ANASTROL anastrozole 1mg tablet blister pack

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

anastrozole, Quantity: 1 mg

제공처:

Teva Pharma Australia Pty Ltd

INN (국제 이름):

Anastrozole

약제 형태:

Tablet, film coated

구성:

Excipient Ingredients: sodium starch glycollate type A; titanium dioxide; macrogol 6000; hypromellose; macrogol 400; magnesium stearate; povidone; lactose monohydrate

관리 경로:

Oral

패키지 단위:

60, 100, 90, 30

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

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.

제품 요약:

Visual Identification: ANASTROL is a round, white to off white, film-coated tablet debossed with "93" on one side and "A10" on the other.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 30 Months; Container Temperature: Store below 25 degrees Celsius

승인 상태:

Registered

승인 날짜:

2011-04-01

환자 정보 전단

ANASTROL – Consumer Medicine Information
Page 1 of 4
ANASTROL
®
_Anastrozole _
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common
questions
people
ask
about
Anastrol.
It
does
not
contain all the information that is
known about Anastrol.
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
Anastrol 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
ANASTROL
IS
USED FOR
Anastrol 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.
Anastrol
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,
Anastrol
may slow or stop the growth of
cancer.
ASK YOUR DOCTOR IF YOU HAVE
ANY
QUESTIONS
ABOUT
WHY
ANASTROL HAS BEEN PRESCRIBED
FOR YOU.
Your doctor may have prescribed
it for another reason.
This
medicine
is
only
available
with a doctor's prescription.
Anastrol is not addictive.
BEFORE YOU TAKE IT
_ _
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE ANASTROL IF YOU ARE
PREGNANT OR INTEND TO BECOME
PREGNANT.
It
may
affect
your
developing
baby
if
you
take
it
during
pregnancy.
DO
NOT
BREASTFEED
WHILE
TAKING ANASTROL.
Your baby can take in Anastrol
from
breast
milk
if
you
are
breastfeeding.
DO NOT TAKE ANASTROL IF YOU
HAVE AN ALLERGY TO:

anastrozole

any of the ingredients listed at
the end of this leaflet

other
anti-oestrogen
medicines.
Symptoms of an allergic reaction
may include shortness of breath,
wheezing or difficulty in breathing;
swelling of the face, lips, tongue
or any other parts of the body;
rash, itching or hives on the skin.
DO

제품 특성 요약

1
AUSTRALIAN PRODUCT INFORMATION
ANASTROL (ANASTROZOLE) FILM COATED TABLETS
1
NAME OF THE MEDICINE
Anastrozole
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ANASTROL tablets contain the active 1 mg anastrozole.
List of excipients with known effects: lactose monohydrate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
ANASTROL is a round, white to off white, film-coated tablet debossed
with “93” on one side and
“A10” on the other.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
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.
4.2
D
OSE AND METHOD OF ADMINISTRATION
ADULTS INCLUDING THE ELDERLY
One tablet (1 mg) to be taken orally once a day.
For early breast cancer, the recommended total duration of hormonal
therapy is 5 years. For
patients being switched to ANASTROL from tamoxifen, the switch should
occur after completion
of 2 to 3 years of tamoxifen therapy. There are no data to support
switching at earlier or later
time points.
CHILDREN
Not recommended for use in children.
2
USE IN ADULTS WITH RENAL IMPAIRMENT
No dose change is recommended.
USE IN ADULTS WITH HEPATIC IMPAIRMENT
No dose change is recommended.
4.3
C
ONTRAINDICATIONS
Anastrozole must not be administered during pregnancy or lactation.
Known hypersensitivity to the active substance or to any of the
excipients of this product.
4.4
S
PECIAL WARNINGS AND PRECAUTIONS FOR USE
BONE MINERAL DENSITY
As anastrozole lowers circulating oestrogen levels it may cause a
reduction in bone mineral
density with a possible c