Bortezomib Sun

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

bortezomib

Saadav alates:

SUN Pharmaceutical Industries (Europe) B.V.

ATC kood:

L01XG01

INN (Rahvusvaheline Nimetus):

bortezomib

Terapeutiline rühm:

Antineoplastic agents

Terapeutiline ala:

Multiple Myeloma

Näidustused:

Bortezomib SUN 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 SUN 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 SUN 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 SUN 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.

Toote kokkuvõte:

Revision: 12

Volitamisolek:

Authorised

Loa andmise kuupäev:

2016-07-22

Infovoldik

45
B. PACKAGE LEAFLET
46
PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB SUN 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 SUN is and what it is used for
2.
What you need to know before you are given Bortezomib SUN
3.
How to use Bortezomib SUN
4.
Possible side effects
5.
How to store Bortezomib SUN
6.
Contents of the pack and other information
1.
WHAT BORTEZOMIB SUN IS AND WHAT IT IS USED FOR
Bortezomib SUN 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 SUN 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).
-
MANTLE CELL LYMPHOMA
(a type of cancer affecting the lymph nodes) in patients 18 years or
older in combination

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Bortezomib SUN 3.5 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder 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 lyophilized powder or cake.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bortezomib SUN 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 SUN 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 SUN 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 SUN 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 SUN treatment must be initiated under supervision of a
physician experienced in the
treatment of cancer patients, however Bortezomib SUN may be
administered by a healthcare
professional experienced in use of chemotherapeutic agents. Bortezomi