VELCADE bortezomib 3.0mg powder for injection vial

Šalis: Australija

kalba: anglų

Šaltinis: Department of Health (Therapeutic Goods Administration)

Veiklioji medžiaga:

bortezomib, Quantity: 3 mg

Prieinama:

Janssen-Cilag Pty Ltd

INN (Tarptautinis Pavadinimas):

Bortezomib

Vaisto forma:

Injection, powder for

Sudėtis:

Excipient Ingredients: mannitol; nitrogen

Vartojimo būdas:

Intravenous, Subcutaneous

Vienetai pakuotėje:

1 vial

Recepto tipas:

(S4) Prescription Only Medicine

Terapinės indikacijos:

- VELCADE, in combination with melphalan and prednisone is indicated for the treatment of patients with previously untreated multiple myeloma who are not candidates 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. - VELCADE in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Produkto santrauka:

Visual Identification: White to off-white cake or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Autorizacija statusas:

Licence status A

Leidimo data:

2015-11-17

Pakuotės lapelis

VELCADE
®
(190402) ACMI
1
VELCADE
®
_POWDER FOR INJECTION _
_Bortezomib _
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.
VELCADE is also used for the
treatment of mantle cell lymphoma (a
type of cancer affecting the lymph
nodes) in adults in combination with
the medicines rituximab,
cyclophosphamide, doxorubicin and
prednisone, for patients whose
disease has not been previously
treated.
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

Prekės savybės

CCDS180807
1
VELCADE(190925)API
VELCADE
®
BORTEZOMIB
A
USTRALIAN
P
RODUCT
I
NFORMATION
1. NAME OF THE MEDICINE
Bortezomib
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
VELCADE
(bortezomib)
is
an
antineoplastic
agent
for
intravenous
injection
(IV)
or
subcutaneous (SC) use only. Each single dose vial contains:
•
1 mg of bortezomib as a sterile lyophilised powder. It also contains
10 mg of mannitol.
•
3.0 mg of bortezomib as a sterile lyophilized powder. It also contains
30 mg of mannitol.
•
3.5 mg of bortezomib as a sterile lyophilised powder. It also contains
35 mg mannitol.
The 5 mL vial contains 11 mg powder (1.0 mg bortezomib) for solution
for IV injection only.
The 10 mL vial contains 33 mg powder for the 3.0 mg product, and 38.5
mg powder for the
3.5 mg product, for solution for IV or SC injection.
For a full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
Powder for injection. White to off-white cake or powder.
Bortezomib is a modified dipeptidyl boronic acid. The product is
provided as a mannitol
boronic ester which, in reconstituted form, consists of the mannitol
ester in equilibrium with
its hydrolysis product, the monomeric boronic acid. The drug substance
exists in its cyclic
anhydride form as a trimeric boroxine.
The chemical name for bortezomib, the monomeric boronic acid, is
[(1R)-3-methyl-1-[[(2S)-
1-oxo-3-phenyl-2-[(pyrazinylcarbonyl)amino]propyl]amino]butyl] boronic
acid.
The solubility of bortezomib, as the monomeric boronic acid, in water
is: 3.3 – 3.8 mg/mL in
a pH range of 2 – 6.5.
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
candidates for high dose
chemotherapy.
Product Information - Australia
CCDS180807
2
VELCADE(190925)API
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 ag