HALAVEN

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

ERIBULIN AS MESILATE

Disponibbli minn:

EISAI ISRAEL LTD., ISRAEL

Kodiċi ATC:

L01XX41

Għamla farmaċewtika:

SOLUTION FOR INJECTION

Kompożizzjoni:

ERIBULIN AS MESILATE 0.44 MG/ML

Rotta amministrattiva:

I.V

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

EISAI MANUFACTURING LIMITED, UK

Grupp terapewtiku:

ERIBULIN

Żona terapewtika:

ERIBULIN

Indikazzjonijiet terapewtiċi:

Halaven is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.Halaven is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.

Data ta 'l-awtorizzazzjoni:

2017-04-30

Fuljett ta 'informazzjoni

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
אפור
אפור
אפור
ןכדועמ(
ןכדועמ(
ןכדועמ(
.102.50
.102.50
.102.50
)
)
)
:ךיראת
01/01/110/
םושיר רפסמו תילגנאב רישכת םש
:
33511
-
18
-
148
Halaven
:םושירה לעב םש
Neopharm Scientific Ltd.
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
שדח טסקט
4.8 UNDESIRABLE EFFECTS
Summary of safety profile
The most commonly reported adverse reactions related to
HALAVEN, are bone marrow suppression manifested as
neutropenia, leucopenia, anaemia, thrombocytopenia with
associated infections. New onset or worsening of pre-existing
peripheral neuropathy has also been reported. Gastrointestinal
toxicities, manifested as anorexia, nausea, vomiting, diarrhoea,
constipation, and stomatitis are among reported undesirable effects.
Other undesirable effects include fatigue, alopecia, increased liver
enzymes, sepsis and musculoskeletal pain syndrome.
Tabulated list of adverse reactions
Unless otherwise noted, the table shows the incidence rates of
adverse reactions observed in breast cancer and soft tissue sarcoma
patients who received the recommended dose in Phase 2 and Phase
3 studies.
[…]
Summary of safety profile
The most commonly reported adverse reactions related to
HALAVEN, are bone marrow suppression manifested as
neutropenia, leucopenia, anaemia, thrombocytopenia with associated
infections. New onset or worsening of pre-existing peripheral
neuropathy has also been reported. Gastrointestinal toxicities,
manifested as anorexia, nausea, vomiting, diarrhoea, constipation,
and stomatitis are among reported undesirable effects. Other
undesirable effects include fatigue, alopecia, increased liver
enzymes, sepsis and musculoskeletal pain syndrome.
Tabulated list of adverse reactions
Unle

Karatteristiċi tal-prodott

1
1.
NAME OF THE MEDICINAL PRODUCT
HALAVEN
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ml contains eribulin mesilate equivalent to 0.44 mg eribulin.
Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg
eribulin.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless aqueous solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
HALAVEN is indicated for the treatment of adult patients with locally
advanced or metastatic breast
cancer who have progressed after at least one chemotherapeutic regimen
for advanced disease (see
section 5.1). Prior therapy should have included an anthracycline and
a taxane in either the adjuvant or
metastatic setting unless patients were not suitable for these
treatments.
HALAVEN is indicated for the treatment of adult patients with
unresectable liposarcoma who have
received prior anthracycline containing therapy (unless unsuitable)
for advanced or metastatic disease
(see section 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
HALAVEN should only be prescribed by a qualified physician experienced
in the appropriate use of
anti-cancer therapy. It should be administered by an appropriately
qualified healthcare professional
only.
Posology
The recommended dose of eribulin as the ready to use solution is 1.23
mg/m
2
which should be
administered intravenously over 2 to 5 minutes on Days 1 and 8 of
every 21-day cycle.
PLEASE NOTE:
In Israel and EU the recommended dose refers to the base of the active
substance (eribulin). Calculation
of the individual dose to be administered to a patient must be based
on the strength of the ready to use
solution that contains 0.44 mg/ml eribulin and the dose recommendation
of 1.23 mg/m
2
. The dose
reduction recommendations shown below are also shown as the dose of
eribulin to be administered
based on the strength of the ready to use solution.
In the pivotal trials, the corresponding publications and in some
other regions e.g. the United States and
Switzerland, the recommended dos