Bortezomib 3.5mg powder for solution for injection

Страна: Малта

Език: английски

Източник: Medicines Authority

Активна съставка:

BORTEZOMIB

Предлага се от:

Baxter Holding B.V. Kobaltweg 49, 3542CE Utrecht, Netherlands

АТС код:

L01XX32

INN (Международно Name):

BORTEZOMIB 3.5 mg

Лекарствена форма:

POWDER FOR SOLUTION FOR INJECTION

Композиция:

BORTEZOMIB 3.5 mg

Вид предписание :

POM

Терапевтична област:

ANTINEOPLASTIC AGENTS

Каталог на резюме:

Licence number in the source country: NOT APPLICAPABLE

Статус Оторизация:

Authorised

Дата Оторизация:

2021-12-31

Листовка

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

Данни за продукта

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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bortezomib 3.5 mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial 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. Lyophilised white to off-white cake
or powder.
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 h