BORTEZOMIB TEVA 3.5 MG

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

BORTEZOMIB

Tilgjengelig fra:

TEVA ISRAEL LTD

ATC-kode:

L01XX32

Legemiddelform:

POWDER FOR SOLUTION FOR INJECTION

Sammensetning:

BORTEZOMIB 3.5 MG

Administreringsrute:

S.C, I.V

Resept typen:

Required

Produsert av:

TEVA ISRAEL LTD, ISRAEL

Terapeutisk område:

BORTEZOMIB

Indikasjoner:

Bortezomib Teva is indicated for the treatment of patients with multiple myeloma. Bortezomib Teva is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Bortezomib Teva in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma who are unsuitable for haematopoietic stem cell transplantation

Autorisasjon dato:

2022-06-30

Preparatomtale

Page 1 of 63
Bortezomib-Teva-3.5mg-powder-for-sol-for inj-SPC-notif-KK-01-2023
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BORTEZOMIB TEVA 3.5 MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3.5 mg of bortezomib (as a mannitol boronic ester).
After
reconstitution,
1
ml
of
solution
for
subcutaneous
injection
contains
2.5
mg
bortezomib.
After reconstitution, 1 ml of solution for intravenous injection
contains 1 mg bortezomib.
For the full list of excipients, see section 6.
Powder for Solution for Injection I.V., S.C.
3.
THERAPUETIC INDICATIONS
3.1 Multiple Myeloma
Bortezomib Teva 3.5 mg is indicated for the treatment of patients with
multiple myeloma.
3.2 Mantle Cell Lymphoma
Bortezomib Teva 3.5 mg is indicated for the treatment of patients with
mantle cell
lymphoma who have received at least one prior therapy.
Bortezomib Teva 3.5 mg in combination with rituximab,
cyclophosphamide, doxorubicin
and prednisone is indicated for the treatment of adult patients with
previously untreated
mantle cell lymphoma who are unsuitable for haematopoietic stem cell
transplantation.
4.
DOSAGE AND ADMINISTRATION
General Dosing Guidelines
Bortezomib Teva 3.5 mg is for intravenous or subcutaneous use only.
Bortezomib Teva 3.5 mg must not be administered by any other route.
Intrathecal administration has resulted in death.
Because each route of administration has a different reconstituted
concentration,
caution should be used when calculating the volume to be administered.
The recommended starting dose of Bortezomib Teva 3.5 mg (bortezomib)
is 1.3mg/m
2
.
Page 2 of 63
Bortezomib-Teva-3.5mg-powder-for-sol-for inj-SPC-notif-KK-01-2023
Bortezomib Teva 3.5 mg may be administered intravenously at a
concentration of 1mg/mL,
or subcutaneously at a concentration of 2.5 mg/mL (see
reconstitution/preparation for
intravenous
and
subcutaneous
administration
(section
4.8)).
When
administered
intravenously, Bortezomib Teva 3.5 mg is administered as a 3 to 5
second bolus
intravenous injection.
4.1 Dosage in P