Bortezomib Biotech Pharma 3.5 mg powder for solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Bortezomib

Available from:

Target Healthcare Limited

ATC code:

L01XX32

INN (International Name):

Bortezomib

Pharmaceutical form:

Powder for solution for injection

Therapeutic area:

bortezomib

Authorization status:

Not marketed

Authorization date:

2020-06-26

Patient Information leaflet

2
PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB BIOTECH PHARMA 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 <,>
.
-
If you get any side effects, talk to your <,>
. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Bortezomib Biotech Pharma is and what it is used for
2.
What you need to know before you Bortezomib Biotech Pharma
3.
How to use Bortezomib Biotech Pharma
4.
Possible side effects
5.
How to store Bortezomib Biotech Pharma
6.
Contents of the pack and other information
1.
WHAT BORTEZOMIB BIOTECH PHARMA IS AND WHAT IT IS USED FOR
Bortezomib Biotech Pharma 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 Biotech Pharma 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

Summary of Product characteristics

Health Products Regulatory Authority
20 March 2024
CRN00DVDH
Page 1 of 28
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bortezomib Biotech Pharma 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, 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 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for injection.
White to off-white lyophilized mass.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bortezomib Biotech Pharma 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 Biotech Pharma 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 Biotech Pharma 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 Biotech Pharma 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 Biotech Pharma treatment must be initiated under
supervision of a physician experienced in the treatment of
cancer patients, however Bortezomib Biot