BENDAMUSTINE SANDOZ bendamustine hydrochloride (as monohydrate) 25 mg powder for injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

bendamustine hydrochloride monohydrate, Quantity: 25 mg

Available from:

Sandoz Pty Ltd

Pharmaceutical form:

Injection, powder for

Composition:

Excipient Ingredients: mannitol

Administration route:

Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

First-line treatment of chronic lymphocytic leukaemia (Binet stage B or C). Efficacy relative to first- line therapies other than chlorambucil has not been established.,Previously untreated indolent CD20-positive, stage III-IV Non-Hodgkin?s lymphoma, in combination with rituximab.,Previously untreated CD20-positive, stage III-IV Mantle Cell Lymphoma in combination with rituximab, in patients ineligible for autologous stem cell transplantation.,Relapsed/Refractory indolent Non-Hodgkin?s lymphoma.

Product summary:

Visual Identification: White to off-white, freeze-dried, lyophilisate powder for concentrate for solution for infusion; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2021-05-17

Patient Information leaflet

Bendamustine Sandoz® CMI v1.0
1
BENDAMUSTINE SANDOZ®
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 BENDAMUSTINE SANDOZ?
Bendamustine Sandoz contains the active ingredient bendamustine
hydrochloride (as monohydrate). Bendamustine Sandoz is
used is used for the treatment of certain types of cancer.
For more information, see Section 1. Why am I using Bendamustine
Sandoz? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE BENDAMUSTINE SANDOZ?
Do not use if you have ever had an allergic reaction to bendamustine
hydrochloride 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
Bendamustine Sandoz? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Bendamustine Sandoz 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 BENDAMUSTINE SANDOZ?
•
Your treatment with Bendamustine Sandoz will take place in a
specialised medical unit, under the supervision of a doctor
experienced in the use of cytotoxic medicinal products.
•
Your doctor will decide what dose you will receive. The dose will be
calculated from your height and weight. It will also
depend on factors such as kidney function, liver function and other
medicines you are being given.
More instructions can be found in Section 4. How do I use Bendamustine
Sandoz? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING BENDAMUSTINE SANDOZ?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Bendamustine Sandoz.
•
Keep all of your doctor’s appointments and keep follow-up
appointments with your doctor to check
your progress.
•
Avoid peo

Summary of Product characteristics

231005-bendamustine sandoz-pi-v1.0
Page 1 of 27
AUSTRALIAN PRODUCT INFORMATION
BENDAMUSTINE SANDOZ
® (BENDAMUSTINE HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Bendamustine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
BENDAMUSTINE SANDOZ 25 MG POWDER FOR INJECTION VIAL
Each 25 mg vial contains 25 mg of bendamustine hydrochloride
(equivalent to 26.1 mg bendamustine
hydrochloride monohydrate).
BENDAMUSTINE SANDOZ 100 MG POWDER FOR INJECTION VIAL
Each 100 mg vial contains 100 mg of bendamustine hydrochloride
(equivalent to 104.6 mg bendamustine
hydrochloride monohydrate).
_List of excipients with known effect_
: mannitol.
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Powder for injection, for intravenous infusion.
Bendamustine Sandoz is a white to off-white, freeze-dried,
lyophilisate powder for concentrate for
solution for infusion.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
First-line treatment of chronic lymphocytic leukaemia (Binet stage B
or C). Efficacy relative to first-
line therapies other than chlorambucil has not been established.
Previously untreated indolent CD20-positive, stage III-IV
Non-Hodgkin’s lymphoma, in combination
with rituximab.
Previously untreated CD20-positive, stage III-IV Mantle Cell Lymphoma
in combination with
rituximab, in patients ineligible for autologous stem cell
transplantation.
Relapsed/Refractory indolent Non-Hodgkin’s lymphoma.
4.2.
D
OSE AND METHOD OF ADMINISTRATION
For intravenous infusion over 30-60 minutes (see Section 4.2 Dose and
method of administration - Special
Precautions for Disposal and Handling).
Infusion must be administered under the supervision of a physician
qualified and experienced in the use of
chemotherapeutic agents.
Poor bone marrow function is related to increased chemotherapy-induced
haematological toxicity.
Treatment should not be started if leukocyte and/or platelet values
drop to < 3x10
9
/L or < 75x10
9
/L,
respectively (see Section 4.4
Special warnings and precautions for use –