LETROZOLE FBM letrozole 2.5 mg film-coated tablet blister pack

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Активни састојак:

letrozole, Quantity: 2.5 mg

Доступно од:

Southern Cross Pharma Pty Ltd

Фармацеутски облик:

Tablet, film coated

Састав:

Excipient Ingredients: microcrystalline cellulose; lactose monohydrate; sodium starch glycollate type A; maize starch; hypromellose; colloidal anhydrous silica; magnesium stearate; titanium dioxide; purified talc; iron oxide yellow; macrogol 400

Пут администрације:

Oral

Јединице у пакету:

30 tablets

Тип рецептора:

(S4) Prescription Only Medicine

Терапеутске индикације:

Indicated for the treatment of post menopausal women with hormone receptor positive breast cancer. The safety and efficacy of neoadjuvant use of Letrozole has not been established. Letrozole is not indicated in hormone receptor negative disease.

Резиме производа:

Visual Identification: Yellow, round, biconvex, film-coated tablet plain on both sides.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Статус ауторизације:

Registered

Датум одобрења:

2018-03-19

Карактеристике производа

AUSTRALIAN PRODUCT INFORMATION
LETROZOLE FBM 2.5 MG FILM-COATED TABLET
_ _
1. NAME OF THE MEDICINE
Letrozole
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Letrozole FBM film coated tablets contain the active ingredient
letrozole.
Each Letrozole FBM film coated tablet contains 2.5 mg of letrozole.
Letrozole is a white or yellowish crystalline powder. It is
practically insoluble in water, freely soluble in
methylene chloride and sparingly soluble in methanol.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3. PHARMACEUTICAL FORM
LETROZOLE FBM 2.5 mg film coated tablets are yellow, round, biconvex,
film-coated tablets plain on both
sides.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Treatment of post-menopausal women with hormone receptor-positive
breast cancer (see section 4 CLINICAL
PARTICULARS).
The safety and efficacy of neoadjuvant use of letrozole have not been
established. Letrozole is not indicated
in hormone receptor negative disease.
4.2. DOSE AND METHOD OF ADMINISTRATION
ADULTS
The recommended dose for adults is one tablet daily.
In the adjuvant setting, treatment should continue for 5 years or
until tumour relapse occurs, whichever
comes first.
In the extended adjuvant setting, the optimal treatment duration with
letrozole is not known. Treatment in
the pivotal study was planned for 5 years. However, at the time of the
analysis, the median duration of
treatment was 24 months, 25% of patients were treated for at least
three years and less than 1% of patients
were treated for the planned 5 years. The median duration of follow-up
was 28 months. Treatment should be
discontinued at tumour relapse.
In the adjuvant setting, the median duration of treatment was 25
months, 73% of the patients were treated
for more than 2 years, 22% of the patients for more than 4 years. The
median duration of follow up was
30 months (the efficacy data mentioned in section 4 CLINICAL
PARTICULARS are based on the Primary Core
Analysis with a median duration of follow up of 26 months).
Letrozole FBM – AU