Bortezomib 2.5 mg/ml solution for injection

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Bortezomib

から入手可能:

EVER Valinject GmbH

ATCコード:

L01XX32

INN（国際名）:

Bortezomib

投薬量:

2.5 milligram(s)/millilitre

医薬品形態:

Solution for injection

治療領域:

bortezomib

認証ステータス:

Marketed

承認日:

2021-11-19

情報リーフレット

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PACKAGE LEAFLET: INFORMATION FOR THE USER
[INVENTED NAME] 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 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 [Invented name] is and what it is used for
2.
What you need to know before you use [Invented name]
3.
How to use [Invented name]
4.
Possible side effects
5.
How to store [Invented name]
6.
Contents of the pack and other information
1.
WHAT [INVENTED NAME] IS AND WHAT IT IS USED FOR
[Invented 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.
[Invented 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.
−
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).
[Invented name] is used for the treatment of mantle cell lymphoma (a
type of cancer affecting the
lymph nodes) in patient

製品の特徴

Health Products Regulatory Authority
01 March 2022
CRN00CLZC
Page 1 of 29
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Bortezomib 2.5 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains 2.5 mg bortezomib (as a mannitol
boronic ester).
Each vial with 1 ml solution for injection contains 2.5 mg bortezomib
(as a mannitol boronic ester).
Each vial with 1.4 ml solution for injection contains 3.5 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, colourless to light yellow solution with a pH of 4.0 – 5.5.
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 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 haema