Farmorubicin Rapid Dissolution powder lyophilized for solution for infusion

Šalis: Armėnija

kalba: anglų

Šaltinis: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Veiklioji medžiaga:

epirubicin (epirubicin hydrochloride)

Prieinama:

Corden Pharma Latina S.p.A

ATC kodas:

L01DB03

INN (Tarptautinis Pavadinimas):

epirubicin (epirubicin hydrochloride)

Dozė:

50mg

Vaisto forma:

powder lyophilized for solution for infusion

Vienetai pakuotėje:

glass vial

Recepto tipas:

Prescription

Autorizacija statusas:

Registered

Leidimo data:

2023-04-08

Prekės savybės

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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Farmorubicin has been found to be capable of inducing useful responses
in a wide
spectrum of neoplastic diseases including carcinoma of the breast;
malignant
lymphomas; sarcomas of the soft tissues; gastric carcinoma; carcinoma
of the liver,
pancreas, sigmoid rectum; carcinoma of the cervical-facial area;
carcinoma of the lung;
carcinoma of the ovary; leukaemia.
By intravesical instillation, Farmorubicin is indicated in the
treatment of surface
carcinomas of the bladder (transitional cell carcinoma, carcinoma in
situ) and as
prophylaxis against recurrence after transurethral resection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
INTRAVENOUS ADMINISTRATION
Dosage plan for standard doses
When Farmorubicin is used as the sole antiblastic agent, the
recommended dose for
adults is 60-90 mg/m² of body surface area, to be administered by
intravenous
injection over 5-10 minutes at intervals of 21 days, compatibly with
blood/bone
marrow conditions.
Dosage plan for high doses
• CARCINOMA OF THE LUNG
When used as a single agent at high doses in the treatment of
pulmonary carcinoma,
Farmorubicin should be administered according to the following
regimens:
3
-
small cell lung cancer in previously untreated patients: 120 mg/m² on
day 1,
every three weeks.
-
non small cell lung cancer (epidermoid, squamous and adenocarcinoma)
in
previously untreated patients: 135 mg/m²
on day 1 or 45 mg/m² on Days 1,2,3,
every three weeks.
• CARCINOMA OF THE BREAST
Doses of