natgillin/translations-raw huggingface dataset:
● The patient alert card shall contain the following key messages: Instructions for patients to carry the card at any time, including in conditions of emergency and to present the card at visits to doctors, hospital clinics, carers, laboratory professionals or pharmacists to inform on emicizumab treatment and risks; Information on serious, life-threatening thromboembolic events or thrombotic microangiopathy events that have been observed with the concomitant use of emicizumab with activated prothrombin complex concentrate (aPCC) in patients on emicizumab prophylaxis; 
Navodila za bolnike, da imajo kartico vedno pri sebi, tudi v nujnih stanjih, in jo pokažejo zdravniku, v bolnišnici, skrbniku, laboratorijskemu delavcu ali farmacevtu, da jih obvestijo o zdravljenju z emicizumabom in tveganjih;
Treated bleeds = bleeds treated with bypassing agents. 
Zdravljene krvavitve = krvavitve, zdravljene z obvodnimi zdravili.
Each vial of 1 mL contains 150 mg of emicizumab at a concentration of 150 mg/mL. 
Ena viala z 1 ml vsebuje 150 mg emicizumaba v koncentraciji 150 mg/ml.
Adults and Adolescents Health-Related outcome measures 
Ocenjevanje zdravstvenega izida pri odraslih in mladostnikih
● To calculate the volume to be administered divide calculated dose 360 mg by 150 mg/mL: 360 mg of emicizumab ÷ 150 mg/mL = 2.4 mL of 150 mg/mL Hemlibra concentration to be injected every four weeks. 
● Za izračun potrebnega volumna delite izračunani odmerek 360 mg s 150 mg/ml: 360 mg emicizumaba ÷ 150 mg/ml = 2,4 ml je volumen zdravila Hemlibra s koncentracijo 150 mg/ml, ki ga je treba injicirati na štiri tedne
● If you get any side effects, talk to your doctor, pharmacist or nurse. 
● Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The metabolism of emicizumab has not been studied. 
Presnova Presnove emicizumaba niso raziskali.
Each vial of 0.7 mL contains 105 mg of emicizumab at a concentration of 150 mg/mL. 
Ena viala z 0,7 ml vsebuje 105 mg emicizumaba v koncentraciji 150 mg/ml.
● Loading dose (first 4 weeks) example: 16 kg x 3 mg/kg = 48 mg of emicizumab needed for the loading dose. 
● Primer polnilnega odmerka (prve 4 tedne): 16 kg x 3 mg/kg = 48 mg emicizumaba, potrebnega za polnilni odmerek
In clinical trials, no cases of TMA or thrombotic events were observed with use of activated recombinant human FVII (rFVIIa) alone in patients receiving Hemlibra prophylaxis. 
Pri bolnikih, ki so prejemali profilakso z zdravilom Hemlibra in sočasno le aktivirani rekombinantni humani FVII (rFVIIa), v kliničnih preskušanjih niso opažali TMA ali trombotičnih dogodkov.
1 mL syringe 
0,1 ml.
Index Utility Score Adjusted mean 
Indeksna ocena koristnosti
The patient/carer educational material should contain: 
● Vodnik za bolnike/skrbnike mora vsebovati naslednja ključna sporočila:
● Remove the syringe from the vial adapter by twisting anticlockwise and gently pulling. 
● Odstranite brizgo z adapterja za vialo tako, da jo zasukate v smeri, nasprotni smeri urnega kazalca, in jo previdno potegnite.
● Remove the transfer needle from the syringe by twisting anticlockwise and gently pulling. 
● Odstranite iglo za prenos z brizge tako, da jo zasukate v smeri, nasprotni smeri urnega kazalca, in jo previdno potegnite.
Table 6 HAVEN 1: Annualized Bleed Rate with Hemlibra prophylaxis arm versus no prophylaxis arm in patients ≥ 12 years of age with factor VIII inhibitors 
Študija HAVEN 1: Na leto preračunani delež krvavitev v skupini, ki je prejemala profilakso z zdravilom Hemlibra, v primerjavi s skupino brez profilakse pri bolnikih, starih ≥ 12 let z inhibitorji faktorja VIII
NOT INCLUDED IN THE BOX: 
Škatla ne vsebuje:
● Maintenance dose (from week 5 on) example: 40 kg x 3 mg/kg = 120 mg of emicizumab needed for the maintenance dose. 
● Primer vzdrževalnega odmerka (od 5. tedna naprej): 40 kg x 3 mg/kg = 120 mg emicizumaba, potrebnega za vzdrževalni odmerek
Hemlibra was investigated in a single arm, multicenter, phase III clinical study in 41 adult and adolescent males (aged ≥ 12 years and > 40 kg) who have hemophilia A with FVIII inhibitors or severe hemophilia A without FVIII inhibitors who previously received either episodic (“on demand”) or prophylactic treatment with bypassing agents or FVIII. 
41 odraslih in mladostnikih moškega spola (starih ≥ 12 let in s telesno maso > 40 kg), ki so imeli hemofilijo A z inhibitorji FVIII ali hudo hemofilijo A brez inhibitorjev FVIII in so predhodno ali občasno ("po potrebi") ali profilaktično prejemali zdravljenje z obvodnimi zdravili ali FVIII.
Remove transfer needle 
Snemite iglo za prenos
● A 2 to 3 mL syringe should be used for an injection greater than 1 mL and up to 2 mL of Hemlibra solution. 
● Za injiciranje več kot 1 ml in do 2 ml raztopine zdravila Hemlibra je treba uporabiti 2- do 3-ml brizgo.
Endpoints aABR (95% CI) 
ABR (95-% IZ)
Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany 
D-79639 Grenzach-Wyhlen
● Slowly pull back the plunger to fill the syringe with more than the amount of medicine needed for your prescribed dose. 
● Počasi izvlečite bat, da boste brizgo napolnili s količino zdravila, večjo od potrebne za predpisani odmerek.
Common: may affect up to 1 in 10 people 
Pogosti: pojavijo se lahko pri do 1 od 10 bolnikov ● zvišana telesna temperatura
● Loading dose (first 4 weeks) example: 60 kg x 3 mg/kg = 180 mg of emicizumab needed for the loading dose. 
● Primer za polnilni odmerek (prve 4 tedne): 60 kg x 3 mg/kg = 180 mg emicizumaba, potrebnega za polnilni odmerek
● muscle aches 
● Gaze ● Kosma vate
(bilirubin ≤ ULN and AST > ULN or bilirubin from 1.0 to 1.5 × ULN and any AST, N = 51). 
Večina bolnikov s hemofilijo A v populacijski farmakokinetični analizi je imela normalno delovanje jeter (bilirubin in AST ≤ ZMN, n = 300) ali blago okvaro jeter (bilirubin ≤ ZMN in AST > ZMN ali bilirubin od 1,0 do 1,5 × ZMN in kakršen koli AST, n = 51).
Step C. Connect new vial adapter to syringe 
Korak C. Na brizgo namestite nov adapter za vialo
The solution should be discarded if particulate matter is visible or product is discoloured. 
Če so v raztopini vidni delci ali je spremenjene barve, jo je treba zavreči.
● Throw away any used caps, vial(s), vial adapters, needles and syringes in a sharps or puncture-proof container. 
● Vse uporabljene pokrovčke, viale, adapterje za viale, igle in injekcijske brizge zavrzite v vsebnik za ostre odpadke oziroma vsebnik, odporen proti prebadanju.
Table 4 HAVEN 3 study: Annualised Bleed Rate for Hemlibra prophylaxis arm versus no prophylaxis arm in patients ≥ 12 years of age without factor VIII inhibitors 
Študija HAVEN 3: Na leto preračunani delež krvavitev v skupini, ki je prejemala profilakso z zdravilom Hemlibra, v primerjavi s skupino brez profilakse pri bolnikih, starih ≥ 12 let z inhibitorji faktorja VIII
● Do not recap the injection needle with the cap. 
● Ne pokrivajte igle za injiciranje z njenim pokrovčkom.
● Throw away the cap into a sharps disposal container. 
● Pokrovček zavrzite v vsebnik za ostre odpadke.
Adjust plunger to prescribed dose 
Nastavite bat na predpisani odmerek
● The guide for patients/carers shall contain the following key messages: - What is emicizumab, how emicizumab has been tested, and how to use emicizumab; - Warning on the risks associated with the concomitant use of bypassing agents and Hemlibra and to discuss with their doctor if they are receiving activated prothrombin complex concentrate (aPCC) when being prescribed or while receiving Hemlibra; 
Opozorilo o tveganjih, povezanih s sočasno uporabo obvodnih zdravil in zdravila Hemlibra, in nujnost pogovora z zdravnikom, če prejemajo koncentrat aktiviranega protrombinskega kompleksa (aPCC), ko jim je predpisano zdravilo Hemlibra ali ko ga prejemajo,
● Push and twist a new transfer needle clockwise on to the syringe until it is fully attached. 
● Potisnite novo iglo za prenos na brizgo in iglo zasučite v smeri urnega kazalca, dokler ni povsem nameščena.
L-Arginine L-Histidine L-Aspartic acid Poloxamer 188 
L-asparaginska kislina poloksamer 188 voda za injekcije
Arm C: Hemlibra 1.5 mg/kg weekly 
Skupina C: zdravilo Hemlibra 1,5 mg/kg na teden n = 24
What Hemlibra is used for 
Za kaj uporabljamo zdravilo Hemlibra
Arm A: Hemlibra 1.5 mg/kg weekly (N = 36) 
Skupina A: 1,5 mg/kg zdravila Hemlibra na teden (n = 36)
● Push and twist the syringe clockwise on to the vial adapter until it is fully attached. 
● Potisnite brizgo na adapter za vialo in jo zasučite v smeri urnega kazalca, dokler ni povsem nameščena.
There are no data in children < 1 year of age. 
mlajše od 1 leta, ni podatkov.
Combining Vials 
Združevanje vial
Different Hemlibra concentrations (30 mg/mL and 150 mg/mL) should not be combined in a single injection when making up the total volume to be injected. 
Pri pripravi celotnega volumna, ki ga je treba injicirati, se v eni injekciji ne sme kombinirati različnih koncentracij (30 mg/ml in 150 mg/ml) zdravila Hemlibra.
- Immuno-based assays (e.g. ELISA, turbidimetric methods) - Genetic tests of coagulation factors (e.g. 
- Imunske metode (npr. ELISA, turbidimetrične metode) - Genetski testi koagulacijskih faktorjev (npr. faktor V Leiden, protrombin 20210) 1Za pomembne informacije glede kromogenih metod določanja aktivnosti FVIII glejte poglavje 4.4.
Physical health score (range 0 to 100)a Mean baseline score (95% CI) (n = 18) Mean change from baseline (95% CI) (n = 15) 
Srednja izhodiščna ocena (95-% IZ) (n = 18) Srednja sprememba od izhodišča (95-% IZ) (n = 15)
Table 7 HAVEN 1: Intra-patient comparison of Annualised Bleed Rate (treated bleeds) with Hemlibra prophylaxis versus previous bypassing agent prophylaxis (NIS patients) 
Študija HAVEN 1: Intraindividualna primerjava na leto preračunanega deleža krvavitev (zdravljene krvavitve) med profilakso z zdravilom Hemlibra v primerjavi s predhodno profilakso z obvodnim zdravilom (bolniki iz neintervencijske študije)
No dose adjustments are recommended in patients with mild , renal or hepatic impairment (see section 5.2). 
Za bolnike z blago okvaro ledvic ali jeter ni priporočenih prilagoditev odmerjanja (glejte poglavje
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 1 mL contains 30 mg of emicizumab at a concentration of 30 mg/mL. 
Ena viala z 1 ml vsebuje 30 mg emicizumaba v koncentraciji 30 mg/ml.
Treated Bleeds ABR (95% CI) % reduction (RR), p-value 
Zdravljene krvavitve ABR (95-% IZ) % zmanjšanje (RR), vrednost p
Table 8 HAVEN 4: Annualized Bleed Rate with Hemlibra prophylaxis in Patients ≥12 Years of Age with or without Factor VIII Inhibitors Hemlibra 6mg/kg Q4W 
Študija HAVEN 4: Na leto preračunani delež krvavitev med profilakso z zdravilom Hemlibra pri bolnikih, starih ≥ 12 let z inhibitorji faktorja VIII ali brez njih
NA 95% (0.05), <0.0001 95% (0.05), 
Srednja izhodiščna ocena (95-% IZ) (n = 54) Srednja izhodiščna vrednost (95-% IZ (95-% IZ)
● To calculate the volume to be administered divide calculated dose 48 mg by 150 mg/mL: 48 mg of emicizumab ÷ 150 mg/mL = 0.32 mL of 150 mg/mL Hemlibra concentration to be injected. 
● Za izračun potrebnega volumna delite izračunani odmerek 48 mg s 150 mg/ml: 48 mg emicizumaba ÷ 150 mg/ml = 0,32 ml je volumen zdravila Hemlibra s koncentracijo 150 mg/ml, ki ga je treba injicirati
NAME OF THE MEDICINAL PRODUCT Hemlibra 30 mg/mL solution for injection emicizumab 
Hemlibra 30 mg/ml raztopina za injiciranje emicizumab
● Keep the transfer needle in the vial and turn the vial upside down. 
● Medtem ko je igla za prenos v viali, obrnite vialo na glavo.
NAME OF THE MEDICINAL PRODUCT Hemlibra 150 mg/mL solution for injection emicizumab 
Hemlibra 150 mg/ml raztopina za injiciranje emicizumab
● If the amount of medicine in the syringe is now at or below your prescribed dose, move the tip of the needle to within the medicine and slowly pull back the plunger until you have more than the amount of medicine needed for your prescribed dose. 
● Če je v brizgi zdaj toliko ali manj zdravila, kot ga potrebujete za predpisani odmerek, pomaknite konico igle, da bo v zdravilu.
Different Hemlibra vial concentrations (30 mg/mL and 150 mg/mL) should not be combined in a single injection to administer the prescribed dose. 
Za pripravo predpisanega odmerka se v eni injekciji ne sme združevati vial zdravila Hemlibra z različno koncentracijo zdravila (30 mg/ml in 150 mg/ml).
● Loading dose (first 4 weeks) example: 40 kg x 3 mg/kg = 120 mg of emicizumab needed for the loading dose. 
● Primer polnilnega odmerka (prve 4 tedne): 40 kg x 3 mg/kg = 120 mg emicizumaba, potrebnega za polnilni odmerek
Table 12 HAVEN 2: Intra-patient comparison of Annualised Bleed Rate (treated bleeds) with Hemlibra prophylaxis versus previous bypassing agent prophylaxis 
Študija HAVEN 2: Intraindividualna primerjava na leto preračunanega deleža krvavitev (zdravljene krvavitve) med profilakso z zdravilom Hemlibra v primerjavi s predhodno profilakso z obvodnim zdravilom
● Do not touch the needle tip or place it on a surface after the needle cap has been removed. 
● Po odstranitvi pokrovčka igle se ne dotikajte konice igle in igle ne polagajte nikamor.
Arm A: Hemlibra 1.5 mg/kg weekly (N=29) 
Skupina A: 1,5 mg/kg zdravila Hemlibra na teden (n = 29)
● If you are not sure what to do, ask your doctor, pharmacist or nurse. 
● Če ste negotovi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The physician should immediately discontinue aPCC and interrupt Hemlibra therapy if clinical symptoms and/or laboratory findings consistent with TMA occur, and manage as clinically indicated. 
V primeru pojava kliničnih simptomov in/ali laboratorijski izvidov, skladnih s TMA, mora zdravnik nemudoma prenehati uporabljati aPCC, prekiniti zdravljenje z zdravilom Hemlibra in stanje obravnavati, kot je klinično ustrezno.
Arm A: Hemlibra 1.5 mg/kg weekly (N=25) 
Skupina A: 1,5 mg/kg zdravila Hemlibra na teden (n = 25)
Refer to the Hemlibra “Instructions for Use” for handling instructions when combining vials in a syringe. 
Za navodila za ravnanje v primeru uporabe vsebine več vial v eni brizgi glejte "Navodila za uporabo"
● Followed by a maintenance dose of either 1.5 mg/kg once weekly, 3 mg/kg every two weeks or 6 mg/kg every four weeks, from week 5 on: Patient bodyweight (kg) x dose (1.5; 3 or 6 mg/kg) = total amount (mg) of emicizumab to be administered 
● Sledi vzdrževalni odmerek bodisi 1,5 mg/kg enkrat na teden, 3 mg/kg enkrat na dva tedna ali 6 mg/kg enkrat na štiri tedne od 5. tedna naprej:
If you are not sure, talk to your doctor, pharmacist or nurse before using Hemlibra. 
Če ste negotovi, se pred začetkom uporabe zdravila Hemlibra posvetujte z zdravnikom,
Stop using Hemlibra and aPCC, and talk to a doctor immediately if you or your caregiver notices any symptoms of thrombotic microangiopathy. 
Če vi ali vaš skrbnik opazite kateri koli simptom trombotične mikroangiopatije, nemudoma prenehajte uporabljati zdravilo Hemlibra in aPCC in se nemudoma posvetujte z zdravnikom.
Other objectives of the study included evaluation of the randomized comparison of Arms A or B and Arm C for the efficacy of Hemlibra prophylaxis in reducing the number of all bleeds, spontaneous bleeds, joint bleeds, and target joint bleeds (see Table 4), as well as assessing patient treatment preference using a preference survey. 
Hemlibra, kar zadeva zmanjšanje števila vseh krvavitev, spontanih krvavitev, krvavitev v sklepe in krvavitev v tarčne sklepe (glejte preglednico 4), ter ocena bolnikove preference glede zdravljenja na podlagi ankete o preferenci.
● To calculate the volume to be administered divide calculated dose 180 mg by 150 mg/mL: 180 mg of emicizumab ÷ 150 mg/mL = 1.20 mL of 150 mg/mL Hemlibra concentration to be injected. 
● Za izračun potrebnega volumna delite izračunani odmerek 180 mg s 150 mg/ml: 180 mg emicizumaba ÷ 150 mg/ml = 1,20 ml je volumen zdravila Hemlibra s koncentracijo 150 mg/ml, ki ga je treba injicirati
● Keep the needle in the vial and turn the vial upside down. 
● Medtem ko je igla v viali, obrnite vialo na glavo.
The physician should immediately discontinue aPCC and interrupt Hemlibra therapy if clinical symptoms, imaging, and/or laboratory findings consistent with thrombotic events occur, and manage as clinically indicated. 
V primeru pojava kliničnih simptomov, slikovnih preiskav in/ali laboratorijskih izvidov, skladnih s trombotičnimi dogodki, mora zdravnik nemudoma prenehati uporabljati aPCC, prekiniti zdravljenje z zdravilom Hemlibra in stanje obravnavati, kot je klinično ustrezno.
● Push and twist the injection needle clockwise onto the syringe until it is fully attached. 
● Potisnite iglo za injiciranje na brizgo in jo zasučite v smeri urnega kazalca, dokler ni povsem nameščena.
The primary objective of the study was to evaluate, among patients previously treated with episodic (“on-demand”) bypassing agents, the treatment effect of weekly Hemlibra prophylaxis compared with no prophylaxis (Arm A vs. 
Primarni cilj študije je bil med bolniki, predhodno občasno (po potrebi) zdravljenimi z obvodnimi zdravili, oceniti učinek zdravljenja tedenske profilakse z zdravilom Hemlibra v primerjavi z obravnavo brez profilakse (skupina A v primerjavi s skupino B) na število krvavitev, ki so zahtevale zdravljenje s koagulacijskimi faktorji skozi čas (najmanj 24 tednov ali do datuma prenehanja) (glejte preglednico 6).
● To calculate the volume to be administered divide calculated dose 120 mg by 150 mg/mL: 120 mg of emicizumab ÷ 150 mg/mL = 0.8 mL of 150 mg/mL Hemlibra concentration to be injected every two weeks. 
● Za izračun potrebnega volumna delite izračunani odmerek 120 mg s 150 mg/ml: 120 mg emicizumaba ÷ 150 mg/ml = 0,8 ml je volumen zdravila Hemlibra s koncentracijo 150 mg/ml, ki ga je treba injicirati na dva tedna
● 18G Transfer Needle Note: If you need to use more than 1 vial to inject your prescribed dose, you must use a new transfer needle for each vial. 
● Alkoholnih lističev Opomba: Če morate za predpisani odmerek uporabiti več kot 1 vialo,
● Inspect the supplies for damage. 
● Preglejte material in se prepričajte, da ni poškodovan.
Information on assays and methods not affected by emicizumab that may be used to monitor coagulation parameters during treatment, with specific considerations for FVIII chromogenic activity assays; 
Informacije o testih in metodah, na katere emicizumab ne vpliva in se lahko uporabljajo za spremljanje koagulacijskih parametrov med zdravljenjem, s specifičnim upoštevanjem značilnosti kromogenih testov aktivnosti faktorja VIII; Navedba laboratorijskih testov, na katere emicizumab ne vpliva;
Each mL of solution contains 30 mg of emicizumab* Each vial of 1 mL contains 30 mg of emicizumab at a concentration of 30 mg/mL. 
Ena 1-ml viala vsebuje 30 mg emicizumaba v koncentraciji 30 mg/ml.
Treated bleeds ABR (95% CI) 
bMediani ABR (IQR) % z 0 krvavitvami (95-% IZ)
Hemlibra contains the active substance “emicizumab”. 
Zdravilo Hemlibra vsebuje učinkovino emicizumab.
Table 14 Mean (± SD) steady-state emicizumab concentrations 
Povprečna (± SD) koncentracija emicizumaba v stanju dinamičnega ravnovesja
● Peel off back to open the blister pack. 
● Da odprete pretisni omot, odstranite njegov hrbtni del.
Transfer Needle 
OVOJNINAH VIALA
● Keep this leaflet. 
● Navodilo shranite.
Storing Hemlibra vials, vial adapters, needles and syringes: ● Keep the vial in the original box to protect the medicine from light. 
Shranjevanje vial, adapterjev za viale, igel in brizg zdravila Hemlibra:
Vascular disorders 
varnostni ščitnik pokrovček
● Loading dose (3 mg/kg) once weekly for the first 4 weeks: Patient bodyweight (kg) x dose (3 mg/kg) = total amount (mg) of emicizumab to be administered 
Bolnikova telesna masa (kg) x odmerek (3 mg/kg) = celotna količina (mg) emicizumaba, ki jo je treba uporabiti
Treated bleeds ABR (95% CI) % reduction (RR), p-value 
Zdravljene krvavitve ABR (95-% IZ) % zmanjšanje (RR), vrednost p neaplikabilno
Arm A: 1.5 mg/kg Hemlibra weekly 
Skupina A: 1,5 mg/kg zdravila Hemlibra na teden n = 18
Keeping a record 
Vodenje evidence
● To calculate the volume to be administered divide calculated dose 120 mg by 150 mg/mL: 120 mg of emicizumab ÷ 150 mg/mL = 0.8 mL of 150 mg/mL Hemlibra concentration to be injected. 
● Za izračun potrebnega volumna delite izračunani odmerek 120 mg s 150 mg/ml: 120 mg emicizumaba ÷ 150 mg/ml = 0,8 ml je volumen zdravila Hemlibra s koncentracijo 150 mg/ml, ki ga je treba injicirati
Musculoskeletal and connective tissue disorders 
Bolezni mišično-skeletnega sistema in vezivnega tkiva artralgija zelo pogosti mialgija pogosti
● blood clot in a vein behind your eye (cavernous sinus thrombosis) 
● propadanje rdečih krvnih celic (trombotična mikroangiopatija) ● krvni strdek v veni za očesom (tromboza kavernoznega sinusa)
ABR= Annualised Bleed Rate; CI= confidence interval; RR= rate ratio; IQR=interquartile range, 25th percentile to 75 
ABR = na leto preračunani delež krvavitev (annualized bleed rate), IZ = interval zaupanja, RR = razmerje deležev (rate ratio), IQR = kvartilni razpon (interquartile range) (od 25. do 75. percentila)
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 0.4 mL contains 60 mg of emicizumab at a concentration of 150 mg/mL. 
Ena viala z 0,4 ml vsebuje 60 mg emicizumaba v koncentraciji 150 mg/ml.
● With the syringe pointing upwards, slowly pull back the plunger to fill the syringe with more than the amount of medicine needed for your prescribed dose. 
● Počasi izvlecite bat, da boste brizgo napolnili s količino zdravila, večjo od potrebne za predpisani odmerek.
Effects of emicizumab on coagulation tests 
Testi, na katere emicizumab vpliva
Reminder to report any adverse events associated with the use of emicizumab. 
Opomnik za poročanje o vseh neželenih dogodkih, povezanih z uporabo emicizumaba ● Opozorilna kartica za bolnika mora vsebovati naslednja ključna sporočila:
ABR (95% CI) % reduction (RR), p-value 
Mediani ABR (IQR) % zmanjšanja (RR), vrednost p
PREPARATION Step 1. 
Preglednica 1.
● Throw away any used caps, vial(s), needles and syringes in a sharps or puncture-proof container. 
● Vse uporabljene pokrovčke, viale, igle in injekcijske brizge zavrzite v vsebnik za ostre odpadke oziroma vsebnik, odporen proti prebadanju.
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/004 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1271/004
Each vial of Hemlibra contains 30 mg (1 mL at a concentration of 30 mg/mL) of emicizumab. 
Ena viala zdravila Hemlibra vsebuje 30 mg (1 ml s koncentracijo
● Push and twist the transfer needle clockwise on to the syringe until it is fully attached. 
● Potisnite iglo za prenos na brizgo in jo zasučite v smeri urnega kazalca, dokler ni povsem nameščena.
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/002 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1271/002
● Once removed from the refrigerator, the unopened vial can be kept at room temperature for up to 7 days After storage at room temperature unopened vials may be returned to the refrigerator. 
● Potem, ko vialo vzamete iz hladilnika, je lahko neodprta viala shranjena na sobni temperaturi do
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/001 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1271/001
How to store Hemlibra 
Shranjevanje zdravila Hemlibra
ABR=Annualized Bleed Rate, CI=confidence interval; IQR=interquartile range; 25th percentile to 75th percentile 
ABR = na leto preračunani delež krvavitev (annualized bleed rate), IZ = interval zaupanja, IQR = kvartilni razpon (od 25. do 75. percentila)
- Treating physicians must carefully weigh the risk of TMA and thromboembolism against the risk of bleeding when considering aPCC treatment. 
- Uporabi aPCC se je treba izogibati, razen če ni na voljo nobenih drugih možnosti zdravljenja/alternativ, in v primeru, da je aPCC edina možnost, upoštevati priporočila za odmerjanje aPCC; - Pri odločanju za zdravljenje z aPCC mora lečeči zdravnik skrbno pretehtati tveganje za TMA in trombembolijo v primerjavi s tveganjem za krvavitve.
Tabulated list of adverse drug reactions 
predhodna profilaksa z obvodnim zdravilom
MARKETING AUTHORISATION NUMBER(S) EU/1/18/1271/003 
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/18/1271/003