BORTEZOMIB-TEVA bortezomib 3.5 mg powder for injection vial

מדינה: אוסטרליה

שפה: אנגלית

מקור: Department of Health (Therapeutic Goods Administration)

מרכיב פעיל:

bortezomib, Quantity: 3.5 mg

זמין מ:

Teva Pharma Australia Pty Ltd

טופס פרצבטיות:

Injection, powder for

הרכב:

Excipient Ingredients: mannitol; nitrogen

מסלול נתינה (של תרופות):

Intravenous, Subcutaneous

יחידות באריזה:

1

סוג מרשם:

(S4) Prescription Only Medicine

סממני תרפויטית:

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

leaflet_short:

Visual Identification: White to off-white cake or powder; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius

מצב אישור:

Registered

תאריך אישור:

2019-05-14

עלון מידע

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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-TEVA?
Bortezomib-Teva contains the active ingredient bortezomib.
Bortezomib-Teva is used to treat adults with multiple myeloma (cancer
of the bone marrow). It is also used to treat those not previously
treated for mantle cell lymphoma (a type of cancer affecting the
lymph nodes) in adults in combination with the medicines rituximab,
cyclophosphamide, doxorubicin and prednisone,
For more information, see Section 1. Why am I using Bortezomib-Teva?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BORTEZOMIB-TEVA?
Do not use if you have ever had an allergic reaction to
Bortezomib-Teva 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-Teva? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Bortezomib-Teva and affect how it
works.
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-TEVA?
•
Your doctor will decide what dose you will receive. The dose will be
calculated from your height and weight, as well as factors
such as kidney function, liver function and other medicines you are
being given.
•
The doctor will determine the number of cycles of treatment also.
More instructions can be found in Section 4. How do I use
Bortezomib-Teva? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BORTEZOMIB-TEVA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Bortezomib-Teva.
•
Keep all doctor’s appointments and follow doctor’s instruction.
You may need to take other

מאפייני מוצר

Bortezomib-Teva PI version 2.0
AUSTRALIAN PRODUCT INFORMATION – BORTEZOMIB-TEVA
(BORTEZOMIB) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Bortezomib.
2
& 3 QUALITATIVE AND QUANTITATIVE COMPOSITION AND
PHARMACEUTICAL FORM
Each vial contains 3.5 mg bortezomib as a powder for injection for
intravenous or subcutaneous
injection. The powder for injection is a white to off-white cake or
powder.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Bortezomib, 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, 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 is also indicated for the treatment of multiple myeloma
patients who have received at
least one prior therapy, and who have progressive disease.
Bortezomib 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
Note that 1.0 mg and 3.0 mg strengths can be available from other
brand/s.
Bortezomib-Teva 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-TEVA IS FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY.
INTRATHECAL
ADMINISTRATION HAS RESULTED IN DEATH.
Bortezomib-Teva PI version 2.0
RECOMMENDED DOSAGE
_PREVIOUSLY UNTREATED MULTIPLE MYELOMA – TRANSPLANT ELIGIBLE _
_1._
_ _
_Bortezomib-Teva plus thalidomide-dexamethasone _
During the induction stage, Bortezomib-Teva (borte