RIBOMUSTIN bendamustine hydrochloride 25 mg powder for injection vial
Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Patient Information leaflet
(PIL)
24-08-2020
Summary of Product characteristics
(SPC)
16-09-2021
Public Assessment Report
(PAR)
26-11-2017
Active ingredient:
bendamustine hydrochloride, Quantity: 25 mg
Available from:
Janssen-Cilag Pty Ltd
INN (International Name):
Bendamustine hydrochloride
Pharmaceutical form:
Injection, powder for
Composition:
Excipient Ingredients: mannitol
Administration route:
Intravenous
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, microcrystalline lyophilisate; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Authorization status:
Licence status A
Authorization date:
2014-06-30
Patient Information leaflet
RIBOMUSTIN
®
1
RIBOMUSTIN®
BENDAMUSTINE HYDROCHLORIDE
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about RIBOMUSTIN
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
RIBOMUSTIN 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 RIBOMUSTIN is
used for
RIBOMUSTIN 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.
RIBOMUSTIN is used for the
treatment of certain types of cancer.
RIBOMUSTIN 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
RIBOMUSTIN
When you must not use it
DO NOT USE RIBOMUSTIN 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 eyes caused by liver
or blood problems (jaundice);
•
Read the complete document
Summary of Product characteristics
CCDS200921
1
RIBOMUSTIN bendamustine (210902) API
RIBOMUSTIN
®
BENDAMUSTINE
HYDROCHLORIDE
A
USTRALIAN
P
RODUCT
I
NFORMATION
1. NAME OF THE MEDICINE
Bendamustine hydrochloride
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
RIBOMUSTIN contains bendamustine hydrochloride, an alkylating drug, as
the active ingredient.
Bendamustine hydrochloride contains a mechlorethamine group and a
benzimidazole heterocyclic
ring with a butyric acid substituent.
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%).
RIBOMUSTIN BENDAMUSTINE HYDROCHLORIDE 25 MG POWDER FOR INJECTION
Each
25 mg
vial
contains
25
mg
of
bendamustine
hydrochloride
(equivalent
to
22.7mg
bendamustine) and 30 mg of mannitol.
RIBOMUSTIN BENDAMUSTINE HYDROCHLORIDE 100 MG POWDER FOR INJECTION VIAL
Each 100 mg vial contains 100 mg of bendamustine hydrochloride
(equivalent to 90.8 bendamustine)
and 120 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.
RIBOMUSTIN is a white, microcrystalline lyophilisate powder for
concentrate for solution for infusion.
4. CLINICAL PARTICULARS
4.1 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 Information - Australia
CCDS200921
2
RIBOMUSTIN bendamustine (210902) API
4.2 DOSE AND METHOD OF ADMINISTRATION
For intravenous
Read the complete document
