ADCETRIS 50 MG

Maa: Israel

Kieli: englanti

Lähde: Ministry of Health

Aktiivinen ainesosa:

BRENTUXIMAB VEDOTIN

Saatavilla:

TAKEDA ISRAEL LTD

ATC-koodi:

L01XC12

Lääkemuoto:

POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION

Koostumus:

BRENTUXIMAB VEDOTIN 50 MG/VIAL

Antoreitti:

I.V

Prescription tyyppi:

Required

Valmistaja:

TAKEDA PHARMA A/S, DENMARK

Terapeuttinen alue:

BRENTUXIMAB VEDOTIN

Käyttöaiheet:

ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory CD30+ Hodgkin lymphoma (HL): 1. following autologous stem cell transplant (ASCT) or 2. following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option. ADCETRIS is indicated for the treatment of adult patients with relapsed or refractory systemic anaplastic large cell lymphoma (sALCL). ADCETRIS is indicated for the treatment of adult patients with CD30+ HL at increased risk of relapse or progression following ASCT. ADCETRIS is indicated for the treatment of adult patients with CD30+ cutaneous T-cell lymphoma (CTCL) after at least 1 prior systemic therapy . ADCETRIS is indicated for the treatment of adult patients with previously untreated Stage III or IV classical Hodgkin lymphoma (cHL), in combination with doxorubicin, vinblastine, and dacarbazine.ADCETRIS is indicated for the treatment of adult patients with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not otherwise specified, in combination with cyclophosphamide, doxorubicin, and prednisone.

Valtuutus päivämäärä:

2019-05-31

Pakkausseloste

Takeda Israel Ltd.
25
Efal st., P.O.B 4140, Petach-Tikva 4951125
Tel:[phone] Fax (local) : + 972-3-3733150
יאמ
2023
אפור
/
ה
,
חקור
/
ת
דבכנ
/
ה
, :ןודנה
(brentuximab vedotin)
50mg
®
ETRIS
ADC ןוכדע אפורל ןולעה
מ"עב לארשי הדקט תרבח
מ
עדיל תשקב
יכ
ןכדוע ןודנבש רישכתה לש אפורל ןולעה
הנורחאל
.
וותה
תוי
תומושרה
הז רישכתל
:
1.
ADCETRIS is indicated for the treatment of adult patients with
relapsed or refractory CD30+
Hodgkin lymphoma (HL):
1)
following autologous stem cell transplant (ASCT) or
2)
following at least two prior therapies when ASCT or multi-agent
chemotherapy is
not a treatment option.
2.
ADCETRIS is indicated for the treatment of adult patients with
relapsed or refractory
systemic anaplastic large cell lymphoma (sALCL).
3.
ADCETRIS is indicated for the treatment of adult patients with CD30+
HL at increased risk of
relapse or progression following ASCT.
4.
ADCETRIS is indicated for the treatment of adult patients with CD30+
cutaneous T-cell
lymphoma (CTCL) after at least 1 prior systemic therapy.
5.
ADCETRIS is indicated for the treatment of adult patients with
previously untreated Stage III
or IV classical Hodgkin lymphoma (cHL), in combination with
doxorubicin, vinblastine, and
dacarbazine.
6.
ADCETRIS is indicated for the treatment of adult patients with
previously untreated systemic
anaplastic
large
cell
lymphoma
(sALCL)
or
other
CD30-expressing
peripheral
T-cell
lymphomas (PTCL), including angioimmunoblastic T-cell lymphoma and
PTCL not otherwise
specified, in combination with cyclophosphamide, doxorubicin, and
prednisone.
:ליעפ ביכרמ
brentuximab vedotin 50 mg/vial
ןלהל
טוריפ
םייונישה
םיירקיעה
ולעב
ורל ן
אפ
)
טסקט
ףסונש
ןמוסמ
וחכב
ל
,
סקט
ט
טמשוהש
ןמוסמ
טסקטכ
םודא
םע
וק
הצוח
,
מחה הווהמה טסקט
בוהצב שגדומ הר
(
:
4.8
Undesirable effects
…
_Monotherapy _

Valmisteyhteenveto

1
1.
NAME OF THE MEDICINAL PRODUCT
ADCETRIS
®
50 mg powder for concentrate for solution for infusion.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 50 mg of brentuximab vedotin.
After reconstitution (see section 6.6), each mL contains 5 mg of
brentuximab vedotin.
ADCETRIS is an antibody-drug conjugate composed of a CD30-directed
monoclonal antibody
(recombinant chimeric immunoglobulin G1 [IgG1], produced by
recombinant DNA technology in
Chinese Hamster ovary cells) that is covalently linked to the
antimicrotubule agent monomethyl
auristatin E (MMAE).
Excipient with known effect
Each vial contains approximately 13.2 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for concentrate for solution for infusion.
White to off-white cake or powder.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
Hodgkin lymphoma
ADCETRIS is indicated for the treatment of adult patients with
previously untreated
Stage III or IV classical Hodgkin lymphoma (cHL), in combination with
doxorubicin, vinblastine, and
dacarbazine.
ADCETRIS is indicated for the treatment of adult patients with CD30+
HL at increased risk of relapse
or progression following autologous stem cell transplant (ASCT) (see
section 5.1).
ADCETRIS is indicated for the treatment of adult patients with
relapsed or refractory CD30+ Hodgkin
lymphoma (HL):
1.
following ASCT, or
2.
following at least two prior therapies when ASCT or multi-agent
chemotherapy is not a
treatment option.
Systemic anaplastic large cell lymphoma and Peripheral T-cell
lymphomas (PTCL)
ADCETRIS is indicated for the treatment of adult patients with
previously untreated systemic
anaplastic large cell lymphoma (sALCL) or other CD30-expressing
peripheral T-cell lymphomas
(PTCL), including angioimmunoblastic T-cell lymphoma and PTCL not
otherwise specified, in
combination with cyclophosphamide, doxorubicin, and prednisone.
ADCETRIS is indicated for the treatment of adult patients with
relapsed or refractory sALCL.
2
Cutaneous T-cell lymphoma
AD