FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you use Hemlibra
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Hemlibra Ne uporabljajte zdravila Hemlibra:
English: ● Slowly pull back on the plunger and draw air into the syringe that is the same amount as your prescribed dose.
Slovenian: ● Počasi izvlecite bat in potegnite v brizgo toliko zraka, kot ustreza količini vašega predpisanega odmerka.
English: Once removed from the refrigerator, unopened vials can be kept at room temperature (below 30°C) for up to 7 days.
Slovenian: Ko neodprte viale vzamete iz hladilnika, so lahko shranjene na sobni temperaturi (do 30 °C) do 7 dni.
English: A volume greater than 2 mL per injection should not be administered.
Slovenian: Ne sme se uporabiti volumna, večjega od 2 ml na injekcijo.
English: In the HAVEN 1 study a randomised, multicentre, open-label clinical study in 109 adolescent and adult males (aged ≥ 12 years old) with haemophilia A with factor VIII inhibitors who had previously received either episodic or prophylactic treatment with bypassing agents (aPCC and rFVIIa).
Slovenian: Študija HAVEN 1 je bila randomizirana, multicentrična, odprta klinična študija pri 109 mladostnikih in odraslih moškega spola (starih > 12 let) s hemofilijo A, ki so imeli inhibitorje faktorja VIII in so predhodno prejemali bodisi občasno ali profilaktično zdravljenje z obvodnimi zdravili (aPCC in rFVIIa).
English: In the HAVEN 3 clinical study intra-patient analysis, Hemlibra prophylaxis resulted in a statistically significant (p<0.0001) reduction (68 %) in bleed rate for treated bleeds compared with previous FVIII prophylaxis collected in the NIS prior to enrollment (see Table 5).
Slovenian: V intraindividualni analizi klinične študije HAVEN 3 je profilaksa z zdravilom Hemlibra statistično značilno (p < 0,0001) zmanjšala (68 %) delež krvavitev za zdravljene krvavitve v primerjavi s predhodno profilakso s FVIII iz neintervencijske študije pred vključitvijo v to študijo (glejte preglednico 5).
English: ● Once the needle is covered, push the transfer needle cap towards the syringe to fully attach it with one hand to prevent accidentally injuring yourself with the needle.
Slovenian: ● Ko je igla pokrita, potisnite pokrovček igle za prenos proti brizgi, da ga boste povsem namestili; potisnite z eno roko, da boste preprečili naključno poškodbo z iglo.
English: Patients received Hemlibra prophylaxis at 3 mg/kg once weekly for the first 4 weeks followed by 1.5 mg/kg once weekly thereafter.
Slovenian: Bolniki so prejemali profilakso z zdravilom Hemlibra v odmerku 3 mg/kg enkrat na teden prve 4 tedne in pozneje 1,5 mg/kg enkrat na teden.
English: 6.1 List of excipients
Slovenian: 6.1 Seznam pomožnih snov
English: Clinically meaningful difference: VAS: 7 points, Index Utility Score: 0.07 points
Slovenian: Klinično pomembna razlika: VAS: 7 točk, indeksna ocena koristnosti: 0,07 točke Analize temeljijo na podatkih posameznikov z odzivi na podlagi ocen v izhodišču in v 25. tednu.
English: ● If you have any further questions, ask your doctor, pharmacist or nurse.
Slovenian: ● Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: When used together with a vial adapter, a low dead space plunger 1 mL syringe (transparent polypropylene or polycarbonate syringe with Luer lock tip, graduation 0.01 mL) must be used.
Slovenian: Če se uporablja skupaj z adapterjem za vialo, moramo uporabiti 1-ml brizgo z majhnim volumnom mrtvega prostora (prozorna polipropilenska ali polikarbonatna brizga z Luer-lock nastavkom in merilno skalo 0,01 ml).
English: 2.INJECTION
Slovenian: INJICIRANJE
English: Although a higher adherence was observed with emicizumab prophylaxis than with prior bypassing agent (BPA) prophylaxis, no difference in ABR in patients with ≥ 80% or < 80% compliant doses on BPA prophylaxis according to standard label requirements could be identified (data to be interpreted with caution due to small sample sizes).
Slovenian: Čeprav so pri profilaksi z emicizumabom opazili večjo adherenco kot pri predhodni profilaksi z obvodnimi zdravili, razlike v na leto preračunanem deležu krvavitev pri bolnikih s komplianco profilakse z obvodnimi zdravili ≥ 80 % ali < 80 % glede na standardne zahteve predpisovanja, ni bilo mogoče določiti (podatke moramo zaradi majhnih velikosti vzorcev previdno interpretirati).
English: Remove vial cap and clean top
Slovenian: Odstranite pokrovček viale in očistite njen vrhnji del
English: - Emicizumab increases the patient's coagulation potential and the dose and duration of treatment with bypassing agents may require adjustment depending on the location and extent of bleeding and on the patient's clinical conditions; - For all coagulation agents (aPCC, rFVIIa, FVIII, etc.), consideration should be given to verifying bleeds prior to repeated dosing; - Use of aPCC should be avoided unless no other treatment options/alternatives are available and aPCC dosing recommendations in case aPCC is the only option.
Slovenian: - Zdravniki se morajo z vsemi bolniki in/ali skrbniki pogovoriti o natančnem odmerku in časovnem razporedu uporabe obvodnih zdravil, ki jih uporabljajo med profilakso z emicizumabom, če je potrebno; - Emicizumab poveča bolnikov koagulacijski potencial; glede na mesto in obseg krvavitve ter glede na bolnikovo klinično stanje je lahko potrebna prilagoditev odmerka obvodnih zdravil in trajanje zdravljenja z njimi; - Pri zdravilih, ki vpivajo na koagulacijo (aPCC, rFVIIa, FVIII, itd.), je treba pred ponovnim odmerjanjem razmisliti o preverjanju krvavitve;
English: There were 82 instances of aPCC treatment* in patients receiving Hemlibra prophylaxis, of which eight instances (10%) consisted of on average a cumulative amount of >100 U/kg/24 hours of aPCC for 24 hours or more; two of the eight instances were associated with thrombotic events and three of the eight instances were associated with TMA (Table 3).
Slovenian: V osmih primerih (10 %) so bolniki v 24 urah ali več prejeli povprečno kumulativno količino aPCC > 100 e./kg/24 ur; v dveh od teh osmih primerov so se pojavili trombotični dogodki in v treh od osmih primerov se je pojavila TMA (preglednica 3).
English: Step 10.
Slovenian: 10. korak.
English: Thrombotic microangiopathy b Thrombotic event
Slovenian: Trombotična mikroangiopatija b
English: HAVEN 2 Health-Related Outcomes
Slovenian: Zdravstveni izidi v študiji HAVEN 2
English: ● Injection needle: Stainless steel with Luer-lock connection, gauge 26 G (acceptable range: 2527 gauge), length preferably 9 mm (3/8″) or maximally 13mm (½″),preferably including needle safety feature.
Slovenian: ● Igla za injiciranje: iz nerjavnega jekla z Luer-lock nastavkom, debelina 26 G (sprejemljiv razpon debeline: 25-27 G), dolžina po možnosti 9 mm (3/8″) oz. največ 13 mm (½″), po možnosti z varnostno opremo za iglo.
English: Only patients who participated in the NIS and in study HAVEN 2 are included.
Slovenian: Vključeni so le bolniki, ki so sodelovali v neintervencijski študiji in v študiji HAVEN 2.
English: However, the possibility of thrombotic events should be considered when systemic anti-fibrinolytics are used in combination with aPCC or rFVIIa in patients receiving emicizumab.
Slovenian: Pri bolnikih, ki prejemajo emicizumab, je treba upoštevati možnost trombotičnih dogodkov, če se sistemski antifibrinolitiki uporabljajo v kombinaciji z aPCC ali rFVIIa.
English: ● haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors
Slovenian: ● hemofilijo A (prirojenim pomanjkanjem faktorja VIII) z inhibitorji faktorja VIII,
English: HAVEN 1 Health Status Outcomes
Slovenian: Izidi zdravstvenega statusa v študiji HAVEN 1
English: Remove syringe from vial adapter
Slovenian: Brizgo snemite z adapterja za vialo
English: Do not hold or push on the plunger while inserting the needle.
Slovenian: Ne držite in ne pritiskajte bata, medtem ko zabadate iglo.
English: ● Polycarbonate with Luer-lock connection, sterile, fitting 15 mm vial neck outer diameter, single-use, latex-free and non-pyrogenic.
Slovenian: ● Polikarbonatni, z Luer-lock nastavkom, sterilni, ki se prilegajo 15-mm zunanjemu premeru vratu vial, za enkratno uporabo, brez lateksa in apirogeni.
English: ● With the new vial on the flat working surface, insert the new transfer needle and syringe, straight down into the centre of the vial stopper.
Slovenian: ● Ko imate novo vialo postavljeno na ravno delovno površino, vanjo zabodite na brizgi nameščeno novo iglo za prenos naravnost navzdol skozi sredino zamaška viale.
English: ● Guide for Laboratory Professionals
Slovenian: ● Vodnik za laboratorijske delavce
English: Administration of Hemlibra subcutaneous injection in the upper outer arm should be performed by a caregiver or healthcare professional.
Slovenian: V zunanji del nadlahti mora zdravilo Hemlibra subkutano injicirati bolnikov skrbnik ali zdravstveni delavec.
English: ● Alcohol wipes Note: If you need to use more than 1 vial to inject your prescribed dose, you must use a new alcohol wipe for each vial.
Slovenian: Opomba: Če morate za predpisani odmerek uporabiti več kot 1 vialo, morate za vsako vialo uporabiti nov alkoholni listič.
English: When used together with a vial adapter, a low dead space plunger 3 mL syringe (transparent polypropylene or polycarbonate syringe with Luer lock tip, graduation 0.1 mL) must be used.
Slovenian: Če se uporablja skupaj z adapterjem za vialo, moramo uporabiti 3-ml brizgo z majhnim volumnom mrtvega prostora (prozorna polipropilenska ali polikarbonatna brizga z Luer-lock nastavkom in merilno skalo 0,1 ml).
English: headache, numbness in your face, eye pain or swelling or problems with your visionthese symptoms may be signs of a blood clot in a vein behind your eye. blackening of the skin - this symptom may be a sign of severe damage to the skin tissue.
Slovenian: Glavobol, omrtvičenost obraza, bolečina ali oteklost očesa ali težave z vidom - ti simptomi so lahko znaki krvnega strdka v veni za očesom.
English: Mild renal impairment did not affect the pharmacokinetics of emicizumab.
Slovenian: Blaga okvara ledvic ni vplivala na farmakokinetiko emicizumaba.
English: Step 15.
Slovenian: 15. korak.
English: Step 11.
Slovenian: 11. korak.
English: Do not use the syringe if the needle touches any surface
Slovenian: Injekcijske brizge ne uporabite, če se igla dotakne česar koli.
English: Slowly push the plunger to push the large air bubbles out of the syringe.
Slovenian: Počasi potisnite bat navzgor, da boste iz brizge iztisnili zračne mehurčke.
English: Arm B: no prophylaxis (N=14)
Slovenian: Skupina B: brez profilakse (n = 14)
English: Vial Adapter
Slovenian: Adapter za vialo
English: What Hemlibra contains
Slovenian: Kaj vsebuje zdravilo Hemlibra
English: Emicizumab has not been studied in patients with severe renal or hepatic impairment
Slovenian: Emicizumaba pri bolnikih s hudo okvaro ledvic ali jeter niso preskušali.
English: Only patients who participated in the NIS and in study HAVEN 1 are included.
Slovenian: Vključeni so le bolniki, ki so sodelovali v neintervencijski študiji in v študiji HAVEN 1.
English: Arm B: no prophylaxis (N=16)
Slovenian: Skupina B: brez profilakse (n = 16)
English: If stored out of and then returned to refrigeration, the total combined time out of refrigeration should not exceed 7 days.
Slovenian: Če so shranjene zunaj hladilnika in jih nato daste nazaj v hladilnik, celotni čas zunaj hladilnika skupaj ne sme preseči
English: Eighty-nine patients previously treated with episodic (“on demand”) FVIII were randomized in a 2:2:1 ratio to receive Hemlibra either once weekly (Arm A; N = 36), every two weeks (Arm B; N = 35) or no prophylaxis (Arm C; N = 18), with stratification by prior 24-week bleed rate (< 9 or ≥ 9).
Slovenian: 2:2:1 randomizirali na prejemanje zdravila Hemlibra bodisi enkrat na teden (skupina A, n = 36) bodisi na dva tedna (skupina B, n = 35) ali na obravnavo brez profilakse (skupina C, n = 18) s stratifikacijo po krvavitvah v zadnjih 24 tednih (< 9 ali ≥ 9).
English: Table 11 HAVEN 2: Overview of efficacy (interim analysis)
Slovenian: Študija HAVEN 2: Pregled učinkovitosti (vmesna analiza) Opazovani dogodek aABR (95-% IZ)
English: The total aPCC dose should not exceed 100 U/kg in the first 24-hours of treatment.
Slovenian: 24 urah zdravljenja ne sme preseči 100 e./kg.
English: Criteria for vial adapter: Polycarbonate with Luer-lock connection, sterile, fitting 15 mm vial neck outer diameter, single-use, latex-free and non-pyrogenic.
Slovenian: Merila za adapter za vialo: polikarbonaten, z Luer-lock nastavkom, sterilen, ki se prilega 15-mm zunanjemu premeru vratu viale, za enkratno uporabo, brez lateksa in apirogen.
English: Step 5.
Slovenian: 5. korak.
English: ● Use the syringes, vial adapters and injection needles only once.
Slovenian: ● Brizge, adapterje za viale in igle za injiciranje uporabite le enkrat.
English: Haemophilia A is an inherited condition caused by a lack of factor VIII, an essential substance required for blood to clot and stop any bleeding.
Slovenian: Povzroča jo pomanjkanje faktorja VIII, bistvene snovi, potrebne za strjevanje krvi in zaustavitev krvavitev.
English: Patients received Hemlibra prophylaxis3 mg/kg once weekly for four weeks followed by 6 mg/kg every four weeks thereafter.
Slovenian: Bolniki so prejemali profilakso z zdravilom Hemlibra - v odmerku 3 mg/kg enkrat na teden štiri tedne in nato 6 mg/kg na štiri tedne.
English: Do not refrigerate the solution in the syringe.
Slovenian: Raztopine v brizgi ne shranjujte v hladilniku.
English: All 3 TMAs occurred when on average a cumulative amount of > 100 U/Kg/24 hours of aPCC for 24 hours or more was administered during a treatment event (see section 4.4).
Slovenian: Vsi 3 primeri TMA so se pojavili, ko je bila med zdravljenjem uporabljena povprečna kumulativna količina > 100 e./kg/24 ur aPCC 24 ur ali več (glejte poglavje 4.4).
English: ● Use the syringes, transfer needles and injection needles only once.
Slovenian: ● Brizge, igle za prenos in igle za injiciranje uporabite le enkrat.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 105 mg/0.7 mL
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 105 mg/0,7 ml
English: Only patients who participated in the NIS and in study HAVEN 3 are included.
Slovenian: Vključeni so le bolniki, ki so sodelovali v neintervencijski študiji in v študiji HAVEN 3.
English: % patients with zero bleeds (95% CI)
Slovenian: % bolnikov z 0 krvavitvami (95-% IZ)
English: Step 12.
Slovenian: 12. korak.
English: ● Keep the needle in the vial and check the syringe for larger air bubbles.
Slovenian: ● Brizgo pustite nameščeno na viali in preverite, ali so v njej prisotni večji zračni mehurčki.
English: ● either haemophilia A who have developed factor VIII inhibitors
Slovenian: ● hemofilijo A, pri katerih so se pojavili inhibitorji faktorja VIII ali
English: Step 17.
Slovenian: 17. korak.
English: Physicians and patients/caregivers should weigh the benefits and risks of resuming Hemlibra prophylaxis following complete resolution of TMA on a case-by-case basis.
Slovenian: Zdravniki in bolniki/skrbniki morajo za vsak primer posebej pretehtati koristi in tveganja nadaljnje profilakse z zdravilom Hemlibra, ko TMA popolnoma izzveni.
English: Step 14.
Slovenian: 14. korak.
English: Hemlibra 30 mg/mL solution for injection 30 months.
Slovenian: Hemlibra 30 mg/ml raztopina za injiciranje 30 mesecev
English: What Hemlibra is and what it is used for
Slovenian: Kaj je zdravilo Hemlibra in za kaj ga uporabljamo Kaj je zdravilo Hemlibra
English: ● Put your used vial adapters, needles and syringes in a sharps disposal container straight away after use.
Slovenian: ● Uporabljene adapterje za viale, igle in brizge takoj po uporabi zavrzite v vsebnik za ostre odpadke.
English: Patient's bodyweight of 60 kg, under a maintenance dose regimen of 6 mg/kg every four weeks:
Slovenian: Bolnik s telesno maso 60 kg s shemo vzdrževalnega odmerka 6 mg/kg na štiri tedne:
English: However, single factor assays utilising chromogenic or immuno-based methods are not affected by emicizumab and may be used to monitor coagulation parameters during treatment, with specific considerations for FVIII chromogenic activity assays as described below.
Slovenian: Emicizumab pa ne vpliva na teste posameznih faktorjev, ki uporabljajo kromogene ali imunske metode, in ti se lahko uporabljajo za nadzor koagulacijskih parametrov med zdravljenjem, s specifičnim upoštevanjem značilnosti kromogenih testov aktivnosti FVIII, kot je opisano spodaj.
English: A 1 mL syringe should be used for an injection up to 1 mL of Hemlibra solution, whereas a 2 to 3 mL syringe should be used for an injection greater than 1 mL and up to 2 mL.
Slovenian: Za injiciranje do 1 ml raztopine treba uporabiti 1-ml brizgo, za injiciranje več kot 1 ml in do 2 ml pa je treba uporabiti 2- ali 3-ml brizgo.
English: Cases of thrombotic microangiopathy (TMA) were reported from a clinical trial in patients receiving Hemlibra prophylaxis when on average a cumulative amount of >100U/kg/24 hours of activated prothrombin complex concentrate (aPCC) for 24 hours or more was administered (see section 4.8).
Slovenian: V kliničnih preskušanjih so poročali o primerih trombotične mikroangiopatije (TMA) pri bolnikih, ki so prejemali profilakso z zdravilom Hemlibra in sočasno koncentrat aktiviranega protrombinskega kompleksa (aPCC - activated prothrombin complex concentrate), in sicer, kadar so oboje prejemali 24 ur ali več in pri povprečni kumulativni količini aPCC > 100 e./kg/24 ur (glejte poglavje 4.8).
English: For bypassing agent guidance refer to section 4.4.
Slovenian: Za smernice za uporabo obvodnih zdravil glejte poglavje 4.4.
English: ● Blood clots (thromboembolism)
Slovenian: ● Krvni strdki (trombembolija)
English: The efficacy results of Hemlibra prophylaxis compared with no prophylaxis with respect to rate of treated bleeds, all bleeds, treated spontaneous bleeds, treated joint bleeds, and treated target joint bleeds are shown in Table 6.
Slovenian: Rezultati učinkovitosti profilakse z zdravilom Hemlibra v primerjavi z obravnavo brez profilakse, kar zadeva delež zdravljenih krvavitev, vseh krvavitev, zdravljenih spontanih krvavitev, zdravljenih krvavitev v sklepe in zdravljenih krvavitev v tarčne sklepe, so prikazani v preglednici 6.
English: Emicizumab exhibited dose-proportional pharmacokinetics in patients with haemophilia A after the first dose of Hemlibra over a dose range from 0.3 to 6 mg/kg .
Slovenian: Po prvem odmerku zdravila Hemlibra je imel emicizumab v razponu odmerkov od 0,3 do 6 mg/kg pri bolnikih s hemofilijo A odmerku sorazmerno farmakokinetiko.
English: Emicizumab is a monoclonal antibody and is cleared via catabolism rather than renal excretion and a change in dose is not expected to be required for patients with renal impairment.
Slovenian: Emicizumab je monoklonsko protitelo, ki se pretežno odstrani s katabolizmom (ne z izločanjem skozi ledvice), zato se pri bolnikih z okvaro ledvic ne pričakuje, da bi bilo odmerek treba prilagoditi (glejte poglavje 5.2).
English: No dedicated studies of the effect of renal impairment on the pharmacokinetics of emicizumab have been conducted.
Slovenian: Namenskih študij za ugotavljanje vpliva okvare ledvic na farmakokinetiko emicizumaba niso izvedli.
English: The HAVEN 3 study was a randomized, multicenter, open-label, phase III clinical study in 152 adult and adolescent males (aged ≥ 12 years and > 40 kg) with severe hemophilia A without FVIII inhibitors who previously received either episodic (“on demand”) or prophylactic treatment with FVIII.
Slovenian: Študija HAVEN 3 je bila randomizirana, multicentrična klinična študija faze III z odprtim načrtom zdravljenja pri 152 odraslih in mladostnikih moškega spola (starih ≥ 12 let s telesno maso > 40 kg) s hudo hemofilijo A brez inhibitorjev FVIII, ki so predhodno ali občasno ("po potrebi") ali profilaktično prejemali zdravljenje s FVIII.
English: Fifty-three patients previously treated with episodic (“on-demand”) bypassing agents were randomised in a 2:1 ratio to receive Hemlibra prophylaxis (Arm A) or no prophylaxis (Arm B), with stratification by prior 24-week bleed rate (< 9 or ≥ 9).
Slovenian: Triinpetdeset bolnikov, ki so predhodno občasno (“po potrebi”) prejemali obvodna zdravila, so v razmerju 2:1 randomizirali na prejemanje profilakse z zdravilom Hemlibra (skupina A) ali na obravnavo brez profilakse (skupina B), s stratifikacijo glede na delež krvavitev v predhodnih 24 tednih
English: Treated Bleeds
Slovenian: Zdravljene krvavitve
English: Step 7.
Slovenian: 7. korak.
English: ● Keep vials, vial adapters, needles and syringes out of the sight and reach of children.
Slovenian: ● Viale, adapterje za viale, igle in brizge shranjujte nedosegljive otrokom!
English: 15 minutes on a clean flat surface away from direct sunlight.
Slovenian: ● Vialo/viale približno 15 minut pred uporabo pustite na čisti, ravni površini, zaščitene pred neposredno sončno svetlobo,
English: Pharmacodynamics
Slovenian: Farmakodinamika
English: Hemlibra 150 mg/mL solution for injection 3 years.
Slovenian: Hemlibra 150 mg/ml raztopina za injiciranje 3 leta
English: ● 2 to 3 mL syringe: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.1 mL.
Slovenian: ● 2- do 3-ml brizga: prozorna polipropilenska ali polikarbonatna brizga z Luer-lock nastavkom in merilno skalo 0,1 ml.
English: Patients randomized to Arm B could switch to Hemlibra prophylaxis after completing at least 24 weeks without prophylaxis.
Slovenian: Hemlibra, potem ko so dokončali vsaj 24 tednov brez profilakse.
English: Each vial contains 105 mg emicizumab in 0.7 mL of solution for injection.
Slovenian: Ena viala vsebuje 105 mg emicizumaba v 0,7 ml raztopine za injiciranje.
English: ● Carefully pull the injection needle cap straightaway from the syringe.
Slovenian: ● Previdno potegnite pokrovček igle za injiciranje naravnost z brizge.
English: You must read, understand and follow the Instructions for Use before injecting Hemlibra.
Slovenian: Pred injiciranjem zdravila Hemlibra morate prebrati ta navodila za uporabo, jih razumeti in upoštevati.
English: ● Do not insert the injection needle into vial adapter or use the injection needle to withdraw medicine from vial.
Slovenian: ● Igle za injiciranje ne vstavljajte v adapter za vialo in je ne uporabljajte za jemanje zdravila iz viale.
English: INFORMATION IN BRAILLE hemlibra 105 mg
Slovenian: PODATKI V BRAILLOVI PISAVI hemlibra 105 mg
English: Patients received subcutaneous Hemlibra, 3 mg/kg once weekly for the first four weeks followed by either 1.5 mg/kg once weekly (Arms A and D) or 3 mg/kg every two weeks (Arm B) thereafter, or no prophylaxis (Arm C).
Slovenian: Bolniki so prejemali zdravilo Hemlibra subkutano v odmerku 3 mg/kg enkrat na teden prve štiri tedne, nato pa ali 1,5 mg/kg enkrat na teden (skupini A in D) ali 3 mg/kg na dva tedna (skupina B) oziroma nobene profilakse (skupina C).
English: INFORMATION IN BRAILLE hemlibra 30 mg
Slovenian: PODATKI V BRAILLOVI PISAVI hemlibra 30 mg
English: One patient resumed Hemlibra following resolution of thrombotic event and continued to be treated safely.
Slovenian: Ko je trombotični dogodek izzvenel, je en bolnik ponovno začel zdravljenje z zdravilom Hemlibra in ga varno nadaljeval.
English: Criteria for transfer needle: Stainless steel with Luer-lock connection, gauge 18 G, length 35mm (1½″), preferably semi-blunted tip.
Slovenian: Merila za iglo za prenos: Izdelana iz nerjavnega jekla, z Luer-lock nastavkom, debelina 18 G, dolžina 35 mm (1½″), po možnosti s poltopo konico.
English: Step 6.
Slovenian: 6. korak.
English: ● To calculate the volume to be administered divide calculated dose 24 mg by 30 mg/mL: 24 mg of emicizumab ÷ 30 mg/mL = 0.8 mL of 30 mg/mL Hemlibra concentration to be injected once weekly.
Slovenian: ● Za izračun potrebnega volumna delite izračunani odmerek 24 mg s 30 mg/ml: 24 mg emicizumaba ÷ 30 mg/ml = 0,8 ml je volumen zdravila Hemlibra s koncentracijo 30 mg/ml, ki ga je treba injicirati enkrat na teden
English: Table 1 Coagulation test results affected and unaffected by emicizumab
Slovenian: Koagulacijski testi, na katere emicizumab vpliva oziroma ne vpliva