BORTEZOMIB EBEWE 3.5 Milligram Pdr for Soln for Injection

البلد: أيرلندا

اللغة: الإنجليزية

المصدر: HPRA (Health Products Regulatory Authority)

متاح من:

Rowex Ltd

ATC رمز:

L01XX32

جرعة:

3.5 Milligram

الشكل الصيدلاني:

Pdr for Soln for Injection

نوع الوصفة الطبية :

Product subject to prescription which may not be renewed (A)

المجال العلاجي:

Other antineoplastic agents

الوضع إذن:

Authorised

تاريخ الترخيص:

2017-08-25

نشرة المعلومات

PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB EBEWE 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 possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Bortezomib Ebewe is and what it is used for
2. What you need to know before you use Bortezomib Ebewe
3. How to use Bortezomib Ebewe
4. Possible side effects
5. How to store Bortezomib Ebewe
6. Contents of the pack and other information
1. WHAT BORTEZOMIB EBEWE IS AND WHAT IT IS USED FOR
Bortezomib Ebewe 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 Ebewe 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 Ebewe is used for the treatment of mantle cell lymphoma (a
type of cancer affecting the
lymph nodes) in patient

خصائص المنتج

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bortezomib Ebewe 3.5 mg Powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3.5 mg of bortezomib (as mannitol boronic ester).
After reconstitution with 3.5 ml, 1 ml of solution for intravenous
injection contains 1 mg bortezomib.
After reconstitution with 1.4 ml, 1 ml of solution for subcutaneous
injection contains 2.5 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
pH of the reconstituted solution: 4.0 -7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bortezomib Ebewe 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 Ebewe 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 Ebewe 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 Ebewe 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 and administered under the supervision of
a physician qualified and experienced in the use
of chemotherapeutic agents. Bortezomib must be reconstituted by a
healthcare professional.
Posolo