BORTEZOMIB SANDOZ bortezomib 3.5 mg powder for injection vial

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

bortezomib, Quantity: 3.5 mg

Dostupné s:

Sandoz Pty Ltd

Léková forma:

Injection, powder for

Složení:

Excipient Ingredients: mannitol

Podání:

Subcutaneous, Intravenous Bolus

Jednotky v balení:

1 vial

Druh předpisu:

(S4) Prescription Only Medicine

Terapeutické indikace:

BORTEZOMIB SANDOZ, 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.,BORTEZOMIB SANDOZ, 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.,BORTEZOMIB SANDOZ is also indicated for the treatment of multiple myeloma patients who have received at least one prior therapy, and who have progressive disease.,BORTEZOMIB SANDOZ in combination with rituximab, cyclophosphamide, doxorubicin and prednisone is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma.

Přehled produktů:

Visual Identification: BORTEZOMIB SANDOZ bortezomib is supplied in a 10 mL, type I, glass vial with a grey bromobutyl stopper and blue aluminum seal, within a capped transparent tray.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Stav Autorizace:

Registered

Datum autorizace:

2019-10-30

Informace pro uživatele

BORTEZOMIB SANDOZ
®
1
BORTEZOMIB
SANDOZ
®
_bortezomib _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Bortezomib Sandoz.
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 receiving this
medicine against the benefits this
medicine is expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT BORTEZOMIB
SANDOZ IS USED FOR
Bortezomib Sandoz 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.
Bortezomib Sandoz 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.
Bortezomib Sandoz 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
Bortezomib Sandoz for another
reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY BORTEZOMIB
SANDOZ HAS BEEN PRESCRIBED FOR
YOU.
THIS MEDICINE IS AVAILABLE ONLY
WITH A DOCTOR'S PRESCRIPTION.
BEFORE YOU ARE GIVEN
BORTEZOMIB SANDOZ
_WHEN YOU MUST NOT TAKE IT _
DO NOT USE BORTEZOMIB SANDOZ IF
YOU ARE:
•
allergic (hypersensitive) to
bortezomib or boron or mannitol.
Some of the symptoms of an allergic
reaction may include:
•
shortness of breath
•
wheezing or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itch

Charakteristika produktu

191030-bortezomib sandoz-pi
Page 1 of 48
AUSTRALIAN PRODUCT INFORMATION
BORTEZOMIB SANDOZ
® (BORTEZOMIB)
1.
NAME OF THE MEDICINE
Bortezomib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each single dose vial contains 3.5 mg of bortezomib as a sterile
lyophilised powder.
_List of excipients with known effect:_
mannitol.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Bortezomib Sandoz 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 white to off-white
sterile lyophilised cake or powder.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
Bortezomib Sandoz, 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.
Bortezomib Sandoz, 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.
Bortezomib Sandoz is also indicated for the treatment of multiple
myeloma patients who have
received at least one prior therapy, and who have progressive disease.
Bortezomib Sandoz in combination with rituximab, cyclophosphamide,
doxorubicin and
prednisone is indicated for the treatment of adult patients with
previously untreated mantle cell
lymphoma.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
Bortezomib Sandoz 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)
Because each route of administration has a different reconstituted
concentration, caution should
be used when calculating the volume to be administered.
BORTEZOMIB SANDOZ IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY.
INTRATHECAL ADMINISTRATION HAS RESULTED IN DEATH.
191030-bortezomib sandoz-pi
Page 2 of 48
RECOMMENDED DOSAGE
_PREVIOUSLY UNTREATED MULTIPLE MYEL