BENDAMUSTINE JUNO bendamustine hydrochloride 25 mg powder for injection vial

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

bendamustine hydrochloride, Quantity: 25 mg

थमां उपलब्ध:

Juno Pharmaceuticals Pty Ltd

फार्मास्यूटिकल फॉर्म:

Injection, powder for

रचना:

Excipient Ingredients: mannitol

प्रशासन का मार्ग:

Intravenous, Intravenous Infusion

पैकेज में यूनिट:

1 vial; 5 vials

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

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 patient?s ineligible for autologous stem cell transplantation.,Relapsed/Refractory indolent Non-Hodgkin?s lymphoma.

उत्पाद समीक्षा:

Visual Identification: white to off-white sterile lyophilized powder; 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

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2020-09-23

सूचना पत्रक

BENDAMUSTINE JUNO
_(Bendamustine hydrochloride) _
Consumer Medicine Information
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Bendamustine
JUNO
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
Bendamustine JUNO against the
benefits
they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet while being
treated.
You may need to read it again.
WHAT BENDAMUSTINE
JUNO IS USED FOR
Bendamustine JUNO 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.
Bendamustine JUNO is used for
the
treatment of certain types of
cancer.
Bendamustine JUNO is used alone
(monotherapy) or in combination
with other medicines for the
treatment of the following forms of
cancer:
•
Chronic lymphocytic
leukaemia;
•
Indolent, Stage III-IV Non-
Hodgkin's Lymphoma and
Stage
III-IV Mantle Cell
Lymphoma. It is prescribed
for patients who
have not
been previously treated.
•
Indolent Non-Hodgkins
Lymphoma. It is prescribed
for
patients who have
received one or
more prior
treatment and whose
cancer is
still progressing.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE
HAS BEEN PRESCRIBED FOR
YOU.
Your doctor may have prescribed it
for another reason.
This medicine is available only
with
a doctor's prescription.
BEFORE YOU ARE GIVEN
BENDAMUSTINE JUNO
WHEN YOU MUST NOT US E IT
DO NOT USE BENDAMUSTINE JUNO
IF YOU:
•
Are hypersensitive (allergic)
to
the active substance,
bendamustine hydrochloride
or
any of the other ingredients
listed
at the end of this leaflet;
•
Are breastfeeding;
•
Have severe liver dysfunction
(damage to the functional cells
of
the liver);
•
Have yellowing of the skin or
whites of the eye

उत्पाद विशेषताएं

Page 1 of 28
AUSTRALIAN PRODUCT INFORMATION – BENDAMUSTINE JUNO
(BENDAMUSTINE HYDROCHLORIDE) POWDER FOR INJECTION
1
NAME OF THE MEDICINE
Bendamustine hydrochloride (as monohydrate)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Bendamustine is soluble in water when at room temperature. It is
administered by intravenous
infusion after reconstitution with 10 mL (for the 25 mg vial) or 40 mL
(for the 100 mg vial)
water for injection and further dilution with physiological saline
(0.9%).
BENDAMUSTINE JUNO BENDAMUSTINE HYDROCHLORIDE 25 MG (AS MONOHYDRATE)
POWDER FOR
INJECTION
Each 25 mg vial contains 25 mg of bendamustine hydrochloride
(equivalent to 22.7 mg
bendamustine) and 40 mg of mannitol.
BENDAMUSTINE JUNO BENDAMUSTINE HYDROCHLORIDE 100 MG (AS MONOHYDRATE)
POWDER
FOR INJECTION VIAL
Each 100 mg vial contains 100 mg of bendamustine hydrochloride
(equivalent to 90.8 mg
bendamustine) and 160 mg of mannitol.
The pH of the reconstituted solution is 2.5 - 3.5.
For a full list of excipients, see SECTION 6.1.
3
PHARMACEUTICAL FORM
Powder for injection, for intravenous infusion.
BENDAMUSTINE JUNO is a white, microcrystalline lyophilisate powder for
concentrate for
solution for infusion.
Page 2 of 28
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 th