natgillin/translations-raw huggingface dataset:
● Check your dose, ensure the top rim of the plunger is in line with the mark on the syringe for your prescribed dose. 
● Preverite odmerek in poskrbite, da je zgornji rob bata uravnan s tisto oznako na brizgi, ki označuje vaš predpisani odmerek.
● To correctly insert the needle under the skin, pinch a fold of loose skin at the clean injection site with your free hand. 
● Da boste iglo pravilno zabodli pod kožo, s prosto roko na čistem mestu za injiciranje stisnite kožo v gubo.
Hemlibra has no influence on the ability to drive and use machines. 
4.7 Vpliv na sposobnost vožnje in upravljanja strojev Zdravilo Hemlibra ne vpliva na sposobnost vožnje in upravljanja strojev.
Warning that these tests should not be used to monitor for emicizumab activity, determine need for factor replacement dosing, or measure FVIII inhibitors; 
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;
● The guide for healthcare professionals shall contain the following key elements: Brief introduction to emicizumab (chemical class, mode of action, pharmacodynamics and indication) 
Kratko predstavitev emicizumaba (kemijski razred, mehanizem delovanja, farmakodinamika in indikacija);
Step B. Remove used vial adapter 
Korak B. Odstranite uporabljen adapter za vialo
Listing of laboratory tests unaffected by emicizumab; 
Navedba laboratorijskih testov, na katere emicizumab ne vpliva;
When people have this condition, the lining of the blood vessels can be damaged and blood clots may develop in small blood vessels. 
Pri bolnikih s to motnjo se lahko pojavi okvara notranje plasti žil in v malih žilah lahko nastanejo krvni strdki.
Includes data before up-titration only, for patients whose dose was up-titrated. 
Za bolnike, pri katerih je bil odmerek povečan, so vključeni le podatki pred povečanjem odmerka.
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; 
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;
Transfer medicine to syringe 
Prenos zdravila v brizgo
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). 
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).
● Hold the position of the syringe and let go of the pinched injection site. 
● Ohranite položaj brizge in izpustite gubo na mestu injiciranja.
Its structure is different from factor VIII, therefore Hemlibra is not affected by factor VIII inhibitors. 
Struktura zdravila Hemlibra je drugačna od strukture faktorja VIII, zato inhibitorji faktorja VIII na zdravilo Hemlibra ne vplivajo.
Instead, a chromogenic Bethesda assay utilising a bovine based factor VIII chromogenic test that is insensitive to emicizumab may be used. 
Namesto tega je mogoče uporabiti kromogeno metodo Bethesda z uporabo kromogenega testa faktorja VIII na podlagi goveje beljakovine, ki ni občutljiv za emicizumab.
Similar to FVIII prophylaxis, self administration at home was allowed for all subsequent emicizumab doses. 
Podobno kot pri profilaksi s FVIII je bilo dajanje zdravila doma dovoljeno za vse nadaljnje odmerke emicizumaba.
Intra-patient comparator data from the NIS. 
Intraindividualni primerjalni podatki iz neintervencijske študije.
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. 
Če je v perioperativnem obdobju potrebna uporaba obvodnih zdravil (npr. aPCC in rFVIIa), glejte smernice za uporabo obvodnih zdravil v poglavju 4.4.
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). 
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).
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). 
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).
The maintenance dose regimen should be selected based on physician and patient/caregiver dosing regimen preference to support adherence. 
Shemo vzdrževalnega odmerka je za doseganje čim boljše adherence treba izbrati na podlagi zdravnikove in bolnikove/skrbnikove preference.
● Sharps disposal container 
● Vsebnika za ostre odpadke
Where to inject Hemlibra 
Kam injicirati zdravilo Hemlibra
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). 
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).
The Haemo-QoL-SF is a valid and reliable measure of HRQoL. 
Vprašalnik Haemo-QoLSF je veljavno in zanesljivo merilo zdravstvene kakovosti življenja.
Do not use these instructions when using a transfer needle to withdraw Hemlibra from vial. 
Teh navodil ne uporabljajte, če za jemanje zdravila Hemlibra iz viale uporabljate iglo za prenos.
Serious side effects of using aPCC while receiving Hemlibra 
Resni neželeni učinki uporabe aPCC med zdravljenjem z zdravilom Hemlibra
● Important: Always keep the sharps disposal container out of reach of children. 
● Pomembno: Vsebnik za ostre odpadke vedno shranjujte nedosegljiv otrokom.
● Check the expiry date on the box, on the vial label and on the supplies listed below. 
● Preverite datum izteka roka uporabnosti na škatli, na nalepki viale in na spodaj naštetem materialu.
The study evaluated the pharmacokinetics, safety, and efficacy including the efficacy of weekly Hemlibra prophylaxis compared with previous episodic and prophylactic bypassing agent treatment in patients who had participated in the NIS prior to enrolment (intra-patient comparison). 
Študija je ocenila farmakokinetiko, varnost in učinkovitost, vključno z učinkovitostjo tedenske profilakse z zdravilom Hemlibra v primerjavi s predhodno občasno oziroma profilaktično uporabo obvodnih zdravil pri bolnikih, ki so pred vključitvijo v to študijo sodelovali v neintervencijski študiji
● Holding the syringe with one hand, press the safety shield down against a flat surface with a firm, quick motion until you hear a “click”. 
● Medtem ko držite brizgo z eno roko, s čvrstim, hitrim gibom pritisnite varnostni ščitnik navzdol ob ravno površino, dokler ne zaslišite "klik".
The bypassing agent dose required may therefore be lower than that used without Hemlibra prophylaxis. 
Zato je lahko potrebni odmerek obvodnega zdravila manjši kot brez profilakse z zdravilom Hemlibra.
Physical health score (range 0 to 100)a 
Ocena telesnega zdravja (razpon: 0 do 100)a
Due to the short half-life of FVIII, no carryover effect is assumed after it's discontinuation. 
Zaradi kratkega razpolovnega časa FVIII se po prenehanju zdravljenja z njim ne predvideva učinek prenosa.
● Take the vial out of the refrigerator 15 minutes before use and allow it to reach room temperature (below 30°C) before preparing an injection. 
● Vialo vzemite iz hladilnika 15 minut pred uporabo in pustite, da doseže sobno temperaturo (do 30 °C),
Pediatric Health-Related Outcomes Results 
Zdravstveni izidi pri pediatričnih bolnikih
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 
A. IZDELOVALEC BIOLOŠKE UČINKOVINE IN IZDELOVALEC, ODGOVOREN ZA SPROŠČANJE SERIJ
● The Summary of Product Characteristics 
● Povzetek glavnih značilnosti zdravila
Using syringes and needles 
Uporaba brizg in igel
Subcutaneous (under the skin) injection 
Subkutano (podkožno) injiciranje
● Guide for patients/carers 
● Vodnik za bolnike/skrbnike
Seven patients previously treated with episodic (“on-demand”) bypassing agents who had participated in the NIS prior to enrolment but were unable to enroll in HAVEN 1 prior to the closure of Arms A and B were enrolled in Arm D to receive Hemlibra prophylaxis. 
Sedem bolnikov, ki so predhodno občasno (“po potrebi”) prejemali obvodna zdravila in so pred vključitvijo sodelovali v neintervencijski študiji, a se niso mogli vključiti v študijo HAVEN 1 pred zaključkom skupin A in B, so vključili v skupino D in so prejemali profilakso z zdravilom Hemlibra.
● Once the injection needle cap has been removed, the medicine in the syringe must be injected under the skin within 5 minutes. 
● Po odstranitvi pokrovčka igle za injiciranje je treba zdravilo v injekcijski brizgi injicirati pod kožo v 5 minutah.
Do not use the transfer needle to inject the medicine. 
Igle za prenos ne uporabljajte za injiciranje zdravila.
Option (For transfer of HEMLIBRA from vial to syringe) 
Možnost uporabe (za prenos zdravila HEMLIBRA iz viale v brizgo)
● Do not touch the needle tip. 
● Ne dotikajte se konice igle.
If you need to use more than 1 vial to inject your prescribed dose, you must use a new vial adapter for each vial. 
Če za injiciranje predpisanega odmerka potrebujete več kot 1 vialo, morate za vsako vialo uporabiti nov adapter za vialo.
DISPOSAL Step 16. 
ODLAGANJE 16. korak.
● Loading dose regimen: Weeks 1 to 4: The dose is 3 milligrams for every 1 kilogram you weigh, injected once a week. 
● Režim polnilnega odmerka: Od 1. do 4. tedna: Odmerek je 3 miligrame na 1 kilogram telesne mase, injiciran enkrat na teden.
● Take the cap off the vial(s). 
● Snemite pokrovček vial(e).
Hemlibra solution for injection vials are for single-use only. 
Viale z raztopino zdravila Hemlibra za injiciranje so le za enkratno uporabo.
● Prepare and give the injection in clean and germ-free conditions using aseptic technique. 
● Injekcijo pripravite in zdravilo injicirajte v čistih pogojih brez klic ter uporabite aseptičen postopek.
Uncommon: may affect up to 1 in 100 people 
● driska Občasni: pojavijo se lahko pri do 1 od 100 bolnikov
No data are available with respect to potential side effects of emicizumab on embryo-foetal development. 
Podatkov o možnih neželenih učinkih emicizumaba na embrio-fetalni razvoj ni.
All bleeds: bleeds treated and not treated with FVIII or rFVIIa Patients exposed to emicizumab started with a loading dose of 3mg/kg/week for 4 weeks. 
Zdravljene krvavitve = krvavitve, zdravljene s FVIII ali rFVIIa Vse krvavitve: krvavitve, ki so bile in ki niso bile zdravljene s FVIII ali rFVIIa Bolniki, izpostavljeni emicizumabu, so zdravljenje začeli s polnilnim odmerkom 3 mg/kg/teden za 4 tedne.
Do not throw away any loose caps, vials, needles and syringes in your household waste. 
Pokrovčkov, vial, igel in brizg ne odvrzite med gospodinjske odpadke.
● After the injection needle cap has been removed, the medicine in the syringe must be injected within 5 minutes. 
● Po odstranitvi pokrovčka igle za injiciranje je treba zdravilo v injekcijski brizgi injicirati v 5 minutah.
Tell your doctor if you are using Hemlibra before you have laboratory tests to measure how well your blood is clotting. 
Laboratorijske preiskave Zdravnika morate obvestiti, da uporabljate zdravilo Hemlibra, preden opravite laboratorijske preiskave, ki merijo strjevanje krvi.
This belongs to a group of medicines called “monoclonal antibodies”. 
imenovanih "monoklonska protitelesa".
Caution should be used when treating patients who are at high risk for TMA (e.g. have a previous medical history or family history of TMA), or those who are receiving concomitant medications known to be a risk factor for the development of TMA (e.g. ciclosporin, quinine, tacrolimus). 
Pri zdravljenju bolnikov z visokim tveganjem za TMA (npr. s predhodno anamnezo ali družinsko anamnezo TMA) ali tistih, ki sočasno prejemajo zdravila, za katera je znano, da je njihovo jemanje dejavnik tveganja za razvoj TMA (npr. ciklosporin, kinin, takrolimus), je potrebna previdnost.
Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or the skin is broken. 
Ne injicirajte v znamenja, brazgotine, podplute predele ali predele, kjer je koža občutljiva, pordela, trda ali razpokana.
● Collect all supplies listed below to prepare and give your injection. 
● Za pripravo injekcije in injiciranje zdravila zberite ves spodaj našteti material.
Do not use the transfer needle to inject medicine as this may cause harm such as pain and bleeding. 
Igle za prenos ne uporabljajte za injiciranje zdravila, ker vam lahko to škoduje, na primer povzroči bolečine in krvavitev.
For injection, you can use your: 
Injicirate lahko v:
Hemlibra is provided in single-use vials as ready to use solution which does not need to be diluted. 
Kako uporabljati zdravilo Hemlibra Zdravilo Hemlibra je na voljo v vialah za enkratno uporabo kot že pripravljena raztopina, ki je ni treba razredčiti.
● Vial containing the medicine 
● Vialo z zdravilom
● Firmly press down the plastic blister pack with the vial adapter onto the new vial at an angle, until you hear a ‘click'. 
● Trdno pritisnite plastični pretisni omot z adapterjem za vialo na novo vialo pod kotom, dokler ne zaslišite "klik".
Guidance on the use of bypassing agents in patients receiving Hemlibra prophylaxis 
Smernice za uporabo obvodnih zdravil pri bolnikih, ki prejemajo profilakso z zdravilom Hemlibra
● When using Hemlibra, any other medicine injected under the skin should be given in a different area. 
● Ko uporabljate zdravilo Hemlibra, je treba vsa druga zdravila za podkožno injiciranje dati na drugem mestu.
Cavg, ss = average concentration at steady state; Cmax, ss = maximum plasma concentration at steady state; Ctrough, ss = trough concentration at steady state; QW = once weekly; Q2W = every two weeks; Q4W = every four weeks. 
Cavg, ss = povprečna koncentracija v stanju dinamičnega ravnovesja; Cmax, ss = največja koncentracija v plazmi v stanju dinamičnega ravnovesja; Ctrough, ss = najmanjša koncentracija v plazmi pred naslednjim odmerkom v stanju dinamičnega ravnovesja;
The efficacy of Hemlibra for routine prophylaxis in patients with hemophilia A with or without FVIII inhibitors was evaluated in four clinical studies (three adult and adolescent studies [HAVEN 3, HAVEN 1, and HAVEN 4] and a paediatric study [HAVEN 2]). 
Učinkovitost zdravila Hemlibra za rutinsko profilakso pri bolnikih s hemofilijo A z inhibitorji FVIII ali brez njih so ocenili v štirih kliničnih študijah (treh študijah pri odraslih in mladostnikih [HAVEN 3,
The primary objective of the study was to evaluate in patients previously treated with episodic FVIII the efficacy of prophylactic Hemlibra weekly (Arm A) or every two weeks (Arm B) compared to no prophylaxis (Arm C) based on the number of bleeds requiring treatment with coagulation factors (see Table 4). 
Primarni cilj študije je bil med bolniki, predhodno občasno zdravljenimi s FVIII, oceniti učinkovitost profilaktične uporabe zdravila Hemlibra vsak teden (skupina A) ali vsaka dva tedna (skupina B) v primerjavi z bolniki brez profilakse (skupina C) na podlagi števila krvavitev, ki so zahtevale zdravljenje s koagulacijskimi faktorji (glejte preglednico 4).
No dose adjustments are recommended in paediatric patients (see section 5.2). 
Pediatrični bolniki Za pediatrične bolnike ni priporočenih prilagoditev odmerjanja (glejte poglavje 5.2).
% Zero Bleeds (95% CI) bN = 59 
% brez krvavitev (95-% IZ) bn = 59
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders. 
4.2 Odmerjanje in način uporabe Zdravljenje je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem hemofilije in/ali drugih motenj strjevanja krvi.
● Physician educational material 
● Izobraževalno gradivo za zdravnike
● Blood clots (thromboembolism): swelling, warmth, pain or redness - these symptoms may be signs of a blood clot in a vein near the surface of the skin. 
Oteklost, toplota, bolečina ali rdečina - ti simptomi so lahko znaki krvnega strdka v veni blizu površine kože.
Relative bioavailability decreased with older age, but no clinically important differences were observed in the pharmacokinetics of emicizumab between subjects < 65 years and subjects ≥ 65 years. 
Relativna biološka uporabnost se je s starostjo zmanjšala, vendar med preiskovanci, starimi < 65 let, in preiskovanci, starimi ≥ 65 let, niso opazili klinično pomembnih razlik v farmakokinetiki emicizumaba.
What Hemlibra looks like and contents of the pack 
Izgled zdravila Hemlibra in vsebina pakiranja
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT 
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
Reversible hemorrhage, perivascular mononuclear cell infiltration, degeneration/necrosis of subcutis and swelling of endothelium in the subcutis was noted in animals after subcutaneous injection. 
Po subkutanem injiciranju so pri živalih opazili reverzibilno krvavitev, perivaskularno infiltracijo z mononuklearnimi celicami, degeneracijo/nekrozo podkožja in edem endotelija v podkožju.
It is a colourless to slightly yellow liquid. 
● Je brezbarvna do rumenkasta tekočina.
● destruction of red blood cells (thrombotic microangiopathy) 
● Propadanje rdečih krvnih celic (trombotična mikroangiopatija)
● The guide for laboratory professionals shall contain the following key messages: Chemical class, mode of action, pharmacodynamics and indication for emicizumab Information on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability and not accurately reflect the patient's underlying hemostatic status during emicizumab prophylaxis. 
Kemijski razred, mehanizem delovanja, farmakodinamika in indikacija emicizumaba; Informacije, da emicizumab moti nekatere laboratorijske koagulacijske teste, kar vpliva na njihovo zanesljivost, in med profilakso z emicizumabom natančno ne odražajo bolnikovega osnovnega hemostatičnega statusa.
Previous bypassing agent treatment* (N = 18) 
Predhodno zdravljenje z obvodnim zdravilom* (n = 18)
HRQoL for patients ages < 12 years was also evaluated at week 25 based on the Adapted InhibQoL with Aspects of Caregiver Burden questionnaire completed by caregivers (see Table 13). 
Zdravstveno kakovost življenja bolnikov, mlajših od 12 let, so v 25. tednu ocenili tudi s prilagojenim vprašalnikom InhibQoL, ki upošteva vidike bremena skrbnikov (Adapted InhibQoL with Aspects of Caregiver Burden); ta vprašalnik so izpolnili bolnikovi skrbniki.
No TMA or thrombotic events were associated with the remaining instances of aPCC treatment. 
Preostali primeri zdravljenja z aPCC niso bili povezani s TMA ali trombotičnimi dogodki.
In summary, intrinsic pathway clotting-based laboratory test results in patients treated with Hemlibra should not be used to monitor its activity, determine dosing for factor replacement or anti-coagulation, or measure factor VIII inhibitors titers. 
Če povzamemo, se pri bolnikih, zdravljenih z zdravilom Hemlibra, ne sme uporabljati rezultatov laboratorijskih testov intrinzične poti strjevanja za nadzor aktivnosti, določanje odmerkov za nadomeščanje faktorja ali antikoagulacijo ali za merjenje titrov inhibitorjev faktorja VIII.
Important: Always keep the sharps disposal container out of reach of children. 
Pomembno: Vsebnik za ostre odpadke vedno shranjujte nedosegljiv otrokom.
Patients exposed to emicizumab started with a loading dose of 3 mg/kg/week for 4 weeks. 
Bolniki, izpostavljeni emicizumabu, so zdravljenje začeli s polnilnim odmerkom 3 mg/kg/teden za 4 tedne.
LIST OF EXCIPIENTS Excipients: L-Arginine, L-Histidine, L-Aspartic acid, Poloxamer 188, water for injections. 
SEZNAM POMOŽNIH SNOVI Pomožne snovi: L-arginin, L-histidin, L-asparaginska kislina, poloksamer 188, voda za injekcije
Emicizumab restores the tenase cofactor activity of missing activated factor VIII (FVIIIa). 
Vpliv emicizumaba na koagulacijske teste Emicizumab obnovi aktivnost tenaznega kofaktorja manjkajočega aktiviranega faktorja VIII (FVIIIa).
The amount of Hemlibra solution given in each injection must not be more than 2 mL 
Količina raztopine zdravila Hemlibra, ki jo uporabite pri enem injiciranju, ne sme presegati 2 ml.
● Do not rub the injection site after injection. 
● Mesta injiciranja po injiciranju ne drgnite.
Patients (aged ≥ 12 years old and > 40 kg) with hemophilia A without FVIII inhibitors (Study BH30071 - HAVEN 3) 
Bolniki (stari ≥ 12 let s telesno maso > 40 kg) s hemofilijo A brez inhibitorjev FVIII (študija BH30071 - HAVEN 3)
Dose linearity 
Linearnost glede na odmerek
Do not insert injection needle into vial adapter. 
Igle za injiciranje ne vstavljajte v adapter za vialo.
Thromboembolism associated with Hemlibra and activated prothrombin complex concentrate 
Trombembolija, povezana z zdravilom Hemlibra in koncentratom aktiviranega protrombinskega kompleksa
Do not use the transfer needle to inject medicine as this may cause pain and bleeding 2. 
Igle za prenos ne uporabljajte za injiciranje zdravila, ker lahko to povzroči bolečino in krvavitev.
Throw away the syringe and needle. 
Zavrzite brizgo in iglo
Do not throw the cap away. 
Pokrovčka igle ne vrzite proč.
● Clean the chosen injection site area using an alcohol wipe. 
● Očistite izbrani predel za injiciranje z alkoholnim lističem.
● Move the safety shield away from the needle and towards the syringe barrel. 
● Pomaknite varnostni ščitnik z igle proti telesu brizge.
Note: You must use a new transfer needle each time you withdraw medicine from a new vial. 
Opomba: Vsakokrat, ko jemljete zdravilo iz nove viale, morate uporabiti novo iglo za prenos.
The total time the medicine is stored at room temperature should not be more than 7 days. 
Celotni čas, med katerim je zdravilo shranjeno na sobni temperaturi, skupaj ne sme preseči 7 dni.
The exposure (Cavg, ss) of multiple doses is comparable between 1.5 mg/kg every week, 3mg/kg every 2 weeks and 6mg/kg dose every 4 weeks. 
Izpostavljenost (Cavg, ss) večkratnim odmerkom je primerljiva med odmerki 1,5 mg/kg enkrat na teden, 3 mg/kg enkrat na 2 tedna in 6 mg/kg enkrat na 4 tedne.
There are limited data available on the use of Hemlibra in patients with moderate renal impairment (only 2 patients with CLcr of 30-59 mL/min) and no data in patients with severe renal impairment. 
Podatkov o uporabi zdravila Hemlibra pri bolnikih z zmerno okvaro ledvic je malo (le dva bolnika z očistkom kreatinina v območju od 30 do 59 ml/min), pri bolnikih s hudo okvaro ledvic pa jih ni. O vplivu zmerne in hude okvare ledvic na farmakokinetiko emicizumaba ne moremo sklepati.
● Laboratory professionals educational material 
● Izobraževalno gradivo za laboratorijske delavce
● Clean the top of the vial(s) stopper with an alcohol wipe. 
● Očistite zamašek vial(e) z alkoholnim lističem.