HEMLIBRA 30 MGML

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

EMICIZUMAB

Commercializzato da:

ROCHE PHARMACEUTICALS (ISRAEL) LTD

Codice ATC:

B02BX06

Forma farmaceutica:

SOLUTION FOR INJECTION

Composizione:

EMICIZUMAB 30 MG / 1 ML

Via di somministrazione:

S.C

Tipo di ricetta:

Required

Prodotto da:

HOFFMANN LA ROCHE LTD, SWITZERLAND

Area terapeutica:

EMICIZUMAB

Indicazioni terapeutiche:

Hemlibra is indicated for routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes in patients with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.

Data dell'autorizzazione:

2023-11-30

Foglio illustrativo

•
نوكي نأ بجي .نوللا يف رييغتل وأ تايئيزج
دوجول لولحملا صحفا ،ءاودلا لامعتسا
لبق
اذإ ،ركعتم هنأ تظحلا اذإ ءاودلا
لامعتسا عنم
ُ
ي .رفصلأل لئام نول ىتح نوللا ميدع
لولحملا
.نيعلل ةرهاظ تايئيزج ىلع يوتحي ناك اذإ
وأ ،هنول رييغت
•
ة
ّ
لس يف وأ ةيودلأا ءاقلإ عنم
ُ
ي .هلامعتسا م
ّ
تي مل اذإ ةمئلام ةروصب لولحم لك يمرب مق
ص
ّ
لختلا ةيفيك ىلإ ةبسنلاب
ّ
يلديصلا لأسا .
ّ
ي
ّ
حصلا فرصلا هايم يف وأ تيبلا يف
تلامهملا
.ةئيبلا ىلع ظافحلا يف دعاستس تاوطخلا
هذه
ّ
نإ .اهل ةجاحب دعت مل يتلا ةيودلأا نم ة
ّ
يفاضإ تامولعم (
6
غلم
30
ىلع اربيلميه نم ةروراق لك يوتحت
.(emicizumab) باموزيسيمإ ةلا
ّ
عفلا ةداملا
0.7
( غلم
105
،)للم/غلم
150
زيكرتب للم
0.4
( غلم
60
،)للم/غلم
30
زيكرتب للم
1
)
.*باموزيسيمإ نم )للم/غلم
150
زيكرتب للم
1
( غلم
150
وأ )للم/غلم
150
زيكرتب للم
.ءاودلا زيكارت لك قيوست م
ّ
تي لا دق *
:ىلع ا
ً
ضيأ ءاودلا يوتحي ،ةلا
ّ
عفلا ةداملا ىلإ ةفاضلإاب
L-arginine, L-histidine, Poloxamer 188, L-aspartic acid and water
for injection.
؟ة
ّ
وبعلا يوحت اذامو ءاودلا ودبي فيك
.رفصلأل لئام نول ىتح نوللا ميدع
لولحملا .نقحلل لولحم وه اربيلميه
.ةدحاو ةيجاجز ةروراق ىلع اربيلميه نم ة
ّ
وبع لك يوتحت
ة
ّ
وبعلا هذه يف لومشم ريغ وهو اربيلميه
نقح لجأ نم
بولطم اذام
تحت هنقحو ةنقحملا ىلإ ةروراقلا نم
اربيلميه لولحم لقن لجأ نم نقح ةربإو
ل

Scheda tecnica

Page 1 of 30
Hemlibra PI_Version 8
HEMLIBRA
®
EMICIZUMAB
Solution for injection
1.
NAME OF THE MEDICINAL PRODUCT
Hemlibra 30 mg/mL solution for injection
Hemlibra 150 mg/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Hemlibra 30 mg/mL solution for injection
Each mL of solution contains 30 mg of emicizumab*
Each vial of 1 mL contains 30 mg of emicizumab at a concentration of
30 mg/mL.
Hemlibra 150 mg/mL solution for injection
Each mL of solution contains 150 mg of emicizumab*
Each vial of 0.4 mL contains 60 mg of emicizumab at a concentration of
150 mg/mL.
Each vial of 0.7 mL contains 105 mg of emicizumab at a concentration
of 150 mg/mL.
Each vial of 1 mL contains 150 mg of emicizumab at a concentration of
150 mg/mL.
* 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
3.
PHARMACEUTICAL FORM
Solution for injection.
_ _
Colourless to slightly yellow solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Hemlibra is indicated for routine prophylaxis to prevent bleeding or
reduce the frequency of bleeding
episodes in patients with hemophilia A (congenital factor VIII
deficiency) with or without factor VIII
inhibitors.
Page 2 of 30
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated under the supervision of a physician
experienced in the treatment of
haemophilia and/or bleeding disorders.
Posology
Treatment (including routine prophylaxis) with bypassing agents (e.g.
activated prothrombin complex
concentrate [aPCC] and activated recombinant human FVII [rFVIIa])
should be discontinued the day
before starting Hemlibra therapy (see section 4.4).
Factor VIII (FVIII) prophylaxis may be continued for the first 7 days
of Hemlibra treatment.
The recommended dose is 3
mg/kg once weekly for the first 4 weeks (loading dose), followed by a
maintenance dose from week 5, of either 1.5
mg/kg once weekly, 3 mg/kg every t