TAMOXIFEN SANDOZ tamoxifen 10mg (as citrate) tablet blister pack

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

tamoxifen citrate, Quantity: 15.2 mg (Equivalent: tamoxifen, Qty 10 mg)

Διαθέσιμο από:

Sandoz Pty Ltd

Φαρμακοτεχνική μορφή:

Tablet, film coated

Σύνθεση:

Excipient Ingredients: hypromellose; povidone; lactose monohydrate; sodium starch glycollate; titanium dioxide; macrogol 4000; microcrystalline cellulose; magnesium stearate

Οδός χορήγησης:

Oral

Θεραπευτικές ενδείξεις:

Treatment of breast cancer. ? TAMOXIFEN SANDOZ is indicated for the treatment of breast cancer.,Primary reduction of breast cancer risk ? TAMOXIFEN SANDOZ is indicated for the primary reduction of breast cancer risk in women either at moderately increased risk (lifetime breast cancer risk 1.5 to 3 times the population average) or high risk (lifetime breast cancer risk greater than 3 times the population average).

Περίληψη προϊόντος:

Visual Identification: White, round, biconvex film coated tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2001-09-26

Αρχείο Π.Χ.Π.

211116-tamoxifen sandoz-pi
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AUSTRALIAN PRODUCT INFORMATION
TAMOXIFEN SANDOZ
® (TAMOXIFEN CITRATE) TABLETS
1.
NAME OF THE MEDICINE
Tamoxifen citrate.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each Tamoxifen Sandoz 10 mg tablet contains 10 mg tamoxifen citrate.
Each Tamoxifen Sandoz 20 mg tablet contains 20 mg tamoxifen citrate.
_List of excipients with known effect:_
Lactose monohydrate.
_ _
For the full list of excipients, see Section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Tamoxifen Sandoz 10 mg tablets: white, round, biconvex, film coated
tablets in
blisters.
Tamoxifen Sandoz 20 mg tablets: white, round, biconvex, with a score
notch, film coated
tablets in
blisters.
4.
CLINICAL PARTICULARS
4.1.
T
HERAPEUTIC INDICATIONS
_TREATMENT OF BREAST CANCER _
Tamoxifen Sandoz is indicated for the treatment of breast cancer.
_PRIMARY REDUCTION OF BREAST CANCER RISK _
Tamoxifen Sandoz is indicated for the primary reduction of breast
cancer risk in women either
at moderately increased risk (lifetime breast cancer risk 1.5 to 3
times the population average)
or high risk (lifetime breast cancer risk greater than 3 times the
population average).
4.2.
D
OSE AND METHOD OF ADMINISTRATION
DOSAGE
_Adults _
_TREATMENT OF BREAST CANCER _
The initial dose is 20 mg once daily. In advanced breast cancer, if no
response is seen, dosage
may be increased to 40 mg once daily.
_PRIMARY REDUCTION OF BREAST CANCER RISK _
The recommended maximum dose is 20 mg daily for 5 years. There are
insufficient data to
support a higher dose or longer period of use.
An assessment of the potential benefits and risks prior to starting
therapy for reduction in breast
cancer risk is essential. Validated algorithms are available that
calculate breast cancer risk
based on features such as age, family history, genetic factors,
reproductive factors, and history
of breast disease.
211116-tamoxifen sandoz-pi
Page 2 of 15
Tamoxifen Sandoz reduces, but does not eliminate, the risk of breast
cancer. In clinical trials,
Tamoxifen Sandoz decreased th