BORTEZOMIB FRESENIUS KABI 3.5 MG

Country: Israel

Bahasa: Inggeris

Sumber: Ministry of Health

Bahan aktif:

BORTEZOMIB

Boleh didapati daripada:

NEOPHARM (ISRAEL) 1996 LTD

Kod ATC:

L01XX32

Borang farmaseutikal:

POWDER FOR SOLUTION FOR INJECTION

Komposisi:

BORTEZOMIB 3.5 MG/VIAL

Laluan pentadbiran:

I.V, S.C

Jenis preskripsi:

Required

Dikeluarkan oleh:

FRESENIUS KABI ONCOLOGY LIMITED, INDIA

Kawasan terapeutik:

BORTEZOMIB

Tanda-tanda terapeutik:

Multiple MyelomaBortezomib Fresenius Kabi is indicated for the treatment of adult patients with multiple myeloma.Mantle Cell LymphomaBortezomib Fresenius Kabi for injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Bortezomib Fresenius Kabi 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.

Tarikh kebenaran:

2022-06-29

Ciri produk

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
BORTEZOMIB FRESENIUS KABI 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 13.
3
PHARMACEUTICAL FORM
Powder for solution for injection - I.V., S.C.
4
THERAPUETIC INDICATIONS
4.1
MULTIPLE MYELOMA
BORTEZOMIB FRESENIUS KABI is indicated for the treatment of adult
patients with multiple myeloma.
4.2
MANTLE CELL LYMPHOMA
BORTEZOMIB FRESENIUS KABI (bortezomib) for Injection is indicated for
the treatment of patients with mantle cell
Lymphoma who have received at least one prior therapy.
BORTEZOMIB FRESENIUS KABI 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.
5
DOSAGE AND ADMINISTRATION
GENERAL DOSING GUIDELINES
BORTEZOMIB FRESENIUS KABI IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY.
BORTEZOMIB FRESENIUS KABI 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 FRESENIUS KABI is 1.3mg/m
2
. BORTEZOMIB FRESENIUS KABI 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
.9
5
). When administered intravenously,
BORTEZOMIB FRESENIUS KABI is administered as a 3 to 5 second bolus
intravenous injection.
5.1
DOSAGE IN PREVIOUSLY UNTREATED MULTIPLE MYELOMA
BORTEZOMIB FRESENIUS KABI is administered in