ANASTROZOLE FBM anastrozole 1mg tablet blister pack

Country: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

anastrozole, Quantity: 1 mg

Доступно од:

Southern Cross Pharma Pty Ltd

INN (Међународно име):

Anastrozole

Фармацеутски облик:

Tablet, film coated

Састав:

Excipient Ingredients: sodium starch glycollate; titanium dioxide; lactose monohydrate; magnesium stearate; hydrogenated cottonseed oil; hypromellose; macrogol 6000; pregelatinised maize starch; povidone

Пут администрације:

Oral

Јединице у пакету:

30 tablet, Starter Pack size 10 Tablets

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Early breast cancer. Adjuvant treatment of early breast cancer in postmenopausal women with oestrogen/progesterone receptor positive disease. Advanced breast cancer. First line treatment of advanced breast cancer in postmenopausal women with oestrogen/progesterone receptor positive disease. Treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy. Patients with oestrogen receptor negative disease and patients who have not responded to previous tamoxifen therapy rarely respond to anastrozole.

Резиме производа:

Visual Identification: White, round, film-coated tablets; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 4 Years; Container Temperature: Store below 25 degrees Celsius

Статус ауторизације:

Registered

Датум одобрења:

2010-11-22

Информативни летак

________________________________________________________________________________
C: Products/Anastrozole/CMI FBM_21102013_2
Page
1 of 3
ANASTROZOLE FBM
_ Anastrozole_
CONSUMER MEDICINE INFORMATION
_ _
What is in this leaflet
This leaflet answers some common
questions people ask about
ANASTROZOLE FBM. It does not
contain all the information that is
known about ANASTROZOLE FBM.
It does not take the place of talking to
your doctor or pharmacist.
All medicines have risks and benefits.
Your doctor will have weighed the
risks of you taking ANASTROZOLE
FBM against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
What ANASTROZOLE
FBM is used for
ANASTROZOLE FBM is used to treat
breast cancer in women who no longer
have their menstrual periods either
naturally, due to their age or after
surgery, radiotherapy or chemotherapy.
ANASTROZOLE FBM is a non-
steroidal aromatase inhibitor, which
reduces the amount of oestrogen
(female sex hormone) made by the
body. In some types of breast cancer,
oestrogen can help the cancer cells
grow. By blocking oestrogen,
ANASTROZOLE FBM may slow or
stop the growth of cancer.
FOLLOW ALL DIRECTIONS GIVEN TO YOU BY
YOUR DOCTOR.
They may differ from the information
contained in this leaflet.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
ANASTROZOLE FBM HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed
ANASTROZOLE FBM for another
reason.
ANASTROZOLE FBM is only
available with a doctor's prescription.
ANASTROZOLE FBM is not
addictive.
Before you take it
_When you must not take it _
DO NOT TAKE ANASTROZOLE FBM
IF YOU ARE PREGNANT OR INTEND TO
BECOME PREGNANT.
ANASTROZOLE FBM may affect
your developing baby if you take it
during pregnancy.
DO NOT BREASTFEED WHILE TAKING
ANASTROZOLE FBM.
Your baby can take in
ANASTROZOLE FBM from breast
milk if you are breastfeeding.
DO NOT TAKE ANASTROZOLE FBM
IF YOU HAVE AN ALLERGY TO:

Anastrozole

Карактеристике производа

Anastrozole/PI_FBM_10032016
Page 1 of 16
PRODUCT INFORMATION
ANASTROZOLE FBM
NAME OF THE MEDICINE
PROPRIETARY NAME:
ANASTROZOLE FBM
NON PROPRIETARY NAME:
Anastrozole tablets 1 mg
Chemical name:
α,α,α’,α’-Tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl)-m-
benzenediacetonitrile.
The chemical structure of anastrozole is:
Molecular formula: C
17
H
19
N
5
MW: 293.37
CAS number: 120511-73-1.
DESCRIPTION
Anastrozole is a fine white to off white powder. It has moderate
aqueous solubility
(0.53 mg/mL at 25
o
C) which is dependent on pH from pH 1 to 4 but independent of
pH thereafter.
Anastrozole tablets also contain lactose, sodium starch glycollate,
povidone,
magnesium stearate, hypromellose, macrogol 6000, starch –
pregelatinised maize,
cottonseed oil – hydrogenated and titanium dioxide.
Anastrozole/PI_FBM_10032016
Page 2 of 16
PHARMACOLOGY
PHARMACODYNAMIC PROPERTIES
Anastrozole is a potent and highly selective nonsteroidal aromatase
inhibitor. It
significantly lowers serum oestradiol concentrations and has no
detectable effect on
formation of adrenal corticosteroids or aldosterone.
Many breast cancers have oestrogen receptors and growth of these
tumours can be
stimulated by oestrogen. In postmenopausal women, oestradiol is
produced primarily
from the conversion of androstenedione to oestrone through the
aromatase enzyme
complex in peripheral tissues. Oestrone is subsequently converted to
oestradiol. Many
breast cancers also contain aromatase; the importance of tumour
generated oestrogens
is uncertain.
Reducing circulating oestradiol levels has been shown to produce a
beneficial effect
in women with breast cancer. In postmenopausal women, anastrozole at a
daily dose
of 1 mg produced oestradiol suppression of greater than 80% using a
highly sensitive
assay.
Anastrozole does not possess any progestogenic, androgenic or
oestrogenic activity.
Daily doses of anastrozole up to 10 mg do not have any effect on
cortisol or
aldosterone secretion, measured before or after standard
adrenocorticotropic hormone
(ACTH) challen