Bortezomib Koanaa 3.5 mg powder for solution for injection

País: Irlanda

Língua: inglês

Origem: HPRA (Health Products Regulatory Authority)

Ingredientes ativos:

Bortezomib

Disponível em:

Koanaa Healthcare Limited

Código ATC:

L01XX; L01XX32

DCI (Denominação Comum Internacional):

Bortezomib

Dosagem:

3.5 milligram(s)

Forma farmacêutica:

Powder for solution for injection

Tipo de prescrição:

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

Área terapêutica:

Other antineoplastic agents; bortezomib

Status de autorização:

Not marketed

Data de autorização:

2017-02-16

Folheto informativo - Bula

PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB KOANAA 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 side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Bortezomib Koanaa is and what it is used for
2.
What you need to know before you use Bortezomib Koanaa.
3.
How to use Bortezomib Koanaa
4.
Possible side effects
5.
How to store Bortezomib Koanaa
6.
Contents of the pack and other information
1.
WHAT BORTEZOMIB KOANAA IS AND WHAT IT IS USED FOR
Bortezomib Koanaa 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 Koanaa 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 Koanaa is used for the treatment of mantle cell lymphoma (a
type of cancer
affecting the lymph nodes) in patie

Características técnicas

Health Products Regulatory Authority
02 December 2020
CRN00C24S
Page 1 of 30
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bortezomib Koanaa 3.5 mg powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3.5mg 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 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 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 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 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 supervision of a
physician experienced in the treatment of cancer patients,
however Bortezomib may be administered by a healthcare professional
experienced in