Bortezomib Krka 1 mg powder for solution for injection

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Bortezomib

Tilgjengelig fra:

KRKA, d.d., Novo mesto

ATC-kode:

L01XG01

INN (International Name):

Bortezomib

Dosering :

1 milligram(s)

Legemiddelform:

Powder for solution for injection

Terapeutisk område:

bortezomib

Autorisasjon status:

Marketed

Autorisasjon dato:

2019-05-17

Informasjon til brukeren

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first page
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Bortezomib Krka 1 mg
powder for solution for injection
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
or nurse.
• If you get any side effects, talk to your doctor or pharmacist or
nurse. This
includes any possible side effects not listed in this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1. What Bortezomib Krka is and what it is used for
2. What you need to know before you use Bortezomib Krka
3. How to use Bortezomib Krka
4. Possible side effects
5. How to store Bortezomib Krka
6. Contents of the pack and other information
1. What Bortezomib Krka is and what it is used for
Bortezomib Krka 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 Krka 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).
Bortezomib Krka is used for the treat

Preparatomtale

Health Products Regulatory Authority
08 February 2022
CRN00CRD8
Page 1 of 27
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bortezomib Krka 1 mg powder for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1 mg bortezomib (as mannitol boronic ester).
After reconstitution, each 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 (Powder for injection).
White to off white cake or powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bortezomib Krka 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 Krka 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 Krka 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 Krka 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 Krka treatment must be initiated under supervision of a
physician experienced in the treatment of cancer patients,
however Bortezomib Krka may be administered by a healthcare
professional experienced in use of chemotherapeutic agents.
Bortezomib Krka must be reconstitute