FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety, efficacy, and pharmacokinetics of ADYNOVI were evaluated in a pivotal multicenter, open-label, prospective clinical trial that compared the efficacy of a twice weekly prophylactic treatment regimen to on-demand treatment and determined haemostatic efficacy in the treatment of bleeding episodes.
Slovenian: Varnost, učinkovitost in farmakokinetiko zdravila ADYNOVI so vrednotili v ključnem multicentričnem, odprtem, prospektivnem kliničnem preskušanju, v katerem so primerjali učinkovitost profilaktičnega zdravljenja z dvakrat tedenskim odmerjanjem in zdravljenja po potrebi ter ugotavljali hemostatsko učinkovitost pri zdravljenju krvavitev.
English: The human relevance of kidney vacuolation observed in the preclinical study is unknown.
Slovenian: Pomen vakuolizacije v ledvicah, opažene v predklinični študiji, za človeka ni znan.
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 infusions.
Slovenian: Med zdravljenjem je priporočljivo določiti raven faktorja VIII, ki služi kot vodilo za določitev potrebnega odmerka in pogostnosti ponavljanja infuzij.
English: Severe symptoms, including difficulty in breathing and (nearly) fainting, require prompt emergency treatment.
Slovenian: Hudi simptomi, med katere sodijo težave z dihanjem in (grozeča) izguba zavesti, zahtevajo takojšnje nujno medicinsko zdravljenje.
English: If you think that the effect of ADYNOVI is insufficient, talk to your doctor.
Slovenian: Če menite, da učinek zdravila ADYNOVI ni zadosten, se posvetujte z zdravnikom.
English: Immune tolerance induction (ITI) No clinical data for use of ADYNOVI in ITI are available.
Slovenian: Indukcija imunske tolerance (IIT) O uporabi zdravila ADYNOVI pri IIT ni kliničnih podatkov.
English: Do not tilt the system until the transfer is complete.
Slovenian: Sistema ne smete nagniti, dokler se ne pretoči vsa tekočina.
English: Pharmacokinetic parameters calculated from 39 subjects less than 18 years of age (intent-to-treat analysis) are available for 14 children (2 to less than 6 years), 17 older children (6 to less than 12 years) and 8 adolescent subjects (12 to < 18 years of age).
Slovenian: Farmakokinetični parametri, izračunani pri 39 preiskovancih, mlajših od 18 let (analiza z namenom zdravljenja), so na voljo za 14 otrok (starih od 2 do manj kot 6 let), 17 starejših otrok (starih od 6 do manj kot 12 let) in 8 mladostnikov (starih od 12 do < 18 let).
English: Prophylactic treatment
Slovenian: Profilaktično zdravljenje
English: Terminal half--life [h] MRT [h] CL [mL/(kg·h)]
Slovenian: MRT [h] CL [ml/(kg·h)]
English: The median annualised bleed rate (ABR) in the on-demand treatment arm was 41.5 compared to 1.9 while on a twice a week prophylaxis regimen.
Slovenian: Mediana letne stopnje krvavitev (annualised bleed rate - ABR) v skupini z zdravljenjem po potrebi je bila 41,5 v primerjavi z 1,9 v skupini z dvakrat tedensko profilaktično shemo odmerjanja.
English: The dose of ADYNOVI is calculated depending on your body weight and the factor VIII levels to be achieved.
Slovenian: Odmerek zdravila ADYNOVI se izračuna glede na vašo telesno maso in ciljno raven faktorja VIII.
English: If any of these symptoms occur, stop the injection immediately and contact your doctor.
Slovenian: Če opazite katerega koli izmed teh simptomov, nemudoma prekinite injiciranje in se posvetujte z zdravnikom.
English: Each powder vial contains nominally 250, 500,
Slovenian: Ena viala s praškom vsebuje nominalno 250, 500 ali
English: Individual PK with full sampling a
Slovenian: Individualna PK s celotnim vzorčenjem a
English: ADYNOVI is for intravenous use.
Slovenian: Zdravilo ADYNOVI je namenjeno intravenski uporabi.
English: Turn the system upside down (powder vial now on top).
Slovenian: Sistem obrnite navzdol (zdaj je zgoraj viala s praškom).
English: Driving and using machines ADYNOVI has no influence on your ability to drive or to use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Zdravilo ADYNOVI nima vpliva na vašo sposobnost vožnje ali upravljanja strojev.
English: Control of bleeding was rated excellent (full relief of pain and cessation of objective signs of bleeding after a single infusion) or good (definite pain relief and/or improvement in signs of bleeding after a single infusion) in 63 out of 70 (90.0%) bleeding episodes.
Slovenian: Nadzor krvavitve je bil ocenjen kot izvrsten (popolno izginotje bolečine in prenehanje objektivnih znakov krvavitve po enkratni infuziji) ali dober (jasno olajšanje bolečine in/ali izboljšanje znakov krvavitve po enkratni infuziji) pri 63 krvavitvah od 70 (90,0 %).
English: ADYNOVI must not be mixed with other medicinal products or solvents.
Slovenian: Zdravila ADYNOVI ne smete mešati z drugimi zdravili ali vehikli.
English: • Do not use if the lid is not completely sealed on the blister
Slovenian: • Zdravila ne uporabite, če pokrovček ni popolnoma zapečaten na pretisnem omotu
English: A total of 21 major surgical procedures and 5 additional minor surgeries were performed and assessed in 21 unique subjects in the surgery study.
Slovenian: V kirurški študiji so opravili 21 večjih kirurških posegov in 5 dodatne manjše kirurške posege ter ovrednotili 21 udeležencev.
English: The pharmacokinetics (PK) of ADYNOVI were evaluated in a crossover study with octocog alfa in 26 subjects (18 adults and 8 adolescents) and in 22 subjects (16 adults and 6 adolescents) after 6 months of treatment with ADYNOVI.
Slovenian: Farmakokinetiko (PK) zdravila ADYNOVI so ovrednotili v navzkrižni študiji z oktokogom alfa pri 26 preiskovancih (18 odraslih in 8 mladostnikih) ter pri 22 preiskovancih (16 odraslih in 6 mladostnikih) po 6 mesecih zdravljenja z zdravilom ADYNOVI.
English: Baxalta Innovations GmbH A-1221 Vienna Austria
Slovenian: Baxalta Innovations GmbH A-1221 Dunaj Avstrija
English: The mean dose (SD) was 54.3 (6.3) IU/kg and the median frequency of infusions per week was 1.87.
Slovenian: Povprečni odmerek (SD) je bil 54,3 (6,3) i.e./kg, mediana pogostnosti infuzij na teden pa 1,87.
English: Table 1 Guide for dosing in bleeding episodes and surgery Degree of haemorrhage/type of surgical procedure
Slovenian: Preglednica 1 Vodilo za odmerjanje pri krvavitvah in kirurških posegih Stopnja krvavitve/vrsta kirurškega posega
English: The median dosing interval was 3.6 days and the mean dose (SD) was 48.7 (4.4) IU/kg.
Slovenian: Mediana intervala odmerjanja je bila 3,6 dneva, povprečni odmerek (SD) pa 48,7 (4,4) i.e./kg.
English: NA, Not applicable, as Incremental Recovery and Cmax in children were determined by individual PK.
Slovenian: c n.r., ni relevantno, saj sta bila prirastno zvečanje aktivnosti in Cmax pri otrocih določena z individualno PK.
English: Swirl gently until all material is dissolved (Figure 3).
Slovenian: Sistem nežno obračajte, da se vsa vsebina raztopi (slika 3).
English: The number of units of factor VIII administered is expressed in International Units (IU), which are related to the current WHO concentrate standard for factor VIII products.
Slovenian: Število danih enot faktorja VIII je izraženo v mednarodnih enotah (i.e.), ki se nanašajo na trenutni standard SZO za koncentrate za zdravila s faktorjem VIII.
English: In patients with haemophilia A (inborn lack of factor VIII), it is missing or not working properly.
Slovenian: Pri bolnikih s hemofilijo A (prirojenim pomanjkanjem faktorja VIII) ga ni ali ne deluje pravilno.
English: Results for Incremental Recovery and Cmax determined by individual PK in parenthesis.
Slovenian: Rezultati za prirastno zvečanje aktivnosti in Cmax, določeni z individualno PK, so navedeni v oklepajih.
English: In the per-protocol population, i.e. dosed according to the protocol specific dosing requirements, a total of 101 subjects received a twice a week regimen in the prophylaxis arm, and 17 subjects were treated episodically in the on-demand arm.
Slovenian: V populaciji po protokolu, tj. v populaciji, ki je prejemala odmerke v skladu s specifičnimi zahtevami za odmerjanje po protokolu, je skupaj 101 preiskovanec v profilaktični skupini prejemal zdravilo po dvakrat tedenski shemi odmerjanja, 17 preiskovancev v skupini z zdravljenjem po potrebi pa se je zdravilo epizodično.
English: From a microbiological point of view, unless the method of reconstitution precludes the risk of microbial contamination, the product should be used immediately.
Slovenian: Z mikrobiološkega vidika je treba razredčeno zdravilo nemudoma uporabiti, razen če način rekonstitucije izključuje tveganje mikrobne kontaminacije.
English: Table 3: Pharmacokinetic parameters using the chromogenic assay (Arithmetic mean ± SD)
Slovenian: Preglednica 3: Farmakokinetični parametri z uporabo kromogenega testa (aritmetična sredina ± SD)
English: Factor VIII inhibitors (for patients who have received previous treatment with Factor VIII (more than 150 days of treatment))
Slovenian: Zaviralci faktorja VIII (pri bolnikih, ki so se predhodno zdravili s faktorjem VIII (zdravljenje je trajalo več kot 150 dni))
English: ADYNOVI is used for the treatment and prevention of bleeding in patients from 12 years of age with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII).
Slovenian: Zdravilo ADYNOVI se uporablja za zdravljenje in preprečevanje krvavitev pri bolnikih od 12. leta s hemofilijo A (podedovano motnjo strjevanja krvi, ki jo povzroča pomanjkanje faktorja VIII).
English: Reconstitution with the BAXJECT III system Do not use if the lid is not completely sealed on the blister
Slovenian: Rekonstitucija s sistemom BAXJECT III Zdravila ne uporabite, če pokrovček ni popolnoma zapečaten na pretisnem omotu.
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 (central venous access device, CVAD), je treba upoštevati tveganje za zaplete, povezane s CVAD, vključno z lokalnimi okužbami, bakteriemijo in trombozo na mestu katetra.
English: • Inspect the prepared solution for particulate matter and discoloration prior to administration (the solution should be clear, colourless and free from particles).
Slovenian: • Pripravljeno raztopino pred uporabo preglejte glede prisotnosti delcev in sprememb barve (raztopina mora biti bistra, brezbarvna in brez delcev).
English: Octocog alfa is then covalently conjugated with the PEG reagent.
Slovenian: Oktokog alfa je nato kovalentno konjugiran z reagentom PEG.
English: The end of the 3-month storage at room temperature should be recorded on the product carton.
Slovenian: Konec 3mesečnega obdobja hranjenja pri sobni temperaturi je treba zabeležiti na škatlo zdravila.
English: A total of 137 male PTPs (12 to 65 years of age) with severe haemophilia A received at least one infusion with ADYNOVI.
Slovenian: Skupno je 137 predhodno zdravljenih bolnikov moškega spola (starih od 12 do 65 let) s hudo hemofilijo A prejelo vsaj eno infuzijo zdravila ADYNOVI.
English: What ADYNOVI looks like and contents of the pack ADYNOVI is provided as a powder and solvent for solution for injection.
Slovenian: Izgled zdravila ADYNOVI in vsebina pakiranja Zdravilo ADYNOVI je v obliki praška in vehikla za raztopino za injiciranje.
English: Name and batch number of the medicinal product
Slovenian: Ime in serijska številka zdravila
English: A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALEC (IZDELOVALCI) BIOLOŠKE UČINKOVINE (UČINKOVIN) IN IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI) ZA SPROŠČANJE SERIJE
English: If you require a central venous access device (CVAD), risk of CVAD-related complications including local infections, presence of bacteria in the blood and catheter site thrombosis should be considered.
Slovenian: Če potrebujete pripomoček za centralni venski dostop (central venous access device, CVAD), je treba upoštevati tveganje za zaplete, povezane s CVAD, vključno z lokalnimi okužbami, prisotnostjo bakterij v krvi in trombozo na mestu katetra.
English: The target factor VIII levels will depend on the severity and location of the bleeding.
Slovenian: Ciljna raven faktorja VIII je odvisna od resnosti in mesta krvavitve.
English: On demand treatment dosing in paediatric patients (12 to 18 years of age) is the same as for adult patients.
Slovenian: Odmerjanje pri zdravljenju po potrebi pri pediatričnih bolnikih (starih med 12 in 18 let) je enako kot odmerjanje pri odraslih bolnikih.
English: Based on the rare occurrence of haemophilia A in women, experience regarding the use of factor VIII during pregnancy and breast-feeding is not available.
Slovenian: Ker je hemofilija A pri ženskah redka, tudi ni izkušenj z uporabo faktorja VIII med nosečnostjo in dojenjem.
English: With one hand holding the powder vial in the BAXJECT III system, press down firmly on the solvent vial with the other hand until the system is fully collapsed and the solvent flows down into the powder vial (Figure 2).
Slovenian: Z eno roko primite vialo s praškom v sistemu BAXJECT III, z drugo roko pa odločno potisnite na vialo z vehiklom, da se sistem stisne in vehikel začne teči v vialo s praškom (slika 2).
English: For patients who have received previous treatment with Factor VIII (more than 150 days of treatment) inhibitor antibodies (see section 2) may form uncommonly (less than 1 in 100 patients).
Slovenian: Pri bolnikih, ki so se predhodno zdravili s faktorjem VIII (zdravljenje je trajalo več kot 150 dni), zaviralna protitelesa (glejte poglavje 2) lahko nastanejo občasno (pri manj kot 1 od 100 bolnikov).
English: * Human factor VIII produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) cell line.
Slovenian: *Humani faktor VIII, izdelan s tehnologijo rekombinantne DNA iz celične linije jajčnika kitajskega hrčka (CHO).
English: Treatment with ADYNOVI will be started and supervised by a doctor who is experienced in the care of patients with haemophilia A.
Slovenian: Zdravljenje z zdravilom ADYNOVI bo uvedel in nadzoroval zdravnik z izkušnjami pri obravnavi bolnikov s hemofilijo A.
English: Subjects received either prophylactic treatment (n = 120) with ADYNOVI at a dose of 40-50 IU per kg twice weekly or on-demand treatment (n = 17) with ADYNOVI at a dose of 10-60 IU per kg for a 6-month period.
Slovenian: Preiskovanci so prejemali bodisi profilaktično zdravljenje (n = 120) z zdravilom ADYNOVI v odmerku 40-50 i.e. na kilogram dvakrat tedensko bodisi zdravljenje po potrebi (n = 17) z zdravilom ADYNOVI v odmerku 10-60 i.e. na kilogram v 6-mesečnem obdobju.
English: The therapeutic activity of rurioctocog alfa pegol is derived from octocog alfa, which is produced by recombinant DNA technology from a Chinese hamster ovary cell line.
Slovenian: Terapevtska aktivnost rurioktokoga alfa pegola izhaja iz oktokoga alfa, ki je izdelan s tehnologijo rekombinantne DNA iz celične linije jajčnika kitajskega hrčka.
English: Swirl gently until the powder is completely dissolved.
Slovenian: Sistem nežno obračajte, da se prašek popolnoma raztopi.
English: What ADYNOVI is and what it is used for What you need to know before you use ADYNOVI How to use ADYNOVI
Slovenian: Kaj je zdravilo ADYNOVI in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo ADYNOVI Kako uporabljati zdravilo ADYNOVI Možni neželeni učinki
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 svetovati, da ob pojavu simptomov preobčutljivosti nemudoma prekinejo uporabo zdravila in se posvetujejo z zdravnikom.
English: The median joint ABR (Q1 ; Q3) in the on-demand arm was 38.1 (24.5 ; 44.6) compared to 0.0 (0.0 ; 2.0) while on prophylaxis, and the median spontaneous ABR was 21.6 (11.2 ; 33.2) on the on-demand arm compared to 0.0 (0.0 ; 2.2) while on prophylaxis.
Slovenian: Mediana vrednosti ABR v sklepe (Q1 ; Q3) v skupini z zdravljenjem po potrebi je bila 38,1 (24,5 ; 44,6) v primerjavi z 0,0 (0,0 ; 2,0) pri profilaktičnem zdravljenju, mediana vrednosti ABR za spontane krvavitve pa je bila 21,6 (11,2 ; 33,2) v skupini z zdravljenjem po potrebi v primerjavi z 0,0 (0,0 ; 2,2) pri profilaktičnem zdravljenju.
English: By replacement therapy the plasma levels of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and correction of the bleeding tendencies.
Slovenian: nadomestnim zdravljenjem povečamo raven faktorja VIII v plazmi in tako omogočimo začasno odpravo pomanjkanja tega faktorja in zmanjšamo nagnjenost bolnika h krvavitvam.
English: Open the BAXJECT II Hi-Flow device package by peeling away the lid, without touching the inside (Figure A).
Slovenian: Pakiranje pripomočka BAXJECT II Hi-Flow odprite tako, da odlepite pokrov, ne da bi se dotaknili notranjosti (slika A).
English: Catheter-related complications in treatment
Slovenian: S katetrom povezani zapleti zdravljenja
English: Disconnect the syringe; attach a butterfly needle to the syringe and inject the reconstituted solution into a vein.
Slovenian: Snemite brizgo, namestite iglo z metuljčkom in rekonstituirano raztopino injicirajte v veno.
English: More extensive haemarthrosis, muscle bleeding or haematoma
Slovenian: Obsežnejša hemartroza, krvavitev v mišico ali hematom
English: Disconnect the syringe; attach a suitable needle and inject intravenously.
Slovenian: Odvijte brizgo, pritrdite primerno iglo in injicirajte intravensko.
English: This date should never exceed the one initially mentioned on the outer carton.
Slovenian: Ta datum ne sme biti kasnejši od prvotnega datuma na škatli.
English: If you stop using ADYNOVI Do not stop using ADYNOVI without consulting your doctor.
Slovenian: Če ste prenehali uporabljati zdravilo ADYNOVI Uporabe zdravila ADYNOVI ne smete prekiniti brez posvetovanja z zdravnikom.
English: Of the 518 bleeding episodes, 96.1% were rated excellent (full relief of pain and cessation of objective signs of bleeding after a single infusion) or good (definite pain relief and/or improvement in signs of bleeding after a single infusion) in their response to treatment with ADYNOVI.
Slovenian: Od 518 krvavitev so odziv na zdravljenje z zdravilom ADYNOVI pri 96,1 % ocenili kot izvrsten (popolno izginotje bolečine in prenehanje objektivnih znakov krvavitve po enkratni infuziji) ali dober (jasno olajšanje bolečine in/ali izboljšanje znakov krvavitve po enkratni infuziji).
English: Adjustments of doses and administration intervals may be considered based on achieved FVIII levels and individual bleeding tendency (see section 5.2).
Slovenian: Razmislite lahko o prilagajanju odmerkov in intervalov dajanja glede na dosežene ravni faktorja VIII in nagnjenost h krvavitvam posameznika (glejte poglavje 5.2).
English: Discard any unused solution appropriately.
Slovenian: Neporabljeno raztopino na primeren način zavrzite.
English: Do not use ADYNOVI if the solution is not fully clear or not completely dissolved.
Slovenian: Zdravila ADYNOVI ne uporabite, če raztopina ni popolnoma bistra ali zdravilo ni popolnoma raztopljeno.
English: The following Table 1 can be used to guide dosing in bleeding episodes and surgery:
Slovenian: Naslednjo preglednico 1 lahko uporabimo kot vodilo za odmerjanje pri krvavitvah in kirurških posegih:
English: The median dose per infusion to treat all bleeding episodes in the per-protocol population was 32.0 (Interquartile Range (IQR): 21.5) IU per kg.
Slovenian: Mediana odmerka na infuzijo za zdravljenje vseh krvavitev v populaciji po protokolu je bila 32,0 (interkvartilni razpon (IQR): 21,5) i.e. na kilogram.
English: Warnings and precautions Talk to your doctor before using ADYNOVI.
Slovenian: Opozorila in previdnostni ukrepi Pred začetkom uporabe zdravila ADYNOVI se posvetujte z zdravnikom.
English: Clean rubber stoppers with an alcohol wipe and allow to dry prior to use.
Slovenian: Gumijasta zamaška očistite z alkoholno krpico in počakajte, da se osušita.
English: No studies on genotoxicity, carcinogenicity or reproductive toxicity have been performed with ADYNOVI.
Slovenian: Študij genotoksičnosti, kancerogenega potenciala in škodljivih učinkov na sposobnost razmnoževanja z zdravilom ADYNOVI niso izvedli.
English: The safety of ADYNOVI was evaluated in 38 subjects < 6 years and 34 subjects 6 to < 12 years of age having accumulated a total of 2880 EDs and 2975 EDs respectively.
Slovenian: Varnost zdravila ADYNOVI so vrednotili pri 38 preiskovancih, mlajših od 6 let, in 34 preiskovancih, starih od 6 do < 12 let, pri katerih je bilo skupno število dni izpostavljenosti 2880 oziroma 2975.
English: A-1221 Vienna Austria
Slovenian: A-1221 Dunaj Avstrija
English: Do not remove the device from the package.
Slovenian: Pripomočka ne jemljite iz ovojnine.
English: If you inject more ADYNOVI than recommended, tell your doctor as soon as possible.
Slovenian: Če ste injicirali večji odmerek zdravila ADYNOVI, kot je priporočeno, se čim prej posvetujte z zdravnikom.
English: It is strongly recommended that every time ADYNOVI is administered, the name and batch number of the product are recorded.
Slovenian: Zelo priporočljivo je, da si ob vsaki uporabi zdravila ADYNOVI zabeležite ime in serijsko številko zdravila.
English: One hundred eighteen of 120 (98%) prophylaxis subjects remained on the starting recommended regimen without dose adjustment, and 2 subjects increased their dose to 60 IU/kg during prophylaxis due to bleeding in target joints.
Slovenian: Od 120 preiskovancev na profilaktičnem zdravljenju jih je 118 (98 %) ostalo na začetni priporočeni shemi odmerjanja brez prilagoditve odmerka, dva preiskovanca pa sta odmerek med profilaktičnim zdravljenjem povečala na 60 i.e./kg zaradi krvavitev v tarčne sklepe.
English: The potency (International Units) is determined using the chromogenic assay.
Slovenian: Jakost (mednarodne enote) se določa s kromogenim testom.
English: In case of the following haemorrhagic events, factor VIII activity should not fall below the given plasma activity level (in % of normal or IU/dl) in the corresponding period.
Slovenian: V primeru spodaj navedenih vrst krvavitev aktivnost faktorja VIII ne sme pasti pod navedeno raven aktivnosti v plazmi (v % normalne vrednosti ali i.e./dl) v določenem obdobju.
English: Of these, 361 bleeding episodes (n=17 subjects) occurred in the on-demand arm and 157 (n=61 subjects) occurred in the prophylaxis arm.
Slovenian: Med njimi je bilo 361 krvavitev (n = 17 preiskovancev) v skupini z zdravljenjem po potrebi, 157 (n = 61 preiskovancev) pa v skupini s profilaktičnim zdravljenjem.
English: Excipient(s) with known effect Each powder vial contains 0.45 mmol (10 mg) sodium, see section 4.4.
Slovenian: Pomožna(e) snov(i) z znanim učinkom: Ena viala s praškom vsebuje 0,45 mmol (10 mg) natrija, glejte poglavje 4.4.
English: Incremental recovery [(IU/dL)/(IU/kg)]
Slovenian: Prirastno zvečanje aktivnosti [(i.e./dl)/(i.e./kg)]
English: For major surgeries, the preoperative loading dose ranged from 36 IU/kg to 109 IU/kg (median: 63 IU/kg); and postoperative total dose ranged from 186 IU/kg to 1320 IU/kg (median: 490 IU/kg).
Slovenian: Pri večjih kirurških posegih je bil predoperativni začetni odmerek v razponu od 36 i.e./kg do 109 i.e./kg (mediana: 63 i.e./kg), pooperativni skupni odmerek pa v razponu od 186 i.e./kg do 1320 i.e./kg (mediana: 490 i.e./kg).
English: Use only the solvent and the reconstitution device for preparation of the solution that are provided with each package of ADYNOVI.
Slovenian: Za pripravo raztopine uporabljajte izključno vehikel in pripomoček za rekonstitucijo, priložen v vsakem pakiranju zdravila ADYNOVI.
English: When infused into a haemophilic patient, factor VIII binds to von Willebrand factor in the patient's circulation.
Slovenian: Ob infuziji bolniku s hemofilijo se faktor VIII veže na von Willebrandov faktor v bolnikovem krvnem obtoku.
English: The PEG moiety is conjugated to octocog alfa to increase the plasma half-life.
Slovenian: PEG-skupina je konjugirana na oktokog alfa, da poveča razpolovno dobo v plazmi.
English: Perioperative management (surgical prophylaxis)
Slovenian: Perioperativna uporaba (kirurška profilaksa)