natgillin/translations-raw huggingface dataset:
This rapid improvement is distinct from the usual clinical course observed in atypical hemolytic uremic syndrome and classic TMAs, such as thrombotic thrombocytopenic purpura (see section 4.8). 
To hitro izboljšanje se razlikuje od običajnega kliničnega poteka pri atipičnem hemolitičnouremičnem sindromu in klasičnih TMA, kot je trombotična trombocitopenična purpura (glejte poglavje 4.8).
The MAH shall ensure that in each Member State where Hemlibra is marketed, all healthcare professionals, patients/carers who are expected to prescribe, dispense or use Hemlibra, and laboratory professionals, have access to/are provided with the following educational package: 
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da bodo v vseh državah članicah, v katerih je zdravilo Hemlibra na trgu, vsi zdravstveni delavci in bolniki/skrbniki, za katere se pričakuje, da bodo predpisovali, izdajali ali uporabljali zdravilo Hemlibra, ter laboratorijski delavci, imeli dostop oziroma prejeli naslednji paket izobraževalnih gradiv:
How much Hemlibra to use 
Koliko zdravila Hemlibra je treba uporabiti
Clinical studies in adults and adolescents 
Klinične študije pri odraslih in mladostnikih
Before you start using Hemlibra, it is very important to talk to your doctor about using “bypassing agents” (medicines that help blood clot but which work in a different way from factor VIII). 
Zelo pomembno je, da se pred začetkom uporabe zdravila Hemlibra z zdravnikom posvetujete o uporabi "obvodnih zdravil" (zdravil, ki pomagajo krvi, da se strjuje, vendar delujejo drugače kot faktor VIII).
Use only recommended places for injection. 
Za injiciranje uporabite le priporočena mesta.
It is not known whether emicizumab is excreted in human milk. 
Ni znano, ali se emicizumab izloča v materinem mleku.
If you need to use more than 1 vial to get to your prescribed dose, follow these steps after you have drawn up the medicine from the first vial: 
Če za svoj predpisani odmerek potrebujete več kot 1 vialo, sledite spodaj opisanim korakom, potem ko ste že potegnili zdravilo iz prve viale:
What Hemlibra is and what it is used for What you need to know before you use Hemlibra How to use Hemlibra 
Kaj je zdravilo Hemlibra in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Hemlibra Kako uporabljati zdravilo Hemlibra
Please see section 4.2 and package leaflet (section 7 Instructions for Use), for additional information on administration. 
Za dodatne informacije o uporabi zdravila glejte poglavje 4.2 in navodilo za uporabo (poglavje 7, Navodila za uporabo).
● Slide the tip of the needle down so that it is within the medicine. 
● Potegnite konico igle navzdol, tako da je v zdravilu.
Coagulation laboratory tests based on intrinsic clotting, including the activated clotting time (ACT), activated partial thromboplastin time (e.g. aPTT), measure the total clotting time including time needed for activation of FVIII to FVIIIa by thrombin. 
Laboratorijski testi koagulacije, ki temeljijo na intrinzičnem času strjevanja, vključno z aktiviranim časom strjevanja krvi (ACT - activated clotting time) in aktiviranim parcialnim tromboplastinskim časom (npr. aPTČ), merijo celotni čas strjevanja, vključno s časom, potrebnim za aktivacijo FVIII v FVIIIa s trombinom.
Dosage adjustments during treatment 
Prilagoditve odmerjanja med zdravljenjem
If bleeding does not stop, please contact your healthcare provider. 
Če se krvavitev ne ustavi, se posvetujte z zdravnikom.
Following multiple subcutaneous injections in haemophilia A patients, the apparent clearance was 0.272 L/day and the elimination apparent half-life was 26.8 days. 
Po večkratnih subkutanih injekcijah pri bolnikih s hemofilijo A je bil navidezni očistek 0,272 l/dan in navidezni razpolovni čas izločanja 26,8 dneva.
specifically, interruption of emicizumab may not have an immediate effect. 
Učinek prekinitve zdravljenja z emicizumabom morda ne bo takojšen.
Haemo-QoL-SF 
Vprašalnik Haemo-QoL-SF
Ctrough, ss (µg/mL) Cmax/Ctrough ratio 
Ctrough, ss (µg/ml) Cmax/Ctrough razmerje
b Efficacy data from treated patients aged < 12 years who had been on study HAVEN 2 for at least 12 weeks (N = 59), as the study aimed to primarily investigate treatment effect based on age. 
Podatki o učinkovitosti pri zdravljenih bolnikih, starih < 12 let, ki so bili vključeni v študijo HAVEN 2 najmanj 12 tednov (n = 59), kjer je bil namen študije predvsem preiskovanje učinka zdravljenja glede na starost.
Such intrinsic pathway based tests will yield overly shortened clotting times with emicizumab, which does not require activation by thrombin. 
Takšni testi, ki temeljijo na intrinzični poti, pokažejo pretirano kratke čase strjevanja med uporabo emicizumaba, ki ne zahteva aktivacije s trombinom.
However, self-administration is not recommended for children below 7 years of age. 
Samoinjiciranje ni priporočljivo pri otrocih, mlajših od 7 let.
No dosage adjustments of Hemlibra are recommended. 
Za odmerjanje zdravila Hemlibra ni priporočenih prilagoditev.
*Vascular disorders is a secondary SOC for cavernous sinus thrombosis. 
*Žilne bolezni so sekundarni organski sistem za trombozo kavernoznega sinusa.
Hemlibra is a medicine used for treating patients of all ages with 
Zdravilo Hemlibra se uporablja za zdravljenje bolnikov vseh starosti s:
Remove air bubbles 
Odstranite zračne mehurčke
Patients presented with thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury, without severe deficiencies in ADAMTS13 activity. 
Pri bolnikih so se pojavile trombocitopenija, mikroangiopatska hemolitična anemija in akutna okvara ledvic, brez hudega pomanjkanja aktivnosti ADAMTS13.
Once completed, keep the transfer needle inserted in the vial and return to Step 6. 
Ko to dokončate, pustite iglo za prenos zabodeno v viali in se vrnite na 6. korak.
Throw away any unused solution appropriately. 
Morebitno neporabljeno raztopino ustrezno zavrzite.
Step E. Inject air into vial 
Korak E. Injicirajte zrak v vialo
The patient should then administer the next dose on the usual scheduled dosing day. 
Bolnik mora nato uporabiti naslednji odmerek na običajni dan uporabe zdravila po urniku.
If a patient misses a scheduled subcutaneous injection of Hemlibra, the patient should be instructed to take the missed dose as soon as possible, up to a day before the day of the next scheduled dose. 
Če bolnik izpusti načrtovano subkutano injekcijo zdravila Hemlibra, mu je treba naročiti, naj izpuščeni odmerek uporabi čim prej, in sicer do en dan pred dnem, ko ima načrtovan naslednji odmerek.
The corresponding frequency categories for each ADR are based on the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from the available data). 
občasni (≥ 1/1.000 do < 1/100), redki (³ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) in neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
If you use more Hemlibra than you are supposed to, tell your doctor immediately. 
Če ste uporabili več zdravila Hemlibra, kot bi smeli, morate takoj obvestiti zdravnika.
Then, continue to inject the medicine as scheduled. 
Potem nadaljujte injiciranje zdravila po običajnem urniku.
● Your doctor will show you which areas of the body are suitable for injecting Hemlibra. 
● Zdravnik vam bo pokazal, kateri deli telesa so primerni za injiciranje zdravila Hemlibra.
After proper training in subcutaneous injection technique, a patient may self-inject Hemlibra, or the patient's caregiver may administer it, if their physician determines that it is appropriate. 
Po ustreznem usposabljanju za subkutano injiciranje si lahko zdravilo Hemlibra injicira bolnik sam ali mu ga injicira skrbnik, če zdravnik presodi, da je to ustrezno.
All patients were treated by hemophilia experts who confirmed that adequate FVIII propylaxis was administered to patients included in the intra-patient comparison, supporting equivalent usual prophylaxis care across sites and patients. 
Vse bolnike so zdravili strokovnjaki za hemofilijo, ki so potrdili, da so bolniki, vključeni v intraindividualno primerjavo, prejemali zadostno profilakso s FVIII, je zagotavljalo enako običajno profilaktično oskrbo med študijskimi centri in bolniki.
For further information refer to the section “Disposing of the medicine and supplies”. 
Za dodatne informacije glejte poglavje "Kako zavreči zdravilo in material".
Hemlibra increases the ability of your blood to clot. 
Zdravilo Hemlibra poveča zmožnost krvi za strjevanje.
● Keep your fingers behind the safety shield and away from the needle at all times. 
● Prste ves čas držite za varnostnim ščitnikom in proč od igle.
Store the vial in the refrigerator. 
Viale shranjujte v hladilniku.
% reduction (RR) 
% zmanjšanja RR
Population pharmacokinetics analyses in patients with haemophilia A showed that race did not affect the pharmacokinetics of emicizumab. 
Populacijske farmakokinetične analize pri bolnikih s hemofilijo A so pokazale, da rasa ni vplivala na farmakokinetiko emicizumaba.
● Syringe with Low Dead Space (LDS) Plunger Important: 
● Brizge z majhnim volumnom mrtvega prostora Pomembno:
The injection should be restricted to the recommended injection sites: the abdomen, the upper outer arms and the thighs (see section 5.2). 
Injiciranje mora biti omejeno na priporočena mesta za injiciranje: trebuh, zunanji del nadlahti in stegna (glejte poglavje 5.2).
The effect of age on the pharmacokinetics of emicizumab was assessed in a population pharmacokinetic analysis which included thirteen subjects aged 65 years and older (no subjects were older than 77 years of age). 
Vpliv starosti na farmakokinetiko emicizumaba so ocenili v populacijski farmakokinetični analizi, ki je zajela trinajst preiskovancev, starih 65 let ali več (noben preiskovanec ni bil starejši od 77 let).
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription. 
B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom.
Do not inject two doses on the same day to make up for a forgotten dose. 
Ne injicirajte si dveh odmerkov na isti dan, če ste pozabili uporabiti prejšnji odmerek.
After you inject your dose, throw away any unused Hemlibra left in the vial. 
Potem, ko ste odmerek injicirali, morebitni neporabljeni preostanek zdravila Hemlibra v viali zavrzite.
Hemlibra is intended for use under the guidance of a healthcare professional. 
Zdravilo Hemlibra je namenjeno za uporabo pod nadzorom zdravstvenega delavca.
Two hundred and sixtysix (71 %) were adults, 47(13 %) were adolescents (≥ 12 to < 18 years), 55 (15 %) were children (≥ 2 to < 12 years) and five (1 %) were infants and toddlers (1 month to < 2 years). 
Dvesto šestinšestdeset bolnikov (71 %) je bilo odraslih, 47 (13 %) mladostnikov (≥ 12 do < 18 let), 55 (15 %) otrok (≥ 2 do < 12 let) in pet (1 %) dojenčkov in malčkov (1 mesec do < 2 leti).
Treatment for the TMA events included supportive care with or without plasmapheresis and haemodialysis. 
Zdravljenje TMA je obsegalo podporno oskrbo s plazmaferezo in hemodializo ali brez njiju.
- properly labelled to warn of hazardous waste inside the container. 
- biti ustrezno označen z opozorilom, da vsebuje nevarne odpadke.
The overly shortened intrinsic clotting time will then disturb all single factor assays based on aPTT, such as the one stage FVIII activity assay (see section 4.4, Table 1). 
Pretirano kratki časi intrinzičnega časa strjevanja nato zmotijo vse teste posameznih faktorjev na podlagi aPTČ, na primer enostopenjski test aktivnosti FVIII (glejte poglavje 4.4, preglednica 1).
Following single subcutaneous injection in healthy subjects, the elimination half-life was approximately 4 to 5 weeks. 
Po enkratni subkutani injekciji pri zdravih osebah je bil razpolovni čas izločanja približno 4 do
Adapted InhibQoL with aspects of caregiver burden 
Prilagojen vprašalnik InhibQoL, ki upošteva vidike bremena skrbnikov
Further management should be tailored to the individual clinical circumstances. 
Nadaljnje zdravljenje je treba prilagoditi kliničnimu poteku pri posameznem bolniku.
Emicizumab remains active in the presence of inhibitors against factor VIII and so will produce a false negative result in clotting based Bethesda assays for functional inhibition of factor VIII. 
Emicizumab ostane aktiven v prisotnosti inhibitorjev faktorja VIII in tako povzroči lažno negativen rezultat v testih strjevanja na podlagi metode Bethesda za funkcijsko zavrtje faktorja VIII.
Treated spontaneous bleeds 
Zdravljene spontane krvavitve
Bleed definitions adapted based on ISTH criteria. 
Definicije krvavitev so prirejene na podlagi meril ISTH.
The most common ADRs reported in ≥ 10% of patients treated with at least one dose of Hemlibra were: injection site reactions (20 %), arthralgia (15 %) and headache (14 %). 
Najpogostejši neželeni učinki, zabeleženi pri ≥ 10 % bolnikov, ki so prejeli vsaj en odmerek zdravila Hemlibra, so bili: reakcije na mestu injiciranja (20 %), artralgija (15 %) in glavobol (14 %).
The dose of Hemlibra depends on your weight and your doctor will calculate the amount (in mg) and corresponding amount of Hemlibra solution (in mL) to be injected: 
Odmerek zdravila Hemlibra je odvisen od vaše telesne mase; zdravnik bo izračunal količino (v mg) in ustrezni volumen zdravila Hemlibra (v ml) za injiciranje takole:
● Do not try to warm the vial by any other way. 
● Vial ne poskušajte segrevati kako drugače.
Forty one patients ≥ 12 years old were evaluated for efficacy with a median observation time of 25.6 weeks (range 24.1-29.4). 
Enainštirideset (41) bolnikov, starih ≥ 12 let, so ocenili glede učinkovitosti v času opazovanja, ki je mediano trajal 25,6 tedna (razpon: od 24,1 do 29,4).
There are no clinical studies of emicizumab use in pregnant women. 
Kliničnih študij o uporabi emicizumaba pri nosečnicah ni.
Treatment (including routine prophylaxis) with bypassing agents (e.g. aPCC and rFVIIa) should be discontinued the day before starting Hemlibra therapy (see section 4.4). 
Zdravljenje (tudi redno profilakso) z obvodnimi zdravili ("obvodna zdravila" (bypassing agents), npr. aPCC in rFVIIa), je treba prekiniti na dan pred uvedbo zdravljenja z zdravilom Hemlibra (glejte poglavje 4.4).
Move safety shield 
Pomaknite varnostni ščitnik
● Outer area of the upper arm (only if a caregiver is giving the injection). 
● v zunanji del nadlakti (le če vam injekcijo da skrbnik).
Prior to launch of Hemlibra in each Member State the Marketing Authorisation Holder (MAH) must agree about the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority. 
● Dodatni ukrepi za zmanjševanje tveganj Pred prihodom zdravila Hemlibra na trg se mora imetnik dovoljenja za promet z zdravilom v vsaki državi članici z nacionalnim pristojnim organom dogovoriti glede vsebine in oblike izobraževalnega programa, vključno s sredstvi obveščanja, načinom razdeljevanja in vsemi ostalimi vidiki programa.
Administration by the patient and/or caregiver 
Dajanje zdravila s strani bolnika in/ali skrbnika
● If your prescribed dose is more than 2 mL, you will need to have more than one subcutaneous injection of Hemlibra; contact your healthcare provider for the injection instructions. 
● Če imate predpisan odmerek več kot 2 ml, boste potrebovali več kot eno subkutano injekcijo zdravila Hemlibra; za navodila za injiciranje se obrnite na zdravnika.
Inject air into vial 
Injicirajte zrak v vialo
● If you see drops of blood at the injection site, you can press a sterile cotton ball or gauze over the injection site for at least 10 seconds, until bleeding has stopped. 
● Če na mestu injiciranja opazite kapljice krvi, lahko na mesto injiciranja za vsaj 10 sekund pritisnete s sterilnim kosmom vate ali sterilno gazo, dokler se krvavitev ne ustavi.
Only 6 patients had moderate hepatic impairment (1.5 × ULN < bilirubin ≤ 3 × ULN and any AST). 
Le 6 bolnikov je imelo zmerno okvaro jeter (1,5 × ZMN < bilirubin £ 3 × ZMN in kakršen koli AST).
Emicizumab is a humanized monoclonal modified immunoglobulin G4 (IgG4) antibody with a bispecific antibody structure. 
Emicizumab je humanizirano monoklonsko protitelo - spremenjeni imunoglobulin G4 (IgG4) z bispecifično strukturo protitelesa.
● For each injection, use a different area of the body to the one you used last time. 
● Za vsako injiciranje uporabite drug predel na telesu, kot ste ga uporabili predhodno.
● Place the supplies on a clean, well-lit flat work surface. 
● Položite ves material na čisto in dobro osvetljeno, ravno delovno površino.
In rare cases, a blood clot can form inside blood vessels and block them, which may be life-threatening. 
V redkih primerih se lahko v žilah tvori krvni strdek in jih zamaši, kar je lahko življenjsko ogrožajoče.
Emicizumab has no structural relationship or sequence homology to factor VIII and, as such, does not induce or enhance the development of direct inhibitors to factor VIII. 
Emicizumab nima strukturne sorodnosti ali homolognosti zaporedja s faktorjem VIII in tako ne povzroči in ne pospešuje razvoja neposrednih inhibitorjev faktorja VIII.
It is important to know the symptoms of such internal blood clots, in case they develop (see section 4, “Possible side effects” for a list of symptoms). 
Pomembno je, da poznate simptome takšnih notranjih krvnih strdkov za primer, da bi se vam ti pojavili (za seznam simptomov glejte poglavje 4, "Možni neželeni učinki").
Annualized bleed rate and percent of patients with zero bleeds were calculated (see Table 11). 
Izračunali so na leto preračunani delež krvavitev in odstotek bolnikov, ki niso imeli nobene krvavitve (glejte preglednico 11).
Your healthcare provider should show you how to prepare, measure, and inject Hemlibra properly before you use it for the first time. 
Zdravnik vam mora pokazati, kako zdravilo Hemlibra pravilno pripravite, odmerite in injicirate, preden boste to zdravilo prvič uporabili.
Some patients with haemophilia A can develop factor VIII inhibitors (antibodies against factor VIII) which stop the replacement factor VIII from working. 
Nekaterim bolnikom s hemofilijo A se lahko pojavijo inhibitorji faktorja VIII (protitelesa proti faktorju VIII), ki preprečijo delovanje nadomestnega faktorja VIII.
● Make sure the name Hemlibra is on the box and vial label. 
● Preverite, da je na škatli in nalepki viale ime Hemlibra.
Characterization of the interaction between emicizumab and aPCC treatment in pivotal clinical trials 
Opredelitev interakcije med emicizumabom in zdravljenjem z aPCC v ključnih kliničnih preskušanjih
The HAVEN adult and adolescent clinical studies evaluated patient-reported hemophilia-related quality of life outcomes with the Haemophilia-Specific Quality of Life (Haem-A-QoL) questionnaire for adults (> 18 years) and its adolescent version (Haemo-QoL-SF, for 8 to <18 years),the Physical Health Score (i.e., painful swellings, presence of joint pain, pain with movement, difficulty walking far and needing more time to get ready) and Total Score (summary of all scores) were protocol defined endpoints of interest. 
V kliničnih študijah HAVEN pri odraslih in mladostnikih so ocenili izide s hemofilijo povezane kakovosti življenja po navedbi bolnikov z vprašalnikom Haem-A-QoL (Haemophilia-Specific Quality of Life - za hemofilijo specifična kakovost življenja) pri odraslih (starih > 18 let) in z različico tega vprašalnika za mladostnike Haemo-QoL-SF pri bolnikih, starih od 8 do < 18 let; ocena telesnega zdravja (tj. boleče otekline, prisotnost bolečin v sklepih, bolečine pri gibanju, težave pri daljši hoji in bolnikova potreba po več časa, da se pripravi) in celotna ocena (seštevek vseh ocen) sta bila v protokolu opredeljena pomembna opazovana dogodka.
ADRs from the phase III clinical trials in patients who received Hemlibra are listed by MedDRA system organ class (Table 2). 
Neželeni učinki v kliničnih preskušanjih faze III pri bolnikih, ki so prejemali zdravilo Hemlibra, so našteti po organskih sistemih MedDRA (preglednica 2).
● Before opening the vial, read the vial label to make sure you have the correct medicine strength(s) to give the dose prescribed for you. 
● Preden vialo odprete, preberite nalepko viale in se tako prepričajte, da imate ustrezno jakost zdravila za pripravo odmerka, ki vam je bil predpisan.
During treatment with Hemlibra, other medicinal products for subcutaneous administration should, preferably, be injected at different anatomical sites. 
Med zdravljenjem z zdravilom Hemlibra je treba druga zdravila za subkutano uporabo po možnosti injicirati na drugih anatomskih mestih.
● Make sure that you use a new injection needle for each injection and dispose of it after a single use. 
● Poskrbite, da boste za vsako injiciranje uporabili novo injekcijsko iglo in da boste iglo po enkratni uporabi zavrgli.
● Hemlibra is given by injection under the skin (subcutaneously). 
● Zdravilo Hemlibra je treba injicirati pod kožo (subkutano).
Patients who receive an accidental overdose should immediately contact their physician and be monitored closely. 
Bolniki, ki naključno prejmejo prevelik odmerek, se morajo nemudoma obrniti na zdravnika.
Inspecting the medicine and your supplies: 
Pregled zdravila in materiala:
Table 10 HAVEN 1: EQ-5D-5L scores in patients ≥ 12 years at week 25 
Študija HAVEN 1: Ocene EQ-5D-5L pri bolnikih, starih ≥ 12 let, v 25. tednu
Thrombotic events 
Trombotičen dogodek
Do not stop using Hemlibra without talking to your doctor. 
Ne prenehajte uporabljati zdravila Hemlibra, ne da bi se prej posvetovali z zdravnikom.
Median Efficacy Period (weeks) 
Mediano obdobje učinkovitosti
Repeat steps A to F with each additional vial until you have more than your prescribed dose. 
Ponavljajte korake od A do F z vsako dodatno vialo, dokler nimate količine, ki je večja od predpisanega odmerka.
At the time of the primary analysis, two patients underwent up-titration of their maintenance dose to 3 mg/kg once weekly. 
V času primarne analize so dvema bolnikoma vzdrževalni odmerek povečali na 3 mg/kg enkrat na teden.
The developing hemostatic system in neonates and infants is dynamic and evolving, and the relative concentrations of pro- and anticoagulant proteins in these patients should be taken into consideration when making a benefit-risk assessment, including potential risk of thrombosis (e.g. central venous catheter-related thrombosis). 
Razvoj hemostatičnega sistema pri novorojenčkih in dojenčkih je dinamičen in se spreminja, zato je treba pri teh bolnikih za oceno koristi in tveganja upoštevati relativno koncentracijo prokoagulacijskih in antikoagulacijskih beljakovin, vključno z možnim tveganjem za trombozo (npr. trombozo, povezano s centralnim venskim katetrom).
In HAVEN 2, HRQoL for patients aged ≥ 8 to < 12 years was evaluated at week 25 based on the Haemo-QoL-SF questionnaire for children(see Table 13). 
V študiji HAVEN 2 so zdravstveno kakovost življenja bolnikov, starih od ≥ 8 do < 12 let, ocenili v 25. tednu z vprašalnikom Haemo-QoL-SF za otroke (glejte preglednico 13).
Patients in Arm C could switch to Hemlibra (3 mg/kg every two weeks) after completing at least 24 weeks without prophylaxis. 
Bolniki v skupini C so lahko prešli na zdravilo Hemlibra (3 mg/kg na dva tedna), ko so dokončali vsaj 24 tednov brez profilakse.
Mean (±95% CI) plasma emicizumab concentration versus time profiles for patients ≥ 12 years (studies HAVEN 1 and HAVEN 3) compared with patients < 12 years (study HAVEN 2) 
Slika 1: Povprečna (± 95-% IZ) koncentracija emicizumaba v plazmi glede na čas za bolnike ≥ 12 let (študiji HAVEN 1 in HAVEN 3) v primerjavi z bolniki < 12 let (študija HAVEN 2)
Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with 
Zdravilo Hemlibra je indicirano za redno profilakso krvavitev pri bolnikih s:
The most commonly reported ISR symptoms were injection site erythema (11 %), injection site pain (4 %) and injection site pruritus (3 %). 
Najpogosteje zabeleženi simptomi reakcij na mestu injiciranja so bili eritem na mestu injiciranja (11 %), bolečina na mestu injiciranja (4 %) in srbenje na mestu injiciranja (3 %).