Bortezomib 1 mg powder for solution for injection

Země: Irsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktivní složka:

Bortezomib

Dostupné s:

European Regulatory Affairs t/a Ivowen

ATC kód:

L01XX; L01XX32

INN (Mezinárodní Name):

Bortezomib

Dávkování:

1 milligram(s)

Léková forma:

Powder for solution for injection

Terapeutické oblasti:

Other antineoplastic agents; bortezomib

Stav Autorizace:

Not marketed

Datum autorizace:

2017-06-02

Informace pro uživatele

PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB 1 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 is and what it is used for
2.
What you need to know before you use Bortezomib
3.
How to use Bortezomib
4.
Possible side effects
5.
How to store Bortezomib
6.
Contents of the pack and other information
1
WHAT BORTEZOMIB IS AND WHAT IT IS USED FOR
This medicine 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 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 is used for the treatment of mantle cell lymphoma (a type
of cancer affecting the
lymph nodes) in patients 18 years or older in combination with

Charakteristika produktu

Health Products Regulatory Authority
06 August 2021
CRN00CCPJ
Page 1 of 26
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bortezomib 1 mg powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
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 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
Treatment must be initiated under the supervision of a physician
experienced in the treatment of cancer patients, however this
medicine may be administered by a healthcare professional experienced
in use of chemotherapeutic agents. Bortezomib must
be reconstituted by a healthcare professional (see section 6.6).
Posology for treatme