FrancophonIA/ELRC3.0 huggingface dataset:
English: ● Destruction of red blood cells (thrombotic microangiopathy): confusion, weakness, swelling of arms and legs, yellowing of skin and eyes, vague belly (abdominal) or back pain, feeling sick (nausea), being sick (vomiting) or urinating lessthese symptoms may be signs of thrombotic microangiopathy.
Slovenian: Zmedenost, šibkost, otekanje rok in nog, porumenelost kože in oči, nedoločne bolečine v trebuhu (abdomnu) ali bolečine v hrbtu, slabost v želodcu (siljenje na bruhanje), bruhanje ali manjše izločanje urina - ti simptomi so lahko znaki trombotične mikroangiopatije.
English: Therefore, the dose of bypassing agent required may be lower than the dose you used before starting Hemlibra.
Slovenian: Zato boste morda potrebovali manjši odmerek obvodnega zdravila, kot ste ga uporabljali pred začetkom zdravljenja z zdravilom Hemlibra.
English: ● You should use an effective method of birth control (contraception) during treatment with Hemlibra and for 6 months after your last injection of Hemlibra.
Slovenian: ● Med zdravljenjem z zdravilom Hemlibra in še 6 mesecev po zadnji injekciji zdravila Hemlibra morate uporabljati učinkovit način preprečevanja nosečnosti (kontracepcijo).
English: ● severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without factor VIII
Slovenian: ● hudo hemofilijo A (prirojenim pomanjkanjem faktorja VIII, FVIII < 1 %) brez inhibitorjev faktorja VIII.
English: % reduction (RR), p-value
Slovenian: % zmanjšanje (RR), vrednost p neaplikabilno
English: There is a possibility for hypercoagulability with rFVIIa or FVIII with emicizumab based on preclinical experiments.
Slovenian: Na podlagi predkliničnih poskusov obstaja možnost hiperkoagulabilnosti z rFVIIa ali FVIII in emicizumabom.
English: Skin and subcutaneous tissue disorders Skin necrosis
Slovenian: Bolezni kože in podkožja nekroza kože občasni
English: The physician and the caregiver should determine the appropriateness of the child self-injecting Hemlibra.
Slovenian: Zdravnik in skrbnik morata skupaj ugotoviti, ali je primerno, da si otrok sam injicira zdravilo
English: There is limited experience with bypassing agent or FVIII use during surgeries and procedures.
Slovenian: Izkušenj z uporabo obvodnih zdravil ali FVIII med operacijami in posegi je malo.
English: The medicine prevents bleeding or reduces bleeding episodes in people with this condition.
Slovenian: To zdravilo pri bolnikih z omenjeno boleznijo preprečuje krvavitve ali zmanjša njihovo število.
English: Step A. Insert new vial adapter into new vial
Slovenian: Korak A. Na novo vialo namestite nov adapter za vialo
English: In the HAVEN 1 intra-patient analysis, Hemlibra prophylaxis resulted in statistically significant (p = 0.0003) and clinically meaningful reduction (79 %) in bleed rate for treated bleeds compared with previous bypassing agent prophylaxis collected in the NIS prior to enrolment (see Table 7).
Slovenian: V intraindividualni analizi študije HAVEN 1 je profilaksa z zdravilom Hemlibra dosegla statistično značilno (p = 0,0003) in klinično pomembno zmanjšanje (79 %) deleža krvavitev za zdravljene krvavitve v primerjavi s predhodno profilakso z obvodnimi zdravili, evidentirano v neintervencijski študiji pred vključitvijo v to študijo (glejte preglednico 7).
English: Vials that have been kept at room temperature for more than 7 days or exposed to temperatures above 30 °C should be discarded.
Slovenian: Viale, ki so bile shranjene na sobni temperaturi več kot 7 dni ali so bile izpostavljene temperaturam nad 30 °C, je treba zavreči.
English: Paediatric patients (age < 12 years old, or 12 to 17 years old weighing < 40 kg) with haemophilia A with factor VIII inhibitors (Study BH29992 - HAVEN 2)
Slovenian: Pediatrični bolniki (stari < 12 let ali od 12 do 17 let in s telesno maso < 40 kg) s hemofilijo A in z inhibitorji faktorja VIII (študija BH29992 - HAVEN 2)
English: ● Stomach area (abdomen), except for 5 cm around the navel (belly button).
Slovenian: ● trebuh - razen v predel 5 cm okrog popka,
English: Thrombotic microangiopathy associated with Hemlibra and activated prothrombin complex concentrate
Slovenian: Trombotična mikroangiopatija, povezana z zdravilom Hemlibra in koncentratom aktiviranega protrombinskega kompleksa (aPCC)
English: In total three patients (0.8 %) in the clinical trials receiving Hemlibra prophylaxis withdrew from treatment due to ADRs, which were TMA, skin necrosis contemporaneous with superficial thrombophlebitis, and headache.
Slovenian: Iz kliničnih preskušanj so se zaradi neželenih učinkov umaknili skupno trije bolniki (0,8 %); ki so prejemali zdravilo Hemlibra za profilakso; ti neželeni učinki so bili TMA, nekroza kože s sočasnim povrhnjim tromboflebitisom ter glavobol.
English: ● headache
Slovenian: ● glavobol
English: Repeat steps A to D with each additional vial until you have more than the amount of medicine needed for your prescribed dose.
Slovenian: Ponavljajte korake od A do D z vsako dodatno vialo, dokler nimate količine, ki je večja od predpisanega odmerka.
English: Once transferred from the vial to the syringe, use Hemlibra straight away.
Slovenian: Po prenosu zdravila Hemlibra iz viale v brizgo zdravilo uporabite takoj.
English: ● Keep the vial on the flat working surface and insert the transfer needle and syringe straight down into the centre of the vial stopper.
Slovenian: ● Postavite vialo na ravno delovno površino in zabodite na brizgo nameščeno iglo za prenos naravnost navzdol skozi sredino zamaška viale.
English: Table 9 provides a summary of the comparison between the Hemlibra prophylaxis arm (Arm A) and the no prophylaxis arm (Arm B) on the Haem-A-QoL Total Score and Physical Health scale after 24 weeks of treatment adjusting for baseline.
Slovenian: Preglednica 9 prikazuje povzetek primerjave med skupino, ki je prejemala profilakso z zdravilom Hemlibra (skupina A), in skupino brez profilakse (skupina B) na celotno oceno na Haem-A-QoL in lestvico telesnega zdravja po 24 tednih s korekcijo za izhodiščno vrednost.
English: Physicians and patients/caregivers should weigh the benefits and risks of resuming Hemlibra prophylaxis following complete resolution of thrombotic events 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 po popolnem izginotju trombotičnega dogodka.
English: Hemlibra should be inspected visually to ensure there is no particulate matter or discolouration prior to administration.
Slovenian: Zdravilo Hemlibra je treba pred uporabo pregledati in se prepričati, da ne vsebuje delcev in da ni obarvano.
English: Patient's bodyweight of 16 kg, under a maintenance dose regimen of 1.5 mg/kg once weekly:
Slovenian: Bolnik s telesno maso 16 kg s shemo vzdrževalnega odmerka 1,5 mg/kg enkrat na teden:
English: Hemlibra solution is a sterile, preservative-free, and ready to use solution for subcutaneous injection that does not need to be diluted.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom Raztopina zdravila Hemlibra je sterilna, za uporabo pripravljena raztopina brez konzervansov za subkutano injiciranje, ki je ni treba razredčiti.
English: The solution should be colourless to slightly yellow.
Slovenian: Raztopina mora biti brezbarvna do rahlo rumenkasta.
English: Table 3 Characterisation of aPCC treatment* in the pooled phase III clinical studies
Slovenian: Opredelitev zdravljenja z aPCC* v združenih kliničnih študijah faze III Trajanje zdravljenja z aPCC
English: Hemlibra weekly prophylaxis was evaluated in a single-arm, multicentre, open-label clinical study in paediatric patients (age < 12 years old, or 12 to 17 years old weighing < 40 kg) with haemophilia A with factor VIII inhibitors.
Slovenian: Tedensko profilakso z zdravilom Hemlibra so ocenili v multicentrični, odprti klinični študiji z eno samo skupino pri pediatričnih bolnikih (starih < 12 let ali od 12 do 17 let in s telesno maso < 40 kg) s hemofilijo A in z inhibitorji faktorja VIII.
English: Blood and lymphatic system disorders Thrombotic microangiopathy Uncommon Nervous system disorders
Slovenian: Bolezni krvi in limfatičnega sistema trombotična mikroangiopatija občasni
English: Similar PK profiles were observed following once weekly dosing (3 mg/kg/week for 4 weeks followed by 1.5 mg/kg/week) in adults/adolescents (≥ 12 years) and children (< 12 years) (see Figure 1).
Slovenian: Po odmerjanju enkrat na teden (3 mg/kg/teden 4 tedne, nato 1,5 mg/kg/teden) so pri odraslih/mladostnikih (≥ 12 let) in otrocih (< 12 let) opazili podobna farmakokinetična profila (glejte sliko 1).
English: Disposing of the medicine and supplies:
Slovenian: Kako zavreči zdravilo in material:
English: Patients receiving Hemlibra prophylaxis should be monitored for the development of TMA when administering aPCC.
Slovenian: Bolnike, ki prejemajo profilakso z zdravilom Hemlibra, je treba v primeru uporabe aPCC nadzorovati glede TMA.
English: Instructions for Use Hemlibra Injection
Slovenian: ● Navodila za uporabo zdravila HEMLIBRA
English: Treated bleeds = bleeds treated with FVIII.
Slovenian: Zdravljene krvavitve = krvavitve, zdravljene s FVIII.
English: In pooled phase III clinical trials, thrombotic microangiopathy (TMA) events were reported in less than 1 % of patients (3/373) and in 9.7 % of patients (3/31) who received at least one dose of aPCC while being treated with emicizumab.
Slovenian: poročali pri manj kot 1 % bolnikov (3/373) ter pri 9,7 % bolnikov (3/31), ki so med zdravljenjem z emicizumabom prejeli vsaj en odmerek aPCC.
English: Modelling shows that less frequent dosing in patients with hypoalbuminemia and low body weight for their age results in lower emicizumab exposures; simulations indicate that these patients would still benefit from clinically meaningful bleed control.
Slovenian: Na modelih je bilo prikazano, da manj pogosto odmerjanje pri bolnikih s hipoalbuminemijo in majhno telesno maso za njihovo starost povzroči manjše izpostavljenosti emicizumabu; simulacije nakazujejo,
English: Step 9.
Slovenian: 9. korak.
English: Note: Ensure you have enough medicine in the syringe to complete your dose before moving onto the next steps.
Slovenian: Opomba: Poskrbite, da bo v brizgi dovolj zdravila za vaš celotni odmerek, preden nadaljujete z naslednjimi koraki.
English: Other objectives were to evaluate the clinical efficacy of Hemlibra prophylaxis on all bleeds, treated spontaneous bleeds, treated joint bleeds and treated target joint bleeds (see Table 8).
Slovenian: Drugi cilji so bili ocena klinične učinkovitosti profilakse z zdravilom Hemlibra na vse krvavitve, zdravljene spontane krvavitve, zdravljene krvavitve v sklepe in zdravljene krvavitve v tarčne sklepe (glejte preglednico 8).
English: ● Once removed from the refrigerator, the unopened vial can be kept at room temperature for up to 7 days.
Slovenian: ● Potem, ko vialo vzamete iz hladilnika, je lahko neodprta viala shranjena na sobni temperaturi do 7 dni.
English: A syringe, a transfer needle (or vial adapter), and an injection needle are needed to withdraw the Hemlibra solution from the vial to a syringe and inject it under the skin (see section 7, “Instructions for use”).
Slovenian: Kaj je potrebno za dajanje zdravila Hemlibra in ni priloženo v tem pakiranju Za odvzem raztopine zdravila Hemlibra iz viale v brizgo in za injiciranje pod kožo potrebujete injekcijsko brizgo, iglo za prenos (ali adapter za vialo) in iglo za injiciranje (glejte poglavje 7, "Navodila za uporabo").
English: Adults and Adolescents Efficacy Results
Slovenian: Rezultati učinkovitosti pri odraslih in mladostnikih
English: In case a bypassing agent is indicated in a patient receiving Hemlibra prophylaxis, see below for dosing guidance on the use of bypassing agents.
Slovenian: Če je pri bolniku, ki prejema profilakso z zdravilom Hemlibra, indicirano obvodno zdravilo, glejte smernice za uporabo obvodnih zdravil spodaj.
English: ● Using one hand, slide the transfer needle into the cap and scoop upwards to cover the needle.
Slovenian: ● Z eno roko vstavite iglo za prenos v pokrovček in potisnite navzgor, da boste iglo pokrili.
English: Do not recycle your used sharps disposal container.
Slovenian: Uporabljenega vsebnika za ostre odpadke ne uporabite ponovno.
English: Note: Ensure you have enough medicine in the syringe to complete your dose before moving onto the next step.
Slovenian: Opomba: Poskrbite, da bo v brizgi dovolj zdravila za vaš celotni odmerek, preden nadaljujete z naslednjim korakom.
English: Hemlibra should be used during pregnancy only if the potential benefit for the mother outweighs the potential risk to the fetus taking into account that, during pregnancy and after parturition, the risk for thrombosis is increased and that several pregnancy complications are linked to an increased risk for disseminated intravascular coagulation (DIC).
Slovenian: Pri tem je treba upoštevati, da se tveganje za trombozo med nosečnostjo in po porodu poveča in da je več zapletov med nosečnostjo povezanih z večjim tveganjem za diseminirano intravaskularno koagulacijo
English: For each treatment arm, the mean exposure times (+SD) were 28.86 weeks (8.37) for Arm A, 8.79 (3.62) for Arm B, 21.56 (11.85) for Arm C and 7.08 (3.89) for Arm D. One patient in Arm A withdrew from study prior to initiation of Hemlibra.
Slovenian: (3,62) v skupini B, 21,56 (11,85) v skupini C in 7,08 (3,89) v skupini D. En bolnik v skupini A se je iz študije umaknil pred uvedbo zdravila Hemlibra.
English: ● This medicine has been prescribed for you only.
Slovenian: ● Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: Both serious thrombotic events 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.
Slovenian: Oba resna trombotična dogodka sta se pojavila, ko je bila med zdravljenjem uporabljena povprečna kumulativna količina > 100 e./kg/24 ur aPCC 24 ur ali več.
English: There are no data in patients less than 1 year of age.
Slovenian: Pri otrocih, mlajših od 1 leta, ni podatkov.
English: ● Keep the vial adapter attached to the syringe and turn the vial upside down.
Slovenian: ● Brizgo pustite nameščeno na adapter za vialo in vialo obrnite navzdol.
English: Each vial of Hemlibra contains 60 mg (0.4 mL at a concentration of 150 mg/mL), 105 mg (0.7 mL at a concentration of 150 mg/mL) or 150 mg (1 mL at a concentration of 150 mg/mL) of emicizumab.
Slovenian: Ena viala zdravila Hemlibra vsebuje 60 mg (0,4 ml s koncentracijo 150 mg/ml), 105 mg (0,7 ml s koncentracijo 150 mg/ml) ali 150 mg (1 ml s koncentracijo 150 mg/ml) emicizumaba.
English: For injection amount between 1 mL and 2 mL use a 2 mL or 3 mL syringe.
Slovenian: Za injiciranje količine od 1 ml do 2 ml uporabite 2-ml ali 3-ml brizgo.
English: Criteria: Stainless steel with Luer-lock connection, gauge 26 G (acceptable range: 25-27 gauge), length preferably 9 mm (3/8″) or maximally 13mm (½″), preferably including needle safety feature.
Slovenian: Merila: Izdelana 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 varnostnim pripomočkom za iglo.
English: ● Do not give injections where the skin is red, bruised, tender, hard, or areas where there are moles or scars.
Slovenian: ● Zdravila ne injicirajte na mestih, kjer je koža pordela, podpluta, občutljiva, zatrdela, ali kjer so na njej znamenja ali brazgotine.
English: Hemlibra prophylaxis (N = 18)
Slovenian: Profilaksa z zdravilom Hemlibra (n = 18)
English: ● When your sharps disposal container is almost full, you will need to follow your local guidelines for the right way to dispose of your sharps disposal container.
Slovenian: ● Ko je vsebnik za ostre odpadke skoraj poln, ga zavrzite v skladu z lokalnimi smernicami za odstranjevanje takšnih odpadkov.
English: ● Do not freeze.
Slovenian: ● Ne zamrzujte.
English: The effect of age on the pharmacokinetics of emicizumab was assessed in a population pharmacokinetic analysis which included 5 infants (≥ 1 month to < 2 years), 55 children (less than 12 years) and 50 adolescents (12 to < 18 years) with haemophilia A. Age did not affect the pharmacokinetics of emicizumab in paediatric patients.
Slovenian: Pediatrični bolniki Vpliv starosti na farmakokinetiko emicizumaba so ocenili v populacijski farmakokinetični analizi, ki je zajela 5 dojenčkov (≥ 1 mesec do < 2 leti), 55 otrok (starih manj kot 12 let) in 50 mladostnikov (starih od 12 do 18 let) s hemofilijo A.
English: Due to the short half-life of bypassing agents, no carryover effect is assumed after it's discontinuation.
Slovenian: Zaradi kratkega razpolovnega časa obvodnih zdravil se po prenehanju zdravljenja z njimi ne predvideva učinek prenosa.
English: Preclinical data reveal no special hazards for humans based on studies of acute and repeated dose toxicity, including safety pharmacology endpoints and endpoints for reproductive toxicity.
Slovenian: 5.3 Predklinični podatki o varnosti Predklinični podatki na osnovi akutne toksičnosti in toksičnosti ponavljajočih se odmerkov, vključno z opazovanimi dogodki varnostne farmakologije in opazovanimi dogodki glede sposobnosti razmnoževanja, ne kažejo posebnega tveganja za človeka.
English: In pooled phase III clinical trials, serious thrombotic events were reported in less than 1 % of patients (2/373) and in 6.5 % of patients (2/31) who received at least one dose of aPCC while being treated with emicizumab.
Slovenian: 1 % bolnikov (2/373) ter pri 6,5 % bolnikov (2/31), ki so med zdravljenjem z emicizumabom prejeli vsaj en odmerek aPCC.
English: ● Maintenance dose regimen: Week 5 and onwards: The dose is either 1.5 milligrams for every 1 kilogram you weigh, injected once a week, 3 milligrams for every 1 kilogram you weigh, injected every 2 weeks, or 6 milligrams for every 1 kilogram you weigh, injected every 4 weeks.
Slovenian: ● Režim vzdrževalnega odmerka: 5. teden in pozneje: Odmerek je 1,5 miligrama na 1 kilogram telesne mase, injiciran enkrat na teden, ali 3 miligrame na 1 kilogram telesne mase, injiciran enkrat na 2 tedna, ali 6 miligramov na 1 kilogram telesne mase, injiciran enkrat na 4 tedne.
English: the cap covering the stopper is missing.
Slovenian: če manjka pokrovček, ki pokriva zamašek.
English: ● Do not touch the needle tip or allow it to touch any surface.
Slovenian: ● Ne dotikajte se konice igle in pazite, da se z njo česa ne dotaknete.
English: Throw away any used syringes and needles.
Slovenian: Vse uporabljene brizge in igle zavrzite.
English: ● With the needle pointing upwards, inject the air from the syringe above the medicine.
Slovenian: ● Medtem, ko igla gleda navzgor, potisnite zrak iz brizge nad zdravilo.
English: ● The active substance is emicizumab.
Slovenian: ● Učinkovina je emicizumab.
English: Patients have had surgical procedures without discontinuing emicizumab prophylaxis in clinical trials.
Slovenian: Bolniki so imeli v kliničnih preskušanjih operativne posege, ne da bi prekinili profilakso z emicizumabom.
English: Do not use Hemlibra:
Slovenian: ● Viale ne uporabite:
English: This is because treatment with bypassing agents may need to change while receiving Hemlibra.
Slovenian: Zdravljenje z obvodnimi zdravili bo morda treba med zdravljenjem z zdravilom Hemlibra spremeniti.
English: ● Throw away the vial cap(s) into the sharps disposal container.
Slovenian: ● Zavrzite pokrovček vial(e) v vsebnik za ostre odpadke.
English: ● blood clot in a vein near the surface of the skin (superficial thrombophlebitis)
Slovenian: ● huda okvara kožnega tkiva (nekroza kože) ● krvni strdek v veni blizu površine kože (povrhnji tromboflebitis)
English: Patients (aged ≥ 12 years old) with haemophilia A with or without factor VIII inhibitors (Study BO39182 - HAVEN 4)
Slovenian: Bolniki (≥ 12 let) s hemofilijo A z inhibitorji faktorja VIII ali brez njih (študija BO39182 - HAVEN 4)
English: ● Using a bypassing agent while receiving Hemlibra Before you start using Hemlibra, talk to your doctor and carefully follow their instructions on when to use a bypassing agent and the dose and schedule you should use.
Slovenian: Preden začnete uporabljati zdravilo Hemlibra, se posvetujte z zdravnikom in natančno upoštevajte njegova navodila o tem, kdaj naj uporabite obvodno zdravilo,
English: ● Throw away the used transfer needle into a sharps disposal container.
Slovenian: ● Uporabljeno iglo za prenos zavrzite v vsebnik za ostre odpadke.
English: ● Remove and throw away the plastic blister pack.
Slovenian: ● Odstranite plastični pretisni omot in ga zavrzite.
English: ● Hold the syringe with the needle pointing up and slowly push the plunger to your prescribed dose.
Slovenian: ● Brizgo držite tako, da bo igla usmerjena navzgor, in bat počasi potisnite navzgor do svojega predpisanega odmerka.
English: The predicted mean (±SD) Ctrough ,and Cmax and ratios of Cmax/Ctrough at steady- state for the recommended maintenance doses of 1.5 mg/kg once weekly, 3 mg/kg every two weeks or 6 mg/kg every four weeks are shown in Table 14 .
Slovenian: Predvidena povprečna (± std. odklon) Ctrough, Cmax in razmerje Cmax/Ctrough v stanju dinamičnega ravnovesja med uporabo priporočenih vzdrževalnih odmerkov 1,5 mg/kg enkrat na teden, 3 mg/kg na dva tedna in 6 mg/kg na štiri tedne so prikazani v preglednici 14.
English: ● Remove the syringe and transfer needle from the vial.
Slovenian: ● Potegnite brizgo in iglo za prenos iz viale.
English: The decision, to use either the 1.5 mg/kg once weekly, 3 mg/kg every two weeks, or 6 mg/kg every four weeks maintenance dose, should be made in consultation with your doctor and, where applicable, with your caregiver.
Slovenian: Odločitev za uporabo vzdrževalnega odmerka 1,5 mg/kg enkrat na teden ali 3 mg/kg enkrat na dva tedna ali 6 mg/kg enkrat na štiri tedne je treba sprejeti po posvetu z zdravnikom in, če je potrebno,
English: - can be closed with a tight-fitting, puncture resistant lid, without sharps being able to come out.
Slovenian: - imeti povsem prilegajoč se, proti prebadanju odporen pokrov, s katerim ga je mogoče zapreti brez možnosti, da bi ostri odpadki prišli iz njega.
English: syringe.
Slovenian: Hemlibra.
English: In the study, patients received weekly Hemlibra prophylaxis (Arms A, C, and D) - 3 mg/kg once weekly for four weeks followed by 1.5 mg/kg once weekly thereafter - or no prophylaxis (Arm B).
Slovenian: V študiji so bolniki prejemali tedensko profilakso z zdravilom Hemlibra (skupine A, C in D) - 3 mg/kg enkrat na teden štiri tedne in nato 1,5 mg/kg enkrat na teden v nadaljevanju - ali pa nobene profilakse (skupina B).
English: ● If the amount of medicine in the syringe is now at or below your prescribed dose, slowly pull back the plunger until you have more than the amount of medicine needed for your prescribed dose.
Slovenian: ● Če je v brizgi zdaj toliko ali manj zdravila, kot ga potrebujete za predpisani odmerek, počasi izvlecite bat, dokler ni količina zdravila v brizgi večja od količine, potrebne za predpisani odmerek.
English: ● Patient/Carer educational material
Slovenian: ● Izobraževalno gradivo za bolnike/skrbnike
English: The recommended dose is 3 mg/kg once weekly for the first 4 weeks (loading dose), followed by maintenance dose of either 1.5 mg/kg once weekly, 3 mg/kg every two weeks, or 6 mg/kg every four weeks , all doses administered as a subcutaneous injection.
Slovenian: Priporočeni odmerek zdravila Hemlibra je 3 mg/kg enkrat na teden prve 4 tedne (polnilni odmerek) in nato vzdrževalni odmerek bodisi 1,5 mg/kg enkrat na teden, 3 mg/kg enkrat na dva tedna ali 6 mg/kg enkrat na štiri tedne; vsi odmerki se dajejo v obliki subkutane injekcije.
English: Step 1.
Slovenian: 1. korak.
English: Patients receiving Hemlibra prophylaxis should be monitored for the development of thromboembolism when administering aPCC.
Slovenian: Bolnike, ki prejemajo profilakso z zdravilom Hemlibra, je treba v primeru uporabe aPCC nadzorovati glede trombembolij.
English: Patients (aged ≥ 12 years old) with haemophilia A with factor VIII inhibitors (Study BH29884HAVEN 1)
Slovenian: Bolniki (stari ≥ 12 let) s hemofilijo A z inhibitorji faktorja VIII (študija BH29884 - HAVEN 1)