BORTEZOMIB S.K. 3.5 MG

Šalis: Izraelis

kalba: anglų

Šaltinis: Ministry of Health

Veiklioji medžiaga:

BORTEZOMIB AS MANNITOL BORONIC ESTER

Prieinama:

K.S.KIM INTERNATIONAL (SK- PHARMA) LTD., ISRAEL

ATC kodas:

L01XX32

Vaisto forma:

POWDER FOR SOLUTION FOR INJECTION

Sudėtis:

BORTEZOMIB AS MANNITOL BORONIC ESTER 3.5 MG

Vartojimo būdas:

S.C, I.V

Recepto tipas:

Required

Pagaminta:

PHARMAIDEA, LATVIA

Gydymo sritis:

BORTEZOMIB

Terapinės indikacijos:

Multiple MyelomaBORTEZOMIB S.K is indicated for the treatment of patients with multiple myeloma.Mantle Cell LymphomaBORTEZOMIB S.K is indicated for the treatment of patients with mantle cell Lymphoma who have received at least one prior therapy.BORTEZOMIB S.K 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.

Leidimo data:

2021-10-31

Prekės savybės

Page 1 of 40
FULL PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
BORTEZOMIB S.K. 3.5MG
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 12.
Powder for solution for injection I.V., S.C.
3
THERAPUETIC INDICATIONS
3.1
MULTIPLE MYELOMA
BORTEZOMIB S.K
.
is indicated for the treatment of patients with multiple myeloma
3.2
MANTLE CELL LYMPHOMA
BORTEZOMIB S.K
.
(bortezomib) for Injection is indicated for the treatment of patients
with mantle cell Lymphoma who
have received at least one prior therapy
BORTEZOMIB S.K 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 S.K IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY.
BORTEZOMIB S.K
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 S.K is 1.3mg/m
2
. BORTEZOMIB S.K 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 S.K is administered as a 3 to 5
second bolus intravenous injection.
4.1
DOSAGE IN PREVIOUSLY UNTREATED MULTIPLE MYELOMA
BORTEZOMIB S.K is administered in combination with oral melphalan and
oral prednisone for 9, six week treatment
cycles as shown in _Table 1_. In Cycles 1 to 4, BORTEZO