GLIADEL WAFER carmustine 7.7mg/implant implant sachet

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

carmustine, Quantity: 7.7 mg

Available from:

Eisai Australia Pty Ltd

Pharmaceutical form:

Implant

Composition:

Excipient Ingredients: polifeprosan

Administration route:

Intracranial

Units in package:

8 implants

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

GLIADEL is indicated in newly-diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation. GLIADEL is also indicated for use as an adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme (GBM) for whom surgical resection is indicated.

Product summary:

Visual Identification: Off white to pale yellow implant approximately 1.45cm in diameter and 1mm thick.; Container Type: Sachet; Container Material: Al/Al; Container Life Time: 4 Years

Authorization status:

Registered

Authorization date:

2002-05-16

Patient Information leaflet

_Consumer Medicine Information _
_ _
_GLIADEL Implants _
_Page 1 _
GLIADEL
® IMPLANTS
_CARMUSTINE IMPLANT WITH POLIFEPROSAN 20 _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS
LEAFLET
This leaflet answers some
common questions about
GLIADEL. It does not contain
all the available information
that is known about GLIADEL.
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 treatment
with GLIADEL against the
benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS
ABOUT TREATMENT WITH THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET AS YOU MAY
WANT TO READ IT AGAIN AFTER
YOUR GLIADEL TREATMENT.
WHAT GLIADEL IS
USED FOR
GLIADEL is used to treat some
types of brain cancers after
removal by surgery.
GLIADEL works by killing
cancer cells and/or stopping
cancer cells from growing and
multiplying.
GLIADEL belongs to a group
of medicines called
antineoplastic or cytotoxic
medicines. You may also hear
these being called
chemotherapy medicines.
ASK YOUR DOCTOR IF YOU HAVE
ANY QUESTIONS ABOUT WHY
GLIADEL TREATMENT HAS
BEEN PRESCRIBED FOR YOU.
GLIADEL is not addictive.
BEFORE YOU ARE
GIVEN GLIADEL
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN
GLIADEL IF YOU ARE BREAST-
FEEDING OR PLAN TO BREAST-
FEED.
It is recommended that you do
not breast-feed while
undergoing GLIADEL
treatment, as it may pass into
the breast milk and therefore
there is a possibility that the
breast- fed baby may be
affected.
DO NOT USE GLIADEL TO TREAT
CHILDREN.
There is no experience with the
use of GLIADEL in children.
IF YOU ARE NOT SURE WHETHER
YOU SHOULD HAVE GLIADEL,
TALK TO YOUR DOCTOR OR
PHARMACIST.
_BEFORE YOU ARE GIVEN IT _
TELL YOUR DOCTOR OR
PHARMACIST IF YOU HAVE ANY
ALLERGIES TO:
•
any other medicines
•
any other substances, such
as foods, preservatives or
dyes.
TELL YOUR DOCTOR IF YOU ARE
PREGNANT OR INTEND TO BECOME
PREGNANT.
Like most medicines used to
treat cancer, GLIADEL is not
recommended for use du

Summary of Product characteristics

Gliadel PI Version 1.2
Page 1
AUSTRALIAN PRODUCT INFORMATION – GLIADEL
® (CARMUSTINE)
IMPLANT
1
NAME OF THE MEDICINE
Carmustine.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each GLIADEL implant contains 7.7 mg of carmustine
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Implant.
GLIADEL Implants are sterile, off-white to pale yellow implants
approximately 1.45 cm in
diameter and 1 mm thick.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
GLIADEL is indicated in newly-diagnosed high-grade malignant glioma
patients as an
adjunct to surgery and radiation. GLIADEL is also indicated for use as
adjunct to surgery to
prolong survival in patients with recurrent glioblastoma multiforme
(GBM) for whom
surgical resection is indicated.
4.2
D
OSE AND METHOD OF ADMINISTRATION
Each GLIADEL implant contains 7.7 mg of carmustine, resulting in a
dose of 61.6 mg when
eight implants are placed in the tumour resection cavity. It is
recommended that a maximum
of eight implants be placed if the size and shape of the resection
cavity allows it. Otherwise,
use the maximum number of implants possible. No more than eight
implants should be used
per surgical procedure, as there is no clinical experience with this
dose.
HANDLING AND DISPOSAL
GLIADEL implants should be handled with care (see Section 4.4 Special
warnings and
precautions for use on safe handling).
Gliadel PI Version 1.2
Page 2
The sachets containing GLIADEL should be delivered to the operating
room and remain
unopened until ready to place the implants into the resection cavity.
THE OUTSIDE SURFACE OF
THE OUTER FOIL SACHET IS NOT STERILE AND MUST BE REMOVED UNDER STERILE
CONDITIONS FROM THE
STERILE INNER SACHET PRIOR TO IMPLANTATION.
INSTRUCTIONS FOR OPENING SACHET CONTAINING GLIADEL IMPLANT
FIGURE 1: To remove the sterile inner sachet from the outer sachet,
locate the folded corner
and slowly pull in an outward motion.
FIGURE 2: Do NOT pull in a downward motion rolling knuckles over the
sachet. This may
exert pressure on the imp