Bortezomib Teva 3.5 mg Powder for Solution for Injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bortezomib (as mannitol boronic ester)

Available from:

Teva B.V.

ATC code:

L01XX; L01XX32

INN (International Name):

Bortezomib (as mannitol boronic ester)

Dosage:

3.5 milligram(s)

Pharmaceutical form:

Powder for solution for injection

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Other antineoplastic agents; bortezomib

Authorization status:

Authorised

Authorization date:

2016-07-08

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB TEVA 3.5 MG POWDER FOR SOLUTION FOR INJECTION
Bortezomib
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bortezomib Teva is and what it is used for
2.
What you need to know before you use Bortezomib Teva
3.
How to use Bortezomib Teva
4.
Possible side effects
5.
How to store Bortezomib Teva
6.
Contents of the pack and other information
1.
WHAT BORTEZOMIB TEVA IS AND WHAT IT IS USED FOR
Bortezomib Teva contains the active substance bortezomib, a so-called
‘proteasome inhibitor’. Proteasomes
play an important role in controlling cell function and growth. By
interfering with their function, bortezomib
can kill cancer cells.
Bortezomib Teva is used for the treatment of MULTIPLE MYELOMA (a
cancer of the bone marrow) in patients
older than 18 years:
-
alone or together with the medicines pegylated liposomal doxorubicin
or dexamethasone, for patients
whose disease is worsening (progressive) after receiving at least one
prior treatment and for whom
blood stem cell transplantation was not successful or is unsuitable.
-
in combination with the medicines melphalan and prednisone, for
patients whose disease has not been
previously treated and are unsuitable for high-dose chemotherapy with
blood stem cell
transplantation.
-
in combination with the medicines dexamethasone or dexamethasone
together with thalidomide, for
patients whose disease has not been previously treated and before
receiving high-dose chemotherapy
with blood stem cell transplantation (induction treatment).
Bortezomib Teva is used for the treatment of mantle cell lymphoma (a
type of cancer affecting the lymph
nodes) in pa

Summary of Product characteristics

Health Products Regulatory Authority
11 November 2020
CRN00C0Y5
Page 1 of 29
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bortezomib Teva 3.5 mg Powder for Solution for Injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
After reconstitution with 1.4 ml, 1 ml of solution for subcutaneous
injection contains 2.5 mg bortezomib.
After reconstitution with 3.5 ml, 1 ml of solution for intravenous
injection contains 1 mg bortezomib.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection.
White to off-white cake or powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bortezomib Teva as monotherapy or in combination with pegylated
liposomal doxorubicin or dexamethasone is indicated for
the treatment of adult patients with progressive multiple myeloma who
have received at least 1 prior therapy and who have
already undergone or are unsuitable for haematopoietic stem cell
transplantation.
Bortezomib Teva in combination with melphalan and prednisone is
indicated for the treatment of adult patients with previously
untreated multiple myeloma who are not eligible for high-dose
chemotherapy with haematopoietic stem cell transplantation.
Bortezomib Teva in combination with dexamethasone, or with
dexamethasone and thalidomide, is indicated for the induction
treatment of adult patients with previously untreated multiple myeloma
who are eligible for high-dose chemotherapy with
haematopoietic stem cell transplantation.
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.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Bortezomib Teva treatment must be initiated under supervision of a
physician experienced in the treatment of cancer patients,
however Bortezomib Teva may be administered by a healthcar