Bortezomib Fresenius Kabi

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

bortezomib

Διαθέσιμο από:

Fresenius Kabi Deutschland GmbH

Φαρμακολογική κατηγορία (ATC):

L01XG01

INN (Διεθνής Όνομα):

bortezomib

Θεραπευτική ομάδα:

Antineoplastic agents

Θεραπευτική περιοχή:

Multiple Myeloma

Θεραπευτικές ενδείξεις:

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.

Περίληψη προϊόντος:

Revision: 5

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

2019-11-14

Φύλλο οδηγιών χρήσης

84
B. PACKAGE LEAFLET
85
PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB FRESENIUS KABI 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 Bortezomib Fresenius Kabi is and what it is used for
2.
What you need to know before you use Bortezomib Fresenius Kabi
3.
How to use Bortezomib Fresenius Kabi
4.
Possible side effects
5.
How to store Bortezomib Fresenius Kabi
6.
Contents of the pack and other information
1.
WHAT BORTEZOMIB FRESENIUS KABI 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 (

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Bortezomib Fresenius Kabi 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 lyophilized powder or cake.
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 use of chemotherapeutic agents. Bortezomib must be
reconstituted by a healthcare
professional (see section 6.6).
Posology for treatment of progressive multiple m