natgillin/translations-raw huggingface dataset:
Your doctor will consider the benefit of you taking Hemlibra against the risk to your baby. 
Zdravnik bo upošteval koristi uporabe zdravila Hemlibra v primerjavi s tveganjem za otroka.
● Be careful not to pull the plunger out of the syringe. 
● Pazite, da bata ne potegnete iz brizge.
The primary objective of the study was to evaluate the efficacy of Hemlibra prophylaxis given every four weeks in maintaining adequate bleed control, based on treated bleeds. 
Primarni cilj študije je bila ocena učinkovitosti profilakse z zdravilom Hemlibra, uporabljenim na štiri tedne, na vzdrževanje ustreznega nadzora krvavitev (na podlagi zdravljenih krvavitev).
If bleeding is not controlled with the initial dose of aPCC up to 50 U/kg, additional aPCC doses should be administered under medical guidance or supervision with consideration made to laboratory monitoring for the diagnosis of TMA or thromboembolism and verification of bleeds prior to repeated dosing. 
Če krvavitev ni obvladana z začetnim odmerkom aPCC do 50 e./kg, je treba dodatne odmerke aPCC uporabiti pod vodstvom ali nadzorom zdravnika; poskrbeti je treba za laboratorijsko spremljanje morebitne diagnoze TMA ali trombembolije in potrditev krvavitve pred ponovnim odmerjanjem.
In case of thrombotic complication, the physician should consider discontinuing rFVIIa or FVIII and interrupt Hemlibra prophylaxis as clinically indicated. 
V primeru trombotičnega zapleta mora zdravnik razmisliti o prenehanju uporabe rFVIIa ali FVIII in prekiniti profilakso z zdravilom Hemlibra, kot je klinično indicirano.
● Injection needle with safety shield (Used to inject medicine). 
● Igle za injiciranje z varnostnim ščitnikom (uporablja se za injiciranje zdravila).
Preparing the syringe for injection: 
Priprava brizge za injiciranje:
Prophylactic therapy with Hemlibra shortens the aPTT and increases the reported factor VIII activity (using a chromogenic assay with human coagulation factors). 
Profilaktično zdravljenje z zdravilom Hemlibra skrajša aPTČ in poveča aktivnost faktorja VIII (rezultat, dobljen z uporabo kromogenega testa s človeškimi koagulacijskimi faktorji).
Guidance on the use of bypassing agents concomitantly with emicizumab and on the dosing recommendations for patients requiring treatment with bypassing agents in the perioperative setting; 
Smernice o uporabi obvodnih zdravil sočasno z emicizumabom in priporočila za odmerjanje pri bolnikih, ki potrebujejo zdravljenje z obvodnimi zdravili v perioperativnem okolju;
Following subcutaneous administration in haemophilia A patients, the absorption half-life was 1.6 days. 
Po subkutani uporabi pri bolnikih s hemofilijo A je bil absorpcijski razpolovni čas 1,6 dneva.
As with all therapeutic proteins, there is the potential for an immune response in patients treated with emicizumab. 
Tako kot pri vseh terapevtskih beljakovinah obstaja pri bolnikih, zdravljenih z emicizumabom,
● or with severe haemophilia A who have not developed factor VIII inhibitors (the FVIII blood level is less than 1%). 
● hudo hemofilijo A, pri katerih se niso pojavili inhibitorji faktorja VIII (raven FVIII v krvi je nižja od 1 %).
In this Study baseline Total Scores (mean = 41.14 and 44.58, respectively) and Physical Health scale scores (mean = 52.41 and 57.19, respectively) were similar for Hemlibra prophylaxis and no prophylaxis. 
V tej študiji so bile izhodiščne vrednosti celotne ocene (povprečje = 41,14 oziroma 44,58) in ocene na lestvici telesnega zdravja (povprečje = 52,41 in 57,19) podobne med skupinama s profilakso z zdravilom Hemlibra oz. obravnavo brez profilakse.
There are limited data available on the use of Hemlibra in patients with moderate renal or hepatic impairment. 
Na voljo so omejeni podatki za uporabo zdravila Hemlibra pri bolnikih z zmerno okvaro ledvic ali jeter.
Examples of bypassing agents include activated prothrombin complex concentrate (aPCC) and recombinant FVIIa (rFVIIa). 
Primera obvodnih zdravil sta koncentrat aktiviranega protrombinskega kompleksa (aPCC - activated prothrombin complex concentrate) in rekombinantni FVIIa (rFVIIa).
Arm C: includes no prophylaxis period only. 
Skupina C: vključuje le obdobje brez profilakse.
● If you have bruising (small area of bleeding under the skin), an ice pack can also be pressed gently on the site. 
● Če se pojavi podplutba (majhna krvavitev pod kožo), lahko na mesto rahlo pritisnete leden vložek.
cMedian ABR (IQR) bN = 59 
cMediani ABR (IQR) bn = 59
Recommendation that the laboratory director contact the patient's treating physician to discuss any abnormal test results. 
Priporočilo, da se vodja laboratorija o kakršnih koli nenormalnih izvidih posvetuje z bolnikovim lečečim zdravnikom.
Stop using Hemlibra and aPCC and talk to a doctor immediately if you or your caregiver notices any of the following side effects: 
Nemudoma prenehajte uporabljati zdravilo Hemlibra in aPCC in se nemudoma posvetujte z zdravnikom, če vi ali vaš skrbnik opazite katerega od naslednjih neželenih učinkov:
Roche Austria GmbH Engelhorngasse 3 1211 Wien Austria 
Roche Austria GmbH Engelhorngasse 3 1211 Wien Avstrija
- the medicine contains particles. 
- če zdravilo vsebuje delce.
Following a single intravenous dose of 0.25 mg/kg emicizumab in healthy subjects, the volume of distribution at steady state was 106 mL/kg (i.e. 7.4 L for a 70-kg adult). 
Po enkratnem intravenskem odmerku 0,25 mg/kg emicizumaba pri zdravih preiskovancih je bil volumen porazdelitve v stanju dinamičnega ravnovesja 106 ml/kg (to pomeni 7,4 l za 70 kg težkega odraslega).
At the time of the primary analysis, five patients underwent up-titration of their maintenance dose. 
Ob času primarne analize je bilo povečanje vzdrževalnega odmerka zabeleženo pri petih bolnikih.
● Do not try to remove the used injection needle from the used syringe. 
● Ne poskušajte uporabljene igle za injiciranje sneti z uporabljene brizge.
The patient should not take two doses on the same day to make up for a missed dose. 
Bolnik ne sme uporabiti dveh odmerkov v istem dnevu, če je pozabil uporabiti prejšnji odmerek.
Physical health score (range 0 to 100) 
Ocena telesnega zdravja (razpon: 0 do 100)
If you use more Hemlibra than you should 
Če ste uporabili večji odmerek zdravila Hemlibra, kot bi smeli
The apparent volume of distribution (V/F), estimated from the population PK analysis, in haemophilia A patients following multiple subcutaneous doses of emicizumab was 10.4 L. Metabolism 
Navidezni volumen porazdelitve (V/F), ocenjen s populacijsko farmakokinetično analizo, je bil pri bolnikih s hemofilijo A po večkratnih subkutanih odmerkih emicizumaba 10,4 l.
Hemlibra restores the function of missing activated factor VIII that is needed for effective blood clotting. 
Zdravilo Hemlibra obnovi funkcijo manjkajočega aktiviranega faktorja VIII, ki je potreben za učinkovito strjevanje krvi.
No incompatibilities between Hemlibra and polypropylene or polycarbonate syringes , polycarbonate vial adapters and stainless steel needles have been observed. 
Med zdravilom Hemlibra ter polipropilenskimi ali polikarbonatnimi brizgami, polikarbonatnimi adapterji za viale in iglami iz nerjavnega jekla niso opažali inkompatibilnosti.
You may need to use more than 1 vial to give yourself the correct dose. 
Za ustrezen odmerek boste morda morali uporabiti več kot 1 vialo.
The following adverse drug reactions (ADRs) are based on pooled data from four phase III clinical trials (adult and adolescent studies [BH29884 - HAVEN 1, BH30071 - HAVEN 3, and BO39182HAVEN 4] and a paediatric study BH29992 - HAVEN 2]), in which a total of 373 male patients with haemophilia A received at least one dose of Hemlibra as routine prophylaxis. 
(študijah pri odraslih in mladostnikih [BH29884 - HAVEN 1, BH30071 - HAVEN 3 in BO39182HAVEN 4] in študiji pri pediatričnih bolnikih BH29992 - HAVEN 2]), v katerih je skupno 373 moških bolnikov s hemofilijo A prejelo vsaj en odmerek zdravila Hemlibra za redno profilakso.
It is important to know the symptoms of thrombotic microangiopathy, in case you develop the condition (see section 4, “Possible side effects” for a list of symptoms). 
Pomembno je, da poznate simptome trombotične mikroangiopatije za primer, da bi se vam ta pojavila (za seznam simptomov glejte poglavje 4, "Možni neželeni učinki").
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. 
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.
This is because you may be at risk of developing side effects such as blood clots. 
Obstaja namreč tveganje, da se vam pojavijo neželeni učinki, na primer krvni strdki.
Pierced vial and filled syringe 
Prebodena viala in napolnjena brizga
Read the package leaflet before use Do not shake 
Pred uporabo preberite priloženo navodilo Ne pretresajte
In the event of breakthrough bleeding, patients receiving emicizumab prophylaxis should be managed with available therapies. 
V primeru prebojne krvavitve je treba bolnike, ki dobivajo profilaktično zdravljenje z emicizumabom,
Animal reproduction studies have not been conducted with Hemlibra. 
Študij sposobnosti razmnoževanja na živalih z zdravilom Hemlibra niso izvedli.
Roche Austria GmbH Engelhorngasse 3 A-1211 Wien Austria 
Roche Austria GmbH Engelhorngasse 3 A-1211 Wien Avstrija
● Carefully pull the transfer needle cap straight off and away from your body. 
● Previdno potegnite pokrovček igle za prenos naravnost z nje in proč od vašega telesa.
One patient resumed Hemlibra following resolution of the thrombotic event without recurrence (see section 4.4). 
Ko je trombotični dogodek izzvenel, je en bolnik nadaljeval zdravljenje z zdravilom Hemlibra brez ponovitve (glejte poglavje 4.4).
Do not remove the vial adapter from the clear plastic blister pack. 
Adapterja za vialo ne jemljite iz prozornega plastičnega pretisnega omota.
No dose adjustments are recommended in patients ≥ 65 years of age (see sections 5.1 and 5.2). 
Za bolnike, stare ≥ 65 let, ni priporočenih prilagoditev odmerjanja (glejte poglavji 5.1 in 5.2).
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. 
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.
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. 
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.
This medicine is not likely to affect your ability to drive or use machines. 
Vpliv na sposobnost upravljanja vozil in strojev Ni verjetno, da bi to zdravilo vplivalo na vašo sposobnost upravljanja vozil in strojev.
Do not use this medicine if it is cloudy, discoloured, or contains visible particles. 
Zdravila ne uporabite, če je raztopina motna, spremenjene barve ali vsebuje vidne delce.
Arm B: includes no prophylaxis period only. 
Skupina B: vključuje le obdobje brez profilakse.
Step F. Transfer medicine to syringe 
Korak F. Prenos zdravila v brizgo
Laboratory tests affected and unaffected by emicizumab are shown in Table 1 below. 
Laboratorijski testi, na katere emicizumab vpliva oziroma ne vpliva, so prikazani v preglednici 1,
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. 
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.
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). 
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).
Sixty three patients previously treated with prophylactic FVIII were enrolled into Arm D to receiveHemlibra (1.5 mg/kg once weekly). 
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).
The laboratory professional educational material should contain: 
Izobraževalno gradivo za laboratorijske delavce mora vsebovati:
Median ABR (IQR) 
Mediani ABR (IQR)
Mild hepatic impairment did not affect the pharmacokinetics of emicizumab (see section 4.2). 
Blaga okvara jeter ni vplivala na farmakokinetiko emicizumaba (glejte poglavje 4.2).
Treatment with bypassing agents should be discontinued the day before starting Hemlibra therapy. 
Zdravljenje z obvodnimi zdravili je treba prenehati na dan pred začetkom zdravljenja z zdravilom
Option (For transfer of medicine from vial to syringe) 
Možnost uporabe (za prenos zdravila iz viale v brizgo)
Arm B: no prophylaxis 
Skupina B: brez profilakse
● 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. 
● Odstranite večje zračne mehurčke tako, da s prsti rahlo potrkate ob telo brizge, dokler se mehurčki ne dvignejo na njen vrh.
The Adapted InhibQoL is a valid and reliable measure of HRQoL. 
Vprašalnik Adapted InhibQoL je veljavno in zanesljivo merilo zdravstvene kakovosti življenja.
Cover needle with safety shield 
Pokrijte iglo z varnostnim ščitnikom
● Select and clean your injection site with an alcohol wipe. 
● Izberite in očistite mesto injiciranja z alkoholnim lističem.
Bypassing agent dosing guidance should be followed for at least 6 months following discontinuation of Hemlibra prophylaxis (see section 5.2). 
Smernice za odmerjanje obvodnega zdravila je treba upoštevati še vsaj 6 mesecev po prenehanju profilakse z zdravilom Hemlibra (glejte poglavje 5.2).
● The other ingredients are L-arginine, L-histidine, L-aspartic acid, poloxamer 188 and water for injections. 
● Druge sestavine zdravila so L-arginin, L-histidin, L-asparaginska kislina, poloksamer 188 in voda za injekcije.
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). 
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).
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. 
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.
● The recommended places to give an injection are: the front of the waist (lower abdomen), upper outer arms, or the front of the thighs. 
● Priporočena mesta za injiciranje so: sprednja stran pasu (spodnji del trebuha), zunanji zgornji del rok (nadlakti) ali sprednji del stegen.
Note: Used for withdrawing medicine from the vial to the syringe. 
Opomba: Uporablja se za jemanje zdravila iz viale v injekcijsko brizgo.
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. 
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
● Syringes, transfer needles, vial adapters and injection needles are not provided in this pack. 
● Injekcijske brizge, igle za prenos, adapterji za viale in igle za injiciranje niso priloženi v tem pakiranju.
● Pinch the selected injection site and fully insert the needle at a 45° to 90° angle with a quick, firm action. 
● Stisnite izbrano mesto injiciranja v gubo in s hitrim, odločnim gibom do konca zabodite iglo pod kotom 45° do 90°.
Bleeds a Calculated with negative binomial regression (NBR) model b 
Izračunan na podlagi modela z negativno binomsko regresijo (NBR)
Injection site reactions (ISRs) were reported very commonly (20 %) from clinical trials. 
V kliničnih preskušanjih so zelo pogosto (20 %) poročali o reakcijah na mestu injiciranja.
● Do not shake the vial. 
● Viale ne stresajte.
Experience with concomitant administration of anti-fibrinolytics with aPCC or rFVIIa in patients receiving Hemlibra prophylaxis is limited. 
Izkušenj s sočasno uporabo antifibrinolitikov z aPCC ali rFVIIa pri bolnikih, ki prejemajo profilakso z zdravilom Hemlibra, je malo.
the medicine contains particles. 
če zdravilo vsebuje delce.
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. 
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.
Hemlibra is a solution for injection. 
● Zdravilo Hemlibra je raztopina za injiciranje.
● Slowly inject all of the medicine by gently pushing the plunger all the way down. 
● Počasi injicirajte vse zdravilo, tako da bat previdno potisnete povsem do konca.
From a microbiological point of view, once transferred from the vial to the syringe, the medicinal product should be used immediately. 
Z mikrobiološkega stališča je treba zdravilo uporabiti takoj po prenosu iz viale v brizgo.
Vial adapters 
Adapterji za viale
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. 
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.
● Check the expiry date on the box and vial label. 
● Preverite datum izteka roka uporabnosti na škatli in nalepki viale.
Adverse reactions (preferred term, MedDRA) 
(prednostni izraz, MedDRA)
Move the tip of the needle above the medicine and slowly push the plunger up to push the air bubbles out of the syringe. 
Pomaknite konico igle nad zdravilo in počasi potisnite bat navzgor, da boste iz brizge iztisnili zračne mehurčke.
The safety and efficacy of emicizumab have not been specifically tested in patients with hepatic impairment. 
Varnosti in učinkovitosti emicizumaba niso posebej testirali pri bolnikih z okvaro jeter.
METHOD AND ROUTE(S) OF ADMINISTRATION For subcutaneous use 
POSTOPEK IN POT(I) UPORABE ZDRAVILA za subkutano uporabo
Previous FVIII Prophylaxis (N = 48) 
predhodna profilaksa s FVIII (n = 48)
The safety and efficacy of emicizumab in patients receiving ongoing immune tolerance induction have not yet been established. 
Varnost in učinkovitost emicizumaba nista ugotovljeni pri bolnikih, pri katerih poteka indukcija imunske tolerance.
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. 
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.
Forty-nine patients previously treated with prophylactic bypassing agents were enrolled in Arm C to receive Hemlibra prophylaxis. 
Devetinštirideset bolnikov, ki so predhodno prejemali profilakso z obvodnimi zdravili, so vključili v skupino C, da so prejemali profilakso z zdravilom Hemlibra.
● When used together with a vial adapter, a low dead space plunger syringe must be used. 
● Pri uporabi z adapterjem za vialo morate uporabiti brizgo z majhnim volumnom mrtvega prostora.
A total of 398 patients were tested for anti-emicizumab antibodies in the HAVEN 1-4 clinical trials. 
V kliničnih preskušanjih HAVEN 1-4 so glede protiteles proti emicizumabu testirali 398 bolnikov.
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. 
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.
Assays containing human coagulation factors are responsive to emicizumab but may overestimate the clinical haemostatic potential of emicizumab. 
Testi s človeškimi koagulacijskimi faktorji so odzivni na emicizumab, a lahko precenijo njegov klinični hemostatski potencial.
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). 
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).
Emicizumab can be administered interchangeably at these anatomical sites (see section 4.2). 
Emicizumab je mogoče na teh anatomskih mestih uporabljati enakovredno (glejte poglavje 4.2).
All Bleeds 
Vse krvavitve
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). 
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).
Emicizumab bridges activated factor IX and factor X to restore the function of missing activated factor VIII that is needed for effective haemostasis. 
Emicizumab poveže aktivirani faktor IX in faktor X in tako obnovi funkcijo manjkajočega aktiviranega faktorja VIII, ki je potrebna za učinkovito hemostazo.
● Remove the syringe and transfer needle from the first vial. 
● Odstranite brizgo in iglo za prenos iz prve viale.
The safety and efficacy of emicizumab have not been formally evaluated in the surgical setting. 
Varnosti in učinkovitosti emicizumaba niso formalno ocenili v okoliščinah kirurškega posega.