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

Negara: Belanda

Bahasa: Belanda

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

Bahan aktif:

BORTEZOMIB 1-WATER 3,7 mg/flacon SAMENSTELLING overeenkomend met ; BORTEZOMIB 3,5 mg/flacon

Tersedia dari:

Aurobindo Pharma B.V. Baarnsche Dijk 1 3741 LN BAARN

INN (Nama Internasional):

BORTEZOMIB 1-WATER 3,7 mg/flacon SAMENSTELLING overeenkomend met ; BORTEZOMIB 3,5 mg/flacon

Bentuk farmasi:

Poeder voor oplossing voor injectie

Komposisi:

MANNITOL (D-) (E 421)

Rute administrasi :

Intraveneus gebruik, Subcutaan gebruik

Tanggal Otorisasi:

2020-12-30

Selebaran informasi

BORTEZOMIB EUGIA 3,5 MG, POEDER VOOR OPLOSSING VOOR INJECTIE RVG 125205
MODULE 1
Administrative information and prescribing information
1.3.1 BIJSLUITER
Rev.nr. 2205
Pag. 1 van 14 BIJSLUITER: INFORMATIE VOOR DE GEBRUIKER
BORTEZOMIB EUGIA 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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours
-
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 Eugia 3,5 mg is and what it is used for
2.
What you need to know before you use bortezomib
3.
How to use bortezomib
4.
Possible side effects
5.
How to store bortezomib
6.
Contents of the pack and other information
1.
WHAT BORTEZOMIB EUGIA 3,5 MG IS AND WHAT IT IS USED FOR
Bortezomib
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 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
t

Karakteristik produk

BORTEZOMIB EUGIA 3,5 MG, POEDER VOOR OPLOSSING VOOR INJECTIE RVG 125205
MODULE 1
Administrative information and prescribing information
1.3.1 SAMENVATTING VAN DE PRODUCTKENMERKEN
Rev.nr. 2204
Pag. 1 van 40
1
SAMENVATTING VAN DE PRODUCTKENMERKEN
1.
NAAM VAN HET GENEESMIDDEL
Bortezomib Eugia 3,5 mg, poeder voor oplossing voor injectie
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
(as a mannitol boronic ester).
After reconstitution, 1 ml of solution for intravenous injection
contains 1 mg bortezomib (as a
mannitol boronic ester).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for injection.
White to off-white lyophilized cake or powder.
pH reconstitution solution
INTRAVENOUS ADMINISTRATION
: Reconstitution with 3.5 mL 0.9% sodium chloride solution -
5.345
SUBCUTANEOUS ADMINISTRATION:
Reconstitution with 1.4 mL 0.9% sodium chloride solution -
5.137
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 EUGIA 3,5 MG, POEDER VOOR OPLOSSING VOOR INJECTIE RVG 125205
MODULE 1
Administrativ