BORTEZOMIB BAXTER bortezomib 3.5 mg powder for injection vial

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

bortezomib, Quantity: 3.5 mg

Tillgänglig från:

Baxter Healthcare Pty Ltd

Läkemedelsform:

Injection, powder for

Sammansättning:

Excipient Ingredients: mannitol; nitrogen

Administreringssätt:

Intravenous, Subcutaneous

Enheter i paketet:

1 vial

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

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

Produktsammanfattning:

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 30 degrees Celsius

Bemyndigande status:

Registered

Tillstånd datum:

2022-08-04

Bipacksedel

Bortezomib Baxter
1
BORTEZOMIB BAXTER
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING BORTEZOMIB BAXTER?
Bortezomib Baxter contains the active ingredient bortezomib.
Bortezomib Baxter 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
Baxter 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. For more information, see Section 1. Why
am I using Bortezomib Baxter? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BORTEZOMIB BAXTER?
Do not use if you have ever had an allergic reaction to bortezomib or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2.
What should I know before I use Bortezomib Baxter? in
the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Bortezomib Baxter and affect how it
works. Tell your doctor if you are taking any other
medicines, including medicines you can buy without a prescription from
a pharmacy, supermarket or health food shop. A list
of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE BORTEZOMIB BAXTER?
Overall treatment with Bortezomib Baxter must be done under the
supervision of a doctor. Your treatment with Bortezomib
Baxter may be given by a healthcare professional (eg doctor or nurse)
experienced in the administration

Produktens egenskaper

Version 3.0
1
AUSTRALIAN PRODUCT INFORMATION – BORTEZOMIB
BAXTER (BORTEZOMIB)
1.
NAME OF THE MEDICINE
Bortezomib
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bortezomib Baxter (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. It also contains
35 mg
mannitol.
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Bortezomib Baxter, 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 Baxter, 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 Baxter is also indicated for the treatment of multiple
myeloma patients
who have received at least one prior therapy, and who have progressive
disease.
Bortezomib Baxter in combination with rituximab, cyclophosphamide,
doxorubicin, and
prednisone is
indicated for the treatment of adult patients with previously
untreated
mantle cell lymphoma.
4.2
DOSE AND METHOD OF ADMINISTRATION
Bortezomib Baxter 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.
Version 3.0
2
BORTEZOMIB BAXTER IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY.
INTRATHECAL ADMINISTRATION HAS RESULTED IN DEATH.
RECOMMENDED DOSAGE:
_PREVIOUSLY UNTREATED MULTIPLE MYELOMA - TRANSPLANT ELIGIBLE _
1.
_Bortezomib Baxter plus thalidomide-dexamethasone_
During the induction stage, B