Velcade

Riik: Euroopa Liit

keel: inglise

Allikas: EMA (European Medicines Agency)

Toimeaine:

bortezomib

Saadav alates:

Janssen-Cilag International NV

ATC kood:

L01XG01

INN (Rahvusvaheline Nimetus):

bortezomib

Terapeutiline rühm:

Antineoplastic agents

Terapeutiline ala:

Multiple Myeloma

Näidustused:

Velcade 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.Velcade 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.Velcade 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.Velcade 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: 45

Volitamisolek:

Authorised

Loa andmise kuupäev:

2004-04-26

Infovoldik

75
B. PACKAGE LEAFLET
76
PACKAGE LEAFLET: INFORMATION FOR THE USER
VELCADE 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 side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What VELCADE is and what it is used for
2.
What you need to know before you use VELCADE
3.
How to use VELCADE
4.
Possible side effects
5.
How to store VELCADE
6.
Contents of the pack and other information
1.
WHAT VELCADE IS AND WHAT IT IS USED FOR
VELCADE 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.
VELCADE 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).
VELCADE 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 the medicines
rituximab, c

Toote omadused

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
VELCADE 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
VELCADE 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.
VELCADE 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.
VELCADE 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.
VELCADE 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
VELCADE treatment must be initiated under supervision of a physician
experienced in the treatment
of cancer patients, however VELCADE may be administered by a
healthcare professional experienced
in use of chemotherapeutic agents. VELCADE must be reconstituted by a
healthcare professional (see
section 6.6).
Posology for treatment of progressive multiple myeloma (patients who
have received at least one pri