Abormib 2,5 mg, poeder voor oplossing voor injectie

Land: Nederland

Taal: Nederlands

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

Werkstoffen:

BORTEZOMIB ANHYDRIDE SAMENSTELLING overeenkomend met ; BORTEZOMIB

Beschikbaar vanaf:

G.L. Pharma GmbH Schlossplatz 1 A-8502 LANNACH (OOSTENRIJK)

ATC-code:

L01XX32

INN (Algemene Internationale Benaming):

BORTEZOMIB ANHYDRIDE COMPOSITION corresponding to ; BORTEZOMIB

farmaceutische vorm:

Poeder voor oplossing voor injectie

Samenstelling:

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

Toedieningsweg:

Intraveneus gebruik, Subcutaan gebruik

Therapeutisch gebied:

Bortezomib

Autorisatie datum:

2019-03-18

Bijsluiter

PACKAGE LEAFLET: INFORMATION FOR THE USER
ABORMIB 1 MG, POEDER VOOR OPLOSSING VOOR INJECTIE
ABORMIB 2,5 MG, POEDER VOOR OPLOSSING VOOR INJECTIE
ABORMIB 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 Abormib is and what it is used for
2.
What you need to know before you use Abormib
3.
How to use Abormib
4.
Possible side effects
5.
How to store Abormib
6.
Contents of the pack and other information
1
WHAT ABORMIB IS AND WHAT IT IS USED FOR
Abormib
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.
Abormib 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).
Abormib is used for the treatment of mantle cell lymphoma (a type of
cancer

Productkenmerken

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Abormib 1 mg, poeder voor oplossing voor injectie
Abormib 2,5 mg, poeder voor oplossing voor injectie
Abormib 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 2.5 mg bortezomib (as a mannitol boronic ester).
Each vial contains 3.5 mg bortezomib (as a mannitol boronic ester).
<2.5 mg and 3.5 mg only> 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
Abormib
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.
Abormib 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.
Abormib 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.
Abormib 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