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

Country: Netherlands

Language: Dutch

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

Active ingredient:

BORTEZOMIB

Available from:

Sandoz B.V.

ATC code:

L01XX32

INN (International Name):

BORTEZOMIB

Pharmaceutical form:

Poeder voor oplossing voor injectie

Composition:

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

Administration route:

Intraveneus gebruik, Subcutaan gebruik

Therapeutic area:

Bortezomib

Product summary:

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

Authorization date:

2017-02-06

Patient Information leaflet

Sandoz B.V.
Page 1/19
Bortezomib Sandoz 3,5 mg, poeder voor oplossing
voor injectie
RVG 118804
1313-v4
1.3.1.1 Package leaflet
Maart 2019
PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB SANDOZ 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 [Nationally completed name] is and what it is used for
2. What you need to know before you use [Nationally completed name]
3. How to use [Nationally completed name]
4. Possible side effects
5. How to store [Nationally completed name]
6. Contents of the pack and other information
1. WHAT [NATIONALLY COMPLETED NAME] IS AND WHAT IT IS USED FOR
[Nationally completed 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.
[Nationally completed 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.
Sandoz B.V.
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Bortezomib Sandoz 3,5 mg, poeder voor oplossing
voor injectie
RVG 118804
1313-v4
1.3.1.1 Package leaflet
Maart 2019
-
in combination with

Summary of Product characteristics

Sandoz B.V.
Page 1/50
Bortezomib Sandoz 3,5 mg, poeder voor oplossing voor injectie
RVG 118804
1311-v3
1.3.1.1 Samenvatting van de Productkenmerken
Maart 2019
1.
NAME OF THE MEDICINAL PRODUCT
Bortezomib Sandoz 3,5 mg, poeder voor oplossing voor injectie
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3.5 mg of bortezomib (as mannitol boronic ester).
After reconstitution with 3.5 ml, 1 ml of solution for intravenous
injection contains 1 mg
bortezomib.
After reconstitution with 1.4 ml, 1 ml of solution for subcutaneous
injection contains 2.5 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
pH of the reconstituted solution: 4.0 -7.0
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
{[Nationally completed 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.
{[Nationally completed 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.
{[Nationally completed name]} in combination with dexamethasone, or
with dexamethasone
and thalidomide, is indicated for the induction treatment of adult
patients with previously
Sandoz B.V.
Page 2/50
Bortezomib Sandoz 3,5 mg, poeder voor oplossing voor injectie
RVG 118804
1311-v3
1.3.1.1 Samenvatting van de Productkenmerken
Maart 2019
untreated multiple myeloma who are eligible for high-dose chemotherapy
with haematopoietic
stem cell transplantation.
{[Nationally completed name]} in combination with rituximab,
cyclophosphamide,
doxorubicin and prednisone is indicated for the treatment of adult
patients with previously
untreated m