Bortezomib Mylan 3.5 mg powder for solution for injection

Valsts: Īrija

Valoda: angļu

Klimata pārmaiņas: HPRA (Health Products Regulatory Authority)

Aktīvā sastāvdaļa:

Bortezomib

Pieejams no:

McDermott Laboratories Ltd., T/A Gerard Laboratories

ATĶ kods:

L01XX; L01XX32

SNN (starptautisko nepatentēto nosaukumu):

Bortezomib

Deva:

3.5 milligram(s)

Zāļu forma:

Powder for solution for injection

Ārstniecības joma:

Other antineoplastic agents; bortezomib

Autorizācija statuss:

Marketed

Autorizācija datums:

2019-05-17

Lietošanas instrukcija

PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB MYLAN 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 Mylan is and what it is used for
2.
What you need to know before you use Bortezomib Mylan
3.
How to use Bortezomib Mylan
4.
Possible side effects
5.
How to store Bortezomib Mylan
6.
Contents of the pack and other information
1.
WHAT BORTEZOMIB MYLAN IS AND WHAT IT IS USED FOR
Bortezomib Mylan 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 Mylan 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 Mylan is used for the treatment of mantle cell lymphoma (a
type of cancer affecting the
lymph
nod

Produkta apraksts

Health Products Regulatory Authority
16 July 2021
CRN00CFF0
Page 1 of 28
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bortezomib Mylan 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 Mylan 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 Mylan 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 Mylan 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 Mylan 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