Bortezomib Dr. Reddy’s 3.5 mg Powder For Solution For Injection

Nchi: Malta

Lugha: Kiingereza

Chanzo: Malta Medicines Authority

Inapatikana kutoka:

Reddy Pharma Iberia S.A. Avinguda De Josep Tarradellas 38 Barcelona, 08029, Spain

ATC kanuni:

L01XG

INN (Jina la Kimataifa):

BORTEZOMIB 3.5 mg

Dawa fomu:

POWDER FOR SOLUTION FOR INJECTION

Tungo:

BORTEZOMIB 3.5 mg

Dawa ya aina:

POM

Eneo la matibabu:

ANTINEOPLASTIC AGENTS

Bidhaa muhtasari:

Licence number in the source country: NOT APPLICAPABLE

Idhini hali ya:

Authorised

Idhini ya tarehe:

2022-06-20

Taarifa za kipeperushi

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB DR. REDDY’S 3.5 MG POWDER FOR SOLUTION FOR INJECTION
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 3.5 mg powder for solution for injection is and what
it is used for
2.
What you need to know before you use Bortezomib 3.5 mg powder for
solution for injection
3.
How to use Bortezomib 3.5 mg powder for solution for injection
4.
Possible side effects
5.
How to store Bortezomib 3.5 mg powder for solution for injection
6.
Contents of the pack and other information
1.
WHAT BORTEZOMIB 3.5 MG POWDER FOR SOLUTION FOR INJECTION IS AND WHAT
IT IS USED FOR
Bortezomib 3.5 mg powder for solution for injection 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 3.5 mg powder for solution for injection 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 thalidomi

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Bortezomib Dr. Reddy’s 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. 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 healthcare professiona