Bortezomib Koanaa Pdr for Soln for Injection 3.5mg/vial

국가: 몰타

언어: 영어

출처: Malta Medicines Authority

유효 성분:

BORTEZOMIB

제공처:

Koanaa Healthcare Limited 4th Floor, Cavendish House, 369 Burnt Oak, Broadway, Edgware, HA85AW, Middlesex, United Kingdom

ATC 코드:

L01XX32

INN (국제 이름):

BORTEZOMIB 3.5 mg

약제 형태:

POWDER FOR SOLUTION FOR INJECTION

구성:

BORTEZOMIB 3.5 mg

처방전 유형:

POM

치료 영역:

ANTINEOPLASTIC AGENTS

승인 상태:

Withdrawn

승인 날짜:

2016-11-24

환자 정보 전단

Page 1 of 14
PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB KOANAA 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 Koanaa is and what it is used for
2.
What you need to know before you use Bortezomib Koanaa.
3.
How to use Bortezomib Koanaa
4.
Possible side effects
5.
How to store Bortezomib Koanaa
6.
Contents of the pack and other information
1.
WHAT BORTEZOMIB KOANAA IS AND WHAT IT IS USED FOR
Bortezomib Koanaa 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 Koanaa 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 Koanaa is used for the treatment of mantle cell lymphoma (a
type of cancer affecting
the lymph no

제품 특성 요약

Page
1
of
38
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Bortezomib Koanaa 3.5mg powder for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3.5mg bortezomib (as a mannitol boronic ester).
After reconstitution with 1.4 ml, 1 ml of solution for subcutaneous
injection contains 2.5 mg
bortezomib.
After
reconstitution
with
3.5
ml,
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
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
reconstitu