Bortezomib Accord

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

bortezomib

Saatavilla:

Accord Healthcare S.L.U.

ATC-koodi:

L01XX32

INN (Kansainvälinen yleisnimi):

bortezomib

Terapeuttinen ryhmä:

Antineoplastic agents

Terapeuttinen alue:

Multiple Myeloma

Käyttöaiheet:

Bortezomib Accord 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 Accord 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 Accord 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 Accord 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.

Tuoteyhteenveto:

Revision: 13

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2015-07-20

Pakkausseloste

83
B. PACKAGE LEAFLET
84
PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB ACCORD 2.5 MG/ML 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 Accord is and what it is used for
2.
What you need to know before you use Bortezomib Accord
3.
How to use Bortezomib Accord
4.
Possible side effects
5.
How to store Bortezomib Accord
6.
Contents of the pack and other information
1.
WHAT BORTEZOMIB ACCORD IS AND WHAT IT IS USED FOR
Bortezomib Accord 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 Accord 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 Accord is used for the treatment of mantle cell lymphoma (a
type of cancer affecting

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Bortezomib Accord 2.5 mg/mL solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution for injection contains 2.5 mg bortezomib (as a
mannitol boronic ester).
One vial of 1 mL of solution for injection contains 2.5 mg bortezomib.
One vial of 1.4 mL of solution for injection contains 3.5 mg
bortezomib.
After dilution, 1 mL of solution for intravenous injection contains 1
mg bortezomib.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection (injection).
Clear colourless solution with a pH value of 4.0-7.0.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bortezomib Accord 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 Accord 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 Accord 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 Accord 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 Accord treatment must be initiated under supervision of a
physician experienced in the
treatment of cancer patients, however Bortezomib Accord may be
administered by a