Bortezomib Rowex 3.5 mg Powder for solution for injection

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Bortezomib (as mannitol boronic ester)

Tilgjengelig fra:

Rowex Ltd

ATC-kode:

L01XG01

INN (International Name):

Bortezomib (as mannitol boronic ester)

Dosering :

3.5 milligram(s)

Legemiddelform:

Powder for solution for injection

Resept typen:

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

Terapeutisk område:

bortezomib

Autorisasjon status:

Marketed

Autorisasjon dato:

2018-04-13

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB ROWEX 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 or pharmacist.

If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Bortezomib Rowex is and what it is used for
2.
What you need to know before you use Bortezomib Rowex
3.
How to use Bortezomib Rowex
4.
Possible side effects
5.
How to store Bortezomib Rowex
6.
Contents of the pack and other information
1
WHAT BORTEZOMIB ROWEX IS AND WHAT IT IS USED FOR
Bortezomib Rowex 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 Rowex 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 Rowex is used for the treatment of mantle cell lymphoma (a
type of cancer affecting the lymph
nodes) i

Preparatomtale

Health Products Regulatory Authority
01 March 2023
CRN00D9NL
Page 1 of 28
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bortezomib Rowex 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 cake or powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bortezomib Rowex as monotherapy or in combination with pegylated
liposomal doxorubicin or dexamethasone is indicated for
the treatment ofadult 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 Rowex 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 Rowex 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 Rowex 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 treatment must be initiated under the supervision of a
physician experienced in the treatment of cancer patients,
however bortezomib may be administered by a healthcare professional
experienced in