Farmorubicin Rapid Dissolution powder lyophilized for solution for infusion

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

epirubicin (epirubicin hydrochloride)

Available from:

Actavis Italy S.p.A.

ATC code:

L01DB03

INN (International Name):

epirubicin (epirubicin hydrochloride)

Dosage:

50mg

Pharmaceutical form:

powder lyophilized for solution for infusion

Units in package:

glass vial

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-12-24

Summary of Product characteristics

1
_ _
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
FARMORUBICIN
®
rapid dissolution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
_Each vial _contains_: _
_ _
_Active ingredient_: epirubicin hydrochloride — 10 mg or 50 mg
(equivalent to 9.36 or 46.8 mg of
epirubicin, respectively);
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for solution for intravenous and intravesical
administration.
_Lyophilisate: _red lyophilized powder or cake.
_Diluent: _clear, colourless liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Transitional cell carcinoma of the bladder, breast cancer (including
early stage cancer and
metastatic/advanced cancer), stomach and oesophageal cancer, cancer of
the head and neck,
primary hepatocellular cancer, acute leukaemia, non-small cell and
small cell lung cancer,
non-Hodgkin's lymphoma, Hodgkin's lymphoma, multiple myeloma, ovarian
cancer, pancreatic
cancer, cancer of the rectum, soft tissue and bone sarcoma.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Intravenous, intravesical or intraarterial administration.
It is recommended that the reconstituted solution of the medicinal
product be immediately used
after preparation.
The safety and efficacy of administration of epirubicin in children
has not been established.
Intravenous administration
The recommended standard dose as
monotherapy
per
cycle
for
adults
is
60–120
mg/m
2
.
During administration of Farmorubicin
®
rapid dissolution as a component of adjuvant treatment
in breast cancer patients with axillary lymph nodes involvement, the
recommended starting dose
is 100–120 mg/m
2
.
During administration of combined treatment, a starting high dose (up
to 120 mg/m
2
) should be
administered on the first day every 3–4 weeks.
The total dose of the medicinal product per cycle (every 3–4 weeks)
may also be administered
as a single dose or it may be divided for multiple administration over
2–3 days in a row.
If Farmorubicin
®
rapid dissolution is administered