Anastrozole Denk 1mg tablets film-coated

Χώρα: Αρμενία

Γλώσσα: Αγγλικά

Πηγή: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Δραστική ουσία:

anastrozole

Διαθέσιμο από:

Haupt Pharma Muenster GmbH

Φαρμακολογική κατηγορία (ATC):

L02BG03

INN (Διεθνής Όνομα):

anastrozole

Δοσολογία:

1mg

Φαρμακοτεχνική μορφή:

tablets film-coated

Μονάδες σε πακέτο:

(30/3x10/) in blister

Τρόπος διάθεσης:

Prescription

Καθεστώς αδειοδότησης:

Registered

Ημερομηνία της άδειας:

2019-09-23

Αρχείο Π.Χ.Π.

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Anastrozole Denk 1 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substance: anastrozole
Each film-coated tablet contains 1 mg anastrozole.
Excipients with known effect:
Each film-coated tablet contains 90 mg of lactose monohydrate and less
than 1 mmol sodium (23 mg).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet
White to off-white, round, biconvex film-coated tablets.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Anastrozole Denk 1 mg is indicated for the:

treatment of hormone receptor-positive, advanced breast cancer in
postmenopausal women.

adjuvant treatment of hormone receptor-positive, early invasive breast
cancer in postmenopausal
women.

adjuvant treatment of hormone receptor-positive, early invasive breast
cancer in postmenopausal
women already receiving adjuvant tamoxifen for 2 to 3 years.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The recommended dose of anastrozole for adults including elderly
patients is one 1 mg tablet once
daily.
For
postmenopausal
women
with
hormone
receptor-positive,
early
invasive
breast
cancer,
the
recommended duration of adjuvant endocrine therapy is 5 years.
Special patient groups
_ _
_Paediatric population _
Anastrozole is not recommended for use in children and adolescents due
to insufficient data on safety
and efficacy (see sections 4.4 and 5.1).
_Impaired renal function _
No
dose
modification
is
recommended
for
patients
with
mild
or
moderate
renal
impairment.
Anastrozole should be used with caution in patients with severe renal
impairment (see sections 4.4 and
5.2).
_ _
_Impaired hepatic function_
No dose modification is recommended for patients with mild hepatic
impairment. Caution is advised
in patients with moderate to severe hepatic impairment (see section
4.4).
METHOD OF ADMINISTRATION
Anastrozole Denk 1 mg is taken orally.
4.3
CONTRAINDICATIONS
Anastrozole is contraindicated in:

pregnant or breastfeeding women.

hyp