natgillin/translations-raw huggingface dataset:
If stored out of and then returned to refrigeration, the total combined time out of refrigeration should not exceed 7 days.
Če so shranjene zunaj hladilnika in jih nato daste nazaj v hladilnik, celotni čas zunaj hladilnika skupaj ne sme preseči
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).
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).
Table 11 HAVEN 2: Overview of efficacy (interim analysis)
Študija HAVEN 2: Pregled učinkovitosti (vmesna analiza) Opazovani dogodek aABR (95-% IZ)
The total aPCC dose should not exceed 100 U/kg in the first 24-hours of treatment.
24 urah zdravljenja ne sme preseči 100 e./kg.
Criteria for vial adapter: Polycarbonate with Luer-lock connection, sterile, fitting 15 mm vial neck outer diameter, single-use, latex-free and non-pyrogenic.
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.
● Use the syringes, vial adapters and injection needles only once.
● Brizge, adapterje za viale in igle za injiciranje uporabite le enkrat.
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.
Povzroča jo pomanjkanje faktorja VIII, bistvene snovi, potrebne za strjevanje krvi in zaustavitev krvavitev.
Patients received Hemlibra prophylaxis3 mg/kg once weekly for four weeks followed by 6 mg/kg every four weeks thereafter.
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.
Do not refrigerate the solution in the syringe.
Raztopine v brizgi ne shranjujte v hladilniku.
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).
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).
● Use the syringes, transfer needles and injection needles only once.
● Brizge, igle za prenos in igle za injiciranje uporabite le enkrat.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 105 mg/0.7 mL
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 105 mg/0,7 ml
Only patients who participated in the NIS and in study HAVEN 3 are included.
Vključeni so le bolniki, ki so sodelovali v neintervencijski študiji in v študiji HAVEN 3.
% patients with zero bleeds (95% CI)
% bolnikov z 0 krvavitvami (95-% IZ)
Step 12.
12. korak.
● Keep the needle in the vial and check the syringe for larger air bubbles.
● Brizgo pustite nameščeno na viali in preverite, ali so v njej prisotni večji zračni mehurčki.
● either haemophilia A who have developed factor VIII inhibitors
● hemofilijo A, pri katerih so se pojavili inhibitorji faktorja VIII ali
Step 17.
17. korak.
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.
Zdravniki in bolniki/skrbniki morajo za vsak primer posebej pretehtati koristi in tveganja nadaljnje profilakse z zdravilom Hemlibra, ko TMA popolnoma izzveni.
Step 14.
14. korak.
Hemlibra 30 mg/mL solution for injection 30 months.
Hemlibra 30 mg/ml raztopina za injiciranje 30 mesecev
What Hemlibra is and what it is used for
Kaj je zdravilo Hemlibra in za kaj ga uporabljamo Kaj je zdravilo Hemlibra
● Put your used vial adapters, needles and syringes in a sharps disposal container straight away after use.
● Uporabljene adapterje za viale, igle in brizge takoj po uporabi zavrzite v vsebnik za ostre odpadke.
Patient's bodyweight of 60 kg, under a maintenance dose regimen of 6 mg/kg every four weeks:
Bolnik s telesno maso 60 kg s shemo vzdrževalnega odmerka 6 mg/kg na štiri tedne:
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.
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.
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.
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.
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).
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).
For bypassing agent guidance refer to section 4.4.
Za smernice za uporabo obvodnih zdravil glejte poglavje 4.4.
● Blood clots (thromboembolism)
● Krvni strdki (trombembolija)
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.
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.
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 .
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.
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.
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).
No dedicated studies of the effect of renal impairment on the pharmacokinetics of emicizumab have been conducted.
Namenskih študij za ugotavljanje vpliva okvare ledvic na farmakokinetiko emicizumaba niso izvedli.
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.
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.
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).
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
Treated Bleeds
Zdravljene krvavitve
● Keep vials, vial adapters, needles and syringes out of the sight and reach of children.
● Viale, adapterje za viale, igle in brizge shranjujte nedosegljive otrokom!
15 minutes on a clean flat surface away from direct sunlight.
● Vialo/viale približno 15 minut pred uporabo pustite na čisti, ravni površini, zaščitene pred neposredno sončno svetlobo,
Hemlibra 150 mg/mL solution for injection 3 years.
Hemlibra 150 mg/ml raztopina za injiciranje 3 leta
● 2 to 3 mL syringe: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.1 mL.
● 2- do 3-ml brizga: prozorna polipropilenska ali polikarbonatna brizga z Luer-lock nastavkom in merilno skalo 0,1 ml.
Patients randomized to Arm B could switch to Hemlibra prophylaxis after completing at least 24 weeks without prophylaxis.
Hemlibra, potem ko so dokončali vsaj 24 tednov brez profilakse.
Each vial contains 105 mg emicizumab in 0.7 mL of solution for injection.
Ena viala vsebuje 105 mg emicizumaba v 0,7 ml raztopine za injiciranje.
● Carefully pull the injection needle cap straightaway from the syringe.
● Previdno potegnite pokrovček igle za injiciranje naravnost z brizge.
You must read, understand and follow the Instructions for Use before injecting Hemlibra.
Pred injiciranjem zdravila Hemlibra morate prebrati ta navodila za uporabo, jih razumeti in upoštevati.
● Do not insert the injection needle into vial adapter or use the injection needle to withdraw medicine from vial.
● Igle za injiciranje ne vstavljajte v adapter za vialo in je ne uporabljajte za jemanje zdravila iz viale.
INFORMATION IN BRAILLE hemlibra 105 mg
PODATKI V BRAILLOVI PISAVI hemlibra 105 mg
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).
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).
INFORMATION IN BRAILLE hemlibra 30 mg
PODATKI V BRAILLOVI PISAVI hemlibra 30 mg
One patient resumed Hemlibra following resolution of thrombotic event and continued to be treated safely.
Ko je trombotični dogodek izzvenel, je en bolnik ponovno začel zdravljenje z zdravilom Hemlibra in ga varno nadaljeval.
Criteria for transfer needle: Stainless steel with Luer-lock connection, gauge 18 G, length 35mm (1½″), preferably semi-blunted tip.
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.
● 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.
● 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
Table 1 Coagulation test results affected and unaffected by emicizumab
Koagulacijski testi, na katere emicizumab vpliva oziroma ne vpliva
● A 1 mL syringe should be used for an injection up to 1 mL of Hemlibra solution.
● Za injiciranje do 1 ml raztopine zdravila Hemlibra je treba uporabiti 1-ml brizgo.
The total amount time outside cold storage and at room temperature should not exceed 7 days.
Skupni čas, ko zdravilo ni shranjeno na hladnem in je na sobni temperaturi, ne sme preseči 7 dni.
Ask your healthcare provider if you have any questions.
Če imate kakšna vprašanja, se posvetujte z zdravnikom.
ABR (95% CI) % reduction (RR), p-value % patients with 0 bleeds (95% CI)
ABR (95-% IZ) % zmanjšanje (RR), vrednost p % bolnikov z 0 krvavitvami (95-% IZ)
HAVEN 1 health-related outcomes
Zdravstveni izidi v študiji HAVEN 1
Patient's bodyweight of 40 kg, under a maintenance dose regimen of 3 mg/kg every two weeks:
Bolnik s telesno maso 40 kg s shemo vzdrževalnega odmerka 3 mg/kg na dva tedna:
Table 9 HAVEN 1: Change in Haem-A-QoL Physical Health and Total score with Hemlibra prophylaxis versus no prophylaxis in patients ≥ 18 years with factor VIII inhibitors
Študija HAVEN 1: Sprememba ocene telesnega zdravja in celotne ocene na lestvici Haem-A-QoL med bolniki, ki so prejemali profilakso z zdravilom Hemlibra, v primerjavi z bolniki, ki niso prejemali profilakse, starimi ≥ 18 let z inhibitorji faktorja VIII
*Cavernous sinus thrombosis
*tromboza kavernoznega sinusa občasni
● Discard vials that have been kept at room temperature for more than 7 days or have been in temperatures above 30°C.
● Viale, ki so bile shranjene na sobni temperaturi več kot 7 dni, ali na temperaturi nad 30 °C,
One patient resumed Hemlibra following resolution of TMA without recurrence.
Ko je TMA izzvenela, je en bolnik nadaljeval zdravljenje z zdravilom Hemlibra brez ponovitve.
Table 2 Summary of adverse drug reactions from pooled HAVEN clinical trials with Hemlibra
Povzetek neželenih učinkov iz vseh kliničnih preskušanj HAVEN zdravila
● Transfer needle: Stainless steel with Luer-lock connection, gauge 18 G, length 35mm (1½″), preferably semi-blunted tip, and
● Igla za prenos: iz nerjavnega jekla z Luer-lock nastavkom, debelina 18 G, dolžina 35 mm (1½″), po možnosti s poltopo konico, in
● Do not detach the injection needle.
● Igle za injiciranje ne snemite.
● Keep your finger pressed down on the syringe plunger.
● S prstom še naprej tiščite bat brizge.
● With the needle pointing upwards, push on the plunger to inject the air from the syringe above the medicine.
● Medtem, ko igla gleda navzgor, potisnite bat in iztisnite zrak iz brizge nad zdravilo.
● Only use the syringes, vial adapters, and injection needles that your healthcare provider prescribes.
● Uporabljajte samo brizge, adapterje za viale in igle za injiciranje, ki vam jih predpiše zdravnik.
- Activated partial thromboplastin time (aPTT) - Bethesda assays (clotting-based) for FVIII inhibitor titers - One-stage, aPTT-based, single-factor assays - aPTT-based activated protein C resistance (APC-R) - Activated clotting time (ACT)
- Neodzivnost na aktivirani protein C na podlagi aPTČ (APC-R) - Aktivirani čas strjevanja (ACT)
Arm C: No Prophylaxis (N = 18)
Skupina C: Brez profilakse (n = 18)
● Only use the syringes, transfer needles, and injection needles that your healthcare provider prescribes.
● Uporabljajte samo brizge, igle za prenos in igle za injiciranje, ki vam jih predpiše zdravnik.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 150 mg/1 mL
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 150 mg/1 ml
Hemlibra 1.5 mg/kg weekly (N = 48)
1,5 mg/kg zdravila Hemlibra na teden (n = 48)
Dose up-titration to 3 mg/kg once weekly was allowed after 24 weeks on Hemlibra prophylaxis for patients who experienced two or more qualified bleeds (i.e. spontaneous and verified clinically significant bleeds occurring at steady state).
Hemlibra je bilo za bolnike, ki so imeli dve kvalificirani krvavitvi ali več (tj.spontana in preverjena klinično pomembna krvavitev, ki se je pojavila v stanju dinamičnega ravnovesja) dovoljeno povečanje odmerka na 3 mg/kg enkrat na teden.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 60 mg/0.4 mL
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 60 mg/0,4 ml
Difference in adjusted means (95% CI)
Razlika korigiranih povprečij (95-% IZ)
When monitoring a patients underlying hemostatic activity, please refer to section 4.4 for laboratory tests unaffected by emicizumab.
Za spremljanje bolnikovih ostalih testov hemostaze, na katere emicizumab ne vpliva, glejte poglavje 4.4.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 30 mg/1mL
VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 30 mg/1 ml
● Put your used needles and syringes in a sharps disposal container right away after use.
● Uporabljene igle in brizge takoj po uporabi zavrzite v vsebnik za ostre odpadke.
Instructions for Use Hemlibra Injection Single-Dose Vial(s)
Navodila za uporabo Hemlibra Injekcija Viala/viale z enkratnim odmerkom
Emicizumab increases coagulation potential, therefore the FVIIa or FVIII dose required to achieve hemostasis may be lower than when used without Hemlibra prophylaxis.
Emicizumab poveča koagulacijski potencial, zato so lahko odmerki rFVIIa ali FVIII,
No adequate or well-controlled drug-drug interaction studies have been conducted with emicizumab.
4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Z emicizumabom ni bilo izvedenih ustreznih ali dobro kontroliranih študij medsebojnega delovanja zdravil.
Step B. Remove transfer needle
Korak B. Snemite iglo za prenos
Following intravenous administration of 0.25 mg/kg in healthy subjects, the total clearance of emicizumab was 3.26 mL/kg/day (i.e. 0.228 L/d for a 70-kg adult) and the mean terminal half-life was 26.7 days.
3,26 ml/kg/dan (to je 0,228 l/d pri 70 kg težkem odraslem) in povprečni končni razpolovni čas
Each vial contains 30 mg emicizumab in 1 mL of solution for injection.
Ena viala vsebuje 30 mg emicizumaba v 1 ml raztopine za injiciranje.
● You must inject Hemlibra only under the skin.
● Zdravilo Hemlibra morate injicirati le podkožno.
One patient resumed Hemlibra following resolution of TMA and continued to be treated safely.
Ko je TMA izzvenela, je en bolnik ponovno začel zdravljenje z zdravilom Hemlibra in ga varno nadaljeval.
METHOD OF ADMINISTRATION Do not shake.
POSTOPEK UPORABE Ne pretresajte
Do not use if the expiry date has passed.
Če je rok uporabnosti že potekel, omenjenega ne uporabite.
Warning on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability and information that single-factor assays utilizing chromogenic or immuno-based methods are not affected by emicizumab and may be used to monitor coagulation parameters during treatment, with specific consideration for factor VIII chromogenic activity assays;
Opozorilo, da emicizumab moti nekatere laboratorijske koagulacijske teste, kar vpliva na njihovo zanesljivost, in informacije, da emicizumab ne vpliva na teste za določanje posameznih faktorjev z uporabo kromogenih ali imunskih metod in se lahko uporablja za spremljanje koagulacijskih parametrov med zdravljenjem, s specifičnim upoštevanjem značilnosti kromogenih testov aktivnosti faktorja VIII; Kontaktni podatki zdravnika, ki je bolniku predpisal emicizumab; Izobraževalno gradivo za bolnike/skrbnike mora vsebovati:
● HEMLIBRA Instructions for Use
● Navodilo za uporabo
Step 13.
13. korak.
Each vial contains 60 mg emicizumab in 0.4 mL of solution for injection.
Ena viala vsebuje 60 mg emicizumaba v 0,4 ml raztopine za injiciranje.
Arm B: Hemlibra 3 mg/kg every 2 weeks (N = 35)
Skupina B: 3 mg/kg zdravila Hemlibra na 2 tedna (n = 35)
● Do not touch exposed needles or place them on a surface once the cap has been removed.
● Izpostavljenih igel se po odstranitvi pokrovčka ne dotikajte in jih nikamor ne polagajte.
● Keep the transfer needle, injection needle and syringe dry.
● Poskrbite, da ostanejo igla za prenos, igla za injiciranje in injekcijska brizga suhe.
Information on assays and methods not affected by emicizumab and that may be used to monitor coagulation parameters during treatment, with specific considerations for FVIII chromogenic activity assays;
Informacije o testih in metodah, na katere emicizumab ne vpliva, in se lahko uporabljajo za spremljanje koagulacijskih parametrov med zdravljenjem, s specifičnim upoštevanjem značilnosti kromogenih testov aktivnosti faktorja VIII;
INFORMATION IN BRAILLE hemlibra 150 mg
PODATKI V BRAILLOVI PISAVI hemlibra 150 mg
A doctor qualified to care for patients with haemophilia will start you on treatment with Hemlibra.
Zdravljenje z zdravilom Hemlibra vam bo uvedel zdravnik, usposobljen za vodenje bolnikov s hemofilijo.
Treating physicians must carefully weigh the risk of TMA and thromboembolism against the risk of bleeding when considering aPCC treatment beyond a maximum of 100 U/kg in the first 24-hours.
Če lečeči zdravnik razmišlja o zdravljenju z aPCC v odmerku, večjem od maksimalnega 100 e./kg v prvih 24 urah, mora skrbno pretehtati tveganje za TMA in trombembolijo v primerjavi s tveganjem za krvavitev.
Description of the signs and symptoms of the following safety concerns and reminder of the importance of immediately stopping using Hemlibra and aPCC and notifying their treating physician if symptoms occur : - Destruction of red blood cells (thrombotic microangiopathy) - Blood clots (thromboembolism)
Opis znakov in simptomov spodnjih varnostnih tveganj ter opomnik o pomenu takojšnjega prenehanja uporabe zdravila Hemlibra in aPCC ter obveščanja lečečega zdravnika v primeru pojava simptomov:
- Bethesda assays (bovine chromogenic) for FVIII inhibitor titers - Thrombin time (TT) - One-stage, prothrombin time (PT)-based, single-factor assays - Chromogenic-based single-factor assays other than FVIII1
- Trombinski čas (TČ) - Enostopenjska metoda določanja aktivnosti faktorja na podlagi protrombinskega časa (PČ) - Kromogena metoda določanja aktivnosti faktorja razen FVIII1
After storage at room temperature, unopened vials may be returned back to the refrigerator.
Po shranjevanju na sobni temperaturi lahko neodprte viale vrnete nazaj v hladilnik.
Do not insert the injection needle into vial adapter or use the injection needle to withdraw medicine from vial.
Igle za injiciranje ne vstavljajte v adapter za vialo ali za jemanje zdravila iz viale.
Serious thrombotic events were reported from a clinical trial in patients receiving Hemlibra prophylaxis when on average a cumulative amount of >100U/kg/24 hours of aPCC for 24 hours or more was administered (see section 4.8).
V kliničnih preskušanjih so poročali o resnih primerih trombotičnih dogodkih pri bolnikih, ki so prejemali profilakso z zdravilom Hemlibra in sočasno aPCC, 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).
The total volume of Hemlibra to be injected subcutaneously is calculated as follows: Total amount (mg) of emicizumab to be administered ÷ vial concentration (mg/mL) = total volume of Hemlibra (mL) to be injected.
Celotni volumen zdravila Hemlibra, ki ga je treba injicirati subkutano, se izračuna takole: celotna količina (mg) emicizumaba, ki jo je treba uporabiti ÷ koncentracija v viali (mg/ml) = celotni volumen zdravila Hemlibra (ml), ki ga je treba injicirati Pri pripravi celotnega potrebnega volumna se v isti injekcijski brizgi ne sme kombinirati različnih koncentracij (30 mg/ml in 150 mg/ml) zdravila Hemlibra.
Hemlibra 150 mg/mL solution for injection
Hemlibra 150 mg/ml raztopina za injiciranje
● 1 mL syringe: Transparent polypropylene or polycarbonate syringe with Luer-lock tip, graduation 0.01 mL or
● 1-ml brizga: prozorna polipropilenska ali polikarbonatna brizga z Luer-lock nastavkom in merilno skalo 0,01 ml ali
Hemlibra is a colourless to slightly yellow solution.
Zdravilo Hemlibra je brezbarvna do rumenkasta raztopina.
● Maintenance dose (from week 5 on) example: 60 kg x 6 mg/kg = 360 mg of emicizumab needed for the maintenance dose.
● Vzdrževalni odmerek (od 5. tedna naprej): 60 kg x 6 mg/kg = 360 mg emicizumaba, potrebnega za vzdrževalni odmerek.
INFORMATION IN BRAILLE hemlibra 60 mg
PODATKI V BRAILLOVI PISAVI hemlibra 60 mg
Step D. Transfer medicine into syringe
Korak D. V injekcijsko brizgo prenesite zdravilo
● Do not inject into areas that could be irritated by a belt or waistband.
● Ne injicirajte v predele, ki jih lahko draži pas oblačil.
Keep the vial in the outer carton in order to protect from light
Vialo shranjujte v zunanji ovojnini za zagotovitev zaščite pred svetlobo