9 mg/ml (0.9%) solution.
Slovenian: Vehikel je 9 mg/ml (0,9 %) raztopina natrijevega klorida.
English: Store in the original package in order to protect from light
Slovenian: Shranjujte v originalni ovojnini za zagotovitev zaščite pred svetlobo.
English: <6 years) PTP
Slovenian: < 6 let) PNB
English: Once you have reconstituted NovoEight it should be used right away.
Slovenian: Ko je zdravilo NovoEight enkrat pripravljeno, ga je treba uporabiti takoj.
English: Check the reconstituted solution.
Slovenian: • Preverite pripravljeno raztopino.
English: NovoEight 2000 IU
Slovenian: NovoEight 2000 i.e.
English: Unopened vial 30 months when stored in a refrigerator (2°C - 8°C).
Slovenian: 30 mesecev, če se zdravilo shranjuje v hladilniku (2 °C - 8 °C).
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
Slovenian: NovoEight 250 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 500 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 1000 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 1500 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 2000 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 3000 i.e. prašek in vehikel za raztopino za injiciranje
English: • pain in legs and arms
Slovenian: • bolečine v mišicah • bolečine v nogah in rokah
English: While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top.
Slovenian: Medtem ko držite vialo obrnjeno na glavo, previdno potrkajte brizgo, da se bodo zračni mehurčki dvignili na vrh.
English: Do not touch the syringe tip under the syringe cap.
Slovenian: Ne dotikajte se konice brizge pod pokrovčkom brizge.
English: Rubber stopper (under plastic cap)
Slovenian: (pod plastičnim pokrovčkom)
English: Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either spontaneously or as a result of accidental or surgical trauma.
Slovenian: Hemofilija A je na spol vezana dedna motnja strjevanja krvi zaradi pomanjkanja faktorja VIII:C. Povzroči obsežne krvavitve v sklepe, mišice ali notranje organe.
English: NovoEight contains sodium
Slovenian: Zdravilo NovoEight vsebuje natrij
English: The following side effects may occur with this medicine.
Slovenian: Med uporabo tega zdravila se lahko pojavijo neželeni učinki, navedeni v nadaljevanju.
English: Do not dispose of any of the items until after you have injected the reconstituted solution.
Slovenian: Ne zavrzite ničesar, dokler si pripravljene raztopine ne injicirate.
English: Take the vial, the vial adapter and the pre-filled syringe out of the carton.
Slovenian: Vzemite vialo, nastavek za vialo in napolnjeno injekcijsko brizgo iz škatle.
English: Repeat infusion every 12-24 hours for 3-4 days or more until pain and acute disability are resolved
Slovenian: 3 do 4 dni ali več, dokler bolečina in akutna prizadetost ne mineta.
English: If you touch the syringe tip, germs from your fingers can be transferred.
Slovenian: Če se dotaknete konice brizge, lahko nanjo prenesete klice s prstov.
English: Flushing, Thrombophlebitis superficial
Slovenian: hiperemija pogosti zardevanje, površinski tromboflebitis
English: If the plastic cap is loose or missing, do not use the vial.
Slovenian: Če plastični pokrovček ni trdno pričvrščen ali ga ni, viale ne uporabite.
English: Prepare the vial and the syringe Take out the number of NovoEight packages you need.
Slovenian: • Vzemite toliko pakiranj zdravila NovoEight, kot jih potrebujete.
English: Underweight N=5
Slovenian: Premajhna telesna masa N=5
English: NovoEight 1500 IU
Slovenian: NovoEight 1500 i.e.
English: Overweight N=9
Slovenian: Prekomerna telesna masa N=9
English: For children not previously treated with Factor VIII medicines, inhibitor antibodies (see section 2) may form very commonly (more than 1 in 10 patients); however patients who have received previous treatment with Factor VIII (more than 150 days of treatment) the risk is uncommon (less than 1 in 100 patients).
Slovenian: Pri bolnikih, ki pa so se predhodno zdravili z zdravili s faktorjem VIII (zdravljenje je trajalo več kot 150 dni), lahko zaviralna protitelesa nastanejo občasno (pri manj kot 1 od 100 bolnikov).
English: 0 − <6 years 6 − <12 years ≥12 years n=14
Slovenian: ≥ 12 let n = 14
English: L) Unscrew the vial adapter with the vial.
Slovenian: L) Odvijte nastavek za vialo skupaj z vialo.
English: • increased blood pressure
Slovenian: • hitro bitje srca • zvišanje krvnega tlaka
English: Table 2 Frequency of adverse drug reactions in clinical trials
Slovenian: Pogostnost neželenih učinkov v kliničnih preskušanjih Organski sistem
English: You should contact your doctor if you have missed a dose and do not know how to compensate for this.
Slovenian: Če ste pozabili uporabiti zdravilo NovoEight Če ste pozabili uporabiti odmerek in ne veste, kako ga nadomestiti, se posvetujte z zdravnikom.
English: Please record the beginning of storage and the storage temperature on the product carton.
Slovenian: Na škatlo zdravila zapišite začetek shranjevanja izven hladilnika in temperaturo zraka v prostoru shranjevanja.
English: By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of bleeding tendencies.
Slovenian: Tako se začasno popravi pomanjkanje faktorja VIII in se zmanjša nagnjenost h krvavitvam.
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.
Slovenian: Datum izteka roka uporabnosti je natisnjen na škatli in na viali, na nastavku za vialo in na napolnjeni injekcijski brizgi poleg oznake »EXP«.
English: Inject the reconstituted solution
Slovenian: Injicirajte pripravljeno raztopino
English: If the syringe cap is loose or missing, do not use the pre-filled syringe.
Slovenian: Če pokrovček brizge ne sedi trdno ali ga ni, napolnjene injekcijske brizge ne uporabite.
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Slovenian: FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi Prašek:
English: NovoEight 250 IU
Slovenian: NovoEight 250 i.e.
English: • room temperature (≤ 30°C) for a single period no longer than 9 months or
Slovenian: • pri sobni temperaturi (≤ 30 °C) za enkratno obdobje, ki ni daljše od 9 mesecev, ali
English: Table 1 Guide for dosing in bleeding episodes and surgery
Slovenian: Smernice za odmerjanje pri krvavitvah in kirurških posegih
English: AUC ((IU*h)/dl) 1510 (360) 1920 (610) CL (ml/h/kg) t½ (h)
Slovenian: AUC ((i.e.*h)/dl) 1.510 (360) 1.920 (610)
English: Remove the syringe cap from the pre filled syringe by bending it down until the perforation breaks.
Slovenian: Odstranite pokrovček brizge z napolnjene injekcijske brizge tako, da ga upognete, dokler se perforacija ne pretrga.
English: A single dose pharmacokinetic trial (50 IU/kg) was performed in 35 haemophilia patients (≥18 years of age) in different BMI categories.
Slovenian: Pri 35 bolnikih s hemofilijo (starih ≥ 18 let), ki so bili razvrščeni v različne kategorije ITM, je bilo izvedeno farmakokinetično preskušanje z enkratnim odmerkom (50 i.e./kg).
English: This glycoprotein has the same structure as human factor VIII when activated, and posttranslational modifications that are similar to those of the plasma-derived molecule.
Slovenian: Zdravilo NovoEight vsebuje turoktokog alfa, humani koagulacijski faktor VIII (rDNA) s ciljno skrajšano domeno B. Ko je aktiviran, ima ta glikoprotein enako zgradbo kot humani faktor VIII in posttranslacijske spremembe, ki so podobne kot pri molekuli, pridobljeni iz plazme.
English: Push the plunger rod to inject all the solvent into the vial.
Slovenian: • Potisnite nosilec bata, da boste v vialo vbrizgali celotno količino vehikla.
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
Slovenian: Pakiranje vsebuje: 1 vialo s praškom, 4 ml vehikla v napolnjeni injekcijski brizgi, nosilec bata in nastavek za vialo.
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))
Slovenian: NovoEight 500 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 1000 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 1500 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 2000 i.e. prašek in vehikel za raztopino za injiciranje NovoEight 3000 i.e. prašek in vehikel za raztopino za injiciranje turoktokog alfa (humani koagulacijski faktor VIII (rDNA))
English: An updated RMP should be submitted:
Slovenian: Navodilo je bilo nazadnje posodobljeno:
English: Excipient with known effect The medicinal product contains 30.5 mg sodium per reconstituted vial.
Slovenian: Zdravilo po pripravi vsebuje 30,5 mg natrija na vialo.
English: 1 pre-filled syringe with solvent 1 plunger rod (placed under the syringe)
Slovenian: • 1 nosilec bata (nameščen je pod brizgo).
English: Vss (ml/kg)
Slovenian: Vss (ml/kg) Cmax (i.e./dl)
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.
Slovenian: F) Primite nosilec bata za široki zgornji del in ga takoj privijte v brizgo tako, da ga sučete v smeri urinega kazalca v bat, ki je v napolnjeni injekcijski brizgi, dokler ne začutite upora.
English: Attach the vial adapter Remove the protective paper from the vial adapter.
Slovenian: Namestite nastavek za vialo • Odstranite zaščitni papir z nastavka za vialo.
English: READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOEIGHT.
Slovenian: Navodila za uporabo zdravila NovoEight PRED UPORABO ZDRAVILA NOVOEIGHT NATANČNO PREBERITE TA NAVODILA.
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)
Slovenian: Odmerek, uporabljen za preprečevanje krvavitev na bolnika (i.e./kg TM)
English: If you stop using NovoEight
Slovenian: Ne prenehajte uporabljati zdravila NovoEight,
English: Musculoskeletal stiffness, arthropathy, pain in extremity, musculoskeletal pain
Slovenian: Bolezni mišično skeletnega sistema in vezivnega tkiva občasni mišično-skeletna togost, artropatija, bolečina v okončini, mišičnoskeletne bolečine pogosti hemartroza, krvavitev v mišici
English: Talk to your doctor before using NovoEight.
Slovenian: Pred začetkom uporabe zdravila NovoEight se posvetujte z zdravnikom.
English: Powder: Sodium chloride, L-histidine, sucrose, polysorbate 80, L-methionine, calcium chloride dihydrate, sodium hydroxide, hydrochloric acid Solvent: Sodium chloride, water for injections
Slovenian: SEZNAM POMOŽNIH SNOVI Prašek: natrijev klorid, L-histidin, saharoza, polisorbat 80, L-metionin, kalcijev klorid dihidrat,
English: Obese class II/III N=7
Slovenian: razred II/III
English: Keep the plunger rod pushed completely in.
Slovenian: Držite nosilec bata potisnjen do konca.
English: NovoEight 3000 IU
Slovenian: NovoEight 3000 i.e.
English: When you prepare and inject medicine directly into the veins, it is important to use a clean and germ free (aseptic) technique.
Slovenian: Pomembno je, da med pripravo in injiciranjem zdravila neposredno v veno uporabljate čist postopek brez prisotnosti klic (aseptičen postopek).
English: • If the CVAD line needs to be flushed before or after NovoEight injection, use sodium chloride 9 mg/ml solution for injection.
Slovenian: • Če je linijo CVAD pred injiciranjem zdravila NovoEight ali po njem treba sprati, uporabite
English: Turoctocog alfa is a B-domain truncated recombinant human coagulation factor VIII (B-domain consists of 21 amino acids of the wild type B-domain) without any other modifications in the amino acid sequence.
Slovenian: 21 aminokislin divjega tipa domene B), brez kakršnih koli drugih sprememb zaporedja aminokislin.
English: NovoEight is given as an injection into a vein.
Slovenian: Kako uporabljati zdravilo NovoEight Zdravilo NovoEight se daje kot injekcija v veno.
English: Keep reconstituted NovoEight solution out of direct light.
Slovenian: Pripravljena raztopina zdravila NovoEight naj ne bo izpostavljena neposredni svetlobi.
English: System Organ Class Frequencya in PTPs
Slovenian: Pogostnosta pri PZB
English: Do not open the equipment until you are ready to use it. Do not use the equipment if it has been dropped, or if it is damaged.
Slovenian: Ne uporabljajte opreme, če vam je padla ali je poškodovana.
English: • above room temperature (30°C up to 40°C) for a single period no longer than 3 months.
Slovenian: • pri temperaturah, višjih od sobne temperature (30 °C - 40 °C), za enkratno obdobje, ki ni daljše od 3 mesecev.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH
English: Intravenous use Read the package leaflet before use
Slovenian: Pred uporabo preberite priloženo navodilo!
English: Remove the protective paper from the vial adapter.
Slovenian: Odstranite zaščitni papir z nastavka za vialo.
English: Do not store the solution without your doctor's advice.
Slovenian: Raztopine ne shranjujte, če vam tega ne naroči zdravnik.
English: Early haemarthrosis, muscle bleeding or oral bleeding
Slovenian: Krvavitev zgodnja hemartroza, krvavitev v mišico oziroma krvavitev v ustni votlini
English: For long term prophylaxis against bleeding in patients below the age of 12, doses of 25-50 IU of factor VIII per kg body weight every second day or 25-60 IU of factor VIII per kg body weight 3 times weekly are recommended.
Slovenian: faktorja VIII na kg telesne mase vsak drugi dan ali 25-60 i.e. faktorja VIII na kg telesne mase 3-krat na teden.
English: Headache, dizziness, burning sensation
Slovenian: Bolezni živčevja občasni glavobol, omotica, pekoč občutek
English: Do not shake the vial as this will cause foaming.
Slovenian: Viale ne stresajte, ker to povzroča penjenje.
English: NovoEight 500 IU
Slovenian: NovoEight 500 i.e.
English: Attach the plunger rod and the syringe
Slovenian: Namestite nosilec bata in brizgo
English: Hold the pre-filled syringe slightly tilted with the vial pointing downwards.
Slovenian: Držite napolnjeno injekcijsko brizgo rahlo nagnjeno in tako, da je viala obrnjena navzdol.
English: PK parameter
Slovenian: Farmakokinetični parameter
English: Turn the syringe with the vial upside down.
Slovenian: Obrnite brizgo z vialo na glavo.
English: Pharmacotherapeutic group: antihaemorrhagics, blood coagulation factor VIII, ATC code: B02BD02.
Slovenian: Oznaka ATC: B02BD02.
English: SN: NN:
Slovenian: SN:
English: swelling of lips and tongue, difficulty in breathing, wheezing, tightness of the chest, general feeling of being unwell, and dizziness.
Slovenian: Zgodnji znaki alergijske reakcije so izpuščaj, koprivnica, srbenje po celem telesu, oteklost ustnic in jezika, težave z dihanjem, piskajoče dihanje, tiščanje v prsih, splošno slabo počutje in omotica.
English: How to store NovoEight
Slovenian: Shranjevanje zdravila NovoEight
English: If this happens to you or your child´s medicines may stop working properly and you or your child may experience persistent bleeding.
Slovenian: Če pride do nastanka zaviralnih protiteles, vaše zdravilo ali zdravilo vašega otroka morda ne bo več učinkovito in se lahko pojavi krvavitev, ki se ne ustavi.
English: Hypertension, lymphoedema, hyperaemia
Slovenian: Žilne bolezni občasni hipertenzija, limfedem,
English: NovoEight is now ready to be injected into your vein.
Slovenian: Zdravilo NovoEight je zdaj pripravljeno za injiciranje v veno.
English: The calculation of the required dose of factor VIII 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.
Slovenian: (i.e.) faktorja VIII na kilogram telesne mase poveča aktivnost faktorja VIII v plazmi za 2 i.e./dl.
English: Turn over the protective cap and snap the vial adapter onto the vial.
Slovenian: Obrnite zaščitni pokrovček in nataknite nastavek za vialo na vialo.
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.
Slovenian: NovoEight vsebuje vialo z belim do rumenkastim praškom, 4-ml napolnjeno injekcijsko brizgo z bistro, brezbarvno raztopino, nosilec bata in nastavek za vialo.
English: NH 03784
Slovenian: 9 Technology Drive West Lebanon NH 03784
English: 4 hours when stored at room temperature or up to 40°C and within 24 hours when stored at 2°C8°C.
Slovenian: Če pripravljene raztopine zdravila NovoEight ne morete uporabiti takoj, jo morate uporabiti v 4 urah, če je shranjena pri sobni temperaturi oz. pri temperaturi, ki ne presega 40 °C, in v 24 urah, če je shranjena pri temperaturi 2 °C - 8 °C.
English: In the trial with previously untreated patients, between 0 and 6 years of age, a total of 46 adverse reactions were reported in 33 of 60 patients exposed to NovoEight.
Slovenian: V preskušanju s predhodno nezdravljenimi bolniki, starimi od 0 do 6 let, je bilo skupno opisanih
English: NovoEight 250 IU powder and solvent for solution for injection
Slovenian: NovoEight 250 i.e. prašek in vehikel za raztopino za injiciranje
English: Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
Slovenian: Potegnite nosilec bata rahlo navzdol, da boste potegnili pripravljeno raztopino v brizgo.
English: Repeat every 12 to 24 hours, at least 1 day, until the bleeding episode as indicated by pain is resolved or healing achieved
Slovenian: 1 dan, dokler se krvavitev (kot jo kaže bolečina) ne ustavi oziroma je doseženo celjenje.
English: Do not stop using NovoEight without talking to your doctor.
Slovenian: Raztopine ne shranjujte, brez da bi se prej posvetovali z zdravnikom.
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.
Slovenian: c Reakcije na mestu injiciranja vključujejo eritem na mestu injiciranja, ekstravazacijo na mestu injiciranja in srbenje na mestu injiciranja.
English: If you notice visible particles or discolouration, do not use it. Use a new package instead.
Slovenian: Če v njej opazite vidne delce ali če je spremenjene barve, je ne uporabite.
English: NovoEight 1000 IU
Slovenian: NovoEight 1000 i.e.
English: Do not use the equipment without proper training from your doctor or nurse.
Slovenian: Opreme ne uporabite, če vas zdravnik ali medicinska sestra nista posebej usposobila za to. Vedno si umijte roke in poskrbite, da je prostor okrog vas čist.
English: Sucrose
Slovenian: pireksija
English: Turn over the protective cap, and snap the vial adapter onto the vial.
Slovenian: • Obrnite zaščitni pokrovček in nataknite nastavek za vialo na vialo.
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).
Slovenian: • 4 urah, če je raztopina hranjena pri temperaturi, ki ne presega 40 °C, v primeru, da je bilo zdravilo shranjeno pri temperaturah, višjih od sobne temperature (30 °C - 40 °C), za enkratno obdobje, ki ni daljše od 3 mesecev.
English: Heart rate increased
Slovenian: občasni zvišanje frekvence srčnega utripa
English: NovoEight is a powder and solvent for solution for injection.
Slovenian: Zdravilo NovoEight vsebuje prašek in vehikel za raztopino za injiciranje.
English: Vomiting
Slovenian: • zardevanje
English: administration of 50 IU/kg
Slovenian: debelost razreda II/III: ITM ≥ 35 kg/m2
English: Pyrexia, catheter site erythema
Slovenian: • rdečica na mestu vstavljenega katetra
English: Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated with factor VIII, including with NovoEight.
Slovenian: Pri bolnikih s hemofilijo A, zdravljenih s faktorjem VIII, vključno z zdravilom NovoEight, lahko pride do nastanka nevtralizirajočih protiteles (zaviralcev).
English: After reconstitution:
Slovenian: Neodprta viala:
English: The medicinal product contains 30.5 mg sodium per reconstituted vial, equivalent to 1.5% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Slovenian: Opomba o pomožnih snovehZdravilo po pripravi vsebuje 30,5 mg natrija na vialo, kar je enako 1,5 %
English: NovoEight in previously treated patients with severe haemophilia A (FVIII ≤1%).
Slovenian: NovoEight v odmerku 50 i.e./kg pri predhodno že zdravljenih bolnikih s hudo hemofilijo A
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)
Slovenian: • 4 ure v primeru shranjevanja pri temperaturi 30 °C, v primeru, da je bilo zdravilo shranjeno pri sobni temperaturi (≤ 30 °C) za enkratno obdobje, ki ni daljše od 9 mesecev,
English: Management of such patients should be directed by physicians with experience in the care of haemophilia and factor VIII inhibitors.
Slovenian: ki imajo izkušnje z zdravljenjem hemofilije in zaviralci faktorja VIII.
English: Screw the pre-filled syringe securely onto the vial adapter until resistance is felt.
Slovenian: Napolnjeno injekcijsko brizgo trdno privijte na nastavek za vialo, dokler ne začutite upora.
English: After reconstitution NovoEight contains approximately 62.5 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Slovenian: Po pripravi vsebuje zdravilo NovoEight približno 62,5 i.e./ml humanega koagulacijskega faktorja VIII (rDNA) (turoktokog alfa).
English: Table 5 Single-dose pharmacokinetic parameters of NovoEight (50 IU/kg) by age - chromogenic assay - Mean (SD)
Slovenian: Farmakokinetični parametri enkratnega odmerka zdravila NovoEight (50 i.e./kg) glede na starost - kromogeni preizkus - povprečje (SD)
English: • above room temperature (30°C up to 40°C) for a single period no longer than 3 months
Slovenian: • temperaturah, višjih od sobne temperature (30 °C - 40 °C), za enkratno obdobje, ki ni daljše od
English: Overview Vial with NovoEight powder
Slovenian: Pregled viala s praškom zdravila NovoEight plastičen pokrovček gumijasti zamašek
English: Remove the protective cap from the vial adapter.
Slovenian: Odstranite zaščitni pokrovček z nastavka za vialo.
English: NovoEight 250 IU powder for solution for injection turoctocog alfa
Slovenian: NovoEight 250 i.e. prašek za raztopino za injiciranje turoktokog alfa za intravensko uporabo
English: Plunger
Slovenian: OVOJNINAH
English: White or slightly yellow powder or friable mass. Clear and colourless solution for injection.
Slovenian: prašek in vehikel za raztopino za injiciranje Bel ali rumenkast prašek ali krhka masa.
English: After reconstitution NovoEight contains approximately 750 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa.
Slovenian: Po pripravi vsebuje zdravilo NovoEight približno 750 i.e./ml humanega koagulacijskega faktorja VIII (rDNA) (turoktokog alfa).
English: Incorrect dose administered
Slovenian: Napolnjena injekcijska brizga