JAKAVI 5 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

RUXOLITINIB AS PHOSPHATE

متاح من:

NOVARTIS ISRAEL LTD

ATC رمز:

L01XE18

الشكل الصيدلاني:

TABLETS

تركيب:

RUXOLITINIB AS PHOSPHATE 5 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

المجموعة العلاجية:

RUXOLITINIB

المجال العلاجي:

RUXOLITINIB

الخصائص العلاجية:

* * Myelofibrosis (MF) Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis. * Polycythaemia vera (PV) Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.*Graft versus host disease (GvHD)Jakavi is indicated for the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies

تاريخ الترخيص:

2018-04-30

نشرة المعلومات

JAK SPL NOV22 V3
EU PIL April 2022
1
PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS
(PREPARATIONS) -
1986
This medicine is dispensed with a doctor's prescription only
JAKAVI
® 5 MG
JAKAVI
® 10 MG
JAKAVI
® 15 MG
JAKAVI
®
20 MG
TABLETS
TABLETS
TABLETS
TABLETS
Each tablet contains:
ruxolitinib phosphate
6.60 mg
corresponding to
ruxolitinib 5 mg
Each tablet contains:
ruxolitinib phosphate
13.20 mg
corresponding to
ruxolitinib 10 mg
Each tablet contains:
ruxolitinib phosphate
19.80 mg
corresponding to
ruxolitinib 15 mg
Each tablet contains:
ruxolitinib phosphate
26.40 mg
corresponding to
ruxolitinib 20 mg
INACTIVE INGREDIENTS AND ALLERGENS: SEE SECTION 2 "IMPORTANT
INFORMATION ABOUT
SOME OF THE MEDICINE’S INGREDIENTS", AND SECTION 6 "ADDITIONAL
INFORMATION".
READ THE ENTIRE LEAFLET CAREFULLY BEFORE USING THIS MEDICINE, BECAUSE
IT CONTAINS
INFORMATION THAT IS IMPORTANT FOR YOU.
This leaflet contains concise information about this medicine. If you
have any further
questions, refer to your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems to you that their medical condition is
similar to yours.
1. WHAT IS THE MEDICINE INTENDED FOR?
Jakavi is used to treat:
•
Adult
patients
with
an
enlarged
spleen
or
with
symptoms
related
to
myelofibrosis, a rare type of blood cancer.
•
Adult patients with polycythaemia vera who are resistant to or
intolerant of
hydroxyurea.
•
Adults and children aged 12 years and older with acute or chronic
graft-versus-
host disease (GvHD), who have inadequate response to corticosteroids
or other
systemic therapies.
THERAPEUTIC GROUP:
Jakavi belongs to a group of antineoplastic medicines that inhibit
protein-kinase.
Enlargement of the spleen is one of the characteristics of
myelofibrosis. Myelofibrosis
is a disorder of the bone marrow, in which the marrow is replaced by
scar tissue. The
abnormal marrow can no longer produce enough normal blood cells and as
a result
the spleen becomes

خصائص المنتج

1
JAK API FEB23 V6
EU SmPC April 2022
1.
NAME OF THE MEDICINAL PRODUCT
Jakavi
®
5
mg
,
tablets
Jakavi
®
10
mg
,
tablets
Jakavi
®
15
mg
,
tablets
Jakavi
®
20
mg
,
tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Jakavi 5
mg
:
Each tablet contains 6.60 mg ruxolitinib phosphate, corresponding to 5
mg ruxolitinib free base.
_Excipient with known effect_
:
_ _
Each tablet contains 71.45
mg lactose monohydrate.
Jakavi 10
mg
:
Each tablet contains 13.20 mg ruxolitinib phosphate, corresponding to
10 mg ruxolitinib free base.
_Excipient with known effect_
:
Each tablet contains 142.90
mg lactose monohydrate.
Jakavi 15
mg
:
Each tablet contains
19.8
0 mg ruxolitinib phosphate, corresponding to
15
mg ruxolitinib free base.
_Excipient with known effect_
:
Each tablet contains 214.35
mg lactose monohydrate.
Jakavi 20
mg
:
Each tablet contains
26.40
mg ruxolitinib phosphate, corresponding to
20
mg ruxolitinib free base.
_Excipient with known effect_
:
Each tablet contains 285.80
mg lactose monohydrate.
FOR THE FULL LIST OF EXCIPIENTS, SEE SECTION 6.1.
3.
PHARMACEUTICAL FORM
Tablet.
JAKAVI 5
MG
:
Tablet.
Round curved white to almost white tablets of approximately 7.5 mm in
diameter with “NVR”
debossed on one side and “L5” debossed on the other side.
JAKAVI 10
MG
:
Tablet.
Round curved white to almost white tablets of approximately 9.3 mm in
diameter with “NVR”
debossed on one side and “L10” debossed on the other side.
JAKAVI 15
MG
:
Tablet. Ovaloid curved white to almost white tablets of approximately
15.0 x 7.0 mm with “NVR”
debossed on one side and “L15” debossed on the other side.
JAKAVI 20
MG
:
Tablet. Elongated curved white to almost white tablets of
approximately 16.5 x 7.4 mm with “NVR”
debossed on one side and “L20” debossed on the other side.
2
JAK API FEB23 V6
EU SmPC April 2022
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Myelofibrosis (MF)
Jakavi is indicated for the treatment of disease-related splenomegaly
or symptoms in adult patients
with primary myelofibrosis (also