FrancophonIA/ELRC3.0 huggingface dataset:
English: 3 mL clear glass type I vial with butyl rubber stopper laminated with a fluoro-resin film and crimped with an aluminium cap fitted with a plastic flip-off disk.
Slovenian: 3-ml viala iz prozornega stekla tipa I z zamaškom iz butilne gume, laminiranim s fluoro-smolnim filmom, zaprtim z aluminijskim pokrovčkom z nameščeno plastično snemno ploščico.
English: This is because you may be at risk of developing side effects such as blood clots.
Slovenian: Obstaja namreč tveganje, da se vam pojavijo neželeni učinki, na primer krvni strdki.
English: Pierced vial and filled syringe
Slovenian: Prebodena viala in napolnjena brizga
English: Read the package leaflet before use Do not shake
Slovenian: Pred uporabo preberite priloženo navodilo Ne pretresajte
English: In the event of breakthrough bleeding, patients receiving emicizumab prophylaxis should be managed with available therapies.
Slovenian: V primeru prebojne krvavitve je treba bolnike, ki dobivajo profilaktično zdravljenje z emicizumabom,
English: Animal reproduction studies have not been conducted with Hemlibra.
Slovenian: Študij sposobnosti razmnoževanja na živalih z zdravilom Hemlibra niso izvedli.
English: Roche Austria GmbH Engelhorngasse 3 A-1211 Wien Austria
Slovenian: Roche Austria GmbH Engelhorngasse 3 A-1211 Wien Avstrija
English: ● Carefully pull the transfer needle cap straight off and away from your body.
Slovenian: ● Previdno potegnite pokrovček igle za prenos naravnost z nje in proč od vašega telesa.
English: One patient resumed Hemlibra following resolution of the thrombotic event without recurrence (see section 4.4).
Slovenian: Ko je trombotični dogodek izzvenel, je en bolnik nadaljeval zdravljenje z zdravilom Hemlibra brez ponovitve (glejte poglavje 4.4).
English: Do not remove the vial adapter from the clear plastic blister pack.
Slovenian: Adapterja za vialo ne jemljite iz prozornega plastičnega pretisnega omota.
English: No dose adjustments are recommended in patients ≥ 65 years of age (see sections 5.1 and 5.2).
Slovenian: Za bolnike, stare ≥ 65 let, ni priporočenih prilagoditev odmerjanja (glejte poglavji 5.1 in 5.2).
English: Despite limited experience with concomitant administration of anti-fibrinolytics with aPCC or rFVIIa in patients treated with Hemlibra, you should know that there may be a possibility of thrombotic events using anti-fibrinolytics administered intravenously in combination with aPCC or rFVIIa.
Slovenian: Kljub omejenim izkušnjam s sočasno uporabo antifibrinolitikov z aPCC ali rFVIIa pri bolnikih, zdravljenih z zdravilom Hemlibra, morate vedeti, da pri uporabi antifibrinolitikov, ki se dajejo intravensko, v kombinaciji z aPCC ali rFVIIa obstaja možnost trombotičnih dogodkov.
English: The educational programme is aimed at increasing communication and medical and patient education around the important identified risks of thromboembolic events and thrombotic microangiopathy associated with the concomitant use of emicizumab and activated prothrombin complex concentrate (aPCC), and the important potential risk of life-threatening bleeding due to misinterpretation of the standard coagulation tests (unreliable in patients treated with emicizumab) and provide information on how to manage them.
Slovenian: Izobraževalni program je namenjen krepitvi obveščanja ter izobraževanja zdravnikov in bolnikov v zvezi s pomembnimi ugotovljenimi tveganji za trombembolične dogodke in trombotično mikroangiopatijo, povezanimi s sočasno uporabo emicizumaba in koncentrata aktiviranega protrombinskega kompleksa (aPCC), ter pomembnim možnim tveganjem za življenje ogrožajoče krvavitve zaradi napačne razlage standardnih koagulacijskih testov (nezanesljivih pri bolnikih, ki se zdravijo z emicizumabom) in zagotavlja informacije o obvladovanju teh tveganj.
English: This medicine is not likely to affect your ability to drive or use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi to zdravilo vplivalo na vašo sposobnost upravljanja vozil in strojev.
English: Do not use this medicine if it is cloudy, discoloured, or contains visible particles.
Slovenian: Zdravila ne uporabite, če je raztopina motna, spremenjene barve ali vsebuje vidne delce.
English: Arm B: includes no prophylaxis period only.
Slovenian: Skupina B: vključuje le obdobje brez profilakse.
English: Step F. Transfer medicine to syringe
Slovenian: Korak F. Prenos zdravila v brizgo
English: Laboratory tests affected and unaffected by emicizumab are shown in Table 1 below.
Slovenian: Laboratorijski testi, na katere emicizumab vpliva oziroma ne vpliva, so prikazani v preglednici 1,
English: The NIS is an observational study with the main objective of capturing detailed clinical data on the bleeding episodes and haemophilia medication use of patients with haemophilia A outside of an interventional trial setting.
Slovenian: Neintervencijska študija je opazovalna študija, katere glavni cilj je zajeti podrobne klinične podatke o krvavitvah in uporabi zdravil za hemofilijo pri bolnikih s hemofilijo A zunaj okvirja intervencijskega preskušanja.
English: Most of the patients with hemophilia A in the population pharmacokinetic analysis had normal renal function (N = 332; creatinine clearance [CLcr] ≥ 90 mL/min) or mild renal impairment (N = 27; CLcr of 60-89 mL/min).
Slovenian: Večina bolnikov s hemofilijo A v populacijski farmakokinetični analizi je imela normalno delovanje ledvic (n = 332, očistek kreatinina ≥ 90 ml/min) ali blago okvaro ledvic (n = 27, očistek kreatinina 60-89 ml/min).
English: Sixty three patients previously treated with prophylactic FVIII were enrolled into Arm D to receiveHemlibra (1.5 mg/kg once weekly).
Slovenian: Triinšestdeset (63) bolnikov, predhodno zdravljenih s profilaktičnim FVIII, je bilo vključenih v skupino D in so prejemali zdravilo Hemlibra (1,5 mg/kg enkrat na teden).
English: The laboratory professional educational material should contain:
Slovenian: Izobraževalno gradivo za laboratorijske delavce mora vsebovati:
English: Median ABR (IQR)
Slovenian: Mediani ABR (IQR)
English: Mild hepatic impairment did not affect the pharmacokinetics of emicizumab (see section 4.2).
Slovenian: Blaga okvara jeter ni vplivala na farmakokinetiko emicizumaba (glejte poglavje 4.2).
English: Treatment with bypassing agents should be discontinued the day before starting Hemlibra therapy.
Slovenian: Zdravljenje z obvodnimi zdravili je treba prenehati na dan pred začetkom zdravljenja z zdravilom
English: Option (For transfer of medicine from vial to syringe)
Slovenian: Možnost uporabe (za prenos zdravila iz viale v brizgo)
English: Arm B: no prophylaxis
Slovenian: Skupina B: brez profilakse
English: ● Remove the larger air bubbles by gently tapping the syringe barrel with your fingers until the air bubbles rise to the top of the syringe.
Slovenian: ● Odstranite večje zračne mehurčke tako, da s prsti rahlo potrkate ob telo brizge, dokler se mehurčki ne dvignejo na njen vrh.
English: The Adapted InhibQoL is a valid and reliable measure of HRQoL.
Slovenian: Vprašalnik Adapted InhibQoL je veljavno in zanesljivo merilo zdravstvene kakovosti življenja.
English: Cover needle with safety shield
Slovenian: Pokrijte iglo z varnostnim ščitnikom
English: ● Select and clean your injection site with an alcohol wipe.
Slovenian: ● Izberite in očistite mesto injiciranja z alkoholnim lističem.
English: Bypassing agent dosing guidance should be followed for at least 6 months following discontinuation of Hemlibra prophylaxis (see section 5.2).
Slovenian: Smernice za odmerjanje obvodnega zdravila je treba upoštevati še vsaj 6 mesecev po prenehanju profilakse z zdravilom Hemlibra (glejte poglavje 5.2).
English: ● The other ingredients are L-arginine, L-histidine, L-aspartic acid, poloxamer 188 and water for injections.
Slovenian: ● Druge sestavine zdravila so L-arginin, L-histidin, L-asparaginska kislina, poloksamer 188 in voda za injekcije.
English: The paediatric population studied comprises a total of 107 patients, of which 5 (5 %) were infants and toddlers (1 month to less than 2 years of age), 55 (51 %) were children (from 2 to less than 12 years of age) and 47 (44 %) were adolescents (from 12 to less than 18 years old).
Slovenian: Pediatrična populacija Proučevana pediatrična populacija je obsegala skupno 107 bolnikov; 5 (5 %) od teh so bili dojenčki ali malčki (starost od 1 meseca do manj kot 2 leti), 55 (51 %) je bilo otrok (starost od 2 leti do manj kot 12 let) in 47 (44 %) je bilo mladostnikov (starost od 12 do manj kot 18 let).
English: Use of Hemlibra in patients aged 65 and over with haemophilia A is supported by adult and adolescent studies HAVEN 1, HAVEN 3, and HAVEN 4.
Slovenian: Uporabo zdravila Hemlibra pri bolnikih, starih 65 let ali več s hemofilijo A, podpirajo študije HAVEN 1, HAVEN 3 in HAVEN 4, izvedene pri odraslih in mladostnikih.
English: ● The recommended places to give an injection are: the front of the waist (lower abdomen), upper outer arms, or the front of the thighs.
Slovenian: ● Priporočena mesta za injiciranje so: sprednja stran pasu (spodnji del trebuha), zunanji zgornji del rok (nadlakti) ali sprednji del stegen.
English: Note: Used for withdrawing medicine from the vial to the syringe.
Slovenian: Opomba: Uporablja se za jemanje zdravila iz viale v injekcijsko brizgo.
English: Physicians should discuss with all patients and/or caregivers the exact dose and schedule of bypassing agents to use, if required while receiving Hemlibra prophylaxis.
Slovenian: Zdravniki se morajo z vsemi bolniki in/ali skrbniki pogovoriti o natančnem odmerku in časovnem razporedu uporabe obvodnih zdravil, če so ta potrebna med izvajanjem profilakse z zdravilom
English: ● Syringes, transfer needles, vial adapters and injection needles are not provided in this pack.
Slovenian: ● Injekcijske brizge, igle za prenos, adapterji za viale in igle za injiciranje niso priloženi v tem pakiranju.
English: ● Pinch the selected injection site and fully insert the needle at a 45° to 90° angle with a quick, firm action.
Slovenian: ● Stisnite izbrano mesto injiciranja v gubo in s hitrim, odločnim gibom do konca zabodite iglo pod kotom 45° do 90°.
English: Bleeds a Calculated with negative binomial regression (NBR) model b
Slovenian: Izračunan na podlagi modela z negativno binomsko regresijo (NBR)
English: Injection site reactions (ISRs) were reported very commonly (20 %) from clinical trials.
Slovenian: V kliničnih preskušanjih so zelo pogosto (20 %) poročali o reakcijah na mestu injiciranja.
English: ● Do not shake the vial.
Slovenian: ● Viale ne stresajte.
English: Experience with concomitant administration of anti-fibrinolytics with aPCC or rFVIIa in patients receiving Hemlibra prophylaxis is limited.
Slovenian: Izkušenj s sočasno uporabo antifibrinolitikov z aPCC ali rFVIIa pri bolnikih, ki prejemajo profilakso z zdravilom Hemlibra, je malo.
English: the medicine contains particles.
Slovenian: če zdravilo vsebuje delce.
English: All ISRs observed in the Hemlibra clinical trials were reported as being non-serious and mild to moderate in intensity, and 95 % resolved without treatment.
Slovenian: Reakcije na mestu injiciranja, opažene v kliničnih preskušanjih zdravila Hemlibra, niso bile resne in so bile blage do zmerne; 95 % jih je minilo brez zdravljenja.
English: Hemlibra is a solution for injection.
Slovenian: ● Zdravilo Hemlibra je raztopina za injiciranje.
English: ● Slowly inject all of the medicine by gently pushing the plunger all the way down.
Slovenian: ● Počasi injicirajte vse zdravilo, tako da bat previdno potisnete povsem do konca.
English: From a microbiological point of view, once transferred from the vial to the syringe, the medicinal product should be used immediately.
Slovenian: Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po prenosu iz viale v brizgo.
English: Vial adapters
Slovenian: Adapterji za viale
English: These two pharmacodynamic markers do not reflect the true haemostatic effect of emicizumab in vivo (aPTT is overly shortened and reported factor VIII activity may be overestimated) but provide a relative indication of the procoagulant effect of emicizumab.
Slovenian: Ta dva farmakodinamična označevalca ne odražata resničnega hemostatskega učinka emicizumaba in vivo (aPTČ je pretirano kratek in ugotovljena aktivnost faktorja VIII je lahko precenjena), vendar relativno prikažeta prokoagulacijski učinek emicizumaba.
English: ● Check the expiry date on the box and vial label.
Slovenian: ● Preverite datum izteka roka uporabnosti na škatli in nalepki viale.
English: Adverse reactions (preferred term, MedDRA)
Slovenian: (prednostni izraz, MedDRA)
English: Move the tip of the needle above the medicine and slowly push the plunger up to push the air bubbles out of the syringe.
Slovenian: Pomaknite konico igle nad zdravilo in počasi potisnite bat navzgor, da boste iz brizge iztisnili zračne mehurčke.
English: The safety and efficacy of emicizumab have not been specifically tested in patients with hepatic impairment.
Slovenian: Varnosti in učinkovitosti emicizumaba niso posebej testirali pri bolnikih z okvaro jeter.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use
Slovenian: POSTOPEK IN POT(I) UPORABE ZDRAVILA za subkutano uporabo
English: Previous FVIII Prophylaxis (N = 48)
Slovenian: predhodna profilaksa s FVIII (n = 48)
English: The safety and efficacy of emicizumab in patients receiving ongoing immune tolerance induction have not yet been established.
Slovenian: Varnost in učinkovitost emicizumaba nista ugotovljeni pri bolnikih, pri katerih poteka indukcija imunske tolerance.
English: In contrast, assays containing bovine coagulation factors are insensitive to emicizumab (no activity measured) and can be used to monitor endogenous or infused factor VIII activity, or to measure anti FVIII inhibitors.
Slovenian: Nasprotno testi z govejimi koagulacijskimi faktorji niso občutljivi na emicizumab (ni izmerjene aktivnosti) in jih je mogoče uporabljati za nadzor aktivnosti endogenega ali infundiranega faktorja VIII ali za merjenje inhibitorjev FVIII.
English: Forty-nine patients previously treated with prophylactic bypassing agents were enrolled in Arm C to receive Hemlibra prophylaxis.
Slovenian: Devetinštirideset bolnikov, ki so predhodno prejemali profilakso z obvodnimi zdravili, so vključili v skupino C, da so prejemali profilakso z zdravilom Hemlibra.
English: ● When used together with a vial adapter, a low dead space plunger syringe must be used.
Slovenian: ● Pri uporabi z adapterjem za vialo morate uporabiti brizgo z majhnim volumnom mrtvega prostora.
English: A total of 398 patients were tested for anti-emicizumab antibodies in the HAVEN 1-4 clinical trials.
Slovenian: V kliničnih preskušanjih HAVEN 1-4 so glede protiteles proti emicizumabu testirali 398 bolnikov.
English: Weekly Hemlibra prophylaxis showed a statistically significant and clinically meaningful improvement compared with no prophylaxis in the pre-specified endpoints of Haem-A-QoL Physical Health Scale score at the Week 25 assessment.
Slovenian: Tedenska profilaksa z zdravilom Hemlibra v primerjavi z obravnavo brez profilakse je pokazala statistično značilno in klinično pomembno izboljšanje, kar zadeva vnaprej določen opazovani dogodek , oceno telesnega zdravja na lestvici Haem-A-QoL v 25. tednu.
English: Assays containing human coagulation factors are responsive to emicizumab but may overestimate the clinical haemostatic potential of emicizumab.
Slovenian: Testi s človeškimi koagulacijskimi faktorji so odzivni na emicizumab, a lahko precenijo njegov klinični hemostatski potencial.
English: For Arms A and B dose up-titration to 3 mg/kg weekly was allowed after 24 weeks for patients who experienced two or more qualified bleeds (i.e., spontaneous and clinically significant bleeds occurring at steady state).
Slovenian: V skupinah A in B je bilo po 24 tednih dovoljeno povečanje odmerka na 3 mg/kg pri bolnikih, ki so imeli dve kvalificirani krvavitvi ali več (tj. spontani in klinično pomembni krvavitvi v stanju dinamičnega ravnovesja).
English: Emicizumab can be administered interchangeably at these anatomical sites (see section 4.2).
Slovenian: Emicizumab je mogoče na teh anatomskih mestih uporabljati enakovredno (glejte poglavje 4.2).
English: All Bleeds
Slovenian: Vse krvavitve
English: Women of childbearing potential receiving Hemlibra should use effective contraception during, and for at least 6 months after cessation of Hemlibra treatment (see section 5.2).
Slovenian: Ženske v rodni dobi/kontracepcija Ženske v rodni dobi, ki prejemajo zdravilo Hemlibra, morajo med zdravljenjem in vsaj še 6 mesecev po prenehanju zdravljenja s tem zdravilom uporabljati učinkovito kontracepcijo (glejte poglavje 5.2).
English: Emicizumab bridges activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective haemostasis.
Slovenian: Emicizumab poveže aktivirani faktor IX in faktor X in tako obnovi funkcijo manjkajočega aktiviranega faktorja VIII, ki je potrebna za učinkovito hemostazo.
English: ● Remove the syringe and transfer needle from the first vial.
Slovenian: ● Odstranite brizgo in iglo za prenos iz prve viale.
English: The safety and efficacy of emicizumab have not been formally evaluated in the surgical setting.
Slovenian: Varnosti in učinkovitosti emicizumaba niso formalno ocenili v okoliščinah kirurškega posega.
English: ● Check your dose, ensure the top rim of the plunger is in line with the mark on the syringe for your prescribed dose.
Slovenian: ● Preverite odmerek in poskrbite, da je zgornji rob bata uravnan s tisto oznako na brizgi, ki označuje vaš predpisani odmerek.
English: ● To correctly insert the needle under the skin, pinch a fold of loose skin at the clean injection site with your free hand.
Slovenian: ● Da boste iglo pravilno zabodli pod kožo, s prosto roko na čistem mestu za injiciranje stisnite kožo v gubo.
English: Hemlibra has no influence on the ability to drive and use machines.
Slovenian: 4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Hemlibra ne vpliva na sposobnost vožnje in upravljanja strojev.
English: Warning that these tests should not be used to monitor for emicizumab activity, determine need for factor replacement dosing, or measure FVIII inhibitors;
Slovenian: Opozorilo, da se teh testov ne sme uporabljati za spremljanje aktivnosti emicizumaba, določanje potrebe po odmerkih za nadomeščanje faktorja ali za merjenje inhibitorjev faktorja VIII;
English: ● The guide for healthcare professionals shall contain the following key elements: Brief introduction to emicizumab (chemical class, mode of action, pharmacodynamics and indication)
Slovenian: Kratko predstavitev emicizumaba (kemijski razred, mehanizem delovanja, farmakodinamika in indikacija);
English: Step B. Remove used vial adapter
Slovenian: Korak B. Odstranite uporabljen adapter za vialo
English: Listing of laboratory tests unaffected by emicizumab;
Slovenian: Navedba laboratorijskih testov, na katere emicizumab ne vpliva;
English: When people have this condition, the lining of the blood vessels can be damaged and blood clots may develop in small blood vessels.
Slovenian: Pri bolnikih s to motnjo se lahko pojavi okvara notranje plasti žil in v malih žilah lahko nastanejo krvni strdki.
English: Includes data before up-titration only, for patients whose dose was up-titrated.
Slovenian: Za bolnike, pri katerih je bil odmerek povečan, so vključeni le podatki pred povečanjem odmerka.
English: Reminder that all patients receiving treatment with emicizumab should be given a Patient Alert Card and reminded to carry it at all times and show it to any healthcare professionals who may treat them and to laboratory professionals that will perform their coagulation testing;
Slovenian: Opomnik, da morajo dati vsem bolnikom, ki jih zdravijo z emicizumabom, opozorilno kartico za bolnika in jim naročiti, da jo imajo vedno pri sebi in jo pokažejo vsem zdravstvnim delavcem, ki jih zdravijo, ali laboratorijskim delavcem, ki bodo izvajali koagulacijske teste;
English: Transfer medicine to syringe
Slovenian: Prenos zdravila v brizgo
English: Step 8.
Slovenian: 8. korak.
English: Other secondary objectives of the randomised comparison of Arms A and B were the efficacy of weekly Hemlibra prophylaxis in reducing the number of all bleeds, spontaneous bleeds, joint bleeds and target joint bleeds (see Table 6), as well as assessing patients' HRQoL and health status (see Tables 9 and 10).
Slovenian: Drugi sekundarni cilji randomizirane primerjave skupin A in B so bili učinkovitost tedenske profilakse z zdravilom Hemlibra na zmanjšanje števila vseh krvavitev, spontanih krvavitev, krvavitev v sklepe in krvavitev v tarčne sklepe (glejte preglednico 7) ter ocena bolnikove zdravstvene kakovosti življenja in zdravstvenega stanja (glejte preglednici 9 in 10).
English: ● Hold the position of the syringe and let go of the pinched injection site.
Slovenian: ● Ohranite položaj brizge in izpustite gubo na mestu injiciranja.
English: Its structure is different from factor VIII, therefore Hemlibra is not affected by factor VIII inhibitors.
Slovenian: Struktura zdravila Hemlibra je drugačna od strukture faktorja VIII, zato inhibitorji faktorja VIII na zdravilo Hemlibra ne vplivajo.
English: Instead, a chromogenic Bethesda assay utilising a bovine based factor VIII chromogenic test that is insensitive to emicizumab may be used.
Slovenian: Namesto tega je mogoče uporabiti kromogeno metodo Bethesda z uporabo kromogenega testa faktorja VIII na podlagi goveje beljakovine, ki ni občutljiv za emicizumab.
English: Similar to FVIII prophylaxis, self administration at home was allowed for all subsequent emicizumab doses.
Slovenian: Podobno kot pri profilaksi s FVIII je bilo dajanje zdravila doma dovoljeno za vse nadaljnje odmerke emicizumaba.
English: Intra-patient comparator data from the NIS.
Slovenian: Intraindividualni primerjalni podatki iz neintervencijske študije.
English: If bypassing agents (e.g. aPCC and rFVIIa) are required in the perioperative period, please refer to the dosing guidance on the use of bypassing agents in section 4.4.
Slovenian: Če je v perioperativnem obdobju potrebna uporaba obvodnih zdravil (npr. aPCC in rFVIIa), glejte smernice za uporabo obvodnih zdravil v poglavju 4.4.
English: The efficacy of Hemlibra prophylaxis was also compared with previous prophylactic FVIII treatment (Arm D) in patients who had participated in a non-interventional study (NIS) prior to enrollment (see Table 5).
Slovenian: Učinkovitost profilakse z zdravilom Hemlibra so primerjali tudi s predhodnim profilaktičnim zdravljenjem s FVIII (skupina D) pri bolnikih, ki so pred vključitvijo sodelovali v neintervencijski študiji (glejte preglednico 5).
English: The most serious adverse drug reactions (ADRs) reported from the clinical trials with Hemlibra were thrombotic microangiopathy (TMA) and thrombotic events, including cavernous sinus thrombosis (CST) and superficial vein thrombosis contemporaneous with skin necrosis (see below and section 4.4).
Slovenian: Najresnejši neželeni učinki, o katerih so poročali v kliničnih preskušanjih zdravila Hemlibra, so bili trombotična mikroangiopatija (TMA) in trombotični dogodki, vključno s trombozo kavernoznega sinusa in povrhnjo vensko trombozo s sočasno nekrozo kože (glejte spodaj in poglavje 4.4).
English: The maintenance dose regimen should be selected based on physician and patient/caregiver dosing regimen preference to support adherence.
Slovenian: Shemo vzdrževalnega odmerka je za doseganje čim boljše adherence treba izbrati na podlagi zdravnikove in bolnikove/skrbnikove preference.
English: ● Sharps disposal container
Slovenian: ● Vsebnika za ostre odpadke
English: Where to inject Hemlibra
Slovenian: Kam injicirati zdravilo Hemlibra
English: If aPCC is indicated in a patient receiving Hemlibra prophylaxis, the initial dose should not exceed 50 U/kg and laboratory monitoring is recommended (including but not restricted to renal monitoring, platelet testing, and evaluation of thrombosis).
Slovenian: Če je pri bolniku, ki prejema profilakso z zdravilom Hemlibra, indiciran aPCC, začetni odmerek ne sme presegati 50 e./kg; priporočeno je laboratorijsko spremljanje (to naj vključuje najmanj oceno ledvičnega delovanja, preiskave trombocitov in trombotičnih parametrov).