TEMODAL temozolomide 140 mg capsules bottle

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

temozolomide

Disponível em:

Merck Sharp & Dohme (Australia) Pty Ltd

DCI (Denominação Comum Internacional):

Temozolomide

Status de autorização:

Registered

Folheto informativo - Bula

TEMODAL
®
_Temozolomide_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about TEMODAL. 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 taking TEMODAL
against the benefits this medicine is
expected to have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT TEMODAL IS
USED FOR
TEMODAL is used to treat patients
with brain tumours. TEMODAL is
also used to treat adult patients with
advanced metastatic malignant
melanoma.
Your doctor, however, may prescribe
TEMODAL for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TEMODAL
HAS BEEN PRESCRIBED FOR YOU.
TEMODAL belongs to a group of
medicines called cytotoxic or
chemotherapy medicines.
TEMODAL works by killing cancer
cells and stopping cancer cells from
growing and multiplying.
This medicine is only available with
a doctor's prescription.
_USE IN CHILDREN_
Temodal capsules are used to treat
children 3 years and older, with
specific forms of brain tumour
(glioblastoma multiforme or
anaplastic astrocytoma, showing
recurrence or progression after
standard therapy).
BEFORE YOU TAKE
TEMODAL
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE TEMODAL IF:
1.
YOU ARE ALLERGIC TO TEMODAL
(TEMOZOLOMIDE), DACARBAZINE
(DTIC) OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic reaction
may include:
-
hives, itching or skin rash
-
swelling of the face, lips or
tongue. This may lead to
difficulty swallowing.
-
shortness of breath, wheezing,
difficulty breathing or a tight
feeling in your chest.
2.
YOU OR YOUR PARTNER ARE
PREGNANT OR INTEND TO BECOME
PREGNANT.
TEMODAL may cause birth
defects if either the male or
female is using TEMODAL at the
time of conception or during
pregnancy. Therefore, female
patients must have a negative
pregnancy test before

Características técnicas

Page 1 of 16
AUSTRALIAN PRODUCT INFORMATION
TEMODAL
(TEMOZOLOMIDE)
CAPSULES
1
NAME OF THE MEDICINE
Temozolomide
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Temozolomide is slightly soluble in water (3.1 mg/mL), methanol (4.4
mg/mL) and ethanol (0.6
mg/mL).
Each TEMODAL capsule contains temozolomide (5 mg, 20 mg, 100 mg, 140
mg, 180 mg or
250 mg).
List of excipients with known effect:
-
lactose
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
TEMODAL (temozolomide) 5 mg: Size No. 3 capsule with opaque, green cap
and white,
opaque body. The cap is imprinted in black ink with "TEMODAL". The
body is imprinted in
black ink with two stripes, “5 mg”, and the Schering-Plough logo.
TEMODAL (temozolomide) 20 mg: Size No. 2 capsule with yellow cap and
white, opaque
body. The cap is imprinted in black ink with "TEMODAL". The body is
imprinted in black ink
with two stripes, “20 mg”, and the Schering-Plough logo.
TEMODAL (temozolomide) 100 mg: Size No. 1 capsule with pink, opaque
cap and white,
opaque body. The cap is imprinted in black ink with "TEMODAL". The
body is imprinted in
black ink with two stripes, “100 mg”, and the Schering-Plough
logo.
TEMODAL (temozolomide) 140 mg: Size No. 0 capsule with blue, opaque
cap and white,
opaque body. The cap is imprinted in black ink with "TEMODAL". The
body is imprinted in
black ink with two stripes, “140 mg”, and the Schering-Plough
logo.
TEMODAL (temozolomide) 180 mg: Size No. 0 capsule with orange, opaque
cap and white,
opaque body. The cap is imprinted in black ink with "TEMODAL". The
body is imprinted in
black ink with two stripes, “180 mg”, and the Schering-Plough
logo.
TEMODAL (temozolomide) 250 mg: Size No. 0 capsule with white, opaque
cap and body. The
cap is imprinted in black ink with "TEMODAL". The body is imprinted in
black ink with two
stripes, “250 mg”, and the Schering-Plough logo.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TEMODAL is indicated for the treatment of
Page 2 of 16
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patients with n