Bortezomib Glenmark 3,5 mg, poeder voor oplossing voor injectie

Pajjiż: Olanda

Lingwa: Olandiż

Sors: CBG-MEB (College ter Beoordeling van Geneesmiddelen)

Ingredjent attiv:

BORTEZOMIB ANHYDRIDE 3,336 mg/flacon SAMENSTELLING overeenkomend met ; BORTEZOMIB 3,5 mg/flacon

Disponibbli minn:

Glenmark Pharmaceuticals s.r.o. Hvezdova 1716/2b 140 78 PRAHA 4 (TSJECHIË)

Kodiċi ATC:

L01XX32

INN (Isem Internazzjonali):

BORTEZOMIB ANHYDRIDE 3,336 mg/flacon SAMENSTELLING overeenkomend met ; BORTEZOMIB 3,5 mg/flacon

Għamla farmaċewtika:

Poeder voor oplossing voor injectie

Kompożizzjoni:

MANNITOL (D-) (E 421) ; STIKSTOF (HEAD SPACE) (E 941),

Rotta amministrattiva:

Intraveneus gebruik, Subcutaan gebruik

Żona terapewtika:

Bortezomib

Sommarju tal-prodott:

Hulpstoffen: MANNITOL (D-) (E 421); STIKSTOF (HEAD SPACE) (E 941);

Data ta 'l-awtorizzazzjoni:

1900-01-01

Fuljett ta 'informazzjoni

Page 1 of 15
PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB GLENMARK 1 MG, POEDER VOOR OPLOSSING VOOR INJECTIE
BORTEZOMIB GLENMARK 3,5 MG, POEDER VOOR OPLOSSING VOOR INJECTIE
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 Glenmark is and what it is used for
2.
What you need to know before you use Bortezomib Glenmark
3.
How to use Bortezomib Glenmark
4.
Possible side effects
5.
How to store Bortezomib Glenmark
6.
Contents of the pack and other information
1
WHAT BORTEZOMIB GLENMARK IS AND WHAT IT IS USED FOR
Bortezomib Glenmark 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 Glenmark 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).
Bortezo

Karatteristiċi tal-prodott

Page 1 of 38
1 NAME OF THE MEDICINAL PRODUCT
BORTEZOMIB GLENMARK 1 MG, POEDER VOOR OPLOSSING VOOR INJECTIE
BORTEZOMIB GLENMARK 3,5 MG, POEDER VOOR OPLOSSING VOOR INJECTIE
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg bortezomib (as a mannitol boronic ester).
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 Glenmark 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 Glenmark 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 Glenmark 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
Glenmark
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 Glenmark treatment must be initiated under supervision of a
physician experienced in
the treatment of cancer patients, however Bortezomib Glenmar