FrancophonIA/ELRC3.0 huggingface dataset:
English: ● Do not inject air into the medicine as this could create air bubbles in the medicine.
Slovenian: ● Ne injicirajte zraka v zdravilo, ker to lahko povzroči nastanek zračnih mehurčkov v zdravilu.
English: EQ-5D-5L scores after 24 weeks
Slovenian: Ocene EQ-5D-5L po 24 tednih
English: ● Vial adapter (To be added on top of vial).
Slovenian: ● Adapterja za vialo (za pritrditev na vrh viale).
English: Alternating the site of injection may help prevent or reduce injection site reactions (see section 4.8).
Slovenian: Menjavanje mest injiciranja lahko pomaga preprečiti ali zmanjšati reakcije na mestu injiciranja (glejte poglavje 4.8).
English: a Lower scores (negative change scores) are reflective of better functioning.
Slovenian: (n = 43) a nižje ocene (negativne ocene sprememb) pomenijo boljše funkcioniranje.
English: Hemlibra increases the patient's coagulation potential.
Slovenian: Zdravilo Hemlibra poveča bolnikov koagulacijski potencial.
English: The safety profile of Hemlibra was overall consistent between infants, children, adolescents, and adults.
Slovenian: Varnostne značilnosti zdravila Hemlibra pri dojenčkih, otrocih, mladostnikih in odraslih so se na splošno skladale.
English: ● Decision about dose modifications should take into account the half-life of medications;
Slovenian: ● Pri odločitvi o spremembah odmerka je treba upoštevati razpolovni čas zdravil.
English: If you cannot remove all medicine, turn the vial upright to reach the remaining amount
Slovenian: Če iz viale ne morete potegniti vsega zdravila, obrnite vialo pokonci, da boste dosegli preostalo količino.
English: Arm D patients could uptitrate after the second qualifying bleed.
Slovenian: Bolnikom v skupini D so odmerek lahko povečali po drugi kvalificirani krvavitvi.
English: Pharmacokinetic parameters derived from the population PK model.
Slovenian: Farmakokinetični parametri, pridobljeni iz populacijskega farmakokinetičnega modela.
English: ● Move the safety shield forward 90°, away from the syringe barrel.
Slovenian: ● Pomaknite varnostni ščitnik naprej za 90°, proč od telesa brizge.
English: Thus, the effect of emicizumab on male and female fertility is unknown.
Slovenian: Vpliv emicizumaba na plodnost moških in žensk ni znan.
English: If FVIII is required in the perioperative period, please refer to section 4.5.
Slovenian: Če je v perioperativnem obdobju potrebna uporaba FVIII, glejte poglavje 4.5.
English: It is not known whether emicizumab can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
Slovenian: Ni znano, ali lahko emicizumab škoduje plodu, če je uporabljen pri nosečnici, in ali lahko vpliva na reprodukcijsko sposobnost.
English: Average cumulative amount of aPCC over 24 hours (U/kg/24 hours)
Slovenian: Povprečna kumulativna količina aPCC v 24 urah (e./kg/24 ur)
English: Each pack of Hemlibra contains 1 glass vial.
Slovenian: Eno pakiranje zdravila Hemlibra vsebuje 1 stekleno vialo.
English: Haem-A_QoL scales range from 0 to 100; lower scores are reflective of better HRQoL.
Slovenian: Razpon lestvice Haem-A_QoL je od 0 do 100; nižje ocene pomenijo boljšo zdravstveno kakovost življenja.
English: Caution should be taken if intrinsic pathway clotting based laboratory tests are used, as misinterpretation of their results may lead to under-treatment of patients experiencing bleeding episodes, which can potentially result in severe or life-threatening bleeds.
Slovenian: Previdnost je potrebna, če se uporabijo laboratorijske preiskave, ki temeljijo na intrinzični poti strjevanja, saj lahko napačna razlaga njihovih rezultatov povzroči nazadostno zdravljenje bolnikov s krvavitvami, kar lahko povzroči hude ali življenjsko ogrožajoče krvavitve.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Hemlibra in one or more subsets of the paediatric population in the treatment of hereditary factor VIII deficiency (see section 4.2 for information on paediatric use).
Slovenian: Evropska agencija za zdravila je začasno odložila obvezo za predložitev rezultatov študij z zdravilom Hemlibra za eno ali več podskupin pediatrične populacije za zdravljenje prirojenega pomanjkanja faktorja VIII (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
English: Following discontinuation of aPCC and interruption of Hemlibra, evidence of improvement or resolution was seen within one month (see section 4.8).
Slovenian: Po prenehanju uporabe aPCC in prekinitvi zdravljenja z zdravilom Hemlibra so dokaze o izboljšanju ali izginotju opazili v enem mesecu (glejte poglavje 4.8).
English: Accidental overdose may result in hypercoagulability.
Slovenian: Naključno preveliko odmerjanje lahko povzroči hiperkoagulabilnost.
English: Due to its long half-life, these effects on coagulation assays may persist for up to 6 months after the last dose (see section 5.2).
Slovenian: Zaradi dolgega razpolovnega časa lahko ti učinki na teste koagulacije trajajo do 6 mesecev po zadnjem odmerku (glejte poglavje 5.2).
English: Reminder to report any adverse events to their treating doctor.
Slovenian: Opomnik, da vse neželene dogodke poročajo lečečemu zdravniku.
English: Large air bubbles can reduce the dose you receive.
Slovenian: Veliki zračni mehurčki lahko zmanjšajo odmerek, ki ga dobite.
English: The median observation time for these patients was 29.6 weeks (range: 18.4 to 63.0 weeks).
Slovenian: Mediani čas opazovanja teh bolnikov je bil 29,6 tedna (razpon: od 18,4 do 63,0 tednov).
English: ● a reaction in the area where the injection is given (redness, itching, pain)
Slovenian: ● reakcija v predelu, kamor je injicirano zdravilo (pordelost, srbenje, bolečina)
English: Visual Analogue Scale Adjusted mean
Slovenian: Vizualna analogna skala
English: ● You should use a different injection site for each injection, at least 2.5 cm away from the area you used for your previous injection.
Slovenian: ● Za vsako injiciranje zdravila uporabite drugo mesto, ki naj bo vsaj 2,5 cm proč od predela, kamor ste dali prejšnjo injekcijo.
English: Inject the medicine
Slovenian: Injicirajte zdravilo
English: Hemlibra can be used in adolescents and children of all ages.
Slovenian: Zdravilo Hemlibra se lahko uporablja pri mladostnikih in otrocih vseh starosti.
English: ● Choose appropriate dosage and volume from vial strengths available.
Slovenian: ● Izberite ustrezen odmerek in volumen med vialami različnih jakosti, ki so na voljo.
English: Hemlibra is for subcutaneous use only, and it should be administered using appropriate aseptic technique (see section 6.6).
Slovenian: Zdravilo Hemlibra je namenjeno le za subkutano uporabo in ga je treba injicirati z upoštevanjem ustreznega aseptičnega postopka (glejte poglavje 6.6).
English: Other medicines and Hemlibra
Slovenian: Druga zdravila in zdravilo Hemlibra
English: No cases required anticoagulation therapy.
Slovenian: V nobenem primeru ni bilo potrebno antikoagulantno zdravljenje.
English: Emicizumab did not cause any changes in the reproductive organs of male or female cynomolgus monkeys up to the highest tested dose of 30 mg/kg/week (equivalent to 11 times the human exposure at the highest dose of 3 mg/kg/week, based on AUC).
Slovenian: Emicizumab ni povzročil sprememb reproduktivnih organov samcev ali samic opic cynomolgus vse do največjega testiranega odmerka 30 mg/kg/teden (to na podlagi AUC ustreza 11-kratniku izpostavljenosti med uporabo največjega odmerka 3 mg/kg/teden pri človeku).
English: Clinical study in paediatric patients
Slovenian: Klinična študija pri pediatričnih bolnikih
English: Do not use this medicine after the expiry date which is stated on the carton and the vial label after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli in nalepki viale poleg oznak "Uporabno do" in "EXP".
English: ● Repeat the steps above until you have removed the larger air bubbles.
Slovenian: ● Ponavljajte zgornje korake, dokler ne odstranite večjih zračnih mehurčkov.
English: Immune tolerance induction (ITI)
Slovenian: Indukcija imunske tolerance (ITI - immune tolerance induction)
English: ● A child can self-inject the medicine provided the child's healthcare provider and the parent or caregiver agree.
Slovenian: ● Otrok si lahko zdravilo injicira sam, če se otrokov zdravnik in starši ali skrbniki o tem strinjajo.
English: ● Your doctor or nurse will show you how to inject Hemlibra.
Slovenian: ● Zdravnik ali medicinska sestra vam bosta pokazala, kako injicirati zdravilo Hemlibra.
English: These instructions are for use with the Vial Adapter only.
Slovenian: Ta navodila se nanašajo le na uporabo adapterja za vialo.
English: For comprehensive instructions on the administration of Hemlibra, see section 6.6 and package leaflet.
Slovenian: Za izčrpna navodila o uporabi zdravila Hemlibra glejte poglavje 6.6 in navodilo za uporabo.
English: ● If you do not have a sharps disposal container, you may use a household container that is: - made of heavy-duty plastic.
Slovenian: ● Če nimate vsebnika za ostre odpadke, lahko uporabite kakšen vsebnik za gospodinjsko uporabo, ki pa mora: - biti izdelan iz odporne plastike.
English: Bypassing agent or FVIII use during surgeries and procedures was determined by the investigator.
Slovenian: O uporabi obvodnega zdravila ali FVIII med operacijami in posegi se je odločal raziskovalec.
English: Patient treatment preference was also assessed using a preference survey.
Slovenian: Na podlagi ankete o preferenci je bila ocenjena tudi preferenca bolnikov glede zdravljenja.
English: Selecting and preparing an injection site:
Slovenian: Izbira in priprava mesta za injiciranje:
English: Important: If your prescribed dose is more than the amount of medicine in the vial, withdraw all of the medicine and go to the “Combining Vials” section now.
Slovenian: Pomembno: Če je vaš predpisani odmerek večji od količine zdravila v viali, izvlecite vse zdravilo in zdaj nadaljujte pri poglavju "Združevanje vial".
English: A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Hemlibra therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Slovenian: Odločiti se je treba bodisi za prenehanje dojenja bodisi za prekinitev/prenehanje zdravljenja z zdravilom Hemlibra, z upoštevanjem koristi dojenja za otroka in koristi zdravljenja za bolnico.
English: Hemlibra can be used in all age groups.
Slovenian: Zdravilo Hemlibra se lahko uporablja v vseh starostnih skupinah.
English: To measure change in health status, the Index Utility Score (IUS) and the Visual Analog Scale (VAS) from the EuroQoL Five-Dimension-Five Levels Questionnaire (EQ-5D-5L) was examined.
Slovenian: Za merjenje spremembe zdravstvenega stanja sta bila uporabljena IUS (Index Utility Score) in VAS (vizualna analogna skala) vprašalnika EQ-5D5L (EuroQoL Five-Dimension-Five Levels).
English: For more information on using aPCC while receiving Hemlibra, see in section 2: “Potentially serious side effects of using aPCC while receiving Hemlibra”.
Slovenian: Za več informacij o uporabi aPCC med prejemanjem zdravila Hemlibra glejte poglavje 2: "Možni resni neželeni učinki uporabe aPCC med zdravljenjem z zdravilom Hemlibra".
English: Less than 5 % of patients tested positive for anti-emicizumab antibodies and < 1 % of patients had anti-emicizumab antibodies with neutralizing potential (based on declining pharmacokinetics).
Slovenian: Manj kot 5 % bolnikov je imelo pozitiven izvid protiteles proti emicizumabu in < 1 % bolnikov je imel nevtralizacijska protitelesa proti emicizumabu (na podlagi padajoče farmakokinetike).
English: The pharmacokinetics of emicizumab was determined via non-compartmental analysis in healthy subjects and using a population pharmacokinetic analysis on a database composed of 389 patients with haemophilia A.
Slovenian: Farmakokinetiko emicizumaba so ugotavljali z nerazdelčno analizo pri zdravih preiskovancih in z uporabo populacijske farmakokinetične analize baze podatkov o 389 bolnikih s hemofilijo A.
English: No studies have been conducted to assess the impact of emicizumab on milk production or its presence in breast milk.
Slovenian: Študij za oceno vpliva emicizumaba na nastajanje materinega mleka ali za oceno njegove prisotnosti v materinem mleku niso izvedli.
English: If you stop using Hemlibra
Slovenian: Če ste prenehali uporabljati zdravilo Hemlibra
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Slovenian: ● Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
English: The median duration of exposure across the studies was 33 weeks (range: 0.1 to 94.3 weeks).
Slovenian: Mediana izpostavljenosti v študijah je bila 33 tednov (razpon: od 0,1 do 94,3 tedna).
English: PREPARATION
Slovenian: PRIPRAVA
English: The mean exposure time (+SD) for all patients on study was 21.38 weeks (12.01).
Slovenian: (+ std. odklon) vseh bolnikov v študiji je bil 21,38 tedna (12,01).
English: 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).
Slovenian: 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).
English: 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:
Slovenian: 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:
English: How much Hemlibra to use
Slovenian: Koliko zdravila Hemlibra je treba uporabiti
English: Clinical studies in adults and adolescents
Slovenian: Klinične študije pri odraslih in mladostnikih
English: 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).
Slovenian: 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).
English: Use only recommended places for injection.
Slovenian: Za injiciranje uporabite le priporočena mesta.
English: It is not known whether emicizumab is excreted in human milk.
Slovenian: Ni znano, ali se emicizumab izloča v materinem mleku.
English: 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:
Slovenian: Če za svoj predpisani odmerek potrebujete več kot 1 vialo, sledite spodaj opisanim korakom, potem ko ste že potegnili zdravilo iz prve viale:
English: What Hemlibra is and what it is used for What you need to know before you use Hemlibra How to use Hemlibra
Slovenian: Kaj je zdravilo Hemlibra in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Hemlibra Kako uporabljati zdravilo Hemlibra
English: Please see section 4.2 and package leaflet (section 7 Instructions for Use), for additional information on administration.
Slovenian: Za dodatne informacije o uporabi zdravila glejte poglavje 4.2 in navodilo za uporabo (poglavje 7, Navodila za uporabo).
English: ● Slide the tip of the needle down so that it is within the medicine.
Slovenian: ● Potegnite konico igle navzdol, tako da je v zdravilu.
English: 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.
Slovenian: 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.
English: Dosage adjustments during treatment
Slovenian: Prilagoditve odmerjanja med zdravljenjem
English: If bleeding does not stop, please contact your healthcare provider.
Slovenian: Če se krvavitev ne ustavi, se posvetujte z zdravnikom.
English: 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.
Slovenian: 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.
English: specifically, interruption of emicizumab may not have an immediate effect.
Slovenian: Učinek prekinitve zdravljenja z emicizumabom morda ne bo takojšen.
English: Haemo-QoL-SF
Slovenian: Vprašalnik Haemo-QoL-SF
English: Ctrough, ss (µg/mL) Cmax/Ctrough ratio
Slovenian: Ctrough, ss (µg/ml) Cmax/Ctrough razmerje
English: 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.
Slovenian: 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.
English: Such intrinsic pathway based tests will yield overly shortened clotting times with emicizumab, which does not require activation by thrombin.
Slovenian: Takšni testi, ki temeljijo na intrinzični poti, pokažejo pretirano kratke čase strjevanja med uporabo emicizumaba, ki ne zahteva aktivacije s trombinom.
English: However, self-administration is not recommended for children below 7 years of age.
Slovenian: Samoinjiciranje ni priporočljivo pri otrocih, mlajših od 7 let.
English: No dosage adjustments of Hemlibra are recommended.
Slovenian: Za odmerjanje zdravila Hemlibra ni priporočenih prilagoditev.
English: *Vascular disorders is a secondary SOC for cavernous sinus thrombosis.
Slovenian: *Žilne bolezni so sekundarni organski sistem za trombozo kavernoznega sinusa.
English: Hemlibra is a medicine used for treating patients of all ages with
Slovenian: Zdravilo Hemlibra se uporablja za zdravljenje bolnikov vseh starosti s:
English: Remove air bubbles
Slovenian: Odstranite zračne mehurčke
English: Patients presented with thrombocytopenia, microangiopathic hemolytic anemia, and acute kidney injury, without severe deficiencies in ADAMTS13 activity.
Slovenian: Pri bolnikih so se pojavile trombocitopenija, mikroangiopatska hemolitična anemija in akutna okvara ledvic, brez hudega pomanjkanja aktivnosti ADAMTS13.
English: Once completed, keep the transfer needle inserted in the vial and return to Step 6.
Slovenian: Ko to dokončate, pustite iglo za prenos zabodeno v viali in se vrnite na 6. korak.
English: Throw away any unused solution appropriately.
Slovenian: Morebitno neporabljeno raztopino ustrezno zavrzite.
English: Step E. Inject air into vial
Slovenian: Korak E. Injicirajte zrak v vialo
English: The patient should then administer the next dose on the usual scheduled dosing day.
Slovenian: Bolnik mora nato uporabiti naslednji odmerek na običajni dan uporabe zdravila po urniku.
English: 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.
Slovenian: 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.
English: 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).
Slovenian: 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).
English: If you use more Hemlibra than you are supposed to, tell your doctor immediately.
Slovenian: Če ste uporabili več zdravila Hemlibra, kot bi smeli, morate takoj obvestiti zdravnika.
English: Then, continue to inject the medicine as scheduled.
Slovenian: Potem nadaljujte injiciranje zdravila po običajnem urniku.
English: ● Your doctor will show you which areas of the body are suitable for injecting Hemlibra.
Slovenian: ● Zdravnik vam bo pokazal, kateri deli telesa so primerni za injiciranje zdravila Hemlibra.
English: 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.
Slovenian: 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.
English: 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.
Slovenian: 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.
English: For further information refer to the section “Disposing of the medicine and supplies”.
Slovenian: Za dodatne informacije glejte poglavje "Kako zavreči zdravilo in material".
English: Hemlibra increases the ability of your blood to clot.
Slovenian: Zdravilo Hemlibra poveča zmožnost krvi za strjevanje.
English: ● Keep your fingers behind the safety shield and away from the needle at all times.
Slovenian: ● Prste ves čas držite za varnostnim ščitnikom in proč od igle.
English: Store the vial in the refrigerator.
Slovenian: Viale shranjujte v hladilniku.
English: % reduction (RR)
Slovenian: % zmanjšanja RR
English: Population pharmacokinetics analyses in patients with haemophilia A showed that race did not affect the pharmacokinetics of emicizumab.
Slovenian: Populacijske farmakokinetične analize pri bolnikih s hemofilijo A so pokazale, da rasa ni vplivala na farmakokinetiko emicizumaba.
English: ● Syringe with Low Dead Space (LDS) Plunger Important:
Slovenian: ● Brizge z majhnim volumnom mrtvega prostora Pomembno:
English: The injection should be restricted to the recommended injection sites: the abdomen, the upper outer arms and the thighs (see section 5.2).
Slovenian: Injiciranje mora biti omejeno na priporočena mesta za injiciranje: trebuh, zunanji del nadlahti in stegna (glejte poglavje 5.2).
English: 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).
Slovenian: 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).
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted medical prescription.
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le na recept s posebnim režimom.