FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual dose of NovoEight is 20 to 50 international units (IU) per kg of body weight.
Slovenian: Običajen odmerek zdravila NovoEight je od 20 do 50 mednarodnih enot (i.e.) na kg telesne mase.
English: The trials included 298 exposed patients; 175 adolescents or adult patients without inhibitors from the age of 12 years (≥150 exposure days), 63 previously treated paediatric patients without inhibitors below 12 years of age (≥50 exposure days) and 60 previously untreated patients below 6 years of age.
Slovenian: 298 izpostavljenih bolnikov; 175 mladostnikov ali odraslih bolnikov brez zaviralcev, starejših od 12 let (≥ 150 dni izpostavljenosti), 63 predhodno zdravljenih pediatričnih bolnikov brez zaviralcev, mlajših od 12 let (≥ 50 dni izpostavljenosti) in 60 predhodno nezdravljenih bolnikov, mlajših od 6 let.
English: USA
Slovenian: Združene države Amerike
English: Common side effects (may affect up to 1 in 10 people) in patients who have not previously treated with Factor VIII medicines
Slovenian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov) pri bolnikih, ki predhodno niso bili zdravljeni z zdravili s faktorjem VIII
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).
Slovenian: Od 35 neželenih učinkov sta bila 2 opisana pri 1 od 31 bolnikov, mlajših od 6 let, nobeden pri bolnikih od 6. do vključno 12. leta, 1 neželeni učinek pri 1 od 24 bolnikov (starih od 12 do 18 let) in 32 neželenih učinkov pri 21 od 155 odraslih bolnikov (≥ 18 let).
English: Thrombosis in device a Calculated based on total number of unique patients in all clinical trials (301), of which 242 were previously treated patients (PTPs) and 60 were previously untreated patients (PUPs).
Slovenian: Težave z zdravilom pogosti tromboza v pripomočku a Izračunano na podlagi celotnega števila posameznih bolnikov v vseh kliničnih preskušanjih (301), od tega je bilo 242 predhodno zdravljenih bolnikov (PZB) in 60 bolnikov, ki predhodno niso bili zdravljeni (PNB).
English: Some variation was observed in the pharmacokinetic parameters of NovoEight between paediatric and adult patients.
Slovenian: Med farmakokinetičnimi parametri zdravila NovoEight pri pediatričnih in odraslih bolnikih so opažali nekatere razlike.
English: Do not take the vial adapter out of the protective cap with your fingers.
Slovenian: Nastavka za vialo ne jemljite iz zaščitnega pokrovčka s prsti.
English: In a single dose pharmacokinetic study in adult patients the maximum exposure (Cmax) and the total exposure (AUC) increased with increasing body mass index (BMI) indicating that dose adjustments may be required.
Slovenian: V farmakokinetični študiji z enkratnim odmerkom pri odraslih bolnikih sta se z naraščanjem indeksa telesne mase (ITM) povečala največja izpostavljenost (Cmax) in skupna izpostavljenost (AUC), kar kaže na morebitno potrebo po prilagoditvi odmerka.
English: The analysis of plasma samples was conducted using both the one-stage clotting assay and the chromogenic assay.
Slovenian: Analiza vzorcev plazme je bila opravljena tako z enostopenjskim preizkusom strjevanja kot s kromogenim preizkusom.
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.
Slovenian: V vseh kliničnih študijah z zdravilom NovoEight pri predhodno zdravljenih bolnikih je bilo skupno opisanih 35 neželenih učinkov pri 23 od 242 bolnikov, izpostavljenih zdravilu NovoEight.
English: The reconstituted NovoEight must be injected into your vein (intravenous injection).
Slovenian: Pripravljeno zdravilo NovoEight je treba injicirati v veno (intravenska injekcija).
English: • heart attack.
Slovenian: • srčni infarkt
English: Four multi-centre, open-labelled, non-controlled trials have been conducted to evaluate the safety and efficacy of NovoEight in the prevention and treatment of bleeds and during surgery in patients with severe haemophilia A (FVIII activity ≤1%).
Slovenian: Klinična učinkovitost Za oceno varnosti in učinkovitosti zdravila NovoEight za preprečevanje in zdravljenje krvavitev ter med kirurškimi posegi pri bolnikih s hudo hemofilijo A (aktivnost FVIII ≤ 1 %) so bila izvedena
English: In some cases, especially in younger patients, shorter dosage intervals or higher doses may be necessary.
Slovenian: V nekaterih primerih, zlasti pri mlajših bolnikih, so lahko potrebni krajši presledki med uporabo ali večji odmerki.
English: For long term prophylaxis against bleeding in patients with severe haemophilia A. The usual recommended doses are 20-40 IU of factor VIII per kg body weight every second day or 20-50 IU of factor VIII per kg body weight 3 times weekly.
Slovenian: Za dolgotrajno profilakso krvavitev pri bolnikih s hudo hemofilijo A so običajni priporočeni odmerki 20-40 i.e. faktorja VIII na kg telesne mase vsak drugi dan ali 20-50 i.e. faktorja VIII na kg telesne mase 3-krat na teden.
English: Surgery There is limited experience of surgery in paediatric patients.
Slovenian: Pri pediatričnih bolnikih so izkušnje pri kirurških posegih omejene.
English: It may harm them,
Slovenian: Biti mora bistra do rahlo opalescentna (rahlo motna).
English: Grasp the plunger rod by the wide top end and take it out of the carton.
Slovenian: • Primite nosilec bata za široki zgornji del in ga vzemite iz škatle.
English: What NovoEight looks like and contents of the pack
Slovenian: Izgled zdravila NovoEight in vsebina pakiranja
English: The side effects observed in children and adolescents are the same as observed in adults.
Slovenian: Neželeni učinki pri otrocih in mladostnikih Neželeni učinki pri otrocih in mladostnikih so enaki kot pri odraslih.
English: Remove the plastic cap from the vial.
Slovenian: Odstranite plastični pokrovček z viale.
English: Leave the plunger rod untouched in the carton.
Slovenian: Nosilec bata pustite nedotaknjen v škatli.
English: The most frequently reported adverse reactions were injection site reactions, incorrect dose administered and hepatic enzymes increased.
Slovenian: Najpogosteje opisani neželeni učinki so bili: reakcije na mestu injiciranja, uporaba nepravilnega odmerka in zvišanje jetrnih encimov.
English: NovoEight is now ready for injection.
Slovenian: Zdravilo NovoEight je zdaj pripravljeno za injiciranje.
English: If you use more NovoEight than you should, tell your doctor or go to a hospital straight away.
Slovenian: Če ste uporabili večji odmerek zdravila NovoEight, kot bi smeli Če ste uporabili večji odmerek zdravila NovoEight, kot bi smeli, o tem takoj obvestite zdravnika ali takoj pojdite v bolnišnico.
English: NovoEight can be used in children of all ages.
Slovenian: Zdravilo NovoEight se lahko uporablja pri otrocih vseh starosti.
English: If symptoms of hypersensitivity occur, patients should be advised to discontinue use of the medicinal product immediately and contact their physician.
Slovenian: Bolnikom je treba naročiti, da morajo v primeru simptomov preobčutljivosti takoj nehati uporabljati zdravilo in se posvetovati s svojim zdravnikom.
English: The dose of NovoEight is calculated depending on your body weight and the factor VIII levels to be achieved.
Slovenian: Odmerek zdravila NovoEight se izračuna glede na telesno maso in koncentracijo faktorja VIII, ki jo je treba doseči.
English: If you cannot use the reconstituted NovoEight solution immediately, it should be used within:
Slovenian: Če pripravljene raztopine zdravila NovoEight ne morete uporabiti takoj, jo morate uporabiti v:
English: Table 3 Consumption of NovoEight and haemostatic success rates in previously untreated patients (PUP) and previously treated patients (PTP)
Slovenian: Poraba zdravila NovoEight in deleži uspešnosti hemostaze pri predhodno nezdravljenih bolnikih (PNB) ter pri predhodno zdravljenih bolnikih (PZB)
English: Treatment with NovoEight will be started by a doctor who is experienced in the care of patients with haemophilia A. Always use this medicine exactly as your doctor has told you.
Slovenian: Zdravljenje z zdravilom NovoEight bo uvedel zdravnik, ki je izkušen v zdravljenju bolnikov s hemofilijo A. Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika.
English: NovoEight replaces this faulty or missing ‘factor VIII' and helps blood to form clots at the site of bleeding.
Slovenian: Zdravilo NovoEight nadomesti ta pomanjkljivi ali manjkajoči faktor VIII in pomaga, da na mestu krvavitve nastane krvni strdek.
English: If a central venous access device (CVAD) is required, risk of CVAD-related complications including local infections, bacteraemia and catheter site thrombosis should be considered.
Slovenian: Če je potreben pripomoček za centralni venski dostop (CVAD - Central Venous Access Device), je treba upoštevati tveganja za zaplete, povezane s tem pripomočkom, kot npr. lokalne okužbe,
English: An increase in dose may be required for underweight patients (BMI <18.5 kg/m2) and a decrease in dose may be required for obese patients (BMI ≥30 kg/m2), but there is insufficient data to recommend specific dose adjustments, see section 5.2.
Slovenian: Pri bolnikih s premajhno telesno maso (ITM < 18,5 kg/m2) bo odmerek morda treba povečati, pri debelih bolnikih (ITM ≥ 30 kg/m2) pa zmanjšati, vendar pa je na voljo premalo podatkov, da bi lahko priporočili specifične prilagoditve odmerka.
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.
Slovenian: Pojav nevtralizirajočih protiteles (zaviralcev) faktorja VIII je znan zaplet zdravljenja bolnikov s hemofilijo A. Ti zaviralci so po navadi imunoglobulini IgG, ki zavirajo prokoagulantno delovanje faktorja VIII, njihovo količino pa določamo v enotah Bethesda (B.e.) na ml plazme z uporabo prilagojenega testa.
English: Data on Immune Tolerance Induction (ITI) has been collected in patients with haemophilia A who had developed inhibitors to factor VIII.
Slovenian: Podatki o indukciji imunske tolerance (ITI - Immune Tolerance Induction) so bili pridobljeni pri bolnikih s hemofilijo A, pri katerih so se razvili zaviralci faktorja VIII.
English: Mean residence time (h) a BMI groups: Underweight: BMI <18.5 kg/m2, Normal weight: BMI 18.5-24.9 kg/m2, Overweight: BMI 25-29.9 kg/m2, Obese class I: BMI 30-34.9 kg/m2, Obese class II/III: BMI ≥35 kg/m2.
Slovenian: a Skupine ITM: premajhna telesna masa: ITM < 18,5 kg/m2; normalna telesna masa: ITM 18,524,9 kg/m2; prekomerna telesna masa: ITM 25-29,9 kg/m2; debelost razreda I: ITM 30-34,9 kg/m2; debelost razreda II/III: ITM ≥ 35 kg/m2
English: • feeling tired
Slovenian: • utrujenost
English: It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells, and prepared without the addition of any human or animal derived protein in the cell culture process, purification or final formulation.
Slovenian: 1.445 aminokislinami in približno molekulsko maso 166 kDa. Pridobljen je s tehnologijo rekombinantne DNA v celicah jajčnika kitajskega hrčka (CHO - Chinese hamster ovary) in pripravljen brez dodajanja človeških ali živalskih proteinov v postopku celične kulture, prečiščevanja ali končne priprave.
English: Before injection (administration) it must be reconstituted with the solvent supplied in the syringe.
Slovenian: Pred injiciranjem (uporabo) ga je treba pripraviti z vehiklom, ki je priložen v brizgi.
English: Allergic type hypersensitivity reactions are possible with NovoEight.
Slovenian: Na zdravilo NovoEight se lahko pojavijo preobčutljivostne reakcije alergijskega tipa.
English: If the protective paper is not fully sealed or if it is broken, do not use the vial adapter.
Slovenian: Če zaščitni papir ni povsem prilepljen ali če je pretrgan, nastavka za vialo ne uporabite.
English: Do not freeze reconstituted NovoEight solution or store it in syringes.
Slovenian: Ne zamrzujte pripravljene raztopine zdravila NovoEight in ne shranjujte je v brizgi.
English: - The other ingredients are L-histidine, sucrose, polysorbate 80, sodium chloride, L-methionine,
Slovenian: - Druge sestavine zdravila so L-histidin, saharoza, polisorbat 80, natrijev klorid, L-metionin,
English: Intravenous use
Slovenian: za intravensko uporabo
English: Follow the instructions for proper use for your connector and CVAD in consultation with your doctor or nurse.
Slovenian: Upoštevajte navodila zdravnika ali medicinske sestre za pravilno uporabo konektorja in CVAD.
English: Factor VIII inhibitors make NovoEight less effective in preventing or controlling bleeding.
Slovenian: zmanjšajo učinkovitost zdravila NovoEight pri preprečevanju ali obvladovanju krvavitev.
English: calcium chloride dihydrate, sodium hydroxide and hydrochloric acid.
Slovenian: kalcijev klorid dihidrat, natrijev hidroksid in klorovodikova kislina.
English: Store in refrigerator (2°C - 8°C).
Slovenian: Shranjujte v hladilniku (2 °C - 8 °C).
English: Locate a suitable site and slowly inject NovoEight into the vein over a period of 2-5 minutes.
Slovenian: Poiščite primerno mesto in počasi, v času 2 - 5 minut, injicirajte zdravilo NovoEight v veno.
English: If you touch the sides or the thread, germs from your fingers can be transferred.
Slovenian: Če se dotaknete stranskih delov ali navoja, lahko nanje prenesete klice s prstov.
English: Improper technique can introduce germs that can infect the blood.
Slovenian: Če postopek ni pravilen, lahko vnesete klice, ki lahko okužijo kri.
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.
Slovenian: Za shranjevanje pri sobni temperaturi (≤ 30 °C) oz. pri temperaturi, ki ne presega 40 °C, in za pogoje shranjevanja po pripravi zdravila glejte poglavje 6.3.
English: Sinus tachycardia, acute myocardial infarction
Slovenian: Srčne bolezni občasni sinusna tahikardija, akutni miokardni infarkt
English: When infused into a haemophilia patient, factor VIII binds to endogenous von Willebrand Factor in the patient's circulation.
Slovenian: Po injiciranju bolniku s hemofilijo se faktor VIII veže na endogeni von Willebrandov faktor v bolnikovem krvnem obtoku.
English: Disposal 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.
Slovenian: Odstranjevanje Po injiciranju varno zavrzite vso neporabljeno raztopino zdravila NovoEight, brizgo s kompletom za injiciranje, vialo z nastavkom viale in drug odpadni material, kot vam je naročil farmacevt.
English: During storage, the product may be kept at:
Slovenian: V času do izteka roka uporabnosti se zdravilo lahko shranjuje pri:
English: Adolescents <18 years) PTP
Slovenian: Mladostniki < 18 let) PZB
English: For storage conditions of the reconstituted medicinal product see section 6.3.
Slovenian: Za pogoje shranjevanja pripravljenega zdravila glejte poglavje 6.3.
English: Anti factor VIII antibody positive
Slovenian: Zaviralci faktorja VIII
English: NovoEight is supplied as a powder.
Slovenian: Zdravilo NovoEight je na voljo kot prašek.
English: During the course of treatment, appropriate determination of factor VIII levels is advised to guide the dose to be administered and the frequency of repeated injections.
Slovenian: Med zdravljenjem je priporočljivo z ustreznimi testi določati aktivnost faktorja VIII, da se ugotovi potreben odmerek in pogostnost aplikacij.
English: Younger children
Slovenian: Mlajši otroci
English: The reconstituted solution will be clear to slightly opalescent.
Slovenian: Pripravljena raztopina bo bistra do rahlo opalescentna (rahlo motna).
English: These devices are not included in the NovoEight package.
Slovenian: Pakiranje zdravila NovoEight teh pripomočkov ne vsebuje.
English: It is recommended to use NovoEight immediately after reconstitution.
Slovenian: Priporočljivo je, da zdravilo NovoEight uporabite takoj po pripravi.
English: • 24 hours stored at 2°C - 8°C
Slovenian: • 24 ur v primeru shranjevanja pri temperaturi 2 °C - 8 °C,
English: Injecting NovoEight via needleless connectors for intravenous (IV) catheters
Slovenian: Injiciranje zdravila NovoEight preko brezigelnih konektorjev za intravenske (i.v.)
English: When using an in vitro thromboplastin time (aPTT)-based one stage clotting assay for determining factor VIII activity in patients' blood samples, plasma factor VIII activity results can be significantly affected by both the type of aPTT reagent and the reference standard used in the assay.
Slovenian: aktivirani parcialni tromboplastinski čas) za določanje aktivnosti faktorja VIII v vzorcih krvi bolnikov, lahko na rezultate aktivnosti plazemskega faktorja VIII občutno vpliva tako tip aPTČ reagenta kot tudi referenčni standard, uporabljen pri preizkušanju.
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.
Slovenian: Število apliciranih enot faktorja VIII je izraženo v mednarodnih enotah (i.e.), trenutnim standardom
English: • bleeding in muscle tissue
Slovenian: • krvavitev v mišičnem tkivu
English: - The ingredients in the solvent are sodium chloride and water for injections.
Slovenian: - Sestavini vehikla sta natrijev klorid in voda za injekcije.
English: Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis.
Slovenian: Bolnike je treba seznaniti z zgodnjimi znaki preobčutljivostnih reakcij, vključno s koprivnico, generalizirano urtikarijo, tiščanjem v prsih, piskajočim dihanjem,
English: Do not touch the syringe tip.
Slovenian: • Ne dotikajte se konice brizge.
English: Do not use any other way to heat the vial and pre-filled syringe.
Slovenian: • Za gretje viale in napolnjene injekcijske brizge ne uporabljajte nobenega drugega načina.
English: Push the plunger rod slowly until all air bubbles are gone.
Slovenian: Nosilec bata počasi potiskajte, dokler ne izginejo vsi zračni mehurčki.
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.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli, viali in nalepki napolnjene injekcijske brizge poleg oznake »EXP«.
English: Adults (≥18 years) PTP
Slovenian: Odrasli (≥ 18 let)
English: • pain in muscles
Slovenian: • togost v mišicah
English: Psychiatric disorders Uncommon
Slovenian: Psihiatrične motnje občasni nespečnost
English: The potency (IU) is determined using the European Pharmacopoeia (Ph. Eur) chromogenic assay.
Slovenian: Jakost (i.e.) je določena z uporabo kromogenega preizkusa po Evropski farmakopeji (Ph.
English: <12 years) PTP
Slovenian: < 12 let) PZB
English: Severe symptoms, including difficulty in swallowing or breathing and red or swollen face or hands, require prompt emergency treatment.
Slovenian: Hudi simptomi, vključno s težavami pri požiranju ali dihanju in pordelost ali oteklost obraza ali rok,
English: Keep the plunger rod pressed down and swirl the vial gently until all the powder is dissolved.
Slovenian: Držite nosilec bata do konca pritisnjen in previdno vrtite vialo, dokler se ves prašek ne raztopi.
English: How to use NovoEight
Slovenian: Kako uporabljati zdravilo NovoEight
English: Any unused reconstituted product stored at room temperature (≤30°C) or up to 40°C for more than 4 hours should be discarded.
Slovenian: Neporabljeno pripravljeno zdravilo, ki je več kot 4 ure shranjeno pri sobni temperaturi (≤ 30 °C) oz. pri temperaturi do 40 °C, je treba v celoti zavreči.
English: Novo Nordisk US Bio Production Inc. 9 Technology Drive West Lebanon
Slovenian: Velika Britanija Novo Nordisk US Bio Production Inc.
English: After reconstitution the solution appears as a clear or slightly opalescent solution.
Slovenian: Po pripravi je raztopina bistra ali rahlo opalescentna.
English: After reconstitution with the supplied solvent (sodium chloride 9 mg/ml (0.9%) solution for injection), the prepared solution for injection contains 62.5, 125, 250, 375, 500 or 750 IU turoctocog alfa per ml, respectively, (based on the strength of turoctocog alfa, i.e. 250, 500, 1000, 1500, 2000 or 3000 IU).
Slovenian: pripravljena raztopina za injiciranje vsebuje 62,5, 125, 250, 375, 500 ali 750 i.e. turoktokoga alfa na ml (glede na jakost turoktokoga alfa, tj. 250, 500, 1.000, 1.500, 2.000 ali 3.000 i.e.).
English: Vial adapter Protective cap
Slovenian: nastavek za vialo zaščitni pokrovček konica
English: This is because if left, the medicine may no longer be sterile and could cause infections.
Slovenian: Če namreč zdravilo ni uporabljeno takoj, lahko ni več sterilno in bi lahko povzročilo okužbo.
English: The maximum exposure (Cmax) and the total exposure (AUC) increase with increasing BMI indicating that dose adjustments may be required for underweight (BMI <18.5 kg/m2) and obese patients (BMI ≥30 kg/m2), see section 4.2.
Slovenian: Največja izpostavljenost (Cmax) in skupna izpostavljenost (AUC) sta naraščala z naraščanjem ITM, kar kaže na morebitno potrebo po prilagoditvi odmerka pri bolnikih s premajhno telesno maso (ITM < 18,5 kg/m2) in pri debelih bolnikih (ITM ≥ 30 kg/m2).
English: Do not lift the vial adapter from the vial when removing the protective cap.
Slovenian: Pazite, da ne dvignete nastavka za vialo z viale, ko odstranite zaščitni pokrovček.
English: Bring the vial and the pre-filled syringe to room temperature.
Slovenian: Ogrejte vialo in napolnjeno injekcijsko brizgo na sobno temperaturo.
English: Incremental recovery (IU/dl)/(IU/kg)
Slovenian: Inkrementno okrevanje (i.e./dl)/(i.e./kg)
English: Stop pushing the plunger rod and let it move back on its own while the reconstituted solution fills the syringe.
Slovenian: Prenehajte pritiskati nosilec bata in pustite, da se sam od sebe pomika nazaj, medtem ko pripravljena raztopina polni brizgo.
English: The single dose pharmacokinetic parameters of NovoEight are listed in Table 4 for the one-stage clotting assay and in Table 5 for the chromogenic assay.
Slovenian: Farmakokinetični parametri enkratnega odmerka zdravila NovoEight z enostopenjskim preizkusom strjevanja so prikazani v preglednici 4, s kromogenim preizkusom pa v preglednici 5.
English: • joint disease
Slovenian: • bolezen sklepov
English: Method of administration Intravenous use.
Slovenian: Za intravensko uporabo.
English: Wipe the rubber stopper on the vial with a sterile alcohol swab and allow it to air dry for a few seconds before use.
Slovenian: • Obrišite gumijasti zamašek s sterilnim alkoholnim lističem in pustite nekaj sekund, da se na zraku posuši, preden vialo uporabite.
English: More extensive haemarthrosis, muscle bleeding or haematoma
Slovenian: obsežnejša hemartroza, krvavitev v mišico ali hematom
English: Before the NovoEight powder is reconstituted it may be kept at:
Slovenian: Pred pripravo lahko prašek zdravila NovoEight shranjujete pri:
English: Treatment should be under the supervision of a doctor experienced in the treatment of haemophilia.
Slovenian: 4.2 Odmerjanje in način uporabe Zdravljenje mora potekati pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem hemofilije.
English: The following table can be used to guide dosing in bleeding episodes and surgery:
Slovenian: Spodnjo preglednico je mogoče uporabiti kot vodilo za odmerjanje pri krvavitvah in kirurških posegih.
English: NovoEight is to be administered intravenously after reconstitution of the powder with the solvent supplied in the syringe.
Slovenian: Zdravilo NovoEight je treba aplicirati intravensko po pripravi praška z vehiklom, priloženim v brizgi.
English: Cardiovascular event
Slovenian: Srčno-žilni dogodki