BORTEZOMIB FRESENIUS KABI 3.5 MG

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

BORTEZOMIB

可用日期:

NEOPHARM (ISRAEL) 1996 LTD

ATC代码:

L01XX32

药物剂型:

POWDER FOR SOLUTION FOR INJECTION

组成:

BORTEZOMIB 3.5 MG/VIAL

给药途径:

I.V, S.C

处方类型:

Required

厂商:

FRESENIUS KABI ONCOLOGY LIMITED, INDIA

治疗领域:

BORTEZOMIB

疗效迹象:

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.

授权日期:

2022-06-29

产品特点

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