natgillin/translations-raw huggingface dataset:
Rate ratio and confidence interval (CI) comes from negative binomial regression (NBR) model and pvalue from Stratified Wald test, comparing ABR between specified arms.
Razmerje deležev in interval zaupanja (IZ) so dobljeni na podlagi modela z negativno binomsko regresijo (NBR), vrednost p pa s stratificiranim Waldovim testom s primerjavo ABR med opredeljenima skupinama.
Each vial contains 150 mg emicizumab in 1 mL of solution for injection.
Ena viala vsebuje 150 mg emicizumaba v 1 ml raztopine za injiciranje.
Other side effects when using Hemlibra
Drugi neželeni učinki med uporabo zdravila Hemlibra:
Attach injection needle to syringe
Namestite iglo za injiciranje na brizgo
Primary analysis efficacy results of Hemlibra prophylaxis every four weeks with respect to rate of treated bleeds, all bleeds, treated spontaneous bleeds, treated joint bleeds, and treated target joint bleeds are shown in Table 8.
Preglednica 8 prikazuje rezultati primarne analize učinkovitosti profilakse z zdravilom Hemlibra na štiri tedne, kar zadeva delež zdravljenih krvavitev, vseh krvavitev, zdravljenih spontanih krvavitev, zdravljenih krvavitev v sklepe in zdravljenih krvavitev v tarčne sklepe (glejte preglednico 8).
Table 13 HAVEN 2: Change from baseline to week 25 in the Physical Health score of patients (< 12 years of age) following treatment with Hemlibra prophylaxis as reported by patients and caregivers
25. tedna pri bolnikih, < 12 let, po profilaksi z zdravilom Hemlibra, kot so jo ocenili bolniki in skrbniki
Do not touch, fan or blow on the cleaned area before your injection.
Očiščenega predela se pred injiciranjem ne dotikajte, ne sušite ga z ventilatorjem in ne pihajte vanj.
Syringes
Brizge
Step C. Attach a new transfer needle to syringe
Korak C. Na brizgo namestite novo iglo za prenos
● A syringe, a transfer needle (or vial adapter), and an injection needle are needed to draw up the Hemlibra solution from the vial into the syringe and to inject it under the skin.
● 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.
ABR (95% CI) a % reduction (RR), p-value % patients with zero bleeds (95% CI)
ABR (95-% IZ) % zmanjšanje (RR), vrednost p % bolnikov, ki niso imeli nobene krvavitve (95-% IZ)
Management in the perioperative setting
Vodenje v primeru operacije
Following multiple subcutaneous administrations of 3 mg/kg once weekly for the first 4 weeks in haemophilia A patients, mean (±SD) trough plasma concentrations of emicizumab achieved 52.6±13.6 µg/mL at Week 5.
Po večkratni subkutani uporabi 3 mg/kg enkrat na teden v prvih 4 tednih pri bolnikih s hemofilijo A je povprečna (± std. odklon) najmanjša koncentracija emicizumaba v plazmi pred naslednjim odmerkom
In the intra-patient analysis, Hemlibra weekly prophylaxis resulted in a clinical meaningful reduction (98 %) in treated bleed rate in 18 paediatric patients who had at least 12 weeks of Hemlibra prophylaxis compared to their bleed rate collected in the NIS prior to enrolment (Table 12).
(98 %) delež zdravljenih krvavitev pri 18 pediatričnih bolnikih, ki so imeli vsaj 12 tednov profilakse z zdravilom Hemlibra, v primerjavi z njihovim deležem krvavitev, evidentiranih v neintervencijski študiji pred vključitvijo v to študijo (preglednica 12).
* Emicizumab is a humanised monoclonal modified immunoglobulin G4 (IgG4) antibody produced using recombinant DNA technology in mammalian Chinese Hamster Ovary (CHO) cells For the full list of excipients, see section 6.1
* Emicizumab je humanizirano monoklonsko protitelo - spremenjeni imunoglobulin G4 (IgG4),
NAME OF THE MEDICINAL PRODUCT Hemlibra 30 mg/mL solution for injection Hemlibra 150 mg/mL solution for injection
Hemlibra 30 mg/ml raztopina za injiciranje Hemlibra 150 mg/ml raztopina za injiciranje
● Patient alert card
● Vodnik za zdravstvene delavce ● Opozorilno kartico za bolnika
You will need to recap the transfer needle after transferring the medicine.
Potem, ko boste izvlekli zdravilo, boste morali iglo za prenos znova pokriti s pokrovčkom.
All bleeds = bleeds treated and not treated with bypassing agents.
Vse krvavitve = krvavitve, ki so bile in ki niso bile zdravljene z obvodnimi zdravili.
● Maintenance dose (from week 5 on) example: 16 kg x 1.5 mg/kg = 24 mg of emicizumab needed for the maintenance dose.
● Primer vzdrževalnega odmerka (od 5. tedna naprej): 16 kg x 1,5 mg/kg = 24 mg emicizumaba, potrebnega za vzdrževalni odmerek
After storage at room temperature unopened vials may be returned to the refrigerator.
Po shranjevanju na sobni temperaturi lahko neodprte viale daste nazaj v hladilnik.
How Hemlibra works
Kako deluje zdravilo Hemlibra
Patients with mild and moderate hepatic impairment were included in clinical trials.
V klinična preskušanja so bili vključeni bolniki z blago in zmerno okvaro jeter.
Serious and potentially life-threatening side effects can occur when aPCC is used in patients who are also receiving Hemlibra: Potentially serious side effects of using aPCC while receiving Hemlibra
Med uporabo aPCC se lahko pri bolnikih, ki prejemajo tudi zdravilo Hemlibra, pojavijo resni neželeni učinki, ki so lahko življenjsko ogrožajoči.
Hemlibra 30 mg/mL solution for injection
Hemlibra 30 mg/ml raztopina za injiciranje
Myalgia
VIALA
A syringe, a transfer needle (or vial adapter) and an injection needle are needed to withdraw Hemlibra solution from the vial and inject it subcutaneously.
Za odvzem raztopine zdravila Hemlibra iz viale in njeno subkutano injiciranje so potrebne injekcijska brizga, igla za prenos (ali adapter za vialo) in igla za injiciranje.
At the time of the interim analysis, efficacy was evaluated in 59 patients who were < 12 years old and had been receiving weekly Hemlibra prophylaxis for at least 12 weeks, including four patients aged < 2 years old, 17 patients aged 2 to < 6 years, 38 patients aged 6 to < 12 years old.
Rezultati učinkovitosti pri pediatričnih bolnikih v študiji HAVEN 2 (vmesna analiza) Ob času vmesne analize so učinkovitost ocenili pri 59 bolnikih, ki so bili stari < 12 let in so vsaj 12 tednov prejemali profilakso z zdravilom Hemlibra enkrat na teden, vključno s 4 bolniki, starimi
Information that they should be given a Patient Alert Card and reminder to carry it at all times and to show it to any healthcare professionals who may treat them; Information on emicizumab's interference with certain laboratory coagulation tests which will affect their reliability and on the importance to show the patient alert card to any healthcare professionals who may treat them and to laboratory professionals that will perform their coagulation testing;
Podatki, da emicizumab moti nekatere laboratorijske koagulacijske teste, kar vpliva na njihovo zanesljivost, in podatki o pomembnosti, da bolnik svojo opozorilno kartico pokaže vsem zdravstvenim delavcem, ki ga zdravijo, in laboratorijskim delavcem, ki izvajajo koagulacijske teste;
How Hemlibra is given
Kako se daje zdravilo Hemlibra
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hemlibra 30 mg/mL solution for injection emicizumab
IME ZDRAVILA IN POT(I) UPORABE Hemlibra 30 mg/ml raztopina za injiciranje emicizumab za subkutano uporabo
INCLUDED IN THE BOX:
Škatla vsebuje:
Note: Do not use 3 mL LDS syringe for doses up to 1 mL.
Opomba: Za odmerke do 1 ml ne uporabljajte 3-ml brizge z majhnim volumnom mrtvega prostora.
Rate ratio, and confidence interval (CI) come from negative binomial regression (NBR) model and p-value from Stratified Wald test, comparing bleed rate between specified arms.
Razmerje deležev in interval zaupanja (IZ) so dobljeni na podlagi modela z negativno binomsko regresijo (NBR), vrednost p pa s stratificiranim Waldovim testom s primerjavo deleža krvavitev med opredeljenima skupinama.
Treated bleeds = bleeds treated with FVIII All bleeds = bleeds treated and not treated with FVIII.
Vse krvavitve = krvavitve, ki so bile in ki niso bile zdravljene s FVIII.
The study also evaluated the efficacy of weekly Hemlibra prophylaxis compared with previous episodic (on-demand) and prophylactic bypassing agents (separate comparisons) in patients who had participated in the NIS prior to enrolment (Arms A and C, respectively) (see Table 7).
Študija je ocenila tudi učinkovitost tedenske profilakse z zdravilom Hemlibra v primerjavi s predhodno občasno (po potrebi) oziroma profilaktično uporabo obvodnih zdravil (ločeni primerjavi) pri bolnikih, ki so pred vključitvijo v to študijo sodelovali v neintervencijski študiji (skupini A
Before using the medicine, check the solution for particles or discoloration.
Pred uporabo zdravila preverite, da v raztopini ni delcev in da se barva ni spremenila.
● Syringe Note: For injection amount up to 1 mL use a 1 mL syringe.
Opomba: Za injiciranje količine do 1 ml uporabite 1-ml brizgo.
● Throw away any used vial(s), needles, vial or injection needle caps and used syringes in a sharps or puncture-proof container.
● Vse uporabljene viale, igle, pokrovčke vial ali igel za injiciranje in uporabljene injekcijske brizge zavrzite v vsebnik za ostre odpadke oziroma vsebnik, odporen proti prebadanju.
Storing Hemlibra vials, needles and syringes:
Shranjevanje vial, igel in brizg zdravila Hemlibra:
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Hemlibra 150 mg/mL solution for injection emicizumab
IME ZDRAVILA IN POT(I) UPORABE Hemlibra 150 mg/ml raztopina za injiciranje emicizumab za subkutano uporabo
● Keep the vials, needles and syringes out of the sight and reach of children.
● Viale, igle in brizge shranjujte nedosegljive otrokom!
● Keep the vial adapter, injection needle and syringe dry.
● Poskrbite, da ostanejo adapter za vialo, igla za injiciranje in injekcijska brizga suhe.
Throw away any used caps, vial(s) and syringes and needles.
Vse uporabljene pokrovčke, viale, brizge in igle zavrzite.
Water for injections
Igla za injiciranje
Table 5 HAVEN 3 study: Intra-patient comparison of Annualized Bleed Rate (treated Bleeds) with Hemlibra prophylaxis versus previous FVIII prophylaxis
Študija HAVEN 3: Intraindividualna primerjava na leto preračunanega deleža krvavitev (zdravljene krvavitve) med profilakso z zdravilom Hemlibra v primerjavi s predhodno profilakso s FVIII
● Remove the used vial adapter from the syringe by twisting anticlockwise and gently pulling.
● Uporabljen adapter za vialo odstranite z brizge tako, da ga zasukate v smeri, nasprotni smeri urnega kazalca, in ga previdno potegnite.
● The patient alert card shall contain the following key messages: Instructions for patients to carry the card at any time, including in conditions of emergency and to present the card at visits to doctors, hospital clinics, carers, laboratory professionals or pharmacists to inform on emicizumab treatment and risks; Information on serious, life-threatening thromboembolic events or thrombotic microangiopathy events that have been observed with the concomitant use of emicizumab with activated prothrombin complex concentrate (aPCC) in patients on emicizumab prophylaxis;
Navodila za bolnike, da imajo kartico vedno pri sebi, tudi v nujnih stanjih, in jo pokažejo zdravniku, v bolnišnici, skrbniku, laboratorijskemu delavcu ali farmacevtu, da jih obvestijo o zdravljenju z emicizumabom in tveganjih;
Treated bleeds = bleeds treated with bypassing agents.
Zdravljene krvavitve = krvavitve, zdravljene z obvodnimi zdravili.
Each vial of 1 mL contains 150 mg of emicizumab at a concentration of 150 mg/mL.
Ena viala z 1 ml vsebuje 150 mg emicizumaba v koncentraciji 150 mg/ml.
Adults and Adolescents Health-Related outcome measures
Ocenjevanje zdravstvenega izida pri odraslih in mladostnikih
● To calculate the volume to be administered divide calculated dose 360 mg by 150 mg/mL: 360 mg of emicizumab ÷ 150 mg/mL = 2.4 mL of 150 mg/mL Hemlibra concentration to be injected every four weeks.
● Za izračun potrebnega volumna delite izračunani odmerek 360 mg s 150 mg/ml: 360 mg emicizumaba ÷ 150 mg/ml = 2,4 ml je volumen zdravila Hemlibra s koncentracijo 150 mg/ml, ki ga je treba injicirati na štiri tedne
● If you get any side effects, talk to your doctor, pharmacist or nurse.
● Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The metabolism of emicizumab has not been studied.
Presnova Presnove emicizumaba niso raziskali.
Each vial of 0.7 mL contains 105 mg of emicizumab at a concentration of 150 mg/mL.
Ena viala z 0,7 ml vsebuje 105 mg emicizumaba v koncentraciji 150 mg/ml.
● Loading dose (first 4 weeks) example: 16 kg x 3 mg/kg = 48 mg of emicizumab needed for the loading dose.
● Primer polnilnega odmerka (prve 4 tedne): 16 kg x 3 mg/kg = 48 mg emicizumaba, potrebnega za polnilni odmerek
In clinical trials, no cases of TMA or thrombotic events were observed with use of activated recombinant human FVII (rFVIIa) alone in patients receiving Hemlibra prophylaxis.
Pri bolnikih, ki so prejemali profilakso z zdravilom Hemlibra in sočasno le aktivirani rekombinantni humani FVII (rFVIIa), v kliničnih preskušanjih niso opažali TMA ali trombotičnih dogodkov.
1 mL syringe
0,1 ml.
Index Utility Score Adjusted mean
Indeksna ocena koristnosti
The patient/carer educational material should contain:
● Vodnik za bolnike/skrbnike mora vsebovati naslednja ključna sporočila:
● Remove the syringe from the vial adapter by twisting anticlockwise and gently pulling.
● Odstranite brizgo z adapterja za vialo tako, da jo zasukate v smeri, nasprotni smeri urnega kazalca, in jo previdno potegnite.
● Remove the transfer needle from the syringe by twisting anticlockwise and gently pulling.
● Odstranite iglo za prenos z brizge tako, da jo zasukate v smeri, nasprotni smeri urnega kazalca, in jo previdno potegnite.
Table 6 HAVEN 1: Annualized Bleed Rate with Hemlibra prophylaxis arm versus no prophylaxis arm in patients ≥ 12 years of age with factor VIII inhibitors
Študija HAVEN 1: Na leto preračunani delež krvavitev v skupini, ki je prejemala profilakso z zdravilom Hemlibra, v primerjavi s skupino brez profilakse pri bolnikih, starih ≥ 12 let z inhibitorji faktorja VIII
NOT INCLUDED IN THE BOX:
Škatla ne vsebuje:
● Maintenance dose (from week 5 on) example: 40 kg x 3 mg/kg = 120 mg of emicizumab needed for the maintenance dose.
● Primer vzdrževalnega odmerka (od 5. tedna naprej): 40 kg x 3 mg/kg = 120 mg emicizumaba, potrebnega za vzdrževalni odmerek
Hemlibra was investigated in a single arm, multicenter, phase III clinical study in 41 adult and adolescent males (aged ≥ 12 years and > 40 kg) who have hemophilia A with FVIII inhibitors or severe hemophilia A without FVIII inhibitors who previously received either episodic (“on demand”) or prophylactic treatment with bypassing agents or FVIII.
41 odraslih in mladostnikih moškega spola (starih ≥ 12 let in s telesno maso > 40 kg), ki so imeli hemofilijo A z inhibitorji FVIII ali hudo hemofilijo A brez inhibitorjev FVIII in so predhodno ali občasno ("po potrebi") ali profilaktično prejemali zdravljenje z obvodnimi zdravili ali FVIII.
Remove transfer needle
Snemite iglo za prenos
● A 2 to 3 mL syringe should be used for an injection greater than 1 mL and up to 2 mL of Hemlibra solution.
● Za injiciranje več kot 1 ml in do 2 ml raztopine zdravila Hemlibra je treba uporabiti 2- do 3-ml brizgo.
Endpoints aABR (95% CI)
ABR (95-% IZ)
Roche Pharma AG Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany
D-79639 Grenzach-Wyhlen
● Slowly pull back the plunger to fill the syringe with more than the amount of medicine needed for your prescribed dose.
● Počasi izvlečite bat, da boste brizgo napolnili s količino zdravila, večjo od potrebne za predpisani odmerek.
Common: may affect up to 1 in 10 people
Pogosti: pojavijo se lahko pri do 1 od 10 bolnikov ● zvišana telesna temperatura
● Loading dose (first 4 weeks) example: 60 kg x 3 mg/kg = 180 mg of emicizumab needed for the loading dose.
● Primer za polnilni odmerek (prve 4 tedne): 60 kg x 3 mg/kg = 180 mg emicizumaba, potrebnega za polnilni odmerek
● muscle aches
● Gaze ● Kosma vate
(bilirubin ≤ ULN and AST > ULN or bilirubin from 1.0 to 1.5 × ULN and any AST, N = 51).
Večina bolnikov s hemofilijo A v populacijski farmakokinetični analizi je imela normalno delovanje jeter (bilirubin in AST ≤ ZMN, n = 300) ali blago okvaro jeter (bilirubin ≤ ZMN in AST > ZMN ali bilirubin od 1,0 do 1,5 × ZMN in kakršen koli AST, n = 51).
Step C. Connect new vial adapter to syringe
Korak C. Na brizgo namestite nov adapter za vialo
The solution should be discarded if particulate matter is visible or product is discoloured.
Če so v raztopini vidni delci ali je spremenjene barve, jo je treba zavreči.
● Throw away any used caps, vial(s), vial adapters, needles and syringes in a sharps or puncture-proof container.
● Vse uporabljene pokrovčke, viale, adapterje za viale, igle in injekcijske brizge zavrzite v vsebnik za ostre odpadke oziroma vsebnik, odporen proti prebadanju.
Table 4 HAVEN 3 study: Annualised Bleed Rate for Hemlibra prophylaxis arm versus no prophylaxis arm in patients ≥ 12 years of age without factor VIII inhibitors
Študija HAVEN 3: Na leto preračunani delež krvavitev v skupini, ki je prejemala profilakso z zdravilom Hemlibra, v primerjavi s skupino brez profilakse pri bolnikih, starih ≥ 12 let z inhibitorji faktorja VIII
● Do not recap the injection needle with the cap.
● Ne pokrivajte igle za injiciranje z njenim pokrovčkom.
● Throw away the cap into a sharps disposal container.
● Pokrovček zavrzite v vsebnik za ostre odpadke.
Adjust plunger to prescribed dose
Nastavite bat na predpisani odmerek
● The guide for patients/carers shall contain the following key messages: - What is emicizumab, how emicizumab has been tested, and how to use emicizumab; - Warning on the risks associated with the concomitant use of bypassing agents and Hemlibra and to discuss with their doctor if they are receiving activated prothrombin complex concentrate (aPCC) when being prescribed or while receiving Hemlibra;
Opozorilo o tveganjih, povezanih s sočasno uporabo obvodnih zdravil in zdravila Hemlibra, in nujnost pogovora z zdravnikom, če prejemajo koncentrat aktiviranega protrombinskega kompleksa (aPCC), ko jim je predpisano zdravilo Hemlibra ali ko ga prejemajo,
● Push and twist a new transfer needle clockwise on to the syringe until it is fully attached.
● Potisnite novo iglo za prenos na brizgo in iglo zasučite v smeri urnega kazalca, dokler ni povsem nameščena.
L-Arginine L-Histidine L-Aspartic acid Poloxamer 188
L-asparaginska kislina poloksamer 188 voda za injekcije
Arm C: Hemlibra 1.5 mg/kg weekly
Skupina C: zdravilo Hemlibra 1,5 mg/kg na teden n = 24
What Hemlibra is used for
Za kaj uporabljamo zdravilo Hemlibra
Arm A: Hemlibra 1.5 mg/kg weekly (N = 36)
Skupina A: 1,5 mg/kg zdravila Hemlibra na teden (n = 36)
● Push and twist the syringe clockwise on to the vial adapter until it is fully attached.
● Potisnite brizgo na adapter za vialo in jo zasučite v smeri urnega kazalca, dokler ni povsem nameščena.
There are no data in children < 1 year of age.
mlajše od 1 leta, ni podatkov.
Combining Vials
Združevanje vial
Different Hemlibra concentrations (30 mg/mL and 150 mg/mL) should not be combined in a single injection when making up the total volume to be injected.
Pri pripravi celotnega volumna, ki ga je treba injicirati, se v eni injekciji ne sme kombinirati različnih koncentracij (30 mg/ml in 150 mg/ml) zdravila Hemlibra.
- Immuno-based assays (e.g. ELISA, turbidimetric methods) - Genetic tests of coagulation factors (e.g.
- Imunske metode (npr. ELISA, turbidimetrične metode) - Genetski testi koagulacijskih faktorjev (npr. faktor V Leiden, protrombin 20210) 1Za pomembne informacije glede kromogenih metod določanja aktivnosti FVIII glejte poglavje 4.4.
Physical health score (range 0 to 100)a Mean baseline score (95% CI) (n = 18) Mean change from baseline (95% CI) (n = 15)
Srednja izhodiščna ocena (95-% IZ) (n = 18) Srednja sprememba od izhodišča (95-% IZ) (n = 15)
Table 7 HAVEN 1: Intra-patient comparison of Annualised Bleed Rate (treated bleeds) with Hemlibra prophylaxis versus previous bypassing agent prophylaxis (NIS patients)
Študija HAVEN 1: Intraindividualna primerjava na leto preračunanega deleža krvavitev (zdravljene krvavitve) med profilakso z zdravilom Hemlibra v primerjavi s predhodno profilakso z obvodnim zdravilom (bolniki iz neintervencijske študije)
No dose adjustments are recommended in patients with mild , renal or hepatic impairment (see section 5.2).
Za bolnike z blago okvaro ledvic ali jeter ni priporočenih prilagoditev odmerjanja (glejte poglavje
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 1 mL contains 30 mg of emicizumab at a concentration of 30 mg/mL.
Ena viala z 1 ml vsebuje 30 mg emicizumaba v koncentraciji 30 mg/ml.
Treated Bleeds ABR (95% CI) % reduction (RR), p-value
Zdravljene krvavitve ABR (95-% IZ) % zmanjšanje (RR), vrednost p
Table 8 HAVEN 4: Annualized Bleed Rate with Hemlibra prophylaxis in Patients ≥12 Years of Age with or without Factor VIII Inhibitors Hemlibra 6mg/kg Q4W
Študija HAVEN 4: Na leto preračunani delež krvavitev med profilakso z zdravilom Hemlibra pri bolnikih, starih ≥ 12 let z inhibitorji faktorja VIII ali brez njih
NA 95% (0.05), <0.0001 95% (0.05),
Srednja izhodiščna ocena (95-% IZ) (n = 54) Srednja izhodiščna vrednost (95-% IZ (95-% IZ)
● To calculate the volume to be administered divide calculated dose 48 mg by 150 mg/mL: 48 mg of emicizumab ÷ 150 mg/mL = 0.32 mL of 150 mg/mL Hemlibra concentration to be injected.
● Za izračun potrebnega volumna delite izračunani odmerek 48 mg s 150 mg/ml: 48 mg emicizumaba ÷ 150 mg/ml = 0,32 ml je volumen zdravila Hemlibra s koncentracijo 150 mg/ml, ki ga je treba injicirati
NAME OF THE MEDICINAL PRODUCT Hemlibra 30 mg/mL solution for injection emicizumab
Hemlibra 30 mg/ml raztopina za injiciranje emicizumab
● Keep the transfer needle in the vial and turn the vial upside down.
● Medtem ko je igla za prenos v viali, obrnite vialo na glavo.
NAME OF THE MEDICINAL PRODUCT Hemlibra 150 mg/mL solution for injection emicizumab
Hemlibra 150 mg/ml raztopina za injiciranje emicizumab
● If the amount of medicine in the syringe is now at or below your prescribed dose, move the tip of the needle to within the medicine and 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, pomaknite konico igle, da bo v zdravilu.
Different Hemlibra vial concentrations (30 mg/mL and 150 mg/mL) should not be combined in a single injection to administer the prescribed dose.
Za pripravo predpisanega odmerka se v eni injekciji ne sme združevati vial zdravila Hemlibra z različno koncentracijo zdravila (30 mg/ml in 150 mg/ml).
● Loading dose (first 4 weeks) example: 40 kg x 3 mg/kg = 120 mg of emicizumab needed for the loading dose.
● Primer polnilnega odmerka (prve 4 tedne): 40 kg x 3 mg/kg = 120 mg emicizumaba, potrebnega za polnilni odmerek
Table 12 HAVEN 2: Intra-patient comparison of Annualised Bleed Rate (treated bleeds) with Hemlibra prophylaxis versus previous bypassing agent prophylaxis
Študija HAVEN 2: Intraindividualna primerjava na leto preračunanega deleža krvavitev (zdravljene krvavitve) med profilakso z zdravilom Hemlibra v primerjavi s predhodno profilakso z obvodnim zdravilom
● Do not touch the needle tip or place it on a surface after the needle cap has been removed.
● Po odstranitvi pokrovčka igle se ne dotikajte konice igle in igle ne polagajte nikamor.
Arm A: Hemlibra 1.5 mg/kg weekly (N=29)
Skupina A: 1,5 mg/kg zdravila Hemlibra na teden (n = 29)
● If you are not sure what to do, ask your doctor, pharmacist or nurse.
● Če ste negotovi, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
The physician should immediately discontinue aPCC and interrupt Hemlibra therapy if clinical symptoms and/or laboratory findings consistent with TMA occur, and manage as clinically indicated.
V primeru pojava kliničnih simptomov in/ali laboratorijski izvidov, skladnih s TMA, mora zdravnik nemudoma prenehati uporabljati aPCC, prekiniti zdravljenje z zdravilom Hemlibra in stanje obravnavati, kot je klinično ustrezno.
Arm A: Hemlibra 1.5 mg/kg weekly (N=25)
Skupina A: 1,5 mg/kg zdravila Hemlibra na teden (n = 25)