VELCADE 3.5 MG

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

BORTEZOMIB

Disponible desde:

J-C HEALTH CARE LTD

Código ATC:

L01XX32

formulario farmacéutico:

POWDER FOR SOLUTION FOR INJECTION

Composición:

BORTEZOMIB 3.5 MG

Vía de administración:

I.V, S.C

tipo de receta:

Required

Fabricado por:

JANSSEN PHARMACEUTICA N.V.,BELGIUM

Grupo terapéutico:

BORTEZOMIB

Área terapéutica:

BORTEZOMIB

indicaciones terapéuticas:

Velcade (bortezomib) for injection is indicated for the treatment of patients with multiple myeloma.Velcade (bortezomib) for injection is indicated for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy.Velcade 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.

Fecha de autorización:

2014-08-31

Información para el usuario

J-C Health Care Ltd.
Kibbutz Shefayim 6099000, ISRAEL
tel [phone]
fax [phone]
Kibbutz Shefayim, 6099000
ISRAEL
Phone: [phone] Fax: [phone]
בפ
ראור
2021
ה/דבכנ ה/אפור
ה/דבכנ ת/חקור
וננוצרב
איבהל
םכתעידיל
א
ת
ש אפורל ןולעב םינוכדעה
רישכתה ל
:
_VELCADE 3.5MG POWDER FOR SOLUTION FOR INJECTION 131-60-3139-01/02/03_
_ _
:תויוותהל םושרה
Velcade (bortezomib) for injection is indicated for the treatment of
patients with multiple myeloma.
Velcade (bortezomib) for injection is indicated for the treatment of
patients with mantle cell
lymphoma who have received at least one prior therapy.
Velcade 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.
םייוניש ולח
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ל ןולעב
.אפור
ב"צמ
םייקנה םיצבקה
ל
חא
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פל ןתינ םייונישה
דרשמ רתאבש עדימה רגאמל תונ
תבותכב תואירבה
!/byDrug
x.html#
inde
rugs/
ov.il/d
https://data.health.g
.
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ם
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תופו
ש
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ןכ ומכ
,
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ם
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ס
םי
ב
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ל
ןופלט
09-9591111
.
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ןהכ רירפצ
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ה

Ficha técnica

Page 1 of 41
Velcade 3.5mg_PI_Jun2022_Ref_USPI Oct2021 & EU SmPC Feb2021
FULL PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
VELCADE 3.5MG
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 3.5 mg of 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 12.
Powder for solution for injection I.V., S.C.
3
THERAPUETIC INDICATIONS
3.1
MULTIPLE MYELOMA
VELCADE is indicated for the treatment of adult patients with multiple
myeloma.
3.2
MANTLE CELL LYMPHOMA
VELCADE (bortezomib) for Injection is indicated for the treatment of
patients with mantle cell lymphoma who have received
at least one prior therapy.
VELCADE 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
DOSAGE AND ADMINISTRATION
GENERAL DOSING GUIDELINES
VELCADE IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY. VELCADE must not
be administered by any other route.
Intrathecal administration has resulted in death. Intrathecal
administration has resulted in death.
BECAUSE EACH ROUTE OF ADMINISTRATION HAS A DIFFERENT RECONSTITUTED
CONCENTRATION, CAUTION SHOULD BE USED WHEN CALCULATING
THE VOLUME TO BE ADMINISTERED.
The recommended starting dose of VELCADE is 1.3 mg/m
2
. VELCADE may be administered intravenously at a concentration of
1mg/mL, or subcutaneously at a concentration of 2.5 mg/mL (see
reconstitution /preparation for intravenous and
subcutaneous administration section 4.8). When administered
intravenously, VELCADE is administered as a 3 to 5 second bolus
intravenous injection.
4.1
DOSAGE IN PREVIOUSLY UNTREATED MULTIPLE MYELOMA
VELCADE is administered in combination with oral melphalan and oral
prednisone for 9, six week treatment cycles as
s