Velcade

Страна: Нова Зеландия

Език: английски

Източник: Medsafe (Medicines Safety Authority)

Активна съставка:

Bortezomib 3.5mg (as a bortezomib mannitol ester that is formed during FP manufacture.)

Предлага се от:

Janssen-Cilag (New Zealand) Ltd

INN (Международно Name):

Bortezomib 3.5 mg (as a bortezomib mannitol ester that is formed during FP manufacture.)

дозиране:

3.5 mg

Лекарствена форма:

Powder for injection

Композиция:

Active: Bortezomib 3.5mg (as a bortezomib mannitol ester that is formed during FP manufacture.) Excipient: Mannitol

Броя в опаковка:

Vial, glass, Type 1, 3.5mg, 1 dose unit

Клас:

Prescription

Вид предписание :

Prescription

Произведено от:

Cilag AG

Терапевтични показания:

Velcade in combination with melphalan and prednisone, is indicated for the treatment of patients with previously untreated multiple myeloma, who are not suitable for high dose chemotherapy. Velcade as part of combination therapy, is indicated for induction therapy prior to high dose chemotherapy with autologous stem cell rescue for patients under 65 years of age with previously untreated multiple myeloma. Velcade is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.

Каталог на резюме:

Package - Contents - Shelf Life: Vial, glass, Type 1, 3.5mg - 1 dose units - 36 months from date of manufacture stored at or below 25°C protect from light 8 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Дата Оторизация:

2004-06-09

Листовка

1
VELCADE(230316)NZ CMI
VELCADE
 POWDER FOR INJECTION
_Bortezomib 3.5 mg_
_ _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about
VELCADE Powder for Injection. It does not contain all
the available information. It does not take the place of
talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has
weighed the risks of you being given VELCADE
against the benefits this medicine is expected to have
for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
BEING
GIVEN
VELCADE ASK YOUR DOCTOR.
KEEP THIS LEAFLET WHILE BEING TREATED
. You may need
to read it again.
WHAT VELCADE IS USED FOR
VELCADE belongs to a group of medicines called
antineoplastic or cytotoxic medicines. You may also
hear of these being called chemotherapy medicines.
These medicines are used to kill cancer cells.
VELCADE
is
used
to
treat
adults
with
multiple
myeloma (cancer of the bone marrow). It is prescribed
for patients who have not been previously treated for
multiple myeloma. It is also prescribed for patients who
have received one or more prior treatments and whose
cancer is still progressing.
Your doctor may have
prescribed
VELCADE
for
another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT
WHY VELCADE HAS BEEN PRESCRIBED FOR YOU.
THIS MEDICINE IS AVAILABLE ONLY WITH A DOCTOR’S
PRESCRIPTION.
BEFORE YOU ARE GIVEN VELCADE
WHEN YOU MUST NOT USE IT:
DO NOT USE VELCADE IF:
•
you know you are allergic (hypersensitive) to
bortezomib or boron or mannitol.
SYMPTOMS OF AN ALLERGIC REACTION MAY INCLUDE RASH,
ITCHING OR HIVES ON THE SKIN, SHORTNESS OF BREATH,
WHEEZING OR DIFFICULTY BREATHING, SWELLING OF THE
FACE, LIPS, TONGUE OR OTHER PARTS OF THE BODY.
BEFORE YOU START TO USE IT:
TELL YOUR DOCTOR IF YOU HAVE OR HAVE HAD ANY MEDICAL
CONDITIONS, ESPECIALLY THE FOLLOWING:
•
blood disorder with a low level of red or white
blood cells or platelets. This disorder may become
worse during treatment with VELCADE.
•
if you are suffering from diarrhoea or vomiting as
this
may b

Данни за продукта

27.210225
1
VELCADE (230623)ADS
VELCADE

BORTEZOMIB
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
VELCADE 3.5 mg Powder for Injection
2. QUALITITATIVE AND QUANTITATIVE COMPOSITION
VELCADE (bortezomib) is an antineoplastic agent for intravenous
injection (IV) or subcutaneous
(SC) use only. Each single dose vial contains 3.5 mg of bortezomib as
a sterile lyophilised powder.
For the full list of excipients, see SECTION 6.1.
3. PHARMACEUTICAL FORM
Powder for injection
White to off-white cake or powder.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
VELCADE in combination with melphalan and prednisone, is indicated for
the treatment of
patients with previously untreated multiple myeloma, who are not
suitable for high dose
chemotherapy.
VELCADE, as part of combination therapy, is indicated for induction
therapy prior to high dose
chemotherapy with autologous stem cell rescue for patients under 65
years of age with
previously untreated multiple myeloma
VELCADE is also indicated for the treatment of multiple myeloma
patients who have received
at least one prior therapy, and who have progressive disease.
4.2 DOSAGE AND ADMINISTRATION
RECOMMENDED DOSAGE
VELCADE
IS
FOR
INTRAVENOUS
OR
SUBCUTANEOUS
USE
ONLY.
INTRATHECAL
ADMINISTRATION HAS RESULTED IN DEATH.
VELCADE may be administered:
•
Intravenously (at a concentration of 1 mg/mL) as a 3-5 second bolus
injection or
•
Subcutaneously (at a concentration of 2.5 mg/mL). THE SUBCUTANEOUS
ROUTE OF
ADMINISTRATION IS APPLICABLE TO THE 3.5 MG PRESENTATION ONLY.
BECAUSE EACH ROUTE OF ADMINISTRATION HAS A DIFFERENT RECONSTITUTED
CONCENTRATION,
CAUTION SHOULD BE USED WHEN CALCULATING THE VOLUME TO BE ADMINISTERED.
VELCADE retreatment may be considered for multiple myeloma patients
who had previously
responded to treatment with VELCADE (see CLINICAL TRIALS).
27.210225
2
VELCADE (230623)ADS
PREVIOUSLY UNTREATED MULTIPLE MYELOMA
_TRANSPLANT ELIGIBLE _
1.
VELCADE PLUS THALIDOMIDE-DEXAMETHASONE
During the induction stage, VELCADE (bortezomib) is administered twice
weekly in
combination