natgillin/translations-raw huggingface dataset:
Treated bleeds = bleeds treated with FVIII.
Zdravljene krvavitve = krvavitve, zdravljene s FVIII.
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.
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.
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.
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,
Step 9.
9. korak.
Note: Ensure you have enough medicine in the syringe to complete your dose before moving onto the next steps.
Opomba: Poskrbite, da bo v brizgi dovolj zdravila za vaš celotni odmerek, preden nadaljujete z naslednjimi koraki.
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).
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).
● Once removed from the refrigerator, the unopened vial can be kept at room temperature for up to 7 days.
● Potem, ko vialo vzamete iz hladilnika, je lahko neodprta viala shranjena na sobni temperaturi do 7 dni.
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”).
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").
Adults and Adolescents Efficacy Results
Rezultati učinkovitosti pri odraslih in mladostnikih
In case a bypassing agent is indicated in a patient receiving Hemlibra prophylaxis, see below for dosing guidance on the use of bypassing agents.
Če je pri bolniku, ki prejema profilakso z zdravilom Hemlibra, indicirano obvodno zdravilo, glejte smernice za uporabo obvodnih zdravil spodaj.
● Using one hand, slide the transfer needle into the cap and scoop upwards to cover the needle.
● Z eno roko vstavite iglo za prenos v pokrovček in potisnite navzgor, da boste iglo pokrili.
Do not recycle your used sharps disposal container.
Uporabljenega vsebnika za ostre odpadke ne uporabite ponovno.
Note: Ensure you have enough medicine in the syringe to complete your dose before moving onto the next step.
Opomba: Poskrbite, da bo v brizgi dovolj zdravila za vaš celotni odmerek, preden nadaljujete z naslednjim korakom.
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).
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
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.
(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.
● This medicine has been prescribed for you only.
● Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
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.
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.
There are no data in patients less than 1 year of age.
Pri otrocih, mlajših od 1 leta, ni podatkov.
● Keep the vial adapter attached to the syringe and turn the vial upside down.
● Brizgo pustite nameščeno na adapter za vialo in vialo obrnite navzdol.
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.
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.
For injection amount between 1 mL and 2 mL use a 2 mL or 3 mL syringe.
Za injiciranje količine od 1 ml do 2 ml uporabite 2-ml ali 3-ml brizgo.
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.
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.
● Do not give injections where the skin is red, bruised, tender, hard, or areas where there are moles or scars.
● Zdravila ne injicirajte na mestih, kjer je koža pordela, podpluta, občutljiva, zatrdela, ali kjer so na njej znamenja ali brazgotine.
Hemlibra prophylaxis (N = 18)
Profilaksa z zdravilom Hemlibra (n = 18)
● 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.
● Ko je vsebnik za ostre odpadke skoraj poln, ga zavrzite v skladu z lokalnimi smernicami za odstranjevanje takšnih odpadkov.
● Do not freeze.
● Ne zamrzujte.
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.
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.
Due to the short half-life of bypassing agents, no carryover effect is assumed after it's discontinuation.
Zaradi kratkega razpolovnega časa obvodnih zdravil se po prenehanju zdravljenja z njimi ne predvideva učinek prenosa.
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.
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.
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.
1 % bolnikov (2/373) ter pri 6,5 % bolnikov (2/31), ki so med zdravljenjem z emicizumabom prejeli vsaj en odmerek aPCC.
● 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.
● 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.
the cap covering the stopper is missing.
če manjka pokrovček, ki pokriva zamašek.
● Do not touch the needle tip or allow it to touch any surface.
● Ne dotikajte se konice igle in pazite, da se z njo česa ne dotaknete.
Throw away any used syringes and needles.
Vse uporabljene brizge in igle zavrzite.
● With the needle pointing upwards, inject the air from the syringe above the medicine.
● Medtem, ko igla gleda navzgor, potisnite zrak iz brizge nad zdravilo.
● The active substance is emicizumab.
● Učinkovina je emicizumab.
Patients have had surgical procedures without discontinuing emicizumab prophylaxis in clinical trials.
Bolniki so imeli v kliničnih preskušanjih operativne posege, ne da bi prekinili profilakso z emicizumabom.
Do not use Hemlibra:
● Viale ne uporabite:
This is because treatment with bypassing agents may need to change while receiving Hemlibra.
Zdravljenje z obvodnimi zdravili bo morda treba med zdravljenjem z zdravilom Hemlibra spremeniti.
● Throw away the vial cap(s) into the sharps disposal container.
● Zavrzite pokrovček vial(e) v vsebnik za ostre odpadke.
● blood clot in a vein near the surface of the skin (superficial thrombophlebitis)
● huda okvara kožnega tkiva (nekroza kože) ● krvni strdek v veni blizu površine kože (povrhnji tromboflebitis)
Patients (aged ≥ 12 years old) with haemophilia A with or without factor VIII inhibitors (Study BO39182 - HAVEN 4)
Bolniki (≥ 12 let) s hemofilijo A z inhibitorji faktorja VIII ali brez njih (študija BO39182 - HAVEN 4)
● 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.
Preden začnete uporabljati zdravilo Hemlibra, se posvetujte z zdravnikom in natančno upoštevajte njegova navodila o tem, kdaj naj uporabite obvodno zdravilo,
● Throw away the used transfer needle into a sharps disposal container.
● Uporabljeno iglo za prenos zavrzite v vsebnik za ostre odpadke.
● Remove and throw away the plastic blister pack.
● Odstranite plastični pretisni omot in ga zavrzite.
● Hold the syringe with the needle pointing up and slowly push the plunger to your prescribed dose.
● Brizgo držite tako, da bo igla usmerjena navzgor, in bat počasi potisnite navzgor do svojega predpisanega odmerka.
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 .
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.
● Remove the syringe and transfer needle from the vial.
● Potegnite brizgo in iglo za prenos iz viale.
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.
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,
- can be closed with a tight-fitting, puncture resistant lid, without sharps being able to come out.
- imeti povsem prilegajoč se, proti prebadanju odporen pokrov, s katerim ga je mogoče zapreti brez možnosti, da bi ostri odpadki prišli iz njega.
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).
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).
● 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.
● 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.
● Patient/Carer educational material
● Izobraževalno gradivo za bolnike/skrbnike
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.
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.
Patients receiving Hemlibra prophylaxis should be monitored for the development of thromboembolism when administering aPCC.
Bolnike, ki prejemajo profilakso z zdravilom Hemlibra, je treba v primeru uporabe aPCC nadzorovati glede trombembolij.
Patients (aged ≥ 12 years old) with haemophilia A with factor VIII inhibitors (Study BH29884HAVEN 1)
Bolniki (stari ≥ 12 let) s hemofilijo A z inhibitorji faktorja VIII (študija BH29884 - HAVEN 1)
What you need to know before you use Hemlibra
Kaj morate vedeti, preden boste uporabili zdravilo Hemlibra Ne uporabljajte zdravila Hemlibra:
● Slowly pull back on the plunger and draw air into the syringe that is the same amount as your prescribed dose.
● Počasi izvlecite bat in potegnite v brizgo toliko zraka, kot ustreza količini vašega predpisanega odmerka.
Once removed from the refrigerator, unopened vials can be kept at room temperature (below 30°C) for up to 7 days.
Ko neodprte viale vzamete iz hladilnika, so lahko shranjene na sobni temperaturi (do 30 °C) do 7 dni.
A volume greater than 2 mL per injection should not be administered.
Ne sme se uporabiti volumna, večjega od 2 ml na injekcijo.
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).
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).
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).
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).
● 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.
● 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.
Patients received Hemlibra prophylaxis at 3 mg/kg once weekly for the first 4 weeks followed by 1.5 mg/kg once weekly thereafter.
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.
6.1 List of excipients
6.1 Seznam pomožnih snov
Clinically meaningful difference: VAS: 7 points, Index Utility Score: 0.07 points
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.
● If you have any further questions, ask your doctor, pharmacist or nurse.
● Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
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.
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).
2.INJECTION
INJICIRANJE
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).
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).
Remove vial cap and clean top
Odstranite pokrovček viale in očistite njen vrhnji del
- 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.
- 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;
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).
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).
Step 10.
10. korak.
Thrombotic microangiopathy b Thrombotic event
Trombotična mikroangiopatija b
HAVEN 2 Health-Related Outcomes
Zdravstveni izidi v študiji HAVEN 2
● 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.
● 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.
Only patients who participated in the NIS and in study HAVEN 2 are included.
Vključeni so le bolniki, ki so sodelovali v neintervencijski študiji in v študiji HAVEN 2.
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.
Pri bolnikih, ki prejemajo emicizumab, je treba upoštevati možnost trombotičnih dogodkov, če se sistemski antifibrinolitiki uporabljajo v kombinaciji z aPCC ali rFVIIa.
● haemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors
● hemofilijo A (prirojenim pomanjkanjem faktorja VIII) z inhibitorji faktorja VIII,
HAVEN 1 Health Status Outcomes
Izidi zdravstvenega statusa v študiji HAVEN 1
Remove syringe from vial adapter
Brizgo snemite z adapterja za vialo
Do not hold or push on the plunger while inserting the needle.
Ne držite in ne pritiskajte bata, medtem ko zabadate iglo.
● Polycarbonate with Luer-lock connection, sterile, fitting 15 mm vial neck outer diameter, single-use, latex-free and non-pyrogenic.
● Polikarbonatni, z Luer-lock nastavkom, sterilni, ki se prilegajo 15-mm zunanjemu premeru vratu vial, za enkratno uporabo, brez lateksa in apirogeni.
● 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.
● Ko imate novo vialo postavljeno na ravno delovno površino, vanjo zabodite na brizgi nameščeno novo iglo za prenos naravnost navzdol skozi sredino zamaška viale.
● Guide for Laboratory Professionals
● Vodnik za laboratorijske delavce
Administration of Hemlibra subcutaneous injection in the upper outer arm should be performed by a caregiver or healthcare professional.
V zunanji del nadlahti mora zdravilo Hemlibra subkutano injicirati bolnikov skrbnik ali zdravstveni delavec.
● 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.
Opomba: Če morate za predpisani odmerek uporabiti več kot 1 vialo, morate za vsako vialo uporabiti nov alkoholni listič.
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.
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).
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.
Glavobol, omrtvičenost obraza, bolečina ali oteklost očesa ali težave z vidom - ti simptomi so lahko znaki krvnega strdka v veni za očesom.
Mild renal impairment did not affect the pharmacokinetics of emicizumab.
Blaga okvara ledvic ni vplivala na farmakokinetiko emicizumaba.
Step 15.
15. korak.
Step 11.
11. korak.
Do not use the syringe if the needle touches any surface
Injekcijske brizge ne uporabite, če se igla dotakne česar koli.
Slowly push the plunger to push the large air bubbles out of the syringe.
Počasi potisnite bat navzgor, da boste iz brizge iztisnili zračne mehurčke.
Arm B: no prophylaxis (N=14)
Skupina B: brez profilakse (n = 14)
Vial Adapter
Adapter za vialo
What Hemlibra contains
Kaj vsebuje zdravilo Hemlibra
Emicizumab has not been studied in patients with severe renal or hepatic impairment
Emicizumaba pri bolnikih s hudo okvaro ledvic ali jeter niso preskušali.
Only patients who participated in the NIS and in study HAVEN 1 are included.
Vključeni so le bolniki, ki so sodelovali v neintervencijski študiji in v študiji HAVEN 1.
Arm B: no prophylaxis (N=16)
Skupina B: brez profilakse (n = 16)