natgillin/translations-raw huggingface dataset:
Tell your doctor if you are using Hemlibra before you have laboratory tests to measure how well your blood is clotting.
Laboratorijske preiskave Zdravnika morate obvestiti, da uporabljate zdravilo Hemlibra, preden opravite laboratorijske preiskave, ki merijo strjevanje krvi.
This belongs to a group of medicines called “monoclonal antibodies”.
imenovanih "monoklonska protitelesa".
Caution should be used when treating patients who are at high risk for TMA (e.g. have a previous medical history or family history of TMA), or those who are receiving concomitant medications known to be a risk factor for the development of TMA (e.g. ciclosporin, quinine, tacrolimus).
Pri zdravljenju bolnikov z visokim tveganjem za TMA (npr. s predhodno anamnezo ali družinsko anamnezo TMA) ali tistih, ki sočasno prejemajo zdravila, za katera je znano, da je njihovo jemanje dejavnik tveganja za razvoj TMA (npr. ciklosporin, kinin, takrolimus), je potrebna previdnost.
Do not inject into moles, scars, bruises, or areas where the skin is tender, red, hard or the skin is broken.
Ne injicirajte v znamenja, brazgotine, podplute predele ali predele, kjer je koža občutljiva, pordela, trda ali razpokana.
● Collect all supplies listed below to prepare and give your injection.
● Za pripravo injekcije in injiciranje zdravila zberite ves spodaj našteti material.
Do not use the transfer needle to inject medicine as this may cause harm such as pain and bleeding.
Igle za prenos ne uporabljajte za injiciranje zdravila, ker vam lahko to škoduje, na primer povzroči bolečine in krvavitev.
For injection, you can use your:
Injicirate lahko v:
Hemlibra is provided in single-use vials as ready to use solution which does not need to be diluted.
Kako uporabljati zdravilo Hemlibra Zdravilo Hemlibra je na voljo v vialah za enkratno uporabo kot že pripravljena raztopina, ki je ni treba razredčiti.
● Vial containing the medicine
● Vialo z zdravilom
● Firmly press down the plastic blister pack with the vial adapter onto the new vial at an angle, until you hear a ‘click'.
● Trdno pritisnite plastični pretisni omot z adapterjem za vialo na novo vialo pod kotom, dokler ne zaslišite "klik".
Guidance on the use of bypassing agents in patients receiving Hemlibra prophylaxis
Smernice za uporabo obvodnih zdravil pri bolnikih, ki prejemajo profilakso z zdravilom Hemlibra
● When using Hemlibra, any other medicine injected under the skin should be given in a different area.
● Ko uporabljate zdravilo Hemlibra, je treba vsa druga zdravila za podkožno injiciranje dati na drugem mestu.
Cavg, ss = average concentration at steady state; Cmax, ss = maximum plasma concentration at steady state; Ctrough, ss = trough concentration at steady state; QW = once weekly; Q2W = every two weeks; Q4W = every four weeks.
Cavg, ss = povprečna koncentracija v stanju dinamičnega ravnovesja; Cmax, ss = največja koncentracija v plazmi v stanju dinamičnega ravnovesja; Ctrough, ss = najmanjša koncentracija v plazmi pred naslednjim odmerkom v stanju dinamičnega ravnovesja;
The efficacy of Hemlibra for routine prophylaxis in patients with hemophilia A with or without FVIII inhibitors was evaluated in four clinical studies (three adult and adolescent studies [HAVEN 3, HAVEN 1, and HAVEN 4] and a paediatric study [HAVEN 2]).
Učinkovitost zdravila Hemlibra za rutinsko profilakso pri bolnikih s hemofilijo A z inhibitorji FVIII ali brez njih so ocenili v štirih kliničnih študijah (treh študijah pri odraslih in mladostnikih [HAVEN 3,
The primary objective of the study was to evaluate in patients previously treated with episodic FVIII the efficacy of prophylactic Hemlibra weekly (Arm A) or every two weeks (Arm B) compared to no prophylaxis (Arm C) based on the number of bleeds requiring treatment with coagulation factors (see Table 4).
Primarni cilj študije je bil med bolniki, predhodno občasno zdravljenimi s FVIII, oceniti učinkovitost profilaktične uporabe zdravila Hemlibra vsak teden (skupina A) ali vsaka dva tedna (skupina B) v primerjavi z bolniki brez profilakse (skupina C) na podlagi števila krvavitev, ki so zahtevale zdravljenje s koagulacijskimi faktorji (glejte preglednico 4).
No dose adjustments are recommended in paediatric patients (see section 5.2).
Pediatrični bolniki Za pediatrične bolnike ni priporočenih prilagoditev odmerjanja (glejte poglavje 5.2).
% Zero Bleeds (95% CI) bN = 59
% brez krvavitev (95-% IZ) bn = 59
Treatment should be initiated under the supervision of a physician experienced in the treatment of haemophilia and/or bleeding disorders.
4.2 Odmerjanje in način uporabe Zdravljenje je treba začeti pod nadzorom zdravnika, ki ima izkušnje z zdravljenjem hemofilije in/ali drugih motenj strjevanja krvi.
● Physician educational material
● Izobraževalno gradivo za zdravnike
● Blood clots (thromboembolism): swelling, warmth, pain or redness - these symptoms may be signs of a blood clot in a vein near the surface of the skin.
Oteklost, toplota, bolečina ali rdečina - ti simptomi so lahko znaki krvnega strdka v veni blizu površine kože.
Relative bioavailability decreased with older age, but no clinically important differences were observed in the pharmacokinetics of emicizumab between subjects < 65 years and subjects ≥ 65 years.
Relativna biološka uporabnost se je s starostjo zmanjšala, vendar med preiskovanci, starimi < 65 let, in preiskovanci, starimi ≥ 65 let, niso opazili klinično pomembnih razlik v farmakokinetiki emicizumaba.
What Hemlibra looks like and contents of the pack
Izgled zdravila Hemlibra in vsebina pakiranja
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
D. POGOJI ALI OMEJITVE V ZVEZI Z VARNO IN UČINKOVITO UPORABO
Reversible hemorrhage, perivascular mononuclear cell infiltration, degeneration/necrosis of subcutis and swelling of endothelium in the subcutis was noted in animals after subcutaneous injection.
Po subkutanem injiciranju so pri živalih opazili reverzibilno krvavitev, perivaskularno infiltracijo z mononuklearnimi celicami, degeneracijo/nekrozo podkožja in edem endotelija v podkožju.
It is a colourless to slightly yellow liquid.
● Je brezbarvna do rumenkasta tekočina.
● destruction of red blood cells (thrombotic microangiopathy)
● Propadanje rdečih krvnih celic (trombotična mikroangiopatija)
● The guide for laboratory professionals shall contain the following key messages: Chemical class, mode of action, pharmacodynamics and indication for emicizumab Information on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability and not accurately reflect the patient's underlying hemostatic status during emicizumab prophylaxis.
Kemijski razred, mehanizem delovanja, farmakodinamika in indikacija emicizumaba; Informacije, da emicizumab moti nekatere laboratorijske koagulacijske teste, kar vpliva na njihovo zanesljivost, in med profilakso z emicizumabom natančno ne odražajo bolnikovega osnovnega hemostatičnega statusa.
Previous bypassing agent treatment* (N = 18)
Predhodno zdravljenje z obvodnim zdravilom* (n = 18)
HRQoL for patients ages < 12 years was also evaluated at week 25 based on the Adapted InhibQoL with Aspects of Caregiver Burden questionnaire completed by caregivers (see Table 13).
Zdravstveno kakovost življenja bolnikov, mlajših od 12 let, so v 25. tednu ocenili tudi s prilagojenim vprašalnikom InhibQoL, ki upošteva vidike bremena skrbnikov (Adapted InhibQoL with Aspects of Caregiver Burden); ta vprašalnik so izpolnili bolnikovi skrbniki.
No TMA or thrombotic events were associated with the remaining instances of aPCC treatment.
Preostali primeri zdravljenja z aPCC niso bili povezani s TMA ali trombotičnimi dogodki.
In summary, intrinsic pathway clotting-based laboratory test results in patients treated with Hemlibra should not be used to monitor its activity, determine dosing for factor replacement or anti-coagulation, or measure factor VIII inhibitors titers.
Če povzamemo, se pri bolnikih, zdravljenih z zdravilom Hemlibra, ne sme uporabljati rezultatov laboratorijskih testov intrinzične poti strjevanja za nadzor aktivnosti, določanje odmerkov za nadomeščanje faktorja ali antikoagulacijo ali za merjenje titrov inhibitorjev faktorja VIII.
Important: Always keep the sharps disposal container out of reach of children.
Pomembno: Vsebnik za ostre odpadke vedno shranjujte nedosegljiv otrokom.
Patients exposed to emicizumab started with a loading dose of 3 mg/kg/week for 4 weeks.
Bolniki, izpostavljeni emicizumabu, so zdravljenje začeli s polnilnim odmerkom 3 mg/kg/teden za 4 tedne.
LIST OF EXCIPIENTS Excipients: L-Arginine, L-Histidine, L-Aspartic acid, Poloxamer 188, water for injections.
SEZNAM POMOŽNIH SNOVI Pomožne snovi: L-arginin, L-histidin, L-asparaginska kislina, poloksamer 188, voda za injekcije
Emicizumab restores the tenase cofactor activity of missing activated factor VIII (FVIIIa).
Vpliv emicizumaba na koagulacijske teste Emicizumab obnovi aktivnost tenaznega kofaktorja manjkajočega aktiviranega faktorja VIII (FVIIIa).
The amount of Hemlibra solution given in each injection must not be more than 2 mL
Količina raztopine zdravila Hemlibra, ki jo uporabite pri enem injiciranju, ne sme presegati 2 ml.
● Do not rub the injection site after injection.
● Mesta injiciranja po injiciranju ne drgnite.
Patients (aged ≥ 12 years old and > 40 kg) with hemophilia A without FVIII inhibitors (Study BH30071 - HAVEN 3)
Bolniki (stari ≥ 12 let s telesno maso > 40 kg) s hemofilijo A brez inhibitorjev FVIII (študija BH30071 - HAVEN 3)
Dose linearity
Linearnost glede na odmerek
Do not insert injection needle into vial adapter.
Igle za injiciranje ne vstavljajte v adapter za vialo.
Thromboembolism associated with Hemlibra and activated prothrombin complex concentrate
Trombembolija, povezana z zdravilom Hemlibra in koncentratom aktiviranega protrombinskega kompleksa
Do not use the transfer needle to inject medicine as this may cause pain and bleeding 2.
Igle za prenos ne uporabljajte za injiciranje zdravila, ker lahko to povzroči bolečino in krvavitev.
Throw away the syringe and needle.
Zavrzite brizgo in iglo
Do not throw the cap away.
Pokrovčka igle ne vrzite proč.
● Clean the chosen injection site area using an alcohol wipe.
● Očistite izbrani predel za injiciranje z alkoholnim lističem.
● Move the safety shield away from the needle and towards the syringe barrel.
● Pomaknite varnostni ščitnik z igle proti telesu brizge.
Note: You must use a new transfer needle each time you withdraw medicine from a new vial.
Opomba: Vsakokrat, ko jemljete zdravilo iz nove viale, morate uporabiti novo iglo za prenos.
The total time the medicine is stored at room temperature should not be more than 7 days.
Celotni čas, med katerim je zdravilo shranjeno na sobni temperaturi, skupaj ne sme preseči 7 dni.
The exposure (Cavg, ss) of multiple doses is comparable between 1.5 mg/kg every week, 3mg/kg every 2 weeks and 6mg/kg dose every 4 weeks.
Izpostavljenost (Cavg, ss) večkratnim odmerkom je primerljiva med odmerki 1,5 mg/kg enkrat na teden, 3 mg/kg enkrat na 2 tedna in 6 mg/kg enkrat na 4 tedne.
There are limited data available on the use of Hemlibra in patients with moderate renal impairment (only 2 patients with CLcr of 30-59 mL/min) and no data in patients with severe renal impairment.
Podatkov o uporabi zdravila Hemlibra pri bolnikih z zmerno okvaro ledvic je malo (le dva bolnika z očistkom kreatinina v območju od 30 do 59 ml/min), pri bolnikih s hudo okvaro ledvic pa jih ni. O vplivu zmerne in hude okvare ledvic na farmakokinetiko emicizumaba ne moremo sklepati.
● Laboratory professionals educational material
● Izobraževalno gradivo za laboratorijske delavce
● Clean the top of the vial(s) stopper with an alcohol wipe.
● Očistite zamašek vial(e) z alkoholnim lističem.
Table 10 provides a summary of the comparison between the Hemlibra prophylaxis arm (Arm A) and the no prophylaxis arm (Arm B) on the EQ-5D-5L index utility scale and visual analog scale after 24 weeks of treatment adjusting for baseline.
Preglednica 10 prikazuje povzetek primerjav med skupino, ki je prejemala profilakso z zdravilom Hemlibra (skupina A), in skupino brez profilakse (skupina B) na indeksno oceno koristnosti in vizualno analogno skalo EQ-5D-5L po 24 tednih s korekcijo za izhodiščno vrednost.
Although a higher adherence was observed with emicizumab prophylaxis than with prior FVIII prophylaxis, no difference in ABR in patients with ≥80% or < 80% compliant doses on FVIII prophylaxis according to standard label requirements could be identified (data to be interpreted with caution due to small sample sizes).
Čeprav so pri profilaksi z emicizumabom opazili večjo adherenco kot pri predhodni profilaksi s FVIII, razlike v na leto preračunanem deležu krvavitev pri bolnikih s komplianco profilakse s FVIII ≥ 80 % ali < 80 % glede na standardne zahteve predpisovanja, ni bilo mogoče določiti (podatke moramo zaradi majhnih velikosti vzorcev previdno interpretirati).
● Monitoring using a FVIII chromogenic assay may guide the administration of coagulation factors, and testing for thrombophilic traits may be considered.
● Nadomestno zdravljenje s koagulacijskimi faktorji lahko vodimo s pomočjo kromogenih testov aktivnosti FVIII, razmisliti pa velja tudi o testih za ugotavljanje morebitnih trombotičnih stanj.
● Keep the vial in the original box to protect the medicine from light.
● Vialo shranjujte v originalni škatli za zagotovitev zaščite pred svetlobo.
● Slowly pull back the plunger and draw some air into the syringe.
● Počasi izvlecite bat, da boste v brizgo potegnili nekaj zraka.
● Throw away the used vial/vial adapter into a sharps disposal container.
● Uporabljeno vialo/adapter za vialo zavrzite v vsebnik za ostre odpadke.
Transfer needle or vial adapter
Igla za prenos ali adapter za vialo
1.5 mg/kg once weekly 3 mg/kg every two weeks
1,5 mg/kg enkrat na teden 3 mg/kg na dva tedna 6 mg/kg na štiri tedne
There is limited experience with overdose of Hemlibra.
Izkušenj s prevelikim odmerjanjem zdravila Hemlibra je malo.
● If you forget your scheduled injection, inject the forgotten dose as soon as possible before the day of the next scheduled dose.
Če ste pozabili uporabiti zdravilo Hemlibra ● Če pozabite uporabiti injekcijo v skladu z urnikom, si pozabljeni odmerek injicirajte čim prej pred dnem, ko je po urniku na vrsti naslednji odmerek.
● Remove the needle and syringe from the injection site at the same angle as inserted.
● Izvlecite iglo in brizgo iz mesta injiciranja pod istim kotom, pod katerim ste jo zabodli.
Only the first five emicizumab doses had to be administered under supervision to ensure safety and injection technique proficiency.
Za zagotovitev varnosti in strokovnega znanja o tehniki injiciranja je bilo treba dajati pod nadzorom le prvih pet odmerkov emicizumaba.
- the cap covering the stopper is missing.
- če manjka pokrovček, ki pokriva zamašek.
Contents of the pack and other information Instructions for use
Shranjevanje zdravila Hemlibra Vsebina pakiranja in dodatne informacije Navodila za uporabo
Information on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability in the emicizumab setting and warning that these tests should not be used to monitor for emicizumab activity, determine need for factor replacement dosing, or measure FVIII inhibitors.
Informacije, da emicizumab moti nekatere laboratorijske koagulacijske teste, kar vpliva na njihovo zanesljivost med uporabo emicizumaba, in opozorilo, da se teh testov ne sme uporabljati za spremljanje aktivnosti emicizumaba, določanje potrebe po odmerkih za nadomeščanje faktorja ali za merjenje inhibitorjev faktorja VIII;
Only patients from the NIS were included in this comparison, because bleed and treatment data were collected with the same level of granularity as used in HAVEN 3.
ker so bili podatki o krvavitvah in zdravljenju zbrani enako podrobno kot v študiji HAVEN 3.
● 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.
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.
Therefore, the dose of bypassing agent required may be lower than the dose you used before starting Hemlibra.
Zato boste morda potrebovali manjši odmerek obvodnega zdravila, kot ste ga uporabljali pred začetkom zdravljenja z zdravilom Hemlibra.
● You should use an effective method of birth control (contraception) during treatment with Hemlibra and for 6 months after your last injection of Hemlibra.
● Med zdravljenjem z zdravilom Hemlibra in še 6 mesecev po zadnji injekciji zdravila Hemlibra morate uporabljati učinkovit način preprečevanja nosečnosti (kontracepcijo).
● severe haemophilia A (congenital factor VIII deficiency, FVIII < 1%) without factor VIII
● hudo hemofilijo A (prirojenim pomanjkanjem faktorja VIII, FVIII < 1 %) brez inhibitorjev faktorja VIII.
% reduction (RR), p-value
% zmanjšanje (RR), vrednost p neaplikabilno
There is a possibility for hypercoagulability with rFVIIa or FVIII with emicizumab based on preclinical experiments.
Na podlagi predkliničnih poskusov obstaja možnost hiperkoagulabilnosti z rFVIIa ali FVIII in emicizumabom.
Skin and subcutaneous tissue disorders Skin necrosis
Bolezni kože in podkožja nekroza kože občasni
The physician and the caregiver should determine the appropriateness of the child self-injecting Hemlibra.
Zdravnik in skrbnik morata skupaj ugotoviti, ali je primerno, da si otrok sam injicira zdravilo
There is limited experience with bypassing agent or FVIII use during surgeries and procedures.
Izkušenj z uporabo obvodnih zdravil ali FVIII med operacijami in posegi je malo.
The medicine prevents bleeding or reduces bleeding episodes in people with this condition.
To zdravilo pri bolnikih z omenjeno boleznijo preprečuje krvavitve ali zmanjša njihovo število.
Step A. Insert new vial adapter into new vial
Korak A. Na novo vialo namestite nov adapter za vialo
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).
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).
Vials that have been kept at room temperature for more than 7 days or exposed to temperatures above 30 °C should be discarded.
Viale, ki so bile shranjene na sobni temperaturi več kot 7 dni ali so bile izpostavljene temperaturam nad 30 °C, je treba zavreči.
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)
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)
● Stomach area (abdomen), except for 5 cm around the navel (belly button).
● trebuh - razen v predel 5 cm okrog popka,
Thrombotic microangiopathy associated with Hemlibra and activated prothrombin complex concentrate
Trombotična mikroangiopatija, povezana z zdravilom Hemlibra in koncentratom aktiviranega protrombinskega kompleksa (aPCC)
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.
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.
● headache
● glavobol
Repeat steps A to D with each additional vial until you have more than the amount of medicine needed for your prescribed dose.
Ponavljajte korake od A do D z vsako dodatno vialo, dokler nimate količine, ki je večja od predpisanega odmerka.
Once transferred from the vial to the syringe, use Hemlibra straight away.
Po prenosu zdravila Hemlibra iz viale v brizgo zdravilo uporabite takoj.
● Keep the vial on the flat working surface and insert the transfer needle and syringe straight down into the centre of the vial stopper.
● Postavite vialo na ravno delovno površino in zabodite na brizgo nameščeno iglo za prenos naravnost navzdol skozi sredino zamaška viale.
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.
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.
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.
Zdravniki in bolniki/skrbniki morajo za vsak primer posebej pretehtati koristi in tveganja nadaljnje profilakse z zdravilom Hemlibra po popolnem izginotju trombotičnega dogodka.
Hemlibra should be inspected visually to ensure there is no particulate matter or discolouration prior to administration.
Zdravilo Hemlibra je treba pred uporabo pregledati in se prepričati, da ne vsebuje delcev in da ni obarvano.
Patient's bodyweight of 16 kg, under a maintenance dose regimen of 1.5 mg/kg once weekly:
Bolnik s telesno maso 16 kg s shemo vzdrževalnega odmerka 1,5 mg/kg enkrat na teden:
Hemlibra solution is a sterile, preservative-free, and ready to use solution for subcutaneous injection that does not need to be diluted.
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.
The solution should be colourless to slightly yellow.
Raztopina mora biti brezbarvna do rahlo rumenkasta.
Table 3 Characterisation of aPCC treatment* in the pooled phase III clinical studies
Opredelitev zdravljenja z aPCC* v združenih kliničnih študijah faze III Trajanje zdravljenja z aPCC
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.
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.
Blood and lymphatic system disorders Thrombotic microangiopathy Uncommon Nervous system disorders
Bolezni krvi in limfatičnega sistema trombotična mikroangiopatija občasni
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).
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).
Disposing of the medicine and supplies:
Kako zavreči zdravilo in material:
Patients receiving Hemlibra prophylaxis should be monitored for the development of TMA when administering aPCC.
Bolnike, ki prejemajo profilakso z zdravilom Hemlibra, je treba v primeru uporabe aPCC nadzorovati glede TMA.
Instructions for Use Hemlibra Injection
● Navodila za uporabo zdravila HEMLIBRA