Arimidex

מדינה: ניו זילנד

שפה: אנגלית

מקור: Medsafe (Medicines Safety Authority)

מרכיב פעיל:

Anastrozole 1mg;  

זמין מ:

AstraZeneca Limited

INN (שם בינלאומי):

Anastrozole 1 mg

כמות:

1 mg

טופס פרצבטיות:

Film coated tablet

הרכב:

Active: Anastrozole 1mg   Excipient: Hypromellose Lactose monohydrate Macrogol 300 Magnesium stearate Povidone Sodium starch glycolate Titanium dioxide

יחידות באריזה:

Blister pack, 30 tablets, 30 tablets

סיווג:

Prescription

סוג מרשם:

Prescription

תוצרת:

Excella GmbH & Co KG

leaflet_short:

Package - Contents - Shelf Life: Blister pack, - 30 tablets - 60 months from date of manufacture stored at or below 30°C

תאריך אישור:

1995-06-13

עלון מידע

Arimidex
®
CMI 030821
Copyright
1(5)
ARIMIDEX
®
ANASTRAZOLE 1 MG TABLETS
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the common questions people ask about
ARIMIDEX. It does not contain
all the information that is known about ARIMIDEX. 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 ARIMIDEX 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 ARIMIDEX IS USED FOR
ARIMIDEX is used to treat breast cancer in women after the change of
life (menopause). ARIMIDEX
does not kill cancer cells. Rather, it stops or slows their growth.
ARIMIDEX 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, ARIMIDEX may slow or stop the growth of
the cancer.
ARIMIDEX is not addictive.
ARIMIDEX is only available with a doctor’s prescription.
BEFORE YOU USE ARIMIDEX
_WHEN YOU MUST NOT USE IT _
Do not use ARIMIDEX if you have not yet experienced menopause or if
you are a child. We do not
know if ARIMIDEX is safe for these patients.
DO NOT TAKE ARIMIDEX IF YOU ARE A MAN. Men are not normally treated
with ARIMIDEX.
DO NOT USE ARIMIDEX IF YOU ARE PREGNANT OR BREASTFEEDING YOUR BABY.
DO NOT TAKE ARIMIDEX IF YOU HAVE AN ALLERGY TO:

Anastrozole, the active ingredient of ARIMIDEX

Any of the other ingredients of ARIMIDEX 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 not use ARIMIDEX after the expiry date. This date is printed on the
pack. It m

מאפייני מוצר

Arimidex Data Sheet 030821
Copyright
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
A
RIMIDEX
®
1 mg film coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film coated tablet contains 1 mg anastrazole.
3.
PHARMACEUTICAL FORM
Film coated tablet.
A
RIMIDEX
is presented as a round, white, biconvex film-coated tablet containing
1 mg of
anastrozole. The tablets are 6 mm in diameter and are compressed to a
weight of 100 mg.
A logo consisting of the letter 'A' with an arrow head attached to the
foot of the extended
right leg of the 'A' is impressed on one side and a tablet strength
marking ('Adx1') is
impressed on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of early breast cancer in hormone receptor positive
post-menopausal women.
Adjuvant treatment of early breast cancer in hormone receptor positive
postmenopausal
women who have received 2 to 3 years of adjuvant tamoxifen.
Reduction in the incidence of contralateral breast cancers in post
menopausal women
receiving A
RIMIDEX
as adjuvant treatment for early breast cancer.
Treatment of advanced breast cancer in post-menopausal women.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
ADULTS INCLUDING THE ELDERLY
One tablet (1 mg) to be taken orally once a day.
CHILDREN
The use of A
RIMIDEX
is not recommended in children, as efficacy has not been established
(see sections 5.1 and 5.2).
RENAL IMPAIRMENT
No dose change is recommended.
HEPATIC IMPAIRMENT
No dose change is recommended.
Arimidex Data Sheet 030821
Copyright
2
4.3
CONTRAINDICATIONS
A
RIMIDEX
must not be administered during pregnancy or lactation.
Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1.
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
A
RIMIDEX
is not recommended for use in children or in pre-menopausal women as
safety
and efficacy have not been established in these groups of patients
(See sections 5.1 and
5.2).
A
RIMIDEX
has
not
been
investigated
in
patients
with
severe
hepatic
or
severe
renal
impairment. The potential risk/benefit