Zegomib 3,5 mg, poeder voor oplossing voor injectie

देश: नीदरलैंड

भाषा: डच

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

सक्रिय संघटक:

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

थमां उपलब्ध:

Egis Pharmaceuticals Plc Kereszturi ut 30-38 1106 BOEDAPEST (HONGARIJE)

ए.टी.सी कोड:

L01XX32

INN (इंटरनेशनल नाम):

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

फार्मास्यूटिकल फॉर्म:

Poeder voor oplossing voor injectie

रचना:

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

प्रशासन का मार्ग:

Intraveneus gebruik, Subcutaan gebruik

चिकित्सीय क्षेत्र:

Bortezomib

उत्पाद समीक्षा:

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

प्राधिकरण की तारीख:

1900-01-01

सूचना पत्रक

PACKAGE LEAFLET: INFORMATION FOR THE USER
ZEGOMIB 1 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 Zegomib is and what it is used for
2.
What you need to know before you use Zegomib
3.
How to use Zegomib
4.
Possible side effects
5.
How to store Zegomib
6.
Contents of the pack and other information
1.
WHAT ZEGOMIB IS AND WHAT IT IS USED FOR
Zegomib 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.
Zegomib 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).
Zegomib is used for the treatment of mantle cell lymphoma (a type of
cancer affecting the lymph
nodes) in patients 18 years or older in combination with the medicines
rituximab

उत्पाद विशेषताएं

1.
NAME OF THE MEDICINAL PRODUCT
Zegomib, 1 mg, poeder voor oplossing voor injectie
Zegomib, 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
Zegomib 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.
Zegomib 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.
Zegomib 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.
Zegomib 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
Zegomib treatment must be initiated under supervision of a physician
experienced in the treatment of
cancer patients, however Zegomib may be administered by a healthcare
professional experienced in
use of chemotherapeutic agents. Zegom