BORTEZ TEVA 3.5 MG

Država: Izrael

Jezik: angleščina

Source: Ministry of Health

Aktivna sestavina:

BORTEZOMIB

Dostopno od:

ABIC MARKETING LTD, ISRAEL

Koda artikla:

L01XX32

Farmacevtska oblika:

POWDER FOR SOLUTION FOR INJECTION

Sestava:

BORTEZOMIB 3.5 MG

Pot uporabe:

I.V, S.C

Tip zastaranja:

Required

Izdeluje:

S.C SINDAN-PHARMA S.R.L

Terapevtsko območje:

BORTEZOMIB

Terapevtske indikacije:

Bortezo Teva is indicated for the treatment of patients with multiple myeloma. Bortezo Teva is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Bortezo 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.

Datum dovoljenje:

2018-12-05

Lastnosti izdelka

Page
1
of
63
Bortez-Teva-3.5mg-powder-for-sol-for inj-SPC-notif-KK-10-2021
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
BORTEZ TEVA 3.5MG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
After reconstitution, each 1 ml of solution for subcutaneous injection
contains 2.5 mg
bortezomib.
After reconstitution, each 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.
3.
THERAPUETIC INDICATIONS
3.1 MULTIPLE MYELOMA
Bortez Teva 3.5mg is indicated for the treatment of patients with
multiple myeloma.
3.2 MANTLE CELL LYMPHOMA
Bortez Teva 3.5mg is indicated for the treatment of patients with
mantle cell lymphoma
who have received at least one prior therapy.
Bortez Teva 3.5mg 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
Bortez Teva 3.5 mg is for intravenous or subcutaneous use only.
Bortez 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 Bortez Teva 3.5 mg (bortezomib) is
1.3mg/m
2
. Bortez
Page
2
of
63
Bortez-Teva-3.5mg-powder-for-sol-for inj-SPC-notif-KK-10-2021
Teva 3.5 mg may be administered intravenously at a concentration of 1
mg/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, Bortez Teva 3.5 mg is administered as a 3 to 5 second
bolus intravenous
injection.
4.1 DOSAGE IN PREVIOUSLY UNTREATED MULTIPLE MYELOMA
Bortez Teva 3