TEMOZOLOMIDE AN temozolomide 140 mg capsule bottle

Quốc gia: Úc

Ngôn ngữ: Tiếng Anh

Nguồn: Department of Health (Therapeutic Goods Administration)

Thành phần hoạt chất:

Temozolomide

Sẵn có từ:

Southern Cross Pharma Pty Ltd

INN (Tên quốc tế):

Temozolomide

Lớp học:

Medicine Registered

Tờ rơi thông tin

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Temozolomide AN_CMI_18122013
Page
1 of 4
TEMOZOLOMIDE AN
_Temozolomide_
CONSUMER MEDICINE INFORMATION
_ _
What is in this leaflet
This leaflet answers some common
questions about Temozolomide AN. 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 Temozolomide AN 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 Temozolomide AN
is used for
Temozolomide AN is used to treat
patients with brain tumours.
Temozolomide AN is also used to treat
adult patients with advanced metastatic
malignant melanoma.
Your doctor, however, may prescribe
Temozolomide AN for another
purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TEMOZOLOMIDE
AN HAS BEEN PRESCRIBED FOR YOU.
Temozolomide AN belongs to a group
of medicines called cytotoxic or
chemotherapy medicines.
Temozolomide AN 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 _
Temozolomide AN 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 it
_When you must not take it _
DO NOT TAKE TEMOZOLOMIDE AN IF: 1. YOU ARE ALLERGIC TO TEMOZOLOMIDE
AN (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 PR

Đặc tính sản phẩm

Temozolomide AN/PI July 15
Page 1 of 16
PRODUCT INFORMATION
TEMOZOLOMIDE AN CAPSULES 5 MG, 20MG 100MG, 140MG, 180MG
AND 250MG
NAME OF THE MEDICINE
PROPRIETARY NAME: Temozolomide AN Capsules 5 mg, 20mg 100mg, 140mg,
180mg and 250mg
NON PROPRIETARY NAME: Temozolomide Capsules 5 mg, 20mg 100mg, 140mg,
180mg and 250mg
The chemical structure of temozolomide is:
CAS number: 85622-93-1.
Chemical name: imidazo[5,1-d]- 1,2,3,5-tetrazine- 8-carboxamide,
3,4-dihydro-3-
methyl-4-oxo.
Molecular formula: C
6
H
6
N
6
O
2
MW: 194.15
DESCRIPTION
Temozolomide is slightly soluble in water (3.1 mg/mL), methanol (4.4
mg/mL) and
ethanol (0.6 mg/mL).
_ACTIVE _Temozolomide.
_ _
_INACTIVE _Anhydrous lactose (in the 5mg and 20mg capsules only),
sodium starch
glycollate, stearic acid, tartaric acid, microcrystalline cellulose
and colloidal
anhydrous silica.
_CAPSULE SHELL._ Gelatin, purified water, titanium dioxide, iron oxide
yellow (5 mg, 20
mg and 250 mg capsules only), indigo carmine (5 mg and 140mg capsules
only), iron
oxide red (100 mg and 250mg capsules only), iron oxide black (100 mg
and 250 mg
capsules only), sunset yellow FCF (180 mg capsules only), and allura
red AC (180 mg
capsules only).
Capsule printing ink is OPACODE monogramming ink S-1-277002 BLACK,
with
ARTG number 107581.
Temozolomide AN/PI July 15
Page 2 of 16
PHARMACOLOGY
PHARMACOLOGICAL ACTIONS
Single dose toxicity studies of temozolomide were conducted in mice,
rats and dogs.
Estimated LD
50
doses by the oral route were moderately higher in the rat
(approximately 1,900 mg/m
2
) than in the mouse (approximately 1,000 mg/m
2
). The
minimum lethal dose in dogs was 600 mg/m
2
. In the single dose studies, clinical signs
of toxicity and death were generally delayed, reflecting a delayed
toxicity to tissues
that normally proliferate more rapidly resulting in general
deterioration of organ
function; toxicity is consistent with that expected of an alkylating
agent.
Temozolomide is rapidly absorbed following oral administration.
Systemic exposure
at the therapeutic dose level