AROMASIN exemestane 25mg tablet blister pack

Страна: Австралия

Язык: английский

Источник: Department of Health (Therapeutic Goods Administration)

Активный ингредиент:

exemestane, Quantity: 25 mg

Доступна с:

Pfizer Australia Pty Ltd

Фармацевтическая форма:

Tablet, sugar coated

состав:

Excipient Ingredients: silicon dioxide; crospovidone; hypromellose; magnesium carbonate hydrate; mannitol; microcrystalline cellulose; methyl hydroxybenzoate; macrogol 6000; polysorbate 80; polyvinyl alcohol; sodium starch glycollate; sucrose; titanium dioxide; cetyl esters wax; purified talc; Carnauba Wax; Shellac; iron oxide black; magnesium stearate; purified water; sorbic acid; dimeticone 100; dimeticonol; benzoic acid

Администрация маршрут:

Oral

Штук в упаковке:

30 Tablets, 15 Tablets, 90 Tablets

Тип рецепта:

(S4) Prescription Only Medicine

Терапевтические показания :

AROMASIN is indicated for the sequential adjuvant treatment of estrogen receptor-positive early breast cancer in post-menopausal women who have received prior adjuvant tamoxifen therapy.,AROMASIN is indicated for the treatment of estrogen receptor-positive advanced breast cancer in women with natural or induced postmenopausal status whose disease has progressed following anti-estrogen therapy.

Обзор продуктов:

Visual Identification: Round, biconvex, off white to slightly greyish tablets, about 6mm in diameter. The tablets are printed on one side "7663" in black.; Container Type: Blister Pack; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius

Статус Авторизация:

Registered

Дата Авторизация:

2000-11-30

тонкая брошюра

AROMASIN
®
_Exemestane_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AROMASIN.
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 AROMASIN
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT AROMASIN IS
USED FOR
AROMASIN is used to treat breast
cancer in women who no longer have
their menstrual periods, either
naturally due to their age (after
menopause) or because they have
had their ovaries surgically removed.
AROMASIN is used to reduce the
risk of recurrence or spreading of the
breast cancer. It is also used when the
cancer has not responded or has
returned after treatment with another
medicine or medicines.
_HOW AROMASIN WORKS_
AROMASIN is an aromatase
inactivator. It works by significantly
reducing the supply of oestrogen to
cancer cells.
This stops the growth of those cancer
cells which need oestrogen, a natural
female sex hormone, to grow.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY AROMASIN
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another purpose.
AROMASIN is only available with a
doctor's prescription. It is not
addictive.
BEFORE YOU TAKE
AROMASIN
_WHEN YOU MUST NOT TAKE IT_
DO NOT TAKE AROMASIN AND TALK
TO YOUR DOCTOR IF YOU THINK YOU
MAY HAVE AN ALLERGY TO:
•
exemestane, the active ingredient
in AROMASIN
•
any of the other ingredients in
AROMASIN listed at the end of
this leaflet.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty breathing;
swelling of the face, lips, tongue or
other parts of the body; rash, itching
or hives on the skin.
DO NOT TAKE AROMASIN IF YOU ARE
PREGNANT OR INTEND TO BECOME
PREGNANT.
AROMASIN may affect your
developing baby if you take it during
pregnancy.
DO NO

Характеристики продукта

Version: pfparomt11121
Supersedes: pfparomt10919
Page 1 of 17
AUSTRALIAN
PRODUCT
INFORMATION
-
AROMASIN
® (EXEMESTANE) TABLETS
1. NAME OF THE MEDICINE
Exemestane
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 25 mg tablet contains 25 mg exemestane
EXCIPIENTS WITH KNOWN EFFECT
Each tablet contains 30.2 mg of sucrose and 0.003 mg of methyl
hydroxybenzoate.
For the full list of excipients, see Section 6.1, List of Excipients.
3. PHARMACEUTICAL FORM
AROMASIN tablets are sugar-coated tablets for oral administration.
The tablets are imprinted “7663” on one side with black printing
ink.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
AROMASIN is indicated for the sequential adjuvant treatment of
estrogen receptor-positive
early breast cancer in postmenopausal women who have received prior
adjuvant tamoxifen
therapy.
AROMASIN is indicated for the treatment of estrogen receptor-positive
advanced breast cancer
in women with natural or induced postmenopausal status whose disease
has progressed
following anti-estrogen therapy.
4.2 DOSE AND METHOD OF ADMINISTRATION
ADULTS
The recommended dose of AROMASIN in adults is one 25 mg tablet taken
once daily,
preferably after a meal.
In patients with early breast cancer, treatment should continue until
completion of five years
adjuvant hormonal therapy, or until tumour relapse occurs.
In patients with advanced breast cancer, treatment with AROMASIN
should continue until
tumour progression is evident.
Version: pfparomt11121
Supersedes: pfparomt10919
Page 2 of 17
No dose adjustments are required for patients with hepatic or renal
insufficiency.
PAEDIATRIC USE
Not recommended for use in children.
4.3 CONTRAINDICATIONS
AROMASIN tablets are contraindicated in pregnant or lactating women
and in patients with a
known hypersensitivity to the medicine or to any of the excipients.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Check the following before use.
Because of its mode of action, AROMASIN should not be administered to
women with
premenopausal
endocrine
status.
Whenever
clinic