ARIMIDEX

국가: 인도네시아

언어: 인도네시아어

출처: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

유효 성분:

ANASTROZOLE

제공처:

ASTRAZENECA INDONESIA - Indonesia

INN (International Name):

ANASTROZOLE

복용량:

1 MG

약제 형태:

TABLET SALUT SELAPUT

패키지 단위:

DUS, 2 BLISTER @ 14 TABLET SALUT SELAPUT

Manufactured by:

ASTRAZENECA PHARMACEUTICAL COMPANY LTD.

승인 날짜:

2017-11-09

제품 특성 요약

_Page 1 of 9 _
ARIMIDEX
®
_anastrozole _
FILM-COATED TABLETS
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 1 mg anastrozole.
PHARMACEUTICAL FORM
Film-coated tablet.
White, round, biconvex tablet with logo on one side and strength on
the other.
THERAPEUTIC INDICATIONS
Treatment of advanced breast cancer in post-menopausal women with
oestrogen receptor
positive and or progesterone receptor positive.
Adjuvant treatment of post-menopausal women with hormone receptor
positive early
invasive breast cancer.
Adjuvant treatment of early breast cancer in hormone receptor positive
post-menopausal
women, who have received 2 to 3 years of adjuvant tamoxifen.
POSOLOGY AND METHOD OF ADMINISTRATION
Adults including elderly
: One 1 mg tablet to be taken orally once a day. For patients with
advanced breast cancer, ARIMIDEX should be continued until
tumour progression.
Children
: The use of ARIMIDEX is not recommended in children, as
efficacy has not been established.
Renal impairment
: No dose change is recommended in patients with mild or
moderate renal impairment.
Hepatic impairment
: No dose change is recommended in patients with mild hepatic
disease.
CONTRAINDICATIONS
ARIMIDEX is contraindicated in:
-
pre-menopausal women
-
pregnant or lactating women
-
patients with severe renal impairment (creatinine clearance less than
20 ml/min)
-
patients with moderate or severe hepatic disease
-
patients with known hypersensitivity to anastrozole or to any of the
excipients as
referenced on the _List of Excipients_
Oestrogen
–
containing therapies should not be co-administered with ARIMIDEX as
they
would negate its pharmacological action.
Concurrent tamoxifen therapy (see section _Interaction with other
medicinal products and _
_other forms of interaction_).
DISETUJUI OLEH BPOM : 02/11/2021
ID : EREG100422VR12100210
_Page 2 of 9 _
SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE
ARIMIDEX is not recommended for use in children, as safety and
efficacy have not been
established in this group of patients.
ARIMI