TEMOLIDE temozolomide 5 mg capsule bottle

Ülke: Avustralya

Dil: İngilizce

Kaynak: Department of Health (Therapeutic Goods Administration)

Aktif bileşen:

temozolomide

Mevcut itibaren:

Southern Cross Pharma Pty Ltd

INN (International Adı):

Temozolomide

Sınıf:

Medicine Registered

Yetkilendirme durumu:

Registered

Bilgilendirme broşürü

________________________________________________________________________________
August 2016
Page
1 of 4
TEMOLIDE
_Temozolomide_
CONSUMER MEDICINE INFORMATION
_ _
What is in this leaflet
This leaflet answers some common
questions about Temolide. 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 Temolide 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 Temolide is used
for
Temolide is used to treat patients with
brain tumours. Temolide is also used to
treat adult patients with advanced
metastatic malignant melanoma.
Your doctor, however, may prescribe
Temolide for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY TEMOLIDE HAS
BEEN PRESCRIBED FOR YOU.
Temolide belongs to a group of
medicines called cytotoxic or
chemotherapy medicines.
Temolide 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 _
Temolide 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 TEMOLIDE IF: 1. YOU ARE ALLERGIC TO TEMOLIDE
(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.
Temolide may cause birth defects if
either the male or female is using

Ürün özellikleri

Temolide/PI July 16
Page 1 of 16
PRODUCT INFORMATION
TEMOLIDE CAPSULES 5 MG, 20MG 100MG, 140MG, 180MG AND 250MG
NAME OF THE MEDICINE
Temozolomide
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
PROPRIETARY NAME:
Temolide Capsules 5 mg, 20mg 100mg, 140mg, 180mg and
250mg
Temozolomide is slightly soluble in water (3.1 mg/mL), methanol (4.4
mg/mL) and
ethanol (0.6 mg/mL).
_INACTIVE _
Lactose (in the 5mg and 20mg capsules only), sodium starch glycollate,
stearic acid, tartaric acid, microcrystalline cellulose and anhydrous
colloidal silica.
_CAPSULE SHELL. _
Gelatin, water, titanium dioxide (ARTG 94457), iron oxide yellow
(ARTG 93287, 5 mg, 20 mg and 250 mg capsules only), indigo carmine
(ARTG
54048, 5 mg and 140mg capsules only), iron oxide red (ARTG 93285, 100
mg and
250mg capsules only), iron oxide black (ARTG 93283, 100 mg and 250 mg
capsules
only), sunset yellow FCF (ARTG 93377,180 mg capsules only), and allura
red AC
(ARTG 52014, 180 mg capsules only).
Capsule printing ink is Opacode monogramming ink S-1-27794, with ARTG
number
12104.
Temolide/PI July 16
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 in humans is similar to that of the rat and
dog.
Single cycle (five