EPI-CELL 50 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

EPIRUBICIN HYDROCHLORIDE

Available from:

MBI PHARMA LTD., ISRAEL

ATC code:

L01DB03

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

EPIRUBICIN HYDROCHLORIDE 50 MG / 25 ML

Administration route:

I.V, INTRAVESICAL

Prescription type:

Required

Manufactured by:

STADAPHARM GMBH, GERMANY

Therapeutic area:

EPIRUBICIN

Therapeutic indications:

For the treatment of wide spectrum of neoplastic diseases including breast carcinoma, lung carcinoma (high doses), ovarian carcinoma, gastric carcinomas, soft tissue sarcoma. Intravesical administration of epirubicin has been found to be beneficial in the treatment of superficial bladder carcinomas and in the prophylaxis of recurrences after transurethral resection. I.V. administration for the treatment of advanced bladder carcinoma.

Authorization date:

2016-05-08

Summary of Product characteristics

1. NAME OF THE MEDICINAL PRODUCT
EPI-cell
®
50mg Solution for Injection
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Epirubicin hydrochloride 2 mg per ml
25 ml vials contain 50 mg of epirubicin hydrochloride
For the full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Solution for injection
Red, sterile, preservative-free, aqueous solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of a wide spectrum of neoplastic diseases including
breast carcinoma, lung
carcinoma (high doses), ovarian carcinoma, gastric carcinomas, soft
tissue sarcoma.
Intravesical administration of epirubicin has been found to be
beneficial in the treatment of
superficial bladder carcinomas and in the prophylaxis of recurrences
after transurethral
resection.
IV administration for the treatment of advanced bladder carcinoma.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_epirubicin injection is administered to patients by intravenous
infusion. epirubicin is given in _
_repeated 3 to 4-week cycles. The total dose of epirubicin may be
given on Day 1 of each _
_cycle or divided equally and given on Days 1 and 8 of each cycle. To
minimize the risk of _
_thrombosis or perivenous extravasation. The usual infusion times
range between 3 and 20 _
_minutes depending upon dosage and volume of the infusion solution.
The needle should be _
_properly placed in the vein. This reduces the risk of thrombosis and
extravasation that could _
_lead to severe cellulitis and necrosis. In case of extravasation,
administration should be _
_stopped immediately. Injection in small veins and repeated injection
in the same vein can lead _
_to venous sclerosis. _
_The recommended dosages of epirubicin are as follows: _
_ _
_Starting Doses _
The recommended starting dose of epirubicin is 60 to 120 mg/m². The
following regimens
were used in trials supporting use of epirubicin as a component of
adjuvant therapy in
patients with axillary-node positive breast cancer
_ _
CEF-120* Cyclophosphamide 75 mg/m² PO D 1-14
Epirubicin 60 mg/m² IV D 1