Jakavi
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
18-05-2022
Valmisteyhteenveto
(SPC)
18-05-2022
Julkisesta arviointikertomuksesta
(PAR)
18-05-2022
Aktiivinen ainesosa:
ruxolitinib (as phosphate)
Saatavilla:
Novartis Europharm Limited
ATC-koodi:
L01EJ01
INN (Kansainvälinen yleisnimi):
ruxolitinib
Terapeuttinen ryhmä:
Antineoplastic agents
Terapeuttinen alue:
Myeloproliferative Disorders; Polycythemia Vera; Graft vs Host Disease
Käyttöaiheet:
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 (see section 5.1).
Tuoteyhteenveto:
Revision: 28
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2012-08-23
Pakkausseloste
68
B. PACKAGE LEAFLET
69
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
JAKAVI 5 MG TABLETS
JAKAVI 10 MG TABLETS
JAKAVI 15 MG TABLETS
JAKAVI 20 MG TABLETS
ruxolitinib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Jakavi is and what it is used for
2.
What you need to know before you take Jakavi
3.
How to take Jakavi
4.
Possible side effects
5.
How to store Jakavi
6.
Contents of the pack and other information
1.
WHAT JAKAVI IS AND WHAT IT IS USED FOR
Jakavi contains the active substance ruxolitinib.
Jakavi is used to treat adult patients with an enlarged spleen or with
symptoms related to
myelofibrosis, a rare form of blood cancer.
Jakavi is also used to treat adult patients with polycythaemia vera
who are resistant to or intolerant of
hydroxyurea.
Jakavi is also used to treat patients 12 years of age and older and
adults with graft-versus-host disease
(GvHD). There are two forms of GvHD: an early form called acute GvHD
that usually develops soon
after the transplantation and can affect skin, liver and
gastrointestinal tract, and a form called chronic
GvHD, which develops later, usually weeks to months after the
transplantation. Almost any organ can
be affected by chronic GvHD.
70
HOW JAKAVI WORKS
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
significantly enlarged. By
block
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
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 tablets
Each tablet contains 5 mg ruxolitinib (as phosphate).
_Excipient with known effect _
Each tablet contains 71.45 mg lactose monohydrate.
Jakavi 10 mg tablets
Each tablet contains 10 mg ruxolitinib (as phosphate).
_Excipient with known effect_
Each tablet contains 142.90 mg lactose monohydrate.
Jakavi 15 mg tablets
Each tablet contains 15 mg ruxolitinib (as phosphate).
_Excipient with known effect_
Each tablet contains 214.35 mg lactose monohydrate.
Jakavi 20 mg tablets
Each tablet contains 20 mg ruxolitinib (as phosphate).
_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 tablets
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 tablets
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 tablets
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 tablets
Elongated curved white to almost white tablets of approximately 16.5 x
7.4 mm with “NVR” debossed
one one side and “L20” debossed on the other side.
3
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 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
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