Bortezomib Adamed 1 mg, poeder voor oplossing voor injectie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

BORTEZOMIB ANHYDRIDE 0,953 mg/flacon SAMENSTELLING overeenkomend met ; BORTEZOMIB 1 mg/flacon

Beschikbaar vanaf:

Adamed Sp. z o.o. Pienków 149 05152 CZOSNÓW (POLEN)

ATC-code:

L01XX32

INN (Algemene Internationale Benaming):

BORTEZOMIB ANHYDRIDE 0,953 mg/flacon SAMENSTELLING overeenkomend met ; BORTEZOMIB 1 mg/flacon

farmaceutische vorm:

Poeder voor oplossing voor injectie

Samenstelling:

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

Toedieningsweg:

Intraveneus gebruik

Therapeutisch gebied:

Bortezomib

Product samenvatting:

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

Autorisatie datum:

2015-08-10

Bijsluiter

Common Technical Document
Bortezomib
Powder for solution for infusion
M1.3.1_03.BZB.lyo.001.04.Core
Page 1 of 16
1.3.1
Package leaflet - Core
PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB ADAMED, 1 MG, POEDER VOOR OPLOSSING VOOR INJECTIE
BORTEZOMIB ADAMED, 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 [product name] is and what it is used for
2.
What you need to know before you use [product name]
3.
How to use [product name]
4.
Possible side effects
5.
How to store [product name]
6.
Contents of the pack and other information
1
WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR
[product
name]
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.
[product name] 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 receivin

Productkenmerken

Common Technical Document
Bortezomib
Powder for solution for injection
M1.3.1_01.BZB.lyo.001.04.Core
Page 1 of 38
1.3.1
Summary of Product Characteristics - Core
1 NAME OF THE MEDICINAL PRODUCT
Bortezomib Adamed, 1 mg, poeder voor oplossing voor injectie
Bortezomib Adamed, 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
[product
name]
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.
[product name] 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.
[product name] 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.
[product name] 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.
Common Technical Document
Bortezomib
Powder for solution for injection