GLIADEL

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

CARMUSTINE

Available from:

MGI Pharma Limited

ATC code:

L01AD01

INN (International Name):

CARMUSTINE

Dosage:

7.7 Milligram

Pharmaceutical form:

Implant

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

carmustine

Authorization status:

Marketed

Authorization date:

1999-07-07

Patient Information leaflet

GLIADEL, JUNE 2012
17
GLIADEL 7.7 MG IMPLANT
Carmustine
PACKAGE LEAFLET: INFORMATION FOR THE USER
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU RECEIVE GLIADEL
IMPLANTS.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor.
IN THIS LEAFLET:
1.
What GLIADEL Implants are and what they are used for
2.
Before you receive GLIADEL Implants
3.
How GLIADEL Implants are used
4.
Possible side effects
5.
How to store GLIADEL Implants
6.
Further information
1.
WHAT GLIADEL IMPLANTS ARE AND WHAT THEY ARE USED FOR
GLIADEL Implants are a way to deliver the anticancer substance
carmustine directly to the site
of the brain tumour after the tumour has been removed by surgery.
Carmustine belongs to a group
of anticancer substances that act by slowing the growth of cancer
cells in brain.
GLIADEL Implants can be used in combination with radiation for the
treatment of brain tumours.
GLIADEL Implants have been shown to prolong survival in patients with
brain tumours.
2.
BEFORE YOU RECEIVE GLIADEL IMPLANTS
DO NOT USE
GLIADEL Implants if you are allergic to carmustine or Polifeprosan 20.
TAKING OTHER MEDICINES
Please tell your doctor if you are taking or have recently taken any
other medicines, including
medicines obtained without a prescription.
PREGNANCY AND BREAST-FEEDING
Ask your doctor for advice before taking any medicine. GLIADEL
Implants have not been
studied in pregnant women. The active ingredient, carmustine, has been
shown to adversely
affect the development of unborn babies. GLIADEL Implants should not
be used if you are
pregnant or breast-feeding.
DRIVING AND USING MACHINES
Driving is not advisable after treatment. You must check with your
doctor before driving or
operating any tools or machines.
GLIADEL, JUNE 2012
18
3.
HOW GLIADEL IMPLANTS ARE USED
GLIADEL IMPLANTS ARE FOR USE IN ADULTS ONLY
Your surgeon or pharmacist will ensure that the prod

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gliadel 7.7 mg Implant
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each implant contains 7.7 mg of carmustine.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Implant
Off-white to pale yellow flat discoid implant.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
GLIADEL Implant
is indicated for
the treatment
of adult
patients with newly-diagnosed high-grade malignant
glioma as an
adjunct to surgery and radiation.
GLIADEL Implant is indicated as an adjunct to surgery for the
treatment of adult patients with recurrent histologically proved
glioblastoma multiforme and for whom surgical resection is indicated.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
For intralesional use only.
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.
_Paediatric population_
The safety and efficacy of GLIADEL Implant in children under 18 years
of age have not been established. No data are available.
Method of administration
It is recommended that a maximum of eight implants be placed if the
size and shape of the resection cavity allows it.
Implants
broken in half may be used,
but implants broken in more than two pieces should be discarded in the
dedicated biohazard waste
containers (see section 6.6).
It
is recommended that
the placement
of the implants should be directly from the product’s inner sterile
packaging into the
resection cavity. Oxidised regenerated cellulose may be placed over
the implants to secure them to the cavity surface (see section
6.6).
4.3 CONTRAINDICATIONS
Hypersensitivity to the active substance carmustine or to any of the
excipients of GLIADEL Implant.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
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