Bortezomib Clonmel 2.5 mg/ml solution for injection (1.4ml vial)

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

BORTEZOMIB

Available from:

Clonmel Healthcare Limited Waterford Road, Clonmel, Co. Tipperary E91 D768, Ireland

ATC code:

L01XX32

INN (International Name):

BORTEZOMIB 3.5 mg

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

BORTEZOMIB 3.5 mg

Prescription type:

POM

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Licence number in the source country: NOT APPLICAPABLE

Authorization status:

Authorised

Authorization date:

2021-02-25

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
BORTEZOMIB CLONMEL 2.5 MG/ML 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, pharmacist or
nurse.
­
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Bortezomib Clonmel is and what it is used for
2. What you need to know before you use Bortezomib Clonmel
3. How to use Bortezomib Clonmel
4. Possible side effects
5. How to store Bortezomib Clonmel
6. Contents of the pack and other information
1. WHAT BORTEZOMIB CLONMEL IS AND WHAT IT IS USED FOR
Bortezomib Clonmel 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 Clonmel 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 Clonmel is used for the treatment of mantle cell lymphoma
(a type of cancer
affecting the ly

Summary of Product characteristics

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1
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SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
Bortezomib Clonmel 2.5 mg/ml Solution for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 1.4 ml solution for injection which contains 3.5 mg
bortezomib (as a mannitol boronic
ester).
Each vial contains 2.8 ml solution for injection which contains 7 mg
bortezomib (as a mannitol boronic
ester).
For subcutaneous injection, no dilution is necessary.
1 ml of solution for subcutaneous injection contains 2.5 mg
bortezomib.
For intravenous injection, dilution is necessary.
After dilution, 1 ml of solution for intravenous injection contains 1
mg bortezomib.
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection.
_Clear and colourless to light yellow solution with a pH-value of 4.0
– 6.0._
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Bortezomib Clonmel 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 Clonmel 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 Clonmel 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 Clonmel 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 ADMINISTRA